Clinical trials phase iv as topic. Medical search

Planned post-marketing studies of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques that have been approved for general sale. These studies are often conducted to obtain additional data about the safety and efficacy of a product. This concept includes phase IV studies conducted in both the U.S. and in other countries.

Forced expiratory effort against a closed GLOTTIS.

Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.

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.

Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group.

Works about comparative studies to verify the effectiveness of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques determined in phase II studies. During these trials, patients are monitored closely by physicians to identify any adverse reactions from long-term use. These studies are performed on groups of patients large enough to identify clinically significant responses and usually last about three years. This concept includes phase III studies conducted in both the U.S. and in other countries.

Works about studies that are usually controlled to assess the effectiveness and dosage (if appropriate) of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques. These studies are performed on several hundred volunteers, including a limited number of patients with the target disease or disorder, and last about two years. This concept includes phase II studies conducted in both the U.S. and in other countries.

Works about studies performed to evaluate the safety of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques in healthy subjects and to determine the safe dosage range (if appropriate). These tests also are used to determine pharmacologic and pharmacokinetic properties (toxicity, metabolism, absorption, elimination, and preferred route of administration). They involve a small number of persons and usually last about 1 year. This concept includes phase I studies conducted both in the U.S. and in other countries.

A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly.

Acute pain that comes on rapidly despite the use of pain medication.

Insulin derivatives and preparations that are designed to induce a rapid HYPOGLYCEMIC EFFECT.

Administration of a soluble dosage form between the cheek and gingiva. It may involve direct application of a drug onto the buccal mucosa, as by painting or spraying.

A potent narcotic analgesic, abuse of which leads to habituation or addiction. It is primarily a mu-opioid agonist. Fentanyl is also used as an adjunct to general anesthetics, and as an anesthetic for induction and maintenance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1078)

Pain associated with OBSTETRIC LABOR in CHILDBIRTH. It is caused primarily by UTERINE CONTRACTION as well as pressure on the CERVIX; BLADDER; and the GASTROINTESTINAL TRACT. Labor pain mostly occurs in the ABDOMEN; the GROIN; and the BACK.

Compounds with activity like OPIATE ALKALOIDS, acting at OPIOID RECEPTORS. Properties include induction of ANALGESIA or NARCOSIS.

Analysis based on the mathematical function first formulated by Jean-Baptiste-Joseph Fourier in 1807. The function, known as the Fourier transform, describes the sinusoidal pattern of any fluctuating pattern in the physical world in terms of its amplitude and its phase. It has broad applications in biomedicine, e.g., analysis of the x-ray crystallography data pivotal in identifying the double helical nature of DNA and in analysis of other molecules, including viruses, and the modified back-projection algorithm universally used in computerized tomography imaging, etc. (From Segen, The Dictionary of Modern Medicine, 1992)

Programs of surveillance designed to prevent the transmission of disease by any means from person to person or from animal to man.

Studies beyond the bachelor's degree at an institution having graduate programs for the purpose of preparing for entrance into a specific field, and obtaining a higher degree.

Field of medicine concerned with the determination of causes, incidence, and characteristic behavior of disease outbreaks affecting human populations. It includes the interrelationships of host, agent, and environment as related to the distribution and control of disease.

Institutional night care of patients.

Conduct and synthesis of systematic research comparing interventions and strategies to prevent, diagnose, treat, and monitor health conditions. The purpose of this research is to inform patients, providers, and decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances. (hhs.gov/recovery/programs/cer/draftdefinition.html accessed 6/12/2009)

A type of analysis in which subjects in a study group and a comparison group are made comparable with respect to extraneous factors by individually pairing study subjects with the comparison group subjects (e.g., age-matched controls).

An agency of the PUBLIC HEALTH SERVICE established in 1990 to "provide indexing, abstracting, translating, publishing, and other services leading to a more effective and timely dissemination of information on research, demonstration projects, and evaluations with respect to health care to public and private entities and individuals engaged in the improvement of health care delivery..." It supersedes the National Center for Health Services Research. The United States Agency for Health Care Policy and Research was renamed Agency for Healthcare Research and Quality (AHRQ) under the Healthcare Research and Quality Act of 1999.

Public Law No: 111-5, enacted February 2009, makes supplemental appropriations for job preservation and creation, infrastructure investment, energy efficiency and science, assistance to the unemployed, and State and local fiscal stabilization, for fiscal year ending September 30, 2009.

Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.

The deliberate and methodical practice of finding new applications for existing drugs.

Predetermined sets of questions used to collect data - clinical data, social status, occupational group, etc. The term is often applied to a self-completed survey instrument.

Persons who have experienced a prolonged survival after serious disease or who continue to live with a usually life-threatening condition as well as family members, significant others, or individuals surviving traumatic life events.

Malfunction of implantation shunts, valves, etc., and prosthesis loosening, migration, and breaking.

That segment of commercial enterprise devoted to the design, development, and manufacture of chemical products for use in the diagnosis and treatment of disease, disability, or other dysfunction, or to improve function.

A plant genus of the family FABACEAE. Some species were reclassified from CASSIA and Senna.

Sequential operating programs and data which instruct the functioning of a digital computer.

The process of finding chemicals for potential therapeutic use.

A loose confederation of computer communication networks around the world. The networks that make up the Internet are connected through several backbone networks. The Internet grew out of the US Government ARPAnet project and was designed to facilitate information exchange.

Excision of the whole (total gastrectomy) or part (subtotal gastrectomy, partial gastrectomy, gastric resection) of the stomach. (Dorland, 28th ed)

Tumors or cancer of the STOMACH.

Sequelae of gastrectomy from the second week after operation on. Include recurrent or anastomotic ulcer, postprandial syndromes (DUMPING SYNDROME and late postprandial hypoglycemia), disordered bowel action, and nutritional deficiencies.

A variety of surgical reconstructive procedures devised to restore gastrointestinal continuity, The two major classes of reconstruction are the Billroth I (gastroduodenostomy) and Billroth II (gastrojejunostomy) procedures.

A Y-shaped surgical anastomosis of any part of the digestive system which includes the small intestine as the eventual drainage site.

An order of MAMMALS, usually flesh eaters with appropriate dentition. Suborders include the terrestrial carnivores Fissipedia, and the aquatic carnivores PINNIPEDIA.

The deductive study of shape, quantity, and dependence. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed)

Educational institutions providing facilities for teaching and research and authorized to grant academic degrees.

A legal concept for individuals who are designated to act on behalf of persons who are considered incapable of acting in their own behalf, e.g., minors and persons found to be not mentally competent.

Numeric or quantitative entities, descriptions, properties, relationships, operations, and events.

Apomorphine to Uprima: the development of a practical erectogenic drug: a personal perspective. (1/25)

The development process for apomorphine SL as an effective treatment for patients with erectile dysfunction has been somewhat unusual. As often is the case, much of the impetus for the basic research originated in academia. However, somewhat unusually, the impetus for early stage clinical research also lay in the hands of the academics. This article represents a historical perspective from one of those involved throughout. (+info)

Update on intravenous tissue plasminogen activator for acute stroke: from clinical trials to clinical practice. (2/25)

Tissue plasminogen activator (tPA) injected intravenously within 3 hours of symptom onset has emerged as a treatment option for acute ischemic stroke. Although controversial and not universally accepted, its use in carefully selected patients is supported by evidence from randomized controlled trials and by mounting community experience. In this paper we review the literature published in the past 5 years regarding the safety, clinical trial efficacy and real-world effectiveness of intravenous tPA for stroke. First we review data from the phase III clinical trials on which approval for tPA is based. Then we summarize a growing literature of postmarketing phase IV studies and discuss the limitations and challenges that lie ahead. Our aim is to provide clinicians with an overview of this evolving therapy. (+info)

Cardiovascular thrombotic events in controlled, clinical trials of rofecoxib. (3/25)

BACKGROUND: In comparing aspirin, nonselective nonsteroidal antiinflammatory agents (NSAIDs), and cyclooxygenase (COX)-2 inhibitors, variation in platelet inhibitory effects exists that may be associated with differential risks of cardiovascular (CV) thrombotic events. Among the randomized, controlled trials with the COX-2 inhibitor rofecoxib, one study demonstrated a significant difference between rofecoxib and its NSAID comparator (naproxen) in the risk of CV thrombotic events. A combined analysis of individual patient data was undertaken to determine whether there was an excess of CV thrombotic events in patients treated with rofecoxib compared with those treated with placebo or nonselective NSAIDs. METHODS AND RESULTS: CV thrombotic events were assessed across 23 phase IIb to V rofecoxib studies. Comparisons were made between patients taking rofecoxib and those taking either placebo, naproxen (an NSAID with near-complete inhibition of platelet function throughout its dosing interval), or another nonselective NSAIDs used in the development program (diclofenac, ibuprofen, and nabumetone). The major outcome measure was the combined end point used by the Antiplatelet Trialists' Collaboration, which includes CV, hemorrhagic, and unknown deaths; nonfatal myocardial infarctions; and nonfatal strokes. More than 28 000 patients, representing >14 000 patient-years at risk, were analyzed. The relative risk for an end point was 0.84 (95% CI: 0.51, 1.38) when comparing rofecoxib with placebo; 0.79 (95% CI: 0.40, 1.55) when comparing rofecoxib with non-naproxen NSAIDs; and 1.69 (95% CI: 1.07, 2.69) when comparing rofecoxib with naproxen. CONCLUSIONS: This analysis provides no evidence for an excess of CV events for rofecoxib relative to either placebo or the non-naproxen NSAIDs that were studied. Differences observed between rofecoxib and naproxen are likely the result of the antiplatelet effects of the latter agent. (+info)

Clinical data gap between phase III clinical trials (pre-marketing) and phase IV (post-marketing) studies: evaluation of etanercept in rheumatoid arthritis. (4/25)

BACKGROUND: There are fundamental differences in design between phase III clinical trials and phase IV post-marketing studies that involve patient characteristics, the clinical setting (environment) and the manner of drug use. As well, many phase IV studies are extensions of randomized clinical trials (RCTs) and suffer from selection bias. OBJECTIVE: To determine if the data obtained from RCTs of etanercept (Enbrel) in the treatment of rheumatoid arthritis would be representative of the effects attainable in community practice. METHOD: An analysis was conducted comparing data from published RCTs of etanercept use in rheumatoid arthritis patients with data collected in a community based cohort study that was not an extension of an RCT. RESULTS: Baseline clinical data, such as tender or painful joint count, patient's global assessment, the heath assessment questionnaire, physical and mental component summary of the SF-36, and rheumatoid arthritis drug profile were significantly different between the patients receiving etanercept in the phase IV community cohort study and the patients enrolled in the RCTs. Differences in the baseline data for the control patients were also noted amongst the RCT studies. The treatment outcome, American College of Rheumatology (ACR) response rate of 20%, 50% and 70% at 6 month, was the same between the cohort study and the RCTs, but at 12 months the clinical response was less for the community based patients than for the RCT patients. At 6 months there were fewer withdrawals involving community-based patients than RCT patients due to less frequent withdrawals associated with lack of efficacy. At 12 months the withdrawal rate due to either a lack of efficacy or from adverse events was similar between data sets. CONCLUSION: The data from the etanercept phase III RCTs may not reflect the characteristics of patients using etanercept in community practice, nor the clinical outcomes observed by RA patients at 12 months. These discrepancies may be derived from methodological differences in study design and patient selection. On the other hand, outcomes such as withdrawal rates at 12 months appear comparable between the two types of populations. (+info)

Clinical and bacteriologic efficacy of telithromycin in patients with bacteremic community-acquired pneumonia. (5/25)

This retrospective analysis was performed to determine the clinical and bacteriologic efficacy of the ketolide antibacterial telithromycin in patients with community-acquired pneumonia (CAP) with pneumococcal bacteremia. Patients 13 years old with radiologically confirmed CAP and a positive blood culture for Streptococcus pneumoniae at screening were analyzed from eight multicenter Phase III/IV clinical trials. In four open-label, non-comparative studies, patients received telithromycin 800 mg once daily for 7-10 days. In four randomized, controlled, double-blind, comparative studies, patients received telithromycin 800 mg once daily for 5-10 days or a comparator antimicrobial (amoxicillin 1000 mg three times daily, clarithromycin 500 mg twice daily, or trovafloxacin 200 mg once daily) for 7-10 days. In total, 118 patients (telithromycin, 94/1061 [8.9%]; comparator, 24/244 [9.8%]) had documented pneumococcal bacteremia. Those who were treated with telithromycin achieved a clinical cure rate of 90.2% (74/82, per-protocol population); S. pneumoniae was eradicated in 77/82 (93.9%) bacteremic patients who received telithromycin and 15/19 (78.9%) comparator-treated patients. Clinical cure was also observed among telithromycin-treated bacteremic patients who were infected with penicillin- or erythromycin-resistant strains of S. pneumoniae (5/7 and 8/10, respectively). In conclusion, telithromycin achieves high clinical and bacteriologic cure rates in CAP patients with pneumococcal bacteremia. (+info)

Assessing the relationship between antigenicity and immunogenicity of human rabies vaccines. Results of a meta-analysis. (6/25)

A meta-analysis was done to study the relationship between antigenecity and immunogenecity of human rabies vaccines. The data of ten cell culture human rabies vaccine studies conducted at a single centre during 1993-2004 were used in the study. The vaccines studied included Purified Chick Embryo Cell Vaccine (Kaketsuken, Japan and Rabipur, India), Purified Vero cell Rabies Vaccine (Verorab, France), Human Diploid Cell Vaccine (MIRV, France and Rabivax, Adsorbed and Lyophilized, India) and Rhesus Diploid Rabies Vaccine (adsorbed, USA). Interestingly, it was revealed that an higher antigenecity of rabies vaccines viz. potency of > or = 5 IU per single intramuscular dose did not result in significantly higher immunogenecity, as measured by rabies virus neutralizing antibody (RVNA) titers in the vaccinees, both on day 14 (t = 0.42, p > 0.66, GMR = 1.06, 95% CI of GMR = 0.82, 1.37) and day 90 (t = 0.80, p > 0.43, GMR = 1.15, 95% CI of GMR = 0.74, 1.14). However, as there are no reports of meta-analysis of cell culture human rabies vaccine trials, to confirm this observation the authors recommend further studies in this regard. (+info)

Ezetimibe added to statin therapy (EASY study) - an evaluation by Australian general practitioners. (7/25)

BACKGROUND: This study estimated changes in low density lipoprotein cholesterol (LDL-C) levels and proportion of patients attaining goal LDL-C <2.5 mmol/L when ezetimibe was added to existing statin monotherapy under Pharmaceutical Benefits Scheme (PBS) guidelines in a general practice setting. METHODS: Target patients were those with coronary heart disease or diabetes mellitus eligible to receive ezetimibe under PBS guidelines. They were treated with ezetimibe 10 mg/day in addition to existing statin therapy for 6 weeks. RESULTS: One hundred and thirty patients received treatment, but for effectiveness we derived a per protocol subpopulation of 95. Low density lipoprotein cholesterol was reduced by 29% (95% confidence limits, 25-34% reduction), and goal LDL-C <2.5 mmol/L was reached in 70% of patients (95% confidence limits, 59-79%). Six patients were withdrawn because of adverse events. DISCUSSION: Changes in LDL-C and goal attainment in Australian general practice with the use of ezetimibe added to a statin were highly consistent with the findings from controlled clinical trials. (+info)

Clinical trials in severe sepsis with drotrecogin alfa (activated). (8/25)

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July 2017). "Low-dose suramin in autism spectrum disorder: a small, phase I/II, randomized clinical trial". Annals of Clinical ... Suramin contains six aromatic systems - four benzene rings, sandwiched by a pair of naphthalene moieties - plus four amide ... https://health.ucsd.edu/news/topics/Suramin-Autism/Pages/Q-and-A.aspx Zhang YL, Keng YF, Zhao Y, Wu L, Zhang ZY (May 1998). " ... Suramin has been studied in a mouse model of autism and in a small phase I/II human trial. "Suramin Injection Advanced Patient ...

https://en.wikipedia.org/wiki/Suramin

... placebo-controlled phase 2 clinical trial". The Lancet. 381 (9871): 1037-45. doi:10.1016/S0140-6736(12)61764-4. PMID 23352749. ... Pullen, L.C. (November 7, 2011). "Epstein-Barr Virus Vaccine May Soon Enter Phase 3 Trial". Medscape Today. Retrieved April 24 ... Adenovirus Vaccine Efficacy Trial Consortium (2013). "A phase 3, randomized, double-blind, placebo-controlled study of the ... "Inferring Reasons for the Failure of Staphylococcus aureus Vaccines in Clinical Trials". Frontiers in Cellular and Infection ...

https://en.wikipedia.org/wiki/List_of_vaccine_topics

The group 2 (CD1d) ligand alpha-galactosylceramide is currently in phase I clinical trials for the treatment of advanced non- ... Current Topics in Microbiology and Immunology. 314: 27-50. doi:10.1007/978-3-540-69511-0_2. ISBN 978-3-540-69510-3. PMID ... typically represented by interferon-gamma and IL-4 production. ...

https://en.wikipedia.org/wiki/CD1

... at ClinicalTrials.gov Clinical trial number NCT01086657 for "An Open-Label, Randomized Phase I Study in Healthy Adults of the ... Veterinary influenza vaccination aims to achieve the following four objectives: Protection from clinical disease Protection ... Drug Topics. Retrieved January 27, 2020. Fast, Patricia E; Cox, Josephine H (September 1, 2015). "An influenza vaccine pill-can ... at ClinicalTrials.gov Clinical trial number NCT03450915 for "A Pivotal Trial to Assess the Safety and Clinical Efficacy of the ...

https://en.wikipedia.org/wiki/Influenza_vaccine

... on the grounds that in the third phase of Oxford/AstraZeneca's clinical trials too few volunteers over 55 were enrolled; on 8 ... four with Pfizer/BioNTech and three with Oxford/AstraZeneca. On 8 April, CNCAV decided to continue the vaccination with Oxford/ ... Moldovan President Maia Sandu in the country as part of a collaboration project about the COVID-19 pandemic and other topics ... It was announced that the process would be divided into three phases. Medical personnel would be vaccinated first (first phase ...

https://en.wikipedia.org/wiki/COVID-19_vaccination_in_Romania

In 2007, a randomized phase II clinical trial showed that LY-2140023 taken twice daily for 4 weeks improved schizophrenia ... However, a second, multicenter study reported four patients experiencing convulsions, suggesting a potential for increased risk ... Current Topics in Medicinal Chemistry. 8 (16): 1480-1. doi:10.2174/156802608786264209. PMID 19006848. Fraley ME (June 2009). " ... oral bioavailability in humans in a phase I clinical trial. A single dose of 200 mg results in an AUC value of 900 ng*h/ml. The ...

https://en.wikipedia.org/wiki/LY-404,039

Karonudib, an MTH1 inhibitor, is currently being evaluated a phase I clinical trial for safety and tolerability. A potent and ... Research into this topic is ongoing. MTH1 is a potential drug target to treat cancer, however there are conflicting results ... "MTH1, A Phase I, Study on Tumors Inhibition, First in Human, First in Class (MASTIFF)". ClinicalTrials.gov. U.S. National ... This makes it a topic of interest in cancer research, both as a potential method for healthy cells to prevent cancer and a ...

https://en.wikipedia.org/wiki/2-hydroxy-dATP_diphosphatase

... as well as qualifications with respect to the conduct of clinical trials (phase II to IV). The working group "clinical studies ... trials on postoperative nausea and vomiting and other issues in conjunction with perioperative medicine and associated topics. ... Among these trials, many studies were aiming to get a label for the indication of PONV prevention (phase II and III trials). ... Controlled Clinical Trials 2003; 24:736-51 C. C Apfel, P. Kranke, M. H. Katz, C. Goepfert, T. Papenfuss, S. Rauch, R. Heineck, ...

https://en.wikipedia.org/wiki/Peter_Kranke

GSK suspended Phase III clinical trials in October 2008. Informations for this group of inhibitors are quite restricted. ... "Azetidine-Based Inhibitors of Dipeptidyl Peptidase IV (DPP IV)", Current Topics in Medicinal Chemistry, 7 (6): 597-608, doi: ... In January 2007 alogliptin was undergoing the phase III clinical trial and in October 2008 it was being reviewed by the U.S. ... In 2008 BI-1356 was undergoing phase III clinical trials; it was released as linagliptin in May 2011. X-ray crystallography has ...

https://en.wikipedia.org/wiki/Discovery_and_development_of_dipeptidyl_peptidase-4_inhibitors

In clinical trials this measure is to be used for children completed by parents, teachers, and clinicians. Other scales are the ... The point of this phase is to get an individual talking no matter how ridiculous or trivial it may seem. Phase two is about ... In one study, Fox and colleagues found that even at four months of age some infants had negative responses to unfamiliar visual ... An individual should not go over board using them; additionally there are times when initiating some conversation topics and ...

https://en.wikipedia.org/wiki/Social_inhibition

... the Arce government granted emergency approval for the use of the Russian Sputnik V vaccine based on Phase III clinical trials ... Another topic of discussion was the role of the Organization of American States (OAS) which played a major role in the 2019 ... Minister of Public Works Edgar Montaño became the third cabinet minister to contract the virus on 11 January 2021 followed four ... "MAS launches trial against 20 Añez management authorities" (in Spanish). 27 October 2020. "MAS neutralizes the opposition for 5 ...

https://en.wikipedia.org/wiki/Luis_Arce

Oct 1997). "Phase II clinical trial of a vas deferens injectable contraceptive for the male". Contraception. 56 (4): 245-50. ... http://www.plannedparenthood.org/health-topics/birth-control-4211.htm ,. *^ "Condom , Definition of Condom by Merriam-Webster" ... which has completed a small phase II clinical trial in humans in India)[4] and ultrasound (with results so far obtained in ... November 2003). "A clinical trial of 7α-methyl-19-nortestosterone implants for possible use as a long-acting contraceptive for ...

https://en.wikipedia.org/wiki/Male_contraceptive

Clinical Cancer Research; Clinical Trials. 6 (7): 2677-84. PMID 10914709. Avendano, Carmen; Menendez, J. Carlos (April 2008). ... A Phase III study showed benefits of maintenance use of pemetrexed for non-squamous NSCLC. Activity has been shown in malignant ... Cancer Topics - Coping with Cancer. National Cancer Institute. Retrieved 1 December 2008. McLeod HL, Cassidy J, Powrie RH, ... In clinical trials for mesothelioma, folic acid and B12 supplementation reduced the frequency of adverse events.) It is also ...

https://en.wikipedia.org/wiki/Pemetrexed

A randomized single-blind clinical trial", M. R. Popovic, N. Kapadia, V. Zivanovic, J. C. Furlan, B. C. Craven, and C. ... Pappas, I.P.I.; Popovic, M.R.; Keller, T.; Dietz, V.; Morari, M. (June 2001). "A reliable gait phase detection system". IEEE ... Topics in Spinal Cord Injury Rehabilitation. 14 (4): 62-68. doi:10.1310/sci1404-62. ISSN 1082-0744. Popovic, M.R.; Keller, T.; ... A Randomized Clinical Trial". Neurorehabilitation and Neural Repair. 25 (5): 433-442. doi:10.1177/1545968310392924. ISSN 1545- ...

https://en.wikipedia.org/wiki/Milos_R._Popovic

Tables on the Clinical trials of pandemic influenza prototype vaccines. July 2009". WHO.int. Retrieved 19 January 2018.. ... Phase 6. In addition to the criteria defined in Phase 5, the same virus spreads from human-to-human in at least one other ... 2006). Influenza Virology: Current Topics. Caister Academic Press. ISBN 1-904455-06-9. [1].. ... The 1889-1890 and 1918-1919 flu pandemics each came in three or four waves of increasing lethality.[26] But within a wave, ...

https://en.wikipedia.org/wiki/Flu_pandemic

Successful pre-clinical, Phase I, and Phase II trials looked promising to the company and its investors even up until the third ... There is some evidence for accumulation of deramciclane, though it is a topic of debate. It is important to understand the ... A typical PTF (peak trough fluctuation) is 70-80% over four weeks of administration, and is unaffected by dose. The oral tablet ... No severe side effects were reported in any clinical trial, and no side effects were found to be dose-dependent. Trial ...

https://en.wikipedia.org/wiki/Deramciclane

MCZ is currently in phase 2 clinical trials. Stewart Cole was appointed as the 16th director general of the Pasteur Institute ... Over four decades his team has investigated a range of topics including: bacterial electron transport systems; the genomics and ... From the Strategic Plan it is clear that the four missions originally defined by Louis Pasteur for his institute - research, ...

https://en.wikipedia.org/wiki/Stewart_Cole

This work is the scientific background of different clinical trials of CureVac's messenger RNA as vaccines in oncology and ... The biosynthesis of vancomycin-type and other peptide antibiotics is now a major topic of the research group of Roderich ... a Ribosomally Synthesized Polypeptide Antibiotic Containing four Sulphide-Rings. In: Nature, 333, 1988, S. 276-278. G. Jung, K ... of the Nematicidal Cyclododecapeptide Omphalotin A by Using Racemization-free Triphosgene-Mediated Couplings in the Solid Phase ...

https://en.wikipedia.org/wiki/Günther_Jung

Clinical trial[edit]. A randomized phase III clinical trial for the possible treatment of pancreatic cancer with the Gonzalez ... Gonzalez became interested in medical research, cancer research in particular, while covering these topics.[7] ... or Stage IV Pancreatic Cancer". clinicaltrials.gov.. ... What Went Wrong: The Truth Behind the Clinical Trial of the ... A review article from the Journal of Clinical Gastroenterology is cited that notes the clinical efficacy of coffee enemas has ...

https://en.wikipedia.org/wiki/Nicholas_Gonzalez_

List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ... "Phase 2a Immunogenicity Study of Hantaan/Puumala Virus DNA Vaccine for Prevention of Hemorrhagic Fever". ClinicalTrials.gov. ... In addition to Hantavax three more vaccine candidates have been studied in I-II stage clinical trials. They include a ... Field trial of an inactivated vaccine against hemorrhagic fever with renal syndrome in humans. Arch Virol. 1990;1(Suppl):35-47. ...

https://en.wikipedia.org/wiki/Hantavirus_vaccine

Of the drugs started in clinical trials on humans, only 10 percent secure F.D.A. approval. ... Cockbain J (2007). "Intellectual ... The objective of this drug discovery phase is to synthesize lead compounds, new analogs with improved potency, reduced off- ... Current Topics in Medicinal Chemistry. 4 (6): 569-80. doi:10.2174/1568026043451168. PMID 14965294. Fruber M, Narjes F, Steele J ... Clinical development The hit to lead stage starts with confirmation and evaluation of the initial screening hits and is ...

https://en.wikipedia.org/wiki/Hit_to_lead

From 2016 to 2018, Phase III/IIIb open-label clinical trials HOPE (MTN-025) and DREAM (IPM-032) were launched to focus on the ... Four prototypes were initially developed and tested in several clinical studies. There are two diffusion systems of these ... Physical characteristics of the ring such as size and hardness were a topic of concern amongst participants. The ease of ... From 2009 to 2012, two Phase I and one Phase I/II safety trials of the DPV ring were conducted by IPM. Results deemed the ...

https://en.wikipedia.org/wiki/Dapivirine_Ring

A randomized phase III clinical trial for the possible treatment of pancreatic cancer with the Gonzalez Regimen was funded by a ... or Stage IV Pancreatic Cancer". clinicaltrials.gov. "Cancer's Enema No. 1? Make That 2", Wired, 30 October 2002 Chabot JA, Tsai ... and as a freelance writer, covering a variety of health-related topics, including a July 1972 cover story in New York Magazine ... What Went Wrong: The Truth Behind the Clinical Trial of the Enzyme Treatment of Cancer (2012, New Spring Press; ISBN 978-0- ...

https://en.wikipedia.org/wiki/Nicholas_Gonzalez_(physician)

The Phase 2 trials of these studies, conducted in the U.S., Canada, and Israel, consisted of 107 participants who had chronic, ... A randomized clinical trial showed that of those participants who received the treatment, 71% continued to experience a ... Since then there have been many mainstream publications that have published articles regarding this topic and brought attention ... Phase two trials conducted between 2004 and 2010 reported an overall remission rate of 66.2% and low rates of adverse effects ...

https://en.wikipedia.org/wiki/Psychedelic_therapy

Double blind placebo controlled and phase IV trials. Lancet 1:150-152, 1988. Lunenfeld B, Insler V, Glezerman M. Diagnosis and ... He has published hundreds of papers spanning the topics of fertility, obstetrics and gynecology. Marek Glezerman lives in ... A model of efficient and continuous quality improvement in a clinical setting. Int J for Quality in Health Care. 11: 227-232, ... "Five years to the term breech trial: the rise and fall of a randomized controlled trial." American journal of obstetrics and ...

https://en.wikipedia.org/wiki/Marek_Glezerman

... supports companies with their clinical trials, which involves early clinical / Phase IIa, Phase IIb / III services, ... clinical data management analysis and reporting, regulatory services, and Phase IV solutions. In the clinical testing space, ... Covance also shares research on animal welfare topics, such as social housing of nonhuman primates. Covance employees have ... As part of its clinical and non-clinical development services, it provides drug development services across all phases of ...

https://en.wikipedia.org/wiki/Covance

No evidence based on well-controlled clinical trials is available that supports a cause-and-effect relationship between ... "Safety and Health Topics , Multiple Chemical Sensitivities". Osha.gov. Retrieved 2014-06-08.. ... Phase 1 report. Toronto, Ontario: Ministry of Health and Long-Term Care; 2017.p.17 ... and the 1999 Japanese definition requires one or more of four major symptoms - headaches; malaise and fatigue; muscle pain; ...

https://en.wikipedia.org/wiki/Multiple_chemical_sensitivity

Others are in clinical trials. The first FDA approved anti-IL-6 treatment was for rheumatoid arthritis. Anti-IL-6 therapy was ... IL-6 is an important mediator of fever and of the acute phase response. IL-6 is responsible for stimulating acute phase protein ... IL-6, among an increasing number of other recently identified myokines, thus remains an important topic in myokine research. It ... Clinical trial number NCT02473289 for "An Efficacy and Safety Study of Sirukumab in Participants With Major Depressive Disorder ...

https://en.wikipedia.org/wiki/Interleukin_6

Four trials were conducted in ED, the last being a Phase IIb published in 2008. King terminated the co-development agreement ... but these trials were halted by the FDA in 2007, due to increased blood pressure in clinical trial subjects; Palatin stopped ... Current Topics in Medicinal Chemistry. 7 (11): 1098-1106. doi:10.2174/1568026610707011111. PMC 2694735. PMID 17584130. " ... two Phase III trials were launched at the end of 2014. Palatin launched the Phase III trials with bremelanotide administered ...

https://en.wikipedia.org/wiki/Bremelanotide

... clinical statisticians and pharmacologists, use clinical trials to reveal such effects, allowing physicians to offer a ... was reported as showing that the medical profession had responded to the growth of CAM in three phases, and that in each phase ... Atwood, K.C., IV (September-October 2003). "The Ongoing Problem with the National Center for Complementary and Alternative ... teaching includes such topics as doctor-patient communication, ethics, the art of medicine,[96] and engaging in complex ...

https://en.wikipedia.org/wiki/Integrative_medicine

Monitoring Board Recommends Early Termination of Ebola Therapeutics Trial in DRC Because of Favorable Results with Two of Four ... "Clinical Microbiology Reviews (Review). 22 (4): 552-63. doi:10.1128/CMR.00027-09. PMC 2772359. PMID 19822888.. ... Current Topics in Microbiology and Immunology. Ebolavirus and other filoviruses. 315. pp. 363-87. doi:10.1007/978-3-540-70962-6 ... The response to the epidemic then moved to a second phase, as the focus shifted from slowing transmission to ending the ...

https://en.m.wikipedia.org/wiki/Ebola_virus_disease

Ernst E (December 2009). "Spinal manipulation for asthma: a systematic review of randomised clinical trials". Respir Med. 103 ( ... BEIR VII Phase 2. Washington, DC: The National Academies Press. ISBN 0-309-09156-X.. CS1 maint: Multiple names: authors list ( ... List of topics characterized as pseudoscience. *Chiropractic education. *Chiropractic schools. *Councils on Chiropractic ... Ernst E (2009). "Chiropractic spinal manipulation for infant colic: a systematic review of randomised clinical trials". Int J ...

https://en.wikipedia.org/wiki/Chiropractors

42] The law encourages patient diversity in clinical trials submitted to the FDA for review. The study determined that most ... Class IV. Classes I and II distinguish between extremely low and low risk devices. Classes III and IV, moderate and high risk ... The US FDA also published a series of guidances for industry regarding this topic against 21 CFR 820 Subchapter H-Medical ... When in the initial R&D phase, manufacturers are now beginning to design for manufacturability. This means products can be more ...

https://en.m.wikipedia.org/wiki/Medical_device

"ISIS initiates Phase 3 clinical trials for potential SMA therapy ISIS-SMNrx". The SMA Trust.. ... Topics. *Contributing property. *Keeper of the Register. *Historic district. *History of the National Register of Historic ... develop a new clinical cancer research unit at Northwell Health in Lake Success, NY, to support early-phase clinical studies of ... In 2014, Phase 3 trials begin for drug to treat spinal muscular atrophy (SMA), a neurodegenerative disease, based on Adrian ...

https://en.wikipedia.org/wiki/Cold_Spring_Harbor_Laboratory

Phase-locking to stimulus frequencies has been shown in the auditory nerve,[5][6] the cochlear nucleus,[5][7] the inferior ... Musical four-year-olds have been found to have one greater left hemisphere intrahemispheric coherence.[82] Musicians have been ... Chen, R; Hallett, M (1998). "Focal dystonia and repetitive motion disorders". Clinical Orthopaedics and Related Research (351 ... "Decoding auditory attention to instruments in polyphonic music using single-trial EEG classification". Journal of Neural ...

https://en.wikipedia.org/wiki/Cognitive_neuroscience_of_music

List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ... Jenner extended his observations by showing that cowpox could be passed from a lesion on one patient to others through four arm ... It is hoped that further understanding of the molecular basis of immunity will translate to improved clinical practice in the ... From England, the technique spread rapidly to the Colonies, and was also spread by African slaves arriving into Boston.[3][4] ...

https://en.wikipedia.org/wiki/Artificial_induction_of_immunity

... phase I trials - phase II trials - phase III trials - phase IV trials - photosensitivity - PHS - pituitary gland - placebo - ... clinical endpoint - clinical latency - clinical practice guidelines - clinical trial - clinicaltrials.gov - cloning - CMS - CMV ... This is a list of AIDS-related topics, many of which were originally taken from the public domain U.S. Department of Health ... Community Programs for Clinical Research on AIDS (CPCRA) - community-based clinical trial (CBCT) - community-based organization ...

https://en.m.wikipedia.org/wiki/Index_of_AIDS-related_topics

... none of these strategies have proven to be efficacious in TBI clinical trials [13-15]. The failure of clinical therapy trials ... Temporal protein biomarkers in tracking different phases of TBIEdit. A continuum of protein biomarkers in tracking different ... Scholia has a topic profile for Biomarker.. Retrieved from "https://en.wikipedia.org/w/index.php?title=Biomarker&oldid= ... Status and relevance for clinical trials". Mov. Disord. (Review). 33 (4): 528-36. doi:10.1002/mds.27355. PMID 29624752.. ...

https://en.m.wikipedia.org/wiki/Biomarkers

Foster suggests that women would have encountered suspicion about their own lives had they used same-sex love as a topic, and ... Two months later, they were found guilty in a jury trial. The producers were fined $200 and the cast received suspended ... Although he considered bisexuality inherent in all people, and said that most have phases of homosexual attraction or ... Journal of Consulting and Clinical Psychology, 71 (1), pp. 53-61. ...

https://en.wikipedia.org/wiki/Lesbians

This system was phased out in 1972-1977 in favor of the modern system where grades 1-9 are mandatory. After the age of 15, the ... "Public Domain on Trial in Reiss-Engelhorn Museum vs. Wikimedia et al. - International Communia Association". Communia- ... A Bachelor of Medicine (lääketieteen kandidaatti, medicine kandidat) is allowed to conduct clinical work under the supervision ... A bachelor's degree takes about three-four years. Depending on the programme, this may be the point of graduation, but it is ...

https://en.wikipedia.org/wiki/Higher_education_in_Finland

Related to Bernoulli trials (yes/no events, with a given probability)[edit]. *Basic distributions: *Bernoulli distribution, for ... List of statistical topics. *Kirkwood approximation. *Moment-generating function. *Quasiprobability distribution. *Riemann- ... 10.4 Related to Bernoulli trials (yes/no events, with a given probability) ... displaystyle p(2)+p(4)+p(6)=1/6+1/6+1/6=1/2.}. In contrast, when a random variable takes values from a continuum then typically ...

https://en.wikipedia.org/wiki/Discrete_distribution

The earliest publication of a controlled clinical trial appears to be from 1945.[27] Researchers continued to work on this ... Squires VR (2011). The Role of Food, Agriculture, Forestry and Fisheries in Human Nutrition - Volume IV. EOLSS Publications. p ... started publishing research on the topic and also published a book "Vitamin C and the Common Cold" in 1970.[28] A revised and ... "Measurement of intracellular vitamin C levels in human lymphocytes by reverse phase high performance liquid chromatography ( ...

https://en.wikipedia.org/wiki/L-ascorbic_acid

... a phase II trial". Journal of Clinical Oncology. 23 (10): 2332-8. doi:10.1200/JCO.2005.51.008. PMID 15800324.. ... Scholia has a topic profile for Cholangiocarcinoma.. *American Cancer Society Detailed Guide to Bile Duct Cancer. ... a phase II study". Japanese Journal of Clinical Oncology. 35 (2): 68-73. doi:10.1093/jjco/hyi021. PMID 15709089.. ... American Society of Clinical Oncology Educational Book. American Society of Clinical Oncology. Annual Meeting. 35 (36): e194- ...

https://en.m.wikipedia.org/wiki/Cholangiocarcinoma

... placebo-controlled phase 3 trial". The Lancet 381 (9883): 2083-2090. doi:10.1016/S0140-6736(13)61127-7.. ... Bradley's Neurology in Clinical Practice: Expert Consult - Online and Print, 6e (Bradley, Neurology in Clinical Practice e- ... Estadio IV ou SIDA: síntomas graves que inclúen toxoplasmose no cerebro, candidiase no esófago, traquea, bronquios ou pulmóns e ... Walker, BD (2007 Aug-Sep). "Elite control of HIV Infection: implications for vaccines and treatment.". Topics in HIV medicine ...

https://gl.m.wikipedia.org/wiki/Síndrome_de_inmunodeficiencia_adquirida

20-year results of a randomized trial". Journal of Clinical Oncology. 32 (8): 791-7. doi:10.1200/JCO.2013.50.6600. PMID ... Nerve damage from ionizing radiation occurs in phases, the initial phase from microvascular injury, capillary damage and nerve ... Wikibooks has a book on the topic of: Radiation Oncology. Information. *Human Health Campus The official website of the ... This new technology is called image-guided radiation therapy (IGRT) or four-dimensional radiation therapy. ...

https://en.wikipedia.org/wiki/Radiation_therapy

Handbook of Clinical Neurology. 106. pp. 527-40. doi:10.1016/B978-0-444-52002-9.00031-0. ISBN 978-0-444-52002-9. PMID 22608642. ... Delayed sleep phase disorder (DSPD), inability to awaken and fall asleep at socially acceptable times but no problem with sleep ... "UTCAT2395, Found CAT view, CRITICALLY APPRAISED TOPICs". cats.uthscsa.edu. Retrieved 2016-03-08.. ... Stradling, J; Roberts, D; Wilson, A; Lovelock, F (1998). "Controlled trial of hypnotherapy for weight loss in patients with ...

https://en.wikipedia.org/wiki/Sleeping_disorders

... the drug may be used in human clinical trials. Human trials with all of the below HDAC inhibitors are extremely variable and ... Sodium phenylbutyrate phase II human triasl with 12 to 15 g/day showed restored mRNA levels of Htt mutant repressed genes but ... Weihl CC, Connolly AM, Pestronk A (August 2006). "Valproate may improve strength and function in patients with type III/IV ... "British Journal of Clinical Pharmacology. 75 (4): 1152-3. doi:10.1111/j.1365-2125.2012.04444.x. PMC 3612735. PMID 22905989.. ...

https://en.wikipedia.org/wiki/Epigenetics_of_neurodegenerative_diseases

Institute on Aging and the National Institute of Diabetes and Digestive and Kidney Diseases mounted the CALERIE clinical trials ... CR at three sites for six months to a year in Phase 1 and for two years in Phase 2.[40] ... "Journal of Clinical Densitometry. 16 (4): 450-454. doi:10.1016/j.jocd.2013.08.010. PMC 5321047. PMID 24063845.. ... "The American Journal of Clinical Nutrition. 88 (1): 1-11. doi:10.1093/ajcn/88.1.1. PMC 2674146. PMID 18614716.. ...

https://en.wikipedia.org/wiki/Caloric_restriction

... and has now successfully concluded Phase I clinical trials. There has been some research success towards a "universal flu ... Three of the four types of influenza viruses affect humans: Type A, Type B, and Type C.[2][6] Type D has not been known to ... Current Topics in Microbiology and Immunology. 283. pp. 313-42. doi:10.1007/978-3-662-06099-5_9. ISBN 978-3-642-07375-5. . PMID ... a meta-analysis of published and unpublished clinical trials". Family Practice. 30 (2): 125-33. doi:10.1093/fampra/cms059. PMID ...

https://en.m.wikipedia.org/wiki/Influenza

2016). "Synbiotics for Prevention and Treatment of Atopic Dermatitis: A Meta-analysis of Randomized Clinical Trials". JAMA ... Late-phase response[edit]. After the chemical mediators of the acute response subside, late-phase responses can often occur due ... The four types of hypersensitivity reaction are: type 1, immediate IgE-mediated; type 2, cytotoxic; type 3, immune complex- ... a collection of resources on the topic of food allergies and intolerances ...

https://en.wikipedia.org/wiki/Food_allergy

"Randomised controlled trial of cognitive-behavioural therapy in early schizophrenia: acute-phase outcomes". Br J Psychiatry ... Clinical outcome evidence[edit]. A number of studies have been carried out to see whether the early psychosis approach reduces ... where thoughts unrelated to a common topic appear uncontrollably; referential ideation that is immediately corrected; and other ... the TIPS early detection randomised control trial in Norway;[17] and the Danish OPUS trial.[16] In 2001, the United Kingdom ...

https://en.wikipedia.org/wiki/Coordinated_speciality_care

"Data sharing platforms for de-identified data from human clinical trials". Clinical Trials: 1740774518769655. doi:10.1177/ ... TBI field is categorized into four major themes that are briefly described below: *Clinical big data. Clinical big data is a ... Computer models are used to examine various topics such as how exercise affects obesity, healthcare costs, and many more.[35] ... developed computerized systems to automate many aspects of multi-phased health checkups. These systems became the basis the ...

https://en.wikipedia.org/wiki/Health_information_system

Clinical research and experimental design. Overview. *Clinical trial *Trial protocols. *Adaptive clinical trial ... A Phase I discovery will be followed by Phase II reproductions as a drug develops towards commercial production. In recent ... The values obtained from distinct experimental trials are said to be commensurate if they are obtained according to the same ... 4: 170114. doi:10.1038/sdata.2017.114.. *^ Open Science Collaboration (2015). "Estimating the reproducibility of Psychological ...

https://en.wikipedia.org/wiki/Replicability

... clinical hair loss (telogen effluvium) may occur.[citation needed] A disruption of the growing phase causes abnormal loss of ... Baldness is the partial or complete lack of hair growth, and part of the wider topic of "hair thinning". The degree and pattern ... Dietary supplements are not typically recommended.[30] There is only one small trial of saw palmetto which shows tentative ... The procedure can take between four and eight hours, and additional sessions can be carried out to make hair even thicker. ...

https://en.m.wikipedia.org/wiki/Alopecia

List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ... Despite the side effects, its potential benefit has led to a few clinical trials.[9] ... As of 2016, several TLR ligands were in clinical development or being tested in animal models as potential adjuvants.[24] ... "T-cell priming by dendritic cells in lymph nodes occurs in three distinct phases". Nature. 427 (6970): 154-9. Bibcode:2004Natur ...

https://en.wikipedia.org/wiki/Immunologic_adjuvant

and Sanofi affiliate Shantha Biotechnics are currently in Phase III clinical trials.[37][38] ... Four reassortant rotaviruses express one of the outer capsid, VP7, proteins (serotypes G1, G2, G3, or G4) from the human ... "ROTAVAC clinical trial results , DEFEATDD.ORG - Resources to defeat diarrheal disease". www.defeatdd.org. Archived from the ... Clinical trials in the United States, Finland, and Venezuela had found it to be 80 to 100% effective at preventing severe ...

https://en.wikipedia.org/wiki/Rotavirus_vaccine

"ACL Program - Bridge-Enhanced ACL Repair (BEAR) Clinical Trial". www.childrenshospital.org. Retrieved 25 April 2016.. ... Phase 2[edit]. Many of the goals from phase I will be continued to the following phases until they have been reached. Some of ... After four months, more intense activities such as running are possible without risk. After five months, light ball work may ... "Anterior Cruciate Ligament (ACL) Injuries - Topic Overview". www.webmd.com. Retrieved 25 April 2016.. ...

https://en.wikipedia.org/wiki/Anterior_cruciate_ligament_reconstruction

... a meta-analysis of 26 clinical trials reported that high-polyphenol olive oil improved measures of total cholesterol, HDL ... "Mafia Control of Olive Oil the Topic of '60 Minutes' Report". Olive Oil Times. 3 January 2016. Retrieved 28 January 2016.. . ... A Carabinieri investigator interviewed on the program said that "olive oil fraud has gone on for the better part of four ... a drought during the flowering phase, for example, can result in a lower quality (virgin) oil. It is worth noting that olive ...

https://en.wikipedia.org/wiki/Olive_oil

Discussion topics when setting up an experimental design[edit]. An experimental design or randomized clinical trial requires ... A good way to prevent biases potentially leading to false positives in the data collection phase is to use a double-blind ... 4. =. Y. 1. −. Y. 2. +. Y. 3. −. Y. 4. +. Y. 5. −. Y. 6. +. Y. 7. −. Y. 8. 8. .. θ. ^. 5. =. Y. 1. −. Y. 2. +. Y. 3. −. Y. 4. − ... 4. +. Y. 5. +. Y. 6. −. Y. 7. −. Y. 8. 8. .. θ. ^. 3. =. Y. 1. +. Y. 2. −. Y. 3. −. Y. 4. −. Y. 5. −. Y. 6. +. Y. 7. +. Y. 8. 8 ...

https://en.wikipedia.org/wiki/Design_of_Experiments

Trial of Thoracic Epidural Analgesia Versus Four-Quadrant Transversus Abdominus Plane Block in Oncologic Open Liver Surgery. * ... Drug: Topic Morphine. *Drug: Placebo. Interventional. Phase 4. *Hospital General de Niños Pedro de Elizalde ... Prospective Trial: Pain Management After Pectus Excavatum Repair, Epidural Versus PCA. *Pectus Excavatum ... and 4 more...). 76. All. 65 Years to 90 Years (Adult, Senior). NCT03117790. DEXsleep. April 20, 2017. March 2020. March 2020. ...

https://clinicaltrials.gov/ct2/results?recr=Open&intr=%22Pain+Management%22&show_rss=Y&sel_rss=new14

A Phase IV Clinical Trial to Study the Safety, Tolerability and Efficacy of Tinefcon in Patients With Plaque Psoriasis. The ... See Studies by Topic. *See Studies on Map. *How to Search. *How to Use Search Results ... An Open Label, Non-comparative, Multicentre, Phase IV Study to Evaluate the Safety, Tolerability and Efficacy of Tinefcon in ... of the worlds population.This phase IV study is planned to monitor performance of Tinefcon in patients suffering from ...

https://clinicaltrials.gov/show/NCT01373567

... phase 2b/3 trial. Lancet Oncol. 2016 Feb;17(2):212-223. doi: 10.1016/S1470-2045(15)00483-0. Epub 2015 Dec 23. ... See Studies by Topic. *See Studies on Map. *How to Search. *How to Use Search Results ... Phase IIB/III Of TG4010 Immunotherapy In Patients With Stage IV Non-Small Cell Lung Cancer (TIME). The safety and scientific ... Phase 2 : Overall Survival (OS) [ Time Frame: Approximately 15 months ]. *Phase 2 : Overall Response Rate (ORR) [ Time Frame: ...

https://www.clinicaltrials.gov/ct2/show/NCT01383148?term=TG+4010&rank=1

Participation in any clinical trial within the past six months. *History or present evidence of addictions. ... MedlinePlus related topics: Multiple Sclerosis Drug Information available for: Glatiramer Interferon beta-1b Glatiramer acetate ... Phase IV Study, Betaseron Versus Copaxone for Relapsing Remitting or CIS Forms of MS Using Triple Dose Gad 3 T MRI (BECOME). ... Phase IV, Rater-blinded, Randomized Study, Comparing 250 mg of Betaseron With 20 mg of Copaxone in Patients With the Relapsing- ...

https://www.clinicaltrials.gov/ct2/show/NCT00176592?term=GLATIRAMER&

Topics include the definition and history of clinical trials; trial designs, including phase I-IV, cross-over, factorial, and ... covers various topics in the design and conduct of clinical trials, and profiles clinical trials that illustrate these issues. ... Introduces clinical trial design in the context of epidemiological concepts, ... Topics include the definition and history of clinical trials; trial designs, including phase I-IV, cross-over, factorial, and ...

https://www.jhsph.edu/courses/course/32145/2021/340.645.81/introduction-to-clinical-trials

Infant, Premature; Public Health; Smoking Cessation; Clinical Trials, Phase IV as Topic; Biostatistics ... Design and sample size considerations for Phase IV studies is another active research area, in which a new class of hybrid ... Selection of the treatment effect for sample size determination in a superiority clinical trial using a hybrid classical and ... Specialized Terms: Clinical studies; Methodology. Extensive Research Description. *Genetic and Brain Image Analysis of ...

https://medicine.yale.edu/ysph/people/robert_makuch-2.profile

Animal trials make a base for human trials. 2. Clinical trials - phase 1:. • Small group of volunteers given different doses. ... 3. Clinical trials - phase 2:. • A group of 100-300 volunteers with disease treated to look for drug effectiveness. 4. Clinical ... 1. Lag phase -> cells adjust to conditions. 2. Log or exponential phase -> cells divide at fastest possible rate for the given ... trials - phase 3:. • Large group of patients 1000-3000 are divided into two groups. • One group is given a placebo, the other ...

https://www.brainscape.com/flashcards/topic-4-6854634/packs/10782121

Infant, Premature; Public Health; Smoking Cessation; Clinical Trials, Phase IV as Topic; Biostatistics ... Clinical Professor of Epidemiology. Dr. Robert Hecht is the President of Pharos Global Health Advisors. He has more than 30 ... Grau is a clinical psychologist with training in health psychology and expertise in identifying the cognitive and emotional ... Assistant Clinical Professor of Public Health. Dr. Unni Karunakara was International President of Médecins Sans Frontières / ...

http://publichealth.yale.edu/global/people/list.aspx

OR clinical trial, phase iv [pt] OR clinicaltrials.gov [si] OR isrctn [si] OR randomized controlled trials as topic [mh]) OR ( ... The ClinicalTrials.gov search strategy includes Phase III or Phase IV clinical trials or observational studies with an active ... pragmatic trial[tw] OR pragmatic trials[tw] OR practical clinical trial[tw] OR. pragmatic clinical trial [pt] OR "comparative ... randomized controlled trial [pt] OR clinical trial, phase iii [pt] ...

https://www.nlm.nih.gov/nichsr/cer/CER_search_strategies.html

I to IV) of clinical trials correlate with the TRL scale (1 to 9)? Which Phases of clinical trials can be funded under SME ... Can you explain how the different Phases (I to IV) of clinical trials correlate with the TRL scale (1 to 9)?. ... Can you explain how the different Phases ( ... Additional Important Information on Certain Health Topics. More ...

https://www.fitforhealth.eu/faq-page/can-you-explain-how-different-phases-i-iv-clinical-trials-correlate-trl-scale-1-9

A clinical trial is an organized study to answer specific questions about a new drug or treatment or a new way of using an old ... Clinical Trials 101. Clinical Trial Phases. Next » « Previous 2/14. There are four phases of Clinical Trials, plus "IND Exempt ... Post a Comment Have something to add to this topic? Contact Us.. Name. Login to use your name. Anonymous. ... Phase I Clinical Trial. *In General: A Phase I cinical trial is the most experimental phase of clinical trials. Previously, the ...

http://www.survivorshipatoz.org/hiv/topics/clinical-trials-101/?sid=2577

Key Topics *Strategies in maintaining regulatory compliance in Phase IV clinical trials ... 3rd Annual Phase IV Clinical Trials. January 30 - February 1, 2006 * Marriott Atlanta Marquis, GA, USA ... The value and purpose of a Phase IV clinical study is to increase the knowledge surrounding a new drug, tracking side effects, ... This conference will address the key challenges associated with conducting a phase iv trial and the various methods and ...

https://www.pharma-mkting.com/meetings/m003fmtg224/

... the four phases of clinical trials and clinical data management; and the regulatory review and approval process, including ... Topics include the functions and role of pharmacology, drug metabolism, pharmacokinetics, toxicology, CMC/pharmaceutical ...

http://www.bio.net/bionet/mm/bionews/1997-September/004123.html

Landscape of interventional clinical trials involving gastrectomy for gastric cancer Hussein H Khachfe1,2,3, Hamza A Salhab1,4 ... Phase IV trials A single (1%) trial was in phase IV, and it has an unknown status (Table 1). The trial in this phase had 150 ... Table 3. Distribution of treated topics and interventions used in clinical trials involving GC. ... Phase I/II trials Only 3 (2%) trials were in Phase I/II, all of which were completed (Table 1). Phase I/II trials had 117 ...

https://ecancer.org/en/journal/article/1218-landscape-of-interventional-clinical-trials-involving-gastrectomy-for-gastric-cancer

The design and implementation of clinical trials (Phase I to Phase IV) ... Interventions course will provide students with the opportunity to learn more about and discuss the following topics:. ... clinical trial governance issues and how to address them. *Understanding and dealing with key stakeholders in clinical trial ... Understanding and addressing ethical issues in clinical trials - an introduction to Research Ethics ...

http://www.ox.ac.uk/node/45897

clinical trials (phases I-IV, randomised double-blind controlled trial, ethical issues, sample size, early stopping) ... Topics covered on this module include:. *multivariate discrete and continuous distributions (topic includes expectations, ... These topics form the most essential knowledge for you if you intend to start working in the financial fields. They are complex ... Topics covered include:. Rationalisation:. After the introduction of the Poisson process, birth and death processes as well as ...

http://www.sussex.ac.uk/study/undergraduate/courses/mathematics/mathematics-with-economics-mmath

BRIEF-Aradigm Corp presents analysis of results for phase 3 orbit-3, orbit-4 clinical trials * Aradigm Corp presents analysis ... of results for phase 3 orbit-3 and orbit-4 clinical trials - sec filing ...

https://uk.reuters.com/business/stocks/company-news/ARDM.OQ

Systematic review; 20 clinical trials, 1016 patients). * Stone JH, Tuckwell K, Dimonaco S, et al. Trial of tocilizumab in giant ... Phase 3 comparative study, multicenter randomized controlled trial). * Moster ML, Sergott RC, Leiby BE. Dalfampridine treatment ... Browse Topics Take CME Tests About Contact Emergency Physicians PAs & NPs Residents Groups & Hospitals ... Four divisions can assist in considering the differential diagnosis: (1) unilateral or bilateral; (2) painful or painless; (3) ...

https://www.ebmedicine.net/topics/heent/abnormal-vision/podcast

... drug clinical trial studies and guest edited issues to update all those concerned with the treatment of vascular disease ... Current Vascular Pharmacology publishes clinical and research-based reviews, ... and this is now completing Phase 2 clinical trial. He is Associate Editor of 5 international journals, and was awarded the ... Dr Viljoen was a topic expert on NICE Quality Standards and Technology Appraisals. ...

https://benthamscience.com/journals/current-vascular-pharmacology/editorial-board/

... implemented during a large phase 3 clinical trial. MATERIAL AND METHODS: The Tuberculosis Trials Consortium (TBTC) Study 31/ ... CDC twenty four seven. Saving Lives, Protecting People Search Submit For a full list of topics: A-Z Index ... clinical trial sites. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov (Identifier: NCT02410772) on April ... Central monitoring in a randomized, open-label, controlled phase 3 clinical trial for a treatment-shortening regimen for ...

https://www.cdc.gov/library/sciclips/issues/v13issue11.html

Healthy volunteers were given IV a new anti-anginal drug in a phase 1 clinical trial. The results are summarized in the ... Which of these topics are covered in Health Online? (only one answer allowed) ... Tutorials have a way of imparting some knowledge on given topics and studies, and with the introduction of the online health ... This quiz was created to measure the amount of knowledge students have on basic health topics. Play this.... ...

https://www.proprofs.com/quiz-school/topic/health/2

ImmusanTs Celiac Vaccine Passed Phase I Clinical TrialsCeliac.comHer son was diagnosed with celiac disease in 2006, at the age ... Topics. * Need Recovery Help Please. By ChargersFan, 46 minutes ago. in Celiac Disease - Post Diagnosis, Recovery/Treatment(s) ... ImmusanTs Celiac Vaccine Passed Phase I Clinical Trials - Celiac.com * Join our community!. Do you have questions about celiac ... ImmusanTs Celiac Vaccine Passed Phase I Clinical Trials. Celiac.com. Her son was diagnosed with celiac disease in 2006, at the ...

https://www.celiac.com/forums/topic/81369-immusants-celiac-vaccine-passed-phase-i-clinical-trials-celiaccom/

I recently received the papers for a Clinical Trial. for RA. My Hubbie said, "NO" after he read it, but it is my decision. ... is for Phase 3, the next one is Phase 4. I just wanted to know what ... because you will end up going into shock from the withdrawal this shock can be fatal within 20 mins unless treated by IV ... This topic is now archived and is closed to further replies. ##Prednisone :s ....... By KickStart101, March 14, 2006. in Other ...

https://www.diabetesforums.com/forums/topic/8344-prednisone-s/

Clinical Trial Planning Grants for Critical Illness and Injury in Aging (R34) PA-10-045. NIA ... or IV clinical trial.. Topic areas for proposed clinical trials may fall under one of the categories below. Applications may ... Phase III and IV clinical trials related to critical illness and injury in aging. The planning grant mechanism is intended to ... Future Clinical Trial. *Rationale/Significance - Provide the rationale for the future clinical trial, documenting the ...

https://grants.nih.gov/grants/guide/pa-files/PA-10-045.html

... tested in clinical trials and medicines manufacture. Look at medicines packaging and the monitoring of medicine safety. ... Phase 3 clinical trials. This is the main stage in clinical testing of a new medicine. Thousands of patients will take the new ... by topic. Select an age range to seek interactive content for.... * Ages. 5-7. ... Clinical trials. Information gathered from preclinical tests are used to apply for permission to conduct clinical trials. In ...

https://www.abpischools.org.uk/topic/makingmedicines/4

Phase 2 (Infectious Diseases) (U01 Clinical Trial Optional) RFA-AI-19-025. NIAID ... Phase 2 will solicit applications for research under four separate funding opportunity announcements which are outlined in ... Applications proposing the topics below will be considered not responsive and will not be reviewed: ... In addition, for applications involving clinical trials:. Are the scientific rationale and need for a clinical trial to test ...

https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-19-025.html

Mercy Medical Center participates in a number of investigative clinical trials that are vital in developing new treatment ... Topic of Study: Breast Cancer. Sponsor: Alliance for Clinical Trials in Oncology. Principal Investigator: David A. Riseberg, MD ... A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as ... This is a phase III randomized trial evaluate the efficacy and safety of pembrolizumab for women with triple-negative breast ...

https://mdmercy.com/about-mercy/patient-clinical-trials?sc_lang=en

... vaccine were enrolled in a phase IV clinical trial; 646 10-year-olds and 645 11-year-olds completed the study, which involved a ... To date, there have been only three published HIV-1 vaccine trials in infants.We conducted a randomized phase I clinical trial ... A phase I randomized clinical trial of candidate human immunodeficiency virus type 1 vaccine MVA.HIVA administered to Gambian ... Phase II and III clinical studies were conducted to evaluate immunogenicity and safety of a novel DTaP-IPV vaccine consisting ...

https://worldwidescience.org/topicpages/d/diphtheria-tetanus-acellular+pertussis-hepatitis+b-inactivated.html

... is that the criteria can support clinical trials of candidate disease-modifying agents in this phase of AD. The criteria start ... In Honolulu, Craft presented data from a four-month trial of 104 patients with amnestic MCI or early AD. Aptly named SNIFF-120 ... At an ICAD Hot Topics session, Town argued that his TgF344-AD rat may be the first rodent to fit the bill. This AD model is the ... TrialMatchTM at present contains about 150 trials, including all ongoing AD trials in the U.S. governments ClinicalTrials.gov ...

https://www.alzforum.org/print-series/188266

Suzanne Craft of the University of Washington, Seattle, presented data from a four-month Phase 2 study of intranasal insulin, ... For those who had all but turned their noses up at the dearth of big clinical trial news at the International Conference on ... Alzheimers Disease, held 10-15 July 2010 in Honolulu, Hawaii, a Hot Topics presentation offered a whiff of fresh air. ... I look forward to Phase 3 trial results. I think many of us have dismissed the fact that insulin might play a role in dementia ...

https://www.alzforum.org/news/conference-coverage/honolulu-intranasal-insulin-trial-claims-promise-mci-ad

This is a Phase IIb/III randomized, double-blind, placebo-controlled study to compare the efficacy and safety of first-line therapy combined with TG4010 or placebo in stage IV non-small cell lung cancer (NSCLC). (clinicaltrials.gov)
This study is a phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of cenicriviroc for the treatment of liver fibrosis in adult subjects with nonalcoholic steatohepatitis. (mdmercy.com)
Ruthigen plans to enroll 150 patients in the Phase 1/2 trial, which will evaluate RUT58-60's safety, tolerability and potential efficacy for use as an adjunct to systemic antibiotics in patients undergoing abdominal surgery. (thefreelibrary.com)
The first 20 patients in the Phase 1/2 trial will be evaluated initially for safety by a Data Monitoring Committee and will also be included in the total patient population for potential efficacy. (thefreelibrary.com)
In contrast, the case for clinical equipoise is far weaker in initial tests of efficacy because evidence of clinical utility is lacking at the outset, and base rates for discovering a useful intervention low. (genengnews.com)
and the Phase III HGB-210 trial, an ongoing single-arm open-label study designed to evaluate the efficacy and safety of LentiGlobin in patients between two years and 50 years of age with SCD. (genengnews.com)
Preclinical studies to predict efficacy of vascular changes induced by combretastatin a-4 disodium phosphate in patients. (semanticscholar.org)
The approval of QNASL Nasal Aerosol is based on a comprehensive clinical development program that assessed the product's safety and efficacy in the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in adolescent and adult patients age 12 years of age and older. (drugtopics.com)
The safety and efficacy of QNASL Nasal Aerosol was demonstrated in 4, phase 3 randomized, double-blind, parallel-group, multicenter, placebo-controlled clinical trials. (drugtopics.com)
Subjects will be admitted to an inpatient nursing unit, challenged with live GII.4 Norovirus strain by oral administration, remain in the unit for at least 4 days following challenge and then followed for post-challenge safety and efficacy with multiple clinical assessments and collection of blood and stool specimens. (bioportfolio.com)
This is a phase 2 multi-center, double-blind, placebo-controlled study of the efficacy and safety of nitazoxanide for the treatment of solid organ and hematopoietic stem cell transplant re. (bioportfolio.com)
The purpose of this study is to evaluate the efficacy of the Norovirus (NoV) GI.1/GII.4 Bivalent Virus-Like Particle Vaccine against moderate or severe acute gastroenteritis (AGE) due to g. (bioportfolio.com)
Clinical trials are a group of biomedical or behavioral efficacy and safety studies, completed in humans, that are usually broken down in to four phases. (xtalks.com)
Phase I clinical trials test a treatment's safety, dosage range and side effects in a small group of healthy people to determine if a treatment can be checked for efficacy. (xtalks.com)
Phase III clinical trials are administered to a larger group of people to finally verify efficacy and safety. (xtalks.com)
In the initial phase of these clinical studies, intravenous (iv) injection was used according to the route used in pre-clinical efficacy studies. (ovid.com)
The pharmacokinetics, immune stimulation, and anti-tumor efficacy of iv and sc injection routes of ALT-803 in C57BL/6 mice were compared. (ovid.com)
Preliminary data in the research of cervical cancer, gastric cancer and other tumors show that Cadonilimab is significantly less toxic than the combination therapy of PD-1 and CTLA-4, and has obvious safety and efficacy advantages. (echemi.com)
4) large Phase 3 trials confirm safety and efficacy. (agoracom.com)
Now we apply to evaluate the safety, immunogenicity and efficacy of these improved conjugates in 1 to 4 years-old children in Israel. (bioportfolio.com)
http://www.ncbi.nlm.nih.gov/pubmed/30019769?tool=bestpractice.com The safety and efficacy of lefamulin has been evaluated in two phase 3 clinical trials where it was found to be noninferior to moxifloxacin (with or without linezolid) in terms of primary efficacy endpoints (early clinical response, investigator assessment of clinical response). (bmj.com)
Efficacy and safety of IV-to-oral lefamulin, a pleuromutilin antibiotic, for treatment of community-acquired bacterial pneumonia: the phase 3 LEAP 1 trial. (bmj.com)
In addition, the analysis was stratified by Phase III studies (which focused on determining tolerability and efficacy before regulatory approval) and Phase IV studies (which compared the clinical efficacy of the 2 insulins). (nih.gov)
Efficacy and safety of collagenase Clostridium Histolyticum in the treatment of proximal interphalangeal joints in Dupuytren contracture: Combined analysis of 4 phase 3 clinical trials. (epnet.com)
At this time, CDC began a series of clinical trials of rifampin that, in follow-up to key trials conducted by the British Medical Research Council, the British Thoracic Association, and others, helped to establish the efficacy and safety of rifampin-based, 6-month, short-course outpatient therapy for TB. (cdc.gov)
Such was the lack of support for CDC's clinical trials program that a key CDC trial (USPHS Study 21, which confirmed for U.S. TB programs the efficacy of 6-month short-course therapy) was nearly terminated for lack of adequate funding. (cdc.gov)
Adenovirus Vaccine Efficacy Trial Consortium (2013). (wikipedia.org)

January 9, 2019 - Notice of Intent to Publish Funding Opportunity Announcements for Phase 2 of the U.S.-South Africa Program for Collaborative Biomedical Research (R01 and U01, Clinical Trial Optional). (nih.gov)
DUBLIN, June 5, 2019 /PRNewswire/ -- The "Global Psoriasis Clinical Trial Pipeline Highlights - 2019" report has been added to ResearchAndMarkets.com's offering. (epicos.com)
2019 Feb 5;73(4):477-487. (nih.gov)
The 'Erectile Dysfunction - Global API Manufacturers, Marketed and Phase III Drugs Landscape, 2019' drug pipelines has been added to ResearchAndMarkets.com's offering. (prnewswire.com)
Erectile Dysfunction - Global API Manufacturers, Marketed and Phase III Drugs Landscape, 2019' report provides comprehensive insights about marketed and Phase III products for Erectile Dysfunction. (prnewswire.com)
2019 Mar 27;63(4):e02161-18. (bmj.com)
https://www.europeanpharmaceuticalreview.com/news/117962/mers-vaccine-shows-promise-in-clinical-trial-say-researchers/ https://www.sciencedaily.com/releases/2019/04/190415081956.htm#:~:text=Summary%3A,viruses%20in%20the%20same%20family.&text=Nipah%20virus%20is%20a%20type,transmitted%20from%20animals%20to%20humans. (wikipedia.org)

2021 Feb 16;72(4):682-685. (cdc.gov)

On 1 May 2020, ClinicalTrials.gov was explored for interventional trials related to gastrectomy for GC, without adding limitations for location or date. (ecancer.org)
AP Stylebook tips on the coronavirus (Kristen Hare, Poynter, 3-4-2020) For example: "Because COVID-19 is the name of the disease, not the virus, it is not accurate to write a new virus called COVID-19. (writersandeditors.com)
How To Know If You Can Trust That Headline-Grabbing COVID-19 Study (Rachel Fairbank, Lifehacker,4-29-2020) In an analysis of 14 different antibody tests, performed by a team of more than 50 scientists, only three produced consistently reliable results. (writersandeditors.com)
On Covid-19, a Respected Science Watchdog Raises Eyebrows (Michael Schulson, Undark, 4-24-2020) For his Covid-19 work, the Stanford scientist John Ioannidis is being accused of the same bad science he has criticized. (writersandeditors.com)
Journalists are recognizing they're writing a rough draft of history - and can't say definitively 'that's the way it is' (Kevin M. Lerner, The Conversation, 4-13-2020) Journalists have historically done a bad job of explaining to the public that each day's news report is, by necessity, incomplete and provisional. (writersandeditors.com)
During 2010-2020, TBTC's international presence expanded from a few clinical study sites located outside of North America, to sites in Peru, Spain, South Africa (two sites), Uganda, Kenya, Vietnam, and China (Hong Kong). (cdc.gov)
The TBTC 2010-2020 also included U.S. sites in New York, Washington DC, Texas (four sites), Colorado, and Tennessee. (cdc.gov)
The Phase 2b GLIMMER study (GSK2330672 trial of IBAT inhibition with Multidose Measurement for Evaluation of Response), presented today at The Liver Meeting® 2020 as a late breaking abstract, reported that linerixibat significantly improved itch (cholestatic pruritus) in some treatment groups compared to placebo. (drugs.com)

The ClinicalTrials.gov search strategy includes Phase III or Phase IV clinical trials or observational studies with an active comparator. (nih.gov)
Lantheus Medical Imaging, formerly Bristol-Myers Squibb Medical Imaging, has initiated a multicenter Phase IV observational study to evaluate the safety profile of Definity Vial for injectable suspension in patients with suboptimal echocardiograms and provide safety information on the use of ultrasound contrast agents in routine clinical practice. (healthimaging.com)
Purpose: To measure the correlation between subjective symptom score, conventional clinical tests, and Fourier-domain optical coherence tomography (FD-OCT) of lower tear meniscus parameters in patients with dry eye disease.Methods: Eighteen patients with dry eye disease requiring medical therapy and/or punctal occlusion were recruited for this prospective, nonrandomized, observational case series. (octnews.org)

A course is aimed at qualified doctors, especially specialist registrars in clinical pharmacology. (ox.ac.uk)
He is a Fellow of the Royal College of Pathologists (FRCPath), Royal College of Physicians (FRCP), Faculty of Pharmaceutical Medicine (FFPM) and American College of Clinical Pharmacology (FCP). (benthamscience.com)
In this new role, Dr. Pittenger was able to combine her previous academic, industry and research experience to developing new strategies for training sales representatives on topics such as physiology and disease state, pharmacology and clinical research evaluation. (umn.edu)
With more than 25 years of experience from its founding companies, Cetero has conducted more than 10,000 clinical pharmacology studies -- more than any other CRO. (medindia.net)
Cetero's clinical research expertise consists of traditional early-stage, healthy-volunteer clinical pharmacology and bioavailability studies, as well as specialty Phase Ia/b trials in patients. (medindia.net)

It covers emerging therapies for Psoriasis in active clinical development stages including early and late stage clinical trials. (epicos.com)
This report provides a comprehensive understanding of the emerging Phase III therapies for Erectile Dysfunction which can turn out to be future prospective competitors for the marketed products. (prnewswire.com)
For some patients who have exhausted other conventional therapies, a clinical trial can be seen as a lifesaver. (healthydebate.ca)
These trials usually involve a small number of patients for whom other standard therapies have failed or no known alternative therapy is available. (urologycenternj.com)
Drugs or therapies that are shown to be active in phase II trials may become standard treatment or be further evaluated for effectiveness in phase III trials. (urologycenternj.com)

Professor Makuch's primary research interests involve methodologic issues in the design, conduct, and analysis of clinical studies. (yale.edu)
Design and sample size considerations for Phase IV studies is another active research area, in which a new class of hybrid designs has been proposed for scientific and regulatory purposes. (yale.edu)
This CER Randomized Controlled Trials search strategy was developed to identify randomized clinical trials and related controlled intervention studies in PubMed which have some comparison or which discuss treatment outcomes. (nih.gov)
Phase III studies look for a treatment that will provide a longer life expectancy, better quality of life, fewer side effects, and/or a lowered chance of the condition returning. (survivorshipatoz.org)
Phase III compares standard (proven) drugs or treatments or placebos (no treatment) with the drugs or treatments that appeared to be effective in the Phase II studies. (survivorshipatoz.org)
Phase IV studies are done after a drug or treatment has been approved by the FDA and marketed. (survivorshipatoz.org)
This FOA is NOT designed for collecting preliminary data or conducting pilot studies in support of the scientific rationale for a clinical trial. (nih.gov)
This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). (mdmercy.com)
Phase II and III clinical studies were conducted to evaluate immunogenicity and safety of a novel DTaP-IPV vaccine consisting of Sabin inactivated poliovirus vaccine (sIPV) and diphtheria-tetanus-acellular pertussis vaccine (DTaP). (worldwidescience.org)
To this end the journal publishes results of early Phase I and II studies, as well as those of controlled clinical trials of psychotropic drugs in Phase II and IV. (lww.com)
This concept includes phase I studies conducted both in the U.S. and in other countries. (umassmed.edu)
Given that the number of patients in Phase III studies is typically 10-fold greater than in Phase II, these reductions in subject burden can be substantial. (genengnews.com)
Introducing randomization in Phase II studies, for example, roughly doubles the number of patients in trials because the trials now require comparator arms. (genengnews.com)
In areas of vaccine development, the quest for predictive Phase II designs has kindled interest in Phase II "challenge studies," which deliberately infect healthy volunteers with a manageable form of disease. (genengnews.com)
These include establishing the upper and lower bounds on evidence needed to initiate Phase III studies, limiting nontherapeutic risks for trial patient-subjects, and consideration of the potential knowledge-value of decisively negative Phase III results. (genengnews.com)
Dr. Kimmelman directs the Group for Studies of Clinical Translation (G-SCT), which studies scientific, policy, and ethical challenges encountered in transforming laboratory discoveries into medical applications. (genengnews.com)
Reviews on Recent Clinical Trials publishes high quality full-length/mini reviews, original research articles, interesting case reports, drug clinical trial studies and guest edited thematic issues on recent clinical trials of major importance. (benthamscience.com)
PROMETRIKA's team has managed hundreds of clinicaltrials from Phase 1 pharmacokinetic crossover trials to Phase 4 long-termmulti-center studies. (medindia.net)
Relatively few clinical trials are ongoing, compared to the vast body of evidence among completed studies. (prnewswire.co.uk)
Initial clinical reports 1 and early preclinical studies 2 indicated that vitamin C administered intravenously may have potential anticancer benefits. (jaoa.org)
Phase IV studies, or post-marketing studies are completed after the treatment has been brought to market to determine the effect of long-term use in a wide-range of patient populations. (xtalks.com)
Results support sc administration of ALT-803 in clinical studies. (ovid.com)
Biodistribution studies indicated that sc ALT-803, similarly to iv ALT-803 as previously reported, has a greater tissue distribution and longer residence time in lymphoid tissues compared to recombinant IL-15. (ovid.com)
Medical Research Council Population Health Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom. (nih.gov)
Moreover, to the best of our knowledge, no phase IV studies have addressed this topic for the two studied ULTs. (drug-injury.com)
11 A review of similar studies could help address the clinical uncertainty about whether such collaborative interventions can make a difference in more than one domain and inform policy decisions about the potential benefit of adopting such guidance. (ahrq.gov)
Cetero has harmonized the personnel training and specific study processes across the four clinical sites, and has successfully conducted A/I/S studies at these multiple sites using identical scoring and performance standards, with the same protocol and comprehensive final report within one full-service package. (medindia.net)
Our team understands how critical factors such as dose application and removal, skin conditions and diseases, lifestyle history and adverse event assessment (skin and systemic) will impact how the skin absorbs a compound, assuring the design of studies to control for those details," said Dr. Alan Copa, President of Clinical Operations -- Fargo for Cetero Research. (medindia.net)
Negative binomial meta-regression analysis of combined glycosylated hemoglobin and hypoglycemia outcomes across eleven Phase III and IV studies of insulin glargine compared with neutral protamine Hagedorn insulin in type 1 and type 2 diabetes mellitus. (nih.gov)
The adjusted risk reduction with glargine was highest in the Phase IV studies. (nih.gov)
Merck said that its hepatitis C drug boceprevir hit its primary endpoints in two Phase III studies and will file for an approval of the potential blockbuster by the end of this year. (pharmatutor.org)
The first AVAREF joint review was for a clinical trial application of phase II and II-III studies of a conjugate meningitis A vaccine, produced by the Serum Institute of India. (who.int)
Before assessing the clinical utility of a predictive marker in a randomized trial, future studies should focus on prospective validation of the assay in a large and well defined population. (ovid.com)
Inovio is conducting Phase II clinical trials of related vaccine candidates based on DNA associated with leukemia and hepatitis C virus, and Phase I studies for influenza and HIV. (drugs.com)
Results of population studies and clinical trials. (healthlinkbc.ca)
This phase includes continued evaluation of the treatment effectiveness and monitoring of side effects as well as implementing studies to evaluate usefulness in different types of cancers. (urologycenternj.com)

Does Superior Volunteer Management Help Achieve Endpoints and Objectives in Phase I Trials? (xtalks.com)

Psoriasis is a chronic inflammatory hyperproliferative disease of the skin affecting approximately 2% of the world's population.This phase IV study is planned to monitor performance of Tinefcon in patients suffering from psoriasis under conditions of actual use and fulfill requirements to monitor all adverse drug reactions (ADRs) in psoriasis patients treated with Tinefcon. (clinicaltrials.gov)
The study will be performed at the two clinical practice sites of the Multiple Sclerosis Center at University of Medicine and Dentistry New Jersey-New Jersey Medical School, One of the two FDA approved preparations of higher dose interferon beta (Betaseron) will be compared at standard dose every other day (QOD) 250 ug subcutaneously(SQ) with Copaxone at 20mg SQ daily (QD) in 70 to 80 patients. (clinicaltrials.gov)
The study uses brain imaging with 3 Tesla MRI with triple dose Gadolinium for primary and secondary outcomes and several clinical and cognitive measures for secondary outcomes. (clinicaltrials.gov)
The value and purpose of a Phase IV clinical study is to increase the knowledge surrounding a new drug, tracking side effects, exploring new uses for the therapy as well as garnering a full understanding of the capability and uses of the drug. (pharma-mkting.com)
In this study, we explore clinical trials involving gastrectomy for GC, highlighting inadequacies and underlining promising surgical interventions and strategies. (ecancer.org)
Our study exposed a small number of trials, publication rate, absence of geographic variety in clinical trials involving gastrectomy for GC. (ecancer.org)
This study is a phase 4 trial evaluating the effect of obeticholic acid on clinical outcomes in patients with primary biliary cholangitis. (mdmercy.com)
A Phase II study was conducted in 104 healthy infants using Formulation H of the DTaP-sIPV vaccine containing high-dose sIPV (3, 100, and 100 D-antigen units for types 1, 2, and 3, respectively), and Formulations M and L, containing half and one-fourth of the sIPV in Formulation H, respectively. (worldwidescience.org)
A Phase III study was conducted in 342 healthy infants who received either Formulation M + oral polio vaccine (OPV) placebo or DTaP + OPV. (worldwidescience.org)
In the Phase III study, the seropositive rate was 100% for all Sabin strains after primary immunization, and the neutralizing antibody titer after booster immunization was higher than in the control group (DTaP + OPV). (worldwidescience.org)
She and colleagues reported follow-up data on a florbetapir Phase 2 study. (alzforum.org)
Suzanne Craft of the University of Washington, Seattle, presented data from a four-month Phase 2 study of intranasal insulin, which seemed to improve certain measures of cognition and daily function, as well as biomarker profiles, in patients with mild cognitive impairment (MCI) or early Alzheimer disease. (alzforum.org)
Aptly named SNIFF-120 (Study of Nasal Insulin to Fight Forgetfulness), this double-blind Phase 2 trial was funded by the National Institute on Aging. (alzforum.org)
A more in-depth study of the topics introduced in MAT 101. (maine.edu)
Participants assigned to the SI group began the 4-month weight loss phase of the study in April 2005, while DI participants will wait until the end of this first program offering to begin the weight loss program. (clinicaltrials.gov)
Study participants who complete the weight loss program and lose 8 or more pounds will be eligible to continue in the maintenance phase of the intervention. (clinicaltrials.gov)
Absorption, Distribution, Metabolism and Excretion of [14C]- Labeled BIA 5-453 and Metabolites Absorption, Distribution, Metabolism and Excretion of [14C]- Labeled BIA 5-453 and Metabolites - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. (tripdatabase.com)
Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. (tripdatabase.com)
NCT04762680) that is expected to recruit 720 volunteer participants ages 18 and older, with the goal of selecting the most appropriate antigen dosage for a Phase III study expected to begin in the second quarter. (genengnews.com)
According to a research study by CMSInfo, spending on clinical trials inthe United States reached $24 billion in 2005, and it is projected to rise to$32.1 billion by 2011. (medindia.net)
A phase I pharmacokinetic and translational study of the novel vascular targeting agent combretastatin a-4 phosphate on a single-dose intravenous schedule in patients with advanced cancer. (semanticscholar.org)
This study was conducted to identify the correlation between all seven EGFR ligands and clinical outcomes in mCRC treated with anti-EGFR antibodies. (nih.gov)
This is phase I, double blind, placebo-controlled safety and infectivity study of experimental human Norovirus genogroup GII.4 administered to healthy adults 18-49 years of age. (bioportfolio.com)
The purpose of this study is to further develop a formulation and dose regimen of the norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine that is immunogenic and safe in an eld. (bioportfolio.com)
Thus, in October 2006, Cancer Treatment Centers of America (CTCA) initiated a US Food and Drug Administration-approved phase 1 study of intravenous vitamin C for patients with solid tumors who have exhausted all other available treatments. (jaoa.org)
In the CTCA study, the first cohort of 3 patients is being treated with 30 g/m 2 -approximately 50 g for an average-sized individual-vitamin C infusions on 4 consecutive days per week for a period of 4 weeks. (jaoa.org)
Information from this study may provide the basis for a phase 2 trial of intravenous vitamin C. (jaoa.org)
In order to evaluate the possible advantage of subcutaneous (sc) injection versus iv injection, this study compared the biological activity of the two treatment regimens of ALT-803 in pre-clinical in vivo models. (ovid.com)
A toxicity study of mice receiving multiple injections of ALT-803 for 4 weeks by iv or sc routes revealed equivalent immune-related changes. (ovid.com)
Eighty-two previously treated haemophilia A patients with at least 1-year clinical follow-up were included in this study. (surrey.ac.uk)
This is China's first first-line phase III clinical study of dual immunotherapy for cervical cancer. (echemi.com)
By utilizing multiple clinical sites when needed, Cetero can ensure complete study enrollment. (medindia.net)
Third, the PhagoBurn clinical study, representing the world first phage therapy clinical trial using GMP produced phage cocktails, was launched in July 2015 and ended in January 2017. (europa.eu)
Due to an extended period for overcoming manufacturing challenges and consequently obtaining the necessary authorisations to launch the clinical study, only 13 months remained for patient inclusions instead of the 24 months initially planned. (europa.eu)
The approval is based on results from a phase 3 study that found it was noninferior to moxifloxacin. (bmj.com)
Calais da Silva FE, Bono AV, Whelan P, Brausi M, Marques Queimadelos A, Martin JA, Kirkali Z, Calais da Silva FM, Robertson C. Intermittent androgen deprivation for locally advanced and metastatic prostate cancer: results from a randomised phase 3 study of the South European Uroncological Group. (guidelinecentral.com)
Choo R, Klotz L, Danjoux C, Morton GC, DeBoer G, Szumacher E, Fleshner N, Bunting P, Hruby G. Feasibility study: watchful waiting for localized low to intermediate grade prostate carcinoma with selective delayed intervention based on prostate specific antigen, histological and/or clinical progression. (guidelinecentral.com)
Nitric Oxide Donor Isosorbide Mono Nitrate for Induction of Labor With Pre-labor Rupture of Membranes Nitric Oxide Donor Isosorbide Mono Nitrate for Induction of Labor With Pre-labor Rupture of Membranes - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. (tripdatabase.com)
Inovio is currently enrolling patients with CIN 2/3 or CIN 3 cervical dysplasias in its Phase II clinical study being conducted in multiple centers around the US and sites in Canada, Korea, South Africa and Australia. (drugs.com)
Inovio is currently recruiting for its Phase II study, which is designed to enroll 148 patients with cervical dysplasia at approximately 25 study centers. (drugs.com)
The best way of doing this is to study new treatments so we put a high priority on offering our patients the chance to take part in a clinical trial," Dr. Berry said in an interview in the cancer center, the second largest in Canada. (healthydebate.ca)
This trial, called USPHS Study 22, began in 1995, enrolled 1,075 TB patients from the United States and Canada, and reported final results in 2002. (cdc.gov)
We are excited to explore the impact of linerixibat further as we plan for a Phase 3 study. (drugs.com)
Based on these Phase 2b data GSK is preparing for a Phase 3 study and working with 23andMe to help identify patients who may be eligible for this programme, in the hope this could significantly shorten recruitment timelines. (drugs.com)

The most common intervention studied is laparoscopic gastrectomy in 43 (31%) trials. (ecancer.org)
The intervention program, called 'Weight-Wise', consists of a four-month weight loss intervention phase, and a one-year maintenance phase. (clinicaltrials.gov)
Intervention group, mother-infant dyads got a month long weekly based training in small workshop groups about nutrition, feeding and parenting when infants were 4-6 months old. (ichgcp.net)
Clinical trials can last months or years as researchers try to determine the safety of a given intervention and, whether it helps, harms or is no different than what is currently provided. (healthydebate.ca)

The US has a substantial lead in the number of TLS clinical trials globally. (prnewswire.co.uk)
South Africa has a substantial lead in the number of TB clinical trials globally. (yahoo.com)
The UK leads the number of sclerosing cholangitis clinical trials globally. (businessinsider.com)

Introduces clinical trial design in the context of epidemiological concepts, covers various topics in the design and conduct of clinical trials, and profiles clinical trials that illustrate these issues. (jhsph.edu)
Information gathered from preclinical tests are used to apply for permission to conduct clinical trials. (abpischools.org.uk)
Ruthigen plans to complete its Phase 1/2 clinical trial in Q1 2015 and, pending the successful completion of that trial, to conduct pivotal clinical trials. (thefreelibrary.com)
This new equipment will allow the Pre-Clinical Dermatology Research Laboratory to further expand its ability to conduct testing of in vitro percutaneous absorption and semisolid release to GLP standards, including analytical method development and validation. (medindia.net)
Planning together, the researchers and CDC decided to conduct first a randomized, clinical trial comparing a once-weekly, rifapentine-based, continuation-phase regimen to the then-standard, twice-weekly, rifampin-based "Denver" regimen, both given for the last 4 months of the 6-month treatment for TB. (cdc.gov)

The Comparative Effectiveness Research as Topic search strategy has been designed to retrieve citations "about" CER. (nih.gov)
This FOA issued by the National Institute on Aging encourages Clinical Trial Planning Grant (R34) applications to develop research protocols for Phase III and IV clinical trials related to critical illness and injury in aging. (nih.gov)
The planning grant mechanism is intended to permit early peer review of the rationale and design of the proposed Phase III or IV clinical trial, and to support development of a research team, tools for data management and research oversight, recruitment strategies, detailed protocol and Manual of Procedures (MOP), and other essential components necessary for a competitive clinical trial application. (nih.gov)
This FOA will utilize the Clinical Trial Planning Grant (R34) mechanism and runs in parallel with PA-10-042 , that encourages applications under the R01 Research Project grant mechanism, PA-10-043 , that encourages applications under the R03 Small Research Grant mechanism, and PA-10-044 , that encourages applications under the R21 Exploratory/Developmental grant mechanism. (nih.gov)
The purpose of this Funding Opportunity Announcement (FOA) is to continue the U.S.-South Africa Program for Collaborative Biomedical Research into Phase 2. (nih.gov)
Some scientists cautioned that even if the data withstood the FDA's review, it remained to be seen whether insurance will pay for amyloid imaging, and noted that this measure may add more value to clinical detection of early cases for research purposes than for routine diagnosis in the community. (alzforum.org)
International Clinical Psychopharmacology provides an essential link between research and clinical practice throughout psychopharmacology. (lww.com)
Other topics covered include the epidemiology of psychotropic drug prescribing and drug taking, the sociology of psychotropic drugs including compliance, and research into the safety and adverse effects of these compounds. (lww.com)
The scientists say that many trial reforms being considered to raise Phase II positive predictibility (reduction of late-phase attrition) have repercussions for human subjects, as well as the capacity of the research enterprise to "execute its social mission. (genengnews.com)
The research found that weight gain in mice in which activity of eIF4E was inhibited either genetically or by using a compound that is in clinical development against cancer, was only half that of control mice, even if all the animals were fed the same high-fat diet. (genengnews.com)
CAMBRIDGE, Mass., June 17 PROMETRIKA, LLC, a contractresearch organization providing a full range of clinical research services forclients in pharmaceuticals, biologics and medical devices, today announcedthat Faith Haines Kolb has joined the company as senior director of clinicaloperations and data management. (medindia.net)
With more than 19 years of experience inclinical research, Ms. Kolb has set up and managed multiple large scaleclinical research programs from planning through all phases of execution, datamanagement, and reporting. (medindia.net)
As we continue to expand ourservices in the clinical research areas that are critical for our clients atPROMETRIKA, her demonstrated strengths in project management, monitoring,electronic data capture, and working successfully with global researchnetworks will be a tremendous asset for us moving forward," said MiganushStepanians, PhD, president and CEO of PROMETRIKA. (medindia.net)
With a strongfocus on improving clinical research services for pharmaceutical,biotechnology and medical device companies, PROMETRIKA is setting a newstandard in terms of efficiency and quality control for clinical trials. (medindia.net)
The clinical operations team at PROMETRIKA provides research planning andexecution services to support product development in pharmaceuticals,biologics and medical devices for companies around the world. (medindia.net)
The Congressional Budget Office in the United Statesestimates that by 2003 the average cost to develop a drug that represents anew molecular entity (NME) reached $802 million and the development timelinefor NME drugs required an average of 7.5 years of clinical stage research. (medindia.net)
With Faith's experiencein these areas, PROMETRIKA is better prepared than ever before to be acomprehensive resource to help our clients plan and execute strategic andsuccessful clinical research programs," Ms. Stepanians added. (medindia.net)
The company provides a fullrange of clinical research services to pharmaceutical, biotechnology andmedical device companies. (medindia.net)
The report provides Psoriasis pipeline products by clinical trial stages including both early and late stage development - phase 3 clinical trials, phase 2 clinical trials, phase 1 clinical trials, preclinical research, and discovery stage. (epicos.com)
In 2000, Dr. Pittenger joined DaVita Clinical Research as a Clinical Scientist. (umn.edu)
Dr. Pittenger's pharmacy career has included many diverse settings, including basic and clinical research, practice in the critical care setting and with underserved populations, pharmaceutical industry, and academia - specifically distance education/online teaching and now interprofessional education. (umn.edu)
Subjects susceptible to the human norovirus GII.4 challenge strain, CIN-1 (i.e. presence of a functional FUT-2 gene), regardless of ABO blood type, will be housed in the Cincinnati Center for Clinical Research (CCCR) inpatient facility and challenged orally with different doses of the virus. (bioportfolio.com)
Following up on our recent webinar Setting a Real-World Strategy in an Evolving Clinical Research Environment , this is the first of two blogs on this critical topic. (premier-research.com)
In this post, we'll cover the importance of process in ensuring a robust strategy is in place for the acquisition and analysis of trial data in the face of a changing clinical research environment. (premier-research.com)
The clinical research environment has been impacted in multiple ways, ranging from new regulatory requirements to supply chain interruptions and shipping delays. (premier-research.com)
A few days ago, Kangfang Biosciences has successfully held this global phase III clinical research expert seminar. (echemi.com)
CARY, N.C., Aug. 19 Cetero Research, the leading early-stage contract research organization (CRO), today announced the expansion of multiple Clinical Dermatology and Transdermal Delivery System (TDDS) services to four Cetero clinical facilities. (medindia.net)
Cetero's four decades of combined in vitro and in vivo topical pharmacokinetics experience ensures that our clients benefit from rapid, efficient and early product optimization," said Dr. Thomas Franz, M.D., Executive Medical Director of Cetero Research. (medindia.net)
In addition to adding functionality at its clinical facilities, the Pre-Clinical Dermatology Research Laboratory has expanded its analytical capability with the addition of two MicroMass LC/MS/MS systems to complement its current four LC/MS and four LC/UV and GC/MS systems. (medindia.net)
ACTS has partnered with the Clinical Research Forum (CRF) to support the growth and development of JCTS . (cambridge.org)
Nor is this sector limited to the (bio-)pharmaceutical industry, but it also includes health authorities, academia and research centres, clinical investigator sites, contract research organisations (CROs) and many more. (intechopen.com)
Of all the truisms that apply to clinical drug research, probably none is more universally accepted than this one: "There's no substitute for experience. (premier-research.com)
With the decline in opioid research, we're seeing a more diverse range of trials, including more injectables and locally acting patches. (premier-research.com)
In the 1960s, the USPHS TB control and clinical research programs were transferred to CDC from the National Institutes of Health in Maryland. (cdc.gov)
Roughly 80% of 23andMe customers agree to participate in research and are eligible to receive information about relevant clinical trials. (drugs.com)

Ruthigen Announces First Patient Enrollment in the Phase 1/2 Human Clinical Trial of RUT58-60, a Broad-Spectrum Anti-Infective Drug Candidate Designed for Prophylactic Use During Invasive Surgery. (thefreelibrary.com)
There are a wide range of topics covered in our clinical trial webinars - from tips on clinical trial start-up and adaptive trials to risk-based monitoring and best practices for clinical trial enrollment. (xtalks.com)

This Market Spotlight report covers the Migraine market, comprising key pipeline and marketed drugs, clinical trials, upcoming and regulatory events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts. (prnewswire.co.uk)
Pipeline analysis: focus on the seven late-stage pipeline drugs discussing emerging trends as well as overview of earlier phase drugs. (sbwire.com)
This Market Spotlight report covers the Tuberculosis (TB) market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, patent information, a 10-year disease incidence forecast, and licensing and acquisition deals. (yahoo.com)
This Market Spotlight report covers the Primary Sclerosing Cholangitis market, comprising disease background, treatment overview, key pipeline drugs, clinical trials, and a 10-year global disease prevalence forecast. (businessinsider.com)

145 vaccine candidates across the world are under pre-clinical evaluation, around 35 under clinical trials. (livemint.com)
In India, we gave all support to 30 vaccine candidates -3 of these are in advanced trials of phases 1, 2, and 3. (livemint.com)

Adequate management of trial design can help decrease duration and increase validity of results. (ecancer.org)
That way they cannot be biased in their recording of the results of the trial - how well the medicine worked and whether the patient suffered any side effects. (abpischools.org.uk)
Phase I clinical trial of weekly combretastatin A4 phosphate: clinical and pharmacokinetic results. (semanticscholar.org)
High-impact upcoming events for drugs in the migraine space include topline Phase II and Phase III trial results, as well as FDA decisions on BLAs. (prnewswire.co.uk)
BET bromodomain inhibitor, Zenith spin-out, postive Phase 2 results, negative Phase 2 results. (agoracom.com)
Despite this limited number of inclusions, along with stability monitoring and shelf life issues, the trial yielded highly stimulating and informative results, which are in the process of being published in detail in an appropriate scientific journal. (europa.eu)
High-impact upcoming events for drugs in the TB space comprise topline Phase II trial results for GSK3036656 and a meeting with the FDA for SPR720. (yahoo.com)
Five-year results of a randomized clinical trial on treatment in Dupuytren's disease: percutaneous needle fasciotomy versus limited fasciectomy. (epnet.com)
High-impact upcoming events in the primary sclerosing cholangitis space include topline Phase II trial results. (businessinsider.com)
Phase III trials require a large number of patients to measure the statistical validity of the results because patient age, sex, race, and other unknown factors could affect the results. (urologycenternj.com)

Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. (guidelinecentral.com)
A double-blind, placebo-controlled, randomized trial of oral sodium clodronate for metastatic prostate cancer (MRC PR05 Trial). (guidelinecentral.com)

The primary purpose of a Phase I trial is to evaluate the safety of a new drug or treatment. (survivorshipatoz.org)
There are generally no conclusions about how well a drug works in Phase I trials. (survivorshipatoz.org)
If the drug or treatment appears to be safe, it moves to Phase II. (survivorshipatoz.org)
Healthy volunteers were given IV a new anti-anginal drug in a phase 1 clinical trial. (proprofs.com)
A control that is used in drug trials. (abpischools.org.uk)
These and other extra "burdens" in Phase II trials, the ethicists say, are not morally equivalent to those found in Phase III trials because risks of drug administration in confirmatory trials are ethically justified by clinical "equipoise", or a state of collective uncertainty about whether experimental treatment is preferable to standard care, and therefore plausibly claim therapeutic value for subjects. (genengnews.com)
The journal is essential reading for all researchers and clinicians involved in drug therapy and clinical trials. (benthamscience.com)
The company has extensive experience in all areas ofclinical trial management, including strategic planning, data collection andanalysis, and regulatory filings, including new drug applications in the U.S.and Europe. (medindia.net)
Uloric is the only drug in active clinical development in the US for TLS. (prnewswire.co.uk)
Cadonilimab (AK104) is a new and potential next-generation backbone drug for PD-1/CTLA-4 bispecific tumor immunotherapy independently developed by Kangfang Bio. (echemi.com)
It was first discovered in a small molecule screen as a drug that elevated apolipoprotein-AI synthesis and secretion in cells, and was shown in a primate model and early human clinical trials (i.e. (agoracom.com)
Its bioanalytical services support clinical, preclinical drug and biomarker analysis for small and large molecules. (medindia.net)
In the context of a worldwide growing antibiotic resistance threat, notably the emergence of multi-drug resistant, even pan-resistant, bacterial strains, PhagoBurn was launched to evaluate the clinical potential of bacteriophages (phages) as a novel and innovative strategy to fight this critical issue. (europa.eu)
The majority of industry-sponsored drugs in active clinical development for primary sclerosing cholangitis are in Phase II, with just one drug in Phase III. (businessinsider.com)
In one trial a higher percentage of patients taking the drug had to drop out, citing side effects like anemia. (pharmatutor.org)
This phase is probably the most important step in the development of a new drug or therapy. (urologycenternj.com)
However, the primary goals of this phase are to determine anticancer activity in humans, the maximum tolerated dose of the treatment, the manner in which the drug works in the body, the toxic side effects related to different doses and whether toxic side effects are reversible. (urologycenternj.com)
Phase III trials compare a new drug or therapy with a standard therapy in a randomized and controlled manner in order to determine proof of effectiveness. (urologycenternj.com)
Once the drug or treatment becomes part of standard therapy, the manufacturer of the drug may elect to initiate phase IV trials. (urologycenternj.com)

In the 30,000-patient REVEAL (Randomized Evaluation of the Effects of Anacetrapib through Lipid Modification) trial, anacetrapib doubled HDL cholesterol, reduced non-HDL cholesterol by 17 mg/dl (0.44 mmol/l), and reduced major vascular events by 9% over 4 years, but anaceptrapib was found to accumulate in adipose tissue, and regulatory approval is not being sought. (nih.gov)
By way of this Notice, Health Canada is informing stakeholders that it has completed its pilot phase and is implementing its strategy for DSUR regulatory reviews in the Health Product and Food Branch (HPFB). (canada.ca)

Dose-dependent reduction of hazardous alcohol use in a placebo-controlled trial of naltrexone for smoking cessation. (yale.edu)

and use of data from randomized trials. (jhsph.edu)
All data pertaining to the trials were collected. (ecancer.org)
Thousands of patients will take the new medicine, or the best alternative treatment, and the data from these trials will decide if the new medicine is safe and effective enough to be prescribed by doctors for the general population. (abpischools.org.uk)
Even the skies of Honolulu, which hosts the Alzheimer's Association's International Conference on Alzheimer's Disease (ICAD) from 10-15 July 2010, could not have been sunnier than the presentation of Phase 3 histopathology data reported Sunday by Christopher Clark of Avid Radiopharmaceuticals, Philadelphia, Pennsylvania. (alzforum.org)
In Honolulu, Craft presented data from a four-month trial of 104 patients with amnestic MCI or early AD. (alzforum.org)
Can Your Clinical Data Strategy Keep Pace? (premier-research.com)
Underlying it all are the process changes necessary to support the structure of a clinical trial and help us better understand what is possible for speed, cost, and the quality of data. (premier-research.com)
During the clinical trial, processes are what allow us to capture or collect the data needed for specific information. (premier-research.com)
The complexity of running a clinical trial is evident when you consider that each of these data sources employs a different technology or application that is capturing the inputs necessary for decision-making. (premier-research.com)
Then in 2015 came more analyses of Phase 2 trial data showing that apabetalone reduces alkaline phosphatase and that in chronic kidney disease subjects in ASSURE/SUSTAIN that apabetalone improved the eGFR. (agoracom.com)
Process manuscripts describe innovative methods to design clinical trials and to accrue, collate, and analyze data. (cambridge.org)
Patient-level data from all randomized Phase III/IV clinical trials sponsored by the manufacturer of glargine that compared glargine and NPH and were available in May 2004 were included in the model. (nih.gov)
Four other sponsored trials were not included because the databases were not finalized, and 3 investigator-initiated trials were not included because patient-level data were unavailable. (nih.gov)
That way, we can objectively evaluate sites on the basis of the most important criteria, such as data integrity and the ability to manage placebo response - a concern that is of particular (and growing) significance in pain trials. (premier-research.com)

A large number of industry-sponsored drugs in active clinical development for migraine are in Phase III. (prnewswire.co.uk)
The majority of industry-sponsored drugs in active clinical development for TB are in Phase II. (yahoo.com)

Selection of the treatment effect for sample size determination in a superiority clinical trial using a hybrid classical and Bayesian procedure. (yale.edu)
I am currently working in two main areas: identifying novel biomarkers for diagnosis and treatment monitoring of TB, and translating evidence-based strategies for diagnostic evaluation of TB into routine clinical and public health practice using implementation science. (yale.edu)
In Phase I trials, researchers generally administer the new treatment to a small group of people, usually 10-80 participants. (survivorshipatoz.org)
Purpose The primary purpose of a Phase II trial is to determine the effectiveness of a treatment and to further evaluate its safety. (survivorshipatoz.org)
Conclusion If a significant number of patients (usually at least one-fifth) respond favorably to a treatment, it proceeds to Phase III. (survivorshipatoz.org)
If during the trial it is determined that one treatment is superior to another, the trial may be stopped. (survivorshipatoz.org)
Currently, ALT-803 is in clinical trials for treatment of various solid tumors and hematological malignancies. (ovid.com)
The objective clinical activity of immune checkpoint inhibitors has changed this vision, and the near future will very likely take immunotherapy into the frontline of systemic treatment of HCC. (aacrjournals.org)
Inovio's] VGX-3100 is a therapeutic DNA vaccine candidate, now in Phase II testing for the treatment of cervical dysplasia and cancer caused by human papillomavirus (HPV) types 16 and 18. (drugs.com)
Most trials today compare a new treatment to a current one. (healthydebate.ca)
If it works well, it goes onto Phase 3 trials, which are large trials [hundreds or thousands of patients recruited at many centres] that compare a new treatment with the standard one, different doses or ways of giving a standard treatment. (healthydebate.ca)
These trials are randomized, which means that patients are put into two groups: one to get the new treatment and the other to get the standard or placebo [a sugar pill if there is no standard treatment. (healthydebate.ca)
Development of new anticancer agents and treatment strategies occurs in four phases. (urologycenternj.com)
Each phase is designed to determine specific information about the potential new treatment such as its risks, safety and effectiveness compared to standard therapy. (urologycenternj.com)
Once the information is gathered and analyzed from phase I trials, phase II trials are designed to determine the effectiveness of the treatment in a specific patient population at the dose and schedules determined in phase I. These trials usually require a slightly higher number of patients than phase I trials. (urologycenternj.com)

Dr. Cohen's training is in epidemiology and clinical medicine, and his work includes mathematical modeling, fieldwork, and analysis of. (yale.edu)

After getting their brains imaged with florbetapir at baseline, the participants had their symptoms assessed every six months through phone interviews, and returned for clinical and neuropsychological evaluation at 18 months. (alzforum.org)

The distribution of clinical trials across Phase I-IV indicates that the majority of trials for sclerosing cholangitis have been in Phase II, with five trials in Phase II, and only one trial each in Phase I and III. (businessinsider.com)

Union Health Minister Dr Harsh Vardhan on Sunday informed that over four coronavirus vaccines are in advanced stages of pre-clinical trial in India. (livemint.com)

More trials comparing different surgical techniques are needed to update the surgical practice of gastrectomy for GC. (ecancer.org)
The CaRES registry was established following discussions with the FDA to further explore the safety profile of Definity as it is used in clinical practice. (healthimaging.com)

Key topics covered include market characterization, unmet needs, R&D and clinical trials assessment, late stage clinical trial analysis and implications for the migraine therapeutics market. (sbwire.com)

RESTON, Va., Oct. 5, 2011 /PRNewswire/ -- Clinical Care Options (CCO), a leader in next-generation medical education, information, and publishing for healthcare professionals, today announced the addition of the ClinicalTrials.gov database to CCO inPractice™, a free, searchable online point-of-care CME resource for specialists in HIV and oncology. (bio-medicine.org)

Each phase has different purposes and entails different levels of risks for participants. (survivorshipatoz.org)
Number of Participants This larger trial group may include 300-5,000 people or more. (survivorshipatoz.org)
Participants were randomized into three roughly equal groups that received saline placebo or insulin (20 or 40 IU) through the nose each day, and underwent cognitive testing at baseline, two months, and four months. (alzforum.org)
During the 1-year maintenance phase (which will start at the end of the weight loss phase for both SI and DI), participants in the SI group will receive 1 individual face-to-face contact with the health counselor, 8 monthly phone contacts, and 3 group sessions. (clinicaltrials.gov)
Randomized clinical trials with at least 200 participants and meta-analyses . (komen.org)

One hundred thirty-eight clinical trials met the search criteria. (ecancer.org)
Register for upcoming (live) or recorded webinars, choose by topic, or search by keyword to find webinars of interest. (xtalks.com)

We will develop a PMO to skip exon 53 and perform a clinical trial in DMD boys using a world leading pan-European consortium. (europa.eu)

Other scientists' informal hallway comments ranged from enthusiasm that the availability of an approved agent to image a key AD pathology would transform the clinical trial landscape, to more guarded optimism. (alzforum.org)

Although BCC and SCC are by far the most frequent types of nonmelanoma skin cancers, approximately 82 types of skin malignancies, with a wide range of clinical behaviors, fall into the category of nonmelanoma skin cancer. (adventisthealthcare.com)
Currently there are more than 650 clinical trials taking place across Canada for all different forms of cancers. (healthydebate.ca)

Among 36 mCRC patients who had been treated with cetuximab or panitumumab, we identified 26 mCRC patients with wild-type KRAS status treated properly as the second and further lines and analyzed the relationship between immunoreactivity to seven EGFR ligands and clinical outcomes. (nih.gov)
Good clinical outcomes were associated with immunoreactivity against amphiregulin (AR), heparin-binding epidermal growth factor (HB-EGF), transforming growth factor-α (TGF-α), and epiregulin (EREG). (nih.gov)

Apart from these traditional methods of analysis by a reader who will be blinded to patient clinical status and therapy, objective volumetric analysis will be carried out. (clinicaltrials.gov)
This conference will address the key challenges associated with conducting a phase iv trial and the various methods and opportunities available for addressing these obstacles. (pharma-mkting.com)
Particular topics include random variables and their distributions, methods of descriptive statistics, estimation and hypothesis testing, regression, and correlation. (maine.edu)
The lanthanides (III) and yttrium (III) glucoheptonates as well the D-glucoheptono 1-4 lactone were studied using common analytical methods, elemental microanalysis of carbon and hydrogen, thermogravimetry and differential scanning calorimetry. (worldwidescience.org)
Methods:Asymptomatic subjects without known ocular disease recruited over a six-month period .For each eye, two undilated 45 fundus images, and four undilated volume OCT image sets covering the macula and optic nerve, were obtained. (octnews.org)

Approximately 70% of drugs or treatments tested in Phase I trials proceed to the next phase. (survivorshipatoz.org)
Approximately 33% of drugs and treatments proceed to the next phase. (survivorshipatoz.org)
Approximately 25-30% of drugs and treatments will clear this phase. (survivorshipatoz.org)
Reducing false-positives in Phase II trials, the authors say, is ethically attractive because, for example, it reduces the occurrence of failure in Phase III, and can limit the number of patient-volunteers exposed to unsafe and ineffective drugs. (genengnews.com)
Patients with stage III and stage IV cancer can be candidates for phase I and phase II clinical trials testing new drugs, biologicals, or surgical techniques to improve local control and distant metastases. (adventisthealthcare.com)
Drugs, on average, take 9.6 years from Phase I to approval, compared to 9.0 years in the overall infectious disease space. (yahoo.com)
Phase 2 trials try to find out what types of cancer the drugs work for and to get a better idea of side effects. (healthydebate.ca)

Fewer than 3% of cancer patients enter clinical trials in the United States, even though trials are readily available in many parts of the country," said Ramaswamy Govindan, MD, Editor in Chief of CCO inPractice Oncology and Professor of Medicine and Co-Director, Section of Medical Oncology at Washington University School of Medicine, St Louis, Missouri. (bio-medicine.org)
Clinical Care Options, a leader in the development of innovative, interactive, online medical education programs and proprietary medical education technologies for healthcare professionals, creates and publishes original continuing medical education and information resources that are designed specifically for healthcare providers in the areas of HIV, hepatitis/gastroenterology, and hematology/oncology. (bio-medicine.org)

In this position, she was involved in the development and coordination of Phase I-IV clinical trials. (umn.edu)
The distribution of clinical trials across Phase I-IV indicates that the majority of trials for TLS have been in the late phase of development, with 66.6% in Phase III-IV and only 33.3% in Phase I-II. (prnewswire.co.uk)
The mechanisms of escape are complex and incompletely understood, yet they have provided the main rationales for the development of immunotherapy in HCC ( 4 ). (aacrjournals.org)

Clinical and experimental experiences with intravenous vitamin C. J Orthomol Med . (jaoa.org)

He has been awarded Fellowships of the American Heart Association and of the National Academy of Clinical Biochemistry (USA) for his contributions to atherosclerosis and lipid biology which include 300 publications, 19 book chapters and 1 book. (benthamscience.com)
The investigators include an osteopathic internist (C.M.S.), a medical oncologist (R.D.L.), and a clinical epidemiologist (C.G.L. (jaoa.org)
Requirements of this rotation include a case presentation, journal club and topic presentation. (pennstatehealth.org)
Topics of interest include investigations into how to best develop processes and people that translate discoveries into improved health. (cambridge.org)
The open-label, non-randomized CaRES (Contrast Echocardiography REgistry for Safety Surveillance) registry will be conducted in at least 10 clinical sites in the U.S. and include at least 1,600 patients, the North Billerica, Mass.-based Lantheus said. (healthimaging.com)

Phase II is initiated with a therapeutic dose to determine the treatment's effectiveness and further safety. (xtalks.com)
The safety and immunogenicity of these Shigella conjugates in 4 to 6 years-old children in Israel was demonstrated. (bioportfolio.com)
Our online education sessions cover a wide range of topics - from medication safety to aphasia and dementia to the progression of dementia. (alzheimer.mb.ca)
There are four phases to clinical trials, with phase 1 being the earliest, smallest - recruiting up to about 30 patients - and are often referred to as dosing or safety trials. (healthydebate.ca)
Safety and tolerability were considered acceptable to proceed to Phase 3 planning. (drugs.com)

but doesn't it seem like you are always hearing about early human trials for vaccines and whatnot? (letsgopens.com)

In addition to MRI, several clinical and cognitive outcome measures will be used for secondary analysis. (clinicaltrials.gov)
Primary outcome measures were four-month change on cognitive (ADAS-Cog, delayed story recall) and functional (ADCS-ADL, Dementia Severity Rating Scale) tests. (alzforum.org)
To date, 4 CETP inhibitors have entered phase 3 cardiovascular outcome trials. (nih.gov)

The company's clinical program targets an initial $700 million potential market in the prevention of infections associated with abdominal surgery, with the market for the prevention of infections associated with all types of surgery being estimated at $3 billion. (thefreelibrary.com)

TBTC clinical trials have enrolled more than 16,000 patients and volunteers over the past 20 years. (cdc.gov)

This understanding, combined with our advanced technology, allows our integrated team of dermatology experts to seamlessly leverage their knowledge into the design and performance of clinical trials. (medindia.net)
Hopefully, ongoing trials will help to design better treatments in the future. (aacrjournals.org)

The level suggested by chiropractors for these curriculum areas is equal to the "evaluating" level where chiropractic students can remember, understand, apply, and analyze anatomical knowledge to be able to justify a clinical decision. (chiro.org)

In fact, renal and urinary tract disorders were reported (albeit not in detail) during an extended phase III [Uloric (febuxostat)] clinical trial [12]. (drug-injury.com)

As about two thirds of therapeutic interventions that enter Phase III fail to reproduce success observed in Phase II trials. (genengnews.com)

Organisms2

Diseases6

Chemicals and Drugs3

Analytical, Diagnostic and Therapeutic Techniques and Equipment21

Psychiatry and Psychology1

Phenomena and Processes4

Disciplines and Occupations5

Anthropology, Education, Sociology and Social Phenomena3

Technology, Industry, Agriculture1

Information Science4

Named Groups2

Health Care15

Publication Characteristics1

Geographicals6

Apomorphine to Uprima: the development of a practical erectogenic drug: a personal perspective. (1/25)

Update on intravenous tissue plasminogen activator for acute stroke: from clinical trials to clinical practice. (2/25)

Cardiovascular thrombotic events in controlled, clinical trials of rofecoxib. (3/25)

Clinical data gap between phase III clinical trials (pre-marketing) and phase IV (post-marketing) studies: evaluation of etanercept in rheumatoid arthritis. (4/25)

Clinical and bacteriologic efficacy of telithromycin in patients with bacteremic community-acquired pneumonia. (5/25)

Assessing the relationship between antigenicity and immunogenicity of human rabies vaccines. Results of a meta-analysis. (6/25)

Ezetimibe added to statin therapy (EASY study) - an evaluation by Australian general practitioners. (7/25)

Clinical trials in severe sepsis with drotrecogin alfa (activated). (8/25)

Clinical Trials, Phase IV as Topic

Clinical Trial, Phase IV

Valsalva Maneuver

Clinical Trials as Topic

Treatment Outcome

Prospective Studies

Clinical Trials, Phase III as Topic

Clinical Trials, Phase II as Topic

Clinical Trials, Phase I as Topic

Research Design

Breakthrough Pain

Insulin, Short-Acting

Administration, Buccal

Fentanyl

Labor Pain

Analgesics, Opioid

Fourier Analysis

Communicable Disease Control

Education, Graduate

Iceland

Epidemiology

Communicable Diseases

Night Care

Comparative Effectiveness Research

Matched-Pair Analysis

United States Agency for Healthcare Research and Quality

United States

American Recovery and Reinvestment Act

Randomized Controlled Trials as Topic

Drug Repositioning

Questionnaires

Survivors

Prosthesis Failure

San Francisco

Drug Industry

Chamaecrista

Software

Drug Discovery

Internet

Gastrectomy

Stomach Neoplasms

Jordan

Postgastrectomy Syndromes

Gastroenterostomy

Anastomosis, Roux-en-Y

Carnivora

Mathematics

England

Universities

Legal Guardians

Mathematical Concepts

Great Britain

Apomorphine to Uprima: the development of a practical erectogenic drug: a personal perspective. (1/25)

Update on intravenous tissue plasminogen activator for acute stroke: from clinical trials to clinical practice. (2/25)

Cardiovascular thrombotic events in controlled, clinical trials of rofecoxib. (3/25)

Clinical data gap between phase III clinical trials (pre-marketing) and phase IV (post-marketing) studies: evaluation of etanercept in rheumatoid arthritis. (4/25)

Clinical and bacteriologic efficacy of telithromycin in patients with bacteremic community-acquired pneumonia. (5/25)

Assessing the relationship between antigenicity and immunogenicity of human rabies vaccines. Results of a meta-analysis. (6/25)

Ezetimibe added to statin therapy (EASY study) - an evaluation by Australian general practitioners. (7/25)

Clinical trials in severe sepsis with drotrecogin alfa (activated). (8/25)

Erythrocyte Sedimentation Rate Wintrobes Blood in DLF Phase IV, Gurgaon. View Prices, Labs & Book online only on | Practo

Top Paediatric Neurosurgery Hospitals in Dlf City Phase Iv, Gurgaon | Credihealth

20-th National Congress of Anesthesiology and Intensive Care with international participation

Manufacturer of anti-cancer Oncology products in India

The Gideon the Ninth Reread: Chapters 7 and 8 | Tor.com

Global Investigations Review - The Guide to Cyber Investigations - Second Edition

Infant Health and Development Program, Phase IV, 2001-2004 [United States]

A Phase IV Trial of Cesamet™ Given With Standard Antiemetic Therapy for Chemotherapy-induced Nausea and Vomiting - Full Text...

A 8-week, Multi-Centre, Open-label, Non-comparative, Phase IV Study of the Efficacy and Safety of Quetiapine Fumarate Extended...

Mallinckrodt Initiates Phase IV Study on Acthar for Keratitis

Best Neuro Radiologist in Dlf City Phase Iv, Gurgaon | Credihealth

Multicenter, interventional, single-arm, phase IV study evaluating tolerability of Eribulin and its relationship with a set of...

Phase IV - Roadway and Drainage Improvements | Augusta, GA - Official Website

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