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Phase II Randomized Study Of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy For Infantile Spasms Refractory To Standard Treatment PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Phase II Randomized Study Of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy For Infantile Spasms Refractory To Standard Treatment articles that have been published worldwide.
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This sequential multiple assignment randomized trial (SMART) tested the effect of beginning treatment of childhood OCD with fluoxetine (FLX) or group cognitive-behavioral therapy (GCBT) accounting for treatment failures over time.
This randomized controlled study investigated the feasibility of early ambulation after liver resection and the effect of the amount of activity on postoperative recovery.
Phase 1 Single- and Multiple-Ascending-Dose Randomized Studies of the Safety, Pharmacokinetics, and Pharmacodynamics of AG-348, a First-in-Class Allosteric Activator of Pyruvate Kinase R, in Healthy Volunteers.
Pyruvate kinase deficiency is a chronic hemolytic anemia caused by mutations in PK-R, a key glycolytic enzyme in erythrocytes. These 2 phase 1 randomized, placebo-controlled, double-blind healthy-volunteer studies assessed the safety, tolerability, and pharmacokinetics/pharmacodynamics of AG-348, a first-in-class allosteric PK-R activator. Twelve sequential cohorts were randomized 2:6 to receive oral placebo or AG-348, respectively, as a single dose (30-2500 mg) in the single-ascending-dose (SAD) study (Cli...
Fentanyl sublingual spray may be a viable alternative to intravenous (IV) opioids for the treatment of acute pain. As patients with acute pain may include those who have limited prior exposure to opioids, this phase 1, open-label, randomized, multiple ascending-dose study was conducted to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of multiple doses of fentanyl sublingual spray in opioid-naïve participants. This article primarily reports the pharmacokinetics results.
With the improvement of endoscopic diagnosis, the discovery rate of the synchronous multiple primary early cancers in esophagus and stomach is gradually increased, while the traditional surgery bringing serious damages. Endoscopic submucosal dissection (ESD) has become the first treatment option of early cancer in the digestive tract partly. This study intends to explore the feasibility, safety, and effectiveness of ESD in the treatment of the synchronous multiple early gastric cancer or precancerous lesion...
To determine the best available evidence on the efficacy and tolerability of antiepileptic drugs (AEDs) used to treat poststroke seizures and epilepsy.
There is a growing body of evidence suggesting that early and effective management in the critical early years of schizophrenia can improve long-term outcomes. The objective of this study was to evaluate time to relapse of the patients with early-phase psychosis treated in the Centre for integrative psychiatry (CIP).
One of the most critical decision points in clinical development is Go/No-Go decision-making after a proof-of-concept study. Traditional decision-making relies on a formal hypothesis testing with control of type I and type II error rates, which is limited by assessing the strength of efficacy evidence in a small isolated trial. In this article, we propose a quantitative Bayesian/frequentist decision framework for Go/No-Go criteria and sample size evaluation in Phase II randomized studies with a time-to-even...
The MF07-01 trial is a multicenter, phase III, randomized, controlled study comparing locoregional treatment (LRT) followed by systemic therapy (ST) with ST alone for treatment-naïve stage IV breast cancer (BC) patients.
Contingency management (CM) interventions that reinforce attendance have rarely been evaluated in terms of reducing drug use. Using a sequential randomized design, this study examined the efficacy of three attendance CM conditions compared to usual care (UC) on drug use outcomes. It evaluated whether the duration (6 vs. 12 weeks) and timing (early vs. later treatment) of CM delivery impact treatment response.
Previous studies have demonstrated that early surgery in Crohn disease (CD) can result in a better clinical course than late surgery. The aim of this study was to compare the clinical course of CD following bowel resection performed at the time of diagnosis (early surgery) and during the course of the disease (late surgery).We reviewed medical records from a hospital-based cohort database that includes Korean CD patients diagnosed before 2009. Patients who underwent bowel resection were included. Age, sex, ...
The aim of this Phase II, non-randomized study was to assess activity and safety of neoadjuvant chemotherapy (NACT) before chemoradiation (CT/RT) followed by radical surgery (RS) in locally advanced cervical cancer (LACC) patients.
Enhanced Recovery After Surgery (ERAS) guidelines advocate early postoperative mobilisation to counteract catabolic changes due to immobilisation and maintain muscle strength. The present study aimed to assess compliance to postoperative mobilisation according to ERAS recommendations.
Angiogenesis is critical to colorectal cancer (CRC) growth and metastasis. Phase I/II studies have demonstrated the efficacy of nintedanib, a triple angiokinase inhibitor, in patients with metastatic CRC. This global, randomized, phase III study investigated the efficacy and safety of nintedanib in patients with refractory CRC after failure of standard therapies.
Current guidelines for randomized controlled trial (RCT) reporting do not require authors to justify their choice of time horizon. This is concerning, as the time horizon when an outcome is assessed has important implications for the interpretation of study results, and resources allocated to an investigation. Therefore, this study seeks to examine the standards of time horizon reporting in the plastic surgery literature.
Nemolizumab, an anti-interleukin-31 receptor A monoclonal antibody, improved pruritus, dermatitis, and sleep in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments in a phase II, 12-week, randomized, double-blind, placebo-controlled study (Part A) (NCT01986933).
A prospective, Phase IV, multicenter, randomized study.
Although commonly practiced, simultaneous onabotulinumtoxinA injections to multiple facial areas have not been investigated in prospective studies.
The diagnostic value of hemoglobin (Hb) for detecting a significant hemorrhage (SH) in the early phase of trauma remains controversial. The present study aimed to assess the abilities of Hb measurements taken at different times throughout trauma management to identify patients with SH.
Benefits of surgery for early stage non-epithelioid MPM have not been clearly elucidated. This study investigated whether cancer-directed surgery affects overall survival compared to non-surgical therapies for T1-T2N0M0 sarcomatoid or biphasic malignant pleural mesothelioma (MPM) patients.
Suboptimal persistence with injectable disease-modifying therapies (iDMTs; interferon beta-1a/b, glatiramer acetate) is common in patients with relapsing forms of multiple sclerosis (MS), reducing the effectiveness of these agents. Adherence to, and persistence with, an effective therapy is important for patient populations at increased risk of rapid disease progression. African-American individuals with multiple sclerosis may experience a more aggressive disease course than Caucasian patients, with a great...
Cognitive impairment (CI) is a common problem in multiple sclerosis (MS), may occur either in early or late phase of the disease, and impairs quality of life.
Sequential unfolding of monomeric proteins is important for the global understanding of local conformational elements (e.g., secondary structures and domain connections) within those protein assemblies. Ion mobility-mass spectrometry (IM-MS) is an emerging and promising technique for probing gradual protein structural perturbations in the gas phase. However, it is still challenging to track sequential unfolding in the solution phase. Here, we extended IM-MS to track in-solution sequential unfolding of monom...
This is an updated version of the Cochrane Review previously published in Issue 3, 2015.The incidence of seizures following supratentorial craniotomy for non-traumatic pathology has been estimated to be between 15% to 20%; however, the risk of experiencing a seizure appears to vary from 3% to 92% over a five-year period. Postoperative seizures can precipitate the development of epilepsy; seizures are most likely to occur within the first month of cranial surgery. The use of antiepileptic drugs (AEDs) admini...
The aim of the present study was to compare between the efficacy and tolerability of a sequential therapy (ST) as the first-line treatment for adults with Helicobacter pylori infection and that of standard triple therapy (TT).