A Phase II, Randomized, Double -blind, Placebo -controlled ...
• Adverse events, vital signs, 12-lead Electrocardiography (ECG), and clinical safety laboratory abnormalities. Secondary Endpoints • Clinical and endoscopic response (decrease from Baseline in full Mayo score ≥3 and ≥30%,
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New antibiotic treatment options for uncomplicated ...
clinicaltrials.govtreatment options for gonorrhoea and only a few new drugs in the development pipeline, it is important to test existing antibiotics for their efficacy in gonorrhoea treatment. Objective : This project aims to identify new treatment modalities for uncomplicated gonorrhoea using
A PROSPECTIVE MULTI CENTER RANDOMIZED CONTROLLED …
clinicaltrials.govconjunction with Ceramic on Ceramic and Taperloc Complete Microplastyarticulation stem in primary total hip arthroplasty compared to patients who received the Exceed ABT Acetabular system with the same combination.
Title: A Phase 1, Randomized, Double-Blind, Placebo ...
clinicaltrials.govA Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single and Multiple Doses of TAK-653 in Healthy Subjects Phase 1 TAK-653 Escalating Single and Multiple Dose Study in Healthy Subjects Sponsor: Takeda Development Centre Europe Ltd. 61 Aldwych London, WC2B 4AE United Kingdom
Statistical Analysis Plan (SAP) - ClinicalTrials.gov
clinicaltrials.govstatistical analysis. The subsections below will describe analyses in addition to the descriptive statistics. 6.1 Primary outcome The primary analysis will compare intervention groups (water supplementation vs control treatment) on their mean change in fasting plasma glucose between baseline and 12 months using a linear mixed model.
Clinical study protocol template - ClinicalTrials.gov
clinicaltrials.govATC anatomical therapeutic chemical ATS/ERS American Thoracic Society/European Respiratory Society AV atrioventricular BMI body mass index BTPS body temperature and pressure saturated BUN blood urea nitrogen CFR Code of Federal Regulations CK creatine kinase CK-MB creatine kinase isoenzyme MB
Clinical Study Report (CSR) Template (Drug and Device)
clinicaltrials.govATC Anatomical Therapeutic Chemical CFB change from baseline DHA dapsone hydroxylamine eCRF electronic case report form IGA Investigator’s Global Assessment MedDRA Medication Dictionary for Regulatory Activities mITT modified intent-to-treat NAD N-acetyl dapsone PK pharmacokinetic ...
Research Proposal - ClinicalTrials.gov
clinicaltrials.govas fecal microbiota transplantation (FMT). 4. Procedures Tissue samples will be obtained from consenting patients at (SDMCUT), or other relevant facilities (see section 6.i below), in accordance with protocols approved by the University of Texas Institutional Review Board (UTIRB). Patients who meet eligibility criteria will have their
Novartis CSR template
clinicaltrials.gov9.1 Study design Figure 9-1 Study design BID: twice a day, QD: once a day. This was a multicenter, randomized, double-masked, two-arm, placebo-controlled, parallel-group study in patients with normal tension glaucoma who were insufficiently controlled on travoprost 0.004% (Travatan) monotherapy. Approximately 200 patients were planned to be
DETAILED STATISTICAL ANALYSIS PLAN (SAP)
clinicaltrials.govStatistical principles : 4.1. Multiplicity : The diagnostic and prognostic basic stud y and each sub -study consist of one primary outcome and one or more secondary, exploratory outcomes. We will encounter multiplicity issues due to the multiple
Title: TWILIGHT Study - Ticagrelor With Aspirin or Alone ...
clinicaltrials.govPrior stroke Dialysis-dependent renal failure Active bleeding or extreme-risk for major bleeding (e.g. acute ... Life expectancy < 1 year ... 7.3.4 Adverse Events based on signs and symptoms ...
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