Crossover Trial Reset

Dual antiplatelet therapy with aspirin and Clopidogrel for at least one year is essential in patients following an acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) with drug eluting stent(s. Interindividual variability in platelet response to clopidogrel has been reported, with several mechanisms being implicated for high post-clopidogrel treatment PR. High on-treatment platelet reactivity (HTPR) is associated with an increased risk of adverse events after PCI. Studies in patients on chronic clopidogrel treatment are scarce, mainly in diabetic patients where HTPR is frequently present and independently predictive of adverse events. Optimization of platelet inhibition in patients with HTPR by increasing clopidogrel or alternatively, by more potent P2Y12 inhibitors is a controversial issue, mostly studied in post PCI patients, while no data exist, to the best of the investigators knowledge, in stable patients on chronic clopidogrel treatment. Therefore all HTPR patients, that will accept to participate, will be enrolled will randomize (Day 0) in a 1:1 ratio to either clopidogrel 150 mg a day, or prasugrel 10 mg a day, until Day 14 post randomization. A 14 ± 2 day visit will be performed for PR measurement and safety evaluation, with the blood sample being will be obtained 16-18 hours after the last study-drug dose, will follow by crossover directly to the alternate therapy for an additional 14 days without an intervening washout period. At Day 28 ± 2 patients will return for the clinical and laboratory assessment as did on Day 14 visit.

MTN-034 is a Phase 2a, multi-site, randomized, open-label, crossover study to assess safety and adherence of a dapivirine vaginal ring and oral emtricitabine/tenofovir (FTC/TDF) tablets in HIV-uninfected adolescent females between the ages of 16 - 21 years old (inclusive).

Despite these observations, there is little research evidence to support the use of a fan to improve symptom control. We designed a randomized, controlled, crossover trial to test the effectiveness of a handheld fan directed at the face in reducing the sensation of breathlessness for patients who are breathless at rest. The reason to consider a crossover design when planning a clinical trial is that it could yield a more efficient comparison of treatments than a parallel design, i.e., fewer patients might be required in the crossover design in order to attain the same level of statistical power or precision as a parallel design.(This will become more evident. The third trial (Odani in Figure 1), which included 158 patients, almost certainly failed to conceal allocation, used no blinding, and lost 26% of patients to follow-up, many more in the steroid group than the control group(25). This third trial is probably best classified as having very serious risk of bias. Crossover Assignment: Masking: None (Open Label) Primary Purpose: Treatment: Official Title: PhaRmacodynamic Effects of Switching thErapy in paTients With High on Treatment Platelet Reactivity and Genotype Variation: High Clopidogrel Dose Versus Prasugrel RESET GENE Trial: Study Start Date: October 2011: Actual Primary Completion Date. Trial-Reset is an registry cleaning tool (it claims it’s not a crack) that removes the keys generated by commercial and freeware protector of trial period, and hence makes the software as if just freshly installed. It actually automates the process of cleaning up the registry key related to trial expiry mentioned above. The software and its.

The primary objectives of MTN-034 are to collect safety and adherence data for these two study products in an adolescent population and to provide important information regarding individual preference for the products. This trial enrolled 247 healthy, HIV-uninfected, adolescent females. Participants were randomized (1:1) to one of two study product application sequences: (a) daily FTC/TDF oral tablets for 24 weeks, followed by use of the dapivirine VR inserted monthly for 24 weeks; or (b) monthly dapivirine VR for 24 weeks, followed by daily FTC/TDF oral tablets for 24 weeks. After completing the randomized sequence of two study product use periods, participants then selected one of the study products (or neither) to use in the third and final 24 weeks of the trial. In total, participants will be followed up for approximately one and a half years. Participants could choose either or neither study product at any time during the third product use period.

Crossover Linux Trial Reset

The study was closed to accrual on May 28, 2020. Study follow-up is expected to complete in October 2021.

Celum, Connie (Protocol Co-Chair)

Ngure, Kenneth (Protocol Co-Chair)

A Phase 2a Crossover Trial Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population

12066

Closed to Accrual

Vaginal Ring

Truvada® (emtricitabine +tenofovir disoproxil fumarate)

Vaginal

Pharmacokinetics

Phase IIA

Uganda

How To Extend Crossover Trial

Women (cisgender women, non‐transgender women)

Division of AIDS, US National Institute of Allergy and Infectious Diseases
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health

IPM
Gilead Sciences, Inc.

Crossover Trial Reset Tool

Phase 2a, randomized, open label, crossover trial