Retreatment: The therapy of the same disease in a patient, with the same agent or procedure repeated after initial treatment, or with an additional or alternate measure or follow-up. It does not include therapy which requires more than one administration of a therapeutic agent or regimen. Retreatment is often used with reference to a different modality when the original one was inadequate, harmful, or unsuccessful.Melanoma: A malignant neoplasm derived from cells that are capable of forming melanin, which may occur in the skin of any part of the body, in the eye, or, rarely, in the mucous membranes of the genitalia, anus, oral cavity, or other sites. It occurs mostly in adults and may originate de novo or from a pigmented nevus or malignant lentigo. Melanomas frequently metastasize widely, and the regional lymph nodes, liver, lungs, and brain are likely to be involved. The incidence of malignant skin melanomas is rising rapidly in all parts of the world. (Stedman, 25th ed; from Rook et al., Textbook of Dermatology, 4th ed, p2445)Programmed Cell Death 1 Receptor: An inhibitory T-lymphocyte receptor that has specificity for CD274 ANTIGEN and PROGRAMMED CELL DEATH 1 LIGAND 2 PROTEIN. Signaling by the receptor limits T cell proliferation and INTERFERON GAMMA synthesis. The receptor also may play an essential role in the regulatory pathway that induces PERIPHERAL TOLERANCE.Treatment Outcome: 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.Antigens, CD274: An inhibitory B7 antigen that has specificity for the T-CELL receptor PROGRAMMED CELL DEATH 1 PROTEIN. CD274 antigen provides negative signals that control and inhibit T-cell responses and is found at higher than normal levels on tumor cells, suggesting its potential role in TUMOR IMMUNE EVASION.Programmed Cell Death 1 Ligand 2 Protein: A costimulatory B7 antigen that has specificity for the T-CELL receptor PROGRAMMED CELL DEATH 1 RECEPTOR. It is closely-related to CD274 antigen; however, its expression is restricted to DENDRITIC CELLS and activated MACROPHAGES.Melanoma, Experimental: Experimentally induced tumor that produces MELANIN in animals to provide a model for studying human MELANOMA.Follow-Up Studies: Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease.Retrospective Studies: Studies used to test etiologic hypotheses in which inferences about an exposure to putative causal factors are derived from data relating to characteristics of persons under study or to events or experiences in their past. The essential feature is that some of the persons under study have the disease or outcome of interest and their characteristics are compared with those of unaffected persons.Time Factors: Elements of limited time intervals, contributing to particular results or situations.Coronary Artery Disease: Pathological processes of CORONARY ARTERIES that may derive from a congenital abnormality, atherosclerotic, or non-atherosclerotic cause.Coronary Stenosis: Narrowing or constriction of a coronary artery.Coronary Artery Bypass: Surgical therapy of ischemic coronary artery disease achieved by grafting a section of saphenous vein, internal mammary artery, or other substitute between the aorta and the obstructed coronary artery distal to the obstructive lesion.Coronary Angiography: Radiography of the vascular system of the heart muscle after injection of a contrast medium.Drug-Eluting Stents: Stents that are covered with materials that are embedded with chemicals that are gradually released into the surrounding milieu.Angioplasty, Balloon, Coronary: Dilation of an occluded coronary artery (or arteries) by means of a balloon catheter to restore myocardial blood supply.Coronary Vessels: The veins and arteries of the HEART.Stents: Devices that provide support for tubular structures that are being anastomosed or for body cavities during skin grafting.Clinical Trials, Phase III as Topic: 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.Lung Neoplasms: Tumors or cancer of the LUNG.Carcinoma, Non-Small-Cell 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.Clinical Trial, Phase IIIClinical Trials as Topic: 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.Clinical Trials, Phase II as Topic: 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.Antineoplastic Agents: Substances that inhibit or prevent the proliferation of NEOPLASMS.Antineoplastic Combined Chemotherapy Protocols: The use of two or more chemicals simultaneously or sequentially in the drug therapy of neoplasms. The drugs need not be in the same dosage form.Clinical Trials, Phase IV as Topic: Planned post-marketing studies of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques that have been approved for general sale. These studies are often conducted to obtain additional data about the safety and efficacy of a product. This concept includes phase IV studies conducted in both the U.S. and in other countries.Computer Graphics: The process of pictorial communication, between human and computers, in which the computer input and output have the form of charts, drawings, or other appropriate pictorial representation.User-Computer Interface: The portion of an interactive computer program that issues messages to and receives commands from a user.Software: Sequential operating programs and data which instruct the functioning of a digital computer.Internet: A loose confederation of computer communication networks around the world. The networks that make up the Internet are connected through several backbone networks. The Internet grew out of the US Government ARPAnet project and was designed to facilitate information exchange.Data Display: The visual display of data in a man-machine system. An example is when data is called from the computer and transmitted to a CATHODE RAY TUBE DISPLAY or LIQUID CRYSTAL display.Algorithms: A procedure consisting of a sequence of algebraic formulas and/or logical steps to calculate or determine a given task.Programming Languages: Specific languages used to prepare computer programs.Computational Biology: A field of biology concerned with the development of techniques for the collection and manipulation of biological data, and the use of such data to make biological discoveries or predictions. This field encompasses all computational methods and theories for solving biological problems including manipulation of models and datasets.Information Storage and Retrieval: Organized activities related to the storage, location, search, and retrieval of information.Database Management Systems: Software designed to store, manipulate, manage, and control data for specific uses.Migraine Disorders: A class of disabling primary headache disorders, characterized by recurrent unilateral pulsatile headaches. The two major subtypes are common migraine (without aura) and classic migraine (with aura or neurological symptoms). (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)Migraine with Aura: A subtype of migraine disorder, characterized by recurrent attacks of reversible neurological symptoms (aura) that precede or accompany the headache. Aura may include a combination of sensory disturbances, such as blurred VISION; HALLUCINATIONS; VERTIGO; NUMBNESS; and difficulty in concentrating and speaking. Aura is usually followed by features of the COMMON MIGRAINE, such as PHOTOPHOBIA; PHONOPHOBIA; and NAUSEA. (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)Migraine without Aura: Recurrent unilateral pulsatile headaches, not preceded or accompanied by an aura, in attacks lasting 4-72 hours. It is characterized by PAIN of moderate to severe intensity; aggravated by physical activity; and associated with NAUSEA and / or PHOTOPHOBIA and PHONOPHOBIA. (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)Fructose: A monosaccharide in sweet fruits and honey that is soluble in water, alcohol, or ether. It is used as a preservative and an intravenous infusion in parenteral feeding.Breast Neoplasms: Tumors or cancer of the human BREAST.Neoplasm Metastasis: The transfer of a neoplasm from one organ or part of the body to another remote from the primary site.Receptor, erbB-2: A cell surface protein-tyrosine kinase receptor that is overexpressed in a variety of ADENOCARCINOMAS. It has extensive homology to and heterodimerizes with the EGF RECEPTOR, the ERBB-3 RECEPTOR, and the ERBB-4 RECEPTOR. Activation of the erbB-2 receptor occurs through heterodimer formation with a ligand-bound erbB receptor family member.Breast: In humans, one of the paired regions in the anterior portion of the THORAX. The breasts consist of the MAMMARY GLANDS, the SKIN, the MUSCLES, the ADIPOSE TISSUE, and the CONNECTIVE TISSUES.Mechlorethamine: A biologic alkylating agent that exerts its cytotoxic effects by forming DNA ADDUCTS and DNA interstrand crosslinks, thereby inhibiting rapidly proliferating cells. The hydrochloride is an antineoplastic agent used to treat HODGKIN DISEASE and LYMPHOMA.Taxoids: A group of diterpenoid CYCLODECANES named for the taxanes that were discovered in the TAXUS tree. The action on MICROTUBULES has made some of them useful as ANTINEOPLASTIC AGENTS.Prospective Studies: Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group.Randomized Controlled Trials as Topic: Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.Health Status: The level of health of the individual, group, or population as subjectively assessed by the individual or by more objective measures.Public Health: Branch of medicine concerned with the prevention and control of disease and disability, and the promotion of physical and mental health of the population on the international, national, state, or municipal level.Sensitivity and Specificity: Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed)Research Design: 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.Outcome Assessment (Health Care): Research aimed at assessing the quality and effectiveness of health care as measured by the attainment of a specified end result or outcome. Measures include parameters such as improved health, lowered morbidity or mortality, and improvement of abnormal states (such as elevated blood pressure).

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)

*List of vaccine topics

... placebo-controlled phase 2 clinical trial". The Lancet. 381 (9871): 1037-45. doi:10.1016/S0140-6736(12)61764-4. PMID 23352749. ... Schleiss, M. R. (2008). "Cytomegalovirus vaccine development". Current Topics in Microbiology and Immunology. Current Topics in ... Adenovirus Vaccine Efficacy Trial Consortium (2013). "A phase 3, randomized, double-blind, placebo-controlled study of the ... "Inferring Reasons for the Failure of Staphylococcus aureus Vaccines in Clinical Trials". Frontiers in Cellular and Infection ...

*LY-404,039

In 2007, a randomized phase II clinical trial showed that LY-2140023 taken twice daily for 4 weeks improved schizophrenia ... Eli Lilly and Company -Lilly Stops Phase III Development of Pomaglumetad Methionil For the Treatment of Schizophrenia Based on ... Current Topics in Medicinal Chemistry. 8 (16): 1480-1. doi:10.2174/156802608786264209. PMID 19006848. Fraley ME (June 2009). " ... oral bioavailability in humans in a phase I clinical trial. A single dose of 200 mg results in an AUC value of 900 ng*h/ml. The ...

*Hantavirus vaccine

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". ClinicalTrials.gov. ... List of vaccine topics Seoul virus Gou virus Vaccine-naive Schmaljohn, C. S. (2012). "Vaccines for hantaviruses: Progress and ... Field trial of an inactivated vaccine against hemorrhagic fever with renal syndrome in humans. Arch Virol. 1990;1(Suppl):35-47 ...

*Intepirdine

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 Guidances for Statistics in Regulatory Affairs

ICH E9: Statistical principles for clinical trials section III provides a general overview of common designs in clinical trials ... the use of meta-analysis and the use of only a single pivotal study in phase III clinical development. ICH E1: Population ... CPMP/EWP/2330/99: Application with 1. Meta-analyses; 2. One pivotal study (EMA) provides guidance on two topics: ... EMA/286914/2012: Multiplicity issues in clinical trials (EMA) addresses the multiplicity in the clinical trials in the context ...

*Sargramostim

Phase II/III trial 2009-2013". Clinicaltrials.gov. Retrieved 2012-06-20. "Wild-Type Reovirus in Combination With Sargramostim ... Chi, Judy (May 21, 2008). "Bayer launches Leukine without EDTA". Drug Topics. Leukine product website from Genzyme Leukine ... Clinical trials of sargramostim were initiated in 1987; in that same year it was administered to six people as part of a ... The sequence of human GM-CSF was first identified in 1985 and soon three recominbant human GM-CSFs were produced, one in ...

*List of Elsevier periodicals

Construction Law Journal Contemporary Clinical Trials Cortex Cretaceous Research Current Biology Current Opinion Current Topics ... Icarus III-Vs Review Indagationes Mathematicae Information and Computation Information Processing Letters Infrared Physics and ... FEBS Letters Fire Safety Journal Fitoterapia Flight International Fluid Phase Equilibria Fungal Biology Fungal Genetics and ... "Current Topics in Developmental Biology". Book Series. Elsevier. Retrieved 15 May 2013. http://www.jneb.org Elsevier. "Procedia ...

*Discovery and development of dipeptidyl peptidase-4 inhibitors

GSK suspended Phase III clinical trials in October 2008. Informations for this group of inhibitors are quite restricted. ... Current Topics in Medicinal Chemistry, 7 (6): 547-555, doi:10.2174/156802607780091019, PMID 17352676 Wiedeman, Paul (May 2007 ... In January 2007 alogliptin was undergoing the phase III clinical trial and in October 2008 it was being reviewed by the U.S. ... In 2008 BI-1356 was undergoing phase III clinical trials; it was released as linagliptin in May 2011. X-ray crystallography has ...

*Ledipasvir

After completing Phase III clinical trials, on February 10, 2014 Gilead filed for U.S. approval of a ledipasvir/sofosbuvir ... Similar to sofosbuvir, the cost of Harvoni has been a controversial topic. It costs $1,125 per pill in the US, translating to $ ... According to clinical trials, ledipasvir/sofosbuvir has been very well tolerated with the most common side effects being ... March 3-6, 2013. Abstract 41LB. CROI 2013: Sofosbuvir + Ledipasvir + Ribavirin Combo for HCV Produces 100% Sustained Response. ...

*NMDA receptor modulator

... a randomized Phase 2 clinical trial" (PDF). Nature Medicine. Nature Publishing Group. 13 (9): 1102-1107. doi:10.1038/nm1632. ... http://www.esi-topics.com/schizophrenia/interviews/Dr-Daniel-Javitt.html http://archpsyc.ama-assn.org/cgi/content/abstract/56/1 ... NMDA receptor modulators (glutamate modulators) are a new form of antipsychotic that are in Phase II FDA study. The first ... These data suggest that mGlu2/3 receptor agonists have antipsychotic properties and may provide a new alternative for the ...

*Junin virus

Over 90% of the volunteers for Phase 1 and 2 of Clinical Trials developed antibodies against the Junin virus, and 99% developed ... Enria D.A.; Barrera Oro J.G. (2002). "Junin Virus Vaccines" (PDF). Current Topics in Microbiology and Immunology. Archived from ... Moreover, a large efficacy study of n=6,500, where 3, 255 individuals were randomly selected to take Candid 1 and where 3,245 ...

*Neuroplasticity

... in the New England Journal of Medicine in 2014 detailing the results of a multi-center NIH-funded phase III clinical trial of ... The specific details of how this process occurs at the molecular and ultrastructural levels are topics of active neuroscience ... In a clinical trial, a group of severely injured patients had a 60% reduction in mortality after three days of progesterone ... However, clinical trials showed progesterone offers no significant benefit for traumatic brain injury human patients. The term ...

*Pruvanserin

It was in phase II clinical trials in 2008 but appears to have been discontinued as it is no longer in the company's ... Teegarden BR, Al Shamma H, Xiong Y (2008). "5-HT(2A) inverse-agonists for the treatment of insomnia". Current Topics in ... "Efficacy Study of LY2422347 to Treat Insomnia - Full Text View - ClinicalTrials.gov". "Eli Lilly and Company » Research ... 553 (1-3): 163-70. doi:10.1016/j.ejphar.2006.09.027. PMID 17059817. Patel JG, Bartoszyk GD, Edwards E, Ashby CR (April 2004). " ...

*Melatonin receptor agonist

Tasimelteon completed the phase III clinical trial in the United States for primary insomnia in 2010. The Food and Drug ... Current Topics in Medicinal Chemistry. 8 (11): 954-68. doi:10.2174/156802608784936719. PMID 18673165. CS1 maint: Multiple names ... TIK-301 (PD-6735, LY-156,735) has been in phase II clinical trial in the United States (US) since 2002. The FDA granted TIK-301 ... Tasimelteon was developed by Vanda Pharmaceuticals and completed the phase III trial in 2010. It was approved by the FDA on ...

*TIK-301

In a phase I clinical trial, TIK-301 was shown to be effective as a chronobiotic at a dose of 5 mg/L, but not in lower doses. ... In 2005, TIK-301 was expected to go into phase III trials. TIK-301 is a high affinity nonselective MT1/MT2 agonist. Studies ... Current topics in medicinal chemistry. 8 (11): 954-68. doi:10.2174/156802608784936719. PMID 18673165. Mody, Sejal; Hu, Yueping ... in Atlanta, GA by Phase II Discovery, where it was renamed to TIK-301. Currently, clinical trials are ongoing there. Because it ...

*Peter Kranke

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

*Global aphasia

To date, no large scale clinical trials have proven benefits of pharmacological treatment. Kemmerer, David. Cognitive ... Participants with lesions two, three, and four often recovered to a less severe form of aphasia, such as Broca's or ... Communication of basic needs and the comprehension of simple conversations on highly familiar topics, are examples of common ... Clinical Aphasiology, 21. Ozeren, A., Koc, F., Demirkiran, M., Sönmezler, A., & Kibar, M. (2006). Global aphasia due to left ...

*Histone deacetylase inhibitor

Started phase III clinical trials Panobinostat (LBH589) is in clinical trials for various cancers including a phase III trial ... Mwakwari SC, Patil V, Guerrant W, Oyelere AK (2010). "Macrocyclic histone deacetylase inhibitors". Current Topics in Medicinal ... Started pivotal phase II clinical trials none since 2014 ? Started phase II clinical trials Mocetinostat (MGCD0103) is ... Clinical trial number NCT00532818 for "Hydralazine Valproate for Cervical Cancer" at ClinicalTrials.gov Clinical trial number ...

*NUDT1

Karonudib, an MTH1 inhibitor, is currently being evaluated a phase I clinical trial for safety and tolerability. A potent and ... Research into this topic is ongoing. MTH1 is a potential drug target to treat cancer, however there are conflicting results ... Eliminating the MTH1 gene in mice results in over three times more mice developing tumors compared to a control group. The ... "MTH1, A Phase I, Study on Tumors Inhibition, First in Human, First in Class (MASTIFF)". ClinicalTrials.gov. U.S. National ...

*David Berry (inventor)

A Phase 1b clinical trial was launched testing SER-287 in ulcerative colitis in 2015 which showed positive objective responses ... He speaks globally on topics such as innovation and entrepreneurship. Berry was born in New York City in 1978. He graduated ... and has launched a clinical trial with SER-262 in primary C. difficile infection which will readout in the first half of 2018. ... having completed over 18 clinical trials. Former CEO of Sanofi, Chris Viehbacher, joined the company's Board of Directors, ...

*Drinabant

... reached phase IIb clinical trials for this purpose in the treatment of obesity but was shortly thereafter ... Current Topics in Medicinal Chemistry. 9 (6): 482-503. doi:10.2174/156802609788897844. PMID 19689362. ... 3): 156-68. doi:10.1002/tcr.20147. PMID 18563799. Kwon MO, Herrling P (2005). "List of drugs in development for ...

*Negative air ionization therapy

As of 2009[update], the negative ion generators used are still undergoing multicenter phase II clinical trials. A separate ... and low-density negative ions on mood and alertness in mildly depressed and non-depressed adults found that the three first ( ... Topics characterized as pseudoscience Ionized bracelet Earthing Therapy Water ionizer https://jnrbm.biomedcentral.com/articles/ ... Westrin, ÅS.; Lam, R. (2007). "Seasonal Affective Disorder: A Clinical Update". Annals of Clinical Psychiatry. 19 (4): 239-46. ...

*Emergent BioSolutions

In phase II clinical trials, expected to enroll patients in phase III studies in 2018. FLU-IGIV (Seasonal Influenza Therapeutic ... 2001 Anthrax toxin Anthrax Vaccine Immunization Program Biotechnology List of pharmaceutical companies List of vaccine topics ... In phase II clinical trials UV-4B (Dengue Therapeutic) ZIKV-IG (Zika Therapeutic) GC-072 (Burkholderia Therapeutic) FILOV (Pan- ... The vaccine could reach stage-one clinical trials by early 2017. As of the end of June 2016, 60 countries and territories had ...

*Rectal microbicide

As of 2008, 16 topical microbicides entered phase I or II clinical trial and 7 advanced to an additional trial. Previous ... This Phase I safety and acceptability study, launched in October 2011, included 65 men and women from three sites in the United ... and public policy writers have at times faced opposition to promoting discussion on anal topics. Scientists at the Population ... Phase I trials normally focus solely on safety and acceptability, but researchers used a novel approach in this trial: taking ...

*Pemetrexed

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). ... "Oral Complications of Chemotherapy and Head/Neck Radiation". Cancer Topics - Coping with Cancer. National Cancer Institute. ... A Phase III study showed benefits of maintenance use of pemetrexed for non-squamous NSCLC. Activity has been shown in malignant ...

*Pre-exposure prophylaxis

... meaning that patients can be prescribed PrEP but may only be able to access the drug through clinical trials or by importing ... Patients on PrEP take Truvada every day and must also agree to see their healthcare provider at least every three months for ... Celum, CL (December 2011). "HIV preexposure prophylaxis: new data and potential use". Topics in antiviral medicine. 19 (5): 181 ... placebo-controlled phase 3 trial". The Lancet. 381 (9883): 2083-2090. doi:10.1016/S0140-6736(13)61127-7. PMID 23769234. " ...
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 ...
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,
... 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 www.ardelyx.com. 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
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 ...
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
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
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 ...
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...
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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 ...
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...
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.
SAN DIEGO, Sept. 8, 2015-- Neothetics, Inc., a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, today announced completion of enrollment for its two pivotal U.S. The enrollment was completed on schedule, and we are on track for data by end of this calendar year, said George Mahaffey, President and Chief Executive...
DUBLIN, IRELAND--(Marketwired - Sep 7, 2016) - Theravance Biopharma, Inc. (NASDAQ: TBPH) Statistically Significant Benefits in Lung Function, Health-Related Quality of Life and Annual Rate of Exacerbations Observed for Closed Triple as Compared to Symbicort® Turbohaler® Theravance Biopharma Entitled to Receive 85% Economic Interest in Closed Triple Royalties Paid by...
Path: hivnet.org!fido.hivnet.org!aegis.hivnet.org!Mary_Elizabeth ,Newsgroups: hiv.aids.data Distribution: hivnet Date: Wed, 25 Jan 95 06:38:39 +0100 From: Mary_Elizabeth at aegis.hivnet.org Reply-To: Mary_Elizabeth at aegis.hivnet.org Subject: ONCONASE ENTERS PHASE III FOR PANCREATIC Comment-To: All at f927.n103.z1.fido.hivnet.org Message-ID: ,f26af136 at f927.n103.z1.fido.hivnet.org, X-Fidonet-Comment-To: Mary_Elizabeth at aegis.hivnet.org X-FSC-PATH: 103/927 280/413 Lines: 26 Document 165 DOCN AD950165 TI ONCONASE Enters Phase III for Pancreatic Cancer DT 950124 SO Business Wire (01/24/95) AB Alfacell Corp. announced on Tuesday that it will commence Phase III clinical trials for ONCONASE, which is being tested in combination with tamoxifen to treat pancreatic cancer. The FDA approved the companys Phase III protocol design--which calls for a randomized, multi-center trial--on Jan. 23. ONCONASE has been established as a novel enzyme in both structure and function, and is now recognized as the ...
In order to ensure a regular safety monitoring of patients enrolled in ReLive, the organization of a Board of international experts was to meet every 6 months, and/or after inclusion of the first 25 patients, to review the safety data of patients included in the trial, and to recommend possible modifications of the protocol. This type of Board is usually organized in pivotal phase III clinical trials to assure patient safety and integrity of the trial ...
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. ...
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. ...
COLUMBIA, Md., Feb 10, 2010 /PRNewswire via COMTEX News Network/ -- Celsion Corporation (Nasdaq: CLSN) announced today that after reviewing safety data from 120 patients enrolled in the pivotal Phase III ThermoDox(R) clinical trial (
In February 2016 OBI announced that top-line data of the phase 2/3 metastatic breast cancer study did not meet the primary endpoint of progression-free survival. Results were presented in June at ASCO 2016 in Chicago. But, as patients who did show an immune response demonstrated statistically significant progression-free survival versus placebo, coupled with the secondary endpoint of overall survival trending towards statistical significance and no safety issues reported, OBI noted in their February 2016 press release that they expected to forge ahead with a phase III study. Then in a January 20, 2017 press release OBI announced that they met with the FDA for its end-of-phase II meeting and "based on the discussion with the FDA, OBI Pharma plans to prepare its phase III protocol". Just days later (January 24) OBI announced that they received approval from the China FDA to conduct a phase III clinical trial of OBI-822 which OBI notes can be used in a future BLA application ...
Chelsea Therapeutics International, Ltd. (CHTP) said Thursday that all corporate officers and directors of the company will take a voluntary 25% reduction in salary and fees, respectively, effective July 1, until the results of the companys ongoing Phase III trial of Northera are available, currently estimated to be during the first quarter of 2013.
Data from the interim analysis of the on-going PATENT-2 trial with Riociguat, the open-label long-term extension of the pivotal Phase III study PATENT-1, were presented at the American Thoracic Societ ... read article ...
On Monday, Sanofi said a second late-stage Phase III study of its LixiLan diabetes drug had met its key target. This success has made it all set for regulatory submissions by the fourth quarter in the United States and the first quarter of next year in the European Union.. LixiLan includes a single-injection combination of Lyxumia, a drug developed with Danish drugmaker Zealand Pharma, and Sanofis Lantus. It is aimed at patients with type-2 diabetes.. In a statement, the French drugmaker said the full results will be communicated in a future scientific forum.. The French drugmaker said that the LixiLan-L Phase III clinical trial has achieved its primary endpoint in patients with type 2 diabetes, who went under treatment with insulin glargine with or without metformin.. ...
mNaNO3 mNH4NO3 t solid ref. weight 9.0952 0.0000 0.00 2 a(2164) - 7.7585 13.1713 0.00 2 a(2164) - 7.7585 13.1713 0.00 12 a(2164) - 0.0000 14.7906 0.00 12 a(2164) - 9.8701 0.0000 15.00 2 a(2164) - 9.5494 2.9990 15.00 2 a(2164) - 9.3323 5.3475 15.00 2 a(2164) - 9.1794 8.0682 15.00 2 a(2164) - 8.9185 13.8544 15.00 2 a(2164) - 8.8587 18.9811 15.00 2 a(2164) - 8.8639 19.3945 15.00 12 a(2164) - 7.1442 19.4938 15.00 12 a(2164) - 4.2925 19.8564 15.00 12 a(2164) - 3.2706 19.9857 15.00 12 a(2164) - 2.0745 20.2697 15.00 12 a(2164) - 0.0000 20.9112 15.00 12 a(2164) - 11.3085 0.0000 30.00 2 a(2164) - 10.3843 27.5772 30.00 2 a(2164) - 10.3843 27.5772 30.00 12 a(2164) - 0.0000 29.0541 30.00 12 a(2164) - 621.21 1826.52 140.00 2 a(2165) - 621.21 1826.52 140.00 14 a(2165) - 275.83 1082.75 117.00 2 a(2165) - 275.83 1082.75 117.00 13 a(2165) - 39.2180 154.0838 95.00 2 a(2165) - 39.2180 154.0838 95.00 13 a(2165) - 15.4325 52.2446 60.00 2 a(2165) - 15.4325 52.2446 60.00 11 a(2165) - 11.4918 33.4123 40.00 2 a(2165) - ...
Over the several clinical experiences with CF101 for RA, Can-Fite has learned and identified the relationship between A3AR expression and response for CF101. Based on these findings, the companys last Phase IIb trial demonstrated positive data of CF101 for the treatment of RA patients based on the level of A3AR expression. The planned Phase III trial uses the same criteria for screening RA patients, and therefore has a high possibility that it will replicate the results of the last Phase IIb trial. ...
Examine the study design of the pivotal Phase 3 trial and long-term extension study of VIMIZIM® (elosulfase alfa) in patients with Moquino A. View boxed warning, including risk of anaphylaxis.
Imetelstats study in MF will reportedly continue unchanged, keeping the hope alive that this drug will ultimately garner multiple indications in the high-value hematology space. If so, it should turn out to be a blockbuster product. Additionally, J&J and Geron said that the second part of imetelstats other trial in MDS will be submitted for refinements to the FDA. And if all goes according to plan, imetelstat could be in the pivotal phase of its trial for MDS by the fourth quarter of this year. The key takeaway is that imetelstat is starting to look like the real deal. So, while its probably prudent to remain cautious with this small-cap biotech, it might be a good idea to start grabbing at least a few shares in case imetelstat does beat the odds and somehow lives up to the lofty expectations of J&J and Geron. ...
Genentech, a member of the Roche Group, said it will terminate two Phase III trials assessing its Alzheimers disease candidate crenezumab, adding to the list of candidates that have failed clinical studies in the memory-robbing ailment.
Zogenix, Inc. (ZGNX), a global pharmaceutical company developing rare disease therapies, and its wholly-owned subsidiary, Modis Therapeutics, presented positive top-line results from its pivotal Phase 2 RETRO study at the recent World Muscle Society congress in Copenhagen. The data from RETRO form
Conclusions: Holding onto a quick fix is a pivotal phase whereby supports, such as engagement in realistic goal setting, are essential to facilitate family members resolution of driving disruption issues. Family members who see no way out might not actively seek help and these points to a need for long-term and regular follow-ups. Future research can explore ways to support family members at these key times ...
Janssen Research & Development, LLC (Janssen) has announced findings from the first of three pivotal Phase 3 studies evaluating guselkumab, a subcutaneously administered anti-interleukin...
JERUSALEM--(BUSINESS WIRE)--Jan. 22, 2018-- Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced that a Phase III registrati, Teva Announces Top-Line Results from Phase III Studies of Subcutaneously Administered Reslizumab in Patients with Severe Eosinophilic Asthma
JERUSALEM--(BUSINESS WIRE)--Jan. 22, 2018-- Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced that a Phase III registrati, Teva Announces Top-Line Results from Phase III Studies of Subcutaneously Administered Reslizumab in Patients with Severe Eosinophilic Asthma
The hot roll for biotech continued today, with InterMune reporting positive Phase III clinical trial results for its drug pirfenidone
Alcon Incorporated. Protocol C-02-60 information for potential participants about a phase III clinical trial to evaluate an investigational treatment for stopping the progression of dry AMD to wet AMD [online]. Available from URL: http://www.alconlabs.comlus/eo/clinicalstudies/ [Accessed 2005 Feb 21] ...
The Partners PrEP Study is a double-blind, placebo-controlled, phase III clinical trial aimed to assess the safety and efficacy of oral PrEP for the... ...
WOODCLIFF LAKE, N.J. - Eisai Inc. announced July 9 preliminary results from a recently completed phase III study of Halaven versus capecitabine (Xelo
A method of detecting an end point of polishing arranged to perform CMP polishing with which an insulating layer of a wafer incorporating a substrate having a metal-containing permalloy layer formed thereon and the insulating layer formed on the metal-containing permalloy layer is chemimechanically polished to expose the flat permalloy layer, the method of detecting an end point of polishing, having the steps of: collecting abrasive material slurry on a surface plate for polishing as a continuous flow from the start or during CMP polishing; continuously mixing a color developing reagent with the collected continuous flow to prepare a specimen for the continuos flow; reading the color of the specimen as a digital value (Ii) by a color identifying sensor; and determining a moment of time at which the digital value (Ii) reaches a digital value (Io) of a specimen of a waste flow of the abrasive material slurry at the end of polishing to be the end of CMP polishing.
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.
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 ...
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 ...
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 ...
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.
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.
--Two-Year Data from RISE and RIDE Studies Presented at the American Diabetes Association Annual Scientific Sessions -- SAN DIEGO--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO,
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).
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 ...
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." ...
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.
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
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
* 24-month update on Phase III data comparing Tasigna to Glivec in patients with newly diagnosed Ph+ chronic myeloid leukemia in chronic phase, , , , * Afinitor plus hormonal therapy stud...
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...
There will be no CETP heart drug miracle in the works at Merck.. The pharma giant looked over a set of positive but troublesome Phase III data for its drug anacetrapib and concluded today that they will relegate it to the same graveyard that has greeted every other CETP heart drug so far.. The decision underscores a tidal shift in drug developers standards for launching a big new drug into a major market, where the data has to point to a compelling market opportunity. Failing that, marginal drugs dont stand a chance, even if they might pass muster at the FDA.. "Unfortunately, after comprehensive evaluation, we have concluded that the clinical profile for anacetrapib does not support regulatory filings," said Roger Perlmutter, president of Merck Research Laboratories. "During the past half-century, Merck has made numerous, important contributions to the treatment of cardiovascular disease. Our work in cardiovascular research continues.". Once upon a time, CETP offered a bright prospect for some ...
Oct 29, 2015 10:46 AM. SALT LAKE CITY-The U.S. Food and Drug Administration announced on Oct. 27 that it has approved, for the first time, an oncolytic (cancer-killing) viral therapy in the United States. The drug was approved for use against late-stage melanoma, a deadly skin cancer that can be difficult to treat.. The approval came as the result of a recent Phase III study, which showed that more patients with late-stage melanoma, treated with a herpes cold sore virus designed to kill tumor cells, had a better response when compared to a different treatment. Robert Andtbacka, M.D., from Huntsman Cancer Institute at the University of Utah and Howard L. Kaufman, M.D., from Rutgers Cancer Institute of New Jersey, led the multisite study, published May 26 online in the Journal of Clinical Oncology. "The goal of this targeted therapy is to treat late stage patients more effectively and with fewer side effects," says Andtbacka, associate professor of general surgery at the Universitys School of ...
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced the publication of results of the Phase III clinical trial of Milprosa&#8482; (progesterone) vaginal ring in Fertility and Sterility....TEVA
Merck has said that the preliminary results for its pivotal Phase III study of rolofylline (MK-7418), its investigational medicine for the treatment of acute heart failure, did not meet the primary or secondary efficacy endpoints in patients with heart failure.
July 22, 2015 CheckMate -025 (global clinical trial), a Pivotal Phase III Opdivo (nivolumab) Renal Cancer Trial Stopped Early (PRINCETON, NJ, July 20, 2015) Bristol-Myers Squibb Company (NYSE:BMY) announced
AUSTIN, Texas, March 12, 2015-XBiotech announced today that it has launched a website and call center to help patients with metastatic colorectal cancer learn about its U.S. Pivotal Phase III clinical... Continue Reading ...
BOSTON, Feb 11, 2003 (BUSINESS WIRE) --. 48-Week Data from Alize Trial Presented Today at 10th Conference on Retroviruses and Opportunistic Infections. French researchers presented new 48-week data from a Phase III clinical trial today. These data demonstrate that emtricitabine (FTC), an investigational once-daily nucleoside reverse transcriptase inhibitor (NRTI), suppresses HIV when taken as part of a once-daily, protease inhibitor (PI)-sparing antiretroviral regimen. Emtricitabine is being developed by Triangle Pharmaceuticals, which was acquired by Gilead Sciences (Nasdaq:GILD) in January 2003. Dr. Jean-Michel Molina presented the 48-week results of the ANRS 099 Alize trial (Abstract #551) at the 10th Conference on Retroviruses and Opportunistic Infections in Boston, Massachusetts. The ANRS 099 Alize trial is an ongoing three-year, open-label, multicenter study involving 355 patients who at baseline had to have HIV RNA less than 400 copies/mL while receiving PI-based antiretroviral therapy. ...
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EAST BRUNSWICK, N.J., Aug. 16, 2011 /PRNewswire/ -- Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) today announced that results from two pivotal KRYSTEXXAÃ ® (pegloticase) Phase III clinical studies in patients with refractory chronic gout (RCG) have been published in The Journal of the American Medical Association (JAMA). The data demonstrated that treatment with KRYSTEXXA resulted in significant and sustained reductions in uric acid levels along with clinical improvements in a substantial proportion of RCG patients for six months, a timeframe for demonstrating clinical improvement that is unique in randomized controlled studies of urate-lowering therapies. The two replicate, randomized, double-blind, placebo-controlled Phase III studies were designed to evaluate the efficacy and tolerability of treatment with KRYSTEXXA 8 mg every two weeks or every four weeks compared to placebo for the management of RCG patients. Pooled results from these studies demonstrated that treatment with KRYSTEXXA ...
Novartis today presented results from a pivotal Phase III trial showing a 37% improvement in progression-free survival (PFS) when using the investigational compound LBH589 (panobinostat) in combination with bortezomib[*]and dexamethasone compared to treatment with the same regimen with placebo in patients with relapsed or relapsed and refractory multiple myeloma, meeting the primary endpoint of the study (hazard ratio=0.63 [95% confidence interval (CI): 0.52 to 0.76]; p,0.0001)[1]. The PANORAMA-1 (PANobinostat ORAl in Multiple MyelomA) trial results were presented in an oral session at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.. "Almost all patients with multiple myeloma ultimately relapse and become resistant to treatment, so new therapies are critical for continuing to manage the disease and improve outcomes," said study investigator Paul Richardson, MD, Clinical Program Leader and Director of Clinical Research, Jerome Lipper Multiple Myeloma Center ...
Pivotal Phase 3 Nplate(TM) Study in Non-Splenectomized Patients Met Primary Endpoints Data Also Shows Potential of Nplate as a Long-term Treatment Option for Chronic Adult Immune Thrombocytopenia Purpura ATLANTA--(BUSINESS WIRE)--Dec. 10, 2007--Amgen Inc. (NASDAQ:AMGN) today announced results from a second randomized, pivotal Phase 3 study where Nplate(TM) (romiplostim) increased and sustained platelet counts in non-splenectomized (spleen not removed) adult patients with chronic Immune Thrombocytopenic Purpura (ITP). Additionally, Nplate-treated patients taking concurrent ITP medications such as corticosteroids were able to reduce or discontinue these medications. Adult ITP is a chronic and serious autoimmune disorder characterized by low platelet counts in the blood, a condition known as thrombocytopenia. These Phase 3 data were presented today in an oral session at the 49th American Society of Hematology Annual Meeting (ASH) in Atlanta, Georgia (Abstract #565).. "Patients without a ...
Pivotal Phase 3 Romiplostim Study in Splenectomized Patients Meets Primary Endpoints Data Show Romiplostim Increased and Sustained Platelet Counts in Splenectomized Adult Patients with Immune Thrombocytopenic Purpura ATLANTA--(BUSINESS WIRE)--Dec. 8, 2007--Amgen Inc. (NASDAQ:AMGN) today announced results from a randomized, pivotal Phase 3 study that showed romiplostim (AMG 531) increased and sustained platelet counts in splenectomized (spleen removed) adult patients with chronic Immune Thrombocytopenic Purpura (ITP). Additionally, romiplostim-treated patients taking concurrent ITP medications such as corticosteroids were able to reduce or discontinue these medications. Adult ITP is a serious chronic autoimmune disorder characterized by low platelet counts in the blood, a condition known as thrombocytopenia. These Phase 3 data will be presented in a Plenary Session at the American Society of Hematology (ASH) 49th Annual Meeting in Atlanta, GA (Abstract #2).. "The majority of available therapies ...
Eribulin mesylate (eribulin), an analogue of the marine natural product halichondrin B, is a microtubule-depolymerizing drug that has utility in the treatment of patients with breast cancer. Clinical trial results have demonstrated that eribulin treatment provides a survival advantage to patients with metastatic or locally advanced breast cancer previously treated with an anthracycline and a taxane. Furthermore, a pooled analysis of two pivotal phase III trials has demonstrated that eribulin also improves overall survival in several patient subgroups, including in women with HER2-negative disease and triple-negative breast cancer. This review covers the preclinical research that led to the clinical testing and approval of eribulin, as well as subsequent research that was prompted by distinct and unexpected effects of eribulin in the clinic. Initial studies with halichondrin B demonstrated unique effects on tubulin binding that resulted in distinct microtubule-dependent events and antitumor ...
TY - JOUR. T1 - Combined data from two phase III trials of the NK1 antagonist aprepitant plus a 5HT3 antagonist and a corticosteroid for prevention of chemotherapy-induced nausea and vomiting. T2 - Effect of gender on treatment response. AU - Hesketh, P. J.. AU - Grunberg, S. M.. AU - Herrstedt, J.. AU - De Wit, R.. AU - Gralla, Richard J.. AU - Carides, A. D.. AU - Taylor, A.. AU - Evans, J. K.. AU - Horgan, K. J.. PY - 2006/4. Y1 - 2006/4. N2 - Goals of work: Prevention of chemotherapy-induced nausea and vomiting (CINV) with standard antiemetics has been more difficult to achieve in female patients. Data from two phase III trials of the NK1 antagonist aprepitant were assessed for potential effect of gender on treatment response. Patients and methods: 1,044 patients receiving cisplatin (≥70 mg/m 2) were randomly assigned to control regimen [ondansetron (O) 32 mg i.v. and dexamethasone (D) 20 mg p.o. on day 1; D 8 mg twice daily on days 2-4] or aprepitant (A) regimen (A 125 mg p.o. plus O 32 ...

Geometry.Net - Health Conditions: MigraineGeometry.Net - Health Conditions: Migraine

Extractions: DONATE NOW Treatment Management Interactive ... Clinical Trials Migraine is a biological disease that affects more ... Other health topics A B C D E F G H I J K L M N O P Q R S T U V W XYZ List of All Topics. migraine. Search MEDLINE for recent ... During the headache phase of a common migraine, you may have abdominal pain and diarrhea, increased urination, nausea and ... Attacks can be completely disabling, forcing the sufferer to abandon everyday activities for up to 3 days. Even in symptom-free ...
more infohttp://www4.geometry.net/health_conditions/migraine.html

Long-Term Outcomes and Responses to Retreatment in Patients With Melanoma Treated With PD-1 Blockade.Long-Term Outcomes and Responses to Retreatment in Patients With Melanoma Treated With PD-1 Blockade.

Clinical Trials, Phase Iii As Topic. Comparative studies to verify the effectiveness of diagnostic, therapeutic, or ... Clinical Trials [13282 Associated Clinical Trials listed on BioPortfolio]. Long Term Quality of Life in Melanoma Patients in ... Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields ... Relevant Topics. Skin cancers There are three main types of skin cancer: basal cell carcinoma, squamous cell carcinoma and ...
more infohttps://www.bioportfolio.com/resources/pmarticle/2617164/Long-Term-Outcomes-and-Responses-to-Retreatment-in-Patients-With-Melanoma-Treated.html

Comparative determinants of 5-year cardiovascular event rates in patients with unprotected left main coronary artery disease.Comparative determinants of 5-year cardiovascular event rates in patients with unprotected left main coronary artery disease.

Clinical Trials, Phase Iii As Topic. Comparative studies to verify the effectiveness of diagnostic, therapeutic, or ... Clinical Trials [8497 Associated Clinical Trials listed on BioPortfolio]. Predicting Physical Activity Change: an Epidemiologic ... This concept includes phase III studies conducted in both the U.S. and in other countries. ... Topics * All Topics Biotechnology Biotech Business Biotech Products Cancer Cardiovascular Dermatology Drug Discovery ...
more infohttps://www.bioportfolio.com/resources/pmarticle/1781426/Comparative-determinants-of-5-year-cardiovascular-event-rates-in-patients-with-unprotected.html

Time trends in the demographics of patients randomized  | Open-iTime trends in the demographics of patients randomized | Open-i

Time trends in the demographics of patients randomized in phase III trials.A good PS was defined as an Eastern Cooperative ... Clinical Trials, Phase III as Topic*. *Lung Neoplasms/drug therapy*/mortality*. *Small Cell Lung Carcinoma/drug therapy*/ ... pone-0042798-g002: Time trends in the demographics of patients randomized in phase III trials.A good PS was defined as an ... pone-0042798-g002: Time trends in the demographics of patients randomized in phase III trials.A good PS was defined as an ...
more infohttps://openi.nlm.nih.gov/detailedresult.php?img=PMC3412813_pone.0042798.g002&req=4

smoldering multiple myeloma drug therapy 2000:2010[pubdate] *count=100 - BioMedLib™ search enginesmoldering multiple myeloma drug therapy 2000:2010[pubdate] *count=100 - BioMedLib™ search engine

Clinical Trials, Phase II as Topic / statistics & numerical data. Clinical Trials, Phase III as Topic / statistics & numerical ... Clinical Conference. Clinical Trial, Phase I. Clinical Trial, Phase II. Clinical Trial, Phase III. Clinical Trial, Phase IV. ... Publication-type] Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial ... Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Govt; Research Support ...
more infohttp://www.bmlsearch.com/?kwr=smoldering+multiple+myeloma+drug+therapy+2000:2010%5Bpubdate%5D&cxts=100&stmp=b1

occult non small cell lung cancer drug therapy 2000:2010[pubdate] *count=100 - BioMedLib™ search engineoccult non small cell lung cancer drug therapy 2000:2010[pubdate] *count=100 - BioMedLib™ search engine

Clinical Trials, Phase II as Topic. Clinical Trials, Phase III as Topic. Combined Modality Therapy / methods. Forecasting. ... Clinical Conference. Clinical Trial, Phase I. Clinical Trial, Phase II. Clinical Trial, Phase III. Clinical Trial, Phase IV. ... Publication-type] Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural ... ClinicalTrials.gov. clinical trials - ClinicalTrials.gov .. *[Email] Email this result item Email the results to the following ...
more infohttp://www.bmlsearch.com/?kwr=occult+non+small+cell+lung+cancer+drug+therapy+2000:2010%5Bpubdate%5D&cxts=100&stmp=b1

Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer: ASCO Clinical Practice Guideline...Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer: ASCO Clinical Practice Guideline...

Clinical Trials, Phase III as Topic Actions. * Search in PubMed * Search in MeSH ... Results The Expert Panel reviewed phase III trials that evaluated adjuvant capecitabine after completion of standard ... American Society of Clinical Oncology Clinical Practice Guideline Focused Update. Krop I, Ismaila N, Andre F, Bast RC, Barlow W ... An American Society of Clinical Oncology Guideline Adaptation of the Cancer Care Ontario Clinical Practice Guideline. Denduluri ...
more infohttps://phgkb.cdc.gov/PHGKB/phgHome.action?action=forward&dbsource=tier&id=1491

DI-fusion Stemming resistance to HER-2 targeted therapy.DI-fusion Stemming resistance to HER-2 targeted therapy.

Clinical Trials, Phase III as Topic. Drug Resistance, Neoplasm. Humans. Neoplastic Stem Cells -- drug effects. ...
more infohttp://difusion.ulb.ac.be/vufind/Record/ULB-DIPOT:oai:dipot.ulb.ac.be:2013/52340/Details

Efficacy and Safety Outcomes in Patients With Advanced Melanoma Who Discontinued Treatment With Nivolumab and Ipilimumab...Efficacy and Safety Outcomes in Patients With Advanced Melanoma Who Discontinued Treatment With Nivolumab and Ipilimumab...

Clinical Trials, Phase II as Topic. Clinical Trials, Phase III as Topic ... Methods Data were pooled from phase II and III trials of patients who received nivolumab 1 mg/kg plus ipilimumab 3 mg/kg, every ... A Pooled Analysis of Randomized Phase II and III Trials.. ... All of ICR repositoryICR Divisions & RM Clinical UnitsIssue ... Purpose Approximately 40% of patients with advanced melanoma who received nivolumab combined with ipilimumab in clinical trials ...
more infohttps://repository.icr.ac.uk/handle/internal/1565

List of vaccine topics - WikipediaList of vaccine topics - Wikipedia

... 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 ...
more infohttps://en.wikipedia.org/wiki/List_of_vaccine_topics

84 1.2 201084 1.2 2010

Clinical Trials, Phase III as Topic[MESH]*,Antibodies, Monoclonal/adverse effects/chemistry/immunology/*pharmacology[MESH]*, ... Phase 3 study lengths are typically two to four years, so results for some studies might be announced in 2010, but data from ... Phase 3 study lengths are typically two to four years, so results for some studies might be announced in 2010, but data from ... This overview of the 26 candidates provides a brief description of the background and the on-going Phase 3 studies of each mAb ...
more infohttp://www.kidney.de/mlpefetch.php?search=20065640

Search ResultsSearch Results

Clinical Trials, Phase III As Topic (1) Non-Small Cell Lung Cancer (1) Gemcitabine (1) Vinblastine (1) Economic Analysis (1) ... Economic analysis of a randomized phase III trial of gemcitabine plus vinorelbine compared with cisplatin plus vinorelbine or ... Journal Of Clinical Oncology : O... (1) Lung Cancer (Amsterdam, Netherla... (1) Lung Cancer (1) more .... Journal Of Clinical ... Journal of clinical oncology : official journal of the American Society of Clinical Oncology, June 1, 2007, Vol.25(16), pp.2256 ...
more infohttps://beluga.sub.uni-hamburg.de/vufind/Primo/Search?lookfor=Antineoplastic+Combined+Chemotherapy+Protocols%E2%80%93Economics&type=Subject&filter%5B%5D=rtype%3A%22Articles%22&filter%5B%5D=topic%3A%22Carcinoma%2C+Non-Small-Cell+Lung%22&filter%5B%5D=creator%3A%22Evans%2C+William+K%22&filter%5B%5D=creator%3A%22Leighl%2C+Natasha+B%22&dfApplied=1

The reporting of adverse events in oncology phase III trials: a comparison of the current status versus the expectations of the...The reporting of adverse events in oncology phase III trials: a comparison of the current status versus the expectations of the...

Clinical Trials, Phase III as Topic (MeSH) * Europe (MeSH) * Humans (MeSH) * Neoplasms (MeSH) ... The reporting of adverse events in oncology phase III trials: a comparison of the current status versus the expectations of the ... Frequencies of AEs leading to withdrawals were more frequently reported in trials funded by industry (P = 0.005) and in trials ... We assessed the reporting of key AEs in oncology randomized, controlled trials (RCTs) and compared that with the expectations ...
more infohttps://scholars.latrobe.edu.au/display/publication42160

Search Articles | University of Toronto LibrariesSearch Articles | University of Toronto Libraries

clinical trials as topic (2) 2 Filter by. Remove filter. clinical trials, phase iii as topic (2) 2 ... AMERICAN JOURNAL OF CLINICAL ONCOLOGY-CANCER CLINICAL TRIALS, ISSN 0277-3732, 04/2006, Volume 29, Issue 2, pp. 116 - 122 ... American Journal of Clinical Oncology: Cancer Clinical Trials, ISSN 0277-3732, 04/2006, Volume 29, Issue 2, pp. 116 - 122 ... Clinical Trials as Topic , Combined Modality Therapy , Lung Neoplasms - therapy , Carcinoma, Non-Small-Cell Lung - mortality , ...
more infohttps://query.library.utoronto.ca/index.php/search/q?kw=Author:Blanke,%20Charles%20David&sort=PublicationDate:asc

Phase 3 Gene Therapy for Painful Diabetic Neuropathy - Full Text View - ClinicalTrials.govPhase 3 Gene Therapy for Painful Diabetic Neuropathy - Full Text View - ClinicalTrials.gov

A number of clinical trials have established symptomatic treatment but for pathogenetic mechanisms, the only proven treatment ... See Studies by Topic. *See Studies on Map. *How to Search. *How to Use Search Results ... A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of VM202 in ... Phase 3 Gene Therapy for Painful Diabetic Neuropathy. The safety and scientific validity of this study is the responsibility of ...
more infohttps://clinicaltrials.gov/ct2/show/NCT02427464

Phase III Trial of Febuxostat in Korea Gout Patients - Full Text View - ClinicalTrials.govPhase III Trial of Febuxostat in Korea Gout Patients - Full Text View - ClinicalTrials.gov

MedlinePlus related topics: Gout Drug Information available for: Febuxostat U.S. FDA Resources ... Phase III Trial of Febuxostat in Korea Gout Patients. This study has been completed. ... participated in another investigational trial within the 30days prior to the screening visit ... 1.serum urate level ≥8.0mg/dL 2.creatinine level ≤ 1.5mg/dL 3.subject continued to meet all inclusion and no exclusion criteria ...
more infohttps://clinicaltrials.gov/ct2/show/NCT00821392

Topics - gou2016scienceTopics - gou2016science

Hear about the exciting development of a new generation treatment from preclinical concept to a large phase III clinical trial ... A round up of the most important clinical trials in obstetrics running across the world ... Topics Carefully chosen topics - cutting edge science that will make you gasp. ... Hear about the EVERREST Trial from the lead author herself - a six million euro research trial.. ...
more infohttps://sites.google.com/site/gou2016science/scientific-program

Patient Reported Outcomes Burdens and Experiences - Phase 3 - Full Text View - ClinicalTrials.govPatient Reported Outcomes Burdens and Experiences - Phase 3 - Full Text View - ClinicalTrials.gov

Integrating the PROBE questionnaire in clinical trials, longitudinal studies, health technology assessment studies, routine ... Genetics Home Reference related topics: Hemophilia Genetic and Rare Diseases Information Center resources: Hemophilia ... In phase 1 of the study, the investigators developed the questionnaire. In phase 2 of the study, the investigators evaluated ... Patient Reported Outcomes Burdens and Experiences - Phase 3 (PROBE-3). The safety and scientific validity of this study is the ...
more infohttps://www.clinicaltrials.gov/ct2/show/NCT03549858

NovaRx Initiates Pivotal Phase III Clinical Trial in Lung Cancer PatientsNovaRx Initiates Pivotal Phase III Clinical Trial in Lung Cancer Patients

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)( ...
more infohttp://www.medindia.net/health-press-release/NovaRx-Initiates-Pivotal-Phase-III-Clinical-Trial-in-Lung-Cancer-Patients-29925-1.htm

Andersson, Hanna, Dr. (0000-0003-3798-3322)Andersson, Hanna, Dr. (0000-0003-3798-3322)

... phase 2 clinical trial (topic), phase 3 clinical trial (topic), priority journal, protein interaction, renin angiotensin ... Open this publication in new window or tab ,,The three-center-four-electron tetrel bond. Karim, A.. ... Open this publication in new window or tab ,,Carbons Three-Center, Four-Electron Tetrel Bond, Treated Experimentally. Karim, ... At the moment, bacteria need around three months to develop resistance for new type of antibiotics. That is why modern ...
more infohttp://uu.diva-portal.org/smash/person.jsf?pid=authority-person%3A15149

Clinical Trial Phase III to Assess the Non-inferiority of Dalap Duo® Product Compared to Epiduo® in the Treatment of Acne...Clinical Trial Phase III to Assess the Non-inferiority of Dalap Duo® Product Compared to Epiduo® in the Treatment of Acne...

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 ...
more infohttps://www.clinicaltrials.gov/ct2/show/NCT02716090

Decision Making in the PICU: An Examination of Factors Influencing Participation Decisions in Phase III Randomized Clinical...Decision Making in the PICU: An Examination of Factors Influencing Participation Decisions in Phase III Randomized Clinical...

... 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 ...
more infohttps://www.hindawi.com/journals/ijpedi/2014/676023/

Update on Phase 3 Clinical Trials of Lanabecestat for Alzheimers Disease | BenzingaUpdate on Phase 3 Clinical Trials of Lanabecestat for Alzheimer's Disease | Benzinga

Update on Phase 3 Clinical Trials of Lanabecestat for Alzheimers Disease Independent data monitoring committee advises ... Your weekly roundup of hot topics in the exciting world of fintech. ... Patients who completed the AMARANTH trial were given the opportunity to enroll in the AMARANTH extension trial, where all ... and the companies will now work with the clinical trial sites involved to implement the discontinuations. ...
more infohttps://www.benzinga.com/pressreleases/18/06/r11863440/update-on-phase-3-clinical-trials-of-lanabecestat-for-alzheimers-disea

Story: Masitinib Phase 3 Clinical Trial Update | ALS Therapy Development InstituteStory: Masitinib Phase 3 Clinical Trial Update | ALS Therapy Development Institute

It was recently announced via press release from AB Sciences that their drug masitinib will continue to be trialed in ALS. What ... I write about the latest science in ALS and aim to provide a laymans overview of topics important to patients, caregivers, ... FIRST DRUG CANDIDATE FROM ALS THERAPY DEVELOPMENT INSTITUTE STARTS CLINICAL TRIAL. *Family Golf Tourney for ALS Donates $ ... FMI about the Clinical Trial: http://www.als.net/ALS-Research/174/ClinicalTrials/ ...
more infohttps://www.als.net/news/masitinib-phase-3-clinical-trial-update/
  • The primary endpoint of the trial was change from baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13). (benzinga.com)
  • The primary endpoint of the trial was change from baseline on ADAS-Cog13. (benzinga.com)
  • 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. (medindia.net)
  • 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. (medindia.net)
  • 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. (benzinga.com)
  • 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. (medindia.net)
  • Attempts by Eli Lilly and AstraZeneca to replicate findings showing potent partial agonist action of mGluR2/3 agonists at D2 receptors were unsuccessful. (wikipedia.org)
  • Economic analysis of NCIC CTG JBR.10: a randomized trial of adjuvant vinorelbine plus cisplatin compared with observation in early stage non-small-cell lung cancer--a report of the. (uni-hamburg.de)
  • Results At a minimum follow-up of 18 months, median progression-free survival was 8.4 months for patients who discontinued treatment because of AEs during the induction phase and 10.8 months for patients who did not discontinue because of AEs ( P = .97). (icr.ac.uk)
  • 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. (medindia.net)
  • Modern clinical care and increased survival may underlie the recent failures of trials for ceftriaxone and olesoxime, suggested Benjamin Brooks of the University of North Carolina School of Medicine, Charlotte, in an e-mail to Alzforum. (alzforum.org)
  • We assessed the reporting of key AEs in oncology randomized, controlled trials (RCTs) and compared that with the expectations of the European Organization for Research and Treatment of Cancer (EORTC) membership.RCTs reports published between 2007 and 2011 were reviewed regarding the reporting of key AEs, namely: grade 3/4 AEs, grade 5 AEs, and AEs resulting in study withdrawal or in dose reduction. (edu.au)
  • Hear about the EVERREST Trial from the lead author herself - a six million euro research trial. (google.com)
  • 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. (medindia.net)
  • 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 ]. (hindawi.com)
  • It was agreed that Lilly would lead clinical development, working with researchers from AstraZeneca's Research and Development Team, while AstraZeneca would be responsible for manufacturing. (benzinga.com)
  • 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. (routledge.com)
  • Robert Miller of the Forbes Norris MDA/ALS Research Center in San Francisco, California, who presented the trial results at the meeting (see below), hoped the use of historical controls would make recruitment easier. (alzforum.org)
  • Phase 3 studies of melanoma usually exclu. (bioportfolio.com)
  • These studies are performed on groups of patients large enough to identify clinically significant responses and usually last about three years. (bioportfolio.com)
  • This concept includes phase III studies conducted in both the U.S. and in other countries. (bioportfolio.com)
  • Novel molecules are entering clinical study at a rate of nearly 40 per year, and the commercial pipeline includes approximately 240 mAb therapeutics in clinical studies that have not yet progressed to regulatory approval or been approved. (kidney.de)
  • Phase 3 study lengths are typically two to four years, so results for some studies might be announced in 2010, but data from others might not be presented until 2014. (kidney.de)
  • This overview of the 26 candidates provides a brief description of the background and the on-going Phase 3 studies of each mAb. (kidney.de)
  • Additional mAbs that have progressed to regulatory review or been approved may also be in Phase 3 studies, but these, as well as Fc fusion proteins, have been excluded. (kidney.de)
  • Due to the large body of primary literature about the 26 candidates, only selected references are given, with a focus on recent publications and articles that were relevant to Phase 3 studies. (kidney.de)
  • Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. (clinicaltrials.gov)
  • Integrating the PROBE questionnaire in clinical trials, longitudinal studies, health technology assessment studies, routine clinical care, and registries. (clinicaltrials.gov)
  • 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. (medindia.net)
  • 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). (alzforum.org)
  • 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 ). (alzforum.org)
  • They discussed disappointing results from two recent Phase 3 studies. (alzforum.org)
  • DUBLIN, June 5, 2019 /PRNewswire/ -- The "Global Psoriasis Clinical Trial Pipeline Highlights - 2019" report has been added to ResearchAndMarkets.com's offering. (epicos.com)
  • 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. (medindia.net)
  • Through this study we aimed to categorize the risk for cardiovascular events in patients with ULMCA disease using simple clinical descriptors. (bioportfolio.com)
  • In phase 1 of the study, the investigators developed the questionnaire. (clinicaltrials.gov)
  • Data collected during phase 2 of the study will also be used. (clinicaltrials.gov)
  • A second,investigator-initiated phase II study supported these results. (medindia.net)
  • The purpose of this study was to evaluate the role of clinician influence and other factors on decision making regarding participation in a randomized clinical trial (RCT). (hindawi.com)
  • 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 ]. (hindawi.com)
  • NLNK ) announces launching of an open-label, randomized, multi-institutional Phase 3 study in patients with borderline resectable or locally advanced unresectable pancreatic cancer. (benzinga.com)
  • In addition to the olesoxime report, Merit Cudkowicz described final results of a Phase 3 study of ceftriaxone. (alzforum.org)
  • 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. (medindia.net)
  • Researchers also puzzled over one bit of good news for patients, namely that placebo controls are performing better than expected in trials. (alzforum.org)
  • In addition, changing placebo numbers could affect the use of historical controls in trials. (alzforum.org)
  • Since amyotrophic lateral sclerosis progresses quickly, some patients are reluctant to join a trial when they risk being assigned a placebo. (alzforum.org)
  • Treatment-related death in patients with small-cell lung cancer in phase III trials over the last two decades. (nih.gov)
  • 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). (medindia.net)
  • 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. (medindia.net)
  • 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. (benzinga.com)
  • 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. (alzforum.org)
  • The objective response rate was 58.3% for patients who discontinued because of AEs during the induction phase and 50.2% for patients who did not discontinue. (icr.ac.uk)
  • 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. (als.net)
  • Decision rules comparing this dose to rt-PA would cause stopping for futility at phase II end, or continuation to phase III. (nih.gov)
  • The ALS Therapy Development Institute is a registered 501(c)3 nonprofit. (als.net)
  • It covers emerging therapies for Psoriasis in active clinical development stages including early and late stage clinical trials. (epicos.com)
  • However, pharmaceutical company Eli Lilly terminated further development of the compound in 2012 after it failed in phase II clinical trials. (wikipedia.org)
  • Clinical development of LY-404,039 resulted from efforts to discover potent and selective mGluR agonists for the treatment of psychiatric disorders. (wikipedia.org)
  • 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. (als.net)
  • Careful analysis may show that the disease trajectory researchers predict at the start of a trial is too steep, he suggested. (alzforum.org)
  • In this phase, the investigators aim at maintaining the capacity to collect data on PROBE, and the infrastructure will also be modified in order to allow for longitudinal collection of PROBE data (in previous phases, the investigators only collected anonymized data). (clinicaltrials.gov)
  • We examined phase 3 trials conducted between 1990 and 2010 to address the role of systemic treatment for SCLC. (nih.gov)
  • A number of clinical trials have established symptomatic treatment but for pathogenetic mechanisms, the only proven treatment strategy is strict glycemic control. (clinicaltrials.gov)
  • In phase II clinical studiesto date, the side effects of this treatment have included redness or sorenessat the injection site. (medindia.net)
  • 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. (medindia.net)
  • Patients who completed the AMARANTH trial were given the opportunity to enroll in the AMARANTH extension trial, where all patients received active treatment. (benzinga.com)
  • Phase III incorporated two co-primary hypotheses, allowing for a treatment effect at either end of the trichotomized Rankin scale. (nih.gov)
  • Statistical aspects of the TNK-S2B trial of tenecteplase versus alteplase in acute ischemic stroke: an efficient, dose-adaptive, seamless phase II/III design. (nih.gov)
  • 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. (medindia.net)
  • Given the profound and sometimes clinical levels of distress that surrogates (i.e., parents or legal guardians) of children in pediatric intensive care units (PICU) experience [ 15 ], it is important to understand what factors may be influencing the decision making process beyond the informed consent process. (hindawi.com)
  • The overall TRD rate has been low, but not negligible, in phase III trials for SCLC over the past two decades. (nih.gov)
  • Finally, a survey was conducted among the EORTC membership to determine their expectations on key AEs reporting.Although the frequency of grade 3/4 was reported in most reports (96%), only 17% of them described the reporting threshold above which grade 3/4 AEs were included for reporting, raising the possibility that important but less frequent grade 3/4 AEs might be underreported. (edu.au)
  • 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 ]. (hindawi.com)
  • Economic analysis of a randomized phase III trial of gemcitabine plus vinorelbine compared with cisplatin plus vinorelbine or cisplatin plus gemcitabine for advanced non-small-cell. (uni-hamburg.de)
  • In multivariate analysis, frequencies of grade 5 AEs were less frequently reported in European trials (P = 0.004). (edu.au)
  • 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. (medindia.net)
  • the perpendicular distance of the point from any one of the three sides represents the probability of the outcome denoted by the vertex opposite that side. (nih.gov)
  • In another trial, one-tenth of untreated controls showed no change on the ALS Functional Rating Scale (ALSFRS), a common trial outcome measure, over six months. (alzforum.org)
  • Herein, we present an experimental investigation of the carbon-centered, three-center, four-electron tetrel bond, [N-C-N](+), formed by capturing a carbenium ion with a bidentate Lewis base. (diva-portal.org)
  • Almost 10 million new cases of dementia are diagnosed each year worldwide, implying one new case approximately every 3 seconds. (benzinga.com)