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NCT01745822 | 8.3.2 | Expedited Adverse Experience Reporting | 8.3.2. Expedited Adverse Experience Reporting All clinical adverse events and abnormal laboratory values will be recorded and graded. For severe toxicity and serious adverse events, as defined by ICH GCP [83], possibly related to study drugs, an Expedited Adverse Experience Report (EAE) will be sent to the Thai Ministr... | [] |
NCT01745822 | 8.3.3 | Confidentiality | 8.3.3. Confidentiality Every effort will be made to maintain the confidentiality of the study participants. All site staff receive initial and ongoing training on Human Subjects Protection and confidentiality. To minimize this risk, study participants will not be identified by name on any study documents but will be id... | [] |
NCT01745822 | 8.3.4 | Biohazard Containment | 8.3.4. Biohazard Containment As the transmission of HBV and other blood-borne pathogens can occur through contact with contaminated needles, blood, and blood products, appropriate precautions will be used by all personnel in the drawing of blood and shipping and handling of all specimens for this study, as currently re... | [] |
NCT01745822 | 9 | References | 9. References - 1. World Health Organization. Hepatitis B. Fact sheet N'204. Revised August 2008. Available athttp://www.who.inUmediacentre/factsheets/fs204/en/. In: WHO; 2008. - 2. Heathcote EJ. Demography and presentation of chronic hepatitis B virus infection. Am J Med 2008,121 :S3-11. - 3. lavanchy D. Hepatitis B v... | [
"Appendices",
"Appendix 1: Informed Consent Form to Participate in iTAP Study (Thai Language)",
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NCT01756833 | 1.1 | BACKGROUND AND SIGNIFICANCE | 1.1 BACKGROUND AND SIGNIFICANCE Scope of the Clinical Problem. Abdominal aortic aneurysms (AAAs) are a common and life-threatening condition. The natural history of AAA is one of progressive expansion. The rate of aneurysm growth and the risk of rupture are both exponentially related to aneurysm size. Aortic diameter i... | [
"Aneurysm Growth"
] |
NCT01756833 | 1.2 | PRELIMINARY STUDIES | 1.2 PRELIMINARY STUDIES Preliminary studies supporting this application demonstrate that doxycycline can inhibit aneurysm development and expansion in two distinct experimental models of AAA through the inhibition of MMPs. While we understand that information obtained from such models cannot precisely recapitulate the ... | [
"Patient characteristics"
] |
NCT01756833 | 2.1 | PRIMARY AIM | 2.1 PRIMARY AIM 1. Determine if doxycycline (100 mg bid) will inhibit the increase in greatest transverse diameter of small abdominal aortic aneurysms (3.5-5.0 cm in men, 3.5-4.5 cm in women) over a 24-month period of observation in comparison to a placebo-treated control group. | [] |
NCT01756833 | 2.2 | SECONDARY AIMS | 2.2 SECONDARY AIMS - 1. Determine if doxycycline will inhibit circulating MMP-9 levels compared to a control (placebo) group. - 2. Determine if doxycycline (100 mg bid) will prevent the increase in aneurysm volume of small abdominal aortic aneurysms (3.5-5.0 cm in men, 3.5-4.5 cm in women) over a 24-month period of obs... | [] |
NCT01756833 | 2.3 | EXPLORATORY AIMS | 2.3 EXPLORATORY AIMS - 1. Determine if doxycycline will reduce circulating interferon gamma levels compared to a placebo-treated group. - 2. Determine the relationship between interferon gamma and aneurysm expansion rate. | [] |
NCT01756833 | 2.4 | ACCOMPLISHING OBJECTIVES | 2.4 ACCOMPLISHING OBJECTIVES Pools of over nine hundred patients likely to be eligible have been identified at the 15 clinical sites. CT images obtained serially at 6 month intervals at the clinical sites will be transmitted for central reading to a specialized Imaging Core Laboratory (ICL). The blood samples collected... | [
"CHAPTER 3 – OVERVIEW OF STUDY DESIGN AND METHODS"
] |
NCT01756833 | 3.1 | STUDY POPULATION | 3.1 STUDY POPULATION | [] |
NCT01756833 | 3.1.1 | Inclusion Criteria | 3.1.1 Inclusion Criteria The study population will include patients 55 years of age or older who are found to have small (3.5-5.0 cm among men and 3.5 to 4.5 cm among women in the largest transverse diameter) abdominal aortic aneurysms on quantitative computer tomography (CT) scans. | [] |
NCT01756833 | 3.1.2 | Exclusion Criteria | 3.1.2 Exclusion Criteria Patients will be excluded from the study if they are unable to give their own informed consent to participate; have symptoms related to abdominal aortic aneurysm; have other intraabdominal vascular pathology that may require repair within 24 months (e.g., renal artery stenosis, large iliac arte... | [] |
NCT01756833 | 3.2 | STUDY DESIGN | 3.2 STUDY DESIGN We will conduct a randomized, double-blind, parallel, two-group multicenter trial (Exhibit 3-1). A schedule of study procedures and treatments is found in the Appendix. | [] |
NCT01756833 | 3.3 | STUDY TREATMENTS | 3.3 STUDY TREATMENTS Patients will be assigned to doxycycline 100 mg p.o., b.i.d., or matching placebo. Patients randomly assigned to doxycycline will receive bottles containing a sufficient supply of 100 mg doxycycline capsules to take one capsule twice a day until the next appointment (about 100 days). Patients rando... | [] |
NCT01756833 | 3.4 | END POINTS | 3.4 END POINTS | [] |
NCT01756833 | 3.4.1 | Primary Outcome | 3.4.1 Primary Outcome The primary outcome is change in abdominal aortic aneurysm maximum transverse diameter on CT scan from baseline to the follow-up assessment two years after randomization as measured in the Imaging Core Laboratory (ICL). | [] |
NCT01756833 | 3.4.2 | Secondary Outcomes | 3.4.2 Secondary Outcomes Secondary outcomes will derive from central, ICL analyses of the CT scans performed every six months on patients and from the clinical follow-up of randomized patients, from clinical observation, local laboratory findings, study visit quality of life assessments, and from biomarker analyses to ... | [] |
NCT01756833 | 3.4.2.1 | Clinical Outcomes of Interest | 3.4.2.1 Clinical Outcomes of Interest Clinical outcomes of interest related to cardiovascular disease include death, acute myocardial infarction, unstable angina, aortic aneurysm rupture, and aortic aneurysm repair. Clinical outcomes related to chronic tetracycline therapy will include gastrointestinal side effects (e.... | [] |
NCT01756833 | 3.4.2.2 | CT Scan Outcomes | 3.4.2.2 CT Scan Outcomes We will compare treatment groups on central, ICL assessments of infrarenal aneurysm neck length and diameter, aneurysm volume, characteristics of the neck (e.g., suitable or not for endovascular repair, neck angulation), maximum diameter at times other than two years after randomization, serial... | [] |
NCT01756833 | 3.4.2.3 | Clinical Laboratory Studies | 3.4.2.3 Clinical Laboratory Studies Liver function tests (alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase), blood urea nitrogen (BUN), creatinine and complete blood count will be assessed annually at Clinical Site laboratories, reported on study forms and compared between the two treatment... | [] |
NCT01756833 | 3.4.2.4 | Quality of Life | 3.4.2.4 Quality of Life Quality of life will be assessed with the SF-36 administered every six months. | [] |
NCT01756833 | 3.4.3 | Sample Size and Data Analysis | 3.4.3 Sample Size and Data Analysis The study will include 258 randomized patients. Approach to no more than 1600 eligible patients is anticipated to be necessary to obtain consent from 258 (16%). The primary analysis will be performed to test the null hypothesis of no difference in growth of abdominal aortic aneurysms... | [] |
NCT01756833 | 3.4.4 | Time Line | 3.4.4 Time Line The study time line includes six months for planning, training and administrative approvals (e.g., DSMB approval of the final protocol, IRB approvals of the final protocol and final contract negotiations), eighteen months for recruitment, twenty-four months minimum for follow-up, and twelve months for c... | [
"CHAPTER 4 – PATIENT ELIGIBILITY, ORIENTATION AND RETENTION 4.1 INCLUSION CRITERIA"
] |
NCT01756833 | 4.2 | EXCLUSION CRITERIA | 4.2 EXCLUSION CRITERIA - 1. Prior repair of the abdominal aortic aneurysm. - 2. Renal artery involvement or suprarenal extension of the aneurysm. - 3. Documented failure of the aneurysm to increase in size over the two years prior to enrollment if the aneurysm is 2.9 cm in diameter. - 5. Iliac artery occlusive disease ... | [] |
NCT01756833 | 4.3 | INFORMED CONSENT | 4.3 INFORMED CONSENT Informed consent will be obtained by properly trained (in human subjects' research and N-TA3CT Protocol) clinical site investigators (e.g., vascular surgeons), residents, fellows or Clinical Site Coordinators. The patient must be competent and freely willing to give informed consent to participate ... | [] |
NCT01756833 | 4.4 | IDENTIFICATION OF POTENTIAL PATIENTS | 4.4 IDENTIFICATION OF POTENTIAL PATIENTS At the beginning of the study, each lead investigator at a Clinical Site will be personally contacted by the Clinical Site Coordinator. Permission will be sought from each clinical site investigator to recruit patients who have a small, abdominal aortic aneurysm. Each site will ... | [] |
NCT01756833 | 4.5 | PATIENT COMPETENCE TO GIVE INFORMED CONSENT | 4.5 PATIENT COMPETENCE TO GIVE INFORMED CONSENT The individual obtaining informed consent for the patient for N-TA3CT will explain the study to the patient and after providing the explanation ask a brief series of questions about the study (e.g., purpose, treatments, follow-up plans, method to communicate concerns abou... | [] |
NCT01756833 | 4.6 | PROCEEDING FROM INFORMED CONSENT TO RANDOMIZATION | 4.6 PROCEEDING FROM INFORMED CONSENT TO RANDOMIZATION Patients who give written informed consent to enroll in N-TA3CT may proceed to random treatment assignment after satisfactory completion of baseline evaluations (including review of pre-randomization CT scan in the Imaging Core Laboratory) to assure eligibility and ... | [
"NON-INVASIVE TREATMENT OF ABDOMINAL AORTIC ANEURYSM (Consent Evaluation Form) Patient Identification Number \\\\\\ \\\\\\ \\\\\\ - \\\\\\ \\\\\\ \\\\\\ Letter Code \\\\\\ \\\\\\ \\\\\\ Name \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\ To evaluate a patient's competency to give i... |
NCT01756833 | 5.1 | ELIGIBILITY ASSESSMENT | 5.1 ELIGIBILITY ASSESSMENT At the time an eligible patient provides informed consent, Clinical Site staff will complete all sections of the pre-randomization forms, collect pre-randomization blood, plasma and serum specimens, and submit the qualifying CT scan to the Imaging Core Laboratory by overnight courier. Within ... | [] |
NCT01756833 | 5.2 | RANDOM TREATMENT ALLOCATION PROCEDURES | 5.2 RANDOM TREATMENT ALLOCATION PROCEDURES The DCC staff will prepare randomization schedules for each Clinical Site participating in N-TA3CT. The program for generating randomization schedules will have the following characteristics: 1. There will be two randomization strata – one for men and one for women – at each c... | [] |
NCT01756833 | 5.3 | CLINICAL SITE RANDOMIZATION START-UP | 5.3 CLINICAL SITE RANDOMIZATION START-UP Each clinical site will be randomizing patients one by one during the course of the clinical trial. To assure that no clinical site randomizes too few patients to be included in data analyses, randomization of the patients into the study at any given site can begin once clinical... | [
"CHAPTER 6 – STUDY TREATMENTS"
] |
NCT01756833 | 6.1 | INTRODUCTION | 6.1 INTRODUCTION For patients enrolled in N-TA3CT dosage will be fixed at one capsule p.o., b.i.d. (either 100 mg doxycycline or placebo). Capsules should be taken in the morning (e.g., after brushing teeth, with morning coffee) and in the evening (e.g., after dinner). These capsules will be provided to the study patie... | [] |
NCT01756833 | 6.2 | TREATMENT PREPARATION | 6.2 TREATMENT PREPARATION Doxycycline 100 mg capsules will be over-encapsulated at Catalent. Placebo (Starch 1500) will be packed in identically appearing, over-encapsulated capsules. The capsules will all be the same size, and will contain a white powder. The Treatments Distribution Center will count out a three-month... | [] |
NCT01756833 | 6.3 | BLINDING | 6.3 BLINDING In the Clinical Sites, Clinical Coordinating Center, Imaging Core Laboratory and Biomarkers Core Laboratory, the patients, directors (i.e., Clinical Site lead investigator), coordinators, and other study staff will be blinded to treatment assignments. Staff of the Treatments Distribution Center and Data Co... | [] |
NCT01756833 | 6.4 | EMERGENCY UNBLINDING | 6.4 EMERGENCY UNBLINDING Every patient will be given an identification card describing his participation in the study, listing emergency study telephone numbers (e.g., the Clinical Coordinating Center telephone number, Treatments Distribution Center telephone number, the Clinical Site director's telephone number, and t... | [] |
NCT01756833 | 6.5 | TREATMENT INTERRUPTIONS | 6.5 TREATMENT INTERRUPTIONS There may be instances of treatment interruption either related to medical conditions (e.g., acute, intercurrent illnesses such as an infection when it may be advisable to interrupt study therapy without unblinding) or for other reasons (e.g., study treatments lost in a robbery). Nonemergent... | [] |
NCT01756833 | 6.6 | ASSESSMENT OF COMPLIANCE | 6.6 ASSESSMENT OF COMPLIANCE At approximate six-month intervals each patient's plasma samples will be assayed for doxycycline at the Biomarkers Core Laboratory. Capsule counts will be done at each regular follow-up visit. If capsule counts are not consistent with regular compliance, Clinical Site staff will discuss the... | [] |
NCT01756833 | 6.7 | MISSED VISITS AND DROP OUTS | 6.7 MISSED VISITS AND DROP OUTS Each regularly scheduled clinic visit missed by a patient will be reported to the Data Coordinating Center. Patients who do not wish to continue attending clinic visits in N-TA3CT will continue to be followed as much as possible for CT scan evaluations, identifiable events and vital stat... | [] |
NCT01756833 | 6.8 | DURATION OF STUDY TREATMENT | 6.8 DURATION OF STUDY TREATMENT The goal of the study will be to maintain all patients on protocol for two years.
CHAPTER 7 – CONCOMITANT CARE | [
"CHAPTER 7 – CONCOMITANT CARE"
] |
NCT01756833 | 7.1 | INTRODUCTION | 7.1 INTRODUCTION Except for study treatments and CT scan monitoring, care of study patients will be determined by their personal (referring) physicians. Personal physicians will be blind to study treatment and will be advised to select concomitant care to be appropriate whether the patient is receiving doxycycline or p... | [] |
NCT01756833 | 7.2 | HOSPITAL ADMISSIONS | 7.2 HOSPITAL ADMISSIONS During hospital admissions for any cause, the patient's care must be directed to address the patient's main, acute medical condition. If a patient is admitted to a hospital, study drug is to be continued if possible. If a patient forgets to bring medication with him when admitted, a family membe... | [] |
NCT01756833 | 7.3 | BLOOD PRESSURE AND LIPID CONTROL | 7.3 BLOOD PRESSURE AND LIPID CONTROL | [] |
NCT01756833 | 7.3.1 | Anti-Hypertensives | 7.3.1 Anti-Hypertensives At the time or randomization, N-TA3CT patients must have normal blood pressure or be undertaking reasonable treatment for Stage I hypertension (e.g., on one or more appropriate antihypertensive agents with BP ≤ 160/100 mm Hg). Because of the prevalence of high blood pressure among patients who ... | [] |
NCT01756833 | 7.3.2 | HMG-CoA Reductase Inhibitors ("Statins") and Other Lipid Lowering Agents | 7.3.2 HMG-CoA Reductase Inhibitors ("Statins") and Other Lipid Lowering Agents The American Heart Association and American College of Cardiology recommend that abdominal aortic aneurysm be considered equivalent to atherosclerotic cardiovascular disease (ASCVD) based upon historical studies showing that cardiac mortalit... | [] |
NCT01756833 | 7.4 | TREATMENTS WHICH MAY INTERACT WITH DOXYCYCLINE | 7.4 TREATMENTS WHICH MAY INTERACT WITH DOXYCYCLINE | [] |
NCT01756833 | 7.4.1 | Anti-Infectives | 7.4.1 Anti-Infectives Personal physicians will be encouraged to select anti-infectives, should they become necessary for patient management (e.g., to treat an intervening pneumonia or urinary tract infection) as if the patient had been taking doxycycline – i.e., to select bacteriocidal nontetracycline antibiotics as mu... | [] |
NCT01756833 | 7.4.2 | Wafarin | 7.4.2 Wafarin Personal physicians will be advised that if they plan to initiate warfarin therapy for study patients there is a possibility that the study treatment (which is being maintained at a fixed dose) may influence the dose of warfarin used to achieve desired international normalized ratios (INRs). Thus, INR lev... | [] |
NCT01756833 | 7.5 | SMOKING AND OTHER TOBACCO USE CESSATION | 7.5 SMOKING AND OTHER TOBACCO USE CESSATION Clinical Site directors will advise study patients' physicians that avoidance of tobacco use is an important part of management of abdominal aortic aneurysms and encourage the personal physicians' efforts to achieve smoking and other tobacco use cessation in their patients. | [] |
NCT01756833 | 7.6 | SURGERY | 7.6 SURGERY | [] |
NCT01756833 | 7.6.1 | Introduction | 7.6.1 Introduction With the exception of retroperitoneal procedures in the central body area, there are no study-specific recommendations concerning the performance of surgery. | [] |
NCT01756833 | 7.6.2 | Retroperitoneal Surgery | 7.6.2 Retroperitoneal Surgery Because of the potential risk of aneurysm rupture consequent to retroperitoneal surgical procedures, the attending vascular interventionalist may elect to repair the aneurysm before retroperitoneal surgery using an endograft or at the time of the retroperitoneal procedure.
CHAPTER 8 – FOL... | [
"CHAPTER 8 – FOLLOW-UP PROCEDURES"
] |
NCT01756833 | 8.1 | INTRODUCTION | 8.1 INTRODUCTION Patients will be scheduled for follow-up visits every three months. At the time of each scheduled visit, a medical review is conducted including ascertainment of clinical outcomes, study treatment compliance and adverse effects. At semi-annual follow-up visits, outcome CT scans will be collected, speci... | [] |
NCT01756833 | 8.2 | FOLLOW-UP VISITS | 8.2 FOLLOW-UP VISITS At the three-month follow-up visits, a medical review will be conducted including ascertainment of possible adverse effects, current therapies, and collection of the previous study medication and capsule count. The prescribed study medication for the following three months is dispensed. In addition... | [
"Telephone Follow-up Visits",
"Completion of Case Report Forms:"
] |
NCT01756833 | 8.2.1 | CT Scan Acquisition at Enrollment and Follow-up | 8.2.1 CT Scan Acquisition at Enrollment and Follow-up The standardized acquisition protocol for computed tomography (CT) examination of the abdominal aorta and iliac arteries in N-TA3CT is as follows for multidetector, helical CT: - 1) Narrow Field-of-View centered on aorta, < 36 cm encouraged. - 2) Tube current and en... | [] |
NCT01756833 | 8.2.2 | Biomarker Blood Specimen Collection at Enrollment and Follow-up | 8.2.2 Biomarker Blood Specimen Collection at Enrollment and Follow-up Clinical sites must develop a brief but specific plan for the procurement, initial processing and temporary storage of peripheral blood samples from all enrolled patients during the study. Each site will ship specimens to the Biomarkers Core Laborato... | [] |
NCT01756833 | 8.2.3 | Ascertainment of Adverse Events | 8.2.3 Ascertainment of Adverse Events All medical contacts indicating possible serious or unexpected adverse events (SAEs), whether treated on an out-patient or in-patient basis, will be reviewed by the Management Committee. These SAEs will be classified by an independent committee of vascular surgeons who are in insti... | [] |
NCT01756833 | 8.3 | PATIENT MANAGEMENT DURING MEDICAL CONTACTS | 8.3 PATIENT MANAGEMENT DURING MEDICAL CONTACTS Each patient will be given an identification card to be carried at all times and to be presented at any medical contact, stating that he/she is enrolled in the N-TA3CT, that his/her medication must be continued if at all possible, that endograft devices etc. should be depl... | [] |
NCT01756833 | 8.4 | SECONDARY ASSESSMENTS | 8.4 SECONDARY ASSESSMENTS | [] |
NCT01756833 | 8.4.1 | Psychosocial Evaluation | 8.4.1 Psychosocial Evaluation Data from the Medical Outcomes Study Form SF-36 will be used in secondary analyses. Questionnaires will be administered prior to enrollment and every six months during the study and at the close-out visit. | [] |
NCT01756833 | 8.5 | RETENTION | 8.5 RETENTION Maintaining participation post-randomization is especially relevant in studies with older adults who may be lost to follow-up due to changes in living situation, acute illness, cognitive changes, or death. At the time of enrollment, the participant will be asked to provide contact information (names, addr... | [] |
NCT01756833 | 8.5.1 | Retention Promotion Efforts | 8.5.1 Retention Promotion Efforts At the time of randomization, participants will receive clear, easy-to-follow, written instructions about the schedule of follow-up assessments. Reviewing these instructions with the participant prior to departure will be a priority. If demonstrated compliance problems exist, study sta... | [] |
NCT01756833 | 8.5.2 | Monitoring Recruitment and Retention | 8.5.2 Monitoring Recruitment and Retention Retention will be monitored through completion rates of follow-up assessment visits. Regular reports will be available to clinical sites and the Clinical Coordinating Center. Members of the Clinical Coordinating Center maintain regular phone contact with clinic staff to review... | [] |
NCT01756833 | 8.6 | FINAL FOLLOW-UP ASSESSMENT AND CLOSE-OUT | 8.6 FINAL FOLLOW-UP ASSESSMENT AND CLOSE-OUT Patients who complete a two-year follow-up visit after March 29, 2016, and before May 1, 2018, will discontinue study medication at that time. For patients who have completed at least 24 months of therapy and had a two-year follow-up visit before the time of approval of Prot... | [
"CHAPTER 9 – STUDY END POINTS"
] |
NCT01756833 | 9.1 | INTRODUCTION | 9.1 INTRODUCTION The primary objective of the Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA3CT) is to determine the safety and efficacy of doxycycline (100 mg p.o. b.i.d.) in the prevention of growth of small abdominal aortic aneurysms. The primary analysis in this study will compare the chan... | [] |
NCT01756833 | 9.2 | PRIMARY END POINT | 9.2 PRIMARY END POINT For the purpose of defining the primary study outcome, the size of the abdominal aortic aneurysm will be defined as the maximum transverse diameter (adventitia to adventitia) measured on a quantitative CT-scan in the orthogonal plane. The measurements to be used in the primary end point assessment... | [] |
NCT01756833 | 9.3 | STATISTICAL ANALYSIS OF THE PRIMARY END POINT | 9.3 STATISTICAL ANALYSIS OF THE PRIMARY END POINT An attempt will be made to measure for each patient the maximum transverse diameter of the patient's abdominal aortic aneurysm two years after random treatment assignment. It is anticipated that during two years of follow-up a small percentage of the patients may die or... | [] |
NCT01756833 | 9.4 | SECONDARY AND INTERMEDIATE OUTCOMES | 9.4 SECONDARY AND INTERMEDIATE OUTCOMES Secondary and intermediate outcomes will include a variety of clinical findings and quality of life assessments, Biomarker Core Laboratory findings and Imaging Core Laboratory findings. | [] |
NCT01756833 | 9.4.1 | Clinical Secondary and Intermediate Outcomes | 9.4.1 Clinical Secondary and Intermediate Outcomes The clinical components of the primary outcome, death, open repair and closed repairs will be ascertained and compared between the treatment groups. Other clinical outcomes that will be compared between the treatment groups will include myocardial infarction, cerebrova... | [] |
NCT01756833 | 9.4.2 | Biomarker Secondary and Intermediate Outcomes | 9.4.2 Biomarker Secondary and Intermediate Outcomes Blood specimens collected for analysis in the Biomarker Core Laboratory will be used to assess circulating levels of MMP-9, IFN- and high sensitivity (hs) C-reactive protein (CRP) with comparisons between the treatment groups and according to baseline characteristics ... | [] |
NCT01756833 | 9.4.3 | CT-Scan Secondary and Intermediate Outcomes | 9.4.3 CT-Scan Secondary and Intermediate Outcomes CT Scans collected every six months will be analyzed in the Imaging Core Laboratory to make comparisons between the treatment groups of characteristics of abdominal aortic aneurysm dimensions assessed after randomization, other than the primary outcome, with adjustment ... | [
"CHAPTER 10 – DATA MANAGEMENT"
] |
NCT01756833 | 10.1 | INTRODUCTION | 10.1 INTRODUCTION N-TA3CT data management occurs in two phases – pre-randomization and postrandomization. The purpose of data management procedures is to establish in as timely a manner as feasible (as close to "real time" as practical) the set of information necessary to assess the status of every patient with regard ... | [] |
NCT01756833 | 10.2 | FORM DATA | 10.2 FORM DATA The form data will include information collected pre-randomization to establish patient eligibility, assign a study treatment and assign a numeric identification (PID) and alphabetic (Letcode) that will be used to track the patient's study treatments, follow-up visits, clinical data, CT Scans and blood s... | [] |
NCT01756833 | 10.3 | CT SCANS | 10.3 CT SCANS As described in Chapter 8, clinical site staff will transmit CT scans in DICOM format on CD's to the Imaging Core Laboratory. Imaging Core Laboratory staff will assess the abdominal aortic aneurysm measurements in duplicate (one reader, two readings) and create a database of each patient's CT scan measure... | [] |
NCT01756833 | 10.4 | BIOMARKER SPECIMENS | 10.4 BIOMARKER SPECIMENS As described in Chapter 8, clinical site staff will ship frozen blood, plasma and serum specimens to the Biomarkers Core Laboratory. Biomarkers Core Laboratory staff will inventory specimens according to unique label numbers on each vial received. The vials will be numbered uniquely with freeze... | [] |
NCT01756833 | 10.5 | QUALITY CONTROL | 10.5 QUALITY CONTROL The quality of the proposed trial is dependent upon 1) achieving the projected recruitment and randomization rates, 2) the complete and accurate collection of data, and 3) adherence to the protocol. The investigators recognize that effective quality control procedures are of particular importance i... | [] |
NCT01756833 | 10.5.1 | Training of Study Personnel | 10.5.1 Training of Study Personnel The Clinical Site directors and Coordinators are certified in procedures of key importance to the study prior to initiation of recruitment. Initial training for certification is at the first of the annual collaborator's meetings and on site initiation visits. The initial one-day coord... | [] |
NCT01756833 | 10.6.2 | Recruitment and Randomization Rates | 10.6.2 Recruitment and Randomization Rates The DCC will carefully monitor recruitment, minority representation, and randomization rates, and reports will be prepared and distributed weekly for N-TA3CT leadership (Management Committee) conference calls and will be sent in monthly reports to each site. If recruitment is ... | [] |
NCT01756833 | 10.6.3 | Response to Protocol Violations | 10.6.3 Response to Protocol Violations Major protocol violations are those that undermine the fundamental premise of the study (such as failure to administer the assigned treatment) or jeopardize patient safety (such as inappropriate administration of contrast in CT scan performance). The initial response to a major pr... | [] |
NCT01756833 | 10.6.4 | Response to Lapses in Clinical Site Performance | 10.6.4 Response to Lapses in Clinical Site Performance Lapses in Clinical Site performance include the failure to obtain the required CT scans or blood specimens as outlined in the protocol, failure to complete and submit the required forms, and failure to adhere to the assigned treatment. Both the DCC data editing pro... | [
"CHAPTER 11 – DATA ANALYSIS"
] |
NCT01756833 | 11.1 | INTRODUCTION | 11.1 INTRODUCTION The primary analysis will be a linear regression analysis (analysis of covariance -- ANCOVA) to test the hypothesis of no difference in the mean change from baseline in abdominal aortic aneurysm maximum transverse diameter at two years after randomization, allowing for maximum transverse diameter at t... | [] |
NCT01756833 | 11.2 | INTERIM MONITORING | 11.2 INTERIM MONITORING A Data and Safety Monitoring Board (DSMB) will review the accumulating data for early, convincing evidence of benefit or harm. We anticipate DSMB reports at approximately six-month intervals over the period of patient recruitment and follow-up, at least five interim reports followed by a final a... | [] |
NCT01756833 | 11.3 | PRIMARY ANALYSIS | 11.3 PRIMARY ANALYSIS A variety of analytic methods will be used for primary, secondary and other analyses (Table 1). The primary study outcome will be the change from baseline of abdominal aortic aneurysm maximum transverse diameter measured two years from randomization. This outcome will be compared according to assi... | [] |
NCT01756833 | 11.4 | SUBGROUP ANALYSES OTHER SECONDARY OUTCOMES AND ANALYSES | 11.4 SUBGROUP ANALYSES OTHER SECONDARY OUTCOMES AND ANALYSES Linear regression models will be used to explore age, statin use status (user versus nonuser), race/minority status and other factors for effects on growth of abdominal aortic aneurysms. Secondary analyses will be conducted to assess the effect of doxycycline... | [] |
NCT01756833 | 11.5 | STATISTICAL POWER | 11.5 STATISTICAL POWER In this section we consider sample size and power in two stages. First we determine the sample size required for 90% power to find a significant difference between doxycycline and placebo with respect to the change in abdominal aorta diameter from baseline to two years after randomization, at a o... | [
"Statistical Power of a Two Group Comparison at Two-Year Follow-Up",
"CHAPTER 12 – STUDY ORGANIZATION"
] |
NCT01756833 | 12.1 | PARTICIPATING UNITS | 12.1 PARTICIPATING UNITS The participating units in N-TA3CT integrate with the N-TA3CT administrative structure to form the study organization (See Exhibits 12-1 and 12-2). | [] |
NCT01756833 | 12.1.1 | Clinical Site | 12.1.1 Clinical Site At each collaborating hospital, a Clinical Site director and Clinical Site coordinator will be identified. These two people will work closely together to assure successful performance of the trial. Clinical Sites are expected to enroll an average of just over 16 patients each (16 Clinical Sites x 1... | [] |
NCT01756833 | 12.1.1.1 | Clinical Site Director | 12.1.1.1 Clinical Site Director The responsibilities of the Clinical Site director include: 1) To insure that all vascular surgery staff involved with the care of abdominal aortic aneurysm patients are well informed about the trial; 2) To insure that all patients with abdominal aortic aneurysm are routinely considered ... | [] |
NCT01756833 | 12.1.1.2 | Clinical Site Coordinator | 12.1.1.2 Clinical Site Coordinator The responsibilities of the Clinical Site Coordinator include: 1) To identify all abdominal aortic aneurysm patients for the trial; 2) To obtain informed consent from the patient if not obtained by the Clinical Site lead investigator or other investigators, fellow or resident; 3) To e... | [] |
NCT01756833 | 12.1.2 | Clinical Coordinating Center | 12.1.2 Clinical Coordinating Center The University of Nebraska Medical Center, Division of Vascular Surgery will be responsible for clinical coordination of the trial. The responsibilities of the Clinical Coordinating Center are to: 1) Provide administrative and fiscal support for the Clinical Sites; 2) Provide technic... | [] |
NCT01756833 | 12.1.3 | Data Coordinating Center | 12.1.3 Data Coordinating Center The Department of Epidemiology and Preventive Medicine, University of Maryland School of Maryland, Baltimore, Maryland, will be responsible for data coordination of the trial. The responsibilities of the Data Coordinating Center are to: 1) Provide all study materials to centers; 2) Provi... | [] |
NCT01756833 | 12.1.4 | Imaging Core Laboratory | 12.1.4 Imaging Core Laboratory The Imaging Core Laboratory will be responsible for the standardized, quantitative and qualitative assessments of CT scans in N-TA3CT. Using labels provided by the DCC and Clinical Site programming to delete identifiers in the electronic file to obscure patient identification, Clinical Si... | [] |
NCT01756833 | 12.1.5 | Biomarkers Core Laboratory | 12.1.5 Biomarkers Core Laboratory The Biomarkers Core Laboratory will be responsible for measurement of doxycycline levels, high sensitivity C-reactive protein levels and MMP-9 activity as well as preservation of specimens for future research. Specimens will be processed every 6 months and results will be forwarded to ... | [] |
NCT01756833 | 12.1.6 | Study Chairman | 12.1.6 Study Chairman Study Chairman responsibilities will include: 1) To provide overall organization of the trial; 2) To serve as Chair, Steering Committee; 3) To administer the Treatments Distribution Center; 4) To work with the Clinical Sites and Data Coordinating Center to maximize collaboration and to arrange stu... | [] |
NCT01756833 | 12.2 | ADMINISTRATIVE STRUCTURE | 12.2 ADMINISTRATIVE STRUCTURE | [] |
NCT01756833 | 12.2.1 | Steering Committee | 12.2.1 Steering Committee A Steering Committee will be responsible for overseeing the study. This committee will make major organizational and policy decisions. The committee will include the Study Chairman, Core Laboratory Directors, representatives of the Clinical Coordinating Center and the Data Coordinating Center,... | [] |
NCT01756833 | 12.2.2 | Management Committee | 12.2.2 Management Committee A smaller committee involved with the day to day running of the study will have conference calls every two weeks to discuss the progress of the trial (including recruitment and protocol violations). This group will be composed of the Study Chairman, Director of the Data Coordinating Center a... | [] |
NCT01756833 | 12.2.3 | Publications and Ancillary Studies Committee | 12.2.3 Publications and Ancillary Studies Committee A Publications and Ancillary Studies Committee will be formed from the study leadership (Data Coordinating Center, Imaging Core Laboratory, Biomarkers Core Laboratory, and Clinical Coordinating Center) and leading Clinical Site directors. This committee will review al... | [] |
NCT01756833 | 12.2.4 | Data and Safety Monitoring Board | 12.2.4 Data and Safety Monitoring Board Members of the Data Safety and Monitoring Board (DSMB) will be appointed by and report to the National Institute on Aging (NIA) director. They will monitor accruing data in order to confirm that the patients in the trial are being cared for safely. The DSMB will be responsible fo... | [] |
NCT01756833 | 12.2.5 | Role of DCC Staff | 12.2.5 Role of DCC Staff At least one DCC staff member will be assigned to each study committee and subcommittee to participate in all meetings and conference calls. The DCC director will serve as Executive Secretary of the Steering Committee; Management Committee; Publications and Ancillary Studies Committee; Event Cl... | [] |
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