Sentences with phrase «open label study»

It will be an open label study, meaning each patient will know what they are getting.

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 original, randomized, open label study, which enrolled 20 outpatient men with cirrhosis and recurrent HE receiving standard - of - care (SOC) treatment, had previously reported that a single FMT enema after antibiotic pretreatment improved cognitive function at Day 20 and reduced HE episodes and hospitalizations over the following 5 months compared with SOC.1 The long - term outcomes of this study, which were presented today at The International Liver Congress ™ 2018 in Paris, France, demonstrated sustained and statistically significant reductions in the number of HE episodes and hospitalizations as well as improvements in cognitive function over 1 year in the men who received FMT compared with the control group.

Presentations will highlight the short and long - term effects of Ingrezza on tardive dyskinesia symptoms by body region, long term safety and efficacy data from the KINECT 4 phase 3 open label study and also from RE-KINECT (real - world screening study of patients with possible TD).

Not exact matches

This study might open a can of worms for the FDA, which must decide what a gluten - free label claim means.

The Phase I clinical trial of OMP - 54F28 (FZD8 - Fc) is an open - label dose escalation study in patients with advanced solid tumors for which there was no remaining standard curative therapy.

The largest CBD study presented efficacy and safety data on GW Pharmaceutical's investigational medicine, Epidiolex (cannabidiol) from open - label Expanded Access programs at 16 sites.

The open - label ASCEND - 5 study included 231 patients with NSCLC who had received crizotinib.

This writer didn't label it or condemn it — what he did was put forth two sides of the argument and left it open,» says Tadros, who also studies suicide in modern cultures.

This ongoing, open - label study enrolled 90 children aged between six and 11 years with chronic HCV, mostly genotype 1 (n = 86).

The study found that patients who received T - sol during the open - label phase had improved symptoms regardless of whether they had received placebo during the blinded phase.

The authors did a pilot study to assess the feasibility of an open - label trial of PrEP.

In a six - month open - label study of patients receiving T - sol, published in The Journal of Urology ®, researchers noted improvement of low sex drive and low energy symptoms, and did not identify new safety concerns.

The open - label, multicenter study was established to examine the safety and effectiveness of the procedure.

Testosterone levels in 60 % of the former placebo participants and 66 % of the continuing active participants were within the normal range at the end of the open - label study.

«To our knowledge, this open - label study is the first to directly contrast varenicline and C - NRT pharmacotherapies, both with one another and with the nicotine patch.

In the ALLY - 2 randomised, open - label study, the combination of DCV+SOF was well tolerated and effective across the four different genotypes.

All the subjects of the study are now on what's called an «open label extension» - those on placebo have been moved to drug and will continue to be monitored.

A Phase 1, First - in - Man, Multicenter, Open - Label, Two Part Dose - Escalation and Cohort Expansion Study of Single - Agent GBR 1342 in Subjects with Previously Treated Multiple Myeloma

A Phase 3 Open - label, Multicenter, Randomized Study of ASP2215 versus Salvage Chemotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) with FLT3 Mutation

A Phase 3 Open - Label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects with FLT3 - ITD Positive Acute Myeloid Leukemia (AML) Refractory To or Relapsed After First - line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation

14255: STAT3 Signaling During Chemo - Radiation for Squamous Cell Carcinoma of the Head and Neck 14340: A Phase II, Randomized, Open - Label, Multi-Center, Global Study of MEDI4736 Monotherapy, Tremelimumab Monotherapy, and MEDI4736 in Combination with Tremelimumab in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) 14258: Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)

A Phase 1/2, Open - Label, Dose - Escalation, Safety and Tolerability Study of INCB052793 in Subjects With Advanced Malignancies

My Pathway: An Open - Label Phase IIA Study Evaluating Trastuzumab / Pertuzumab, Erlotinib, Vemurafenib / Cobimetinib, Vismodegib, Alectinib, and Atezolizumab in Patients Who Have Advanced Solid Tumors with Mutations or Gene Expression Abnormalities Predictive of Response to One of These Agents

Rituximab plus bendamustine or chlorambucil for chronic lymphocytic leukemia: primary analysis of the randomized, open - label MABLE study

A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza) versus Enzalutamide or Abiraterone Acetate in Men with Metastatic Castration - Resistant Prostate Cancer who have Failed Prior Treatment with a New Hormonal Agent and have Homologous Recombination Repair Gene Mutations.

A Phase 1/2, Multicenter, Open - label Study of FT - 2102 as a Single Agent and in Combination with Azacitidine or Cytarabine in Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome with an IDH1 Mutation

A Phase 1b / 2 Open - Label Study to Evaluate Safety, Clinical Activity, Pharmacokinetics and Pharmacodynamics of Avelumab (MSB0010718C) in Combination with Other Cancer Immunotherapies in Patients with Advanced Malignancies

A Phase 1, Multicenter, Open - Label, Safety Study of AG - 120 or AG - 221 in Combination with Induction Therapy and Consolidation Therapy in Patients with Newly Diagnosed Acute Myeloid Leukemia with an IDH1 and / or IDH2 Mutation

ISIS - SMNRx is also being evaluated in an open - label, multiple - dose, dose - escalation Phase 2 study in infants with Type I SMA.

A Phase 1/2 Open - label Study of the Safety, Tolerability and Efficacy of the Selective Inhibitor of Nuclear Export (SINE) Compound KPT - 8602 in Patients with Relapsed / Refractory Cancer Indications

CARLSBAD, Calif., February 21, 2013 — Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) today announced top - line results from an ongoing open - label, multiple - dose study of ISIS - SMNRx in children with spinal muscular atrophy (SMA).

A Phase 3, Randomized, Open - Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel versus Standard of Care Therapy in Subjects with Relapsed / Refractory Diffuse Large B Cell Lymphoma (ZUMA - 7)

A Phase III Randomized Open - Label Multi-Center Study of Ruxolitinib vs. Best Available Therapy in Patients with Corticosteroid - Refractory Chronic Graft vs Host Disease after Allogenic Stem Cell Transplantation (REACH 3)

An Open - Label, Randomized, Phase 2 Dose - Finding Study of Pacritinib in Patients with Thrombocytopenia and Primary Myelofibrosis, Post - Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocytopenia Myelofibrosis Previously Treated with Ruxolitinib

A Multicenter, Randomized, Open - label, 3 - Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan / Cetuximab or Infusional 5 - Fluorouracil (5 - FU) / Folinic Acid (FA) / Irinotecan (FOLFIRI) / Cetuximab with a Safety Lead - in of Encorafenib + Binimetinib + Cetuximab in Patients with BRAF V600E - mutant Metastatic Colorectal Cancer

An Open Label, Phase II Study of Neratinib in Patients with Solid Tumors with Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations or EGFR Gene Amplification

A Phase I / II, Open - label, Multi-center Study of the Safety and Efficacy of IMCgp100 using the Intra-patient Escalation Dosing Regimen in Patients with Advanced Uveal Melanoma

A Phase Ib, Open - Label Study of the Safety and Tolerability of Atezolizumab in Combination with Radium - 223 Dichloride in Patients with Castrate - Resistant Prostate Cancer who have Progressed Following Treatment with an Androgen Pathway Inhibitor

CARLSBAD, Calif., June 11, 2015 — Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) today provided an update on its ongoing open - label Phase 2 clinical study of ISIS - SMNRx in infants with Type I spinal muscular atrophy (SMA).

A Phase 3, Multicenter, Randomized, Open - Label Study of Guadecitabine (SGI - 110) versus Treatment Choice in Adults with Previously Treated Acute Myeloid Leukemia

An Open - Label Multicenter Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B - 6527 in Subjects with Advanced Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma

An Open - Label, Multicenter Phase I Study to Characterize the Safety, Tolerability, Preliminary Anti-Tumor Activity, Pharmacokinetics and Maximum Tolerated Dose of BAY 1251152 in Patients with Advanced Hematological Malignancies

A Multi-arm, Phase Ib, Open - Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9291 in Combination with Ascending Doses of Novel Therapeutics in Patients with EGFRm + Advanced NSCLC who have progressed following therapy with an EGFR TKI (TATTON)

An Open Label, Multicenter, Single Arm Phase II Pilot Study to Evaluate the Efficacy and Tolerability of the Novel mTOR Inhibitor, MLN0128 (TAK - 228), in Patients with Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract whose Tumors Harbor a TSC1 and / or a TSC2 Mutation

A Phase 2b Open - Label Extension Study to Evaluate the Long - term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001 - 201 (PRONTO)

The agreement labels open water exposed by rapid changes as «Special Areas for Scientific Study.»

Patients in the amaryllis study were all invited to continue taking the drug in an «open label» extension study - open label means the patients knew they were getting the drug for sure.

The Phase 1 open - label, multicenter, dose escalation study of mRNA - 2416 is designed to determine the safety and tolerability of escalating iTu doses of mRNA - 2416 in patients with relapsed / refractory solid tumor malignancies or lymphoma, and define the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) and schedule for iTu injections of mRNA - 2416.

It is also a two - part study with the first part being an open - label dose escalation study in at least 8 infants for 4 weeks to evaluate the safety profile of RG7916 and to determine the dose for Part 2.