Sentences with phrase «evaluate safety and efficacy»

About the Study The study, «Efficacy and safety of oclacitinib for the control of pruritus and associated skin lesions in dogs with canine allergic dermatitis,» was conducted as a double - masked, placebo - controlled clinical trial aimed to evaluate the safety and efficacy of APOQUEL compared with placebo.

There is a need to more fully evaluate the safety and efficacy of combined vaccines, and the strains of viruses used, in young pups.

«A Blinded Randomized Placebo - controlled Trial of the Efficacy and Safety of the Janus Kinase Inhibitor Oclacitinib (Apoquel ®) in Client - owned Dogs with Atopic Dermatitis» was designed in support of a new drug registration to evaluate the safety and efficacy of APOQUEL.

Students will deepen their knowledge of Materia Medica, and learn to evaluate the safety and efficacy of herbal products they see in their patients using.

FORWARD1: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women with Folate Receptor Alpha - Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

Primary analysis of a phase 1b multicenter trial to evaluate safety and efficacy of talimogene laherparepvec (T - VEC) and ipilimumab (ipi) in previously untreated, unresected stage IIIB - IV melanoma.

Immune Design entered into clinical collaboration agreements with Merck, known as MSD outside the U.S. and Canada, to evaluate the safety and efficacy of two Immune Design immuno - oncology investigative agents, G100 and LV305, separately combined with KEYTRUDA ® (pembrolizumab), Merck's anti-PD-1 therapy, in Phase 1 trials in patients with non-Hodgkin's lymphoma (NHL) and melanoma, respectively.

Immune Design entered into a clinical trial collaboration with Genentech, a member of the Roche Group, to evaluate the safety and efficacy of its CMB305 cancer immunotherapy product candidate combined with the investigational cancer immunotherapy atezolizumab in a randomized Phase 2 trial in patients with soft tissue sarcoma.

A second cohort of up to 40 patients is expected to begin enrolling later this year to evaluate both safety and efficacy.

This study is designed to evaluate the safety and efficacy of neoadjuvant and adjuvant atezolizumab in participants with Stage IB, II or IIIA NSCLC who are eligible for surgical resection with curative intent.

REFLECT is a multi-center, randomized, double - masked, placebo - controlled study to evaluate the safety and efficacy of bilateral injections of GS010 in subjects with LHON due to the NADH dehydrogenase 4 (ND4) mutation.

The company's lead proprietary compound, LMTX ®, has recently completed three Phase 3 clinical trials to evaluate its safety and efficacy in the treatment of Alzheimer's disease and behavioural - variant frontotemporal dementia.

«Since these molecules come from species other than humans, many studies must be done to evaluate their safety and efficacy in the context of treatment,» he says.

Finch expects to begin enrolling for a Phase II clinical trial to evaluate the safety and efficacy of FIN - 403 for the prevention of recurrence in recurrent C. difficile patients in the second half of 2017.

SEATTLE, WA and DURHAM, NC — The HIV Vaccine Trials Network (HVTN) and the HIV Prevention Trials Network (HPTN) today announced the initiation of HVTN 704 / HPTN 085, also known as Antibody Mediated Prevention (AMP) or the AMP Study, a Phase 2b clinical trial to evaluate the safety and efficacy of VRC01, a broadly neutralizing monoclonal antibody (bnAb).

Dogs will be a crucial non clinical model to evaluate safety and efficacy of new therapeutics.

A Phase III, Open Label Study to Evaluate the Safety and Efficacy of INSTILADRIN (rAd - IFN / Syn3) Administered Intravesically to Patients with High Grade, BCG Unresponsive Non-Muscle Invasive Bladder Cancer

The Phase 2/3 trials will be sponsored by Vtesse, a new biotech company that was formed specifically to evaluate the safety and efficacy of cyclodextrin for the treatment of NPC and ultimately obtain FDA labeling if the drug is effective.

«The next steps are to develop tau - lowering therapeutics that could be used in humans and to evaluate their safety and efficacy in preclinical studies,» said Dr. Mucke, «objectives we are pursuing actively.»

A clinical trial investigating a treatment for blindness is under way this winter to evaluate the safety and efficacy of replacing diseased eye cells with stem cells.

Researchers conducted a double - blind, randomized, placebo - controlled clinical trial to evaluate the safety and efficacy of pinaverium.

In addition, the NFL should convene an independent committee of medical professionals, without ties to the NFL or any of its teams, to evaluate the safety and efficacy of the therapies, establishing a set of criteria for what is considered «safe» and «effective,» the authors said.

Trials are currently underway to evaluate the safety and efficacy of antiretroviral regimens taken by the mother and / or infant after delivery to prevent transmission through breastfeeding.

The aim of this trial is to evaluate the safety and efficacy of continuous KMC initiated immediately after birth compared to the current recommendation of initiating continuous KMC after stabilization, in improving survival of neonates with birth weight from 1.0 to < 1.8 kg.

Announced a clinical trial collaboration with Pfizer, Inc. (Pfizer) to evaluate the safety and efficacy of the investigational combination of Yescarta and Pfizer's utomilumab, a fully humanized 4 - 1BB agonist monoclonal antibody, in patients with refractory large B - cell lymphoma.

As a first step in evaluating the safety and efficacy of the X4 - ZFNs in vivo, we employed a NSG humanized mouse model.

The funding will help support our current clinical trial evaluating the safety and efficacy of ViaCyte's PEC - Direct product candidate, which is in development as a potential cure for patients with high - risk type 1 diabetes.

The first - in - human STEP ONE * trial is evaluating the safety and efficacy of ViaCyte's PEC - Encap (a.k.a. VC - 01 ™) product candidate, a stem cell - derived, encapsulated cell replacement therapy.

Paris, France, April 3, 2018, 5.35 pm CET — GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA - PME eligible), a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced topline results from the REVERSE Phase III clinical trial evaluating the safety and efficacy of a single intravitreal injection of GS010 (rAAV2 / 2 - ND 4) in 37 subjects whose visual loss due to 11778 - ND4 Leber Hereditary Optic Neuropathy (LHON) commenced between 6 and 12 months prior to study treatment.

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.

CO2 extracts are still very experimental as few clinical trials have been conducted evaluating their safety and efficacy.

Their research focused on evaluating the safety and efficacy of autologous bone marrow - derived stem cell transplantation in individuals with type 2 diabetes with good glycemic control as well, which emerged as an important aspect in the transplantation group as well as in the non-transplanted group.

Not exact matches

Detailed 48 - week results from a Phase 3 study evaluating the efficacy and safety of switching from a regimen containing abacavir, dolutegravir and lamivudine (600 / 50/300 mg)(ABC / DTG / 3TC) to Biktarvy, a once - daily single tablet regimen, in virologically suppressed adults with HIV.

The new administration is taking shape and may potentially include an FDA commissioner who has argued the agency should consider safety when evaluating new drugs and devices and efficacy only after the drug has been legalized.

ObjectiveTo evaluate the efficacy and safety of magnesium sulfate in the resolution of vaginal bleeding and contractions in nonsevere placental abruption.

Further studies in animal models and patients (with altered TRPM7 channel function) have been initiated, in order to evaluate the efficacy and safety of magnesium as a therapeutic for this disease.

The CO-STAR (Hepatitis C Patients on Opioid Substitution Therapy Antiviral Response) trial sought to evaluate the efficacy and safety of elbasvir - grazoprevir for injection drug users.

Mumbengegwi takes these plants back to the lab to evaluate the efficacy, safety, and bioavailability of the various compounds.

The FDA doesn't evaluate foods intended to aid general life conditions, such as mood and mental sharpness, so ginkgo biloba need not be certified for safety or efficacy.

Previous clinical trials have evaluated the efficacy, safety and tolerability of CIP on human patients.

The ADvance Trial, using a device from Functional Neuromodulation, Inc., is aimed at evaluating the safety, efficacy and tolerability of DBS in this patient population.

Dr. Timmerman, who holds the Effie Marie Cain Distinguished Chair in Cancer Therapy Research, has championed the use of SABR globally and has served as the lead investigator in several national trials designed to evaluate the efficacy and safety of SABR to treat cancer in the lung, liver, spine, and prostate.

In a study published online by JAMA Cardiology, Fredrik Björck, M.D., of Umea University, Umea, Sweden and colleagues evaluated the efficacy and safety of well - managed warfarin therapy in patients with nonvalvular atrial fibrillation.

The ENGOT - OV16 / NOVA trial evaluated the efficacy and safety of the PARP inhibitor niraparib as maintenance therapy in patients with recurrent ovarian cancer who respond to platinum - based chemotherapy.

This prospective, single - arm, phase II clinical trial was conducted to evaluate the safety, feasibility, and efficacy of induction chemotherapy followed by SABR in 34 patients who had biopsy - proven PDA.

He will continue evaluating the long - term safety and efficacy of Ins - PBA - F.

Since there is no vaccine or specific approved treatment for Ebola virus disease (EVD), there is a «moral obligation» to collect and share all data generated, to understand the safety and efficacy of any intervention, and to evaluate promising interventions to inform future research, says Dr. Eleanor Fish, the senior author and senior scientist in the Toronto General Hospital Research Institute (TGHRI).

ViaCyte is proceeding to initiate an open - label clinical trial to evaluate the PEC - Direct product candidate for safety and definitive evidence of efficacy.

A Phase 1b / 2a Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 232 Combined with Trametinib and Dabrafenib or Trametinib in Adult Subjects with Metastatic Cutaneous Melanoma

A Randomized, Phase III Trial to Evaluate The Efficacy and Safety of MK - 3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor - Negative Breast Cancer with ≥ 1 cm Residual Invasive Cancer or Positive Lymph Nodes (yPN +) After Neoadjuvant Chemotherapy