Vaccines or candidate vaccines used to prevent infection with WEST NILE VIRUS.
A species of ALPHAVIRUS causing encephalomyelitis in Equidae and humans. The virus ranges along the Atlantic seaboard of the United States and Canada and as far south as the Caribbean, Mexico, and parts of Central and South America. Infections in horses show a mortality of up to 90 percent and in humans as high as 80 percent in epidemics.
An RNA virus infection of rhesus, vervet, and squirrel monkeys transmissible to man.
Vaccines or candidate vaccines used to prevent EBOLA HEMORRHAGIC FEVER.
Vaccines or candidate vaccines used to prevent infection with CYTOMEGALOVIRUS.
Suspensions of killed or attenuated microorganisms (bacteria, viruses, fungi, protozoa), antigenic proteins, synthetic constructs, or other bio-molecular derivatives, administered for the prevention, amelioration, or treatment of infectious and other diseases.
Suspensions of attenuated or killed viruses administered for the prevention or treatment of infectious viral disease.
Neon. A noble gas with the atomic symbol Ne, atomic number 10, and atomic weight 20.18. It is found in the earth's crust and atmosphere as an inert, odorless gas and is used in vacuum tubes and incandescent lamps.
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.
Antibodies produced by a single clone of cells.
One of the three domains of life (the others being Eukarya and ARCHAEA), also called Eubacteria. They are unicellular prokaryotic microorganisms which generally possess rigid cell walls, multiply by cell division, and exhibit three principal forms: round or coccal, rodlike or bacillary, and spiral or spirochetal. Bacteria can be classified by their response to OXYGEN: aerobic, anaerobic, or facultatively anaerobic; by the mode by which they obtain their energy: chemotrophy (via chemical reaction) or PHOTOTROPHY (via light reaction); for chemotrophs by their source of chemical energy: CHEMOLITHOTROPHY (from inorganic compounds) or chemoorganotrophy (from organic compounds); and by their source for CARBON; NITROGEN; etc.; HETEROTROPHY (from organic sources) or AUTOTROPHY (from CARBON DIOXIDE). They can also be classified by whether or not they stain (based on the structure of their CELL WALLS) with CRYSTAL VIOLET dye: gram-negative or gram-positive.
The act or practice of calling public attention to a product, service, need, etc., especially by paid announcements in newspapers, magazines, on radio, or on television. (Random House Unabridged Dictionary, 2d ed)
An ansa macrolide isolated from the MAYTENUS genus of East African shrubs.
Thiohydantoin benzene derivative.
An enzyme that catalyzes the hydrolysis of CHOLESTEROL ESTERS and some other sterol esters, to liberate cholesterol plus a fatty acid anion.
A formal process of examination of patient care or research proposals for conformity with ethical standards. The review is usually conducted by an organized clinical or research ethics committee (CLINICAL ETHICS COMMITTEES or RESEARCH ETHICS COMMITTEES), sometimes by a subset of such a committee, an ad hoc group, or an individual ethicist (ETHICISTS).
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.
Hospital or other institutional committees established to protect the welfare of research subjects. Federal regulations (the "Common Rule" (45 CFR 46)) mandate the use of these committees to monitor federally-funded biomedical and behavioral research involving human subjects.
Diminution or cessation of secretion of one or more hormones from the anterior pituitary gland (including LH; FOLLICLE STIMULATING HORMONE; SOMATOTROPIN; and CORTICOTROPIN). This may result from surgical or radiation ablation, non-secretory PITUITARY NEOPLASMS, metastatic tumors, infarction, PITUITARY APOPLEXY, infiltrative or granulomatous processes, and other conditions.
Unsaturated androstanes which are substituted with one or more hydroxyl groups in any position in the ring system.
The type species of LENTIVIRUS and the etiologic agent of AIDS. It is characterized by its cytopathic effect and affinity for the T4-lymphocyte.
The phenomenon of antibody-mediated target cell destruction by non-sensitized effector cells. The identity of the target cell varies, but it must possess surface IMMUNOGLOBULIN G whose Fc portion is intact. The effector cell is a "killer" cell possessing Fc receptors. It may be a lymphocyte lacking conventional B- or T-cell markers, or a monocyte, macrophage, or polynuclear leukocyte, depending on the identity of the target cell. The reaction is complement-independent.
Vaccines or candidate vaccines containing inactivated HIV or some of its component antigens and designed to prevent or treat AIDS. Some vaccines containing antigens are recombinantly produced.
An HIV species related to HIV-1 but carrying different antigenic components and with differing nucleic acid composition. It shares serologic reactivity and sequence homology with the simian Lentivirus SIMIAN IMMUNODEFICIENCY VIRUS and infects only T4-lymphocytes expressing the CD4 phenotypic marker.
Vaccines in which the infectious microbial nucleic acid components have been destroyed by chemical or physical treatment (e.g., formalin, beta-propiolactone, gamma radiation) without affecting the antigenicity or immunogenicity of the viral coat or bacterial outer membrane proteins.
The branch of mathematics dealing with the purely logical properties of probability. Its theorems underlie most statistical methods. (Last, A Dictionary of Epidemiology, 2d ed)
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.
The non-genetic biological changes of an organism in response to challenges in its ENVIRONMENT.
The number of units (persons, animals, patients, specified circumstances, etc.) in a population to be studied. The sample size should be big enough to have a high likelihood of detecting a true difference between two groups. (From Wassertheil-Smoller, Biostatistics and Epidemiology, 1990, p95)
A large group of diseases which are characterized by a low prevalence in the population. They frequently are associated with problems in diagnosis and treatment.
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 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.
Tumors or cancer of the LUNG.
A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.
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.
Inhibitors of HIV INTEGRASE, an enzyme required for integration of viral DNA into cellular DNA.
Inhibitors of reverse transcriptase (RNA-DIRECTED DNA POLYMERASE), an enzyme that synthesizes DNA on an RNA template.
OXAZINES with a fused BENZENE ring.
An HIV protease inhibitor that works by interfering with the reproductive cycle of HIV. It also inhibits CYTOCHROME P-450 CYP3A.
Six-membered heterocycles containing an oxygen and a nitrogen.
A potent, non-nucleoside reverse transcriptase inhibitor with activity specific for HIV-1.
The ability of viruses to resist or to become tolerant to chemotherapeutic agents or antiviral agents. This resistance is acquired through gene mutation.
Treatment of disease by inserting needles along specific pathways or meridians. The placement varies with the disease being treated. It is sometimes used in conjunction with heat, moxibustion, acupressure, or electric stimulation.
The occupational discipline of the traditional Chinese methods of ACUPUNCTURE THERAPY for treating disease by inserting needles along specific pathways or meridians.
Designated locations along nerves or organ meridians for inserting acupuncture needles.
Therapeutic practices which are not currently considered an integral part of conventional allopathic medical practice. They may lack biomedical explanations but as they become better researched some (PHYSICAL THERAPY MODALITIES; DIET; ACUPUNCTURE) become widely accepted whereas others (humors, radium therapy) quietly fade away, yet are important historical footnotes. Therapies are termed as Complementary when used in addition to conventional treatments and as Alternative when used instead of conventional treatment.
Analgesia produced by the insertion of ACUPUNCTURE needles at certain ACUPUNCTURE POINTS on the body. This activates small myelinated nerve fibers in the muscle which transmit impulses to the spinal cord and then activate three centers - the spinal cord, midbrain and pituitary/hypothalamus - to produce analgesia.
Acupuncture therapy by inserting needles in the ear. It is used to control pain and for treating various ailments.
Time period from 1901 through 2000 of the common era.

Impact of therapeutic research on informed consent and the ethics of clinical trials: a medical oncology perspective. (1/960)

PURPOSE: To create a more meaningful understanding of the informed consent process as it has come to be practiced and regulated in clinical trials, this discussion uses the experience gained from the conduct of therapeutic research that involves cancer patients. DESIGN: After an introduction of the ethical tenets of the consent process in clinical research that involves potentially vulnerable patients as research subjects, background that details the use of written consent documents and of the term "informed consent" is provided. Studies from the cancer setting that examine the inadequacies of written consent documents, and the outcome of the consent process itself, are reviewed. Two ethically challenging areas of cancer clinical research, the phase I trial and the randomized controlled trial, are discussed briefly as a means of highlighting many dilemmas present in clinical trials. Before concluding, areas for future research are discussed. RESULTS: Through an exclusive cancer research perspective, many current deficiencies in the informed consent process for therapeutic clinical trials can be critically examined. Also, new directions for improvements and areas of further research can be outlined and discussed objectively. The goals of such improvements and research should be prevention of further misguided or ineffective efforts to regulate the informed consent process. CONCLUSION: To ignore this rich and interesting perspective potentially contributes to continued misunderstanding and apathy toward fulfilling the regulatory and ethically obligatory requirements involved in an essential communication process between a clinician-investigator and a potentially vulnerable patient who is considering clinical trial participation.  (+info)

The utilization of cytokines in stem cell mobilization strategies. (2/960)

High-dose myeloablative chemotherapy supported by peripheral blood progenitor cell (PBPC) transplant is rapidly replacing bone marrow transplant to treat a number of chemosensitive cancers. Numerous investigators have studied the relationship of CD34+ cell dose and engraftment kinetics in an effort to help define minimum and optimum target stem cell doses. A number of studies suggest that reinfusion of > or = 5 x 10(6) CD34+ PBPCs results in prompt and durable platelet engraftment. Mobilization of stem cells can be accomplished through use of chemotherapy alone, colony-stimulating factors, or a combination of the two. Strategies to improve PBPC yields include filgrastim in combination with chemotherapy or with other hematopoietic growth factors. In this paper, the advantages and disadvantages of these strategies will be discussed, and the results of a recently conducted, randomized, controlled phase 3 clinical trial in breast cancer patients receiving either SCF plus filgrastim or filgrastim alone for PBPC mobilization will be reviewed.  (+info)

Incremental costs of enrolling cancer patients in clinical trials: a population-based study. (3/960)

BACKGROUND: Payment for care provided as part of clinical research has become less predictable as a result of managed care. Because little is known at present about how entry into cancer trials affects the cost of care for cancer patients, we conducted a matched case-control comparison of the incremental medical costs attributable to participation in cancer treatment trials. METHODS: Case patients were residents of Olmsted County, MN, who entered phase II or phase III cancer treatment trials at the Mayo Clinic from 1988 through 1994. Control patients were patients who did not enter trials but who were eligible on the basis of tumor registry matching and medical record review. Sixty-one matched pairs were followed for up to 5 years after the date of trial entry for case patients or from an equivalent date for control patients. Hospital, physician, and ancillary service costs were estimated from a population-based cost database developed at the Mayo Clinic. RESULTS: Trial enrollees incurred modestly (no more than 10%) higher costs over various follow-up periods. The mean cumulative 5-year cost in 1995 inflation-adjusted U.S. dollars among trial enrollees after adjustment for censoring was $46424 compared with $44 133 for control patients. After 1 year, trial enrollee costs were $24645 compared with $23 964 for control patients. CONCLUSIONS: This study suggests that cancer chemotherapy trials may not imply budget-breaking costs. Cancer itself is a high-cost illness. Clinical protocols may add relatively little to that cost.  (+info)

Safety and tolerability of fluconazole in children. (4/960)

The safety profile of fluconazole was assessed for 562 children (ages, 0 to 17 years) comprising 323 males and 239 females. The data are derived from 12 clinical studies of fluconazole as prophylaxis or treatment for a variety of fungal infections in predominantly immunocompromised patients. Most children received multiple doses of fluconazole in the range of 1 to 12 mg/kg of body weight; a few received single doses. Administration was mainly by oral suspension or intravenous injection. Overall, 58 (10.3%) children reported 80 treatment-related side effects. The most common side effects were associated with the gastrointestinal tract (7.7%) or skin (1.2%). Self-limiting, treatment-related side effects affecting the liver and biliary system were reported in three patients (0.5%). Overall, 18 patients (3.2%) discontinued treatment due to side effects, mainly gastrointestinal symptoms. Dose and age did not appear to influence the incidence and pattern of side effects. Treatment-related laboratory abnormalities were uncommon, the most frequent being transient elevated alanine aminotransferase (4.9%), aspartate aminotransferase (2.7%), and alkaline phosphatase (2.3%) levels. Although 98.6% of patients were taking concomitant medications, no clinical or laboratory interactions were observed. The safety profile of fluconazole was compared with those of other antifungal agents, mostly oral polyenes, by using a subset of data from five controlled studies. Side effects were reported by more patients treated with fluconazole (45 of 382; 11.8%) than by those patients treated with comparable agents (25 of 381; 6.6%); vomiting and diarrhea were the most common events in both groups. The incidence and type of treatment-related laboratory abnormalities were similar for the two groups. In conclusion, fluconazole was well tolerated by the pediatric population, many of whom were suffering from severe underlying disease and were taking a variety of concurrent medications. The safety profile of fluconazole in children mirrors the excellent safety profile seen in adults.  (+info)

Use of the Barthel index and modified Rankin scale in acute stroke trials. (5/960)

BACKGROUND AND PURPOSE: The Barthel Index (BI) and the Modified Rankin Scale (MRS) are commonly used scales that measure disability or dependence in activities of daily living in stroke victims. The objective of this study was to investigate how these scales were used and interpreted in acute stroke trials. METHODS: We identified from MEDLINE the major efficacy trials with neuroprotective drugs, thrombolytic drugs, and anticoagulants in acute ischemic stroke published between January 1995 and December 1998. We selected those trials that used the BI and/or MRS as outcome parameters. RESULTS: Fifteen trials fulfilling the inclusion criteria were identified. The BI was used in 13 and the MRS in 8. In 4 trials mean and median scores of the BI were used, and in 1 trial median scores of the MRS were compared. Primary end points included the BI in 7, the MRS in 6, and both the BI and MRS in 3. With regard to the BI, a variety of sum scores between 50 and 95 were used as cutoff scores to define favorable outcome. Favorable outcome on the MRS was defined as either 3, or BI <60.  (+info)

Simulation studies of phase III clinical trials to test the efficacy of a candidate HIV-1 vaccine. (6/960)

One question of particular importance in phase III HIV vaccine trials is the choice of efficacy measure (EM) to validly and precisely estimate the true vaccinal efficacy. Traditional EMs, based on hazard rate ratio (HRR) or cumulative incidence ratio (CIR) are time-sensitive to mode of vaccine action and population heterogeneities. Through Monte-Carlo simulation, the performance of HRR and CIR based EMs are examined across different trial designs and vaccine and population characteristics. A new EM based on log-spline hazard regression (HARE) is proposed. Given that vaccinal properties (mode of action, time-lag, waning) are unknown a priori, appropriate selection of EM is problematic, and HRR and CIR can be unreliable to estimate the true maximum efficacy of candidate products. Non-random sexual mixing can exacerbate biases in HRR and CIR. HARE can offer valid estimation across different modes of vaccine action and in presence of frailty effects, contrary to its traditional counterparts. Our simulation studies highlight the weaknesses of widely used EMs while offering guidelines for trial design and suggesting new avenues for statistical analysis.  (+info)

Twenty years of phase III trials for patients with extensive-stage small-cell lung cancer: perceptible progress. (7/960)

PURPOSE: All cooperative group studies performed in North America for patients with extensive-stage small-cell lung cancer (SCLC) were evaluated to determine the pattern of the clinical trials and the outcome of patients over the past 20 years. PATIENTS AND METHODS: Phase III trials for patients with extensive-stage SCLC were identified through a search of the National Cancer Institute Cancer Therapy Evaluation Program database from 1972 to 1993. Patients with extensive-stage SCLC treated during a similar time interval listed in the Surveillance, Epidemiology, and End Results (SEER) database were also examined. Trends were tested in the number of trials over time, the number and sex of patients entered onto the trials, and the survival time of patients treated over time. RESULTS: Twenty-one phase III trials for patients with extensive-stage SCLC were initiated between 1972 and 1990. The median of the median survival times of patients treated on the control arms of the phase III trials initiated between 1972 and 1981 was 7.0 months; for those patients enrolled onto control arms between 1982 and 1990, the median survival time was 8.9 months (P =.001). Analysis of the SEER database of patients with extensive-stage SCLC over the same time period shows a similar 2-month prolongation in median survival time. CONCLUSION: Analysis of 21 phase III trials initiated in North America and the SEER database from 1972 to 1994 demonstrates that there has been a modest improvement in the survival time of patients with extensive-stage SCLC.  (+info)

Low-grade stage III-IV follicular lymphoma: multivariate analysis of prognostic factors in 484 patients--a study of the groupe d'Etude des lymphomes de l'Adulte. (8/960)

PURPOSE: To identify the prognostic factors that influence overall survival (OS) in patients with stage III-IV follicular lymphomas and evaluate the clinical usefulness and the prognostic value of the International Prognostic Index (IPI). PATIENTS AND METHODS: Four hundred eighty-four patients with Ann Arbor stage III-IV follicular lymphomas treated in two phase III trials from 1986 to 1995 were screened for this study. All histologic slides were reviewed by two hematopathologists. The influence of the initial parameters on survival was defined by univariate (log-rank test) and multivariate (Cox model) analyses. RESULTS: The poor prognostic factors for OS (age > 60 years, "B" symptom(s), > or = two extranodal sites, stage IV disease, tumor bulk > 7 cm, at least three nodal sites > 3 cm, liver involvement, serous effusion-compression or orbital/epidural involvement, and erythrocyte sedimentation rate > 30 mm/h) that were significant in univariate analysis were subjected to multivariate analysis. Three factors remained significant: B symptom(s) (risk ratio = 1.80), age greater than 60 years (risk ratio = 1.60), and at least three nodal sites greater than 3 cm (risk ratio = 1.71). When the IPI was applied to these patients, the score was 1, 2, 3, and 4-5 in 49%, 39%, 11%, and 2%, respectively, and it was significant for progression-free survival (P =.002) and OS (P =.0001). CONCLUSION: Three prognostic factors for poor OS were identified: B symptoms, age greater than 60 years, and at least three nodal sites greater than 3 cm. The IPI was prognostic for OS, but in this population, a very low number of patients belonged to the high-risk groups.  (+info)

Lancet Neurology Publishes Pivotal Phase III Data Supporting Zonegran® (Zonisamide) as a Once-Daily Monotherapy for Newly Diagnosed Partial Onset Epilepsy Patients : Lancet Neurology Publishes Pivotal Phase III Data Supporting Zonegran® (Zonisamide) as a Once-Daily Monotherapy for Newly Diagnosed Partial Onset Epilepsy Patients PR Newswire HATFIELD, England, June 27, 2012 HATFIELD, England, June 27, 2012 /PRNewswire/ -- New monotherapy options are needed as up to a third of epilepsy [1]patients remain uncontrolled Leading international journal, The Lancet
NovaRx Corporation announced today that the company initiated its pivotal Phase III clinical trial of Lucanix(R) (belagenpumatucel-L) in the treatment of advanced non-small cell lung cancer (NSCLC).
London, UK, 26 September 2007: BTG plc (LSE: BGC), the life sciences company, today announces that its licensee, Genzyme Corporation, and Bayer Schering Pharma AG have initiated a pivotal phase III trial of Campath® (alemtuzumab) as a treatment for multiple sclerosis. This follows the announcement of 20 September that Campath® had been approved as a first-line treatment for B-cell chronic lymphocytic leukaemia.. Louise Makin, BTGs CEO, commented: We are excited by the prospects of Campath in multiple sclerosis and delighted that the pivotal phase III trials are under way. If the excellent results from the phase II trials are reproduced, patients will have a new treatment option that has the potential to be much more efficacious than any other existing treatment.. The full text of Genzymes announcement follows.. Genzyme and Bayer Schering Pharma AG, Germany Announce Start of Phase 3 Program with Alemtuzumab for Treatment of Multiple Sclerosis. Date: September 26, 2007. Genzyme Corporation ...
This pivotal phase III trial will investigate the efficacy and tolerability of elinogrel in patients with chronic coronary heart disease and acute coronary
GREER®, a leading developer and provider of allergy immunotherapy products and services, announces that data from its pivotal Phase III investigationa
St. Jude Medical Announces First Implant in Pivotal Phase of Clinical Trial Evaluating AMPLATZER Cardiac Plug for the Prevention of Stroke in Patients with Atrial Fibrillation ST. PAUL,
Basel, 12 August 2015 Pivotal Phase II study of investigational medicine venetoclax met primary endpoint in a hard-to-treat type of chronic lymphocytic leukemia Regulatory applications for...
... SAN DIEGO Mar... We are pleased to be initiating this pivotal Phase 3 trial of ZX002 a...,Zogenix,Initiates,Pivotal,Phase,3,Clinical,Trial,for,Novel,Formulation,of,Oral,Controlled-Release,Hydrocodone,medicine,advanced medical technology,medical laboratory technology,medical device technology,latest medical technology,Health
agents The long-awaited results of the pivotal phase 3 trial of denosumab proved to be AS-605240 good news for Amgen: The bone drug produced statistically significant reductions in the incidence of vertebral nonvertebral and hip fractures compared with placebo. remission of rheumatoid arthritis when it is given early in the course of the disease. A regimen of etanercept and methotrexate in patients whose RA had been classified as moderate to severe for less than 2 years led to remission in about half of the 542 people studied. After 1 year disease progression stopped in 8 of 10 people who received the combination therapy compared with about 6 of 10 patients who were treated with methotrexate alone. Hoping to make its own inroads in the RA market Roche released more positive data from two phase 3 trials of its interleukin 6 receptor blocker AS-605240 tocilizumab (Actemra). One of the studies published in evaluated difficult-to-treat patients with moderate to severe RA who had failed previous ...
Gilead Sciences, Inc. (Nasdaq:GILD) today announced full clinical trial results from a pivotal Phase 3 study evaluating cobicistat, a pharmacoenhancing or &#8220;boosting&#8221; agent for HIV therapy, compared to ......GILD
Aimmune announces 2018 outlook, including upcoming topline data in February from pivotal Phase 3 PALISADE trial of AR101 for peanut allergy.
- Pivotal Phase 3 Top-Line Results for Bempedoic Acid Expected in the Second and Third Quarters of 2018 -- NDA Submission for LDL-C Lowering Indication for Bempedoic Acid Planned by First Quarter 2019 - ANN ARBOR, Mich., Oct. 02, 2017 (GLOBE NEWSWIRE) -- Esperion Therapeutics, Inc. (NASDAQ:ESPR), the Lipid Management Co...
Nachricht: AbbVie Announces Positive Pivotal Phase 3 Data Demonstrating Investigational Medicine Elagolix Reduces Menstrual and Non-Menstrual Pelvic Pain Associated with Endometriosis at the American Society for - 19.10.16 - News
FREMONT, Calif., Dec. 2, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ: ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases, announced that it will hold a conference call tomorrow, December 3, at 8:00 am Eastern Time to review the results from the pivotal Phase 3 PHREEDOM study evaluating tenapanor in chronic kidney disease (CKD) patients on dialysis. Tenapanor is Ardelyxs investigational, first-in-class, small molecule, non-binder, phosphate absorption inhibitor.. To participate in the conference call, please dial (855) 296-9612 (domestic) or (920) 663-6277 (international) and refer to conference ID 8065608. Live audio of the conference call and accompanying slides will be simultaneously webcast and will be available under the Investors section of the companys website at The webcast will be archived and available for replay for 60 days following the call.. About Ardelyx, Inc. ...
Figure 3 Analysis strategies with biomarker-stratified phase III clinical trials. Freidlin, B. & Korn, E. L. ( 2013) Biomarker enrichment strategies: matching trial design to biomarker credentials Nat. Rev. Clin. Oncol. doi:10.1038/nrclinonc.2013.218. Slideshow 6861152 by chantale-scott
FUJIFILM Toyama Chemical Co., Ltd. has announced today the initiation of a phase III clinical trial to evaluate the safety and efficacy of influenza antiviral drug
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the Phase III clinical trial of its investigational antiretroviral agent elvitegravir, a novel oral
Targeted agents form the backbone of most therapeutic strategies in advanced renal cell carcinoma (aRCC) but ultimately resistance develops and toxicity often leads to discontinuation of treatment, limiting the clinical benefits of these treatments. Nivolumab, a fully human IgG4 anti-PD-1 antibody, selectively blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2 and provides a novel therapy option for patients with aRCC. In 2015, the pivotal phase III study CheckMate 025 led to the Food and Drug Administration approval of nivolumab in patients with aRCC who had received prior anti-angiogenic therapy, and in 2017, the phase III study CheckMate 214 showed that combined immunotherapy with nivolumab plus ipilimumab resulted in greater objective response rate and prolonged progression-free survival when compared with sunitinib in intermediate- and poor-risk patients with previously untreated aRCC ...
Trial reaches objectives of significantly reducing allergy symptom scores and anti-allergy medication use during ragweed pollen season LENOIR, N.C. June 12, 201
Top-line data from the double-blind, North American Phase III BLOOM-1 trial in 597 surgically menopausal women showed that transdermal LibiGel missed the co-primary endpoints of significantly increasing the total Read the full 293 word article
Global biotherapeutics leader CSL Behring today presented data from its Phase III PROLONG-9FP clinical program evaluating the efficacy and long-term safety of its investigational long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP).
BioWorld Online is the news service of record for the biotechnology industry and is updated every business morning. BioWorld Online will keep you up to date on all of the industrys business, science and regulatory news -- mergers and collaborations, FDA hearings and results, breakthroughs in research and much more.
...Reinach Switzerland 26 October 2008 Arpida (SWX: ARPN) today presen...Iclaprim a novel antibiotic from the trusted dihydrofolate reductase ... The high efficacy rates and favorable tolerability profile of iclapri...The results presented at the ICAAC/IDSA meeting were gathered from the...,Phase,III,data,show,efficacy/safety,of,iclaprim,in,patients,with,complicated,skin,infections,biological,biology news articles,biology news today,latest biology news,current biology news,biology newsletters
Belgiums UCB has presented fresh data from a late-stage trial of its new rheumatoid arthritis compound Cimzia, in combination with methotrexate, which shows that the drug prevents structural damage to the joints. - News - PharmaTimes
Belgiums UCB has presented encouraging data from a late-stage trial of an extended-release version of its anti-epilepsy blockbuster Keppra. - News - PharmaTimes
Zealand Pharma A S (NASDAQ OMX ZEAL), a biopharmaceutical company dedicated to the discovery and development of innovative peptide drugs, is pleased to announce
Some fraction of phase I clinical trials will move on to the phase II, which seeks to answer the question as to whether the drug has, in fact, an apparent effect against the cancer in question (in our case pancreatic cancer). Many potential drug therapies go no further than phase II - as they show no real effect against pancreatic cancer. Successful phase II candidates move on to phase III clinical trials which seek to determine how the new therapy compares to existing standard therapies. Phase III clinical trials are the core measure of a potential new drug. Phase III clinical trials are controlled experiments whereby patients with similar characteristics are assigned to receive either the existing therapy or to receive the new therapy. After a time, the results of the arms of test are then compared. If the new agent shows similar or improved results as compared to existing therapy, (after another step or two) it is often approved for release by the FDA. There is even a phase IV to this process ...
Table of Contents Changes in regulatory requirements, FDA or EMA guidance or unanticipated events during our global pivotal Phase 3 clinical studies, our global pivotal Phase 3 bridging study for the bempedoic acid / ezetimibe combination, or our CVOT of bempedoic acid may occur, which may result in changes to clinical study protocols or additional clinical study requirements, which could result in increased costs to us and could delay our development timeline. Changes in regulatory requirements, FDA or EMA guidance or unanticipated events during our clinical studies may force us to amend clinical study protocols or the FDA or EMA may impose additional clinical study requirements. Significant amendments to our clinical study protocols may require resubmission to the FDA and/or IRBs for review and approval, which may adversely impact the cost, timing and/or successful completion of these studies. If we experience substantial delays completing or if we terminate any of our global pivotal Phase 3 ...
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 27, 2015. Macrocure Ltd. (NASDAQ:MCUR), announced results from a pivotal Phase 3 multicenter,
Roche announced today that a Phase III study investigating MabThera (rituximab) in combination with chemotherapy has shown a significant improvement in progression free survival in patients with relap...
Phase I (one) medical and clinical trial recruitment. Volunteer to join trials or advertise a clinical trial or medical study on MedTrials.
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BOUDRY, Switzerland--(BUSINESS WIRE)--May. 6, 2013-- Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today announced that statistical significance was achieved for the prim...
The trial is the first large study in a series of NINDS-sponsored clinical trials called NET-PD (NIH Exploratory Trials in Parkinsons Disease). NINDS has organized this large network of sites to allow researchers to work with PD patients over a long period of time, with a goal of finding effective and lasting treatments. NET-PD builds on a developmental research process - from laboratory research to pilot studies in a select group of patients, to the definitive phase III trial of effectiveness in people with Parkinsons disease ...
Study met its primary endpoint demonstrating significant improvement in progression-free survival (PFS) with POMALYST®/IMNOVID® in combination with bortezomib and dexamethasone (PVd) compared with bortezomib and ...
CAMBRIDGE, Mass., May 31, 2011 (GLOBE NEWSWIRE) -- Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR), today announced that 56-week data for its lead compound, lomitapide, in a pivotal Phase III clinical trial, were consistent with the data seen in the same study at 26 weeks. The single-arm, open label trial is designed to evaluate the efficacy and long-term safety of lomitapide for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). HoFH is a rare and often fatal condition characterized by severely elevated levels of low-density lipoprotein cholesterol, or LDL-C, leading to life-threatening cardiovascular events. Lomitapide has been designated by FDA as an orphan drug to treat this condition. The data show that lomitapide reduced cholesterol substantially in patients with HoFH.
Therapeutic area data reported by biopharma companies on phase III trials in February 2020, including: Abbvie, Acucela, Adamas, Allecra, Alnylam, Amgen, Ampio, Arcutis, Astellas, Axsome, Bayer, Biohaven, BMS, Breath, Citius, Crescita, Eli Lilly, Exelixis, Foamix, Genentech, Genfit, Gilead, Incyte, Ionis, Janssen, Kowa, Marinus, Merck, Minerva, Myovant, Novan, Pfizer, Polyphor, Polypid, Proteostasis, PTC, Rebiotix, Sanifit, Scynexis, Servier, Takeda, Teva, Tonix, Vanda, Zynerba.
LAWRENCEVILLE, NJ -- (Marketwire) -- 05/30/12 -- Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced that it has reached its enrollment objective of 700 pa...
Phase I (one) medical and clinical trial recruitment. Volunteer to join trials or advertise a clinical trial or medical study on MedTrials.
OCA Meets Primary Endpoint With High Statistical Significance of p , 0.0001. -Company to Conduct Conference Call and Webcast March 17, 2014 at 8:30 a.m. ET. NEW YORK, March 16, 2014 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept) today announced that its international Phase 3 POISE trial of obeticholic acid (OCA) for the treatment of primary biliary cirrhosis (PBC) demonstrated that OCA, at both a 10 mg dose and a 5 mg dose titrated to 10 mg, met the trials primary endpoint of achieving a reduction in serum alkaline phosphatase (ALP) to , 1.67x ULN with a ≥ 15% reduction from baseline and a normal bilirubin level after 12 months of therapy. The proportion of patients meeting the POISE primary endpoint was: 10% in the placebo group, 47% in the 10 mg OCA group and 46% in the 5-10 mg OCA group (both dose groups p , 0.0001 vs placebo) in an intention to treat analysis. The placebo group experienced a mean decrease in ALP from baseline of 5%, compared to a significant ...
With up to six years of follow-up, results from the RESONATETM study showed patients with previously treated CLL receiving ibrutinib monotherapy sustained progression-free survival and overall survival benefits versus ofatumumab[1]Five-year follow-up data from the RESONATETM-2 study showed sustained progression-free...
Breast cancer is the most common cancer among women, accounting for about one-third of all cancers in women. A recent phase III clinical trial was directed to explore the effectiveness and efficacy of two drug combinations that target HER2 amplification.
40% Reduction in Risk of Disease Progression Seen with Satraplatin Compared to Control, , , , Highly Statistically Significant Results Seen for Progression-Free Survival (p?0.00001), , , , U.S. Regulato...
Novartis International AG / Phase III data shows Sandoz' proposed biosimilar pegfilgrastim has similar safety and efficacy as the reference product . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.
Ceftazidime-avibactam is being developed with Astra Zeneca jointly. Forest Laboratories LLC., a subsidiary of Actavis plc, holds the rights to commercialize ceftazidime-avibactam in North America, while AstraZeneca holds the privileges to commercialize ceftazdime-avibactam in the rest of the global world.. Actavis reports excellent results from ceftazidime-avibactam Phase III studies in cIAI patients Actavis plc today confirmed positive topline results from RECLAIM-1 and -2, pivotal Phase III studies evaluating the prospect of the investigational antibiotic, ceftazidime-avibactam as a treatment for adult hospitalized sufferers with complicated intra-abdominal infections. Ceftazidime-avibactam includes a cephalosporin , an established treatment for significant bacterial infections, and a next generation non-beta lactam beta-lactamase inhibitor .This system appears to be more essential than those earlier described for prolonged stimulation by dopamine, as would be the case in those with ...
Update on Paroxysmal Nocturnal Hemoglobinuria (PNH) Long Term Safety Study Shows 100% Transfusion Independence Two-part pivotal Phase III study of nomacopan in pediatric.
STOCKHOLM - December 7, 2019 - Oncopeptides AB (Nasdaq Stockholm: ONCO) will today present follow-up data from the pivotal Phase 2 HORIZON (OP-106) study at the ASH Annual Meeting 2019. Melflufen showed an overall response rate (ORR) of 29% and clinical benefit rate (CBR) of 37% in patients with late-stage relapsed/refractory multiple myeloma (RRMM). The safety profile remained consistent with prior reports from the HORIZON study. These data reinforce Oncopeptides view that melflufen can play a role in the treatment of patients with RRMM and the Company plans to submit a New Drug Application (NDA) to the FDA in the first half of 2020.
Takeda Presents 18-Month Data from Pivotal Phase 3 Trial of Dengue Vaccine Candidate at the American Society of Tropical Medicine and Hygiene (ASTMH) 68th Annual Meeting
CORAL GABLES, Fla., March 25, 2014 (GLOBE NEWSWIRE) -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX), a specialty pharmaceutical company focused on developing safe and effective approved medicines targeting orphan neuromuscular and neurological diseases, announced today that, at a recently held meeting, the independent Data Monitoring Committee (DMC) overseeing the Companys ongoing pivotal Phase 3 clinical trial evaluating Firdapse™ for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) recommended that the trial be continued as planned based on the committees review of safety and clinical data from the trial.
WOCKHARDT RECEIVES ACKNOWLEDGEMENT OF ITS BREAKTHROUGH SUPERDRUG ANTIBIOTIC WCK 5222 FOR PHASE III CLINICAL TRIAL FROM US FDAIn a recent meeting between Wockhardt Research team and US FDA New Drug Antibiotic Regulatory team, US FDA agreed to abridged
Aurinia Announces Plans For Single Phase III Clinical Trial For Voclosporin In The Treatment Of Lupus Nephritis Following Successful Completion Of End Of Phase II Meeting With FDA - read this article along with other careers information, tips and advice on BioSpace
GlaxoSmithKline plc (GSK,GSK.L) announced that new data from a Phase III clinical study supports the safety and efficacy of Shingrix in preventing shingles when given to adults 18 years and above shortly after undergoing autologous haematopoietic stem cell transplant. Shingrix is a non-live, recombinant adjuvanted subunit vaccine.. The study succeeded in its primary objective by demonstrating an efficacy of 68.17%. The vaccine reduced overall complications linked to shingles episodes by 77.76%. No safety issues related to the vaccine were detected during the study. GSK said it is evaluating these results together with those of other Phase III studies in immune-compromised patient populations. Shingrix is now approved in Canada and US for the prevention of herpes zoster in adults aged 50 years and above. Regulatory reviews are currently underway in the European Union, Australia and Japan. by RTT Staff Writer. For comments and feedback: [email protected] Business News ...
TY - JOUR. T1 - Depressive distress among the spouses of terminally III cancer patients. AU - Siegel, Karolynn. AU - Karus, Daniel G.. AU - Raveis, Victoria. AU - Christ, Grace H.. AU - Mesagno, Frances P.. PY - 1996/1/1. Y1 - 1996/1/1. N2 - Bereaved spouses comprise a population at risk for psychological distress. Evidence suggests that spouses 55 years of age and younger are at increased risk of morbid outcomes, including major depressive episodes. Although the emotional impact of the sudden loss of a spouse has been well studied, less attention has been paid to the psychological impact of loss that is foreseeable, as in the case of a serious illness. In this study, data were obtained from pre-death interviews with 103 well spouses of terminally ill cancer patients. Subjects were white, 55 years of age or younger, and living with the patient and their child(ren) aged 7 to 16 years old. Depressive distress was assessed using the Brief Symptom Inventory. Fifty eight percent of males and 42% of ...
Sanofi reports that the first patient outside of the US has been treated as part of a global clinical program evaluating Sanofis and Regeneron Pharmaceuticals Kevzara (sarilumab) in patients hospitalized with severe COVID-19. The global clinical program has now been initiated in Italy, Spain, Germany, France, Canada, Russia and the US, all countries that have been impacted by COVID-19. Sanofi is leading trials outside the US while Regeneron is leading US trials.. This is the second multi-center, double-blind, Phase II/III trial as part of the Kevzara COVID-19 program, and the companies say that they are continuing to work with authorities around the world to secure initiation at additional sites. This follows Sanofi and Regenerons earlier announcement of the initiation of the first trial, which is US-based.. Kevzara is a fully human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. IL-6 may play a role in driving the overactive ...
Patients were administered FOLFIRI every 2 weeks in one course. FOLFIRI:CPT-11 150 mg per square meter on day1 with l-LV 200 mg per square meter administered as a 2-hour infusion before 5-FU 400 mg per square meter administered as an intravenous bolus injection, and 5-FU 2400 mg per square meter as a 46-hour infusion immediately after 5-FU bolus injection on day1 in 2 weeks ...
This research study is evaluating a drug called isoquercetin to prevent venous thrombosis (blood clots), in participants who have pancreas, non small cell lung
Summary: Naturally occurring mutations in the hepatitis C virus (HCV) are common and many lead to reduced efficacy of antiviral treatments. Faldaprevir* has now been shown to be effective even in patients with the common HCV Q80K variant,1 which affects an estimated 700,0002,3,4 patients in the USA alone. Faldaprevir* is being studied in combinations both with and without interferon. The EMA recently granted accelerated assessment for faldaprevir* as part of an interferon-based regimen and a decision on marketing authorisation is anticipated next year.5,6. For media outside of the US, the UK & Canada only. INGELHEIM, 16 December, 2013 - Data show that Boehringer Ingelheims second-generation protease inhibitor faldaprevir*, when used in combination with pegylated interferon and ribavirin, was effective even with the presence of naturally-occurring mutant variants of the hepatitis C virus (HCV), such as the NS3 Q80K polymorphism. The Q80K mutant was detected in 23% (49/127, STARTVerso™1) and ...
M.D., Ph.D., senior vice president, global development and chief development officer at Ironwood.Pre-clinical and clinical evidence suggest that IW-3718 may offer a treatment option for the millions of patients with GERD who continue to experience frequent and bothersome symptoms such as heartburn and regurgitation despite taking PPIs. Our teams have done excellent work to rapidly initiate these trials. We are hopeful that these studies will generate data in support of a potential approval as quickly as possible. The Phase III program comprises two identical randomized, double-blind, placebo-controlled, multicenter Phase III trials that target enrolling approximately 1,320 patients total (660 in each trial) with persistent GERD who demonstrate evidence of pathological acid reflux. Eligible patients will continue to take PPIs and be randomized to placebo or IW-3718 1500 mg twice a day for eight weeks. The primary endpoint is overall heartburn responder, defined as a patient who experiences at ...
The Phase III RESIST (Randomized Evaluation of Strategic Intervention in Multi-Drug ReSistant Patients with Tipranavir) clinical trial program has been designed to study the safety and efficacy of tipranavir (boosted with low-dose ritonavir) versus a low-dose ritonavir-boosted comparator protease inhibitor (PI) that is chosen by the patients physician on the basis of treatment history and baseline resistance testing. Study participants will all be highly treatment-experienced HIV-positive adults. Phase III of clinical development is the final stage of testing before a drug is submitted to worldwide regulatory authorities for review and consideration for marketing approval. The RESIST Program consists of two Phase III pivotal trials (RESIST 1 and RESIST 2) and two companion trials (study 1182.51 and RESIST 3) available for even more advanced patients ...
Analyses of pivotal study data of Dysport® reveal a large proportion of study patients did not require retreatment for at least 12 weeks (and at least 16 weeks for pediatric upper limb spasticity) This new analysis concluded that Dysport® is associated with a long duration of response These data form one of 26 abstracts Ipsen […]
Read about how Teva Pharmaceuticals investigational treatment for migraine prevention was able to reduce the number of migraine days per month in a recent Phase III clinical trial.
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 11, 2013. Nymox Pharmaceutical Corporation (Nasdaq: NYMX) reported favorable results from the
This resource center is for patients and families coping with cancer and interested in learning about clinical trials for the disease. You can find information here on how clinical trials are structured and managed, how to find and evaluate clinical trials, how eligibility to participate is determined, the ethics of conducting clinical trials, special types of clinical trials, and financial issues related to clinical trials.
Following these, two additional analyses for OS are planned: a second interim analysis and a third and final OS analysis.. With 630 patients, the SYMMETRY trial is over 95% powered to detect a statistically significant improvement in PFS. Secondary endpoints in addition to overall survival include response rate, clinical benefit rate (defined as complete response, partial response, or stable disease at 24 weeks), and duration of response. Projections and powering assumptions are based on detecting an improvement of two months in PFS (67%, hazard ratio 0.60), or three months in OS (33%, hazard ratio 0.75).. Based on our current enrollment and event rate projections, Synta expects to complete the primary endpoint analysis by the end of 2008 and file a New Drug Application (NDA) with the Food and Drug Administration (FDA) by the first half of 2009.. The SYMMETRY trial is now open for patient recruitment. For those interested in more information about the trial, please visit ...
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regenerons products, product candidates, and research and clinical programs now underway or planned, including without limitation sarilumab; ongoing regulatory obligations and oversight impacting Regenerons marketed products, research and clinical programs, and business, ...
CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.--(BUSINESS WIRE)--Today Biogen Idec (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced the full results from the Phase 3 DECIDE clinical trial, which show ZINBRYTA™ (daclizumab high-yield process), dosed subcutaneously once a month, demonstrated a statistically significant improvement in reducing disease activity in people with relapsing-remitting multiple sclerosis (RRMS) compared to AVONEX® (interferon beta-1a).
AbbVie (NYSE: ABBV), a global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), today announced that data...
There is a pressing need for more-efficient trial designs for biomarker-stratified clinical trials. We suggest a new approach to trial design that links novel treatment evaluation with the concurrent evaluation of a biomarker within a confirmatory phase II/III trial setting. We describe a new protocol using this approach in advanced colorectal cancer called FOCUS4. The protocol will ultimately answer three research questions for a number of treatments and biomarkers: (1) After a period of first-line chemotherapy, do targeted novel therapies provide signals of activity in different biomarker-defined populations? (2) If so, do these definitively improve outcomes? (3) Is evidence of activity restricted to the biomarker-defined groups? The protocol randomizes novel agents against placebo concurrently across a number of different biomarker-defined population-enriched cohorts: BRAF mutation; activated AKT pathway: PI3K mutation/absolute PTEN loss tumors; KRAS and NRAS mutations; and wild type at all the
October 2, 2015.. We are delighted to announce that the HiP trial is fully up and running and has dosed its 15th patient. This multi-center, randomized controlled trial is being led by Cork University Hospital and is being conducted in several centers in Europe and Canada. We expect to enroll approximately 750 babies.. About 150,000 pediatric patients, mostly newborn babies and infants, are treated for hypotension in Europe each year. Hypotension can occur as a result of any one of a number of conditions. Those conditions are often life-threatening and require urgent treatment. Currently, pediatric patients are treated with drugs that are not specifically approved for children and are supplied in a form that is appropriate for an adult.. The purpose of the trial is to further refine the optimal treatment protocols for this vulnerably population and it will lead to the development of an age-appropriate dosage form of the most commonly used drug for treating hypotension in pediatric patients. The ...
OncologyPRO is the home of ESMOs educational & scientific resources, with exclusive content for ESMO members such as ESMOs Congresses webcasts,
Bachem and ISA Pharmaceuticals B.V. today announced the conclusion of an agreement for the manufacture of the active ingredients and the supply of finished dosage forms of ISA Pharmaceuticals immunotherapeutic HPV-SLP® product. Press Release. ...
Haihe Biopharma focuses on discovery, development and commercialization of innovative anti-tumor drugs. Guided by our mission, Inclusive and open to diversity, innovation oriented to win together and benefit the mankind, Haihe Biopharma insists on the way of independent innovation and pursues for global development of Chinese original innovative drugs in partnership with Shanghai Institute of Materia Medica, Chinese Academy of Science (SIMM). The company is led by an academician of the Chinese Academy of Engineering. The senior management team has extensive experiences in drug research and development in China and abroad. Haihe Biopharma has built a precision medical platform guided by biomarkers, and established a fully integrated pre-clinical evaluation technical platform and clinical study system for innovative drugs, with advanced technology and operation in consistence with international standards and norms, covering subunits from compound synthesis, CMC study, biomarker discovery and ...
Motif chief executive Graham Lumsden told investors: Resistance to antibiotics is a major global health threat and we believe that iclaprim, a novel antibiotic in the under-utilized dihydrofolate reductase inhibitor class, can become an integral part of hospital doctors life-saving treatment strategies. ...
Complement refers to a cascade of inter-related proteins that are important in defending our bodies against a wide range of bacteria. Over our lifetimes, our bodies have learned to recognize certain markers (antigens) on bacteria and developed antibodies (immunoglobulins) that are specific to each of these antigens. As soon as one of these known bacteria is seen, the antigens on the surface of the bacteria are quickly tagged by the corresponding antibody molecules circulating in our blood. The presence of these antigen-antibody pairs on the surface of the microbe are like neon advertising signs that attract complement proteins to swoop down and kill the cell. I hope you can see the parallel between this scenario and what happens when we treat a CLL patient with a man-made anti-CD20 monoclonal antibody. Here the hapless B-cell is in the role of the bacterium, the CD20 marker it carries is the antigen and the man-made monoclonal antibody drug is the synthetic immunoglobulin that mates with the ...
A group of researchers at Osaka University developed a synthetic tissue using synovium-derived mesenchymal stem cells (MSCs) for treating damaged cartilage, which had previously been incurable and had no effective therapies.
The IMbrave150 study combination immunotherapy, with the PD-L1 inhibitor atezolizumab and the VEGF inhibitor bevacizumab, has proven positive results by enhancing the potential of the immune system to combat Hepatocellular Carcinoma (HCC) among Asian patients
RATIONALE: Drugs used in chemotherapy, such as docetaxel work in different ways to stop the growth of tumor cells, either by killing the cells or by sto
Hi i am new to this site but my husband went in with a seizure in late September of this year and before we knew it within 3 days there was a biopsy preformed and then a few days to follow he was being scheduled for a craniotomy! he is 36 and we have 3 children (12, 10 ,1) fear isnt even the world to being to describe what we both were feeling for each other and our children. We live in buffalo ny and he is now an official patient of Roswell which is not far from our house at all. he was dignaised with AA3 in his right frontal lobe they were able to remove 90% of the tumor he followed up with radiation and chemotherapy pill form and had very little to none of the side effects. He did lose his hair but thats the least of his problems and something that is very managable (bald is beautiful ) we have lucked out so far if thats even a thing with something this devastating but he is able to function 90 percent of his body and uses a cane as he had to reteach his left side to move Simultaneously ...
DARMSTADT, Germany and NEW YORK, November 28, 2017 /PRNewswire/ -- Not intended for UK-based media - Pivotal Phase III Javelin trial investigating
A Randomized Phase II/III Trial of Afatinib Plus Cetuximab Versus Afatinib Alone in Treatment-Naive Patients with Advanced, EGFR Mutation Positive Non-Small Cell Lung Cancer (NSCLC). ...
Amgen and Novartis will expand their collaboration with the Banner Alzheimers Institute by launching a new Phase II/III trial designed to assess whether the oral BACE1 inhibitor CNP520 codeveloped by the companies can prevent or delay symptoms in people at high risk for the disease
Atacicept, a biologic agent that targets two B-cell factors in patients with moderate-to-severe lupus, failed to meet the primary endpoint in a yearlong phase II/III trial, researchers reported.
Comprehensive analyses of pooled data from three randomized, double-blind, placebo-controlled Phase II/III trials showing the efficacy and tolerability of Vimpat® (lacosamide) C-V for...
... company Eli Lilly terminated further development of the compound in 2012 after it failed in phase III clinical trials. In ... Current Topics in Medicinal Chemistry. 8 (16): 1480-1. doi:10.2174/156802608786264209. PMID 19006848. Fraley ME (June 2009). " ... In 2007, a randomized phase II clinical trial showed that LY-2140023 taken twice daily for 4 weeks improved schizophrenia ... 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 ...
... at Clinical trial number NCT01086657 for "An Open-Label, Randomized Phase I Study in Healthy Adults of the ... Their pivotal Phase III study with 12,400 participants has also been completed and results of data analysis were published in ... Drug Topics. Retrieved January 27, 2020. Fast, Patricia E; Cox, Josephine H (September 1, 2015). "An influenza vaccine pill-can ... at Clinical trial number NCT03450915 for "A Pivotal Trial to Assess the Safety and Clinical Efficacy of the ...
... placebo-controlled phase 2 clinical trial". The Lancet. 381 (9871): 1037-45. doi:10.1016/S0140-6736(12)61764-4. PMID 23352749. ... "Current Topics in Microbiology and Immunology. Current Topics in Microbiology and Immunology. 325: 361-382. doi:10.1007/978-3- ... List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ... "Inferring Reasons for the Failure of Staphylococcus aureus Vaccines in Clinical Trials". Frontiers in Cellular and Infection ...
It is the first telomerase inhibitor to enter clinical trials. It is currently in Phase 2/3 trials for various cancer types. ... 2020). "Telomerase-based Cancer Therapeutics: A Review on their Clinical Trials". Current Topics in Medicinal Chemistry. 20 (6 ... Chemically, imetelstat is a synthetic conjugate consisting of three parts: GRN163, a thiophosphoramide oligonucleotide, and a ...
In addition to Hantavax three more vaccine candidates have been studied in I-II stage clinical trials. They include a ... "Phase 2a Immunogenicity Study of Hantaan/Puumala Virus DNA Vaccine for Prevention of Hemorrhagic Fever". ... However, their prospects are unclear List of vaccine topics Seoul virus Gou virus Vaccine-naive Schmaljohn, C. S. (2012). " ... Field trial of an inactivated vaccine against hemorrhagic fever with renal syndrome in humans. Arch Virol. 1990;1(Suppl):35-47 ...
Three primary tasks at this end phase include determining that the project is actually complete, evaluating "the project plan ... From the information technology perspective for clinical trials, it has been guided by another U.S. Food and Drug ... In a Good Manufacturing Practice regulated industry, the topic is frequently encountered by its users. Various industrial ... "Guidance for Industry: Computerized Systems Used in Clinical Trials" (PDF). U.S. Food and Drug Administration. April 1999. ...
... "its fast-growing portfolio of Phase I, Phase II and Phase III clinical trials."[61] Termeer is on the board of directors of the ... Boston Globe staffer Geeta Anand wrote a book on the topic called The Cure.[65] ... Fierce Biotech covers biotechnology news including biopharma deals and clinical trials.[47] ... Regulatory Matters WHO Drug Information 5:3 1991. p 123 *^ a b c d e f g h i j Geeta Anand (November 2005), Why Genzyme Can ...
List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ... 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] ... In fact, the mortality rate of the Varoiola Minor form of smallpox then found in Europe was 1-3% as opposed to 30-50% for the ...
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] ... "T-cell priming by dendritic cells in lymph nodes occurs in three distinct phases". Nature. 427 (6970): 154-9. Bibcode:2004Natur ... As of 2016, several TLR ligands were in clinical development or being tested in animal models as potential adjuvants.[24] ...
List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ...
List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ... The effectiveness of the procedure was proven when, of the nearly three hundred people Boylston inoculated during the outbreak ... Retrieved 3 January 2014.. *^ Boylston, Arthur (July 2012). "The origins of inoculation". Journal of the Royal Society of ... 3 (1): 54-60. doi:10.1016/s1201-9712(98)90096-0. PMID 9831677.. CS1 maint: ref=harv (link). ...
List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ... He is credited with saving more lives than any other medical scientist of the 20th century.[3][4][5] Robert Gallo described him ... Maurice should be recognized as the most successful vaccinologist in history."[3] ...
Results of a phase III clinical trial for the treatment of Alzheimer's disease were reported in September 2017. The trial ... Current Topics in Medicinal Chemistry. 10 (2): 207-21. doi:10.2174/156802610790411036. PMID 20166958. Lowe, Derek (12 May 2015 ... Intepirdine also entered clinical trials for dementia with Lewy bodies, also with negative results. Consequently, Axovant ... GlaxoSmithKline for the treatment of Alzheimer's disease and demonstrated some preliminary efficacy in phase II clinical trials ...
List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ... "Clinical Microbiology Reviews. 11 (3): 430-9. doi:10.1128/CMR.11.3.430. PMC 88889. PMID 9665976.. .mw-parser-output cite. ...
and Sanofi affiliate Shantha Biotechnics are currently in Phase III clinical trials.[37][38] ... "ROTAVAC clinical trial results , DEFEATDD.ORG - Resources to defeat diarrheal disease". Archived from the ... Clinical trials in the United States, Finland, and Venezuela had found it to be 80 to 100% effective at preventing severe ... These novel approaches are being pursued using animal models and, in the case of the NRRV P2-VP8 candidate, clinical trials.[42 ...
List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ... Clark and Offit are two of the three inventors of the rotavirus vaccine RotaTeq,[12] which is credited with saving hundreds of ... as well as dozens of scholarly articles on the topic. Isabelle Rapin, a neurology professor at the Albert Einstein College of ...
List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ... Some efforts have entered Phase I/II human clinical trials.[12] Inovio is developing a synthetic multi-antigen DNA vaccine ... Inovio has the intent to initiate a phase I/IIa clinical study in the fourth quarter of 2013. Following immunization, rhesus ... covering hepatitis C virus (HCV) genotypes 1a and 1b and targeting the HCV antigens nonstructural protein 3 (NS3) and 4A (NS4A ...
List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ... In the Gardasil clinical trials, 1,115 pregnant women received the HPV vaccine. Overall, the proportions of pregnancies with an ... A recent analysis of data from a clinical trial of Cervarix found that this vaccine is just as effective at protecting women ... Extensive clinical trial and post-marketing safety surveillance data indicate that both Gardasil and Cervarix are well ...
Statistical principles for clinical trials[30] section III provides a general overview of common designs in clinical trials. ... References classified by statistical topic[edit]. Good clinical practice[edit]. *ICH E6(R2): Good clinical practice [1] is an ... the use of meta-analysis and the use of only a single pivotal study in phase III clinical development. ... EMA/CHMP/539146/2013 Investigation of subgroups in confirmatory clinical trials *^ a b FDA - Clinical trial endpoints for the ...
... a second round of clinical trials in Korea has begun with 10 hospitals participating. Multiple Phase 2/3 and Phase 3 clinical ... "Current Practices in Acute Blood Purification Therapy in Japan and Topics for Further Study". Contributions to Nephrology. 196 ... "Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial - Full Text View". 2020-07-23. Retrieved 2021- ... This drug has been identified as a potential therapy for COVID-19, with clinical trials in Japan possibly set to begin in March ...
Clinical trials: *†Phase III. *§Never to phase III. *v. *t. *e. Encoded (proteinogenic) amino acids ... "The American Journal of Clinical Nutrition. 94 (3): 847-853. doi:10.3945/ajcn.110.003483. Retrieved 29 November 2018.. ... Cysteine (symbol Cys or C;[3] /ˈsɪstiiːn/)[4] is a semiessential[5] proteinogenic amino acid with the formula HO2CCH(NH2)CH2SH ... 3 (11): 836-47. doi:10.1038/nrm954. PMID 12415301.. *^ Huang, Tzou-Chi; Ho, Chi-Tang. Hui, Y. H.; Nip, Wai-Kit; Rogers, Robert ...
Clinical trials: *†Phase III. *§Never to phase III. *v. *t. *e. Encoded (proteinogenic) amino acids ... Cysteine (symbol Cys or C;[3] /ˈsɪstiiːn/)[4] is a semi-essential[5] proteinogenic amino acid with the formula HO2CCH(NH2)CH2SH ... 3 (11): 836-47. doi:10.1038/nrm954. PMID 12415301.. *^ Huang, Tzou-Chi; Ho, Chi-Tang. Hui, Y. H.; Nip, Wai-Kit; Rogers, Robert ... ISBN 3-527-30673-0.. *^ Hell R (1997). "Molecular physiology of plant sulfur metabolism". Planta. 202 (2): 138-48. doi:10.1007/ ...
A randomized phase III study in advanced non-small cell lung cancer (NSCLC)". American Society of Clinical Oncology. Retrieved ... Clinical Cancer Research; Clinical Trials. 6 (7): 2677-84. PMID 10914709. Avendano, Carmen; Menendez, J. Carlos (April 2008). ... Cancer Topics - Coping with Cancer. National Cancer Institute. Retrieved 1 December 2008. McLeod HL, Cassidy J, Powrie RH, ... A Phase III study showed benefits of maintenance use of pemetrexed for non-squamous NSCLC. Activity has been shown in malignant ...
From 2016 to 2018, Phase III/IIIb open-label clinical trials HOPE (MTN-025) and DREAM (IPM-032) were launched to focus on the ... Physical characteristics of the ring such as size and hardness were a topic of concern amongst participants. The ease of ... Since 2017, a three-month DPV Ring option has been under clinical trial. A number of alternative intravaginal rings made by IPM ... DPV Rings were given to the former Phase III trial participants for one whole year. HOPE ended in October 2018 and DREAM ended ...
List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ...
List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ... പരീക്ഷണ ഘട്ടം III ന്റ ഫലം ഇന്ത്യാ ഗവണ്മെന്റിന്റെ ഡ്രഗ് അധികൃതർക്ക് സമർപ്പിക്കുകയും വിപണന അനുമതി നേടുകയും ചെയ്തു..[7][8] ... മറ്റൊരു നിർജ്ജീവീകരിച്ച വൈറസുകളെ ഉപയോഗിച്ചു നിർമ്മിക്കുന്നവാക്സിനായ The Beijing-3 strain 1968 മുതൽ 2005 വരെ മസ്തിഷ്ക ജ്വര ... SA14-14-2, IC51, ChimeriVax-JE എന്നീ 3 രണ്ടാം തലമുറ മസ്തിഷ്ക ജ്വര പ്രതിരോധമരുന്നുകൾ പിന്നീട് വിപണികളിലെത്തി. ജീവനുള്ളതും എന്നാ ...
... 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 ... teaching includes such topics as doctor-patient communication, ethics, the art of medicine,[96] and engaging in complex ... Gorski, DH; Novella, SP (September 2014). "Clinical trials of integrative medicine: testing whether magic works?". Trends in ...
"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 ... Several trials were conducted in late 2014, and early 2015, but some were abandoned due to lack of efficacy or lack of people ... The Ebola virus may be able to persist for more than three months in the semen after recovery, which could lead to infections ...
Ernst E (December 2009). "Spinal manipulation for asthma: a systematic review of randomised clinical trials". Respir Med. 103 ( ... Joseph C. Keating, Jr., Cleveland CS III, Menke M (2005). "Chiropractic history: a primer" (PDF). Association for the History ... 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 ...
42] The law encourages patient diversity in clinical trials submitted to the FDA for review. The study determined that most ... In vitro diagnostics have three risk classifications.[22]. Rest of the WorldEdit. For the remaining regions in the world the ... 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 ...
... develop a new clinical cancer research unit at Northwell Health in Lake Success, NY, to support early-phase clinical studies of ... As of 2016 a two-week course at CSHL costs between $3,700 and $4,700 per student and a three-day conferences cost about $1,000 ... Topics. *Contributing property. *Keeper of the Register. *Historic district. *History of the National Register of Historic ... "ISIS initiates Phase 3 clinical trials for potential SMA therapy ISIS-SMNrx". The SMA Trust.. ...
Phase-locking to stimulus frequencies has been shown in the auditory nerve,[5][6] the cochlear nucleus,[5][7] the inferior ... Music agnosia, an auditory agnosia, is a syndrome of selective impairment in music recognition.[86] Three cases of music ... 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 ...
... 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 - - 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 ...
... 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 " ... Status and relevance for clinical trials". Mov. Disord. (Review). 33 (4): 528-36. doi:10.1002/mds.27355. PMID 29624752.. ...
Lillian Hellman's play The Children's Hour was converted into a heterosexual love triangle and retitled These Three. Biopic ... 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 ...
... three adults (one teacher and two nurses) for every 12 pupils (or one-to-four); and, for children age three to six: three ... 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 ...
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) ... The probabilities of the singletons {1}, {3}, and {7} are respectively 0.2, 0.5, 0.3. A set not containing any of these points ...
Clinical trials: *†Phase III. *§Never to phase III. Retrieved from " ... started publishing research on the topic and also published a book "Vitamin C and the Common Cold" in 1970.[28] A revised and ... The earliest publication of a controlled clinical trial appears to be from 1945.[27] Researchers continued to work on this ... A meta-analysis of 44 clinical trials has shown a significant positive effect of vitamin C on endothelial function when taken ...
... a phase II trial". Journal of Clinical Oncology. 23 (10): 2332-8. doi:10.1200/JCO.2005.51.008. PMID 15800324.. ... A phase III multicenter prospective randomized controlled trial in patients with resected pancreaticobiliary carcinoma". Cancer ... 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.. ...
Bradley's Neurology in Clinical Practice: Expert Consult - Online and Print, 6e (Bradley, Neurology in Clinical Practice e- ... "Church HIV prayer cure claims 'cause three deaths'". BBC News. October 18, 2011. Consultado o October 18, 2011.. ... Walker, BD (2007 Aug-Sep). "Elite control of HIV Infection: implications for vaccines and treatment.". Topics in HIV medicine ... placebo-controlled phase 3 trial". The Lancet 381 (9883): 2083-2090. doi:10.1016/S0140-6736(13)61127-7.. ...
The earliest publication of a controlled clinical trial appears to be from 1945.[27] Researchers continued to work on this ... These three compounds are also excreted via urine. Humans are better than guinea pigs at converting DHA back to ascorbate, and ... 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 ( ...
... with a break of three months followed by another phase of three gray of radiation for five days.[31] ... 20-year results of a randomized trial". Journal of Clinical Oncology. 32 (8): 791-7. doi:10.1200/JCO.2013.50.6600. PMID ... Wikibooks has a book on the topic of: Radiation Oncology. Information. *Human Health Campus The official website of the ... 1979 Three Mile Island accident and Three Mile Island accident health effects ...
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". Retrieved 2016-03-08.. ... The three major subcategories include intrinsic (i.e., arising from within the body), extrinsic (secondary to environmental ...
... 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 ... The term epigenetics refers to three levels of gene regulation: (1) DNA methylation, (2) histone modifications, and (3) non- ... "British Journal of Clinical Pharmacology. 75 (4): 1152-3. doi:10.1111/j.1365-2125.2012.04444.x. PMC 3612735. PMID 22905989.. ...
CR at three sites for six months to a year in Phase 1 and for two years in Phase 2.[40] ... Institute on Aging and the National Institute of Diabetes and Digestive and Kidney Diseases mounted the CALERIE clinical trials ... "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.. ...
... 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 ...
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 ... Food allergy affects as many as 5% of infants less than three years of age[73] and 3% to 4% of adults.[74][81] The prevalence ... a collection of resources on the topic of food allergies and intolerances ...
Multidisciplinary clinical teams providing an intensive case management approach for the first three to five years. The ... "Randomised controlled trial of cognitive-behavioural therapy in early schizophrenia: acute-phase outcomes". Br J Psychiatry ... 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 ...
"Data sharing platforms for de-identified data from human clinical trials". Clinical Trials: 1740774518769655. doi:10.1177/ ... Computer models are used to examine various topics such as how exercise affects obesity, healthcare costs, and many more.[35] ... Therefore, in late 2003, the health informatics group in Ministry of Health released three projects to deal with issues of ... developed computerized systems to automate many aspects of multi-phased health checkups. These systems became the basis the ...
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 ... 270 researchers from around the world collaborated to replicate 100 empirical studies from three top Psychology journals. Fewer ... The values obtained from distinct experimental trials are said to be commensurate if they are obtained according to the same ...
... clinical hair loss (telogen effluvium) may occur.[citation needed] A disruption of the growing phase causes abnormal loss of ... Three medications have evidence to support their use in male pattern hair loss: minoxidil, finasteride, and dutasteride.[29][30 ... 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 ...
"ACL Program - Bridge-Enhanced ACL Repair (BEAR) Clinical Trial". 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 ... Three sources of replacement material for ACL reconstruction are commonly used: *Autografts (employing bone or tissue harvested ... "Anterior Cruciate Ligament (ACL) Injuries - Topic Overview". Retrieved 25 April 2016.. ...
Topics * All Topics Biotechnology Biotech Business Biotech Products Cancer Cardiovascular Dermatology Drug Discovery ... GenSights LHON drug fails to meet endpoint in Phase III trial *GenSight Biologics reports positive data from REVERSE Phase III ... GenSight Biologics Reports Positive Follow-up Results at Week 72 of the RESCUE Phase III Clinical Trial of GS010 in Leber ... of the RESCUE Phase III clinical trial evaluating the safety and efficacy of a single intravitreal injection of GS010 (rAAV2/2- ...
Related Topics. * Questions to Ask When Considering a Specific Trial Clinical trials that test potential drugs and therapies in ... Back to the Clinical Trial Finder Restore CFTR Function Enrolling Phase 3 study of ivacaftor in babies who have a CFTR gating ... Phase II studies evaluate safety, correct dose and early signs of drug effect. Phase III studies are the final large studies of ... A clinical trial in which a drug is studied by giving an inactive substance (a placebo) to one group of participants, while the ...
... placebo-controlled phase 2 clinical trial". The Lancet. 381 (9871): 1037-45. doi:10.1016/S0140-6736(12)61764-4. PMID 23352749. ... "Current Topics in Microbiology and Immunology. Current Topics in Microbiology and Immunology. 325: 361-382. doi:10.1007/978-3- ... List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ... "Inferring Reasons for the Failure of Staphylococcus aureus Vaccines in Clinical Trials". Frontiers in Cellular and Infection ...
... clinical trials in CLL but final approval to market the drug will depend on the success of the latest Phase-III clinical trial ... Phase III Clinical Trial of HuMax-CD20 in Refractory CLL The scientific name for HuMax-CD20 is ofatumumab - not something that ... The results of this Phase III clinical trial will go a long way to show if this is indeed the case. I am keeping my fingers ... Genmab has just announced the clinical trial on, with all the details. This is a multi-center trial, ...
clinical trials Blogs, Comments and Archive News on ... clinical trials Latest Breaking News, Pictures, Videos, and Special Reports from The Economic Times. ... Zydus Cadila completes phase 2 clinical trial in COVID-19 patients with biological therapy PegiHep. 12 Nov, 2020, 11.35 AM IST ... In a regulatory filing, Zydus Cadila said "it has successfully completed a phase 2 clinical trial in COVID-19 patients with its ...
Serum Institute conducting phase III clinical trial of tuberculosis vaccine: DBT. 27 Jul, 2020, 09.19 PM IST. The BCG vaccine ... expressed optimism that the COVID-19 vaccine could be ready by October-November this year and the next phase of the trial can ... had deferred a decision on the request of SII to start trials and asked the company to amend its protocol for the clinical ... Till the trials are completed successfully for safety and efficacy, vaccines will not be distributed either in India or ...
Psyched: First Psychedelics Company Goes Public, Phase III Clinical Trials On MDMA For PTSD Sunday, March 15, 2020 - 9:38am , ... 30 million necessary to complete phase 3 trials and achieve FDA approval for the drug. The Capstone Challenge,... ... Saturday, June 6, 2020 - 3:15pm , 1484 Psyched is a bi-monthly column covering the most important developments in the industry ... Friday, August 21, 2020 - 3:51pm , 830 MAPS Gets $30M In Funds To Conclude MDMA Research The Multidisciplinary Association for ...
Maryland-based Novavax phase 3 clinical trial expands to include children 12 to 17. - Hallie Miller. A ... Its rosé season, so here are three to pair with the warm spring weather. We have a delightfully unusual Spanish rosado that ... Maryland-based COVID-19 vaccine producer is expanding its late-stage Phase 3 clinical trial study to include children ages 12 ...
More news releases in similar topics. * Health Care & Hospitals * Medical Pharmaceuticals * Clinical Trials & Medical ... including unfavorable new clinical data and additional analyses of existing clinical data; the risk that clinical trial data ... amendments to protocols of the ARCHES and EMBARK clinical trials and the expected primary completion dates of those trials, ... The companies now anticipate the primary completion date for the ARCHES clinical trial to be in late 2018. The previously ...
Patients with a previous malignancy without evidence of disease for , 5 years will be allowed to enter the trial. ... See Studies by Topic. *See Studies on Map. *How to Search. *How to Use Search Results ... Phase III FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer. The safety and scientific validity of this study is ... A Randomized Phase III Study Evaluating Modified FOLFIRINOX (mFFX) With or Without Stereotactic Body Radiotherapy (SBRT) in the ...
Concurrent or previous enrollment in a clinical trial involving investigational drug or a medical device ... See Studies by Topic. *See Studies on Map. *How to Search. *How to Use Search Results ... Phase Acute Kidney Injury Peritonitis Necrotizing Soft Tissue Infection Drug: Reltecimod Drug: 0.9% Sodium Chloride Injection ... Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury. The safety and scientific ...
MedlinePlus related topics: Acne Drug Information available for: Benzoyl peroxide Adapalene U.S. FDA Resources ... Clinical Trial Phase III to Assess the Non-inferiority of Dalap Duo® Product Compared to Epiduo® in the Treatment of Acne ... National Clinical Trial, Phase III, Monocentric, Randomized, Open, Controlled, Parallel Study to Assess the Non-inferiority of ... Person who has participated in clinical trial protocols in the last twelve (12) months, unless the investigator considers that ...
Phase I-II, Not-Randomized, Multicenter Clinical Trial to Evaluate Safety and Efficacy of Sorafenib (BAY-43-9006) in ... MedlinePlus related topics: Soft Tissue Sarcoma Drug Information available for: Ifosfamide Sorafenib ... Phase I-II Trial of Sorafenib in Combination With Ifosfamide in Soft Tissue Sarcoma. The safety and scientific validity of this ... Phase II: Activity profile evaluating of the combination in patients with advanced soft tissue sarcoma. [ Time Frame: Phase II ...
RV144 remains the only HIV-1 vaccine trial to demonstrate efficacy against HIV-1 acquisition. The prespecified analysis of ... Clinical Trials, Phase III as Topic * HIV Envelope Protein gp120 / immunology* * HIV Infections / prevention & control* ... Lessons from the RV144 Thai phase III HIV-1 vaccine trial and the search for correlates of protection Annu Rev Med. 2015;66:423 ... Follow-up clinical trials are ongoing to further dissect the immune responses elicited by the RV144 ALVAC-HIV and AIDSVAX® B/E ...
Based on adaptations applied, adaptive designs can be classified into three categories: prospective, concurrent (ad hoc), and … ... the use of adaptive design methods in clinical research and development based on accrued data has become very popular due to ... Clinical Trials as Topic / methods* * Clinical Trials, Phase II as Topic * Clinical Trials, Phase III as Topic ... An adaptive design allows modifications made to trial and/or statistical procedures of ongoing clinical trials. However, it is ...
Topics: Clinical Trials. Original Article: Genmab Reports Phase III Study Results for Daratumumab in Front-Line Multiple ... Genmab Reports Phase III Study Results for Daratumumab in Front-Line Multiple Myeloma. 14:03 EDT 24 Aug 2017 , Drug Discovery ... More From BioPortfolio on "Genmab Reports Phase III Study Results for Daratumumab in Front-Line Multiple Myeloma". *Related ... Topics * All Topics Biotechnology Biotech Business Biotech Products Cancer Cardiovascular Dermatology Drug Discovery ...
The results presented by the current Phase I clinical trial have brought us greater confidence in the next phase of IBI302 ... The Phase I study of IBI302 is an open-label, multi-center, dose-escalation clinical trial to evaluate the safety and ... The Phase I study of IBI302 is an open-label, multi-center, dose-escalation clinical trial to evaluate the safety and ... Innovent Announces the Results of the Phase I Clinical Trial of IBI302, a First-in-class Ophthalmic Recombinant Human Anti-VEGF ...
Editors Note: We invite comments and request that they be civil and on-topic. We do not moderate or assume any responsibility ... A Phase Me clinical trial confirms this study. World Peace would break out if MDMA was as mandatory as masks. ... 12 responses to "A Phase 3 Clinical Trial Confirms MDMAs Effectiveness As a Psychotherapeutic Catalyst" * Dont look at me!. ... A Phase 3 Clinical Trial Confirms MDMAs Effectiveness As a Psychotherapeutic Catalyst ...
Topics of discussion may include. * Assessing safety in pre-licensure clinical trials (Phase I-III) ... Topics for discussion may include. * Vaccine safety as conceived in the 1986 act that established the Vaccine Injury ... Topics of discussion may include. * Quality and safety of administration, storage, inventory management, cold chain, other ... Center for Clinical Epidemiology and Biostatistics. Assistant Professor of Epidemiology, University of Pennsylvania School of ...
Research ArticleHot Topics. Landscape Analysis of Phase 2 and 3 Clinical Trials for Targeted Radionuclide Therapy. Erik Mittra ... Overall, the results showed 42 clinical trials, including 13 in phase 1/2, 26 in phase 2, and 3 in phase 3. Given this range of ... Phase 2 includes the largest number of trials (26 trials) and the largest spectrum of design. These trials include novel agents ... Phase I trial of 131I-GMIB-Anti-HER2-VHH1, a new promising candidate for HER2-targeted radionuclide therapy in breast cancer ...
... the role of clinician influence and other factors on decision making regarding participation in a randomized clinical trial ( ... Content initiators were also coded in relation to each topic area raised. Past studies achieved between 88 and 93% agreement on ... An Examination of Factors Influencing Participation Decisions in Phase III Randomized Clinical Trials. ... nurses were contacted once a child became eligible to participate in a greater than minimal risk phase III clinical trial. This ...
NASDAQ: ALDX) (Aldeyra), a clinical-stage biotechnology company devoted to treating inflammation, inborn errors of metabolism, ... Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the ... scores during the late phase of ocular allergy observed in Phase 2a and Phase 2b clinical trials have confirmed the clinical ... Aldeyra Therapeutics Announces Results from Allergic Conjunctivitis Phase 2b Clinical Trial and Plans for Phase 3 Clinical ...
NovaRx Corporation announced today that the company initiated its pivotal Phase III clinical trial of Lucanix(R) ( ... Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the ... NovaRx Initiates Pivotal Phase III Clinical Trial in Lung Cancer Patients. Thursday, August 21, 2008 General News ... 21 NovaRx Corporation announced today thatthe company initiated its pivotal Phase III clinical trial of Lucanix(R)( ...
Participation in any other clinical trial (except for the etravirine or maraviroc expanded access program), without prior ... MedlinePlus related topics: HIV/AIDS Drug Information available for: Raltegravir Elvitegravir Raltegravir potassium ... Participants receiving LPV/r or ATV/r as part of their background regimen in the Open-Label Phase will receive EVG 85 mg; all ... EVG 85 mg or 150 mg + RAL placebo + background regimen in the Randomized Phase, followed by EVG 85 mg or 150 mg + background ...
... the results of clinical observations and trials, and possible... ... Two ongoing phase III clinical trials are evaluating the effect ... This information is produced and provided by the National Cancer Institute (NCI). The information in this topic may have ... Current Clinical Trials Check the list of NCI-supported cancer clinical trials for integrative, alternative, and complementary ... Three trials were conducted in the United States and one in Australia. All trials enrolled breast cancer survivors with history ...
Rotavirus vaccines have been shown to be highly efficacious in large scale phase III prelicensing clinical trials ... What is already known on this topic. *. ... in a clinical trial that was designed to simulate real world ... Both vaccines are highly efficacious for the prevention of rotavirus gastroenteritis in large scale clinical trials.11 12 13 14 ... providing protection equivalent to that seen in clinical trial settings ...
... multi-institutional Phase 3 study in patients with borderline resectable ... ... Your weekly roundup of hot topics in the exciting world of fintech. ... NewLink Genetics Announces Phase 3 Clinical Trial of algenpantucel-L Immunotherapy Charles Gross , Benzinga Staff Writer {{ ... If you have any questions as it relates to either of the three newsletters, please feel free to contact us at 1-877-440-ZING. ...
... tralokinumab has failed its second and third Phase III trials in severe, uncontrolled asthma ... FDA Places Another Clinical Hold on Trial for Solids DMD Gene Therapy. ... AstraZeneca Asthma Candidate Tralokinumab Fails Two Phase III Trials. November 1, 2017. 0 ... Topics *. AllBioprocessingCancerDrug DiscoveryOMICsTranslational MedicineGenome Editing. Solid Biosciences ...
Clinical Trial Outlook 2025 report has been added to ResearchAndMarkets.coms offering. This report on the Controlled Release ... Majority Drugs In Phase-II & Phase-III Trials: More Than 80 * Global Controlled Drug Delivery Market Future Outlook ... Key Topics Covered: 1. Drug Delivery: An Advancing Trajectory 1.1 Preamble Towards Drug Delivery ... Global Controlled Release Drug Clinical Pipeline by Phase, Indication, Drug Class * Global Controlled Release Drug Clinical ...
  • With these changes, the estimated primary completion date for the EMBARK clinical trial is mid-2020. (
  • This landscape analysis was completed by searching for the terms "radionuclide therapy," "radioisotope therapy," "radiopharmaceutical therapy," and "radioligand therapy" on in November 2020. (
  • Given the balance sheet (c.£29m net cash at 30 June 2020), underlying growth and previous clinical trial successes, we believe the risk/reward profile is highly attractive and reiterate our target price of 40p. (
  • CAMBRIDGE, Mass., July 24, 2020 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) today announced there will be multiple data presentations from its Alzheimer's disease (AD) clinical development portfolio, a virtual satellite symposium and AD PACE poster presentations at the Alzheimer's Association International Conference (AAIC), which will be held online July 27-31. (
  • While AVAREF's initial focus was on vaccine clinical trials, its new mandate includes improving and harmonizing ethics and regulatory processes for clinical trials of vaccines as well as medical products and devices, in line with its 2018-2020 strategic plan. (
  • Till the trials are completed successfully for safety and efficacy, vaccines will not be distributed either in India or anywhere else in the world," Adar Poonawalla, Chief Executive Officer, SII, said. (
  • Kenji Yasukawa , Ph.D., 'Astellas') today announced amendments to the protocols for two registrational Phase 3 trials, ARCHES and EMBARK, designed to evaluate the safety and efficacy of XTANDI ® (enzalutamide) in men with hormone-sensitive prostate cancer (HSPC). (
  • for Overweight and Obesity Management), the first of two pivotal trials evaluating the safety and efficacy of lorcaserin for weight management. (
  • The interim recommendation might be updated over the coming weeks based on additional safety and efficacy data from phase III clinical trials and conditions of FDA Emergency Use Authorization. (
  • DUBLIN, June 5, 2019 /PRNewswire/ -- The "Global Psoriasis Clinical Trial Pipeline Highlights - 2019" report has been added to's offering. (
  • Date:3/14/2019). (
  • The trial was recruiting patients as of April 12, according to, and has an estimated primary completion date is June 2019. (
  • Moderna and the National Institutes of Allergy and Infectious Diseases have initiated a phase 3 trial evaluating the vaccine candidate mRNA-1273 against coronavirus disease 2019 (COVID-19). (
  •,viruses%20in%20the%20same%20family.&text=Nipah%20virus%20is%20a%20type,transmitted%20from%20animals%20to%20humans. (
  • Phase 3 multicenter study to be conducted in up to 90 qualified participating sites globally to assess the efficacy and safety of Reltecimod vs placebo in patients with sepsis-associated Stage 2/3 AKI. (
  • The largest is a multicenter (United States and Canada) trial sponsored by the Children's Oncology Group, with an enrollment of up to 813 participants, comparing 131 I-iobenguane versus crizotinib plus standard therapy for younger patients with newly diagnosed high-risk neuroblastoma or ganglioneuroblastoma. (
  • It is aninternational, multicenter, randomized, double-blind study involving up to 700individuals with advanced stage NSCLC, and will be conducted at approximately90 clinical sites in the U.S., Canada, India, and Europe. (
  • Conducted as a multicenter, multinational clinical trial in centers in Europe, the Middle East, and North and South America, the trial randomized 117 subjects with CIDP. (
  • The trial is limited to CLL patients who have had fludarabine in the past and subsequently relapsed. (
  • The target profile of Campath relapse suggests patients recruited for this HuMax-CD20 trial are likely to have bulky lymph nodes, something that stymies even Campath. (
  • ARCHES is a randomized Phase 3 study evaluating the efficacy and safety of enzalutamide plus androgen deprivation therapy (ADT) versus ADT alone in metastatic HSPC patients. (
  • Our goal is to build upon the body of clinical evidence for enzalutamide in an effort to help address the unmet needs of an even broader spectrum of prostate cancer patients. (
  • Seizure occurred in 0.4% of patients receiving XTANDI in clinical studies. (
  • A recent trial, however, reported an unexpected incidence of cardiac toxicity in patients with STS treated with Bevacizumab, a monoclonal antibody that binds VEGF, in combination with Doxorubicin (11). (
  • The Phase I study of IBI302 is an open-label, multi-center, dose-escalation clinical trial to evaluate the safety and tolerability of a single intravitreal injection of IBI302 in patients with nAMD. (
  • Patients who participated in clinical trials were unaware of the particulars of the research (e.g., randomization, treatment arms, etc.) or that the treatment was experimental in nature [ 7 - 9 ], and information presented in the consent form was not always taken into account when making medical decisions [ 10 ]. (
  • Physicians have significant influence on medical decisions that are made by their patients [ 16 - 18 ], and communication with the physician during clinical encounters is an important factor in the final decision to participate in clinical trials [ 19 - 21 ]. (
  • In a study involving oncology patients, 68% of the time physicians recommended that their patients participate in a clinical trial, which was related to the resultant decision to participate [ 22 ]. (
  • biotechnology company devoted to treating inflammation, inborn errors of metabolism, and other diseases related to aldehyde toxicity, today announced results from a Phase 2b clinical trial of topical ocular ADX-102 in patients with allergic conjunctivitis. (
  • While the one-point improvement relative to control component of the primary endpoint was not met, the threshold was approached in seasonal allergy patients, with peak changes of 0.8, and was exceeded on a percent change basis in this population 30 to 60 minutes after allergen challenge, which we believe represents a novel activity profile that addresses late phase inflammation generally not affected by antihistamines. (
  • The randomized, dose-ranging, parallel-group, double-masked, vehicle-controlled, conjunctival allergen challenge (ORA-CAC ) Phase 2b clinical trial of 0.1% and 0.5% ADX-102 ophthalmic solution enrolled 154 patients (approximately 50 per arm) with allergic conjunctivitis, including subjects with seasonal and perennial allergies. (
  • Aldeyra is not aware of any therapy that has demonstrated activity during the late phase allergy response, which is responsible for persistent disease in patients with serious and chronic forms of allergic conjunctivitis that do not respond optimally to antihistamines. (
  • In a Phase II clinical trial, two-year survival among patients with stagesIIIB and IV disease who received Lucanix(R) was significantly longer than thatof individuals being treated with the current standard of care. (
  • I am very excited to be apart of this confirmatory effort, and to be able to offer this uniquetreatment option to my patients," said Dr. Lyudmila Bazhenova, principalinvestigator of the STOP trial at the Rebecca and John Moore's Cancer Centerof UCSD. (
  • I am confident that this Phase III trialwill establish Lucanix(R) as a viable treatment option for patients with thisdreaded disease," said Dr. Habib Fakhrai, president and co-founder of NovaRx. (
  • In Phase II testing, 50 percent of patients entering the trial with stabledisease who received Lucanix(TM) following one frontline regimen ofchemotherapy lived more than 44 months, compared to less than 10-12 months forsuch patients under the current standard of care. (
  • The aim of most acupuncture clinical observation and clinical trials in cancer patients has been to evaluate the effects of acupuncture on symptom management. (
  • NLNK ) announces launching of an open-label, randomized, multi-institutional Phase 3 study in patients with borderline resectable or locally advanced unresectable pancreatic cancer. (
  • We have made significant progress in our Phase 3 trial with algenpantucel-L for resected pancreas cancer patients since its launch in May of 2010," commented Dr. Charles Link, Chief Executive Officer of NewLink. (
  • Tralokinumab also missed its primary endpoint in the 140-patient TROPOS trial of a statistically significant reduction in oral corticosteroid (OCS) use when added to standard of care in patients dependent on OCS. (
  • The company submitted data from the Phase II ACE-LY-004 open-label, single-arm trial in 124 adult patients with relapsed or refractory MCL. (
  • So these trials are carried out in patients suffering from the disease the medicine is intended to treat. (
  • Usually around 200 patients will be treated in this phase. (
  • 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. (
  • I write about the latest science in ALS and aim to provide a layman's overview of topics important to patients, caregivers, clinicians and researchers alike. (
  • The Phase III study, involving 142 patients, is a placebo controlled, double blind trial designed to evaluate the efficacy and safety of Xepol® in PPS, a neurological pain and weakness syndrome in patients that have survived poliovirus infection. (
  • For safety purposes, clinical trials start with small groups of patients to find out whether a new approach causes any harm. (
  • Treatment-related death in patients with small-cell lung cancer in phase III trials over the last two decades. (
  • In total, 97 trials including nearly 25,000 enrolled patients were analyzed. (
  • Time trends in the demographics of patients randomized in phase III trials.A good PS was defined as an Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. (
  • Pharm-Olam was hired to support a Phase 3 study of a monoclonal antibody (mAb) and its impact on patients with ventilator-associated pneumonia. (
  • The dosage level is slowly increased as new patients enter the trial. (
  • For this reason, some phase I trials may be limited to patients whose condition cannot be helped by other known or proven treatments. (
  • Conclusion If a significant number of patients (usually at least one-fifth) respond favorably to a treatment, it proceeds to Phase III. (
  • Researchers also puzzled over one bit of good news for patients, namely that placebo controls are performing better than expected in trials. (
  • Since amyotrophic lateral sclerosis progresses quickly, some patients are reluctant to join a trial when they risk being assigned a placebo. (
  • 0.0001) was achieved on all three of the hierarchically ordered co-primary endpoints for patients treated with lorcaserin versus placebo. (
  • Clinical researchers in the Liver Disease Management and Transplant Program are leading new investigations into hepatitis B and C disease management, hepatoma, hepatitis and HIV co-infection, nonalcoholic steatohepatitis, hepatorenal syndrome, and the care of liver transplant patients. (
  • Lymphography after ic injection was in the normal range in 2/3 of the patients with lymphedema and is therefore of no diagnostic value. (
  • The Phase III HALO EM clinical trial recruited 1,130 patients for a 16-week study. (
  • Patients were randomly assigned to one of three groups: monthly dosing of fremanezumab, quarterly dosing or a placebo. (
  • These top-line results reflect our differentiated clinical development program and add to a growing body of evidence that supports the development of CGRP targeted therapy in migraine, including patients with very severe forms of the disease, with flexible dosing regimens," said Dr. Marcelo Bigal, Chief Medical Officer & Head of Specialty Clinical Development at Teva. (
  • This trial was performed to assess the feasibility and safety of controlled resuscitation (CR) versus standard resuscitation (SR) in hypotensive trauma patients. (
  • Among patients with blunt trauma, 24-hour mortality was 3% (CR) and 18% (SR) with an adjusted odds ratio of 0.17 (0.03-0.92). (
  • Last year, the Society of Urologic Oncology and the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC) published a study reporting positive results from an earlier Phase II trial ( NCT01687244 ) showing the potential effectiveness of nadofaragene firadenovec/Syn3 in patients with high-grade, BCG refractory or relapsed NMIBC. (
  • The SUO-CTC study reported that BCG-unresponsive NMIBC bladder cancer patients who were given one dose of nadofaragene firadenovec/Syn3 every three months were free of high-grade disease one year after treatment-more than a three-fold improvement in recurrence-free survival compared to valrubicin, which is marketed as Valstar ® by Endo Pharmaceuticals. (
  • We also have a robust clinical trials program, offering patients the option to access some of the latest treatments before they are widely available elsewhere. (
  • Genentech has completed enrollment for a Phase III clinical trial investigating the use of Actemra (tocilizumab) in patients with systemic sclerosis. (
  • The patients were on hemodialysis three times per week. (
  • The results of these clinical trials were presented at the Vaccines for Enteric Disease Conference 2017, held in Albufeira, Portugal. (
  • 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. (
  • With TINNET entering its final year of EU funding, the results were published in a special research topic on tinnitus, which turned out to become the most viewed research topic in the journal Frontiers [2] in 2017. (
  •, 07/25/2017. (
  • Annualized OUD therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in three patient segments (mild, moderate, severe) forecast from 2017 to 2027. (
  • 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. (
  • 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. (
  • Pharmalink currently carries three clinical phase development projects, Nefecon®, Xepol® and Busulipo_, mature for out-licensing to a commercial partner and also seeks to refill its development pipeline by inlicensing. (
  • However, two drug candidates in the Post-Traumatic Stress Disorder (PTSD) pipeline that are expected to launch in the seven major markets (7MM - US, France, Germany, Italy, Spain, UK and Japan) by 2022 are set to revolutionize the treatment of the disorder, as evidenced by promising results in clinical trials. (
  • 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. (
  • Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. (
  • Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. (
  • Some of the best CLL expert centers are participating in this trial. (
  • Even with the large number of centers participating in this trial, this would mean a significant amount of travel to and from the trial center for most of us and you should be prepared for that. (
  • The National Heart, Lung, and Blood Institute (NHLBI) and other National Institutes of Health (NIH) Institutes and Centers sponsor clinical trials. (
  • NIH Institutes and Centers (including the NHLBI) usually sponsor trials that test principles or strategies. (
  • Nadofaragene firadenovec/Syn3 is the subject of a Phase III open-label study that was launched in 2016, and is projected to enroll up to 150 participants across 35 centers in the U.S. ( NCT02773849 ). (
  • The investigational product produced by Aché that will be evaluated in this trial is a cream gel, comprising 0.1% of adapalene 2.5% and benzoyl peroxide. (
  • DUBLIN , April 27, 2018 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) today announced the presentation of clinical data from a Phase 2b investigational study of collagenase clostridium histolyticum (CCH) for the treatment of cellulite. (
  • In addition, Encap has manufactured all the investigational new drug registration batches for the upcoming Phase III clinical supply and stability registration. (
  • Results from early-stage clinical testing indicate the investigational mRNA-1273 vaccine is safe and immunogenic, supporting the initiation of a phase 3 clinical trial," said NIAID Director Anthony S. Fauci, MD. (
  • Last year, Roche tried and failed last year to advance another IL-13 inhibitor indicated for asthma, lebrikizumab, acknowledging disappointing results from two Phase III trials in February 2016. (
  • An Update from AB Science on this trial came out in April 2016: To read that update, click here. (
  • Yanxing Chen, Jianfang Zhang, Baorong Zhang and Cheng-Xin Gong, "Targeting Insulin Signaling for the Treatment of Alzheimer's Disease", Current Topics in Medicinal Chemistry (2016) 16: 485. (
  • After successful completion of the preclinical animal studies and obtaining regulatory clearance for human studies, Hilleman Laboratories had initiated a clinical study in April 2016, to establish proof-of-concept for its heat stable Rotavirus vaccine. (
  • Oddo Securities donderdag herhaalde haar aanbeveling 'kopen' en zijn koersdoel tot 46 euro op GENFIT na de publicatie van de financiële resultaten van 2016 het biofarmaceutisch bedrijf. (
  • In later phases of clinical trials, researchers learn more about the new approach's risks and benefits. (
  • In Phase I trials, researchers generally administer the new treatment to a small group of people, usually 10-80 participants. (
  • Careful analysis may show that the disease trajectory researchers predict at the start of a trial is too steep, he suggested. (
  • By tapping old records for control data, researchers performing Phase 1 or 2 studies should be able to reduce the control populations they need, the theory goes, boosting participants' chances of receiving active drug and improving recruitment (see ARF related news story ). (
  • With their unique mixes of varied contributions from Original Research to Review Articles, Research Topics unify the most influential researchers, the latest key findings and historical advances in a hot research area! (
  • TINNET Action was funded by the COST organisation and with this funding, tinnitus researchers from 30 participating European countries were able to meet together, organise scientific and clinical meetings, teach young researchers and promote knowledge exchange between the partners within the network. (
  • Pune based Serum Institute of India (SII) that is conducting Phase 3 trial of the Oxford Covid-19 vaccine has approached India's drug regulator seeking approval for changes to its protocol to broaden the horizon of the trials. (
  • A Maryland-based COVID-19 vaccine producer is expanding its late-stage Phase 3 clinical trial study to include children ages 12 to 17. (
  • AstraZeneca resumes Phase 3 COVID-19 vaccine trial in the U.K. (
  • The Advisory Committee on Immunization Practices (ACIP) recommended, as interim guidance, that both 1) health care personnel and 2) residents of long-term care facilities be offered COVID-19 vaccine in the initial phase of the vaccination program. (
  • Evidence-based information addressing COVID-19 vaccine topics including early allocation has been explicitly and transparently reviewed during seven public ACIP meetings ( 1 ). (
  • The CF Foundation offers a number of resources for learning about clinical trials and treatments that are being developed to improve the treatment of cystic fibrosis. (
  • To evaluate acute (within 3 months of treatment) grade 2 or greater gastritis, fistula, enteritis, or ulcer and any other grade 3-4 gastrointestinal toxicity within 3 months of treatment. (
  • Therefore, there are still huge unmet clinical needs in AMD treatment. (
  • IBI302 was designed to provide more targeted treatment and interventions to the cause of AMD by adding additional targets, and to bring more clinical benefits compared to anti-VEGF antibody. (
  • We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation. (
  • SAN DIEGO, Aug. 21 NovaRx Corporation announced today thatthe company initiated its pivotal Phase III clinical trial of Lucanix(R)(belagenpumatucel-L) in the treatment of advanced non-small cell lung cancer(NSCLC). (
  • In phase II clinical studiesto date, the side effects of this treatment have included redness or sorenessat the injection site. (
  • After Week 96, participants will continue to take their blinded study drug and attend visits until treatment assignments are unblinded, at which point they will be given the option to participate in an open-label EVG extension phase of the study. (
  • 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. (
  • The primary endpoint, response in functional disability, was observed in 54 percent of subjects treated with Gamunex (2g/kg loading dose, followed by 1g/kg maintenance dose every three weeks) compared to 21 percent on placebo when assessed up to six months in the first treatment period. (
  • The study, published last week in The Lancet Neurology entitled "Intravenous immune globulin (10 percent caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomized, placebo-controlled trial," was sponsored by Talecris Biotherapeutics, Inc.( (
  • Eligible CIDP trial subjects were randomized to treatment with Gamunex (2g/kg as loading dose followed by 1g/kg every three weeks) or placebo for up to 24 weeks. (
  • First period non-responders, i.e., those trial subjects with a one point or greater deterioration, no improvement during the first six week treatment period, or initial improvement followed by deterioration, were rescued by crossing over to the alternate therapy for up to 24 weeks or until non-response to alternate therapy was observed. (
  • During the 24-week extension phase, the sub-group of 57 trial subjects who responded to Gamunex during the first treatment or rescue (crossover) period (31 were randomly reassigned to Gamunex and 26 received placebo) were assessed to determine if treatment with Gamunex (up to one year) could maintain long-term benefit. (
  • STOCKHOLM, SWEDEN, August 26, 2008 - Pharmalink AB today announces positive results from a follow-on Phase III study of Xepol®, its candidate for the treatment of post-polio syndrome (PPS). (
  • 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. (
  • 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. (
  • When the trial began, HT was already in common use for the treatment of menopausal symptoms. (
  • We examined phase 3 trials conducted between 1990 and 2010 to address the role of systemic treatment for SCLC. (
  • Each subject received up to three treatment sessions of CCH (0.84 mg / session) or placebo with each treatment session occurring approximately 21 days apart. (
  • Surgery has traditionally been the treatment of choice, although physicians typically recommend a trial of nonsurgical care prior to surgery. (
  • This randomized clinical trial will compare surgical decompression versus nonsurgical treatment (i.e., physical therapy) of lumbar spinal stenosis. (
  • The primary purpose of a Phase I trial is to evaluate the safety of a new drug or treatment. (
  • If the drug or treatment appears to be safe, it moves to Phase II. (
  • Purpose The primary purpose of a Phase II trial is to determine the effectiveness of a treatment and to further evaluate its safety. (
  • 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. (
  • 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. (
  • If during the trial it is determined that one treatment is superior to another, the trial may be stopped. (
  • Phase IV studies are done after a drug or treatment has been approved by the FDA and marketed. (
  • Prospective, Randomized, Blinded Phase 2 Pharmacokinetic/Pharmacodynamic Study of the Efficacy and Tolerability of Levofloxacin in Combination with Optimized Background Regimen (OBR) for the treatment of MDR-TB. (
  • Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial. (
  • Randomized, Phase II clinical trial assessing the antimicrobial activity and safety of substitution of rifapentine for rifampin in standard intensive phase TB treatment regimen. (
  • Randomized, double-blind, Phase II clinical trial assessing impact on 2-month sputum conversion rate of substitution of moxifloxacin for isoniazid in standard intensive phase TB treatment regimen. (
  • Randomized, open-label Phase III clinical trial of ultra short-course treatment of latent TB infection among contacts of active cases, using a 3-month once-weekly regimen of isoniazid and rifapentine, compared to standard 9-month daily therapy with isoniazid. (
  • A Phase 2b clinical trial of AD04 for the treatment of AUD showed promising results in reducing frequency of drinking, quantity of drinking and heavy drinking (all with statistical significance), and no overt safety concerns (there were no statistically significant serious adverse events reported). (
  • The Company plans to commence a Phase 3 clinical trial using AD04 for the potential treatment of AUD in subjects with certain target genotypes, which are to be identified using the Company's proprietary companion diagnostic genetic test. (
  • At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. (
  • It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes. (
  • Treatment with lenabasum failed to outperform a placebo when given as an add-on to standard immunosuppressants in adults with dcSSc, top-line data from a Phase 3 trial show. (
  • If that is true, then we are at a point where longer trial times are necessary, similar to the early days of breast cancer treatment in the past," Brooks wrote. (
  • Although larger clinical trials are needed for validating their efficacy for the treatment of cognitive impairment and AD, results of animal studies and clinical trials available to date are encouraging. (
  • Aubagio (teriflunomide) is indicated as a monotherapy for the treatment of people with relapsing-remitting MS (RRMS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability. (
  • Juan Frias and Philip Newsome: Learn about the agents in phase II and III clinical trials and their potential use in treatment. (
  • The treatment has completed three clinical trials in the U.S. to date. (
  • FKD cited earlier studies showing that more than 60% of high-grade NMIBC cases eventually reoccur despite treatment with the standard of care, BCG-a population of high unmet clinical need, the company reasons. (
  • Clinical development of LY-404,039 resulted from efforts to discover potent and selective mGluR agonists for the treatment of psychiatric disorders. (
  • Given this range of phases, the planned enrollment varies widely from 10 to 813, with an average of 147 participants. (
  • 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. (
  • Genentech Completes Phase III Enrollment for Study of Actemra in Systemic Sclerosis. (
  • A large-scale, Phase III trial to examine its effects on survival and other clinical outcomes is warranted. (
  • For example, the National Heart, Lung, and Blood Institute (NHLBI) sponsored a trial of two different combinations of asthma treatments. (
  • Although the treatments have been well tested in the lab prior to the trial, there may still be significant risk. (
  • Approximately 70% of drugs or treatments tested in Phase I trials proceed to the next phase. (
  • Approximately 33% of drugs and treatments proceed to the next phase. (
  • Approximately 25-30% of drugs and treatments will clear this phase. (
  • Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. (
  • Written by research leaders from the University of Texas MD Anderson Cancer Center, this book shows how Bayesian designs for early-phase clinical trials can explore, refine, and optimize new experimental treatments. (
  • Toward that end, early results from Phase 1 and 2 trials for several treatments offered a glimmer of hope, but more immediately, two large studies disappointed (see below). (
  • The HillcholTM vaccine consists of a novel Hikojima strain that expresses both the Ogawa and Inaba serotypes, and also replaces three virulent O1 strains inactivated by two different processes used in currently licensed vaccines. (
  • Since 2006, AVAREF has convened annual meetings to review clinical trial applications for vaccines against meningitis, malaria, tuberculosis, and other diseases. (
  • The trial, which is the first to be implemented under Operation Warp Speed , is expected to enroll around 30,000 adults and will be conducted at multiple clinical research sites across the US. (
  • The Multidisciplinary Association for Psychedelic Studies, a non-profit working to legalize the psychedelic MDMA for assisted psychotherapy, announced Thursday that it has raised the $30 million necessary to complete phase 3 trials and achieve FDA approval for the drug. (
  • Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. (
  • The double-blind, placebo-controlled trial, which was sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), confirms MDMA's potential. (
  • Clinical trials for targeted radionuclide therapy, most of which involve PRRT (15 studies) or PRRT combinations (5 studies) predominantly for neuroendocrine neoplasms, mainly with 177 Lu-DOTATATE (16 studies). (
  • Radioligand therapy with PSMA agents, alone (5 studies) or in combination (3 studies), and 223 Ra-dichloride, mainly in combinations (5 studies), account for most remaining studies, directed mainly at prostate cancer. (
  • A one-point difference at 5 minutes post-challenge, which has been typically used in antihistamine and corticosteroid allergic conjunctivitis studies for endpoint assessment, represents a 38% improvement in itch score relative to that of the vehicle values observed in the trial. (
  • The summary includes a brief history of acupuncture practice, a review of laboratory and animal studies, the results of clinical observations and trials, and possible side effects of acupuncture therapy. (
  • The search strategy includes Phase III or Phase IV clinical trials or observational studies with an active comparator. (
  • Relatively few clinical trials are ongoing, compared to the vast body of evidence among completed studies. (
  • The purpose of clinical trials is research, so the studies follow strict scientific standards. (
  • Bayesian Designs for Phase I-II Clinical Trials describes how phase I-II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. (
  • They discussed disappointing results from two recent Phase 3 studies. (
  • However, McHutchison noted that this study was the smallest of the three late-stage studies of filgotinib in treating rheumatoid arthritis. (
  • Contrary to previous belief that insulin would not act in the brain, studies in the last three decades have proven important roles of insulin and insulin signaling in various biological functions in the brain. (
  • Speaking on the results Dr. Tarun Sharma, Director R&D at Hilleman Labs said,"The Hillchol" Phase I/II clinical trial results support the Hikojima vaccine design and mirrors the impressive results achieved in preclinical studies. (
  • At the conference, Biogen will share an encore platform presentation of the previously reported topline results from the aducanumab Phase 3 EMERGE and ENGAGE studies. (
  • Encore platform presentation and Q&A: EMERGE and ENGAGE topline results: phase 3 studies of aducanumab in early AD. (
  • Tumor associated carbohydrate antigens can be coupled covalently to protein carriers to target MHC receptors and improve immunogenicity and have reached already pre-clinical and clinical studies. (
  • The network also relies on a statistical and clinical coordinating center to monitor trials and coordinate data from its studies. (
  • The primary endpoint of the trial is radiographic progression-free survival (rPFS). (
  • The primary endpoint of the trial is metastasis-free survival (MFS). (
  • In subjects with seasonal allergy, reductions in itching were up to 0.8 points over vehicle (on a 0 to 4 point scale, p=0.002), approaching the one-point threshold of activity required for achievement of the primary endpoint of the trial. (
  • It is important to note that masitinib is also in a large Phase 2b/3 clinical trial for Multiple Sclerosis. (
  • In the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial, Aubagio 14 mg significantly reduced the annualized relapse rate and slowed disability progression at two years versus placebo in people with RRMS. (
  • In the TOWER (Teriflunomide Oral in people With relapsing remitting multiplE sclerosis) trial, Aubagio 14 mg significantly reduced the annualized relapse rate and slowed disability progression sustained for 12 weeks was statistically significantly reduced versus placebo in people with RRMS. (
  • We are excited to initiate an additional Phase 3 clinical trial for algenpantucel-L to potentially expand into a new indication for locally advanced pancreatic cancer. (
  • Download this ebook to learn the formula for success when conducting rare disease clinical trials. (
  • These are often called randomised-controlled trials, or double-blind trials. (
  • The original placebo controlled, double blind Phase III trial was six months (Gonzalez et al (2006) Lancet Neurology 5:493-500) and this follow-up period was another six months. (
  • Randomized, placebo-controlled, double-blind Phase I/II clinical trial assessing the safety and microbiological activity of Linezolid added to Optimized Background Therapy (OBT) for MDR TB or XDR TB. (
  • The Trial is a double-blind, placebo-controlled trial with the primary objective to evaluate the efficacy of AD04 to reduce alcohol consumption in subjects with AUD that are positive for certain genetic biomarkers. (
  • In addition, HSRV elicited comparable Geometric Mean Titre relative to RotaTeq, 1 month after completion of 3-dose vaccination schedule. (
  • A PrEP clinical trial that involved men who had sex with men and transgender women who had sex with men found that PrEP reduced the risk of acquiring HIV infection by 44 percent. (
  • The Network is currently focusing on three main work streams: Allergy, Infection and TB. (
  • McHutchison stated that the phase 3 results for the immunology drug were what the company expected to see. (
  • Search the NHLBI, use the drop down list to select: the entire site, the Health Topics section only, or the News and Resources section. (
  • The findings echo a current trend in Alzheimer's trials, where placebo groups decline more gradually than has been seen in the past (see ARF related news story ). (
  • We continually strive to design and implement clinical trials that bring innovations to people with the greatest need,' said Steven Benner , M.D., senior vice president and global therapeutic area head, Oncology Development, Astellas. (
  • In recent years, the use of adaptive design methods in clinical research and development based on accrued data has become very popular due to its flexibility and efficiency. (
  • Strategies for the use of adaptive design in clinical development of rare diseases are discussed. (
  • The results presented by the current Phase I clinical trial have brought us greater confidence in the next phase of IBI302 research and development. (
  • It covers emerging therapies for Psoriasis in active clinical development stages including early and late stage clinical trials. (
  • The ALS Therapy Development Institute is a registered 501(c)3 nonprofit. (
  • A large number of industry-sponsored drugs in active clinical development for migraine are in Phase III. (
  • being highlighted at Hot Topics is an important milestone in Endo's development program of CCH for Cellulite as we pursue entry into the Medical Aesthetics community. (
  • As previously announced, the Company has partnered with Catalent Pharma Solutions, a leading global provider of advanced delivery, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, to advance clinical activities related to AD04, including packaging and distribution. (
  • These agents have been licensed to Celgene for clinical development in the years ahead. (
  • The most promising candidates in Phase III development are profiled. (
  • However, pharmaceutical company Eli Lilly terminated further development of the compound in 2012 after it failed in phase III clinical trials. (
  • AstraZeneca acknowledged today that its anti-interleukin-13 (anti-IL-13) human monoclonal antibody (mAb) tralokinumab has failed its second and third Phase III trials in severe, uncontrolled asthma. (
  • AstraZeneca disclosed the tralokinumab trial failures a day after winning FDA accelerated approval for Calquence ® (acalabrutinib), a selective Bruton's tyrosine kinase (BTK) inhibitor indicated for adults with mantle cell lymphoma (MCL) who have received at least one prior therapy. (
  • Attempts by Eli Lilly and AstraZeneca to replicate findings showing potent partial agonist action of mGluR2/3 agonists at D2 receptors were unsuccessful. (
  • Earlier this year Endo announced the initiation of two identical Phase 3 RELEASE * clinical trials. (
  • Phase II is initiated with a therapeutic dose to determine the treatment's effectiveness and further safety. (
  • The second is a single-site randomized trial (the ESCALATE trial at the Carolina Urologic Research Center) of 499 participants comparing 223 Ra plus enzalutamide or darolutamide versus enzalutamide or darolutamide alone for metastatic castration-resistant prostate cancer. (
  • This is a multisite, randomized trial of 300 participants with gastroenteropancreatic neuroendocrine tumors. (
  • Each phase has different purposes and entails different levels of risks for participants. (
  • Number of Participants This larger trial group may include 300-5,000 people or more. (
  • Information gathered from preclinical tests are used to apply for permission to conduct clinical trials. (
  • Adenovirus Vaccine Efficacy Trial Consortium (2013). (
  • Based on the data from the trial and the differentiated late-phase anti-inflammatory profile of ADX-102 that could apply to a large underserved population with allergic conjunctivitis, Aldeyra currently plans to initiate Phase 3 clinical testing with 0.5% ADX-102 following discussion with the regulatory authorities in the second half of this year. (
  • The clinical data announced today represent a unique activity profile that is distinguished from antihistamines, the standard of care in allergic conjunctivitis. (
  • It is one of the jobs of this board to review data continuously throughout the trial and to make a recommendation for its continuation or cancellation based on that data. (
  • In July it was granted the opportunity to carry out a new phase III clinical study on its short-course birch pollen inoculation after a tranche of data was declared invalid. (
  • Clinical trials produce the best data available for health care decisionmaking. (
  • However, based on extrapolation of Medicare fee-for-service data to the U.S. population, it has been estimated that the total number of persons treated for nonmelanoma skin cancers in 2012 was about 3 million. (
  • LMDS broadband services in the United States provide high data rates, but only over a relatively short distance of three miles. (
  • Phase II clinical results for rAd-IFN/Syn3 were very encouraging, and we look forward to the Phase III data," added Ferring CMO Prof. Klaus Dugi, M.D. (
  • Each site employs a qualified obstetrician/gynecologist (for female-focused sites) or andrologist/urologist (for male-focused sites), study coordinator, and data/research manager, and has access to clinical facilities capable of recruiting for and conducting Phase I, II, and III clinical trials. (
  • Phase III clinical trials are administered to a larger group of people to finally verify efficacy and safety. (
  • An adaptive design allows modifications made to trial and/or statistical procedures of ongoing clinical trials. (
  • In addition, major adaptations of trial and/or statistical procedures of on-going trials may result in a totally different trial that is unable to address the scientific/medical questions the trial intends to answer. (
  • The pharma giant announced topline results from the two trials, STRATOS 2 ( NCT02194699 ) and TROPOS ( NCT02281357 ). (
  • Chairman of Dr Reddys Laboratories, Satish Reddy said, "We are pleased with the collaboration with BIRAC as an advisory partner for clinical trials of the Sputnik V vaccine in India. (
  • These will be used for phase 3 clinical trials conducted in India as well as sold commercially if the vaccine is approved for emergency use. (
  • Genmab has just announced the clinical trial on , with all the details. (
  • Based on adaptations applied, adaptive designs can be classified into three categories: prospective, concurrent (ad hoc), and retrospective adaptive designs. (
  • In this article, several commonly considered adaptive designs in clinical trials are reviewed. (
  • Practical issues that are commonly encountered when implementing adaptive design methods in clinical trials are also discussed. (
  • This KOL Insight briefing focuses on KOLs views of Adaptive trial designs in IBD. (
  • The companies now anticipate the primary completion date for the ARCHES clinical trial to be in late 2018. (
  • The Comparative Effectiveness Research as Topic search strategy has been designed to retrieve citations "about" CER. (
  • Register for upcoming (live) or recorded webinars, choose by topic, or search by keyword to find webinars of interest. (
  • True, it has received fast-track status from the FDA for clinical trials in CLL but final approval to market the drug will depend on the success of the latest Phase-III clinical trial that has been launched. (
  • This is a single agent trial - the only drug given is HuMax-CD20. (
  • The results of the Phase 3 clinical trial, which are consistent with earlier research , mean that MDMA, which was banned in 1985, is on track to be approved as a prescription drug by the Food and Drug Administration (FDA) as soon as 2023 . (
  • The "Global Controlled-Release Drug Delivery Market - Opportunity & Clinical Trial Outlook 2025" report has been added to's offering. (
  • The report concludes with comprehensive insight on ongoing clinical trials of controlled delivered drugs and future trends which clearly highlights it as one of the most promising market in the modern drug delivery segment. (
  • Newer, more sophisticated, transdermal patches and other transdermal controlled drug delivery systems are being developed that are currently being tested in clinical trials. (
  • First period responders or rescue responders to either study drug who showed and maintained a one point or greater adjusted INCAT score improvement were randomly reassigned to Gamunex or placebo for an additional 24-week long-term extension phase. (
  • A control that is used in drug trials. (
  • It was recently announced via press release from AB Sciences that their drug masitinib will continue to be trialed in ALS. (
  • The U.S. Food and Drug Administration (FDA) oversees these clinical trials. (
  • There are generally no conclusions about how well a drug works in Phase I trials. (
  • Experts from FDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), the University of Maryland and the University of Pennsylvania will provide a deep dive into the scientific background and practical methodology needed when conducting clinical trials. (
  • That practice was approved for the first time by the Food and Drug Administration in 2011 to amplify the power of an ALS trial for sodium chlorite, a mineral formulation also known as NP001. (
  • Encap Drug Delivery , part of Capsugel's Dosage Form Solutions business unit, will collaborate with Lipocine, a specialty pharmaceutical company, to manufacture Phase III clinical trial and ICH stability registration batches of Lipocine's oral testosterone product, LPCN 1021. (
  • This FOA is not intended to fund drug discovery or large scale clinical trials. (
  • Since the country of Botswana was one of the sites for the PrEP drug trial, Blower and her colleagues chose it for their modeling. (
  • 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. (
  • In infants, when administered as 3-dose primary series, HSRV had a safety profile similar to RotaTeq in terms of frequency, severity, and causality of solicited adverse effect. (
  • Find out more on how to host your own Frontiers Research Topic or contribute to one as an author. (
  • In medical research, you see something like this once in a lifetime,"said John Nemunaitis, M.D., executive director at the Mary Crowley MedicalResearch Center in Dallas, TX and principal investigator of both the Phase IILucanix(R) study and the investigator-initiated Phase II trial. (
  • The BLOOM results, demonstrating lorcaserin's medically important weight loss coupled with the tolerability and safety profile displayed in this trial, differentiate lorcaserin from approved drugs or other agents in clinical trials," commented Steven R. Smith, M.D., Co-Principal Investigator and Professor and Assistant Director for Clinical Research at the Pennington Biomedical Research Center. (
  • All types of clinical trials contribute to medical knowledge and practice. (
  • AVAREF emerged as the natural outgrowth of a 2006 joint review of a clinical trial application for a new group A meningococcal conjugate vaccine and the subsequent joint good clinical practice (GCP) inspection of the vaccine's phase II trial. (
  • 1 ] The incidence of nonmelanoma skin cancer appears to be increasing in some,[ 2 ] but not all,[ 3 ] areas of the United States. (
  • The big biotech, along with its smaller partner, Galapagos ( NASDAQ:GLPG ) , announced positive results from a phase 3 clinical study evaluating filgotinib in treating rheumatoid arthritis. (
  • Within nuclear medicine, theranostics has revitalized the field of targeted radionuclide therapy, and there are a growing number of investigator-initiated and industry-sponsored clinical trials of targeted radionuclide therapy. (
  • A second,investigator-initiated phase II study supported these results. (
  • The key measure of visual function - best-corrected visual acuity (BCVA) -continued to improve at Week 72 compared to Week 48, demonstrating sustained recovery from the lowest point, or nadir, experienced in the acute phase of the disease. (
  • Traditional chemotherapy for stage IV NSCLC still yieldsdisappointing results, and my hope is that this trial will improve thenatural history of the disease. (
  • To learn more about this study and our expertise in the conduct of pneumonia clinical trials and infectious disease in general, please see the helpful resources included below. (
  • Identifying early molecular or genetic changes - which may be detected before the disease manifests any clinical symptoms - could lead to interventions that reduce the severity of liver disease, or even prevent it from developing. (
  • The clinical trials were conducted in partnership with the International Centre for Diarrhoeal Disease Research (ICDDR), Bangladesh. (