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protocol_id stringclasses 263 values	section_number stringlengths 1 12	title stringlengths 1 1.88k	content stringlengths 0 866k	merged_titles listlengths 0 491
NCT03784898	8.1	INVESTIGATIONAL MEDICINAL PRODUCT	8.1 INVESTIGATIONAL MEDICINAL PRODUCT No IMP will be administered to patients.	[]
NCT03784898	8.2	OTHER PRODUCTS	8.2 OTHER PRODUCTS Not applicable.	[]
NCT03784898	8.3	PACKAGING AND LABELING	8.3 PACKAGING AND LABELING Not applicable.	[]
NCT03784898	8.4	STORAGE CONDITIONS AND SHELF LIFE	8.4 STORAGE CONDITIONS AND SHELF LIFE Not applicable.	[]
NCT03784898	8.5	RESPONSIBILITIES	8.5 RESPONSIBILITIES Not applicable.	[]
NCT03784898	8.6	CONCOMITANT MEDICATION	8.6 CONCOMITANT MEDICATION Not applicable.	[]
NCT03784898	8.7	TREATMENT ACCOUNTABILITY AND COMPLIANCE	8.7 TREATMENT ACCOUNTABILITY AND COMPLIANCE Not applicable.	[]
NCT03784898	9	ASSESSMENTS	9 ASSESSMENTS	[]
NCT03784898	9.1	SAFETY	9.1 SAFETY	[]
NCT03784898	9.1.1	Baseline demographic characteristics	9.1.1 Baseline demographic characteristics Baseline demographic characteristics will consist of: - Age (years) - Date of birth - Gender - Race/ethnicity: Subject race (African/American, Caucasian, Asian, Other) and ethnicity ("Hispanic" or "Not Hispanic") will be collected in this study because analysis of results acco...	[]
NCT03784898	9.1.2	History of clinical and pathological characteristics	9.1.2 History of clinical and pathological characteristics History of clinical and pathological characteristics, if available from the prescriber, patient, and/or medical records, will consist of: - Time since MS symptom onset/MS diagnosis - Previous MS therapies - Prior history of ITP/coagulation disorders, thyroid or...	[]
NCT03784898	9.1.3	Safety assessment	9.1.3 Safety assessment Adverse events (AEs) and serious adverse events (SAEs) related to study procedures will be recorded spanning from the signature of the ICF until the end of the study. As there is no investigational product administration, assessment of the relationship of AEs or SAEs to procedures (ie, blood sam...	[]
NCT03784898	9.2	PHARMACOGENETICS	9.2 PHARMACOGENETICS	[]
NCT03784898	9.2.1	Pharmacogenetic assessment	9.2.1 Pharmacogenetic assessment Samples will be processed for DNA isolation. These blood samples will be transferred to a site that will, on behalf of Sanofi, extract DNA. Material extracted will remain labelled with the same identifiers used during the study (ie, patient ID, sample ID). They will be transferred to a ...	[]
NCT03784898	9.2.2	Sampling times	9.2.2 Sampling times A blood draw will be collected at the study visit(s) for DNA extraction and sample storage as specified in the study flow chart [$Section](#page-6-4) [1$](#page-6-4). Blood will be collected preferably late in the day to comply with sample management requirement – overnight shipment of the sample...	[]
NCT03784898	9.2.3	Number of samples	9.2.3 Number of samples The number of sample per patient is indicated in [Table](#page-20-2) 1.	[]
NCT03784898	9.2.4	Sample handling procedure	9.2.4 Sample handling procedure Special procedures for collection, shipment, processing and storage of samples will be provided in the laboratory manual. Property of the Sanofi Group - strictly confidential Page 20	[]
NCT03784898	9.2.5	Sampled blood volume	9.2.5 Sampled blood volume A total of 69 ml of whole blood will be collected as shown in [Table](#page-20-2) 1 and under the priority rank indicated. At the discretion of the medical team, for some patients the collection of 69 ml at one single draw may be inappropriate. In such cases, either additional draws may be pe...	[]
NCT03784898	9.2.6	Future use of samples	9.2.6 Future use of samples The DNA samples will be stored for up to 15 years from the completion of the clinical study report in the US. A part of this DNA will be used for sequencing analysis. The DNA samples that will be unused or left over after testing may be used for additional research purposes related to better...	[]
NCT03784898	9.2.7	Sample destruction	9.2.7 Sample destruction If a patient, via written request, asks for destruction of his/her samples, the Sponsor will destroy the samples per applicable guidelines; however, any data already generated will not be destroyed. The Sponsor will notify the Investigator in writing that the samples have been destroyed. Howeve...	[]
NCT03784898	10	SUBJECT SAFETY	10 SUBJECT SAFETY The Investigator is the primary person responsible for making all clinically relevant decisions on safety issues.	[]
NCT03784898	10.1	ADVERSE EVENT MONITORING	10.1 ADVERSE EVENT MONITORING All events will be managed and reported in compliance with all applicable regulations, and included in the final clinical study report.	[]
NCT03784898	10.2	DEFINITIONS OF ADVERSE EVENTS	10.2 DEFINITIONS OF ADVERSE EVENTS	[]
NCT03784898	10.2.1	Adverse event	10.2.1 Adverse event An adverse event (AE) is any untoward medical occurrence in a subject which does not necessarily have to have a causal relationship with this treatment. Adverse events and SAEs related to study procedures will be recorded spanning from the signature of the ICF until the end of the study. As there i...	[]
NCT03784898	10.2.2	Serious adverse event	10.2.2 Serious adverse event A serious adverse event (SAE) is any untoward medical occurrence that at any dose: - Results in death, or - Is life-threatening, or Note: The term "life-threatening" in the definition of "serious" refers to an event in which the subject was at risk of death at the time of the event; it does...	[]
NCT03784898	10.3	OBLIGATION OF THE INVESTIGATOR REGARDING SAFETY REPORTING	10.3 OBLIGATION OF THE INVESTIGATOR REGARDING SAFETY REPORTING	[]
NCT03784898	10.3.1	General guidelines for reporting adverse events	10.3.1 General guidelines for reporting adverse events All AEs related to study procedures, regardless of seriousness, spanning from the signature of the ICF until the end of the study as defined by the protocol, are to be recorded on the corresponding page(s) or screen(s) of the case report form (CRF) for included sub...	[]
NCT03784898	10.3.2	Guidelines for reporting serious adverse events	10.3.2 Guidelines for reporting serious adverse events In the case of a SAE, the Investigator must immediately: - SEND (within 24 hours, preferably by fax or e-mail) the signed and dated corresponding page(s) in the CRF to the representative of the monitoring team whose name, fax number, and e-mail address appear on th...	[]
NCT03784898	10.4	OBLIGATIONS OF THE SPONSOR	10.4 OBLIGATIONS OF THE SPONSOR The Sponsor will report all safety observations made during the conduct of the trial in the clinical study report.	[]
NCT03784898	11	HANDLING OF PATIENT WITHDRAWAL	11 HANDLING OF PATIENT WITHDRAWAL	[]
NCT03784898	11.1	LIST OF TREATMENT WITHDRAWAL CRITERIA	11.1 LIST OF TREATMENT WITHDRAWAL CRITERIA Not applicable.	[]
NCT03784898	11.2	REASONS FOR STUDY WITHDRAWAL	11.2 REASONS FOR STUDY WITHDRAWAL - The patient may withdraw from the study if they decide to do so, at any time and irrespective of the reason, or upon the Investigator's decision or at the specific request of the Sponsor. - In case of withdrawal, the patient should withdraw consent in writing and, if the patient refu...	[]
NCT03784898	11.3	WITHDRAWAL FOLLOW-UP PROCEDURE	11.3 WITHDRAWAL FOLLOW-UP PROCEDURE All study withdrawals should be recorded by the Investigator on the appropriate CRF pages or screens for electronic CRF (eCRF) when considered as confirmed. Patients withdrawn from the study must not be reincluded in the study. Their Subject ID numbers must not be reused.	[]
NCT03784898	12	STUDY PROCEDURES	12 STUDY PROCEDURES	[]
NCT03784898	12.1	VISIT SCHEDULE	12.1 VISIT SCHEDULE	[]
NCT03784898	12.1.1	Screening procedures	12.1.1 Screening procedures The screening and visit(s) can be performed the same day or on separate days with a maximum timeframe of 30 days apart. The patient will receive information on the study objective(s) and procedures from the Investigator. The patient must sign the informed consent prior to any action related ...	[]
NCT03784898	12.1.2	Description of the inclusion visit	12.1.2 Description of the inclusion visit The visit will be performed either at the study center or at the patient's home if he/she cannot reach the study center. The visit will occur late in the day to comply with sample management requirements. Prior to any assessments an informed consent signed by the patients must ...	[]
NCT03784898	12.2	DEFINITION OF SOURCE DATA	12.2 DEFINITION OF SOURCE DATA All evaluations that are reported in the CRF must be supported by appropriately identified source documentation.	[]
NCT03784898	13	STATISTICAL CONSIDERATIONS	13 STATISTICAL CONSIDERATIONS For the current study, data from patients with ITP only will be collected. Statistical data processing and quality control steps will be performed. Descriptive statistics and sensitivity analysis will be provided. The formal statistical analysis to find predictive biomarkers for ITP events...	[]
NCT03784898	13.1	DETERMINATION OF SAMPLE SIZE	13.1 DETERMINATION OF SAMPLE SIZE Sample size for this study was based upon empirical considerations. No sample size calculation was performed.	[]
NCT03784898	13.2	SUBJECT DESCRIPTION	13.2 SUBJECT DESCRIPTION Not applicable.	[]
NCT03784898	13.3	ANALYSIS POPULATION	13.3 ANALYSIS POPULATION The safety population will consist of all patients included into the study.	[]
NCT03784898	13.4	DEMOGRAPHIC AND BASELINE CHARACTERISTICS	13.4 DEMOGRAPHIC AND BASELINE CHARACTERISTICS Continuous variables (age) and qualitative variables (gender, race/ethnicity) will be summarized by descriptive statistics for the safety population.	[]
NCT03784898	13.5	EXTENT OF STUDY TREATMENT EXPOSURE AND COMPLIANCE	13.5 EXTENT OF STUDY TREATMENT EXPOSURE AND COMPLIANCE Not applicable.	[]
NCT03784898	13.6	PRIOR/CONCOMITANT MEDICATION/THERAPY	13.6 PRIOR/CONCOMITANT MEDICATION/THERAPY Not applicable.	[]
NCT03784898	13.7	ANALYSIS OF PHARMACOGENETIC VARIABLES	13.7 ANALYSIS OF PHARMACOGENETIC VARIABLES The statistical analysis of pharmacogenetics variables will be part of a global biomarker program and is not in the scope of this study.	[]
NCT03784898	13.8	ANALYSIS OF SAFETY DATA	13.8 ANALYSIS OF SAFETY DATA The safety evaluation will be based on the review of individual values and descriptive statistics of AEs related to study procedures during the study visit.	[]
NCT03784898	13.9	ANALYSIS OF PHARMACOKINETIC DATA	13.9 ANALYSIS OF PHARMACOKINETIC DATA Not applicable.	[]
NCT03784898	13.10	PHARMACOKINETIC/PHARMACODYNAMIC ANALYSIS	13.10 PHARMACOKINETIC/PHARMACODYNAMIC ANALYSIS Not applicable.	[]
NCT03784898	13.11	INTERIM ANALYSIS	13.11 INTERIM ANALYSIS No interim analysis is planned.	[]
NCT03784898	14	ETHICAL AND REGULATORY CONSIDERATIONS	14 ETHICAL AND REGULATORY CONSIDERATIONS	[]
NCT03784898	14.1	ETHICAL AND REGULATORY STANDARDS	14.1 ETHICAL AND REGULATORY STANDARDS This clinical trial will be conducted by the Sponsor, the Investigator, delegated Investigator staff and Subinvestigator, in accordance with consensus ethics principles derived from international ethics guidelines, including the Declaration of Helsinki, and the ICH guidelines for G...	[]
NCT03784898	14.2	INFORMED CONSENT	14.2 INFORMED CONSENT The Investigator (according to applicable regulatory requirements), or a person designated by the Investigator and under the Investigator's responsibility, should fully inform the patient of all pertinent aspects of the clinical trial including the written information giving approval/favorable opi...	[]
NCT03784898	14.3	HEALTH AUTHORITIES AND INSTITUTIONAL REVIEW BOARD (IRB)	14.3 HEALTH AUTHORITIES AND INSTITUTIONAL REVIEW BOARD (IRB) As required by local regulation, the Investigator or the Sponsor must submit this clinical trial protocol to the Health Authorities (Competent Regulatory Authority) and the appropriate IRB, and is required to forward to the respective other party a copy of th...	[]
NCT03784898	15	STUDY MONITORING	15 STUDY MONITORING	[]
NCT03784898	15.1	RESPONSIBILITIES OF THE INVESTIGATOR(S)	15.1 RESPONSIBILITIES OF THE INVESTIGATOR(S) The Investigator is required to ensure compliance with all procedures required by the clinical trial protocol and with all study procedures provided by the Sponsor (including security rules). The Investigator agrees to provide reliable data and all information requested by t...	[]
NCT03784898	15.2	RESPONSIBILITIES OF THE SPONSOR	15.2 RESPONSIBILITIES OF THE SPONSOR The Sponsor of this clinical trial is responsible to regulatory authorities for taking all reasonable steps to ensure the proper conduct of the clinical trial as regards ethics, clinical trial protocol compliance, and integrity and validity of the data recorded on the CRFs. Thus, th...	[]
NCT03784898	15.3	SOURCE DOCUMENT REQUIREMENTS	15.3 SOURCE DOCUMENT REQUIREMENTS According to the ICH GCP, the monitoring team must check the CRF entries against the source documents, except for the preidentified source data directly recorded in the CRF. The ICF will include a statement by which the patient allows the Sponsor's duly authorized personnel, the IRB, a...	[]
NCT03784898	15.4	USE AND COMPLETION OF CASE REPORT FORMS (CRFS) AND ADDITIONAL REQUEST	15.4 USE AND COMPLETION OF CASE REPORT FORMS (CRFS) AND ADDITIONAL REQUEST It is the responsibility of the Investigator to maintain adequate and accurate CRFs (according to the technology used) designed by the Sponsor to record (according to Sponsor instructions) all observations and other data pertinent to the clinica...	[]
NCT03784898	15.5	USE OF COMPUTERIZED SYSTEMS	15.5 USE OF COMPUTERIZED SYSTEMS The complete list of computerized systems used for the study is provided in a separate document which is maintained in the Sponsor and Investigator study files.	[]
NCT03784898	16	ADDITIONAL REQUIREMENTS	16 ADDITIONAL REQUIREMENTS	[]
NCT03784898	16.1	CURRICULUM VITAE	16.1 CURRICULUM VITAE A current copy of the curriculum vitae describing the experience, qualification and training of each Investigator and Subinvestigator will be signed, dated and provided to the Sponsor prior to the beginning of the clinical trial.	[]
NCT03784898	16.2	RECORD RETENTION IN STUDY SITE(S)	16.2 RECORD RETENTION IN STUDY SITE(S) The Investigator must maintain confidential all study documentation, and take measures to prevent accidental or premature destruction of these documents. The Investigator should retain the study documents at least 15 years after the completion or discontinuation of the clinical tr...	[]
NCT03784898	16.3	CONFIDENTIALITY	16.3 CONFIDENTIALITY All information disclosed or provided by the Sponsor (or any company/institution acting on their behalf), or produced during the clinical trial, including, but not limited to, the clinical trial protocol, personal data in relation to the patients, the CRFs, the Investigator's Brochure, and the resu...	[]
NCT03784898	16.4	PROPERTY RIGHTS	16.4 PROPERTY RIGHTS All information and documents provided by the Sponsor or its designee are and remain the sole property of the Sponsor. The Investigator shall not and shall cause the delegated Investigator staff /Subinvestigator not to mention any information or the Product in any application for a patent or for an...	[]
NCT03784898	16.5	DATA PROTECTION	16.5 DATA PROTECTION - The patient's personal data, which are included in the Sponsor database, shall be treated in compliance with all applicable laws and regulations. - When archiving or processing personal data pertaining to the Investigator and/or to the patients, the Sponsor shall take all appropriate measures to ...	[]
NCT03784898	16.6	INSURANCE COMPENSATION	16.6 INSURANCE COMPENSATION The Sponsor certifies that it has taken out a liability insurance policy covering all clinical trials under its sponsorship. This insurance policy is in accordance with local laws and requirements. The insurance of the Sponsor does not relieve the Investigator and the collaborators from any ...	[]
NCT03784898	16.7	SPONSOR AUDITS AND INSPECTIONS BY REGULATORY AGENCIES	16.7 SPONSOR AUDITS AND INSPECTIONS BY REGULATORY AGENCIES For the purpose of ensuring compliance with the clinical trial protocol, GCP, and applicable regulatory requirements, the Investigator should permit auditing by or on the behalf of the Sponsor and inspection by regulatory authorities. The Investigator agrees to...	[]
NCT03784898	16.8	PREMATURE DISCONTINUATION OF THE STUDY OR PREMATURE CLOSE-OUT OF A SITE	16.8 PREMATURE DISCONTINUATION OF THE STUDY OR PREMATURE CLOSE-OUT OF A SITE	[]
NCT03784898	16.8.1	By the Sponsor	16.8.1 By the Sponsor The Sponsor has the right to terminate the participation of either an individual site or the study at any time, for any reason, including but not limited to the following: - The information on the product leads to doubt as to the benefit/risk ratio; - Patient enrollment is unsatisfactory; - The In...	[]
NCT03784898	16.8.2	By the Investigator	16.8.2 By the Investigator The Investigator may terminate his/her participation upon 30 days' prior written notice if the study site or the Investigator for any reason becomes unable to perform or complete the clinical trial. In the event of premature discontinuation of the study or premature close-out of a site, for a...	[]
NCT03784898	16.9	CLINICAL TRIAL RESULTS	16.9 CLINICAL TRIAL RESULTS The Sponsor will be responsible for preparing a clinical study report and to provide a summary of the study results to the Investigator.	[]
NCT03784898	16.10	PUBLICATIONS AND COMMUNICATIONS	16.10 PUBLICATIONS AND COMMUNICATIONS The Investigator undertakes not to make any publication or release pertaining to the study and/or results of the study prior to the Sponsor's written consent, being understood that the Sponsor will not unreasonably withhold its approval. The Investigator shall not use the name(s) o...	[]
NCT03784898	17	CLINICAL TRIAL PROTOCOL AMENDMENTS	17 CLINICAL TRIAL PROTOCOL AMENDMENTS All appendices attached hereto and referred to herein are made part of this clinical trial protocol. The Investigator should not implement any deviation from, or changes of the clinical trial protocol without agreement by the Sponsor and prior review and documented approval/favorab...	[]
NCT03784898	18	BIBLIOGRAPHIC REFERENCES	18 BIBLIOGRAPHIC REFERENCES - 1. National Multiple Sclerosis Society. Multiple sclerosis: Just the facts [Online]. 2011 [cited 2011 Oct 27]; Available from: URL:http://www.nationalmssociety.org/about-multiplesclerosis/index.aspx - 2. Moreau T, Coles A, Wing M, Thorpe J, Miller D, Moseley I, et al. CAMPATH-IH in multipl...	[]
NCT03784898	19	APPENDICES	19 APPENDICES Not applicable. Signature Page for VV-CLIN-0539965 v1.0 asy15905-16-1-1-amended-protocol01 \| Approve & eSign \| \| \|-----------------\|--\| \| \| \| \| Approve & eSign \| \| \| \| \|	[ "Signature Page for VV-CLIN-0539965 v1.0 asy15905-16-1-1-amended-protocol01" ]
NCT03818035	1	INTRODUCTION	1. INTRODUCTION	[]
NCT03818035	1.1	Background	1.1. Background Psoriasis is a chronic inflammatory immune-mediated disease characterized by patches of inflamed skin covered with silvery-white scaly skin. Psoriasis pathogenesis involves the dysregulation of interleukin (IL)-23 mediated immune responses (Kollipara, et al. 2015). IL-23 is a key regulatory cytokine pro...	[]
NCT03818035	1.2	Overall Rationale for the Study	1.2. Overall Rationale for the Study Previous guselkumab studies suggest that after achieving a PASI 90 response some patients were still able to keep their responses for months after stopping the treatment. Several parameters including shorter disease duration, absolute PASI of 0 at week 28 and inflammatory cytokine s...	[]
NCT03818035	1.3	Benefit/Risk Assessment	1.3. Benefit/Risk Assessment A large global Phase 3 program consisting of 3 studies (CNT1959PSO3001, CNTO1959PSO3002, and CNTO1959PSO3003) has been conducted to investigate the efficacy and safety of sc guselkumab in adult patients with moderate to severe plaque psoriasis. The longer-term efficacy and safety of guselku...	[]
NCT03818035	2	OBJECTIVES, ENDPOINTS, AND HYPOTHESIS	2. OBJECTIVES, ENDPOINTS, AND HYPOTHESIS	[]
NCT03818035	2.1	Objectives and Endpoints	2.1. Objectives and Endpoints	[]
NCT03818035	2.1.1	Objectives	2.1.1. Objectives Primary objective The primary objective of the study is to demonstrate that Super-Responders (SRe; defined as psoriasis subjects who receive on-label guselkumab treatment until week 20 and respond with a Psoriasis Area and Severity Index [PASI] score=0 at weeks 20 and 28) maintain control of disease ...	[ "Primary objective", "Secondary objectives", "Exploratory objectives" ]
NCT03818035	2.1.2	Endpoints	2.1.2. Endpoints For the endpoints, the following terms were defined: - x Control of disease: PASI score 5. Study groups are defined as follows: - x 1: All participating subjects who are enrolled and are scheduled to receive guselkumab 100 mg at weeks 0, 4, q8w until week 28 (Study Part 1) - x 2a: SRe (PASI score=0 at ...	[ "Primary endpoint", "Major secondary endpoints", "Other secondary endpoints of this study are:" ]
NCT03818035	2.2	Hypothesis	2.2. Hypothesis In this study, Super-Responders (SRe) are defined as psoriasis subjects achieving clear skin (measured as absolute PASI score=0) at weeks 20 and 28 of treatment. Subjects with shorter GLVHDVH GXUDWLRQ years calculated from date at which first symptoms [plaque] were reported by subject to date of screeni...	[]
NCT03818035	3	STUDY DESIGN AND RATIONALE	3. STUDY DESIGN AND RATIONALE	[]
NCT03818035	3.1	Overview of Study Design	3.1. Overview of Study Design The present trial is designed as a phase 3b, randomized, double-blind, parallel-group, multicenter, comparison study in subjects of at least 18 years of age with moderate to severe plaque-type psoriasis. It is planned to achieve about 280 subjects categorized as Super-Responders (SRe, ie, ...	[ "Study Part 1: Screening through Week 28:", "Study Part 2: Week 28 through Week 68:", "Study Part 3: Week 68 through Week 220:", "Re-treatment", "Photo-documentation", "TLSS", "Treatment compliance", "Efficacy measurements", "Safety measurements", "Study duration", "Substudies", "Substudy 1 (C...
NCT03818035	3.2	Study Design Rationale	3.2. Study Design Rationale Dose rationale A dose regimen of guselkumab 100 mg at weeks 0, 4 and q8w thereafter was selected for Study Part 1. This is the dose regimen, which is known to result in clinically meaningful improvement of the disease (SmPC TREMFYA®). In Study Part 2, subjects with a PASI score=0 at weeks 2...	[ "Dose rationale", "Duration of treatment period and whole study period", "Blinding and randomization", "Biomarker and DNA collection" ]
NCT03818035	4	SUBJECT POPULATION	4. SUBJECT POPULATION Screening for eligible subjects will be performed within 4 weeks before administration of the study drug. The inclusion and exclusion criteria for enrolling subjects in this study are described in the following two subsections. If there is a question about the inclusion or exclusion criteria below...	[]
NCT03818035	4.1	Inclusion Criteria	4.1. Inclusion Criteria Each potential subject must satisfy all of the following criteria to be enrolled in the study: - 1. Male or female with at least 18 years of age. - 2. Has a GLVHDVH GXUDWLRQ RI SODTXH SVRULDVLV RI HLWKHU years or >2 years calculated from date at which first symptoms [plaque] were reported by sub...	[ "Reproduction-related inclusion criteria" ]
NCT03818035	10	TB-related inclusion criteria:	10. TB-related inclusion criteria: Subjects are considered eligible according to the following TB screening criteria: - a. Have no history of latent or active TB before screening. - o an exception is made for subjects who have a history of latent TB and - are currently receiving treatment for latent TB, - will initiate...	[]
NCT03818035	13	Clinical laboratory-related inclusion criteria:	13. Clinical laboratory-related inclusion criteria: Has screening laboratory test results within the following parameters, if one or more of the laboratory parameters is out of range, a single retest of laboratory values is permitted: - Hemoglobin >10 g/dL (SI: =100 g/L) p - White blood cells >3.5 x 10¥/uL (SI: 3.5 GI/...	[ "Other inclusion criteria:", "4.2. Exclusion Criteria", "Medical history-related exclusion criteria:", "Concomitant or previous medical therapies-related exclusion criteria:", "Infections or predisposition to infections-related exclusion criteria:", "Malignancy or increased potential for malignancy-relate...
NCT03818035	40	Criterion added per Amendment 4:	40. Criterion added per Amendment 4: Exclusion: a potential participant with the following features will be excluded from participating in the study protocol: o During the 6 weeks prior to baseline, have had ANY of (a) confirmed SARS-CoV-2 (COVID-19) infection (test positive), OR (b) suspected SARS-CoV-2 infection (cli...	[ "AND", "NOTES on COVID-related exclusion:", "NOTES:", "4.3. Prohibitions and Restrictions", "5. TREATMENT ALLOCATION AND BLINDING", "Treatment Allocation/ Procedures for Randomization", "Blinding", "6. DOSAGE AND ADMINISTRATION", "7. TREATMENT COMPLIANCE", "8. CONCOMITANT THERAPY", "8.1. Concomi...
NCT03860077	2	Protocol Narrative	2. Protocol Narrative a. Aims & Methodology - a) Aim 1: To determine the effects of VLNC vs. NNC cigarettes on cigarettes smoked per day and frequency of alternative tobacco product use in adolescent cigarette smokers. We hypothesize that use of VLNC cigarettes will be associated with a decrease in combustible cigaret...	[ "a. Aims & Methodology", "PIs: Cassidy & Colby", "PIs: Cassidy & Colby" ]
NCT03860077	4	Screening	4. Screening a. During the initial in-person screening, participants will complete several questionnaires and have their CO taken to confirm eligibility to enroll. Female participants will also submit a urine sample to test for pregnancy. Urine will be sampled for cotinine levels if necessary. The Timeline Follow back,...	[ "b. Inclusion Criteria", "PIs: Cassidy & Colby", "Exclusion Criteria", "PIs: Cassidy & Colby" ]
NCT03860077	5	Baseline 1 Session	5. Baseline 1 Session - a. Purpose: If the participant is eligible after screening procedures, the first baseline session (BL1) will immediately begin. Participants who are ineligible will be paid \$25 and will not complete the BL1 procedures. The RA will make the initial determination of eligibility; final eligibility...	[]
NCT03860077	6	Baseline 2 (BL2) Laboratory Session	6. Baseline 2 (BL2) Laboratory Session - a. Purpose: During this session, participants will be randomized to their study cigarette. Using multiple laboratory-based measures, this session establishes the acute effects of study cigarettes on craving, withdrawal symptoms, and subjective reinforcement value of the particip...	[ "PIs: Cassidy & Colby", "PIs: Cassidy & Colby", "PIs: Cassidy & Colby" ]
NCT03860077	7	Week 1 Safety & Product Dispensation Check-In	7. Week 1 Safety & Product Dispensation Check-In - a. Purpose: This check-in visit can occur either at our research lab or in the community at the participant's preference and convenience. The purpose of this check-in is to check on safety/any adverse events, check CO level, and dispense product; allowing participants ...	[]
NCT03860077	8	Week 2 Laboratory Session	8. Week 2 Laboratory Session - a. Purpose: This laboratory session will evaluate mid-point responses to study cigarettes. - b. Procedures: At the beginning of the session, participants will provide a breath CO sample, complete a timeline follow-back measure for the interim week which will query their use of study and n...	[]
NCT03860077	9	Week 3 Safety & Product Dispensation Check-In	9. Week 3 Safety & Product Dispensation Check-In - a. Purpose: As described above (Week 1 Check-In), this check-in visit can occur either at our research lab or in the community; the purpose is to check on safety/any adverse events, check CO, and dispense product. - b. Procedures: Participants will provide breath CO, c...	[]

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