randomized controlled phase 3 trial
A phase 1/2 trial to evaluate the pharmacokinetics, safety, and efficacy of NI 03 in patients with chronic pancreatitis: study protocol for a randomized controlled trial on the assessment of camostat treatment in chronic pancreatitis (TACTIC)
... Safety will be monitored through weekly contact: tele- phone calls during weeks 1 and 3 and office visits during weeks 2 and 4. All adverse events will be recorded. The investigator will determine both the ...
7
Discrete strategies to reduce intake of discretionary food choices: a scoping review
... OR Randomized Controlled Trials OR Single-Blind Studies OR Random Assignment OR Double Blind Studies OR Single Blind Studies OR Clinical Trials OR Phase 1 clinical trial OR Phase 2 ...
22
First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma
... a Phase 3 randomized, double-blinded, placebo-controlled clini- cal trial of an autologous tumor lysate-pulsed dendritic cell vaccine (DCVax ® -L) for newly diagnosed glio- ...this ...
9
Profile of mirabegron in the treatment of overactive bladder: place in therapy
... a Phase II, factorial design, randomized, double-blind, parallel-group, placebo- and monotherapy-controlled trial conducted at 141 sites in 20 European ...least 3 months. In this ...
5
Droxidopa for neurogenic orthostatic hypotensionA randomized, placebo-controlled, phase 3 trial
... Responders were defined as having any improvement from baseline (i.e., $1 unit) on OHQ item 1, plus a $10 mm Hg increase from baseline in standing systolic BP. After 7-day wash- out, responders were assigned by a ...
10
A phase 3 randomized placebo-controlled trial of tadalafil for Duchenne muscular dystrophy
... Inclusion criteria were male with proven DMD, age of 7 to 14 years, 6-minute walk distance (6MWD) between 200 and 400 m, 2 baseline 6MWDs differing by ,20%, left ventricular ejection fraction $50%, and systemic ...
11
Safety and Immunogenicity of DNA Prime and Modified Vaccinia Ankara Virus-HIV Subtype C Vaccine Boost in Healthy Adults
... A randomized, double-blind, placebo-controlled phase I trial was conducted in 32 HIV-uninfected healthy volunteers to assess the safety and immunogenicity of 3 doses of DNA vaccine ...
12
Cost-effectiveness of SQ® HDM SLIT-tablet in addition to pharmacotherapy for the treatment of house dust mite allergic rhinitis in Germany
... the phase III randomized controlled trial of a sublingual tablet treatment for HDM allergic rhinitis, indicate that over the nine-year time horizon, SQ HDM SLIT- tablet patients generated ...
8
<p>Safety, Tolerability, and Effect on Opioid Use of Meloxicam IV Following Orthopedic Surgery</p>
... a phase 3 multi- center, randomized, double-blind, placebo-controlled trial evaluating the safety of meloxicam IV in adult subjects undergoing major surgery, including, but not limited ...
9
Linaclotide: evidence for its potential use in irritable bowel syndrome and chronic constipation
... double-blind randomized controlled Phase III trial evaluated the efficacy and safety of linaclotide 266 µ g (n = 405) versus placebo (n = 395) for 12 ...previously randomized to placebo ...
9
Minimally invasive versus open pancreatoduodenectomy (LEOPARD 2): study protocol for a randomized controlled trial
... a randomized controlled, parallel-group, patient-blinded, multicenter, phase 2/3, superiority trial in centers that completed the Dutch Pancreatic Cancer Group LAELAPS-2 training ...
10
Barriers encountered during enrollment in an internet mediated randomized controlled trial
... a trial multiple times using differ- ent identities in order to gain access to multiple arms of a trial or receive multiple incentives ...internet-mediated randomized controlled trials (RCTs) ...
8
Harpgophytum procumbens for osteoarthritis and low back pain: A systematic review
... A total of 130 citations were isolated from electronic searches and all abstracts were retrieved. A total of three additional references were supplied by content experts. A total of 120 papers were excluded because of ...
10
A randomized controlled trial on the use of pessary plus progesterone to prevent preterm birth in women with short cervical length (P5 trial)
... Preterm birth (PTB), defined as birth before 37 weeks of gestation, is in quantity and in severity one of the most important issue in obstetric care in the world. Globally, around 15 million preterm births are born every ...
9
<p>Evaluating vandetanib in the treatment of medullary thyroid cancer: patient-reported outcomes</p>
... after 3 years and 8 months from the beginning of the therapy, indicating the long-term effectiveness of vandetanib in maintaining the control of hypercortisolism in MTC-related ...
15
Ustekinumab for the treatment of psoriatic arthritis: an update
... In PSUMMIT 1, 1,174 patients were screened, and 615 eligible patients with active PsA were randomly assigned to treatment groups. The patient population was from 14 coun- tries in North America, Europe, and the ...
7
Comparative efficacy of alemtuzumab and established treatment in the management of multiple sclerosis
... Generally, natalizumab appears to be more effective than the injectable treatments. Fingolimod was compared with intramuscular interferon b -1a in one of its Phase III trials and demonstrated greater efficacy. ...
9
Pharmacotherapies for chronic obstructive pulmonary disease: a multiple treatment comparison meta-analysis
... included randomized clinical trials (RCTs) evaluating long-acting β 2 agonists (LABA), long-acting muscarinic antagonists (LAMA), inhaled glucocorticosterioids (ICS), and the phosphodiesterase-4 (PDE4) inhibitor ...
23
Sleep Hygiene for Children With Neurodevelopmental Disabilities
... NDDs and physical disabilities, often with the use of various mechanical devices, can be helpful in sleep pro- motion; however, this requires experience with motor disabilities and frequently involves a ...
10
Promoting physical activity for elders with compromised function: the Lifestyle Interventions and Independence for Elders (LIFE) Study physical activity intervention
... a Phase III randomized controlled clinical trial ...the trial along with accelerometry data on patterns of PA during exercise ...
13