protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT05330975 | 6.1.2 | Study Monitoring | 6.1.2. Study Monitoring Before an investigational site can enter a participant into the study, a representative of the Sponsor or its representatives will visit the investigational study site to: - Determine the adequacy of the facilities. - Discuss with the investigator(s) and other personnel their responsibilities wi... | [] |
NCT05330975 | 6.1.3 | Audits and Inspections | 6.1.3. Audits and Inspections The Sponsor, their designee(s), the IRB, or regulatory authorities will be allowed to conduct site visits to the investigational facilities for the purpose of monitoring or inspecting any aspect of the study. The investigator agrees to allow the Sponsor, their designee(s), the IRB, or regu... | [] |
NCT05330975 | 6.1.4 | Financial Disclosure | 6.1.4. Financial Disclosure The investigator is required to provide financial disclosure information to allow the Sponsor to submit the complete and accurate certification or disclosure statements required under 21 CFR 54. In addition, the investigator must provide the Sponsor with a commitment to promptly update this ... | [] |
NCT05330975 | 6.1.5 | Recruitment Procedures | 6.1.5. Recruitment Procedures Advertisements to be used for the recruitment of study participants and any other written information regarding this study to be provided to the participant should be submitted to the Sponsor for approval. All documents must be approved by the IRB. | [] |
NCT05330975 | 6.1.6 | Informed Consent/Assent Process | 6.1.6. Informed Consent/Assent Process The informed consent document(s) must meet the requirements of 21 CFR 50, local regulations, ICH guidelines, Health Insurance Portability and Accountability Act requirements, where applicable, and the IRB or study center. All consent documents will be approved by the appropriate I... | [] |
NCT05330975 | 6.1.7 | Protocol Amendments | 6.1.7. Protocol Amendments No change or amendment to this protocol may be made by the investigator or the Sponsor after the protocol has been agreed to and signed by all parties unless such change(s) or amendment(s) has (have) been agreed upon by the investigator or the Sponsor. Any change agreed upon will be recorded ... | [] |
NCT05330975 | 6.1.8 | Protocol Deviations | 6.1.8. Protocol Deviations Noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a result of deviations, corrective actions are to be developed by the site and implemented promptly. It is the responsibility of the site investigator to use continuous vigilance to ident... | [] |
NCT05330975 | 6.1.9 | Data Protection | 6.1.9. Data Protection Participants will be assigned a unique identifier by the Sponsor. Any participant records or datasets that are transferred to the Sponsor will contain the identifier only; participant names or any information that would make the participant identifiable will not be transferred. The participant mu... | [] |
NCT05330975 | 6.1.10 | Sample Retention and Future Biomedical Research | 6.1.10. Sample Retention and Future Biomedical Research The Sponsor may store samples for the time frame specified in the ICF to achieve the study objectives. In addition, identifiable samples can be destroyed at any time at the request of the participant. During the study, or during the retention period, in addition t... | [] |
NCT05330975 | 6.1.11 | Safety Oversight | 6.1.11. Safety Oversight Safety monitoring for the study is described in Section [2.7.6,](#page-60-3) Section [3.7.6,](#page-91-11) and Section [4.7.6.](#page-120-10) | [] |
NCT05330975 | 6.1.12 | Dissemination of Clinical Study Data | 6.1.12. Dissemination of Clinical Study Data The Sponsor shares information about clinical trials and results on publicly accessible websites, based on international and local legal and regulatory requirements, and other clinical trial disclosure commitments established by pharmaceutical industry associations. These we... | [] |
NCT05330975 | 6.1.13 | Data Quality Assurance and Quality Control | 6.1.13. Data Quality Assurance and Quality Control Data collection is the responsibility of the clinical study staff at the site under the supervision of the site investigator. The investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data reported. - All participant dat... | [] |
NCT05330975 | 6.1.14 | Data Collection and Management | 6.1.14. Data Collection and Management This study will be conducted in compliance with ICH CGP guidelines. This study will also be conducted in accordance with the most recent version of the Declaration of Helsinki. This study will use electronic data collection to collect data directly from the study site using eCRFs.... | [] |
NCT05330975 | 6.1.15 | Source Documents | 6.1.15. Source Documents Source documents are original documents or certified copies, and include, but are not limited to, eDiaries, medical and hospital records, screening logs, ICFs, telephone contact logs, and worksheets. Source documents provide evidence for the existence of the participant and substantiate the int... | [] |
NCT05330975 | 6.1.16 | Retention of Records | 6.1.16. Retention of Records The principal investigator must maintain all documentation relating to the study for a period of at least 2 years after the last marketing application approval or, if not approved, 2 years following the discontinuance of the test article for investigation. If this requirement differs from a... | [] |
NCT05330975 | 6.1.17 | Study and Site Closure | 6.1.17. Study and Site Closure If the study is prematurely terminated or suspended, the Sponsor shall promptly inform the investigators, the IRBs, the regulatory authorities, and any CRO(s) used in the study of the reason for termination or suspension, as specified by the applicable regulatory requirements. The investi... | [] |
NCT05330975 | 6.1.18 | Publication Policy | 6.1.18. Publication Policy The results of this study may be published or presented at scientific meetings. If this is foreseen, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. The Sponsor... | [] |
NCT05330975 | 6.2 | APPENDIX 2: Contraceptive Guidance and Collection of Pregnancy Information | 6.2. APPENDIX 2: Contraceptive Guidance and Collection of Pregnancy Information
Definitions: Woman of Child-bearing Potential Women of child-bearing potential are those who are considered fertile following menarche and until becoming postmenopausal unless permanently sterile (see below). If fertility is unclear (eg, a... | [
"Definitions: Woman of Child-bearing Potential",
"Contraception Guidance",
"Collection of Pregnancy Information",
"Female Participants Who Become Pregnant"
] |
NCT05330975 | 6.3 | APPENDIX 3: Adverse Events of Special Interest | 6.3. APPENDIX 3: Adverse Events of Special Interest | [] |
NCT05330975 | 6.3.1 | AESIs for RSV and Influenza | 6.3.1. AESIs for RSV and Influenza Investigators should report all events that fall into the categories presented in [Table 14](#page-139-3) as an AESI per the reporting processes specified in Section [2.7.4.11.](#page-58-1) These AESIs are medical concepts that are generally of interest in vaccine safety surveillance ... | [] |
NCT05330975 | 6.3.2 | AESIs for COVID (Part B only) | 6.3.2. AESIs for COVID (Part B only) The investigator's medical judgment must be applied to assess an event as an AESI because most AESIs are based on medical concepts. The table below does not provide a comprehensive list of terms. The following table describes events/medical concepts that are of interest in COVID-19 ... | [] |
NCT05330975 | 6.4 | APPENDIX 4: CDC Working Case Definition of Pericarditis, Myocarditis, and Myopericarditis Occurring After Receipt of COVID-19 mRNA Vaccines | 6.4. APPENDIX 4: CDC Working Case Definition of Pericarditis, Myocarditis, and Myopericarditis Occurring After Receipt of COVID-19 mRNA Vaccines The CDC working case definition of pericarditis, myocarditis, and myopericarditis to be used in this study is presented in [Table](#page-143-1) 16. Table 16: CDC Working Case ... | [] |
NCT05330975 | 6.5 | APPENDIX 5: Protocol Amendment History | 6.5. APPENDIX 5: Protocol Amendment History | [] |
NCT05330975 | 6.5.1 | Protocol Amendment 4 | 6.5.1. Protocol Amendment 4 Amendment 4, 14 Feb 2023:   | [] |
NCT05330975 | 6.5.2 | Protocol Amendment 3 | 6.5.2. Protocol Amendment 3 Amendment 3, 17 June 2022:   | [] |
NCT05330975 | 6.5.3 | Protocol Amendment 2 Amendment 2, 10 May 2022: | 6.5.3. Protocol Amendment 2 Amendment 2, 10 May 2022:    | [] |
NCT05330975 | 6.5.4 | Protocol Amendment 1 | 6.5.4. Protocol Amendment 1 Amendment 1, 17 Mar 2022:   
Signature Page for VV-CLIN-003910 v10.0 | 2nd Approval | PPD | (Moderna) | |--------------|---------|-------------------------------| | | Medical | | | | | 23-Jun-2023 18:16:49 GMT+0000 | ... | [
"Signature Page for VV-CLIN-003910 v10.0"
] |
NCT05351164 | 1.0 | BACKGROUND AND RATIONALE | 1.0 BACKGROUND AND RATIONALE | [] |
NCT05351164 | 1.1 | Multiple Symmetric Lipomatosis and Adipose Tissue Physiology | 1.1 Multiple Symmetric Lipomatosis and Adipose Tissue Physiology Adipose tissue (AT) depots differ in embryological origins, gene expression profiles and hormonal regulation pattern according to anatomical location (visceral or subcutaneous) and major cell type constituent (white, brown, or beige/brite adipocyte) (Kahn... | [] |
NCT05351164 | 1.2 | A brief summary of patients with MFN2 associated lipodystrophy/MSL | 1.2 A brief summary of patients with MFN2 associated lipodystrophy/MSL At the University of Michigan, we are currently following three pedigrees, each with two affected siblings with MFN2 associated MSL. Homozygous MFN2 R707W (c.2119C>T) pathogenic variant was detected in all patients. Patient 3 (Now an 18-year-old men... | [] |
NCT05351164 | 1.3 | Leptin levels are low in MSL | 1.3 Leptin levels are low in MSL Despite prominent upper body adipose overgrowth in MSL, levels of adipocyte hormones leptin and adiponectin are strikingly low, adding the name of the disease to the list of disorders with severe leptin deficiency in humans. Rocha et al. showed that leptin secretion from adipose explant... | [] |
NCT05351164 | 1.4 | Myalept: a treatment for lipodystrophy and leptin deficiency | 1.4 Myalept: a treatment for lipodystrophy and leptin deficiency Metreleptin was approved in the US as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (USPI). The pivotal efficacy data supporting the approval was... | [] |
NCT05351164 | 1.5 | Rationale for proposed studies | 1.5 Rationale for proposed studies Taken together, our data suggest that the mutated MFN2 impairs mitochondrial fusion ability, increasing fission and leading to mitochondrial fragmentation and mitophagy in white AT. Therefore, we hypothesize that MFN2 mutation has different consequences in white and brown AT, leading ... | [] |
NCT05351164 | 2.0 | PATIENT-SPECIFIC PROTOCOL OBJECTIVE AND ENDPOINTS | 2.0 PATIENT-SPECIFIC PROTOCOL OBJECTIVE AND ENDPOINTS | [] |
NCT05351164 | 2.1 | Protocol Objectives | 2.1 Protocol Objectives The study aims to evaluate the safety and effectiveness of Metreleptin in individuals with clinical diagnosis of MSL. This study will document the metabolic, morphometric, and molecular changes associated with Metreleptin treatment. | [] |
NCT05351164 | 2.2 | Protocol Endpoints | 2.2 Protocol Endpoints Evaluate the effects of Metreleptin on body composition, truncal adiposity and AT gene signatures while patients are being treated with commercial grade Myalept to target their metabolic defects. Outcome measures: Truncal adiposity by DEXA, total adiposity (Primary) - performed at baseline and vi... | [] |
NCT05351164 | 2.3 | Exploratory Endpoints | 2.3 Exploratory Endpoints Triglyceride levels, liver fat percentage, insulin sensitivity by HOMA\IR, adipose tissue sensitivity by Adipo-IR (exploratory) Adipose tissue gene expression and morphometry (detailed below) (exploratory) Patient self-evaluation of distress scale (RAND SF-36 and DDS adapted to lipomatosis) Me... | [] |
NCT05351164 | 2.4 | Additional data elements collected from medical records which will be collected in the course of clinical care before and after treatment | 2.4 Additional data elements collected from medical records which will be collected in the course of clinical care before and after treatment Changes in signs and symptoms of obstructive sleep apnea e.g., CPAP requirements Full neurological assessment. Dose decreases in or discontinuation of medication used to treat me... | [] |
NCT05351164 | 3.0 | INVESTIGATIONAL PLAN | 3.0 INVESTIGATIONAL PLAN | [] |
NCT05351164 | 3.1 | Overview Design and Plan of the Protocol | 3.1 Overview Design and Plan of the Protocol This is a pilot protocol to evaluate and document the clinical effects and safety of Metreleptin in patients with MSL. The protocol includes four visits. The endpoints will be evaluated by the change in parameters from baseline and six months after starting the treatment wit... | [] |
NCT05351164 | 3.2 | Investigation of a unique cohort of patients | 3.2 Investigation of a unique cohort of patients As previously described in section 1.2, we follow three pedigrees at the University of Michigan, each with affected individuals with MFN2 R707W mutation. | [] |
NCT05351164 | 3.3 | Eligibility Criteria | 3.3 Eligibility Criteria The study will enroll the patients identified in table 1. . The patient under 18 will only be enrolled after we have preliminary evidence of benefit in the 2 adult patients, or the patient has reached the age of 18. Eligibility criteria are as follows: - Have the clinical diagnosis of MSL and b... | [] |
NCT05351164 | 3.4 | Exclusion Criteria | 3.4 Exclusion Criteria • Presence of advanced liver disease (abnormal synthetic function, PT, or albumin) in medical records - Evidence of other etiologies of viral hepatitis in medical records - Presence of active hematologic, bone marrow or other abnormalities that may increase risk of bleeding in medical records. - ... | [] |
NCT05351164 | 3.5 | Lifestyle Guidance | 3.5 Lifestyle Guidance Lifestyle guidance for healthy metabolic health will be provided per the 2020 Diabetes Care guidelines of ADA. | [] |
NCT05351164 | 4.0 | Study Drug: | 4.0 Study Drug: The study drug is Metreleptin (Myalept) as manufactured by Amryt Pharmaceuticals | [] |
NCT05351164 | 4.1 | Study Drug Preparation | 4.1 Study Drug Preparation Study drug for injection is supplied in a carton containing 30 vials for reconstitution. Each vial contains 11.3 mg of the study drug as a sterile, white, solid, lyophilized cake or powder to deliver 5 mg/mL of the study drug when reconstituted with 2.2 mL of bacteriostatic water. After recon... | [] |
NCT05351164 | 4.2 | Labeling | 4.2 Labeling Metreleptin labels will include the statement "Caution: New Drug – Limited by Federal law to investigational use". The label will also include information on the storage conditions, lot number and expiry date. | [] |
NCT05351164 | 4.3 | Dose and Treatment Regimens | 4.3 Dose and Treatment Regimens
a) Starting and Maximum Doses The starting doses of the study drug to be administered will be as follows 2.5 mg (0.5mL) for males and 5 mg (1mL) for females daily. The maximum daily dose should not exceed 10 mg (2mL).
b) Dose Adjustments The dose adjustments of the study treatment are ... | [
"a) Starting and Maximum Doses",
"b) Dose Adjustments"
] |
NCT05351164 | 4.4 | Storage | 4.4 Storage The study drug in a form of lyophilized powder should be stored in the refrigerator at 36°F to 46°F (2°C to 8°C) in a carton and protected from light until prepared for use; the study drug should not be frozen. When the study drug is reconstituted with WFI, it should be administered immediately and cannot b... | [] |
NCT05351164 | 4.5 | Compliance | 4.5 Compliance The administration of the study treatment (dose and duration) should be recorded by the investigator monthly. Subjects will keep dose diaries to be provided by the investigative team to document timing and administered dose as another source of compliance. | [] |
NCT05351164 | 4.6 | Study Drug Handling and Accountability | 4.6 Study Drug Handling and Accountability The Investigator or designee must confirm appropriate temperature conditions have been maintained during transit for all study treatment received, and any discrepancies are reported and resolved before use of the study treatment. All study treatments must be stored in a secure... | [] |
NCT05351164 | 4.7 | Concomitant and Other Treatments | 4.7 Concomitant and Other Treatments Unless excluded, medication considered necessary for the subject's safety and well-being may be given at the discretion of the Investigator and should be recorded in the appropriate sections of the eCRF. Special attention should be paid to recording changes to the subject's anti-dia... | [] |
NCT05351164 | 5.0 | PROTOCOL VISITS | 5.0 PROTOCOL VISITS | [] |
NCT05351164 | 5.1 | Duration of Patient Participation | 5.1 Duration of Patient Participation The total protocol duration will be four visits over a period of 7 months. There will be a baseline visit and then the first two visits (Visit 1 and Visit 2) will be 6 weeks apart from baseline and Visit 3 will be three months (12 weeks) after visit 2. There will be a follow-up vis... | [] |
NCT05351164 | 5.2 | Protocol Discontinuation | 5.2 Protocol Discontinuation The execution of this protocol may be prematurely terminated if, in the opinion of the Principal Investigator, there is sufficiently reasonable cause. The Principal Investigator will provide written notification documenting the reason for protocol termination to the IRBMed and also to the F... | [] |
NCT05351164 | 5.3 | Open-Label Treatment Extension | 5.3 Open-Label Treatment Extension If patients experience substantial reduction of disfiguring lipomatosis and/or experience reduction in triglycerides or liver fat, we will offer a long-term extension phase after the 4-week follow up. Participants will have the option to continue the treatment during the first month d... | [
"PROTOCOL ASSESSMENTS"
] |
NCT05351164 | 6.1 | Overview of Schedule of Assessments | 6.1 Overview of Schedule of Assessments The Schedule of Assessments (SOA) to be conducted during the protocol is depicted in Table Laboratory and testing assessments are also described in Table 4. Patients will be required to 4. fast overnight on the day preceding all visits. In addition, they will be allowed to take t... | [
"Footnotes for Table 6: Schedule of Assessments"
] |
NCT05351164 | 6.2 | Measurements and Sampling | 6.2 Measurements and Sampling All studies will be performed in the fasted state (10-12 hours). Baseline and 6 month assessments will be conducted on site. Visit 1 and 2 may also be conducted on site if pandemic-related conditions allow. | [] |
NCT05351164 | 6.3 | Clinical Procedures | 6.3 Clinical Procedures
a) Informed Consent/Assent A complete description of the protocol will be presented to the patients and their parents or guardian. The signed and dated informed consent and/or assent will be obtained before any protocol-specific procedures are performed. In the case of minor patients, the assen... | [
"a) Informed Consent/Assent",
"b) Demographics and Medical History",
"c) Physical Examination",
"d) Medication Review",
"e) Vital Signs",
"Blood Pressure and Heart Rate",
"Body Temperature and Respiration Rate",
"f) 12-Lead Electrocardiogram",
"g) Metabolic measurement",
"h) Oral glucose Tolerance... |
NCT05351164 | 7.0 | ADVERSE EVENTS AND RISKS | 7.0 ADVERSE EVENTS AND RISKS | [] |
NCT05351164 | 7.1 | Adverse events | 7.1 Adverse events Patients will be carefully monitored for the development of any AEs throughout the protocol from the time the patient provides informed consent through the Final Protocol Visit. Biopsy-related bleeding and scarring will be closely monitored. Patients will be questioned on skin integrity, erythema, sw... | [] |
NCT05351164 | 7.2 | Monitoring of Adverse Events and Period of Observation | 7.2 Monitoring of Adverse Events and Period of Observation AEs will be recorded in the source documents. SAEs and deaths will be recorded on the SAE CRFs starting from the time the ICF is signed and continuing through the Final Protocol Visit. All AEs will be monitored until they are resolved or are clearly determined ... | [] |
NCT05351164 | 7.3 | Risks associated with evaluation methods | 7.3 Risks associated with evaluation methods
m) Imaging modalities While MRI scanning is thought to be safe, the procedure may cause anxiety in some patients since current equipment used at the University of Michigan uses a closed tube. Dexa is fairly simple, but subjects need to lie flat for about 15 minutes or less.... | [
"m) Imaging modalities",
"n) Risks with blood tests",
"o) Risks with study procedures"
] |
NCT05351164 | 7.4 | Mitigation of Risk | 7.4 Mitigation of Risk The potential risks will be carefully mitigated using strategies included in the description of each risk and via our adverse event monitoring strategies outlined above. Subject privacy will also be protected via team training and all the precautions listed in the appropriate sections above. | [] |
NCT05351164 | 8.0 | DRUG SAFETY | 8.0 DRUG SAFETY | [] |
NCT05351164 | 8.1 | General Considerations | 8.1 General Considerations The Investigator is responsible for ensuring that all staff involved in the study are familiar with the content of this section. All AEs, including AEs leading to discontinuation of study treatment, AESIs and SAEs will be recorded on the applicable eCRF. Additionally, all SAEs and AESIs requi... | [] |
NCT05351164 | 8.2 | Definition of Adverse Events | 8.2 Definition of Adverse Events An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the study product. An undesirable medical condition can be sympto... | [] |
NCT05351164 | 8.3 | Definition of Adverse Events of Special Interest | 8.3 Definition of Adverse Events of Special Interest AESIs include the following: - All serious and severe infections (regardless of suspicion of loss of endogenous leptin or metreleptin action) - Potential Hy's Law events (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] ≥3× upper limit of normal [UL... | [] |
NCT05351164 | 8.4 | Definition of Serious Adverse Events | 8.4 Definition of Serious Adverse Events An SAE is an AE occurring during any study phase (i.e., period between ICF and first administration of study treatment, treatment, withdrawal, follow-up), that fulfills one or more of the following criteria: - Results in death - Is immediately life-threatening defined as an even... | [] |
NCT05351164 | 8.5 | Recording of Adverse Events | 8.5 Recording of Adverse Events
i) Time Period for Collection of Adverse Events All AEs and SAEs will be collected from the signing of the ICF until the follow-up visit and as soon as informed to the investigator.
ii) Follow-up of Unresolved Adverse Events Any AEs, including SAEs, AEs leading to discontinuation of th... | [
"i) Time Period for Collection of Adverse Events",
"ii) Follow-up of Unresolved Adverse Events",
"iii) Variables",
"iv) Causality Collection",
"v) Collection of Adverse Events Based on Signs and Symptoms",
"vi) Collection of Adverse Events Based on Examinations and Tests",
"vii) Hy's Law",
"vii) Colle... |
NCT05351164 | 8.6 | Reporting of Serious Adverse Events | 8.6 Reporting of Serious Adverse Events All SAEs must be reported whether or not considered causally related to the study treatment, or to the study procedures (Section 8.4). All SAEs will be recorded in the applicable eCRF. If an SAE occurs during the course of the study, then Investigators or other site personnel mus... | [] |
NCT05351164 | 8.7 | Overdose | 8.7 Overdose An overdose is considered a dose of study treatment that exceeds the maximum daily dose of f 10 mg (2 mL) . An overdose is considered a medication error and should be reported on the applicable eCRF as an AESI (Section 8.3). If an overdose fulfills the serious criteria, the SAE should be reported to the Sp... | [] |
NCT05351164 | 8.8 | Reporting Safety Observations by the Investigator to the Sponsor | 8.8 Reporting Safety Observations by the Investigator to the Sponsor The Investigator or site personnel will be responsible for detecting, documenting, and reporting events that meet the definition of an AE, SAE, and AESI. All SAEs and applicable AESIs (as per Section 8.4) collected according to the schedule of study a... | [] |
NCT05351164 | 8.9 | Management of the Study Treatment-related Toxicities | 8.9 Management of the Study Treatment-related Toxicities There have been reports of generalized hypersensitivity (e.g., urticaria or generalized rash) in subjects taking metreleptin. If a hypersensitivity reaction occurs, the Investigator should discuss the proper clinical treatment for the event, including possible di... | [] |
NCT05351164 | 8.10 | Clinical Trial Monitoring | 8.10 Clinical Trial Monitoring To assure adequate protection of the rights of human subjects, per 21 CFR §312.50, 312.53, this study, if deemed to require an IND, will be monitored by the University of Michigan Institute for Clinical and Health Research (MICHR). Routine monitoring will be scheduled at appropriate inter... | [] |
NCT05351164 | 9.0 | STATISTICAL PROCEDURES | 9.0 STATISTICAL PROCEDURES | [] |
NCT05351164 | 9.1 | Analyses and sample size considerations | 9.1 Analyses and sample size considerations With only four subjects, we have not planned formal statistical testing, but we are planning to generate result tables. | [] |
NCT05351164 | 9.2 | Expected results, interpretations, and alternative approaches | 9.2 Expected results, interpretations, and alternative approaches With these methods, we anticipate that we will see weight loss and reduction in the truncal adiposity. We also anticipate improvements in triglyceride levels, insulin resistance and hepatic steatosis. The adipose tissue morphometric and molecular studies... | [] |
NCT05351164 | 10 | SUMMARY AND FUTURE DIRECTIONS | 10. SUMMARY AND FUTURE DIRECTIONS With this study, we will have the opportunity to investigate the effects of Metreleptin on body composition, truncal adiposity, metabolic endpoints, adipose tissue morphometry and gene signatures. This is a pilot study and will inform us if a favorable effect of Metreleptin can be obse... | [] |
NCT05351164 | 11 | ADMINISTRATIVE REQUIREMENTS | 11. ADMINISTRATIVE REQUIREMENTS | [] |
NCT05351164 | 11.1 | Ethical Considerations | 11.1 Ethical Considerations The protocol will be conducted in accordance with ethical principles founded in the Declaration of Helsinki (see Appendix). The IRB/IEC will review all appropriate protocol documentation in order to safeguard the rights, safety, and well-being of the patient. | [] |
NCT05351164 | 11.2 | Patient Information and Informed Consent | 11.2 Patient Information and Informed Consent After the protocol has been fully explained, written informed consent will be obtained from either the patient or his/her guardian or legal representative prior to protocol participation. The method of obtaining and documenting the informed consent and the contents of the c... | [] |
NCT05351164 | 11.3 | Sources of materials | 11.3 Sources of materials Serum and plasma samples, circulating monocytes, and fat biopsy specimens obtained from the patients constitute the study materials. In addition, patients will undergo imaging studies that will be used to determine their body composition, and hepatic fat, as well as elastography. All data coll... | [] |
NCT05351164 | 11.4 | Subject Privacy | 11.4 Subject Privacy The subject interviews during the study visits and administering of study tests will take place in a private room. Results of testing data will be shared with the participant or participant's legally authorized representative if the participant has consented to that. Informed consent documents cont... | [] |
NCT05351164 | 11.5 | Data security | 11.5 Data security
p) Data Storage We will use Research Electronic Data Capture (REDCap). This is a secure web-based application that provides an intuitive interface for data entry, audit trails, automated export and import procedures, and advanced features such as branching logic and calculated fields.
q) Confidenti... | [
"p) Data Storage",
"q) Confidentiality agreements",
"r) c) System controls to limit access to the data",
"s) Computer system security plan",
"t) Virus protection software",
"u) Firewall",
"v) Computer locking",
"w) Physical security",
"x) Securing electronic copies",
"y) Securing paper copies"
] |
NCT05351164 | 11.6 | Publication of Protocol Findings and Use of Information | 11.6 Publication of Protocol Findings and Use of Information The information obtained from the clinical protocol will be disclosed to regulatory authority(ies) and may be disclosed to other Investigators or consultants as required. Subjects' confidentiality will be protected. We have every intention to disseminate thes... | [] |
NCT05351164 | 12.0 | REFERENCES | 12.0 REFERENCES Ajluni, N., R. Meral, A. H. Neidert, G. F. Brady, E. Buras, B. McKenna, F. DiPaola, T. L. Chenevert, J. F. Horowitz, C. Buggs-Saxton, A. R. Rupani, P. E. Thomas, M. K. Tayeh, J. W. Innis, M. B. Omary, H. Conjeevaram and E. A. Oral (2017). "Spectrum of disease associated with partial lipodystrophy: lesso... | [] |
NCT05351164 | 13.0 | APPENDICES | 13.0 APPENDICES
Standardization of Blood Pressure Measurement For BP measurements, the patient will remain in the sitting position for at least 5 minutes before any BP readings are recorded. Systolic and diastolic blood pressures will be determined by averaging three (3) consecutive measurements obtained 2 minutes apa... | [
"Standardization of Blood Pressure Measurement",
"Special Pitfalls and Problems",
"The Auscultatory Gap",
"Effect of Arm Position",
"Large Arm Size",
"Creatinine Clearance Estimate by Cockcroft-Gault Equation",
"HEALTH CARE",
"36-ItemShortForm Survey Instrument(SF-36)",
"RAND 36-Item Health Survey 1... |
NCT05377866 | 1 | Background | 1. Background | [] |
NCT05377866 | 1.1 | CTO | 1.1 CTO Chronic total occlusion (CTO) of one or more coronary vessels are relatively common findings in coronary angiography. One large-scale registry showed that up to 20% of patient with coronary artery disease had a CTO. (1) Compared to percutaneous coronary intervention (PCI) of non-occluded vessel, CTO PCI has a l... | [] |
NCT05377866 | 1.2 | CTO Proctoring | 1.2 CTO Proctoring Several studies have showed a relationship between physician volume and outcomes of percutaneous coronary interventions (PCI) with better outcomes reported for high volume operators when compared with low volume operators.(3) Proctoring in medicine is related to better outcomes. Specifically, in CTO ... | [] |
NCT05377866 | 1.3 | Microsoft HoloLens in proctoring | 1.3 Microsoft HoloLens in proctoring This study aims to evaluate the Microsoft HoloLens as a potential platform in proctoring and effective real time communication between PCI operators located at different geographical locations. The proctor and the local operator interact using a head mounted mixed reality (MR) displ... | [] |
NCT05377866 | 1.4 | Mixed reality in medicine | 1.4 Mixed reality in medicine The Microsoft HoloLens is a mixed reality head mounted display, which allows users to interact with their environment using a Hologram. Mixed reality (MR) like augmented reality (AR) and virtual reality (VR) are defined like extended reality. Extended reality describes the spectrum of virt... | [] |
NCT05377866 | 1.5 | Microsoft HoloLens in medicine | 1.5 Microsoft HoloLens in medicine To our knowledge, this device has never been used in clinical practice connected to interventional cardiology but HoloLens and similar devices have been explored within surgical innovation (7), education in medicine (8) to treat anxiety during procedures (9) and in stroke rehabilitati... | [] |
NCT05377866 | 2 | Study objective | 2. Study objective | [] |
NCT05377866 | 2.1 | Primary objective | 2.1 Primary objective Assess Microsoft HoloLens as an interactive communication device in remote proctoring, and enhancement of teamwork in complex CTO procedures. | [] |
NCT05377866 | 2.2 | Secondary objective | 2.2 Secondary objective - a) To assess image quality, sound quality, multitasking, comfort, sterility, practicality, spatial awareness and possibility of communication with assisting nurse. - b) Can use of HoloLens in CTO procedures increase effectiveness compared with conventional way of communication between operator... | [] |
NCT05377866 | 3 | Methods | 3. Methods | [] |
NCT05377866 | 3.1 | Design | 3.1 Design Feasibility study to asses effectiveness of Microsoft HoloLens as an interactive communications tool in CTO PCI procedures. | [] |
NCT05377866 | 3.2 | Patients | 3.2 Patients Consecutive patients are included based on the following criteria: - 3.2.1 Inclusion criteria - 3.2.1.1 Clinical inclusion criteria - Stable angina pectoris, or dyspnoea as an angina equivalent - Age ≥18 yrs. - Able to provide written informed consent - 3.2.1.2 Angiographic inclusion criteria - One or more... | [] |
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