protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT04396756 | 14.4 | Participant Confidentiality | 14.4 Participant Confidentiality The Investigator must ensure that the participant's privacy is maintained. On the CRF and other documents submitted to the Sponsor, participants will be identified by a participant study number only. Documents that are not submitted to the Sponsor (eg, signed ICF) should be kept in a st... | [] |
NCT04396756 | 14.5 | Study Monitoring | 14.5 Study Monitoring The Investigator must allow the Study Monitors to periodically review, at mutually convenient times, during the study and after the study has been completed, all eCRFs and office, hospital, and laboratory records supporting the participation of each participant in the study (source data). The eCRF... | [] |
NCT04396756 | 14.6 | Case Report Forms and Study Records | 14.6 Case Report Forms and Study Records The investigative site will use eCRFs to record all the protocol-specified data for each participant enrolled in this study. Entries made in the eCRF must be verifiable against source documents. Data reported in the eCRF that are derived from source documents should be consisten... | [] |
NCT04396756 | 14.7 | Data Monitoring Committee | 14.7 Data Monitoring Committee A DSMB will be established to assess participant safety at predetermined intervals during the study, and as needed. Refer to the DSMB Charter for further details. | [] |
NCT04396756 | 14.8 | Data Generation and Analysis | 14.8 Data Generation and Analysis The investigative site will use eCRFs to record all the protocol-specified data for each participant enrolled in this study. Entries made in the eCRF must be verifiable against source documents. Data reported in the eCRF that are derived from source documents should be consistent with ... | [] |
NCT04396756 | 14.9 | Retention of Data | 14.9 Retention of Data The Investigator must ensure that all records pertaining to the conduct of the clinical study, ICFs, drug accountability records, source documents, and other study documentation are adequately maintained for a period of 2 years after the last approval of a marketing application in an ICH region a... | [] |
NCT04396756 | 14.10 | Financial Disclosure | 14.10 Financial Disclosure Financial Disclosure statements will be handled in a separate agreement apart from the protocol, kept on file, and submitted as applicable with any subsequent license application. | [] |
NCT04396756 | 14.11 | Publication and Disclosure Policy | 14.11 Publication and Disclosure Policy The data generated in this clinical study are the exclusive property of the Sponsor and are confidential. Any publication of the results of this study must be authorized by the Sponsor. The Sponsor will have the opportunity to review any publications that arise from the Investiga... | [
"APPENDIX 1 SCHEDULE OF EVENTS: PARTS B AND C",
"APPENDIX 2 SCHEDULE OF EVENTS: PART D",
"Screening through Week 12 Visit",
"APPENDIX 3 SPONSOR SIGNATURE",
"APPENDIX 4 INVESTIGATOR'S SIGNATURE"
] |
NCT04420533 | 1 | OBJECTIVE AND ENDPOINTS | 1. OBJECTIVE AND ENDPOINTS The objective of this study is to evaluate and compare the therapeutic effects on OAB symptoms, and sexual functions, in terms of erectile function and ejaculatory function, in sexually active OAB male treated with behavior therapy or behavior therapy plus Mirabegron (50 mg). The primary and ... | [
"(1) Primary End-point (3 months)",
"(2) Secondary end-points",
"Efficacy",
"Safety",
"(2) Randomization",
"(3) Blinding"
] |
NCT04420533 | 2 | SUBJECTS | 2. SUBJECTS | [] |
NCT04420533 | 2.1 | Number and Source | 2.1. Number and Source This study will be conducted at Kaohsiung Chang Gung Memorial Hospital, and 4 other medical centers. Approximately 150 patients will be enrolled and completed within the two-year study period. | [] |
NCT04420533 | 2.2 | Inclusion Criteria | 2.2. Inclusion Criteria Patients must meet all the following criteria to be eligible to enter the trial: - 2.2.1. Sexually active men with OAB ≥ 20 year. - 2.2.2. Diagnosed with OAB based on OABSS (OABSS urgency score of ≥2 and sum score of ≥3). - 2.2.3 Patients can sign informed consent and record voiding diary. | [] |
NCT04420533 | 2.3 | Exclusion Criteria | 2.3. Exclusion Criteria - 2.3.1. Concurrent use of PDE5 inhibitor or testosterone therapy during study period. - 2.3.2. History of stress urinary incontinence. - 2.3.3. Neurologic conditions associated with OAB symptoms. - 2.3.4. Evidence of active urinary tract infection or urinary tract stone at screening. - 2.3.5. C... | [] |
NCT04420533 | 3 | STUDY PROCEDURE | 3. STUDY PROCEDURE Patients who fulfill the inclusion criteria and sign informed consent will be randomized to behavior therapy or behavior therapy plus mirabegron 50mg OD (by the central study nurse) and followed up at 1 month, and 3 months (primary end-point). 
Behavior therapies [1]: - 1. redu... | [
"Behavior therapies [1]:",
"REFERENCES"
] |
NCT04427007 | 1 | Background and Introduction | 1. Background and Introduction The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm and ultimately moist environment. These layers consist of a... | [] |
NCT04427007 | 2 | Study Rationale | 2. Study Rationale This study will focus on investigating the efficacy of this novel moisture and thermal management (experimental) liner. The rationale for this study is to determine how well the new technology can regulate the residual limb temperature, reduce the moisture generation, and remove excess moisture in a ... | [] |
NCT04427007 | 3 | Objectives | 3. Objectives The primary objective of this study is to measure the effects experimental techniques of moisture and thermal management has on moisture and temperature in the socket. Moisture and thermal management of the residual limb inside the prosthetic socket could result in greater comfort while wearing the prosth... | [] |
NCT04427007 | 4 | Study Design | 4. Study Design A repeated measures study will be conducted to analyze the temperature and moisture generation of the residual limb with and without the experimental liner and active cooling system within a standard prosthetic socket. Both able-bodied research subjects, and lower limb amputee research subjects who use ... | [] |
NCT04427007 | 5 | Study Population | 5. Study Population Both able-bodied persons and persons with transfemoral and transtibial limb loss who are able to walk with a prosthesis will be recruited for this study. Able-bodied subjects will be recruited via word of mouth. LTI will enlist the aid of its current in-house prosthetist, Michael Amrich, CPO and its... | [] |
NCT04427007 | 6 | Participant Eligibility | 6. Participant Eligibility Lower limb amputees will be identified who meet the following inclusion criteria: must be 18-89 years old, be willing and able to complete the tasks outlined, are at least 6 months on a definitive prosthesis, fits within an experimental liner, and can understand English in order to be properl... | [] |
NCT04427007 | 7 | Study Methodology | 7. Study Methodology Visit 1: During the first visit, the subject will be consented and enrolled in the study. Measurements and molds will be taken of the residual limb so an experimental socket can be fabricated. For the purposes of this study, the prosthetic liner is being standardized and all subjects will be provid... | [] |
NCT04427007 | 8 | Study Conduct | 8. Study Conduct Subjects will be consented and screened for eligibility criteria. If they decide to participate, an experimental liner will be made that fits the size and shape of their limb and an experimental socket to fit the experimental liner will be fabricated using standard prosthetic techniques. ![](page5Pictu... | [] |
NCT04427007 | 9 | Study Treatment | 9. Study Treatment This is not a treatment study. The purpose of the study is to evaluate the effectiveness of a moisture removal and thermally conductive liner. | [] |
NCT04427007 | 10 | Evaluation of Adverse Events | 10. Evaluation of Adverse Events Based on past testing and data collection, no adverse events are expected. Adverse events could include: discomfort or dermatological reaction to experimental liner materials or sensors in the socket, tripping while walking on the treadmill, overheating or overcooling due to controller,... | [] |
NCT04427007 | 11 | Ethical Considerations | 11. Ethical Considerations There is no direct benefit to the user. Participating in this study may potentially advance the scientific community's understanding on the ability of reducing intra-socket moisture generation and cooling intra-socket temperatures to improve comfort and quality of life for lower limb amputees... | [] |
NCT04427007 | 12 | Study Monitoring and Oversight | 12. Study Monitoring and Oversight The oversight of the study falls on the PI and co-investigators. They will be responsible for ensuring the study follows the approved protocol and for reporting any deviations or adverse events that occur during the study to Solutions IRB and HRPO. De-identified data, photos, and vide... | [] |
NCT04427007 | 13 | Investigational Product Management | 13. Investigational Product Management The experimental liners tested in this study are modified to increase the thermal conductivity and remove moisture from the limb to regulate intra-socket temperature and reduce moisture accumulation. The ICE technology tested in this study is a cooling device for the residual limb... | [
"EXPERIMENTAL LINER",
"INTRASOCKET COOLING ELEMENT",
"SOCKETS",
"CONTROL LINERS",
"PROSTHETIC SOCKS",
"TEMPERATURE SENSORS",
"HUMIDITY SENSORS"
] |
NCT04427007 | 14 | Data Analysis | 14. Data Analysis The data collected in the laboratory will include limb temperature, ambient temperature, limb humidity, ambient humidity, and moisture generation on the limb. Standard outcomes measures will include: Dermatology Life Quality Index, Modified Dermatology Life Quality Index, the Residual Limb Health sect... | [] |
NCT04427007 | 15 | References | 15. References - [1] J. T. Peery, W. R. Ledoux, and G. K. Klute, "Residual-limb skin temperature in transtibial sockets," The Journal of Rehabilitation Research and Development, vol. 42, no. 2, pp. 147–154, 2005. - [2] E. A. Huff, W. R. Ledoux, J. S. Berge, and G. K. Klute, "Measuring Residual Limb Skin Temperatures at... | [
"APPENDIX A – QUESTIONNAIRES EXPLANATION",
"Surveys and Questionnaires",
"Visit #1 – Part #1 – Dermatology Life Quality Index",
"Visit #1 – Part #2 – Modified Dermatology Life Quality Index",
"Visit #1 – Part #3 – EuroQoL-5D",
"Visit #1 – Part #4 – Residual Limb Health Scale",
"Visit #2 & Visit #3 – Par... |
NCT04460911 | 1 | LIST OF ABBREVIATIONS | 1. LIST OF ABBREVIATIONS CCI | Abbreviation | Definition | | | | |--------------|-------------------------------------------------------------------------------|--|--|--| | AE | Adverse events | | | | | AEM | Adverse event monitoring | | | | | BC | Breast cancer | | | | | BMI | Body mass index | | | | | BOR | Best over... | [] |
NCT04460911 | 2 | RESPONSIBLE PARTIES | 2. RESPONSIBLE PARTIES CCI
Principal Investigator(s) of the Protocol | Name, degree(s) | | Job Title | Affiliation | Address | |-----------------|--------|-------------------------|--------------|-----------------| | PPD | , MD | Medical Director | PPD | PPDPPD, | | PPD | , MPH | Sr. ResearchManager | PPD | PPDPPD, | ... | [
"Principal Investigator(s) of the Protocol"
] |
NCT04460911 | 3 | ABSTRACT | 3. ABSTRACT Title: Treatment Patterns And Clinical Outcomes Among Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer (mBC) Receiving Palbociclib in Combination with Fulvestrant (PB+FUL) In the US Community Oncology Setting Protocol date/version: August 30,... | [
"Research question and objectives:",
"Primary Objectives",
"Secondary Objectives"
] |
NCT04460911 | 4 | AMENDMENTS AND UPDATES | 4. AMENDMENTS AND UPDATES CCI | Amendmentnumber | Date | ProtocolSummary of amendment(s)section(s)changed | | Reason | |---------------------|--------------------------|--------------------------------------------------------------|----------------------------------------------------------------------------------------... | [
"Palbociclib (IBRANCE) Study Number A5481128 NON-INTERVENTIONAL STUDY PROTOCOL Protocol Version 2, August 30, 2021"
] |
NCT04460911 | 5 | MILESTONES | 5. MILESTONES CCI The table below reflects actual and planned completion dates of study milestones. Note, some milestones were completed under prior versions of this protocol. Table 1. Study milestones | Milestone | Planned/completed date | |------------------------------------------------------------------------------... | [] |
NCT04460911 | 6 | RATIONALE AND BACKGROUND | 6. RATIONALE AND BACKGROUND Breast cancer is the most common noncutaneous cancer in the United States (US), with 279,100 new cases expected in 2020.1 Breast cancer predominantly occurs among women, with men accounting for approximately 1% of new cases.2 Among women diagnosed with localized or regional disease, the 5-ye... | [] |
NCT04460911 | 7 | RESEARCH QUESTION AND OBJECTIVES | 7. RESEARCH QUESTION AND OBJECTIVES The overall objective of this study is to understand the demographic, clinical, and treatment characteristics, as well as clinical outcomes of hormone receptor-positive/human epidermal growth factor receptor 2-negative mBC patients in the US community oncology setting. Complete study... | [] |
NCT04460911 | 7.1 | Primary objectives | 7.1. Primary objectives - 1. Describe baseline patient demographic and clinical characteristics, as well as provider- and clinic-level characteristics - 2. Describe treatment patterns including number of complete cycles, postdiscontinuation treatment regimens and treatment initiation by quarter | [] |
NCT04460911 | 7.2 | Secondary objectives | 7.2. Secondary objectives - 3. Evaluate, from initiation of index treatment: - o Time to chemotherapy - o Reasons for treatment discontinuation - o Real-world duration of therapy (rwDOT) - o Time to next treatment (TTNT) - o Provider-documented progression - o Real-world time to progression (rwTTP) - o Real-world progr... | [] |
NCT04460911 | 8 | RESEARCH METHODS | 8. RESEARCH METHODS | [] |
NCT04460911 | 8.1 | Study design | 8.1. Study design CCI The is a retrospective observational cohort study to examine patient and practice-level characteristics, treatment patterns and clinical outcomes among hormone receptorpositive/human epidermal growth factor receptor 2-negative mBC patients treated in the US Oncology Network (USON). Patients who in... | [] |
NCT04460911 | 8.2 | Setting | 8.2. Setting The study population will consist of patients with a diagnosis of hormone receptorpositive/human epidermal growth factor receptor 2-negative mBC who initiated a who initiated PB+FUL and The USON includes 1,200 affiliated physicians operating in over 470 sites of care across states and treats approximately ... | [] |
NCT04460911 | 8.2.1 | Inclusion criteria | 8.2.1. Inclusion criteria CCI Patients must meet all the following inclusion criteria to be eligible for inclusion in the study: \ Data can be updated at a later time to extend the follow-up period through an amendment to refresh the data and revisit charts of patients who were alive at the end of the original study pe... | [] |
NCT04460911 | 8.2.2 | Exclusion criteria | 8.2.2. Exclusion criteria Patients meeting any of the following criteria will not be included in the study: - 1) Enrollment in an interventional clinical trial during the study observation period since clinical trial participants may have clinical scenarios that deviate from the population of interest. - 2) Evidence of... | [] |
NCT04460911 | 8.2.3 | Cohort definitions and stratifications | 8.2.3. Cohort definitions and stratifications Patients who meet the eligibility criteria described in Sections [8.2.1](#page-20-1)[-8.2.2](#page-21-0) will be classified into the following cohorts described in Section [8.1](#page-18-1). As supported by the final sample size, each of the results tables and figures will ... | [] |
NCT04460911 | 8.2.4 | Chart review selection | 8.2.4. Chart review selection CCI For an initial feasibility assessment, all patients who meet the eligibility criteria described in Sections [8.2.1](#page-20-1)[-8.2.2](#page-21-0) were included in the interim analysis. A subset of patients (n=1035) who initiated PB+FUL and in the first- through third-line setting wer... | [] |
NCT04460911 | 8.3 | Variables | 8.3. Variables CCI [Table](#page-24-0) 2 presents the list of variables that will be considered for this study. Most data will originate from 1 of 2 sources: the iKM EHR database (structured data) or chart review (unstructured data), although some variables may be derived from these raw data sources (e.g., age from dat... | [] |
NCT04460911 | 8.4 | Data sources | 8.4. Data sources CCI [Table 2](#page-24-0) presents the data elements that will be evaluated through this study and their associated source. Most study data will originate from the EHR system of the USON, iKM. iKM captures outpatient practice encounter histories for patients under community-based care, including, but ... | [] |
NCT04460911 | 8.5 | Study size | 8.5. Study size | A feasibility assessment from iKM identified 783 patients who met study eligibility criteria | | | |--------------------------------------------------------------------------------------------------|----------------------------------|------------| | CCIand initiated PB+FUL and | | (Table 3). | | CCITh... | [] |
NCT04460911 | 8.6 | Data management | 8.6. Data management CCI A description of the data sources to be used for this study is provided in Section [8.4](#page-37-0). Operational definitions, periods of assessment and data sources of all data elements to be used for this study, along with descriptions of how raw data elements will be transformed into derived... | [] |
NCT04460911 | 8.6.1 | Case report forms (CRFs)/Data collection tools (DCTs)/Electronic data record | 8.6.1. Case report forms (CRFs)/Data collection tools (DCTs)/Electronic data record As used in this protocol, the term CRF should be understood to refer to either a paper form or an electronic data record or both, depending on the data collection method used in this study. A CRF is required and should be completed for ... | [
"[8.8.](#page-47-1) Record retention"
] |
NCT04460911 | 8.7 | Data analysis | 8.7. Data analysis Detailed methodology for summary and statistical analyses of data collected in this study will be documented in a statistical analysis plan (SAP), which will be dated, filed and maintained by Pfizer. The SAP may modify the plans outlined in the protocol; any major modifications of primary endpoint de... | [] |
NCT04460911 | 8.7.1 | Analysis sets | 8.7.1. Analysis sets Separate analysis sets will be created to address the study objectives based on the cohorts of patients to be included (an overview of these analyses is presented in Table 2). For the primary and secondary objectives, the analyses will consist of patients who initiated first-line PB+FUL, CCI | [] |
NCT04460911 | 8.7.2 | Derived and transformed data | 8.7.2. Derived and transformed data Some of the data elements needed for the study objectives will be derived from available data during the analysis phase of the study. Details about these calculations are provided along with the operational definition in [Table 2](#page-24-0). Prior to constructing these variables, t... | [] |
NCT04460911 | 8.7.3 | Statistical methods | 8.7.3. Statistical methods CCI
Description of study enrollment To be included in the study patients must meet each of the inclusion criteria and none of the exclusion criteria listed in Sections [8.2.1-](#page-20-1)[8.2.2](#page-21-0). Counts of patients excluded for each criterion will be summarized.
Description of ... | [
"Description of study enrollment",
"Description of patient demographic, clinical and treatment characteristics",
"Clinical outcomes",
"Additional analyses"
] |
NCT04460911 | 8.7.4 | Sequence of analyses | 8.7.4. Sequence of analyses An initial feasibility assessment has been performed based solely on structured data. Following chart review, analyses will be undertaken to meet the primary and secondary objectives for the final study population using both structured an unstructured data. CCI | [] |
NCT04460911 | 8.8 | Quality control | 8.8. Quality control CCI For structured data, McKesson's Commercial Intelligence and Real World Evidence teams conduct quality assurance checks on all analytics projects. The process includes both technical and clinical quality checks. Technical review of the dataset consists of identifying inappropriate values (e.g., ... | [] |
NCT04460911 | 8.9 | Limitations of the research methods | 8.9. Limitations of the research methods | [] |
NCT04460911 | 8.9.1 | Internal validity of study design | 8.9.1. Internal validity of study design CCI
Measurement error(s)/misclassification(s) This observational and retrospective study uses iKM EHR data. The iKM database is not collected for research purposes but for clinical practice reasons. This may impede the standardization of the data collection methods and instrume... | [
"Measurement error(s)/misclassification(s)",
"Information bias",
"Confounding"
] |
NCT04460911 | 8.9.2 | External validity of study design (generalizability) | 8.9.2. External validity of study design (generalizability) Not all community oncology practices are included in the iKM dataset. Furthermore, not all of the USON utilize the full capabilities of the iKM EHR. The USON encourages use of evidence-based treatment guidelines. Therefore, practices that participate in the US... | [] |
NCT04460911 | 8.9.3 | Analysis limitations | 8.9.3. Analysis limitations As a retrospective observational study, data entry errors at the point of care cannot be detected or corrected during analysis. | [] |
NCT04460911 | 8.9.4 | Limitations due to missing data and/or incomplete data | 8.9.4. Limitations due to missing data and/or incomplete data Although data quality checks are conducted, it is possible that some variables of interest may not be as complete across the entire population. | [] |
NCT04460911 | 8.10 | Other aspects | 8.10. Other aspects Not applicable. CCI | [] |
NCT04460911 | 9 | PROTECTION OF HUMAN SUBJECTS | 9. PROTECTION OF HUMAN SUBJECTS This study will include both a structured data analysis and human-level review of unstructured (chart review). As such, separate patient protections and reporting requirements are described below for each phase. | [] |
NCT04460911 | 9.1 | Patient information | 9.1. Patient information
Structured data analysis This study involves data that exist in anonymized structured format and contain no patient personal information.
Human Review of Unstructured Data All parties will comply with all applicable laws, including laws regarding the implementation of organizational and techn... | [
"Structured data analysis",
"Human Review of Unstructured Data"
] |
NCT04460911 | 9.2 | Patient consent | 9.2. Patient consent As this study does not involve data subject to privacy laws according to applicable legal requirements, obtaining informed consent from patients by Pfizer is not required. The McKesson study team will submit a request for exemption, waiver of informed consent and authorization to the Intuitional Re... | [] |
NCT04460911 | 9.3 | Patient withdrawal | 9.3. Patient withdrawal CCI Not applicable, as this project does not require informed consent. | [] |
NCT04460911 | 9.4 | Institutional review board (IRB)/Independent ethics committee (IEC) | 9.4. Institutional review board (IRB)/Independent ethics committee (IEC) There must be prospective approval of the study protocol, protocol amendments, and other relevant documents (e.g., informed consent forms if applicable) from the relevant IRBs/IECs. All correspondence with the IRB/IEC must be retained. Copies of I... | [] |
NCT04460911 | 9.5 | Ethical conduct of the study | 9.5. Ethical conduct of the study The study will be conducted in accordance with legal and regulatory requirements, as well as with scientific purpose, value and rigor and follow generally accepted research practices described in Guidelines for Good Pharmacoepidemiology Practices (GPP) issued by the International Socie... | [] |
NCT04460911 | 10 | MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE REACTIONS REQUIREMENTS | 10. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE REACTIONS REQUIREMENTS
Structured Data Analysis This study involves EHR data that exist as structured data by the time of study start or a combination of existing structured data and unstructured data, which will be converted to structured form during the implemen... | [
"Structured Data Analysis",
"Human Review of Unstructured Data"
] |
NCT04460911 | 11 | PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS | 11. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS In the event of any prohibition or restriction imposed (e.g., clinical hold) by an applicable competent authority in any area of the world, or if the investigator is aware of any new information which might influence the evaluation of the benefits and risks of... | [
"Study reporting",
"Publication"
] |
NCT04460911 | 13 | REFERENCES | 13. REFERENCES - 1. Siegel RL, Miller KD, Jemal A: Cancer statistics, 2020. CA Cancer J Clin 70:7-30, 2020 - 2. Breast Cancer Treatment (PDQ(R)): Health Professional Version: PDQ Cancer Information Summaries. Bethesda (MD), 2002 - 3. National Cancer Institute Surveillance Epidemiology and End Results (Seer) Program: Ca... | [
"ANNEX 1. LIST OF STAND ALONE DOCUMENTS",
"ANNEX 2. ENCEPP CHECKLIST FOR STUDY PROTOCOLS",
"ANNEX 3. ADDITIONAL INFORMATION",
"Study Sponsor Sign-Off page"
] |
NCT04484805 | 1 | Background and Introduction | 1. Background and Introduction The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm and ultimately moist environment. Studies found increases i... | [] |
NCT04484805 | 2 | Study Rationale | 2. Study Rationale This study will focus on investigating the efficacy of this novel socket cooling technology. The rationale for this study is to determine how well the new technology can cool the residual limb not only in a controlled laboratory environment, but also in a home environment where the device would ultim... | [] |
NCT04484805 | 3 | Objectives | 3. Objectives The primary objective of this study is to measure the effects of cooling the residual limb on quality of life (QoL) and functional outcomes. Cooling the residual limb inside the prosthetic socket would result in less sweating and greater comfort while wearing the prosthesis, and ultimately greater functio... | [] |
NCT04484805 | 4 | Study Design | 4. Study Design A two group, prospective, double-blinded, block randomized, crossover study design will be implemented. Research participants will be consented and have baseline activity and socket temperature data collected from their usual prosthesis during normal use (4 weeks). The ICE system will be integrated into... | [] |
NCT04484805 | 5 | Study Population | 5. Study Population Lower limb prosthesis users will be recruited for the study and consented with an approved protocol. Research participants will represent a convenience sample and will reflect the local population of both above-knee (AK) and belowknee (BK) amputees of various K-levels using a variety of suspension t... | [] |
NCT04484805 | 6 | Participant Eligibility | 6. Participant Eligibility Lower limb amputees will be identified who meet the following inclusion criteria: must be 18 -89 years old, be willing and able to complete the tasks outlined, have no symptoms consistent with peripheral neuropathy or other sensory diagnosis that could prevent them from feeling the temperatur... | [] |
NCT04484805 | 7 | Study Methodology | 7. Study Methodology Visit 1: During the first visit, the subject will be consented and enrolled in the study. Measurements and molds will be taken of the residual limb so an experimental socket can be fabricated. For the purposes of this study, the prosthetic liner is being standardized and all subjects will be provid... | [] |
NCT04484805 | 8 | Study Conduct | 8. Study Conduct Subjects will be consented and screened for eligibility criteria. If they decide to participate, their usual socket will be duplicated to create the experimental socket and then it will be instrumented with an activity monitor and temperature sensors. The subject will wear the instrumented usual socket... | [] |
NCT04484805 | 9 | Study Treatment | 9. Study Treatment This is not a treatment study. The purpose of the study is to evaluate the effectiveness of the ICE system. | [] |
NCT04484805 | 10 | Evaluation of Adverse Events | 10. Evaluation of Adverse Events Based on past testing and data collection, no adverse events are expected. Adverse events could include: discomfort or dermatological reaction to sensors in the socket, tripping while walking on the treadmill, overheating or overcooling due to controller, sensor, or battery malfunction ... | [] |
NCT04484805 | 11 | Ethical Considerations | 11. Ethical Considerations  There is no direct benefit to the user. Participating in this study may potentially advance the scientific community's understanding of the effect of cooling intra-socket temperatures on the activity, comfort and quality of life of lower limb amputees. The protocol, co... | [] |
NCT04484805 | 12 | Study Monitoring and Oversight | 12. Study Monitoring and Oversight The oversight of the study falls on the co-investigators. They will be responsible for ensuring the study follows the approved protocol and for reporting any deviations or adverse events that occur during the study to New England IRB and HRPO. De-identified data, photos, and videos wi... | [] |
NCT04484805 | 13 | Investigational Product Management | 13. Investigational Product Management The ICE technology tested in this study is cooling device for the residual limb that is an add-on system to a standard prosthetic socket. Additionally, commercially-available activity monitors and temperature sensors may also be used in the instrumented sockets. INTRASOCKET COOLIN... | [
"SOCKETS",
"PROSTHETIC SOCKS",
"ACTIVITY MONITORS",
"TEMPERATURE SENSORS",
"SILICONE"
] |
NCT04484805 | 14 | Data Analysis | 14. Data Analysis The data collected in the laboratory and in the take-home portions of this study will include limb temperature, ambient temperature, activity (steps), ICE system use time (collected via the written log and the ICE unit), and standard outcomes measures for both the usual socket, and ON and OFF conditio... | [] |
NCT04495478 | 1 | Protocol Summary | 1. Protocol Summary | [] |
NCT04495478 | 1.1 | Synopsis | 1.1. Synopsis Protocol Title: A Single-Dose Study in Healthy Participants to Characterize Ramucirumab Pharmacokinetics and Investigate Injection Site Reactions Following an Intravenous Infusion or Subcutaneous Administration of Ramucirumab Short Title: Single-Dose Study in Healthy Participants to Characterize Ramucirum... | [
"Rationale:",
"Overall Design",
"Number of Participants:",
"Intervention Groups and Duration:",
"Data Monitoring Committee: No"
] |
NCT04495478 | 1.2 | Schema | 1.2. Schema  Abbreviations: IV = intravenous; LY = ramucirumab (LY3009806); Pbo = placebo; PK = pharmacokinetic(s); SC = subcutaneous. | Procedures/ | Screening | Baseline | | Inpatient | | | | | | | | Outpatient | EoT | | | F/U | | Comments | |--------------------------------------|-----------|... | [] |
NCT04495478 | 2 | Introduction | 2. Introduction Ramucirumab is a human receptor-targeted monoclonal antibody (mAb) that specifically binds vascular endothelial growth factor (VEGF) receptor 2. Ramucirumab has been marketed worldwide as an intravenous (IV) formulation since 2014 and is well-established treatment, as a single agent and/or in combinatio... | [] |
NCT04495478 | 2.1 | Study Rationale | 2.1. Study Rationale Ramucirumab presents a biphasic disposition PK following IV administration, with a distribution apparent terminal elimination half-life (t1/2) of approximately 20 hours and elimination t1/2 of approximately 10 days to 2 weeks. Consequently, there is an initial 2-fold decline in ramucirumab concentr... | [] |
NCT04495478 | 2.2 | Background | 2.2. Background See Section [2](#page-24-1) and Section [2.1.](#page-24-0) | [] |
NCT04495478 | 2.3 | Benefit/Risk Assessment | 2.3. Benefit/Risk Assessment More detailed information about the known and expected benefits and risks and reasonably expected adverse events (AEs) of ramucirumab may be found in the Investigator's Brochure (IB). The safety profile of ramucirumab given IV in adults with advanced cancers across a number of indications i... | [] |
NCT04495478 | 3 | Objectives and Endpoints | 3. Objectives and Endpoints | Objectives | Endpoints | | | | |----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT04495478 | 4 | Study Design | 4. Study Design | [] |
NCT04495478 | 4.1 | Overall Design | 4.1. Overall Design This is a single-site study in healthy participants who will receive a single dose of SC or IV ramucirumab. The study will be participant- and investigator-blinded, randomized, and placebo-controlled (7 ramucirumab:3 placebo per group/dose level). Placebo will be used as a comparator for both IV and... | [
"Group 3 will test a ramucirumab IV dose (maximum of 350 mg)",
"Group 4 will test a ramucirumab 350-mg SC dose",
"Group 5 will test a ramucirumab 350-mg SC dose"
] |
NCT04495478 | 4.2 | Scientific Rationale for Study Design | 4.2. Scientific Rationale for Study Design The healthy population was selected to participate in this study because it is the most optimal setting to gather intensive PK information over an extended period of time. This PK data are needed to answer the scientific objectives of the study, which are to assess the bioavai... | [] |
NCT04495478 | 4.3 | Justification for Dose | 4.3. Justification for Dose The overall principle for the choice of SC ramucirumab dose levels to be tested in this single-ascending dose study in healthy participants is: - To support appropriate dose selection in subsequent studies in cancer patients with multiple repeated SC ramucirumab administration - To support s... | [] |
NCT04495478 | 4.4 | End of Study Definition | 4.4. End of Study Definition A participant is considered to have completed the study if he/she has completed the first 40 days of study procedures as per the schedule of events. If a participant does not complete the 40 days procedure, he/she maybe replaced. The end of the study is defined as the date of the last visit... | [] |
NCT04495478 | 5 | Study Population | 5. Study Population Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as protocol waivers or exemptions, is not permitted. | [] |
NCT04495478 | 5.1 | Inclusion Criteria | 5.1. Inclusion Criteria Participants are eligible to be included in the study only if all of the following criteria apply:
Age 1. Participant must be between the ages of 18 and 60 years of age, inclusive, at the time of signing the informed consent.
Type of Participant and Disease Characteristics - 2. Participants wh... | [
"Age",
"Type of Participant and Disease Characteristics",
"Weight",
"Sex",
"Informed Consent"
] |
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