Sentences with phrase «controlled phase i trial»
In their first - in - human, double - blind, placebo - controlled Phase I trial, Prothena scientists recruited 40 healthy people without PD to receive either placebo injections or or one of 5 doses of PRX002, ranging from 1 to 30 mg / kg.
http://www.sens.org/ Not exact matches
Now that they've demonstrated the significance of insulin signaling in the human mammary gland, they are planning a phase I / II clinical trial with a drug used to control blood sugar in type 2 diabetes to determine whether it improves insulin action in the mammary gland, thus improving milk supply.
In households where women between the ages of 15 and 40 were pregnant, volunteer participants were administered either influenza vaccine or placebo as part of a randomized, placebo - controlled Phase 4 clinical trial.
Only 10 (23 %) of these additional recommendations were based on evidence from randomised controlled trials, and seven (16 %) were based on evidence from phase III studies.
NRG Oncology / RTOG 0232 is a phase III, multi-institutional trial conducted at 68 cancer centers throughout the U.S. and Canada from 2003 to 2012 to assess whether adding EBT to transperineal interstitial permanent brachytherapy conveyed an additional benefit in progression free survival (PFS), or control of the cancer growth, at five years following treatment.
Immunotherapy with a live bacterium combined with chemotherapy demonstrated more than 90 % disease control and 59 % response rate in patients with malignant pleural mesothelioma (MPM), according to the results of a phase Ib trial presented today at the European Lung Cancer Conference (ELCC) 2016 in Geneva, Switzerland.1
Two hundred twenty - five people with schizophrenia, schizoaffective disorder or a mood disorder participated in the phase 3 randomized double blind, placebo - controlled trial.
Healthy adults mounted strong immune responses after receiving an investigational whole inactivated Zika virus vaccine, according to interim analyses of three Phase 1, placebo - controlled, double - blind trials conducted at Beth Israel Deaconess Medical Center (BIDMC), Walter Reed Army Institute of Research (WRAIR), and Saint Louis University School of Medicine.
A total of 2,129 patients with mild dementia due to Alzheimer's disease participated in the double - blind, placebo - controlled, phase 3 multicenter trial.
PRIME 2 is an international, phase III, randomized, controlled trial that set out to address the question of whether whole - breast radiotherapy can be omitted in carefully defined groups of older patients receiving appropriate therapy.
It is the first and largest phase III randomized controlled trial of stable, synthetic human angiotensin II.
The resveratrol clinical trial was a randomized, phase II, placebo - controlled, double blind study in patients with mild to moderate dementia due to Alzheimer's disease.
The researchers plan to carry out phase III randomized controlled clinical trials to determine the actual rate of effectiveness by comparing those treated with the ketogenic diet to a group tube - fed a normal, nonketogenic diet.
Based on the results of this trial and past work, Ory said a larger phase three clinical trial — that is both randomized and controlled — is already underway investigating cyclodextrin for patients with NPC.
This study, «Final Results of Local - Regional Control and Late Toxicity of RTOG 9003: A Randomized Trial of Altered Fractionation Radiation for Locally Advanced Head and Neck Cancer,» is a multi-institutional, randomized Phase III trial of fractionation in locally advanced head and neck caTrial of Altered Fractionation Radiation for Locally Advanced Head and Neck Cancer,» is a multi-institutional, randomized Phase III trial of fractionation in locally advanced head and neck catrial of fractionation in locally advanced head and neck cancer.
The phase 2 program was comprised of two prospective, randomized double - blind, placebo - controlled, parallel group trials (ATHENA and ATHENA II).
White MT, Verity R, Griffin JT, et al.White MT, Verity R, Griffin JT, Asante KP, Owusu - Agyei S, Greenwood B, Drakeley C, Gesase S, Lusingu J, Ansong D, Adjei S, Agbenyega T, Ogutu B, Otieno L, Otieno W, Agnandji ST, Lell B, Kremsner P, Hoffman I, Martinson F, Kamthunzu P, Tinto H, Valea I, Sorgho H, Oneko M, Otieno K, Hamel MJ, Salim N, Mtoro A, Abdulla S, Aide P, Sacarlal J, Aponte JJ, Njuguna P, Marsh K, Bejon P, Riley EM, Ghani AC close, 2015, Immunogenicity of the RTS, S / AS01 malaria vaccine and implications for duration of vaccine efficacy: secondary analysis of data from a phase 3 randomised controlled trial, Lancet Infectious Diseases, Vol: 15, ISSN: 1473 - 3099, Pages: 1450 - 1458
Adjuvant lymph - node field radiotherapy versus observation only in patients with melanoma at high risk of further lymph - node field relapse after lymphadenectomy (ANZMTG 01.02 / TROG 02.01): 6 - year follow - up of a phase 3, randomised controlled trial.
This led to initiate an overseas, randomized controlled registered phase I / II trial in humans including 70 chronic SCI patients.
ARandomized, Phase III, Double - Blind Placebo - Controlled Trial of Sunitinib as Maintenance Therapy in Non-Progressing Patients following an Initial Four Cycles of Platinum - Based Combination Chemotherapy in Advanced, Stage IIIB / IV Non-Small Cell Lung Cancer
Phase III Randomized, Placebo - Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy + / - One Year of Everolimus in Patients with High - Risk, Hormone Receptor - Positive and HER2 / neu Negative Breast Cancer.
Ribas A, Puzanov I, Dummer R, Schadendorf D, Hamid O, Robert C, Hodi FS, Schachter J, Pavlick AC, Lewis KD, Cranmer LD, Blank CU, O'Day SJ, Ascierto PA, Salama AK, Margolin KA, Loquai C, Eigentler TK, Gangadhar TC, Carlino MS, Agarwala SS, Moschos SJ, Sosman JA, Goldinger SM, Shapira - Frommer R, Gonzalez R, Kirkwood JM, Wolchok JD, Eggermont A, Li XN, Zhou W, Zernhelt AM, Lis J, Ebbinghaus S, Kang SP, Daud A. Pembrolizumab versus investigator - choice chemotherapy for ipilimumab - refractory melanoma (KEYNOTE - 002): a randomized, controlled, phase 2 trial.
iBET's infrastructure comprises 16 laboratories fully equipped with state - of - the - art technology (70 m2 each), including a BSL2 laboratory for working with viruses; a GMP Analytical Services Unit certified by the INFARMED (the Portuguese medicines authority, EMA Portuguese branch) and by DGAV (the Portuguese veterinary authority) for quality control and batch release of human and veterinary pharmaceuticals, biopharmaceuticals as well as experimental new drugs; a GMP Mass - Spectroscopy Unit that provides state - of - the - art MS services to the scientific community and Industry; a 2600 m2 bio-pilot plant supporting production and purification of proteins ATMPs and vaccines from bench top to 300 L scale and privileged access to GeniBET Biopharmaceuticals, an iBET spin - off producing ATMPs under cGMP certification for phase I / II / III clinical trials.
In that randomized, double - blind, placebo - controlled, phase III trial, 561 patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who were in complete or partial response to platinum - based chemotherapy were treated with either rucaparib 600 mg orally twice daily (372 patients) or to placebo (189 patients).
A Phase 1 double blind randomized controlled dose escalation trial was conducted in Bandiagara, Mali, West Africa, a rural town with intense seasonal transmission of Plasmodium falciparum malaria.
Immunogenicity and safety of three consecutive production lots of the non replicating smallpox vaccine MVA: A randomised, double blind, placebo controlled phase III trial.
Citation: Thera MA, Doumbo OK, Coulibaly D, Laurens MB, Kone AK, Guindo AB, et al. (2010) Safety and Immunogenicity of an AMA1 Malaria Vaccine in Malian Children: Results of a Phase 1 Randomized Controlled Trial.
The double - blind, variable - dose, placebo - controlled, crossover Phase IIa study was conducted in Iceland with 172 participants completing the trial.
Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): an international, multicentre, randomised, placebo - controlled, phase 3 trial.
[44] Two other phase II clinical trials evaluated the efficacy of imatinib in patients with melanoma — including mucosal melanomas — harboring KIT mutations and / or amplifications, with a subset of cases involving mucosal primaries, and both found a disease control rate of approximately 50 %.
P27A can proceed to a controlled human malaria infection phase IIa clinical trial when additional funding is available.
Within monts, PRX002 became the subject of two randomized, double - blind, placebo - controlled clinical trials: a three - month single - dose trial (Phase Ia) and a six - month multiple - dose ascending trial (Phase Ib).
[iv] Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open - label, phase 3 trial.
RESCUE and REVERSE are two separate randomized, double - masked, sham - controlled pivotal Phase III trials designed to evaluate the efficacy of a single intravitreal injection of GS010 (rAAV2 / 2 - ND 4) in subjects affected by LHON due to the G11778A mutation in the mitochondrial ND4 gene.
Intracoronary autologous cardiac progenitor cell transfer in patients with hypoplastic left heart syndrome: the TICAP prospective phase 1 controlled trial.
REFLECT is a randomized, double - masked, placebo - controlled Phase III trial evaluating the safety and efficacy of bilateral injections of GS010 in patients with < 1 year of onset of vision loss in LHON.
A Double Blind Placebo - Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0 - III Colon or Rectal Cancer Phase III Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES)
The authors concluded that although the studies included in this review provided important information, double - blinded, sham - controlled phase II and phase III clinical trials with larger sample sizes are needed to validate this novel therapeutic approach.
The median overall survival of patients in the Phase 1 resection injection study, where Toca 511 was injected into the wall of the resection cavity after removal of the tumor, exceeds historical controls across a variety of previously reported clinical trials.
The approval came on the heels of the first phase III clinical trial ever shown to improve overall survival in patients with the disease, with median overall survival of 10.1 months, versus 6.4 months in the control group.
The first phase of developing this methodology for rodents involves proof - of - concept trials under controlled simulated field conditions.
The efficacy of the elimination phase of the low - FODMAP diet for overall gastrointestinal symptom relief in adult patients with IBS has been seen in randomized, controlled trials; a blinded, randomized, rechallenge study; and observational studies that have been reviewed in detail elsewhere
In a study published in 1999, A placebo - controlled clinical trial of L - tryptophan in premenstrual dysphoria, tryptophan was found to reduce symptoms of PMS when used in the luteal phase or second half of the cycle (i.e. after ovulation)
RAND, a prestigious non-profit research organization, is conducting a «gold standard» randomized control trial in order to determine the impacts of NISL's Executive Development Program (EDP) and aligned coaching model on principals participating in the early phases of NISL's Advanced Credentialing System.
The bottom line is that if a drug can not pass the rigorous phase I to phase III trials required by the FDA (which are usually double blind, randomized, and controlled for all known variables that could influence the outcome), it will not be approved.
Instead, Mr. Groia's allegedly uncivil conduct during the trial came to light when the OSC made an application to judicially review the first phase of trial proceedings on the basis of the judge having lost jurisdiction for failing to control the proceedings (para. 10).
Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Pharmaceutical, Chemistry, Willing to relocate, clinical, clinical trials, research, regulatory, phase i, phase ii, cro
Tags for this Online Resume: Management, Process Improvements, Risk Management, Clinical Operations, Clinical Research, Research, Pharmaceutical, clinical, phase iv, phase iii, pharmaceutical, quality, clinical QA, GCP, document control, clinical trials, IRB, consent document, essential documents, nonessential documents, SOPs, Work Instructions
The first phase was a cluster randomised intervention trial in which general practices were randomly allocated to either an intervention group, in which nurse - led collaborative care was undertaken, or to a wait - list control group in which usual care led by the general practitioner (GP) was continued.
The London - East Anglia randomised controlled trial of cognitive behaviour therapy for psychosis: effects of the treatment phase.