Sentences with phrase «open label trials»

Open label trials are susceptible to bias through placebo effects.

Cognitex supplementation in elderly adults with memory complaints: an uncontrolled open label trial.

Not exact matches

This open label, multicentre, phase 1B trial investigated the safety and efficacy of omaveloxolone in combination with the checkpoint inhibitors ipilimumab or nivolumab.

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.

Direct - acting antiviral prophylaxis in kidney transplantation from Hepatitis C virus - infected donors to noninfected recipients: an open - label nonrandomized trial.

A novel strategy to screen pregnant women for malaria with rapid diagnostic tests and treat the test - positive women with effective antimalarials does not lower the risk of adverse pregnancy outcomes compared with treating all pregnant women with the malaria preventive sulfadoxine - pyrimethamine (SP) in sub-Saharan Africa, according to an open label randomized trial published this week in PLOS Medicine by Feiko ter Kuile, of the Liverpool School of Tropical Medicine, and colleagues.

The US Food and Drug Administration has noted a higher - than - expected rate of suicide attempts in open - label extensions of controlled trials of duloxetine for stress urinary incontinence.

Only 5 were randomized controlled trials, the others being case reports, open - label trials, parent surveys or case series.

The patients knew they were receiving psilocybin (an «open - label» trial) and the effect of psilocybin was not compared with a placebo.

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

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

Randomized, Open - Label, Phase 3 Trial of Nivolumab plus Ipilimumab or Nivolumab plus Platinum - Doublet Chemotherapy versus Platinum - Doublet Chemotherapy in Early Stage NSCLC

Bornhäuser M, Kienast J, Trenschel R, et al Reduced - intensity conditioning versus standard conditioning before allogeneic haemopoietic cell transplantation in patients with acute myeloid leukaemia in first complete remission: a prospective, open - label randomised phase 3 trial.

The COLUMBUS trial was a randomized, open - label, phase III trial that took place in 28 countries.

AST - VAC1 was previously tested in a multi-center, open - label, Phase 2 clinical trial in patients with intermediate and high risk AML.

The clinical trial is open labelled for the phase Ia arm conducted in Tübingen, Germany and double blinded for the phase Ib conducted at the Institut de Recherche Clinique du Bénin, Benin.

Phase II, open - label, single - arm trial of imatinib mesylate in patients with metastatic melanoma harboring c - Kit mutation or amplification.

The 46 volunteers in the trial that just finished will be invited to participate in an «open - label extension» study or OLE.

Effect of Repeated Anthelminthic Treatment on Malaria in School Children in Kenya: A Randomized, Open - Label, Equivalence Trial.

The SCiStar study is an open - label, single - arm trial testing three sequential escalating doses of AST - OPC1 administered at up to 20 million AST - OPC1 cells in 25 subjects with subacute motor complete (AIS - A or AIS - B) cervical (C - 4 to C - 7) spinal cord injury.

Now, in a study published in Stem Cells, the laboratory of Seung Hyun Kim (Hanyang University, Seoul, Korea) report on an open ‐ label, single ‐ arm, investigator ‐ initiated trial to identify biological markers of MSCs to predict response to in patients with ALS [3].

Interim data from a parallel open - label study of the ring called HOPE, led by the US National Institutes of Health - funded Microbicide Trials Network (MTN), reported nearly identical results today at CROI.

[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.

In a significant update, the company has announced two important milestones: the trial is now fully recruited, and an «open - label extension» will be activated for the volunteers in the current trial.

If you weren't in the blinded safety trial, you will not be able to sign up for the open - label extension.

And second, the company is launching an open label extension to the current trial.

One randomized trial found no significant difference between TMS and non-dominant unilateral ECT on performance on neuropsychological tests at 2 and at 4 weeks of treatment, although a small open - label trial reported a greater degree of memory difficulties with ECT than with TMS shortly after the treatment course.»

The open - label extension study will only be available to volunteers in the current trial.

A Non-randomized, Open - label Dose - finding Trial of Combined Cytotoxic and Immune - Stimulatory Strategy for the Treatment of Resectable Primary Malignant Glioma

In an open - label extension trial, or OLE, the volunteers from a blinded trial are invited to come back for further doses, and every volunteer gets the active drug rather than some receiving drug and some the placebo — usually at the highest dose that was safely tried in the blinded trial.

In open - label trials, all patients receive (and know they are receiving) the experimental treatment being studied.

U.S. Phase 1 Trial in SMA Type 2 (STRONG) The open - label, dose - comparison, multi-center Phase 1 trial — known as STRONG — is designed to evaluate the safety, optimal dosing, and proof of concept for efficacy of AVXS - 101 in two distinct age groups of patients with SMA Type 2, utilizing a one - time IT route of administraTrial in SMA Type 2 (STRONG) The open - label, dose - comparison, multi-center Phase 1 trial — known as STRONG — is designed to evaluate the safety, optimal dosing, and proof of concept for efficacy of AVXS - 101 in two distinct age groups of patients with SMA Type 2, utilizing a one - time IT route of administratrial — known as STRONG — is designed to evaluate the safety, optimal dosing, and proof of concept for efficacy of AVXS - 101 in two distinct age groups of patients with SMA Type 2, utilizing a one - time IT route of administration.

We also performed subgroup meta - analyses by type of prevention (primary v secondary: in this study, trials involving healthy populations or patients with any specific disease except for cardiovascular disease were classified as primary prevention trials, and trials involving patients with cardiovascular disease were classified as secondary prevention trials), type of supplement by quality and dose (each supplement, vitamins only, antioxidants only, or antioxidants excluding vitamins), type of outcome (cardiovascular death, angina, fatal or non-fatal myocardial infarction, stroke, or transient ischaemic attack), type of outcome in each supplement, type of study design (randomised, double blind, placebo controlled trial v open label, randomised controlled trial), methodological quality (high v low), duration of treatment (< 5 years v ≥ 5 years), funding source (pharmaceutical industry v independent organisation), provider of supplements (pharmaceutical industry v not pharmaceutical industry), type of control (placebo v no placebo), number of participants (≥ 10000 v < 10000), and supplements given singly or in combination with other vitamin or antioxidant supplements by quality.

A multicenter, open - label trial of talimogene laherparepvec (T - VEC) plus pembrolizumab vs pembrolizumab monotherapy in previously untreated, unresected, stage IIIB - IV melanoma.

A phase II multicenter, randomized, open - label trial of T - VEC [28] in patients with resectable stage IIIB, IIIC, or IV M1a melanoma testing that hypothesis is in the enrollment phase.

The randomized, open label Phase 2 trial is ongoing and evaluating CMB305 and atezolizumab in patients with locally advanced, relapsed, or metastatic synovial sarcoma or myxoid / round - cell liposarcoma, two types of sarcoma that tend to express NY - ESO - 1 broadly.

PPMD and Action Duchenne hosted a webinar update last week on the recent report that Summit has announced positive 24 - week interim results from the open - label Phase 2 proof of concept clinical trial, PhaseOut DMD.

PPMD and Catabasis Pharmaceuticals recently hosted a webinar to hear a community update on the results from the open - label extension of the MoveDMD trial.

Ranjan A, Schmidt S, Damm - Frydenberg C, Holst J, Madsbad S, Nørgaard K. Short - term Effects of Low Carbohydrate Diet on Glycaemic Parameters and Cardiovascular Risk Markers in Patients with Type 1 Diabetes - A Randomised Open - label Cross-over Trial.

Twelve subjects were subjected to an open - labeled, three - period trial involving sequential oral administration of placebo, 2g GABA once, and 2g GABA three times / day for 7 days, with a 7 - day washout between each period.

The Use of Ascorbigen in the Treatment of Fibromyalgia Patients: A Preliminary Trial Alternative Medicine Review 2000 (Oct); 5 (5): 455 — 462 ~ FULL TEXT Twelve female fibromyalgia syndrome (FMS) patients were given 500 mg per day of a blend containing 100 mg ascorbigen and 400 mg broccoli powder in a preliminary, one - month, open - label tTrial Alternative Medicine Review 2000 (Oct); 5 (5): 455 — 462 ~ FULL TEXT Twelve female fibromyalgia syndrome (FMS) patients were given 500 mg per day of a blend containing 100 mg ascorbigen and 400 mg broccoli powder in a preliminary, one - month, open - label trialtrial.

Effect of a single inactivated poliovirus vaccine dose on intestinal immunity against poliovirus in children previously given oral vaccine: an open - label, randomized control trial.

An open - label trial of divalproex sodium extended release for pediatric bipolar spectrum disorder in children age 6 - 12 years

An open - label trial using low doses (mean 1.2 ± 0.5 mg) of risperidone in children and adolescents with SMD showed significant reductions in irritability scores.17

Effect of Vitamin E and Alpha Lipoic Acid in Nonalcoholic Fatty Liver Disease: A Randomized, Placebo - Controlled, Open - Label, Prospective Clinical Trial (VAIN Trial)