Subjects will use dust mite Dermatophagoides pteronyssinus (Dp) extract or placebo nasal spray at home for 2 weeks, with a 1 month washout period followed by 2 weeks of the other nasal spray.

ALLERGIC RHINITIS

intervention will be to stop study drug or placebo

dust mite extract or placebo

Usf Asthma Allergy and Immunology Cru

Repeated Nasal Challenge in Skin Prick-puncture Negative and Intradermal Positive Dust Mite Allergic Rhinitis Patients

Repeated Nasal Challenge in Skin Prick-puncture Negative and Intradermal Positive Dust Mite Allergic Rhinitis Patients.

Mean increase in nasal lavage PGD2 and ECP by greater than 15 percent from baseline levels. Correlation between the orthogonol diameter of the wheal and flare of the intradermal skin test and the degree of symptom worse

Richard Lockey

Principal Investigator

University of South Florida

The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and "closed cell" architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion.

CYPHER® Stent

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Target lesion failure (TLF) is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months.

Phase I: the Rate of Target Lesion Failure (TLF)

A study device success is defined as achievement of a final residual diameter stenosis of < 50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used.

Rate of Device Success

Lesion success is defined as the attainment of < 50% residual stenosis (by Quantitative coronary angiography (QCA)) using any percutaneous method.

Rate of Lesion Success

Procedure success is defined as the achievement of a final diameter stenosis of < 50% (by QCA) using any percutaneous method, without the occurrence of death, Myocardial infarction (MI), or repeat coronary revascularization of the target lesion during the hospital stay.

Rate of Procedure Success

Defined as any "clinically-driven" repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis ≥50% by QCA.

Rate of Clinically-driven Target Lesion Revascularization (TVR)

Defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis ≥50% by QCA.

Rate of Clinically Driven Target Vessel Revascularization (TVR)

Defined as target vessel revascularization, recurrent infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel.

Rate of Target Vessel Failure (TVF)

MACE includes Death, myocardial infarction, emergent bypass surgery, or target lesion revascularization at 12 months

Rate of Major Adverse Cardiac Events (MACE)

Protocol defined ST includes early and late ST. Early thrombosis is defined as composite thirty-day ischemic endpoint including death, Q-wave myocardial infarction, or subabrupt closure requiring revascularization. Late thrombosis is defined as myocardial infarction occurring > 30 days after the index procedure and attributable to the target vessel with angiographic documentation (site reported or by qualitative coronary angiography) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel.

Rate of Protocol Defined Stent Thrombosis (ST)

ARC defined ST classifies ST by type - definite, probable, possible; by timing - acute, sub-acute, late, very late. Definite includes angiographic or pathologic confirmation; probable includes Any unexplained death within the first 30 days or Any MI (related to documented acute ischemia and without another obvious cause) in the territory of the stent; Possible includes Any unexplained death > 30 days. Acute includes those ≤ 24 hours post procedure; sub-acute includes those > 24 hours to ≤ 30 days post procedure; and late includes those > 30 days to ≤ 1 year post procedure; and very late includes those > 1 year post procedure.

Rate of Academic Research Consortium (ARC) Defined Stent Thrombosis (ST)

Defined by the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification, including severe and moderate bleeding combined.

Rate of Protocol Defined Major Bleeding Complications

Include all deaths due to cardiac causes.

Rate of Cardiac Death

Include all deaths due to non-cardiac causes.

Rate of Non-cardiac Death

Subjects signed the consent forms and met all protocol defined inclusion criteria and none of the exclusion criteria.

All Enrolled Subjects

Overall Study

Amy Orlick, Associate Director

Coronary Artery Disease

This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of thienopyridine treatment in addition to aspirin.

Clopidogrel & Aspirin, Prasugrel & Aspirin

This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.

Placebo & Aspirin

University Hospitals, Case Medical Center (Cleveland)

CYPRESS - CYPHER for Evaluating Sustained Safety

A Prospective, Randomized, Multi-Center, Double-Blind Trial to Assess the Effectiveness and Safety of Different Durations of Dual Anti-Platelet Therapy (DAPT) in Subjects Undergoing Percutaneous Coronary Intervention With the CYPHER® Sirolimus-eluting Coronary Stent (CYPHER® Stent)

Cordis Corporation

Acute Hypovolemia

Crystalloid vs. Hypertonic Saline Solution

Volume resuscitation (Crystalloid)

Volume resuscitation (Hypertonic Saline Solution)

University of California Davis Medical Center

Esophageal Echo Assessment of LV Function During Acute Normovolemic Hemodilution Using Crystalloid or Hypertonic Saline

Use of Transesophageal Echocardiography to Assess Left Ventricular Performance During Acute Normovolemic Hemodilution and Randomized Replacement With Intravenous Crystalloid or Hypertonic Saline

cupressus cashmeriana/hemorrhage

Repeated Nasal Challenge in Skin Prick-puncture Negative and Intradermal Positive Dust Mite Allergic Rhinitis Patients

CYPRESS - CYPHER for Evaluating Sustained Safety

Esophageal Echo Assessment of LV Function During Acute Normovolemic Hemodilution Using Crystalloid or Hypertonic Saline

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