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## Protocol Section ### Identification Module **NCT ID:** NCT02012179 **Acronym:** SODIUM-HF **Brief Title:** SODIUM-HF: Study of Dietary Intervention Under 100 MMOL in Heart Failure **Official Title:** The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure #### Organization Study ID Info **ID:** MOP130275 #### Organization **Class:** OTHER **Full Name:** University of Alberta ### Status Module #### Completion Date **Date:** 2023-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-01-31 **Type:** ACTUAL **Last Update Submit Date:** 2023-01-30 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-09 **Type:** ACTUAL #### Start Date **Date:** 2014-03-24 **Type:** ACTUAL **Status Verified Date:** 2023-01 #### Study First Post Date **Date:** 2013-12-16 **Type:** ESTIMATED **Study First Submit Date:** 2013-12-10 **Study First Submit QC Date:** 2013-12-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Alberta #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** SODIUM-HF is a multicenter clinical trial in ambulatory patients with chronic HF to evaluate the efficacy of a low sodium containing diet on a composite clinical outcome composed of of all-cause mortality, cardiovascular hospitalizations and cardiovascular emergency department visits. The hypothesis of this study is that patients following a low-sodium containing diet will have fewer clinical events (fewer hospital readmissions or emergency department visits, longer survival) than those randomized to Usual Care. ### Conditions Module **Conditions:** - Heart Failure **Keywords:** - Diet - Dietary sodium reduction - Salt restriction - Nutrition ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 806 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Low sodium diet (65 mmol or 1500 mg/day) **Intervention Names:** - Other: Low sodium diet **Label:** Low sodium diet **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** General advice to limit dietary sodium as it is provided during routine clinic practice **Label:** Usual Care **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Low sodium diet **Description:** Low sodium diet (65 mmol or 1500 mg/day) **Name:** Low sodium diet **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** All-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits **Measure:** Composite Clinical Outcomes **Time Frame:** 12 months #### Secondary Outcomes **Description:** Change in exercise capacity as measured by the 6-minute walk test (6MWT) **Measure:** Exercise capacity **Time Frame:** 12 months **Description:** Change in NYHA class treated as a categorical variable **Measure:** NYHA functional class **Time Frame:** 12 months **Description:** Change in quality of life assessed by the KCCQ **Measure:** Quality of life (KCCQ) **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients recruited if they are 18+ years or older, with confirmed diagnosis of HF (both reduced and preserved systolic function are eligible), NYHA class II-III, and willing to sign informed consent. Exclusion Criteria: Subjects will be excluded if: * Average dietary intake of \<1500 mg/ day by a quantitative or semi-quantitative method * Serum sodium \<130mmol/L * Renal failure (glomerular filtration rate \<30 mL/min) * Hepatic failure * Uncontrolled thyroid disorder * Cardiac device (ICD or CRT) or revascularization procedure (PCI or CABG) in previous month or planned in next 3 months * Hospitalization due to cardiovascular causes in previous 1 month * Uncontrolled atrial fibrillation (resting heart rate \>90 bpm) * Active malignancy * Moderate-severe dementia * Enrolled in another interventional research study * Patients will be excluded, if in the opinion of the investigator, another condition exists that would preclude dietary compliance or compliance with the protocol. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Chermside **Country:** Australia **Facility:** The Prince Charles Hospital **Location 2:** **City:** Darlinghurst **Country:** Australia **Facility:** St. Vincent's Hospital Sydney **Location 3:** **City:** Herston **Country:** Australia **Facility:** Metro North Hospital and Health Service **Location 4:** **City:** Calgary **Country:** Canada **Facility:** University of Calgary / Foothills Medical Centre **State:** Alberta **Location 5:** **City:** Camrose **Country:** Canada **Facility:** St. Mary's Hospital **State:** Alberta **Location 6:** **City:** Edmonton **Country:** Canada **Facility:** University of Alberta Hospital **State:** Alberta **Location 7:** **City:** Red Deer **Country:** Canada **Facility:** Red Deer Regional Hospital **State:** Alberta **Location 8:** **City:** Delta **Country:** Canada **Facility:** Private Cardiology Practice **State:** British Columbia **Location 9:** **City:** Vancouver **Country:** Canada **Facility:** St. Paul's Hospital **State:** British Columbia **Location 10:** **City:** Vancouver **Country:** Canada **Facility:** Vancouver General Hospital **State:** British Columbia **Location 11:** **City:** Winnipeg **Country:** Canada **Facility:** St. Boniface Hospital **State:** Manitoba **Location 12:** **City:** Halifax **Country:** Canada **Facility:** Queen Elizabeth II Health Sciences Centre **State:** Nova Scotia **Location 13:** **City:** Brampton **Country:** Canada **Facility:** Brampton Research Associates **State:** Ontario **Location 14:** **City:** Hamilton **Country:** Canada **Facility:** Hamilton Health Sciences **State:** Ontario **Location 15:** **City:** Newmarket **Country:** Canada **Facility:** Southlake Regional Health Centre **State:** Ontario **Location 16:** **City:** Thunder Bay **Country:** Canada **Facility:** Curans Heart Centre **State:** Ontario **Location 17:** **City:** Toronto **Country:** Canada **Facility:** St. Michael's Hospital **State:** Ontario **Location 18:** **City:** Toronto **Country:** Canada **Facility:** Toronto General Hospital **State:** Ontario **Location 19:** **City:** Regina **Country:** Canada **Facility:** Prairie Vascular Research Inc. **State:** Saskatchewan **Location 20:** **City:** Saskatoon **Country:** Canada **Facility:** Royal University Hospital **State:** Saskatchewan **Location 21:** **City:** Osorno **Country:** Chile **Facility:** Hospital Base Osorno **Location 22:** **City:** Temuco **Country:** Chile **Facility:** Centro de estudios cardiologicas y de Medicine Interna Ltda (Centre for Cardiology and Internal Medicine Studies) **Location 23:** **City:** Mexico City **Country:** Mexico **Facility:** Unidad de Investigación en Epidemiología Clínica Hospital General Regional No. 1, IMSS **Location 24:** **City:** Auckland **Country:** New Zealand **Facility:** Middlemore Clinical Trials **Location 25:** **City:** Auckland **Country:** New Zealand **Facility:** University of Auckland **Location 26:** **City:** Christchurch **Country:** New Zealand **Facility:** Christchurch Heart Institute / University of Otago #### Overall Officials **Official 1:** **Affiliation:** University of Alberta **Name:** Justin Ezekowitz, MBBCh **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Ezekowitz JA, Colin-Ramirez E, Ross H, Escobedo J, Macdonald P, Troughton R, Saldarriaga C, Alemayehu W, McAlister FA, Arcand J, Atherton J, Doughty R, Gupta M, Howlett J, Jaffer S, Lavoie A, Lund M, Marwick T, McKelvie R, Moe G, Pandey AS, Porepa L, Rajda M, Rheault H, Singh J, Toma M, Virani S, Zieroth S; SODIUM-HF Investigators. Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomised, controlled trial. Lancet. 2022 Apr 9;399(10333):1391-1400. doi: 10.1016/S0140-6736(22)00369-5. Epub 2022 Apr 2. Erratum In: Lancet. 2022 Oct 8;400(10359):1194. **PMID:** 35381194 **Citation:** Colin-Ramirez E, Ezekowitz JA; SODIUM-HF investigators. Rationale and design of the Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF). Am Heart J. 2018 Nov;205:87-96. doi: 10.1016/j.ahj.2018.08.005. Epub 2018 Aug 16. **PMID:** 30205241 #### See Also Links **Label:** SODIUM-HF Webpage **URL:** https://www.sodiumhftrial.com/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00003979 **Brief Title:** CHS 828 in Treating Patients With Solid Tumors **Official Title:** Phase I and Pharmacokinetics Study to Determine the Safety of CHS 828 in Patients With a Solid Tumor on a Single Oral Dose Repeated Every 3 Weeks #### Organization Study ID Info **ID:** EORTC-16985 #### Organization **Class:** NETWORK **Full Name:** European Organisation for Research and Treatment of Cancer - EORTC #### Secondary ID Infos **ID:** EORTC-16985 ### Status Module #### Expanded Access Info #### Last Update Post Date **Date:** 2012-07-11 **Type:** ESTIMATED **Last Update Submit Date:** 2012-07-10 **Overall Status:** WITHDRAWN #### Start Date **Date:** 1999-04 **Status Verified Date:** 2012-07 #### Study First Post Date **Date:** 2003-01-27 **Type:** ESTIMATED **Study First Submit Date:** 1999-11-01 **Study First Submit QC Date:** 2003-01-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NETWORK **Name:** European Organisation for Research and Treatment of Cancer - EORTC #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of CHS 828 in treating patients who have solid tumors. **Detailed Description:** OBJECTIVES: * Determine the maximum tolerated dose of oral CHS 828 in patients with solid tumors. * Determine the qualitative and quantitative toxic effects of this regimen in these patients. * Determine a safe dose of this regimen for phase II evaluation. * Determine the pharmacokinetic profile of this regimen in these patients. * Determine any antitumor activity in these patients. OUTLINE: Patients receive oral CHS 828 every 3 weeks. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CHS 828 until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity. Patients are followed for up to 4 weeks. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12 months. ### Conditions Module **Conditions:** - Unspecified Adult Solid Tumor, Protocol Specific **Keywords:** - unspecified adult solid tumor, protocol specific ### Design Module #### Design Info **Primary Purpose:** TREATMENT #### Enrollment Info **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** CHS 828 **Type:** DRUG ### Eligibility Module **Eligibility Criteria:** DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumor not amenable to standard therapy * No symptomatic brain or leptomeningeal involvement PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * WHO 0-2 Life expectancy: * At least 3 months Hematopoietic: * WBC at least 4,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 1.5 mg/dL * Other liver function tests no greater than 2 times upper limit of normal (unless related to liver metastases) Renal: * Creatinine no greater than 1.4 mg/dL Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No active bacterial infection * No other nonmalignant disease * No alcoholism, drug addiction, or psychiatric disorders * Able to take oral medication PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy (6 weeks since extensive radiotherapy) * No concurrent radiotherapy (except palliative radiotherapy) Surgery: * Not specified Other: * No other concurrent investigational drugs * No other concurrent antitumor drugs **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Innsbruck **Country:** Austria **Facility:** Innsbruck Universitaetsklinik **Zip:** A-6020 **Location 2:** **City:** Vienna **Country:** Austria **Facility:** Kaiser Franz Josef Hospital **Zip:** A-1100 **Location 3:** **City:** Brussels **Country:** Belgium **Facility:** Institut Jules Bordet **Zip:** B-1000 **Location 4:** **City:** Brussels **Country:** Belgium **Facility:** Ludwig Institute for Cancer Research **Zip:** B-1200 **Location 5:** **City:** Edegem **Country:** Belgium **Facility:** Universitair Ziekenhuis Antwerpen **Zip:** B-2650 **Location 6:** **City:** Leuven **Country:** Belgium **Facility:** U.Z. Gasthuisberg **Zip:** B-3000 **Location 7:** **City:** Copenhagen **Country:** Denmark **Facility:** Herlev Hospital - University Hospital of Copenhagen **Zip:** DK-2730 **Location 8:** **City:** Bordeaux **Country:** France **Facility:** Institut Bergonie **Zip:** 33076 **Location 9:** **City:** Clermont-Ferrand **Country:** France **Facility:** Centre Jean Perrin **Zip:** 63011 **Location 10:** **City:** Lyon **Country:** France **Facility:** Centre Leon Berard **Zip:** 69373 **Location 11:** **City:** Nantes-Saint Herblain **Country:** France **Facility:** CRLCC Nantes - Atlantique **Zip:** 44805 **Location 12:** **City:** Toulouse **Country:** France **Facility:** Institut Claudius Regaud **Zip:** 31052 **Location 13:** **City:** Villejuif **Country:** France **Facility:** Institut Gustave Roussy **Zip:** F-94805 **Location 14:** **City:** Essen **Country:** Germany **Facility:** Universitaetsklinik und Strahlenklinik - Essen **Zip:** D-45122 **Location 15:** **City:** Nuremberg **Country:** Germany **Facility:** Klinikum Nuernberg - Klinikum Nord **Zip:** 90340 **Location 16:** **City:** Amsterdam **Country:** Netherlands **Facility:** Vrije Universiteit Medisch Centrum **Zip:** 1001HV **Location 17:** **City:** Amsterdam **Country:** Netherlands **Facility:** Antoni van Leeuwenhoekhuis **Zip:** 1066 CX **Location 18:** **City:** Groningen **Country:** Netherlands **Facility:** Academisch Ziekenhuis Groningen **Zip:** 9700 RB **Location 19:** **City:** Nijmegen **Country:** Netherlands **Facility:** University Medical Center Nijmegen **Zip:** NL-6500 HB **Location 20:** **City:** Rotterdam **Country:** Netherlands **Facility:** Erasmus Medical Center **Zip:** 3075 EA **Location 21:** **City:** Oslo **Country:** Norway **Facility:** Norwegian Radium Hospital **Zip:** N-0310 **Location 22:** **City:** Basel **Country:** Switzerland **Facility:** University Hospital **Zip:** CH-4031 **Location 23:** **City:** Bern **Country:** Switzerland **Facility:** Inselspital, Bern **Zip:** CH-3010 **Location 24:** **City:** St. Gallen **Country:** Switzerland **Facility:** Kantonsspital - St. Gallen **Zip:** CH-9007 **Location 25:** **City:** Newcastle Upon Tyne **Country:** United Kingdom **Facility:** Newcastle General Hospital **State:** England **Zip:** NE4 6BE **Location 26:** **City:** Dundee **Country:** United Kingdom **Facility:** Ninewells Hospital and Medical School **State:** Scotland **Zip:** DD1 9SY **Location 27:** **City:** Edinburgh **Country:** United Kingdom **Facility:** Western General Hospital **State:** Scotland **Zip:** EH4 2XU **Location 28:** **City:** Glasgow **Country:** United Kingdom **Facility:** C.R.C. Beatson Laboratories **State:** Scotland **Zip:** G61 1BD #### Overall Officials **Official 1:** **Affiliation:** Cantonal Hospital of St. Gallen **Name:** Thomas Cerny, MD **Role:** STUDY_CHAIR ### References Module #### References **Citation:** Ravaud A, Cerny T, Terret C, Wanders J, Bui BN, Hess D, Droz JP, Fumoleau P, Twelves C. Phase I study and pharmacokinetic of CHS-828, a guanidino-containing compound, administered orally as a single dose every 3 weeks in solid tumours: an ECSG/EORTC study. Eur J Cancer. 2005 Mar;41(5):702-7. doi: 10.1016/j.ejca.2004.12.023. **PMID:** 15763645 ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06059079 **Brief Title:** Using Higher Cut-off Values to Diagnose Acute Myocardial Infarction in Patients With Elevated Hs-cTnT Concentrations **Official Title:** Using Higher Cut-off Values to Diagnose Acute Myocardial Infarction in Patients With Elevated Hs-cTnT Concentrations #### Organization Study ID Info **ID:** 023 #### Organization **Class:** OTHER **Full Name:** The First Affiliated Hospital with Nanjing Medical University ### Status Module #### Completion Date **Date:** 2023-05-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-09-28 **Type:** ACTUAL **Last Update Submit Date:** 2023-09-26 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-05-31 **Type:** ACTUAL #### Start Date **Date:** 2015-01-01 **Type:** ACTUAL **Status Verified Date:** 2023-09 #### Study First Post Date **Date:** 2023-09-28 **Type:** ACTUAL **Study First Submit Date:** 2023-09-20 **Study First Submit QC Date:** 2023-09-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The First Affiliated Hospital with Nanjing Medical University #### Responsible Party **Investigator Affiliation:** The First Affiliated Hospital with Nanjing Medical University **Investigator Full Name:** Chunjian Li **Investigator Title:** Director of Cardiology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** High-sensitive cardiac troponin T (hs-cTnT) is a cornerstone for diagnosing acute myocardial infarction (AMI). However, it is often challenging to diagnose AMI in patients with elevated hs-cTnT before a rise or fall of hs-cTnT can be observed. The elevations of hs-cTnT are caused not only by AMI, but also by other cardiac or even non-cardiac diseases. Thresholds above the 99th percentile have been proposed to improve the specificity and to accelerate the rule in of myocardial infarction. This study aimed to find a more accurate cut-off value to rule in AMI in patients with elevated hs-cTnT. **Detailed Description:** Acute myocardial infarction (AMI) is a major cause of morbidity and mortality worldwide. In real clinical practice, early and accurate recognition of AMI is crucial to accelerate effective reperfusion therapy. High-sensitivity cardiac troponin T (hs-cTnT) is an important protein that regulates cardiomyocytes excitability, which can be proliferated in cardiomyocytes and released into the blood after myocardial injury or infarction. According to the fourth universal definition of AMI, a rise and/or fall of cTn values with at least one value above the 99th percentile URL is the essential precondition for diagnosing AMI. However, it is challenging for clinicians to diagnose AMI in patients with elevated hs-cTnT levels before a rise and/or fall of hs-cTnT values can be observed, particularly for those who present atypical symptoms and non-significant changes in electrocardiograms (ECG). When the 99th percentile upper reference limit (URL) is referred, it happens frequently that the elevations of hs-cTnT are not caused by AMI, but by other cardiac or even non-cardiac diseases. Therefore, thresholds above the 99th percentile have been proposed to improve the specificity and to accelerate the rule in of myocardial infarction. This study aimed to find a higher and more accurate cut-off value of hs-cTnT to rule in AMI in a large volume of patients with elevated hs-cTnT. ### Conditions Module **Conditions:** - Acute Myocardial Infarction **Keywords:** - Acute Myocardial Infarction - High sensitivity cardiac troponin T - Rule in ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 80000 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: No Intervention **Label:** Elevated hs-cTnT group ### Interventions #### Intervention 1 **Arm Group Labels:** - Elevated hs-cTnT group **Description:** No Intervention **Name:** No Intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Number of patients diagnosed with acute myocardial infarction **Time Frame:** Within 3 days of experiencing chest pain, electrocardiogram changes, or abnormal hs-cTnT values. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients hospitalized from January 1,2015 to May 31,2023 in the First Affiliated Hospital of Nanjing Medical University with hs-cTnT concentrations over 14.0 ng/L were enrolled. Exclusion Criteria: * Patients who underwent major cardiac surgeries during the hospitalization. **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Inpatients' data were obtained from hospital's Clinical Data Repository (CDR), which integrates patients' baseline characteristics, laboratory results, clinical diagnosis, and treatment information during the index hospitalization. And all of the patients hospitalized from January 1,2015 to May 31,2023 in the First Affiliated Hospital of Nanjing Medical University with hs-cTnT concentrations over 14.0 ng/L were enrolled. ### Contacts Locations Module #### Locations **Location 1:** **City:** Nanjing **Country:** China **Facility:** The First Affiliated Hospital of Nanjing Medical University **State:** Jiangsu **Zip:** 210029 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Roth GA, Forouzanfar MH, Moran AE, Barber R, Nguyen G, Feigin VL, Naghavi M, Mensah GA, Murray CJ. Demographic and epidemiologic drivers of global cardiovascular mortality. N Engl J Med. 2015 Apr 2;372(14):1333-41. doi: 10.1056/NEJMoa1406656. **PMID:** 25830423 **Citation:** Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available. Erratum In: Circulation. 2020 Jan 14;141(2):e33. **PMID:** 30700139 **Citation:** Sandoval Y, Lewis BR, Mehta RA, Ola O, Knott JD, De Michieli L, Akula A, Lobo R, Yang EH, Gharacholou SM, Dworak M, Crockford E, Rastas N, Grube E, Karturi S, Wohlrab S, Hodge DO, Tak T, Cagin C, Gulati R, Jaffe AS. Rapid Exclusion of Acute Myocardial Injury and Infarction With a Single High-Sensitivity Cardiac Troponin T in the Emergency Department: A Multicenter United States Evaluation. Circulation. 2022 Jun 7;145(23):1708-1719. doi: 10.1161/CIRCULATIONAHA.122.059235. Epub 2022 May 10. **PMID:** 35535607 **Citation:** Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. No abstract available. **PMID:** 30153967 **Citation:** Eggers KM, Hammarsten O, Aldous SJ, Cullen L, Greenslade JH, Lindahl B, Parsonage WA, Pemberton CJ, Pickering JW, Richards AM, Troughton RW, Than MP. Diagnostic and prognostic performance of the ratio between high-sensitivity cardiac troponin I and troponin T in patients with chest pain. PLoS One. 2022 Nov 1;17(11):e0276645. doi: 10.1371/journal.pone.0276645. eCollection 2022. **PMID:** 36318533 **Citation:** Nestelberger T, Boeddinghaus J, Gimenez MR, Lopez-Ayala P, Ratmann PD, Badertscher P, Wildi K, Wussler D, Koechlin L, Arslani K, Zimmermann T, Freese M, Rinderknecht T, Miro O, Martin-Sanchez FJ, Kawecki D, Geigy N, Keller D, Twerenbold R, Muller C; APACE investigators. Direct comparison of high-sensitivity cardiac troponin T and I in the early differentiation of type 1 vs. type 2 myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2022 Jan 12;11(1):62-74. doi: 10.1093/ehjacc/zuab039. **PMID:** 34195803 **Citation:** Wereski R, Kimenai DM, Taggart C, Doudesis D, Lee KK, Lowry MTH, Bularga A, Lowe DJ, Fujisawa T, Apple FS, Collinson PO, Anand A, Chapman AR, Mills NL. Cardiac Troponin Thresholds and Kinetics to Differentiate Myocardial Injury and Myocardial Infarction. Circulation. 2021 Aug 17;144(7):528-538. doi: 10.1161/CIRCULATIONAHA.121.054302. Epub 2021 Jun 25. **PMID:** 34167318 **Citation:** Collet JP, Thiele H, Barbato E, Barthelemy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Juni P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Sibbing D, Siontis GCM; ESC Scientific Document Group. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021 Apr 7;42(14):1289-1367. doi: 10.1093/eurheartj/ehaa575. No abstract available. Erratum In: Eur Heart J. 2021 May 14;42(19):1908. Eur Heart J. 2021 May 14;42(19):1925. Eur Heart J. 2021 May 13;: Eur Heart J. 2024 Feb 1;45(5):404-405. **PMID:** 32860058 **Citation:** China Society of Cardiology of Chinese Medical Association; Editorial Board of Chinese Journal of Cardiology. [Guideline for diagnosis and treatment of patients with ST-elevation myocardial infarction]. Zhonghua Xin Xue Guan Bing Za Zhi. 2010 Aug;38(8):675-90. No abstract available. Chinese. **PMID:** 21055132 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007511 - Term: Ischemia - ID: D000010335 - Term: Pathologic Processes - ID: D000009336 - Term: Necrosis - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M12155 - Name: Myocardial Infarction - Relevance: HIGH - As Found: Myocardial Infarction - ID: M10282 - Name: Infarction - Relevance: HIGH - As Found: Infarction - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M12284 - Name: Necrosis - Relevance: LOW - As Found: Unknown - ID: M6546 - Name: Coronary Artery Disease - Relevance: LOW - As Found: Unknown - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009203 - Term: Myocardial Infarction - ID: D000007238 - Term: Infarction ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02936479 **Brief Title:** C1-Inhibitor (INH) for Refractory Antibody Mediated Renal Allograft Rejection **Official Title:** Use of C1-INH (Berinert) for Renal Allograft Salvage in Refractory Antibody Mediated Rejection #### Organization Study ID Info **ID:** 16-01851 #### Organization **Class:** OTHER **Full Name:** NYU Langone Health ### Status Module #### Completion Date **Date:** 2018-10-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-07-11 **Type:** ACTUAL **Last Update Submit Date:** 2019-07-10 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-10-30 **Type:** ACTUAL #### Results First Post Date **Date:** 2019-07-11 **Type:** ACTUAL **Results First Submit Date:** 2018-12-24 **Results First Submit QC Date:** 2019-07-10 #### Start Date **Date:** 2016-10 **Type:** ACTUAL **Status Verified Date:** 2019-07 #### Study First Post Date **Date:** 2016-10-18 **Type:** ESTIMATED **Study First Submit Date:** 2016-10-14 **Study First Submit QC Date:** 2016-10-14 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** CSL Behring #### Lead Sponsor **Class:** OTHER **Name:** NYU Langone Health #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is an open-label, single arm trial in which patient who have ongoing antibody mediated rejection of a kidney transplant deemed refractory to maximal medical therapy are given the complement inhibitor C1-INH (Berinert) in an effort to protect the graft from ongoing antibody mediated injury. A maximum of 5 patients will be enrolled. ### Conditions Module **Conditions:** - Antibody Mediated Rejection of Kidney Transplant ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 1 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: C1-INH (Berinert) **Label:** Berinert treatment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Berinert treatment **Name:** C1-INH (Berinert) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** number of patients that presented with severe and refractory Antibody Mediated Renal (AMR) following kidney transplant and survived beyond one year after study drug administration **Measure:** Renal Allograft Survival Measured by Severe and Refractory Antibody Mediated Renal (AMR) **Time Frame:** 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Kidney transplant with acute antibody mediated rejection refractory to standard therapy Exclusion Criteria: * Patients with known intolerance of or anaphylaxis to Berinert **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** New York **Country:** United States **Facility:** New York University School of Medicine **State:** New York **Zip:** 10016 #### Overall Officials **Official 1:** **Affiliation:** NYU Langone Health **Name:** Robert Montgomery, MD **Role:** PRINCIPAL_INVESTIGATOR ## Document Section ### Large Document Module #### Large Docs - Date: 2016-10-28 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 750513 - Type Abbrev: Prot_SAP - Upload Date: 2018-12-20T14:36 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M27584 - Name: Angioedemas, Hereditary - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000051056 - Term: Complement Inactivating Agents - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M26365 - Name: Complement C1 Inhibitor Protein - Relevance: HIGH - As Found: Reboxetine - ID: M6392 - Name: Complement System Proteins - Relevance: LOW - As Found: Unknown - ID: M6401 - Name: Complement C1 Inactivator Proteins - Relevance: HIGH - As Found: Reboxetine - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000003174 - Term: Complement C1 Inactivator Proteins - ID: D000050718 - Term: Complement C1 Inhibitor Protein ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Berinert Treatment **Deaths Num At Risk:** 1 **Description:** C1-INH (Berinert) **ID:** EG000 **Other Num Affected:** 1 **Other Num at Risk:** 1 **Serious Number At Risk:** 1 **Title:** Berinert Treatment **Frequency Threshold:** 0 #### Other Events **Term:** skin infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** left posterior extremity skin infection **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** **Term:** urinary tract infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** klebsiella pneumoniae urinary tract infection **Organ System:** Renal and urinary disorders **Source Vocabulary:** **Time Frame:** 17 months ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 1 **Units:** Participants ### Group **ID:** BG000 **Title:** Berinert Treatment **Description:** C1-INH (Berinert) ### Measure #### Measurement **Group ID:** BG000 **Value:** 1 **Class Title:** 54 Years Old ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 1 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 1 **Category Title:** Not Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 1 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 1 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Customized **Unit of Measure:** Participants ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Ethnicity (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 5 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement **PI Sponsor Employee:** True ### Point of Contact **Email:** Cecilia.Deterville@nyulangone.org **Organization:** NYU Langone Health- Transplant Institute **Phone:** 212.263.3620 **Title:** Cecilia Deterville, MS, CCRC ## Results Section - Outcome Measures Module ### Outcome Measure 1 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** number of patients that presented with severe and refractory Antibody Mediated Renal (AMR) following kidney transplant and survived beyond one year after study drug administration **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** 24 months **Title:** Renal Allograft Survival Measured by Severe and Refractory Antibody Mediated Renal (AMR) **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** C1-INH (Berinert) **ID:** OG000 **Title:** Berinert Treatment ### Participant Flow Module #### Group **Description:** C1-Inhibitor (INH) (Berinert): C1 esterase inhibitor, Berinert, 25-50 units/kg, intravenous, 7 doses on days 1, 3, 5, 7, 9, 11, 13 and 50 units/kg twice weekly for a total study period of 6 months. **ID:** FG000 **Title:** Berinert Treatment #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 1 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 1 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT01887379 **Brief Title:** Magnetic Marker Monitoring of Furosemide-containing Gastroretentive Formulation in Healthy Male Subjects (Fasting and Fed Conditions) **Official Title:** Characterisation of Gastric Residence of a Furosemide-containing New Gastric Retention System by Means of MMM Measurement and Determination of Pharmacokinetics, Pharmacodynamics and Safety #### Organization Study ID Info **ID:** LTS 03/10 #### Organization **Class:** INDUSTRY **Full Name:** LTS Lohmann Therapie-Systeme AG #### Secondary ID Infos **ID:** 2013-001063-23 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2013-08 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2013-12-12 **Type:** ESTIMATED **Last Update Submit Date:** 2013-12-11 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2013-08 **Type:** ACTUAL #### Start Date **Date:** 2013-06 **Status Verified Date:** 2013-12 #### Study First Post Date **Date:** 2013-06-26 **Type:** ESTIMATED **Study First Submit Date:** 2013-06-24 **Study First Submit QC Date:** 2013-06-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** LTS Lohmann Therapie-Systeme AG #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Furosemide is a diuretic drug, used in the treatment of oedematous states associated with cardiac, renal, and hepatic disorder, and may be effective in patients unresponsive to thiazide diuretics. Furosemide is also used in the treatment of hypertension. Absorption of furosemide from the gastrointestinal tract is fairly rapid; bioavailability is 60-70%, but variable and not predictable, with large intra- and inter-individual variability, and are influenced by dosage form, underlying diseases, and by the presence of food after oral administration. Data from animal model show that furosemide administered into the stomach is more rapidly absorbed than if is administered into the small intestine. To increase the residency of furosemide in the stomach after oral administration, a gastroretentive dosage form (GRDF) of furosemide has been developed. In the current study, the new formulation (30mg furosemide coated tablet) will be tested in healthy male subjects. Absorption will be characterised by an effective and safe imaging technique - Magnetic Marker Monitoring (MMM), based on Fe3O4 added to the drug product to generate magnetic signal that can be used for up to 12 h after furosemide administration to localize the medication in the gastrointestinal tract. Fe3O4 is frequently used as colouring pigment in medicinal products. It does not exhibit own pharmacodynamic activity and is considered as an inactive ingredient. In the current study, GRDF formulation of furosemide will be evaluated for: gastric residence as well as pharmacokinetic and pharmacodynamic characteristics under fasting and fed conditions. As part of the study, the subjects will be hospitalized for 1 day during each drug administration. The duration of the stay will depend on the intestinal behaviour of the investigational product. **Detailed Description:** Furosemide is a diuretic drug, widely used in the treatment of oedematous states associated with cardiac, renal, and hepatic disorder, and may be effective in patients unresponsive to thiazide diuretics. Furosemide is also used in the treatment of hypertension. Absorption of furosemide from the gastrointestinal tract is fairly rapid. Bioavailability is reported as 60-70%, but is variable and not predictable. The rate and extent of absorption show a large intra- and inter-individual variability and are influenced by dosage form, underlying diseases, and by the presence of food after oral administration. Results obtained with an animal model indicate that furosemide administered into the stomach is more rapidly absorbed than if is is administered into the small intestine. To increase the residency of furosemide in the stomach after oral administration, a gastroretentive dosage form (GRDF) of furosemide has been developed. In this study, the new formulation(30mg furosemide coated tablet) will be tested in healthy male subjects. Absorption will be characterised by imaging technique - Magnetic Marker Monitoring (MMM), which is the most effective and safe imaging technique currently available. MMM is based on a iron-III-oxide (Fe3O4) added to the drug product to generate magnetic signal that can be used to localize the administered medication in the gastrointestinal tract. Fe3O4 is frequently used as colouring pigment in medicinal products. It does not exhibit own pharmacodynamic activity and thus, it is considered as clinically inactive ingredient. Fe3O4 exhibits a dipole moment and thus, after magnetisation of solid oral dosage forms containing homogenously distributed Fe3O4, the product generates a magnetic signal, which can be used for localisation of the dosage form in the gastrointestinal tract by Magnetic Marker Monitoring technique. The aim of the current study is to evaluate the GRDF formulation of furosemide for: gastric residence, pharmacokinetic and pharmacodynamic characteristics under fasting and fed conditions. As part of the study, the subjects will be hospitalized for 1 day during each drug administration (i.e. a total of two days). The duration of the stay will depend on the intestinal behaviour of the investigational product. The MMM monitoring be performed for up to 12 h after furosemide administration. For pharmacokinetic determinations, liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) will be used to analyze furosemide in plasma. ### Conditions Module **Conditions:** - Gastroretentive Drug Formulation of Furosemide - Oedema **Keywords:** - Gastroretentive drug formulation - Furosemide - Magnetic Marker Monitoring - Magnetic marker - Oedema ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects will be tested under fasting conditions after administration of GRDF Furosemide. **Intervention Names:** - Drug: GRDF furosemide **Label:** GRDF furosemide fasting conditions **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Subjects will be tested under fed conditions after administration of GRDF Furosemide. **Intervention Names:** - Drug: GRDF furosemide **Label:** GRDF furosemide fed conditions **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - GRDF furosemide fasting conditions - GRDF furosemide fed conditions **Description:** The GRDF furosemide tablet contains Fe3O4, which serves as an inactive magnetic marker to allow monitoring of the tablet transit through the gastrointestinal tract, using the MMM imaging technique. **Name:** GRDF furosemide **Other Names:** - GRDF furosemide is a gastro retentive dosage form of furesomide **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Residency time of GRDF furosemide in the gastrointestinal track will be monitored using the non-invasive MMM technique under fasted and fed conditions. Measurements will start after each administration and last until 2 hours after gastric emptying indicated by the MMM measurement, but not longer than 12 h post administration. Each observation interval for each subject will last for a minimum of 10 min followed by a break of maximum 20 min. For meal intake, a break of the MMM measuring of 30 minutes will be performed. Anatomical localisation within the measuring sequences will be listed for each subject and treatment Statistical evaluation of gastric emptying time will include: arithmetic means, medians, minimum , maximum, standard deviation. GRDF=Gastro retentive dosage formulation **Measure:** Residency time of GRDF furosemide in the gastrointestinal tract, evaluated with MMM technique, under fasted and fed conditions. **Time Frame:** every 30 min for up to 12 h after drug administration; maximal observation time 12 h #### Secondary Outcomes **Description:** Characterization of the pharmacokinetic (PK) properties of GRDF furosemide, with special focus on the absorption phase of furosemide. Compare results during fasted and fed state. Blood samples for the determination of furosemide concentration will be taken at pre-dose (within 1 h prior to administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after administration. LC-MS/MS will be used to analyze furosemide in plasma. Cmax = maximum concentration in plasma; GRDF=Gastro retentive dosage formulation **Measure:** Cmax of GRDF furosemide under fasted conditions **Time Frame:** pre-dose (within 1 h prior to drug administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after drug administration. **Description:** Characterization of the pharmacokinetic (PK) properties of GRDF furosemide, with special focus on the absorption phase of furosemide. Compare results during fasted and fed state. Blood samples for the determination of furosemide concentration will be taken at pre-dose (within 1 h prior to administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after administration. LC-MS/MS will be used to analyze furosemide in plasma. Cmax = maximum concentration in plasma; GRDF=Gastro retentive dosage formulation **Measure:** Cmax of GRDF furosemide under fed conditions **Time Frame:** pre-dose (within 1 h prior to drug administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after drug administration. **Description:** Characterization of the pharmacokinetic (PK) properties of GRDF furosemide, with special focus on the absorption phase of furosemide. Compare results during fasted and fed state. Blood samples for the determination of furosemide concentration will be taken at pre-dose (within 1 h prior to administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after administration. LC-MS/MS will be used to analyze furosemide in plasma. tmax = time to reach maximum concentration in plasma; GRDF=Gastro retentive dosage formulation **Measure:** tmax of GRDF furosemide under fasted conditions **Time Frame:** pre-dose (within 1 h prior to drug administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after drug administration. **Description:** Characterization of the pharmacokinetic (PK) properties of GRDF furosemide, with special focus on the absorption phase of furosemide. Compare results during fasted and fed state. Blood samples for the determination of furosemide concentration will be taken at pre-dose (within 1 h prior to administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after administration. LC-MS/MS will be used to analyze furosemide in plasma. tmax = time to reach maximum concentration in plasma; GRDF=Gastro retentive dosage formulation **Measure:** tmax of GRDF furosemide under fed conditions **Time Frame:** pre-dose (within 1 h prior to drug administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after drug administration. **Description:** Characterization of the pharmacokinetic (PK) properties of GRDF furosemide, with special focus on the absorption phase of furosemide. Compare results during fasted and fed state. Blood samples for the determination of furosemide concentration will be taken at pre-dose (within 1 h prior to administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after administration. LC-MS/MS will be used to analyze furosemide in plasma. t1/2 = apparent terminal elimination half-life; GRDF=Gastro retentive dosage formulation **Measure:** t1/2 of GRDF furosemide under fasted conditions **Time Frame:** pre-dose (within 1 h prior to drug administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after drug administration. **Description:** Characterization of the pharmacokinetic (PK) properties of GRDF furosemide, with special focus on the absorption phase of furosemide. Compare results during fasted and fed state. Blood samples for the determination of furosemide concentration will be taken at pre-dose (within 1 h prior to administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after administration. LC-MS/MS will be used to analyze furosemide in plasma. t1/2 = apparent terminal elimination half-life; GRDF=Gastro retentive dosage formulation **Measure:** t1/2 of GRDF furosemide under fed conditions **Time Frame:** pre-dose (within 1 h prior to drug administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after drug administration. **Description:** Characterization of the pharmacokinetic (PK) properties of GRDF furosemide, with special focus on the absorption phase of furosemide. Compare results during fasted and fed state. Blood samples for the determination of furosemide concentration will be taken at pre-dose (within 1 h prior to administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after administration. LC-MS/MS will be used to analyze furosemide in plasma. AUC0 = area under the plasma concentration vs. time curve from dosing time to the last measurement time point with a concentration value above the lower limit of quantitation, calculated by means of the linear up/log down method (linear trapezoidal rule for increases in concentration/logarithmic trapezoidal rule for decreases in concentrations; GRDF=Gastro retentive dosage formulation **Measure:** AUC0-tlast of GRDF furosemide under fasted conditions **Time Frame:** pre-dose (within 1 h prior to drug administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after drug administration. **Description:** Characterization of the pharmacokinetic (PK) properties of GRDF furosemide, with special focus on the absorption phase of furosemide. Compare results during fasted and fed state. Blood samples for the determination of furosemide concentration will be taken at pre-dose (within 1 h prior to administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after administration. LC-MS/MS will be used to analyze furosemide in plasma. AUC0-tlast = area under the plasma concentration vs. time curve from dosing time to the last measurement time point with a concentration value above the lower limit of quantitation, calculated by means of the linear up/log down method (linear trapezoidal rule for increases in concentration/logarithmic trapezoidal rule for decreases in concentrations; GRDF=Gastro retentive dosage formulation **Measure:** AUC0-tlast of GRDF furosemide under fed conditions **Time Frame:** pre-dose (within 1 h prior to drug administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after drug administration. **Description:** Characterization of the pharmacokinetic (PK) properties of GRDF furosemide, with special focus on the absorption phase of furosemide. Compare results during fasted and fed state. Blood samples for the determination of furosemide concentration will be taken at pre-dose (within 1 h prior to administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after administration. LC-MS/MS will be used to analyze furosemide in plasma. AUC0-infinity = AUC0-tlast + AUCexpol; GRDF=Gastro retentive dosage formulation **Measure:** AUC 0-infinity of GRDF furosemide under fasted conditions **Time Frame:** pre-dose (within 1 h prior to drug administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after drug administration. **Description:** Characterization of the pharmacokinetic (PK) properties of GRDF furosemide, with special focus on the absorption phase of furosemide. Compare results during fasted and fed state. Blood samples for the determination of furosemide concentration will be taken at pre-dose (within 1 h prior to administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after administration. LC-MS/MS will be used to analyze furosemide in plasma. AUC0-infinity = AUC0-tlast + AUCexpol; GRDF=Gastro retentive dosage formulation **Measure:** AUC 0-infinity of GRDF furosemide under fed conditions **Time Frame:** pre-dose (within 1 h prior to drug administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after drug administration. **Description:** Characterization of the pharmacokinetic (PK) properties of GRDF furosemide, with special focus on the absorption phase of furosemide. Compare results during fasted and fed state. Blood samples for the determination of furosemide concentration will be taken at pre-dose (within 1 h prior to administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after administration. LC-MS/MS will be used to analyze furosemide in plasma. AUCextrapol = AUCextrapolated = Clast/lamda; lamda = apparent terminal elimination rate constant determined by log-linear regression; GRDF=Gastro retentive dosage formulation **Measure:** AUCextrapol of GRDF furosemide under fasted conditions **Time Frame:** pre-dose (within 1 h prior to drug administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after drug administration. **Description:** Characterization of the pharmacokinetic (PK) properties of GRDF furosemide, with special focus on the absorption phase of furosemide. Compare results during fasted and fed state. Blood samples for the determination of furosemide concentration will be taken at pre-dose (within 1 h prior to administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after administration. LC-MS/MS will be used to analyze furosemide in plasma. AUCextrapol = AUCextrapolated = Clast/lamda; lamda = apparent terminal elimination rate constant determined by log-linear regression; GRDF=Gastro retentive dosage formulation **Measure:** AUCextrapol of GRDF furosemide under fed conditions **Time Frame:** pre-dose (within 1 h prior to drug administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after drug administration. **Description:** Characterization of the pharmacodynamic properties of GRDF furosemide, with special focus on the absorption phase of furosemide. Compare results during fasted and fed state. Blood samples for the determination of furosemide concentration will be taken at pre-dose (within 1 h prior to administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after administration. LC-MS/MS will be used to analyze furosemide in plasma. CL_f = apparent total body clearance of furosemide: dose / AUC0-∞; GRDF=Gastro retentive dosage formulation **Measure:** CL_f of GRDF furosemide under fasted conditions **Time Frame:** pre-dose (within 1 h prior to drug administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after drug administration. **Description:** Characterization of the pharmacodynamic properties of GRDF furosemide, with special focus on the absorption phase of furosemide. Compare results during fasted and fed state. Blood samples for the determination of furosemide concentration will be taken at pre-dose (within 1 h prior to administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after administration. LC-MS/MS will be used to analyze furosemide in plasma. CL_f = apparent total body clearance of furosemide: dose / AUC0-∞; GRDF=Gastro retentive dosage formulation **Measure:** CL_f of GRDF furosemide under fed conditions **Time Frame:** pre-dose (within 1 h prior to drug administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after drug administration. **Description:** Characterization of the pharmacodynamic properties of GRDF furosemide, with special focus on the absorption phase of furosemide. Compare results during fasted and fed state. Blood samples for the determination of furosemide concentration will be taken at pre-dose (within 1 h prior to administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after administration. LC-MS/MS will be used to analyze furosemide in plasma. Vdz = apparent volume of distribution of furosemide: dose / (AUC0-∞ x λ); GRDF=Gastro retentive dosage formulation; λ=apparent terminal elimination rate constant determined by log-linear regression **Measure:** Vdz of GRDF furosemide under fasted conditions **Time Frame:** pre-dose (within 1 h prior to drug administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after drug administration. **Description:** Characterization of the pharmacodynamic properties of GRDF furosemide, with special focus on the absorption phase of furosemide. Compare results during fasted and fed state. Blood samples for the determination of furosemide concentration will be taken at pre-dose (within 1 h prior to administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after administration. LC-MS/MS will be used to analyze furosemide in plasma. Vdz = apparent volume of distribution of furosemide: dose / (AUC0-∞ x λ); GRDF=Gastro retentive dosage formulation; λ=apparent terminal elimination rate constant determined by log-linear regression **Measure:** Vdz of GRDF furosemide under fed conditions **Time Frame:** pre-dose (within 1 h prior to drug administration) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 h after drug administration. **Description:** Sodium in urine will be measured for each time interval and total sampling time. Urine will be collected and sampled during the following sample intervals: pre-dose (within 1 hour prior to administration), 0-2h, 2-4h, 4-8h, and 8-12h after administration. **Measure:** Sodium excretion over time under fasted conditions **Time Frame:** pre-dose (within 1 hour prior to administration), 0-2h, 2-4h, 4-8h, and 8-12h after administration. **Description:** Sodium in urine will be measured for each time interval and total sampling time. Urine will be collected and sampled during the following sample intervals: pre-dose (within 1 hour prior to administration), 0-2h, 2-4h, 4-8h, and 8-12h after administration. **Measure:** Sodium excretion over time under fed conditions **Time Frame:** pre-dose (within 1 hour prior to administration), 0-2h, 2-4h, 4-8h, and 8-12h after administration. **Description:** Urine volume will be measured for each time interval and total sampling time. Urine will be collected and sampled during the following sample intervals: pre-dose (within 1 hour prior to administration), 0-2h, 2-4h, 4-8h, and 8-12h after administration. **Measure:** Urine excretion over time under fasted conditions **Time Frame:** pre-dose (within 1 hour prior to administration), 0-2h, 2-4h, 4-8h, and 8-12h after administration. **Description:** Urine volume will be measured for each time interval and total sampling time. Urine will be collected and sampled during the following sample intervals: pre-dose (within 1 hour prior to administration), 0-2h, 2-4h, 4-8h, and 8-12h after administration. **Measure:** Urine excretion over time under fed conditions **Time Frame:** pre-dose (within 1 hour prior to administration), 0-2h, 2-4h, 4-8h, and 8-12h after administration. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. sex: male 2. ethnic origin: Caucasian 3. age: 18 years to 55 years 4. body-mass index (BMI): \> or = 19 kg/m² and \< or = 27 kg/m² 5. good state of health 6. non-smoker or ex-smoker for at least 1 month 7. written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial Exclusion Criteria: 1. existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient 2. existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient 3. existing gastrointestinal diseases or pathological findings, which might interfere with the safety and tolerability or with gastric emptying and the gastrointestinal transport (e.g. inflammatory bowel diseases, ileus) 4. history of relevant central nervous system (CNS) and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders 5. any surgery at the gastrointestinal tract, which might interfere with the safety of the test product or any stomach reduction like Bioenterics Intragastric Balloon (BIB) or gastric banding 6. known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations 7. known allergic reactions to sulphonamide 8. subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator 9. heart rate \< 50 bpm or \> 90 bpm 10. systolic blood pressure of \< 100 mmHg and \> 140 mmHg, diastolic blood pressure of \< 60 mmHg and \>90 mmHg 11. laboratory values, especially for sodium, potassium, calcium, creatinine, urea, uric acid, and blood glucose out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator 12. positive anti-human immunodeficiency virus-test (if positive to be verified by western blot), surface antigen of the hepatitis B virus (HBs-AG)test \[if positive to be verified by test for hepatitis B Core (HBc-IgM)\] or anti-hepatitis C virus-test 13. renal failure with anuria 14. coma and praecoma hepatica 15. severe hypokalemia and/or hyponatremia 16. hypovolemia or dehydration 17. subjects with manifest or latent diabetes mellitus or gout 18. subjects with cerebrovascular insufficiency or coronary heart disease 19. subjects with bladder outlet obstruction (BOO) e.g. prostatic hypertrophy, hydronephrosis or ureteral stenosis 20. hypoproteinemia 21. liver cirrhosis and simultaneous limitation of kidney function 22. acute or chronic diseases which could affect gastric emptying and the gastrointestinal transport 23. history of or current drug or alcohol dependence 24. positive alcohol or drug test at screening examination 25. regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol for male per day 26. subjects who are on a diet which could affect gastric emptying and the gastro-intestinal transport 27. regular intake of caffeine containing food or beverages of ≥ 500 mg caffeine per day 28. subjects with claustrophobia 29. ferromagnetic implants or any other magnetic disturbance, which can affect the Magnetic Marker Monitoring measurement 30. blood donation or other blood loss of more than 400 ml within the last two months prior to individual enrolment of the subject 31. participation in a clinical trial during the last two months prior to individual enrolment of the subject 32. regular treatment with any systemically available medication including all ototoxic medication like aminoglycosides and medication which could affect gastric emptying and the gastrointestinal transport (e.g. laxatives, metoclopramide, loperamide, antacids, H2-receptor antagonists) or antibiotics 33. subjects, who report a frequent occurrence of migraine attacks 34. subjects suspected or known not to follow instructions 35. subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial 36. subjects who have forfeited their own freedom by administrative or legal award, or who are under guardianship or have been admitted in a sanitary or social institution **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Berlin **Country:** Germany **Facility:** SocraTec R&D GmbH Clinical Pharmacology Unit **Zip:** 10578 #### Overall Officials **Official 1:** **Affiliation:** SocraTec R&D GmbH, Clinical Pharmacology Unit **Name:** Frank Donath, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7657 - Name: Edema - Relevance: HIGH - As Found: Edema ### Condition Browse Module - Meshes - ID: D000004487 - Term: Edema ### Intervention Browse Module - Ancestors - ID: D000004232 - Term: Diuretics - ID: D000045283 - Term: Natriuretic Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000049994 - Term: Sodium Potassium Chloride Symporter Inhibitors - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: NaAg - Name: Natriuretic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Hemat - Name: Hematinics - Abbrev: PhSol - Name: Pharmaceutical Solutions ### Intervention Browse Module - Browse Leaves - ID: M8784 - Name: Furosemide - Relevance: HIGH - As Found: TAK- - ID: M26996 - Name: Ferrosoferric Oxide - Relevance: LOW - As Found: Unknown - ID: M7411 - Name: Diuretics - Relevance: LOW - As Found: Unknown - ID: M26153 - Name: Sodium Potassium Chloride Symporter Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000005665 - Term: Furosemide ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03599479 **Brief Title:** Virtual Reality Experiences on Acute Pain and Distress **Official Title:** The Efficacy of Virtual Reality Experiences on Acute Pain and Distress Caused by Fluoroscopic Pain Intervention in Chronic Pain Patients - A Randomized Controlled Clinical Trial #### Organization Study ID Info **ID:** 1802-028-920 #### Organization **Class:** OTHER **Full Name:** Seoul National University ### Status Module #### Completion Date **Date:** 2021-01-02 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-11-04 **Type:** ACTUAL **Last Update Submit Date:** 2022-11-03 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-08-28 **Type:** ACTUAL #### Start Date **Date:** 2018-12-27 **Type:** ACTUAL **Status Verified Date:** 2022-11 #### Study First Post Date **Date:** 2018-07-26 **Type:** ACTUAL **Study First Submit Date:** 2018-06-24 **Study First Submit QC Date:** 2018-07-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Seoul National University #### Responsible Party **Investigator Affiliation:** Seoul National University **Investigator Full Name:** Jeeyoun Moon **Investigator Title:** Associate professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The aim of this study is to evaluate the efficacy of virtual reality experiences on acute pain and distress caused by fluoroscopic pain intervention in chronic pain patient. **Detailed Description:** The investigators perform lots of interventions for patients. But unfortunately, patients cannot help being exposed to the acute pain and fear during the interventions. "Virtual Reality(VR)" is a state-of-art advanced technology, which is now being extended to various medical fields such as pain management, dental treatment, body rehabilitation and cancer pain. There is no study that have conjugated the virtual reality experience for patients' acute pain and anxiety which occurs during the pain interventions. So the investigators like to evaluate the effects of virtual reality experience on acute pain and anxiety precipitated by the pain interventions. ### Conditions Module **Conditions:** - Virtual Reality - Acute Pain - Anxiety **Keywords:** - Virtual reality - Acute pain - Anxiety ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 44 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** * After experiencing the VR machine in the transfer bed for 5 minutes, the subject moves to the operating room. * After the subject moves to the surgical bed, he/she takes the appropriate position for the fluoroscopic pain intervention, and wears the virtual reality device (headset, headphone, smartphone). * After the subject starts the VR program, the practitioner starts the fluoroscopic pain intervention. * Lidocaine skin infiltration and description of the practitioner during the intervention are performed with the intervention when necessary. **Intervention Names:** - Device: Virtual reality group **Label:** Virtual reality group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The fluoroscopic pain intervention is performed using only local anesthetics and description of the practitioner during the intervention as in the conventional cases. **Label:** Conventional group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Virtual reality group **Description:** Virtual reality group The study intervention is to provide acute pain management for the subject undergoing fluoroscopic pain intervention by using the virtual reality program provided by the collaborator through virtual reality device (headset, headphone, and smartphone) that are commercialized on the market. **Name:** Virtual reality group **Other Names:** - Experimental **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** 11-point scale pain score was assessed by the patient during the fluoroscopic-guided intervention, 0-10. 0 means no pain, 10 means the most severe pain one can imagine **Measure:** 11-point scale pain score **Time Frame:** 15min after the procedure #### Secondary Outcomes **Description:** total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. **Measure:** Hamilton Anxiety rating score (HAM-A) **Time Frame:** 15min after the procedure **Description:** On a scale of 0 to 10, score 10 means most likely to recommend VR to a friend or a colleague **Measure:** Net Promotor Score (NPS) by patient **Time Frame:** 15min after the procedure **Description:** On a scale of 0 to 10, score 10 means most likely to recommend VR to a friend or a colleague **Measure:** Net Promotor Score (NPS) by physician **Time Frame:** 15min after the procedure **Description:** Total amount of local anesthetics used to skin infiltration (ml) **Measure:** Total amount of local anesthetics used to skin infiltration **Time Frame:** intraoperative **Description:** Total procedural time (minute) **Measure:** Total procedural time **Time Frame:** intraoperative **Description:** Percutaneous oxygen saturation(SPO2,%) **Measure:** Vital sign of the patient: Percutaneous oxygen saturation(SPO2,%) **Time Frame:** Intraoperative **Description:** noninvasive blood pressure(NIBP, mm Hg) **Measure:** Vital sign of the patient: noninvasive blood pressure(NIBP, mm Hg) **Time Frame:** Intraoperative **Description:** Arrhythmia **Measure:** Vital sign of the patient: electrocardiogram(ECG) **Time Frame:** Intraoperative **Description:** Heart rate (beat per minute) **Measure:** Vital sign of the patient: Heart rate (beat per minute) **Time Frame:** Intraoperative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: If all of the following conditions are met : * Patient who has chronic pain lasting more than 3 months and whose pain doctor determined that he or she needs following fluoroscopic pain intervention : Lumbar sympathetic ganglion block (LSGB), Fluoroscopic-guided pulsed radiofrequency ablation (pRF), Fluoroscopic-guided radiofrequency thermocoagulation (hRF) * Adults who are at least 20 years of age * Patients whose American Society of Anesthesiologists(ASA) physical status is classified as 1 or 2. * A person who voluntarily agrees to participate in this clinical trial and has agreed in informed consent. Exclusion Criteria: If the subject falls under any of the following conditions : * Patients who cannot have virtual reality experience due to hearing or visual impairment * If the patient has difficulty communicating due to lack of cognitive ability * Patients that examiners deemed unsuitable for this trial **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Seoul National University Hospital #### Overall Officials **Official 1:** **Affiliation:** Seoul National University Hospital **Name:** Jee Youn Moon, MD, PhD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Linton SJ. A review of psychological risk factors in back and neck pain. Spine (Phila Pa 1976). 2000 May 1;25(9):1148-56. doi: 10.1097/00007632-200005010-00017. **PMID:** 10788861 **Citation:** Li A, Montano Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147-157. doi: 10.2217/pmt.10.15. **PMID:** 21779307 **Citation:** Hoffman HG, Patterson DR, Seibel E, Soltani M, Jewett-Leahy L, Sharar SR. Virtual reality pain control during burn wound debridement in the hydrotank. Clin J Pain. 2008 May;24(4):299-304. doi: 10.1097/AJP.0b013e318164d2cc. **PMID:** 18427228 **Citation:** Nilsson S, Finnstrom B, Kokinsky E, Enskar K. The use of Virtual Reality for needle-related procedural pain and distress in children and adolescents in a paediatric oncology unit. Eur J Oncol Nurs. 2009 Apr;13(2):102-9. doi: 10.1016/j.ejon.2009.01.003. Epub 2009 Feb 20. **PMID:** 19230769 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M29442 - Name: Chronic Pain - Relevance: LOW - As Found: Unknown - ID: M29525 - Name: Acute Pain - Relevance: HIGH - As Found: Acute Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000059787 - Term: Acute Pain ### Intervention Browse Module - Browse Branches - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11014 - Name: Lidocaine - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01537679 **Acronym:** Meditation **Brief Title:** Meditation to Reduce Caregiver Stress **Official Title:** Meditation or Relaxation Used to Reduce Stress Response and Improve Cognitive Functioning in Older Family Dementia Caregivers #### Organization Study ID Info **ID:** 10-000270; 09-03-086-01D #### Organization **Class:** OTHER **Full Name:** University of California, Los Angeles ### Status Module #### Completion Date **Date:** 2012-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2016-11-28 **Type:** ESTIMATED **Last Update Submit Date:** 2016-11-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2010-08 **Type:** ACTUAL #### Start Date **Date:** 2010-03 **Status Verified Date:** 2016-11 #### Study First Post Date **Date:** 2012-02-23 **Type:** ESTIMATED **Study First Submit Date:** 2012-02-10 **Study First Submit QC Date:** 2012-02-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of California, Los Angeles #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to determine whether meditation will reduce stress and depressive of adult caregivers of a person with dementia. **Detailed Description:** This is an 8-week study to determine if meditation or listening to a relaxation CD will be effective in reducing depressive symptoms and stress, and in improving memory and cognition of caregivers who perform a daily meditation for 12 minutes a day for 8 weeks compared to caregivers listening to a relaxation CD for 12 minutes a day for 8 weeks. A second purpose of this study is to examine the role of genetic and inflammatory markers in response to listening to a relaxation CD and meditation. ### Conditions Module **Conditions:** - Depression NOS - Major Depressive Disorder - Anxiety NOS **Keywords:** - Caregiver - meditation - relaxation - stress ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 40 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Kirtan Kriya meditation **Label:** Meditation Intervention **Type:** OTHER #### Arm Group 2 **Intervention Names:** - Behavioral: Relaxation **Label:** Relaxation Intervention **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Meditation Intervention **Description:** Meditation will be taught to 20 caregivers and supervised by Helen Lavretsky, M.D during their first visit. Meditation Kirtan Kriya will be performed for 12 minutes every day at the same time of the day for 8 weeks. Compliance will be monitored during visits and by daily diaries that will be reviewed at each visit. **Name:** Kirtan Kriya meditation **Other Names:** - Kundalini yoga meditation **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Relaxation Intervention **Description:** Participants in the relaxation group will be asked to relax in a quiet place with eyes closed while listening to the music on the relaxation CD for 12 minutes every day at the same time for 8 weeks. **Name:** Relaxation **Other Names:** - Relaxation techniques **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Measure:** Hamilton Depression Rating Scale (HDRS) **Time Frame:** 8 weeks #### Secondary Outcomes **Measure:** Caregiver Burden Scale **Time Frame:** Week 1 and 8 **Measure:** Connor-Davidson Resilience scale (CD-RISC) **Time Frame:** Week 1 and 8 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Caregivers of relatives with dementia who present to the Alzheimer s Disease Center or other UCLA geriatric or memory clinics for evaluation of dementia, cognitive impairment and/or co-existing behavioral disturbances. Caregivers will be identified by the family member with dementia or the physician as the primary source of assistance and/or support, 45 years of age or older, in contact with the individual with dementia at least three times/week for no less than one year, and a relative of the care-recipient (i.e., spouse or adult child). This criteria will ensure that the caregivers had been affected by substantial chronic stress, and they will also meet criteria specified below. 2. Adequate written and oral fluency in English to understand and complete study forms and converse with study personnel. 3. Caregivers enrolled in the trial could meet the DSM-IVR criteria for minor depression or depression not otherwise specified (NOS), but not for other diagnosis of unipolar or bipolar major depression. 4. Score between 6 and 15 on the Hamilton Depression Rating Scale-24 item (HAM-D). 5. Score of 26 or higher on the Folstein Mini-Mental State Examination (MMSE). Exclusion Criteria: 1. Current diagnosis of unipolar major depression, schizophrenia, bipolar, psychotic disorders including psychotic depression or dementia, attention deficit or hyperactivity disorder, anxiety, and alcohol or drug dependence. Those with lifetime history of psychiatric conditions other than unipolar major depression will be also excluded. 2. Medically unstable, delirious, or terminally ill (e.g. medical illness requiring hospitalization or intense outpatient management, such as heart disease; heart attack in the past 6 months; Congestive Heart failure; severe heart arrythmias; unstable hypertension; poorly controlled diabetes; recent head trauma with loss of consciousness; recent stroke with residual neurological symptoms; recent cancer with ongoing treatment, or any other medical conditions requiring weekly visits to PCP or pending surgery). 3. Level of suicidal risk precludes safe treatment on an outpatient basis with Hamilton Depression rating scale item number 3 rated as = 3. 4. Subjects reporting daily use of alcohol will be excluded. 5. Diagnosis of amnestic MCI by the analyses of delayed verbal recall on the California Verbal Learning Scale that will be 1.5 SD below the age/education adjusted norms for the general population. **Minimum Age:** 45 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Los Angeles **Country:** United States **Facility:** UCLA Semel Institute **State:** California **Zip:** 90095 #### Overall Officials **Official 1:** **Affiliation:** University of California, Los Angeles **Name:** Helen Lavretsky, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** Meditation to Reduce Caregiver Stress **URL:** http://www.semel.ucla.edu/latelife ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6904 - Name: Dementia - Relevance: LOW - As Found: Unknown - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depressive Disorder - ID: M7060 - Name: Depressive Disorder, Major - Relevance: HIGH - As Found: Major Depressive Disorder - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003866 - Term: Depressive Disorder - ID: D000003865 - Term: Depressive Disorder, Major ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01242579 **Brief Title:** A Safety and Pharmacokinetic Study for Dapivirine and Maraviroc Gel in Belgium **Official Title:** A Double-Blind, Randomised, Placebo-Controlled Phase I Trial to Compare the Pharmacokinetics of Maraviroc and Dapivirine Following Application of Maraviroc Vaginal Vaginal Gel, 0.1% 2.5g, Dapivirine Vaginal Gel, 0.05%, 2.5g and Maraviroc 0.1% + Dapivirine 0.05% Vaginal Gel, 2.5g Formulations, and to Assess Their Safety as Compared to the Matching Placebo Vaginal Gel, 2.5g in Healthy, HIV-Negative Women #### Organization Study ID Info **ID:** IPM 025 #### Organization **Class:** INDUSTRY **Full Name:** International Partnership for Microbicides, Inc. ### Status Module #### Completion Date **Date:** 2011-07 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2011-09-09 **Type:** ESTIMATED **Last Update Submit Date:** 2011-09-08 **Overall Status:** WITHDRAWN #### Primary Completion Date **Date:** 2011-07 **Type:** ACTUAL #### Start Date **Date:** 2011-01 **Status Verified Date:** 2011-09 #### Study First Post Date **Date:** 2010-11-17 **Type:** ESTIMATED **Study First Submit Date:** 2010-11-15 **Study First Submit QC Date:** 2010-11-16 **Why Stopped:** In order to focus efforts on the combination ring formulation, IPM decided not to move forward with this trial. ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** International Partnership for Microbicides, Inc. #### Responsible Party **Old Name Title:** Annalene Nel, MBChB, PhD **Old Organization:** IPM ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to assess the pharmacokinetics of the combination dapivirine and maraviroc gel and determine whether it is safe for daily use by healthy women in the United Kingdom ### Conditions Module **Conditions:** - HIV Infections ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** PREVENTION #### Enrollment Info **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Drug: Maraviroc dosage form: vaginal gel dosage: 2.5g frequency: once daily duration: 11 days **Intervention Names:** - Drug: Maraviroc Vaginal Gel **Label:** Maraviroc Vaginal Gel **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Drug: Dapivirine dosage form: vaginal gel dosage: 2.5g dapivirine frequency: once daily duration: 11 days **Intervention Names:** - Drug: Dapivirine Vaginal Gel **Label:** Dapivirine Vaginal Gel **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Drug: placebo dosage form: vaginal gel dosage: 2.5g placebo frequency: once daily duration: 11 days **Intervention Names:** - Drug: Matching Placebo Gel **Label:** Matching Placebo Gel **Type:** PLACEBO_COMPARATOR #### Arm Group 4 **Description:** Drug: Maraviroc/Dapivirine dosage form: combination vaginal gel dosage: 2.5g - Maraviroc 0.1%, Dapivirine 0.05% frequency: once daily duration: 11 days **Intervention Names:** - Drug: Maraviroc/Dapivirine Gel **Label:** Maraviroc/Dapivirine Gel **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Maraviroc/Dapivirine Gel **Description:** Vaginal gel containing 2.5g - Maraviroc 0.1%, Dapivirine 0.05% **Name:** Maraviroc/Dapivirine Gel **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Dapivirine Vaginal Gel **Description:** Dapivirine vaginal gel containing 2.5g **Name:** Dapivirine Vaginal Gel **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Maraviroc Vaginal Gel **Description:** Maraviroc vaginal gel containing 2.5g **Name:** Maraviroc Vaginal Gel **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Matching Placebo Gel **Description:** Matching placebo gel containing 2.5g **Name:** Matching Placebo Gel **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** * Mucosal abnormalities (as defined in the WHO/CONRAD manual) visible during naked eye examination and/or colposcopy; * Abnormal vaginal pH and/or abnormal vaginal flora during the course of the trial; * Positive diagnostic tests for trichomonas, gonorrhoea and/or chlamydia; * At least one adverse event during the 2 month trial period; * Any laboratory abnormalities on haematology, electrolytes, liver function, and renal function. **Measure:** Safety: To assess the safety and tolerability of the combination maraviroc and dapivirine gel, the endpoint was the proportion of women in the four arms experiencing specific, protocol defined safety events during the study (see description). **Time Frame:** 8 weeks **Measure:** Pharmacokinetics: assessment of local and systemic pharmacokinetics of maraviroc and dapivirine in plasma, vaginal fluid and cervical tissue before, during and after 11 days. **Time Frame:** 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Women 18 to40 years of age who can give written informed consent (illiterate participants may provide a thumbprint or mark witnessed and signed by a person independent from trial staff); * Available for all visits and consent to follow all procedures scheduled for the trial; * HIV-negative as determined by an HIV test at time of enrollment; * Be on a stable form of contraception, defined as: * A stable oral contraceptive regimen for at least 2 months prior to enrollment, OR, * Transdermal contraceptive patch for at least 3 months prior to enrollment, OR, * Long-acting progestins for at least 6 months prior to enrollment, OR, * An IUD inserted (with no vaginal or gynaecological complaints associated with its use) at least 3 months prior to enrolment, OR, * Have undergone surgical sterilization at least 3 months prior to enrollment; * In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle, defined as having a minimum of 21 days and a maximum of 35 days between menses; * Upon pelvic examination and colposcopy at the time of enrollment, the cervix and vagina appear normal as determined by the Investigator; * Asymptomatic for genital infections at the time of enrollment (if a woman is diagnosed with any treatable STI, either syndromically or by laboratory test at the time of screening, she must receive treatment at least 2 weeks prior to enrollment and have completed treatment); * Willing to refrain from the use of vaginal products or objects including, tampons, female condoms, cotton wool, rags, diaphragms, cervical caps (or any other vaginal barrier method), douches, lubricants, vibrators/dildos, and drying agents for 14 days prior to enrollment and for the duration of the trial; * Willing to use oral contraceptives to avoid menstruation, if necessary, while taking part in this trial; * Documentation of no abnormality on Pap test, including grossly bloody smear, within 3 months prior to screening; * Willing to refrain from participation in any other research trial for the duration of this trial; * Willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures \[e.g., by home visit or telephone; or via family or close neighbour contacts (confidentiality to be maintained)\]; * Willing to agree to abstain from oral contact with her genitalia for gel use period, as well as for a total of 3 days (72 hours) after the biopsy procedure: * Willing to remain sexually abstinent for the gel use period in this trial; * Hepatitis B and C negative at the time of enrollment. Exclusion Criteria: * Currently pregnant or having had their last pregnancy outcome within 3 months prior to screening; * Currently breast-feeding; * Currently or within two months of participation in any other clinical research trial involving investigational or marketed products prior to screening; * Untreated symptomatic urogenital infections, e.g., urinary tract or other sexually transmitted infections, or other gynaecological conditions such as vaginal itching, pain, or discharge, within 2 weeks prior to enrolment; * Presence of any abnormal clinically significant physical finding on the vulva, vaginal walls or cervix during pelvic examination and/or colposcopy at pre-enrolment; * History of urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction, incontinence or urge incontinence; * Current vulvar or vaginal symptoms/abnormalities that could influence the trial results; * Pap test result that requires cryotherapy, biopsy, treatment (other than for infection); or further evaluation \[this includes any findings of atypical squamous cells of undetermined significance (ASCUS)\]; * Symptomatic genital HSV infection or a history of genital herpetic infection; * Any Grade 2, 3 or 4 haematology, chemistry or urinalysis laboratory abnormality at baseline (screening) according to the DAIDS Table for Grading Adverse Events (NOTE: This table can be found at: http://rcc.tech-res.com/safetyandpharmacovigilance;and a standardized version will be provided to the research centre in the Study Operations Manual); * Unexplained, abnormal bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrollment; * Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex or silicone; * Any serious acute, chronic or progressive disease (e.g., any known history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV, AIDS, or blood dyscrasias), or signs of cardiac disease, renal failure, or severe malnutrition; * Have undergone a hysterectomy; * History of drug abuse within 1 year of enrollment; * Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives. **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000086982 - Term: Blood-Borne Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000007239 - Term: Infections - ID: D000015229 - Term: Sexually Transmitted Diseases, Viral - ID: D000012749 - Term: Sexually Transmitted Diseases - ID: D000016180 - Term: Lentivirus Infections - ID: D000012192 - Term: Retroviridae Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000014777 - Term: Virus Diseases - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000007153 - Term: Immunologic Deficiency Syndromes - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M3522 - Name: Acquired Immunodeficiency Syndrome - Relevance: LOW - As Found: Unknown - ID: M18250 - Name: HIV Infections - Relevance: HIGH - As Found: HIV Infections - ID: M2593 - Name: Blood-Borne Infections - Relevance: LOW - As Found: Unknown - ID: M15558 - Name: Sexually Transmitted Diseases - Relevance: LOW - As Found: Unknown - ID: M17933 - Name: Sexually Transmitted Diseases, Viral - Relevance: LOW - As Found: Unknown - ID: M18640 - Name: Lentivirus Infections - Relevance: LOW - As Found: Unknown - ID: M15026 - Name: Retroviridae Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M10199 - Name: Immunologic Deficiency Syndromes - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015658 - Term: HIV Infections ### Intervention Browse Module - Ancestors - ID: D000023581 - Term: HIV Fusion Inhibitors - ID: D000065147 - Term: Viral Fusion Protein Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000019380 - Term: Anti-HIV Agents - ID: D000044966 - Term: Anti-Retroviral Agents - ID: D000000998 - Term: Antiviral Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000065100 - Term: CCR5 Receptor Antagonists ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M256068 - Name: Dapivirine - Relevance: HIGH - As Found: Adult acute lymphoblastic leukemia - ID: M1852 - Name: Maraviroc - Relevance: HIGH - As Found: Group C - ID: M21350 - Name: Anti-HIV Agents - Relevance: LOW - As Found: Unknown - ID: M25428 - Name: Anti-Retroviral Agents - Relevance: LOW - As Found: Unknown - ID: M4314 - Name: Antiviral Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077592 - Term: Maraviroc - ID: C000481671 - Term: Dapivirine ### Misc Info Module #### Removed Countries - Country: Belgium - Country: United Kingdom - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00066079 **Brief Title:** Home Based Massage and Relaxation for Sickle Cell Pain **Official Title:** Home Based Massage and Relaxation for Sickle Cell Pain #### Organization Study ID Info **ID:** R21AT001078-01A1 **Link:** https://reporter.nih.gov/quickSearch/R21AT001078-01A1 **Type:** NIH #### Organization **Class:** NIH **Full Name:** National Center for Complementary and Integrative Health (NCCIH) ### Status Module #### Completion Date **Date:** 2006-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2008-08-06 **Type:** ESTIMATED **Last Update Submit Date:** 2008-08-04 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2006-11 **Type:** ACTUAL #### Start Date **Date:** 2003-08 **Status Verified Date:** 2008-08 #### Study First Post Date **Date:** 2003-08-05 **Type:** ESTIMATED **Study First Submit Date:** 2003-08-01 **Study First Submit QC Date:** 2003-08-04 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NIH **Name:** National Center for Complementary and Integrative Health (NCCIH) ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to compare the effects of in-home, family-administered massage and in-home relaxation training on measures of physical status and health care utilization in a sample of African American adolescents age 15 years and older and adults with chronic pain associated with sickle cell disease who have been randomly assigned to six sessions of either family-administered massage or progressive muscle relaxation training. ### Conditions Module **Conditions:** - Sickle Cell Disease **Keywords:** - Sickle Cell Pain - Sickle Cell Disease - Chronic Pain - Alternative Medicine/Therapy - Complementary Medicine - Massage Therapy - Relaxation Technique - Home-based Therapy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** massage **Type:** PROCEDURE #### Intervention 2 **Name:** relaxation **Type:** BEHAVIORAL ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: * Medically diagnosed with sickle cell disease, including hemoglobin SS disease, hemoglobin SD disease, hemoglobin SC disease, or sickle-thalassemia * Self-report of having experienced chronic pain related to sickle cell disease during the past 30 days. * Availability of a family member or friend who agrees to be trained to administer massages if the participant is randomized to the massage arm of the study. Exclusion Criteria: * Sickle cell trait instead of sickle cell disease diagnosis. * Diagnosis of disease in addition to sickle cell disease which requires regular use of pain medication. (Please note, regular use of pain medication for sickle cell pain is NOT an exclusion) **Maximum Age:** 65 Years **Minimum Age:** 15 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Los Angeles **Country:** United States **Facility:** Los Angeles Orthopaedic Hospital - Vascular Medicine Program **State:** California **Zip:** 90007 **Location 2:** **City:** Tampa **Country:** United States **Facility:** Moffitt Cancer Center and Research Institute **State:** Florida **Zip:** 33612 #### Overall Officials **Official 1:** **Affiliation:** The Moffitt Cancer Center **Name:** Cynthia D. Myers, PhD, LMT **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Shapiro BS, Dinges DF, Orne EC, Bauer N, Reilly LB, Whitehouse WG, Ohene-Frempong K, Orne MT. Home management of sickle cell-related pain in children and adolescents: natural history and impact on school attendance. Pain. 1995 Apr;61(1):139-144. doi: 10.1016/0304-3959(94)00164-A. **PMID:** 7644237 **Citation:** Elander J, Midence K. A review of evidence about factors affecting quality of pain management in sickle cell disease. Clin J Pain. 1996 Sep;12(3):180-93. doi: 10.1097/00002508-199609000-00006. **PMID:** 8866159 **Citation:** Zeltzer L, Dash J, Holland JP. Hypnotically induced pain control in sickle cell anemia. Pediatrics. 1979 Oct;64(4):533-6. **PMID:** 492819 **Citation:** Co LL, Schmitz TH, Havdala H, Reyes A, Westerman MP. Acupuncture: an evaluation in the painful crises of sickle cell anaemia. Pain. 1979 Oct;7(2):181-185. doi: 10.1016/0304-3959(79)90009-5. **PMID:** 523174 **Citation:** Thomas JE, Koshy M, Patterson L, Dorn L, Thomas K. Management of pain in sickle cell disease using biofeedback therapy: a preliminary study. Biofeedback Self Regul. 1984 Dec;9(4):413-20. doi: 10.1007/BF01000558. **PMID:** 6399460 **Citation:** Cozzi L, Tryon WW, Sedlacek K. The effectiveness of biofeedback-assisted relaxation in modifying sickle cell crises. Biofeedback Self Regul. 1987 Mar;12(1):51-61. doi: 10.1007/BF01000078. **PMID:** 3663738 **Citation:** Wang WC, George SL, Wilimas JA. Transcutaneous electrical nerve stimulation treatment of sickle cell pain crises. Acta Haematol. 1988;80(2):99-102. doi: 10.1159/000205612. **PMID:** 3138879 **Citation:** Gil KM, Wilson JJ, Edens JL, Webster DA, Abrams MA, Orringer E, Grant M, Clark WC, Janal MN. Effects of cognitive coping skills training on coping strategies and experimental pain sensitivity in African American adults with sickle cell disease. Health Psychol. 1996 Jan;15(1):3-10. doi: 10.1037//0278-6133.15.1.3. **PMID:** 8788535 **Citation:** Gil KM, Carson JW, Sedway JA, Porter LS, Schaeffer JJ, Orringer E. Follow-up of coping skills training in adults with sickle cell disease: analysis of daily pain and coping practice diaries. Health Psychol. 2000 Jan;19(1):85-90. doi: 10.1037//0278-6133.19.1.85. **PMID:** 10711591 **Citation:** Dinges DF, Whitehouse WG, Orne EC, Bloom PB, Carlin MM, Bauer NK, Gillen KA, Shapiro BS, Ohene-Frempong K, Dampier C, Orne MT. Self-hypnosis training as an adjunctive treatment in the management of pain associated with sickle cell disease. Int J Clin Exp Hypn. 1997 Oct;45(4):417-32. doi: 10.1080/00207149708416141. **PMID:** 9308268 **Citation:** Jacobson E. 1974. Progressive muscle relaxation. Chicago: University of Chicago Press, Midway Reprint. **Citation:** Field TM. Massage therapy effects. Am Psychol. 1998 Dec;53(12):1270-81. doi: 10.1037//0003-066x.53.12.1270. **PMID:** 9872050 **Citation:** Myers CD, Robinson ME, Guthrie TH, Jr, Lamp SP, Lottenberg R. Adjunctive approaches for sickle cell chronic pain. Alternative Health Practitioner 1999;5:203-212.36. **Citation:** Benjamin LJ, Dampier CD, Jacox AK, Odesina V, Phoenix D, Shapiro B, Strafford M, Treadwell M. Guideline for the management of acute and chronic pain in sickle-cell disease. APS Clinical Practice Guidelines Series, No. 1. 1999. Glenview, IL: American Pain Society. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000745 - Term: Anemia, Hemolytic, Congenital - ID: D000000743 - Term: Anemia, Hemolytic - ID: D000000740 - Term: Anemia - ID: D000006402 - Term: Hematologic Diseases - ID: D000006453 - Term: Hemoglobinopathies - ID: D000030342 - Term: Genetic Diseases, Inborn ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M29442 - Name: Chronic Pain - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M4085 - Name: Anemia, Sickle Cell - Relevance: HIGH - As Found: Sickle Cell Disease - ID: M4070 - Name: Anemia - Relevance: LOW - As Found: Unknown - ID: M9547 - Name: Hemolysis - Relevance: LOW - As Found: Unknown - ID: M4073 - Name: Anemia, Hemolytic - Relevance: LOW - As Found: Unknown - ID: M4075 - Name: Anemia, Hemolytic, Congenital - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M9539 - Name: Hemoglobinopathies - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T5229 - Name: Sickle Cell Anemia - Relevance: HIGH - As Found: Sickle Cell Disease ### Condition Browse Module - Meshes - ID: D000000755 - Term: Anemia, Sickle Cell ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02703779 **Brief Title:** Exploratory Trial to Estimate Proportion of Patients With Tumor Cell Contaminated Leukapheresis Products With and Without Bortezomib With In-vivo Purging - Multiple Myeloma (MM) **Official Title:** An Exploratory Trial to Estimate the Proportion of Patients With Tumor Cell Contaminated, Flow Positive Leukapheresis Products Collected With and Without Bortezomib as In-vivo Purging Prior to Autologous Stem Cell Harvest for Multiple Myeloma #### Organization Study ID Info **ID:** 2015-IIT-BMT-MM-AutoSCT #### Organization **Class:** OTHER **Full Name:** University of Kansas Medical Center ### Status Module #### Completion Date **Date:** 2020-04-08 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-06-18 **Type:** ACTUAL **Last Update Submit Date:** 2021-05-24 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-10-04 **Type:** ACTUAL #### Results First Post Date **Date:** 2021-06-18 **Type:** ACTUAL **Results First Submit Date:** 2021-04-29 **Results First Submit QC Date:** 2021-05-24 #### Start Date **Date:** 2016-03 **Type:** ACTUAL **Status Verified Date:** 2021-05 #### Study First Post Date **Date:** 2016-03-09 **Type:** ESTIMATED **Study First Submit Date:** 2016-02-18 **Study First Submit QC Date:** 2016-03-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Siddhartha Ganguly #### Responsible Party **Investigator Affiliation:** University of Kansas Medical Center **Investigator Full Name:** Siddhartha Ganguly **Investigator Title:** Medical Doctor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** Explore stem cell collection with or without bortezomib with in-vivo purging in multiple myeloma. **Detailed Description:** High dose chemotherapy with autologous stem cell transplant has resulted in improved overall survival and is currently considered an effective first line therapy applicable to the majority of patients with multiple myeloma. However disease relapse is inevitable and remains the primary cause of mortality in this cohort. The purpose of this study is to estimate the proportion of subjects with plasma cell contamination of harvested stem cell product in standard and treatment arms. The study will explore whether or not in-vivo purging of malignant tumor plasma cells will improve progression free survival (PFS) for patients. The study will consist of two groups: Group A: Standard of Care (SOC) stem cell collection without in-vivo purging with bortezomib. Granulocyte colony-stimulating factor (G-CSF) and Mozobil used if needed. Group B: Bortezomib 1.3mg/m\^2 will be given subcutaneously (SQ) on days -11 and -8 followed by Granulocyte colony-stimulating factor (G-CSF) on days -4 through -1 prior to stem cell harvest (day 0). ### Conditions Module **Conditions:** - Multiple Myeloma **Keywords:** - Multiple Myeloma - Bortezomib - Autologous - Stem Cell - Purging - In-vivo purging - Ex-vivo purging - Leukapheresis - Contaminated - Stem Cell Harvest - Stem Cell Transplant - Transplantation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 101 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed). NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B **Intervention Names:** - Drug: Granulocyte colony-stimulating factor (G-CSF) - Drug: Mozobil **Label:** Stem cell collection without in-vivo purging with Bortezomib **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed. There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B **Intervention Names:** - Drug: Bortezomib - Drug: Granulocyte colony-stimulating factor (G-CSF) - Drug: Mozobil **Label:** Stem cell collection with in-vivo purging with Bortezomib **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Stem cell collection with in-vivo purging with Bortezomib **Description:** Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection. **Name:** Bortezomib **Other Names:** - VELCADE **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Stem cell collection with in-vivo purging with Bortezomib - Stem cell collection without in-vivo purging with Bortezomib **Description:** Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. **Name:** Granulocyte colony-stimulating factor (G-CSF) **Other Names:** - NEUPOGEN - filgrastim - filgrastim-sndz - Zarxio **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Stem cell collection with in-vivo purging with Bortezomib - Stem cell collection without in-vivo purging with Bortezomib **Description:** Mozobil will be given to all participants by injection under the skin only if needed per Investigator. **Name:** Mozobil **Other Names:** - plerixafor **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Estimate the proportion of subjects with plasma cell contamination (defined as \>0.01% and at least 100 cellular events) of harvested stem cell product by multi parametric flow cytometry (MFC) from patients with myeloma undergoing autologous stem cell collection 1) by standard of care mobilization using Granulocyte colony-stimulating factor (G-CSF) with or without Mozobil and 2) after two doses of bortezomib as in vivo purging plus standard of care using G-CSF with or without Mozobil. **Measure:** Multiparametric Flow Cytometry - Minimum Residual Disease **Time Frame:** Day 0 for all subjects (Day 0 is the day of stem cell collection) #### Secondary Outcomes **Description:** Estimate the proportion of subjects who have a successful collection of stem cells (\> 2 million Cluster of Differentiation 34 (CD34) cells/Kg of body weight) for autologous transplant in both treatment groups. **Measure:** Multiparametric Flow Cytometry - Cluster of Differentiation 34 (CD34)Assessment **Time Frame:** Within the first 30 days after stem cell collection **Description:** Estimate the percentage of Cluster of Differentiation 34 (CD34) positive cells in circulating peripheral blood as a measure of mobilization on the days of collection. **Measure:** Cluster of Differentiation 34 (CD34) Enumeration **Time Frame:** Within the first 30 days after stem cell collection ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subjects must meet all of the inclusion criteria to participate in this study. * Ability to understand, and the willingness to sign a written Informed Consent Form * Diagnosis of multiple myeloma undergoing planned autologous stem cell transplantation * Age ≥ 18 years * Karnofsky Performance Status (KPS) 70 or above, Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2 * Adequate organ and marrow function as defined below: * leukocytes ≥ 3,000/micro Liter (mcL) * absolute neutrophil count ≥ 1,500/mcL * platelets ≥ 100,000/mcL * total bilirubin within normal institutional limits NOTE: For this study, subjects with bilirubin levels \> 1.5 Upper Limit of Normal (ULN) are excluded from enrollment in this study. * Aspartate Aminotransferase (AST) ( Serum Glutamic Oxaloacetic Transaminase \[SGOT\]) ≤ 2.5 X institutional upper limit of normal * Alanine Aminotransferase (ALT) (Serum Pyruvic Glutamic Transaminase \[SPGT\]) ≤ 2.5 X institutional upper limit of normal * creatinine within normal institutional limits * Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a woman or partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately. * A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) Exclusion Criteria: * Subjects meeting any of the exclusion criteria at baseline will be excluded from study participation. * Current or anticipated use of other investigational agents. NOTE the following clarification for this study: Prohibited Concurrent Therapy: Participation in clinical trials with other investigational agents that are not included in this trial, within 14 days of the start of this trial until 2 weeks after participant has received the last dose of bortezomib for mobilization. * Hypersensitivity to bortezomib, boron or mannitol or Granulocyte colony-stimulating factor (G-CSF) * Subject has received \> 6 months of lenalidomide (Revlimid®) therapy prior to stem cell collection * Subject has known brain metastases. Presence of brain metastases should be excluded from this clinical trial because of poor prognosis and because patients often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * Grade 3 or higher peripheral neuropathy * Bilirubin levels \> 1.5 ULN * Uncontrolled inter-current illness including, but not limited to * ongoing or active infection * symptomatic congestive heart failure * unstable angina pectoris * cardiac arrhythmia * psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or nursing: There is a potential for congenital abnormalities and for this regimen to harm nursing infants. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Westwood **Country:** United States **Facility:** The University of Kansas Medical Center **State:** Kansas **Zip:** 66205 #### Overall Officials **Official 1:** **Affiliation:** The University of Kansas - Cancer Center **Name:** Siddhartha Ganguly, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Rawstron AC, Orfao A, Beksac M, Bezdickova L, Brooimans RA, Bumbea H, Dalva K, Fuhler G, Gratama J, Hose D, Kovarova L, Lioznov M, Mateo G, Morilla R, Mylin AK, Omede P, Pellat-Deceunynck C, Perez Andres M, Petrucci M, Ruggeri M, Rymkiewicz G, Schmitz A, Schreder M, Seynaeve C, Spacek M, de Tute RM, Van Valckenborgh E, Weston-Bell N, Owen RG, San Miguel JF, Sonneveld P, Johnsen HE; European Myeloma Network. Report of the European Myeloma Network on multiparametric flow cytometry in multiple myeloma and related disorders. Haematologica. 2008 Mar;93(3):431-8. doi: 10.3324/haematol.11080. Epub 2008 Feb 11. **PMID:** 18268286 ## Document Section ### Large Document Module #### Large Docs - Date: 2016-11-21 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 7919295 - Type Abbrev: Prot_SAP - Upload Date: 2021-04-27T15:36 - Date: 2019-05-28 - Filename: ICF_001.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 262326 - Type Abbrev: ICF - Upload Date: 2021-04-27T15:35 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000020141 - Term: Hemostatic Disorders - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010265 - Term: Paraproteinemias - ID: D000001796 - Term: Blood Protein Disorders - ID: D000006402 - Term: Hematologic Diseases - ID: D000006474 - Term: Hemorrhagic Disorders - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12058 - Name: Multiple Myeloma - Relevance: HIGH - As Found: Multiple Myeloma - ID: M27588 - Name: Neoplasms, Plasma Cell - Relevance: HIGH - As Found: Multiple Myeloma - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M21977 - Name: Hemostatic Disorders - Relevance: LOW - As Found: Unknown - ID: M5059 - Name: Blood Coagulation Disorders - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M13178 - Name: Paraproteinemias - Relevance: LOW - As Found: Unknown - ID: M5077 - Name: Blood Protein Disorders - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M9560 - Name: Hemorrhagic Disorders - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T3947 - Name: Multiple Myeloma - Relevance: HIGH - As Found: Multiple Myeloma ### Condition Browse Module - Meshes - ID: D000009101 - Term: Multiple Myeloma - ID: D000054219 - Term: Neoplasms, Plasma Cell ### Intervention Browse Module - Ancestors - ID: D000000276 - Term: Adjuvants, Immunologic - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000970 - Term: Antineoplastic Agents - ID: D000019380 - Term: Anti-HIV Agents - ID: D000044966 - Term: Anti-Retroviral Agents - ID: D000000998 - Term: Antiviral Agents - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M340828 - Name: Plerixafor - Relevance: HIGH - As Found: Autonomic - ID: M1945 - Name: Lenograstim - Relevance: HIGH - As Found: 30 minutes - ID: M376 - Name: Bortezomib - Relevance: HIGH - As Found: 14 days - ID: M3628 - Name: Adjuvants, Immunologic - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M21350 - Name: Anti-HIV Agents - Relevance: LOW - As Found: Unknown - ID: M25428 - Name: Anti-Retroviral Agents - Relevance: LOW - As Found: Unknown - ID: M4314 - Name: Antiviral Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000088327 - Term: Plerixafor - ID: D000069286 - Term: Bortezomib - ID: D000078224 - Term: Lenograstim ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Stem Cell Collection Without In-vivo Purging With Bortezomib **Deaths Num Affected:** 3 **Deaths Num At Risk:** 51 **Description:** Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed). NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator. **ID:** EG000 **Other Num Affected:** 39 **Other Num at Risk:** 51 **Serious Number Affected:** 12 **Serious Number At Risk:** 51 **Title:** Stem Cell Collection Without In-vivo Purging With Bortezomib **Group ID:** EG001 **Title:** Stem Cell Collection With In-vivo Purging With Bortezomib **Deaths Num Affected:** 1 **Deaths Num At Risk:** 50 **Description:** Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed. There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection. Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator. **ID:** EG001 **Other Num Affected:** 39 **Other Num at Risk:** 50 **Serious Number Affected:** 24 **Serious Number At Risk:** 50 **Title:** Stem Cell Collection With In-vivo Purging With Bortezomib **Frequency Threshold:** 5 #### Other Events **Term:** Anemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** **Term:** Anorexia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Anxiety **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** **Term:** Back pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** **Term:** Bone pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** **Term:** Constipation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Diarrhea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Dyspnea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** **Term:** Edema limbs **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** **Term:** Fatigue **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** **Term:** Generalized muscle weakness **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** **Term:** Hypertension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** **Term:** Hypokalemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Hypomagnesemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Hyponatremia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Insomnia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** **Term:** Mucositis oral **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Nausea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Neutrophil count decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Platelet count decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Vomiting **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** White blood cell decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** #### Serious Events **Term:** Febrile neutropenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders ##### Stats **Group ID:** EG000 **Num Affected:** 8 **Num At Risk:** 51 **Num Events:** 8 **Group ID:** EG001 **Num Affected:** 7 **Num At Risk:** 50 **Num Events:** 7 **Term:** Atrial fibrillation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 51 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 50 **Num Events:** 2 **Term:** Diarrhea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 51 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 50 **Num Events:** 1 **Term:** Enterocolitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 51 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 50 **Term:** Fatigue **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 51 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 50 **Term:** Abdominal pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 51 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 50 **Num Events:** 1 **Term:** Acute kidney injury **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 51 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 50 **Num Events:** 1 **Term:** Fever **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 51 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 50 **Num Events:** 1 **Term:** Hypotension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 51 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 50 **Num Events:** 2 **Term:** Infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num At Risk:** 51 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 50 **Num Events:** 1 **Term:** Mucositis oral **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 51 **Group ID:** EG001 **Num Affected:** 4 **Num At Risk:** 50 **Num Events:** 4 **Term:** Peripheral sensory neuropathy **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 51 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 50 **Num Events:** 1 **Term:** Sepsis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num At Risk:** 51 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 50 **Num Events:** 1 **Term:** Syncope **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 51 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 50 **Num Events:** 2 **Time Frame:** From the time of signing the consent until 30 days after collection or up to 2 months. ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 51 **Group ID:** BG001 **Value:** 50 **Group ID:** BG002 **Value:** 101 **Units:** Participants ### Group **ID:** BG000 **Title:** Stem Cell Collection Without In-vivo Purging With Bortezomib **Description:** Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed). NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator. ### Group **ID:** BG001 **Title:** Stem Cell Collection With In-vivo Purging With Bortezomib **Description:** Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed. There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection. Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 37 #### Measurement **Group ID:** BG001 **Value:** 29 #### Measurement **Group ID:** BG002 **Value:** 66 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 14 #### Measurement **Group ID:** BG001 **Value:** 21 #### Measurement **Group ID:** BG002 **Value:** 35 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 21 #### Measurement **Group ID:** BG001 **Value:** 21 #### Measurement **Group ID:** BG002 **Value:** 42 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 30 #### Measurement **Group ID:** BG001 **Value:** 29 #### Measurement **Group ID:** BG002 **Value:** 59 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 4 #### Measurement **Group ID:** BG002 **Value:** 5 **Category Title:** Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 49 #### Measurement **Group ID:** BG001 **Value:** 46 #### Measurement **Group ID:** BG002 **Value:** 95 **Category Title:** Not Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 1 **Category Title:** Unknown or Not Reported **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Ethnicity (NIH/OMB) **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement **PI Sponsor Employee:** True ### Point of Contact **Email:** sganguly@kumc.edu **Organization:** University of Kansas Cancer Center **Phone:** 913-588-6030 **Title:** Dr. Sid Ganguly ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 11 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 13 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 51 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 50 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.1 - **Upper Limit:** - **Value:** 8.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.1 - **Upper Limit:** - **Value:** 7.8 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Estimate the proportion of subjects with plasma cell contamination (defined as \>0.01% and at least 100 cellular events) of harvested stem cell product by multi parametric flow cytometry (MFC) from patients with myeloma undergoing autologous stem cell collection 1) by standard of care mobilization using Granulocyte colony-stimulating factor (G-CSF) with or without Mozobil and 2) after two doses of bortezomib as in vivo purging plus standard of care using G-CSF with or without Mozobil. **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** Day 0 for all subjects (Day 0 is the day of stem cell collection) **Title:** Multiparametric Flow Cytometry - Minimum Residual Disease **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed). NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator. **ID:** OG000 **Title:** Stem Cell Collection Without In-vivo Purging With Bortezomib ##### Group **Description:** Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed. There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection. Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator. **ID:** OG001 **Title:** Stem Cell Collection With In-vivo Purging With Bortezomib #### Outcome Measure 2 **Description:** Estimate the proportion of subjects who have a successful collection of stem cells (\> 2 million Cluster of Differentiation 34 (CD34) cells/Kg of body weight) for autologous transplant in both treatment groups. **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** Within the first 30 days after stem cell collection **Title:** Multiparametric Flow Cytometry - Cluster of Differentiation 34 (CD34)Assessment **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed). NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator. **ID:** OG000 **Title:** Stem Cell Collection Without In-vivo Purging With Bortezomib ##### Group **Description:** Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed. There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection. Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator. **ID:** OG001 **Title:** Stem Cell Collection With In-vivo Purging With Bortezomib #### Outcome Measure 3 **Description:** Estimate the percentage of Cluster of Differentiation 34 (CD34) positive cells in circulating peripheral blood as a measure of mobilization on the days of collection. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Within the first 30 days after stem cell collection **Title:** Cluster of Differentiation 34 (CD34) Enumeration **Type:** SECONDARY **Unit of Measure:** percentage of CD34 positive cells ##### Group **Description:** Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed). NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator. **ID:** OG000 **Title:** Stem Cell Collection Without In-vivo Purging With Bortezomib ##### Group **Description:** Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed. There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection. Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator. **ID:** OG001 **Title:** Stem Cell Collection With In-vivo Purging With Bortezomib ### Participant Flow Module #### Group **Description:** Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed). NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator. **ID:** FG000 **Title:** Stem Cell Collection Without In-vivo Purging With Bortezomib #### Group **Description:** Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed. There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection. Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator. **ID:** FG001 **Title:** Stem Cell Collection With In-vivo Purging With Bortezomib #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 51 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 50 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 51 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 50 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT02627079 **Brief Title:** ICanSTEP : Increasing Physical Activity With Text Messaging **Official Title:** ICanSTEP: Increasing Physical Activity in Cancer Survivors Through a Text-messaging Exercise Motivation Program #### Organization Study ID Info **ID:** Pro00068978 #### Organization **Class:** OTHER **Full Name:** Duke University ### Status Module #### Completion Date **Date:** 2018-05-21 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-06-10 **Type:** ACTUAL **Last Update Submit Date:** 2021-06-07 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-02-06 **Type:** ACTUAL #### Start Date **Date:** 2016-08-04 **Type:** ACTUAL **Status Verified Date:** 2021-06 #### Study First Post Date **Date:** 2015-12-10 **Type:** ESTIMATED **Study First Submit Date:** 2015-12-08 **Study First Submit QC Date:** 2015-12-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Duke University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The proposed pilot study will develop and test feasibility and preliminary efficacy of an exercise motivation intervention using a 12-week smartphone-text messaging program tailored to physical activity data retrieved from a Fitbit. Target population is 15 cancer survivors and 15 patients actively undergoing cancer treatment. **Detailed Description:** Cancer survivors have substantial residual cardiometabolic risk due to the fact that they are living longer and are exposed to the same lifestyle and environmental factors that have led to the drastic increase in obesity and diabetes in Western societies over the last four decades. In addition, survivors' cardiovascular health is significantly impaired due to cancer treatment. Research has shown that physical activity improves quality of life in cancer survivors, ameliorates treatment-related side effects reduces the risk of cancer recurrence, and extends overall survival. Despite these advantages, most cancer patients are sedentary. The early survivor period is a teachable moment to improve healthy behaviors. Social Cognitive Theory argues that to change exercise behavior, we must increase behavior change self-efficacy of participants (i.e., confidence), increase their outcome expectations that changing their behavior will lead to better health, enhance motivation to exercise, enhance their ability to regulate their behavior (self-regulation), teach them tangible behavior change skills, and help them overcome barriers to behavior change. In this study validated patient-reported outcomes will be performed at baseline and at 12 weeks - FACIT-F to document general cancer symptoms with additional questions on fatigue, the Beck Depression Inventory (BDI-II), and the modified Godin-Leisure Questionnaire as a measure of activity level. The investigators will also perform baseline and 3 month weight / BMI and 6-minute walk testing as a second well-validated objective measure of fitness. At enrollment and at 3 months, patients will be queried as to barriers to behavior change. At 3 months, patients will be asked by 5-point Likert scale how helpful the program was in increasing their physical activity. Six months after enrollment (+/- 4 weeks), level of physical activity and use of Fitbit will be determined. ### Conditions Module **Conditions:** - A Diagnosis of Any Hematologic or Solid Malignancy ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Cohort 1 will include 15 sedentary participants who have completed all cancer therapy except adjuvant hormonal therapy. All participants will be provided a Fitbit. Participants will then be provided daily SMS text messaging tailored to their activity level for 12 weeks.. **Intervention Names:** - Other: Daily SMS text messaging **Label:** Cohort 1 **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Cohort 2 will include 15 sedentary participants in active treatment. All participants will be provided a Fitbit. Participants will then be provided daily SMS text messaging tailored to their activity levels for 12 weeks. **Intervention Names:** - Other: Daily SMS text messaging **Label:** Cohort 2 **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Cohort 1 - Cohort 2 **Name:** Daily SMS text messaging **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Feasibility, as measured by the percentage of eligible patients who can be enrolled **Time Frame:** 6 months **Measure:** Feasibility, as measured by accrual rate **Time Frame:** 6 months **Measure:** Change in daily step count, as measured by Fitbit **Time Frame:** Baseline, 12 weeks **Measure:** Change in minutes of weekly exercise, as measured by Fitbit **Time Frame:** Baseline, 12 weeks **Measure:** Change in fatigue, as measured by questionnaire **Time Frame:** Baseline, 12 weeks **Measure:** Change in depression, as measured by questionnaire **Time Frame:** Baseline, 12 weeks **Measure:** Change in general activity, as measured by questionnaire **Time Frame:** Baseline, 6 months **Measure:** Change in quality of life, as measured by questionnaire **Time Frame:** Baseline, 12 weeks **Measure:** Change in body mass index (BMI) **Time Frame:** Baseline, 12 weeks #### Secondary Outcomes **Description:** This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time. **Measure:** Mean difference in daily step count, as measured by Fitbit **Time Frame:** Baseline, 12 weeks **Description:** This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time. **Measure:** Mean difference in minutes of weekly exercise, as measured by Fitbit **Time Frame:** Baseline, 12 weeks **Description:** This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time. **Measure:** Mean difference in fatigue, as measured by questionnaire **Time Frame:** Baseline, 12 weeks **Description:** This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time. **Measure:** Mean difference in depression, as measured by questionnaire **Time Frame:** Baseline, 12 weeks **Description:** This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time. **Measure:** Mean difference in general activity, as measured by questionnaire **Time Frame:** Baseline, 12 weeks **Description:** This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time. **Measure:** Mean difference in quality of life, as measured by questionnaire **Time Frame:** Baseline, 12 weeks **Description:** This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time. **Measure:** Mean difference in body mass index (BMI) **Time Frame:** Baseline, 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Eligible participants must be / have 1. age 18 or older, 2. a diagnosis of any hematologic or solid malignancy 3. a life expectancy of at least 12 months 4. ECOG \< /=2 5. in active cancer treatment or have completed active cancer treatment within one year of obtaining consent (with the exception of adjuvant hormonal therapy), 6. not scheduled for any major surgery during the anticipated study period, 7. able to read and understand English 8. sedentary defined as participating in 2 or less days of dedicated physical activity per week, 9. consistent daily access to a smartphone 10. a text messaging plan that includes a minimum of 150 text messages a month at no additional cost 11. capable of providing informed consent. Exclusion Criteria: 1. Significant cardiac disease (i.e., left ventricular ejection fraction of \<50%, unstable angina, placement of cardiac stents and myocardial infarction within previous 6 months) 2. Contraindications to a 6-minute walk test as recommended by the American Thoracic Society: (a) acute myocardial infarction (3-5 days), (b) unstable angina, (c) uncontrolled arrhythmias causing symptoms or hemodynamic compromise, (d) syncope, (e) acute endocarditis, (f) acute myocarditis or pericarditis, (g) uncontrolled heart failure, (h) acute pulmonary embolus or pulmonary infarction, (i) thrombosis of lower extremities, (j) suspected dissecting aneurysm, (k) uncontrolled asthma, (l) pulmonary edema, (m) room air desaturation at rest ≤85%, (n) respiratory failure, (o) acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise, (p) mental impairment leading to inability to cooperate, and (q) extensive bone metastases 3. ECOG \>2 4. Participates in 3 or more days of dedicated physical activity per week 5. Known allergic reaction to nickel 6. No access to a smart phone or text messaging plan less than 150 messages per month 7. Physical or psychological contraindication to participation at the discretion of the treating physician. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Durham **Country:** United States **Facility:** Duke Cancer Center **State:** North Carolina **Zip:** 27710 #### Overall Officials **Official 1:** **Affiliation:** Duke University **Name:** Bridget Koontz, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Koontz BF, Levine E, McSherry F, Niedzwiecki D, Sutton L, Dale T, Streicher M, Rushing C, Owen L, Kraus WE, Bennett G, Pollak KI. Increasing physical activity in Cancer Survivors through a Text-messaging Exercise motivation Program (ICanSTEP). Support Care Cancer. 2021 Dec;29(12):7339-7349. doi: 10.1007/s00520-021-06281-y. Epub 2021 May 28. **PMID:** 34050402 ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04249479 **Acronym:** CATCHY **Brief Title:** Contrast Media Temperature and Patient Comfort in CT of the Abdomen **Official Title:** The Effect of ContrAst Media Temperature on Patient Comfort in Computed tomograpHY of the Abdomen. #### Organization Study ID Info **ID:** NL68789.068.19 #### Organization **Class:** OTHER **Full Name:** Maastricht University Medical Center ### Status Module #### Completion Date **Date:** 2020-08-24 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-04-02 **Type:** ACTUAL **Last Update Submit Date:** 2021-03-30 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-08-24 **Type:** ACTUAL #### Start Date **Date:** 2020-02-03 **Type:** ACTUAL **Status Verified Date:** 2021-03 #### Study First Post Date **Date:** 2020-01-31 **Type:** ACTUAL **Study First Submit Date:** 2019-12-01 **Study First Submit QC Date:** 2020-01-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Maastricht University Medical Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Abdominal computed tomographic (CT) is an important prognostic tool with regard to the detection of oncological, infectious and other abdominal disorders. The total iodine load (TIL) is regarded as a decisive factor in the opacification of parenchymal structures. The EICAR trial demonstrated that injection with high flow rates of prewarmed contrast media (CM) was safe and patients did not experience any pain, stress of discomfort during injection. Flow rates as high as 8.8 ml/s were injected without any discomfort. All concentrations used (e.g. 240, 300 and 370 mg I/ml) in this study were prewarmed. According to the recent recommendations (ESUR guidelines 10.0) it should be considered to warm iodine-based CM before administration. The hypothesis is that although using CM at room temperature (\~23°C \[\~73°F\]) might result in lower attenuation of the liver parenchyma than would be achieved using CM pre-warmed to body temperature, diagnostic image quality, patient safety and comfort will not be compromised by not pre-warming CM in this setting. According to the guidelines, it is regarded as best clinical practice to pre-warm CM. Surprisingly, these recommendations are merely based on a hypothetical assumption. In the literature, there are no studies evaluating this topic and it has never been clearly shown to result in a better patient comfort. For this reason, many clinics do not pre-warm their CM in daily clinical routine. Only one study evaluated subjective comfort in hysterosalpingography (HSG), in which CM is injected in to the cavity of the uterus. This study found that prewarmed CM alleviates the pain and decreased the incidence of vasovagal episodes during HSG. To the best of our knowledge, no study showed that prewarmed CM in CT resulted in higher patient comfort, in comparison to CM at room temperature (20° C). Up till now, all CM in the department is prewarmed. In case this study does not show a difference in patient comfort, prewarming the CM can be stopped, resulting in a considerable simplified workflow. The hypothesis is that usage of CM at room temperature (20° C) might result in a decreased level of patient comfort in abdominal CT, in comparison to pre-heated (37° C) CM, with no significant difference in diagnostic attenuation of the liver parenchyma between groups. **Detailed Description:** Abdominal computed tomography (CT) scans are performed daily on a regular basis. Since its advent, rapid technical advances in CT continuously improved image quality. Besides scan technique, the contrast media (CM) injection protocol is the crucial factor in abdominal imaging. Parenchymal contrast enhancement is determined by patient related factors (e.g. cardiac output, blood volume and patient weight), the CM injection protocol and the scan protocol. Much literature has been performed with regard to optimizing CM application and the scan protocol. Flow rate of the CM and patient discomfort have been thoroughly investigated in our department. Heating CM up to body temperature has been daily clinical routine in our department for years. According to the recent recommendations (ESUR guidelines 10.0) it is advised to warm iodine-based CM before administration. Warming the CM is expected to result in a higher patient comfort, based on clinical observation. Kok et al. showed in phantom experiments that high temperature, low iodine concentration and low viscosity significantly decreases injection pressure. Subsequently, as increased temperature reduces the viscosity of the CM, the decreased viscosity is hypothesized to reduce the risk of extravasation. A decreased viscosity might also have a substantial impact on individual tailored CM injection protocols in daily routine scanning as it is speculated that a decrease of viscosity and subsequent decrease in peak injection pressure could influence patient comfort during injection. The EICAR trial showed that prewarmed CM can be safely injected at high flow rates, without patient discomfort, pain or stress. However, the latter was not compared to CM at room temperature. Different CM concentrations are used in different hospitals throughout the world. The higher the concentration, the higher the viscosity of the CM. In present study, only one CM concentrations (e.g. 300 mg/ml) will be used, which is used in daily clinical practice for years. Heating the CM decreases the viscosity. It is therefore expected that the preheated CM in a concentration of 300 mg/ml has a lower viscosity in comparison to the CM at 20° C. Pre-warming CM might be regarded as best clinical practice. No studies have been performed to investigate this statement, nor is there any literature that shows that prewarmed CM has a favorable patient comfort compared to CM injected at room temperature. For these reasons, there remains to be some reluctance and many clinics still not pre-warm their CM. One study, in which CM is injected in to the cavity of the uterus to check for any anatomical variants and causes for infertility, showed a preference for prewarmed CM in hysterosalpingography (HCG). This study found that prewarmed CM alleviates the pain and decreased the incidence of vasovagal episode during the HCG. The hypothesis is that although using CM at room temperature (\~23°C \[\~73°F\]) might result in lower attenuation of the liver parenchyma than would be achieved using CM pre-warmed to body temperature, diagnostic image quality, patient safety and comfort will not be compromised by not pre-warming CM in this setting. Pre-warming CM requires special equipment and more complex planning and logistics. On the other hand, pre-warming CM may yield higher attenuation levels, comfort and image quality. In case this study does not show a significant difference in patient comfort and diagnostic quality between groups, pre-warming the CM can be stopped, resulting in a considerable simplified workflow. ### Conditions Module **Conditions:** - Contrast Media - Comfort - Temperature - Abdomen ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** It is a double-blinded randomised controlled non-inferiority trial conducted according to Guidelines of Good Clinical Practice. The aim of the study is to prospectively compare room temperature CM to pre-warmed CM with regard to image quality, safety, and participant comfort in portal venous abdominal imaging. We are aiming to prospectively enrol 216 consecutive patients, who will be scheduled for contrast enhanced abdominal CT. 216 patients will be divided into 2 different groups: * Group I: 300 mg/ml at a temperature of 20° C * Group II: 300 mg/ml at a temperature of 37° C Iodine concentrated CM of 300 mg/ml is clinically used as a standard routine injection protocol for all CT scans in our department, including abdominal CT. The scan protocol is identical to our daily clinical practice. The only difference is that 50% of the included patients will receive CM warmed at room temperature. Both CM temperatures are saved/warmed in an incubator. ##### Masking Info **Masking:** DOUBLE **Masking Description:** All subjects will be randomized into two different groups as listed in the study outline. The randomization schedule will be prepared and centrally administered. A computer random number generator prepares the randomization schedule in a 1:1 fashion (balanced randomization). Stratification is performed, based on age (\< 60 and ≥ 60 years) and weight (\< 80 and ≥ 80 kg). Variable block randomization will distribute patients equally over time. The blinding and randomization process will be conducted by Clinical Trial Centre Maastricht (CTCM, www.CTCM.nl) with a randomization program designed for usage of different techniques (minimization, block method, biased-coin, etc). The technician who administers the CM is aware of the CM temperature. Therefore, the technicians will be instructed before start of the study, not to give this information to the patient, not even when requested by the patient. **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 218 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** CM is administered to the patient at a temperature of 20° C. **Intervention Names:** - Other: CM Temperature (20° C) - Other: Weight **Label:** CM temperature 20° C **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** CM is administered to the patient at a temperature of 37° C. **Intervention Names:** - Other: CM Temperature (37° C) - Other: Weight **Label:** CM temperature 37° C **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - CM temperature 20° C **Description:** CM will be administered at 20° C (room temperature). **Name:** CM Temperature (20° C) **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - CM temperature 37° C **Description:** CM will be administered at 37° C (pre-heated). **Name:** CM Temperature (37° C) **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - CM temperature 20° C - CM temperature 37° C **Description:** The patients' weight is measured prior to scanning by a technician on a weighing scale available in the scanner room. **Name:** Weight **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Mean attenuation in Hounsfield Units (HU) is based on three liver segments, preferably segments 2, 5 and 8 (Couinaud classification). Absolute difference in mean attenuation of the liver parenchyma between groups was calculated with a two-sided 95% confidence interval of the difference. **Measure:** Liver attenuation **Time Frame:** Expected within one month after the CT is performed #### Secondary Outcomes **Description:** Patient (dis)comfort during and after injection of CM with varying temperatures, rated on a questionnaire **Measure:** Patient comfort **Time Frame:** Immediately after CT **Description:** Assessed with a questionnaire with the option yes/no **Measure:** Pain during injection **Time Frame:** Questionnaire immediately after CT **Description:** Assessed with a 11-point numeric rating scale (0=no pain; 10=very severe pain) **Measure:** Pain rate **Time Frame:** Questionnaire immediately after CT **Description:** Questionnaire has to be filled in which people can tick a box if they had feelings of shivering/goosebumps/or being cold. There is some free space to write down other sensations. **Measure:** Different physiological reactions and sensations injection **Time Frame:** Immediately after the CT **Description:** mean attenuation of the liver divided by the mean standard deviation **Measure:** Objective image quality - Signal-to-noise ratio **Time Frame:** Within one month after the CT is performed **Description:** Mean liver attenuation minus HU of the left paraspinal muscle, divided by the SD of the attenuation of the paraspinal muscle **Measure:** Objective image quality - Contrast-to-noise ratio **Time Frame:** Within one month after the CT is performed **Description:** Rated in consensus on a 5-point Likert scale by two readers **Measure:** Subjective image quality **Time Frame:** Within one month after the end of the study **Description:** Weight is measured on a weighing scale **Measure:** Body weight **Time Frame:** Right before the scan is performed **Description:** The milliliter of CM administered **Measure:** CM volume **Time Frame:** Information is expected to be collected from the Certegra form available in Impax within 1 month **Description:** Flow rate of the contrast media in ml/s **Measure:** Flow rate **Time Frame:** Information is expected to be collected from the Certegra form available in Impax within 1 month **Description:** Injection site of the CM **Measure:** Injection site **Time Frame:** Information is expected to be collected from the Certegra form available in Impax within 1 month **Description:** Catheter size used for CM injection **Measure:** Catheter Gauge **Time Frame:** Information is expected to be collected from the Certegra form available in Impax within 1 month **Description:** The effective mAs used in the specific patient **Measure:** Effective milliamperes (mAs) **Time Frame:** Information is expected to be collected from the Certegra form available in Impax within 1 month **Description:** CTDIvol (in mGy) the patient received **Measure:** CT Dose Index (CTDI)vol **Time Frame:** Information is expected to be collected from Impax within 1 month **Description:** DLP (in mGycm) the patient received **Measure:** Dose-length product (DLP) **Time Frame:** Information is expected to be collected from Impax within 1 month **Description:** Tube voltage used in the specific scan **Measure:** Tube voltage **Time Frame:** Information is expected to be collected from Impax within 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion criteria * Patients referred for abdominal CT * Patient ≥ 18 years old and competent to sign informed consent Exclusion criteria * Hemodynamic instability * Pregnancy * Renal insufficiency defined as glomerular filtration rate (GFR) \< 30ml/min/1.73m2 (Odin protocol 004720) * Iodine allergy (Odin protocol 022199) * Age \< 18 year * Unable to give informed consent or no informed consent obtained * Inability to position an 18 gauge cannula in an antecubital vein **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Maastricht **Country:** Netherlands **Facility:** MaastrichtUMC **State:** Limburg **Zip:** 6229 HX #### Overall Officials **Official 1:** **Affiliation:** Maastricht University Medical Center **Name:** Joachim E Wildberger, Professor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** The results will be published in international peer reviewed journals in order to spread new insights regarding contrast media temperature in abdominal CT imaging. Both positive and negative results will be published according to the guidelines of the 'Centrale Commissie Mensgebonden Onderzoek' (CCMO). **Info Types:** - CSR **IPD Sharing:** YES **Time Frame:** Within 18 months after completion ### References Module #### References **Citation:** Martens B, Wildberger JE, Van Kuijk SMJ, De Vos-Geelen J, Jeukens CRLPN, Mihl C. Influence of Contrast Material Temperature on Patient Comfort and Image Quality in Computed Tomography of the Abdomen: A Randomized Controlled Trial. Invest Radiol. 2022 Feb 1;57(2):85-89. doi: 10.1097/RLI.0000000000000807. **PMID:** 34280944 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04829279 **Brief Title:** Evaluation of Effectiveness for Connected Network for EMS Comprehensive Technical-support Using Artificial Intelligence (CONNECT-AI) System by Community Intervention **Official Title:** Evaluation of Effectiveness for Connected Network for EMS Comprehensive Technical-support Using Artificial Intelligence (CONNECT-AI) System by Community Intervention: A Prospective Crossover Interventional Study #### Organization Study ID Info **ID:** 4-2021-0217 #### Organization **Class:** OTHER **Full Name:** Yonsei University ### Status Module #### Completion Date **Date:** 2021-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-07-07 **Type:** ACTUAL **Last Update Submit Date:** 2023-07-05 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-12-31 **Type:** ACTUAL #### Start Date **Date:** 2021-05-01 **Type:** ACTUAL **Status Verified Date:** 2023-07 #### Study First Post Date **Date:** 2021-04-02 **Type:** ACTUAL **Study First Submit Date:** 2021-03-29 **Study First Submit QC Date:** 2021-03-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Yonsei University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aims to verify the effectiveness of the connected network for EMS comprehensive technical-support using artificial intelligence (CONNECT-AI) system through demonstration in the local community. The study was designed as a prospective non-random cross-intervention study design in two preselected communities. The subjects of the study are patients transferred to the local emergency department(ED) through an ambulance of a fire department in the selected community. If the storage and transmission of information collected by an ambulance fails or the information of the transferred patient cannot be verified in the transferred ED, it is excluded from the study. In this study, the developed CONNECT-AI system was installed in all emergency vehicles and EDs in two regional cohorts, and the effectiveness was measured by operating an intersection for the same period. The primary outcome is the transfer time spent in the pre-hospital stage, and the secondary outcome is whether the optimal transfer hospital is selected. ### Conditions Module **Conditions:** - Emergency Patient Transported by Ambulance ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 15392 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Emergency patient transferred by CONNECT AI system **Intervention Names:** - Other: CONNECT AI system group **Label:** Case **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Emergency patient transferred by conventional EMS **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Case **Description:** A. During the Intervention period, paramedics wear equipment for multi-faceted data acquisition and press the start button of the system. B. During the Intervention period, inside the ambulance, a application that implements a function that automatically evaluates the patient's severity, displays a list of optimal transfer hospitals based on this, and shares real-time information of the hospitals, is installed so that paramedics can refer to the work. C. ED's medical staff will receive through ER-kiosk pre-hospital patient information collected and analyzed through the CONNECT AI system before arrival. **Name:** CONNECT AI system group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Time taken from the time the paramedic arrives at the scene to the transfer hospital **Measure:** transfer time spent in the pre-hospital stage **Time Frame:** up to 1 month #### Secondary Outcomes **Description:** In the case of transfer to another hospital or death without resolving the emergency situation at the initial ED **Measure:** Whether to select the optimal transfer hospital **Time Frame:** up to 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients transferred to the local emergency department(ED) through an ambulance of a fire department in the selected community. Exclusion Criteria: * If the storage and transmission of information collected by an ambulance fails or the information of the transferred patient cannot be verified in the transferred ED **Maximum Age:** 100 Years **Minimum Age:** 0 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Yonsei University #### Overall Officials **Official 1:** **Affiliation:** Division of Cardiology, Yonsei university college of medicine **Name:** Hyuk-Jae Chang **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7796 - Name: Emergencies - Relevance: HIGH - As Found: Emergency - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004630 - Term: Emergencies ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05758779 **Acronym:** DANFOCOS **Brief Title:** The Danish Familial Hypercholesterolemia Organized Coronary Screening Trial **Official Title:** Coronary CT Screening of Patients With Familial Hypercholesterolemia - The Prevalence of Subclinical Atherosclerosis in Familial Hypercholesterolemia in the Region of Southern Denmark #### Organization Study ID Info **ID:** DANFOCOS #### Organization **Class:** OTHER **Full Name:** Odense University Hospital ### Status Module #### Completion Date **Date:** 2025-05-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-12-29 **Type:** ACTUAL **Last Update Submit Date:** 2023-12-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-09-01 **Type:** ACTUAL **Status Verified Date:** 2023-12 #### Study First Post Date **Date:** 2023-03-07 **Type:** ACTUAL **Study First Submit Date:** 2023-02-01 **Study First Submit QC Date:** 2023-03-06 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Odense University Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Familial hypercholesterolemia (FH) is the most common inherited cause of atherosclerotic cardiovascular disease (ASCVD) with a prevalence of approximately one in 200 individuals, however only few of the estimated 30.000 patients with FH in Denmark has been diagnosed. FH is characterized by high levels of low-density lipoprotein cholesterol (LDL-C) and a high risk of premature ASCVD in particular coronary artery disease. The presence of atherosclerosis measured by cardiac computed tomography (CT) is a reliable predictor of future cardiovascular events and may help guide clinicians with regard to the lifestyle modifying therapies and lipid-lowering treatment. However, the prevalence and degree of coronary atherosclerosis in Danish FH patients without symptoms of ASCVD is unknown. Therefore, the invetigators aimed to: * Screen FH patients in a Danish setting for subclinical coronary atherosclerosis to improve lipid-lowering treatment and, * Test if coronary CT screening can help to reach LDL-C therapy goals and reduce smoking. This study will consist of a local cross sectional pilotstudy including 100 asymptomatic FH patients recruited from the lipid clinic at Odense University Hospital and hereafter a regional cross-sectional on approximately 600 asymptomatic FH patients in the Region of Southern Denmark recruited from the lipid clinics trough the national patient registry. In the pilot study, patients will undergo lipid analysis and non-contrast / contrast CT for description of coronary arterial calcium, and plaque morphology in this patient group. This will provide knowledge for planning the regional cross sectional study describing subclinical atherosclerosis in this population. Patients will furthermore be randomized to see their coronary CT scan or not. Mean LDL-C change and smoking status will be evaluated one year after. The benefit of finding subclinical atherosclerotic disease with the possibility to improve lipid-lowering treatment for prevention of future premature ischemic heart disease is considered to outweigh the minor radiation exposure in this trial. If LDL-C is reduced significantly and smoking reduction is significant trough a simple intervention as showing the CT scan to the patient, this study can provide knowledge whether CT screening of this patient group should be considered in Denmark. **Detailed Description:** 1. Introduction: Familial hypercholesterolemia (FH) is the most common inherited cause of atherosclerotic cardiovascular disease (ASCVD) with a prevalence of 1/200. More than 30.000 patients in Denmark are expected to have FH, however, few of these patients is diagnosed. Patients with FH may have up to a 13-fold higher risk of coronary artery disease compared to the background population. However, FH can be treated with appropriate lipid-lowering treatment, and early initiation of lipid-lowering treatment may lower the risk of ASCVD to be comparable with individuals without FH. Early diagnosis and initiation of lifestyle modifying therapies and lipid-lowering treatment is of major importance to lower the risk of ASCVD in FH patients and their affected relatives. However, limited knowledge exist on whether risk stratification using objective measures of coronary artery atherosclerosis may be used to identify FH patients that require more intensive lipid-lowering treatment than others. FH should be suspected in individuals with severely elevated low-density lipoprotein - cholesterol (LDL-C) in, or in families with premature ASCVD. A diagnosis of FH is most often based on clinical scores such as the Simon Broome Criteria or the Dutch Lipid Clinical Network (DLCN) Criteria, which both include information on genetic testing for pathogenic FH mutations as an important part of making a definite diagnosis of FH. The lipid-lowering treatment in most FH patients include statins and ezetimibe. Proprotein-convertase-subtilisin/kexin-type 9 (PCSK9)-inhibitors are very potent and has been shown to reduce atherosclerotic plaques, but these agents are currently very expensive and their use in FH patients in the context of primary prevention is limited to patients with highly elevated LDL-C despite standard treatment. However FH remains under diagnosed, resulting in premature ASCVD and death. Thus, there is a need for optimized screening for ASCVD in asymptomatic FH patients for optimization in treatment. The Spanish SAFEHEART study was the first study to screen a larger population of patients with FH with coronary contrast and non-contrast CT scan for ASCVD. In this study 440 FH patients were included and screened with coronary CT and followed for a maximum of 3 years for development of cardiovascular disease. Interestingly, this study showed a significant prevalence of coronary atherosclerosis visualized by CT-scan, even in patients on lipid-lowering treatment, with 55% of the population with coronary calcium present. Coronary atherosclerosis is associated with increased risk of cardiovascular events, and the study concluded that coronary CT screening may be beneficial in risk stratification of asymptomatic FH patients, and that systematic screening potentially could benefit FH patients. However, whether CT screening for coronary atherosclerosis in asymptomatic FH patients has a potential in a Danish setting for risk stratification and optimizing in treatment remain unsettled. The recently published DANCAVAS 5 year outcome, found a benefit of CT-screening on all-cause mortality among men aged 65-69 years, and this support the rationale for screening younger patients in high-risk of ischemic heart disease. A minor study has been done with non-contrast coronary CT in Denmark including 88 FH patients in 2000, concluding that age adjusted coronary arterial calcium score (CACS) was strongly associated with ASCVD, however investigation of a larger population remains yet to be done. 2. Purpose: This study will by coronary CT screening investigate the prevalence of asymptomatic coronary atherosclerosis in patients with FH in the Region of Southern Denmark. The definition of subclinical coronary atherosclerosis will be finally settled through a pilot study describing coronary arterial calcium score (CACS), severity of stenosis, plaque composition and LDL-C in 100 patients with FH in different age groups. Furthermore participants will be randomized to see their coronary imaging at screening. Change in LDL-C and smoking status one year after screening will be evaluated as an indicator for optimized treatment. Finally, the investigators will screen for subjects beeing candidates for a future interventional study with intensified lipid lowering treatment with PCSK9-inhibitors. The investigators hypothesize that approximately 50% of the FH patients has subclinical atherosclerosis before the age of 50, and that coronary CT screening can be used for optimizing lipid-lowering treatment by stratifying FH patient according to presence of subclinical coronary atherosclerosis and adjusting LDL-C treatment targets. In addition, the investigators hypothesize that visualization of the coronary arteries for the patient is associated with a reduction in LDL-C and a reduction in smoking one year after screening. 3. Method: 3.1 Design: The project include a cross-sectional pilot study that will be conducted at the Department of Cardiology at Odense University Hospital and a larger regional cross-sectional study, in cooperation with the departments of cardiology in the Region of Southern Denmark. Furthermore the study will include an imbeded Randomized Controlled Trial (RCT). 3.2 Intervention: This is primary a cross sectional study screening asymptomatic patients with FH with coronary CT, describing the prevalence of subclinical atherosclerosis. Coronary CT scan will be performed according to the local guidelines for optimal imaging quality, Image analysis will be done using standard software for CACS analysis (Synovia, Siemens Healthineers solution, Forcheim Tyskland) and Autoplaq software (Cedars Sinai Medical Center, LA, California, USA). The study will include an imbeded RCT randomizing the patients to see or not see their coronary CT image, evaluating effect on cholesterol and smoking status. Questionary will be completed before CT-scanning and one year after CT scanning. 3.2.1 Pilot study Initially a pilotstudy on 100 patients will be conducted at the Department of Cardiology at Odense University Hospital. Eligible patients will be identified at first contact or during follow-up in the lipid clinic. The eligible patients will be invited to participation in the trial by mail/letter containing information regarding the trial. If he/she is willing to participate in the study, informed consent is obtained at first visit and echocardiography, ultrasound of femoral and carotid arteries, and ECG will be performed and blood samples (lipidprofile, Hba1c, TSH, liver and kidney parameters) will be collected prior to coronary CT with and without contrast. The investigators aim to recruit patients evenly distributed on age and sex from 20-70 years. The purpose of the pilot study is to investigate the prevalence of coronary atherosclerosis in asymptomatic men and women in different age groups, providing knowledge for planning the regional cross sectional study. 3.2.2 Regional cross-sectional study In the regional cross-sectional study, eligible patients with a diagnosis of FH will be identified through the National Patients Registry and in cooperation with the local lipid clinics. The investigators estimate that approximately 1000 will be eligible and that 600 will participate in the study. Eligible patients will be invited to participate in the trial at ambulatory contacts or by mail/letter containing information regarding the trial. Age group for invitation to the study will be settled according to findings from the pilot study, probably 30-70 years. If he/she is willing to participate in the study, informed consent will be obtained at first visit and echocardiography, ultrasound of femoral and carotid arteries, and ECG will be performed and blood samples (lipidprofile, Hba1c, TSH, liver and kidney parameters) will be collected prior to coronary CT. 3.2.3 Imbedded RCT. 200 patients from the regional cross sectional study will be randomized to see or not see their coronary CT image. Follow up will be after one year, measuring LDL-C and evaluating smoking status by a survey. Outcome will be differences in LDL-C and probability of being a smoker, defined as odds ratio (OR) for being a smoker between the two groups. 3.3 Sample size: The aim is to include 400 patients in a future pharmacological interventional study. Therefore the investigators aim to include 600 patients in the regional cross-sectional study taking account for exclusion/dropout of 25 % in the pharmacological interventional study. 3.4 Randomisation In both the pilot study and the regional cross -sectional study, patients will be randomized to seeing their coronary CT image or not. LDL-C levels and smoking status will be evaluated after one year. The investigator analyzing endpoints will be blinded to whether the patients has seen there CT or not. 3.5 Statistical analyses The pilot study will describe median CACS, plaque composition (proportion of soft versus calcified plaques), severity of stenosis and LDL-C levels. Statistical analysis on LDL-C change and smoking status one year after coronary CT screening and randomization to either seeing the coronary imaging or not will be performed by STATA. 3.5.1 Numerical outcomes: For change in LDL-C levels and number of cigarettes per day after one year, the difference in means between the group seeing the coronary imaging and the group not seeing the coronary imaging will be calculated by Students T-test. 3.5.2 Binary outcomes: For smoking status one year after randomization to seeing the coronary imaging or not, the probability for being a smoker, defined as odds ratio (OR) for being a smoker will be calculated by chi squared test. 4. Ethics: The average dose of one non-contrast cardiac CT scan is 1 mSv and the average dose of an additional contrast cardiac CT scan is 3 mSv. The 100 participants in the DANFOCOS pilot study will therefore receive 4 mSv, corresponding to one contrast and one non contrast cardiac CT scan. For comparison, the annual background radiation dose in Denmark is 3 mSv, and the average annual limit for radiation workers is 20 mSv. Overall the benefits of finding premature atherosclerotic disease with the possibility to improve treatment is considered to outweigh the radiation dose. 5. Organization: This Project is initiated from the cardiological department at Odense University Hospital as part of a PhD program with MD. Jakob Knold. The project will be associated with the Clinical Institute at University of Southern Denmark. The Steering Commitee will consist of main supervisor Associated Professor Finn Lund Henriksen (PI, Department of Cardiology OUH). Professor Axel Diederichsen (Department of Cardiology OUH), Associated Professor Kristian Altern Øvrehus (Department of Cardiology OUH), PhD Christian Sørensen Bork (Department of Cardiology AAUH). MD. Jakob Knold (Department of Cardiology OUH). The data registration will be performed via REDCap with logging and secure storage directly on a server under Odense Patient Data Explorative Network (OPEN), Region of Southern Denmark. 6. Economi and Funding Private and public foundations are sought for funding. The investigators has no economical affiliation or conflicts of interest. 7. Perspectives This study will be the largest screening of asymptomatic FH patients with coronary CT in a Danish setting and test if visualization of the coronary arteries for the patient has an effect on LDL-C levels and smoking status after one year. The study will identify patients with asymptomatic coronary atherosclerosis which require a lower LDL-C target than patients without coronary atherosclerosis and thereby elucidate whether coronary CT screening of FH patients can improve treatment of this patient group in Denmark. The study will identify eligible subjects for a future interventional study with intensified lipid lowering treatment (PCSK9-inhibitors), which could have implications for the current guideline regarding PCSK9-inhibitors, improving the treatment of FH patients in the future. ### Conditions Module **Conditions:** - Familial Hypercholesterolemia - Atherosclerosis **Keywords:** - Familial Hypercholesterolemia - Subclinical Coronary Atherosclerosis - Coronary computerized tomography - Coronary arterial calcium score - Screening - Risc stratification ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomised controlled trial ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The patient is allowed to see the CT image of his/hers coronary vessels, including oral describtion of the findings. **Intervention Names:** - Behavioral: Visualization of coronary Imaging and oral description **Label:** Coronary CT scan visualized for patient **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The patient is not allowed to see the CT image of his/hers coronary vessels. **Label:** Coronary CT scan NOT visualized for patient **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Coronary CT scan visualized for patient **Description:** The participants is allowed to see their coronary CT scan including oral description. The study will test the effect on smoking habit and changes in LDL-C in one year. **Name:** Visualization of coronary Imaging and oral description **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Mean CACS of the population **Measure:** Coronary arterial calcium score (CACS) **Time Frame:** 18 months **Description:** Median CACS of the population **Measure:** CACS **Time Frame:** 18 months **Description:** proportion of soft and calcified plaques **Measure:** Plaque composition **Time Frame:** 18 months **Description:** Mean size of plaques described in mm. **Measure:** Plaque volume (mean) **Time Frame:** 18 months **Description:** Median size of plaques described in mm. **Measure:** Plaque volume (median) **Time Frame:** 18 months **Description:** Percentage of vessel lumen compromised by plaque described as number of minor, moderate and severe stenosis. **Measure:** Severity of stenosis (number of stenosis) **Time Frame:** 18 months **Description:** Percentage of vessel lumen compromised by plaque described as proportion of minor, moderate and severe stenosis. **Measure:** Severity of stenosis (proportion of stenosis) **Time Frame:** 18 months #### Secondary Outcomes **Description:** Mean change in LDL-C levels one year after randomization to see coronary imaging. Difference in mean between the two groups **Measure:** Change in LDL-C levels. **Time Frame:** 12 months **Description:** Odds ratio for being af smoker one year after randomization to see or not see your coronary imaging **Measure:** Change in smoking status **Time Frame:** 12 months **Description:** Mean change in number of smoked cigarettes per day, one year after randomization to see coronary imaging. Difference in mean between the two groups **Measure:** Change in mean consumption cigarettes per day **Time Frame:** 12 months **Description:** Prevalence of femoral and carotid plaques visualized by ultrasound, described as proportion of plaques in the population. **Measure:** Prevalence of femoral and carotid plaques **Time Frame:** 18 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients diagnosed with genetically or clinically FH (DLCN score \> 6) between the age of 20 and 70 are eligible patients in DANFOCOS. Exclusion Criteria: * History of ASCVD defined as myocardialinfarction, procedural revascularisation, CABG and/or objective evidence if ischaemia (exercise stress test, stress echocardiography, myocardial perfusion scintigraphy, stress cardiac magnetic resonance, coronary angiography, cardiac CT), angina pectoris, ischaemic stroke or a medically (aspirin, clopidogrel, persantin) treated transitory ischaemic attack, and symptomatic peripheral vascular disease with ankle-brachial index below 0.9 or procedural revascularisation. * Current Pregnancy or planning pregnancy (due to radiation issues) * eGFR \< 60 ml/min/1,73 m2 (due to CT-contrast) * Prior allergic reaction to CT-contrast. * PCSK9-inhibitor treatment * Life expectancy \< 5 years. * Secondary dyslipidemia * Dysregulated diabetes * Dysregulated hypothyreosis TSH \> 4,0 IU/L. * Combined hyperlipidemia: TG \> 4 mmol/L * Nefrotic syndrome: proteinuria \> 3 g/L and s-albumin \< 30 g/l * History of primary billiary cirrhosis * Low-carb-high-fat diet. * Pharmacological induced dyslipidemia Findings on Coronary CT leads to exclusion * Three vessels disease * Left main coronary artery stenosis * Proximal left anterior descending coronary artery stenosis * Proximal right coronary artery stenosis **Maximum Age:** 70 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jakob.knold@rsyd.dk **Name:** Jakob Knold, MD **Phone:** 004541278928 **Role:** CONTACT **Contact 2:** **Email:** finn.l.henriksen@rsyd.dk **Name:** Finn Lund Henriksen, PhD **Phone:** 004529679722 **Role:** CONTACT #### Locations **Location 1:** **City:** Odense **Contacts:** ***Contact 1:*** - **Name:** Jakob Knold, MD - **Role:** CONTACT **Country:** Denmark **Facility:** Odense University Hospital **Status:** RECRUITING **Zip:** 5000 #### Overall Officials **Official 1:** **Affiliation:** Odense University Hospital **Name:** Finn Lund Henriksen, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Levenson AE, de Ferranti SD. Familial Hypercholesterolemia. In: Feingold KR, Anawalt B, Boyce A, Chrousos G, de Herder WW, Dhatariya K, et al., editors. Endotext. South Dartmouth (MA)2000 **Citation:** Bundgaard H SMea. Regionernes klinisk kvalitetsdatabase. Familiær hyperkolesterolæmi databasen. 2020 [Available from: https://www.rkkp.dk/kvalitetsdatabaser/databaser/databasen-for-familiaer-hyperkolesterolaemi/ **Citation:** Nordestgaard BG, Chapman MJ, Humphries SE, Ginsberg HN, Masana L, Descamps OS, Wiklund O, Hegele RA, Raal FJ, Defesche JC, Wiegman A, Santos RD, Watts GF, Parhofer KG, Hovingh GK, Kovanen PT, Boileau C, Averna M, Boren J, Bruckert E, Catapano AL, Kuivenhoven JA, Pajukanta P, Ray K, Stalenhoef AF, Stroes E, Taskinen MR, Tybjaerg-Hansen A; European Atherosclerosis Society Consensus Panel. Familial hypercholesterolaemia is underdiagnosed and undertreated in the general population: guidance for clinicians to prevent coronary heart disease: consensus statement of the European Atherosclerosis Society. Eur Heart J. 2013 Dec;34(45):3478-90a. doi: 10.1093/eurheartj/eht273. Epub 2013 Aug 15. Erratum In: Eur Heart J. 2020 Dec 14;41(47):4517. **PMID:** 23956253 **Citation:** Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, Chapman MJ, De Backer GG, Delgado V, Ference BA, Graham IM, Halliday A, Landmesser U, Mihaylova B, Pedersen TR, Riccardi G, Richter DJ, Sabatine MS, Taskinen MR, Tokgozoglu L, Wiklund O; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020 Jan 1;41(1):111-188. doi: 10.1093/eurheartj/ehz455. No abstract available. Erratum In: Eur Heart J. 2020 Nov 21;41(44):4255. **PMID:** 31504418 **Citation:** Rosso A, Pitini E, D'Andrea E, Massimi A, De Vito C, Marzuillo C, Villari P. The Cost-effectiveness of Genetic Screening for Familial Hypercholesterolemia: a Systematic Review. Ann Ig. 2017 Sep-Oct;29(5):464-480. doi: 10.7416/ai.2017.2178. **PMID:** 28715059 **Citation:** Sturm AC, Knowles JW, Gidding SS, Ahmad ZS, Ahmed CD, Ballantyne CM, Baum SJ, Bourbon M, Carrie A, Cuchel M, de Ferranti SD, Defesche JC, Freiberger T, Hershberger RE, Hovingh GK, Karayan L, Kastelein JJP, Kindt I, Lane SR, Leigh SE, Linton MF, Mata P, Neal WA, Nordestgaard BG, Santos RD, Harada-Shiba M, Sijbrands EJ, Stitziel NO, Yamashita S, Wilemon KA, Ledbetter DH, Rader DJ; Convened by the Familial Hypercholesterolemia Foundation. Clinical Genetic Testing for Familial Hypercholesterolemia: JACC Scientific Expert Panel. J Am Coll Cardiol. 2018 Aug 7;72(6):662-680. doi: 10.1016/j.jacc.2018.05.044. **PMID:** 30071997 **Citation:** Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JJ, Koenig W, Somaratne R, Kassahun H, Yang J, Wasserman SM, Scott R, Ungi I, Podolec J, Ophuis AO, Cornel JH, Borgman M, Brennan DM, Nissen SE. Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial. JAMA. 2016 Dec 13;316(22):2373-2384. doi: 10.1001/jama.2016.16951. **PMID:** 27846344 **Citation:** Raal FJ, Hovingh GK, Catapano AL. Familial hypercholesterolemia treatments: Guidelines and new therapies. Atherosclerosis. 2018 Oct;277:483-492. doi: 10.1016/j.atherosclerosis.2018.06.859. **PMID:** 30270089 **Citation:** Hedegaard BS. A danish nationwide study og individuals suspected of FH referred from general practice to lipid clinics: Clinical characteristics, plasma lpipoprotein(A) and final diagnosis. Atherosclerosis. 2021. **Citation:** Schmidt EB, Hedegaard BS, Retterstol K. Familial hypercholesterolaemia: history, diagnosis, screening, management and challenges. Heart. 2020 Dec;106(24):1940-1946. doi: 10.1136/heartjnl-2019-316276. Epub 2020 Sep 15. No abstract available. **PMID:** 32933999 **Citation:** Perez de Isla L, Alonso R, Muniz-Grijalvo O, Diaz-Diaz JL, Zambon D, Miramontes JP, Fuentes F, Gomez de Diego JJ, Gonzalez-Estrada A, Mata N, Saltijeral A, Barreiro M, Tomas M, de Andres R, Argueso R, Serrano Gotarredona MP, Navarro Herrero S, Perea Palazon RJ, de Caralt TM, Suarez de Centi LA, Zhilina S, Espejo Perez S, Padro T, Mata P; SAFEHEART investigators. Coronary computed tomographic angiography findings and their therapeutic implications in asymptomatic patients with familial hypercholesterolemia. Lessons from the SAFEHEART study. J Clin Lipidol. 2018 Jul-Aug;12(4):948-957. doi: 10.1016/j.jacl.2018.04.003. Epub 2018 Apr 17. **PMID:** 29753733 **Citation:** Luirink IK, Kuipers IM, Hutten BA, Planken RN, Backx APCM, Groothoff JW, Wiegman A. Coronary computed tomography angiography and echocardiography in children with homozygous familial hypercholesterolemia. Atherosclerosis. 2019 Jun;285:87-92. doi: 10.1016/j.atherosclerosis.2019.04.219. Epub 2019 Apr 11. **PMID:** 31048103 **Citation:** Lindholt JS, Sogaard R, Rasmussen LM, Mejldal A, Lambrechtsen J, Steffensen FH, Frost L, Egstrup K, Urbonaviciene G, Busk M, Diederichsen ACP. Five-Year Outcomes of the Danish Cardiovascular Screening (DANCAVAS) Trial. N Engl J Med. 2022 Oct 13;387(15):1385-1394. doi: 10.1056/NEJMoa2208681. Epub 2022 Aug 27. **PMID:** 36027560 **Citation:** Jensen JM, Gerdes LU, Jensen HK, Christiansen TM, Brorholt-Petersen JU, Faergeman O. Association of coronary heart disease with age-adjusted aortocoronary calcification in patients with familial hypercholesterolaemia. J Intern Med. 2000 Apr;247(4):479-84. doi: 10.1046/j.1365-2796.2000.00630.x. **PMID:** 10792562 **Citation:** Wang W, Yang L, Wang S, Wang Q, Xu L. An automated quantification method for the Agatston coronary artery calcium score on coronary computed tomography angiography. Quant Imaging Med Surg. 2022 Mar;12(3):1787-1799. doi: 10.21037/qims-21-775. **PMID:** 35284280 **Citation:** Romanens M, Mortensen MB, Sudano I, Szucs T, Adams A. Extensive carotid atherosclerosis and the diagnostic accuracy of coronary risk calculators. Prev Med Rep. 2017 Mar 14;6:182-186. doi: 10.1016/j.pmedr.2017.03.006. eCollection 2017 Jun. **PMID:** 28352516 **Citation:** Preston DL, Ron E, Tokuoka S, Funamoto S, Nishi N, Soda M, Mabuchi K, Kodama K. Solid cancer incidence in atomic bomb survivors: 1958-1998. Radiat Res. 2007 Jul;168(1):1-64. doi: 10.1667/RR0763.1. **PMID:** 17722996 **Citation:** Einstein AJ, Knuuti J. Cardiac imaging: does radiation matter? Eur Heart J. 2012 Mar;33(5):573-8. doi: 10.1093/eurheartj/ehr281. Epub 2011 Aug 9. **PMID:** 21828062 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000006949 - Term: Hyperlipidemias - ID: D000050171 - Term: Dyslipidemias - ID: D000052439 - Term: Lipid Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000008052 - Term: Lipid Metabolism, Inborn Errors - ID: D000008661 - Term: Metabolism, Inborn Errors - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000006951 - Term: Hyperlipoproteinemias ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M6546 - Name: Coronary Artery Disease - Relevance: LOW - As Found: Unknown - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M26188 - Name: Atherosclerosis - Relevance: HIGH - As Found: Atherosclerosis - ID: M9988 - Name: Hypercholesterolemia - Relevance: HIGH - As Found: Hypercholesterolemia - ID: M10000 - Name: Hyperlipidemias - Relevance: LOW - As Found: Unknown - ID: M10002 - Name: Hyperlipoproteinemias - Relevance: LOW - As Found: Unknown - ID: M9989 - Name: Hyperlipoproteinemia Type II - Relevance: HIGH - As Found: Familial Hypercholesterolemia - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M26181 - Name: Dyslipidemias - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M27029 - Name: Lipid Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M11641 - Name: Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: M11054 - Name: Lipid Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000050197 - Term: Atherosclerosis - ID: D000006938 - Term: Hyperlipoproteinemia Type II - ID: D000006937 - Term: Hypercholesterolemia ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: BDCA - Name: Bone Density Conservation Agents ### Intervention Browse Module - Browse Leaves - ID: M5381 - Name: Calcium - Relevance: LOW - As Found: Unknown - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02140879 **Acronym:** LAMBS **Brief Title:** LA Moms and Babies Study (LAMBS) for Nutrition and Growth **Official Title:** LA Moms and Babies Study (LAMBS) for Nutrition and Growth #### Organization Study ID Info **ID:** PBRC 11031 #### Organization **Class:** OTHER **Full Name:** Pennington Biomedical Research Center ### Status Module #### Completion Date **Date:** 2017-08 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-09-15 **Type:** ACTUAL **Last Update Submit Date:** 2022-09-13 **Overall Status:** WITHDRAWN #### Primary Completion Date **Date:** 2016-04 **Type:** ACTUAL #### Start Date **Date:** 2014-04 **Type:** ACTUAL **Status Verified Date:** 2022-09 #### Study First Post Date **Date:** 2014-05-16 **Type:** ESTIMATED **Study First Submit Date:** 2014-04-24 **Study First Submit QC Date:** 2014-05-14 **Why Stopped:** IRB closed on 9/5/2018 ### Sponsor Collaborators Module #### Collaborators **Class:** FED **Name:** United States Department of Agriculture (USDA) #### Lead Sponsor **Class:** OTHER **Name:** Pennington Biomedical Research Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This research study will examine how diet during pregnancy can benefit pregnancy and pregnancy outcome, such as your baby's weight. More specifically, the investigators will study the effects of two different food oils/fats that are commonly consumed to determine if one is more effective in limiting maternal inflammation during pregnancy. You are being asked to take part in this study because it will help us update and make the best dietary recommendations for pregnant women and women of child bearing ages. **Detailed Description:** Pregnant women will be asked to consume dietary supplements (2 capsules, from the Pennington Biomedical Pharmacy) each day during pregnancy. They will begin taking the capsules around 17 weeks of pregnancy and take them each day until their babies are born. Women will be randomized to one of two groups. Randomization means they will be put into a group by chance, similar to flipping a coin. One group, the placebo group of the study, will take capsules containing oil '1 ' which is a mixture of corn and soy oils . The other group, the supplement group, will take capsules containing oil '2' which is an algal oil. Both oils are found in our diets. Neither the subject nor the study staff will know which group women are in. Women will also keep a diary of how many capsules they take. At around 17, 22, 24, 26, 30, 32, and 36 weeks of pregnancy, women will go to Woman's Hospital to get new capsules and return any remaining capsules and their capsule diary. If they are not able to go to Woman's Hospital at weeks 22, 26, or 32 a researcher will arrange to meet them at an agreed upon prearranged place, such as a pharmacy, a library, or Pennington Biomedical, for example. At the same visits to Woman's Hospital at weeks 17, 24, 30, and 36 weeks of pregnancy women will also have their blood drawn (approximately one tablespoon). At 17, 22, 24, 26, 30, 32 and 36 weeks of pregnancy we will also ask women about the foods they are eating. We will do this by a prearranged phone call; women will not need to meet us in person for this. Researchers will contact subjects weekly by phone to inquire about compliance with consumption of capsules. Contact will only take place during weeks in which a visit or phone call regarding diet is not required. At 17, 24, 30, and 36 weeks of pregnancy small blood samples will be collected from their arm (approximately one tablespoon at each collection) for laboratory analyses. At the birth of their baby a sample of blood will be collected from the umbilical cord after their baby is delivered. All blood samples will be stored at Pennington Biomedical. Blood samples will be analyzed by the researchers who are involved in the study. Some analyses will take place at Pennington Biomedical and Louisiana State University (LSU). Deidentified (without subject names) samples will be sent to study researchers at Northeastern University in Boston, LSU Health Sciences Center in New Orleans, and DSM Nutritional Products in Columbia, Maryland for some of the analyses. At the end of the study remaining blood samples will be discarded unless women consent for their blood to be used for future research. Should women decide to withdraw from the study, any samples collected thus far will be included in the study since they will be deidentified and the investigators will not know which samples belong to each person. We will also collect information about the baby's birth weight, length, and health from the baby's hospital chart. When the baby is 2 weeks, 6 months, and 12 months of age we will measure the baby's body fat and lean tissue. To do this measurement the baby will lie or sit in an enclosed chamber where the mother can see her baby during the measurements. There are no attachments made to the baby. At these times we will also determine the baby's body fat by measuring the thickness of the baby's skinfold; this is done by gently lifting a double fold of skin on the baby's hip, upper arm (triceps), and back of the thigh and measuring the thickness of that fold with a handheld instrument with two hinged arms that fit over the skinfold. There is no discomfort associated with this procedure. The measurements will be made at Woman's Hospital. During these visits we will also ask questions about how the mother is feeding her baby. Between these visits (when the baby is 2, 4, 8, and 10 months old) we will phone to ask about how the baby is being fed and to inquire about the mother's and baby's well-being. ### Conditions Module **Conditions:** - Pregnancy - Inflammation **Keywords:** - pregnancy - inflammation - infant assessment ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Placebo is a mixture of corn and soy oils. **Intervention Names:** - Dietary Supplement: Capsule 1 or Capsule 2 - Dietary Supplement: Capsule 2 **Label:** Capsule 1 **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Active supplement group, will take capsules containing oil '2' which is an algal oil. **Intervention Names:** - Dietary Supplement: Capsule 1 or Capsule 2 - Dietary Supplement: Capsule 2 **Label:** Capsule 2 **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Capsule 1 - Capsule 2 **Description:** Capsules will be consumed on a daily basis during pregnancy. One group, the placebo group of the study, will take capsules (2/day) containing oil '1 ' which is a mixture of corn and soy oils . The other group, the supplement group, will take capsules containing oil '2' which is an algal oil. Both oils are found in our diets. **Name:** Capsule 1 or Capsule 2 **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Capsule 1 - Capsule 2 **Description:** Two capsules will be consumed on a daily basis during pregnancy. The other group, the supplement group, will take capsules containing oil '2' which is an algal oil. Both oils are found in our diets. One group, the placebo group of the study, will take capsules containing oil '1 ' which is a mixture of corn and soy oils . **Name:** Capsule 2 **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Pregnancy creates a state of insulin resistance that is worsened by excess weight during pregnancy and it is accompanied by inflammation. Inflammation in pregnant women will be measured by a blood draw from the arm and analysis of the blood. **Measure:** Differences in maternal inflammation between the two study groups. **Time Frame:** The Participant will be followed during pregnancy, between the 17th and 36th week of pregnancy, on average of 19 weeks. #### Secondary Outcomes **Description:** Measurements of the baby will be calculated in an enclosed chamber where the baby will lie on a tray in a bassinet-like crib with a plastic cover where the baby will be able to see his mother. There will be no attachments to the baby. At these time periods the baby's body fat will also be measured by the thickness of the baby's skinfold; this is done by gently lifting a double fold of skin on the baby's hip, upper arm (triceps), and back of the thigh and measuring the thickness of that fold with a handheld instrument with two hinged arms that fit over the skinfold. There is no discomfort associated with this procedure. **Measure:** Differences in infant growth will be determined with measurements of infant height and weight and with an instrument that determines air displaced by the baby's body. **Time Frame:** The participant will be followed the First year of life, an expected average of 52 weeks. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Confirmed pregnancy * Caucasian/White and African-American ethnicities * Between the ages of 18 and 35 years * Overweight before becoming pregnant (BMI=25.0-29.9 kg/m2) * Pass on the glucose tolerance test for diabetes Exclusion Criteria: * Have more than 5 children * Have a history of high blood pressure, high blood lipids, kidney or liver disease * Have inability to handle blood sugar normally * Have polycystic ovary syndrome * Have thyroid disorder * Have multiple fetuses, pregnancy related complications (preterm labor; diagnosed with gestational diabetes mellitus, pregnancy impaired glucose tolerance, preeclampsia, a first degree relative with diabetes, gave birth to a previous large for gestational age infanthigh blood pressure, premature rupture of the membranes) * Have smoked in the past 6 months * Have been pregnant or lactating (breastfeeding) in the past year * Do not want their baby's body fat measured throughout the first year of life * Do not bring their prenatal record and study information copies to Woman's Hospital for delivery * Deliver at a hospital other than Woman's Hospital * Test positive for human immunodeficiency Virus (HIV), syphilis, sepsis, group B streptococcus, Hepatitis B * Do not follow study procedures * Planning to bank cord blood or unwilling to donate cord blood * Planned/elective C-section. **Healthy Volunteers:** True **Maximum Age:** 35 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Baton Rouge **Country:** United States **Facility:** Womans Hospital **State:** Louisiana **Zip:** 70803 #### Overall Officials **Official 1:** **Affiliation:** PBRC **Name:** Carol J Lammi-Keefe, PhD, RD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation ### Condition Browse Module - Meshes - ID: D000007249 - Term: Inflammation ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M4002 - Name: Amphotericin B - Relevance: LOW - As Found: Unknown - ID: M255436 - Name: Liposomal amphotericin B - Relevance: LOW - As Found: Unknown - ID: T294 - Name: Soy Bean - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06116279 **Brief Title:** First-in-human Experience Using Novel Ultraflexible Low-impedance Electrode Arrays: an IDEAL Stage 1 Study **Official Title:** First-in-human Experience Using Novel Ultraflexible Low-impedance Electrode Arrays: an IDEAL Stage 1 Study #### Organization Study ID Info **ID:** 21BI27 #### Organization **Class:** OTHER **Full Name:** Great Ormond Street Hospital for Children NHS Foundation Trust ### Status Module #### Completion Date **Date:** 2025-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-11-03 **Type:** ACTUAL **Last Update Submit Date:** 2023-11-02 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-02-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-01 **Type:** ESTIMATED **Status Verified Date:** 2023-11 #### Study First Post Date **Date:** 2023-11-03 **Type:** ACTUAL **Study First Submit Date:** 2023-07-26 **Study First Submit QC Date:** 2023-11-02 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Great Ormond Street Hospital for Children NHS Foundation Trust #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this first-in-human study is to evaluate a novel ultraflexible microelectrode in children undergoing neurosurgery to remove tissue that causes epilepsy (seizures) in focal cortical dysplasia (FCD) or long-term epilepsy-associated tumours (LEAT). The main questions it aims to answer are: 1. The safety and feasibility of the novel microelectrode into current operative workflow 2. The unique electrophysiological tissue signatures in FCD or LEAT **Detailed Description:** Epilepsy affects 100,000 people under 25. Many children with epilepsy also have a learning disability or developmental problems and 25-30% continue to have seizures despite best medical treatment. Neuromodulation or brain stimulation is the delivery of electricity to the brain cells. It may alter the brain activity and overall brain connectivity and currently is rarely used as a treatment for epilepsy. However, it has the potential to reduce the number of seizures and improve other problems that children with epilepsy may have such as concentration, memory and learning. 'Precision neuromodulation', which involves individually tailored treatments requires us to identify where in the brain to stimulate and what the best settings are in each individual. A limitation of current neuromodulation treatment is limited understanding of the abnormal signatures of electrical activity in abnormal tissue. The investigators have developed a novel electrode that can record signals from the brain at higher resolution than current electrodes. The 2 micrometer, ultraflexible, low-impedance electrode arrays are smaller, less damaging, and provide multiple contacts at multiple depths. The investigators propose a first-in-human study to investigate the feasibility and safety of using these electrodes in patients undergoing surgery for epilepsy - either focal cortical dysplasia (FCD) or long-term associated epilepsy tumours (LEAT). The investigators will insert the electrode into brain tissue that is going to be removed as part of the planned surgery. The extent of tissue damage caused by insertion will be examined, and whether the electrode is able to capture signals at difference scales from the brain will be assessed; this includes signals from an area of tissue (termed local field potential) and signals from single nerve cells (termed single unit recordings). If safe, it will lay the foundation to use these electrodes in future precision neuromodulation platforms that can be applied to epilepsy and other neurological diseases. ### Conditions Module **Conditions:** - Epilepsy - Focal Cortical Dysplasia **Keywords:** - Epilepsy - FCD - LEAT - Neurosurgery - Microelectrode - Local field potential - Epileptic zone ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** The investigators will adhere to the internationally accepted five-stage Idea, Development, Evaluation, Assessment, Long-term study (IDEAL) framework for novel surgical device innovation. An IDEAL Stage 1 study requires a highly-selected patient group (n=6) and focuses on novel device innovation feasibility and safety. Adhering to the IDEAL framework will facilitate the development and evaluation of the novel device in a logical manner that balances innovation and safety. ##### Masking Info **Masking:** NONE **Primary Purpose:** DEVICE_FEASIBILITY #### Enrollment Info **Count:** 6 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** During the surgical procedure, following exposure of the brain via a craniotomy, the novel electrodes will be inserted into tissue planned for resection. This will be targeted using the existing neuronavigation software that is being used during the surgery and may be augmented by intraoperative ultrasound, also a common adjunct used in these surgeries. Following insertion of the electrode, the cables will be connected to a specialised (portable) amplifier inside the operating theatre and 15 minutes of data will be recoded. The electrodes will then be removed and the surgical resection will then proceed as planned. The content of the recordings will not be available in real-time and will not be used to inform or change the surgical resection plan in any way. **Intervention Names:** - Device: Insertion of electrode during planned neurosurgery for epilepsy **Label:** Insertion of electrode during planned neurosurgery for epilepsy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Insertion of electrode during planned neurosurgery for epilepsy **Description:** A novel, 300 micrometer, ultraflexible, low-impedance electrode proposes to cause minimal parenchymal (brain tissue) damage, and provide multiple contacts at multiple depths to allow unit-level recordings for a period of 15 minutes. **Name:** Insertion of electrode during planned neurosurgery for epilepsy **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Document total length of set up and recording with electrode (recorded in minutes) **Measure:** Feasibility of novel electrode into current operative workflow **Time Frame:** At operation #### Secondary Outcomes **Description:** Neuropathologists will perform haematoxylin and eosin histological (H\&E), luxol fast blue, and neutral red to describe the insertion tract lesion and neocortical cytoarchitecture **Measure:** Resected tissue assessed histologically for damage from novel electrode **Time Frame:** 4 weeks following operation **Description:** The data obtained from intraoperative recording will be analysed by computational neuroscientists **Measure:** Analysis of recorded electrophysiological data from intraoperative recording by novel electrode **Time Frame:** 6 months **Description:** Intraoperative events occur (haemorrhage, seizure, stroke) **Measure:** Safety of novel electrode insertion and recording **Time Frame:** At operation ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Radiologically visible epileptogenic lesion (focal cortical dysplasia or long-term epilepsy associated tumour) undergoing planned resective surgery Exclusion Criteria: 1. Unable to provide informed consent **Healthy Volunteers:** True **Maximum Age:** 18 Years **Minimum Age:** 3 Months **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** martin.tisdall@gosh.nhs.uk **Name:** Martin Tisdall, MD FRCS **Phone:** 07726780817 **Role:** CONTACT #### Locations **Location 1:** **City:** London **Contacts:** ***Contact 1:*** - **Email:** martin.tisdall@gosh.nhs.uk - **Name:** Martin Tisdall, MD FRCS - **Phone:** 07726780817 - **Role:** CONTACT **Country:** United Kingdom **Facility:** Great Ormond Street Hospital **Zip:** WC1N 3JH #### Overall Officials **Official 1:** **Affiliation:** Great Ormond Street Hospital **Name:** Martin Tisdall, MD FRCS **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009421 - Term: Nervous System Malformations - ID: D000000013 - Term: Congenital Abnormalities - ID: D000065703 - Term: Malformations of Cortical Development, Group I ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M7983 - Name: Epilepsy - Relevance: HIGH - As Found: Epilepsy - ID: M2907 - Name: Focal Cortical Dysplasia - Relevance: HIGH - As Found: Focal Cortical Dysplasia - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M27589 - Name: Malformations of Cortical Development - Relevance: HIGH - As Found: Cortical Dysplasia - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12365 - Name: Nervous System Malformations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004827 - Term: Epilepsy - ID: D000054220 - Term: Malformations of Cortical Development - ID: D000092222 - Term: Focal Cortical Dysplasia ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04811079 **Brief Title:** The Role of Spectral Filtering in a Spectrally Adjustable Ocular Photosensitivity Analyzer **Official Title:** The Role of Spectral Filtering in a Spectrally Adjustable Ocular Photosensitivity Analyzer #### Organization Study ID Info **ID:** CR-6402 #### Organization **Class:** INDUSTRY **Full Name:** Johnson & Johnson Vision Care, Inc. ### Status Module #### Completion Date **Date:** 2022-05-16 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-06-05 **Type:** ACTUAL **Last Update Submit Date:** 2023-06-02 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-05-16 **Type:** ACTUAL #### Start Date **Date:** 2021-07-14 **Type:** ACTUAL **Status Verified Date:** 2023-06 #### Study First Post Date **Date:** 2021-03-23 **Type:** ACTUAL **Study First Submit Date:** 2021-03-22 **Study First Submit QC Date:** 2021-03-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Johnson & Johnson Vision Care, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a 6-visit, single-center, non-dispensing, randomized, single-masked, 5×5 crossover study. Subjects will participate in 6 scheduled over the duration of approximately 10.5 months. ### Conditions Module **Conditions:** - Photosensitivity ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 53 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** (419nm, 437nm, 373nm, 456nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 1. **Intervention Names:** - Other: 419 nm Spectacle Filter - Other: 437 nm Spectacle Filter - Other: 456 nm Spectacle Filter - Other: 476 nm Spectacle Filter - Other: 373 nm Spectacle Filter **Label:** Spectacle Filter Sequence 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** (437nm, 456nm, 419nm, 476nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 2. **Intervention Names:** - Other: 419 nm Spectacle Filter - Other: 437 nm Spectacle Filter - Other: 456 nm Spectacle Filter - Other: 476 nm Spectacle Filter - Other: 373 nm Spectacle Filter **Label:** Spectacle Filter Sequence 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** (456nm, 476nm, 437nm, 373nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 3. **Intervention Names:** - Other: 419 nm Spectacle Filter - Other: 437 nm Spectacle Filter - Other: 456 nm Spectacle Filter - Other: 476 nm Spectacle Filter - Other: 373 nm Spectacle Filter **Label:** Spectacle Filter Sequence 3 **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** (476nm, 373nm, 456nm, 419nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 4. **Intervention Names:** - Other: 419 nm Spectacle Filter - Other: 437 nm Spectacle Filter - Other: 456 nm Spectacle Filter - Other: 476 nm Spectacle Filter - Other: 373 nm Spectacle Filter **Label:** Spectacle Filter Sequence 4 **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** (373nm, 419nm, 476nm, 437nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 5. **Intervention Names:** - Other: 419 nm Spectacle Filter - Other: 437 nm Spectacle Filter - Other: 456 nm Spectacle Filter - Other: 476 nm Spectacle Filter - Other: 373 nm Spectacle Filter **Label:** Spectacle Filter Sequence 5 **Type:** EXPERIMENTAL #### Arm Group 6 **Description:** (476nm, 456nm, 373nm, 437nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 6. **Intervention Names:** - Other: 419 nm Spectacle Filter - Other: 437 nm Spectacle Filter - Other: 456 nm Spectacle Filter - Other: 476 nm Spectacle Filter - Other: 373 nm Spectacle Filter **Label:** Spectacle Filter Sequence 6 **Type:** EXPERIMENTAL #### Arm Group 7 **Description:** (373nm, 476nm, 419nm, 456nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 7. **Intervention Names:** - Other: 419 nm Spectacle Filter - Other: 437 nm Spectacle Filter - Other: 456 nm Spectacle Filter - Other: 476 nm Spectacle Filter - Other: 373 nm Spectacle Filter **Label:** Spectacle Filter Sequence 7 **Type:** EXPERIMENTAL #### Arm Group 8 **Description:** (419nm, 373nm, 437nm, 476nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 8. **Intervention Names:** - Other: 419 nm Spectacle Filter - Other: 437 nm Spectacle Filter - Other: 456 nm Spectacle Filter - Other: 476 nm Spectacle Filter - Other: 373 nm Spectacle Filter **Label:** Spectacle Filter Sequence 8 **Type:** EXPERIMENTAL #### Arm Group 9 **Description:** (437nm, 419nm, 456nm, 373nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 9. **Intervention Names:** - Other: 419 nm Spectacle Filter - Other: 437 nm Spectacle Filter - Other: 456 nm Spectacle Filter - Other: 476 nm Spectacle Filter - Other: 373 nm Spectacle Filter **Label:** Spectacle Filter Sequence 9 **Type:** EXPERIMENTAL #### Arm Group 10 **Description:** (456nm, 437nm, 476nm, 419nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 10. **Intervention Names:** - Other: 419 nm Spectacle Filter - Other: 437 nm Spectacle Filter - Other: 456 nm Spectacle Filter - Other: 476 nm Spectacle Filter - Other: 373 nm Spectacle Filter **Label:** Spectacle Filter Sequence 10 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Spectacle Filter Sequence 1 - Spectacle Filter Sequence 10 - Spectacle Filter Sequence 2 - Spectacle Filter Sequence 3 - Spectacle Filter Sequence 4 - Spectacle Filter Sequence 5 - Spectacle Filter Sequence 6 - Spectacle Filter Sequence 7 - Spectacle Filter Sequence 8 - Spectacle Filter Sequence 9 **Description:** TEST **Name:** 419 nm Spectacle Filter **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Spectacle Filter Sequence 1 - Spectacle Filter Sequence 10 - Spectacle Filter Sequence 2 - Spectacle Filter Sequence 3 - Spectacle Filter Sequence 4 - Spectacle Filter Sequence 5 - Spectacle Filter Sequence 6 - Spectacle Filter Sequence 7 - Spectacle Filter Sequence 8 - Spectacle Filter Sequence 9 **Description:** TEST **Name:** 437 nm Spectacle Filter **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Spectacle Filter Sequence 1 - Spectacle Filter Sequence 10 - Spectacle Filter Sequence 2 - Spectacle Filter Sequence 3 - Spectacle Filter Sequence 4 - Spectacle Filter Sequence 5 - Spectacle Filter Sequence 6 - Spectacle Filter Sequence 7 - Spectacle Filter Sequence 8 - Spectacle Filter Sequence 9 **Description:** TEST **Name:** 456 nm Spectacle Filter **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Spectacle Filter Sequence 1 - Spectacle Filter Sequence 10 - Spectacle Filter Sequence 2 - Spectacle Filter Sequence 3 - Spectacle Filter Sequence 4 - Spectacle Filter Sequence 5 - Spectacle Filter Sequence 6 - Spectacle Filter Sequence 7 - Spectacle Filter Sequence 8 - Spectacle Filter Sequence 9 **Description:** TEST **Name:** 476 nm Spectacle Filter **Type:** OTHER #### Intervention 5 **Arm Group Labels:** - Spectacle Filter Sequence 1 - Spectacle Filter Sequence 10 - Spectacle Filter Sequence 2 - Spectacle Filter Sequence 3 - Spectacle Filter Sequence 4 - Spectacle Filter Sequence 5 - Spectacle Filter Sequence 6 - Spectacle Filter Sequence 7 - Spectacle Filter Sequence 8 - Spectacle Filter Sequence 9 **Description:** CONTROL **Name:** 373 nm Spectacle Filter **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** VPT will measured via the SAOPA instrument. VPT is the point at which a sensation of pain or discomfort occurs when the intensity of light is gradually increased from a low level. Subject's discomfort responses will be indicated via a button press. Testing is complete when 10 response reversals are acquired. **Measure:** Visual Photosensitivity Threshold (VPT) **Time Frame:** at approximately 2-week follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. The subject must read and sign the Informed Consent form. 2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. Healthy adult males or females age ≥18 and ≤30 years of age. 4. Normal color vision as measured using the Ishihara 38-plate test. 5. Normal stereopsis as measured by a suitable test. 6. Auto-refraction must show a spherical component of -2.00 through +2.00 D, and a cylindrical component of 0.00 through 1.50 D. 7. The subject's distance refractive sphere must be between -2.00 and +2.00 D in each eye. 8. The subject's distance refractive cylinder must be ≤ 1.50 D in each eye. 9. The subject must have unaided distance Snellen visual acuity of 20/200 or better for each eye. 10. The subject must have best corrected distance Snellen visual acuity of 20/25 or better for each eye. Exclusion Criteria: * Potential subjects who meet any of the following criteria will be excluded from participating in the study: 1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). 2. History of refractive surgery or other ocular surgery. 3. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). 4. Subjects that participated in the pilot study CR-6318. 5. Systemic conditions or the use of medications that the investigator believes will contraindicate participation in this study. 6. Abnormal Level 3 neuro-ophthalmology exam including crystalline lens clarity Grade 3 or worse (Lens Opacities Classification System). 7. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA Slit Lamp Classification Scale. **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Coral Gables **Country:** United States **Facility:** University of Miami Health - Bascom Palmer Eye Institute **State:** Florida **Zip:** 33146 #### Overall Officials **Official 1:** **Affiliation:** Johnson & Johnson Vision Care, Inc. **Name:** Johnson & Johnson Vision Care, Inc. Clinical Trial **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu **IPD Sharing:** YES **URL:** http://yoda.yale.edu ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012871 - Term: Skin Diseases - ID: D000014786 - Term: Vision Disorders - ID: D000012678 - Term: Sensation Disorders - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC11 - Name: Eye Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M22550 - Name: Photophobia - Relevance: HIGH - As Found: Ocular Photosensitivity - ID: M13686 - Name: Photosensitivity Disorders - Relevance: HIGH - As Found: Photosensitivity - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M17530 - Name: Vision Disorders - Relevance: LOW - As Found: Unknown - ID: M15490 - Name: Sensation Disorders - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020795 - Term: Photophobia - ID: D000010787 - Term: Photosensitivity Disorders ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02937779 **Acronym:** TA-PROHM **Brief Title:** Tenofovir As Prevention Of Hepatitis b Mother-to-child Transmission **Official Title:** Tenofovir As Prevention Of Hepatitis b Mother-to-child Transmission #### Organization Study ID Info **ID:** ANRS 12345 #### Organization **Class:** OTHER_GOV **Full Name:** ANRS, Emerging Infectious Diseases ### Status Module #### Completion Date **Date:** 2020-03-31 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** ACTIVE_NOT_RECRUITING #### Last Update Post Date **Date:** 2019-10-16 **Type:** ACTUAL **Last Update Submit Date:** 2019-10-15 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2020-03-31 **Type:** ESTIMATED #### Start Date **Date:** 2017-10-04 **Type:** ACTUAL **Status Verified Date:** 2019-10 #### Study First Post Date **Date:** 2016-10-19 **Type:** ESTIMATED **Study First Submit Date:** 2016-10-17 **Study First Submit QC Date:** 2016-10-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** ANRS, Emerging Infectious Diseases #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The World Health Organization recommends that all high endemic countries for HBV infection based their mother to child transmission prevention strategies on vaccination of all children and administration of immunoglobulins (HBIG) to infants born to infected mothers in the first 24 hours after birth. Lack of access to antenatal screening and to HBIG significantly results in failure of this strategy in many countries. Moreover, despite sero-vaccination, 10 to 15% of infants of mothers that are positive for HBsAg and HBeAg are still infected, as high levels of HBV replication occurring in the third quarter of pregnancy act as a major risk factor. The objective of this study is to assess the effectiveness of an operational strategy to prevent HBV mother-to-child transmission (MTCT) in Cambodia based on the use of rapid tests HBs Ag and HBe Ag to screen HBV infection and a treatment by TDF for patients with a positive HBeAg test with a "test and treat" strategy for those seen for Antenatal Care (ANC) from 24 weeks of amenorrhea. In all cases, vaccination of the newborn will be carried out according to the national protocol in Cambodia i.e. 4 injections at 24 hours, 6, 10 and 14 weeks of age. A phase IV multicenter observational and interventional non randomized prospective study will be conducted in 4 maternity in Cambodia. The primary outcome will be the proportion of active HBV infection in new-born at 6 months of life estimated by HBs Ag positivity. The study will aim to document the acceptability and the operational implementation of the study using rapid tests usable in all health centers and a drug available in all the country thanks to HIV national program. The results will be helpful for Cambodian government in order to implement guidelines and algorithm follow-up for HBV-infected pregnant women. **Detailed Description:** Principal objective: Assess the effectiveness of a strategy to prevent HBV mother-to-child transmission (MTCT) in Cambodia based on the use of rapid tests HBs Ag and HBe Ag to screen HBV infection and a treatment by TDF for patients with a positive HBeAg test with a "test and treat" strategy for those seen for Antenatal Care (ANC) from 24 weeks of amenorrhea. Secondary objectives Assess the feasibility and acceptability for patients and health care providers of the rapid tests screening strategy Assess the acceptability of the test and treat strategy for patients seen after 24 weeks of amenorrhea Describe the HBV viral load (VL) decrease caused by the TDF Estimate the rate of HBV transmission to newborns according to the time spent on TDF as well as initial viral load level and delivery viral load level Estimate the rate of HBV transmission to newborns for HBe Ag negative women Describe the correlation between HBV viral load level and HBe Ag status Describe subgroups of mothers and new-borns for which the strategy seems more effective Assess TDF safety in mothers Analyse the cost-effectiveness of the strategy compare to international guidelines (WHO, APASL) Each woman will be informed of the objectives and the total duration of the study as well as the benefits and risks to participate. An information sheet in Khmer will be given to each woman. The study will be composed of two phases of information's and consent. The first one will be done during the HBs Ag screening using rapid test; the screening will be proposed to all pregnant women attending ANC in one of the affiliated centres. The second phase will be done during the inclusion visit and will concern only HBs Ag positive women. The study will concern only HBs Ag positive women with 1) follow up of all HBsAg positive women from inclusion up to 6 months postpartum 2) For HBeAg positive women, initiation of treatment by fumarate de tenofovir disoproxil (Viread®), with a daily administration of one 300mg pill. Women will be treated from 24 weeks of amenorrhea until 6 weeks post-partum. For women with first ANC after 24 weeks of amenorrhea, treatment will begin the day of inclusion. Treatment will be given for 4 weeks and adherence will be estimated. In all cases, vaccination of the newborn will be carried out according to the national protocol in Cambodia i.e. 4 injections at 24 hours, 6, 10 and 14 weeks of age. A total of 933 positive HBs Ag pregnant women will be enrolled including 280 HBe Ag positive women and 653 HBe negative women. ### Conditions Module **Conditions:** - Hepatitis B Chronic Infection - Pregnancy ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 933 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** tenofovir disoproxil fumarate 300 mg one tablet once daily from 24 weeks of amennorrhea to 6 weeks post-partum for positive Hbe Ag women. No treatment for negative HBe Ag women **Intervention Names:** - Drug: Tenofovir disoproxil fumarate - Device: Rapid tests HBe Ag **Label:** HBs Ag positive **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - HBs Ag positive **Description:** tenofovir disoproxil fumarate 300 mg one tablet once daily from 24 weeks of amennorrhea to 6 weeks post-partum for HBe Ag positive women only. **Name:** Tenofovir disoproxil fumarate **Other Names:** - TDF **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - HBs Ag positive **Description:** For all HBs Ag positive women **Name:** Rapid tests HBe Ag **Type:** DEVICE ### Outcomes Module #### Other Outcomes **Measure:** Process and acceptability of the drug's intervention **Time Frame:** Enrollement **Measure:** Proportion of women with viral load > 6 Log among those HBe Ag negative **Time Frame:** Enrollement **Measure:** Proportion of new-born with positive HBs Ag at 6 months according to treatment duration, initial and delivery viral load level **Time Frame:** 6 months post-partum **Measure:** Decrease curve of HBV VL after TDF initiation over time **Time Frame:** From enrollement to 8 weeks or 6 months post-partum **Measure:** Occurrence of maternal adverse events including serious adverse events and adverse events grade 3 or 4 **Time Frame:** From enrollement to 6 months post-partum **Measure:** Proportion of women needing treatment continuation in post-partum among those to whom treatment was initiated **Time Frame:** 6 weeks post-partum **Measure:** Occurrence of acute exacerbation after treatment interruption **Time Frame:** From 8 weeks post-partum to 6 months post-partum #### Primary Outcomes **Description:** The proportion will be estimated by HBs Ag positivity **Measure:** Proportion of active HBV infection in new-born at 6 months of life **Time Frame:** 6 months post-partum #### Secondary Outcomes **Description:** Proportion of women with screening proposed among those eligible in antenatal consultation (ANC) **Measure:** Process and acceptability of the screening phase **Time Frame:** Enrollement **Description:** Proportion of women with a done screening among those to whom screening was proposed **Measure:** Process and acceptability of the screening phase **Time Frame:** Enrollement **Description:** Proportion of women with a given results in less than one day among those to whom the test was made **Measure:** Process and acceptability of the screening phase **Time Frame:** Enrollement **Description:** Care-giver satisfaction regarding the strategy (estimated by questionnaires) **Measure:** Process and acceptability of the screening phase **Time Frame:** Enrollement ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * \>= 18 years old the day of inclusion * Pregnancy * Positive HBs Ag * Informed consent obtained with information sheet given and explained and the consent form signed by the participant of the project investigator at the latest the day of the inclusion Exclusion Criteria: * Women refusing HBs Ag test * HIV co-infection * HCV co-infection * HBV treatment ongoing at the day of inclusion * Creatinine clearance \< 30 mL/min * Severe gravidic disease present at inclusion involving life threatening to the mother and/or the child * Evidence of pre-existing fetal anomalies incompatible with the child's life * Imminent child's birth defined as cervix dilatation up to 7 centimeters * Intention to deliver in a maternity not linked to the study * Any concomitant medical condition that, according to the clinical site investigator would contraindicate participation in the study. * Concurrent participation in any other clinical trial without written agreement of the two study teams **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Kampong Cham **Country:** Cambodia **Facility:** Kampong Cham Provincial Hospital **Location 2:** **City:** Phnom Penh **Country:** Cambodia **Facility:** Calmette Hospital **Location 3:** **City:** Phnom Penh **Country:** Cambodia **Facility:** National Mother and Child Health Center #### Overall Officials **Official 1:** **Affiliation:** Calmette Hospital **Name:** Samsorphea CHHUN, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Segeral O, Dim B, Durier C, Nhoueng S, Chhim K, Sovann S, Yom S, Vong C, Yin S, Ros B, Ky V, Pech S, Nem B, Hout K, Guillebaud J, Ear E, Caroupaye-Caroupin L, Rekacewicz C, Fernandez L, Laurent D, Yay C, Kim R, Meyer L, Chhun S; Laurence Borand for the ANRS-MIE TA PROHM Study Group. Immunoglobulin-free strategy to prevent HBV mother-to-child transmission in Cambodia (TA-PROHM): a single-arm, multicentre, phase 4 trial. Lancet Infect Dis. 2022 Aug;22(8):1181-1190. doi: 10.1016/S1473-3099(22)00206-7. Epub 2022 May 25. **PMID:** 35643089 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008107 - Term: Liver Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000006525 - Term: Hepatitis, Viral, Human - ID: D000014777 - Term: Virus Diseases - ID: D000007239 - Term: Infections - ID: D000004769 - Term: Enterovirus Infections - ID: D000010850 - Term: Picornaviridae Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000086982 - Term: Blood-Borne Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000018347 - Term: Hepadnaviridae Infections - ID: D000004266 - Term: DNA Virus Infections - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000006521 - Term: Hepatitis, Chronic - ID: D000002908 - Term: Chronic Disease ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M9592 - Name: Hepatitis A - Relevance: HIGH - As Found: Hepatitis - ID: M9595 - Name: Hepatitis B - Relevance: HIGH - As Found: Hepatitis B - ID: M21609 - Name: Hepatitis B, Chronic - Relevance: HIGH - As Found: Hepatitis B Chronic - ID: M9591 - Name: Hepatitis - Relevance: HIGH - As Found: Hepatitis - ID: M2664 - Name: Persistent Infection - Relevance: HIGH - As Found: Chronic Infection - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M9610 - Name: Hepatitis, Viral, Human - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M7930 - Name: Enterovirus Infections - Relevance: LOW - As Found: Unknown - ID: M13745 - Name: Picornaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M2593 - Name: Blood-Borne Infections - Relevance: LOW - As Found: Unknown - ID: M20487 - Name: Hepadnaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M7442 - Name: DNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M9607 - Name: Hepatitis, Chronic - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006506 - Term: Hepatitis A - ID: D000006509 - Term: Hepatitis B - ID: D000088562 - Term: Persistent Infection - ID: D000019694 - Term: Hepatitis B, Chronic - ID: D000006505 - Term: Hepatitis ### Intervention Browse Module - Ancestors - ID: D000000998 - Term: Antiviral Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000018894 - Term: Reverse Transcriptase Inhibitors - ID: D000019384 - Term: Nucleic Acid Synthesis Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000019380 - Term: Anti-HIV Agents - ID: D000044966 - Term: Anti-Retroviral Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M296 - Name: Tenofovir - Relevance: HIGH - As Found: Working - ID: M4314 - Name: Antiviral Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M20935 - Name: Reverse Transcriptase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M21350 - Name: Anti-HIV Agents - Relevance: LOW - As Found: Unknown - ID: M25428 - Name: Anti-Retroviral Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000068698 - Term: Tenofovir ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00778479 **Brief Title:** Evaluation of the Safety of Sepraspray in Open Abdominal Surgery **Official Title:** Evaluation of the Safety of Sepraspray in Open Abdominal Surgery #### Organization Study ID Info **ID:** SSPRAY00508 #### Organization **Class:** INDUSTRY **Full Name:** Sanofi ### Status Module #### Completion Date **Date:** 2009-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2015-03-24 **Type:** ESTIMATED **Last Update Submit Date:** 2015-03-19 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2009-05 **Type:** ACTUAL #### Start Date **Date:** 2008-10 **Status Verified Date:** 2015-03 #### Study First Post Date **Date:** 2008-10-23 **Type:** ESTIMATED **Study First Submit Date:** 2008-10-22 **Study First Submit QC Date:** 2008-10-22 **Why Stopped:** Terminated by Sponsor: see details below ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Genzyme, a Sanofi Company #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study will examine the Performance of Sepraspray in Patients undergoing open abdominal surgery NOTE regarding reason for study termination: A patient death reported during the trial warranted temporary suspension for review by the independent data review committee. Although the committee recommended continuing enrollment, enrollment was electively terminated by the sponsor. A preliminary analysis did not identify any new risk that was not listed on the investigational labeling for this product. A full analysis of the results is expected to allow characterization of the risk/benefit and clinical utility of the product in the exposed patient population. ### Conditions Module **Conditions:** - Adhesion Prevention (Abdominal) ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 155 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Receive Sepraspray **Intervention Names:** - Device: Sepraspray **Label:** Sepraspray **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** no treatment **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Sepraspray **Description:** Max. 10g of Sepraspray **Name:** Sepraspray **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** Morbidity **Time Frame:** 30 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients 18 years old and over that require open abdominal surgery Exclusion Criteria: * Patients who are pregnant or have ongoing abdominal abscess or bacterial peritonitis or have infectious complications from a previous laparectomy **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Clamond **Country:** France **Facility:** Chu Hotel Dieu **Location 2:** **City:** Lille **Country:** France **Facility:** CHRU de Lille, Hopital Huriez **Location 3:** **City:** Lyon **Country:** France **Facility:** Hopital de la Croix Rousse **Location 4:** **City:** Paris **Country:** France **Facility:** Hopital Lariboisiere **Location 5:** **City:** Linkoping **Country:** Sweden **Facility:** University Hospital **Location 6:** **City:** Stockholm **Country:** Sweden **Facility:** Karolinska University Hospital **Location 7:** **City:** Uppsala **Country:** Sweden **Facility:** Akademiska Sjukhuset #### Overall Officials **Official 1:** **Affiliation:** Genzyme, a Sanofi Company **Name:** Medical Monitor **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002921 - Term: Cicatrix - ID: D000005355 - Term: Fibrosis - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M3620 - Name: Tissue Adhesions - Relevance: HIGH - As Found: Adhesion - ID: M6160 - Name: Cicatrix - Relevance: LOW - As Found: Unknown - ID: M8485 - Name: Fibrosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000267 - Term: Tissue Adhesions ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06114979 **Brief Title:** Silodosin vs Placebo in the Treatment of Female LUTS **Official Title:** Silodosin vs Placebo in the Treatment of Female Lower Urinary Tract Symptoms: A Randomized Controlled Trial #### Organization Study ID Info **ID:** Silodosin for female LUTS #### Organization **Class:** OTHER **Full Name:** Mansoura University #### Secondary ID Infos **Domain:** Research Coordination Committee **ID:** 937/2018 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-11-02 **Type:** ACTUAL **Last Update Submit Date:** 2023-10-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-10-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-01 **Type:** ESTIMATED **Status Verified Date:** 2023-10 #### Study First Post Date **Date:** 2023-11-02 **Type:** ACTUAL **Study First Submit Date:** 2023-10-20 **Study First Submit QC Date:** 2023-10-30 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Amiri Hospital #### Lead Sponsor **Class:** OTHER **Name:** Mansoura University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This trial will be conducted to study the efficacy and safety of Silodosin in the treatment of female lower urinary tract symptoms. **Detailed Description:** The double blinded randomized controlled trial will evaluate efficacy and safety of silodosin in treatment of female lower urinary tract symptoms by comparing with placebo. ### Conditions Module **Conditions:** - Lower Urinary Tract Symptoms **Keywords:** - Silodosin - LUTS - Female ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 278 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will receive 8 mg of Silodosin tablet once daily. **Intervention Names:** - Drug: Silodosin **Label:** Silodosin **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients will receive placebo pill once daily, **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Silodosin **Description:** Each patient will receive 8 mg of silodosin tablet once daily. **Name:** Silodosin **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Each patient will receive placebo tablet. **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** International Prostate Symptom Score will be recorded for each patient. The score ranged between 7 and 35. Higher scores means worse outcome. **Measure:** International Prostate Symptom Score **Time Frame:** 8 weeks **Description:** Overactive Bladder Validated 8-question will be recorded for each patient. The score ranged between 2 and 42. Higher scores means worse outcome. **Measure:** Overactive Bladder Validated 8-question **Time Frame:** 8 weeks #### Secondary Outcomes **Description:** Voided volume , Maximum flow, Voiding time, Post void residual **Measure:** Uroflometry **Time Frame:** 8 weeks **Description:** Side effects of the treatment will be recorded **Measure:** Adverse events **Time Frame:** 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Females complaining of lower urinary tract symptoms * IPSS ≥ 8 or OAB - V8 score ≥ 8 Exclusion Criteria: 1. Patients with documented hypersensitivity to Silodosin. 2. Patients receiving alpha blockers or anticholinergic medications for any other reason. 3. Patients with history of orthostatic hypotension. 4. Pregnant or breastfeeding females. 5. Patients with stress urinary incontinence. 6. Patients with active urinary tract infection. 7. History of previous pelvic surgery or radiation. 8. Patient with diabetes mellitus. 9. Patients diagnosed with bladder cancer. 10. Patients with hepatic impairment (Child-Pugh score \>9). 11. Patients with severe renal impairment with creatinine clearance of less than 10 mL/min. 12. Patients planned to undergo any ophthalmic procedure. 13. Patients with history of urinary retention or gastric retention. **Gender Based:** True **Maximum Age:** 75 Years **Minimum Age:** 21 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** majd.qabbani@gmail.com **Name:** Majd Alkabbani, MD **Phone:** 0097450322671 **Role:** CONTACT **Contact 2:** **Email:** tshaiji@gmail.com **Name:** Tariq F AL-Shaiji, MD **Phone:** 0096599099915 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Amiri Hospital **Name:** Tariq F AL-Shaiji, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020924 - Term: Urological Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M29464 - Name: Lower Urinary Tract Symptoms - Relevance: HIGH - As Found: Lower Urinary Tract Symptoms - ID: M22659 - Name: Urological Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000059411 - Term: Lower Urinary Tract Symptoms ### Intervention Browse Module - Ancestors - ID: D000058668 - Term: Adrenergic alpha-1 Receptor Antagonists - ID: D000000317 - Term: Adrenergic alpha-Antagonists - ID: D000018674 - Term: Adrenergic Antagonists - ID: D000018663 - Term: Adrenergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000064804 - Term: Urological Agents ### Intervention Browse Module - Browse Branches - Abbrev: Urol - Name: Urological Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M228332 - Name: Silodosin - Relevance: HIGH - As Found: Purchase - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown - ID: M29194 - Name: Adrenergic alpha-1 Receptor Antagonists - Relevance: LOW - As Found: Unknown - ID: M3669 - Name: Adrenergic alpha-Antagonists - Relevance: LOW - As Found: Unknown - ID: M20755 - Name: Adrenergic Antagonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000095285 - Term: Silodosin ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02623179 **Brief Title:** Conventional and Molecular Diagnostic Method for Patients With Suspected UTI **Official Title:** Conventional and Molecular Diagnostic Method for Patients With Suspected Urinary Tract Infections: Clinical, Economic, and Quality of Life Outcomes #### Organization Study ID Info **ID:** PATUTI #### Organization **Class:** INDUSTRY **Full Name:** Southwest Regional PCR, LLC ### Status Module #### Completion Date **Date:** 2016-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-10-05 **Type:** ACTUAL **Last Update Submit Date:** 2017-10-03 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-12-31 **Type:** ACTUAL #### Start Date **Date:** 2016-01-15 **Type:** ACTUAL **Status Verified Date:** 2017-10 #### Study First Post Date **Date:** 2015-12-07 **Type:** ESTIMATED **Study First Submit Date:** 2015-12-01 **Study First Submit QC Date:** 2015-12-04 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Southwest Regional PCR, LLC #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** In this protocol, the investigators are examining the use of a novel pathogen testing technology and method of identification of antibiotic susceptibility against the conventional C \& S testing for patients with both complicated and uncomplicated UTIs. The investigators will examine the two modes in terms of objective patient related outcomes, i.e. 1) diagnostic accuracy and degree of detail of final analysis; 2) time to resolution of symptoms; 3) quality of life as defined by particularly symptomology and "bothersomeness" of the symptoms; and 4) overall cost. ### Conditions Module **Conditions:** - Urinary Tract Infections-UTI ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Diagnosis by Culture and Sensitivity group-Treatment based on the results of the FH C \& S testing - Odd Numbers on randomization table **Intervention Names:** - Other: culture versus Molecular diagnostics **Label:** A-Culture and Sensitivity group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Diagnosis by Molecular Testing-Treatment based on the results of the PathoGenius molecular testing - Even Numbers on randomization table **Intervention Names:** - Other: culture versus Molecular diagnostics **Label:** B-Diagnosis by Molecular Testing **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - A-Culture and Sensitivity group - B-Diagnosis by Molecular Testing **Description:** Treatment based on the results of the FH C \& S testing - Odd Numbers on randomization table **Name:** culture versus Molecular diagnostics **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** comparison of culture and sensitivity results to the molecular results **Measure:** To quantify differences in the relative abundance and presence of microbial lineages as determined by culture and sequencing technologies. **Time Frame:** 1 year #### Secondary Outcomes **Description:** time from collection of sample to diagnostic result delivery **Measure:** Time (as measured in hours) to preliminary and final identification of organism(s) and antibiotic sensitivity(s) results **Time Frame:** 1 year **Description:** collect time of reported UTI from Subject **Measure:** Time from participant reported start of UTI symptoms to resolution. **Time Frame:** 1 year **Description:** collect data from Subject as outlined in the Quality of Life Assessment **Measure:** Participant Quality of Life as measured by a UTI specific severity and bothersome of symptoms survey taken at baseline (at clinic visit) and at set time points post urine testing **Time Frame:** 1 year **Description:** collect data on the overall cost of Subject treatment **Measure:** Overall cost **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * • Age greater than or equal to 18 and less than or equal to 89 years. * The PI suspects the patient has a complicated or uncomplicated UTI that requires urine testing to confirm diagnosis * Able to provide at least 8 ml urine total (urine for 2 pathology tests). * Is willing to complete one follow up surveys and send back to FH. Exclusion Criteria: * • Unable or unwilling to provide written informed consent. * Unable to read and write English (surveys are not available or validated in any other language than English). * Currently on any antibiotic for any clinical indication. **Maximum Age:** 89 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Florida Hospital Celebration Health **Name:** Michael McDonald, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M17302 - Name: Urinary Tract Infections - Relevance: HIGH - As Found: Urinary Tract Infections - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000014552 - Term: Urinary Tract Infections ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01453179 **Acronym:** LEIDA 2 **Brief Title:** Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses (LEIDA 2) **Official Title:** Long-term Effects of Aldara® 5% Cream and Solaraze® 3% Gel in the Treatment of Actinic Keratoses on the Face or Scalp With Respect to the Risk of Progression to In-situ and Invasive Squamous Cell Carcinoma #### Organization Study ID Info **ID:** X-03016-3284 #### Organization **Class:** INDUSTRY **Full Name:** Viatris Inc. #### Secondary ID Infos **ID:** 2010-022054-16 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2015-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-02-07 **Type:** ACTUAL **Last Update Submit Date:** 2022-02-04 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2015-03 **Type:** ACTUAL #### Start Date **Date:** 2011-10 **Status Verified Date:** 2015-04 #### Study First Post Date **Date:** 2011-10-17 **Type:** ESTIMATED **Study First Submit Date:** 2011-09-30 **Study First Submit QC Date:** 2011-10-12 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Siro Clinpharm Germany GmbH (until June 2013) **Class:** INDUSTRY **Name:** Accovion GmbH #### Lead Sponsor **Class:** INDUSTRY **Name:** MEDA Pharma GmbH & Co. KG #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This clinical trial serves the purpose to compare the long-term effects of a treatment of actinic keratosis - your skin disorder - using Aldara® 5% cream (Imiquimod) or Solaraze® 3% gel (Diclofenac) on the face or the scalp. In particular, it should be found out whether the healing effect of these two medications on the skin lesions (i.e. the damaged skin parts) can be maintained for a prolonged period. ### Conditions Module **Conditions:** - Actinic Keratosis **Keywords:** - actinic keratosis - invasive SCC - in situ SCC - histological classification - histological progression - clinical clearance - cryotherapy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 221 **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Imiquimod **Label:** Aldara 5% Cream **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Diclofenac **Label:** Solaraze 3% Gel **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Aldara 5% Cream **Description:** One course of treatment (COT) consisting of an overnight application of IMIQ (1 sachet for up to 50 cm2), applied 3 nights per week (e.g. Monday, Wednesday, Friday) for 4 weeks followed by a 4 weeks treatment pause. If necessary, this may be followed by a second COT. **Name:** Imiquimod **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Solaraze 3% Gel **Description:** Solaraze® is applied locally to the skin 2 times daily and smoothed into the skin gently. The amount needed depends on the size of the lesion. Normally 0.5 grams (the size of a pea) of the gel is used on a 25 cm2 lesion site. The duration of therapy is 12 weeks. **Name:** Diclofenac **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Long-term outcome with respect to the risk of progression to SCC (in situ and/or invasive) of treatment with Aldara® 5% cream (IMIQ) and Solaraze® 3% gel (DIC) with increased precision (meta-analysis with study 3271). **Time Frame:** 3 years #### Secondary Outcomes **Measure:** Recurrence rate **Time Frame:** 3 years **Measure:** Time to recurrence **Time Frame:** 3 years **Measure:** Need of rescue treatment **Time Frame:** 3 year **Description:** Cosmetic outcome assessed by patient and investigator on a verbal rating scale. **Measure:** Cosmetic outcome **Time Frame:** 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: To be eligible, a patient must comply with all of the following criteria: * Immunocompetent patient. * A study treatment area must be identifiable: Minimum of 5 and maximum of 10 typical visible AKs in one contiguous area of up to 50 cm2 on the face or scalp. The eyelids, the inside of the nostrils or ears, or the lip area inside the vermilion border must not be part of this area. * A positive histological finding for AK grade I or II. This will be determined from the most suspicious lesion in the STA and there from the most pathological area biopsied during screening visit. This analysis will be done by the central histopathological laboratory. * Willingness to comply with the obligations of the study. Exclusion Criteria: A patient is ineligible and must not enter the study if any of the following criteria is met: Safety concerns: * History of hypersensitivity to imiquimod, diclofenac, acetyl salicylic acid, other non steroidal anti-inflammatory drugs (NSAID), hyaluronic acid, or relevant excipients. * Pregnancy, breast-feeding or planned pregnancy during the study. Women of child bearing potential not using a highly effective method of birth control defined as those which result in a low failure rate (i.e. \<1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, tubal ligation or vasectomised partner. Lack of suitability for the study: * Presence of AK lesions in the STA with clinically excessive hyperkeratosis as seen in cutaneous horns. * Any topical AK treatment including imiquimod or diclofenac, or any systemic AK treatment such as systemic retinoids, or any surgical AK treatment at the STA within the last 2 months prior to randomisation. * Persisting AK lesion at screening visit following topical treatment with imiquimod or diclofenac in the STA. * Presence of any histologically confirmed skin tumour in the STA: in situ SCC including Bowen's disease, invasive SCC, basal cell carcinoma, or other malignant tumours. * Any dermatological disease or condition that may exacerbate by treatment with imiquimod or diclofenac (e.g. rosacea, psoriasis, atopic dermatitis). * Any dermatological disease or condition in the STA that causes difficulty with examination (e.g. eczema). * Systemic immunomodulatory treatment such as interferon, azathioprine, cyclosporine, retinoids, any oral or injectable corticosteroids, or inhaled or nasal corticosteroids with dosages of \>1200 µg/day beclomethasone or equivalent within 4 weeks before start of study treatment. * History of any malignant tumour with high tumour burden or any systemic antitumour treatment (incl. radiotherapy). * History of any malignant skin tumour having metastasised or in which metastasis within the study period is likely. * History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological, or other disease within the last two years which might hinder regular treatment and supervision and might lead to premature withdrawal from the study. * Mentally incapacitated patient. * Present or history of drug or alcohol abuse within the last 3 years. Administrative reasons: * Exposure to an investigational product within the last 3 months. * Lack of ability or willingness to give informed consent. * Age below 18 years. * Lack of willingness to have personal study related data collected, archived or transmitted according to protocol. * Anticipated non-availability for study visits/procedures. * Vulnerable subjects (such as persons kept in detention). **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Graz **Country:** Austria **Facility:** Medical University Graz, University Clinic for Dermatology and Venerology Graz **Zip:** A-8036 **Location 2:** **City:** Maria Enzersdorf **Country:** Austria **Facility:** Medical Practice **Zip:** A-2344 **Location 3:** **City:** Vienna **Country:** Austria **Facility:** Medical University Vienna, Department for General Dermatology **Zip:** A-1090 **Location 4:** **City:** Augsburg **Country:** Germany **Facility:** Medical Supply Center **Zip:** D-86163 **Location 5:** **City:** Augsburg **Country:** Germany **Facility:** Licca Clinical Research Institute, Clinic for Dermatolgy and Surgery **Zip:** D-86179 **Location 6:** **City:** Berlin **Country:** Germany **Facility:** Medical Practice **Zip:** D-10437 **Location 7:** **City:** Duelmen **Country:** Germany **Facility:** Medical Practice **Zip:** D-48249 **Location 8:** **City:** Germering **Country:** Germany **Facility:** Medical Practice **Zip:** D-82110 **Location 9:** **City:** Magdeburg **Country:** Germany **Facility:** Medical Department of Otto-von-Guericke-University Magdeburg, University Clinic for Dermatology and Venerology **Zip:** D-39120 **Location 10:** **City:** Mahlow **Country:** Germany **Facility:** Medical Practice **Zip:** D-15831 **Location 11:** **City:** Mainz **Country:** Germany **Facility:** Department of Dermatology Johannes Gutenberg-University Mainz, Clinical Research Center **Zip:** D-55131 **Location 12:** **City:** Markkleeberg **Country:** Germany **Facility:** Medical Practice **Zip:** D-04416 **Location 13:** **City:** Mönchengladbach **Country:** Germany **Facility:** Medical Practice for Dermatology and Medical Cosmetics **Zip:** D-41061 **Location 14:** **City:** Münster **Country:** Germany **Facility:** Medical Practice **Zip:** D-48143 **Location 15:** **City:** Vechta **Country:** Germany **Facility:** Derma Center Vechta, Clinic for Dermatology **Zip:** D-49377 **Location 16:** **City:** Witten **Country:** Germany **Facility:** Centrovital, Medical Practice for Dermatology **Zip:** D-58453 **Location 17:** **City:** Wuppertal **Country:** Germany **Facility:** Medical Practice for Dermatology and Venerology **Zip:** D-42275 #### Overall Officials **Official 1:** **Affiliation:** MEDA Pharma GmbH & Co. KG **Name:** Ursula Petzold, Dr. **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Otto-von-Guericke-University of Magdeburg **Name:** Harald Gollnick, Prof. Dr. **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Gollnick H, Dirschka T, Ostendorf R, Kerl H, Kunstfeld R. Long-term clinical outcomes of imiquimod 5% cream vs. diclofenac 3% gel for actinic keratosis on the face or scalp: a pooled analysis of two randomized controlled trials. J Eur Acad Dermatol Venereol. 2020 Jan;34(1):82-89. doi: 10.1111/jdv.15868. Epub 2019 Sep 12. **PMID:** 31407414 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012871 - Term: Skin Diseases - ID: D000011230 - Term: Precancerous Conditions - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M28268 - Name: Keratosis, Actinic - Relevance: HIGH - As Found: Actinic Keratosis - ID: M10668 - Name: Keratosis - Relevance: HIGH - As Found: Keratosis - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M5550 - Name: Carcinoma, Squamous Cell - Relevance: LOW - As Found: Unknown - ID: M20559 - Name: Disease Progression - Relevance: LOW - As Found: Unknown - ID: M21089 - Name: Facies - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M14111 - Name: Precancerous Conditions - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000055623 - Term: Keratosis, Actinic - ID: D000007642 - Term: Keratosis ### Intervention Browse Module - Ancestors - ID: D000000894 - Term: Anti-Inflammatory Agents, Non-Steroidal - ID: D000018712 - Term: Analgesics, Non-Narcotic - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000018501 - Term: Antirheumatic Agents - ID: D000016861 - Term: Cyclooxygenase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000097912 - Term: Toll-Like Receptor Agonists - ID: D000091369 - Term: Immunomodulating Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000000276 - Term: Adjuvants, Immunologic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000007369 - Term: Interferon Inducers ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Analg - Name: Analgesics - Abbrev: Micro - Name: Micronutrients - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M1727 - Name: Imiquimod - Relevance: HIGH - As Found: Mycophenolate Mofetil - ID: M7197 - Name: Diclofenac - Relevance: HIGH - As Found: Personalized - ID: M17544 - Name: Vitamin A - Relevance: LOW - As Found: Unknown - ID: M302395 - Name: Retinol palmitate - Relevance: LOW - As Found: Unknown - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4218 - Name: Anti-Inflammatory Agents, Non-Steroidal - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M20786 - Name: Analgesics, Non-Narcotic - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M19209 - Name: Cyclooxygenase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M3628 - Name: Adjuvants, Immunologic - Relevance: LOW - As Found: Unknown - ID: M10407 - Name: Interferons - Relevance: LOW - As Found: Unknown - ID: T468 - Name: Vitamin A - Relevance: LOW - As Found: Unknown - ID: T462 - Name: Retinol - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000004008 - Term: Diclofenac - ID: D000077271 - Term: Imiquimod ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05861479 **Brief Title:** Prognostic Value of Estimated Plasma Volume in Pulmonary Hypertension **Official Title:** Assessment of the Prognostic Value of the Estimation of Plasma Volume or Its Variation in Patients With Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) After Acute Right Heart Failure #### Organization Study ID Info **ID:** 2022PI167 #### Organization **Class:** OTHER **Full Name:** Central Hospital, Nancy, France ### Status Module #### Completion Date **Date:** 2023-04-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2023-05-05 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-01-01 **Type:** ACTUAL #### Start Date **Date:** 2015-01-01 **Type:** ACTUAL **Status Verified Date:** 2023-04 #### Study First Post Date **Date:** 2023-05-17 **Type:** ACTUAL **Study First Submit Date:** 2023-05-05 **Study First Submit QC Date:** 2023-05-05 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Central Hospital, Nancy, France #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Assessment of the prognostic value of the estimation of plasma volume or its variation in patients with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH) after acute right heart failure. **Detailed Description:** The aim of the study is to show that a low plasma volume status, assessed by the Strauss (estimated plasma volume variation) and the Duarte (instantaneous estimated plasma volume) formulas evaluated during acute right heart failure in patients presenting with PAH or CTEPH, is associated with better long-term outcomes. Optimization of plasma volume is important for patients with PAH and CTEPH and constitutes a prognostic factor. However, plasma volume status can be difficult to assess in clinical practice. Different formulas have been developed and have shown interest in patients with congestive heart failure with an association between plasma volume estimation and long-term prognosis. Acute right heart failure may occur in patients with PAH and CTEPH. Thus, the investigators plan to study the prognostic value of these formulas evaluating plasma volume, in patients with PAH or CTEPH, after acute right heart failure. ### Conditions Module **Conditions:** - Pulmonary Arterial Hypertension - Chronic Thromboembolic Pulmonary Hypertension - Acute Right Heart Failure ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Death **Measure:** Survival **Time Frame:** From the first visit to 1st April 2023 **Description:** Hospital admission for acute right heart failure **Measure:** Recurrence of acute right heart failure **Time Frame:** From the first visit to 1st April 2023 **Description:** First event: death or hospital admission for acute right heart failure **Measure:** Acute right heart failure-free survival **Time Frame:** From the first visit to 1st April 2023 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients with confirmed diagnosis of PAH or CTEPH, referred to the medical department of the investigators 2. Patient with acute right heart failure defined by at least 2 of the following clinical features: worsening of peripheral oedema, development or increase of ascites, weight gain of more than 2.5 kg in 1 week preceding the visit and decline in one NYHA functional class compared to the previous stable state Exclusion Criteria: 1) Patients with another cause of pulmonary hypertension than PAH or CTEPH, either groups 2, 3 or 5 of the current clinical classification of pulmonary hypertension **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** One hundred patients with idiopathic, heritable, drug-induced, connective tissue disease-associated, porto-pulmonary or HIV-associated disease were enrolled. At the diagnosis visit, mean±SD age was 59±12 years, 56% of the patients were women and most patients were in World Health Organization/New York Heart Association (WHO/NYHA) Functional Class III or IV. ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000006331 - Term: Heart Diseases - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Hypertension - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M10027 - Name: Hypertension, Pulmonary - Relevance: HIGH - As Found: Pulmonary Hypertension - ID: M2261 - Name: Pulmonary Arterial Hypertension - Relevance: HIGH - As Found: Pulmonary Arterial Hypertension - ID: M30541 - Name: Familial Primary Pulmonary Hypertension - Relevance: HIGH - As Found: Pulmonary Arterial Hypertension - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T4807 - Name: Pulmonary Arterial Hypertension - Relevance: HIGH - As Found: Pulmonary Arterial Hypertension - ID: T1316 - Name: Chronic Thromboembolic Pulmonary Hypertension - Relevance: HIGH - As Found: Chronic Thromboembolic Pulmonary Hypertension ### Condition Browse Module - Meshes - ID: D000006976 - Term: Hypertension, Pulmonary - ID: D000081029 - Term: Pulmonary Arterial Hypertension - ID: D000065627 - Term: Familial Primary Pulmonary Hypertension - ID: D000006973 - Term: Hypertension - ID: D000006333 - Term: Heart Failure ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00238979 **Brief Title:** A Study to Investigate the Tolerability and Safety of Converting Stable Renal Transplant Recipients Who Receive Tacrolimus With or Without Corticosteroids From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) **Official Title:** A 6-month, 1-arm, Open-label Study to Investigate the Tolerability and Safety of Converting Stable Renal Transplant Recipients Who Receive Tacrolimus With or Without Corticosteroids From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) #### Organization Study ID Info **ID:** CERL080ADE03 #### Organization **Class:** INDUSTRY **Full Name:** Novartis ### Status Module #### Expanded Access Info #### Last Update Post Date **Date:** 2011-11-02 **Type:** ESTIMATED **Last Update Submit Date:** 2011-11-01 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2005-02 **Type:** ACTUAL #### Start Date **Date:** 2003-01 **Status Verified Date:** 2011-11 #### Study First Post Date **Date:** 2005-10-14 **Type:** ESTIMATED **Study First Submit Date:** 2005-10-12 **Study First Submit QC Date:** 2005-10-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Novartis Pharmaceuticals #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** The aim of this study is whether a switch of stable renal transplant recipients who receive tacrolimus with or without corticosteroids from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) is safe and well tolerated by the patients. ### Conditions Module **Conditions:** - Renal Transplantation **Keywords:** - Renal transplantation, Enteric-coated mycophenolate sodium ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 50 **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** Enteric-Coated Mycophenolate Sodium (EC-MPS) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Tolerability based on adverse events within 6 months after switch from MMF to an optimized enteric-coated mycophenolate sodium regimen. #### Secondary Outcomes **Measure:** Safety based on renal function within 6 months after medication switch. **Measure:** Pharmacokinetics of enteric-coated mycophenolate sodium in combination with tacrolimus in a subpopulation at baseline, week 2, month 3 **Measure:** Influence of enteric-coated mycophenolate sodium on the activity of an enzyme at baseline, week 2, month 3 **Measure:** Incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch. **Measure:** Graft survival and patient survival 6 months post medication switch. ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: * Recipients of first or secondary cadaveric heart-beating, living unrelated or living related kidney transplant. * Currently receiving 1, 1.5, or 2 g MMF/day, tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months. * In a stable condition in terms of graft function. Exclusion criteria: * Patients who had taken an investigational drug within four weeks prior to study entry * History of malignancy within the last 5 years, except excised squamous or basal cell carcinoma of the skin. * Thrombocytopenia (\<75,000/mm3), with an absolute neutrophil count of \<1,500/mm3 and/or leukocytopenia (\<2,500/mm3), and/or hemoglobin \<6.0 g/dL prior to enrollment * Clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus, evidence of severe liver disease, HIV or Hepatitis B surface antigen positive. Other protocol-defined inclusion/exclusion criteria may apply. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Novartis **Name:** Novartis **Role:** STUDY_DIRECTOR ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000903 - Term: Antibiotics, Antineoplastic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000000904 - Term: Antibiotics, Antitubercular - ID: D000000995 - Term: Antitubercular Agents - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M12128 - Name: Mycophenolic Acid - Relevance: HIGH - As Found: Exhaled - ID: M18950 - Name: Tacrolimus - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M4311 - Name: Antitubercular Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000009173 - Term: Mycophenolic Acid ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00162279 **Brief Title:** The Study of Abatacept in Combination With Etanercept **Official Title:** A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Clinical Efficacy of Intravenous Infusions of BMS-188667 (10 mg/kg) Given Monthly in Combination With Subcutaneous Injections of Etanercept (25mg)Given Twice Weekly to Subjects With Active Rheumatoid Arthritis #### Organization Study ID Info **ID:** IM101-101 #### Organization **Class:** INDUSTRY **Full Name:** Bristol-Myers Squibb ### Status Module #### Completion Date **Date:** 2007-02 **Type:** ACTUAL #### Disp First Post Date **Date:** 2010-09-14 **Type:** ESTIMATED **Disp First Submit Date:** 2010-09-10 **Disp First Submit QC Date:** 2010-09-10 #### Last Update Post Date **Date:** 2010-12-06 **Type:** ESTIMATED **Last Update Submit Date:** 2010-12-02 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2007-02 **Type:** ACTUAL #### Start Date **Date:** 2000-10 **Status Verified Date:** 2010-12 #### Study First Post Date **Date:** 2005-09-13 **Type:** ESTIMATED **Study First Submit Date:** 2005-09-09 **Study First Submit QC Date:** 2005-09-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Bristol-Myers Squibb ### Description Module **Brief Summary:** The Study was designed to look at the safety and efficacy of abatacept in combination with etanercept. ### Conditions Module **Conditions:** - Rheumatoid Arthritis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** DOUBLE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 141 **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** Abatacept **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Abatacept combined with etanercept will have greater clinical efficacy compared to subjects receiving etanercept alone **Time Frame:** at 6 months #### Secondary Outcomes **Measure:** ACR 50 and 70 will be evaluated **Time Frame:** at 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All subjects who had completed the short term portion of IM101-101. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Huntsville **Country:** United States **Facility:** Local Institution **State:** Alabama **Location 2:** **City:** La Jolla **Country:** United States **Facility:** Local Institution **State:** California **Location 3:** **City:** Long Beach **Country:** United States **Facility:** Local Institution **State:** California **Location 4:** **City:** Los Angeles **Country:** United States **Facility:** Local Institution **State:** California **Location 5:** **City:** Palo Alto **Country:** United States **Facility:** Local Institution **State:** California **Location 6:** **City:** San Francisco **Country:** United States **Facility:** Local Institution **State:** California **Location 7:** **City:** Denver **Country:** United States **Facility:** Local Institution **State:** Colorado **Location 8:** **City:** Ft. Lauderdale **Country:** United States **Facility:** Local Institution **State:** Florida **Location 9:** **City:** Titusville **Country:** United States **Facility:** Local Institution **State:** Florida **Location 10:** **City:** Rome **Country:** United States **Facility:** Local Institution **State:** Georgia **Location 11:** **City:** Chicago **Country:** United States **Facility:** Local Institution **State:** Illinois **Location 12:** **City:** Hagerstown **Country:** United States **Facility:** Local Institution **State:** Maryland **Location 13:** **City:** Boston **Country:** United States **Facility:** Local Institution **State:** Massachusetts **Location 14:** **City:** Springfield **Country:** United States **Facility:** Local Institution **State:** Massachusetts **Location 15:** **City:** Duluth **Country:** United States **Facility:** Local Institution **State:** Minnesota **Location 16:** **City:** Lincoln **Country:** United States **Facility:** Local Institution **State:** Nebraska **Location 17:** **City:** New Brunswick **Country:** United States **Facility:** Local Institution **State:** New Jersey **Location 18:** **City:** Los Alamos **Country:** United States **Facility:** Local Institution **State:** New Mexico **Location 19:** **City:** Albany **Country:** United States **Facility:** Local Institution **State:** New York **Location 20:** **City:** Mineola **Country:** United States **Facility:** Local Institution **State:** New York **Location 21:** **City:** New York **Country:** United States **Facility:** Local Institution **State:** New York **Location 22:** **City:** Bismarck **Country:** United States **Facility:** Local Institution **State:** North Dakota **Location 23:** **City:** Cincinnati **Country:** United States **Facility:** Local Institution **State:** Ohio **Location 24:** **City:** Portland **Country:** United States **Facility:** Local Institution **State:** Oregon **Location 25:** **City:** Duncansville **Country:** United States **Facility:** Local Institution **State:** Pennsylvania **Location 26:** **City:** Norristown **Country:** United States **Facility:** Local Institution **State:** Pennsylvania **Location 27:** **City:** Charleston **Country:** United States **Facility:** Local Institution **State:** South Carolina **Location 28:** **City:** Knoxville **Country:** United States **Facility:** Local Institution **State:** Tennessee **Location 29:** **City:** Austin **Country:** United States **Facility:** Local Institution **State:** Texas **Location 30:** **City:** Dallas **Country:** United States **Facility:** Local Institution **State:** Texas **Location 31:** **City:** Temple **Country:** United States **Facility:** Local Institution **State:** Texas **Location 32:** **City:** Salt Lake City **Country:** United States **Facility:** Local Institution **State:** Utah **Location 33:** **City:** Edmonds **Country:** United States **Facility:** Local Institution **State:** Washington **Location 34:** **City:** Tacoma **Country:** United States **Facility:** Local Institution **State:** Washington **Location 35:** **City:** Glendale **Country:** United States **Facility:** Local Institution **State:** Wisconsin ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M4476 - Name: Arthritis - Relevance: HIGH - As Found: Arthritis - ID: M4480 - Name: Arthritis, Rheumatoid - Relevance: HIGH - As Found: Rheumatoid Arthritis - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001168 - Term: Arthritis - ID: D000001172 - Term: Arthritis, Rheumatoid ### Intervention Browse Module - Ancestors - ID: D000082082 - Term: Immune Checkpoint Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018501 - Term: Antirheumatic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: Analg - Name: Analgesics - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M483 - Name: Abatacept - Relevance: HIGH - As Found: Panel - ID: M311 - Name: Etanercept - Relevance: LOW - As Found: Unknown - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069594 - Term: Abatacept ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04343079 **Brief Title:** Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer. **Official Title:** Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer. #### Organization Study ID Info **ID:** EC/2017/0200 #### Organization **Class:** OTHER **Full Name:** University Hospital, Ghent ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-01-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-01-20 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2018-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2020-04-13 **Type:** ACTUAL **Study First Submit Date:** 2020-01-20 **Study First Submit QC Date:** 2020-04-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Ghent #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Examination of the feasibility of intra-operative pet CT to detect surgical margins in breast conservative surgery to prevent re-excision. ### Conditions Module **Conditions:** - Breast Cancer Female - Breast Neoplasms ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** breast cancer patients **Intervention Names:** - Diagnostic Test: PET CT **Label:** braeast cancer **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - braeast cancer **Description:** measurement of surgical margins during lumpectomy **Name:** PET CT **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** study the feasibility of PET/CT **Measure:** investigate the ability of (micro)PET/CT to evaluate the excision margins and determine negativity of these margins, as compared to the gold standard of sectional histopathological evaluation. **Time Frame:** 2 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * • female and 18 years of age or older * diagnosed with an early-stage (T1 or T2, and N0 or N1; according to the TNM-classification) invasive breast cancer * eligible for breast conserving surgery Exclusion Criteria: * • Pregnancy or lactation * Diabetes * Multifocal tumor disease * Diagnosis of inflammatory breast cancer * Appointment at the nuclear medicine department for 18F-FDG administration would result in a unacceptable delay of surgery * Subject has had exposure to ionizing radiation of more than 1 mSv in other research studies within the last 12 months * Subject has recently (\<60 days) or is simultaneously participating in another clinical trial. **Gender Based:** True **Gender Description:** women with breast cancer **Maximum Age:** 85 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Ghent **Contacts:** ***Contact 1:*** - **Email:** menekse.goker@uzgent.be - **Name:** Menekse Goker - **Phone:** 0498677037 - **Role:** CONTACT **Country:** Belgium **Facility:** University Hospital Ghent **State:** Oost Vlaanderen **Status:** RECRUITING **Zip:** 9000 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01269879 **Acronym:** VIBES **Brief Title:** VIBration Training in EpicondylitiS **Official Title:** Vibration Training in Epicondylitis - a Randomized Trial #### Organization Study ID Info **ID:** VIBES-2010 #### Organization **Class:** OTHER **Full Name:** Hannover Medical School ### Status Module #### Completion Date **Date:** 2011-09 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** NOT_YET_RECRUITING #### Last Update Post Date **Date:** 2011-01-04 **Type:** ESTIMATED **Last Update Submit Date:** 2011-01-03 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2011-09 **Type:** ESTIMATED #### Start Date **Date:** 2011-01 **Status Verified Date:** 2011-01 #### Study First Post Date **Date:** 2011-01-04 **Type:** ESTIMATED **Study First Submit Date:** 2011-01-03 **Study First Submit QC Date:** 2011-01-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hannover Medical School #### Responsible Party **Old Name Title:** Hannover Medical School, Karsten Knobloch, MD, PHD, FACS **Old Organization:** Hannover Medical School, Plastic, Hand and Reconstructive Surgery ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** A number of different therapeutic approaches to treat lateral epicondylitis have been tested partly in randomized trials, such as polidocanol sclerosing injections, botulinom toxin A injections, braces, surgery and topical NO patches. One study indicates that patients with lateral epicondylitis (lateral elbow tendinopathy) have poorer elbow proprioception in contrast to healthy controls (Juul-Kristensen B, et al., J Shoulder Elbow Surg 2008;17(1 Suppl):72S-81S.) Based on a suggested poorer elbow proprioception in lateral elbow tendinopathy, The investigators hypothesize that a dedicated proprioceptive intervention might be able to reduce pain and improve function. As such a RCT is planned with two intervention arms with proprioceptive training using the Flexi-Bar vibration device (www.flexi-bar.co.uk) +/- the XCO-Trainer (www.xco-trainer.co.uk) over twelve weeks. **Detailed Description:** The investigators sought to evaluate the clinical effects of either a vibration training using the Flexi-Bar vibration device (www.flexi-bar.co.uk) +/- the XCO-Trainer (www.xco-trainer.co.uk) in a randomized trial among patients suffering lateral elbow tendinopathy (lateral epicondylitis). Primary outcome measure of this clinical trial is pain on a visual analogue scale (VAS 0-10) before and after 12 weeks of training. Secondary outcome parameters involve DASH score before and after, grip strength (JAMAR), vibration and two-point discrimination (mm). ### Conditions Module **Conditions:** - Epicondylitis - Pain - Tendinopathy **Keywords:** - epicondylitis - pain - tendon ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 70 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Flexi-Bar vibration training only over 12 weeks with three distinct exercises and 10min training twice daily **Intervention Names:** - Device: Flexi-Bar vibration device only **Label:** Active control (Flexi-Bar only) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Combination intervention using vibration device Flexi-Bar and XCO-Trainer (oscillating mass witin a tube moved during running 40-60min/week suggested) **Intervention Names:** - Device: Flexi-Bar + XCO-Trainer **Label:** Intervention Flexi-Bar + XCO-Trainer **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Active control (Flexi-Bar only) **Description:** daily vibration training 10min twice **Name:** Flexi-Bar vibration device only **Other Names:** - vibration - Flexi bar **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Intervention Flexi-Bar + XCO-Trainer **Description:** XCO-Trainer is a way to overload the cardiovascular system and the core muscles during running. An oscillating mass inside the XCO-Trainer is activated when the XCO is propelled forward and backward with force. The movement of the mass triggers a series of responses from the runners' body. In addition Flexi-Bar vibration training as in the referred active comparator group **Name:** Flexi-Bar + XCO-Trainer **Other Names:** - XCO - XCO Trainer - Flexibar - vibration **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Pain on VAS (0=no pain at all, 10= worst pain imaginable) before and 12 weeks after the intervention. **Measure:** Pain on a visual analogue scale (VAS 0-10) **Time Frame:** before and 12 weeks after #### Secondary Outcomes **Description:** DASH score (0=no impairment, 100=severe impairment) of daily activities **Measure:** DASH Score **Time Frame:** before and 12 weeks after **Description:** Grip strength (JAMAR) in two elbow positions (0° flexion, 90° flexion) before and after 12 weeks of intervention **Measure:** Grip strength (JAMAR) **Time Frame:** before and after 12 weeks **Description:** Vibration using a 128Hz tuning fork before and 12 weeks after the intervention **Measure:** Vibration **Time Frame:** before and 12 weeks after **Description:** 2-point discrimination (mm) before and after the intervention and the finger tips **Measure:** 2-point discrimination **Time Frame:** before and 12 weeks after the intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * lateral elbow tendinopathy * informed consent * ability to run at least 40-60min per week with a XCO-Trainer device Exclusion Criteria: * other sources of lateral elbow pain (joint instabilities, fractures) * no consent * no ability to run at least 40-60min per week using a XCO-Trainer device **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** knobloch.karsten@mh-hannover.de **Name:** Karsten Knobloch, FACS, MD, PhD **Phone:** +495115328864 **Role:** CONTACT #### Locations **Location 1:** **City:** Hannover **Contacts:** ***Contact 1:*** - **Email:** knobloch.karsten@mh-hannover.de - **Name:** Karsten Knobloch, MD, PhD, FACS - **Phone:** +495115328864 - **Role:** CONTACT ***Contact 2:*** - **Name:** Karsten Knobloch, MD, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Germany **Facility:** Hannover Medical School, Plastic, Hand and Reconstructive Surgery **Zip:** 30625 #### Overall Officials **Official 1:** **Affiliation:** Hannover Medical School **Name:** Karsten Knobloch, FACS, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Knobloch K. Lateral elbow tendinopathy. Am J Sports Med. 2010 Nov;38(11):NP3; author reply NP3-4. doi: 10.1177/0363546510383492. No abstract available. **PMID:** 20971969 **Citation:** Knobloch K. [Non-operative therapy in lateral epicondylitis]. MMW Fortschr Med. 2009 Feb 19;151(8):28-30. No abstract available. German. **PMID:** 19432271 **Citation:** Knobloch K. Re: Radiofrequency microtenotomy: a promising method for treatment of recalcitrant lateral epicondylitis. Am J Sports Med. 2008 Nov;36(11):e2-3; author reply e3. doi: 10.1177/0363546508325661. No abstract available. **PMID:** 18978181 **Citation:** Knobloch K, Spies M, Busch KH, Vogt PM. Sclerosing therapy and eccentric training in flexor carpi radialis tendinopathy in a tennis player. Br J Sports Med. 2007 Dec;41(12):920-1. doi: 10.1136/bjsm.2007.036558. Epub 2007 May 11. **PMID:** 17496066 **Citation:** Knobloch K. [Eccentric exercise in tendinopathies]. Sportverletz Sportschaden. 2010 Dec;24(4):187. doi: 10.1055/s-0029-1245845. Epub 2010 Dec 14. No abstract available. German. **PMID:** 21157652 **Citation:** Knobloch K, Gohritz A. Dr Runge: a German pioneer in sclerosing therapy in epicondylitis in 1873. Br J Sports Med. 2010 Nov 16. doi: 10.1136/bjsm.2008.051326. Online ahead of print. No abstract available. **PMID:** 21081643 **Citation:** Yoon U, Knobloch K. Reporting quality in evidence-based studies. J Am Coll Surg. 2010 Apr;210(4):533. doi: 10.1016/j.jamcollsurg.2009.12.028. No abstract available. **PMID:** 20347748 **Citation:** Yoon U, Knobloch K. Quality of reporting in sports injury prevention abstracts according to the CONSORT and STROBE criteria: an analysis of the World Congress of Sports Injury Prevention in 2005 and 2008. Br J Sports Med. 2012 Mar;46(3):202-6. doi: 10.1136/bjsm.2008.053876. Epub 2009 Jul 26. **PMID:** 19656768 **Citation:** Juul-Kristensen B, Lund H, Hansen K, Christensen H, Danneskiold-Samsoe B, Bliddal H. Poorer elbow proprioception in patients with lateral epicondylitis than in healthy controls: a cross-sectional study. J Shoulder Elbow Surg. 2008 Jan-Feb;17(1 Suppl):72S-81S. doi: 10.1016/j.jse.2007.07.003. Epub 2007 Nov 26. **PMID:** 18036844 **Citation:** Garg R, Adamson GJ, Dawson PA, Shankwiler JA, Pink MM. A prospective randomized study comparing a forearm strap brace versus a wrist splint for the treatment of lateral epicondylitis. J Shoulder Elbow Surg. 2010 Jun;19(4):508-12. doi: 10.1016/j.jse.2009.12.015. Epub 2010 Apr 2. **PMID:** 20363158 **Citation:** Mileva KN, Kadr M, Amin N, Bowtell JL. Acute effects of Flexi-bar vs. Sham-bar exercise on muscle electromyography activity and performance. J Strength Cond Res. 2010 Mar;24(3):737-48. doi: 10.1519/JSC.0b013e3181c7c2d8. **PMID:** 20145560 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000013708 - Term: Tendon Injuries - ID: D000014947 - Term: Wounds and Injuries - ID: D000070639 - Term: Elbow Tendinopathy - ID: D000092464 - Term: Elbow Injuries - ID: D000001134 - Term: Arm Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M27013 - Name: Tendinopathy - Relevance: HIGH - As Found: Tendinopathy - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M16486 - Name: Tennis Elbow - Relevance: HIGH - As Found: Epicondylitis - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M16479 - Name: Tendon Injuries - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M627 - Name: Elbow Tendinopathy - Relevance: LOW - As Found: Unknown - ID: M2926 - Name: Elbow Injuries - Relevance: LOW - As Found: Unknown - ID: M4444 - Name: Arm Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000052256 - Term: Tendinopathy - ID: D000013716 - Term: Tennis Elbow ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03778879 **Brief Title:** Pre-operative Stereotactic Body Radiation Therapy for Pancreatic Adenocarcinoma With or Without CCX872-B **Official Title:** A Phase 1b Trial of Neoadjuvant Stereotactic Body Radiotherapy With or Without CCR2 Inhibitor (CCX872-B) Immunotherapy for Preoperative Treatment of Resectable Pancreatic Cancer #### Organization Study ID Info **ID:** UGIP18131 #### Organization **Class:** OTHER **Full Name:** University of Rochester ### Status Module #### Completion Date **Date:** 2019-08-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2019-07-19 **Type:** ACTUAL **Last Update Submit Date:** 2019-07-17 **Overall Status:** WITHDRAWN #### Primary Completion Date **Date:** 2019-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2019-08-01 **Type:** ESTIMATED **Status Verified Date:** 2019-07 #### Study First Post Date **Date:** 2018-12-19 **Type:** ACTUAL **Study First Submit Date:** 2018-12-15 **Study First Submit QC Date:** 2018-12-15 **Why Stopped:** CCX872-B will not be available in sufficient quantity to conduct the study. ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Alan Katz #### Responsible Party **Investigator Affiliation:** University of Rochester **Investigator Full Name:** Alan Katz **Investigator Title:** Associate Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** Standard treatment for newly diagnosed operable pancreatic cancer usually involves undergoing surgery first and then receiving chemotherapy with or without radiation therapy. However, the pancreatic cancer often comes back after this treatment. Therefore, the investigators are studying whether giving treatment prior to surgery can help decrease the risk the cancer returns. Stereotactic Body Radiation Therapy (SBRT) is a highly focused type of radiation therapy commonly used in the treatment of pancreatic cancer. This treatment has been shown to be safe and effective for the preoperative treatment of pancreatic cancer. The purpose of this study is to determine if combining an experimental drug, CCX872-B, with SBRT continues to be safe and whether the combination treatment may be more effective at boosting the participant's immune system's ability to kill the pancreatic cancer. **Detailed Description:** The investigators have shown that preoperative SBRT followed by surgical resection is feasible and safe in patients in the previous trial UGIP14107. The investigators have also presented preclinical evidence that inhibiting entry of CCR2+ IM using a small molecule antagonist against CCR2 results in enhanced efficacy of RT 26. The investigators hypothesize that inhibition of the CCR2 axis can potentially up regulate the immune response following radiation, therefore leading to a more robust tumor killing response. In preclinical studies, CCR2 inhibitor has little effect in the absence of RT, therefore, the investigators are not including a drug therapy alone group. To test this hypothesis, a phase Ib clinical trial has been proposed to evaluate the effect of combining stereotactic body radiotherapy with CCR2 inhibition in the neoadjuvant treatment of surgically resectable adenocarcinoma of the head of the pancreas. The study will consist of two parts in sequential fashion. The first fifteen patients will be assigned to Group 1 and undergo SBRT with CCR2 inhibitor CCX872-B. The primary objective is to establish safety and feasibility of the treatment and analyze biomarkers to determine if combined treatment can stimulate an immune response in human patients. A second group of 5 patients will undergo SBRT alone as a comparison group for biomarker immune response. The investigators would like to proceed with SBRT and CCX872-B as Group 1 given the investigators already have sufficient data from UGIP14107 to show that SBRT is safe and feasible and studying the combination of SBRT with CCX872-B is the primary scientific objective of this study. If unexpected safety issues occur with Group 1, the investigators would consider closing trial at that time without enrolling any patients in Group 2 which would reduce the number of patients exposed to the study. ### Conditions Module **Conditions:** - Adenocarcinoma of the Pancreas - Pancreas Cancer **Keywords:** - Adenocarcinoma - Pancreas - Radiation Therapy - CCX872-B ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Type:** ACTUAL **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Concurrent SBRT 25 Gy in 5 fractions over 5-7 days, and 21 days of CCX872-B therapy. CCX872-B 150 mg by mouth twice daily approximately 12 hours apart. **Intervention Names:** - Drug: CCX872-B **Label:** Group 1:With CCX872-B **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** SBRT Alone: 25 Gy in 5 fractions over 5-7 days **Label:** Group 2:Without CCX872-B **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Group 1:With CCX872-B **Description:** CCX872-B concurrent with stereotactic body radiation therapy for pancreatic adenocarcinoma. **Name:** CCX872-B **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Number of patients who proceed through radiation and drug treatment and undergo surgical resection in a timely manner. **Measure:** Percentage of patients who complete radiation therapy, drug treatment and surgery **Time Frame:** 6 weeks **Description:** Assessment of whether patients are made ineligible for surgical resection solely due to toxicities from SBRT + CCX872-B or SBRT alone. Measure of Grade 3 toxicity directly attributable to SBRT+ CCX872-B or SBRT alone. Analyze rate of grade 2 or greater acute toxicity caused by SBRT with or without CCX872-B. Determination of intraoperative and postoperative surgical morbidity following neoadjuvant treatment including the amount of fibrosis and total operative time. **Measure:** Percentage of patients who are ineligible for surgical resection due to toxicity from SBRT + CCX872-B or SBRT alone **Time Frame:** 12 weeks #### Secondary Outcomes **Description:** Count subjects with no further growth of cancer at original site **Measure:** Number of participants with no further growth of cancer at original site **Time Frame:** 2 years **Description:** Compare recurrence locations (metastases to other organs or non-regional adenopathy) of treated patients relative to historical controls **Measure:** Number of subjects with recurrence of cancer in other body sites **Time Frame:** 2 years **Description:** Duration of progression free survival of treated patients **Measure:** Mean time to progression of pancreatic cancer **Time Frame:** 4 years **Description:** Measure duration of survival of treated patients **Measure:** Mean time to death **Time Frame:** 4 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patient with pathologically proven diagnosis of adenocarcinoma of the head of the pancreas 2. CT w/ contrast or MRI of the abdomen and pelvis with contrast within 6 weeks prior to registration 3. CT chest or PET/CT within 6 weeks prior to registration 4. Clinically determined to be resectable based on NCCN Criteria 3.2017: No arterial tumor contact (celiac axis, superior mesenteric artery or common hepatic artery) and no tumor contact with the superior mesenteric vein or portal vein, or \< 180 degrees contact without vein contour irregularity 5. No evidence of metastatic disease and/or non-regional lymph node metastases 6. Adequate cardiopulmonary reserves to tolerate surgery 7. ECOG performance status 0-2 8. Adequate bone marrow function defined as follows: White blood cell\> 3000cells/mm\^3, Absolute neutrophil count (ANC) ≥ 1500 cells/mm3, Platelets ≥ 100,000 cells/mm3, Hemoglobin ≥ 9.0 g/dl 9. Male or female subjects, aged at least 18 years; Female subjects of childbearing potential may participate if adequate contraception is used during, and for at least the three months after study completion; Male subjects with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during, and for at least the three months after study completion; Adequate contraception is defined as resulting in a failure rate of less than 1% per year 10. Patient must sign study specific informed consent prior to study entry 11. Anticipated life expectancy ≥ 12 weeks; - Exclusion Criteria: 1. Prior surgical resection of any pancreatic malignancy 2. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years 3. Any prior systemic or radiation treatment, including investigational treatments, of the patient's pancreatic tumor. 4. Prior radiotherapy to the region of pancreatic cancer that would result in overlap of radiation therapy fields 5. Severe, active comorbidity, defined as follows: 1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months 2. Transmural myocardial infarction within the last 6 months 3. Clinically significant ECG abnormalities e.g. QTcF \>450msec 4. Acute viral, bacterial or fungal infection requiring intravenous antibiotics at the within 4 weeks of registration 5. Known active HIV, HBV or HCV infections 6. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration. 7. Uncontrolled diabetes or hypertension 8. Serious psychiatric illness or altered mental status 6. Severe, uncorrectable hepatic insufficiency and/or coagulation defects due to liver failure 7. Any evidence of distant metastases (M1) 8. (ONLY applies for Group 1 patients taking CCX872-B )Taking agents known to be strong inhibitors or inducers of CYP3A4 or UGT1A1 within 2 weeks prior to Day 1 dosing; these include atazanavir, boceprevir, clarithromycin, conivaptan, gemfibrozil, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole, rifampin, and carbamazepine; use of these drugs must be avoided during the study and until 2 weeks after stopping CCX872-B treatment - **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Rochester **Country:** United States **Facility:** University of Rochester Medical Center **State:** New York **Zip:** 14642 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000010182 - Term: Pancreatic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13110 - Name: Pancreatic Neoplasms - Relevance: HIGH - As Found: Pancreas Cancer - ID: M3585 - Name: Adenocarcinoma - Relevance: HIGH - As Found: Adenocarcinoma - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M13102 - Name: Pancreatic Diseases - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: T4387 - Name: Pancreatic Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000230 - Term: Adenocarcinoma - ID: D000010190 - Term: Pancreatic Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M22554 - Name: Pancrelipase - Relevance: LOW - As Found: Unknown - ID: M13114 - Name: Pancreatin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01160679 **Acronym:** PLEASURE **Brief Title:** Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia **Official Title:** Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia #### Organization Study ID Info **ID:** NIS-NKR-SER-2010/1 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca ### Status Module #### Completion Date **Date:** 2011-08 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2011-08-18 **Type:** ESTIMATED **Last Update Submit Date:** 2011-08-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2011-08 **Type:** ACTUAL #### Start Date **Date:** 2010-08 **Status Verified Date:** 2011-08 #### Study First Post Date **Date:** 2010-07-12 **Type:** ESTIMATED **Study First Submit Date:** 2010-07-07 **Study First Submit QC Date:** 2010-07-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AstraZeneca #### Responsible Party **Old Name Title:** Marketing Company Medical Director **Old Organization:** AstraZeneca ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This prospective, multi-center, 12 weeks naturalistic NIS trial will be conducted in 25 hospitals in naturalistic treatment setting. There will be no experimental component associated with this study and all observational activities have to be part of routine care visit: baseline (week 0), week 4 and week 12. ### Conditions Module **Conditions:** - Schizophrenia **Keywords:** - anhedonic features in patients with schizophrenia ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 231 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Measure:** The change of total score of SHAPS **Time Frame:** At baseline **Measure:** The change of total score of SHAPS **Time Frame:** At 12 weeks #### Secondary Outcomes **Measure:** Changes of Clinical Global Impression (CGI)-Severity score **Time Frame:** At baseline **Measure:** Changes of Clinical Global Impression (CGI)-Severity score **Time Frame:** At 12 weeks **Measure:** Proportion of patients having a score of 1 or 2 in CGI-I score **Time Frame:** At 12 weeks **Measure:** Proportion of significantly improved patients in SHAPS total score (more than 30%) **Time Frame:** At baseline **Measure:** The mean change MADRS total score **Time Frame:** At baseline **Measure:** The mean change MADRS total score **Time Frame:** At 12 weeks **Measure:** Proportion of significantly improved patients in SHAPS total score (more than 30%) **Time Frame:** At 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Documented clinical diagnosis of schizophrenia meeting the Diagnostic and Statistical Manual of Mental Disorders,(DSM-IV-TR) criteria * Patients who already take one atypical at inclusion it is started at least 1 week and up to 4 weeks before the inclusion Exclusion Criteria: * Meeting the criteria for any other (than schizophrenia) DSM-IV Axis I * Patients with antipsychotic combinations (more than two agents) * Patients who are already on any mood stabilizers and antidepressant * Known lack of response to clozapine or treatment with clozapine within 4 weeks prior to enrollment * Patients who have been treated with antipsychotics in depot formulations for the last two months * Previous enrollment or randomisation of treatment in the present NIS * Patients who had participated in other clinical trials within 4 weeks prior to enrollment period * Pregnant women or women who are breast-feeding **Minimum Age:** 20 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Department of psychiatry of 25 hospitals ### Contacts Locations Module #### Locations **Location 1:** **City:** Gongju-si **Country:** Korea, Republic of **Facility:** Research Site **State:** Chungcheongnam-do **Location 2:** **City:** Chuncheon **Country:** Korea, Republic of **Facility:** Research Site **State:** Gangwon-do **Location 3:** **City:** Anyang-si **Country:** Korea, Republic of **Facility:** Research Site **State:** Gyeonggi-do **Location 4:** **City:** Bucheon **Country:** Korea, Republic of **Facility:** Research Site **State:** Gyeonggi-do **Location 5:** **City:** Goyang-si **Country:** Korea, Republic of **Facility:** Research Site **State:** Gyeonggi-do **Location 6:** **City:** Yongin-si **Country:** Korea, Republic of **Facility:** Research Site **State:** Gyeonggi-do **Location 7:** **City:** Gyeongju-si **Country:** Korea, Republic of **Facility:** Research Site **State:** Gyeongsangbuk-do **Location 8:** **City:** Changnyeong-gun **Country:** Korea, Republic of **Facility:** Research Site **State:** Gyeongsangnam-do **Location 9:** **City:** Busan **Country:** Korea, Republic of **Facility:** Research Site **Location 10:** **City:** Daegu **Country:** Korea, Republic of **Facility:** Research Site **Location 11:** **City:** Daejeon **Country:** Korea, Republic of **Facility:** Research Site **Location 12:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Research Site #### Overall Officials **Official 1:** **Affiliation:** Department of Psychiatry **Name:** Sang-Woo Han, MD, PhD **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019967 - Term: Schizophrenia Spectrum and Other Psychotic Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15376 - Name: Schizophrenia - Relevance: HIGH - As Found: Schizophrenia - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M21838 - Name: Schizophrenia Spectrum and Other Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012559 - Term: Schizophrenia ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M16904 - Name: Antipsychotic Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01944579 **Brief Title:** Blackberry Flavonoid Absorption and Effects on Intestinal Bacteria #### Organization Study ID Info **ID:** HS40 #### Organization **Class:** FED **Full Name:** USDA Beltsville Human Nutrition Research Center ### Status Module #### Completion Date **Date:** 2014-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2014-07-22 **Type:** ESTIMATED **Last Update Submit Date:** 2014-07-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2014-04 **Type:** ACTUAL #### Start Date **Date:** 2013-09 **Status Verified Date:** 2014-07 #### Study First Post Date **Date:** 2013-09-17 **Type:** ESTIMATED **Study First Submit Date:** 2013-09-12 **Study First Submit QC Date:** 2013-09-12 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** FED **Name:** Janet Novotny #### Responsible Party **Investigator Affiliation:** USDA Beltsville Human Nutrition Research Center **Investigator Full Name:** Janet Novotny **Investigator Title:** Research Physiologist **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Intestinal bacteria can metabolize unabsorbed polyphenols (plant compounds) to produce smaller molecules which may impact health. In addition, evidence suggests that this process may be affected by body fatness. This study aims to investigate absorption of blackberry polyphenols, their impact on intestinal bacteria, polyphenol metabolites formed by intestinal bacteria, and how these processes differ for obese and lean individuals. It is hypothesized that polyphenol absorption and metabolism will differ between obese and lean individuals and that differences in intestinal microbiota may play a role. ### Conditions Module **Conditions:** - Metabolic Syndrome ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR #### Enrollment Info **Count:** 46 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive a controlled diet with the control food (jello) first and then cross over to the controlled diet with blackberries. **Intervention Names:** - Other: Blackberries - Other: Control **Label:** Control-Blackberry **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive a controlled diet with blackberries first and then cross over to the controlled diet with the control food (jello). **Intervention Names:** - Other: Blackberries - Other: Control **Label:** Blackberry-Control **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Blackberry-Control - Control-Blackberry **Description:** Participants will receive blackberries as part of a controlled diet. **Name:** Blackberries **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Blackberry-Control - Control-Blackberry **Description:** Participants will receive a control food (jello) as part of a controlled diet. **Name:** Control **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Gene expression in whole blood will be evaluated at the beginning and end of each diet period, through global gene expression using the Affymetrix platform. Changes in specific genes observed with global gene expression technology will be confirmed through RT-PCR. **Measure:** Change in gene expression **Time Frame:** 0 weeks, 4 weeks **Description:** Blood, urine, and feces will be analyzed by a technique called metabolomics, which is a broad sampling of metabolites. **Measure:** Change in metabolomics **Time Frame:** 0 weeks, 4 weeks **Description:** Biomarkers of cancer risk such as oxidative stress and inflammatory markers will be analyzed at the beginning and end of each diet period. **Measure:** Change in biomarkers of cancer **Time Frame:** 0 weeks, 4 weeks **Description:** Lipopolysaccharide will be measured in the blood as a measure of gut leakiness. **Measure:** Change in lipopolysaccharide **Time Frame:** 0 weeks, 4 weeks #### Primary Outcomes **Description:** Feces will be analyzed for bacterial typing at 0 and 4 weeks of each diet period. **Measure:** Change in fecal microbiota **Time Frame:** 0 weeks, 4 weeks #### Secondary Outcomes **Measure:** Change in blackberry nutrients & metabolites **Time Frame:** 0, 30, 60, 90, 120, 150, 180, 240, 300, 360, and 420 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 25-75 years old Exclusion Criteria: * Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol (dicumarol), or Miradon (anisindione) * Presence of any gastrointestinal disease, metabolic disease, or malabsorption syndromes that may interfere with the study goals * Have been pregnant during the previous 12 months, are currently pregnant or lactating, or plan to become pregnant during the study * Type 2 diabetes requiring the use of oral antidiabetic agents or insulin * Fasting triglycerides greater than 300 mg/dL * Fasting glucose greater than 126 mg/dL * History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets) * Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanolamine, ephedrine, caffeine) during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity * Active cardiovascular disease (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months). * Use of any tobacco products in past 3 months * Unwillingness to abstain from herbal supplements for two weeks prior to the study and during the study * Known (self-reported) allergy or adverse reaction to blackberries or other study foods * Unable or unwilling to give informed consent or communicate with study staff * Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion) * Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 25 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Beltsville **Country:** United States **Facility:** Beltsville Human Nutrition Research Center **State:** Maryland **Zip:** 20906 #### Overall Officials **Official 1:** **Affiliation:** USDA Beltsville Human Nutrition Research Center **Name:** Janet A Novotny, Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007333 - Term: Insulin Resistance - ID: D000006946 - Term: Hyperinsulinism - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M23005 - Name: Metabolic Syndrome - Relevance: HIGH - As Found: Metabolic Syndrome - ID: M10370 - Name: Insulin Resistance - Relevance: LOW - As Found: Unknown - ID: M9997 - Name: Hyperinsulinism - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000024821 - Term: Metabolic Syndrome ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T75 - Name: Blackberry - Relevance: HIGH - As Found: TIGIT ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01395979 **Acronym:** THRIVE **Brief Title:** HIV Prevention and Trauma Treatment for Men Who Have Sex With Men With Childhood Sexual Abuse Histories #### Organization Study ID Info **ID:** R01MH095624-01 **Link:** https://reporter.nih.gov/quickSearch/R01MH095624-01 **Type:** NIH #### Organization **Class:** OTHER **Full Name:** Massachusetts General Hospital ### Status Module #### Completion Date **Date:** 2017-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-03-30 **Type:** ACTUAL **Last Update Submit Date:** 2018-03-29 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-05 **Type:** ACTUAL #### Start Date **Date:** 2011-10 **Type:** ACTUAL **Status Verified Date:** 2018-03 #### Study First Post Date **Date:** 2011-07-18 **Type:** ESTIMATED **Study First Submit Date:** 2011-07-11 **Study First Submit QC Date:** 2011-07-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Fenway Community Health **Class:** OTHER **Name:** University of Miami #### Lead Sponsor **Class:** OTHER **Name:** Massachusetts General Hospital #### Responsible Party **Investigator Affiliation:** Massachusetts General Hospital **Investigator Full Name:** Conall O'Cleirigh **Investigator Title:** Ph.D. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** Brief Summary: The specific aims of this study are: 1. To test, in a two-arm randomized controlled trial, the efficacy of cognitive processing therapy for sexual risk and posttraumatic symptom severity reduction (CPT-SR) in HIV-uninfected men who have sex with men (MSM) who have histories of childhood sexual abuse (CSA). The primary outcome is reduction in unprotected anal/vaginal intercourse (number and proportion) with serodiscordant partners. The investigators will also examine the intervention effect on CSA-related trauma symptom severity and cognitions and behaviors. 2. To examine the degree to which intervention-related reductions in sexual risk behavior are mediated by reductions in CSA-related symptom severity, cognitions, and behaviors. 3. To examine the degree to which the intervention reduces incident sexually transmitted infections (STIs) during the study period, as well as to explore additional potential moderators and mediators of intervention efficacy. Study hypotheses: 1. For the primary outcome, the investigators hypothesize that those who receive the intervention will have reduced transmission-risk behavior. 2. For the secondary outcome, the investigators hypothesize that those who receive the intervention will have reduced trauma symptom severity (cognitions and behaviors). **Detailed Description:** The prevalence of HIV among men who have sex with men (MSM) is estimated at an alarming 19% domestically (CDC 2010), rates comparable to endemic settings in certain regions of sub-Saharan Africa where approximately 20% of the adult population is HIV infected. Studies have also demonstrated a staggeringly high prevalence of childhood sexual abuse (CSA) in MSM, and shown an association between CSA and HIV risk in MSM. A successful intervention for MSM with a CSA history to prevent HIV has the potential to avert infections among some of the riskiest members of the most HIV vulnerable group in the U.S. Notwithstanding the ability of the existing HIV prevention interventions to show reductions in sexual risk taking, the recent successes of chemoprophylaxis, current policy initiatives, and empirically supported recommendations, all support development of combination prevention interventions that can specify multiple prevention targets, address related risk factors and barriers, and are grounded in a community context. The pathways from CSA to adult sexual risk behavior are varied and complex and this complexity is appropriately addressed in individual-based interventions where empirically supported interventions for CSA related trauma were efficacy tested. The development of an integrated prevention intervention that utilizes cognitive behavioral technologies to address co-occurring and interfering CSA and sexual risk represents a novel and largely untested innovative application that is theoretically designed to address sexual risk directly and indirectly through reductions in CSA-related trauma symptoms. The flexibility of integrated and combination prevention programs has the potential to support triage of MSM with particular risk profiles to the programs that best meet their prevention needs. This two-arm RCT is designed to test the efficacy of a psycho-social intervention that addresses intersecting epidemics among MSM, HIV and CSA. The experimental condition integrates sexual risk reduction counseling with Cognitive Processing Therapy for Sexual Risk (CPT-SR). CPT-SR has been specifically piloted on MSM with CSA histories and sexual risk to reduce interfering negative CSA-related thoughts about self, to more accurately appraise sexual risk, and to decrease avoidance of sexual safety considerations through rehearsals of sexual safety behaviors. The active and time-matched comparison condition is risk reduction counseling plus supportive psychotherapy. The investigators will randomize HIV-uninfected MSM who report a history of CSA and multiple recent sexual risk episodes for HIV (unprotected anal/vaginal intercourse) across two sites (Boston and Miami). The primary outcome will be self-reported sexual risk taking as assessed via a computer-based questionnaire. Secondary outcomes include trauma symptom severity, both cognitive and behavioral. Study assessment points are at baseline, 3 (post treatment), 6, 9, and 12-month follow-ups. ### Conditions Module **Conditions:** - Sexual Risk Behavior - Childhood Sexual Abuse - Stress Disorders, Post-Traumatic ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 232 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The CPT-SR condition will be comprised of 10 individual therapy sessions fully integrating sexual risk reduction counseling into cognitive therapy for sexual abuse-related trauma. **Intervention Names:** - Behavioral: Cognitive Processing Therapy for Sexual Risk - Behavioral: Sexual Risk Reduction Intervention **Label:** Cognitive Processing Therapy for Sexual Risk (CPT-SR) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The TMC will be comprised of sexual risk reduction counseling/education and supportive psychotherapy. **Intervention Names:** - Behavioral: Supportive Psychotherapy - Behavioral: Sexual Risk Reduction Intervention **Label:** Time-Matched Control (TMC) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Cognitive Processing Therapy for Sexual Risk (CPT-SR) **Description:** Eight weekly sessions, 4 modules. **Name:** Cognitive Processing Therapy for Sexual Risk **Other Names:** - CPT-SR **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Time-Matched Control (TMC) **Description:** Eight weekly sessions **Name:** Supportive Psychotherapy **Other Names:** - TMC **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Cognitive Processing Therapy for Sexual Risk (CPT-SR) - Time-Matched Control (TMC) **Description:** Two weekly sessions. **Name:** Sexual Risk Reduction Intervention **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Number of unprotected (no condom was used) insertive or receptive anal or vaginal intercourse acts reported in the past 3 months with casual partners or with partners with unknown or positive HIV status. **Measure:** Changes from Baseline in Sexual Risk Behavior for HIV Acquisition **Time Frame:** Baseline, (2 weeks post-baseline pre-randomization), 3,6, 9, and 12 month follow ups #### Secondary Outcomes **Description:** Davidson Trauma Scale which has been correlated with measures of Post-Traumatic Stress Disorder (PTSD) severity, depression, and general anxiety, and discriminated well between traumatized individuals with and without PTSD. **Measure:** Changes from Baseline in Trauma Symptom Severity **Time Frame:** Baseline assessment, 3, 6, and 9-month follow-up assessments ### Eligibility Module **Eligibility Criteria:** Eligibility Criteria: Inclusion Criteria: * Identifies as MSM. * Reports history of CSA (sexual contact before the age of 13 with an adult or person 5 years older or sexual contact with the threat of force or harm between the ages of 13 and 16 inclusive or with a person 10 years older). * Reports \>1 episode of unprotected anal or vaginal intercourse within the past three months. * Reports HIV-negative status confirmed by rapid HIV test. * Is capable of completing and fully understanding the informed consent process and the study procedures. Exclusion Criteria: * All episodes of unprotected anal or vaginal intercourse occurred with only a single, primary HIV-negative partner. * Significant mental health diagnosis requiring immediate treatment (e.g. bipolar disorder; any psychotic disorder). * Inability to complete informed consent process (e.g. substantial cognitive impairment, inadequate English language skills). * Has received CPT for PTSD within the past 12 months. **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Coral Gables **Country:** United States **Facility:** University of Miami **State:** Florida **Zip:** 33124-0751 **Location 2:** **City:** Boston **Country:** United States **Facility:** Massachusetts General Hospital **State:** Massachusetts **Zip:** 02114-2919 **Location 3:** **City:** Boston **Country:** United States **Facility:** The Fenway Institute **State:** Massachusetts **Zip:** 02215 #### Overall Officials **Official 1:** **Affiliation:** Massachusetts General Hospital **Name:** Conall O'Cleirigh, Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Batchelder AW, Fitch C, Feinstein BA, Thiim A, O'Cleirigh C. Psychiatric, Substance Use, and Structural Disparities Between Gay and Bisexual Men with Histories of Childhood Sexual Abuse and Recent Sexual Risk Behavior. Arch Sex Behav. 2021 Oct;50(7):2861-2873. doi: 10.1007/s10508-021-02037-1. Epub 2021 Oct 21. **PMID:** 34676467 **Citation:** Batchelder AW, Choi K, Dale SK, Pierre-Louis C, Sweek EW, Ironson G, Safren SA, O'Cleirigh C. Effects of syndemic psychiatric diagnoses on health indicators in men who have sex with men. Health Psychol. 2019 Jun;38(6):509-517. doi: 10.1037/hea0000724. Epub 2019 Apr 11. **PMID:** 30973745 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000040921 - Term: Stress Disorders, Traumatic - ID: D000068099 - Term: Trauma and Stressor Related Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC01 - Name: Infections - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M16103 - Name: Stress Disorders, Post-Traumatic - Relevance: HIGH - As Found: Stress Disorders, Post-Traumatic - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M3522 - Name: Acquired Immunodeficiency Syndrome - Relevance: LOW - As Found: Unknown - ID: M18250 - Name: HIV Infections - Relevance: LOW - As Found: Unknown - ID: M24916 - Name: Stress Disorders, Traumatic - Relevance: LOW - As Found: Unknown - ID: M222 - Name: Trauma and Stressor Related Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013313 - Term: Stress Disorders, Post-Traumatic ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03663179 **Brief Title:** Transcranial Magnetic Stimulation for Attention Deficit/Hyperactivity Disorder (ADHD) **Official Title:** A Pilot Study of Repetitive Transcranial Magnetic Stimulation for Adult ADHD #### Organization Study ID Info **ID:** 826586 #### Organization **Class:** OTHER **Full Name:** University of Pennsylvania ### Status Module #### Completion Date **Date:** 2020-01-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-08-05 **Type:** ACTUAL **Last Update Submit Date:** 2022-08-03 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-03-31 **Type:** ACTUAL #### Results First Post Date **Date:** 2019-10-28 **Type:** ACTUAL **Results First Submit Date:** 2019-09-09 **Results First Submit QC Date:** 2019-10-24 #### Start Date **Date:** 2017-01 **Type:** ACTUAL **Status Verified Date:** 2022-08 #### Study First Post Date **Date:** 2018-09-10 **Type:** ACTUAL **Study First Submit Date:** 2018-08-02 **Study First Submit QC Date:** 2018-09-06 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Pennsylvania #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study will test the effects of transcranial magnetic stimulation (TMS) on clinical measures of ADHD symptoms. **Detailed Description:** Attention Deficit Hyperactivity Disorder (ADHD) is characterized by symptoms of impulsivity, inattention, and hyperactivity that emerge in childhood and frequently persist into adulthood. These symptoms are accompanied by deficits in cognitive control and risky decision making that can lead to negative psychosocial and health-related outcomes. With advances in the neuroimaging field, researchers are learning where and how self-control over decisions and behaviors is executed in the brain. This work points to the central role of neural activity in the dorsolateral prefrontal cortices (DLPFC) in self-control processes that contribute to healthy choices. Emerging evidence shows that activity in the prefrontal cortices and cognitive control circuits can be modulated using a noninvasive and safe intervention: repetitive TMS. This within-subject proof of concept study will investigate whether 20 sessions of TMS (versus sham stimulation) can enhance executive cognitive function in adults with ADHD. ### Conditions Module **Conditions:** - Attention Deficit Disorder With Hyperactivity (ADHD) **Keywords:** - ADHD - TMS ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 32 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive 20 sessions of active TMS targeting the left DLPFC. **Intervention Names:** - Device: Transcranial Magnetic Stimulation (TMS) **Label:** Active TMS **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive 20 sessions of sham TMS over the left DLPFC. **Intervention Names:** - Device: Sham Transcranial Magnetic Stimulation (Sham TMS) **Label:** Sham TMS **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Active TMS **Description:** A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (\~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks). **Name:** Transcranial Magnetic Stimulation (TMS) **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Sham TMS **Description:** A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks). **Name:** Sham Transcranial Magnetic Stimulation (Sham TMS) **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** ADHD symptoms will be assessed using the well-validated Conners Adult ADHD Rating Scale - Self-Report: Long Version (CAARS-S:L). The CAARS-S:L is a 66-item rating scale designed to assess ADHD symptoms in adults. The scale contains multiple subscales to assess Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) specified ADHD criteria as well as other facets of ADHD such as inattention/memory problems, hyperactivity/restlessness, impulsivity/emotionality, and problems with self-concept. Subscale results are converted to T-scores (range: 25-90), where 50 is the standardized population mean and every 10 points indicates one standard deviation from the mean. Higher values generally indicate more difficulties with ADHD symptoms. This measure will be administered at baseline at at the end of 4 weeks of treatment. The primary outcome will be the change from baseline to week 4. **Measure:** Change in Performance on Conners Adult ADHD Rating Scale - Self-Report: Long Version (ADHD Symptoms) **Time Frame:** Baseline and week 4 #### Secondary Outcomes **Description:** The Conners Continuous Performance Task (Conners CPT) will be administered and baseline and weekly during the treatment period to assess sustained attention. In this task, participants are shown a series of letters on a computer screen and are asked to press the spacebar in response to all letters except for the letter X. The primary outcome for the Conners CPT is the change in number of commission errors (e.g., false positives) from baseline to week 4. **Measure:** Change in Performance on Conners Continuous Performance Task (Sustained Attention) **Time Frame:** Baseline and week 4 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Eligible participants will be: 1. Healthy males and females who are between 18 and 65 years of age with an ADHD diagnosis (meet diagnostic criteria for ADHD on the SCID-5 module for adult ADHD). 2. Planning to live in the area for at least the next 6 weeks; 3. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form; 4. Able to communicate fluently in English (speaking, writing, and reading). Exclusion Criteria: Subjects who present and/or self-report with the following criteria at any point during study participation will not be eligible to participate in the study: Alcohol/Drugs: 1. History or current diagnosis or treatment for alcohol or drug abuse (as reported during phone screen); 2. Positive breath alcohol concentration test (BrAC greater than or equal to 0.01) at intake; 3. A positive urine drug screen for cocaine, phencyclidine (PCP), amphetamines, methamphetamines, benzodiazepines, methadone, and/or barbiturates at Intake, Baseline, or Sessions 5, 10, 15 or 20. Medication: Current use or recent discontinuation (within the past 6 months at the time of Intake) of: 1. Gamma-Aminobutyric Acid (GABA)-ergic medications 2. Glutamatergic medications 3. Any medication for the treatment of ADHD 4. Benzodiazepines 5. Any medication that is known to lower the seizure threshold (e.g.,clozapine, bupropion, tramadol, carbapenems, stimulants) 6. Any medication that could compromise participant safety as determined by the Principal Investigator and/or Study Physician Current use or recent discontinuation (within the last 14 days at the time of Intake) of: 7. Anti-psychotic medications 8. Nicotine replacement therapy (NRT) Daily use of: 9. Opiate-containing medications for chronic pain Medical/Neuropsychiatric: 1. Women who are pregnant, planning a pregnancy, and/or breast feeding. 2. History of seizures, epilepsy, or history of epilepsy in first-degree relative 3. History of stroke or transient ischemic attack (warning stroke) 4. History of traumatic brain injury or self-report of brain or spinal tumor 5. History of head injury with unconsciousness lasting more than 5 minutes 6. Previous brain surgery 7. Any additional neurological condition that would likely reduce the safety of study participation, including central nervous system (CNS) vasculitis, intracranial tumor, intracranial aneurysm, multiple sclerosis or arteriovenous malformations 8. History of tinnitus 9. History of diabetes mellitus 10. History of atherosclerotic vascular disease 11. A medically unstable cardiopulmonary or metabolic disorder 12. Increased risk for myocardial infarction or other major cardiopulmonary complications. 13. Any uncorrected visual impairment or abnormality 14. Self-reported history, current diagnosis of psychosis or symptoms consistent with a mood disorder based upon the Structured Clinical Interview for DSM-5 (SCID); including schizophrenia, mania, bipolar disorder, an eating disorder, obsessive compulsive disorder, an anxiety disorder, major depression (subjects with a history of major depression but in remission for past 6 months are eligible). TMS-related: 1. Subjects with ferromagnetic material in or in close proximity to the head (with the exception of oral dental devices) 2. Implanted devices (including vagus nerve stimulator (VNS), deep brain stimulator (DBS), pacemakers, spinal cord stimulators, medication pumps, ventriculo peritoneal shunts, defibrillators, intracardiac lines) 3. Self-report of any skull fracture or opening 4. A disturbance in normal sleep patterns/sleep deprivation General Exclusion: 1. Any medical condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, or affect clinical or cognitive outcomes, as determined by the Principal Investigator 2. Inability to complete study tasks and provide quality data, as determined by the Principal Investigator 3. Low or borderline intellectual functioning - determined by a score of less than 90 on the Shipley Institute of Living Scale (SILS) (administered at Intake Visit). The SILS correlates with the Wechsler Adult Intelligence Scale-Revised (WAIS-R) Estimated Intelligence Quotient (IQ) Test 4. Inability to provide informed consent **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Philadelphia **Country:** United States **Facility:** University of Pennsylvania **State:** Pennsylvania **Zip:** 19104 #### Overall Officials **Official 1:** **Affiliation:** University of Pennsylvania **Name:** James Loughead, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Document Section ### Large Document Module #### Large Docs - Date: 2019-01-29 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 534775 - Type Abbrev: Prot_SAP - Upload Date: 2019-09-09T16:00 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019958 - Term: Attention Deficit and Disruptive Behavior Disorders - ID: D000065886 - Term: Neurodevelopmental Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000020820 - Term: Dyskinesias - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M4594 - Name: Attention Deficit Disorder with Hyperactivity - Relevance: HIGH - As Found: Attention Deficit Disorder With Hyperactivity - ID: M9999 - Name: Hyperkinesis - Relevance: HIGH - As Found: Hyperactivity - ID: M21830 - Name: Attention Deficit and Disruptive Behavior Disorders - Relevance: LOW - As Found: Unknown - ID: M30644 - Name: Neurodevelopmental Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M22574 - Name: Dyskinesias - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006948 - Term: Hyperkinesis - ID: D000001289 - Term: Attention Deficit Disorder with Hyperactivity ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Active TMS **Deaths Num At Risk:** 18 **Description:** Participants will receive 20 sessions of active TMS targeting the left DLPFC. Transcranial Magnetic Stimulation (TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (\~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks). **ID:** EG000 **Other Num Affected:** 4 **Other Num at Risk:** 18 **Serious Number At Risk:** 18 **Title:** Active TMS **Group ID:** EG001 **Title:** Sham TMS **Deaths Num At Risk:** 14 **Description:** Participants will receive 20 sessions of sham TMS over the left DLPFC. Sham Transcranial Magnetic Stimulation (Sham TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks). **ID:** EG001 **Other Num Affected:** 1 **Other Num at Risk:** 14 **Serious Number At Risk:** 14 **Title:** Sham TMS **Frequency Threshold:** 5 #### Other Events **Term:** Sleep disturbance **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** Participant experienced insomnia several times during the first week of treatment and revealed a history of insomnia prior to enrollment. **Organ System:** General disorders **Source Vocabulary:** **Term:** allergic reaction **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** Participant unknowingly consumed peanuts while at their personal gym and experienced an allergic reaction. **Organ System:** Immune system disorders **Source Vocabulary:** **Term:** Visual disturbance **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** Participant reported seeing a white flash while completing computer tasks after receiving her 10th session of TMS. **Organ System:** Eye disorders **Source Vocabulary:** **Term:** Injury **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** Participant diagnosed with tendinitis in left foot and needed to wear a boot. **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** **Term:** Depression symptoms **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** Participant reported depression symptoms. **Organ System:** Psychiatric disorders **Source Vocabulary:** **Time Frame:** Baseline until end of treatment, an average of 4 weeks. ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 14 **Group ID:** BG001 **Value:** 13 **Group ID:** BG002 **Value:** 27 **Units:** Participants ### Group **ID:** BG000 **Title:** Active TMS **Description:** Participants will receive 20 sessions of active TMS targeting the left DLPFC. Transcranial Magnetic Stimulation (TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (\~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks). ### Group **ID:** BG001 **Title:** Sham TMS **Description:** Participants will receive 20 sessions of sham TMS over the left DLPFC. Sham Transcranial Magnetic Stimulation (Sham TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks). ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 9.9 **Value:** 32.9 #### Measurement **Group ID:** BG001 **Spread:** 6.0 **Value:** 36.0 #### Measurement **Group ID:** BG002 **Spread:** 13.0 **Value:** 34.4 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 5 #### Measurement **Group ID:** BG001 **Value:** 4 #### Measurement **Group ID:** BG002 **Value:** 9 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 9 #### Measurement **Group ID:** BG001 **Value:** 9 #### Measurement **Group ID:** BG002 **Value:** 18 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 2 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 4 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 10 #### Measurement **Group ID:** BG001 **Value:** 9 #### Measurement **Group ID:** BG002 **Value:** 19 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 2 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 7 #### Measurement **Group ID:** BG001 **Value:** 4 #### Measurement **Group ID:** BG002 **Value:** 11 **Category Title:** high school/some college #### Measurement **Group ID:** BG000 **Value:** 7 #### Measurement **Group ID:** BG001 **Value:** 9 #### Measurement **Group ID:** BG002 **Value:** 16 **Category Title:** college graduate **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 6 **Category Title:** smokers #### Measurement **Group ID:** BG000 **Value:** 10 #### Measurement **Group ID:** BG001 **Value:** 11 #### Measurement **Group ID:** BG002 **Value:** 21 **Category Title:** non-smokers **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Education **Unit of Measure:** Participants ### Measure 5 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Smoking Status **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement **PI Sponsor Employee:** True ### Point of Contact **Email:** lleah@pennmedicine.upenn.edu **Organization:** University of Pennsylvania **Phone:** 2157467162 **Title:** Leah Bernardo ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 9.4 - **Upper Limit:** - **Value:** -4.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 7.6 - **Upper Limit:** - **Value:** -5.1 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 17.6 - **Upper Limit:** - **Value:** -16.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 18.0 - **Upper Limit:** - **Value:** -4.8 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** ADHD symptoms will be assessed using the well-validated Conners Adult ADHD Rating Scale - Self-Report: Long Version (CAARS-S:L). The CAARS-S:L is a 66-item rating scale designed to assess ADHD symptoms in adults. The scale contains multiple subscales to assess Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) specified ADHD criteria as well as other facets of ADHD such as inattention/memory problems, hyperactivity/restlessness, impulsivity/emotionality, and problems with self-concept. Subscale results are converted to T-scores (range: 25-90), where 50 is the standardized population mean and every 10 points indicates one standard deviation from the mean. Higher values generally indicate more difficulties with ADHD symptoms. This measure will be administered at baseline at at the end of 4 weeks of treatment. The primary outcome will be the change from baseline to week 4. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline and week 4 **Title:** Change in Performance on Conners Adult ADHD Rating Scale - Self-Report: Long Version (ADHD Symptoms) **Type:** PRIMARY **Unit of Measure:** t-score ##### Group **Description:** Participants will receive 20 sessions of active TMS targeting the left DLPFC. Transcranial Magnetic Stimulation (TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (\~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks). **ID:** OG000 **Title:** Active TMS ##### Group **Description:** Participants will receive 20 sessions of sham TMS over the left DLPFC. Sham Transcranial Magnetic Stimulation (Sham TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks). **ID:** OG001 **Title:** Sham TMS #### Outcome Measure 2 **Description:** The Conners Continuous Performance Task (Conners CPT) will be administered and baseline and weekly during the treatment period to assess sustained attention. In this task, participants are shown a series of letters on a computer screen and are asked to press the spacebar in response to all letters except for the letter X. The primary outcome for the Conners CPT is the change in number of commission errors (e.g., false positives) from baseline to week 4. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline and week 4 **Title:** Change in Performance on Conners Continuous Performance Task (Sustained Attention) **Type:** SECONDARY **Unit of Measure:** Commission Errors ##### Group **Description:** Participants will receive 20 sessions of active TMS targeting the left DLPFC. Transcranial Magnetic Stimulation (TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (\~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks). **ID:** OG000 **Title:** Active TMS ##### Group **Description:** Participants will receive 20 sessions of sham TMS over the left DLPFC. Sham Transcranial Magnetic Stimulation (Sham TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks). **ID:** OG001 **Title:** Sham TMS ### Participant Flow Module #### Group **Description:** Participants will receive 20 sessions of active TMS targeting the left DLPFC. Transcranial Magnetic Stimulation (TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (\~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks). **ID:** FG000 **Title:** Active TMS #### Group **Description:** Participants will receive 20 sessions of sham TMS over the left DLPFC. Sham Transcranial Magnetic Stimulation (Sham TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks). **ID:** FG001 **Title:** Sham TMS #### Period **Title:** Overall Study ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ##### Withdraw **Type:** Revealed exclusionary condition ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 18 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 14 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 14 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 13 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 4 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 1 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT03652779 **Brief Title:** A Study to Evaluate the Safety and Tolerability of Tecarfarin in Healthy Chinese Volunteers **Official Title:** An Open-label, Phase 1, Sequential Cohort, Single-Dose Escalation Study to Assess the Safety and Tolerability of Tecarfarin (ATI-5923) in Healthy Chinese Volunteers #### Organization Study ID Info **ID:** LP-HK-001 #### Organization **Class:** INDUSTRY **Full Name:** Lee's Pharmaceutical Limited ### Status Module #### Completion Date **Date:** 2019-10-28 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-11-21 **Type:** ACTUAL **Last Update Submit Date:** 2019-11-20 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-10-28 **Type:** ACTUAL #### Start Date **Date:** 2018-06-22 **Type:** ACTUAL **Status Verified Date:** 2019-09 #### Study First Post Date **Date:** 2018-08-29 **Type:** ACTUAL **Study First Submit Date:** 2018-08-28 **Study First Submit QC Date:** 2018-08-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Lee's Pharmaceutical Limited #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of the study is to evaluate the safety and tolerability of a single dose of tecarfarin in healthy Chinese Volunteers. the Pharmacokinetic and pharmacodynamic profile of tecarfarin will also be evaluated. ### Conditions Module **Conditions:** - Pharmacokinetic and Pharmacodynamic Profile of Tecarfarin ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 40 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Tecarfarin 10mg **Label:** Tecarfarin 10mg **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Tecarfarin 20mg **Label:** Tecarfarin 20mg **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Drug: Tecarfarin 30mg **Label:** Tecarfarin 30mg **Type:** EXPERIMENTAL #### Arm Group 4 **Intervention Names:** - Drug: Tecarfarin 40mg **Label:** Tecarfarin 40mg **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Tecarfarin 10mg **Description:** Tecarfarin 10mg tablets **Name:** Tecarfarin 10mg **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Tecarfarin 20mg **Description:** two tecarfarin 10mg tablets **Name:** Tecarfarin 20mg **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Tecarfarin 30mg **Description:** three tecarfarin 10mg tablets **Name:** Tecarfarin 30mg **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Tecarfarin 40mg **Description:** four tecarfarin 10mg tablets **Name:** Tecarfarin 40mg **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Adverse Events Frequency **Time Frame:** 15 Days **Measure:** Adverse Events Severity **Time Frame:** 15 Days #### Secondary Outcomes **Measure:** Area under the plasma concentration versus time curve **Time Frame:** 336 Hours **Measure:** Peak Plasma Concentration **Time Frame:** 336 Hours **Measure:** Time which Peak Plasma Concentration is Reached **Time Frame:** 336 Hours **Measure:** Elimination Rate Constant **Time Frame:** 336 Hours **Measure:** Elimination Half Life **Time Frame:** 336 Hours **Measure:** Clearance **Time Frame:** 336 Hours **Measure:** Volume of Distribution **Time Frame:** 336 Hours **Measure:** International Normalized Ratios **Time Frame:** 0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15 **Measure:** Prothrombin Time **Time Frame:** 0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15 **Measure:** Activated Partial Thromboplastin Time **Time Frame:** 0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15 **Description:** 0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15 **Measure:** Coagulation Factor II **Time Frame:** 8 Days **Description:** 0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15 **Measure:** Coagulation Factor VII **Time Frame:** 8 Days **Description:** 0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15 **Measure:** Coagulation Factor X **Time Frame:** 8 Days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Subject must voluntarily sign and date an informed consent form, approved by the Institutional Review Board (IRB), prior to the initiation of any study-specific procedure. 2. Healthy Chinese\* volunteers aged between 18 and 55 years inclusive, at the time of Screening \*Definition of "Chinese": Subject is a Han Chinese who born in China (including Hong Kong) with Han Chinese parents and grandparents who born in China (including Hong Kong). 3. Body Mass Index (BMI) ≥19 and ≤ 24 kg/m2 4. Subject has been a non-smoker or has not used tobacco or nicotine-containing products for at least 3 months before Screening and prior to Day 1. 5. Subjects are in general good health with no history of significant diseases and no clinically significant abnormal findings based upon the results of physical examination, 12-lead ECG, laboratory safety tests and vital signs at screening and prior to dosing. • Vital signs (measured in a sitting position for at least 5 minutes) include tympanic temperature \[T\], pulse rate \[PR\], respiratory rate \[RR\], and blood pressure \[BP\]). 6. Female subjects must be non-pregnant, non-lactating or either postmenopausal for at least 2 years or surgically sterile (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal occlusion or ligation) for at least 6 months. For female subjects of child bearing potential, they need to consentient to use appropriate contraceptive methods (abstinence, intrauterine device, diaphragm with spermicide, use by partner of a condom with spermicide) at least 28 days prior to and after dosing. Use of oral contraceptive and implantation of contraceptive methods by female subjects are not acceptable. 7. Male subjects who have female partners of reproductive potential must either: * Abstinence from sexual intercourse during Day -1 to Day 28, or * Use an approved method of contraception (which may include use of a condom with spermicide or use by partner of oral, implantable or injectable contraceptives, intrauterine device, diaphragm with spermicide) during Day -1 to Day 28. * Refrain from sperm donation during Day -1 to Day 28. 8. Able and willing to follow instructions and to comply with protocol requirements. Exclusion Criteria: 1. Positive test results for HIV, syphilis antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV Ab) at Screening. 2. Positive tests for alcohol breathalyzer or urine drugs of abuse at Screening or Day -1 or a history of drug abuse/dependence. 3. Use of tobacco or nicotine products 3 months before screening and prior to Day 1. 4. Heavy caffeine drinker (\> 5 cups or glasses of caffeinated beverages \[e.g., coffee tea, cola, energy drinks\] per day) within 3 months prior to screening. 5. Heavy alcohol drinker (more than 30 gram alcohol per day within 3 months prior to screening (30 gram alcohol is approximately equivalent to: i.e. 100ml of aperitif, 300ml of wine or 500ml of beer)). 6. Any clinically significant above normal range of prothrombin time, activated partial thromboplastin time, or international normalized ratio or below normal range of Protein C or Protein S laboratory result at Screening. 7. Documented history of bleeding diathesis, coagulopathy, or inherited disorders of coagulation. 8. Evidence of active bleeding, including but not limited to bleeding ulcer, bleeding gums, urinalysis positive for more than trace blood at Screening and presence of occult blood in the stool at Screening. 9. Subjects with a QTcB interval (QT interval corrected for heart rate according to Bazett's formula) \> 450 msec at Screening, confirmed by a repeat assessment. 10. Conditions predisposing to QT prolongation including pathological Q-wave (defined as Q-wave \>40 msec or depth \> 0.4-0.5 mV). 11. History or presence of cardiac abnormalities or congenital long QT syndrome based on the final investigators' judgment. 12. History or presence of malignancy within the past 2 years, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma) or carcinoma in-situ of the cervix. 13. Participation in a previous clinical trial within 3 months prior to Screening. 14. Clinically significant surgical procedure within 3 months prior to Screening. 15. Clinically significant blood loss or blood donation \> 550 ml within 3 months prior to Day 1. 16. Any laboratory results from complete blood picture suspicious of ongoing blood loss. 17. Taking any prescription medication 14 days prior to Day -1. 18. Routine or as needed consumption of medications, herbal, vitamins or hormone supplements 14 days prior to Day -1 or subject is unable to withhold these medications due to underlying clinical conditions, or unwilling to refrain from taking these medications, during the study period (Day -1 to Day 15). 19. Known allergy or hypersensitivity to warfarin or the investigational product. 20. Any other conditions or clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during Screening that, in the opinion of the Principal Investigator would make the subject unsuitable for the study or put them at additional risks. **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hong Kong **Country:** Hong Kong **Facility:** HKU Phase 1 Clinical Trial Centre, The University of Hong Kong **Zip:** 000000 #### Overall Officials **Official 1:** **Affiliation:** Queen Mary Hospital, Hong Kong **Name:** Jo Jo SH Hai, MBBS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02172079 **Brief Title:** Mobilization With Movement for Shoulder Impingement **Official Title:** Effects of Mobilization-with-Movement on Pain and Range of Motion in Unilateral Shoulder Impingement Syndrome: A Randomized Controlled Trial #### Organization Study ID Info **ID:** USAL201000048540 #### Organization **Class:** OTHER **Full Name:** Universidad Rey Juan Carlos ### Status Module #### Completion Date **Date:** 2014-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2014-06-24 **Type:** ESTIMATED **Last Update Submit Date:** 2014-06-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2014-01 **Type:** ACTUAL #### Start Date **Date:** 2013-01 **Status Verified Date:** 2014-06 #### Study First Post Date **Date:** 2014-06-24 **Type:** ESTIMATED **Study First Submit Date:** 2014-06-22 **Study First Submit QC Date:** 2014-06-23 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Salamanca #### Lead Sponsor **Class:** OTHER **Name:** César Fernández-de-las-Peñas #### Responsible Party **Investigator Affiliation:** Universidad Rey Juan Carlos **Investigator Full Name:** César Fernández-de-las-Peñas **Investigator Title:** Proffesor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** Controversy exists regarding the effectiveness of manual therapy techniques for the management of impingement syndrome. However, no adequately powered clinical trials have examined the effects of mobilization-with-movement. The purpose of the current study was to perform a randomized controlled trial comparing the effects of real MWM to a group receiving a sham intervention on shoulder pain at different moments and active shoulder range of motion in an adequately powered sample of patients with shoulder impingement syndrome. ### Conditions Module **Conditions:** - Shoulder Impingement Syndrome **Keywords:** - shoulder impingement, manual therapy, pain, motion. ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 42 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** For the MWM group, an accessory posterior-lateral gliding movement in the humeral head combined with a movement of active shoulder flexion will be applied. One hand will be placed over the scapula posteriorly while the thenar eminence of the other hand will be placed over the anterior aspect of the head of the humerus **Intervention Names:** - Other: Real mobilization-with-movement (MWM) **Label:** Real mobilization-with-movement (MWM) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The sham condition will replicate the treatment condition except for the hand positioning. The therapist locates one hand over the belly of the pectoralis major muscle and the other over scapula without applying any pressure. The patient will be asked to move the arm in a similar manner as in the MWM group **Intervention Names:** - Other: Sham mobilization-with-movement (MWM) **Label:** Sham mobilization-with-movement (MWM) **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Real mobilization-with-movement (MWM) **Name:** Real mobilization-with-movement (MWM) **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Sham mobilization-with-movement (MWM) **Name:** Sham mobilization-with-movement (MWM) **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Participants were asked to rate the intensity of their pain using an 11-point numerical pain rating scale (NPRS; 0: no pain; 10: maximum pain) for 3 scores of perceived pain: 1, the intensity of shoulder pain experienced in the last 24h; 2, the intensity of shoulder pain at night; 3, the intensity of shoulder pain during shoulder flexion. **Measure:** Changes in the intensity of shoulder pain before and after the treatment **Time Frame:** Baseline and one week after intervention #### Secondary Outcomes **Description:** A universal goniometer was used to assess the participant's shoulder range of motion in the following motions: * Pain-free and maximum (painful) range of motion in shoulder flexion * Pain-free range of motion in shoulder extension * Pain-free range of motion in shoulder abduction * Pain-free range of motion in shoulder external rotation * Pain-free range of motion in shoulder medial (internal) rotation **Measure:** Changes in shoulder range of motion before and after the treatment **Time Frame:** Baseline and one week after the intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * history of shoulder pain of \> 3months duration * pain localized at the proximal anterolateral shoulder region * medical diagnosis of shoulder impingement syndrome * at least 2 positive impingement tests including Neer, Hawking, or Jobe test Exclusion Criteria: * diagnosis of fibromyalgia * pregnancy * a history of traumatic onset of shoulder pain * other histories of shoulder injury * ligamentous laxity based on a positive Sulcus test and apprehension test * numbness or tingling in the upper extremity * previous shoulder or cervical spine surgery * corticosteroid injection on the shoulder within 1 year of the study * physical therapy 6 months prior to the study **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Salamanca **Country:** Spain **Facility:** Francisco Alburquerque Sendín **Zip:** 37008 #### Overall Officials **Official 1:** **Affiliation:** University of Salamanca **Name:** Francisco Alburquerque Sendín, PT, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Universidad Rey Juan Carlos **Name:** César Fernández de las Peñas, PT, PhD **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000014947 - Term: Wounds and Injuries - ID: D000070599 - Term: Shoulder Injuries - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M21476 - Name: Shoulder Impingement Syndrome - Relevance: HIGH - As Found: Shoulder Impingement Syndrome - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M602 - Name: Shoulder Injuries - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000019534 - Term: Shoulder Impingement Syndrome - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02593279 **Acronym:** AVAD **Brief Title:** AVAD: Asthma With Small Airways Dysfunction **Official Title:** AVAD: Asthma With Small Airways Dysfunction. Clinical, Immunobiological, Tomodensitometric Description, Genetic Signature Compared With Asthmatic Population With Proximal Airways Obstruction #### Organization Study ID Info **ID:** 69HCL14_0212 #### Organization **Class:** OTHER **Full Name:** Hospices Civils de Lyon ### Status Module #### Completion Date **Date:** 2017-07 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-01-23 **Type:** ACTUAL **Last Update Submit Date:** 2019-01-21 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2017-07 **Type:** ACTUAL #### Start Date **Date:** 2016-02 **Type:** ACTUAL **Status Verified Date:** 2019-01 #### Study First Post Date **Date:** 2015-11-01 **Type:** ESTIMATED **Study First Submit Date:** 2015-10-28 **Study First Submit QC Date:** 2015-10-29 **Why Stopped:** difficulties of enrollment ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hospices Civils de Lyon #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of the study is to describe asthma phenotype with small airways dysfunction, in a multiparametric manner, with clinical, biological, morphological and genetic elements compared with asthma with proximal airways obstruction. The objective of this study is also to complete the clinical, immunobiological and morphological analysis of asthma with small airways dysfunction. ### Conditions Module **Conditions:** - ASTHMA **Keywords:** - Asthma - phenotype - small - airway - proximal - dysfunction ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 11 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Genetic: asthma with proximal airways obstruction phenotype profile description with clinical, biological, morphologic and genetic elements. **Label:** asthma with proximal or diffuse lung damage **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Genetic: asthma with small airways dysfunction phenotype profile description with clinical, biological, morphologic and genetic elements. **Label:** asthma with small airway prevailing damage **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - asthma with proximal or diffuse lung damage **Description:** symptoms, medical history, date of start, date of aggravation, comorbidities, increased factors related to asthma, blood eosinophils, blood periostin, allergologic patch test, igE analysis, tomodensitometric test. **Name:** asthma with proximal airways obstruction phenotype profile description with clinical, biological, morphologic and genetic elements. **Type:** GENETIC #### Intervention 2 **Arm Group Labels:** - asthma with small airway prevailing damage **Description:** symptoms, medical history, date of start, date of aggravation, comorbidities, increased factors related to asthma, blood eosinophils, blood periostin, allergologic patch test, IgE analysis, tomodensitometric test. **Name:** asthma with small airways dysfunction phenotype profile description with clinical, biological, morphologic and genetic elements. **Type:** GENETIC ### Outcomes Module #### Primary Outcomes **Description:** mRNA expression levels will be measured by microarray analysis. **Measure:** mRNA expression levels. **Time Frame:** maximum 4 weeks after the inclusion visit. #### Secondary Outcomes **Description:** symptoms **Measure:** clinical asthma profile : symptoms **Time Frame:** maximum 4 weeks after the inclusion visit. **Description:** medical history **Measure:** clinical asthma profile : medical history **Time Frame:** maximum 4 weeks after the inclusion visit. **Description:** date of start **Measure:** clinical asthma profile : date of start **Time Frame:** maximum 4 weeks after the inclusion visit. **Description:** date of aggravation **Measure:** clinical asthma profile : date of aggravation **Time Frame:** maximum 4 weeks after the inclusion visit. **Description:** comorbidities **Measure:** clinical asthma profile : comorbidities **Time Frame:** maximum 4 weeks after the inclusion visit. **Description:** increased factors related to asthma. **Measure:** clinical asthma profile : increased factors related to asthma. **Time Frame:** maximum 4 weeks after the inclusion visit. **Description:** blood eosinophils **Measure:** biological asthma profile :blood eosinophils **Time Frame:** maximum 4 weeks after the inclusion visit. **Description:** blood periostin **Measure:** biological asthma profile : blood periostin **Time Frame:** maximum 4 weeks after the inclusion visit. **Description:** allergologic patch test **Measure:** biological asthma profile : allergologic patch test **Time Frame:** maximum 4 weeks after the inclusion visit. **Description:** IgE analysis **Measure:** biological asthma profile : IgE analysis **Time Frame:** maximum 4 weeks after the inclusion visit. **Description:** Chest X Ray (tomodensitometric test). **Measure:** morphological asthma profile : Chest X Ray (tomodensitometric test). **Time Frame:** maximum 4 weeks after the inclusion visit. ### Eligibility Module **Eligibility Criteria:** General Inclusion Criteria: * man or woman * age ≥ 18 years * asthma * inform consent signed * affiliated to health insurance Specific inclusion criteria : asthma with proximal airways obstruction GROUP * Maximal Voluntary Ventilation (MMV)\<80% * MMV / Forced Vital Capacity (FVC)≤70% * Carbon Monoxide Transfer Coefficient (KcO)\>80% Specific inclusion criteria : asthma with small airways dysfunction GROUP * Maximal Voluntary Ventilation (MMV)≥80% * MMV / Vital Capacity(VC)\>70% * Carbon Monoxide Transfer Coefficient (KcO)\>80% General Exclusion Criteria: * pregnant woman or breastfeeding * patient participating to other biomedical research * patient who have participated to other biomedical research within the past 3 months * patient refusing to sign the inform consent Specific exclusion criteria : * Patient who stopped smoking since less than 12 months * Pathological state related to obstructive distal airway damage * Broncho-pulmonary infectious disease within the past 4 weeks * Solid tumor curated by chemotherapy or chest radiotherapy * Chronic respiratory disease * Asthma exacerbation within the past 3 months * Oral or systemic corticotherapy within the past 3 months **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Caluire-et-Cuire **Country:** France **Facility:** Cabinets de Pneumologie Liberale **Location 2:** **City:** Lyon **Country:** France **Facility:** Hospices Civils de Lyon **Zip:** 69002 **Location 3:** **City:** Lyon **Country:** France **Facility:** CABINETS DE PNEUMOLOGIE LIBERALE HIA Desgenettes **Location 4:** **City:** Pierre-Bénite **Country:** France **Facility:** HC pneumo C #### Overall Officials **Official 1:** **Affiliation:** Hospices Civils de Lyon **Name:** GILLES DEVOUASSOUX, Pr **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M3750 - Name: Airway Obstruction - Relevance: LOW - As Found: Unknown - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02381379 **Acronym:** MSIT **Brief Title:** Malaysia Stop Tyrosine Kinase Inhibitor Trial **Official Title:** A Randomized Control Trial Comparing Peginterferon-α-2a Versus Observation After Stopping Tyrosine Kinase Inhibitor in Chronic Myeloid Leukemia With Deep Molecular Response for at Least Two Years #### Organization Study ID Info **ID:** NMRR-13-1186-15491 #### Organization **Class:** OTHER_GOV **Full Name:** Ministry of Health, Malaysia ### Status Module #### Completion Date **Date:** 2021-10 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** ACTIVE_NOT_RECRUITING #### Last Update Post Date **Date:** 2020-09-14 **Type:** ACTUAL **Last Update Submit Date:** 2020-09-11 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2018-10 **Type:** ACTUAL #### Start Date **Date:** 2015-03 **Type:** ACTUAL **Status Verified Date:** 2020-09 #### Study First Post Date **Date:** 2015-03-06 **Type:** ESTIMATED **Study First Submit Date:** 2015-03-02 **Study First Submit QC Date:** 2015-03-05 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Ministry of Health, Malaysia #### Responsible Party **Investigator Affiliation:** Ministry of Health, Malaysia **Investigator Full Name:** Dr Kuan Jew Win **Investigator Title:** Dr **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** To compare administration of peginterferon-α-2a for 1 year versus observation after stopping tyrosine kinase inhibitor (TKI) in chronic myeloid leukemia (CML) patients with deep MR ≥ 2 years. **Detailed Description:** Chronic myeloid leukemia (CML) is a chronic myeloproliferative neoplasm signified by the presence of Philadephia chromosome, which is the derivative of chromosome 22 after translocation between chromosome 9 and 22. The Philadephia chromosome will produce the mutated tyrosine kinase (BCR-ABL1), which will initiate the pathogenesis of the disease. Imatinib is the first tyrosine kinase inhibitor (TKI), which has changed the treatment paradigm of CML since its approval from U.S. Food and Drug Administration in 2001 for the treatment of CML. It signifies a new era of oncological treatment using targeted therapy. Subsequent generation TKIs have been marketed as a more potent therapy for CML. Tyrosine kinase inhibitor is conventionally thought not able to cure CML and it has to be taken for life. It is able to induce a very deep molecular response (MR) in about 10% of CML patients as evidenced by persistent undetectable or ≤0.0032% (International Scale IS) BCR-ABL1 transcript in quantitative polymerase chain reaction (PCR) test on current molecular assays, which is labelled as MR4.5 or more. However these patients have to continue taking their TKIs as per recommendations from the European Leukaemia Net and this is the current practice in our institution and in Malaysia. Long term treatment is cumbersome, there is a concern of chronic side effects with long term tyrosine kinase inhibition and it is a financial burden on most countries' health budget as these drugs are very expensive. Current available data showed that 40% of CML patients with prior stable MR4.5 for 2 years or more will be able to stay imatinib-free for at least 2 years. About 13% of patients without confirmed molecular relapse by the study criteria have low persistent BCR-ABL1 but remain imatinib-free for median follow-up of 22 months (range 6 - 35). A few patients with confirmed molecular relapse by study criteria remained drug free on follow-up. This postulates a component of immunity suppressing the leukemic clone. Interferon is the standard treatment of CML before the era of TKI. As a single agent, it induces complete cytogenetic response (CCR) in about 20%, and non-sustainable deep MR in about 10% of patients in early chronic phase. These are much smaller figures compared to TKI. Imatinib at the dose of 400mg daily induces CCR in about 70% and deep MR in about 10% of patient in chronic phase after one year of treatment. However, interferon-responded patients may indeed retain the response once interferon was withdrawn via interferon-induced immunity towards the leukemic clone, which leads to longer drug free period compared to TKI. Hence, it is logical to postulate the use of interferon after TKI was stopped when patients have attained deep MR for more than two years will increase the percentage of patients remain TKI-free on follow-up. Unfortunately, there are not many studies concerning this matter. Carella et al described a case series of five patients with deep MR ranging from 12 to 41 months, were put on interferon with follow-up ranging from three to 16 months. Recently, there was a study from Japan, nine out of 12 analyzable patients including 3 patients with previous treatment of interferon, who stopped TKI, was put on interferon remained in deep MR after median follow-up of 23 months (6-27 months). In regards to peginterferon, there is a small studies by Hardan I et al describing 11 CML patients with various responses after imatinib (from complete cytogenetic response N=3, major molecular response N=6, deep MR N=2) were put on peginterferon-α-2a for nine months together with imatinib, then imatinib was stopped and continued with peginterferon-α-2a for another three months. It is difficult to draw any conclusion from this paper because of the small number of subjects, only two subjects have achieved deep MR (with unknown duration) before study entry, and peginterferon-α-2a was combined with imatinib for nine months which will cloud the true effect of peginterferon-α-2a after imatinib was stopped. So far, there is no randomized study comparing interferon administered for fix duration after TKI was stopped versus observation to see whether the percentage and duration of CML patient who remains TKI-free can be increased and prolonged with interferon, respectively. It will be of interest to see how long the group which was given interferon remains TKI-free. If they remain TKI-free for a long duration, it not only suggests the interferon-induced immunity, but also suggests the interferon-induced immunity can be induced when only a very low level of leukemic cells present. Economical wise, TKI-free certainly give a big relief on the limited health budget of the on-growing CML population. ### Conditions Module **Conditions:** - Leukemia, Chronic Myeloid **Keywords:** - CML - peginterferon - stop - BCR-ABL ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 118 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subcutaneous peginterferon-α-2a (PEGASYS®) starting at 180µg weekly for one year **Intervention Names:** - Drug: Peginterferon-α-2a **Label:** Peginterferon-α-2a (Pegasys®) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Stop tyrosine kinase inhibitor that was on and no active medication that might affect CML, for example any immune-modulatory agents, traditional herbs or medications, chemotherapeutic agents, growth factors, or colony stimulating factors is allowed during the trial period. **Label:** Observation **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Peginterferon-α-2a (Pegasys®) **Description:** Subcutaneous peginterferon-α-2a (PEGASYS®) starting at 180µg weekly for one year. **Name:** Peginterferon-α-2a **Other Names:** - Pegasys® **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Relapse is defined as either i. Loss of MMR, which is a reading of \> 0.1% IS, which need to be confirmed by a second analysis point if no previous increasing trend of PCR result, or ii. Positivity of BCR-ABL1 transcripts in quantitative PCR, as confirmed by a second analysis point, indicating the increase (at least 1 log) in relation to the first analysis point at two successive assessments. **Measure:** Relapse rate **Time Frame:** 3 years #### Secondary Outcomes **Description:** The number of patients who developed adverse side-effects of interferon vs observation arm. **Measure:** The number of patients who developed adverse side-effects of interferon **Time Frame:** 1 year **Description:** The success rate of reattaining deep MR after restarting TKI in those patients who relapse. **Measure:** The rate of reattaining deep MR **Time Frame:** 3 years **Description:** Defined as time of relapse to the first time point, after restarting whatever treatment, patient has deep MR confirmed by second analysis point. **Measure:** Time to regain deep MR after relapse **Time Frame:** 3 years **Description:** Assessed by questionnaire from INTERNATIONAL PROJECT ON QUALITY OF LIFE IN CHRONIC MYELOID LEUKEMIA. **Measure:** Quality of life (QoL) assessment **Time Frame:** 3 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * The subject must be 18 years old or above * The subject has CML in chronic phase during diagnosis * The subject is treated with ongoing TKI at any dose for at least 3 years * The subject has achieved stable deep molecular response (DMR) on International Scale (IS) for 2 years or more by any TKI * Definition of deep molecular response (IS) ≥ 2 years * Deep molecular response = MR4 (IS 0.01%) or better * There must be at least 2 results (including the latest) of MR4.5 with an acceptable control gene copy number for the assay over the last two years * There must not be any result exceeding a major molecular response (MMR) (IS 0.1%) over the last two years * The latest PCR result should be compelled with Intervention Start Date, which is within 4 weeks of Study Entry Date or 17 weeks of the latest PCR test. Exclusion Criteria: * The subject has previous history of any TKI failure as according to European LeukemiaNet 2009(17). * The subject has previous history of successfully engrafted autologous or allogeneic haematopoeitic stem cell transplant and after transplant no disease relapse as defined by MSIT protocol * The subject is planned for autologous or allogeneic stem cell transplantation * The subject has previous history of interferon or peginterferon administration and achieved complete cytogenetic response with interferon or peginterferon * The subject had undergone or on immune-modulatory treatments other than interferon or peginterferon * The subject is undergoing treatment for other malignancies * The subject has haemoglobin \<9g/dL and platelet count \<90x109/L for two successive readings of 1 month apart * The subject has positive Hepatitis B surface Ag (HBsAg), Hepatitis C antibody (anti-HCV), or Human Immunodeficiency Virus 1 antibody (anti-HIV1) * The subject has creatinine clearance of ≤50mL/min * The subject has persistent alanine transaminase ≥2x upper normal limit for two successive readings of 1 month apart. * Adults under law protection or without ability to consent * The subject has previous history or on-going psychiatric illness **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Johor Bahru **Country:** Malaysia **Facility:** Sultanah Aminah Hospital **State:** Johor **Zip:** 80100 **Location 2:** **City:** Alor Setar **Country:** Malaysia **Facility:** Sultanah Bahiyah Hospital **State:** Kedah **Zip:** 05460 **Location 3:** **City:** Kota Kinabalu **Country:** Malaysia **Facility:** Queen Elizabeth Hospital **State:** Sabah **Location 4:** **City:** Kuching **Country:** Malaysia **Facility:** Sarawak General Hospital **State:** Sarawak **Zip:** 93586 **Location 5:** **City:** Miri **Country:** Malaysia **Facility:** Miri Hospital **State:** Sarawak **Zip:** 98000 **Location 6:** **City:** Sibu **Country:** Malaysia **Facility:** Sibu Hospital **State:** Sarawak **Zip:** 96000 **Location 7:** **City:** Ampang **Country:** Malaysia **Facility:** Ampang Hospital **State:** Selangor **Zip:** 68000 **Location 8:** **City:** Melaka **Country:** Malaysia **Facility:** Malacca General Hospital **Zip:** 75400 **Location 9:** **City:** Pulau Pinang **Country:** Malaysia **Facility:** Hospital Pulau Pinang #### Overall Officials **Official 1:** **Affiliation:** Ampang Hospital, Malaysia **Name:** Kian Meng Chang, FRCP(London) **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Mahon FX, Rea D, Guilhot J, Guilhot F, Huguet F, Nicolini F, Legros L, Charbonnier A, Guerci A, Varet B, Etienne G, Reiffers J, Rousselot P; Intergroupe Francais des Leucemies Myeloides Chroniques. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol. 2010 Nov;11(11):1029-35. doi: 10.1016/S1470-2045(10)70233-3. Epub 2010 Oct 19. **PMID:** 20965785 **Citation:** Ross DM, Branford S, Seymour JF, Schwarer AP, Arthur C, Bartley PA, Slader C, Field C, Dang P, Filshie RJ, Mills AK, Grigg AP, Melo JV, Hughes TP. Patients with chronic myeloid leukemia who maintain a complete molecular response after stopping imatinib treatment have evidence of persistent leukemia by DNA PCR. Leukemia. 2010 Oct;24(10):1719-24. doi: 10.1038/leu.2010.185. Epub 2010 Sep 2. **PMID:** 20811403 **Citation:** Kantarjian HM, O'Brien S, Cortes JE, Shan J, Giles FJ, Rios MB, Faderl SH, Wierda WG, Ferrajoli A, Verstovsek S, Keating MJ, Freireich EJ, Talpaz M. Complete cytogenetic and molecular responses to interferon-alpha-based therapy for chronic myelogenous leukemia are associated with excellent long-term prognosis. Cancer. 2003 Feb 15;97(4):1033-41. doi: 10.1002/cncr.11223. **PMID:** 12569603 **Citation:** Preudhomme C, Guilhot J, Nicolini FE, Guerci-Bresler A, Rigal-Huguet F, Maloisel F, Coiteux V, Gardembas M, Berthou C, Vekhoff A, Rea D, Jourdan E, Allard C, Delmer A, Rousselot P, Legros L, Berger M, Corm S, Etienne G, Roche-Lestienne C, Eclache V, Mahon FX, Guilhot F; SPIRIT Investigators; France Intergroupe des Leucemies Myeloides Chroniques (Fi-LMC). Imatinib plus peginterferon alfa-2a in chronic myeloid leukemia. N Engl J Med. 2010 Dec 23;363(26):2511-21. doi: 10.1056/NEJMoa1004095. **PMID:** 21175313 **Citation:** Verbeek W, Konig H, Boehm J, Kohl D, Lange C, Heuer T, Scheibenbogen C, Reis HE, Hochhaus A, Graeven U. Continuous complete hematological and cytogenetic remission with molecular minimal residual disease 9 years after discontinuation of interferon-alpha in a patient with Philadelphia chromosome-positive chronic myeloid leukemia. Acta Haematol. 2006;115(1-2):109-12. doi: 10.1159/000089476. **PMID:** 16424660 **Citation:** Mahon FX, Delbrel X, Cony-Makhoul P, Faberes C, Boiron JM, Barthe C, Bilhou-Nabera C, Pigneux A, Marit G, Reiffers J. Follow-up of complete cytogenetic remission in patients with chronic myeloid leukemia after cessation of interferon alfa. J Clin Oncol. 2002 Jan 1;20(1):214-20. doi: 10.1200/JCO.2002.20.1.214. **PMID:** 11773172 **Citation:** Usuki K, Kanda Y, Iijima K, Iki S, Hirai H, Urabe A. [Chronic myelogenous leukemia in cessation of therapy after sustained CCR with interferon]. Rinsho Ketsueki. 2003 Dec;44(12):1161-5. Japanese. **PMID:** 14978932 **Citation:** Mauro E. Long-term molecular response after discontinuation of interferon-alpha in two patients with chronic myeloid leukaemia. Blood Transfus. 2012 Oct;10(4):559; author reply 560. doi: 10.2450/2012.0144-11. Epub 2012 Feb 29. No abstract available. **PMID:** 22395358 **Citation:** Veneri D, Tecchio C, De Matteis G, Paviati E, Benati M, Franchini M, Pizzolo G. Long-term persistence of molecular response after discontinuation of interferon-alpha in two patients with chronic myeloid leukaemia. Blood Transfus. 2012 Apr;10(2):233-4. doi: 10.2450/2011.0057-11. Epub 2011 Sep 22. No abstract available. **PMID:** 22044951 **Citation:** Hardan I, Stanevsky A, Volchek Y, Tohami T, Amariglio N, Trakhtenbrot L, Koren-Michowitz M, Shimoni A, Nagler A. Treatment with interferon alpha prior to discontinuation of imatinib in patients with chronic myeloid leukemia. Cytokine. 2012 Feb;57(2):290-3. doi: 10.1016/j.cyto.2011.11.018. Epub 2011 Dec 13. **PMID:** 22169779 **Citation:** Carella AM. Interferon-alpha is able to maintain complete molecular remission induced by imatinib after its discontinuation. Leukemia. 2008 May;22(5):1090-1. doi: 10.1038/leu.2008.94. Epub 2008 Apr 3. No abstract available. **PMID:** 18385749 **Citation:** Baccarani M, Cortes J, Pane F, Niederwieser D, Saglio G, Apperley J, Cervantes F, Deininger M, Gratwohl A, Guilhot F, Hochhaus A, Horowitz M, Hughes T, Kantarjian H, Larson R, Radich J, Simonsson B, Silver RT, Goldman J, Hehlmann R; European LeukemiaNet. Chronic myeloid leukemia: an update of concepts and management recommendations of European LeukemiaNet. J Clin Oncol. 2009 Dec 10;27(35):6041-51. doi: 10.1200/JCO.2009.25.0779. Epub 2009 Nov 2. **PMID:** 19884523 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000006402 - Term: Hematologic Diseases - ID: D000007951 - Term: Leukemia, Myeloid - ID: D000009196 - Term: Myeloproliferative Disorders - ID: D000001855 - Term: Bone Marrow Diseases - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10945 - Name: Leukemia - Relevance: HIGH - As Found: Leukemia - ID: M10955 - Name: Leukemia, Myeloid - Relevance: LOW - As Found: Unknown - ID: M18123 - Name: Leukemia, Myelogenous, Chronic, BCR-ABL Positive - Relevance: HIGH - As Found: Leukemia, Chronic Myeloid - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M12149 - Name: Myeloproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M5134 - Name: Bone Marrow Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T3995 - Name: Myeloid Leukemia - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T1309 - Name: Chronic Myeloid Leukemia - Relevance: HIGH - As Found: Leukemia, Chronic Myeloid - ID: T1311 - Name: Chronic Myeloproliferative Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007938 - Term: Leukemia - ID: D000015464 - Term: Leukemia, Myelogenous, Chronic, BCR-ABL Positive ### Intervention Browse Module - Ancestors - ID: D000000998 - Term: Antiviral Agents - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M16759 - Name: Tin Fluorides - Relevance: LOW - As Found: Unknown - ID: M11900 - Name: Mitogens - Relevance: LOW - As Found: Unknown - ID: M2889 - Name: Tyrosine Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M247369 - Name: Peginterferon alfa-2a - Relevance: HIGH - As Found: Retrospective - ID: M4314 - Name: Antiviral Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: T22 - Name: Tyrosine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000100416 - Term: Peginterferon alfa-2a ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05320679 **Brief Title:** Development of Pain Related Avoidance of Movement Questionnaire **Official Title:** Development and Implementation of Pain Related Avoidance of Movement #### Organization Study ID Info **ID:** 2020/021 #### Organization **Class:** OTHER **Full Name:** Hasan Kalyoncu University ### Status Module #### Completion Date **Date:** 2022-12-30 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2022-04-15 **Type:** ACTUAL **Last Update Submit Date:** 2022-04-08 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2022-08-30 **Type:** ESTIMATED #### Start Date **Date:** 2022-04-02 **Type:** ACTUAL **Status Verified Date:** 2022-04 #### Study First Post Date **Date:** 2022-04-11 **Type:** ACTUAL **Study First Submit Date:** 2022-04-02 **Study First Submit QC Date:** 2022-04-02 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hasan Kalyoncu University #### Responsible Party **Investigator Affiliation:** Hasan Kalyoncu University **Investigator Full Name:** Yavuz Yakut **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In recent studies, it has been shown that people may have avoidance of movement due to pain. However, there is no scale that evaluates avoidance of movement due to pain in musculoskeletal problems. The aim of this study is to develop a scale to measure how much pain-related movement and activity is avoided in individuals with musculoskeletal pain, and to examine the results of its clinical application. **Detailed Description:** Approaches and methods to be applied in the research; * Demographic information (age, gender, weight, height, pain location, pain duration and diagnose) form will be recorded. * Creation of questionnaire items * Reviewing of items/questions * Patients who accept to fill out the questionnaire and who has complain of musculoskeletal pain will be asked to answer the questions. * Editing the scale according to the answers * Reliability and validity studies of the questionnaire * Investigation of the results of applying the scale with clinical follow-up To compare results of Pain-Related Avoidance of Movement Questionnaire following common used questionnaires are going to be used; * Visual Analogue Scale (VAS) * Tampa Kinesiophobia Scale * Oswestry Low Back Pain and Disability Index-2.0 SPSS version 23 (SPSS Inc, Armonk, NY) program will be used in the analysis of the data. ### Conditions Module **Conditions:** - Musculoskeletal Pain - Low Back Pain - Back Pain **Keywords:** - Musculoskeletal pain - Kinesiophobia - Questionnaire ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 400 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients who have musculoskeletal pain **Intervention Names:** - Other: Implementation of Questionnaire **Label:** Study Group ### Interventions #### Intervention 1 **Arm Group Labels:** - Study Group **Description:** Compartment of results of questionnaires which already been used in literature and results of developing Pain Related Avoidance of Movement Questionnaire **Name:** Implementation of Questionnaire **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Pain related avoidance of movement score is going to be assess by Pain Related Avoidance of Movement Questionnaire to determine change from baseline and, to examine correlation of other questionnaires. **Measure:** Total points of Pain Related Avoidance of Movement Questionnaire **Time Frame:** 1 week #### Secondary Outcomes **Description:** Pain score is going to be assess by VAS to determine change from baseline. Normal range of VAS score is between 0 point to 10 points. Higher score means worse pain level. **Measure:** Change from baseline score in pain score **Time Frame:** 1 week **Description:** Kinesiophobia score is going to be assess by Tampa Kinesiophobia Scale to determine change from baseline. The normal range of kinesiophobia score is between 17 points to 68 points. Higher score means worse kinesiophobia level. **Measure:** Change from baseline score in kinesiophobia score **Time Frame:** 1 week **Description:** Disability score is going to be assess by Oswestry Disability Index to determine the change from baseline. The normal range of percentage is between 0 to 100. Higher percentage means worse disability level. **Measure:** Change from baseline in disability score **Time Frame:** 1 week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria; * Having agreed to fill out the questionnaire * Having pain caused by problems related to the musculoskeletal system * Not having any disability in performing activities of daily living Exclusion Criteria; * Individuals who are not allowed to move due to pain * If they have undergone surgery, individuals who have inconveniences in moving due to surgery * Individuals who have cognitive problems in completing the questionnaire **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Participants are going to be patients who have musculoskeletal pain problem. ### Contacts Locations Module #### Locations **Location 1:** **City:** Gaziantep **Contacts:** ***Contact 1:*** - **Email:** yyakut@yahoo.com - **Name:** Yavuz Yakut, Prof. Dr. - **Phone:** +905324181001 - **Role:** CONTACT **Country:** Turkey **Facility:** Hasan Kalyoncu University **Status:** RECRUITING **Zip:** 27100 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M4714 - Name: Back Pain - Relevance: HIGH - As Found: Back Pain - ID: M19433 - Name: Low Back Pain - Relevance: HIGH - As Found: Low Back Pain - ID: M2922 - Name: Kinesiophobia - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M29444 - Name: Musculoskeletal Pain - Relevance: HIGH - As Found: Musculoskeletal Pain - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000059352 - Term: Musculoskeletal Pain - ID: D000001416 - Term: Back Pain - ID: D000017116 - Term: Low Back Pain ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02029079 **Brief Title:** The Effect of Food and Beverage Based Nutritional Supplements in Recipients of Home Care Services at Risk of Malnutrition **Official Title:** The Effect of Food and Beverage Based Nutritional Supplements in Recipients of Home Care Services at Risk of Malnutrition #### Organization Study ID Info **ID:** 2013/962 #### Organization **Class:** OTHER **Full Name:** Haukeland University Hospital ### Status Module #### Completion Date **Date:** 2013-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2014-01-13 **Type:** ESTIMATED **Last Update Submit Date:** 2014-01-10 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2013-12 **Type:** ACTUAL #### Start Date **Date:** 2013-08 **Status Verified Date:** 2014-01 #### Study First Post Date **Date:** 2014-01-07 **Type:** ESTIMATED **Study First Submit Date:** 2013-12-18 **Study First Submit QC Date:** 2014-01-05 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Haukeland University Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Malnutrition increases the risk of complications and predisposes ti infections through impaired immune response and wound healing. Healthcare costs related to the management of malnourished patients is estimated to be more than double the amount spent managing non- malnourished The objective of this study is to examine the effect of newly developed energy and nutrients-dense beverage product on the nutritional status among patients at risk of malnutrition. **Detailed Description:** Malnutrition is a complex state described as a deficiency of energy, protein and other nutrients causing measurable adverse effect on body tissue, function and clinical outcome. Oral nutritional supplementation has in multiple individual trials and meta-analyzes shown an increased total energy intake and protein intake in patients in hospital settings as well as in the community. The largest producer of dairy products in Norway, TINE AS released a new milk based energy- and nutrient dense product, called E+. The initiative behind this was Haukeland University Hospital and the municipality of Bergen. The product were developed to prevent malnutrition in the elderly and patients with a low food intake and high energy requirements. The overall contribution to this study will be to provide new insight on how to offer malnourished patients the best available treatment. ### Conditions Module **Conditions:** - Malnutrition **Keywords:** - Malnutrition ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 38 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The intervention consists of 300 ml E+ per day for 35 days in addition to a normal food intake. This means 525 kcal, and 22.5 gram protein extra per day for five weeks. **Intervention Names:** - Dietary Supplement: E+ **Label:** E+ drink, enriched with energy and nutrients. **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Subjects in the control group will be assessed in the same way and same time as the intervention group. **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - E+ drink, enriched with energy and nutrients. **Description:** 300 ml E+ per day (525 kcal, 22.5 gram protein) for 35 days. **Name:** E+ **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Hand grip strength will be measured in kg with a handgrip dynamometer. Subjects will be asked to perform a maximal contraction for a few seconds with the non-dominant hand three times with about 10-20 seconds between each trial. **Measure:** Change in Hand grip strength **Time Frame:** Assessment at day 0, 35 and 70. **Description:** Participants will be asked to remove shoes, socks, heavy clothing and jewelry for measurement of body weight to the nearest 100 g using portable digital scales. **Measure:** Change in Body weight **Time Frame:** At day 0, 35 and 70 **Description:** A Bioelectric impedance analysis will be used to calculate change in body composition. Measurements will be conducted by a device sending weak electric signals through the participant's body. The method is non-invasive and is commonly used by medical, health and fitness professionals. **Measure:** Change in Body composition **Time Frame:** At day 0, 35 and 70 #### Secondary Outcomes **Description:** Dietary intake will be assessed for each study participant using a twenty-four-hour recall method conducted by the investigator and two additional people employed to help with the data collection. All three data collectors will use a standardized interview. The data collected will be used to calculate daily calorie and protein intake by entering the food records into a computerized version of a food composition table, Dietist XP. **Measure:** Change in Nutritional intake **Time Frame:** At day 0, 35 and 70 **Description:** Measurements of global subjective well-being and quality of life will be assessed using a simple visual analogue scale (VAS QL). **Measure:** Change in Quality of life **Time Frame:** At day 0, 35 and 70 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Recipients of homecare services in the municipality of Bergen * Recipients determined as at-risk of malnutrition based on screening with MNA (mini-nutritional assessment) * Informed consent by participant * Informed consent by participants and close relatives or guardian in case of dementia Exclusion Criteria: * Terminal care patients with \< 3 month life expectancy * Patients using parenteral or enteral nutrition * Patients prescribed oral nutritional supplementation before recruitment * Pregnancy * Diabetes Mellitus * Lactose intolerance * Patients without a norwegian personal identification number * Psychiatric patients **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bergen **Country:** Norway **Facility:** Home Care Services **Zip:** 5000 #### Overall Officials **Official 1:** **Affiliation:** Clinical Dietitian at Haukeland University Hospital **Name:** Randi J Tangvik, PhD-student **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009748 - Term: Nutrition Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M25306 - Name: Malnutrition - Relevance: HIGH - As Found: Malnutrition - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000044342 - Term: Malnutrition ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01002079 **Brief Title:** Drug-Drug Interaction Study With Rifampin **Official Title:** A Study of the Effect of Concomitant Administration of Rifampin on the Pharmacokinetics of BMS-708163 in Healthy Subjects #### Organization Study ID Info **ID:** CN156-028 #### Organization **Class:** INDUSTRY **Full Name:** Bristol-Myers Squibb ### Status Module #### Completion Date **Date:** 2010-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2011-01-25 **Type:** ESTIMATED **Last Update Submit Date:** 2011-01-24 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2010-10 **Type:** ACTUAL #### Start Date **Date:** 2010-08 **Status Verified Date:** 2010-11 #### Study First Post Date **Date:** 2009-10-27 **Type:** ESTIMATED **Study First Submit Date:** 2009-10-26 **Study First Submit QC Date:** 2009-10-26 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** PRA Health Sciences #### Lead Sponsor **Class:** INDUSTRY **Name:** Bristol-Myers Squibb #### Responsible Party **Old Name Title:** Study Director **Old Organization:** Bristol-Myers Squibb ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of the study is to determine if the concomitant administration of rifampin with BMS-708163 will affect the Pharmacokinetics of BMS-708163 and to assess safety and tolerability of co-administration BMS-708163 and rifampin ### Conditions Module **Conditions:** - Alzheimer Disease ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 20 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: BMS-708163 **Label:** BMS-708163 **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Rifampin **Label:** Rifampin **Type:** OTHER #### Arm Group 3 **Intervention Names:** - Drug: BMS-708163 - Drug: Rifampin **Label:** Rifampin + BMS-708163 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - BMS-708163 - Rifampin + BMS-708163 **Description:** Capsule, Oral, 125 mg, Once daily, 1 day **Name:** BMS-708163 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Rifampin **Description:** Capsule, Oral, 600 mg, Once daily, 7 days **Name:** Rifampin **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Rifampin + BMS-708163 **Description:** Capsule, Oral, 600 mg, Once daily, 6 days **Name:** Rifampin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** BMS-708163 alone and with rifampin: BMS-708163 single dose PK parameters (Cmax, Tmax, T-HALF, AUC(0-T), AUC(INF), CLT/F and molar AUCmet/AUCparent ratios will be assessed without rifampin (Day 1) and with rifampin (Day 13) **Time Frame:** Within 30 days after dose #### Secondary Outcomes **Measure:** BMS-708163 alone and with rifampin: Safety and tolerability (AE's, ECG, vital signs, safety labs) **Time Frame:** Within 30 days after dose ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy male and postmenopausal female subjects, 18-55 yrs old inclusive Exclusion Criteria: * Women of childbearing potential * Tuberculosis **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bangalore **Country:** India **Facility:** Local Institution **Zip:** 560100 #### Overall Officials **Official 1:** **Affiliation:** Bristol-Myers Squibb **Name:** Bristol-Myers Squibb **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003704 - Term: Dementia - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000024801 - Term: Tauopathies - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M3885 - Name: Alzheimer Disease - Relevance: HIGH - As Found: Alzheimer's Disease - ID: M6904 - Name: Dementia - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M23002 - Name: Tauopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M21836 - Name: Neurocognitive Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: T2192 - Name: Familial Alzheimer Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000544 - Term: Alzheimer Disease ### Intervention Browse Module - Ancestors - ID: D000000904 - Term: Antibiotics, Antitubercular - ID: D000000995 - Term: Antitubercular Agents - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000007917 - Term: Leprostatic Agents - ID: D000019384 - Term: Nucleic Acid Synthesis Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000065695 - Term: Cytochrome P-450 CYP2B6 Inducers - ID: D000065693 - Term: Cytochrome P-450 Enzyme Inducers - ID: D000065696 - Term: Cytochrome P-450 CYP2C8 Inducers - ID: D000065697 - Term: Cytochrome P-450 CYP2C19 Inducers - ID: D000065698 - Term: Cytochrome P-450 CYP2C9 Inducers - ID: D000065701 - Term: Cytochrome P-450 CYP3A Inducers - ID: D000091062 - Term: Gamma Secretase Inhibitors and Modulators ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M15118 - Name: Rifampin - Relevance: HIGH - As Found: Match - ID: M348455 - Name: BMS 708163 - Relevance: HIGH - As Found: Complete denture - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M4311 - Name: Antitubercular Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M2816 - Name: Gamma Secretase Inhibitors and Modulators - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000012293 - Term: Rifampin - ID: C000554092 - Term: BMS 708163 ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03634579 **Brief Title:** MRI Guided Prostate Cancer Focal Laser Ablation **Official Title:** Magnetic Resonance Imaging (MRI) Guided Focal Laser Interstitial Thermal Ablation of Localized Prostate Cancer #### Organization Study ID Info **ID:** IRB00094958 #### Organization **Class:** OTHER **Full Name:** Emory University ### Status Module #### Completion Date **Date:** 2019-03-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-03-23 **Type:** ACTUAL **Last Update Submit Date:** 2020-03-09 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2019-03-15 **Type:** ACTUAL #### Results First Post Date **Date:** 2020-03-23 **Type:** ACTUAL **Results First Submit Date:** 2020-03-09 **Results First Submit QC Date:** 2020-03-09 #### Start Date **Date:** 2018-06-01 **Type:** ACTUAL **Status Verified Date:** 2020-03 #### Study First Post Date **Date:** 2018-08-16 **Type:** ACTUAL **Study First Submit Date:** 2018-07-19 **Study First Submit QC Date:** 2018-08-15 **Why Stopped:** Lack of funding for continuation. ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Emory University #### Responsible Party **Investigator Affiliation:** Emory University **Investigator Full Name:** Sherif G. Nour **Investigator Title:** Associate Professor of Radiology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The study is a prospective, single-arm, non-randomized, unblinded trial to determine the safety and efficacy of MRI guided focal laser ablation of localized low and intermediate risk prostate cancer. All subjects meeting the inclusion exclusion criteria and are enrolled will undergo a MRI guided focal laser ablation procedure. The primary aim of the study is to study the safety and efficacy of the procedure. **Detailed Description:** Prostate cancer should be viewed as a spectrum of diseases ranging from a very indolent low-risk process to an aggressive high-risk potentially fatal disease. Active surveillance has been introduced as an alternative treatment to patients with low- risk prostate cancers.Focal therapy techniques have been introduced in prostate cancer to destroy the tumor itself with adequate safety margin with the advantage of preserving the surrounding non-cancerous tissue. Thus maintaining disease control at acceptable levels, while minimizing complications. With the advent of multiparametric MRI (Mp-MRI), it is now possible to identify suspicious prostate gland focal lesions, determining their extent and targeting them for biopsy and focal ablation. Laser interstitial thermal therapy (LITT) is well suited for MRI environment. Laser fibers are flexible so they can fit into the MRI gantry. Laser has been shown to produce homogenous tissue necrosis that can be monitored by real time temperature maps, a feature that facilitates effective and safe ablation. 20 subjects with localized low and intermediate risk prostate cancer that meet the inclusion and exclusion criteria will be enrolled. During baseline evaluation, subjects will undergo lab tests, MR imaging, and will complete QOL questionnaires. Subsequently, subjects will undergo the Magnetic Resonance Imaging (MRI) Guided Focal Laser Interstitial Thermal Ablation procedure. Subjects will be followed immediately after the procedure, at 3 weeks, 3 months, 6 months, one year and two years after procedure for adverse events and recurrence of prostate cancer ### Conditions Module **Conditions:** - Prostate Cancer **Keywords:** - Cancer/Carcinogenesis - Laser Treatment - Magnetic Resonance Imaging (MRI) - Radiology ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Prospective, Interventional, Single-Arm, Unblinded trial ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 9 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer. **Intervention Names:** - Device: MRI Guided Focal Laser Interstitial Thermal Ablation **Label:** MRI-guided focal laser ablation **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - MRI-guided focal laser ablation **Description:** The procedure is done under general anesthesia. Laser fiber placement will be performed by one of two approaches (Trans gluteal or trans rectal) based on the target location within the prostate gland. When the needle position is deemed satisfactory, a 1.5-cm-active tip diode laser fiber will be introduced within an internally cooled catheter through the introducing sheath. The catheter tip location will be confirmed on Turbo Spin-Echo (TSE) T2-weighted images in the axial and sagittal oblique planes.The introducer sheath will be withdrawn to allow contact of the active laser tip with the lesion. A laser test dose will be done at 9 Watts for about 30 seconds to confirm the site of fiber placement with the subsequent delivery of full dose ablation at 12-27 Watts. Ablation duration is determined based on real time feedback of response using real time temperature and damage estimate maps. **Name:** MRI Guided Focal Laser Interstitial Thermal Ablation **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Efficacy is assessed by recurrence rate at 1 year, defined as the number of recurrences divided by the number of patients treated with MRI Guided Focal Laser Interstitial Thermal Ablation **Measure:** Number of Recurrences of Prostate Cancer at the End of 1 Year Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation **Time Frame:** Up to 12 months **Description:** Safety is assessed by percentage of grade 3 or higher complications or adverse events (AE) as defined as National cancer institute's common toxicity criteria version 4: incontinence or urinary retention necessitating surgical intervention or new-onset erectile dysfunction not responsive to medication.Grade refers to the severity of the AE. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.Grade 2 Moderate; minimal, local or non invasive intervention indicated; limiting age appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. **Measure:** Percentage of Grade 3 or Higher Complications as Defined as National Cancer Institute's Common Toxicity Criteria Version 4 Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation **Time Frame:** Up to 24 months **Description:** Change in erectile function is assessed using Sexual Health Inventory For Men (SHIM) for erectile function. There are 5 questions and each question has 5 possible responses. If the patient's score is 21 or less, erectile dysfunction (ED) is present. **Measure:** Number of Subjects Experienced Change in Erectile Function **Time Frame:** 3 weeks follow up **Description:** Urinary function will be assessed using International Prostate Symptom Score (IPSS) assessment for urinary function. The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions (maximum score 35) concerning urinary symptoms and one question concerning quality of life. Any score \> 1 indicates presence of urinary dysfunction, higher score indicates increased severity. **Measure:** Number of Subjects Experienced Change in Urinary Function **Time Frame:** 3 weeks follow up #### Secondary Outcomes **Description:** Efficacy is assessed by recurrence rate at end of 2nd year, defined as the number of recurrences divided by the number of patients treated with MRI Guided Focal Laser Interstitial Thermal Ablation **Measure:** Number of Recurrences of Prostate Cancer at the End of 2nd Year Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation **Time Frame:** Up to 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥18 years * Patients with primary organ confined prostate cancer (≤T2c) and Gleason score ≤4+3=7 * Lesions visible on multiparametric MRI and subsequently diagnosed by targeted MRI guided biopsy Exclusion Criteria: * Multifocal intra-prostatic disease, defined as the presence the presence of ≥ 3 non- contiguous pathologically proven foci of cancer. * Gleason score \>4+3=7. * Extracapsular spread. * Nodal or distant metastasis * Contraindications to MRI or general anesthesia. * Uncorrectable Coagulopathy. * Refusal of participation. * Lesions not visualized on the multiparametric MRI **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Atlanta **Country:** United States **Facility:** Emory University Hospital **State:** Georgia **Zip:** 30322 #### Overall Officials **Official 1:** **Affiliation:** Emory University **Name:** Sherif G Nour, MD **Role:** PRINCIPAL_INVESTIGATOR ## Document Section ### Large Document Module #### Large Docs - Date: 2018-05-08 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 797645 - Type Abbrev: Prot_SAP - Upload Date: 2020-03-09T12:46 - Date: 2018-05-05 - Filename: ICF_001.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 274708 - Type Abbrev: ICF - Upload Date: 2020-03-09T12:52 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005834 - Term: Genital Neoplasms, Male - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000011469 - Term: Prostatic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M14335 - Name: Prostatic Neoplasms - Relevance: HIGH - As Found: Prostate Cancer - ID: M30145 - Name: Carcinogenesis - Relevance: LOW - As Found: Unknown - ID: M8946 - Name: Genital Neoplasms, Male - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14333 - Name: Prostatic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011471 - Term: Prostatic Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** MRI-guided Focal Laser Ablation **Deaths Num At Risk:** 9 **Description:** Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer. **ID:** EG000 **Other Num Affected:** 4 **Other Num at Risk:** 9 **Serious Number At Risk:** 9 **Title:** MRI-guided Focal Laser Ablation **Frequency Threshold:** 0 #### Other Events **Term:** Erectile disfunction **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Reproductive system and breast disorders **Source Vocabulary:** **Term:** Urinary incontinence **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** **Time Frame:** 2 years ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 9 **Units:** Participants ### Group **ID:** BG000 **Title:** MRI-guided Focal Laser Ablation **Description:** Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer. ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 1 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 8 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 9 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 1 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 8 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 9 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement **PI Sponsor Employee:** True ### Point of Contact **Email:** sherif.nour@emoryhealthcare.org **Organization:** Emory University **Phone:** 404-778-3800 **Title:** Sherif Nour ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ### Outcome Measure 5 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 **Title:** #### Outcome Measure 5 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Efficacy is assessed by recurrence rate at 1 year, defined as the number of recurrences divided by the number of patients treated with MRI Guided Focal Laser Interstitial Thermal Ablation **Population Description:** Data were not collected/analyzed due to the study termination **Reporting Status:** POSTED **Time Frame:** Up to 12 months **Title:** Number of Recurrences of Prostate Cancer at the End of 1 Year Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation **Type:** PRIMARY ##### Group **Description:** Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer. **ID:** OG000 **Title:** MRI-guided Focal Laser Ablation #### Outcome Measure 2 **Description:** Safety is assessed by percentage of grade 3 or higher complications or adverse events (AE) as defined as National cancer institute's common toxicity criteria version 4: incontinence or urinary retention necessitating surgical intervention or new-onset erectile dysfunction not responsive to medication.Grade refers to the severity of the AE. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.Grade 2 Moderate; minimal, local or non invasive intervention indicated; limiting age appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Up to 24 months **Title:** Percentage of Grade 3 or Higher Complications as Defined as National Cancer Institute's Common Toxicity Criteria Version 4 Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation **Type:** PRIMARY **Unit of Measure:** percentage of grade 3 or higher complica ##### Group **Description:** Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer. **ID:** OG000 **Title:** MRI-guided Focal Laser Ablation #### Outcome Measure 3 **Description:** Change in erectile function is assessed using Sexual Health Inventory For Men (SHIM) for erectile function. There are 5 questions and each question has 5 possible responses. If the patient's score is 21 or less, erectile dysfunction (ED) is present. **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** 3 weeks follow up **Title:** Number of Subjects Experienced Change in Erectile Function **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer. **ID:** OG000 **Title:** MRI-guided Focal Laser Ablation #### Outcome Measure 4 **Description:** Urinary function will be assessed using International Prostate Symptom Score (IPSS) assessment for urinary function. The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions (maximum score 35) concerning urinary symptoms and one question concerning quality of life. Any score \> 1 indicates presence of urinary dysfunction, higher score indicates increased severity. **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** 3 weeks follow up **Title:** Number of Subjects Experienced Change in Urinary Function **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer. **ID:** OG000 **Title:** MRI-guided Focal Laser Ablation #### Outcome Measure 5 **Description:** Efficacy is assessed by recurrence rate at end of 2nd year, defined as the number of recurrences divided by the number of patients treated with MRI Guided Focal Laser Interstitial Thermal Ablation **Population Description:** Data were not collected/analyzed due to the study termination **Reporting Status:** POSTED **Time Frame:** Up to 24 months **Title:** Number of Recurrences of Prostate Cancer at the End of 2nd Year Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation **Type:** SECONDARY ##### Group **Description:** Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer. **ID:** OG000 **Title:** MRI-guided Focal Laser Ablation ### Participant Flow Module #### Group **Description:** Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer. **ID:** FG000 **Title:** MRI-guided Focal Laser Ablation #### Period **Title:** Overall Study ##### Withdraw **Type:** study termination ###### Reason **Group ID:** FG000 **Number of Subjects:** 9 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 9 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 9 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT05207579 **Brief Title:** Urdu Version of Lower Extremity Functional Scale: Reliability and Validity Study **Official Title:** Psychometric Analysis of Urdu Version of Shoulder Pain and Disability Index: A Reliability and Validity Study #### Organization Study ID Info **ID:** REC/FSD/0294 #### Organization **Class:** OTHER **Full Name:** Riphah International University ### Status Module #### Completion Date **Date:** 2022-04-28 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-05-19 **Type:** ACTUAL **Last Update Submit Date:** 2022-05-18 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-04-25 **Type:** ACTUAL #### Start Date **Date:** 2021-05-30 **Type:** ACTUAL **Status Verified Date:** 2022-05 #### Study First Post Date **Date:** 2022-01-26 **Type:** ACTUAL **Study First Submit Date:** 2022-01-24 **Study First Submit QC Date:** 2022-01-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Riphah International University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The objective of the research is to translate and to culturally familiarize the Lower extremity functional scale into the Urdu language along the investigation if the Lower Extremity Functional Scale is reliable and validate in the Pakistani population with Lower extremity musculoskeletal disorders and to check the correlation with Short Form - 36. **Detailed Description:** The questionnaire will be translated into Urdu and cross-culturally modified. Internal consistency, test-retest reliability, conceptual validity, discriminative validity, responsiveness, and concurrent validity will be examined in 150 participants seeking treatment for lower extremity dysfunction using the Urdu version of the Lower Extremity Functional Scale. ### Conditions Module **Conditions:** - Musculoskeletal Disorder **Keywords:** - Lower Extremity Functional Scale - Musculoskeletal Disorder - Cultural adaptation - Validity - Urdu Version - Reliability - Lower Extremity ### Design Module #### Design Info **Observational Model:** ECOLOGIC_OR_COMMUNITY **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 150 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Lower Extremity Functional Scale is a valid and reliable instrument to determine the functional status for acute and chronic lower extremity musculoskeletal dysfunction due to the importance of evidence-based health care **Measure:** Lower Extremity Functional Scale **Time Frame:** 1st day **Description:** Short Form-36 is one of the most widely used and evaluated generic health-related quality of life questionnaires. **Measure:** Short Form-36 **Time Frame:** 1st day ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * From16 years Old to 60 Years Old * Presence of an Lower extremity musculoskeletal disorders like soft tissue injuries, joints and muscles injuries * No intervention between the test-retest assessments Exclusion Criteria: * To complete the forms because of a psychological Impairment. * Illiteracy or lack of understanding of Urdu Language * The presence of any kind of bone fracture **Maximum Age:** 60 Years **Minimum Age:** 16 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** Pakistani population with Lower extremity musculoskeletal disorders was included in the study. ### Contacts Locations Module #### Locations **Location 1:** **City:** Faisalabad **Country:** Pakistan **Facility:** Ripah International University **State:** Punjab **Zip:** 38000 #### Overall Officials **Official 1:** **Affiliation:** Riphah International University **Name:** Muhammad Kashif **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M21907 - Name: Shoulder Pain - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: HIGH - As Found: Musculoskeletal Disorders ### Condition Browse Module - Meshes - ID: D000009140 - Term: Musculoskeletal Diseases ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02394379 **Brief Title:** Post Approval Study to Evaluate the Trulign™ Toric Posterior Chamber IOL **Official Title:** A Prospective, Post Approval Study to Evaluate the Trulign™ Toric Posterior Chamber Intraocular Lens (IOL) #### Organization Study ID Info **ID:** 858 #### Organization **Class:** INDUSTRY **Full Name:** Bausch & Lomb Incorporated ### Status Module #### Completion Date **Date:** 2019-08-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-11-13 **Type:** ACTUAL **Last Update Submit Date:** 2019-11-12 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-08-05 **Type:** ACTUAL #### Start Date **Date:** 2015-03-19 **Type:** ACTUAL **Status Verified Date:** 2019-11 #### Study First Post Date **Date:** 2015-03-20 **Type:** ESTIMATED **Study First Submit Date:** 2015-03-09 **Study First Submit QC Date:** 2015-03-16 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Bausch Health Americas, Inc. #### Lead Sponsor **Class:** INDUSTRY **Name:** Bausch & Lomb Incorporated #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** To evaluate the incidence of IOL vaulting (ie, position change) of the Trulign™ Toric IOL following cataract surgery. **Detailed Description:** The objective of this post approval safety study is to evaluate the incidence of IOL vaulting (ie, position change) of the Trulign™ Toric IOL following cataract surgery at up to three years post implantation. ### Conditions Module **Conditions:** - Cataract ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 600 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Trulign™ Toric Posterior Chamber IOL is a modified plate haptic lens **Intervention Names:** - Device: Trulign™ Toric IOL **Label:** Trulign™ Toric IOL ### Interventions #### Intervention 1 **Arm Group Labels:** - Trulign™ Toric IOL **Description:** Trulign™ Toric Posterior Chamber IOL is a modified plate haptic lens **Name:** Trulign™ Toric IOL **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** IOL vaulting is position change such as clinically significant anterior vaulting, clinically significant tilt, and secondary surgical intervention related to such vaulting. The proportion of study eyes experiencing vaulting will be estimated by Kaplan-Meier method. **Measure:** Incidence of clinically significant IOL vaulting **Time Frame:** Up to 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subjects who are able and willing to comply with the follow-up schedule * Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction * Subjects must require a lens power from 4 to 33 D * Subjects must have a Best Corrected Visual Acuity (BCVA) equal to or worse than 20/40, with or without a glare source Exclusion Criteria: * Subjects with any anterior segment pathology in the study eye likely to increase the risk of complications from phacoemulsification cataract surgery * Subjects with associated ocular conditions which could affect the stability of the IOL * Subjects with clinically significant irregular corneal astigmatism in the study eye **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Subjects will be chosen from 30-50 clinical sites in the US. All subjects who meet Eligibility Criteria (below) will be consecutively offered enrollment until the site meets the maximum number of enrollees. ### Contacts Locations Module #### Locations **Location 1:** **City:** Rochester **Country:** United States **Facility:** Bausch & Lomb Incorporated **State:** New York **Zip:** 14609 #### Overall Officials **Official 1:** **Affiliation:** Valeant Pharmaceuticals NA / Bausch & Lomb **Name:** Anya Loncaric **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007905 - Term: Lens Diseases - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5638 - Name: Cataract - Relevance: HIGH - As Found: Cataract - ID: M10917 - Name: Lens Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002386 - Term: Cataract ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01349179 **Acronym:** ETOSA **Brief Title:** Scan Hip Evaluation **Official Title:** Scan Evaluation at 9 Years of the Bone Acetabular Supporting Cups Without Cement (Couple Metal/Metal in Diameter 28 mm) #### Organization Study ID Info **ID:** CHU-089 #### Organization **Class:** OTHER **Full Name:** University Hospital, Clermont-Ferrand ### Status Module #### Completion Date **Date:** 2011-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2014-07-08 **Type:** ESTIMATED **Last Update Submit Date:** 2014-07-04 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2011-09 **Type:** ACTUAL #### Start Date **Date:** 2010-12 **Status Verified Date:** 2014-07 #### Study First Post Date **Date:** 2011-05-06 **Type:** ESTIMATED **Study First Submit Date:** 2011-02-22 **Study First Submit QC Date:** 2011-05-05 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Clermont-Ferrand #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** The couple of friction metal-polyethylene is regarded as the couple of reference in spite of the osteolysis induced by the wear of the polyethylene which remains the independent factor of long-term failure. This is all the more true as the patients are young, thus justifying the recourse to alternate couples of friction. The Metasul® couple was introduced on the French market under its current form in 1995 (year of its marking EC). The use of a couple of friction metal-metal (MM) is justified because it would be likely to improve longevity of the total arthroplasties of the active subjects by the reduction in osteolysis related to the wear of polyethylene. Various studies highlight evolutions different according to the types of fixing acetabular; favourable results of the not cemented cups contrasting with unsealings and the evolutionary edgings of the Metasul® cups cemented of or the cups "of cemented Weber type". **Detailed Description:** Radiographies standards allow the follow-up of the total prostheses of hip but those underestimate the incidence and the extension of osteolyses perished-acetabular which are generally asymptomatic initially. The lack of international consensus on the definition of the parameters of interpretation of the radiological follow-up of the PTH makes difficult the comparison of the various results. The purpose of the study is to evaluate the presence of geodes acetabular and femoral with scan examination. ### Conditions Module **Conditions:** - Hip Arthroplasty **Keywords:** - Hip - Arthroplasty - Metal on metal - operated on 2002 ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 54 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** The purpose of the study is to evaluate the presence of geodes acetabular and femoral with scan examination. **Name:** Metal on metal hip arthroplasty operated on 2002 **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** Realization of a scan nine years after the surgery of total hip arthroplasty **Time Frame:** after nine years #### Secondary Outcomes **Measure:** Clinical results preoperative Postel Merle d'Aubigné, Harris score preoperative and SF12 scores preoperative (before the hip surgery) **Time Frame:** after nine years **Measure:** Cooperating X-ray assessments and scan **Time Frame:** after nine years **Measure:** Realization of a X-ray and a scan then comparison of the results obtained **Time Frame:** after nine years **Measure:** Concentrations of cobalt: chrome and nickel in blood **Time Frame:** after nine years **Measure:** Rate of survival of the prosthesis **Time Frame:** after nine years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Metal on metal hip arthroplasty operated on 2002 * Age older than 40 years Exclusion Criteria: * Expectant mothers **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Clermont-Ferrand **Country:** France **Facility:** CHU Clermont-Ferrand **Zip:** 63003 #### Overall Officials **Official 1:** **Affiliation:** University Hospital, Clermont-Ferrand **Name:** Stéphane DESCAMPS, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04020679 **Acronym:** GOCI **Brief Title:** The Goals of Care Initiative **Official Title:** A Hybrid Implementation-effectiveness Stepped Wedge Cluster Randomised Controlled Trial to Determine the Effectiveness of the Goals of Care Initiative #### Organization Study ID Info **ID:** 18_CPCR_17 #### Organization **Class:** OTHER **Full Name:** The Christie NHS Foundation Trust ### Status Module #### Completion Date **Date:** 2021-01-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-06-21 **Type:** ACTUAL **Last Update Submit Date:** 2021-06-16 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2021-01-11 **Type:** ACTUAL #### Start Date **Date:** 2019-06-11 **Type:** ACTUAL **Status Verified Date:** 2021-06 #### Study First Post Date **Date:** 2019-07-16 **Type:** ACTUAL **Study First Submit Date:** 2019-07-10 **Study First Submit QC Date:** 2019-07-15 **Why Stopped:** Funding withdrawn ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Manchester #### Lead Sponsor **Class:** OTHER **Name:** The Christie NHS Foundation Trust #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** A single site hybrid implement-evaluation stepped wedge cluster randomised controlled trial in which cancer cluster groups (lung, colorectal, breast, renal, ovarian, upper GI \& sarcoma) are randomised sequentially to initiate the Goals of Care Initiative into clinical practice. ### Conditions Module **Conditions:** - Decision-Making Oncology - Chemotherapy Effect ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL **Intervention Model Description:** Stepped Wedge Cluster Randomised Controlled Trial ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 220 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will not receive GOCI materials **Label:** Control arm **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Participants will receive GOCI materials and clinicians will receive training. **Intervention Names:** - Behavioral: Goals of Care Initiative **Label:** Intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** Can-GUIDE will provide videos on a number of SDM topics including interviews with patients and clinicians discussing patient involvement in SDM and how goal conversations can inform the decision making process. Furthermore, there will be instructional videos on how to complete the Goal conversations sheet. Accompanying the videos will be interactive elements which will help users consider the types of questions that they wish to ask their clinical teams. The goal conversation sheet allows patients to list their goals and priorities that they wish to bring up in the consultation with their clinical teams. The Goals of Care (GOC) tool is a communication aid for clinicians to summarise goals of care discussions such as those facilitated by the goals conversation sheet. The completed tool will then be logged onto the Electronic Patient Record (EPR) and is then disseminated to other HCPs involved in the patients care. **Name:** Goals of Care Initiative **Other Names:** - Can-GUIDE **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Patient involvement in decision making will be measured using the SDM-Q-9 questionnaire. The questionnaire contains nine items with respondents scoring on a six point scale (0 represents completely disagree to 5 which represents completely disagree) how much they agree with the presented statement. The highest score attainable, 45, represents the highest level of perceived Shared Decision Making and 0 represents no perceived involvement in Shared Decision Making. **Measure:** SDM-Q-9 **Time Frame:** Immediately following intervention **Description:** Patient satisfaction with decision and overall decision conflict will be measured using the Ottawa Decisional Conflict Scale. The scale consists of 16 items with patients scoring themselves on a five point scale (0, Strongly Agree - 4, Strongly Disagree). The scale includes five subscales: uncertainty, support, values, informed, effective decision. The total score and subscale scores are calculated by dividing the sum of the items by the number of items within that subscale and multiplying by twenty five (scored range from 0 to 100; 0 score indicates no decisional conflict, 100 indicates extremely high decisional conflict). This scale evaluates the quality of decision as outlined within internationally recognised guidelines to establish the effectiveness of decision aids. Furthermore, some of the subscales address evaluating the quality of the decision process (feeling informed about the options, clarity of values). **Measure:** Decision Conflict Scale **Time Frame:** Immediately following intervention #### Secondary Outcomes **Description:** A patient's ability to make a decision about treatment (or decision self-efficacy) will be measured using the Ottawa Decision Self-Efficacy scale. The scale consists of 11 items where patients score themselves on a five point scale (0, not at all confident - 4, Very confident); high score indicates greater decision self-efficacy. The total score provides a global rating of self confidence in the patient's ability to engage with decision making regarding their treatment. The total score is calculated by summing the 11 items, dividing by 11 and then multiply by 25. **Measure:** Decision Self Efficacy Scale **Time Frame:** Immediately following intervention, then at 6 weeks and 12 weeks. **Description:** EQ-5D is a standardised instrument for use as a measure of health outcome and it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys. The EuroQoL 5-level version (EQ-5D-5L) will be assessed to provide a preference based measure of health-related quality-of-life which will enable us to calculate a quality adjusted life-year (QALY) for use in the cost-effectiveness analysis. The preference weights to estimate utility values and QALYs will be those recommended by NICE at the time of data analysis. Participants are asked to choose a statement which best relates to their current experience relating to the following health domains: mobility, self-care, ability to carry out usual activities, pain/discomfort, anxiety/depression. **Measure:** EQ-5D-5L **Time Frame:** Immediately following intervention, then at 6 weeks and 12 weeks. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Undergoing, or being considered for, systemic treatment from one of the cluster teams. * 18+ years. * Able to give written consent. * Able to understand verbal and written English. Exclusion Criteria: • Patient is not being considered for Systemic Anti-Cancer Treatment. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Manchester **Country:** United Kingdom **Facility:** The Christie NHS Foundation Trust **Zip:** M20 4BX #### Overall Officials **Official 1:** **Affiliation:** University of Manchester **Name:** Janelle Yorke, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03596879 **Acronym:** PPD **Brief Title:** Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression **Official Title:** Insomnia and Rumination in Late-pregnancy and the Risk for Postpartum Depression (PPD): A Randomized Controlled Trial of Online Cognitive Behavioral Therapy for Insomnia to Prevent PPD #### Organization Study ID Info **ID:** 12204 #### Organization **Class:** OTHER **Full Name:** Henry Ford Health System ### Status Module #### Completion Date **Date:** 2019-07-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-12-05 **Type:** ACTUAL **Last Update Submit Date:** 2019-12-04 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-07-31 **Type:** ACTUAL #### Start Date **Date:** 2018-07-18 **Type:** ACTUAL **Status Verified Date:** 2019-12 #### Study First Post Date **Date:** 2018-07-24 **Type:** ACTUAL **Study First Submit Date:** 2018-06-08 **Study First Submit QC Date:** 2018-07-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Henry Ford Health System #### Responsible Party **Investigator Affiliation:** Henry Ford Health System **Investigator Full Name:** David Kalmbach **Investigator Title:** Bioscientific Staff Researcher **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The primary objective of the proposed research is to determine whether prenatal insomnia and ruminative thinking predict severity of postpartum depression (PPD) symptoms. Additionally, the investigators will also determine the effectiveness of digital/internet-based Cognitive Behavioral Therapy for Insomnia (dCBTI) in reducing the risk for PPD. **Detailed Description:** The purpose of this study is to 1) explore the relationship between prenatal insomnia, ruminative thinking and the severity of PPD symptoms. and 2) determine the effectiveness of Digital Cognitive Behavioral Therapy (dCBTI) in reducing the risk for postpartum depression in pregnant mothers entering into their third trimester. dCBTI is an online form of Cognitive Behavioral Therapy (CBT) that is used with people who experience trouble sleeping at night (insomniacs). As pregnant women are especially vulnerable to sleep problems during this period, this study will help us determine whether dCBTI is helpful in improving sleep and reducing the risk for PPD in this population. Pregnant women entering their third trimester will be recruited from the Henry Ford Health System through the HFHS Electronic Medical Record (EPIC). They will receive an email from study personnel describing the study, and encouraged to schedule a phone call to discuss study details. Participants will then complete a consent and an online screening survey. Upon meeting inclusion criteria, participants will complete weekly surveys and randomized into one of 2 active online insomnia treatment conditions. Each treatment involves 6 weekly "sessions" which each take up to 20 minutes to complete. Subjects will complete weekly online surveys beginning at week 30 of pregnancy, and continuing through 6 weeks after giving birth. ### Conditions Module **Conditions:** - Insomnia - Post Partum Depression **Keywords:** - insomnia - post partum depression (PPD) - digital CBTI (dCBTI) - online CBTI - rumination ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 91 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Online access to the digital CBTI program Sleepio. **Intervention Names:** - Behavioral: dCBTI **Label:** dCBTI **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Weekly email messages with sleep hygiene recommendations. **Intervention Names:** - Behavioral: Sleep Education **Label:** Sleep Education **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - dCBTI **Description:** Online access to the digital CBTI program Sleepio based off of traditional face-to-face Cognitive Behavioral Therapy, six weekly sessions done online. **Name:** dCBTI **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Sleep Education **Description:** Six weekly email messages with sleep hygiene recommendations. Subjects are encouraged to read through the information and apply it to their sleep. **Name:** Sleep Education **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The Insomnia Severity Index (ISI) is a commonly used self-report measure of insomnia symptoms that has been validated for use in community samples and clinical trials. The ISI scores range from 0-28, with a higher score indicating a greater severity of insomnia. **Measure:** Improvement in Sleep - Insomnia Severity Index **Time Frame:** Year 1 **Description:** The Edinburgh Postnatal Depression (EPDS) is the most widely used depression measure in both pregnant and postnatal women. It is validated for use in community samples and clinical trials. The EPDS scores range from 0-30, with a higher score indicating a greater severity of depression. **Measure:** Prevention of Postpartum Depression Symptoms - Edinburg Postnatal Depression Scale (EPDS) **Time Frame:** Year 1 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Must be entering their 3rd trimester of pregnancy * Must deny any concerns or indications of a high risk pregnancy associated with increased risk for the mother or fetus for negative health outcomes Exclusion Criteria: * Age \< 18 years old * Bipolar or seizure disorders (due to risk in CBTI) * Known sleep disorders other than insomnia (eg narcolepsy, restless legs syndrome, obstructive sleep apnea) * Women already in their 3rd trimester * Women who are not pregnant * Women with high risk pregnancy **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Novi **Country:** United States **Facility:** Henry Ford Medical Center **State:** Michigan **Zip:** 48377 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Kalmbach DA, Cheng P, Roth T, Swanson LM, Cuamatzi-Castelan A, Roth A, Drake CL. Examining Patient Feedback and the Role of Cognitive Arousal in Treatment Non-response to Digital Cognitive-behavioral Therapy for Insomnia during Pregnancy. Behav Sleep Med. 2022 Mar-Apr;20(2):143-163. doi: 10.1080/15402002.2021.1895793. Epub 2021 Mar 15. **PMID:** 33719795 **Citation:** Kalmbach DA, Cheng P, O'Brien LM, Swanson LM, Sangha R, Sen S, Guille C, Cuamatzi-Castelan A, Henry AL, Roth T, Drake CL. A randomized controlled trial of digital cognitive behavioral therapy for insomnia in pregnant women. Sleep Med. 2020 Aug;72:82-92. doi: 10.1016/j.sleep.2020.03.016. Epub 2020 Mar 21. **PMID:** 32559716 **Citation:** Kalmbach DA, Cheng P, Ong JC, Ciesla JA, Kingsberg SA, Sangha R, Swanson LM, O'Brien LM, Roth T, Drake CL. Depression and suicidal ideation in pregnancy: exploring relationships with insomnia, short sleep, and nocturnal rumination. Sleep Med. 2020 Jan;65:62-73. doi: 10.1016/j.sleep.2019.07.010. Epub 2019 Jul 22. **PMID:** 31710876 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000020919 - Term: Sleep Disorders, Intrinsic - ID: D000020920 - Term: Dyssomnias - ID: D000012893 - Term: Sleep Wake Disorders - ID: D000009422 - Term: Nervous System Diseases - ID: D000011644 - Term: Puerperal Disorders - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000001068 - Term: Feeding and Eating Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depression - ID: M21076 - Name: Depression, Postpartum - Relevance: HIGH - As Found: Post Partum Depression - ID: M2062 - Name: Rumination Syndrome - Relevance: HIGH - As Found: Rumination - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M10356 - Name: Sleep Initiation and Maintenance Disorders - Relevance: HIGH - As Found: Insomnia - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M22242 - Name: Parasomnias - Relevance: LOW - As Found: Unknown - ID: M22654 - Name: Sleep Disorders, Intrinsic - Relevance: LOW - As Found: Unknown - ID: M22655 - Name: Dyssomnias - Relevance: LOW - As Found: Unknown - ID: M15696 - Name: Sleep Wake Disorders - Relevance: LOW - As Found: Unknown - ID: M14499 - Name: Puerperal Disorders - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M4380 - Name: Feeding and Eating Disorders - Relevance: LOW - As Found: Unknown - ID: T5077 - Name: Rumination Disorder - Relevance: HIGH - As Found: Rumination ### Condition Browse Module - Meshes - ID: D000079562 - Term: Rumination Syndrome - ID: D000007319 - Term: Sleep Initiation and Maintenance Disorders - ID: D000019052 - Term: Depression, Postpartum - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01688479 **Brief Title:** Trial Comparing Calendula Officinalis With Aqueous Cream "Essex" to Treat Skin Reactions From Radiotherapy of Breast Cancer **Official Title:** Randomized, Blinded Phase III Trial Comparing Calendula Officinalis Cream With Standard Aqueous Cream "Essex" for Treatment of Skin Reactions Caused by Postoperative Radiotherapy of Breast Cancer #### Organization Study ID Info **ID:** Calendula trial #### Organization **Class:** OTHER **Full Name:** Karolinska University Hospital ### Status Module #### Completion Date **Date:** 2012-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2015-09-17 **Type:** ESTIMATED **Last Update Submit Date:** 2015-09-16 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2012-03 **Type:** ACTUAL #### Start Date **Date:** 2011-02 **Status Verified Date:** 2015-09 #### Study First Post Date **Date:** 2012-09-20 **Type:** ESTIMATED **Study First Submit Date:** 2012-09-15 **Study First Submit QC Date:** 2012-09-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Karolinska University Hospital #### Responsible Party **Investigator Affiliation:** Karolinska University Hospital **Investigator Full Name:** Thomas Hatschek **Investigator Title:** MD, PhD, Assoc. prof. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Acute radiation skin reactions (ARSR) occur in the majority of patients undergoing postoperative radiotherapy (RT). Some patients experience more severe reactions such as dry and/or moist desquamation but most patients experience mild reactions e.g. erythema (Lopez et al., 2005). The radiation dose, volume, RT technique and previous treatment, such as type of surgery and previous chemotherapy, are factors that might impact on the risk for ARSR together with patient-related factors such as body mass index (BMI), smoking status and previous skin damage (Porock et al., 1998; Wells et al., 2004). In a pilot study (n=93) of the frequency of ARSR in patients with breast cancer who underwent adjuvant RT it was shown that 93% developed ARSR, mostly mild reactions. Patients reported low scores on pain and itching (Sharp et al., 2011). Over 80% of the patients reported adherence to the skin care recommendations which included application of a thin layer of Essex® cream, a non-perfumed aqueous cream, on the irradiated area at least two times a day (Sharp et al., 2011). The effects of skin care products containing Calendula Officinalis (marigold plant) on ARSR in patients with breast cancer were investigated in a randomized clinical trial (Pommier et al., 2004). Patients in the experimental group, treated with calendula cream had a statistically significant lower incidence of severe ARSR, pain and treatment interruptions in comparison with the patients in the control group, treated with trolamine. The purpose of this blinded, randomized clinical trial is to compare two topical agents, Calendula Weleda® cream and Essex® cream, in terms of efficacy to reduce the risk of severe acute radiation skin reactions (ARSR) in relation to adjuvant radiotherapy (RT) for breast cancer. Patients were instructed to apply a thin layer of the assigned cream twice a day, starting at the onset of RT and continue until two weeks after termination, or until the ARSR is healed. The application should include the whole treatment area including the armpit and shoulder/back area in patients treated with modified radical mastectomy. Patients are also advised to not apply the cream within two hours before the RT in order to avoid possible build-up effect. Daily wash with perfume free soap and tap water are recommended and patients are advised to refrain from use of other topical agents in the irradiated area. The primary endpoint is the efficacy to reduce acute radiation skin reactions (ARSR), assessed with the Radiation Therapy Oncology Group/The Organization for Research and Treatment of Cancer Acute Radiation Morbidity Scoring Criteria (RTOG/EORTC scale) at follow-up. Secondary endpoints include patient reported outcome measures; Quality of Life Questionnaire (QLQ-C30), Sleep disturbances (MOS-sleep questionnaire) and symptoms experienced from the irradiated area (visual analogue scale). Patients' experiences and adherence to the topical agents are also evaluated. A total of 400 patients are required to detect a true absolute reduction in the proportion of patients with ARSR, from 35% with standard treatment (Essex® cream) to 20% with the experimental treatment (Calendula Weleda® cream), with a significance level of 5% a power of 90%. With this sample size, 95% confidence intervals for the difference in proportions are estimated to be in the order of ±10%. Assuming a rate of 5% of non-responders, the target size has been set to 420 patients. ### Conditions Module **Conditions:** - Postoperative Radiotherapy Breast Cancer **Keywords:** - Postoperative radiotherapy - breast cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 420 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Calendula Officinalis (marigold plant) is applied twice daily on the skin in the radiated area during the entire treatment period and until the skin reaction subsided **Intervention Names:** - Drug: Calendula Weleda cream (Weleda AG, Sweden) contains extracts of marigold plant (Calendula Officinalis 10%), wool fat and sesame oil **Label:** Calendula Weleda® cream (Weleda) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Essex cream is applied twice daily on the skin in the radiated area during the entire treatment period and until the skin reaction subsided **Intervention Names:** - Drug: Essex® cream (Schering-Plough), aqueous cream without parabens **Label:** Essex® cream (Schering-Plough) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Calendula Weleda® cream (Weleda) **Name:** Calendula Weleda cream (Weleda AG, Sweden) contains extracts of marigold plant (Calendula Officinalis 10%), wool fat and sesame oil **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Essex® cream (Schering-Plough) **Name:** Essex® cream (Schering-Plough), aqueous cream without parabens **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Collection of data on smoking habits and measurements of carbon monoxide in exhaled air **Measure:** Impact of smoking habits on the intensity of the skin reaction **Time Frame:** 8 weeks #### Primary Outcomes **Description:** Skin reactions due to radiotherapy using RTOG scale **Measure:** Grade of skin reactions to radiotherapy **Time Frame:** 8 weeks #### Secondary Outcomes **Description:** Measurements of sleep disturbances acc. to the MOS-SLEEP scale and QoL acc. to EORTC QLQ-C30 **Measure:** Quality of life in relation to skin reaction **Time Frame:** 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * radically operated for breast cancer, * aged 18 years or older, * signed informed consent Exclusion Criteria: * previous radiation in the same area, * severe general health problems, * ECOG performance status \> 3, * reduced cognitive ability, * allergy to marigold plant **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Stockholm **Country:** Sweden **Facility:** Department of Oncology, Karolinska University Hospital **Zip:** 17176 #### Overall Officials **Official 1:** **Affiliation:** Dept of Oncology, Karolinska University Hospital, Stockholm, Sweden **Name:** Maria AC Bergenmar, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Dept of Oncology, Karolinska University Hospital, Stockholm, Sweden **Name:** Lena Sharp, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Dept of Oncology, Karolinska University Hospital, Stockholm, Sweden **Name:** Thomas Hatschek, MD, PhD **Role:** STUDY_CHAIR ### References Module #### References **Citation:** Sharp L, Finnila K, Johansson H, Abrahamsson M, Hatschek T, Bergenmar M. No differences between Calendula cream and aqueous cream in the prevention of acute radiation skin reactions--results from a randomised blinded trial. Eur J Oncol Nurs. 2013 Aug;17(4):429-35. doi: 10.1016/j.ejon.2012.11.003. Epub 2012 Dec 13. **PMID:** 23245940 **Citation:** Sharp L, Johansson H, Hatschek T, Bergenmar M. Smoking as an independent risk factor for severe skin reactions due to adjuvant radiotherapy for breast cancer. Breast. 2013 Oct;22(5):634-8. doi: 10.1016/j.breast.2013.07.047. Epub 2013 Aug 13. **PMID:** 23953136 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T89 - Name: Calendula - Relevance: HIGH - As Found: Disposable needles ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02838979 **Brief Title:** Trial of Oral Glutamine on Mitochondrial Function in CKD **Official Title:** Randomized Cross-over Trial of Oral L-Glutamine vs Maltodextrin on Mitochondrial Function in Chronic Kidney Disease #### Organization Study ID Info **ID:** 47861 #### Organization **Class:** OTHER **Full Name:** University of Washington #### Secondary ID Infos **ID:** 5K23DK099442 **Link:** https://reporter.nih.gov/quickSearch/5K23DK099442 **Type:** NIH ### Status Module #### Completion Date **Date:** 2018-01-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-07-14 **Type:** ACTUAL **Last Update Submit Date:** 2022-06-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-10-01 **Type:** ACTUAL #### Results First Post Date **Date:** 2022-07-14 **Type:** ACTUAL **Results First Submit Date:** 2021-12-03 **Results First Submit QC Date:** 2022-06-21 #### Start Date **Date:** 2016-02-25 **Type:** ACTUAL **Status Verified Date:** 2022-03 #### Study First Post Date **Date:** 2016-07-20 **Type:** ESTIMATED **Study First Submit Date:** 2016-07-08 **Study First Submit QC Date:** 2016-07-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** New York Medical College **Class:** OTHER **Name:** Emory University **Class:** OTHER **Name:** Vanderbilt University **Class:** NIH **Name:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) #### Lead Sponsor **Class:** OTHER **Name:** University of Washington #### Responsible Party **Investigator Affiliation:** University of Washington **Investigator Full Name:** Jonathan Himmelfarb **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The primary goal of proposed investigation is to study the impact of oral glutamine supplementation on muscle mitochondrial and endothelial cell function measured mitochondrial energetics and vascular function using 31P magnetic resonance spectroscopy and optical spectroscopy (MRS/OS) among persons with moderate-severe CKD. The secondary objective is to describe the impact of oral glutamine supplementation on mitochondrial metabolic profile as well as inflammatory and oxidative stress biomarkers among persons with chronic kidney disease. **Detailed Description:** Chronic kidney disease is associated with endothelial cell dysfunction and muscle wasting contributing to the heightened risk of cardiovascular morbidity, mortality and functional limitation. Accumulation of toxins in renal disease may adversely impact endothelial cell nitric oxide bioavailability and endothelial Nitric Oxide Synthase (eNOS) function consequently heightening oxidative stress and suppressing mitochondrial biogenesis. To date no studies have investigated potential therapies for endothelial and muscle dysfunction in renal disease target mitochondrial metabolic and energetic processes. Animal studies of uremia underscore mitochondrial dysfunction as a potential precursor for endothelial dysfunction. In particular, uremia has been linked to a proteomic signature indicative of metabolic blockage of TCA cycle activity and fatty acid beta-oxidation. Both of these processes are localized to the mitochondria and may suggest that decreased mitochondrial mass or function may augur endothelial dysfunction in renal disease. Glutamine, an anaplerotic agent and precursor to the antioxidant glutathione, is a potential therapeutic agent bypassing the metabolic block associated with reduced TCA cycle and improving antioxidant reserve. The primary goal of proposed investigation is to study the impact of oral glutamine supplementation on muscle mitochondrial and endothelial cell function measured mitochondrial energetics and vascular function using 31P MRS/OS among persons with moderate-severe CKD. The secondary objective is to describe the impact of oral glutamine supplementation on mitochondrial metabolic profile as well as inflammatory and oxidative stress biomarkers among persons with chronic kidney disease. ### Conditions Module **Conditions:** - Cardiovascular Disease - Sarcopenia - Endothelial Dysfunction - Muscle Mitochondrial Function - Kidney Disease **Keywords:** - Glutamine - Chronic Kidney Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 11 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects will receive 0.4 g/kg/day of L-glutamine (Nutrestore, EMMAUS Life Sciences, Inc Torrance, CA) in three divided daily doses OR identical appearing maltodextrin powder. Duration 2 weeks **Intervention Names:** - Dietary Supplement: First Intervention (14 days) - Other: Washout (3 weeks) - Dietary Supplement: Second Intervention (14 days) **Label:** Oral L-Glutamine first, then Maltodextrin **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Subjects will crossover to receiving the study product which they did not receive in the first period. Either 0.4 g/kg/day of L-glutamine in three divided daily doses OR identical appearing maltodextrin powder. Duration 2 weeks **Intervention Names:** - Dietary Supplement: First Intervention (14 days) - Other: Washout (3 weeks) - Dietary Supplement: Second Intervention (14 days) **Label:** Maltodextrin first, then L-glutamine **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Maltodextrin first, then L-glutamine - Oral L-Glutamine first, then Maltodextrin **Description:** Oral Glutamine or Maltodextrin for 2 weeks **Name:** First Intervention (14 days) **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Maltodextrin first, then L-glutamine - Oral L-Glutamine first, then Maltodextrin **Description:** No study product is taken prior to beginning crossover **Name:** Washout (3 weeks) **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Maltodextrin first, then L-glutamine - Oral L-Glutamine first, then Maltodextrin **Description:** Oral Glutamine or Maltodextrin for 2 weeks **Name:** Second Intervention (14 days) **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Other Outcomes **Description:** To test if glutamine improves plasma NAD+ compared to placebo. Plasma NAD+ concentrations were quantified in mM using 31p MRS based in vivo assay. **Measure:** Plasma NAD+ Levels **Time Frame:** 2 weeks #### Primary Outcomes **Description:** 31P MRS/OS was used to measure mitochondrial phosphorylation capacity (ATPmax). **Measure:** Muscle Mitochondrial Function **Time Frame:** 2 weeks #### Secondary Outcomes **Description:** To test if glutamine improves objective isometric muscle fatigue by comparing the measurement of FTI from each arm. Muscle fatigability was tested by calculating FTI as the area under the force-time curve during isometric force generated at 70 % of maximal voluntary contraction (MVC), **Measure:** Change in Force-time Integral Area Under the Curve in Active Agent vs. Placebo **Time Frame:** 2 weeks **Description:** To test the effect of glutamine supplementation on muscle endurance, sum of the muscle force (force-time integral, FTI, N\*s) normalized to maximum voluntary contraction (MVC, N) generated during voluntary contraction. **Measure:** Muscle Fatigue **Time Frame:** 2 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults between 20 and 69 years of age * Diagnosis of moderate-severe CKD, defined in this study as an estimated glomerular filtration rate (eGFR) of ≤60ml/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration equation * Ability to understand and provide informed consent to participate in the study Exclusion Criteria: * On chronic dialysis * Expectation to start dialysis within 6 months or dialysis access in place. * Pregnant * Have physical immobility (defined by wheelchair use) * Insulin dependent diabetes * Have implants incompatible with MRI * Exercise limiting cardiopulmonary disease (e.g. angina, severe heart valve disease, severe COPD, coronary ischemia) * Use of anticoagulation (i.e. warfarin) * Baseline systolic blood pressure \>160 or diastolic blood pressure \>100 * Inflammatory conditions (e.g. autoimmune disease, HIV) * Thyroid disease * Dementia or inability to consent * Cirrhosis, active/chronic hepatitis * Use medications interfering with muscle or mitochondrial function, including steroids, anti-psychotic, Coenzyme Q-10, immunosuppresssives, antivirals, and muscle relaxants * Weight \>300 lbs * Personal history or family history of deep vein thrombosis, pulmonary embolism * Active malignancy * Patients hospitalized within the past 60 days for any reason. * Patients with a history of a major atherosclerotic event (defined as combined incidence of myocardial infarction, urgent target-vessel revascularization, coronary bypass surgery, and stroke) within 3 months **Maximum Age:** 69 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Seattle **Country:** United States **Facility:** Kidney Research Institute, University of Washington **State:** Washington **Zip:** 98104 #### Overall Officials **Official 1:** **Affiliation:** Kidney Research Insitute **Name:** Jonathan Himmelfarb, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Ziegler TR, Benfell K, Smith RJ, Young LS, Brown E, Ferrari-Baliviera E, Lowe DK, Wilmore DW. Safety and metabolic effects of L-glutamine administration in humans. JPEN J Parenter Enteral Nutr. 1990 Jul-Aug;14(4 Suppl):137S-146S. doi: 10.1177/0148607190014004201. **PMID:** 2119459 **Citation:** Amara CE, Marcinek DJ, Shankland EG, Schenkman KA, Arakaki LS, Conley KE. Mitochondrial function in vivo: spectroscopy provides window on cellular energetics. Methods. 2008 Dec;46(4):312-8. doi: 10.1016/j.ymeth.2008.10.001. Epub 2008 Oct 16. **PMID:** 18930151 **Citation:** Jones DP, Liang Y. Measuring the poise of thiol/disulfide couples in vivo. Free Radic Biol Med. 2009 Nov 15;47(10):1329-38. doi: 10.1016/j.freeradbiomed.2009.08.021. Epub 2009 Aug 26. **PMID:** 19715755 ## Document Section ### Large Document Module #### Large Docs - Date: 2015-12-07 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 516448 - Type Abbrev: Prot_SAP - Upload Date: 2021-12-02T18:44 - Date: 2016-03-24 - Filename: ICF_001.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 1796522 - Type Abbrev: ICF - Upload Date: 2021-12-02T18:45 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000009133 - Term: Muscular Atrophy - ID: D000020879 - Term: Neuromuscular Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000001284 - Term: Atrophy - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Kidney Disease - ID: M28396 - Name: Sarcopenia - Relevance: HIGH - As Found: Sarcopenia - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M12090 - Name: Muscular Atrophy - Relevance: LOW - As Found: Unknown - ID: M4589 - Name: Atrophy - Relevance: LOW - As Found: Unknown - ID: M22619 - Name: Neuromuscular Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000055948 - Term: Sarcopenia - ID: D000007674 - Term: Kidney Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Intervention Browse Module - Browse Branches - Abbrev: AA - Name: Amino Acids - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T6 - Name: Glutamine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** L-Glutamine **Deaths Num At Risk:** 11 **Description:** L-glutamine: Oral Glutamine for 2 weeks at dose of 0.4mg/kg/day in three divided daily doses **ID:** EG000 **Other Num at Risk:** 11 **Serious Number At Risk:** 11 **Title:** L-Glutamine **Group ID:** EG001 **Title:** Maltodextrin **Deaths Num At Risk:** 11 **Description:** Identical appearing maltodextrin powder. **ID:** EG001 **Other Num at Risk:** 11 **Serious Number At Risk:** 11 **Title:** Maltodextrin **Frequency Threshold:** 0 **Time Frame:** 7 weeks ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 6 **Group ID:** BG001 **Value:** 5 **Group ID:** BG002 **Value:** 11 **Units:** Participants ### Group **ID:** BG000 **Title:** L-Glutamine First, Then Maltodextrin **Description:** Subjects will first receive 0.4 g/kg/day of L-glutamine (Nutrestore, EMMAUS Life Sciences, Inc Torrance, CA) first, then crossover taking Maltodextrin. ### Group **ID:** BG001 **Title:** Maltodextrin First, Then L-glutamine **Description:** Subjects will first receive Identical appearing maltodextrin powder first, then crossover to taking L-glutamine. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 16.6 **Value:** 57 #### Measurement **Group ID:** BG001 **Spread:** 9.8 **Value:** 58 #### Measurement **Group ID:** BG002 **Spread:** 13.3 **Value:** 58 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 5 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 4 #### Measurement **Group ID:** BG002 **Value:** 6 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 6 #### Measurement **Group ID:** BG001 **Value:** 5 #### Measurement **Group ID:** BG002 **Value:** 11 **Category Title:** Not Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 3 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 5 #### Measurement **Group ID:** BG001 **Value:** 3 #### Measurement **Group ID:** BG002 **Value:** 8 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 6 #### Measurement **Group ID:** BG001 **Value:** 5 #### Measurement **Group ID:** BG002 **Value:** 11 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Ethnicity (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 5 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** ayerse@uw.edu **Organization:** University of Washington **Phone:** 206-685-1423 **Title:** Ernest Ayers ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_DEVIATION **Dispersion Value:** 0.34 **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.15 **P-Value Comment:** P-value for the interaction of treatment and sequence **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** -0.01 **Statistical Comment:** Two-way ANOVA was used to assess differences between the groups **Statistical Method:** ANOVA **Tested Non-Inferiority:** ### Outcome Measure 2 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_DEVIATION **Dispersion Value:** 22.18 **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.86 **P-Value Comment:** P-value for the interaction of treatment and sequence **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** -7.39 **Statistical Comment:** Two-way ANOVA was used to assess differences between the groups **Statistical Method:** ANOVA **Tested Non-Inferiority:** ### Outcome Measure 3 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_DEVIATION **Dispersion Value:** 1.04 **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.44 **P-Value Comment:** P-value for the interaction of treatment and sequence **Parameter Type:** Median Difference (Final Values) **Parameter Value:** -0.10 **Statistical Comment:** Two-way ANOVA was used to assess differences between the groups **Statistical Method:** ANOVA **Tested Non-Inferiority:** ### Outcome Measure 4 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_DEVIATION **Dispersion Value:** 0.21 **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.36 **P-Value Comment:** P-value for the interaction of treatment and sequence **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** 0.06 **Statistical Comment:** Two-way ANOVA was used to assess differences between the groups **Statistical Method:** ANOVA **Tested Non-Inferiority:** ### Outcome Measure 5 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_DEVIATION **Dispersion Value:** 7.87 **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.60 **P-Value Comment:** P-value for the interaction of treatment and sequence **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** -0.45 **Statistical Comment:** Two-way ANOVA was used to assess differences between the groups **Statistical Method:** ANOVA **Tested Non-Inferiority:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.30 - **Upper Limit:** - **Value:** 0.88 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.34 - **Upper Limit:** - **Value:** 0.90 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 24.07 - **Upper Limit:** - **Value:** 58.87 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 21.22 - **Upper Limit:** - **Value:** 52.36 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.09 - **Upper Limit:** - **Value:** 2.52 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.03 - **Upper Limit:** - **Value:** 2.41 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.25 - **Upper Limit:** - **Value:** 0.95 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.19 - **Upper Limit:** - **Value:** 0.98 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 6.834 - **Upper Limit:** - **Value:** 23.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 8.967 - **Upper Limit:** - **Value:** 23.22 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** 31P MRS/OS was used to measure mitochondrial phosphorylation capacity (ATPmax). **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 2 weeks **Title:** Muscle Mitochondrial Function **Type:** PRIMARY **Unit of Measure:** mM ATP/s ##### Group **Description:** L-glutamine: Oral Glutamine for 2 weeks at dose of 0.4mg/kg/day in three divided daily doses **ID:** OG000 **Title:** L-Glutamine ##### Group **Description:** Identical appearing maltodextrin powder. Maltodextrin: Oral maltodextrin as described for the active agent: 2 weeks at dose of 0.4mg/kg/day in three divided daily doses. **ID:** OG001 **Title:** Maltodextrin #### Outcome Measure 2 **Description:** To test if glutamine improves objective isometric muscle fatigue by comparing the measurement of FTI from each arm. Muscle fatigability was tested by calculating FTI as the area under the force-time curve during isometric force generated at 70 % of maximal voluntary contraction (MVC), **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 2 weeks **Title:** Change in Force-time Integral Area Under the Curve in Active Agent vs. Placebo **Type:** SECONDARY **Unit of Measure:** N*s ##### Group **Description:** L-glutamine: Oral Glutamine for 2 weeks at dose of 0.4mg/kg/day in three divided daily doses **ID:** OG000 **Title:** L-Glutamine ##### Group **Description:** Identical appearing maltodextrin powder. Maltodextrin: Oral maltodextrin as described for the active agent: 2 weeks at dose of 0.4mg/kg/day in three divided daily doses. **ID:** OG001 **Title:** Maltodextrin #### Outcome Measure 3 **Description:** To test the effect of glutamine supplementation on muscle endurance, sum of the muscle force (force-time integral, FTI, N\*s) normalized to maximum voluntary contraction (MVC, N) generated during voluntary contraction. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 2 weeks **Title:** Muscle Fatigue **Type:** SECONDARY **Unit of Measure:** s-1 ##### Group **Description:** L-glutamine: Oral Glutamine for 2 weeks at dose of 0.4mg/kg/day in three divided daily doses **ID:** OG000 **Title:** L-Glutamine ##### Group **Description:** Identical appearing maltodextrin powder. Maltodextrin: Oral maltodextrin as described for the active agent: 2 weeks at dose of 0.4mg/kg/day in three divided daily doses. **ID:** OG001 **Title:** Maltodextrin #### Outcome Measure 4 **Description:** To test if glutamine improves plasma NAD+ compared to placebo. Plasma NAD+ concentrations were quantified in mM using 31p MRS based in vivo assay. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 2 weeks **Title:** Plasma NAD+ Levels **Type:** OTHER_PRE_SPECIFIED **Unit of Measure:** mM ##### Group **Description:** L-glutamine: Oral Glutamine for 2 weeks at dose of 0.4mg/kg/day in three divided daily doses **ID:** OG000 **Title:** L-Glutamine ##### Group **Description:** Identical appearing maltodextrin powder. Maltodextrin: Oral maltodextrin as described for the active agent: 2 weeks at dose of 0.4mg/kg/day in three divided daily doses. **ID:** OG001 **Title:** Maltodextrin #### Outcome Measure 5 **Description:** To test if glutamine improves maximal voluntary contraction compared to placebo. Maximum voluntary contraction (MVC) was determined by the isometric force generated using first dorsal interosseous (FDI) muscle against a force transducer. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 2 weeks **Title:** Maximal Voluntary Contraction **Type:** POST_HOC **Unit of Measure:** N/m ##### Group **Description:** L-glutamine: Oral Glutamine for 2 weeks at dose of 0.4mg/kg/day in three divided daily doses **ID:** OG000 **Title:** L-Glutamine ##### Group **Description:** Identical appearing maltodextrin powder. Maltodextrin: Oral maltodextrin as described for the active agent: 2 weeks at dose of 0.4mg/kg/day in three divided daily doses. **ID:** OG001 **Title:** Maltodextrin ### Participant Flow Module #### Group **Description:** Subjects will receive 0.4 g/kg/day of L-glutamine (Nutrestore, EMMAUS Life Sciences, Inc Torrance, CA) in three divided daily doses. Duration 2 weeks L-glutamine: Oral Glutamine for 2 weeks at dose of 0.4mg/kg/day in three divided daily doses **ID:** FG000 **Title:** Oral L-Glutamine First, Then Maltodestrin #### Group **Description:** Identical appearing maltodextrin powder. Maltodextrin: Oral maltodextrin as described for the active agent: 2 weeks at dose of 0.4mg/kg/day in three divided daily doses. **ID:** FG001 **Title:** Maltodextrin First, Then L-glutamine #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 6 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 5 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 6 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 5 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT02131779 **Acronym:** M-PACT **Brief Title:** Men's Prostate Awareness Church Training **Official Title:** Prostate Cancer Education in African American Churches #### Organization Study ID Info **ID:** 12-0095 #### Organization **Class:** OTHER **Full Name:** University of Maryland, College Park #### Secondary ID Infos **Domain:** 119421-RSGT-10-113-01-CPPB **ID:** American Cancer Society **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2018-01-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2022-05-16 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-01-04 **Type:** ACTUAL #### Start Date **Date:** 2012-02 **Status Verified Date:** 2022-05 #### Study First Post Date **Date:** 2014-05-06 **Type:** ESTIMATED **Study First Submit Date:** 2014-04-28 **Study First Submit QC Date:** 2014-05-02 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Maryland, College Park #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The objective of the Prostate Cancer Education in African American Churches project is to develop and evaluate a spiritually-based educational intervention for Informed Decision Making (IDM) for prostate cancer screening to be delivered to African American men in church settings. **Detailed Description:** The specific aims of the project are to 1) develop, and 2) test the efficacy of a spiritually-based cancer communication intervention to increase IDM for prostate cancer screening among African American men in church settings, and including women as supportive "health partners". A randomized controlled trial is utilized, in which churches will be randomized to: 1) male-only educational groups; and 2) co-educational groups where women supportive "health partners" are invited to attend with the men in dyads, and then break out into men's and women's discussion groups. These two approaches are compared through use of cluster randomized design to determine whether the addition of the women health partner increases the intervention efficacy in the study outcome of informed decision making for prostate cancer screening. ### Conditions Module **Conditions:** - Prostate Cancer **Keywords:** - prostate cancer disparities - African American - Spiritually based intervention - Men's Health - Informed Decision Making - Community Based Participatory Research - Health Communication - Health Information Technology - Community Health Advisors ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** SCREENING #### Enrollment Info **Count:** 536 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Community health advisors will be trained using traditional/classroom methods and provided with technical assistance/support to implement the 4 part health series with men and women dyads. Technical assistance and support will be given as needed to community health advisors. Workshop sessions will include didactic lecture, group discussions, video and group exercises. **Intervention Names:** - Behavioral: Co-Educational Workshops **Label:** Co-Educational Workshops **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Community health advisors will be trained using traditional/classroom methods and provided with technical assistance/support as needed to deliver 4 part educational sessions to men only groups to relay information about making an informed decision about prostate cancer screening. Workshop sessions will include didactic lecture, group discussions, video and group exercises. **Intervention Names:** - Behavioral: Men's Workshops **Label:** Men's Workshops **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Men's Workshops **Description:** Two male Community Health Advisors will be trained using traditional/classroom methods and provided with technical assistance/support to implement the 4 part workshop series. **Name:** Men's Workshops **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Co-Educational Workshops **Description:** One male and one female Community Health Advisor will be trained using traditional/classroom methods and provided with technical assistance/support to implement the 4 part workshop series. Two break out sessions will occur in the Health Partner condition with separate discussion sessions for men and female health partners. **Name:** Co-Educational Workshops **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** IDM for prostate cancer screening for African American men participating in a church-based group educational workshops will be measured at baseline and 12 months. Survey assessments items for informed decision making include: stage of decision making, preference for decision making, and self-efficacy for decision making. **Measure:** Informed Decision making for Prostate Cancer Screening **Time Frame:** Baseline to 12 month follow-up #### Secondary Outcomes **Description:** Health Belief Model-based scales including perceived benefits of screening; perceived barriers to screening; self-efficacy for screening; and knowledge including prostate cancer knowledge; knowledge about the prostate cancer screening controversy; and prostate cancer screening through self-report receipt of prostate specific antigen test and digital rectal examination **Measure:** Theory-based measures, prostate cancer knowledge, and prostate cancer screening **Time Frame:** Change from baseline to 12 month follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Male Study Participants * African American Men church attending men * 40-69 years of age Advisory Panel * Knowledgeable about the community where the intervention is implemented, adults ages 21+, review materials and provide input for intervention development and program implementation Pastors * Willing to conduct the intervention at church * Support the program * Designate two individuals to serve as community health advisors * Identify a ministry in the church which will champion the project Community Health Advisors * attend a 6 hour training and 1 hour certification * assist in recruitment of study participants * recruit up to 24 men * recruit up to 24 females to attend sessions with men in 10 Health Partner Churches * prepare and conduct the 4 part workshop series * serve as liaisons between the project and study team Workshop Participants * self-identified, African American men (40-69), Health Partners --over 18 years of age, able to complete self-administered paper-and-pencil surveys Exclusion Criteria: * Workshop participants with a history of prostate cancer, do not meet the age criteria **Healthy Volunteers:** True **Maximum Age:** 69 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** College Park **Country:** United States **Facility:** University of Maryland School of Public Health **State:** Maryland **Zip:** 20742 #### Overall Officials **Official 1:** **Affiliation:** University of Maryland School of Public Health **Name:** Cheryl L Holt, PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Saunders DR, Holt CL, Whitehead TL, Atkinson NL, Le D, Wang MQ, Slade JL, Muwwakkil B, Williams R, Schulz E, Naslund M. Development of the men's prostate awareness church training: church-based workshops for African American men. Fam Community Health. 2013 Jul-Sep;36(3):224-35. doi: 10.1097/FCH.0b013e318292eb40. **PMID:** 23718958 **Citation:** Le D, Holt CL, Saunders DR, Wang MQ, Coriolan A, Savoy AD, Slade JL, Muwwakkil B, Atkinson NL. Feasibility and acceptability of SMS text messaging in a prostate cancer educational intervention for African American men. Health Informatics J. 2016 Dec;22(4):932-947. doi: 10.1177/1460458215598636. Epub 2015 Aug 30. **PMID:** 26324051 **Citation:** Saunders DR, Holt CL, Le D, Slade JL, Muwwakkil B, Savoy A, Williams R, Whitehead TL, Wang MQ, Naslund MJ. Recruitment and Participation of African American Men in Church-Based Health Promotion Workshops. J Community Health. 2015 Dec;40(6):1300-10. doi: 10.1007/s10900-015-0054-9. **PMID:** 26089253 **Citation:** Holt CL, Le D, Saunders DR, Wang MQ, Slade JL, Muwwakkil B, Williams R, Atkinson NL, Whitehead TL, Naslund M. Informed Decision-Making and Satisfaction with a Church-Based Men's Health Workshop Series for African-American Men: Men-Only vs. Mixed-Gender Format. J Cancer Educ. 2015 Sep;30(3):530-4. doi: 10.1007/s13187-014-0731-x. **PMID:** 25330866 #### See Also Links **Label:** Community Health Awareness, Messages \& Prevention --University of Maryland, Research lab where the project is based **URL:** https://sph.umd.edu/research-impact/laboratories-projects-and-programs/community-health-awareness-messages-and-prevention-champ-lab **Label:** American Cancer Society **URL:** http://www.cancer.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005834 - Term: Genital Neoplasms, Male - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000011469 - Term: Prostatic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14335 - Name: Prostatic Neoplasms - Relevance: HIGH - As Found: Prostate Cancer - ID: M8946 - Name: Genital Neoplasms, Male - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14333 - Name: Prostatic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011471 - Term: Prostatic Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00220779 **Acronym:** PRIVIG **Brief Title:** Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis **Official Title:** Randomized, Double-Blind, Placebo-Controlled Study to Compare the Effects of Different Dose Regimens of IGIV Chromatography (IGIV-C), 10% Treatment on Relapses in Patients With Relapsing Remitting Multiple Sclerosis #### Organization Study ID Info **ID:** 100434 #### Organization **Class:** INDUSTRY **Full Name:** Grifols Therapeutics LLC ### Status Module #### Completion Date **Date:** 2005-02 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2016-04-27 **Type:** ESTIMATED **Last Update Submit Date:** 2016-03-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2005-02 **Type:** ACTUAL #### Results First Post Date **Date:** 2014-04-11 **Type:** ESTIMATED **Results First Submit Date:** 2009-09-24 **Results First Submit QC Date:** 2014-03-06 #### Start Date **Date:** 2002-12 **Status Verified Date:** 2016-03 #### Study First Post Date **Date:** 2005-09-22 **Type:** ESTIMATED **Study First Submit Date:** 2005-09-13 **Study First Submit QC Date:** 2005-09-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Grifols Therapeutics LLC #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The trial will study 2 doses of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the number of relapses that occur in a 1 year treatment period. **Detailed Description:** This trial is designed as a multi-national, randomized, double-blind, placebo-controlled prospective trial with three parallel groups. One hundred twenty (120) patients, 40 per treatment arm, with relapsing-remitting (RR) multiple sclerosis will be enrolled in this trial. Eligible patients must have a diagnosis of MS as per the McDonald Criteria. In addition, patients must have a diagnosis of relapsing-remitting course of MS defined as periods of worsening of neurological function with full recovery or with sequelae and residual deficit upon recovery; periods between disease relapses characterized by lack of disease progression. Patients must also have active disease with at least 1 defined documented relapse in the last year. During a 2 month run-in period, 2 MRIs will be performed 6 weeks apart and patients will be stratified based on the presence or absence of 1 or more Gadolinium enhancing lesions on the first MRI (Gd-enhancing lesion yes-no) and will be randomized to one of two dose regimens of IGIV-C or matching placebo. Patients will receive study drug infusions every 4 weeks for 48 weeks for a total of 12 infusions. Patients will be evaluated by MRI every 6 weeks and by clinical assessments every 3 months. A follow-up visit will occur 4 weeks after the last infusion. The treatment groups are as follows: * IGIV-C - 0.2 g/kg body weight (bw)/infusion (2 ml/kg bw) * IGIV-C - 0.4 g/kg bw/infusion (4 ml/kg bw) * placebo (0.1% albumin) - 4 ml/kg bw/infusion For blinding purposes, at each infusion, all patients will receive a total volume of 4 ml/kg bw. For patients receiving 0.2 g/kg bw of IGIV-C, the final volume of 4 ml/kg bw will be adjusted by the addition of dextrose 5%. Placebo will be supplied as Albumin 5% or Albumin 25% and diluted with either dextrose 5% or saline to a final concentration of 0.1% albumin. Dose adaptation will be performed for subsequent infusions in case the patient's body weight has changed \> 10%. The maximum amount available per infusion will be 400 ml (8 vials) calculated for a patient with a body weight of 100 kg. The suggested initial infusion rate will be 0.02 ml/kg/min for the first 15 minutes. If there is no evidence of a hypersensitivity reaction, the infusion may be given at a slowly increasing rate over the next 30 minutes up to a maximum allowable rate of 0.08 ml/kg/min. As such, the infusion for a 70 kg patient will take approximately 1hour 15 min. The overall infusion time may have a range from 1 to 2 hours. ### Conditions Module **Conditions:** - Multiple Sclerosis, Relapsing-Remitting ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 128 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** IGIV-C 0.2 g/kg bw/infusion (2 ml/kg bw) **Intervention Names:** - Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified **Label:** Group 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** IGIV-C 0.4 g/kg bw/infusion (4 ml/kg bw) **Intervention Names:** - Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified **Label:** Group 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** placebo (0.1% albumin) 4 ml/kg bw/infusion **Intervention Names:** - Drug: Albumin (Human) 25%, United States Pharmacopeia (USP) **Label:** Group 3 **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group 1 - Group 2 **Name:** Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified **Other Names:** - Gamunex® - IGIVnex® - Gaminex - IGIV-C - Immune Globulin Intravenous (Human) , 10% - IGIV - BAY 41-1000 - TAL-05-00004 - IGIV-C, 10% - IVIG - Immune Globulin (Human), 10% (IGIV) - Immune Globulin Intravenous, 10% by Chromatography Process - NDC 13533-645-12 - NDC 13533-645-15 - NDC 13533-645-20 - NDC 13533-645-24 - NDC 13533-645-71 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Group 3 **Name:** Albumin (Human) 25%, United States Pharmacopeia (USP) **Other Names:** - Plasbumin®-5 - Plasbumin®-25 - Plasbumin®-5 (Low Aluminum) - Plasbumin®-25 (Low Aluminum) - Albumin (Human) 5%, USP - Albumin (Human) 25%, USP - TAL-05-00009 - TAL-05-00023 - TAL-05-00025 - TAL-05-00026 - BAY 34-9255 - NDC 13533-684-16 - NDC 13533-684-25 - NDC 13533-684-71 - NDC 13533-685-20 - NDC 13533-685-25 - NDC 13533-685-27 - NDC 13533-690-20 - NDC 13533-690-25 - NDC 13533-690-27 - NDC 13533-692-16 - NDC 13533-692-20 - NDC 13533-692-71 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** A relapse was defined for the purposes of this study as the appearance or reappearance of one or more neurological symptoms or worsening of an old symptom attributed to multiple sclerosis (MS) persisting for at least 48 hours and immediately preceded by a relatively stable or improving neurological state of at least 30 days. **Measure:** Percentage of Relapse Free Subjects (no Relapse) **Time Frame:** 12 months #### Secondary Outcomes **Measure:** Effect on the Combined Unique Lesion Activity on Magnetic Resonance Imaging (MRI) **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Symptoms consistent with Multiple Sclerosis up to 5 years * Diagnosis of multiple sclerosis according to McDonald criteria. * Diagnosis of relapsing-remitting (RR) multiple sclerosis (MS) (Defined as periods of worsening of neurological function with full recovery or with sequelae and residual deficit upon recovery; periods between disease relapses characterized by lack of disease progression * Kurtzke Extended Disability Status Scale (EDSS) \< 5.0 * At least 1 defined and documented relapse during the last year. Prior relapses where symptoms were due solely to a change in Bowel/Bladder Function or Cognitive Function will not be considered relapses as defined by this protocol and therefore not counted for inclusion into the study. * Females or males; females of childbearing potential must use adequate contraception * Clinically stable for at least 30 days prior to entry * At least 9 hyperintense T2 lesions on MRI or 1 Gd-enhancing lesion according to McDonald/Barkhof dissemination-in-space criteria at entry * Patients who have been informed about available treatments and decided, not to go on these treatments * Written informed consent obtained prior to the initiation of any study related procedures Exclusion Criteria: * Females who are pregnant, breast feeding, or if, of childbearing potential, unwilling to practice adequate contraception throughout the study * Prior therapy with azathioprine or any immunosuppressant agents within 6 months prior to study entry * Prior steroid, methylprednisolone or adrenocorticotropic hormone (ACTH) therapy within 30 days prior to study entry * Therapy with interferons (Betaseron®, Avonex®, Rebif®), glatiramer acetate (Copaxone®) or IGIV within 3 months prior to study entry or during the study * Use of an investigational compound within 6 months prior to study entry * Previous lymphoid irradiation or prior to treatment with cyclophosphamide, methotrexate or mitoxantrone * Cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease (CCS III or IV), or malignant hypertension * History of renal insufficiency or serum creatinine levels greater than 2.5 mg/dL (221 µmol/L) * Known selective immunoglobulin A (IgA) deficiency or known antibodies to IgA * Conditions whose symptoms and effects could alter protein catabolism and/or immunoglobulin G (IgG) utilization (e.g., protein-losing enteropathies, nephrotic syndrome) * Any medical, psychiatric or other circumstances which impede or restrict the patient's participation in the study or any contraindication to contrast enhanced MRI (e.g.,pacemaker, aortic clip or any metal implant) * Patients with clinically significant medical conditions including, but not limited to cardiac, pulmonary, hepatic, hematological (e.g. known coagulation disorder, history of deep venous thrombosis and/or pulmonary embolism), endocrine,or renal dysfunction, autoimmune disorders, severe environmental allergies or chronic infections **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Phoenix **Country:** United States **Facility:** Barrow Neurological Institute at St. Joseph's Hospital and Medical Center **State:** Arizona **Zip:** 85013 **Location 2:** **City:** Tucson **Country:** United States **Facility:** Northwest NeuroSpecialists, PLLC **State:** Arizona **Zip:** 85741-3537 **Location 3:** **City:** New York **Country:** United States **Facility:** The Mt. Sinai Medical Center, Department of Neurology **State:** New York **Zip:** 10029 **Location 4:** **City:** Stony Brook **Country:** United States **Facility:** SUNY Health Science Center at Stony Brook, Department of Neurology **State:** New York **Zip:** 11794-8121 **Location 5:** **City:** Winston-Salem **Country:** United States **Facility:** Wake Forest University - School of Medicine **State:** North Carolina **Zip:** 27157 **Location 6:** **City:** Burlington **Country:** United States **Facility:** Neurology Health Care Service, Fletcher Allen Health Care **State:** Vermont **Zip:** 05401 **Location 7:** **City:** Graz **Country:** Austria **Facility:** Department of Neurology, Karl-Franzens University **Zip:** 8010 **Location 8:** **City:** Calgary **Country:** Canada **Facility:** Foothills Hospital **State:** Alberta **Zip:** T2N 2T9 **Location 9:** **City:** London **Country:** Canada **Facility:** London Health Sciences Centre **State:** Ontario **Zip:** N6A 5A5 **Location 10:** **City:** Ottawa **Country:** Canada **Facility:** The Ottawa Hospital, General Campus - Neurology Division **State:** Ontario **Zip:** K1H 8L6 **Location 11:** **City:** Montreal **Country:** Canada **Facility:** CHUM Hospital Notre Dame **State:** Quebec **Zip:** H2L4M1 **Location 12:** **City:** Brno **Country:** Czech Republic **Facility:** Fakultni nemocnice Brno-Bohunice **Zip:** 63900 **Location 13:** **City:** Brno **Country:** Czech Republic **Facility:** St. Anna's Teaching Hospital **Zip:** 65691 **Location 14:** **City:** Prague 2 **Country:** Czech Republic **Facility:** Všeobecná fakultní nemocnice **Zip:** 12808 **Location 15:** **City:** Prague **Country:** Czech Republic **Facility:** Department of Neurology, Motol Teaching Hospital **Zip:** 15600 **Location 16:** **City:** Dusseldorf **Country:** Germany **Facility:** Medizinische Einrichtungen der Heinrich Heine Universitat, Neurologische Klinik **Zip:** 40225 **Location 17:** **City:** Erfurt **Country:** Germany **Facility:** HELIOS Klinikum Erfurt GmbH, Klinik und Poliklinik fur Neurologie **Zip:** 99089 **Location 18:** **City:** Giessen **Country:** Germany **Facility:** Klinikum der Justus-Liebig-Universitat, Zentrum fur Neurologie und Neurochirurgie **Location 19:** **City:** Munster **Country:** Germany **Facility:** Universitatsklinikum Munster, Klinik und Poliklinik fur Neurologie **Zip:** 48149 **Location 20:** **City:** Osnabrück **Country:** Germany **Facility:** Klinikum Osnabrück GmbH **Zip:** 49076 **Location 21:** **City:** Ulm **Country:** Germany **Facility:** Universitatsklinikum Ulm, Poliklinik fur Neurologie **Zip:** 89075 **Location 22:** **City:** Wurzburg **Country:** Germany **Facility:** Klinijum der Universitat Wurzburg, Neurologische Klinik und Poliklinik **Location 23:** **City:** Athens **Country:** Greece **Facility:** Henry Dunant Hospital **Zip:** 11526 **Location 24:** **City:** Budapest **Country:** Hungary **Facility:** Szent Imre Korhaz Neurologia **Zip:** 115 **Location 25:** **City:** Budapest **Country:** Hungary **Facility:** Uzsoki Street Hospital **Zip:** H-1145 **Location 26:** **City:** Budapest **Country:** Hungary **Facility:** Jahn Ferenc Delpesti Teaching Hospital **Zip:** H-1204 **Location 27:** **City:** Szeged **Country:** Hungary **Facility:** Szeged University of Science **Zip:** H-5720 **Location 28:** **City:** Haifa **Country:** Israel **Facility:** Lady Davis Carmel Medical Center **Zip:** 34362 **Location 29:** **City:** Katowice-Ligota **Country:** Poland **Facility:** Katedra I Klinika Neurologii; Slaskiej Akademii Medycznej, Samodzielny Publiczny Centralny Szpital Kliniczny **Zip:** 40-752 **Location 30:** **City:** Lodz **Country:** Poland **Facility:** Katedra I Klinika Neurologii, Univerytetu Medycznego w Lodzi **Zip:** 90-153 **Location 31:** **City:** Lublin **Country:** Poland **Facility:** Katedra I Klinika Neurologii **Zip:** 20-954 **Location 32:** **City:** Warsaw **Country:** Poland **Facility:** Klinika Neurologiczna, Wojskowy Instut Medyczny **Zip:** 00-909 **Location 33:** **City:** Bratislava 2 **Country:** Slovakia **Facility:** Fakultna menocnica Bratislava **Zip:** 83-305 **Location 34:** **City:** Bratislava 2 **Country:** Slovakia **Facility:** Dererova nemocnica s Poliklinikou Nerologicka Klinika **Zip:** 833 05 **Location 35:** **City:** Lund **Country:** Sweden **Facility:** Lasarette Neurologiavdeling **Location 36:** **City:** Stockholm **Country:** Sweden **Facility:** Karilinska Sjukhuset **Location 37:** **City:** Nottingham **Country:** United Kingdom **Facility:** University Hospital, Queens Medical Centre **Zip:** NG7 2UH #### Overall Officials **Official 1:** **Affiliation:** Mt Sinai Medical Center, New York, NY **Name:** Fred D Lublin, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Fazekas F, Lublin FD, Li D, Freedman MS, Hartung HP, Rieckmann P, Sorensen PS, Maas-Enriquez M, Sommerauer B, Hanna K; PRIVIG Study Group; UBC MS/MRI Research Group. Intravenous immunoglobulin in relapsing-remitting multiple sclerosis: a dose-finding trial. Neurology. 2008 Jul 22;71(4):265-71. doi: 10.1212/01.wnl.0000318281.98220.6f. **PMID:** 18645164 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000020278 - Term: Demyelinating Autoimmune Diseases, CNS - ID: D000020274 - Term: Autoimmune Diseases of the Nervous System - ID: D000009422 - Term: Nervous System Diseases - ID: D000003711 - Term: Demyelinating Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M12060 - Name: Multiple Sclerosis - Relevance: HIGH - As Found: Multiple Sclerosis - ID: M15415 - Name: Sclerosis - Relevance: HIGH - As Found: Sclerosis - ID: M22314 - Name: Multiple Sclerosis, Relapsing-Remitting - Relevance: HIGH - As Found: Multiple Sclerosis, Relapsing-Remitting - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M22098 - Name: Demyelinating Autoimmune Diseases, CNS - Relevance: LOW - As Found: Unknown - ID: M22094 - Name: Autoimmune Diseases of the Nervous System - Relevance: LOW - As Found: Unknown - ID: M6909 - Name: Demyelinating Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009103 - Term: Multiple Sclerosis - ID: D000020529 - Term: Multiple Sclerosis, Relapsing-Remitting - ID: D000012598 - Term: Sclerosis ### Intervention Browse Module - Ancestors - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: HIGH - As Found: Cap - ID: M10184 - Name: Immunoglobulins - Relevance: HIGH - As Found: Cap - ID: M19117 - Name: Immunoglobulins, Intravenous - Relevance: HIGH - As Found: Dronabinol - ID: M8836 - Name: gamma-Globulins - Relevance: HIGH - As Found: Dronabinol - ID: M20191 - Name: Rho(D) Immune Globulin - Relevance: HIGH - As Found: Dronabinol - ID: M10122 - Name: Immunoglobulin G - Relevance: HIGH - As Found: Cap - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007136 - Term: Immunoglobulins - ID: D000000906 - Term: Antibodies - ID: D000005719 - Term: gamma-Globulins - ID: D000016756 - Term: Immunoglobulins, Intravenous - ID: D000018029 - Term: Rho(D) Immune Globulin - ID: D000007074 - Term: Immunoglobulin G ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw) **ID:** EG000 **Other Num Affected:** 32 **Other Num at Risk:** 45 **Serious Number Affected:** 2 **Serious Number At Risk:** 45 **Title:** IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw) **Group ID:** EG001 **Title:** IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw) **ID:** EG001 **Other Num Affected:** 26 **Other Num at Risk:** 42 **Serious Number Affected:** 2 **Serious Number At Risk:** 42 **Title:** IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw) **Group ID:** EG002 **Title:** Placebo (0.1% Albumin) 4 mL/kg bw/Infusion **ID:** EG002 **Other Num Affected:** 29 **Other Num at Risk:** 41 **Serious Number Affected:** 1 **Serious Number At Risk:** 41 **Title:** Placebo (0.1% Albumin) 4 mL/kg bw/Infusion **Frequency Threshold:** 5 #### Other Events **Term:** Vertigo **Organ System:** Ear and labyrinth disorders **Source Vocabulary:** **Term:** Nausea **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Vomiting **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Asthenia **Organ System:** General disorders **Source Vocabulary:** **Term:** Fatigue **Organ System:** General disorders **Source Vocabulary:** **Term:** Feeling cold **Organ System:** General disorders **Source Vocabulary:** **Term:** Pyrexia **Organ System:** General disorders **Source Vocabulary:** **Term:** Bronchitis **Organ System:** Infections and infestations **Source Vocabulary:** **Term:** Influenza **Organ System:** Infections and infestations **Source Vocabulary:** **Term:** Nasopharyngitis **Organ System:** Infections and infestations **Source Vocabulary:** **Term:** Rhinitis **Organ System:** Infections and infestations **Source Vocabulary:** **Term:** Upper respiratory tract infection **Organ System:** Infections and infestations **Source Vocabulary:** **Term:** Urinary tract infection **Organ System:** Infections and infestations **Source Vocabulary:** **Term:** Arthralgia **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** **Term:** Back pain **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** **Term:** Dizziness **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Headache **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Hypoaesthesia **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Paraesthesia **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Depression **Organ System:** Psychiatric disorders **Source Vocabulary:** **Term:** Cough **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** **Term:** Pharyngolaryngeal pain **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** **Term:** Erythema **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** #### Serious Events **Term:** Headache **Notes:** Subject #2005 **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 45 **Group ID:** EG001 **Num At Risk:** 42 **Group ID:** EG002 **Num At Risk:** 41 **Term:** Herpes Zoster ophthalmic **Notes:** Subject #506004 **Organ System:** Eye disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 45 **Group ID:** EG001 **Num At Risk:** 42 **Group ID:** EG002 **Num At Risk:** 41 **Term:** Vasculitis, peripheral **Notes:** Subject #502004 **Organ System:** Vascular disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 45 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 42 **Group ID:** EG002 **Num At Risk:** 41 **Term:** Panic attacks **Notes:** Subject #506003 **Organ System:** Psychiatric disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 45 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 42 **Group ID:** EG002 **Num At Risk:** 41 **Term:** Toothache **Notes:** Subject #507003 **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 45 **Group ID:** EG001 **Num At Risk:** 42 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 41 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 45 **Group ID:** BG001 **Value:** 42 **Group ID:** BG002 **Value:** 41 **Group ID:** BG003 **Value:** 128 **Units:** Participants ### Group **ID:** BG000 **Title:** IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw) ### Group **ID:** BG001 **Title:** IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw) ### Group **ID:** BG002 **Title:** Placebo (0.1% Albumin) 4 mL/kg bw/Infusion ### Group **ID:** BG003 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 0 #### Measurement **Group ID:** BG003 **Value:** 1 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 45 #### Measurement **Group ID:** BG001 **Value:** 41 #### Measurement **Group ID:** BG002 **Value:** 41 #### Measurement **Group ID:** BG003 **Value:** 127 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 #### Measurement **Group ID:** BG003 **Value:** 0 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 7.5 **Value:** 31.9 #### Measurement **Group ID:** BG001 **Spread:** 7.9 **Value:** 34.4 #### Measurement **Group ID:** BG002 **Spread:** 8.7 **Value:** 33.0 #### Measurement **Group ID:** BG003 **Spread:** 8.0 **Value:** 33.1 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 38 #### Measurement **Group ID:** BG001 **Value:** 27 #### Measurement **Group ID:** BG002 **Value:** 31 #### Measurement **Group ID:** BG003 **Value:** 96 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 7 #### Measurement **Group ID:** BG001 **Value:** 15 #### Measurement **Group ID:** BG002 **Value:** 10 #### Measurement **Group ID:** BG003 **Value:** 32 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 5 #### Measurement **Group ID:** BG001 **Value:** 3 #### Measurement **Group ID:** BG002 **Value:** 3 #### Measurement **Group ID:** BG003 **Value:** 11 **Class Title:** United States #### Measurement **Group ID:** BG000 **Value:** 6 #### Measurement **Group ID:** BG001 **Value:** 10 #### Measurement **Group ID:** BG002 **Value:** 6 #### Measurement **Group ID:** BG003 **Value:** 22 **Class Title:** Czech Republic #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 2 #### Measurement **Group ID:** BG003 **Value:** 8 **Class Title:** Hungary #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 0 #### Measurement **Group ID:** BG003 **Value:** 3 **Class Title:** Greece #### Measurement **Group ID:** BG000 **Value:** 5 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 5 #### Measurement **Group ID:** BG003 **Value:** 11 **Class Title:** Canada #### Measurement **Group ID:** BG000 **Value:** 10 #### Measurement **Group ID:** BG001 **Value:** 6 #### Measurement **Group ID:** BG002 **Value:** 8 #### Measurement **Group ID:** BG003 **Value:** 24 **Class Title:** Poland #### Measurement **Group ID:** BG000 **Value:** 3 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 2 #### Measurement **Group ID:** BG003 **Value:** 6 **Class Title:** Austria #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 2 #### Measurement **Group ID:** BG003 **Value:** 3 **Class Title:** Israel #### Measurement **Group ID:** BG000 **Value:** 9 #### Measurement **Group ID:** BG001 **Value:** 15 #### Measurement **Group ID:** BG002 **Value:** 11 #### Measurement **Group ID:** BG003 **Value:** 35 **Class Title:** Germany #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 2 #### Measurement **Group ID:** BG003 **Value:** 5 **Class Title:** United Kingdom **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement **Other Details:** The investigator must send a draft manuscript of the publication or abstract to the sponsor thirty days in advance of submission in order to obtain approval prior to submission of the final version for publication. This will be reviewed promptly and approval will not be withheld unreasonably. In case of a difference of opinion between the sponsor and the investigator(s), the contents of the publication will be discussed in order to find a solution which satisfies both parties. **Restriction Type:** OTHER **Restrictive Agreement:** True ### Point of Contact **Email:** ralph.kantor@talecris.com **Organization:** Talecris Biotherapeutics **Phone:** 1-800-520-2807 **Title:** Ralph Kantor, PhD ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** The primary efficacy comparison was the comparison of the proportions of relapse free subjects (relapse defined as reported, not necessarily confirmed relapse). The multiple test procedure (hierarchical procedure) was to be stopped as soon as one of the statistical tests resulted in a non-significant P value \> 0.05. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.221 **P-Value Comment:** 0.2g/kg IGIV Group versus Placebo **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Cochran-Mantel-Haenszel **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** The primary efficacy comparison was the comparison of the proportions of relapse free subjects (relapse defined as reported, not necessarily confirmed relapse). The multiple test procedure (hierarchical procedure) was to be stopped as soon as one of the statistical tests resulted in a non-significant P value \> 0.05. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.471 **P-Value Comment:** 0.4 g/kg IGIV Group versus Placebo **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Cochran-Mantel-Haenszel **Tested Non-Inferiority:** False ## Results Section ### Outcome Measures Module #### Outcome Measure 1 #### Outcome Measure 2 **Anticipated Posting Date:** 2009-09 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 56.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 59.5 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 68.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 43.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 40.5 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 31.7 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Reporting Status:** NOT_POSTED **Time Frame:** 1 year **Title:** Effect on the Combined Unique Lesion Activity on Magnetic Resonance Imaging (MRI) **Type:** SECONDARY #### Outcome Measure 2 **Description:** A relapse was defined for the purposes of this study as the appearance or reappearance of one or more neurological symptoms or worsening of an old symptom attributed to multiple sclerosis (MS) persisting for at least 48 hours and immediately preceded by a relatively stable or improving neurological state of at least 30 days. **Parameter Type:** NUMBER **Population Description:** Intent-to-Treat (ITT) Population was all randomized subjects. This was the primary analysis population. **Reporting Status:** POSTED **Time Frame:** 12 months **Title:** Percentage of Relapse Free Subjects (no Relapse) **Type:** PRIMARY **Unit of Measure:** percentage of participants ##### Group **ID:** OG000 **Title:** IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw) ##### Group **ID:** OG001 **Title:** IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw) ##### Group **ID:** OG002 **Title:** Placebo (0.1% Albumin) 4 mL/kg bw/Infusion ### Participant Flow Module #### Group **Description:** Immune globulin (intravenous) (IGIV) **ID:** FG000 **Title:** IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg Body Weight) #### Group **Description:** Immune globulin (intravenous) (IGIV) **ID:** FG001 **Title:** IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg Body Weight) #### Group **Description:** Immune globulin (intravenous) (IGIV) **ID:** FG002 **Title:** Placebo (0.1% Albumin) 4 mL/kg Body Weight/Infusion #### Period **Title:** Overall Study ##### Withdraw **Type:** Adverse Event ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ###### Reason **Group ID:** FG002 **Number of Subjects:** 0 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 4 ###### Reason **Group ID:** FG002 **Number of Subjects:** 1 ##### Withdraw **Type:** Non-compliance ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ###### Reason **Group ID:** FG002 **Number of Subjects:** 0 ##### Withdraw **Type:** Too time consuming ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ###### Reason **Group ID:** FG002 **Number of Subjects:** 0 ##### Withdraw **Type:** Pregnancy ###### Reason **Group ID:** FG000 **Number of Subjects:** 0 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ###### Reason **Group ID:** FG002 **Number of Subjects:** 2 ##### Withdraw **Type:** Lack of Efficacy ###### Reason **Group ID:** FG000 **Number of Subjects:** 3 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ###### Reason **Group ID:** FG002 **Number of Subjects:** 1 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 45 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 42 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 41 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 38 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 38 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 37 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 7 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 4 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 4 **Recruitment Details:** The study was conducted in 31 study centers in Austria, Canada, Czech Republic, Germany, United Kingdom, Greece, Hungary, Israel, Poland, and the United States. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT04080479 **Brief Title:** Bolus Versus Continuous Enteral Tube Feeding **Official Title:** Bolus Versus Continuous Enteral Feeding in Critically Ill Patients #### Organization Study ID Info **ID:** FNO-KARIM-12-Enteral_Feeding #### Organization **Class:** OTHER **Full Name:** University Hospital Ostrava ### Status Module #### Completion Date **Date:** 2021-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-12-07 **Type:** ACTUAL **Last Update Submit Date:** 2022-12-06 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-09-30 **Type:** ACTUAL #### Start Date **Date:** 2019-10-01 **Type:** ACTUAL **Status Verified Date:** 2022-12 #### Study First Post Date **Date:** 2019-09-06 **Type:** ACTUAL **Study First Submit Date:** 2019-09-03 **Study First Submit QC Date:** 2019-09-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital Ostrava #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Stress metabolisms induced by severe trauma, large abdominal surgery procedures, sepsis, etc. leads to metabolic changes, which increase energy expenditure, enhanced protein catabolism, insulin resistance. Muscle proteolysis is massively stimulated. Critically ill patients pay for survival with a loss of muscles. Enteral nutrition, especially protein delivery to critically ill, is very important for optimizing their outcome. Standard enteral feeding regiments are generally based on continuous feeding, which is thought to be better tolerated by critically ill patients with easier glycaemic control by continuous infusion of insulin, translated in less glycaemic variability. But this approach is not physiological, continuous feeding does not allow protein synthesis. Optimal protein synthesis requires a pulsatile increase in branched-chain amino acids. Bolus feeding activates the entrohormonal axis (bioactive peptides, insulin), and stimulates skeletal muscle synthesis to the maximum extent. The question is, whether bolus enteral feeding in critically ill patients with limited gastrointestinal function delivers a greater amount of protein, improves nutritional parameters, with higher quadriceps muscle layer thickness (QMLT) and muscle strength. **Detailed Description:** The trial has been designed in accordance with the Recommendations for Interventional Trials (SPIRIT 2013) and the Consolidated Standards for Reporting of Trials CONSORT guidelines. Patients who meet the study inclusion criteria (severe trauma patients, surgical patients and medical patients with sepsis, with inserted nasogastric/nasoduodenal feed-ing tube) will be eligible to participate, especially patients who are mechanically ventilated. The last criterion is not a necessary precondition (a module of indirect calorimetry will be used in these patients). The necessary condition is the elimination of shock within 24 hours from the ICU admission and tolerance of trophic enteral feed-ing (20ml/hour) at for the period of at least 24 hours. Patients will be randomized in a ratio of 1:1 within 72 hours of their admission to receive bolus or continuous enteral feeding (sealed envelopes method). In both groups, the same goals of energy and protein will be observed (Day 1-2: E 15 kcal/kg/day, protein 0.8-1 g/kg/day; Day 3-4: E 20 kcal/kg/day, protein 1. 2 g/kg/day; Day ≥ 5: E 25 kcal/kg/day, protein 1.5-2 g/kg/day), according to protocol. The bolus enteral group will receive the amount of enteral nutrition in six boluses (per 60min dose), the continuous enteral group will receive the amount using a pump, within the timeframe of 6am-24pm. The need for parenteral nutrition will be determined by treating clinical staff independently to group allocation. Demographic data collection: (weight, high, BMI) and conditions (trauma, surgical, medical patients), Acute Physiology and Chronic Health Evaluation (APACHE) Sequential Organ Failure Assessment (SOFA), Nutritional Risk Screening (NRS 2002). Daily observations: glucose, mean glucose changes, insulin (IU/d), energy and protein intake (administered calories divided by the calculated energy expenditure and administered protein divided by calculated protein intake) - Adjusted/calculated energy and protein (%). Feeding intolerance (tolerating less than 40% of requirements via the enteral route for ≥ 3 days, diarrhea ≥ 500ml per day or five bowel actions). Mechanically ventilated patients (Resting Energy Expenditure (REE) and Respiratory Quotient (RQ) measured with indirect calorimetry) Day 1, 3, 5, 7: Nutritional parameters (serum albumin prealbumin, C-reactive protein (CRP), urine urea, N balance). Day 1 and 7: Muscle layer thickness (QMLT by ultrasound measurement and mid-upper arm circumference) and muscle strength (dynamometer) from baseline to discharge. Outcomes of muscle strength/ultrasound and dynamometer) will be measured by an investigator blinded to the group allocation. ### Conditions Module **Conditions:** - Trauma Injury - Major Abdominal Surgery - Sepsis **Keywords:** - bolus enteral feeding - continuous enteral feeding - protein synthesis - nutritional parameters ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The study subjects will be randomized into one of the two study arms. ##### Masking Info **Masking:** NONE **Masking Description:** No masking will be used in the study. **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The patients randomized into this study arm will receive bolus enteral feeding. The study subjects will undergo the following interventions: * Quadriceps Muscle Layer Fitness measurement * Muscle Strength measurement * Acute Physiology and Chronic Health Evaluation * Sequential Organ Failure Assessment * Nutritional Risk Screening * Energy and Protein Intake **Intervention Names:** - Diagnostic Test: Quadriceps Muscle Layer Fitness - Diagnostic Test: Muscle Strength - Diagnostic Test: Acute Physiology and Chronic Health Evaluation - Diagnostic Test: Sequential Organ Failure Assessment - Diagnostic Test: Nutritional Risk Screening - Diagnostic Test: Energy and Protein Intake **Label:** Bolus enteral feeding **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The patients randomized into this study arm will receive bolus enteral feeding. The study subjects will undergo the following interventions: * Quadriceps Muscle Layer Fitness measurement * Muscle Strength measurement * Acute Physiology and Chronic Health Evaluation * Sequential Organ Failure Assessment * Nutritional Risk Screening * Energy and Protein Intake **Intervention Names:** - Diagnostic Test: Quadriceps Muscle Layer Fitness - Diagnostic Test: Muscle Strength - Diagnostic Test: Acute Physiology and Chronic Health Evaluation - Diagnostic Test: Sequential Organ Failure Assessment - Diagnostic Test: Nutritional Risk Screening - Diagnostic Test: Energy and Protein Intake **Label:** Continuous enteral feeding **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Bolus enteral feeding - Continuous enteral feeding **Description:** The QMLF examination will be performed in all study subjects, with both bolus and continuous enteral feeding. **Name:** Quadriceps Muscle Layer Fitness **Other Names:** - QMLF **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - Bolus enteral feeding - Continuous enteral feeding **Description:** All study subjects, with both bolus and continuous enteral feeding, will undergo measurement of the muscle strength using dynamometer. **Name:** Muscle Strength **Type:** DIAGNOSTIC_TEST #### Intervention 3 **Arm Group Labels:** - Bolus enteral feeding - Continuous enteral feeding **Description:** All study subjects, with both bolus and continuous enteral feeding, will undergo the APACHE evaluation. **Name:** Acute Physiology and Chronic Health Evaluation **Other Names:** - APACHE **Type:** DIAGNOSTIC_TEST #### Intervention 4 **Arm Group Labels:** - Bolus enteral feeding - Continuous enteral feeding **Description:** All study subjects, with both bolus and continuous enteral feeding, will undergo the SOFA assessment. **Name:** Sequential Organ Failure Assessment **Other Names:** - SOFA **Type:** DIAGNOSTIC_TEST #### Intervention 5 **Arm Group Labels:** - Bolus enteral feeding - Continuous enteral feeding **Description:** All study subjects, with both bolus and continuous enteral feeding, will undergo the NSR screening. **Name:** Nutritional Risk Screening **Other Names:** - NSR **Type:** DIAGNOSTIC_TEST #### Intervention 6 **Arm Group Labels:** - Bolus enteral feeding - Continuous enteral feeding **Description:** The amount of energy and protein supplied to the study subjects will be observed daily in all study subjects, with both bolus and continuous enteral feeding, the percentage of the planned daily intake will be analyzed. **Name:** Energy and Protein Intake **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** The development of the serum albumin levels in g/dL will be observed. **Measure:** Change in nutritional parameters - serum albumin **Time Frame:** 7 days **Description:** The development of the serum albumin levels in mg/dL will be observed. **Measure:** Change in nutritional parameters - prealbumin **Time Frame:** 7 days **Description:** The development of inflammatory parameters in mg/L will be observed. **Measure:** Change in inflammatory parameters - C-reactive protein (CRP) **Time Frame:** 7 days **Description:** The development of muscle mass (circumference in centimetres) will be measured. **Measure:** Change in muscle mass **Time Frame:** 7 days **Description:** The development of muscle strength (in kilograms) will be measured. **Measure:** Change in muscle strength **Time Frame:** 7 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * polytrauma * major abdominal surgery * sepsis * ICU stay * enteral feeding tube * artificial ventilation Exclusion Criteria: * contraindication of enteral feeding * infaust prognosis * prolonged shock (more than 24 hours) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Ostrava **Country:** Czechia **Facility:** University Hospital Ostrava **State:** Moravian-Silesian Region **Zip:** 70852 #### Overall Officials **Official 1:** **Affiliation:** University Hospital Ostrava **Name:** Marcela Káňová, MD,PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** There is no plan to make individual participant data available to other researchers. **IPD Sharing:** NO ### References Module #### References **Citation:** Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586. **PMID:** 23303884 **Citation:** Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672-7. doi: 10.1016/j.ijsu.2011.09.004. Epub 2011 Oct 13. No abstract available. **PMID:** 22019563 **Citation:** Fetterplace K, Deane AM, Tierney A, Beach L, Knight LD, Rechnitzer T, Forsyth A, Mourtzakis M, Presneill J, MacIsaac C. Targeted full energy and protein delivery in critically ill patients: a study protocol for a pilot randomised control trial (FEED Trial). Pilot Feasibility Stud. 2018 Feb 20;4:52. doi: 10.1186/s40814-018-0249-9. eCollection 2018. **PMID:** 29484196 **Citation:** Tillquist M, Kutsogiannis DJ, Wischmeyer PE, Kummerlen C, Leung R, Stollery D, Karvellas CJ, Preiser JC, Bird N, Kozar R, Heyland DK. Bedside ultrasound is a practical and reliable measurement tool for assessing quadriceps muscle layer thickness. JPEN J Parenter Enteral Nutr. 2014 Sep;38(7):886-90. doi: 10.1177/0148607113501327. Epub 2013 Aug 26. **PMID:** 23980134 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC01 - Name: Infections ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M19010 - Name: Critical Illness - Relevance: LOW - As Found: Unknown - ID: M20864 - Name: Sepsis - Relevance: LOW - As Found: Unknown - ID: M16869 - Name: Toxemia - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00933179 **Brief Title:** FC Patch Low: Metabolism Study **Official Title:** A Single-Center, Open-Label, Crossover, Randomized Study to Investigate the Impact of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene (Material no. 80876395) in a 21-day Regimen as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (0.03mg/0.15mg) in a 21-day Regimen on Hemostatic Parameters in 30 Women Aged 18 182 35 Years Over 3 Treatment Cycles in Each Period #### Organization Study ID Info **ID:** 91557 #### Organization **Class:** INDUSTRY **Full Name:** Bayer #### Secondary ID Infos **ID:** 2008-007024-26 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2010-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2014-11-14 **Type:** ESTIMATED **Last Update Submit Date:** 2014-11-13 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2010-09 **Type:** ACTUAL #### Start Date **Date:** 2009-06 **Status Verified Date:** 2014-11 #### Study First Post Date **Date:** 2009-07-07 **Type:** ESTIMATED **Study First Submit Date:** 2009-07-03 **Study First Submit QC Date:** 2009-07-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Bayer #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The aim of the present study is to investigate the effects of the transdermal patch on the parameters of hemostasis (blood clotting), lipid (fat), and carbohydrate (sugars) metabolism in healthy women who require contraception. ### Conditions Module **Conditions:** - Contraception **Keywords:** - Prevention of pregnancy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Gestodene/EE Patch (BAY86-5016) **Label:** Arm 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: EE/Levonorgestrel (Microgynon, BAY86-4977) **Label:** Arm 2 **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm 1 **Description:** 21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 3 cycles **Name:** Gestodene/EE Patch (BAY86-5016) **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Arm 2 **Description:** 21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 3 cycles **Name:** EE/Levonorgestrel (Microgynon, BAY86-4977) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Prothrombin fragment 1+2, D-dimer **Time Frame:** Screening, visit 3-7 #### Secondary Outcomes **Measure:** Procoagulatory parameters **Time Frame:** Screening, visit 3-7 **Measure:** Anticoagulatory parameters **Time Frame:** Screening, visit 3-7 **Measure:** Thrombin and Fibrin turnover parameters **Time Frame:** Screening, visit 3-7 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy woman requesting contraception * Normal cervical smear not requiring further follow-up * History of regular cyclic menstrual periods * Willingness to use non-hormonal contraception during the two wash-out cycles both before the start of treatment and between the two treatment periods Exclusion Criteria: * Pregnancy or lactation - Obesity (Body Mass Index \[BMI\] \> 30.0 kg/m2) * Any diseases or conditions that can compromise the function of the body systems * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results * Any disease or condition that may worsen under hormonal treatment * Undiagnosed abnormal genital bleeding * Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results **Healthy Volunteers:** True **Maximum Age:** 35 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Berlin **Country:** Germany **Zip:** 10115 #### Overall Officials **Official 1:** **Affiliation:** Bayer **Name:** Bayer Study Director **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Junge W, Heger-Mahn D, Trummer D, Merz M. Investigation of the hemostatic effect of a transdermal patch containing 0.55 mg ethinyl estradiol and 2.1 mg gestodene compared with a monophasic oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel: an open-label, randomized, crossover study. Drugs R D. 2013 Sep;13(3):223-33. doi: 10.1007/s40268-013-0028-2. **PMID:** 24043457 #### See Also Links **Label:** Click here to find information about studies related to Bayer Healthcare products conducted in Europe **URL:** http://www.clinicaltrialsregister.eu/ ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000080066 - Term: Contraceptive Agents, Hormonal - ID: D000003270 - Term: Contraceptive Agents - ID: D000012102 - Term: Reproductive Control Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000003271 - Term: Contraceptive Agents, Female - ID: D000003280 - Term: Contraceptives, Oral, Synthetic - ID: D000003276 - Term: Contraceptives, Oral - ID: D000003277 - Term: Contraceptives, Oral, Combined - ID: D000003278 - Term: Contraceptives, Oral, Hormonal - ID: D000003282 - Term: Contraceptives, Postcoital, Hormonal - ID: D000003281 - Term: Contraceptives, Postcoital - ID: D000003283 - Term: Contraceptives, Postcoital, Synthetic - ID: D000011372 - Term: Progestins - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Coag - Name: Coagulants ### Intervention Browse Module - Browse Leaves - ID: M8145 - Name: Ethinyl Estradiol - Relevance: LOW - As Found: Unknown - ID: M266284 - Name: Gestodene - Relevance: HIGH - As Found: FEES - ID: M9576 - Name: Hemostatics - Relevance: LOW - As Found: Unknown - ID: M19256 - Name: Levonorgestrel - Relevance: HIGH - As Found: SBRT - ID: M6494 - Name: Contraceptive Agents - Relevance: LOW - As Found: Unknown - ID: M21285 - Name: Ethinyl Estradiol-Norgestrel Combination - Relevance: HIGH - As Found: Clotting - ID: M266279 - Name: Estradiol 17 beta-cypionate - Relevance: LOW - As Found: Unknown - ID: M266280 - Name: Estradiol 3-benzoate - Relevance: LOW - As Found: Unknown - ID: M8108 - Name: Estradiol - Relevance: LOW - As Found: Unknown - ID: M234941 - Name: Polyestradiol phosphate - Relevance: LOW - As Found: Unknown - ID: M265601 - Name: Ethinyl estradiol, levonorgestrel drug combination - Relevance: HIGH - As Found: Clotting - ID: M12581 - Name: Norgestrel - Relevance: LOW - As Found: Unknown - ID: M2116 - Name: Contraceptive Agents, Hormonal - Relevance: LOW - As Found: Unknown - ID: M6495 - Name: Contraceptive Agents, Female - Relevance: LOW - As Found: Unknown - ID: M6500 - Name: Contraceptives, Oral - Relevance: LOW - As Found: Unknown - ID: M6501 - Name: Contraceptives, Oral, Combined - Relevance: LOW - As Found: Unknown - ID: M6502 - Name: Contraceptives, Oral, Hormonal - Relevance: LOW - As Found: Unknown - ID: M6505 - Name: Contraceptives, Postcoital - Relevance: LOW - As Found: Unknown - ID: M14244 - Name: Progestins - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000016912 - Term: Levonorgestrel - ID: C000072593 - Term: Ethinyl estradiol, levonorgestrel drug combination - ID: D000019304 - Term: Ethinyl Estradiol-Norgestrel Combination - ID: C000033273 - Term: Gestodene ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05996679 **Acronym:** ASARD-TMA **Brief Title:** Automated Surveillance, Alert, and Rapid Diagnosis of Thrombotic Microangiopathies: the ASARD-TMA Study **Official Title:** Automated Surveillance, Alert, and Rapid Diagnosis of Thrombotic Microangiopathies: the ASARD-TMA Study #### Organization Study ID Info **ID:** 5761 #### Organization **Class:** OTHER **Full Name:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Status Module #### Completion Date **Date:** 2025-10-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-08-18 **Type:** ACTUAL **Last Update Submit Date:** 2023-08-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-10-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-10-01 **Type:** ESTIMATED **Status Verified Date:** 2023-08 #### Study First Post Date **Date:** 2023-08-18 **Type:** ACTUAL **Study First Submit Date:** 2023-08-10 **Study First Submit QC Date:** 2023-08-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS #### Responsible Party **Investigator Affiliation:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS **Investigator Full Name:** DE STEFANO VALERIO **Investigator Title:** Full Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Recently a pilot study was conducted to evaluate the impact of an electronic alert (e-alert) triggered by the automated algorithm in the efficiency and rapidity in TMA patients' identification in our University Hospital A. Gemelli over 12 months.the TMA diagnostic algorithm has been implemented in the laboratory software of the hospital and applied whenever a patient in the Emergency ward or any other department undergoes blood tests that include platelet count and lactate dehydrogenase. The basic profile in the Emergency ward always has these two parameters. The algorithm automatically identifies patients with a predicted probability of TMA \>90% (6); if this criterion is associated with a platelet count\<100 x 109/L, an automated warning to the hematologist on-call is issued with an SMS, and the patient enters the TMA diagnostic process defined in the diagnostic and treatment pathways (Percorso Diagnostico e Terapeutico Assistensiale, PDTA). The on-duty hematologist urgently evaluates the patient for whom a warning has been issued, relating with the clinician(s) of the ward in which the patient is located. If the suspicion of TMA is confirmed, the diagnostic procedures outlined in the PDTA are performed, with the immediate execution of 2nd level tests. If the on-duty hematologist considers the diagnosis of aHUS possible, they contact the on-call Nephrologist directly for immediate diagnostic investigation and specific urgent therapeutic measures, as needed. The TMA-expert Hematologist and/or TMA-expert Nephrologist is notified as soon as possible by the on-duty hematologist of all cases, both highly suspected and uncertain, and follow up all patients to complete the diagnostic workup to confirm or rule out the diagnosis and implement the appropriate clinical measures. Therefore, the treatment in smaller hospitals that do not have a 24-hour hematological guard service available and the same awareness for TMA. The present study aims to validate these results by testing the system in a multicenter study involving centers with different availability of the hematologist and awareness for TMA. ### Conditions Module **Conditions:** - Thrombotic Microangiopathies ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 29 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Evaluating algorithm to speed up diagnosis and treatment of TMA in smaller hospitals that do not have a 24-hour hematological guard service available and the same awareness for TMA. **Measure:** Time of diagnosis and treatment of Thrombotic microangiopathies **Time Frame:** 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Patients admitted to the Emergency ward or inpatients of the involved Hospitals with suspicion of TMA: * Based on the clinical evaluation of the care physicians * Based on the alerts issued by the automated algorithm Exclusion Criteria: * Patients with a predictive probability of TMA \< 90% (6) according to the diagnostic algorithm **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study will be conducted in 4 Hospitals (Nefrologia e Dialisi Ospedale Maggiore Verona; Area Aggregata di Ematologia, Fondazione Policlinico Tor Vergata, Roma; Nefrologia e Dialisi ASST Santi Paolo e Carlo, Università di Milano; Nefrologia e Dialisi AOU G. Martino - Università degli Studi di Messina) over 12 months. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000013921 - Term: Thrombocytopenia - ID: D000001791 - Term: Blood Platelet Disorders - ID: D000006402 - Term: Hematologic Diseases - ID: D000095542 - Term: Cytopenia ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M28682 - Name: Thrombotic Microangiopathies - Relevance: HIGH - As Found: Thrombotic Microangiopathy - ID: M17400 - Name: Vascular Diseases - Relevance: HIGH - As Found: Microangiopathy - ID: M16680 - Name: Thrombocytopenia - Relevance: LOW - As Found: Unknown - ID: M5072 - Name: Blood Platelet Disorders - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M3170 - Name: Cytopenia - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014652 - Term: Vascular Diseases - ID: D000057049 - Term: Thrombotic Microangiopathies ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03163979 **Acronym:** PROGRAMMA **Brief Title:** Individualized Precise Radiotherapy With the Guidance of Radiosensitivity of Locally Advanced Cervical Cancer **Official Title:** Individualized Precise Radiotherapy With the Guidance of Radiosensitivity: A Study on the Clinical Management Model of Locally Advanced Cervical Cancer #### Organization Study ID Info **ID:** BE2015645 #### Organization **Class:** OTHER **Full Name:** Nanjing Medical University ### Status Module #### Completion Date **Date:** 2019-07-31 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2017-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2017-05-21 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2019-04-30 **Type:** ESTIMATED #### Start Date **Date:** 2015-07-01 **Type:** ACTUAL **Status Verified Date:** 2017-05 #### Study First Post Date **Date:** 2017-05-23 **Type:** ACTUAL **Study First Submit Date:** 2017-04-17 **Study First Submit QC Date:** 2017-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Nanjing Medical University #### Responsible Party **Investigator Affiliation:** Nanjing Medical University **Investigator Full Name:** Ke Gu **Investigator Title:** associate professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Cisplatin-based chemoradiation (CCRT) has been considered as the standard care for patients with locally advanced cervical cancer (LACC). Nevertheless, increasingly more radio-resistant tumors still recur. IMRT including Rapid-Arc have obvious advantage in the dose distribution and organ protection, and positron emission tomography (PET) with F-18 fluorodeoxyglucose (FDG) and Comet analysis have good sensitivity for detecting sites and radiosensitivity of disease. These may be helpful to individualized CCRT of LACC. Three hundred LACC patients are enrolled in the study, who were with FIGO stages IB2-IVA and had no para-aortic lymphadenopathy (\>10 mm) assessed by PET-CT or MRI. All the patients received definitive radiotherapy consisting of external beam whole pelvic RT and HDR-ICBT. The cumulative linear quadratic equivalent dose (EQD2) was 70-75Gy prescribed at point A. Cisplatin 30 mg/m2 weekly was administered concurrently for 5 courses. 2-4 cycles TP (Taxol 135 mg/m2, D1 and DDP 25 mg/m2, D1-3) regimen sequential chemotherapy were performed if complete response (CR) not achieved according to magnetic resonance imaging (MRI) or PET-CT after CCRT. Hypothesis of the study is that CCRT and sequential chemotherapy is safe. Based on FDG-PET/CT and Comet assay, higher doses can be safely delivered individually to accurate tumor volume, while the doses to bladder and rectum are relative low. Comet and FDG-PET/CT-guided IMRT including RapidArc may improve survival in terms of time to progression (TTP), progression-free survival (PFS) and overall survival (OS) and less treatment-related toxicity. The data will be observed and analyzed. **Detailed Description:** Cisplatin-based chemoradiation (CCRT) has been considered as the standard care for patients with locally advanced cervical cancer (LACC). Nevertheless, increasingly more radio-resistant tumors still recur. IMRT including Rapid-Arc have obvious advantage in the dose distribution and organ protection, and positron emission tomography (PET) with F-18 fluorodeoxyglucose (FDG) and Comet analysis have good sensitivity for detecting sites and radiosensitivity of disease. These may be helpful to individualized CCRT of LACC. IMRT including RapidArc could be considered as a treatment selection for LACC patients, and it aims to improve the degree of target coverage, to protect organ at risk (OARs) and healthy tissue sparing compared to other RT solutions and to reduce significantly the treatment time as to RapidArc. Several studies have indicated that FDG-PET/CT increases the accordance between biopsies and delineated tumor volume and has the potential to positively impact the course of treatment. The Comet assay is attractive as a potential clinical test of tumour radiosensitivity. During radiotherapy, accurately defining disease areas is critical to avoid unnecessary irradiation of normal tissue. Based on FDG-PET/CT and Comet assay, higher doses can be safely delivered individually to accurate tumor volume, while the doses to bladder and rectum are relative low. Three hundred LACC patients are enrolled in the study, who were with FIGO stages IB2-IVA and had no para-aortic lymphadenopathy (\>10 mm) assessed by PET-CT or MRI. All the patients received definitive radiotherapy consisting of external beam whole pelvic RT and HDR-ICBT. The cumulative linear quadratic equivalent dose (EQD2) was 70-75Gy prescribed at point A. Cisplatin 30 mg/m2 weekly was administered concurrently for 5 courses. 2-4 cycles TP (Taxol 135 mg/m2, D1 and DDP 25 mg/m2, D1-3) regimen sequential chemotherapy were performed if complete response (CR) not achieved according to magnetic resonance imaging (MRI) or PET-CT after CCRT. Hypothesis of the study is that CCRT and sequential chemotherapy is safe. Comet and FDG-PET/CT-guided IMRT including RapidArc may improve survival in terms of time to progression (TTP), progression-free survival (PFS) and overall survival (OS) and less treatment-related toxicity. The data will be observed and analyzed. ### Conditions Module **Conditions:** - Cervical Cancer **Keywords:** - locally advanced cervical cancer; radiotherapy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 18F-FDG PET/CT and Comet assay guide IMRT Based on FDG-PET/CT and comet analysis, higher doses of irradiation can be delivered to low sensitivity tumor region, so as to achieve individualized treatment. **Intervention Names:** - Biological: 18F-FDG PET/CT and Comet assay guide IMRT **Label:** PET/CT and Comet assay guided IMRT **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** 18F-FDG PET/CT and Comet assay guide RapidArc: 1.A Rapid-Arc plan for cancer of the cervix uteri improved the sparing of organs at risk (OARs) with uncompromised target coverage. 2.Based on FDG-PET/CT and comet analysis, higher doses of irradiation can be delivered to low sensitivity tumor region, so as to achieve individualized treatment. **Intervention Names:** - Biological: 18F-FDG PET/CT and Comet assay guide RapidArc **Label:** PET/CT and Comet assay guided RapidArc **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** RapidArc: A maximum DR of 600 MU/min was set for comparing the 7f-IMRT treatment time. Two 360° coplanar arcs (one clockwise arc rotated from 181° to 179° and the other counter-clockwise arc rotated from 179° to 181°) sharing the same isocentre were used. **Intervention Names:** - Biological: RapidArc **Label:** RapidArc **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Description:** seventy-five patients received IMRT. The 7f-IMRT gantry angles were 0°, 51°, 102°, 153°, 204°, 255° and 306°, with 20 intensity levels and a dose rate of 400 monitor units (MU)/min. Doses were delivered using the step-and-shoot method.Conventional fractionation was used in all patients for a total dose 45-50.4 Gy with 6 MV high-energy photons. **Intervention Names:** - Biological: 7f-IMRT **Label:** 7f-IMRT **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - PET/CT and Comet assay guided RapidArc **Description:** 1.A Rapid-Arc plan for cancer of the cervix uteri improved the sparing of organs at risk (OARs) with uncompromised target coverage. 2.Based on FDG-PET/CT and comet analysis, higher doses of irradiation can be delivered to low sensitivity tumor region, so as to achieve individualized treatment. **Name:** 18F-FDG PET/CT and Comet assay guide RapidArc **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - PET/CT and Comet assay guided IMRT **Description:** Based on FDG-PET/CT and comet analysis, higher doses of irradiation can be delivered to low sensitivity tumor region, so as to achieve individualized treatment. **Name:** 18F-FDG PET/CT and Comet assay guide IMRT **Type:** BIOLOGICAL #### Intervention 3 **Arm Group Labels:** - RapidArc **Description:** RapidArc: A maximum DR of 600 MU/min was set for comparing the 7f-IMRT treatment time. Two 360° coplanar arcs (one clockwise arc rotated from 181° to 179° and the other counter-clockwise arc rotated from 179° to 181°) sharing the same isocentre were used. **Name:** RapidArc **Type:** BIOLOGICAL #### Intervention 4 **Arm Group Labels:** - 7f-IMRT **Description:** seventy-five patients received IMRT. The 7f-IMRT gantry angles were 0°, 51°, 102°, 153°, 204°, 255° and 306°, with 20 intensity levels and a dose rate of 400 monitor units (MU)/min. Doses were delivered using the step-and-shoot method.Conventional fractionation was used in all patients for a total dose 45-50.4 Gy with 6 MV high-energy photons. **Name:** 7f-IMRT **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Progression-Free-Survival **Measure:** PFS **Time Frame:** 3 years #### Secondary Outcomes **Description:** Overall survival **Measure:** OS **Time Frame:** 3 years **Description:** Time to progression **Measure:** TTP **Time Frame:** 3years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age : 18-70 years old; 2. Histology or cytology confirmed cervical squamous cell carcinomas; 3. 2009 FIGO stage includesⅠB2, ⅡA2, ⅡB-ⅣA; 4. Performance status(PS): 0-1; 5. Peripheral blood meet the following conditions: neutrophil count \> 2.0 \* 109/L, white blood cell count \> 4.0 \* 109/L, the platelet count \> 100.0 \* 109/L; 6. Liver and kidney function meet the following conditions: bilirubin \< 1.5 mg/dl, AST and ALT \< 2 times the upper limit of normal serum creatinine \< 1.5 mg/dl, creatinine clearance \> 50 ml/min; 7. Signed informed consent before treatment. Exclusion Criteria: 1. There is no definite pathological diagnosis; 2. Clinical or imaging examination revealed distant metastases; 3. Pelvic had received radiotherapy; 4. Patients can't attend the study because of the associated with other diseases; 5. Patients can't sign the informed consent because of mental disorders, mental disorders; 6. Uncontrolled active infection; 7. No follow-up. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** dr.guke@hotmail.com **Name:** Ke Gu, Doctor **Phone:** +86-512-62364013 **Role:** CONTACT #### Locations **Location 1:** **City:** Suzhou **Contacts:** ***Contact 1:*** - **Email:** dr.guke@hotmail.com - **Name:** Ke Gu, doctor - **Phone:** +86-512-62364013 - **Role:** CONTACT **Country:** China **Facility:** Nanjing Medical University Affiliated Suzhou Hospital **State:** Jiangsu **Status:** RECRUITING **Zip:** 215000 #### Overall Officials **Official 1:** **Affiliation:** Health and Family Planning Commission of Jiangsu Province, China **Name:** Zhi-liang Ding **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Ji S, Hu Q, Zhu J, Chen J, Chen Q, Liu Z, Shen C, Yang R, Sun H, Wu J, Gu K. Combined pretreatment with 18F-FDG PET/CT and Comet assay guides the concurrent chemoradiotherapy of locally advanced cervical cancer: study protocol for a randomized controlled trial. Trials. 2018 Aug 3;19(1):416. doi: 10.1186/s13063-018-2800-7. **PMID:** 30075736 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014594 - Term: Uterine Neoplasms - ID: D000005833 - Term: Genital Neoplasms, Female - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000002577 - Term: Uterine Cervical Diseases - ID: D000014591 - Term: Uterine Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5830 - Name: Uterine Cervical Neoplasms - Relevance: HIGH - As Found: Cervical Cancer - ID: M17342 - Name: Uterine Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8945 - Name: Genital Neoplasms, Female - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5825 - Name: Uterine Cervical Diseases - Relevance: LOW - As Found: Unknown - ID: M17339 - Name: Uterine Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002583 - Term: Uterine Cervical Neoplasms ### Intervention Browse Module - Ancestors - ID: D000019275 - Term: Radiopharmaceuticals - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21686 - Name: Fluorodeoxyglucose F18 - Relevance: HIGH - As Found: Moxifloxacin - ID: M21258 - Name: Radiopharmaceuticals - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000019788 - Term: Fluorodeoxyglucose F18 ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03495479 **Acronym:** CAMPAS **Brief Title:** Aneustat Treatment of Localized Prostate Cancer Under Active Surveillance **Official Title:** Phase IIA, Single-Center, Single-Arm Clinical Study of OMN54 (Aneustat) in Men Diagnosed With Prostate Cancer Being Followed by Active Surveillance #### Organization Study ID Info **ID:** OMN54-PC-02 #### Organization **Class:** INDUSTRY **Full Name:** Omnitura Therapeutics, Inc. ### Status Module #### Completion Date **Date:** 2029-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2021-10-18 **Type:** ACTUAL **Last Update Submit Date:** 2021-10-14 **Overall Status:** WITHDRAWN #### Primary Completion Date **Date:** 2028-01 **Type:** ESTIMATED #### Start Date **Date:** 2025-01 **Type:** ESTIMATED **Status Verified Date:** 2021-10 #### Study First Post Date **Date:** 2018-04-12 **Type:** ACTUAL **Study First Submit Date:** 2016-06-14 **Study First Submit QC Date:** 2018-04-04 **Why Stopped:** No funding ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Vancouver Prostate Centre #### Lead Sponsor **Class:** INDUSTRY **Name:** Omnitura Therapeutics, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Assessment of the effects of OMN54 (Aneustat) in a population of men with indolent prostate cancer who are otherwise healthy and free of significant co-morbidities and have chosen active surveillance for disease management. The investigators will assess how OMN54 affects PSA, overall tumor burden in addition to any changes in urinary flow. Other biomarkers will be tested to follow disease evolution. ### Conditions Module **Conditions:** - Prostate Cancer **Keywords:** - Prostate Cancer - PC - Active Surveillance - Chemonaiive - OMN54 - Aneustat (TM) - PSA - BPH ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Six-month, daily oral dosing in softgel capsules throughout the first 6 months of treat. **Intervention Names:** - Drug: OMN54 **Label:** OMN54 -Treated ### Interventions #### Intervention 1 **Arm Group Labels:** - OMN54 -Treated **Description:** Twice daily, self administered, oral dosing of OMN54. A daily diary log will be prepared by each participant and reviewed by the Investigator. **Name:** OMN54 **Other Names:** - Aneustat(TM) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Quarterly assessment of serum Prostate Specific Antigen (PSA) **Measure:** Changes in Prostate Specific Antigen **Time Frame:** 12 months **Description:** Changes in tumor size based on semi-annual MRI **Measure:** Changes in Tumor Size **Time Frame:** 12 months **Description:** Quartelry assessment of patient urinary flow based on patient IPSS Questionnaire **Measure:** Changes in Urinary Flow **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - Localized prostate cancer suitable for active surveillance 1. Histologically confirmed adenocarcinoma of the prostate, with Gleason Score 6 or less prostate cancer. No limit in the percentage of cancer in each core or percentage of positive cores. 2. Male, 18 years or older 3. Able to swallow the soft gelatin capsule form of the drug which is \~6mm long. 4. Clinically localized prostate cancer: T1-2, NX or N0, MX or M0. 5. No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy). 6. ECOG Performance Status 0 or 1. 7. Patient has elected Active Surveillance as preferred management plan for prostate cancer. 8. Written informed consent obtained prior to any patient participation. 9. Participant is accessible and compliant for follow-up. 10. Prostate biopsy requirements: 1. If diagnosis was within one year of baseline visit, participant must have at least one biopsy with at least 10 cores. 2. If diagnosis was more than 1 year prior to baseline visit, participant must have a minimum of 2 biopsies, one of which must be within 2 years prior to baseline visit. 11. Voiding requirements: IPSS score of at least 15 and Qmax \< 15 cc/s. 12. Adequate hematopoietic function as demonstrated by: * hemoglobin of ≥ 9.0 g/dL without need for sustained blood transfusions * Platelet count ≥100,000 platelet/mm3 (100 x 109/L) * White Blood Cell (WBC) count ≥ 2.0 x109/L and Absolute Neutrophil Count (ANC) ≥1.5 x109/L 13. Adequate hepatobiliary function as demonstrated by: * Total bilirubin level within normal limits * Alanine aminotransferase (ALT) levels within normal limits * Adequate renal function as demonstrated by creatinine level within normal limits or creatinine clearance within normal limits * Coagulation profile (PT, PTT, INR and TCT) within normal limits 14. If of reproductive capacity, willing to use an effective double barrier method of birth control (i.e., latex condom, partner use of diaphragm, cervical cap, etc) during the study and for 30 days after the last administration of OMN54 Exclusion Criteria: 1. Unwillingness or inability to undergo serial prostate biopsy or MRI. 2. History of other malignancies, except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer (Ta) or other solid tumors curatively treated with no evidence of disease for \> 5 years. 3. Previous surgical intervention for BPH 4. Active uncontrolled infection, including known history of HIV, hepatitis B or C 5. Concurrent uncontrolled hypertension 6. Congestive Heart Failure 7. Hepatic disease (cirrhosis, hepatitis, hepatocellular carcinoma or liver failure of unknown etiology) 8. Renal disease (glomerulonephritis, nephropathy, polycystic kidney disease) 9. Patients requiring new treatment of BPH (either medical or surgical) are not eligible. 10. Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption. 11. Known hypersensitivity to any of the three botanical constituents of Aneustat™ (OMN54); soy; any of the plants belonging to the Ganodermataceae family, e.g., reishi mushroom (Ganoderma lucidum, lingzhi); any plants belonging to Labiatae or Lamiaceae families, e.g., culinary herbs including basil, mint, rosemary, sage, savory, marjoram, oregano, thyme, lavender, and perilla; or Aneustat™ (OMN54) excipients. 12. Concurrent administration, or exposure within 30 days, of: * Investigational drugs and devices * Chemotherapy * Radiation therapy * Immunotherapy **Maximum Age:** 72 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Men diagnosed with early stage prostate cancer that elect to pursue active surveillance for disease management and agree to take the study drug. ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Prostate Centre at Vancouver General Hospital **Name:** Alan So, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** This is undecided and will be decided in consultation with the PI. **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005834 - Term: Genital Neoplasms, Male - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000011469 - Term: Prostatic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14335 - Name: Prostatic Neoplasms - Relevance: HIGH - As Found: Prostate Cancer - ID: M8946 - Name: Genital Neoplasms, Male - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14333 - Name: Prostatic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011471 - Term: Prostatic Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01081379 **Brief Title:** The Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection **Official Title:** The Relation Between the Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection #### Organization Study ID Info **ID:** Schlesinger - CMV #### Organization **Class:** OTHER **Full Name:** Shaare Zedek Medical Center ### Status Module #### Completion Date **Date:** 2022-08 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2019-11-13 **Type:** ACTUAL **Last Update Submit Date:** 2019-11-10 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2021-08 **Type:** ESTIMATED #### Start Date **Date:** 2014-02 **Type:** ACTUAL **Status Verified Date:** 2019-11 #### Study First Post Date **Date:** 2010-03-05 **Type:** ESTIMATED **Study First Submit Date:** 2010-03-04 **Study First Submit QC Date:** 2010-03-04 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Shaare Zedek Medical Center #### Responsible Party **Investigator Affiliation:** Shaare Zedek Medical Center **Investigator Full Name:** Yedidia Yifat **Investigator Title:** Yechiel Schlesinger, MD, Shaare Zedek Medical Center. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to find a correlation between function of cytomegalovirus -specific T cells and the probability for intrauterine transmission. **Detailed Description:** Fetal infection with CMV is the most common cause of intrauterine infection. Only 40% of pregnant women with primary CMV transmit the virus to their fetus. Many of these women are referred to amniocentesis and many elect to terminate pregnancy without knowledge about fetal infection or damage. Currently it is assumed that transmission is dictated by variety of factors including maternal and fetal immune system. Efforts to find correlation between maternal immune system and fetal infection which can be used as a diagnostic marker were unsuccessful. Our hypothesis is that there is a correlation between cellular immune response of the mother to CMV infection and viral transmission to the fetus. Pregnant women with primary CMV infection (40% of whom are expected to be transmitters)and with pre-conception immunity will participate in this study. Blood from these women will be incubated with CMV peptides and T cell activation will be measured by the secretion of various cytokines. ### Conditions Module **Conditions:** - Pregnant Women - Cytomegalovirus Infections **Keywords:** - Cytomegalovirus Infections - Pregnancy - T-Lymphocytes - Transmission ### Design Module #### Bio Spec **Description:** serum **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** pre-conception immunity- pregnant women with CMV seropositive **Label:** pre-conception immunity #### Arm Group 2 **Description:** primary CMV infection- pregnant women with primary CMV infection (defined as CMV IgG sero-conversion, the presence of low avidity IgG antibodies or the presence of IgM with no previous IgG antibodies). **Label:** primary CMV infection ### Outcomes Module #### Primary Outcomes **Measure:** Maternal-Fetal transmission of CMV **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Pregnant women * CMV IgG sero-conversion or the presence of low avidity IgG antibodies or the presence of IgM with no previous IgG antibodies. Exclusion Criteria: * Underlying immune deficiencies * Other pregnancy complications **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** Pregnant women with primary CMV ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** s.yechiel@gmail.com **Name:** Yechiel Schlesinger, M.D. **Phone:** 972-2-6555-147 **Role:** CONTACT **Contact 2:** **Email:** yifat4@gmail.com **Name:** Yifat Yedidia-Eldar, Ph. D. **Phone:** 972-26666-775 **Role:** CONTACT #### Locations **Location 1:** **City:** Jerusalem **Contacts:** ***Contact 1:*** - **Name:** Yechiel Schlesinger, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Israel **Facility:** Shaare Zedek Medical Center **Status:** RECRUITING **Zip:** 91031 #### Overall Officials **Official 1:** **Affiliation:** Shaare Zedek Medical Center **Name:** Yechiel Schlesinger, M.D. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000006566 - Term: Herpesviridae Infections - ID: D000004266 - Term: DNA Virus Infections - ID: D000014777 - Term: Virus Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M6791 - Name: Cytomegalovirus Infections - Relevance: HIGH - As Found: Cytomegalovirus Infections - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M9643 - Name: Herpesviridae Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M7442 - Name: DNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: T1720 - Name: Cytomegalic Inclusion Disease - Relevance: HIGH - As Found: Cytomegalovirus Infections ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000003586 - Term: Cytomegalovirus Infections ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M10122 - Name: Immunoglobulin G - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04267679 **Brief Title:** Cannabidiol for Anxiety **Official Title:** Prospective Evaluation of Cannabidiol (CBD) on Anxiety: A Pilot Study #### Organization Study ID Info **ID:** GL-2020 #### Organization **Class:** OTHER **Full Name:** CB2 Insights ### Status Module #### Completion Date **Date:** 2020-12-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-12-19 **Type:** ACTUAL **Last Update Submit Date:** 2020-12-17 **Overall Status:** WITHDRAWN #### Primary Completion Date **Date:** 2020-12-01 **Type:** ACTUAL #### Start Date **Date:** 2020-03-01 **Type:** ACTUAL **Status Verified Date:** 2020-12 #### Study First Post Date **Date:** 2020-02-13 **Type:** ACTUAL **Study First Submit Date:** 2020-02-06 **Study First Submit QC Date:** 2020-02-10 **Why Stopped:** Stopped due to COVID-19 pandemic. ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Green Lotus Hemp #### Lead Sponsor **Class:** OTHER **Name:** CB2 Insights #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This pilot trial seeks to investigate the effect of 25 mg full-spectrum CBD soft gel capsules (up to a total dosage of 100mg per day) on individuals with diagnosed anxiety. All participants will take CBD soft gel capsules for 12 weeks, and will be assessed at 6 weeks and 12 weeks post-enrollment using measures of anxiety, sleep and perception of change. ### Conditions Module **Conditions:** - Anxiety ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will take 25 mg full-spectrum CBD soft gel capsules (2 to 4 per day) for 12 weeks. **Intervention Names:** - Drug: Cannabidiol **Label:** Cannabidiol **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Cannabidiol **Description:** 25 mg full-spectrum CBD soft gel capsules **Name:** Cannabidiol **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The Generalized Anxiety Disorder 7-item scale is one of the most frequently used, validated self-reported questionnaires that is used to screen for, diagnose, and assess severity of generalized anxiety disorder. **Measure:** Generalized Anxiety Disorder 7-item scale **Time Frame:** 12 weeks #### Secondary Outcomes **Description:** Participants will complete the Patients' Global Impression of Change (PGIC) scale at each follow-up visit, which has been regarded as an important self-reported indicator of change. **Measure:** Perception of change **Time Frame:** 12 weeks **Description:** Participants will self-report their intervention compliance using a simple log that will be provided to them at their enrollment visit and will be asked to bring their CBD log to every follow-up visit. Participants will also self-report any medical cannabis or opioid usage. **Measure:** Protocol Compliance **Time Frame:** 12 weeks **Description:** Participants will be asked whether they believe that the CBD intervention has impacted their sleep quality. They will be asked to complete a short 2-question survey. **Measure:** Sleep quality **Time Frame:** 12 weeks ### Eligibility Module **Eligibility Criteria:** 1. Male or female patients 18 years of age or older with a GAD-7 score of 10 or greater 2. Presenting to a participating clinic for initial evaluation for a medical cannabis card 3. Willingness to abstain from the use of all other cannabis products for the trial period (3 months) 4. Not pregnant or planning to become pregnant during the trial period (3 months) 5. Not breastfeeding or planning to breastfeed during the trial period (3 months) 6. No history of cannabis use within 4 weeks of enrollment 7. No history of lifetime cannabis use disorder or other substance use disorders (except: tobacco use disorder) 8. No history of lifetime daily cannabis use 9. No family history of psychosis (e.g., bipolar disorder or schizophrenia) 10. No history of adverse reactions to cannabis 11. No recent changes to prescribed anxiety medications (within the last 1 month) 12. Provision of informed consent **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001008 - Term: Anxiety Disorders ### Intervention Browse Module - Ancestors - ID: D000000927 - Term: Anticonvulsants ### Intervention Browse Module - Browse Branches - Abbrev: AntiConv - Name: Anticonvulsants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M5445 - Name: Cannabidiol - Relevance: HIGH - As Found: Sarcoma - ID: M4246 - Name: Anticonvulsants - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002185 - Term: Cannabidiol ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04367779 **Acronym:** PROTONBIOMARKS **Brief Title:** Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients. **Official Title:** PROTONBIOMARKS - Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients: A Genomic, Epigenetic, and Immunological Analysis #### Organization Study ID Info **ID:** ET19-284 #### Organization **Class:** OTHER **Full Name:** Centre Leon Berard ### Status Module #### Completion Date **Date:** 2024-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-09-13 **Type:** ACTUAL **Last Update Submit Date:** 2023-09-12 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06 **Type:** ESTIMATED #### Start Date **Date:** 2020-09-24 **Type:** ACTUAL **Status Verified Date:** 2023-09 #### Study First Post Date **Date:** 2020-04-29 **Type:** ACTUAL **Study First Submit Date:** 2020-04-24 **Study First Submit QC Date:** 2020-04-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Centre Leon Berard #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This trial is a paucicentric, clinico-biological cohort study with retrospective and prospective enrollment, aiming to identify biomarkers predictive of response to Proton Beam Therapy (PBT) in cancer patients (high grade sarcoma, brain tumors and meningioma). This study include collection of clinical data, of tumor samples (collected during standard of care) and a blood sample for alive patients. **Detailed Description:** The proton beam model policy adopted by the American Society of Radiation Oncology (ASTRO) in 2017 supports proton therapy in primary solid neoplasms in children treated with curative intent. To date, PBT is also recognised in adults as a valid option providing life expectancy \> 10 years, for inoperable axial or head and neck sarcomas, low grade brain tumors (i.e. low grade astrocytoma, oligodendroglioma and ependymoma), non-operated meningioma of skull base and other rare clinical situations (re-irradiation, locally aggressive tumor malignant or not arising in sites which preclude R0 or R1 surgical resection). Recently, Jhaveri et al. have reported the retrospective analysis of a National Cancer Data Base (NCDB) and shown an improved overall survival in adult Grade I-IV glioma patients treated with PBT versus patients treated with radiotherapy (XRT). Positive impact on toxicity free survival and general health status of patients were reported in others indications. centers join their expertise (pediatric, brain and sarcoma cancers for Centre Léon Bérard (CLB) and protons for CAL) and their recruitment to optimize the treatment strategy for these patients. The Centre Leon Bérard recently reported on the ProfilER protocol (NCT01774409). It is the largest molecular characterization program in France with now over 4000 patients included. It enabled to identify genomic biomarkers of radio resistance. In this context, the investigator's proposal is to conduct a genomic, epigenetic, and immunological analysis of patients treated with proton beam therapy with the aim to identify Biomarkers of response to PBT in pediatric and adult patients. ### Conditions Module **Conditions:** - Brain Cancer - Meningioma - Sarcoma **Keywords:** - Proton Beam Therapy - Biomarkers - Pediatric and adult cancers - Proton Therapy ### Design Module #### Bio Spec **Description:** Tumor sample(s) (FFPE and/or Frozen) from primary tumor (biopsy or surgery specimen) Blood sample (only for alive patients) collected at the time of PBT initiation or during any clinical exam performed after validation of inclusion **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** OTHER #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Pediatric and adult patients with High Grade Sarcoma treated or to be treated with Proton Beam Therapy (PBT) and not candidate to surgery before PBT. **Label:** A : High Grade Sarcoma #### Arm Group 2 **Description:** Pediatric and adult patients with Brain Tumors treated or to be treated with Proton Beam Therapy (PBT) and not candidate to surgery before PBT. **Label:** B : Brain tumors #### Arm Group 3 **Description:** Pediatric and adult patients with Meningioma treated or to be treated with Proton Beam Therapy (PBT) and not candidate to surgery before PBT. **Label:** C : Meningioma ### Outcomes Module #### Primary Outcomes **Description:** Correlation between local tumor response according to RECIST 1.1 criteria and expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC) **Measure:** Identify predictive biomarkers for local response at 6 months after the end of Proton Beam Therapy **Time Frame:** At 6 months after the end of Proton Beam Therapy #### Secondary Outcomes **Description:** Correlation between local tumor response according to RECIST 1.1 criteria and expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC) **Measure:** To identify predictive biomarkers for clinical outcomes **Time Frame:** At 12 months and at 24 months after the end of Proton Beam Therapy **Description:** Correlation between progression free survival and expression of biomarkers expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC) **Measure:** To identify predictive biomarkers for clinical outcomes **Time Frame:** From the start of Proton Beam Therapy until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 48 months **Description:** Correlation between overall survival and expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC) **Measure:** To identify predictive biomarkers for clinical outcomes **Time Frame:** From the start of Proton Beam Therapy until the date of death from any cause, assessed up to 48 months **Description:** Correlation between radiation related toxicity (only Adverse Event (AE) Grade ≥3) according to NCI-CTCAE V5.0. and expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC) **Measure:** To identify predictive biomarkers for clinical outcomes **Time Frame:** From the start of Proton Beam Therapy until at least 24 months after the end of Proton Beam Therapy ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * I1 Male or female patients, all ages are eligible. * I2 Confirmed diagnosis of macroscopic tumor previously treated since 2016 (retrospective cohort) or to be treated (prospective cohort) with PBT including one of the following tumor types:Cohort A : high grade sarcoma ; Cohort B: brain tumors; Cohort C: meningioma. * I3 Presence of at least one measurable lesion before PBT initiation. Post operative situation is possible providing a measurable macroscopic residue, non candidate to a new surgery before PBT. * I4 Availability of archival representative formalin-fixed, paraffin-embedded (FFPE) and/or frozen tumor sample, with the corresponding hematoxylin and eosin stained slide and a pathological report, meeting the following quality/quantity control (QC) criteria confirmed by a central pathological review: (this sample will be also used to confirm pathological diagnosis ) : at least 20% of tumor cells and a surface area \> 5mm2 with \> 90μm of depth. * I5. Performance status before PBT: Lansky Play score for pediatric patients \< 12 years of age ≥ 70%; Karnofsky performance status for pediatric patients ≥ 12 years of age ≥ 70%; PS ECOG for adult patients: 0, 1 or 2. * I6. For prospective cohort : Life-expectancy before PBT \> 2 years . * I7. For prospective cohort : Women of child-bearing potential and men must agree to use (must have used for retrospective cohort) adequate contraception during all the radiotherapy procedure * I8. For alive patients - Written informed consent from patient, parents if applicable/legal representative, before any study-specific screening procedures, and willingness to comply to study visits and procedures. Exclusion Criteria: * E1. Patients previously treated with radiotherapy in the same site (re-irradiation), either with protons or photons * E2. Pregnant or breast-feeding patients at time of PBT initiation. **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Alive or Dead cancer patients with high grade sarcoma, brain tumors or meningioma Previously treated with PBT since 2016 (Retrospective cohort) or Patients to be treated with PBT (Prospective cohort) ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** gwenaelle.garin@lyon.unicancer.fr **Name:** Gwenaële Garin **Phone:** + 33 (0)4 78 78 28 28 **Role:** CONTACT **Contact 2:** **Email:** line.claude@lyon.unicancer.fr **Name:** Claude Line **Phone:** + 33 (0)4 78 78 28 28 **Role:** CONTACT #### Locations **Location 1:** **City:** Lyon **Contacts:** ***Contact 1:*** - **Email:** line.claude@lyon.unicancer.fr - **Name:** Claude Line - **Phone:** +33(0)4 78 78 28 28 - **Role:** CONTACT ***Contact 2:*** - **Name:** SUNYACH Marie-Pierre - **Role:** SUB_INVESTIGATOR ***Contact 3:*** - **Name:** GREGOIRE Vincent - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** TANGUY Ronan - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** POMMIER Pascal - **Role:** SUB_INVESTIGATOR **Country:** France **Facility:** Centre Léon Bérard **Status:** RECRUITING **Zip:** 69008 **Location 2:** **City:** Nice **Contacts:** ***Contact 1:*** - **Email:** pierre-yves.bondiau@nice.unicancer.fr - **Name:** BONDIAU Pierre - **Phone:** 04 92 03 12 72 - **Role:** CONTACT ***Contact 2:*** - **Name:** DOYEN Jérôme - **Role:** SUB_INVESTIGATOR **Country:** France **Facility:** Centre Antoine Lacassagne **Status:** RECRUITING **Zip:** 06189 #### Overall Officials **Official 1:** **Affiliation:** Centre Leon Berard **Name:** Claude Line **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009380 - Term: Neoplasms, Nerve Tissue - ID: D000009383 - Term: Neoplasms, Vascular Tissue - ID: D000008577 - Term: Meningeal Neoplasms - ID: D000016543 - Term: Central Nervous System Neoplasms - ID: D000009423 - Term: Nervous System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009422 - Term: Nervous System Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15327 - Name: Sarcoma - Relevance: LOW - As Found: Unknown - ID: M5209 - Name: Brain Neoplasms - Relevance: HIGH - As Found: Brain Cancer - ID: M11562 - Name: Meningioma - Relevance: HIGH - As Found: Meningioma - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: M12328 - Name: Neoplasms, Vascular Tissue - Relevance: LOW - As Found: Unknown - ID: M11560 - Name: Meningeal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M18937 - Name: Central Nervous System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12367 - Name: Nervous System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: T5284 - Name: Soft Tissue Sarcoma - Relevance: LOW - As Found: Unknown - ID: T3707 - Name: Meningioma - Relevance: HIGH - As Found: Meningioma ### Condition Browse Module - Meshes - ID: D000008579 - Term: Meningioma - ID: D000001932 - Term: Brain Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05532579 **Brief Title:** Effectiveness of an Invasive Physical Therapy Protocol in Primary Care Patients With Low Back Pain. Randomized Controlled Clinical Trial **Official Title:** Effectiveness of an Invasive Physical Therapy Protocol in Primary Care Patients With Low Back Pain and Lower Extremity Irradiation. Randomized Controlled Clinical Trial #### Organization Study ID Info **ID:** CFC22LBP #### Organization **Class:** OTHER **Full Name:** Universitat Internacional de Catalunya ### Status Module #### Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2022-09-08 **Type:** ACTUAL **Last Update Submit Date:** 2022-09-04 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-04-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-04-01 **Type:** ESTIMATED **Status Verified Date:** 2022-09 #### Study First Post Date **Date:** 2022-09-08 **Type:** ACTUAL **Study First Submit Date:** 2022-09-04 **Study First Submit QC Date:** 2022-09-04 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universitat Internacional de Catalunya #### Responsible Party **Investigator Affiliation:** Universitat Internacional de Catalunya **Investigator Full Name:** Jacobo Rodríguez Sanz **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Low back pain or lumbar pain is the most frequent cause of incapacity for work in Spain, occupying first place among the most common pathologies diagnosed in this country, followed by cervical pain. Non-specific low back pain is the main cause of public spending on health care and labor concepts, with a prevalence of 80%. Furthermore, this pathology represents more than half (52.92%) of the diagnoses of chronic pain that is neither oncologic nor neuropathic. This situation generates high economic, health care and labor costs, representing an equivalent cost of between 1.7% and 2.1% of the Gross Domestic Product. Low back pain is described as pain located between the lower limit of the ribs and the lower limit of the buttocks, the intensity of which varies according to posture and physical activity, and which is usually accompanied by painful limitation of movement. Approximately 40% of patients with low back pain present irradiation in the lower extremity. The chronification of low back pain can result in central sensitization, causing hypersensitivity to non-painful and painful stimuli even long after the onset of the acute episode of low back pain. The approach to low back pain offers options such as the administration of drugs, prescription of physical exercise, pain education and modification of patients' habits. Minimally invasive techniques in the management of low back pain are arousing greater interest due to their great advantages. In the field of physical therapy, novel techniques have been developed in recent years, such as ultrasound-guided percutaneous musculoskeletal electrolysis and ultrasound-guided percutaneous neuromodulation, in which different types of electric current are applied through solid needles. Different mechanisms of action have been associated with these invasive techniques, such as a potential effect on the activation of descending pain inhibitory system pathways, the reduction of evoked motor potentials and an increase in intracortical inhibition, suggesting benefits in patients with central sensitization. The invasive techniques of electrolysis and neuromodulation have been applied in other studies at the nervous level, especially in the sciatic nerve at the piriformis and ischiotibial level, in the popliteal fossa and in the foot. It has given good results in lumbar pain. However, there is no study carried out in patients with low back pain and the presence of hernias or protrusions, nor is there any control of the evolution in the medium and long term. The application of percutaneous neuromodulation has the capacity to modulate neuronal activity in the primary motor cortex, promoting transient and long-term neuroplastic effects. The modulation of this region is related to a decrease in pain due to the relationship with pain processing areas, such as the thalamus, cingulate cortex and periaqueductal gray matter. Electrical stimulation of the peripheral nervous system percutaneously activates a complex neural network that in turn involves a series of neurotransmitters and receptors, such mechanisms being able to promote segmental analgesia and extra-segmental analgesia. Some studies suggest that percutaneous neuromodulation therapy may have a possible beneficial effect in patients with central sensitization, producing improved conditioned pain modulation, reduced motor evoked potential and enhanced intracortical inhibition. To the authors' knowledge, there are no studies that prove the effectiveness of these invasive techniques in the improvement of neurophysiological parameters in patients with low back pain with irradiation in the lower extremity, presence of hernias and/or protrusions. Taking into account the good empirical results found in private clinics and the precedents of other studies carried out with short-term follow-up in other regions, this treatment approach of outpatient application in primary care centers could mean a discharge of patients who are referred to the hospital for medical care, imaging tests and surgical interventions. **Detailed Description:** Low back pain or lumbar pain is the most frequent cause of incapacity for work in Spain, occupying first place among the most common pathologies diagnosed in this country, followed by cervical pain. Non-specific low back pain is the main cause of public spending on health care and labor concepts, with a prevalence of 80%. Furthermore, this pathology represents more than half (52.92%) of the diagnoses of chronic pain that is neither oncologic nor neuropathic. This situation generates high economic, health care and labor costs, representing an equivalent cost of between 1.7% and 2.1% of the Gross Domestic Product. Low back pain is described as pain located between the lower limit of the ribs and the lower limit of the buttocks, the intensity of which varies according to posture and physical activity, and which is usually accompanied by painful limitation of movement. Approximately 40% of patients with low back pain present irradiation in the lower extremity. The chronification of low back pain can result in central sensitization, causing hypersensitivity to non-painful and painful stimuli even long after the onset of the acute episode of low back pain. The approach to low back pain offers options such as the administration of drugs, prescription of physical exercise, pain education and modification of patients' habits. Minimally invasive techniques in the management of low back pain are arousing greater interest due to their great advantages. In the field of physical therapy, novel techniques have been developed in recent years, such as ultrasound-guided percutaneous musculoskeletal electrolysis and ultrasound-guided percutaneous neuromodulation, in which different types of electric current are applied through solid needles. Different mechanisms of action have been associated with these invasive techniques, such as a potential effect on the activation of descending pain inhibitory system pathways, the reduction of evoked motor potentials and an increase in intracortical inhibition, suggesting benefits in patients with central sensitization. The invasive techniques of electrolysis and neuromodulation have been applied in other studies at the nervous level, especially in the sciatic nerve at the piriformis and ischiotibial level, in the popliteal fossa and in the foot. It has given good results in lumbar pain. However, there is no study carried out in patients with low back pain and the presence of hernias or protrusions, nor is there any control of the evolution in the medium and long term. The application of percutaneous neuromodulation has the capacity to modulate neuronal activity in the primary motor cortex, promoting transient and long-term neuroplastic effects. The modulation of this region is related to a decrease in pain due to the relationship with pain processing areas, such as the thalamus, cingulate cortex and periaqueductal gray matter. Electrical stimulation of the peripheral nervous system percutaneously activates a complex neural network that in turn involves a series of neurotransmitters and receptors, such mechanisms being able to promote segmental analgesia and extra-segmental analgesia. Some studies suggest that percutaneous neuromodulation therapy may have a possible beneficial effect in patients with central sensitization, producing improved conditioned pain modulation, reduced motor evoked potential and enhanced intracortical inhibition. To the authors' knowledge, there are no studies that prove the effectiveness of these invasive techniques in the improvement of neurophysiological parameters in patients with low back pain with irradiation in the lower extremity, presence of hernias and/or protrusions. Taking into account the good empirical results found in private clinics and the precedents of other studies carried out with short-term follow-up in other regions, this treatment approach of outpatient application in primary care centers could mean a discharge of patients who are referred to the hospital for medical care, imaging tests and surgical interventions. ### Conditions Module **Conditions:** - Low Back Pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 38 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Invasive Physiotherapy Group **Label:** Invasive Physiotherapy **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Other: Sham Group **Label:** Sham Group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Invasive Physiotherapy **Description:** The study participants corresponding to the intervention group will receive the treatment proposed by their medical doctor. In addition, and as the main part of the intervention, they will receive an invasive physiotherapy protocol consisting of 3 sessions of ultrasound-guided percutaneous neuromodulation, with a time margin of one week between the first and second session and two weeks between the second and third session. The session will last approximately 15 minutes. Each treatment session will consist of the application of a symmetric biphasic current of 3Hz frequency, 250µsec pulse width, 10 impacts of 10 seconds duration with 10 seconds of rest between them. This application will be performed with acupuncture needles placed in an echoguided manner in the proximity of the dorsal root of the last 3 lumbar levels and in the proximity of the sciatic nerve at its exit from the piriformis muscle. **Name:** Invasive Physiotherapy Group **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Sham Group **Description:** Study participants corresponding to the sham group will receive the treatment proposed by their medical doctor. In addition, they will receive the application of the simulated transcutaneous electrical stimulation technique, placing the patches on the same points where the needles are located, remaining in prone position for the necessary time after the technique is performed until 15 minutes have elapsed. This technique has been studied as a placebo technique for neuromodulation interventions. **Name:** Sham Group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The intensity of hand pain will be recorded, using an 11-point numerical scale (NPRS) (0=no pain, 10=maximum pain). They will be asked for current pain. Because there is no value that determines the minimum clinically relevant difference in hand pain, a 2-point change, or 30% change, will be considered clinically relevant **Measure:** Change in Present Pain Intensity (NPRS 0-10) **Time Frame:** Baseline; 1 month follow-up; 6 month follow-up #### Secondary Outcomes **Description:** The procedures will be performed by a neurophysiologist with more than 10 years of clinical and research experience using an electroneurogram (needles, electrodes and nerve conduction information processors). The electrophysiological diagnostic criteria for low back pain and lumbar nerve root involvement of the American Association of Neuromuscular and Electrodiagnostic Medicine and the normal ranges of motor and sensory nerve conduction as described in the literature will be used. The following will be taken as study variables: existence of denervation, distal motor latency of the sciatic nerve, distal sensory latency of the sciatic nerve, conduction velocity, action potential amplitude. **Measure:** Change in Neurophysiological study (m/s) **Time Frame:** Baseline; 1 month follow-up; 6 month follow-up **Description:** The straight leg elevation test will be used to determine the mechanosensitivity of the sciatic nerve. In this test, a structural differentiation of the symptoms will be made at a distance from the area of symptom onset. Performing an internal rotation of the hip if the symptoms are distal (below the knee) or with a dorsiflexion of the ankles if the symptoms are proximal. This test has obtained consistent values in patients with low back pain, with good inter-examiner reliability in its application. **Measure:** Change in straight leg elevation test (range of motion) **Time Frame:** Baseline; 1 month follow-up; 6 month follow-up **Description:** Questionnaire to determine the degree of physical disability derived from low back pain. A self-administered questionnaire consisting of 24 sentences in which the patient has to indicate whether they relate to his or her current situation or not. Score from 0 to 24. **Measure:** Roland Morris disability Questionnaire **Time Frame:** Baseline; 1 month follow-up; 6 month follow-up **Description:** Scale of global change perceived by the patient, designed to detect improvement or deterioration of the patient over time. An 11-point numerical scale (-7=evolving to much worse; +7=fully recovered). Considering +4 and +5 moderate positive changes and +6 and +7 notable changes. **Measure:** Change in Global rating of change scale **Time Frame:** Baseline; 1 month follow-up; 6 month follow-up **Description:** The strength of the affected lower extremity will be measured with a hand-held dynamometer (MicroFET 2). The functional movements of hip flexion and extension, knee flexion and extension and ankle flexion and extension will be measured. Three measurements per movement will be taken and the average of them will be obtained. **Measure:** Change in lower extremity strength (Newtons) **Time Frame:** Baseline; 1 month follow-up; 6 month follow-up **Description:** The discrimination of two points on the back of the thigh, on the front and back of the leg and the entire region of the foot and ankle will be assessed with a digital caliper. Pressure will be applied with one or two points until causing some discomfort to the patient, having to discriminate whether the patient is stimulated with 1 or 2 points, the minimum distance that he/she manages to discriminate will be recorded. With the patient lying down with eyes closed, the patient will be asked to say "one" when he/she feels that he/she is touched with one point and "two" when he/she feels that he/she is touched with two points. **Measure:** Change in Sensitivity (discrimination of two points) **Time Frame:** Baseline; 1 month follow-up; 6 month follow-up **Description:** Stimulation by means of pressure filaments, seeking to detect the sensitive threshold by means of 1-second pressures, the necessary pressure will be applied to cause a slight deformation of the filament. The numbers of the filaments (1.65-6.65) of Semmes-Weinstein Monofilament, correspond to a logarithmic function of the equivalent forces (0.0045-447 g). The lightest filament detected will be recorded. With the patient lying down, eyes closed, the subject is asked to verbally signal the moment he/she feels the stimulus in the region to be explored. The filament will be applied vertically over the assessment point, slowly, until the filament bends. **Measure:** Change in Sensitivity (Semmes-Weinstein Monofilament Test) **Time Frame:** Baseline; 1 month follow-up; 6 month follow-up **Description:** It will be performed with the aim of exploring the descending inhibitory pathway. In a first term, the test of pain thresholds by pressure in the affected area is performed. A remote area, usually the arm or hand, is subjected to a painful stimulus (ice cube) or ischemia cuff (maximum 10 min at 200 mmHg or up to VAS 6). At that time, the pressure pain threshold test is repeated on the affected area. An increase in the value of the pressure threshold test will denote a correct functioning of the inhibitory modulation. **Measure:** Change in Inhibitory modulation conditioned by pain (Kpa) **Time Frame:** Baseline; 1 month follow-up; 6 month follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age equal to or more than 18 years old. * Have a medical diagnosis of low back pain with or without radicular involvement and irradiation of symptoms in the lower extremity, by the specialist of the Neurophysiology Service of the Hospital de Terrassa "Consorci Sanitari de Terrassa" or of the Hospital Clínico Universitario de Zaragoza, with confirmation of neurophysiological study, in any of its stages. * Have access and be able (or have help) to use an online platform to conduct "meetings" with the health professional. * Read the informed consent and understand the objectives and development of the study. Exclusion Criteria: * Be pending compensation or litigation for health problems. * Receiving physiotherapeutic treatment in the region in the month prior to the study. * Present severe diseases that may be related to the clinical results: malignancy or history of cancer, tumors or fractures in the region to be treated, blood dyscrasia, severe trauma in the previous 3 months, surgery in the region in the previous 12 months. * Present contraindications to the therapeutic approach such as: Belonephobia (fear of needles), coagulation alteration, history of adverse reactions, patients reluctant to this type of treatment. * Subjects who have previously received percutaneous neuromodulation. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Sant Cugat Del Vallès **Country:** Spain **Facility:** Universitat Internacional de Catalunya **State:** Barcelona **Zip:** 08195 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M4714 - Name: Back Pain - Relevance: HIGH - As Found: Back Pain - ID: M19433 - Name: Low Back Pain - Relevance: HIGH - As Found: Low Back Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001416 - Term: Back Pain - ID: D000017116 - Term: Low Back Pain ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04800679 **Brief Title:** Intravitreal Bevacizumab vs Laser vs Combination of Bevacizumab and Modified Laser in PDR **Official Title:** Combination Therapy for PDR #### Organization Study ID Info **ID:** 97378 #### Organization **Class:** OTHER **Full Name:** Shahid Beheshti University of Medical Sciences ### Status Module #### Completion Date **Date:** 2021-12 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2021-03-16 **Type:** ACTUAL **Last Update Submit Date:** 2021-03-13 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2020-07-01 **Type:** ACTUAL #### Start Date **Date:** 2020-03-01 **Type:** ACTUAL **Status Verified Date:** 2020-12 #### Study First Post Date **Date:** 2021-03-16 **Type:** ACTUAL **Study First Submit Date:** 2019-12-28 **Study First Submit QC Date:** 2021-03-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Shahid Beheshti University of Medical Sciences #### Responsible Party **Investigator Affiliation:** Shahid Beheshti University of Medical Sciences **Investigator Full Name:** Zahra Rabbani Khah **Investigator Title:** Head of ophthalmic research center **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** In this randomized 3-armed clinical trial, 105 eyes with PDR will be included and divided randomly into 3 groups: IVB group (35 eyes) that receive 4 monthly IVB injections and then rescue IVB, PRP group (35 eyes) that undergo full PRP in 2 or 3 sessions and then rescue IVB, and combination group (35 eyes) that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser. Diabetic macular edema (DME) will be treated independently in all groups by IVB. Primary outcome will be the number and activity of neovascularizations at 4,8 and 12 months and secondary measures will be changes in best corrected visual acuity (BCVA) and central macular thickness (CMT), and number of examinations and injection. ### Conditions Module **Conditions:** - Proliferative Diabetic Retinopathy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 105 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: receive 4 monthly IVB injections and then rescue IVB **Label:** intravitreal bevacizumab injections and then rescue **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Drug: PRP group **Label:** PRP group **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Intervention Names:** - Drug: IVB injections and a modified laser **Label:** IVB injections and a modified laser **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - intravitreal bevacizumab injections and then rescue **Description:** IVB group that receive 4 monthly IVB injections and then rescue IVB **Name:** receive 4 monthly IVB injections and then rescue IVB **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - PRP group **Description:** PRP group that undergo full PRP in 2 or 3 sessions and then rescue IVB **Name:** PRP group **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - IVB injections and a modified laser **Description:** Combination group that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser **Name:** IVB injections and a modified laser **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Number of neovascular tissue counted by investigator according to FAG **Measure:** Extent of neovascular tissues in disc-diameter measured by investigator according to the wide-field FAG **Time Frame:** 12 months #### Secondary Outcomes **Measure:** Best corrected visual acuity based on Snellen chart **Time Frame:** 12 months **Measure:** Central retinal thickness according to macular OCT **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Presence of PDR with the indication of full PRP according the intend of investigator * Best corrected visual acuity of 20/320 or better * Media clarity, pupillary dilation and patient's cooperation sufficient for full PRP, wide-field FAG and OCT Exclusion Criteria: * History of prior PRP with more than 100 burns outside the posterior pole * Tractional retinal detachment involving the macula * Evidence of neoplasia of angle on examination * Macular edema due to a cause other than DME * Any ocular condition which may change visual acuity during the study * Substantial cataract which has declined the vision by 3 lines or more * History of intravitreal injection of anti-VEGF agent in past 2 months * History of any use of corticosteroid during past 4 months * History of major intra-ocular surgery except cataract surgery * History of YAG laser capsulotomy during past 2 months * Aphakia and uncontrolled glaucoma according to investigator judgment **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** labbafi@hotmail.com **Name:** Alireza Ramezani, MD **Phone:** 009822591616 **Role:** CONTACT #### Locations **Location 1:** **City:** Tehran **Contacts:** ***Contact 1:*** - **Email:** labbafi@hotmail.com - **Name:** Ali reza Ramezani, MD - **Phone:** 009822591616 - **Role:** CONTACT **Country:** Iran, Islamic Republic of **Facility:** Ophthalmic Research Center **Status:** RECRUITING ### References Module #### References **Citation:** Shahraki T, Arabi A, Nourinia R, Beheshtizadeh NF, Entezari M, Nikkhah H, Karimi S, Ramezani A. PANRETINAL PHOTOCOAGULATION VERSUS INTRAVITREAL BEVACIZUMAB VERSUS A PROPOSED MODIFIED COMBINATION THERAPY FOR TREATMENT OF PROLIFERATIVE DIABETIC RETINOPATHY: A Randomized Three-Arm Clinical Trial (CTPDR Study). Retina. 2022 Jun 1;42(6):1065-1076. doi: 10.1097/IAE.0000000000003450. **PMID:** 35594075 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012164 - Term: Retinal Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000003925 - Term: Diabetic Angiopathies - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000048909 - Term: Diabetes Complications - ID: D000003920 - Term: Diabetes Mellitus - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M7125 - Name: Diabetic Retinopathy - Relevance: HIGH - As Found: Diabetic Retinopathy - ID: M14999 - Name: Retinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M7120 - Name: Diabetic Angiopathies - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M26004 - Name: Diabetes Complications - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003930 - Term: Diabetic Retinopathy ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M246 - Name: Bevacizumab - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06112379 **Brief Title:** A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer **Official Title:** A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04) #### Organization Study ID Info **ID:** D926QC00001 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca ### Status Module #### Completion Date **Date:** 2030-08-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2028-03-29 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-14 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2023-11-01 **Type:** ACTUAL **Study First Submit Date:** 2023-10-12 **Study First Submit QC Date:** 2023-10-31 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Daiichi Sankyo #### Lead Sponsor **Class:** INDUSTRY **Name:** AstraZeneca #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer. **Detailed Description:** The primary objectives of the study are to demonstrate superiority of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor low/HER2-negative breast cancer, by central assessment of pCR and/or to demonstrate superiority of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer, by investigator assessment of EFS ### Conditions Module **Conditions:** - Breast Cancer **Keywords:** - Breast Cancer; - Dato-DXd; DS1062a; - TROP2; - TNBC; - HR low: - Datopotamab deruxtecan; - Antibody Drug Conjugate; - ADC; - neoadjuvant therapy; - adjuvant therapy; - durvalumab; - PD-L1; - immune-checkpoint inhibitor (ICI); ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Participants will be randomised in a 1:1 ratio to one of two intervention groups. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 1728 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants receive durvalumab every 3 weeks (Q3W) + Dato-DXd Q3W as neoadjuvant therapy prior to surgery; followed by 9 cycles of durvaluamb Q3W as adjuvant therapy post-surgery. Adjuvant chemotherapy may be given in combination with durvalumab only if participants have residual disease. Olaparib may be given for participants with gBRCA-positive tumours and residual disease Adjuvant chemotherapy may be one of these: 1. Doxorubicin (Q3W) or epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks) followed by paclitaxel (weekly) and carboplatin (weekly or Q3W) for 4 cycles (12 weeks); 2. Doxorubicin (Q3W) or epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks) followed by paclitaxel (weekly) for 4 cycles (12 weeks); 3. Carboplatin (weekly or Q3W) + paclitaxel (weekly) for 4 cycles (12 weeks); 4. Capecitabine (Q3W) for 8 cycles. **Intervention Names:** - Drug: Dato-DXd - Drug: Durvalumab - Drug: Doxorubicin - Drug: Epirubicin - Drug: Cyclophosphamide - Drug: Paclitaxel - Drug: Carboplatin - Drug: Capecitabine - Drug: Olaparib **Label:** Dato-DXd plus durvalumab **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants receive pembrolizumab every 3 weeks (Q3W) + paclitaxel weekly + carboplatin (weekly or Q3W) x 4 cycles, followed by pembrolizumab Q3W + (doxorubicin OR epirubicin) + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy prior to surgery; followed by 9 cycles of pembrolizumab Q3W as adjuvant therapy post-surgery. Adjuvant capecitabine (Q3W) for 8 cycles may be given in combination with pembrolizumab only if participants have residual disease. Olaparib may be given for participants with gBRCA-positive tumours and residual disease. **Intervention Names:** - Drug: Pembrolizumab - Drug: Doxorubicin - Drug: Epirubicin - Drug: Cyclophosphamide - Drug: Paclitaxel - Drug: Carboplatin - Drug: Capecitabine - Drug: Olaparib **Label:** Pembrolizumab plus chemotherapy **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Dato-DXd plus durvalumab **Description:** Experimental drug IV infusion **Name:** Dato-DXd **Other Names:** - Datopotamab deruxtecan (Dato-DXd, DS-1062a) **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Dato-DXd plus durvalumab **Description:** Experimental drug IV Infusion **Name:** Durvalumab **Other Names:** - MEDI4736 **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Pembrolizumab plus chemotherapy **Description:** IV Infusion Active comparator **Name:** Pembrolizumab **Other Names:** - KEYTRUDA® **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Dato-DXd plus durvalumab - Pembrolizumab plus chemotherapy **Description:** IV infusion Experimental/Active Comparator **Name:** Doxorubicin **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Dato-DXd plus durvalumab - Pembrolizumab plus chemotherapy **Description:** IV Infusion Experimental/Active Comparator **Name:** Epirubicin **Type:** DRUG #### Intervention 6 **Arm Group Labels:** - Dato-DXd plus durvalumab - Pembrolizumab plus chemotherapy **Description:** IV infusion Experimental/Active Comparator **Name:** Cyclophosphamide **Type:** DRUG #### Intervention 7 **Arm Group Labels:** - Dato-DXd plus durvalumab - Pembrolizumab plus chemotherapy **Description:** IV infusion Experimental/Active Comparator **Name:** Paclitaxel **Type:** DRUG #### Intervention 8 **Arm Group Labels:** - Dato-DXd plus durvalumab - Pembrolizumab plus chemotherapy **Description:** IV infusion Experimental/Active Comparator **Name:** Carboplatin **Type:** DRUG #### Intervention 9 **Arm Group Labels:** - Dato-DXd plus durvalumab - Pembrolizumab plus chemotherapy **Description:** Tablet Oral route of administration Experimental/Active Comparator **Name:** Capecitabine **Other Names:** - XELODA®, Capecitabine Cell Pharm, Capecitabine EG, Capecitabine Accord **Type:** DRUG #### Intervention 10 **Arm Group Labels:** - Dato-DXd plus durvalumab - Pembrolizumab plus chemotherapy **Description:** Tablet Oral route of administration Experimental/Active Comparator **Name:** Olaparib **Other Names:** - LYNPARZA® **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** pCR rate is defined as the proportion of participants who have no evidence by haematoxylin and eosin staining of residual invasive disease at the time of definitive surgery in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0) by blinded central evaluation. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy. The measure of interest will be the difference between the pCR rates. **Measure:** Pathologic Complete Response (pCR) in the experimental vs control arms **Time Frame:** At the time of definitive surgery **Description:** EFS is defined as the time from the date of randomisation until the date of the first occurrence of any of the following events: disease progression precluding surgery, disease recurrence (local, regional, distant, or contralateral), second primary non-breast invasive cancer (other than squamous or basal cell skin cancer), or death by any cause (in the absence of recurrence). The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy. The measure of interest will be the Hazard Ratio of EFS. **Measure:** Event-free survival (EFS) in the experimental vs control arms **Time Frame:** Date of randomization to date of the EFS event, up to 68 months after the first subject randomized #### Secondary Outcomes **Description:** OS is defined as the time from the date of randomisation until the date of death due to any cause. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy. The measure of interest will be the Hazard Ratio of OS. **Measure:** Overall Survival (OS) in the experimental vs control arms **Time Frame:** Date of randomization to date of death due to any cause, up to 82 months after the first subject randomized **Description:** DDFS is defined as the time from the date of randomisation until the date of the first occurrence of any of the following events: distant metastasis, occurrence of second primary non-breast invasive cancer (other than squamous or basal cell skin cancer), or death by any cause (in the absence of recurrence). The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy. The measure of interest will be the Hazard Ratio of DDFS. **Measure:** Distant disease-free survival (DDFS) in the experimental vs control arms **Time Frame:** Date of randomization to date of the DDFS event, up to 68 months after the first subject randomized **Description:** Breast and arm symptoms measured by the EORTC IL116. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy. The measure of interest is the mean between-arm difference in breast and arm symptom scores. **Measure:** Participant-reported breast and arm symptoms in the experimental vs. control arms **Time Frame:** From Cycle 1 Day 1 of neoadjuvant treatment until pre-surgery safety FU visit (for approximately 24 weeks) or EOT - whichever occurs first. **Description:** Physical function measured by the PROMIS Physical Function Short Form 8c. The analysis will include all dosed participants. The measure of interest is the mean between-arm difference in physical function scores. **Measure:** Participant-reported physical function in the experimental vs. control arms **Time Frame:** From Cycle 1 Day 1 of neoadjuvant treatment until pre-surgery safety FU visit (for approximately 24 weeks) or EOT - whichever occurs first, and then from Cycle 1 Day 1 of adjuvant treatment until EOT (for approximately 27 weeks). **Description:** Fatigue measured by the PROMIS Fatigue Short Form 7a. The analysis will include all dosed participants. The measure of interest will be the difference on the proportions of participants reporting different levels of fatigue and mean between-arm difference in the fatigue scores. **Measure:** Participant-reported fatigue in the experimental vs. control arms **Time Frame:** From Cycle 1 Day 1 of neoadjuvant treatment until pre-surgery safety FU visit (for approximately 24 weeks) or EOT - whichever occurs first, and then from Cycle 1 Day 1 of adjuvant treatment until EOT (for approximately 27 weeks). **Description:** Global health status/Quality of life measured by EORTC IL172. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy. The measure of interest is the mean between-arm difference in GHS/QoL scores. **Measure:** Participant-reported Global health status/Quality of life (GHS/QoL)in the experimental vs. control arms **Time Frame:** From Cycle 1 Day 1 of neoadjuvant treatment until pre-surgery safety FU visit (for approximately 24 weeks) or EOT - whichever occurs first, and then from Cycle 1 Day 1 of adjuvant treatment until EOT (for approximately 27 weeks). **Description:** Plasma concentrations of Dato-DXd (ug/ml ) **Measure:** Pharmacokinetics of Dato-DXd (in combination with durvalumab) **Time Frame:** Day 1 of cycles 1,2,4,8 (Each cycle is 21 days) and at pre-surgery safety follow up visit **Description:** Plasma concentrations of total anti-TROP2 antibody (ug/ml ) **Measure:** Pharmacokinetics of Dato-DXd (in combination with durvalumab) **Time Frame:** Day 1 of cycles 1,2,4,8 (Each cycle is 21 days) and at pre-surgery safety follow up visit **Description:** Plasma concentrations of DXd (MAAA-1181a) (ng/ml) **Measure:** Pharmacokinetics of Dato-DXd (in combination with durvalumab) **Time Frame:** Day 1 of cycles 1,2,4,8 (Each cycle is 21 days) and at pre-surgery safety follow up visit **Description:** Presence of antidrug antibodies (ADAs) for Dato-DXd (confirmatory results: positive or negative, titres). **Measure:** Immunogenicity of Dato-DXd (in combination with durvalumab) **Time Frame:** Day 1 of cycles 1,2,4,8 (Each cycle is 21 days) and at pre-surgery safety follow up visit **Description:** Safety and tolerability will be evaluated in terms of AEs graded by CTCAE version 5.0 **Measure:** Safety of Dato-DXd (in combination with durvalumab) **Time Frame:** Randomization to final safety follow-up visit, either 90 days after last dose of study intervention for those who complete planned study intervention or 90 days after date of discontinuation for those who discontinue study intervention prematurely ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participant must be ≥ 18 years, at the time of signing the ICF. * Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC or hormone receptor-low/HER2-negative breast cancer * ECOG PS of 0 or 1 * Provision of acceptable tumor sample * Adequate bone marrow reserve and organ function * Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion criteria: * History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before randomization and of low potential risk for recurrence. * Evidence of distant disease. * Clinically significant corneal disease. * Has active or uncontrolled hepatitis B or C virus infection. * Known HIV infection that is not well controlled. * Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals; suspected infections; or inability to rule out infections. * Known to have active tuberculosis infection * Resting ECG with clinically significant abnormal findings. * Uncontrolled or significant cardiac disease. * History of non-infectious ILD/pneumonitis * Any prior or concurrent surgery, radiotherapy or systemic anticancer therapy for TNBC or hormone receptor-low/HER2-negative breast cancer * For females only: is pregnant (confirmed with positive serum pregnancy test) or breastfeeding, or planning to become pregnant. * Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of study intervention, or as dictated by local PI for SoC if longer. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** information.center@astrazeneca.com **Name:** AstraZeneca Clinical Study Information Center **Phone:** 1-877-240-9479 **Role:** CONTACT #### Locations **Location 1:** **City:** Daphne **Country:** United States **Facility:** Research Site **State:** Alabama **Status:** NOT_YET_RECRUITING **Zip:** 36526 **Location 2:** **City:** Goodyear **Country:** United States **Facility:** Research Site **State:** Arizona **Status:** NOT_YET_RECRUITING **Zip:** 85395 **Location 3:** **City:** Phoenix **Country:** United States **Facility:** Research Site **State:** Arizona **Status:** NOT_YET_RECRUITING **Zip:** 85054 **Location 4:** **City:** Tucson **Country:** United States **Facility:** Research Site **State:** Arizona **Status:** NOT_YET_RECRUITING **Zip:** 85711 **Location 5:** **City:** Jonesboro **Country:** United States **Facility:** Research Site **State:** Arkansas **Status:** RECRUITING **Zip:** 72401 **Location 6:** **City:** Rogers **Country:** United States **Facility:** Research Site **State:** Arkansas **Status:** RECRUITING **Zip:** 72758 **Location 7:** **City:** Bakersfield **Country:** United States **Facility:** Research Site **State:** California **Status:** RECRUITING **Zip:** 93309 **Location 8:** **City:** Fullerton **Country:** United States **Facility:** Research Site **State:** California **Status:** RECRUITING **Zip:** 92835 **Location 9:** **City:** Los Angeles **Country:** United States **Facility:** Research Site **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 90033 **Location 10:** **City:** Los Angeles **Country:** United States **Facility:** Research Site **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 90095 **Location 11:** **City:** Orange **Country:** United States **Facility:** Research Site **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 92868 **Location 12:** **City:** Santa Barbara **Country:** United States **Facility:** Research Site **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 93105 **Location 13:** **City:** Santa Rosa **Country:** United States **Facility:** Research Site **State:** California **Status:** RECRUITING **Zip:** 92805 **Location 14:** **City:** Sylmar **Country:** United States **Facility:** Research Site **State:** California **Status:** WITHDRAWN **Zip:** 91342 **Location 15:** **City:** Torrance **Country:** United States **Facility:** Research Site **State:** California **Status:** RECRUITING **Zip:** 90505 **Location 16:** **City:** Van Nuys **Country:** United States **Facility:** Research Site **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 91405 **Location 17:** **City:** Aurora **Country:** United States **Facility:** Research Site **State:** Colorado **Status:** NOT_YET_RECRUITING **Zip:** 80045 **Location 18:** **City:** Fort Collins **Country:** United States **Facility:** Research Site **State:** Colorado **Status:** NOT_YET_RECRUITING **Zip:** 80528 **Location 19:** **City:** Longmont **Country:** United States **Facility:** Research Site **State:** Colorado **Status:** NOT_YET_RECRUITING **Zip:** 80504 **Location 20:** **City:** Bridgeport **Country:** United States **Facility:** Research Site **State:** Connecticut **Status:** NOT_YET_RECRUITING **Zip:** 06606 **Location 21:** **City:** New Haven **Country:** United States **Facility:** Research Site **State:** Connecticut **Status:** RECRUITING **Zip:** 06510 **Location 22:** **City:** Newark **Country:** United States **Facility:** Research Site **State:** Delaware **Status:** WITHDRAWN **Zip:** 19713 **Location 23:** **City:** Fort Myers **Country:** United States **Facility:** Research Site **State:** Florida **Status:** NOT_YET_RECRUITING **Zip:** 33901 **Location 24:** **City:** Jacksonville **Country:** United States **Facility:** Research Site **State:** Florida **Status:** NOT_YET_RECRUITING **Zip:** 32224 **Location 25:** **City:** Jacksonville **Country:** United States **Facility:** Research Site **State:** Florida **Status:** RECRUITING **Zip:** 32256 **Location 26:** **City:** Port Saint Lucie **Country:** United States **Facility:** Research Site **State:** Florida **Status:** WITHDRAWN **Zip:** 34952 **Location 27:** **City:** Saint Petersburg **Country:** United States **Facility:** Research Site **State:** Florida **Status:** NOT_YET_RECRUITING **Zip:** 33705 **Location 28:** **City:** Tallahassee **Country:** United States **Facility:** Research Site **State:** Florida **Status:** NOT_YET_RECRUITING **Zip:** 32308 **Location 29:** **City:** West Palm Beach **Country:** United States **Facility:** Research Site **State:** Florida **Status:** NOT_YET_RECRUITING **Zip:** 33401 **Location 30:** **City:** Atlanta **Country:** United States **Facility:** Research Site **State:** Georgia **Status:** NOT_YET_RECRUITING **Zip:** 30322 **Location 31:** **City:** Atlanta **Country:** United States **Facility:** Research Site **State:** Georgia **Status:** NOT_YET_RECRUITING **Zip:** 30342 **Location 32:** **City:** Des Moines **Country:** United States **Facility:** Research Site **State:** Iowa **Status:** RECRUITING **Zip:** 50309 **Location 33:** **City:** Edgewood **Country:** United States **Facility:** Research Site **State:** Kentucky **Status:** NOT_YET_RECRUITING **Zip:** 41017 **Location 34:** **City:** Louisville **Country:** United States **Facility:** Research Site **State:** Kentucky **Status:** NOT_YET_RECRUITING **Zip:** 40202 **Location 35:** **City:** Baton Rouge **Country:** United States **Facility:** Research Site **State:** Louisiana **Status:** NOT_YET_RECRUITING **Zip:** 70817 **Location 36:** **City:** Annapolis **Country:** United States **Facility:** Research Site **State:** Maryland **Status:** NOT_YET_RECRUITING **Zip:** 21401 **Location 37:** **City:** Boston **Country:** United States **Facility:** Research Site **State:** Massachusetts **Status:** NOT_YET_RECRUITING **Zip:** 02215 **Location 38:** **City:** Detroit **Country:** United States **Facility:** Research Site **State:** Michigan **Status:** NOT_YET_RECRUITING **Zip:** 48202 **Location 39:** **City:** Grand Rapids **Country:** United States **Facility:** Research Site **State:** Michigan **Status:** RECRUITING **Zip:** 49503 **Location 40:** **City:** Traverse City **Country:** United States **Facility:** Research Site **State:** Michigan **Status:** RECRUITING **Zip:** 49684 **Location 41:** **City:** Burnsville **Country:** United States **Facility:** Research Site **State:** Minnesota **Status:** NOT_YET_RECRUITING **Zip:** 55337 **Location 42:** **City:** Minneapolis **Country:** United States **Facility:** Research Site **State:** Minnesota **Status:** NOT_YET_RECRUITING **Zip:** 55407 **Location 43:** **City:** Columbia **Country:** United States **Facility:** Research Site **State:** Missouri **Status:** NOT_YET_RECRUITING **Zip:** 65212 **Location 44:** **City:** Saint Louis **Country:** United States **Facility:** Research Site **State:** Missouri **Status:** WITHDRAWN **Zip:** 63110 **Location 45:** **City:** Omaha **Country:** United States **Facility:** Research Site **State:** Nebraska **Status:** NOT_YET_RECRUITING **Zip:** 68130 **Location 46:** **City:** Henderson **Country:** United States **Facility:** Research Site **State:** Nevada **Status:** NOT_YET_RECRUITING **Zip:** 89074 **Location 47:** **City:** Camden **Country:** United States **Facility:** Research Site **State:** New Jersey **Status:** NOT_YET_RECRUITING **Zip:** 08103 **Location 48:** **City:** East Brunswick **Country:** United States **Facility:** Research Site **State:** New Jersey **Status:** NOT_YET_RECRUITING **Zip:** 08816 **Location 49:** **City:** New Brunswick **Country:** United States **Facility:** Research Site **State:** New Jersey **Status:** NOT_YET_RECRUITING **Zip:** 08901 **Location 50:** **City:** Commack **Country:** United States **Facility:** Research Site **State:** New York **Status:** NOT_YET_RECRUITING **Zip:** 11725 **Location 51:** **City:** New York **Country:** United States **Facility:** Research Site **State:** New York **Status:** NOT_YET_RECRUITING **Zip:** 10065 **Location 52:** **City:** Port Jefferson Station **Country:** United States **Facility:** Research Site **State:** New York **Status:** WITHDRAWN **Zip:** 11776 **Location 53:** **City:** Charlotte **Country:** United States **Facility:** Research Site **State:** North Carolina **Status:** NOT_YET_RECRUITING **Zip:** 28204 **Location 54:** **City:** Durham **Country:** United States **Facility:** Research Site **State:** North Carolina **Status:** NOT_YET_RECRUITING **Zip:** 27710 **Location 55:** **City:** Canton **Country:** United States **Facility:** Research Site **State:** Ohio **Status:** RECRUITING **Zip:** 44710 **Location 56:** **City:** Eugene **Country:** United States **Facility:** Research Site **State:** Oregon **Status:** NOT_YET_RECRUITING **Zip:** 97401 **Location 57:** **City:** Portland **Country:** United States **Facility:** Research Site **State:** Oregon **Status:** NOT_YET_RECRUITING **Zip:** 97223 **Location 58:** **City:** Horsham **Country:** United States **Facility:** Research Site **State:** Pennsylvania **Status:** NOT_YET_RECRUITING **Zip:** 19044 **Location 59:** **City:** Philadelphia **Country:** United States **Facility:** Research Site **State:** Pennsylvania **Status:** NOT_YET_RECRUITING **Zip:** 19104 **Location 60:** **City:** Pittsburgh **Country:** United States **Facility:** Research Site **State:** Pennsylvania **Status:** NOT_YET_RECRUITING **Zip:** 15212 **Location 61:** **City:** Providence **Country:** United States **Facility:** Research Site **State:** Rhode Island **Status:** WITHDRAWN **Zip:** 02903 **Location 62:** **City:** Nashville **Country:** United States **Facility:** Research Site **State:** Tennessee **Status:** NOT_YET_RECRUITING **Zip:** 37203 **Location 63:** **City:** Austin **Country:** United States **Facility:** Research Site **State:** Texas **Status:** NOT_YET_RECRUITING **Zip:** 78731 **Location 64:** **City:** Dallas **Country:** United States **Facility:** Research Site **State:** Texas **Status:** WITHDRAWN **Zip:** 75230 **Location 65:** **City:** Dallas **Country:** United States **Facility:** Research Site **State:** Texas **Status:** NOT_YET_RECRUITING **Zip:** 75231 **Location 66:** **City:** Dallas **Country:** United States **Facility:** Research Site **State:** Texas **Status:** WITHDRAWN **Zip:** 75246 **Location 67:** **City:** Dallas **Country:** United States **Facility:** Research Site **State:** Texas **Status:** NOT_YET_RECRUITING **Zip:** 75390-8843 **Location 68:** **City:** El Paso **Country:** United States **Facility:** Research Site **State:** Texas **Status:** NOT_YET_RECRUITING **Zip:** 79902 **Location 69:** **City:** Flower Mound **Country:** United States **Facility:** Research Site **State:** Texas **Status:** NOT_YET_RECRUITING **Zip:** 75028 **Location 70:** **City:** Fort Worth **Country:** United States **Facility:** Research Site **State:** Texas **Status:** NOT_YET_RECRUITING **Zip:** 76104 **Location 71:** **City:** Houston **Country:** United States **Facility:** Research Site **State:** Texas **Status:** NOT_YET_RECRUITING **Zip:** 77030 **Location 72:** **City:** San Antonio **Country:** United States **Facility:** Research Site **State:** Texas **Status:** NOT_YET_RECRUITING **Zip:** 78240 **Location 73:** **City:** Webster **Country:** United States **Facility:** Research Site **State:** Texas **Status:** NOT_YET_RECRUITING **Zip:** 77598 **Location 74:** **City:** Falls Church **Country:** United States **Facility:** Research Site **State:** Virginia **Status:** NOT_YET_RECRUITING **Zip:** 22042 **Location 75:** **City:** Norfolk **Country:** United States **Facility:** Research Site **State:** Virginia **Status:** NOT_YET_RECRUITING **Zip:** 23502 **Location 76:** **City:** Richmond **Country:** United States **Facility:** Research Site **State:** Virginia **Status:** WITHDRAWN **Zip:** 23298 **Location 77:** **City:** Roanoke **Country:** United States **Facility:** Research Site **State:** Virginia **Status:** NOT_YET_RECRUITING **Zip:** 24014 **Location 78:** **City:** Winchester **Country:** United States **Facility:** Research Site **State:** Virginia **Status:** NOT_YET_RECRUITING **Zip:** 22601 **Location 79:** **City:** Tacoma **Country:** United States **Facility:** Research Site **State:** Washington **Status:** RECRUITING **Zip:** 98405 **Location 80:** **City:** Madison **Country:** United States **Facility:** Research Site **State:** Wisconsin **Status:** WITHDRAWN **Zip:** 53715 **Location 81:** **City:** Darlinghurst **Country:** Australia **Facility:** Research Site **Status:** RECRUITING **Zip:** 2010 **Location 82:** **City:** East Melbourne **Country:** Australia **Facility:** Research Site **Status:** RECRUITING **Zip:** 3002 **Location 83:** **City:** Heidelberg **Country:** Australia **Facility:** Research Site **Status:** RECRUITING **Zip:** 3084 **Location 84:** **City:** Herston **Country:** Australia **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 4029 **Location 85:** **City:** Nedlands **Country:** Australia **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 6009 **Location 86:** **City:** Waratah **Country:** Australia **Facility:** Research Site **Status:** RECRUITING **Zip:** 2298 **Location 87:** **City:** Feldkirch **Country:** Austria **Facility:** Research Site **Status:** RECRUITING **Zip:** 6807 **Location 88:** **City:** Graz **Country:** Austria **Facility:** Research Site **Status:** RECRUITING **Zip:** 8036 **Location 89:** **City:** Innsbruck **Country:** Austria **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 6020 **Location 90:** **City:** Linz **Country:** Austria **Facility:** Research Site **Status:** RECRUITING **Zip:** 4010 **Location 91:** **City:** Salzburg **Country:** Austria **Facility:** Research Site **Status:** RECRUITING **Zip:** 5020 **Location 92:** **City:** Brasschaat **Country:** Belgium **Facility:** Research Site **Status:** RECRUITING **Zip:** 2930 **Location 93:** **City:** Charleroi **Country:** Belgium **Facility:** Research Site **Status:** RECRUITING **Zip:** 6000 **Location 94:** **City:** Gent **Country:** Belgium **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 9000 **Location 95:** **City:** Leuven **Country:** Belgium **Facility:** Research Site **Status:** RECRUITING **Zip:** 3000 **Location 96:** **City:** Libramont-Chevigny **Country:** Belgium **Facility:** Research Site **Status:** RECRUITING **Zip:** 6800 **Location 97:** **City:** Wilrijk **Country:** Belgium **Facility:** Research Site **Status:** RECRUITING **Zip:** 2610 **Location 98:** **City:** Brasilia **Country:** Brazil **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 71681-603 **Location 99:** **City:** Curitiba **Country:** Brazil **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 80440-220 **Location 100:** **City:** Fortaleza **Country:** Brazil **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 60336-045 **Location 101:** **City:** Londrina **Country:** Brazil **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 86015-520 **Location 102:** **City:** Natal **Country:** Brazil **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 59075-740 **Location 103:** **City:** Porto Alegre **Country:** Brazil **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 90035-000 **Location 104:** **City:** Porto Alegre **Country:** Brazil **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 90035-903 **Location 105:** **City:** Ribeirão Preto **Country:** Brazil **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 14051-140 **Location 106:** **City:** Santo Andre **Country:** Brazil **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 09060-650 **Location 107:** **City:** São Paulo **Country:** Brazil **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 01246-000 **Location 108:** **City:** Taubaté **Country:** Brazil **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 12030-200 **Location 109:** **City:** Vitória **Country:** Brazil **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 29043-260 **Location 110:** **City:** Plovdiv **Country:** Bulgaria **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 4004 **Location 111:** **City:** Shumen **Country:** Bulgaria **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 9700 **Location 112:** **City:** Sofia **Country:** Bulgaria **Facility:** Research Site **Status:** RECRUITING **Zip:** 1330 **Location 113:** **City:** Sofia **Country:** Bulgaria **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 1431 **Location 114:** **City:** Sofia **Country:** Bulgaria **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 1797 **Location 115:** **City:** Sofia **Country:** Bulgaria **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Location 116:** **City:** Vratza **Country:** Bulgaria **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 3000 **Location 117:** **City:** Calgary **Country:** Canada **Facility:** Research Site **State:** Alberta **Status:** NOT_YET_RECRUITING **Zip:** T2N 4N2 **Location 118:** **City:** Abbotsford **Country:** Canada **Facility:** Research Site **State:** British Columbia **Status:** NOT_YET_RECRUITING **Zip:** V2S0C2 **Location 119:** **City:** Vancouver **Country:** Canada **Facility:** Research Site **State:** British Columbia **Status:** NOT_YET_RECRUITING **Zip:** VSZ 4E6 **Location 120:** **City:** St. John's **Country:** Canada **Facility:** Research Site **State:** Newfoundland and Labrador **Status:** NOT_YET_RECRUITING **Zip:** A1B 3V6 **Location 121:** **City:** Barrie **Country:** Canada **Facility:** Research Site **State:** Ontario **Status:** NOT_YET_RECRUITING **Zip:** L4M 6M2 **Location 122:** **City:** London **Country:** Canada **Facility:** Research Site **State:** Ontario **Status:** NOT_YET_RECRUITING **Zip:** N6A 5W9 **Location 123:** **City:** Oshawa **Country:** Canada **Facility:** Research Site **State:** Ontario **Status:** RECRUITING **Zip:** L1G 2B9 **Location 124:** **City:** Toronto **Country:** Canada **Facility:** Research Site **State:** Ontario **Status:** NOT_YET_RECRUITING **Zip:** M5G 2M9 **Location 125:** **City:** Levis **Country:** Canada **Facility:** Research Site **State:** Quebec **Status:** RECRUITING **Zip:** G6V 3Z1 **Location 126:** **City:** Montreal **Country:** Canada **Facility:** Research Site **State:** Quebec **Status:** RECRUITING **Zip:** H1T 2M4 **Location 127:** **City:** Montreal **Country:** Canada **Facility:** Research Site **State:** Quebec **Status:** RECRUITING **Zip:** H2X 0C1 **Location 128:** **City:** Montreal **Country:** Canada **Facility:** Research Site **State:** Quebec **Status:** RECRUITING **Zip:** H4A-3J1 **Location 129:** **City:** Sherbrooke **Country:** Canada **Facility:** Research Site **State:** Quebec **Status:** RECRUITING **Zip:** J1H 5N4 **Location 130:** **City:** St-Jerome **Country:** Canada **Facility:** Research Site **State:** Quebec **Status:** RECRUITING **Zip:** J7Z 5T3 **Location 131:** **City:** Saskatoon **Country:** Canada **Facility:** Research Site **State:** Saskatchewan **Status:** NOT_YET_RECRUITING **Zip:** S7N 4H4 **Location 132:** **City:** Montreal **Country:** Canada **Facility:** Research Site **Status:** RECRUITING **Zip:** H3T 1E2 **Location 133:** **City:** Ottawa **Country:** Canada **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** K1H 8L6 **Location 134:** **City:** Beijing **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 100044 **Location 135:** **City:** Beijing **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 211405 **Location 136:** **City:** Bengbu **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 233060 **Location 137:** **City:** Changchun **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 130021 **Location 138:** **City:** Changsha **Country:** China **Facility:** Research Site **Status:** RECRUITING **Zip:** 410008 **Location 139:** **City:** Changsha **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 410013 **Location 140:** **City:** Chengdu **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 610000 **Location 141:** **City:** Chongqing **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 400030 **Location 142:** **City:** Guangzhou **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 510060 **Location 143:** **City:** Guangzhou **Country:** China **Facility:** Research Site **Status:** RECRUITING **Zip:** 510120 **Location 144:** **City:** Hangzhou **Country:** China **Facility:** Research Site **Status:** RECRUITING **Zip:** 310009 **Location 145:** **City:** Hangzhou **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 310022 **Location 146:** **City:** Harbin **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 150049 **Location 147:** **City:** Hefei **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 230012 **Location 148:** **City:** Jinan **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 250117 **Location 149:** **City:** Kunming **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 650118 **Location 150:** **City:** Linhai **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 318000 **Location 151:** **City:** Nanchang **Country:** China **Facility:** Research Site **Status:** RECRUITING **Zip:** 330009 **Location 152:** **City:** Nanchang **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 330029 **Location 153:** **City:** Nanjing **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 210008 **Location 154:** **City:** Nanjing **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 210029 **Location 155:** **City:** Nanning **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 530021 **Location 156:** **City:** Shanghai **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 200025 **Location 157:** **City:** Shenyang **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 110004 **Location 158:** **City:** Shenyang **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 110042 **Location 159:** **City:** Shijiazhuang **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 050020 **Location 160:** **City:** Suining **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 629000 **Location 161:** **City:** Suzhou **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 215004 **Location 162:** **City:** Tianjin **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 300060 **Location 163:** **City:** Urumqi **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 830000 **Location 164:** **City:** Wuhan **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 430022 **Location 165:** **City:** Xi'an **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 710061 **Location 166:** **City:** Xintai **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 54031 **Location 167:** **City:** Avignon **Country:** France **Facility:** Research Site **Status:** RECRUITING **Zip:** 84918 **Location 168:** **City:** Bayonne **Country:** France **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 64100 **Location 169:** **City:** Caen Cedex 5 **Country:** France **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 41076 **Location 170:** **City:** Clermont Ferrand **Country:** France **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 63011 **Location 171:** **City:** Limoges **Country:** France **Facility:** Research Site **Status:** RECRUITING **Zip:** 87000 **Location 172:** **City:** Lyon **Country:** France **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 69373 **Location 173:** **City:** Marseille **Country:** France **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 13273 **Location 174:** **City:** Montpellier **Country:** France **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 34298 **Location 175:** **City:** Nice **Country:** France **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 06100 **Location 176:** **City:** Paris **Country:** France **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 75010 **Location 177:** **City:** Reims Cedex **Country:** France **Facility:** Research Site **Status:** RECRUITING **Zip:** 51056 **Location 178:** **City:** Saint Herblain **Country:** France **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 44805 **Location 179:** **City:** Toulouse **Country:** France **Facility:** Research Site **Status:** RECRUITING **Zip:** 31100 **Location 180:** **City:** Vandoeuvre les Nancy **Country:** France **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 54519 **Location 181:** **City:** Villejuif Cedex **Country:** France **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 94805 **Location 182:** **City:** Augsburg **Country:** Germany **Facility:** Research Site **Status:** RECRUITING **Zip:** 86150 **Location 183:** **City:** Berlin **Country:** Germany **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 10967 **Location 184:** **City:** Berlin **Country:** Germany **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 13125 **Location 185:** **City:** Dessau-Roßlau **Country:** Germany **Facility:** Research Site **Status:** RECRUITING **Zip:** 06847 **Location 186:** **City:** Dresden **Country:** Germany **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 01307 **Location 187:** **City:** Erlangen **Country:** Germany **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 91054 **Location 188:** **City:** Essen **Country:** Germany **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 45130 **Location 189:** **City:** Esslingen am Neckar **Country:** Germany **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 73730 **Location 190:** **City:** Frankfurt am Main **Country:** Germany **Facility:** Research Site **Status:** RECRUITING **Zip:** 60431 **Location 191:** **City:** Freiburg **Country:** Germany **Facility:** Research Site **Status:** SUSPENDED **Zip:** 79106 **Location 192:** **City:** Freiburg **Country:** Germany **Facility:** Research Site **Status:** RECRUITING **Zip:** 79110 **Location 193:** **City:** Hannover **Country:** Germany **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 30559 **Location 194:** **City:** Hannover **Country:** Germany **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 30625 **Location 195:** **City:** Heidelberg **Country:** Germany **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 69120 **Location 196:** **City:** Kiel **Country:** Germany **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 24105 **Location 197:** **City:** Mainz **Country:** Germany **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 55131 **Location 198:** **City:** Mannheim **Country:** Germany **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 68167 **Location 199:** **City:** München **Country:** Germany **Facility:** Research Site **Status:** RECRUITING **Zip:** 80637 **Location 200:** **City:** Münster **Country:** Germany **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 48149 **Location 201:** **City:** Trier **Country:** Germany **Facility:** Research Site **Status:** RECRUITING **Zip:** 54290 **Location 202:** **City:** Ulm **Country:** Germany **Facility:** Research Site **Status:** RECRUITING **Zip:** 89075 **Location 203:** **City:** Hong Kong **Country:** Hong Kong **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 00000 **Location 204:** **City:** Hong Kong **Country:** Hong Kong **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 999077 **Location 205:** **City:** Hong Kong **Country:** Hong Kong **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Location 206:** **City:** Kwai Chung **Country:** Hong Kong **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 999077 **Location 207:** **City:** Budapest **Country:** Hungary **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 1122 **Location 208:** **City:** Kecskemét **Country:** Hungary **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 6000 **Location 209:** **City:** Miskolc **Country:** Hungary **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 3526 **Location 210:** **City:** Nyíregyháza **Country:** Hungary **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 4400 **Location 211:** **City:** Salgótarján **Country:** Hungary **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 3100 **Location 212:** **City:** Szekszárd **Country:** Hungary **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 7100 **Location 213:** **City:** Bengaluru **Country:** India **Facility:** Research Site **Status:** RECRUITING **Zip:** 560085 **Location 214:** **City:** Dehradun **Country:** India **Facility:** Research Site **Status:** SUSPENDED **Zip:** 248016 **Location 215:** **City:** Delhi **Country:** India **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 110029 **Location 216:** **City:** Delhi **Country:** India **Facility:** Research Site **Status:** RECRUITING **Zip:** 110085 **Location 217:** **City:** Kolkata **Country:** India **Facility:** Research Site **Status:** RECRUITING **Zip:** 700016 **Location 218:** **City:** Kolkata **Country:** India **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 700099 **Location 219:** **City:** Marg Jaipur **Country:** India **Facility:** Research Site **Status:** RECRUITING **Zip:** 302004 **Location 220:** **City:** Nagpur **Country:** India **Facility:** Research Site **Status:** RECRUITING **Zip:** 440001 **Location 221:** **City:** Nashik **Country:** India **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 422011 **Location 222:** **City:** Puducherry **Country:** India **Facility:** Research Site **Status:** SUSPENDED **Zip:** 605006 **Location 223:** **City:** Thiruvananthapuram **Country:** India **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 695011 **Location 224:** **City:** Vadodara **Country:** India **Facility:** Research Site **Status:** RECRUITING **Zip:** 391760 **Location 225:** **City:** Empoli **Country:** Italy **Facility:** Research Site **Status:** RECRUITING **Zip:** 50053 **Location 226:** **City:** Lucca **Country:** Italy **Facility:** Research Site **Status:** RECRUITING **Zip:** 55100 **Location 227:** **City:** Macerata **Country:** Italy **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 62100 **Location 228:** **City:** Milano **Country:** Italy **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 20132 **Location 229:** **City:** Modena **Country:** Italy **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 41124 **Location 230:** **City:** Napoli **Country:** Italy **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 80131 **Location 231:** **City:** Padova **Country:** Italy **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 35128 **Location 232:** **City:** Roma **Country:** Italy **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 00168 **Location 233:** **City:** Rozzano **Country:** Italy **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 20089 **Location 234:** **City:** Torino **Country:** Italy **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 10126 **Location 235:** **City:** Tricase **Country:** Italy **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 73039 **Location 236:** **City:** Udine **Country:** Italy **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 33100 **Location 237:** **City:** Akashi-shi **Country:** Japan **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 673-8558 **Location 238:** **City:** Akita-shi **Country:** Japan **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 010-8543 **Location 239:** **City:** Bunkyo-ku **Country:** Japan **Facility:** Research Site **Status:** RECRUITING **Zip:** 113-8431 **Location 240:** **City:** Chiba-shi **Country:** Japan **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 260-8717 **Location 241:** **City:** Chuo-ku **Country:** Japan **Facility:** Research Site **Status:** RECRUITING **Zip:** 104-8560 **Location 242:** **City:** Fukuoka-shi **Country:** Japan **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 811-1395 **Location 243:** **City:** Fukushima-shi **Country:** Japan **Facility:** Research Site **Status:** RECRUITING **Zip:** 960-1295 **Location 244:** **City:** Gifu-shi **Country:** Japan **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 501-1194 **Location 245:** **City:** Hidaka-shi **Country:** Japan **Facility:** Research Site **Status:** RECRUITING **Zip:** 350-1298 **Location 246:** **City:** Hirakata-shi **Country:** Japan **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 573-1191 **Location 247:** **City:** Hiroshima-shi **Country:** Japan **Facility:** Research Site **Status:** RECRUITING **Zip:** 730-0011 **Location 248:** **City:** Hiroshima-shi **Country:** Japan **Facility:** Research Site **Status:** RECRUITING **Zip:** 734-8551 **Location 249:** **City:** Isehara-shi **Country:** Japan **Facility:** Research Site **Status:** RECRUITING **Zip:** 259-1193 **Location 250:** **City:** Kashiwa **Country:** Japan **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 227-8577 **Location 251:** **City:** Koto-ku **Country:** Japan **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 135-8550 **Location 252:** **City:** Kumamoto-shi **Country:** Japan **Facility:** Research Site **Status:** RECRUITING **Zip:** 860-8556 **Location 253:** **City:** Kurume-shi **Country:** Japan **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 830-0011 **Location 254:** **City:** Matsuyama-shi **Country:** Japan **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 791-0280 **Location 255:** **City:** Nagoya-shi **Country:** Japan **Facility:** Research Site **Status:** RECRUITING **Zip:** 460-0001 **Location 256:** **City:** Nagoya-shi **Country:** Japan **Facility:** Research Site **Status:** RECRUITING **Zip:** 466-8560 **Location 257:** **City:** Nagoya-shi **Country:** Japan **Facility:** Research Site **Status:** RECRUITING **Zip:** 467-0001 **Location 258:** **City:** Niigata-shi **Country:** Japan **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 951-8566 **Location 259:** **City:** Okayama **Country:** Japan **Facility:** Research Site **Status:** RECRUITING **Zip:** 700-8558 **Location 260:** **City:** Osaka-shi **Country:** Japan **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 541-8567 **Location 261:** **City:** Sapporo-shi **Country:** Japan **Facility:** Research Site **Status:** RECRUITING **Zip:** 003-0804 **Location 262:** **City:** Sapporo-shi **Country:** Japan **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 060-8648 **Location 263:** **City:** Sendai-shi **Country:** Japan **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 980-8574 **Location 264:** **City:** Shinagawa-ku **Country:** Japan **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 142-8666 **Location 265:** **City:** Shinjuku-ku **Country:** Japan **Facility:** Research Site **Status:** RECRUITING **Zip:** 160-0023 **Location 266:** **City:** Shinjuku-ku **Country:** Japan **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 162-8655 **Location 267:** **City:** Sunto-gun **Country:** Japan **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 411-8777 **Location 268:** **City:** Tokyo **Country:** Japan **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 104-0045 **Location 269:** **City:** Tsu-shi **Country:** Japan **Facility:** Research Site **Status:** RECRUITING **Zip:** 514-8507 **Location 270:** **City:** Yokohama-shi **Country:** Japan **Facility:** Research Site **Status:** RECRUITING **Zip:** 241-8515 **Location 271:** **City:** Daegu **Country:** Korea, Republic of **Facility:** Research Site **Status:** RECRUITING **Zip:** 41404 **Location 272:** **City:** Goyang-si **Country:** Korea, Republic of **Facility:** Research Site **Status:** RECRUITING **Zip:** 10408 **Location 273:** **City:** Seongnam **Country:** Korea, Republic of **Facility:** Research Site **Status:** RECRUITING **Zip:** 13620 **Location 274:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Research Site **Status:** RECRUITING **Zip:** 02841 **Location 275:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Research Site **Status:** RECRUITING **Zip:** 03080 **Location 276:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Research Site **Status:** RECRUITING **Zip:** 03722 **Location 277:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Research Site **Status:** RECRUITING **Zip:** 05505 **Location 278:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Research Site **Status:** RECRUITING **Zip:** 06273 **Location 279:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Research Site **Status:** RECRUITING **Zip:** 06351 **Location 280:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Research Site **Status:** RECRUITING **Zip:** 06591 **Location 281:** **City:** George Town **Country:** Malaysia **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 10990 **Location 282:** **City:** Kuala Lumpur **Country:** Malaysia **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 50586 **Location 283:** **City:** Kuala Lumpur **Country:** Malaysia **Facility:** Research Site **Status:** RECRUITING **Zip:** 59100 **Location 284:** **City:** Kuching **Country:** Malaysia **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 93586 **Location 285:** **City:** Selangor **Country:** Malaysia **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 62250 **Location 286:** **City:** Bialystok **Country:** Poland **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 15-027 **Location 287:** **City:** Bydgoszcz **Country:** Poland **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 85-796 **Location 288:** **City:** Gdańsk **Country:** Poland **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 80-214 **Location 289:** **City:** Gdynia **Country:** Poland **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 81-519 **Location 290:** **City:** Tomaszów Mazowiecki **Country:** Poland **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 97-200 **Location 291:** **City:** Warszawa **Country:** Poland **Facility:** Research Site **Status:** RECRUITING **Zip:** 02-781 **Location 292:** **City:** Wroclaw **Country:** Poland **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 53-413 **Location 293:** **City:** Łódź **Country:** Poland **Facility:** Research Site **Status:** RECRUITING **Zip:** 93-338 **Location 294:** **City:** Singapore **Country:** Singapore **Facility:** Research Site **Status:** RECRUITING **Zip:** 168583 **Location 295:** **City:** Barcelona **Country:** Spain **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 08036 **Location 296:** **City:** Barcelona **Country:** Spain **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 8035 **Location 297:** **City:** Granada **Country:** Spain **Facility:** Research Site **Status:** RECRUITING **Zip:** 18016 **Location 298:** **City:** Hospitalet deLlobregat **Country:** Spain **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 08907 **Location 299:** **City:** Madrid **Country:** Spain **Facility:** Research Site **Status:** RECRUITING **Zip:** 28007 **Location 300:** **City:** Madrid **Country:** Spain **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 28034 **Location 301:** **City:** Santiago de Compostela **Country:** Spain **Facility:** Research Site **Status:** RECRUITING **Zip:** 15706 **Location 302:** **City:** Sevilla **Country:** Spain **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 41009 **Location 303:** **City:** Zaragoza **Country:** Spain **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 50009 **Location 304:** **City:** Baden **Country:** Switzerland **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** CH-5405 **Location 305:** **City:** Basel **Country:** Switzerland **Facility:** Research Site **Status:** RECRUITING **Zip:** 4031 **Location 306:** **City:** Bern **Country:** Switzerland **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 3010 **Location 307:** **City:** Frauenfeld **Country:** Switzerland **Facility:** Research Site **Status:** RECRUITING **Zip:** 8501 **Location 308:** **City:** Rennaz **Country:** Switzerland **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 1847 **Location 309:** **City:** Changhua **Country:** Taiwan **Facility:** Research Site **Status:** RECRUITING **Zip:** 500 **Location 310:** **City:** Kaohsiung **Country:** Taiwan **Facility:** Research Site **Status:** RECRUITING **Zip:** 82445 **Location 311:** **City:** Taichung **Country:** Taiwan **Facility:** Research Site **Status:** RECRUITING **Zip:** 40447 **Location 312:** **City:** Tainan **Country:** Taiwan **Facility:** Research Site **Status:** RECRUITING **Zip:** 704 **Location 313:** **City:** Taipei **Country:** Taiwan **Facility:** Research Site **Status:** RECRUITING **Zip:** 10002 **Location 314:** **City:** Taipei **Country:** Taiwan **Facility:** Research Site **Status:** RECRUITING **Zip:** 10449 **Location 315:** **City:** Taipei **Country:** Taiwan **Facility:** Research Site **Status:** RECRUITING **Zip:** 112 **Location 316:** **City:** Taoyuan **Country:** Taiwan **Facility:** Research Site **Status:** RECRUITING **Zip:** 333 **Location 317:** **City:** Bangkok **Country:** Thailand **Facility:** Research Site **Status:** RECRUITING **Zip:** 10210 **Location 318:** **City:** Bangkok **Country:** Thailand **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 10330 **Location 319:** **City:** Dusit **Country:** Thailand **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 10300 **Location 320:** **City:** Muang **Country:** Thailand **Facility:** Research Site **Status:** RECRUITING **Zip:** 50200 **Location 321:** **City:** Songkhla **Country:** Thailand **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 90110 **Location 322:** **City:** Adapazari **Country:** Turkey **Facility:** Research Site **Status:** RECRUITING **Zip:** 54290 **Location 323:** **City:** Ankara **Country:** Turkey **Facility:** Research Site **Status:** RECRUITING **Zip:** 06010 **Location 324:** **City:** Ankara **Country:** Turkey **Facility:** Research Site **Status:** RECRUITING **Zip:** 06340 **Location 325:** **City:** Ankara **Country:** Turkey **Facility:** Research Site **Status:** RECRUITING **Zip:** 06520 **Location 326:** **City:** Istanbul **Country:** Turkey **Facility:** Research Site **Status:** RECRUITING **Zip:** 34722 **Location 327:** **City:** Kayseri **Country:** Turkey **Facility:** Research Site **Status:** RECRUITING **Zip:** 38039 **Location 328:** **City:** Samsun **Country:** Turkey **Facility:** Research Site **Status:** RECRUITING **Location 329:** **City:** Birmingham **Country:** United Kingdom **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** B15 2TG **Location 330:** **City:** Cardiff **Country:** United Kingdom **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** CF14 2TL **Location 331:** **City:** Edinburgh **Country:** United Kingdom **Facility:** Research Site **Status:** RECRUITING **Zip:** EH1 3EG **Location 332:** **City:** Guildford **Country:** United Kingdom **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Location 333:** **City:** Lancaster **Country:** United Kingdom **Facility:** Research Site **Status:** RECRUITING **Zip:** LA1 4RP **Location 334:** **City:** London **Country:** United Kingdom **Facility:** Research Site **Status:** RECRUITING **Zip:** EC1A 7BE **Location 335:** **City:** Northampton **Country:** United Kingdom **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** NN1 5BD **Location 336:** **City:** Oxford **Country:** United Kingdom **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** OX3 7LE **Location 337:** **City:** Hanoi **Country:** Vietnam **Facility:** Research Site **Status:** RECRUITING **Zip:** 100000 **Location 338:** **City:** Hanoi **Country:** Vietnam **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 100000 **Location 339:** **City:** Ho Chi Minh city **Country:** Vietnam **Facility:** Research Site **Status:** RECRUITING **Zip:** 700000 **Location 340:** **City:** Ho Chi Minh city **Country:** Vietnam **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 700000 **Location 341:** **City:** Vinh **Country:** Vietnam **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Zip:** 460000 ### IPD Sharing Statement Module **Access Criteria:** When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. **Description:** Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES **Time Frame:** AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure **URL:** https://astrazenecagroup-dt.pharmacm.com/DT/Home ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Intervention Browse Module - Ancestors - ID: D000000972 - Term: Antineoplastic Agents, Phytogenic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018501 - Term: Antirheumatic Agents - ID: D000018906 - Term: Antineoplastic Agents, Alkylating - ID: D000000477 - Term: Alkylating Agents - ID: D000019653 - Term: Myeloablative Agonists - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000082082 - Term: Immune Checkpoint Inhibitors - ID: D000000903 - Term: Antibiotics, Antineoplastic - ID: D000059005 - Term: Topoisomerase II Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites - ID: D000067856 - Term: Poly(ADP-ribose) Polymerase Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M19537 - Name: Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M6727 - Name: Cyclophosphamide - Relevance: HIGH - As Found: Cycle - ID: M7492 - Name: Doxorubicin - Relevance: HIGH - As Found: Women - ID: M227339 - Name: Liposomal doxorubicin - Relevance: LOW - As Found: Unknown - ID: M377 - Name: Capecitabine - Relevance: HIGH - As Found: Function - ID: M349416 - Name: Pembrolizumab - Relevance: HIGH - As Found: Blind - ID: M17954 - Name: Epirubicin - Relevance: HIGH - As Found: 12 hours - ID: M18650 - Name: Carboplatin - Relevance: HIGH - As Found: System - ID: M272500 - Name: Durvalumab - Relevance: HIGH - As Found: Non-Small Cell - ID: M233003 - Name: Olaparib - Relevance: HIGH - As Found: Fentanyl - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M20942 - Name: Antineoplastic Agents, Alkylating - Relevance: LOW - As Found: Unknown - ID: M3820 - Name: Alkylating Agents - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M205 - Name: Poly(ADP-ribose) Polymerase Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017239 - Term: Paclitaxel - ID: D000003520 - Term: Cyclophosphamide - ID: D000016190 - Term: Carboplatin - ID: C000582435 - Term: Pembrolizumab - ID: D000004317 - Term: Doxorubicin - ID: D000069287 - Term: Capecitabine - ID: C000613593 - Term: Durvalumab - ID: D000015251 - Term: Epirubicin - ID: C000531550 - Term: Olaparib ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02919579 **Acronym:** DriveSaFe2 **Brief Title:** A Study to Evaluate the Effects of a Single-Dose and Repeat-Administration of Intranasal Esketamine on On-Road Driving in Participants With Major Depressive Disorder **Official Title:** A Placebo- and Active-Controlled Study to Evaluate the Effects of a Single-Dose and Repeat-Administration of Intranasal Esketamine on On-Road Driving in Subjects With Major Depressive Disorder (DriveSaFe2) #### Organization Study ID Info **ID:** CR108228 #### Organization **Class:** INDUSTRY **Full Name:** Janssen Research & Development, LLC #### Secondary ID Infos **ID:** 2016-002424-86 **Type:** EUDRACT_NUMBER **Domain:** Janssen Research & Development, LLC **ID:** 54135419TRD1019 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2018-06-29 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-04-24 **Type:** ACTUAL **Last Update Submit Date:** 2019-04-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-06-29 **Type:** ACTUAL #### Start Date **Date:** 2016-10-07 **Type:** ACTUAL **Status Verified Date:** 2019-04 #### Study First Post Date **Date:** 2016-09-29 **Type:** ESTIMATED **Study First Submit Date:** 2016-09-01 **Study First Submit QC Date:** 2016-09-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Janssen Research & Development, LLC #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The primary purpose of this study is to evaluate the effect of a single 84-milligram (mg) dose of intranasal esketamine compared to placebo, on next day driving performance and repeated administration of 84 mg intranasal esketamine on same-day driving performance as assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test. ### Conditions Module **Conditions:** - Depressive Disorder, Major ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 27 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive intranasal placebo on Day 1 and oral placebo on Day 2 \[Treatment A\] in Period 1, then intranasal placebo on Day 1 and Oral alcohol on Day 2 \[Treatment B\] in Period 2, followed by intranasal esketamine on Day 1 and oral placebo on Day 2 \[Treatment C\] in Period 3. **Intervention Names:** - Drug: Placebo (Intranasal) - Drug: Esketamine - Other: Alcohol - Drug: Placebo (Oral) **Label:** Part A: Sequence ABC (Placebo+Alcohol+Esketamine) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive Treatment B in Period 1, then Treatment C in Period 2, followed by Treatment A in Period 3. **Intervention Names:** - Drug: Placebo (Intranasal) - Drug: Esketamine - Other: Alcohol - Drug: Placebo (Oral) **Label:** Part A: Sequence BCA (Placebo+Alcohol+Esketamine) **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants will receive Treatment C in Period 1, then Treatment A in Period 2, followed by Treatment B in Period 3. **Intervention Names:** - Drug: Placebo (Intranasal) - Drug: Esketamine - Other: Alcohol - Drug: Placebo (Oral) **Label:** Part A: Sequence CAB (Placebo+Alcohol+Esketamine) **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Participants will receive Treatment C in Period 1, then Treatment B in Period 2, followed by Treatment A in Period 3. **Intervention Names:** - Drug: Placebo (Intranasal) - Drug: Esketamine - Other: Alcohol - Drug: Placebo (Oral) **Label:** Part A: Sequence CBA (Placebo+Alcohol+Esketamine) **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** Participants will receive Treatment A in Period 1, then Treatment C in Period 2, followed by Treatment B in Period 3. **Intervention Names:** - Drug: Placebo (Intranasal) - Drug: Esketamine - Other: Alcohol - Drug: Placebo (Oral) **Label:** Part A: Sequence ACB (Placebo+Alcohol+Esketamine) **Type:** EXPERIMENTAL #### Arm Group 6 **Description:** Participants will receive Treatment B in Period 1, then Treatment A in Period 2, followed by Treatment C in Period 3. **Intervention Names:** - Drug: Placebo (Intranasal) - Drug: Esketamine - Other: Alcohol - Drug: Placebo (Oral) **Label:** Part A: Sequence BAC (Placebo+Alcohol+Esketamine) **Type:** EXPERIMENTAL #### Arm Group 7 **Description:** Participants will receive intranasal placebo on Day 1, followed by intranasal esketamine on Days 4, 8, 11, 15, 18, 22 and 25. **Intervention Names:** - Drug: Placebo (Intranasal) - Drug: Esketamine **Label:** Part B: Placebo+Esketamine **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Part A: Sequence ABC (Placebo+Alcohol+Esketamine) - Part A: Sequence ACB (Placebo+Alcohol+Esketamine) - Part A: Sequence BAC (Placebo+Alcohol+Esketamine) - Part A: Sequence BCA (Placebo+Alcohol+Esketamine) - Part A: Sequence CAB (Placebo+Alcohol+Esketamine) - Part A: Sequence CBA (Placebo+Alcohol+Esketamine) - Part B: Placebo+Esketamine **Description:** Participants will receive intranasal placebo in Part A (as per the treatment sequence in period 1,2 and 3) and Part B. **Name:** Placebo (Intranasal) **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Part A: Sequence ABC (Placebo+Alcohol+Esketamine) - Part A: Sequence ACB (Placebo+Alcohol+Esketamine) - Part A: Sequence BAC (Placebo+Alcohol+Esketamine) - Part A: Sequence BCA (Placebo+Alcohol+Esketamine) - Part A: Sequence CAB (Placebo+Alcohol+Esketamine) - Part A: Sequence CBA (Placebo+Alcohol+Esketamine) - Part B: Placebo+Esketamine **Description:** Participants will receive intranasal esketamine in Part A (as per the treatment sequence in period 1,2 and 3) and Part B. **Name:** Esketamine **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Part A: Sequence ABC (Placebo+Alcohol+Esketamine) - Part A: Sequence ACB (Placebo+Alcohol+Esketamine) - Part A: Sequence BAC (Placebo+Alcohol+Esketamine) - Part A: Sequence BCA (Placebo+Alcohol+Esketamine) - Part A: Sequence CAB (Placebo+Alcohol+Esketamine) - Part A: Sequence CBA (Placebo+Alcohol+Esketamine) **Description:** Participants will receive oral alcohol in Part A (as per the treatment sequence in period 1,2 and 3). **Name:** Alcohol **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Part A: Sequence ABC (Placebo+Alcohol+Esketamine) - Part A: Sequence ACB (Placebo+Alcohol+Esketamine) - Part A: Sequence BAC (Placebo+Alcohol+Esketamine) - Part A: Sequence BCA (Placebo+Alcohol+Esketamine) - Part A: Sequence CAB (Placebo+Alcohol+Esketamine) - Part A: Sequence CBA (Placebo+Alcohol+Esketamine) **Description:** Participants will receive oral placebo in Part A (as per the treatment sequence in period 1,2 and 3). **Name:** Placebo (Oral) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Driving performance will be assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test. **Measure:** The Effect of a Single 84-Milligram (mg) Dose of Intranasal Esketamine Compared to Placebo, on Next day Driving Performance and Repeated Administration of 84 mg Intranasal Esketamine on Same-day Driving Performance **Time Frame:** Part A: Day 2 **Description:** Driving performance will be assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test. **Measure:** The Effect of a Single 84-mg Dose of Intranasal Esketamine Compared to Placebo, on Next day Driving Performance and Repeated Administration of 84 mg Intranasal Esketamine on Same-day Driving Performance **Time Frame:** Part B: Day 1 **Description:** Driving performance will be assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test. **Measure:** The Effect of a Single 84-mg Dose of Intranasal Esketamine Compared to Placebo, on Next day Driving Performance and Repeated Administration of 84 mg Intranasal Esketamine on Same-day Driving Performance **Time Frame:** Part B: Day 11 **Description:** Driving performance will be assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test. **Measure:** The Effect of a Single 84-mg Dose of Intranasal Esketamine Compared to Placebo, on Next day Driving Performance and Repeated Administration of 84 mg Intranasal Esketamine on Same-day Driving Performance **Time Frame:** Part B: Day 18 **Description:** Driving performance will be assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test. **Measure:** The Effect of a Single 84-mg Dose of Intranasal Esketamine Compared to Placebo, on Next day Driving Performance and Repeated Administration of 84 mg Intranasal Esketamine on Same-day Driving Performance **Time Frame:** Part B: Day 25 #### Secondary Outcomes **Description:** Immediately after each driving test, subjects will indicate the perceived quality of their driving performance on a visual analog scale from 0 ('I drove exceptionally poorly') to 20 ('I drove exceptionally well') around a midpoint of 'I drove normally'. **Measure:** Effect on Subjective Driving Ability Scale **Time Frame:** Part A: Day 2; Part B: Day 1, 11, 18 and 25 **Description:** KSS is a participant reported assessment used to rate sleepiness on a scale of 1 to 9, ranging from 'extremely alert' (1) to 'very sleepy, great effort to keep awake, fighting sleep (9). **Measure:** Karolinska Sleepiness Scale (KSS) Score **Time Frame:** Part A: Day 2; Part B: Day 1, 11, 18 and 25 **Description:** MADRS consists of 10 items covering all the important complaints which Participant with depression have (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Item is scored from 0 (normal) to 6 (severe). Total score (0 to 60) is calculated by adding the scores of all 10 items. A higher score represents a more severe condition. Negative Change in Score Indicates Improvement. **Measure:** Efficacy Measured by the Montgomery Asberg Depression Rating Scale (MADRS) **Time Frame:** Baseline; Part A: Predose, Day 2; Part B: Predose, Days 1, 11, 18, and 25; End of study (up to Day 98) **Description:** C-SSRS is a clinician rated assessment of suicidal behavior and / or intent. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses are listed. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline. **Measure:** Effects on Suicidal Ideation/Behavior Measured by the Columbia Suicide Severity Rating Scale (C-SSRS) **Time Frame:** Baseline; Part A: Predose, Day 2; Part B: Predose, Days 1, 11, 18, and 25; End of study (up to Day 98) **Description:** The CADSS is an instrument for the measurement of present-state dissociative symptoms. The CADSS comprises 23 subjective items, divided into 3 components: Depersonalization, Derealization and Amnesia. Participant's responses are coded on a 5-point scale (0 = "Not at all" through to 4 = "Extremely"). **Measure:** Effects on Dissociative Symptoms Using the Clinician-Administered Dissociative State Scale (CADSS) **Time Frame:** Baseline; Part A: Predose, Day 1; Part B: Predose, Days 1, 11, 18, and 25 **Description:** Potential relationship will be assessed using visual displays of data. The relationship between the standard deviation of lateral position (SDLP) and the concentration of esketamine and noresketamine in plasma will be evaluated. **Measure:** Potential Relationship Between Changes in SDLP and the Plasma Concentration of Esketamine and Noresketamine **Time Frame:** Part A: 1 hour postdose (Day 1); Part B: 1 hour postdose (Day 11, 18 and 25) **Description:** The level of mental effort the participant had to invest in performing the driving test will be assessed on a 15 centimeter (cm) visual analogue scale with markings ranging from 'absolutely no effort' to over 'extreme effort. **Measure:** Effect on Subjective Mental Effort Scale **Time Frame:** Part A: Day 2; Part B: Day 1, 11, 18 and 25 **Description:** Potential relationship will be assessed using visual displays of data. The relationship between the MLP and the concentration of esketamine and noresketamine in plasma will be evaluated. The MLP will be measured from a validated on-road driving test in a 100 kilometer (km) highway-driving lane. **Measure:** Potential Relationship Between Changes in Mean Lateral Position (MLP) and the Plasma Concentration of Esketamine and Noresketamine **Time Frame:** Part A: 1 hour postdose (Day 1); Part B: 1 hour postdose (Day 11, 18 and 25) **Description:** Potential relationship will be assessed using visual displays of data. The relationship between the mean speed (MS) and the concentration of esketamine and noresketamine in plasma will be evaluated. The MS will be measured from a validated on-road driving test in a 100 km highway-driving lane. **Measure:** Potential Relationship Between Changes in Mean Speed and the Plasma Concentration of Esketamine and Noresketamine **Time Frame:** Part A: 1 hour postdose (Day 1); Part B: 1 hour postdose (Day 11, 18 and 25) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Willing and able to adhere to the prohibitions and restrictions specified in this protocol * If a woman, must have a negative serum beta human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test on Day 1 of Period 1 in Part A and prior to study drug administration in Part B * Comfortable with self-administration of intranasal medication and able to follow instructions provided * Normal visual acuity (corrected or uncorrected) * Based on self-report, able to consume an amount of alcohol that typically produces a blood alcohol concentration (BAC) of 0.05 percent (that is, 2 to 3 alcoholic drinks ingested within 2 hours on a single occasion) Exclusion Criteria: * Current or prior diagnosis of psychosis/psychotic or bipolar disorder * Primary sleep disorder, such as insomnia, requiring pharmacological intervention at Screening * Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or Day 1 of Period 1 as deemed appropriate by the investigator * Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at screening or Day 1 of Period 1 as deemed appropriate by the investigator * History of moderate or severe use disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV or DSM-5) criteria within 1 year before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening and Day 1 of Period 1 **Maximum Age:** 60 Years **Minimum Age:** 22 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Leiden **Country:** Netherlands #### Overall Officials **Official 1:** **Affiliation:** Janssen Research & Development, LLC **Name:** Janssen Research & Development, LLC Clinical Trial **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Dijkstra FM, van de Loo AJ, Abdulahad S, Bosma ER, Hartog M, Huls H, Kuijper DC, de Vries E, Solanki B, Singh J, Aluisio L, Zannikos P, Stuurman FE, Jacobs GE, Verster JC. The effects of intranasal esketamine on on-road driving performance in patients with major depressive disorder or persistent depressive disorder. J Psychopharmacol. 2022 May;36(5):614-625. doi: 10.1177/02698811221078764. Epub 2022 Feb 25. **PMID:** 35212235 #### See Also Links **Label:** A Placebo- and Active-Controlled Study to Evaluate the Effects of a Single-Dose and Repeat-Administration of Intranasal Esketamine on On-Road Driving in Subjects With Major Depressive Disorder (DriveSaFe2) **URL:** https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&amp;parentIdentifier=CR108228&amp;attachmentIdentifier=d2a59202-2675-439e-a1f3-fe2d4c870cd2&amp;fileName=CR108228_CSR_Synopsis.pdf&amp;versionIdentifier= ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depressive Disorder - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depressive Disorder - ID: M7060 - Name: Depressive Disorder, Major - Relevance: HIGH - As Found: Depressive Disorder, Major - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003866 - Term: Depressive Disorder - ID: D000003863 - Term: Depression - ID: D000003865 - Term: Depressive Disorder, Major ### Intervention Browse Module - Ancestors - ID: D000000928 - Term: Antidepressive Agents - ID: D000011619 - Term: Psychotropic Drugs ### Intervention Browse Module - Browse Branches - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants ### Intervention Browse Module - Browse Leaves - ID: M271980 - Name: Esketamine - Relevance: HIGH - As Found: Auditory - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown - ID: M4247 - Name: Antidepressive Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000629870 - Term: Esketamine ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04926779 **Brief Title:** Study Utilizing BIOZEK COVID-19 Antigen Rapid Test **Official Title:** Open Label, Single-Center Study Utilizing BIOZEK COVID-19 Antigen Rapid Test: Comparison of Biozek COVID-19 Antigen Rapid Test Results Performed on Self-collected Samples by the Subjects, to Results of COVID-19 RT-PCR as a Standard of Care #### Organization Study ID Info **ID:** Biozek-ARTC-US/002/4-12-2021 #### Organization **Class:** INDUSTRY **Full Name:** Mach-E B.V. ### Status Module #### Completion Date **Date:** 2022-11-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-12-20 **Type:** ACTUAL **Last Update Submit Date:** 2023-12-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-11-04 **Type:** ACTUAL #### Results First Post Date **Date:** 2023-12-20 **Type:** ACTUAL **Results First Submit Date:** 2023-11-04 **Results First Submit QC Date:** 2023-12-17 #### Start Date **Date:** 2021-05-24 **Type:** ACTUAL **Status Verified Date:** 2023-12 #### Study First Post Date **Date:** 2021-06-15 **Type:** ACTUAL **Study First Submit Date:** 2021-06-11 **Study First Submit QC Date:** 2021-06-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Mach-E B.V. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is Unapproved Device:** True **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a research study to evaluate the Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test (Saliva) and BIOZEK COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) on samples that are self-collected; and to perform analysis to compare results. In addition, to obtain RT-PCR test results, performed prior to enrollment, and compare all three results. ### Conditions Module **Conditions:** - Covid-19 Testing **Keywords:** - Covid-19 - Antigen - Rapid - Test ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 185 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Self-collection of nasopharyngeal and saliva samples and self test performance - Biozek Covid-19 Antigen Rapid Test (Saliva) and Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab). Both procedures are supervised by trained study personnel. **Name:** Biozek Covid-19 Antigen Rapid Test (Saliva) **Other Names:** - Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab) **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** The Biozek Antigen Rapid Tests performed by subjects on the self-collected, oral fluid samples . Sensitivity was calculated using (TP/TP+FN)\*100% formula. Specificity was calculated using (TN/TN+FP)\*100% formula. **Measure:** Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva) **Time Frame:** 6 months **Description:** The Biozek Antigen Rapid Tests performed by subjects on the self-collected, nasopharyngeal samples . Sensitivity was calculated using (TP/TP+FN)\*100% formula. Specificity was calculated using (TN/TN+FP)\*100% formula. **Measure:** Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab) **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subjects must be ≥18 years of age and have had an RT-PCR test performed prior to enrollment. * Subjects must be able to understand and willingly sign a written informed consent. Additionally, participants need to meet at least 1 of the criteria listed below: * Currently experiencing symptoms of COVID-19. * Be clinically diagnosed or suspected to have COVID-19. * Recent past (3 weeks) exhibited symptoms of COVID-19. * Be capable of performing a self-collection of a nasopharyngeal sample with use of nasal swab kit. * Be capable of performing a self-collection of an oral fluid sample with use of oral fluid collection kit. * Interacted with a COVID-19 positive individual. Exclusion Criteria: Subjects who meet any of the following exclusion criteria may not be enrolled in this study: * Cannot perform self-collection of a nasopharyngeal sample with use of nasal swab kit. * Cannot perform self-collection of an oral fluid sample with use of oral fluid collection kit. * Have a deviated nasal septum. * Cognitively impaired individuals resulting in the inability to provide informed consent **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Flushing **Country:** United States **Facility:** Mobile Covid Services LLC **State:** New York **Zip:** 11354 **Location 2:** **City:** Southampton **Country:** United States **Facility:** Quality Research and Invention LLC **State:** New York **Zip:** 11968 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Document Section ### Large Document Module #### Large Docs - Date: 2021-06-01 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 690053 - Type Abbrev: Prot_SAP - Upload Date: 2023-11-04T11:22 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000014777 - Term: Virus Diseases - ID: D000018352 - Term: Coronavirus Infections - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: COVID-19 - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 ### Misc Info Module #### Submission Tracking ##### First MCP Info ###### Post Date - Date: 2023-11-29 - Type: ACTUAL - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** BIOZEK COVID-19 Antigen Rapid Test (Oral Fluid) **Deaths Num At Risk:** 185 **Description:** BIOZEK COVID-19 Antigen Rapid Test performed by subjects on self-collected, oral fluid samples compared to RT-PCR. **ID:** EG000 **Other Num at Risk:** 185 **Serious Number At Risk:** 185 **Title:** BIOZEK COVID-19 Antigen Rapid Test (Oral Fluid) **Frequency Threshold:** 0 **Time Frame:** 1 visit - up to 2 hours ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 185 **Units:** Participants ### Group **ID:** BG000 **Title:** BIOZEK COVID-19 Antigen Rapid Test (Oral Fluid) **Description:** BIOZEK COVID-19 Antigen Rapid Test performed by subjects on self-collected, oral fluid samples compared to RT-PCR. ### Measure #### Measurement **Group ID:** BG000 **Value:** 36 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 185 **Class Title:** 18-24 years #### Measurement **Group ID:** BG000 **Value:** 128 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 185 **Class Title:** 25-64 years #### Measurement **Group ID:** BG000 **Value:** 19 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 185 **Class Title:** 65-87 years #### Measurement **Group ID:** BG000 **Value:** 2 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 185 **Class Title:** Unknown ### Measure #### Measurement **Group ID:** BG000 **Value:** 111 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 71 **Category Title:** Male #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 182 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 1 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 185 **Class Title:** Arabic #### Measurement **Group ID:** BG000 **Value:** 12 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 185 **Class Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 51 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 185 **Class Title:** Black #### Measurement **Group ID:** BG000 **Value:** 74 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 185 **Class Title:** Caucasian #### Measurement **Group ID:** BG000 **Value:** 31 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 185 **Class Title:** Hispanic/Latino #### Measurement **Group ID:** BG000 **Value:** 1 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 185 **Class Title:** Indian #### Measurement **Group ID:** BG000 **Value:** 1 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 185 **Class Title:** Native American #### Measurement **Group ID:** BG000 **Value:** 4 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 185 **Class Title:** Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 10 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 185 **Class Title:** Unknown ### Measure #### Measurement **Group ID:** BG000 **Value:** 185 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 185 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Customized **Unit of Measure:** Participants ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Data was not captured for 3 participants. **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race/Ethnicity, Customized **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** jstega@optonline.net **Organization:** Quality Research and Invention LLC **Phone:** 6462718593 **Title:** Zanetta Malanowska-Stega ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 97.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 97.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** The Biozek Antigen Rapid Tests performed by subjects on the self-collected, oral fluid samples . Sensitivity was calculated using (TP/TP+FN)\*100% formula. Specificity was calculated using (TN/TN+FP)\*100% formula. **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** 6 months **Title:** Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva) **Type:** PRIMARY **Unit of Measure:** percentage - Sensitivity and specificity ##### Group **Description:** BIOZEK COVID-19 Antigen Rapid Test performed by subjects on self-collected, oral fluid samples compared to RT-PCR. **ID:** OG000 **Title:** BIOZEK COVID-19 Antigen Rapid Test (Oral Fluid) #### Outcome Measure 2 **Description:** The Biozek Antigen Rapid Tests performed by subjects on the self-collected, nasopharyngeal samples . Sensitivity was calculated using (TP/TP+FN)\*100% formula. Specificity was calculated using (TN/TN+FP)\*100% formula. **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** 6 months **Title:** Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab) **Type:** PRIMARY **Unit of Measure:** percentage - Sensitivity and specificity ##### Group **Description:** The Biozek Antigen Rapid Tests performed by subjects on the self-collected, nasopharyngeal samples . Sensitivity was calculated using (TP/TP+FN)\*100% formula. Specificity was calculated using (TN/TN+FP)\*100% formula. **ID:** OG000 **Title:** BIOZEK COVID-19 Antigen Rapid Test (Oral Fluid) ### Participant Flow Module #### Group **Description:** BIOZEK COVID-19 Antigen Rapid Test (Saliva) and BIOZEK COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) was performed by subjects on samples that were self-collected; In addition, RT-PCR test (performed prior enrollment) results were obtained. **ID:** FG000 **Title:** BIOZEK COVID-19 Antigen Rapid Test #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 185 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 185 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT03076879 **Brief Title:** Increasing Participation in Cervical Cancer Screening and Risk for Beliefs/Attitudes Among Women at Risk **Official Title:** The Effect of Nursing Interventions on Women's Cervical Cancer Risk for Beliefs / Attitudes and Attendance to Screening Programme; Study Protocol for a Randomized Controlled Trial #### Organization Study ID Info **ID:** 2014-066 #### Organization **Class:** OTHER **Full Name:** Selcuk University ### Status Module #### Completion Date **Date:** 2017-06-19 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-09-18 **Type:** ACTUAL **Last Update Submit Date:** 2019-09-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-03-22 **Type:** ACTUAL #### Start Date **Date:** 2017-03-15 **Type:** ACTUAL **Status Verified Date:** 2017-09 #### Study First Post Date **Date:** 2017-03-10 **Type:** ACTUAL **Study First Submit Date:** 2017-02-26 **Study First Submit QC Date:** 2017-03-06 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Selcuk University #### Responsible Party **Investigator Affiliation:** Selcuk University **Investigator Full Name:** BUSRA ALTINEL **Investigator Title:** Research Assistant **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In order to evaluate the effectiveness of nursing interventions aimed at the early detection of cervical cancer, health belief and participation in the screening of women aged 40-55 at risk for the purpose of cervical cancer, One-way blind pre-test and post-test randomized controlled trial. **Detailed Description:** Cervical cancer is the 4th most common cancer type in the world, among women, in all age groups. Cervical cancer is a high-risk disease, and every two minutes, a woman loses her life due to cervical cancer. In Turkey, among the most common cancers among all age groups among women, 9th is the 5th among the most common cancers in the 25-49 age group. Cervix cancer is a type of cancer that can be prevented and treated at an early stage. Because cervical cancer has a long preclinical period, it has an early diagnosis possibility. For this reason, cervical cancer is one of the cancers recommended by World Health Organization (WHO) screening programs. In countries where regular screenings have been conducted, death rates from cervical cancer have decreased. In developing countries, high incidence and mortality continue due to the inadequacy of screening programs. The first step in the early diagnosis of cervical cancer is usually the result of an abnormal Pap smear test. The Pap smear test is an ideal cytologic screening test used for screening because it can identify early onset of a cellular change that may be a starting point for cervical cancer and is cost effective. The number of women who have had the Pap smear test, which is so important in early diagnosis, is not at a level all over the world and in our country. In developed countries, cervical cancer screening rates are over 60%, while in underdeveloped and developing countries this rate is below 20%. In our country, the rate of not having any pap smear test over the age of 15 years is 77.9%. Studies have shown that when women with cervical cancer are diagnosed early, their life span is prolonged and their chances of survival increase. Early diagnosis of cervical cancer is a simple, feasible and economical method. Women's lack of knowledge, worries about negative test results, and their reasons for not having a Pap smear test are among the reasons. Along with being semi-empirical studies in our country, most are based solely on education and do not involve a risk group approach. In addition, there was no randomized controlled trial (RCT) with evidence in the definition of causal relationship in our country. For this reason, determining the factors affecting the early diagnosis behavior of women, planning and implementing nursing interventions for these factors will contribute to the improvement of early diagnosis behavior of women with cervical cancer. In this respect, health education for cervical cancer and early diagnosis to be made to women in the risk group will have made a unique contribution to RCT including motivational initiatives and home visits. In order to evaluate the effectiveness of nursing interventions aimed at early detection of cervical cancer, health beliefs and participation in scans in women aged 40-55 years at risk for prognostic cervical cancer, One-way blind pre-test - final test was planned as RCT. In this context, women in the risk group of 40-55 years of age with cervical cancer in the project will constitute the universe of RCT. No pap smear test, no previous training for cervical cancer, no previous hysterectomy, no previous cancer diagnosis, no current or past sexual life and at least one of the identified risk factors Will have women involved. Women who are in the risk group for cervical cancer and meet the inclusion and exclusion criteria of the study will be randomly assigned to the experimental and control groups. In the experimental group, cervical cancer will constitute nursing initiatives for health education, home visits, problem-specific counseling and phone reminders for women at risk. Women in the experimental group will receive a 15-week follow-up. Two reminders will be used to increase motivation between home visits and trainings. The effectiveness of counseling and training programs will be assessed by means of data collection tools that will be used for pretest / posttest for women in the experimental and control groups and the data form prepared by the researcher in the light of the literature. Depending on the project, women are expected to participate in the cervical cancer screening program. Home visits, trainings, counseling and reminders by phone will raise awareness levels of women at risk for cervical cancer as a result. As a result, increased participation of women in the risk group in screening programs will increase the probability of early diagnosis and reduce cervical cancer mortality, reduce the cost and improve the health of the community. ### Conditions Module **Conditions:** - Cervical Cancer **Keywords:** - Cervical Cancer - Pap smear - Screening - Beliefs - Attitude - Nursing ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Masking Description:** Blindness in the study will be done by data collectors and statisticians. The data will be collected by the assistant investigator who does not know who is in the experiment and control group and the data will be recorded on the computer by the assistant investigator without specifying the experiment and control group. The experimental and control groups will be codified by the co-investigator. The analysis of the data encoded by the groups will be done by a statistical expert. Data collectors, statistical analyzes and report writing will be blinded. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 114 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The selected ASM was associated with risk factors related to direct cervical cancer in Turkey (using age 5 or older oral contraceptives, having three or more children, initiating sexual intercourse 16 years or older, at least one parenthesized smear test between 40-55 years) And randomly assigned to the experimental group to promoting participation in cervical cancer screening **Intervention Names:** - Behavioral: Promoting participation in cervical cancer screening **Label:** Intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The selected ASM is the most common and associated with direct cervical cancer-related risk factors in Turkey (using oral contraceptives for longer than five years, having three or more children, starting sexual intercourse at the age of 16 and before, Women who are randomly assigned to the control group of women who have at least one pap smear test between the ages of 40 and 55 and who have at least one pap smear test in the family (especially a mother and a sister) **Label:** Control Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention group **Description:** Nursing education: Women in the experimental group will be trained three times in total, one for the cervical cancer screening and the other two for the individual. Reminders by phone; Short messages and calls will be reminiscent of women's participation in cervical cancer screenings. Home visit; The content of the training is the key to cervical cancer and screening. After the group training, it is aimed to be an interactive education and counseling service in the form of question-answer method which is not understood by home visiting method. Brochure; The brochure for cervical cancer and screening will be given after group training. **Name:** Promoting participation in cervical cancer screening **Other Names:** - Education - Counseling - Home Visit - Reminder by phone **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** This form, prepared by the researcher, consists of four questions that question the participation status of the scan and which application is more effective. This form will only be applied in the final test. **Measure:** Pap Smear Management Related Evaluation Form **Time Frame:** 14 weeks after group training #### Secondary Outcomes **Description:** It consists of 35 items in total. There are 5 sub-dimensions of related scale. These; Benefit and motivation perception (8), The obstacle sensation 14, The perception of seriousness of cervical cancer (7),Sensitivity sense (3) And health motivation (3). In the scale, the answer is 1, "I do not agree" 2, "I am undecided" 3, "I agree" 4 and "I strongly agree" 5.No item on the scale is scored in reverse. In the evaluation, scores are obtained for each individual as the number of sub-dimensions. From the subscales of the scale, at least 8, at most 40 for Pap smear benefit and motivation; Pap smear for at least 14, at most 70; At least 7, at most 35 for cervical cancer care / seriousness; At least 3, at most 15 for cervical cancer susceptibility and at least 3, at most 15 for cervical cancer health motivation. The increase in the scores means that the sensitivity, the importance and health motivation increase; Benefits for benefit perception, and high perception for obstacle perception. **Measure:** Cervix Cancer And Pap-Smear Test Health Belief Model Scale **Time Frame:** Before work begins and 14 weeks after group training **Description:** The scale measures health-promoting behaviors associated with the individual's healthy lifestyle. This scale, consisting of 52 items, has a total of six sub-dimensions including spiritual development, health responsibility, physical activity, nutrition, interpersonal relations and stress management. All of the items of the scale are indicative and quartile likert (never (1), sometimes (2), often (3), regularly (4)). Only the health responsibility sub-dimension will be used in this study. In the sub-dimension of health responsibility, the lowest score is 9 and the highest score is 36. The lower the score, the lower the health responsibility, and as the score increases, the health responsibility also increases. **Measure:** Healthy Lifestyle Behavior Scale (Health Responsibility) **Time Frame:** Before work begins and 14 weeks after group training ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being literate * Have not received any training on cervical cancer before Exclusion Criteria: * Being pregnant or postpartum quarterly * Have already been diagnosed with any cancer * Not having sexual experience * Having undergone hysterectomy operation **Gender Based:** True **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 40 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Konya **Country:** Turkey **Facility:** Selçuk University **State:** Selçuklu **Zip:** 42100 #### Overall Officials **Official 1:** **Affiliation:** SELÇUK ÜNİVERSİTESİ **Name:** Belgin Akın, PhD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014594 - Term: Uterine Neoplasms - ID: D000005833 - Term: Genital Neoplasms, Female - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000002577 - Term: Uterine Cervical Diseases - ID: D000014591 - Term: Uterine Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5830 - Name: Uterine Cervical Neoplasms - Relevance: HIGH - As Found: Cervical Cancer - ID: M17342 - Name: Uterine Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8945 - Name: Genital Neoplasms, Female - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5825 - Name: Uterine Cervical Diseases - Relevance: LOW - As Found: Unknown - ID: M17339 - Name: Uterine Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002583 - Term: Uterine Cervical Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6494 - Name: Contraceptive Agents - Relevance: LOW - As Found: Unknown - ID: M6500 - Name: Contraceptives, Oral - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02646579 **Brief Title:** Effects of Dry Needling Using Spinal and Peripheral Sites Versus Peripheral Sites Only **Official Title:** Effects of Dry Needling Using Spinal and Peripheral Sites Versus Peripheral Sites Only Among Individuals With Chronic Lower Extremity Conditions #### Organization Study ID Info **ID:** IRB00084277 #### Organization **Class:** OTHER **Full Name:** Emory University ### Status Module #### Completion Date **Date:** 2019-05-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-07-18 **Type:** ACTUAL **Last Update Submit Date:** 2019-07-16 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-05-01 **Type:** ACTUAL #### Start Date **Date:** 2017-10-27 **Type:** ACTUAL **Status Verified Date:** 2019-07 #### Study First Post Date **Date:** 2016-01-05 **Type:** ESTIMATED **Study First Submit Date:** 2016-01-04 **Study First Submit QC Date:** 2016-01-04 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Emory University #### Responsible Party **Investigator Affiliation:** Emory University **Investigator Full Name:** Marie Johanson **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to determine if dry needling both low back and extremity areas is more effective for reducing pain and improving strength, balance and functional performance among patients with chronic musculoskeletal conditions compared to dry needling of extremity areas only. **Detailed Description:** This study will determine if spinal and peripheral dry needling sites results in decreased pain, increased muscle strength, increased proprioception and increased functional performance among individuals with chronic musculoskeletal conditions of the lower extremities, such as plantar fasciitis, Achilles tendinopathy, and patellofemoral pain syndrome. Specific aims are to determine if individuals with chronic musculoskeletal conditions of the lower extremities receiving dry needling to both spinal and peripheral sites exhibit differences in pain, muscle strength, proprioception, and unilateral hop test scores compared to individuals with chronic musculoskeletal conditions of the lower extremities receiving dry needling to peripheral sites only. ### Conditions Module **Conditions:** - Plantar Fasciitis - Achilles Tendinitis - Patellofemoral Pain Syndrome **Keywords:** - Orthopedics ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 34 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive dry needling to the low back and painful areas in the leg. **Intervention Names:** - Procedure: Spinal and Peripheral Dry Needling **Label:** Spinal and Peripheral Dry Needling **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive dry needling to painful areas in the leg. **Intervention Names:** - Procedure: Peripheral Dry Needling **Label:** Peripheral Dry Needling **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Spinal and Peripheral Dry Needling **Description:** Participants will be positioned lying flat and the relevant spinal level will be treated using a Seirin L- type 50 mm needle. The needle will be inserted to a depth no greater than three-quarters length of the needle for 30 seconds using a vertical pistoning technique and then statically up to 10 minutes. **Name:** Spinal and Peripheral Dry Needling **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Peripheral Dry Needling **Description:** Participants will be positioned lying flat and the relevant peripheral points will be treated using a Seirin L- type 50 mm needle. The peripheral treatment site(s) will be determined by the physical therapist's palpation of active or latent trigger points or tender points. The needle will be inserted to a depth no greater than three-quarters length of the needle for 30 seconds using a vertical pistoning technique and then statically up to 10 minutes. **Name:** Peripheral Dry Needling **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Pain level will be assessed using the Visual Analogue Scale (VAS). The pain VAS is a self-reported, single-item scale that ranks pain level from no pain to worst imaginable pain on a single scale line. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the participant's mark, providing a range of scores from 0-100. **Measure:** Change in Pain Level assessed using the Visual Analogue Scale (VAS) **Time Frame:** Baseline, Visit 2 (Up to 7 days) #### Secondary Outcomes **Description:** The strength of the hip abductors will be assessed using a dynamometer. The subjects will be asked to exert maximal force against the dynamometer and the reading is recorded. Scores are based on force production in kilograms or pounds; kilograms (0-90), pounds (0-200). Higher pressure scores indicate better muscle strength of the hip abductor muscles. **Measure:** Change in Muscle Strength of Hip Abductors assessed using a dynamometer **Time Frame:** Baseline, Visit 2 (Up to 7 days) **Description:** The strength of the knee extensors/flexors will be assessed using a dynamometer. The subjects will be asked to exert maximal force against the dynamometer and the reading is recorded. Scores are based on force production in kilograms or pounds; kilograms (0-90), pounds (0-200). Higher pressure scores indicate better muscle strength of the knee extensor/flexor muscles. **Measure:** Change in Muscle Strength of Knee Extensors/Flexors assessed using a dynamometer **Time Frame:** Baseline, Visit 2 (Up to 7 days) **Description:** The strength of the ankle dorsiflexors/platarflexors will be assessed using a dynamometer. The subjects will be asked to exert maximal force against the dynamometer and the reading is recorded. Scores are based on force production in kilograms or pounds; kilograms (0-90), pounds (0-200). Higher pressure scores indicate better muscle strength of the ankle dorsiflexor/platarflexor muscles. **Measure:** Change in Muscle Strength of Ankle Dorsiflexors/Platarflexors assessed using a dynamometer **Time Frame:** Baseline, Visit 2 (Up to 7 days) **Description:** Participants will perform a single leg hop for distance with each lower extremity. After demonstration, each participant will be allowed 1 trial per leg. Beginning with the toes immediately behind the starting line, participants will perform one hop to complete a trial. The hop will be measured from the starting line to the end of the toes after completion of a trial. Each limb will be tested two times with the maximal distance scored for each limb. Scores will be recorded as absolute distance (in centimeters). An increase in the score (distance covered) from baseline visit to visit 2 indicates better functional performance of the muscles. **Measure:** Change in Unilateral Hop Distance **Time Frame:** Baseline, Visit 2 (Up to 7 days) **Description:** Participants will attempt to balance themselves within a defined area on a single limb. The maximum amount of time will be calculated both with and without their eyes closed. The opposite leg must be out in front of the participant fully extended and will not be allowed to touch any part of the body. The test will be timed, up to two minutes, on each limb with two trials on either side. **Measure:** Change in Single-limb Standing Balance Test Time **Time Frame:** Baseline, Visit 2 (Up to 7 days) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Unilateral chronic lower extremity musculoskeletal condition * Ability to perform a unilateral one-quarter squat on involved side without pain * Asymptomatic during walking Exclusion Criteria: * History of systemic neurological or arthritic condition * History of bony or peripheral nerve trauma or surgery lower extremities * No contraindications to dry needling * Not currently receiving treatment for the chronic lower extremity musculoskeletal condition **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Atlanta **Country:** United States **Facility:** The Emory Clinic **State:** Georgia **Zip:** 30322 #### Overall Officials **Official 1:** **Affiliation:** Emory University **Name:** Marie Johanson, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000005534 - Term: Foot Diseases - ID: D000007592 - Term: Joint Diseases - ID: D000009135 - Term: Muscular Diseases - ID: D000013708 - Term: Tendon Injuries - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M8351 - Name: Fasciitis - Relevance: HIGH - As Found: Fasciitis - ID: M24656 - Name: Fasciitis, Plantar - Relevance: HIGH - As Found: Plantar Fasciitis - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M25706 - Name: Patellofemoral Pain Syndrome - Relevance: HIGH - As Found: Patellofemoral Pain Syndrome - ID: M27013 - Name: Tendinopathy - Relevance: HIGH - As Found: Tendinitis - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M8658 - Name: Foot Diseases - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M16479 - Name: Tendon Injuries - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005208 - Term: Fasciitis - ID: D000036981 - Term: Fasciitis, Plantar - ID: D000046788 - Term: Patellofemoral Pain Syndrome - ID: D000052256 - Term: Tendinopathy ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04352179 **Brief Title:** Evaluation of Patient Education Simulations to Promote Health and Wellness **Official Title:** Evaluation of Patient Education Simulations to Promote Health and Wellness in Patients With Chronic Disease #### Organization Study ID Info **ID:** 19-00460 #### Organization **Class:** OTHER **Full Name:** NYU Langone Health ### Status Module #### Completion Date **Date:** 2021-10-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-02-09 **Type:** ACTUAL **Last Update Submit Date:** 2022-02-07 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-07-24 **Type:** ACTUAL #### Start Date **Date:** 2019-12-05 **Type:** ACTUAL **Status Verified Date:** 2022-02 #### Study First Post Date **Date:** 2020-04-20 **Type:** ACTUAL **Study First Submit Date:** 2020-04-16 **Study First Submit QC Date:** 2020-04-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** NYU Langone Health #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This pilot study will use a pre-post design to explore the utility of using virtual simulations to provide participant education and counseling for adopting healthy lifestyle behaviors (i.e., physical activity, nutrition, smoking, alcohol use, and anxiety/distress screening) to 60 participants with chronic diseases where lifestyle management is paramount to well-being and disease control (e.g., cardiovascular disease, stroke, diabetes, cancer, chronic obstructive pulmonary disease, osteoarthritis). Participants will have access to the simulations through a unique password-protected link over the course of one month. Participants will complete two study visits that are 30-60 minutes in duration each. There is also one optional telephone interview with a mental health professional. The telephone interview it estimated to be 10 minutes in duration and will be audiotapes, with participants' permission. The study surveys will be administrated at baseline, immediately following the simulation use and at one-month baseline measures. The measures will assess lifestyle behaviors related to healthy eating, physical activity, emotional health, smoking behaviors and alcohol use. Measures will also assess the psycho-social constructs of intrinsic motivation and self-efficacy. Finally, the usability of and satisfaction with the simulations will be explored through feedback surveys. The investigator will also seek permission to collect data from the patient's medical chart. Feedback will also be collected from four healthcare providers. **Detailed Description:** The overarching goal of the pilot study is to assess the acceptability and potential efficacy of the participant education simulation on changes in participants with chronic diseases' lifestyle behaviors as well as motivation and self-efficacy to change. The primary objective is to examine the acceptability (satisfaction, usability) of using virtual simulations to deliver participant education and counseling for adopting healthy lifestyle behaviors among a sample of four healthcare providers and 60 participants with chronic disease. The secondary objectives include examining changes in lifestyle behaviors (e.g., healthy eating, physical activity) one-month following the use of the participant education simulations in a sample of 60 participants with chronic disease (e.g. cancer, cardiovascular disease, diabetes, stroke, arthritis) and to explore the potential mediators (e.g. motivation and self-efficacy) of the simulation effects on the changes in participants' lifestyle behaviors. Participants will communicate with a virtual human, Linda, by selecting from a dynamic menu of dialogue options. Once the learner chooses a dialogue option, they see the virtual human respond by providing personalized feedback and give users an opportunity to revise their choice. In this study, the simulations will be a bundle of four topic-based conversations with Linda, which include fitness and nutrition, smoking cessation, alcohol use, distress and anxiety. ### Conditions Module **Conditions:** - Chronic Disease **Keywords:** - Lifestyle ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 37 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All participants will have access to the virtual education simulations. **Intervention Names:** - Behavioral: Virtual Education Simulation **Label:** Virtual Education Simulation **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Virtual Education Simulation **Description:** The simulations will be developed using Kognito's proprietary Conversation Platform. In this pilot study, the simulations will be a bundle of four topic-based conversations with Linda, a virtual peer with a chronic disease. The four wellness topics are: 1. Fitness \& Nutrition 2. Smoking Cessation 3. Alcohol Use 4. Distress \& Anxiety **Name:** Virtual Education Simulation **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** A Usability Questionnaire will be used for participants to rate how much they agree or disagree with 14 questions as they relate to the participants' conversation with the virtual coach. Choices for each question range include: strongly disagree, somewhat disagree, somewhat agree, and strongly agree. No numerical scale is used. **Measure:** Number of participants who were unsatisfied and satisfied by use of virtual simulations for education delivery and counseling **Time Frame:** Immediately post-simulation (Day 0) #### Secondary Outcomes **Description:** The AASE Scale consists of 40 situations that lead some people to drink. Participants mark answers which reflect how tempted they may be to drink in each situation at the present time. The answers choices range from 0 (not at all) to 4 (extremely). The range of score is 0-160. The higher the score, the higher the temptation to drink. **Measure:** Change in score of Alcohol Abstinence Self-Efficacy (AASE) Scale **Time Frame:** Baseline (Day 0), Day 30 +/- 7 days post-intervention **Description:** 10 questions will be asked to the participants. All responses must be given without reference to calendar, newspaper, birth certificate, or other aid to memory. The total number of errors based on the answers to the 10 questions will be recorded as the score. The lower the score, the better. 0-2 errors = Intact Intellectual Functioning, 3-4 errors = Mild Intellectual Impairment, 5-7 errors = Moderate Intellectual Impairment, 8-10 errors = Severe Intellectual Impairment. **Measure:** Score of Short Portable Mental Status Questionnaire (SPMSQ) **Time Frame:** Baseline (Day 0) **Description:** The SASEQ consists of 6 situations that lead some people to smoke. Participants mark answers which reflect how confident they feel that they will not smoke in each situation. The answer choices range from 0 (certainly) to 4 (certainly not). The range of score is 0-24. **Measure:** Change in score of Smoking Abstinence Self-Efficacy Questionnaire (SASEQ) **Time Frame:** Baseline (Day 0), Day 30 +/- 7 days post-intervention **Description:** PHQ-8 consists of 8 problem situations. The questionnaire asks the participants how often they have been bothered by each problem over the last 2 weeks. The total score ranges from 0-12, with categories of psychological distress being: none (0-2), mild (3-5), moderate (6-8), and severe (9-12). Therefore, the lower the score, the better. **Measure:** Score of Patient Health Questionnaire-8 (PHQ-8) **Time Frame:** Baseline (Day 0) **Description:** Three types of physical activity will be reported on: vigorous, moderate, and walking. Participants will report how many days they did vigorous physical activities (like heavy lifting, digging, aerobics, or fast bicycling), how many days they did moderate (carrying light loads, bicycling at a regular pace, doubles tennis), and how many days they walked for at least 10 minutes during the last 7 days. **Measure:** Change in amount of days of physical activity **Time Frame:** Baseline (Day 0), Day 30 +/- 7 days post-intervention **Description:** This questionnaire consists of 10 statements. The participant must rate how confident they are about each of the statements. The responses range from 0 (not at all sure) to 3 (very sure). The total score ranges from 0-30. The higher the score, the more confident the participant is about incorporating fruits and vegetables into their lifestyle. **Measure:** Change in Score of Self Efficacy Fruits and Vegetables Questionnaire **Time Frame:** Baseline (Day 0), Day 30 +/- 7 days post-intervention **Description:** This questionnaire consists of 11 statements. The participant must rate how confident they are about each of the statements. The responses range from 0 (not at all sure) to 3 (very sure). The total score ranges from 0-30. The higher the score, the more confident the participant is about incorporating exercise into their lifestyle. **Measure:** Change in Score of Self Efficacy Exercising Questionnaire **Time Frame:** Baseline (Day 0), Day 30 +/- 7 days post-intervention **Description:** In the format of a questionnaire, participants are asked to indicate the extent to which each reason is true for them, using a 7-point scale. Why they eat fruits and vegetables (from a list of 17 reasons). Each individual question is assessed separately, so no total range is given. **Measure:** Change in Intrinsic Motivation for Eating Fruits and Vegetables **Time Frame:** Baseline (Day 0), Day 30 +/- 7 days post-intervention **Description:** In the format of a questionnaire, participants are asked to indicate the extent to which each reason is true for them, using a 7-point scale. Why they choose to exercise (from a list of 15 reasons). **Measure:** Change in Intrinsic Motivation for Exercising **Time Frame:** Baseline (Day 0), Day 30 +/- 7 days post-intervention **Description:** This questionnaire consists of 9 statements. Participants are asked to rate how confident they are about each of the statements. Their responses range from 0 (no confidence) to 4 (complete confidence). The total score ranges from 0-36. The higher the score, the more confident the participant is about seeking mental health care. **Measure:** Self Efficacy in Seeking Mental Health Treatment (SESMHC) **Time Frame:** Immediately post-simulation (Day 0) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age 18 years or older; 2. Have a diagnosis of a chronic disease (e.g., osteoarthritis, coronary artery disease, chronic obstructive pulmonary disease, asthma, diabetes, hypertension, stroke, and congestive heart failure) as indicated by self-report or review of the electronic medical record; and 3. Receiving care within the NYU Langone Health Network (e.g., Faculty Group Practices and ambulatory care centers, NYU Winthrop Surgical Associates) Exclusion Criteria: 1. Are unable to give informed consent 2. Refuse to participate 3. Any active terminal illness, mental incompetence, or uncontrolled psychiatric illness. These exclusions were based on the premise that the presence of any of these conditions would dominate the subject's perception of lifestyle management of their chronic disease. 4. Unable to speak and read in English. Patients that are unable to speak and read in English will be excluded from the proposed project because the simulations are being developed in English only. Once we demonstrate the initial efficacy of this tool, future simulations will be developed in languages other than English. Despite the language restrictions, no exclusion will be made based on patient racial/ethnic origin. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** New York **Country:** United States **Facility:** NYU Langone Health **State:** New York **Zip:** 10016 #### Overall Officials **Official 1:** **Affiliation:** NYU Langone Health **Name:** Antoinette Shoenthaler, EdD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Antoinette.Schoenthaler@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. **Description:** Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared. **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES **Time Frame:** Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M6147 - Name: Chronic Disease - Relevance: HIGH - As Found: Chronic Disease - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002908 - Term: Chronic Disease ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03089879 **Brief Title:** A Study to Evaluate Safety and Immunogenicity of 1 Booster Dose of 1790GAHB Vaccine in Healthy Adults Primed With 3 Doses of 1790GAHB Vaccine in Study H03_01TP Compared to 1 Vaccination of 1790GAHB in Either Subjects Who Received Placebo in the Same Study or naïve Subjects Not Part of H03_01TP Study **Official Title:** A Phase 1, Open Label, Non-randomized, Single Center Study to Evaluate the Safety and Immunogenicity of 1 Booster Vaccination With (GVGH Shigella Sonnei 1790GAHB) Vaccine Administered Intramuscularly in Healthy Adults Previously Primed With Three Doses of the Same Vaccine in Study H03_01TP Compared to 1 Vaccination With (1790GAHB) Administered Intramuscularly Either to Subjects Who Received Placebo in the H03_01TP Study or naïve Subjects Who Were Not Part of H03_01TP Study #### Organization Study ID Info **ID:** 205905 #### Organization **Class:** INDUSTRY **Full Name:** GlaxoSmithKline #### Secondary ID Infos **ID:** 2016-004178-16 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2017-08-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-06-28 **Type:** ACTUAL **Last Update Submit Date:** 2019-06-13 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-08-31 **Type:** ACTUAL #### Results First Post Date **Date:** 2019-03-07 **Type:** ACTUAL **Results First Submit Date:** 2018-08-29 **Results First Submit QC Date:** 2019-03-06 #### Start Date **Date:** 2017-03-16 **Type:** ACTUAL **Status Verified Date:** 2019-06 #### Study First Post Date **Date:** 2017-03-24 **Type:** ACTUAL **Study First Submit Date:** 2017-03-21 **Study First Submit QC Date:** 2017-03-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** GlaxoSmithKline #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** GVGH Shigella Sonnei 1970GAHB is a vaccine aimed at preventing the disease caused by Shigella sonnei. A post-hoc analysis of subjects who participated in the parent study showed significantly different responses in subjects with detectable versus undetectable antibody titres at baseline, suggesting the possibility that the vaccine might not be sufficiently immunogenic in completely naïve adults. This study was then designed to further characterize the immunogenicity profile of the vaccine and to evaluate whether it was able to induce an immunological memory response. ### Conditions Module **Conditions:** - Dysentery, Bacillary **Keywords:** - Immunogenicity, Vaccine - Immunologic Memory - GMMA - Shigella Vaccines - Shigellosis - Dysentery, Bacillary - Healthy Volunteers - Safety - Bacteria - Clinical Trials, Phase 1 - Shigella sonnei ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 35 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1. **Intervention Names:** - Biological: GVGH Shigella sonnei 1790GAHB vaccine **Label:** Shigella Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. **Intervention Names:** - Biological: GVGH Shigella sonnei 1790GAHB vaccine **Label:** Placebo Group **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Healthy male and female subjects, aged 22 to 50 years, who were not part of H03_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. **Intervention Names:** - Biological: GVGH Shigella sonnei 1790GAHB vaccine **Label:** Naïve Group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Naïve Group - Placebo Group - Shigella Group **Description:** Single dose administered at Day 1, by intramuscular injection. **Name:** GVGH Shigella sonnei 1790GAHB vaccine **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** IgG concentrations are expressed as Geometric Mean Concentrations (GMCs), as determined by the Enzyme-linked immunosorbent assay (ELISA) with Shigella sonnei (S.sonnei) O-antigen containing Lipopolysaccharide (LPS) coating antigen. Concentrations are presented as GMCs expressed in ELISA units per milliliter (EU/mL). **Measure:** Concentrations of Immunoglobulin (IgG) Against Lipopolysaccharide (LPS) S. Sonnei O-antigen **Time Frame:** At Day 8 (7 days after vaccination) #### Secondary Outcomes **Description:** Assessed haematological parameters are: basophils (BAS), eosinophils (EOS), erythrocytes (ERCS), hematocrit (HCT), hemoglobin (HGB), leukocytes (LKCS), lymphocytes (LYM), monocytes (MONO), neutrophils (NEU) and platelet (PLT). **Measure:** Number of Subjects With Abnormal Haematological Test Values **Time Frame:** At Day 8 (7 days after vaccination) and Day 85 (84 days after vaccination) **Description:** Assessed solicited local adverse events include injection site erythema, injection site induration and injection site pain. Any symptom = occurrence of the symptom regardless of intensity grade. **Measure:** Number of Subjects With Solicited Local Adverse Events **Time Frame:** From 30 minutes through Day 7 post-vaccination **Description:** Assessed solicited systemic adverse events include arthralgia, chills, fatigue, headache, malaise, myalgia and oral fever. Other indicators of solicited adverse events include prevention of pain and/or fever and treatment of pain and/or fever. Any symptom = occurrence of the symptom regardless of intensity grade. Fever = body temperature (measured orally) equal to or above (≥) 38.0 °C. **Measure:** Number of Subjects With Solicited Systemic Adverse Events **Time Frame:** From 30 minutes through Day 7 post-vaccination **Description:** An unsolicited adverse event (AE) is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject. Any = occurrence of the symptom regardless of intensity grade. Grade 3 AE = AE that prevented daily activity. Possibly/probably related AE = AE determined by the investigator as possibly related (the administration of the investigational vaccine and AE are considered reasonably related in time and the AE could be explained by exposure to the investigational vaccine or by other causes) or probably related (exposure to the investigational vaccine and AE are reasonably related in time and no alternative explanation has been identified) to the study vaccination. **Measure:** Number of Subjects With Unsolicited Adverse Events **Time Frame:** Throughout the study period (From Day 1 up to Day 85) **Description:** A serious adverse event is defined as an untoward medical occurrence that at any dose resulted in death, was life-threatening, required hospitalization or prolonged hospitalization, resulted in persistent or significant disability/incapacity, or in a congenital anomaly/birth defect; an important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. **Measure:** Number of Subjects With Serious Adverse Events (SAEs) **Time Frame:** Throughout the study period (from Day 1 up to Day 85) **Description:** Concentrations of IgG against S.sonnei O-antigen are presented as GMCs, expressed in ELISA units per milliliter (EU/mL). **Measure:** Concentrations of IgG Against LPS S. Sonnei O-antigen **Time Frame:** At Days 15, 29 and 85 (14, 28 and 84 days after vaccination) **Description:** Within-subject Geometric mean ratios (GMRs) were computed for GMCs at 7, 14, 28 and 84 days after vaccination versus baseline (Day 1). The GMRs and 95% confidence intervals (CIs) were constructed by exponentiating the mean within-subject differences in log-transformed concentrations and the corresponding 95% CIs. **Measure:** Anti-LPS S. Sonnei IgG Geometric Mean Ratios **Time Frame:** At Days 8, 15, 29 and 85 (7, 14, 28 and 84 days after vaccination) **Description:** Seroresponse is aimed to define a significant increase in post-vaccination samples based on the biological performance of this specific serology assay and it is defined as follows: - If the baseline value is greater than 50 ELISA Units (EU) then an increase of at least 50% in the post-vaccination sample as compared to baseline \[i.e. ((Post-vac minus baseline)/baseline)100% ≥ 50%\]. - If the baseline value is less or equal to 50 EU then an increase of at least 25 EU in the post-vaccination sample as compared to baseline \[i.e. (Postvac minus baseline) ≥ 25 EU. **Measure:** Percentage of Subjects With Seroresponse for Anti-LPS S. Sonnei **Time Frame:** At Days 8, 15, 29 and 85 (7, 14, 28 and 84 days after vaccination) **Description:** Anti-LPS S.sonnei antibody concentrations were assessed by ELISA. The assay cut-off value was 121 EU/mL. **Measure:** Percentage of Subjects With Anti-LPS S. Sonnei Concentrations Equal to or Above (≥) 121 EU/mL **Time Frame:** At Days 8, 15, 29 and 85 (7, 14, 28 and 84 days after vaccination) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Males and females, aged 22 to 50 years, who were previously vaccinated, with either vaccine (3 doses) or placebo, in H03_01TP and who had undetectable antibody titers at baseline, or Males and females, aged 22 to 50 years, who were not part of H03_01TP. * Individuals who, after the nature of the study has been explained to them, and prior to any protocol specific procedures being performed, have given written consent according to local regulatory requirements. * Individuals in good health as determined by the outcome of medical history, physical examination, hematological blood tests and clinical judgment of the investigator. * If women of child-bearing potential, have a negative urinary pregnancy test prior study vaccination and willingness to use acceptable birth control measures for the entire study duration. * Individuals affiliated to a social security regimen. Exclusion Criteria: * Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study. * Individuals with any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome. * Individuals who are not able to understand and to follow all required study procedures for the whole period of the study. * Individuals with known hepatitis B or C or suspected HIV infection or HIV related disease with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system. * Progressive, unstable or uncontrolled clinical conditions. * Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study. * Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. * Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. * Abnormal function of the immune system resulting from: * Clinical conditions; * Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to informed consent; * Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. * Received immunoglobulins or any blood products within 180 days prior to informed consent. * Study personnel as an immediate family or household member. * Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study. * Individuals who have received an investigational product in another clinical trial 28 days prior to first study visit or intent to receive another investigational product at any time during the conduct of this study. * Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within the entire study duration. Inactivated influenza vaccine can be given, but only 4 weeks earlier or 4 weeks later than the date of immunization. * Individuals who have received blood, blood products, and/or plasma derivatives including parenteral immunoglobulin preparations in the past 180 days. * Individuals with body temperature \> 38.0 degrees Celsius within 3 days of intended study vaccination. * Individuals with Body Mass Index \> 30 kg/m2. * Individuals with history of substance or alcohol abuse within the past 2 years. * Women who are pregnant or are breast-feeding, or are of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. * Females with history of stillbirth, neonatal loss, or previous infant with anomaly. * Individuals who have a previously laboratory confirmed or suspected disease caused by S. sonnei. * Individuals who have had household contact with/and or intimate exposure to an individual with laboratory confirmed S. sonnei. * Any condition, which, in the opinion of the investigator may pose an increased and unreasonable safety risk to the subject if participating to the present study. * Individuals with a neutrophil count value lower than 1.8 10\^9/L at screening assessment. * Individuals with human leukocyte antigen (HLA)-B27 positive and/or with history of reactive arthritis. * Previous history of Benign Ethnic Neutropenia or drug related Neutropenia and/or concomitant treatment with neutropenic agents. **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 22 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Paris **Country:** France **Facility:** GSK Investigational Site **Zip:** 75679 #### Overall Officials **Official 1:** **Affiliation:** GlaxoSmithKline **Name:** GSK Clinical Trials **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months. **Description:** IPD for this study will be made available via the Clinical Study Data Request site. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** IPD is available via the Clinical Study Data Request site (click on the link provided below) **URL:** https://www.clinicalstudydatarequest.com/SearchAllPostings.aspx?searchparam=200147 ### References Module #### References **Citation:** Launay O, Ndiaye AGW, Conti V, Loulergue P, Scire AS, Landre AM, Ferruzzi P, Nedjaai N, Schutte LD, Auerbach J, Marchetti E, Saul A, Martin LB, Podda A. Booster Vaccination With GVGH Shigella sonnei 1790GAHB GMMA Vaccine Compared to Single Vaccination in Unvaccinated Healthy European Adults: Results From a Phase 1 Clinical Trial. Front Immunol. 2019 Mar 8;10:335. doi: 10.3389/fimmu.2019.00335. eCollection 2019. **PMID:** 30906291 **Citation:** Micoli F, Rossi O, Conti V, Launay O, Scire AS, Aruta MG, Nakakana UN, Marchetti E, Rappuoli R, Saul A, Martin LB, Necchi F, Podda A. Antibodies Elicited by the Shigella sonnei GMMA Vaccine in Adults Trigger Complement-Mediated Serum Bactericidal Activity: Results From a Phase 1 Dose Escalation Trial Followed by a Booster Extension. Front Immunol. 2021 May 4;12:671325. doi: 10.3389/fimmu.2021.671325. eCollection 2021. **PMID:** 34017343 ## Document Section ### Large Document Module #### Large Docs - Date: 2017-02-08 - Filename: Prot_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 3773876 - Type Abbrev: Prot - Upload Date: 2018-08-29T08:18 - Date: 2017-12-29 - Filename: SAP_001.pdf - Has ICF: False - Has Protocol: False - Has SAP: True - Label: Statistical Analysis Plan - Size: 362214 - Type Abbrev: SAP - Upload Date: 2018-08-29T08:21 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005759 - Term: Gastroenteritis - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000004756 - Term: Enterobacteriaceae Infections - ID: D000016905 - Term: Gram-Negative Bacterial Infections - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7577 - Name: Dysentery - Relevance: HIGH - As Found: Dysentery - ID: M7579 - Name: Dysentery, Bacillary - Relevance: HIGH - As Found: Dysentery, Bacillary - ID: M8875 - Name: Gastroenteritis - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M7918 - Name: Enterobacteriaceae Infections - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M19249 - Name: Gram-Negative Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown - ID: T5205 - Name: Shigellosis - Relevance: HIGH - As Found: Dysentery, Bacillary ### Condition Browse Module - Meshes - ID: D000004405 - Term: Dysentery, Bacillary - ID: D000004403 - Term: Dysentery ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial. #### Event Groups **Group ID:** EG000 **Title:** Shigella Group **Deaths Num At Risk:** 7 **Description:** Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1. **ID:** EG000 **Other Num Affected:** 7 **Other Num at Risk:** 7 **Serious Number At Risk:** 7 **Title:** Shigella Group **Group ID:** EG001 **Title:** Placebo + Naïve Group **Deaths Num At Risk:** 28 **Description:** Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03_01TP parent study and who had undetectable antibodies at baseline (Placebo Group), or subjects who were not part of H03_01TP parent study (Naïve Group) were pooled into the Placebo + Naïve Group. All subjects received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. **ID:** EG001 **Other Num Affected:** 25 **Other Num at Risk:** 28 **Serious Number At Risk:** 28 **Title:** Placebo + Naïve Group **Frequency Threshold:** 5 #### Other Events **Term:** Chills **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA **Term:** Fatigue **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA **Term:** Injection site erythema **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA **Term:** Injection site induration **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA **Term:** Injection site pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA **Term:** Malaise **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA **Term:** Nasopharyngitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA **Term:** Arthralgia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA **Term:** Musculoskeletal pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 20.1 **Term:** Myalgia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 20.1 **Term:** Headache **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 20.1 **Term:** Dysmenorrhoea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Reproductive system and breast disorders **Source Vocabulary:** MedDRA 20.1 **Time Frame:** Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 7 **Group ID:** BG001 **Value:** 2 **Group ID:** BG002 **Value:** 26 **Group ID:** BG003 **Value:** 35 **Units:** Participants ### Group **ID:** BG000 **Title:** Shigella Group **Description:** Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1. ### Group **ID:** BG001 **Title:** Placebo Group **Description:** Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. ### Group **ID:** BG002 **Title:** Naïve Group **Description:** Healthy male and female subjects, aged 22 to 50 years, who were not part of H03_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. ### Group **ID:** BG003 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 7.89 **Value:** 37.7 #### Measurement **Group ID:** BG001 **Spread:** 10.61 **Value:** 40.5 #### Measurement **Group ID:** BG002 **Spread:** 8.41 **Value:** 33.8 #### Measurement **Group ID:** BG003 **Spread:** 8.41 **Value:** 34.9 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 9 #### Measurement **Group ID:** BG003 **Value:** 15 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 3 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 17 #### Measurement **Group ID:** BG003 **Value:** 20 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 1 #### Measurement **Group ID:** BG003 **Value:** 2 **Class Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 6 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 24 #### Measurement **Group ID:** BG003 **Value:** 32 **Class Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 1 #### Measurement **Group ID:** BG003 **Value:** 1 **Class Title:** Unspecified **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** Years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race/Ethnicity, Customized **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement **Other Details:** GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial. **Restriction Type:** OTHER **Restrictive Agreement:** True ### Point of Contact **Email:** ass77028@gsk.com **Organization:** GlaxoSmithKline **Phone:** 866-435-7343 **Title:** GSK Response Center ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ### Outcome Measure 5 ### Outcome Measure 6 ### Outcome Measure 7 ### Outcome Measure 8 ### Outcome Measure 9 ### Outcome Measure 10 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 32 - **Spread:** - **Upper Limit:** 889 - **Value:** 168 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.033 - **Spread:** - **Upper Limit:** 810 - **Value:** 5.17 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 20 - **Spread:** - **Upper Limit:** 72 - **Value:** 38 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 28 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 28 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 21 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 22 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 26 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 27 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 26 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 26 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 27 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 26 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 25 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 26 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 21 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 20 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 28 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 28 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 28 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 28 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 28 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 28 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 24 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 11 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** #### Outcome Measure 7 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 249 - **Spread:** - **Upper Limit:** 3126 - **Value:** 883 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.89 - **Spread:** - **Upper Limit:** 1474 - **Value:** 36 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 53 - **Spread:** - **Upper Limit:** 211 - **Value:** 106 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 7 - **Group ID:** OG001 - **Value:** 2 - **Group ID:** OG002 - **Value:** 25 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 159 - **Spread:** - **Upper Limit:** 2446 - **Value:** 623 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2.36 - **Spread:** - **Upper Limit:** 531 - **Value:** 35 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 56 - **Spread:** - **Upper Limit:** 213 - **Value:** 110 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 7 - **Group ID:** OG001 - **Value:** 2 - **Group ID:** OG002 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 113 - **Spread:** - **Upper Limit:** 1797 - **Value:** 451 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.51 - **Spread:** - **Upper Limit:** 4250 - **Value:** 47 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 48 - **Spread:** - **Upper Limit:** 184 - **Value:** 94 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 7 - **Group ID:** OG001 - **Value:** 2 - **Group ID:** OG002 - **Value:** 25 **Units:** Participants #### Outcome Measure 8 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2.69 - **Spread:** - **Upper Limit:** 18 - **Value:** 6.87 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.0095 - **Spread:** - **Upper Limit:** 233 - **Value:** 1.49 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 1.42 - **Spread:** - **Upper Limit:** 3.82 - **Value:** 2.32 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 7 - **Group ID:** OG001 - **Value:** 2 - **Group ID:** OG002 - **Value:** 23 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 14 - **Spread:** - **Upper Limit:** 93 - **Value:** 36 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.26 - **Spread:** - **Upper Limit:** 424 - **Value:** 10 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 3.77 - **Spread:** - **Upper Limit:** 13 - **Value:** 6.88 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 7 - **Group ID:** OG001 - **Value:** 2 - **Group ID:** OG002 - **Value:** 25 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 8.88 - **Spread:** - **Upper Limit:** 73 - **Value:** 26 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.68 - **Spread:** - **Upper Limit:** 153 - **Value:** 10 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 4.03 - **Spread:** - **Upper Limit:** 13 - **Value:** 7.21 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 7 - **Group ID:** OG001 - **Value:** 2 - **Group ID:** OG002 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 5.37 - **Spread:** - **Upper Limit:** 64 - **Value:** 18 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.15 - **Spread:** - **Upper Limit:** 1223 - **Value:** 13 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 3.43 - **Spread:** - **Upper Limit:** 11 - **Value:** 6.11 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 7 - **Group ID:** OG001 - **Value:** 2 - **Group ID:** OG002 - **Value:** 25 **Units:** Participants #### Outcome Measure 9 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 42.1 - **Spread:** - **Upper Limit:** 99.64 - **Value:** 86 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0 - **Spread:** - **Upper Limit:** 84.2 - **Value:** 0 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 10.2 - **Spread:** - **Upper Limit:** 48.4 - **Value:** 26 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 7 - **Group ID:** OG001 - **Value:** 2 - **Group ID:** OG002 - **Value:** 25 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 59.0 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 1.3 - **Spread:** - **Upper Limit:** 98.7 - **Value:** 50 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 50.6 - **Spread:** - **Upper Limit:** 87.9 - **Value:** 72 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 7 - **Group ID:** OG001 - **Value:** 2 - **Group ID:** OG002 - **Value:** 25 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 59.0 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 15.8 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 44.7 - **Spread:** - **Upper Limit:** 84.4 - **Value:** 67 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 7 - **Group ID:** OG001 - **Value:** 2 - **Group ID:** OG002 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 59.0 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 15.8 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 42.5 - **Spread:** - **Upper Limit:** 82.0 - **Value:** 64 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 7 - **Group ID:** OG001 - **Value:** 2 - **Group ID:** OG002 - **Value:** 25 **Units:** Participants #### Outcome Measure 10 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 29.0 - **Spread:** - **Upper Limit:** 96.3 - **Value:** 71 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.0 - **Spread:** - **Upper Limit:** 84.2 - **Value:** 0 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 13.2 - **Spread:** - **Upper Limit:** 52.9 - **Value:** 30 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 7 - **Group ID:** OG001 - **Value:** 2 - **Group ID:** OG002 - **Value:** 23 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 42.1 - **Spread:** - **Upper Limit:** 99.64 - **Value:** 86 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.0 - **Spread:** - **Upper Limit:** 84.2 - **Value:** 0 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 21.1 - **Spread:** - **Upper Limit:** 61.3 - **Value:** 40 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 7 - **Group ID:** OG001 - **Value:** 2 - **Group ID:** OG002 - **Value:** 25 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 42.1 - **Spread:** - **Upper Limit:** 99.64 - **Value:** 86 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.0 - **Spread:** - **Upper Limit:** 84.2 - **Value:** 0 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 22.1 - **Spread:** - **Upper Limit:** 63.4 - **Value:** 42 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 7 - **Group ID:** OG001 - **Value:** 2 - **Group ID:** OG002 - **Value:** 24 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 42.1 - **Spread:** - **Upper Limit:** 99.64 - **Value:** 86 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.0 - **Spread:** - **Upper Limit:** 84.2 - **Value:** 0 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 21.1 - **Spread:** - **Upper Limit:** 61.3 - **Value:** 40 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 7 - **Group ID:** OG001 - **Value:** 2 - **Group ID:** OG002 - **Value:** 25 **Units:** Participants ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** IgG concentrations are expressed as Geometric Mean Concentrations (GMCs), as determined by the Enzyme-linked immunosorbent assay (ELISA) with Shigella sonnei (S.sonnei) O-antigen containing Lipopolysaccharide (LPS) coating antigen. Concentrations are presented as GMCs expressed in ELISA units per milliliter (EU/mL). **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** The analysis was performed on the Full Analysis Set, which included all enrolled subjects who received a study vaccination and provided immunogenicity data at relevant time points. **Reporting Status:** POSTED **Time Frame:** At Day 8 (7 days after vaccination) **Title:** Concentrations of Immunoglobulin (IgG) Against Lipopolysaccharide (LPS) S. Sonnei O-antigen **Type:** PRIMARY **Unit of Measure:** EU/mL ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1. **ID:** OG000 **Title:** Shigella Group ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. **ID:** OG001 **Title:** Placebo Group ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, who were not part of H03_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. **ID:** OG002 **Title:** Naïve Group #### Outcome Measure 2 **Description:** Assessed haematological parameters are: basophils (BAS), eosinophils (EOS), erythrocytes (ERCS), hematocrit (HCT), hemoglobin (HGB), leukocytes (LKCS), lymphocytes (LYM), monocytes (MONO), neutrophils (NEU) and platelet (PLT). **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** The analysis was performed on the Overall Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited and unsolicited adverse event data were available. For the purpose of this analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo + Naïve Group). **Reporting Status:** POSTED **Time Frame:** At Day 8 (7 days after vaccination) and Day 85 (84 days after vaccination) **Title:** Number of Subjects With Abnormal Haematological Test Values **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1. **ID:** OG000 **Title:** Shigella Group ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03_01TP parent study and who had undetectable antibodies at baseline (Placebo Group), or subjects who were not part of H03_01TP parent study (Naïve Group) were pooled into the Placebo + Naïve Group. All subjects received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. **ID:** OG001 **Title:** Placebo + Naïve Group #### Outcome Measure 3 **Description:** Assessed solicited local adverse events include injection site erythema, injection site induration and injection site pain. Any symptom = occurrence of the symptom regardless of intensity grade. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** The analysis was performed on the Solicited Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited adverse event data were available. For the purpose of this analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). **Reporting Status:** POSTED **Time Frame:** From 30 minutes through Day 7 post-vaccination **Title:** Number of Subjects With Solicited Local Adverse Events **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1. **ID:** OG000 **Title:** Shigella Group ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03_01TP parent study and who had undetectable antibodies at baseline (Placebo Group), or subjects who were not part of H03_01TP parent study (Naïve Group) were pooled into the Placebo + Naïve Group. All subjects received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. **ID:** OG001 **Title:** Placebo + Naïve Group #### Outcome Measure 4 **Description:** Assessed solicited systemic adverse events include arthralgia, chills, fatigue, headache, malaise, myalgia and oral fever. Other indicators of solicited adverse events include prevention of pain and/or fever and treatment of pain and/or fever. Any symptom = occurrence of the symptom regardless of intensity grade. Fever = body temperature (measured orally) equal to or above (≥) 38.0 °C. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** The analysis was performed on the Solicited Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited adverse event data were available. For the purpose of this analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). **Reporting Status:** POSTED **Time Frame:** From 30 minutes through Day 7 post-vaccination **Title:** Number of Subjects With Solicited Systemic Adverse Events **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1. **ID:** OG000 **Title:** Shigella Group ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03_01TP parent study and who had undetectable antibodies at baseline (Placebo Group), or subjects who were not part of H03_01TP parent study (Naïve Group) were pooled into the Placebo + Naïve Group. All subjects received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. **ID:** OG001 **Title:** Placebo + Naïve Group #### Outcome Measure 5 **Description:** An unsolicited adverse event (AE) is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject. Any = occurrence of the symptom regardless of intensity grade. Grade 3 AE = AE that prevented daily activity. Possibly/probably related AE = AE determined by the investigator as possibly related (the administration of the investigational vaccine and AE are considered reasonably related in time and the AE could be explained by exposure to the investigational vaccine or by other causes) or probably related (exposure to the investigational vaccine and AE are reasonably related in time and no alternative explanation has been identified) to the study vaccination. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** The analysis was performed on the Unsolicited Safety Set, which included all enrolled subjects who received a study vaccination and for whom unsolicited adverse event data were available. For the purpose of this analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). **Reporting Status:** POSTED **Time Frame:** Throughout the study period (From Day 1 up to Day 85) **Title:** Number of Subjects With Unsolicited Adverse Events **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1. **ID:** OG000 **Title:** Shigella Group ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03_01TP parent study and who had undetectable antibodies at baseline (Placebo Group), or subjects who were not part of H03_01TP parent study (Naïve Group) were pooled into the Placebo + Naïve Group. All subjects received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. **ID:** OG001 **Title:** Placebo + Naïve Group #### Outcome Measure 6 **Description:** A serious adverse event is defined as an untoward medical occurrence that at any dose resulted in death, was life-threatening, required hospitalization or prolonged hospitalization, resulted in persistent or significant disability/incapacity, or in a congenital anomaly/birth defect; an important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** The analysis was performed on the Overall Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited and unsolicited adverse event data were available. For the purpose of this analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). **Reporting Status:** POSTED **Time Frame:** Throughout the study period (from Day 1 up to Day 85) **Title:** Number of Subjects With Serious Adverse Events (SAEs) **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1. **ID:** OG000 **Title:** Shigella Group ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03_01TP parent study and who had undetectable antibodies at baseline (Placebo Group), or subjects who were not part of H03_01TP parent study (Naïve Group) were pooled into the Placebo + Naïve Group. All subjects received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. **ID:** OG001 **Title:** Placebo + Naive Group #### Outcome Measure 7 **Description:** Concentrations of IgG against S.sonnei O-antigen are presented as GMCs, expressed in ELISA units per milliliter (EU/mL). **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** The analysis was performed on the Full Analysis Set, which included all enrolled subjects who received a study vaccination and who provided immunogenicity data at relevant time points. **Reporting Status:** POSTED **Time Frame:** At Days 15, 29 and 85 (14, 28 and 84 days after vaccination) **Title:** Concentrations of IgG Against LPS S. Sonnei O-antigen **Type:** SECONDARY **Unit of Measure:** EU/mL ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1. **ID:** OG000 **Title:** Shigella Group ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. **ID:** OG001 **Title:** Placebo Group ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, who were not part of H03_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. **ID:** OG002 **Title:** Naïve Group #### Outcome Measure 8 **Description:** Within-subject Geometric mean ratios (GMRs) were computed for GMCs at 7, 14, 28 and 84 days after vaccination versus baseline (Day 1). The GMRs and 95% confidence intervals (CIs) were constructed by exponentiating the mean within-subject differences in log-transformed concentrations and the corresponding 95% CIs. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** The analysis was performed on the Full Analysis Set, which included all enrolled subjects who received a study vaccination and who provided immunogenicity data at relevant time points. **Reporting Status:** POSTED **Time Frame:** At Days 8, 15, 29 and 85 (7, 14, 28 and 84 days after vaccination) **Title:** Anti-LPS S. Sonnei IgG Geometric Mean Ratios **Type:** SECONDARY **Unit of Measure:** Ratio ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1. **ID:** OG000 **Title:** Shigella Group ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. **ID:** OG001 **Title:** Placebo Group ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, who were not part of H03_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. **ID:** OG002 **Title:** Naïve Group #### Outcome Measure 9 **Description:** Seroresponse is aimed to define a significant increase in post-vaccination samples based on the biological performance of this specific serology assay and it is defined as follows: - If the baseline value is greater than 50 ELISA Units (EU) then an increase of at least 50% in the post-vaccination sample as compared to baseline \[i.e. ((Post-vac minus baseline)/baseline)100% ≥ 50%\]. - If the baseline value is less or equal to 50 EU then an increase of at least 25 EU in the post-vaccination sample as compared to baseline \[i.e. (Postvac minus baseline) ≥ 25 EU. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** The analysis was performed on the Full Analysis Set, which included all enrolled subjects who received a study vaccination and provided immunogenicity data at relevant time points. **Reporting Status:** POSTED **Time Frame:** At Days 8, 15, 29 and 85 (7, 14, 28 and 84 days after vaccination) **Title:** Percentage of Subjects With Seroresponse for Anti-LPS S. Sonnei **Type:** SECONDARY **Unit of Measure:** Percentage of subjects ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1. **ID:** OG000 **Title:** Shigella Group ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. **ID:** OG001 **Title:** Placebo Group ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, who were not part of H03_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. **ID:** OG002 **Title:** Naïve Group #### Outcome Measure 10 **Description:** Anti-LPS S.sonnei antibody concentrations were assessed by ELISA. The assay cut-off value was 121 EU/mL. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** The analysis was performed on the Full Analysis Set, which included all enrolled subjects who received a study vaccination and provided immunogenicity data at relevant time points. **Reporting Status:** POSTED **Time Frame:** At Days 8, 15, 29 and 85 (7, 14, 28 and 84 days after vaccination) **Title:** Percentage of Subjects With Anti-LPS S. Sonnei Concentrations Equal to or Above (≥) 121 EU/mL **Type:** SECONDARY **Unit of Measure:** Percentage of subjects ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1. **ID:** OG000 **Title:** Shigella Group ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. **ID:** OG001 **Title:** Placebo Group ##### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, who were not part of H03_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. **ID:** OG002 **Title:** Naïve Group ### Participant Flow Module #### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1. **ID:** FG000 **Title:** Shigella Group #### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. **ID:** FG001 **Title:** Placebo Group #### Group **Description:** Healthy male and female subjects, aged 22 to 50 years, who were not part of H03_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. **ID:** FG002 **Title:** Naïve Group #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 7 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 26 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 7 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 26 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 0 **Pre-Assignment Details:** The subjects in Naive Group, who were not part of the H03_01TP study, were added in order to have a more balanced number of previously unvaccinated and vaccinated subjects in the extension trial. **Recruitment Details:** A total of 35 subjects were enrolled into the study. Of these, 7 and 2 eligible subjects from the H03_01TP parent study were enrolled into the Shigella Group and Placebo Group, respectively. 26 subjects were enrolled into the Naïve Group. All 35 subjects were vaccinated and analyzed for immunogenicity and safety. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT01198379 **Brief Title:** Aspirin in the Prevention of Cardiovascular Events in Hemodialysis Patients **Official Title:** Efficacy of Monitoring of Aspirin Responsiveness in the Prevention of Cardiovascular Events and Decrease in Bleeding Complications in Patients With End-Stage Kidney Disease Undergoing Hemodialysis #### Organization Study ID Info **ID:** BTCGHTN01 #### Organization **Class:** OTHER **Full Name:** Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation ### Status Module #### Completion Date **Date:** 2018-01-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-01-17 **Type:** ACTUAL **Last Update Submit Date:** 2019-01-15 **Overall Status:** WITHDRAWN #### Primary Completion Date **Date:** 2018-01-15 **Type:** ACTUAL #### Start Date **Date:** 2010-02 **Type:** ESTIMATED **Status Verified Date:** 2018-01 #### Study First Post Date **Date:** 2010-09-10 **Type:** ESTIMATED **Study First Submit Date:** 2010-08-24 **Study First Submit QC Date:** 2010-09-08 **Why Stopped:** No participants enrolled ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Taipei Veterans General Hospital, Taiwan #### Lead Sponsor **Class:** OTHER **Name:** Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The study is prospectively initiated to: (1) evaluate the alterations in platelet function to aspirin therapy and the prevalence of aspirin resistance in patients with chronic kidney disease undergoing hemodialysis, and (2) compare the incidence of vascular events (myocardial infarction, cardiac death, stroke, vascular access thrombosis, or revascularization procedure) and the safety profile among placebo-treated, aspirin-resistant and aspirin-sensitive patients. ### Conditions Module **Conditions:** - End-Stage Renal Disease **Keywords:** - aspirin - aspirin resistance - hemodialysis - cardiovascular - Prevalence of aspirin resistance, cardiovascular events, and safety profile ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER **Primary Purpose:** TREATMENT #### Enrollment Info **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: aspirin **Label:** Aspirin **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Hemodialysis (HD) patients receive placebo not containing aspirin in this study. **Intervention Names:** - Drug: Placebo **Label:** Sugar pills **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Aspirin **Description:** aspirin 100 mg qd for 3 years **Name:** aspirin **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Sugar pills **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** the prevalence of aspirin resistance **Time Frame:** 3 years #### Secondary Outcomes **Measure:** the incidence of vascular events (myocardial infarction, cardiac death, stroke, vascular access thrombosis, or revascularization procedure) **Time Frame:** 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients with end-stage renal disease who are undergoing long-term hemodialysis. Exclusion Criteria: Patients will be excluded if there is evidence of * a recent history of acute uremia, * previous adverse reaction to a aspirin or history of aspirin hypersensitivity (eg, aspirin-induced asthma or angioedema), * concurrent treatment with other antiplatelet agent (clopidogrel or ticlopidine), steroidal drugs, or nonsteroidal anti-inflammatory drugs, * high immediate risk for bleeding (eg, active peptic ulceration, recent injury, or hemophilia), or * life-threatening condition other than end-stage renal disease or vascular disease (eg, non-skin cancer). **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Taipei **Country:** Taiwan **Facility:** Taipei Veterans General Hospital #### Overall Officials **Official 1:** **Affiliation:** Taipei Veterans General Hospital, Taiwan **Name:** Der-Cherng Tarng, MD, PhD **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4. **PMID:** 35224730 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000051436 - Term: Renal Insufficiency, Chronic - ID: D000051437 - Term: Renal Insufficiency - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9556 - Name: Hemorrhage - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M10699 - Name: Kidney Failure, Chronic - Relevance: HIGH - As Found: End Stage Renal Disease - ID: M26718 - Name: Renal Insufficiency - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007676 - Term: Kidney Failure, Chronic ### Intervention Browse Module - Ancestors - ID: D000000894 - Term: Anti-Inflammatory Agents, Non-Steroidal - ID: D000018712 - Term: Analgesics, Non-Narcotic - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000018501 - Term: Antirheumatic Agents - ID: D000005343 - Term: Fibrinolytic Agents - ID: D000050299 - Term: Fibrin Modulating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000010975 - Term: Platelet Aggregation Inhibitors - ID: D000016861 - Term: Cyclooxygenase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000058633 - Term: Antipyretics ### Intervention Browse Module - Browse Branches - Abbrev: Antipy - Name: Antipyretics - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: FiAg - Name: Fibrinolytic Agents - Abbrev: Analg - Name: Analgesics - Abbrev: PlAggInh - Name: Platelet Aggregation Inhibitors - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4548 - Name: Aspirin - Relevance: HIGH - As Found: Progression - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4218 - Name: Anti-Inflammatory Agents, Non-Steroidal - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M20786 - Name: Analgesics, Non-Narcotic - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M8473 - Name: Fibrinolytic Agents - Relevance: LOW - As Found: Unknown - ID: M13865 - Name: Platelet Aggregation Inhibitors - Relevance: LOW - As Found: Unknown - ID: M19209 - Name: Cyclooxygenase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M29176 - Name: Antipyretics - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000001241 - Term: Aspirin ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04480879 **Brief Title:** Evaluation of AZD8154 Concentrations in Blood **Official Title:** A Randomised, 3 Period, Single Dose, Open-label Crossover Study to Evaluate the Systemic Exposure of AZD8154 While Administered Via Inhalation Using a Nebuliser Formulation and a Monodose Dry Powder Inhaler (DPI) Formulation in Healthy Subjects #### Organization Study ID Info **ID:** D8900C00005 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca ### Status Module #### Completion Date **Date:** 2020-09-02 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-08-24 **Type:** ACTUAL **Last Update Submit Date:** 2021-08-23 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2020-09-02 **Type:** ACTUAL #### Start Date **Date:** 2020-07-17 **Type:** ACTUAL **Status Verified Date:** 2021-08 #### Study First Post Date **Date:** 2020-07-21 **Type:** ACTUAL **Study First Submit Date:** 2020-07-17 **Study First Submit QC Date:** 2020-07-17 **Why Stopped:** Need for evaluation of emerging pre-clinical toxicology findings ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Parexel #### Lead Sponsor **Class:** INDUSTRY **Name:** AstraZeneca #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is intended to evaluate the systemic pharmacokinetic (PK) characteristics and the safety of AZD8154 following administration of the Monodose DPI formulation compared with the administration of the nebuliser suspension. **Detailed Description:** This study will be a randomised, open-label, 3-period, single-dose, single-centre, crossover study in healthy males and healthy females of non-childbearing potential. The study will comprise: * A Screening Period of maximum 28 days; * Three treatment periods during which subjects will be resident at the Clinical Unit from the morning of the day before dosing with AZD8154 or placebo (Day 1) until 72 hours following dosing for collection of PK samples; discharged on the morning of Day 4 of each treatment period; * A Follow up Visit within 6 ± 1 days after last dose administration of investigational medicinal products (IMPs) (i.e., AZD8154 or placebo). A total of 15 healthy subjects will be randomised in this study to ensure that at least 12 subjects are evaluable. Each subject will be involved in the study for approximately 9 weeks. ### Conditions Module **Conditions:** - Asthma **Keywords:** - Phase 1, Phosphoinositide 3-kinase inhibitor, open-label crossover study ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 10 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The study subjects will receive 1 mg delivered dose of AZD8154 nebuliser suspension **Intervention Names:** - Drug: AZD8154 nebuliser **Label:** AZD8154 nebuliser suspension **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The study subjects will receive 1 mg capsule delivered dose of AZD8154 Monodose DPI formulation **Intervention Names:** - Drug: AZD8154 Monodose DPI presented in capsules **Label:** AZD8154 Monodose **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** The study subjects will receive AZD8154 placebo Monodose DPI formulation dosed to correspond to 1 mg delivered dose AZD8154 Monodose DPI formulation **Intervention Names:** - Drug: AZD8154 Placebo Monodose DPI presented in capsules **Label:** AZD8154 Placebo Monodose DPI **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - AZD8154 nebuliser suspension **Description:** Nebuliser suspension **Name:** AZD8154 nebuliser **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - AZD8154 Monodose **Description:** AZD8154 Monodose DPI formulation delivered dose **Name:** AZD8154 Monodose DPI presented in capsules **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - AZD8154 Placebo Monodose DPI **Description:** The dose correspond to AZD8154 Monodose DPI formulation **Name:** AZD8154 Placebo Monodose DPI presented in capsules **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** To evaluate the PK characteristics of AZD8154 following inhaled single dose administration of a Monodose DPI formulation when compared with inhaled single dose administration of a nebuliser suspension. **Measure:** Area under the plasma concentration time curve from zero to infinity (AUCinf) **Time Frame:** Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 and 72 hours post dose) **Description:** To evaluate the PK characteristics of AZD8154 following inhaled single dose administration of a Monodose DPI formulation when compared with inhaled single dose administration of a nebuliser suspension. **Measure:** Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUClast) **Time Frame:** Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 and 72 hours post dose) **Description:** To evaluate the PK characteristics of AZD8154 following inhaled single dose administration of a Monodose DPI formulation when compared with inhaled single dose administration of a nebuliser suspension. **Measure:** Maximum observed plasma (peak) drug concentration (Cmax) **Time Frame:** Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 and 72 hours post dose) **Description:** To evaluate the PK characteristics of AZD8154 following inhaled single dose administration of a Monodose DPI formulation when compared with inhaled single dose administration of a nebuliser suspension. **Measure:** Dose normalised AUCinf **Time Frame:** Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 and 72 hours post dose) **Description:** To evaluate the PK characteristics of AZD8154 following inhaled single dose administration of a Monodose DPI formulation when compared with inhaled single dose administration of a nebuliser suspension. **Measure:** Dose normalised AUClast **Time Frame:** Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 and 72 hours post dose) **Description:** To evaluate the PK characteristics of AZD8154 following inhaled single dose administration of a Monodose DPI formulation when compared with inhaled single dose administration of a nebuliser suspension. **Measure:** Dose normalised Cmax **Time Frame:** Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 and 72 hours post dose) #### Secondary Outcomes **Description:** To evaluate further PK parameters of AZD8154 following inhaled single dose administration of a Monodose DPI formulation and an inhaled single dose administration of a nebuliser suspension. **Measure:** Time to reach peak or maximum observed concentration or response following drug administration (tmax) **Time Frame:** Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 12, 18, 24, 36, 48 and 72 hours post dose) **Description:** To evaluate further PK parameters of AZD8154 following inhaled single dose administration of a Monodose DPI formulation and an inhaled single dose administration of a nebuliser suspension. **Measure:** Half life associated with terminal slope of a semi logarithmic concentration time curve (t½λz) **Time Frame:** Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 12, 18, 24, 36, 48 and 72 hours post dose) **Description:** To evaluate further PK parameters of AZD8154 following inhaled single dose administration of a Monodose DPI formulation and an inhaled single dose administration of a nebuliser suspension. **Measure:** Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRT) **Time Frame:** Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 12, 18, 24, 36, 48 and 72 hours post dose) **Description:** To evaluate further PK parameters of AZD8154 following inhaled single dose administration of a Monodose DPI formulation and an inhaled single dose administration of a nebuliser suspension. **Measure:** Terminal elimination rate constant (λz) **Time Frame:** Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 12, 18, 24, 36, 48 and 72 hours post dose) **Description:** To evaluate further PK parameters of AZD8154 following inhaled single dose administration of a Monodose DPI formulation and an inhaled single dose administration of a nebuliser suspension. **Measure:** Apparent total body clearance of drug from plasma after extravascular administration (CL/F) **Time Frame:** Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 12, 18, 24, 36, 48 and 72 hours post dose) **Description:** To evaluate further PK parameters of AZD8154 following inhaled single dose administration of a Monodose DPI formulation and an inhaled single dose administration of a nebuliser suspension. **Measure:** Volume of distribution following extravascular administration (based on terminal phase) (Vz/F) **Time Frame:** Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 12, 18, 24, 36, 48 and 72 hours post dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with adverse events **Time Frame:** Day-1, 1 to 4 (Spontaneous plus pre dose, 3, 12, 24, 48 and 72 hrs post dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal blood pressure **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 (Predose and 72hrs post dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal pulse rate **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 (Predose and 72hrs post dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal tympanic temperature **Time Frame:** At screening (Day-28 to-2), Day-1, Day 1 to 4 (Predose, 24, 48, and 72 hrs post dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal respiratory rate **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 (Predose and 72hrs post dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal ECG **Time Frame:** At screening (Day-28 to-2), Day-1, Day 1 to 4 (Predose and 72 hrs post dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal physical examination **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal spirometry **Time Frame:** At screening(Day-28 to-2), Day-1, Day1 to 4 (Predose and 30min, 90min, 3hrs, 12hrs and 24hrs postdose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal White blood cell (WBC) count **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Red blood cell (RBC) count **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Haemoglobin (Hb) **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Haematocrit (HCT) **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Mean corpuscular volume (MCV) **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Mean corpuscular haemoglobin (MCH) **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Mean corpuscular haemoglobin concentration (MCHC) **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Neutrophils absolute count **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Lymphocytes absolute count **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Monocytes absolute count **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Eosinophils absolute count **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Basophils absolute count **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Platelets **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Reticulocytes absolute count **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Sodium **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Potassium **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Urea **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Creatinine **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Albumin **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Calcium **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Phosphate **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Glucose(fasting) **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal C-reactive protein (CRP) **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Alkaline phosphatase (ALP) **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Alanine aminotransferase (ALT) **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Aspartate aminotransferase (AST) **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Gamma glutamyl transpeptidase (GGT) **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Total Bilirubin (TBL) **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects **Measure:** Number of subjects with abnormal Unconjugated bilirubin **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) **Description:** To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects. The parameters to be assessed are glucose, protein and blood in urine **Measure:** Number of subjects with abnormal Urinalysis **Time Frame:** At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male and/or healthy female subjects of non childbearing potential aged 18 to 55 years (inclusive at the Screening Visit) with suitable veins for cannulation or repeated venipuncture. 3. Females must have a negative pregnancy test at Screening Visit and on admission to the Clinical Unit, must not be lactating and must be of non childbearing potential, confirmed at Screening by fulfilling 1 of the following criteria (i) Females are considered postmenopausal if they have had amenorrhea for at least 12 months without an alternative medical cause. The following age specific requirements apply: Women under 50 years old are considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments and with luteinising hormone and follicle stimulating hormone levels are in the postmenopausal range. Women over 50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments. (ii) Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation. 4. Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 60 kg and no more than 100 kg inclusive. 5. Subject has a forced expiratory volume in 1 second ≥ 80% of the predicted value regarding age, height, gender and ethnicity at the Screening Visit. Exclusion Criteria: 1. History of any clinically significant disease or disorder which, in the opinion of the Principal Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study. 2. Subject is immune compromised. 3. History of diabetes, impaired fasting glucose, metabolic syndrome, hypertriglyceridemia or familial lipid disorders. 4. Current or previous history of malignancy of any kind except cutaneous basal or squamous cell carcinoma successful treated with therapy. 5. History of any respiratory disorders such as asthma, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis (IPF), or infantile bronchiolitis. 6. Subject with latent or active tuberculosis, as confirmed by a positive QuantiFERON® TB Gold test or as judged by the Investigator at the Screening Visit. 7. History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs, or bowel disorders not otherwise specified. 8. Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the IMP. 9. Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results, defined as the following: (i) Alanine aminotransferase and/or aspartate aminotransferase \> 1.5 x the upper limit of the normal (ULN) laboratory range. (ii) Bilirubin \> 1.5 times the ULN laboratory range. (iii) Absolute neutrophil count \< lower limit of normal (LLN). (iv) Absolute lymphocyte count \< LLN. 10. Any positive result at the Screening Visit for serum hepatitis B surface antigen OR hepatitis B core antibodies, hepatitis C virus antibody (anti HCV) and human immunodeficiency virus. 11. Abnormal vital signs, after 5 minutes supine rest, defined as any of the following: (i) Systolic blood pressure (BP) \< 90 mmHg or \> 140 mmHg. (ii) Diastolic BP \< 50 mmHg or \> 90 mmHg. (iii) Pulse \< 50 or \> 90 beats per minute (bpm). 12. Any clinically important abnormalities in rhythm, conduction or morphology of the 12 lead safety ECG as judged by the Investigator. (i) Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 450 ms or shortened QTcF \< 340 ms or family history of long QT syndrome. (ii) PR (PQ) interval shortening \< 120 ms (PR \> 110 ms but \< 120 ms is acceptable if there is no evidence of ventricular pre excitation). (iii) PR (PQ) interval prolongation (\> 220 ms) intermittent second (Wenckebach block while asleep is not exclusive) or third degree atrioventricular (AV) block, or AV dissociation. (iv) Persistent or intermittent complete bundle branch block (BBB), incomplete bundle branch block (IBBB), or intraventricular conduction delay (IVCD) with QRS \> 110 ms. Subjects with QRS \> 110 ms but \< 115 ms are acceptable if there is no evidence of e.g., ventricular hypertrophy or pre excitation. 13. Previous use of a mechanistic target of rapamycin (mTOR) antagonist (e.g., rapamycin, everolimus) or PI3K inhibitor (selective or non selective PI3K inhibitors). 14. Known or suspected history of drug abuse as judged by the Investigator. 15. Current smokers or those who have smoked or used nicotine products (including e cigarettes) within the previous 3 months. 16. History of alcohol abuse or excessive intake of alcohol as judged by the Investigator. 17. Positive screen for drugs of abuse or cotinine (nicotine) at the Screening Visit or admission to the Clinical Unit or positive screen for alcohol on admission to the Clinical Unit before the first administration of the IMP. 18. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD8154. 19. Receipt of live attenuated vaccines 2 months before first administration of the IMP and 3 months after the last IMP administration. 20. Excessive intake of caffeine-containing drinks or food (e.g., coffee, tea, chocolate) as judged by the Investigator. 21. Use of drugs with cytochrome P450 (CYP) 3A enzyme inducing or inhibition properties within 3 weeks before first administration of IMP. 22. Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks before the first administration of the IMP or longer if the medication has a long half life. 23. Plasma donation within 1 month of the Screening Visit or any blood donation/blood loss \> 500 mL during the 2 months before the Screening Visit. 24. Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration the IMP in this study. The period of exclusion begins 3 months after the final dose or 1 month after the last visit whichever is the longest. 25. Involvement of any Astra Zeneca or study site employee or their close relatives. 26. Judgement by the Investigator that the subject should not participate in the study if they have any ongoing or recent (i.e., during the Screening Period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements. 27. Subjects who cannot communicate reliably with the Investigator and/or is not able to read speak and understand the German language. 28. Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship or committed to an institution by governmental or juridical order. 29. Subject has a positive test result for SARS-CoV-2 RT-PCR before randomisation. 30. Subject has clinical signs and symptoms consistent with COVID-19, e.g., fever, dry cough, dyspnoea, sore throat, fatigue, or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on first admission. 31. History of severe COVID-19 (hospitalisation, extracorporeal membrane oxygenation, mechanically ventilated). 32. Subjects who are regularly exposed to COVID-19 as part of their daily life (e.g., health care professionals working in COVID-19 wards or at emergency departments). **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Berlin **Country:** Germany **Facility:** Research Site **Zip:** 14050 ### IPD Sharing Statement Module **Access Criteria:** When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. **Description:** Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. **IPD Sharing:** YES **Time Frame:** AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. **URL:** https://astrazenecagroup-dt.pharmacm.com/DT/Home ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M4556 - Name: Asthma - Relevance: LOW - As Found: Unknown - ID: M27137 - Name: Respiratory Aspiration - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M2270 - Name: Phosphoinositide-3 Kinase Inhibitors - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00086879 **Brief Title:** Erlotinib Compared With Temozolomide or Carmustine in Treating Patients With Recurrent Glioblastoma Multiforme **Official Title:** Randomized Phase II of TARCEVA™ (Erlotinib) Versus Temozolomide Or BCNU in Patients With Recurrent Glioblastoma Multiforme #### Organization Study ID Info **ID:** EORTC-26034-16031 #### Organization **Class:** NETWORK **Full Name:** European Organisation for Research and Treatment of Cancer - EORTC #### Secondary ID Infos **ID:** EORTC-26034-16031 ### Status Module #### Completion Date **Date:** 2011-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-07-27 **Type:** ACTUAL **Last Update Submit Date:** 2017-07-26 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2006-03 **Type:** ACTUAL #### Start Date **Date:** 2004-05 **Status Verified Date:** 2017-07 #### Study First Post Date **Date:** 2004-07-12 **Type:** ESTIMATED **Study First Submit Date:** 2004-07-08 **Study First Submit QC Date:** 2004-07-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NETWORK **Name:** European Organisation for Research and Treatment of Cancer - EORTC #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as temozolomide and carmustine, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether erlotinib is more effective than temozolomide or carmustine in treating recurrent glioblastoma multiforme. PURPOSE: This randomized phase II trial is studying erlotinib to see how well it works compared to temozolomide or carmustine in treating patients with recurrent glioblastoma multiforme. **Detailed Description:** OBJECTIVES: Primary * Compare the therapeutic activity of erlotinib vs temozolomide or carmustine in patients with recurrent glioblastoma multiforme. * Compare 6-month progression-free survival in patients treated with these drugs. Secondary * Compare the safety of these drugs in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral erlotinib\* once daily on day 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: \*Patients treated with enzyme inducing anti-epileptic drugs (EIAEDs) receive a higher dose of erlotinib than patients not receiving any anti-epileptic drugs or EIAEDs. * Arm II: Patients who have not received prior temozolomide are assigned to receive temozolomide. Patients who have received prior temozolomide are assigned to receive carmustine. Patients receive 1 of the following treatment regimens: * Patients receive oral temozolomide\* once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. * Patients receive carmustine IV once daily on days 1-3. Treatment repeats every 56 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. NOTE: \*Chemotherapy-naïve patients receive a higher dose of temozolomide than patients who have received prior adjuvant chemotherapy. Patients are followed every 8 weeks until disease progression and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 100-110 patients (50-55 per treatment arm) will be accrued for this study. ### Conditions Module **Conditions:** - Brain and Central Nervous System Tumors **Keywords:** - adult glioblastoma - recurrent adult brain tumor - adult giant cell glioblastoma - adult gliosarcoma ### Design Module #### Design Info **Allocation:** RANDOMIZED ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 110 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** carmustine **Type:** DRUG #### Intervention 2 **Name:** erlotinib hydrochloride **Type:** DRUG #### Intervention 3 **Name:** temozolomide **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Progression-free survival at 6 months #### Secondary Outcomes **Measure:** Response (complete [CR] or partial response [PR]) measured by McDonald's criteria at least 4 weeks after first documented response and every 8 weeks until disease progression or until start of another treatment **Measure:** Severe toxic events assessed by CTCAE v3.0 at the end of each course **Measure:** Progression-free survival at 1 year **Measure:** Overall survival at 6 months and 1 year ### Eligibility Module **Eligibility Criteria:** DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed glioblastoma multiforme * Some oligodendroglial elements allowed provided they make up \< 25% of the tumor * Recurrent disease documented by MRI after prior radiotherapy * At least 1 bidimensionally measurable target lesion ≥ 2 cm by MRI * Undergone prior surgery for recurrent primary brain tumor more than 3 months before study entry * Must have a clearly limited target lesion ≥ 2 cm OR evidence of progressive and measurable target lesion OR a second measurable target lesion outside the surgical area PATIENT CHARACTERISTICS: Age * Over 18 Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm \^3 Hepatic * AST and ALT \< 2.5 times upper limit of normal (ULN) * Bilirubin \< 1.5 times ULN Renal * Creatinine \< 1.5 times ULN Cardiovascular * Clinically normal cardiac function * No ischemic heart disease within the past 12 months * No New York Heart Association grade III or IV cardiac insufficiency * No unstable angina * No arryhthmia Pulmonary * DLCO \> 70% of predicted (for patients randomized to receive erlotinib \[arm I\] or carmustine \[arm II\]) * No history of pulmonary disease that would affect pulmonary function including any of the following: * Chronic bronchopneumopathy * Pleural effusion * Interstitial pnuemonia * Pulmonary lymphangitis Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * No other malignancy except cone biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer * No psychological, familial, sociological, or geographical factors that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * No prior HER-targeted agents * No concurrent growth factors for neutrophil count elevation * No concurrent epoetin alfa Chemotherapy * Prior adjuvant temozolomide allowed * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) * No more than 1 prior adjuvant chemotherapy regimen * No prior chemotherapy for recurrent disease Endocrine therapy * Must be on a stable or decreasing dose of corticosteroids for at least 2 weeks before study entry Radiotherapy * See Disease Characteristics * More than 3 months since prior radiotherapy to the brain * No prior high-dose radiotherapy (\> 65 Gy), stereotactic radiosurgery, or internal radiotherapy unless disease recurrence confirmed Surgery * See Disease Characteristics Other * No prior participation in experimental therapies * No concurrent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, troleandomycin, cimetidine, or grapefruit juice) * No concurrent warfarin or other coumarin derivatives * Concurrent low-molecular weight heparin allowed * No other concurrent investigational drugs **Maximum Age:** 120 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Leuven **Country:** Belgium **Facility:** U.Z. Gasthuisberg **Zip:** B-3000 **Location 2:** **City:** Dijon **Country:** France **Facility:** Centre de Lutte Contre le Cancer Georges-Francois Leclerc **Zip:** 21079 **Location 3:** **City:** Nantes-Saint Herblain **Country:** France **Facility:** Centre Regional Rene Gauducheau **Zip:** 44805 **Location 4:** **City:** Nice **Country:** France **Facility:** Centre Antoine Lacassagne **Zip:** 06189 **Location 5:** **City:** Paris **Country:** France **Facility:** CHU Pitie-Salpetriere **Zip:** 75651 **Location 6:** **City:** Villejuif **Country:** France **Facility:** Institut Gustave Roussy **Zip:** F-94805 **Location 7:** **City:** Padova **Country:** Italy **Facility:** Azienda Ospedaliera di Padova **Zip:** 35128 **Location 8:** **City:** 's-Gravenhage **Country:** Netherlands **Facility:** Medisch Centrum Haaglanden **Zip:** 2501 CK **Location 9:** **City:** Rotterdam **Country:** Netherlands **Facility:** University Medical Center Rotterdam at Erasmus Medical Center **Zip:** 3000 CA **Location 10:** **City:** Glasgow **Country:** United Kingdom **Facility:** Western Infirmary **State:** Scotland **Zip:** G11 6NT #### Overall Officials **Official 1:** **Affiliation:** Daniel Den Hoed Cancer Center at Erasmus Medical Center **Name:** Martin J. van Den Bent, MD **Role:** STUDY_CHAIR ### References Module #### References **Citation:** van den Bent MJ, Brandes AA, Rampling R, Kouwenhoven MC, Kros JM, Carpentier AF, Clement PM, Frenay M, Campone M, Baurain JF, Armand JP, Taphoorn MJ, Tosoni A, Kletzl H, Klughammer B, Lacombe D, Gorlia T. Randomized phase II trial of erlotinib versus temozolomide or carmustine in recurrent glioblastoma: EORTC brain tumor group study 26034. J Clin Oncol. 2009 Mar 10;27(8):1268-74. doi: 10.1200/JCO.2008.17.5984. Epub 2009 Feb 9. **PMID:** 19204207 **Citation:** van den Bent MJ, Brandes A, Rampling R, et al.: Randomized phase II trial of erlotinib (E) versus temozolomide (TMZ) or BCNU in recurrent glioblastoma multiforme (GBM): EORTC 26034. [Abstract] J Clin Oncol 25 (Suppl 18): A-2005, 2007. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001254 - Term: Astrocytoma - ID: D000005910 - Term: Glioma - ID: D000018302 - Term: Neoplasms, Neuroepithelial - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009380 - Term: Neoplasms, Nerve Tissue - ID: D000009371 - Term: Neoplasms by Site - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M9019 - Name: Glioblastoma - Relevance: HIGH - As Found: Glioblastoma - ID: M5209 - Name: Brain Neoplasms - Relevance: LOW - As Found: Unknown - ID: M18937 - Name: Central Nervous System Neoplasms - Relevance: HIGH - As Found: Central Nervous System Tumors - ID: M12367 - Name: Nervous System Neoplasms - Relevance: HIGH - As Found: Nervous System Tumors - ID: M20460 - Name: Gliosarcoma - Relevance: LOW - As Found: Unknown - ID: M4561 - Name: Astrocytoma - Relevance: LOW - As Found: Unknown - ID: M9020 - Name: Glioma - Relevance: LOW - As Found: Unknown - ID: M20446 - Name: Neoplasms, Neuroepithelial - Relevance: LOW - As Found: Unknown - ID: M19845 - Name: Neuroectodermal Tumors - Relevance: LOW - As Found: Unknown - ID: M20388 - Name: Neuroectodermal Tumors, Primitive - Relevance: LOW - As Found: Unknown - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: T2518 - Name: Glioblastoma - Relevance: HIGH - As Found: Glioblastoma - ID: T851 - Name: Brain Tumor, Adult - Relevance: LOW - As Found: Unknown - ID: T2522 - Name: Gliosarcoma - Relevance: LOW - As Found: Unknown - ID: T2519 - Name: Glioma - Relevance: LOW - As Found: Unknown - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005909 - Term: Glioblastoma - ID: D000009423 - Term: Nervous System Neoplasms - ID: D000016543 - Term: Central Nervous System Neoplasms ### Intervention Browse Module - Ancestors - ID: D000018906 - Term: Antineoplastic Agents, Alkylating - ID: D000000477 - Term: Alkylating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000092004 - Term: Tyrosine Kinase Inhibitors - ID: D000047428 - Term: Protein Kinase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M1692 - Name: Temozolomide - Relevance: HIGH - As Found: Skills - ID: M5585 - Name: Carmustine - Relevance: HIGH - As Found: Needling - ID: M398 - Name: Erlotinib Hydrochloride - Relevance: HIGH - As Found: On study - ID: M20942 - Name: Antineoplastic Agents, Alkylating - Relevance: LOW - As Found: Unknown - ID: M3820 - Name: Alkylating Agents - Relevance: LOW - As Found: Unknown - ID: M2889 - Name: Tyrosine Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M25820 - Name: Protein Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: T22 - Name: Tyrosine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077204 - Term: Temozolomide - ID: D000002330 - Term: Carmustine - ID: D000069347 - Term: Erlotinib Hydrochloride ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01289379 **Acronym:** HFJV **Brief Title:** The Effect of High Frequency Jet Ventilation (HFJV)During Laparoscopic Operations **Official Title:** The Effect of High Frequency Jet Ventilation (HFJV)on Pneumoperitoneum Induced Cardiovascular Changes, During Laparoscopic Surgery. #### Organization Study ID Info **ID:** Bickel-HFJV #### Organization **Class:** OTHER_GOV **Full Name:** Western Galilee Hospital-Nahariya ### Status Module #### Expanded Access Info #### Last Update Post Date **Date:** 2011-02-03 **Type:** ESTIMATED **Last Update Submit Date:** 2011-02-02 **Overall Status:** COMPLETED **Status Verified Date:** 2011-02 #### Study First Post Date **Date:** 2011-02-03 **Type:** ESTIMATED **Study First Submit Date:** 2010-10-19 **Study First Submit QC Date:** 2011-02-02 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Western Galilee Hospital-Nahariya ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Investigators conducted a randomised perspective study to determine whether the use of HFJV instead of conventional mechanical ventilation will reduce the adverse cardiovascular effects of pneumoperitoneum during laparoscopic surgery. ### Conditions Module **Conditions:** - Cholecystolithiasis **Keywords:** - pneumoperitoneum - laparoscopy - HFJV - cardiovascular - Symptomatic ### Design Module **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: High Frequency Jet Ventilation - Procedure: HFJV **Label:** HFJV **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - HFJV **Name:** High Frequency Jet Ventilation **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - HFJV **Name:** HFJV **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Cardiac functionality (Cardiac output,VOLUME) **Measure:** Cardiac functionality (Cardiac output,VOLUME) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy patients, undergoing laparoscopic surgery for Symptomatic cholecystolithiasis. Exclusion Criteria: * ASA 3 and 4 **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Nahariya **Country:** Israel **Facility:** Western Galilee Hospital **Zip:** 22100 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010532 - Term: Peritoneal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000001660 - Term: Biliary Tract Diseases - ID: D000005705 - Term: Gallbladder Diseases - ID: D000002137 - Term: Calculi - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M13917 - Name: Pneumoperitoneum - Relevance: HIGH - As Found: Pneumoperitoneum - ID: M25095 - Name: Gallstones - Relevance: HIGH - As Found: Cholecystolithiasis - ID: M6010 - Name: Cholelithiasis - Relevance: HIGH - As Found: Cholecystolithiasis - ID: M24980 - Name: Cholecystolithiasis - Relevance: HIGH - As Found: Cholecystolithiasis - ID: M13441 - Name: Peritoneal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M4946 - Name: Biliary Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M8823 - Name: Gallbladder Diseases - Relevance: LOW - As Found: Unknown - ID: M5399 - Name: Calculi - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011027 - Term: Pneumoperitoneum - ID: D000041761 - Term: Cholecystolithiasis - ID: D000002769 - Term: Cholelithiasis - ID: D000042882 - Term: Gallstones ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00909779 **Brief Title:** Safety Study of Arformoterol Tartrate Inhalation Solution in Chronic Obstructive Pulmonary Disease (COPD) Subjects **Official Title:** A Large Simple Safety Study of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease #### Organization Study ID Info **ID:** 091-080 #### Organization **Class:** INDUSTRY **Full Name:** Sumitomo Pharma America, Inc. ### Status Module #### Completion Date **Date:** 2012-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2013-11-11 **Type:** ESTIMATED **Last Update Submit Date:** 2013-09-12 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2012-06 **Type:** ACTUAL #### Results First Post Date **Date:** 2013-11-11 **Type:** ESTIMATED **Results First Submit Date:** 2013-06-21 **Results First Submit QC Date:** 2013-09-12 #### Start Date **Date:** 2009-06 **Status Verified Date:** 2013-09 #### Study First Post Date **Date:** 2009-05-28 **Type:** ESTIMATED **Study First Submit Date:** 2009-05-26 **Study First Submit QC Date:** 2009-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Sumitomo Pharma America, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a multi-center study to evaluate the long-term safety of arformoterol 15 mcg twice daily (BID) in the treatment of subjects with moderate-to-severe COPD. Study participation will consist of a total of 6 visits over approximately 1 year. **Detailed Description:** This is a multi-center, double-blind, randomized, placebo-controlled, parallel-group, outpatient, safety study to evaluate the long-term safety of arformoterol 15 mcg twice daily (BID) in the treatment of subjects with moderate-to-severe COPD. The administration of arformoterol in subjects with moderate to severe COPD will not result in a meaningfully greater incidence of respiratory death and COPD exacerbation -related hospitalizations compared to placebo (nebulized saline and non-long-acting beta2-agonist \[LABA\] COPD standard of care treatments). This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc. ### Conditions Module **Conditions:** - Chronic Obstructive Pulmonary Disease **Keywords:** - Chronic obstructive pulmonary disease (COPD) - respiratory - long-acting beta agonist (LABA) ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 841 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms. **Intervention Names:** - Drug: Arformoterol **Label:** Arformoterol 15 mcg twice daily **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms. **Intervention Names:** - Drug: Placebo **Label:** Placebo twice daily **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Arformoterol 15 mcg twice daily **Description:** Arformoterol Tartrate Inhalation Solution 15 mcg twice daily (BID) for a duration of one year **Name:** Arformoterol **Other Names:** - Brovana **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo twice daily **Description:** Placebo inhalation solution, twice daily (BID) for a duration of one year. **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** COPD exacerbation: an increase in COPD symptoms that necessitated any change in baseline medication (bronchodilators,anti-inflammatory agents, antibiotics, supplemental oxygen therapy, etc.).Hospitalization: any inpatient admission or any emergency department visit \> 24 hours in duration. Hospice was considered hospitalization.COPD exacerbation related hospitalization: hospitalization that was due to 1) COPD exacerbation or 2) a COPD exacerbation preceded, or occurred concomitantly with the onset of, the event for which the subject was hospitalized.Respiratory-related death: For each death the Primary Investigator designated a 'probable cause', which was the primary condition that precipitated the terminal events that were the immediate cause of death. If a probable cause could not be ascertained, the cause of death was considered 'UNKNOWN'. Cause other than 'UNKNOWN' was categorized as either respiratory or non-respiratory. Deaths of 'UNKNOWN' cause were counted as primary events. **Measure:** Time From Randomization to Respiratory Death or First COPD Exacerbation Related Hospitalization (Whichever Occurs First). **Time Frame:** 0-12 months #### Secondary Outcomes **Description:** A protocol-defined exacerbation of COPD was defined as an increase in respiratory symptoms (classically, increased shortness of breath, increased sputum production, and/or increased sputum purulence) that necessitates any change in baseline medication other than bronchodilators (e.g., anti-inflammatory agents, antibiotics, supplemental oxygen therapy, etc) or causes the subject to require additional medical attention (i.e., emergency room visit or hospitalization). **Measure:** The Incidence of Protocol Defined COPD Exacerbations. **Time Frame:** 0-12 months **Description:** Survival status at the end of the study will be determined for each subject. The proportion of subjects dead and the annual event rate will be summarized by treatment. **Measure:** The Incidence of All Cause Mortality **Time Frame:** 0-12 months **Description:** TEAEs were defined as: 1) adverse events that occurred on or after the date of first dose of study medication, 2) adverse events with a missing start date and a stop date on or after the date of first does of study medication, or 3) adverse events with both a missing start and stop date. The frequency and percentage of subjects with TEAEs were summarized. At each level of summarization, a subject was counted only once for each AE he/she experienced within that level. The percentage of subjects having had at least 1 AE at each level was calculated. **Measure:** The Incidence of Treatment Emergent AEs **Time Frame:** 0-12 months **Description:** The SGRQ assessed health status and consisted of 3 component scores (Symptoms, Activity, and Impacts) as well as a total score. Items were scored in accordance with the developer's guidelines. Scores were expressed as a percentage of overall impairment, where 100 represented worst possible health status and 0 indicated best possible health status. The SGRQ was assessed pre-dose at baseline, months 3, 6 and 12 or the end of study (EOS). Visit 2 was defined as baseline. A change from baseline in the Total Score of ≥ 4 units is considered the minimal clinically important difference (MCID) for SGRQ. **Measure:** SGRQ: Mean Change From Baseline in Total Score **Time Frame:** Baseline and on treatment at months 3, 6 and 12 (or early termination) **Description:** FEV1 was measured at Visit 1 (screening), pre- and post-albuterol administration for reversibility testing, pre-dose at baseline, months 3, 6, 9 and 12/EOS. The best FEV1 from at least 3 acceptable maneuvers was recorded. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last FEV1 value obtained prior to first treatment was used for baseline. **Measure:** FEV1: Mean Change From Baseline **Time Frame:** Baseline and on treatments at months 3, 6, 9 and 12 (or early termination) **Description:** Percent predicted FEV1: measured FEV1 as a percent of the "predicted values" for the patients of similar characteristics (height, age, sex, and sometimes race and weight). Best FEV1 percent predicted was measured at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS, as described for FEV1. **Measure:** Percent Predicted FEV1: Mean Change From Baseline **Time Frame:** Baseline and on treatments at months 3, 6, 9 and 12 (or early termination) **Description:** Forced Vital capacity: the volume of air that can forcibly be blown out after full inspiration. Best FVC was measured at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS. The best FVC from at least 3 acceptable maneuvers was recorded. **Measure:** Forced Vital Capacity (FVC): Mean Change From Baseline **Time Frame:** Baseline and on treatment at months 3, 6, 9 and 12 (or early termination) **Description:** IC: the total amount of air that can be drawn into the lungs after normal expiration. IC was measured pre- and post-albuterol administration at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS. IC maneuvers were done in triplicate. The mean of all recorded IC values was used for each subject at each time point. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last IC value obtained prior to first treatment dose was used for baseline. **Measure:** Inspiratory Capacity (IC): Mean Change From Baseline **Time Frame:** Baseline and on treatment at months 3, 6, 9 and 12 (or early termination) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subject must give written informed consent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation. * Females considered not of childbearing potential must be surgically sterile (total hysterectomy, bilateral salpingo oophorectomy, or tubal ligation) or post-menopausal, which is defined as a complete cessation of menstruation for at least 1 year. * Male and female subjects must be at least 40 years old at the time of consent. * Subjects must have a pre-established, documented primary clinical diagnosis of non-asthmatic COPD or are referred for diagnosis of non-asthmatic COPD. * Subjects must have a baseline FEV1 of ≤50% predicted volume at Visits 1 and 2 (pre-dose). * Subjects must have a FEV1 \>0.50 L at either Visit 1 or 2 (pre-dose). * Subject's respiratory status must be clinically stable. * Subjects must have a FEV1/forced vital capacity (FVC) ratio of ≤70% at either Visit 1 or 2 (pre-dose). * Subjects must have had at least 1 COPD exacerbation within the last year (defined as initiation or an increase in the dose of oral steroids or antibiotics for the treatment of COPD). * Subjects must have a ≥15 pack-year smoking history and a baseline breathlessness severity grade of ≥2 (Modified Medical Research Council \[MMRC\] Dyspnea Scale Score) at Visit 2. * Female subjects ≤65 years of age must have a negative serum pregnancy test conducted at Visit 1 prior to randomization. Females of childbearing potential must be using an acceptable method of birth control. * Subjects' overall health must be sufficiently stable to complete the study requirements based on the screening physical examination (defined as the absence of any clinically relevant abnormalities), medical history, 12-lead ECG, and clinical laboratory values (hematology, serum chemistry and urinalysis), and vital signs (heart rate, respiratory rate, and blood pressure) that have been conducted within 30 days of Visit 2 (randomization). If any of the hematology, chemistry, or urinalysis results are not within the laboratory's reference range, then the subject can be included only if the investigator judges the deviations to be not clinically significant. * Subjects must have a minimum blood pressure of 105/60 mmHg and a minimum resting pulse of 50 bpm at Screening Visit 1. Subjects who do not meet these criteria at Screening Visit 1 must meet the criteria on the first day of dosing (Day 1) in order to be eligible for the study. Subjects with a medical condition which causes low blood pressure or low heart rate, but, in the opinion of the Principal Investigator or designee the medical condition could resolve, may be rescreened when the condition is resolved. * Subjects must be willing and able to complete all study questionnaires and logs reliably. * Subjects must be willing and able to comply with study procedures and visit schedule. * Subjects must have sufficient understanding of English to complete all questionnaires and logs. Exclusion Criteria: * Female subjects who are pregnant or lactating. * Subjects with a history of asthma, with the exception of asthma diagnosed in childhood. * Subjects with a blood eosinophil count \>5% of total white blood cell count. * Subjects with a febrile illness within 3 days before Screening. * Subjects with a malignant neoplasm other than non melanomatous basal cell skin cancer. Subjects with a history of malignancy who have been cancer free for 5 years or more may be enrolled. * Subjects who are currently using disallowed medications or will be unable to complete the medication washout periods. Subjects taking a prohibited concurrent medication which requires a washout of \>30 days may be rescreened when the washout of the prohibited concurrent medication has been met. * Subjects with life threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days prior to screening. * Subjects who have had a change in dose or type of any medications for COPD within 2 weeks prior to the screening visit. Subjects not on a stable dose of COPD medications may be rescreened after being on a stable dose for at least 14 days * Subjects with a chest x ray taken ≤3 months prior to screening that suggests a diagnosis other than COPD (eg, diagnostic of pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing pulmonary conditions). If there is no chest x ray taken ≤3 months prior to screening, or if recent results are unavailable for review, a chest x ray must be performed prior to visit 2. Subjects with a medical condition that caused the abnormal finding, but, in the opinion of the Principal Investigator or designee the medical condition could resolve, may be rescreened when the condition is resolved * Subjects with a positive urine drug test during screening. * Subjects with a known history of alcohol abuse may be enrolled in the study if the subject's current alcohol use does not exceed more than 3 alcoholic beverages per day. * Subjects whose schedule or travel prevents the completion of all required visits. * Subjects who are scheduled for inpatient hospitalization or elective surgery (inpatient or outpatient) during the trial. Subjects may be rescreened when the condition is resolved. * Subjects have participated in an investigational drug study and/or any COPD interventional trial within 30 days prior to screening or who are currently participating in another investigational drug study or COPD interventional trial. * Subjects with a history of allergic reaction to the study medication or any components of the study medications. * Subjects who are study site staff members or relatives of study site staff members directly involved in this study. * Subjects with clinically significant cardiac, (Functional Class III and IV; Objective Class C and D by New York Heart Association \[NYHA\] Functional Classification),hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol. **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Birmingham **Country:** United States **Facility:** Jefferson Clinic **State:** Alabama **Zip:** 25233 **Location 2:** **City:** Birmingham **Country:** United States **Facility:** Alabama Clinical Therapeutic, LLC **State:** Alabama **Zip:** 35235 **Location 3:** **City:** Brimingham **Country:** United States **Facility:** Achieve Clinical Research **State:** Alabama **Zip:** 35209 **Location 4:** **City:** Jasper **Country:** United States **Facility:** Jasper Summit Research, LLC **State:** Alabama **Zip:** 35501 **Location 5:** **City:** Anaheim **Country:** United States **Facility:** Chest Critical Care Consultants **State:** California **Zip:** 92801 **Location 6:** **City:** Fullerton **Country:** United States **Facility:** California Research Medical Group **State:** California **Zip:** 92835 **Location 7:** **City:** Riverside **Country:** United States **Facility:** Integrated Research Group **State:** California **Zip:** 92506 **Location 8:** **City:** Roseville **Country:** United States **Facility:** Quality Control Research Inc. **State:** California **Zip:** 95661 **Location 9:** **City:** Sacramento **Country:** United States **Facility:** Sockolov and Sockolov APC **State:** California **Zip:** 95825 **Location 10:** **City:** Sacremento **Country:** United States **Facility:** Centers for Clinical Trials of Sacremento **State:** California **Zip:** 95823 **Location 11:** **City:** San Diego **Country:** United States **Facility:** Institute of HealthCare Assessment, Inc. **State:** California **Zip:** 92120 **Location 12:** **City:** Denver **Country:** United States **Facility:** National Jewish Health **State:** Colorado **Zip:** 80206 **Location 13:** **City:** Chiefland **Country:** United States **Facility:** Southeast Clinical Research **State:** Florida **Zip:** 32626 **Location 14:** **City:** Clearwater **Country:** United States **Facility:** Tampa Bay Medical Research Inc. **State:** Florida **Zip:** 33761 **Location 15:** **City:** Clearwater **Country:** United States **Facility:** Clinical Research of West Florida, Inc. **State:** Florida **Zip:** 33765 **Location 16:** **City:** DeLand **Country:** United States **Facility:** Avail Clinical Research **State:** Florida **Zip:** 32720 **Location 17:** **City:** Kissimmee **Country:** United States **Facility:** The Lung Clinic, P.A. **State:** Florida **Zip:** 34741 **Location 18:** **City:** Orlando **Country:** United States **Facility:** DCT **State:** Florida **Zip:** 32806 **Location 19:** **City:** Tampa **Country:** United States **Facility:** Clinical Research of West Florida **State:** Florida **Zip:** 33603 **Location 20:** **City:** Canton **Country:** United States **State:** Georgia **Zip:** 30114 **Location 21:** **City:** Columbus **Country:** United States **Facility:** Southeast Regional Research Group **State:** Georgia **Zip:** 31904 **Location 22:** **City:** Decatur **Country:** United States **Facility:** Atlanta Pharmaceutical Research **State:** Georgia **Zip:** 30033 **Location 23:** **City:** Marietta **Country:** United States **Facility:** Wellstar Marietta Pulmonary Medicine **State:** Georgia **Zip:** 30060 **Location 24:** **City:** Rincon **Country:** United States **Facility:** Southeast Regional Research Group **State:** Georgia **Zip:** 31326 **Location 25:** **City:** Evansville **Country:** United States **Facility:** Medisphere Medical Research Center **State:** Indiana **Zip:** 47714 **Location 26:** **City:** Iowa City **Country:** United States **Facility:** University of Iowa Hospitals and Clinics **State:** Iowa **Zip:** 52242 **Location 27:** **City:** Hazard **Country:** United States **Facility:** Kentucky Lung Clinic **State:** Kentucky **Zip:** 41701 **Location 28:** **City:** Lafayette **Country:** United States **Facility:** Bendel Medical Research Center, LLC **State:** Louisiana **Zip:** 70503 **Location 29:** **City:** Ann Arbor **Country:** United States **Facility:** ClinSite LLC **State:** Michigan **Zip:** 48106 **Location 30:** **City:** Minneapolis **Country:** United States **Facility:** Clinical Research Institute Inc. **State:** Minnesota **Zip:** 55402 **Location 31:** **City:** St. Charles **Country:** United States **Facility:** Midwest Chest Consultants **State:** Missouri **Zip:** 63301 **Location 32:** **City:** St. Louis **Country:** United States **Facility:** C.A.R.E. Clinical Research **State:** Missouri **Zip:** 63141 **Location 33:** **City:** Berlin **Country:** United States **Facility:** Comprehensive Clinical Research **State:** New Jersey **Zip:** 08009 **Location 34:** **City:** Cherry Hill **Country:** United States **Facility:** Delaware Valley Clinical Research **State:** New Jersey **Zip:** 08003 **Location 35:** **City:** New York **Country:** United States **Facility:** New York Pulmonary and Clinical Care Associates, PC **State:** New York **Zip:** 10016 **Location 36:** **City:** Newburgh **Country:** United States **Facility:** ENT & Allergy Associates **State:** New York **Zip:** 12550 **Location 37:** **City:** Rochester **Country:** United States **Facility:** Rochester Clinical Research **State:** New York **Zip:** 14609 **Location 38:** **City:** Rochester **Country:** United States **Facility:** AAIR Research Center **State:** New York **Zip:** 14618 **Location 39:** **City:** Charlotte **Country:** United States **Facility:** American Health Research Inc. **State:** North Carolina **Zip:** 28207 **Location 40:** **City:** Winston-Salem **Country:** United States **Facility:** Piedmont Medical Research **State:** North Carolina **Zip:** 27103 **Location 41:** **City:** Akron **Country:** United States **Facility:** DayStar Clinical Research, Inc. **State:** Ohio **Zip:** 44313 **Location 42:** **City:** Cincinnati **Country:** United States **Facility:** Bernstein Clinical Research Center **State:** Ohio **Zip:** 45231 **Location 43:** **City:** Medford **Country:** United States **Facility:** Clinical Research Institute of Southern Oregon, PC **State:** Oregon **Zip:** 97504 **Location 44:** **City:** Portland **Country:** United States **Facility:** Allergy Associates Research Center **State:** Oregon **Zip:** 97216 **Location 45:** **City:** Philadelphia **Country:** United States **Facility:** Arcuri Clinical Research, LLC **State:** Pennsylvania **Zip:** 19142 **Location 46:** **City:** Pawtucket **Country:** United States **Facility:** Biomedical Research Alliance at Hypertension and Nephrology **State:** Rhode Island **Zip:** 02860 **Location 47:** **City:** Warwick **Country:** United States **Facility:** Omega Medical Research **State:** Rhode Island **Zip:** 02886 **Location 48:** **City:** Charleston **Country:** United States **Facility:** Lowcountry Lung & Critical Care, PA **State:** South Carolina **Zip:** 29406 **Location 49:** **City:** Columbia **Country:** United States **Facility:** Neem Research Group, Inc. **State:** South Carolina **Zip:** 29201 **Location 50:** **City:** Gaffney **Country:** United States **Facility:** Gaffney Pharmaceutical Research **State:** South Carolina **Zip:** 29340 **Location 51:** **City:** Greenville **Country:** United States **Facility:** Greenville Pharmaceutical Research **State:** South Carolina **Zip:** 29615 **Location 52:** **City:** Greenville **Country:** United States **Facility:** Upstate Pharmaceutical Research **State:** South Carolina **Zip:** 29615 **Location 53:** **City:** Greer **Country:** United States **Facility:** Mountain View Clinical Research, Inc. **State:** South Carolina **Zip:** 29651 **Location 54:** **City:** Spartanburg **Country:** United States **Facility:** S. Carolina Pharmaceutical Research **State:** South Carolina **Zip:** 29303 **Location 55:** **City:** Union **Country:** United States **Facility:** CU Pharmaceutical Research **State:** South Carolina **Zip:** 29379 **Location 56:** **City:** Knoxville **Country:** United States **Facility:** Allergy Associates **State:** Tennessee **Zip:** 37909 **Location 57:** **City:** Knoxville **Country:** United States **Facility:** Volunteer Research Group **State:** Tennessee **Zip:** 37920 **Location 58:** **City:** Arlington **Country:** United States **Facility:** DCT **State:** Texas **Zip:** 76014 **Location 59:** **City:** Houston **Country:** United States **Facility:** Baylor College of Medicine, Clinical Studies Unit, Ben Taub General Hospital **State:** Texas **Zip:** 77030 **Location 60:** **City:** Houston **Country:** United States **Facility:** VAMC **State:** Texas **Zip:** 77030 **Location 61:** **City:** Kingwood **Country:** United States **Facility:** Kingwood Research Institute, LLC **State:** Texas **Zip:** 77339 **Location 62:** **City:** San Antonio **Country:** United States **Facility:** Physician PrimeCare Research **State:** Texas **Zip:** 78212 **Location 63:** **City:** San Antonio **Country:** United States **Facility:** Diagnostics Research Group **State:** Texas **Zip:** 78229 **Location 64:** **City:** Sugar Land **Country:** United States **Facility:** DCT **State:** Texas **Zip:** 77878 **Location 65:** **City:** Webster **Country:** United States **Facility:** SouthEast Research Institute **State:** Texas **Zip:** 77598 **Location 66:** **City:** Provo **Country:** United States **Facility:** National Clinical Resources, Inc. **State:** Utah **Zip:** 84604 **Location 67:** **City:** Salt Lake City **Country:** United States **Facility:** Utah Clinical Trials LLC **State:** Utah **Zip:** 84107 **Location 68:** **City:** Charlottesville **Country:** United States **Facility:** Charlottesville Medical Research Inc. **State:** Virginia **Zip:** 22911 **Location 69:** **City:** Manassas **Country:** United States **Facility:** Manassas Clinical Research Center **State:** Virginia **Zip:** 20110 **Location 70:** **City:** Richmond **Country:** United States **Facility:** Dominion Medical Associates **State:** Virginia **Zip:** 23219 **Location 71:** **City:** Richmond **Country:** United States **Facility:** Pulmonary Associates of Richmond Inc. **State:** Virginia **Zip:** 23225 **Location 72:** **City:** Richmond **Country:** United States **Facility:** Pulmonary Associates of Richmond, Inc. **State:** Virginia **Zip:** 23229 **Location 73:** **City:** Tacoma **Country:** United States **Facility:** Pulmonary Consultants, PLLC **State:** Washington **Zip:** 98405 ### References Module #### References **Citation:** Donohue JF, Ganapathy V, Bollu V, Stensland MD, Nelson LM. Health Status of Patients with Moderate to Severe COPD after Treatment with Nebulized Arformoterol Tartrate or Placebo for 1 Year. Clin Ther. 2017 Jan;39(1):66-74. doi: 10.1016/j.clinthera.2016.11.021. Epub 2016 Dec 20. **PMID:** 28011247 **Citation:** Donohue JF, Hanania NA, Make B, Miles MC, Mahler DA, Curry L, Tosiello R, Wheeler A, Tashkin DP. One-year safety and efficacy study of arformoterol tartrate in patients with moderate to severe COPD. Chest. 2014 Dec;146(6):1531-1542. doi: 10.1378/chest.14-0117. **PMID:** 25451347 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11168 - Name: Lung Diseases - Relevance: HIGH - As Found: Pulmonary Disease - ID: M27137 - Name: Respiratory Aspiration - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: HIGH - As Found: Obstructive Pulmonary Disease - ID: M23449 - Name: Pulmonary Disease, Chronic Obstructive - Relevance: HIGH - As Found: Chronic Obstructive Pulmonary Disease - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: HIGH - As Found: Chronic ### Condition Browse Module - Meshes - ID: D000008171 - Term: Lung Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000029424 - Term: Pulmonary Disease, Chronic Obstructive ### Intervention Browse Module - Ancestors - ID: D000001993 - Term: Bronchodilator Agents - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018927 - Term: Anti-Asthmatic Agents - ID: D000019141 - Term: Respiratory System Agents - ID: D000058666 - Term: Adrenergic beta-2 Receptor Agonists - ID: D000000318 - Term: Adrenergic beta-Agonists - ID: D000000322 - Term: Adrenergic Agonists - ID: D000018663 - Term: Adrenergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PhSol - Name: Pharmaceutical Solutions ### Intervention Browse Module - Browse Leaves - ID: M3767 - Name: Albuterol - Relevance: LOW - As Found: Unknown - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M304 - Name: Formoterol Fumarate - Relevance: HIGH - As Found: Chicago - ID: M5269 - Name: Bronchodilator Agents - Relevance: LOW - As Found: Unknown - ID: M20963 - Name: Anti-Asthmatic Agents - Relevance: LOW - As Found: Unknown - ID: M21137 - Name: Respiratory System Agents - Relevance: LOW - As Found: Unknown - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown - ID: M3670 - Name: Adrenergic beta-Agonists - Relevance: LOW - As Found: Unknown - ID: M3673 - Name: Adrenergic Agonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000068759 - Term: Formoterol Fumarate ### Misc Info Module #### Removed Countries - Country: Albania - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Placebo Comparator: Placebo Twice Daily **Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms. **ID:** EG000 **Other Num Affected:** 180 **Other Num at Risk:** 421 **Serious Number Affected:** 95 **Serious Number At Risk:** 421 **Title:** Placebo Comparator: Placebo Twice Daily **Group ID:** EG001 **Title:** Experimental: Arformoterol 15 Mcg Twice Daily **Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms. **ID:** EG001 **Other Num Affected:** 174 **Other Num at Risk:** 420 **Serious Number Affected:** 86 **Serious Number At Risk:** 420 **Title:** Experimental: Arformoterol 15 Mcg Twice Daily **Frequency Threshold:** 5 #### Other Events **Term:** Bronchitis **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 **Term:** Nasopharyngitis **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 **Term:** Sinusitis **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 **Term:** Upper respiratory tract infection **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 **Term:** Headache **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 15.0 **Term:** Chronic obstructive pulmonary disease **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 15.0 **Term:** Dyspnoea **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 15.0 #### Serious Events **Term:** Anemia **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Leukocytosis **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Acute coronary syndrome **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Acute myocardial infarction **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Angina pectoris **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 420 **Num Events:** 3 **Term:** Angina Unstable **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Atrial fibrillation **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 421 **Num Events:** 2 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 420 **Num Events:** 3 **Term:** Atrioventricular block complete **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Bundle branch block right **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Cardiac failure congestive **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 421 **Num Events:** 3 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 420 **Num Events:** 2 **Term:** Cardio-respiratory arrest **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 420 **Num Events:** 2 **Term:** Cardiomyopathy **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Corpulmonale **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Coronary artery disease **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 420 **Num Events:** 3 **Term:** Myocardial infarction **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 421 **Num Events:** 2 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Myocardial ischaemia **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Vertigo **Organ System:** Ear and labyrinth disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 2 **Term:** Iridocyclitis **Organ System:** Eye disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Retinal artery occlusion **Organ System:** Eye disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Abdominal pain **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Abdominal pain upper **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Barrett's oesophagus **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Colonic polyp **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Diverticular perforation **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Enteritis **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Gastric ulcer **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Gastric ulcer haemorrhage **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Gastritis erosive **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Gastrointestinal haemorrhage **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 421 **Num Events:** 2 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 420 **Num Events:** 2 **Term:** Gastrooesophageal reflux disease **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Hiatus hernia **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Intestinal perforation **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Pancreatitis acute **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Rectal haemorrhage **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Small intestinal obstruction **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Non-cardiac chest pain **Organ System:** General disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 420 **Num Events:** 3 **Term:** Oedema peripheral **Organ System:** General disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Cholecystitis **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Gallbladder perforation **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Abscess limb **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Bronchitis **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 9 **Num At Risk:** 421 **Num Events:** 10 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 420 **Num Events:** 4 **Term:** Bronchopneumonia **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Cellulitis **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Clostridial infection **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Clostridium difficile colitis **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Diverticulitis **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Gastritis fungal **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Gastroenteritis bacteria **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Influenza **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Osteomyelitis **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Osteomy **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Osteomyelitis acute **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Peridiverticular abscess **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Pneumonia **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 14 **Num At Risk:** 421 **Num Events:** 18 **Group ID:** EG001 **Num Affected:** 12 **Num At Risk:** 420 **Num Events:** 13 **Term:** Postoperative wound infection **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Sepsis **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 420 **Num Events:** 3 **Term:** Septic shock **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Urinary tract infection **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Accidental overdose **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Alcohol poisoning **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 4 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Ankle fracture **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Cervical vertebral fracture **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Fibula fracture **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Head injury **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Incisional hernia **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Injury **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Open wound **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Thermal burn **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Tibia fracture **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Toxicity to various agents **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Blood phosphorus decreased **Organ System:** Investigations **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Dehydration **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 421 **Num Events:** 2 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Diabetes mellitus inadequate control **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 2 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Hypocalcaemia **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Hypokalaemia **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Arthralgia **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 421 **Num Events:** 2 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Cervical spinal stenosis **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Intervertebral disc protrusion **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Muscular weakness **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Musculoskeletal chest pain **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 421 **Num Events:** 2 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Rotator cuff syndrome **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Bladder cancer **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Brain neoplasm **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Breast cancer **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Lung neoplasm malignant **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Metastases to lymph nodes **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Oesophageal carcinoma **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Squamous cell carcinoma **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Throat cancer **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Altered state of consciousness **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Ataxia **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Carotid artery aneurysm **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Carotid artery disease **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Cerebrovascular accident **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Headache **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Ischaemic stroke **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Sensory disturbance **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Syncope **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 421 **Num Events:** 2 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Transient ischaemic attack **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Affective disorder **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 4 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Alcohol withdrawal syndrome **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Depression **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Major depression **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 420 **Num Events:** 2 **Term:** Mental status changes **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Haematuria **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Nephropathy **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Renal artery stenosis **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Renal failure **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Renal failure acute **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Urethral obstruction **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Urinary retention **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Acute respiratory distress syndrome **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Acute respiratory failure **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 421 **Num Events:** 5 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Bronchiectasis **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Bronchospasm **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Chronic obstructive pulmonary disease **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 55 **Num At Risk:** 421 **Num Events:** 76 **Group ID:** EG001 **Num Affected:** 35 **Num At Risk:** 420 **Num Events:** 44 **Term:** Haemoptysis **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 421 **Num Events:** 3 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Hypoxia **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Pleuritic pain **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Pneumothorax **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 421 **Num Events:** 2 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Pulmonary embolism **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Respiratory arrest **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Respiratory distress **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Respiratory failure **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 421 **Num Events:** 3 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 420 **Num Events:** 2 **Term:** Urticaria **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Aortic aneurysm **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Hypertension **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Hypertensive crisis **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Hypertensive emergency **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Term:** Hypotension **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** Iliac artery stenosis **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 420 **Num Events:** 2 **Term:** Peripheral arterial occlusive disease **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 421 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 420 **Num Events:** 1 **Term:** C-reactive protein increased **Organ System:** Investigations **Source Vocabulary:** MedDRA 15.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 421 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 420 **Time Frame:** 1 year ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 421 **Group ID:** BG001 **Value:** 420 **Group ID:** BG002 **Value:** 841 **Units:** Participants ### Group **ID:** BG000 **Title:** Placebo Comparator: Placebo Twice Daily **Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms. ### Group **ID:** BG001 **Title:** Experimental: Arformoterol 15 Mcg Twice Daily **Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 222 #### Measurement **Group ID:** BG001 **Value:** 204 #### Measurement **Group ID:** BG002 **Value:** 426 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 199 #### Measurement **Group ID:** BG001 **Value:** 216 #### Measurement **Group ID:** BG002 **Value:** 415 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 9.5 **Value:** 63.3 #### Measurement **Group ID:** BG001 **Spread:** 9.3 **Value:** 64.2 #### Measurement **Group ID:** BG002 **Spread:** 9.4 **Value:** 63.8 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 178 #### Measurement **Group ID:** BG001 **Value:** 183 #### Measurement **Group ID:** BG002 **Value:** 361 **Class Title:** Female #### Measurement **Group ID:** BG000 **Value:** 243 #### Measurement **Group ID:** BG001 **Value:** 236 #### Measurement **Group ID:** BG002 **Value:** 479 **Class Title:** Male #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 1 **Class Title:** Undifferentiated ### Measure #### Measurement **Group ID:** BG000 **Value:** 15 #### Measurement **Group ID:** BG001 **Value:** 9 #### Measurement **Group ID:** BG002 **Value:** 24 **Category Title:** Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 402 #### Measurement **Group ID:** BG001 **Value:** 411 #### Measurement **Group ID:** BG002 **Value:** 813 **Category Title:** Not Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 4 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 2 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 4 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 43 #### Measurement **Group ID:** BG001 **Value:** 45 #### Measurement **Group ID:** BG002 **Value:** 88 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 374 #### Measurement **Group ID:** BG001 **Value:** 372 #### Measurement **Group ID:** BG002 **Value:** 746 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 1 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 421 #### Measurement **Group ID:** BG001 **Value:** 420 #### Measurement **Group ID:** BG002 **Value:** 841 **Class Title:** United States ### Measure #### Measurement **Group ID:** BG000 **Spread:** 1.1 **Value:** 0.8 #### Measurement **Group ID:** BG001 **Spread:** 1.4 **Value:** 1.0 #### Measurement **Group ID:** BG002 **Spread:** 1.3 **Value:** 0.9 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 0.487 **Value:** 1.178 #### Measurement **Group ID:** BG001 **Spread:** 0.482 **Value:** 1.176 #### Measurement **Group ID:** BG002 **Spread:** 0.485 **Value:** 1.177 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 13.9 **Value:** 39.4 #### Measurement **Group ID:** BG001 **Spread:** 13.2 **Value:** 39.7 #### Measurement **Group ID:** BG002 **Spread:** 13.5 **Value:** 39.5 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 218 #### Measurement **Group ID:** BG001 **Value:** 214 #### Measurement **Group ID:** BG002 **Value:** 432 **Class Title:** Current #### Measurement **Group ID:** BG000 **Value:** 203 #### Measurement **Group ID:** BG001 **Value:** 206 #### Measurement **Group ID:** BG002 **Value:** 409 **Class Title:** Former ### Measure #### Measurement **Group ID:** BG000 **Spread:** 9.7 **Value:** 41 #### Measurement **Group ID:** BG001 **Spread:** 9.5 **Value:** 40 #### Measurement **Group ID:** BG002 **Spread:** 9.6 **Value:** 81 **Class Title:** ≥ 15 - < 25 #### Measurement **Group ID:** BG000 **Spread:** 8.6 **Value:** 36 #### Measurement **Group ID:** BG001 **Spread:** 6.9 **Value:** 29 #### Measurement **Group ID:** BG002 **Spread:** 7.7 **Value:** 65 **Class Title:** ≥ 25 - < 30 #### Measurement **Group ID:** BG000 **Spread:** 81.7 **Value:** 344 #### Measurement **Group ID:** BG001 **Spread:** 83.6 **Value:** 351 #### Measurement **Group ID:** BG002 **Spread:** 82.6 **Value:** 695 **Class Title:** ≥ 30 ### Measure #### Measurement **Group ID:** BG000 **Spread:** 48.0 **Value:** 202 #### Measurement **Group ID:** BG001 **Spread:** 48.1 **Value:** 202 #### Measurement **Group ID:** BG002 **Spread:** 48.0 **Value:** 404 **Class Title:** No #### Measurement **Group ID:** BG000 **Spread:** 52.0 **Value:** 219 #### Measurement **Group ID:** BG001 **Spread:** 51.9 **Value:** 218 #### Measurement **Group ID:** BG002 **Spread:** 52.0 **Value:** 437 **Class Title:** Yes ### Measure #### Measurement **Group ID:** BG000 **Spread:** 78.4 **Value:** 330 #### Measurement **Group ID:** BG001 **Spread:** 79.5 **Value:** 334 #### Measurement **Group ID:** BG002 **Spread:** 79.0 **Value:** 664 **Class Title:** No #### Measurement **Group ID:** BG000 **Spread:** 21.6 **Value:** 91 #### Measurement **Group ID:** BG001 **Spread:** 20.5 **Value:** 86 #### Measurement **Group ID:** BG002 **Spread:** 21.0 **Value:** 177 **Class Title:** Yes **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age Continuous **Unit of Measure:** years ### Measure 3 **Parameter Type:** NUMBER **Title:** Sex/Gender, Customized **Unit of Measure:** participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Ethnicity (NIH/OMB) **Unit of Measure:** Participants ### Measure 5 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 6 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ### Measure 7 **Description:** The average number of COPD exacerbations during the previous year **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Number of COPD exacerbations in last year **Unit of Measure:** Number of occurrences ### Measure 8 **Description:** FEV1: Forced expiratory volume in one second. FEV1 was measured at Visit 1 (screening), pre- and post-albuterol administration for reversibility testing, pre-dose at Visits 2 through 5, and at Visit 6/EOS. The best FEV1 from at least 3 acceptable maneuvers was recorded. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last FEV1 value obtained prior to first treatment was used for baseline. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** FEV1 **Unit of Measure:** Liter ### Measure 9 **Description:** Best FEV1 percent predicted was measured at Visit 1 (screening), pre-dose at Visits 2 through 5, and at Visit 6/EOS, as described for FEV1. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Percent predicted FEV1 (%) **Unit of Measure:** Percentage (%) ### Measure 10 **Description:** Smoking status was recorded at each visit. At baseline, a subject was only defined as a former smoker if they had given up smoking at least 6 calendar months prior to the Visit 1 (screening) date based on the smoking cessation date. Otherwise, they were classified as a current smoker. **Parameter Type:** NUMBER **Title:** Baseline smoking status **Unit of Measure:** Current ### Measure 11 **Description:** Number of pack-years smoked was defined as the number of cigarette packs smoked per day times the number of years smoked. **Parameter Type:** NUMBER **Title:** Number of pack-years smoked **Unit of Measure:** Pack-years ### Measure 12 **Description:** Oral or inhaled corticosteroid use **Parameter Type:** NUMBER **Title:** Baseline Oral/Inhaled Corticosteroid Use **Unit of Measure:** participants ### Measure 13 **Description:** Oxygen therapy use at baseline **Parameter Type:** NUMBER **Title:** Baseline Oxygen Therapy Use **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement **Other Details:** In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish. **Restriction Type:** OTHER **Restrictive Agreement:** True ### Limitations and Caveats **Description:** Although LABAs other than study medication were discontinued, other medications were not controlled for. A large number of subjects discontinued after a primary event and their eventual outcomes are unknown. ### Point of Contact **Organization:** Sunovion **Phone:** 1-866-503-6351 **Title:** Respiratory Medical Director ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** 0.425 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.864 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** Hazard ratio was calculated as arformoterol vs. placebo. **Group Description:** The null hypothesis is: There is 40% or higher excess risk of the primary events in the arformoterol group relative to placebo (a constant hazard ratio of 1.4). The primary analysis was a Cox proportional hazards regression model, with treatment group, baseline smoking status, sex, age, BMI, and baseline FEV1 as covariates. The hazard ratio and 90% two-sided confidence interval for the hazard ratio (adjusted for the interim analysis) comparing arformoterol to placebo were estimated. **Non-Inferiority Comment:** The study was powered under a one-sided alternative hypothesis, in which arformoterol is superior to placebo, with a hazard ratio of 0.80 or less. To achieve 80% power, it was necessary to observe 86 total events for the primary endpoint adjusted for interim analysis. Assuming an annual event proportion of 17.3% in the placebo group and 30% lost to follow-up, we anticipated to randomize approximately 900 subjects (450 per arm). The non-inferiority margin for the hazard ratio is 1.4. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.606 **Statistical Comment:** **Statistical Method:** Regression, Cox **Tested Non-Inferiority:** True ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ### Outcome Measure 5 ### Outcome Measure 6 ### Outcome Measure 7 ### Outcome Measure 8 ### Outcome Measure 9 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.425 - **Spread:** 91.2 - **Upper Limit:** 0.864 - **Value:** 155.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 98.7 - **Upper Limit:** - **Value:** 171.7 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 132 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 122 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 72 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 71 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 34 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 29 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 26 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 22 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 10 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 12 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 287 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 306 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.609 - **Upper Limit:** - **Value:** -1.544 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.575 - **Upper Limit:** - **Value:** -3.876 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.746 - **Upper Limit:** - **Value:** -1.855 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.679 - **Upper Limit:** - **Value:** -4.054 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.800 - **Upper Limit:** - **Value:** -2.673 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.735 - **Upper Limit:** - **Value:** -4.796 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.616 - **Upper Limit:** - **Value:** -0.587 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.613 - **Upper Limit:** - **Value:** -3.231 **Title:** #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.018 - **Upper Limit:** - **Value:** 0.027 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.016 - **Upper Limit:** - **Value:** 0.093 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.023 - **Upper Limit:** - **Value:** 0.036 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.021 - **Upper Limit:** - **Value:** 0.090 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.019 - **Upper Limit:** - **Value:** 0.048 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.018 - **Upper Limit:** - **Value:** 0.092 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.020 - **Upper Limit:** - **Value:** 0.020 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.018 - **Upper Limit:** - **Value:** 0.059 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.016 - **Upper Limit:** - **Value:** 0.047 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.016 - **Upper Limit:** - **Value:** 0.072 **Title:** #### Outcome Measure 7 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.533 - **Upper Limit:** - **Value:** 1.410 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.498 - **Upper Limit:** - **Value:** 3.480 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.648 - **Upper Limit:** - **Value:** 1.768 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.594 - **Upper Limit:** - **Value:** 3.460 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.626 - **Upper Limit:** - **Value:** 2.606 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.576 - **Upper Limit:** - **Value:** 3.651 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.642 - **Upper Limit:** - **Value:** 1.678 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.586 - **Upper Limit:** - **Value:** 2.662 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.493 - **Upper Limit:** - **Value:** 2.156 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.486 - **Upper Limit:** - **Value:** 2.936 **Title:** #### Outcome Measure 8 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.024 - **Upper Limit:** - **Value:** 0.039 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.022 - **Upper Limit:** - **Value:** 0.139 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.031 - **Upper Limit:** - **Value:** 0.056 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.028 - **Upper Limit:** - **Value:** 0.120 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.029 - **Upper Limit:** - **Value:** 0.049 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.027 - **Upper Limit:** - **Value:** 0.139 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.029 - **Upper Limit:** - **Value:** 0.040 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.027 - **Upper Limit:** - **Value:** 0.088 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.022 - **Upper Limit:** - **Value:** 0.056 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.022 - **Upper Limit:** - **Value:** 0.102 **Title:** #### Outcome Measure 9 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.023 - **Upper Limit:** - **Value:** 0.030 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.021 - **Upper Limit:** - **Value:** 0.054 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.026 - **Upper Limit:** - **Value:** -0.011 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.024 - **Upper Limit:** - **Value:** 0.067 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.029 - **Upper Limit:** - **Value:** 0.046 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.027 - **Upper Limit:** - **Value:** 0.096 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.029 - **Upper Limit:** - **Value:** 0.004 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.027 - **Upper Limit:** - **Value:** 0.035 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.022 - **Upper Limit:** - **Value:** 0.031 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.021 - **Upper Limit:** - **Value:** 0.058 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** COPD exacerbation: an increase in COPD symptoms that necessitated any change in baseline medication (bronchodilators,anti-inflammatory agents, antibiotics, supplemental oxygen therapy, etc.).Hospitalization: any inpatient admission or any emergency department visit \> 24 hours in duration. Hospice was considered hospitalization.COPD exacerbation related hospitalization: hospitalization that was due to 1) COPD exacerbation or 2) a COPD exacerbation preceded, or occurred concomitantly with the onset of, the event for which the subject was hospitalized.Respiratory-related death: For each death the Primary Investigator designated a 'probable cause', which was the primary condition that precipitated the terminal events that were the immediate cause of death. If a probable cause could not be ascertained, the cause of death was considered 'UNKNOWN'. Cause other than 'UNKNOWN' was categorized as either respiratory or non-respiratory. Deaths of 'UNKNOWN' cause were counted as primary events. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication. **Reporting Status:** POSTED **Time Frame:** 0-12 months **Title:** Time From Randomization to Respiratory Death or First COPD Exacerbation Related Hospitalization (Whichever Occurs First). **Type:** PRIMARY **Type Units Analyzed:** Subjects with Primary Event **Unit of Measure:** Days ##### Group **Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms. **ID:** OG000 **Title:** Experimental: Arformoterol 15 Mcg Twice Daily ##### Group **Description:** Placebo twice daily **ID:** OG001 **Title:** Placebo #### Outcome Measure 2 **Description:** A protocol-defined exacerbation of COPD was defined as an increase in respiratory symptoms (classically, increased shortness of breath, increased sputum production, and/or increased sputum purulence) that necessitates any change in baseline medication other than bronchodilators (e.g., anti-inflammatory agents, antibiotics, supplemental oxygen therapy, etc) or causes the subject to require additional medical attention (i.e., emergency room visit or hospitalization). **Parameter Type:** NUMBER **Population Description:** Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication. **Reporting Status:** POSTED **Time Frame:** 0-12 months **Title:** The Incidence of Protocol Defined COPD Exacerbations. **Type:** SECONDARY **Unit of Measure:** participants ##### Group **Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms. **ID:** OG000 **Title:** Placebo Comparator: Placebo Twice Daily ##### Group **Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms. **ID:** OG001 **Title:** Experimental: Arformoterol 15 Mcg Twice Daily #### Outcome Measure 3 **Description:** Survival status at the end of the study will be determined for each subject. The proportion of subjects dead and the annual event rate will be summarized by treatment. **Parameter Type:** NUMBER **Population Description:** Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication. **Reporting Status:** POSTED **Time Frame:** 0-12 months **Title:** The Incidence of All Cause Mortality **Type:** SECONDARY **Unit of Measure:** participants ##### Group **Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms. **ID:** OG000 **Title:** Placebo Comparator: Placebo Twice Daily ##### Group **Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms. **ID:** OG001 **Title:** Experimental: Arformoterol 15 Mcg Twice Daily #### Outcome Measure 4 **Description:** TEAEs were defined as: 1) adverse events that occurred on or after the date of first dose of study medication, 2) adverse events with a missing start date and a stop date on or after the date of first does of study medication, or 3) adverse events with both a missing start and stop date. The frequency and percentage of subjects with TEAEs were summarized. At each level of summarization, a subject was counted only once for each AE he/she experienced within that level. The percentage of subjects having had at least 1 AE at each level was calculated. **Parameter Type:** NUMBER **Population Description:** Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication. **Reporting Status:** POSTED **Time Frame:** 0-12 months **Title:** The Incidence of Treatment Emergent AEs **Type:** SECONDARY **Unit of Measure:** participants ##### Group **Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms. **ID:** OG000 **Title:** Placebo Comparator: Placebo Twice Daily ##### Group **Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms. **ID:** OG001 **Title:** Experimental: Arformoterol 15 Mcg Twice Daily #### Outcome Measure 5 **Description:** The SGRQ assessed health status and consisted of 3 component scores (Symptoms, Activity, and Impacts) as well as a total score. Items were scored in accordance with the developer's guidelines. Scores were expressed as a percentage of overall impairment, where 100 represented worst possible health status and 0 indicated best possible health status. The SGRQ was assessed pre-dose at baseline, months 3, 6 and 12 or the end of study (EOS). Visit 2 was defined as baseline. A change from baseline in the Total Score of ≥ 4 units is considered the minimal clinically important difference (MCID) for SGRQ. **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication. **Reporting Status:** POSTED **Time Frame:** Baseline and on treatment at months 3, 6 and 12 (or early termination) **Title:** SGRQ: Mean Change From Baseline in Total Score **Type:** SECONDARY **Unit of Measure:** Score ##### Group **Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms. **ID:** OG000 **Title:** Placebo Comparator: Placebo Twice Daily ##### Group **Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms. **ID:** OG001 **Title:** Experimental: Arformoterol 15 Mcg Twice Daily #### Outcome Measure 6 **Description:** FEV1 was measured at Visit 1 (screening), pre- and post-albuterol administration for reversibility testing, pre-dose at baseline, months 3, 6, 9 and 12/EOS. The best FEV1 from at least 3 acceptable maneuvers was recorded. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last FEV1 value obtained prior to first treatment was used for baseline. **Dispersion Type:** Standard Error **Parameter Type:** MEAN **Population Description:** Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication. **Reporting Status:** POSTED **Time Frame:** Baseline and on treatments at months 3, 6, 9 and 12 (or early termination) **Title:** FEV1: Mean Change From Baseline **Type:** SECONDARY **Unit of Measure:** Liter ##### Group **Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms. **ID:** OG000 **Title:** Placebo Comparator: Placebo Twice Daily ##### Group **Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms. **ID:** OG001 **Title:** Experimental: Arformoterol 15 Mcg Twice Daily #### Outcome Measure 7 **Description:** Percent predicted FEV1: measured FEV1 as a percent of the "predicted values" for the patients of similar characteristics (height, age, sex, and sometimes race and weight). Best FEV1 percent predicted was measured at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS, as described for FEV1. **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication. **Reporting Status:** POSTED **Time Frame:** Baseline and on treatments at months 3, 6, 9 and 12 (or early termination) **Title:** Percent Predicted FEV1: Mean Change From Baseline **Type:** SECONDARY **Unit of Measure:** Liter ##### Group **Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms. **ID:** OG000 **Title:** Placebo Comparator: Placebo Twice Daily ##### Group **Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms. **ID:** OG001 **Title:** Experimental: Arformoterol 15 Mcg Twice Daily #### Outcome Measure 8 **Description:** Forced Vital capacity: the volume of air that can forcibly be blown out after full inspiration. Best FVC was measured at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS. The best FVC from at least 3 acceptable maneuvers was recorded. **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication. **Reporting Status:** POSTED **Time Frame:** Baseline and on treatment at months 3, 6, 9 and 12 (or early termination) **Title:** Forced Vital Capacity (FVC): Mean Change From Baseline **Type:** SECONDARY **Unit of Measure:** Liter ##### Group **Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms. **ID:** OG000 **Title:** Placebo Comparator: Placebo Twice Daily ##### Group **Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms. **ID:** OG001 **Title:** Experimental: Arformoterol 15 Mcg Twice Daily #### Outcome Measure 9 **Description:** IC: the total amount of air that can be drawn into the lungs after normal expiration. IC was measured pre- and post-albuterol administration at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS. IC maneuvers were done in triplicate. The mean of all recorded IC values was used for each subject at each time point. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last IC value obtained prior to first treatment dose was used for baseline. **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication. **Reporting Status:** POSTED **Time Frame:** Baseline and on treatment at months 3, 6, 9 and 12 (or early termination) **Title:** Inspiratory Capacity (IC): Mean Change From Baseline **Type:** SECONDARY **Unit of Measure:** Liter ##### Group **Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms. **ID:** OG000 **Title:** Placebo Comparator: Placebo Twice Daily ##### Group **Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms. **ID:** OG001 **Title:** Experimental: Arformoterol 15 Mcg Twice Daily ### Participant Flow Module #### Group **Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms. **ID:** FG000 **Title:** Placebo Twice Daily #### Group **Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms. **ID:** FG001 **Title:** Arformoterol 15 Mcg Twice Daily #### Period **Title:** Overall Study ##### Withdraw **Type:** Adverse Event ###### Reason **Group ID:** FG000 **Number of Subjects:** 53 ###### Reason **Group ID:** FG001 **Number of Subjects:** 55 ##### Withdraw **Type:** Lack of Efficacy ###### Reason **Group ID:** FG000 **Number of Subjects:** 7 ###### Reason **Group ID:** FG001 **Number of Subjects:** 4 ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 19 ###### Reason **Group ID:** FG001 **Number of Subjects:** 15 ##### Withdraw **Type:** Physician Decision ###### Reason **Group ID:** FG000 **Number of Subjects:** 8 ###### Reason **Group ID:** FG001 **Number of Subjects:** 2 ##### Withdraw **Type:** Protocol Violation ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ###### Reason **Group ID:** FG001 **Number of Subjects:** 5 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 116 ###### Reason **Group ID:** FG001 **Number of Subjects:** 80 ##### Withdraw **Type:** Site Ceasing Operation ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ###### Reason **Group ID:** FG001 **Number of Subjects:** 2 ##### Withdraw **Type:** Medical Monitor Decision ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ##### Withdraw **Type:** Noncompliance ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ##### Withdraw **Type:** Randomized in error ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 421 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 420 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 211 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 255 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 210 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 165 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT01791179 **Acronym:** CADRE **Brief Title:** Carolina Alcohol and Drug Resources **Official Title:** Carolina Alcohol and Drug Resources #### Organization Study ID Info **ID:** Pro00042125 #### Organization **Class:** OTHER **Full Name:** Duke University #### Secondary ID Infos **ID:** 1H79TI024350-01 **Link:** https://reporter.nih.gov/quickSearch/1H79TI024350-01 **Type:** SAMHSA ### Status Module #### Completion Date **Date:** 2018-01-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-02-28 **Type:** ACTUAL **Last Update Submit Date:** 2018-02-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-10-30 **Type:** ACTUAL #### Start Date **Date:** 2013-02 **Type:** ACTUAL **Status Verified Date:** 2018-02 #### Study First Post Date **Date:** 2013-02-13 **Type:** ESTIMATED **Study First Submit Date:** 2013-02-12 **Study First Submit QC Date:** 2013-02-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Duke University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** Substance abuse is highly prevalent among individuals with HIV and associated with negative outcomes including poorer medication adherence and HIV risk behavior. The primary aim of this project is to address substance abuse among individuals with or at high-risk for HIV by enhancing and expanding the substance abuse services provided in the formerly Substance Abuse and Mental Health Services Administration (SAMHSA) funded Carolinas Alcohol and Drug Expansion Team (CADET) program, which offered comprehensive substance abuse care for individuals with HIV living primarily in the Durham NC area. Services will be enhanced by adding peer outreach and navigation services to improve treatment engagement and participation and expanded to replicate the enhanced CADET service model in Charlotte NC. The target population for this project is minority individuals, primarily African-Americans, with HIV or at high-risk for HIV with a particular focus on minority men who have sex with men (MSM)s. The program will provide up to 18 months of comprehensive services for approximately 315 individuals and will include: 1) peer outreach to facilitate and enhance treatment engagement 2) individual and group substance abuse treatment using evidence-based models 3) ongoing recovery groups for individuals who have completed the intensive substance abuse treatment phase and 4) linkage to needed services such as case management, psychiatric care, and HIV/Hepatitis medical care. We will also target HIV and Hepatitis C testing and treatment services for minority MSM of unknown HIV status to increase access and utilization of substance use services and identify HIV and Hepatitis status. The study evaluation will involve analysis of participant survey data gathered at baseline, 6, 12, 18 months of study participation to determine the effect of the comprehensive substance abuse care services on outcomes for individuals with HIV including substance use, mental health, HIV treatment adherence, HIV risk behavior, and access and utilization of HIV services. The study will also determine the effect of the comprehensive substance use program on substance abuse, mental health, and risk behavior outcomes for minority MSM who are not HIV-positive. ### Conditions Module **Conditions:** - HIV ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 306 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Comprehensive substance abuse services **Label:** Substance Abuse Treatment Group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Substance Abuse Treatment Group **Name:** Comprehensive substance abuse services **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Substance use information will be collected at baseline, 6, and 12 months through surveys using standardized substance use measures including the Addiction Severity Index (ASI). **Measure:** Change in substance use **Time Frame:** 12 months #### Secondary Outcomes **Description:** HIV medication adherence data will be collected at baseline, 6, and 12 months through surveys using standardized adherence measures in the visual analog scale and CASE adherence measure. **Measure:** Change in medication adherence **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * HIV-positive or minority MSM * substance abuse * 18 or over Exclusion Criteria: * Under 18 * cognitive impairment that would preclude participation in substance abuse treatment **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Durham **Country:** United States **Facility:** Duke University **State:** North Carolina **Zip:** 27705 #### Overall Officials **Official 1:** **Affiliation:** Duke University **Name:** Susan S. Reif, PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** Related Info **URL:** http://chpir.org ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M3522 - Name: Acquired Immunodeficiency Syndrome - Relevance: LOW - As Found: Unknown - ID: M18250 - Name: HIV Infections - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00307879 **Brief Title:** Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion **Official Title:** Phase 2 MAGIC Cell (Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion) Trial #### Organization Study ID Info **ID:** SNUH-MAGIC1 #### Organization **Class:** OTHER **Full Name:** Seoul National University Hospital ### Status Module #### Completion Date **Date:** 2005-02 #### Expanded Access Info #### Last Update Post Date **Date:** 2006-03-28 **Type:** ESTIMATED **Last Update Submit Date:** 2006-03-27 **Overall Status:** TERMINATED #### Start Date **Date:** 2004-03 **Status Verified Date:** 2004-03 #### Study First Post Date **Date:** 2006-03-28 **Type:** ESTIMATED **Study First Submit Date:** 2006-03-27 **Study First Submit QC Date:** 2006-03-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Seoul National University Hospital ### Description Module **Brief Summary:** This trial was performed to evaluate the safety and the efficacy of G-CSF based stem cell therapy in patients with AMI. MAGIC Cell-1 trial enrolled patients with acute and old myocardial infarction, and had two groups of cell infusion, and G-CSF alone. MAGIC Cell-2 trial enrolled patients with acute myocardial infarction presented within 12 hours after onset of chest pain who underwent successful primary PCI. We randomized patients into the G-CSF group and the control group. **Detailed Description:** We compared intra-coronary infusion of the mobilized PBSCs with G-CSF (n=10) and mobilization alone with G-CSF (n=10) in patients with myocardial infarction in MAGIC Cell -1 trial and G-CSF alone (n=6) and control (n=6) in MAGIC Cell-2 trial. This study was a randomized, controlled phase II clinical trial. The Institutional Review Board of Seoul National University Hospital approved the study protocol. The informed written consents were obtained from patients after explaining the procedure and risk. This study consisted of 2 sub-studies; MAGIC Cell (Myocardial Regeneration and Angiogenesis in Myocardial Infarction with G-CSF and Intra-Coronary Stem Cell Infusion)-1 and 2 trial. In brief, MAGIC Cell-1 trial enrolled patients with acute and old myocardial infarction, and had two groups of cell infusion, and G-CSF alone. PBSCs were mobilized by daily subcutaneous injections of G-CSF (Dong-A pharmaceutical, Seoul, Korea) with 10 g/kg body weight for four days before percutaneous coronary intervention (PCI). After completion of G-CSF injection, all patients underwent PCI and implantation of stents for the culprit lesion of infarct related artery. Immediately after PCI, patients in the cell infusion group received intra-coronary infusion of the collected PBSC, which were mobilized and collected before PCI. The enrollment of patients to MAGIC Cell-1 trial was terminated prematurely due to potential adverse reaction of increased restenosis. However, follow up of the enrolled patients were completed until 1 year as scheduled. MAGIC Cell-2 trial enrolled patients with acute myocardial infarction presented within 12 hours after onset of chest pain who underwent successful primary PCI. We randomized patients into the G-CSF group and the control group. The patients in the G-CSF group received G-CSF of 10 g/kg body weight for four days at least 24hours after primary PCI. The enrollment of patients to MAGIC Cell-2 trial was also terminated prematurely due to potential adverse reaction of increased restenosis reported in MAGIC Cell-1 trial. However, follow up of the enrolled patients were also completed until 1 year as scheduled ### Conditions Module **Conditions:** - Myocardial Infarction **Keywords:** - Myocardial infarction - revascularization - granulocyte colony stimulating factor (G-CSF) ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** Drug: G-CSF (Dong-A pharmaceutical, Seoul, Korea) **Type:** DRUG #### Intervention 2 **Name:** collection of mobilized peripheral blood stem cells **Type:** PROCEDURE #### Intervention 3 **Name:** Intracoronary infusion of mobilized cells **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** the change in left ventricular ejection fraction, measured by SPECT, echocardiography #### Secondary Outcomes **Measure:** changes in left ventricular volume by SPECT, echocardiography **Measure:** the development of major adverse cardiac events ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * MAGIC Cell-1 trial enrolled patients with acute and old myocardial infarction * MAGIC Cell-2 trial enrolled patients with acute myocardial infarction presented within 12 hours after onset of chest pain who underwent successful primary PCI. Exclusion Criteria: * Persistent severe heart failure (above Killip class II or LVEF \< 25 %) * Uncontrolled myocardial ischemia or ventricular tachycardia * Culprit lesion of infarct related artery not feasible for PCI or unsuccessful PCI * Age \> 75 years * Malignancy * Serious current infection or hematologic disease * Life expectancy under one year. **Maximum Age:** 80 Years **Minimum Age:** 0 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Seoul National University Hospital, Yon-Gon Dong, Chongno-Gu **Zip:** 110-744 #### Overall Officials **Official 1:** **Affiliation:** Associated Professor of Seoul National University Hospital **Name:** Hyo-Soo Kim, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Kang HJ, Kim HS, Zhang SY, Park KW, Cho HJ, Koo BK, Kim YJ, Soo Lee D, Sohn DW, Han KS, Oh BH, Lee MM, Park YB. Effects of intracoronary infusion of peripheral blood stem-cells mobilised with granulocyte-colony stimulating factor on left ventricular systolic function and restenosis after coronary stenting in myocardial infarction: the MAGIC cell randomised clinical trial. Lancet. 2004 Mar 6;363(9411):751-6. doi: 10.1016/S0140-6736(04)15689-4. **PMID:** 15016484 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007511 - Term: Ischemia - ID: D000010335 - Term: Pathologic Processes - ID: D000009336 - Term: Necrosis - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12155 - Name: Myocardial Infarction - Relevance: HIGH - As Found: Myocardial Infarction - ID: M10282 - Name: Infarction - Relevance: HIGH - As Found: Infarction - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M12284 - Name: Necrosis - Relevance: LOW - As Found: Unknown - ID: M6546 - Name: Coronary Artery Disease - Relevance: LOW - As Found: Unknown - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009203 - Term: Myocardial Infarction - ID: D000007238 - Term: Infarction ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1945 - Name: Lenograstim - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02519179 **Acronym:** OBS-II **Brief Title:** Influence of Bottle-Type of Infant Feeding Behavior #### Organization Study ID Info **ID:** 00000 #### Organization **Class:** OTHER **Full Name:** California Polytechnic State University-San Luis Obispo ### Status Module #### Completion Date **Date:** 2018-08 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-10-09 **Type:** ACTUAL **Last Update Submit Date:** 2018-10-08 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-09 **Type:** ACTUAL #### Start Date **Date:** 2015-06 **Type:** ACTUAL **Status Verified Date:** 2018-01 #### Study First Post Date **Date:** 2015-08-10 **Type:** ESTIMATED **Study First Submit Date:** 2015-08-05 **Study First Submit QC Date:** 2015-08-06 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** California Polytechnic State University-San Luis Obispo #### Responsible Party **Investigator Affiliation:** California Polytechnic State University-San Luis Obispo **Investigator Full Name:** Alison Ventura **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The objective this research is to conduct a within-subject, experimental study that will describe mothers' feeding practices during typical bottle-feeding conditions and will examine whether removal of visual cues related to the amount of milk/formula in the bottle will alter these feeding practices. The investigators hypothesize that mothers will show higher levels of infant-directed feeding practices and lower levels of mother-directed feeding practices when using opaque, weighted bottles compared to when using standard, clear bottles. The investigators also hypothesize that infants will consume less breast milk or formula when fed from opaque, weighted bottles compared to when fed from standard, clear bottles. ### Conditions Module **Conditions:** - Bottle Feeding ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** This is a within-subject study; mothers are observed during both feeding conditions. ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 48 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This is a within-subject experiment; mothers will be asked to feed their infants from a clear, conventional bottle during one visit and an opaque, weighted bottle during the other visit. Order of conditions will be counterbalanced. **Intervention Names:** - Behavioral: Opaque, weighted bottle - Behavioral: Clear, conventional bottle **Label:** Conventional vs. Opaque, Weighted Bottle **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Conventional vs. Opaque, Weighted Bottle **Description:** This is the experimental condition; mothers will be asked to feed their infants from an opaque, weighted bottle. **Name:** Opaque, weighted bottle **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Conventional vs. Opaque, Weighted Bottle **Description:** This is the control condition; mothers will be asked to feed their infants from a clear, conventional bottle. **Name:** Clear, conventional bottle **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Infant intake within a feeding (mL) assessed by weighing the bottle before and after a feeding. **Measure:** Infant intake **Time Frame:** 3-hour period **Description:** Maternal responsiveness to infant cues during a feeding assessed by Nursing Child Assessment Satellite Training Parent-Child Interaction Feeding Scale. **Measure:** Maternal responsiveness **Time Frame:** 3-hour period #### Secondary Outcomes **Description:** Maternal perception/acceptance of the bottles during a feeding assessed through a mixed methods interview. **Measure:** Maternal acceptance/perception of intervention **Time Frame:** 3-hour period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Mothers must be 18 years or older * Infants must be between 0-6 months of age * Infants must be prior to the introduction of solid foods Exclusion Criteria: * Preterm birth * Medical conditions that interfere with feeding **Healthy Volunteers:** True **Maximum Age:** 6 Months **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** San Luis Obispo **Country:** United States **Facility:** California Polytechnic State University **State:** California **Zip:** 93401 #### Overall Officials **Official 1:** **Affiliation:** Assistant Professor **Name:** Alison K Ventura, PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Ventura AK, Pollack Golen R. A pilot study comparing opaque, weighted bottles with conventional, clear bottles for infant feeding. Appetite. 2015 Feb;85:178-84. doi: 10.1016/j.appet.2014.11.028. Epub 2014 Nov 28. **PMID:** 25445988 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03153579 **Acronym:** LSD-assist **Brief Title:** LSD Treatment in Persons Suffering From Anxiety Symptoms in Severe Somatic Diseases or in Psychiatric Anxiety Disorders **Official Title:** LSD Treatment in Persons Suffering From Anxiety Symptoms in Severe Somatic Diseases or in Psychiatric Anxiety Disorders: a Randomized, Double-blind, Placebo-controlled Phase II Study #### Organization Study ID Info **ID:** BASEC 2016-00992 #### Organization **Class:** OTHER **Full Name:** University Hospital, Basel, Switzerland ### Status Module #### Completion Date **Date:** 2021-12-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-12-22 **Type:** ACTUAL **Last Update Submit Date:** 2021-12-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-12-15 **Type:** ACTUAL #### Start Date **Date:** 2017-06-23 **Type:** ACTUAL **Status Verified Date:** 2021-12 #### Study First Post Date **Date:** 2017-05-15 **Type:** ACTUAL **Study First Submit Date:** 2017-05-09 **Study First Submit QC Date:** 2017-05-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Basel, Switzerland #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Background: Lysergic acid diethylamide (LSD) was extensively investigated in humans in the 1950s and 1960s. Particularly, LSD attenuated anxiety in patients with cancer. Clinical research with LSD ended in the 1970s due to regulatory restrictions but its use for personal and recreational purposes continued. In recent years, there has been a renewed interest in the use hallucinogens in psychiatric research and practices. LSD and psilocybin were reused in experimental studies in healthy subjects and in the treatment for anxiety in patients with life-threatening diseases. Specifically, a pilot study documented that LSD can be used safely and may reduce anxiety in these patients. Larger well-designed and placebo-controlled studies are warranted. Similar studies have recently been completed with the hallucinogen psilocybin. Objective: To test the efficacy of LSD in patients with anxiety with or without life-threatening diseases. Design: Double-blind, placebo-controlled random-order cross-over trial using two LSD (200 µg) and two placebo sessions with subjects acting as their own control. Participants: 40 patients aged \> 25 years with anxiety disorder (according to DSM-IV or a state-trait anxiety inventory score \>40 in the STAI trait or state scale) with or without life-threatening illness. Main outcome measures: Reduction in anxiety (STAI), depression (Hamilton depression rating scale, HDRS and Beck depression inventory, BDI), and general psychopathological symptoms (Symptom Check List 90 items, SCL-90) at 2, 8, and 16 weeks after LSD- compared with placebo-assisted psychotherapy. Significance: Anxiety disorder (alone or in the context of life-threatening illness) is frequent and often insufficiently managed with available medications. This study will evaluate the potential benefits of single treatments with LSD in anxiety disorder. ### Conditions Module **Conditions:** - Patients - Anxiety Disorders ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** randomized, double-blind, placebo-controlled, crossover ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** randomized, double-blind, placebo-controlled, crossover **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 46 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo or lysergic acid diethylamide (LSD) **Intervention Names:** - Drug: Placebo **Label:** Placebo, LSD **Type:** OTHER #### Arm Group 2 **Description:** Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo or lysergic acid diethylamide (LSD) **Intervention Names:** - Drug: LSD **Label:** LSD, Placebo **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - LSD, Placebo **Description:** Lysergic Acid Diethylamide 200ug per os, single dose **Name:** LSD **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo, LSD **Description:** Capsules containing mannitol looking identical to LSD **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Reduction in anxiety assessed by questionnaires (STAI) 16 weeks after LSD compared with placebo **Measure:** Reduction in anxiety assessed by questionnaires **Time Frame:** 16 weeks post-intervention #### Secondary Outcomes **Description:** Reduction in depression will be assessed by questionnaires (HDRS, BDI) 2, 8 and 16 weeks after LSD compared with placebo **Measure:** Reduction in Depression assessed by questionnaires **Time Frame:** 2, 8 and 16 weeks post-intervention **Description:** Reduction in anxiety will be assessed by questionnaire (STAI) 2 and 8 weeks after LSD compared with placebo **Measure:** Reduction in anxiety assessed by questionnaires **Time Frame:** 2 and 8 weeks post-intervention **Description:** Reduction of psychopathological symptoms will be assessed by questionnaire (SCL-90) 2, 8, and 16 weeks after LSD compared with placebo **Measure:** Reduction of psychopathological symptoms assessed by questionnaires **Time Frame:** 2, 8 and 16 weeks post-intervention **Description:** Follow-up using different questionnaires to compare (within-subject) the 52-week response with Responses from baseline and 16-weeks. **Measure:** Sustained Response assessed by questionnaires **Time Frame:** 52 weeks post intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age \> 25 years. 2. Meet DSM-IV criteria for anxiety disorder as indicated by the Structured Clinical Interview for the DSM (SCID)-IV or have a score of at least 40 on the state- or trait STAI scale at study inclusion. 3. 40% or more of the participants should have a diagnosis of advanced-stage potentially fatal illness (autoimmune, neurological, or cancer without central nervous system (CNS) involvement). Patients should be ambulatory and not terminal and likely to have a roughly estimated life expectancy of \> twelve months. 4. Patients without advanced-stage potentially fatal illness need to meet DSM-IV criteria for anxiety disorder (elevated STAI score not sufficient for inclusion) 5. Sufficient understanding of the study procedures and risks associated with the study. 6. Participants must be willing to adhere to the study procedures and sign the consent form. 7. Participants are willing to refrain from taking any psychiatric medications during the experimental session period. If they are being treated with antidepressants or are taking anxiolytic medications on a fixed daily regimen such drugs must be discontinued long enough before the LSD/placebo treatment session to avoid the possibility of a drug-drug interaction (the interval will be at least 5 times the particular drug's half-life \[typically 3-7 days\]). 8. If in ongoing psychotherapy, those recruited into the study may continue to see their outside therapist, provided they sign a release for the investigators to communicate directly with their therapist. Participants should not change therapists, increase or decrease the frequency of therapy or commence any new type of therapy during the study (not including the follow-up). 9. Participants must also refrain from the use of any psychoactive drugs, with the exception of the long term pain medication or caffeine or nicotine, within 24 hours of each LSD/placebo treatment session. They must agree not to use nicotine for at least 2 hours before and 6 hours after each dose of LSD. They must agree to not ingest alcohol-containing beverages for at least 1 day before each LSD treatment session. Non-routine medications for treating breakthrough pain taken in the 24 hours before the LSD treatment session may result in rescheduling the treatment session to another date, with the decision at the discretion of the investigators after discussion with the participant. 10. Participants must be willing not to drive a traffic vehicle or to operate machines within 24 h after LSD/placebo administration. Exclusion Criteria: 1. Women who are pregnant or nursing, or of child bearing potential and are not practicing an effective means of birth control (double-barrier method, i.e. pill/intrauterine device and preservative/diaphragm). 2. Past or present diagnosis of a primary psychotic disorder. Subjects with a first degree relative with psychotic disorders are also excluded. 3. Past or present bipolar disorder (DSM-IV) 4. Current substance use disorder (within the last 2 months, DSM-V, except nicotine) 5. Somatic disorders including central nervous system (CNS) involvement of the cancer, severe cardiovascular disease, untreated hypertension, severe liver disease (liver enzymes increase by more than 5 times the upper limit or normal) or severely impaired renal function (estimated creatinine clearance \<30 ml/min), or other that in the judgement of the investigators pose too great potential for side effects 6. Weight \< 45 kg 7. Suicide risk or likely to require psychiatric hospitalization during the course of the study 8. Requiring ongoing concomitant therapy with a psychotropic drug (other than as needed, anxiety medications, and pain control medications) and unable or unwilling to comply with the washout period. **Minimum Age:** 25 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Basel **Country:** Switzerland **Facility:** University Hospital Basel **State:** BS **Zip:** 4056 **Location 2:** **City:** Solothurn **Country:** Switzerland **Facility:** Private Practice P.Gasser **State:** SO **Zip:** 4500 #### Overall Officials **Official 1:** **Affiliation:** Private Practice **Name:** Peter Gasser, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety Disorder - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001008 - Term: Anxiety Disorders ### Intervention Browse Module - Browse Branches - Abbrev: NaAg - Name: Natriuretic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PsychDr - Name: Psychotropic Drugs ### Intervention Browse Module - Browse Leaves - ID: M11342 - Name: Mannitol - Relevance: LOW - As Found: Unknown - ID: M11231 - Name: Lysergic Acid Diethylamide - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00474279 **Acronym:** MOT089 **Brief Title:** Effects of an Oral GH Secretagogue (MK-677) on Body Composition and Functional Ability of Older Adults **Official Title:** Effects of an Oral GH Secretagogue (MK-677) on Body Composition and Functional Ability of Older Adults #### Organization Study ID Info **ID:** HIC #7444 #### Organization **Class:** OTHER **Full Name:** University of Virginia #### Secondary ID Infos **ID:** NIH RO1 DK32632 ### Status Module #### Completion Date **Date:** 2004-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2007-05-16 **Type:** ESTIMATED **Last Update Submit Date:** 2007-05-15 **Overall Status:** COMPLETED #### Start Date **Date:** 1998-07 **Status Verified Date:** 2007-05 #### Study First Post Date **Date:** 2007-05-16 **Type:** ESTIMATED **Study First Submit Date:** 2007-05-15 **Study First Submit QC Date:** 2007-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Virginia ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to determine whether treatment of healthy older men and women with oral MK-677 for 12 months will enhance pulsatile GH release and increase mean GH and IGF-I concentrations into the range of young adults and will have favorable effects on body composition and functional ability on older adults. **Detailed Description:** This is a two year, double-blind, placebo-controlled cross-over trial of once daily administration of MK-677, an oral GH secretagogue, to healthy older adults. During the first year, subjects will be randomized to MK-677 or placebo treatment. In each of three subgroups of subjects (men, women off and women on hormone replacement therapy), 16 subjects will receive MK-677 and 8 will receive placebo. After 1 year, the subjects who received placebo will be switched to MK-677 treatment; the subjects who received MK-677 for the first year will be randomized to either placebo or MK-677 for the second year of the study.The study will test changes in GH, IGF-I, body composition and function. ### Conditions Module **Conditions:** - Aging **Keywords:** - Growth hormone secretagogue - Body composition - Functional ability - Aging - Sarcopenia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** DOUBLE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 72 **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** Orally active growth hormone secretagogue (MK-677) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** At 12 months: 24-hour mean growth hormone concentrations **Measure:** Insulin-like growth factor-I concentrations **Measure:** Body weight and fat mass, specifically abdominal visceral fat **Measure:** Fat-free mass **Measure:** Safety determined by routine laboratory tests at 1 to 3 month intervals, yearly pap smears and mammograms #### Secondary Outcomes **Measure:** at 12 months: Growth hormone secretory dynamics **Measure:** Isokinetic muscle strength (knee and shoulder) **Measure:** Thigh muscle cross-sectional area **Measure:** Function tests (timed walks, stair climb, chair rise) **Measure:** Quality of life assessments **Measure:** Insulin sensitivity **Measure:** Lipid profile **Measure:** Resting metabolic rate **Measure:** Aerobic exercise capacity **Measure:** Exploratory outcomes: **Measure:** effects of gender and HRT on primary outcomes **Measure:** effects of treatment in year 2: Year 2 outcomes include effects of continuation on MK-677, or crossover to placebo, placebo to MK-677 **Measure:** bone mineral density at end of year 2. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy men and women  60 years of age, with a body mass index of \< 35 kg/m2. Exclusion Criteria: * Medication known to affect GH secretion, other than estrogen replacement therapy * Coronary artery disease, * Congestive heart failure, * Peripheral vascular disease, * Diabetes mellitus (requiring insulin or an oral hypoglycemic agent), * Significant hypertension (BP \>180 systolic or \>100 diastolic at rest); * Renal, hepatic, pulmonary disease; * Untreated hypothyroidism, untreated hyperthyroidism; * History of seizure disorder; * History of malignancy (other than some skin cancers), history of active chronic infections (e.g., HIV, tuberculosis). * Hematocrit \< 40%, men, \< 36%, women * History of daily tobacco use within past 3 months * Chronic alcohol abuse * Strenuous exercise for average of more than 60 min/day * Investigational drug within past 6 weeks * Psychiatric history, especially anorexia nervosa * Transmeridian travel within 2 weeks prior to or during study **Healthy Volunteers:** True **Minimum Age:** 60 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Charlottesville **Country:** United States **Facility:** University of Virginia **State:** Virginia **Zip:** 22908 #### Overall Officials **Official 1:** **Affiliation:** University of Virginia **Name:** Michael O. Thorner, MBBS, DSc, **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Chapman IM, Bach MA, Van Cauter E, Farmer M, Krupa D, Taylor AM, Schilling LM, Cole KY, Skiles EH, Pezzoli SS, Hartman ML, Veldhuis JD, Gormley GJ, Thorner MO. Stimulation of the growth hormone (GH)-insulin-like growth factor I axis by daily oral administration of a GH secretogogue (MK-677) in healthy elderly subjects. J Clin Endocrinol Metab. 1996 Dec;81(12):4249-57. doi: 10.1210/jcem.81.12.8954023. **PMID:** 8954023 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M28396 - Name: Sarcopenia - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9789 - Name: Hormones - Relevance: HIGH - As Found: Loss - ID: M1985 - Name: Secretagogues - Relevance: HIGH - As Found: Dormicum - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000006728 - Term: Hormones - ID: D000078604 - Term: Secretagogues ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02152579 **Brief Title:** Efficacy and Safety of Monocordil Manufactured by Laboratórios Baldacci **Official Title:** Open Monocentric Clinical Study for the Evaluation of Efficacy and Safety of 20 mg Monocordil Tablets Manufactured by Laboratórios Baldacci in Patients With Stable Angina #### Organization Study ID Info **ID:** ATC 001/14 #### Organization **Class:** INDUSTRY **Full Name:** Laboratórios Baldacci S.A ### Status Module #### Completion Date **Date:** 2014-10 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** NOT_YET_RECRUITING #### Last Update Post Date **Date:** 2014-06-02 **Type:** ESTIMATED **Last Update Submit Date:** 2014-05-30 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2014-09 **Type:** ESTIMATED #### Start Date **Date:** 2014-07 **Status Verified Date:** 2014-05 #### Study First Post Date **Date:** 2014-06-02 **Type:** ESTIMATED **Study First Submit Date:** 2014-05-29 **Study First Submit QC Date:** 2014-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Laboratórios Baldacci S.A #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Phase III clinical study for the evaluation of clinic and cardiologic effects of isosorbide mononitrate from the incidence of events (angina episodes). This is an open, comparative, monocentric trial. The hypothesis, regarding the number of angina episodes, to be tested are: * H0: μD = 0 ot H0: μAfter = μBefore * HA: μD ≠ 0 ot HA: μBefore ≠ μAfter **Detailed Description:** Phase III study, monocentric, open, with a single treatment arm in patients with stable angina to evaluates efficacy and safety. The study will be sponsored by pelo Laboratórios Baldacci. All patients who participate in the study shall sign two copies of the informed consent form. The inclusion of patients is expected to last until 12 months from the approval of the Ethics Committee and ANVISA. Follow up will last at least 2 weeks for each included patient. A total of 86 patients will be recruited for this study and all of them will initiate treatment with 20 mg monocordil tablets. After 2 consecutive weeks using the investigational product (+2 days), the patients will be evaluated again, particularly for the parameters under study, this is, quantity and severity of angina episodes and adverse events. The selected patients shall also be 18-80 years old of both genders, with proved diagnosis of stable angina through clinical exams such as ECG, physical effort tests or similar. Patients will receive 20mg monocordil tablets (Baldacci Laboratories). The evaluations will take place in two opportunities: one at the visit of medical evaluation and recruitment in the study (along with the deliver of the study medication and a diary) and the second one after 2 weeks (+2 days) of use of 20mg monocordil tablets for medical evaluation and discharge of the study (return of the diary and medication accountability). ### Conditions Module **Conditions:** - Stable Angina **Keywords:** - Stable Angina ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 86 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Single treatment arm. **Intervention Names:** - Drug: Isosorbide-5-mononitrate **Label:** Isosorbide-5-mononitrate, tablet **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Isosorbide-5-mononitrate, tablet **Description:** Patients will receive 20mg monocordil tablets (Baldacci Laboratories). **Name:** Isosorbide-5-mononitrate **Other Names:** - Monocordil **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The absolute parameter of incidence of improvement will be used as primary endpoint, being considered as improvement the reduction in the number of events in 15 days, after the beginning of the intake of the study medication, and the intensity of the angina crisis **Measure:** Absolute number of episodes of angina **Time Frame:** 15 days #### Secondary Outcomes **Description:** The secondary endpoints to be used are the other parameters supplied by the diary (incidence and intensity of Adverse Events). **Measure:** Adverse events **Time Frame:** 15 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Capacity for understanding and agreement in signing the informed consent form * Age 18 between 18 and 80 years old * Have a diagnosis of stable angina, proved by ECG, test of physical effort or similar * Not being under treatment with other nitrate for stable angina * Medical indication for the use of isosorbide mononitrate (Monocordil) Exclusion Criteria: * Presence or serious comorbidities (under judgement of the investigator) * Allergy to any of the component of the investigational product * Pregnant female patients, brest feeding and/or in fertile condition who wish to get pregnant during the study and deny the use of contraceptives **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** rodrigo_modolo@yahoo.com.br **Name:** Rodrigo G Modolo, MD **Phone:** 55 19 3305 7391 **Role:** CONTACT **Contact 2:** **Email:** carsver@atcgen.com.br **Name:** Carlos Sverdloff, MSc **Phone:** 19 98121 8440 **Role:** CONTACT #### Locations **Location 1:** **City:** Campinas **Contacts:** ***Contact 1:*** - **Email:** rodrigo_modolo@yahoo.com.br - **Name:** Rodrigo G Modolo, MD - **Phone:** 55 19 3232 8524 - **Role:** CONTACT **Country:** Brazil **Facility:** Clinicordis **State:** SP **Zip:** 13076 628 #### Overall Officials **Official 1:** **Affiliation:** ATCGen **Name:** Rodrigo G Modolo, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002637 - Term: Chest Pain - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M4117 - Name: Angina Pectoris - Relevance: HIGH - As Found: Angina - ID: M29575 - Name: Angina, Stable - Relevance: HIGH - As Found: Stable Angina - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M6546 - Name: Coronary Artery Disease - Relevance: LOW - As Found: Unknown - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M5882 - Name: Chest Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000787 - Term: Angina Pectoris - ID: D000060050 - Term: Angina, Stable ### Intervention Browse Module - Ancestors - ID: D000004234 - Term: Diuretics, Osmotic - ID: D000004232 - Term: Diuretics - ID: D000045283 - Term: Natriuretic Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000014665 - Term: Vasodilator Agents - ID: D000020030 - Term: Nitric Oxide Donors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: NaAg - Name: Natriuretic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: NiOxD - Name: Nitric Oxide Donors - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: Resp - Name: Respiratory System Agents ### Intervention Browse Module - Browse Leaves - ID: M10578 - Name: Isosorbide - Relevance: HIGH - As Found: 210 - ID: M10579 - Name: Isosorbide Dinitrate - Relevance: HIGH - As Found: Urinary urgency - ID: M244430 - Name: Isosorbide-5-mononitrate - Relevance: HIGH - As Found: Urinary urgency - ID: M7411 - Name: Diuretics - Relevance: LOW - As Found: Unknown - ID: M17412 - Name: Vasodilator Agents - Relevance: LOW - As Found: Unknown - ID: M12507 - Name: Nitric Oxide - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007547 - Term: Isosorbide - ID: D000007548 - Term: Isosorbide Dinitrate - ID: C000030397 - Term: Isosorbide-5-mononitrate ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04122079 **Brief Title:** Validation of the Spanish Version of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) in Chile **Official Title:** Validation of the Spanish Version of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) in Chile #### Organization Study ID Info **ID:** 181130009 #### Organization **Class:** OTHER **Full Name:** Pontificia Universidad Catolica de Chile ### Status Module #### Completion Date **Date:** 2021-09-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-02-01 **Type:** ACTUAL **Last Update Submit Date:** 2024-01-30 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-09-30 **Type:** ACTUAL #### Start Date **Date:** 2019-01-09 **Type:** ACTUAL **Status Verified Date:** 2019-10 #### Study First Post Date **Date:** 2019-10-10 **Type:** ACTUAL **Study First Submit Date:** 2019-10-02 **Study First Submit QC Date:** 2019-10-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Pontificia Universidad Catolica de Chile #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** AIM: study the psychometric properties of the Spanish version of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), an instrument that measures psychological distress, in the Chilean population. SAMPLES: two clinical samples (1. outpatients from three psychotherapeutic centers; two university clinics and a family mental health clinic and 2. self-reported clinical) and two non-clinical (1. university students; and 2. general community) samples. Students and community nonstudent participants who reported receiving psychological or psychiatric treatment (exclusion criterion) were excluded from the non-clinical sample and classified as self-reported clinical. DATA COLLECTION: In the clinical sample, data is collected at one point if the patient is undergoing treatment and at four points (at baseline (i.e. before the first session), at 2, 5 and 8-weeks) if the patient is recruited before attending the first psychotherapy session. Participants complete a paper questionnaire in the waiting room of one of the clinics. Participants from the second university outpatient clinic and a family mental health clinic complete a digital version. At baseline, participants are presented with the CORE-OM and the Outcome Questionnaire (OQ-45). At each follow-up point, they are presented with the CORE-OM plus mental health service evaluation items. In the student and community samples, data is collected at two time points (i.e. baseline and retest). At baseline, participants are presented with the CORE-OM and OQ-45. After two weeks (i.e. retest) participants are contacted via email and presented with the CORE-OM. The application modality in the non-clinical samples is mixed: students and general community participants complete paper or digital versions of the questionnaire in the classroom or community, respectively. The digital version of the questionnaire can be accessed by clicking a Uniform Resource Locator embedded in an email/message, or by scanning a Quick Response (QR) code with a smartphone. RECRUITMENT: The clinical sample is recruited at two university outpatient clinics and a family mental health clinic of Santiago, Chile which provide services to patients of low to medium income. Patients in one of the university clinics are approached in the waiting area, and those meeting inclusion criteria, and willing to participate, fill out an informed consent before responding the questionnaire. Patients from the second university clinic/family mental health clinic are referred when booking their first appointment and contacted via email by a research team member. The student sample is recruited in classrooms of Pontificia Universidad Católica. A member of the research team presents the study and invites students to participate. Students agreeing to participate fill out an informed consent form before completing paper/digital versions of the questionnaire. The general community sample is recruited using a convenience sampling method. As in other samples, participants sign an informed consent before answering the questionnaire. ANALYSES: internal consistency, test-retest stability, convergent validity and discrimination. Clinical cut-off values will be calculated by domain and sex between the clinical and non-clinical samples and sensitivity to change will be assessed using data from the subsample of outpatients who respond an online questionnaire before their first session and at one follow up point. **Detailed Description:** The AIM is to study the psychometric properties of the Spanish version of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), an instrument that measures psychological distress, in the Chilean population. To test internal consistency, test-retest stability, convergent validity and discrimination, the CORE-OM is applied in four SAMPLES: two clinical samples (1. outpatients from three psychotherapeutic centers; two university clinics and a family mental health clinic (n=200 \~) and 2. self-reported clinical (n=200 \~)) and two non-clinical (1. university students (n=400 \~); and 2. general community (n=300\~)) samples. Students and community nonstudent participants who reported receiving psychological or psychiatric treatment (exclusion criterion) were excluded from the non-clinical sample and classified as self-reported clinical. Specific modalities of DATA COLLECTION are used for each sample. In the clinical sample, data is collected at one time point if the patient is undergoing treatment and at four time points (at baseline (i.e. before the first session), at 2 weeks (follow-up 1), at 5 weeks (follow-up 2), and at 8 weeks (follow-up 3)) if the patient is recruited before attending the first session of psychotherapy. Participants in the clinical sample complete a paper version of the questionnaire in the waiting room of one of the university outpatient clinics. Participants from the second university outpatient and family mental health clinics complete a digital version programmed in Google forms. At baseline, participants are presented with the CORE-OM, the Outcome Questionnaire (OQ-45) and a set of sociodemographic and mental health service use items. At each follow-up point they are presented with the CORE-OM plus mental health service evaluation items. In the student and community samples, data is collected at two time points (i.e. baseline and retest). At baseline, participants are presented with the CORE-OM, OQ-45 and a set of sociodemographic and mental health service use items. After two weeks (i.e. retest) participants are presented with the CORE-OM plus an item about mental health service use in the last 30 days. Student and community participants are contacted via email after 2 weeks to respond the online retest questionnaire. The application modality in the non-clinical samples is mixed: students and general community participants complete paper or digital versions of the questionnaire in the classroom or community, respectively. The digital version of the questionnaire is in surveygizmo™ and can be accessed by clicking a Uniform Resource Locator (URL) embedded in an email/message, or by scanning a Quick Response (QR) code with a smartphone. RECRUITMENT: The clinical sample is recruited at two university outpatient clinics and a family mental health clinic of Santiago, Chile all of which provide services to patients of low to medium income. Patients in one of the university clinics are approached by research assistants in the waiting area, before or after their psychotherapy/psychiatry session. Patients meeting inclusion criteria, and willing to participate, fill out an informed consent before responding the questionnaire. Patients form the second university clinic and the family mental health clinic are referred when booking their first appointment and contacted via email by a member of the research team. Questionnaire completion and responses to risk items are reviewed within 24 hours. Treating psychiatrists/psychologists are contacted via email when their patients respond "often" or "most of the time" to items signaling self-harm and thoughts of suicide (i.e. items 9, 16, 24 and 34 of the CORE-OM or item 8 of the OQ-45). The student sample is recruited in the classrooms of Pontificia Universidad Católica de Chile. A member of the research team presents the study and invites students to participate. Students agreeing to participate fill out an informed consent form before completing paper/digital versions of the questionnaire. Any student responding "often" or "most of the time" to items signaling self-harm and thoughts of suicide in the CORE-OM/OQ-45 receives an email from the Responsible Investigator with information about the University´s counseling services within 24 hours. The general community sample is recruited using a convenience sampling method (e.g. contacts of research team). As in the other samples, participants sign an informed consent before answering the questionnaire. Since the non-clinical samples serve to test stability, students/general community are asked to provide a valid email address in order to send them an email invitation after two weeks to complete the CORE-OM. Clinical cut-off values will be calculated by domain and sex between the clinical and non-clinical samples and sensitivity to change will be assessed using data from the subsample of outpatients who respond an online questionnaire before their first session and at one follow up point. ### Conditions Module **Conditions:** - Psychological Distress **Keywords:** - CORE-OM - Outcome measures - Psychometric validation - Psychological distress ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 1120 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients receiving mental health treatment at the three psychotherapeutic centers; two university clinics and a family mental health clinic **Label:** Clinical (outpatients) #### Arm Group 2 **Description:** Students and community nonstudent participants who were receiving psychological or psychiatric treatment **Label:** Clinical (self-reported) #### Arm Group 3 **Description:** Members of the community **Label:** Non-clinical (Community) #### Arm Group 4 **Description:** University undergraduate students **Label:** Non-clinical (Students) ### Outcomes Module #### Primary Outcomes **Description:** A self-report questionnaire which measures general psychological distress It consists of 34 items that assess four domains: 1. Well-being (W) 2. Problems/Symptoms (P) 3. Functioning (F) 4. Risk (R) Each of the 34 items is scored on a 5-point scale ranging from 0 to 4. A total psychological distress score, ranging from 0 to136, can be calculated by adding all items, with higher scores indicating higher levels of psychological distress. A Well-Being dimension score, ranging from 0 to 16, can be calculated with higher scores indicating lower levels of subjective wellbeing. A Problems/Symptoms dimension score, ranging from 0 to 48, can be calculated with higher scores indicating higher levels of reported problems/distress. A Functioning dimension score, ranging from 0 to 48, can be calculated with higher scores indicating lower levels of functioning. A Risk dimension score, ranging from 0 to 24, can be calculated with higher scores indicating a greater level of risk. **Measure:** Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM). **Time Frame:** Baseline **Description:** A self-report questionnaire which measures general psychological distress It consists of 34 items that assess four domains: 1. Well-being (W) 2. Problems/Symptoms (P) 3. Functioning (F) 4. Risk (R) Each of the 34 items is scored on a 5-point scale ranging from 0 to 4. A total psychological distress score, ranging from 0 to136, can be calculated by adding all items, with higher scores indicating higher levels of psychological distress. A Well-Being dimension score, ranging from 0 to 16, can be calculated with higher scores indicating lower levels of subjective wellbeing. A Problems/Symptoms dimension score, ranging from 0 to 48, can be calculated with higher scores indicating higher levels of reported problems/distress. A Functioning dimension score, ranging from 0 to 48, can be calculated with higher scores indicating lower levels of functioning. A Risk dimension score, ranging from 0 to 24, can be calculated with higher scores indicating a greater level of risk. **Measure:** Change from baseline on the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) at 2 to 3 weeks. **Time Frame:** Follow-up after two to three weeks (non-clinical sample) **Description:** A self-report questionnaire which measures general psychological distress It consists of 34 items that assess four domains: 1. Well-being (W) 2. Problems/Symptoms (P) 3. Functioning (F) 4. Risk (R) Each of the 34 items is scored on a 5-point scale ranging from 0 to 4. A total psychological distress score, ranging from 0 to136, can be calculated by adding all items, with higher scores indicating higher levels of psychological distress. A Well-Being dimension score, ranging from 0 to 16, can be calculated with higher scores indicating lower levels of subjective wellbeing. A Problems/Symptoms dimension score, ranging from 0 to 48, can be calculated with higher scores indicating higher levels of reported problems/distress. A Functioning dimension score, ranging from 0 to 48, can be calculated with higher scores indicating lower levels of functioning. A Risk dimension score, ranging from 0 to 24, can be calculated with higher scores indicating a greater level of risk. **Measure:** Change from baseline on the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) at 2 to 3 weeks. **Time Frame:** Follow-up after two, five and eight weeks (clinical sample) **Description:** A self-report questionnaire which measures general psychological distress and is designed to monitor treatment outcomes in mental health settings. It consists of 45 items and contains three subscales: 1. Symptom Distress (SD) 2. Interpersonal Relations (IR) 3. Social Role (SR) The OQ-45 provides a total score, ranging from 0 to 180, and three subscores per subscale. Symptom Distress (SD) scores range from 0 to 100, Interpersonal Relations (IR) scores range from 0 to 44 and Social Role (SR) scores range from 0 to 36. Higher scores reflect increased psychological distress associateed to experiencing a high number of symptoms (SD), interpersonal difficulties (IR), and/or decreased satisfaction and quality of life (SR). The clinical cut-off scores in the Chilean population are: SD=43; IR=16; SR=14 and Total Score=73. **Measure:** Outcome Questionnaire (OQ45/OQ45.2) **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Born in Chile * Currently receiving mental health treatment at the University Outpatient Clinic (Centro Médico San Joaquín) (only Clinical Sample) * Currently enrolled at the Universidad Catolica de Chile (only Student Sample) Exclusion Criteria: * Aged \< 18 * Currently receiving psychological, psychiatric or neurological treatment (only Student and Community Sample) * Full-time students (only Community Sample) **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Four samples: 1. Clinical (outpatients) 2. Clinical (self-reported patients): university students or non-student community participant who report receiving mental health treatment 2. Non-clinical (University students) 3. Non-clinical (Community) ### Contacts Locations Module #### Locations **Location 1:** **City:** Santiago **Country:** Chile **Facility:** Pontificia Universidad Catolica de Chile **State:** Región Metropolitana **Zip:** 8331150 #### Overall Officials **Official 1:** **Affiliation:** Universidad Catolica de Chile **Name:** Antonia Errazuriz, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** For research use (authorization by PI) **Description:** There is a plan to make IPD and related data dictionaries available to researchers via Dataverse **Info Types:** - SAP - ICF **IPD Sharing:** YES **Time Frame:** Once manuscript is submitted **URL:** https://doi.org/10.7910/DVN/IPNZYR ### References Module #### References **Citation:** Evans, C., Mellor-Clark, J., Margison, F., Barkham, M., Audin, K., Connell, J., & McGrath, G. (2000). CORE: Clinical Outcomes in Routine Evaluation. Journal of Mental Health, 9(3), 247-255 **Citation:** Evans C, Connell J, Barkham M, Margison F, McGrath G, Mellor-Clark J, Audin K. Towards a standardised brief outcome measure: psychometric properties and utility of the CORE-OM. Br J Psychiatry. 2002 Jan;180:51-60. doi: 10.1192/bjp.180.1.51. **PMID:** 11772852 **Citation:** Von Bergen A., De la Parra G. (2002). OQ-45.2, Cuestionario para la evaluación de resultados y evolución en psicoterapia: adaptación, validación e indicaciones para su aplicación e interpretación [Questionnaire for the evaluation of results and evolution in psychotherapy: adaptation, validation and indications for its application and interpretation]. Ter. Psicol. 20 161-176 ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01554579 **Brief Title:** A Four-Week Multicenter Study Evaluating the Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Subjects With Osteoarthritis of the Knee #### Organization Study ID Info **ID:** 7264-004 #### Organization **Class:** INDUSTRY **Full Name:** Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) #### Secondary ID Infos **Domain:** Afferent Pharmaceuticals **ID:** AF219004 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2013-11-21 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-06-27 **Type:** ACTUAL **Last Update Submit Date:** 2019-06-20 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2013-11-11 **Type:** ACTUAL #### Results First Post Date **Date:** 2017-03-01 **Type:** ACTUAL **Results First Submit Date:** 2016-09-23 **Results First Submit QC Date:** 2017-01-10 #### Start Date **Date:** 2012-03-29 **Type:** ACTUAL **Status Verified Date:** 2019-06 #### Study First Post Date **Date:** 2012-03-15 **Type:** ESTIMATED **Study First Submit Date:** 2012-03-12 **Study First Submit QC Date:** 2012-03-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to assess the efficacy of a single dose level of gefapixant (AF-219/MK-7264) in subjects with moderate to severe pain associated with osteoarthritis (OA) of the knee compared with placebo after 4 weeks of treatment. The study will also assess the safety and tolerability, changes in physical function, stiffness, treatment response and health outcomes. **Detailed Description:** Subjects who satisfy entry criteria at Screening will enter the Washout Phase, discontinuing their current nonsteroidal anti-inflammatory drug (NSAID) therapy. Up to 220 subjects who fulfill flare (and other entry) criteria will be randomized to gefapixant or placebo. Subjects will complete Treatment Visits 1, 2, 3, and 4 weeks after starting study drug. At each Treatment Visit, subjects will undergo efficacy assessments and safety procedures. During the Washout and Treatment Phases subjects will complete the 'average pain' Numeric Pain Rating Scale (NPRS) and count of rescue medication used for the preceding 24 hours. Subjects will return 2 weeks after their last Treatment Visit (for a Follow-Up Visit). ### Conditions Module **Conditions:** - Osteoarthritis of the Knee ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 171 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Sugar Pill **Label:** Sugar pill **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Intervention Names:** - Drug: Gefapixant **Label:** Gefapixant **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Gefapixant **Description:** BID **Name:** Gefapixant **Other Names:** - AF-219 - MK-7264 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Sugar pill **Description:** Placebo **Name:** Sugar Pill **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Subjects were instructed to select a number on a scale that best described their knee arthritis pain during the past 24 hours. The scale was between 0 and 10 where 0 was no pain and 10 was the worst possible pain. The scale was completed by telephone (an interactive voice response system \[IVRS\]) every evening before bedtime. **Measure:** The Primary Efficacy Endpoint of This Study is the Weekly Average Daily NPRS (Average Pain) **Time Frame:** 2 Weeks #### Secondary Outcomes **Description:** This is the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). This is a questionnaire that asks subjects to evaluate their pain, stiffness, and physical activities affecting their knee over the past 48 hours. Subjects evaluate their pain, stiffness and physical activities by selecting a number between 0 and 10 where 0 is no pain/no stiffness/no difficulty doing physical activities and 10 is extreme pain/extreme stiffness/extreme difficulty doing physical activities. The questionnaire was administered at Screening, Baseline and at the end of Week 4 by telephone (an interactive voice response system \[IVRS\]) before bedtime. The scores for each category are totaled (range is 0-100). A lower total score means less pain and a higher total score means greater pain. **Measure:** WOMAC Scores **Time Frame:** 4 Weeks **Description:** The SF-36 (acute version 2) was a 36 question survey administered at Baseline and at the end of study or early termination (Week 4). The questionnaire contained numerous domain scores to evaluate physical function, mental function, general health, bodily pain, social functioning and vitality. The question of interest for the analysis was question #1 regarding walking pain. Scores range from 0 - 100. A lower score means decreased pain while walking and a higher score means increased pain while walking. **Measure:** SF-36 **Time Frame:** 4 Weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Men or women * Women of child bearing potential must not be pregnant during the study and must use two forms of birth control * Men and their female partners must use two forms of birth control * Clinical and radiographic evidence of chronic knee osteoarthritis * An average NPRS score of \>=5 and \<=9 over a 4-7 day washout period of their previous osteoarthritis medications * Ambulatory * Have provided written informed consent **Maximum Age:** 80 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Phoenix **Country:** United States **Facility:** Afferent Investigative Site **State:** Arizona **Zip:** 85018 **Location 2:** **City:** Phoenix **Country:** United States **Facility:** Afferent Investigative Site **State:** Arizona **Zip:** 85027 **Location 3:** **City:** San Diego **Country:** United States **Facility:** Afferent Investigative Site **State:** California **Zip:** 92108 **Location 4:** **City:** Clearwater **Country:** United States **Facility:** Afferent Investigative Site **State:** Florida **Zip:** 33756 **Location 5:** **City:** Orlando **Country:** United States **Facility:** Afferent Investigative Site **State:** Florida **Zip:** 32806 **Location 6:** **City:** Pinellas Park **Country:** United States **Facility:** Afferent Investigative Site **State:** Florida **Zip:** 33781 **Location 7:** **City:** Atlanta **Country:** United States **Facility:** Afferent Investigative Site **State:** Georgia **Zip:** 30329 **Location 8:** **City:** Wichita **Country:** United States **Facility:** Afferent Investigative Site **State:** Kansas **Zip:** 67203 **Location 9:** **City:** New Bedford **Country:** United States **Facility:** Afferent Investigative Site **State:** Massachusetts **Zip:** 02740 **Location 10:** **City:** Watertown **Country:** United States **Facility:** Afferent Investigative Site **State:** Massachusetts **Zip:** 02472 **Location 11:** **City:** Troy **Country:** United States **Facility:** Afferent Investigative Site **State:** Michigan **Zip:** 48098 **Location 12:** **City:** Olive Branch **Country:** United States **Facility:** Afferent Investigative Site **State:** Mississippi **Zip:** 38654 **Location 13:** **City:** Hazelwood **Country:** United States **Facility:** Afferent Investigative Site **State:** Missouri **Zip:** 63042 **Location 14:** **City:** Saint Louis **Country:** United States **Facility:** Afferent Investigative Site **State:** Missouri **Zip:** 63141 **Location 15:** **City:** Albuquerque **Country:** United States **Facility:** Afferent Investigative Site **State:** New Mexico **Zip:** 87102 **Location 16:** **City:** Asheville **Country:** United States **Facility:** Afferent Investigative Site **State:** North Carolina **Zip:** 28803 **Location 17:** **City:** Greensboro **Country:** United States **Facility:** Afferent Investigative Site **State:** North Carolina **Zip:** 27408 **Location 18:** **City:** Winston-Salem **Country:** United States **Facility:** Afferent Investigative Site **State:** North Carolina **Zip:** 27103 **Location 19:** **City:** Cincinnati **Country:** United States **Facility:** Afferent Investigative Site **State:** Ohio **Zip:** 45219 **Location 20:** **City:** Toledo **Country:** United States **Facility:** Afferent Investigative Site **State:** Ohio **Zip:** 43623 **Location 21:** **City:** Medford **Country:** United States **Facility:** Afferent Investigative Site **State:** Oregon **Zip:** 97504 **Location 22:** **City:** Duncansville **Country:** United States **Facility:** Afferent Investigative Site **State:** Pennsylvania **Zip:** 16635 **Location 23:** **City:** Warwick **Country:** United States **Facility:** Afferent Investigative Site **State:** Rhode Island **Zip:** 02886 **Location 24:** **City:** Greer **Country:** United States **Facility:** Afferent Investigative Site **State:** South Carolina **Zip:** 29650 **Location 25:** **City:** Mount Pleasant **Country:** United States **Facility:** Afferent Investigative Site **State:** South Carolina **Zip:** 29464 **Location 26:** **City:** Austin **Country:** United States **Facility:** Afferent Investigative Site **State:** Texas **Zip:** 78705 **Location 27:** **City:** Dallas **Country:** United States **Facility:** Afferent Investigative Site **State:** Texas **Zip:** 75231 **Location 28:** **City:** Houston **Country:** United States **Facility:** Afferent Investigative Site **State:** Texas **Zip:** 77062 **Location 29:** **City:** San Antonio **Country:** United States **Facility:** Afferent Investigative Site **State:** Texas **Zip:** 78209 **Location 30:** **City:** San Antonio **Country:** United States **Facility:** Afferent Investigative Site **State:** Texas **Zip:** 78229 **Location 31:** **City:** Clinton **Country:** United States **Facility:** Afferent Investigative Site **State:** Utah **Zip:** 84015 **Location 32:** **City:** Roanoke **Country:** United States **Facility:** Afferent Investigative Site **State:** Virginia **Zip:** 24018 **Location 33:** **City:** Renton **Country:** United States **Facility:** Afferent Investigative Site **State:** Washington **Zip:** 98057 **Location 34:** **City:** Kenosha **Country:** United States **Facility:** Afferent Investigative Site **State:** Wisconsin **Zip:** 53142 ### IPD Sharing Statement Module **Description:** http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf **IPD Sharing:** YES **URL:** http://engagezone.msd.com/ds_documentation.php ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M12926 - Name: Osteoarthritis - Relevance: HIGH - As Found: Osteoarthritis - ID: M22168 - Name: Osteoarthritis, Knee - Relevance: HIGH - As Found: Osteoarthritis of the Knee - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010003 - Term: Osteoarthritis - ID: D000020370 - Term: Osteoarthritis, Knee ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Sugar Pill **Description:** Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks. **ID:** EG000 **Other Num Affected:** 17 **Other Num at Risk:** 86 **Serious Number Affected:** 1 **Serious Number At Risk:** 86 **Title:** Sugar Pill **Group ID:** EG001 **Title:** Gefapixant **Description:** Gefapixant: BID Subjects received one tablet twice daily for 4 weeks. **ID:** EG001 **Other Num Affected:** 75 **Other Num at Risk:** 85 **Serious Number At Risk:** 85 **Title:** Gefapixant **Frequency Threshold:** 5 #### Other Events **Term:** Dysgeusia **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Ageusia **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** headache **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** hypogeusia **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** dizziness **Organ System:** Nervous system disorders **Source Vocabulary:** #### Serious Events **Term:** Bronchitis **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 86 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 85 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 86 **Group ID:** BG001 **Value:** 85 **Group ID:** BG002 **Value:** 171 **Units:** Participants ### Group **ID:** BG000 **Title:** Sugar Pill **Description:** Sugar Pill: Placebo ### Group **ID:** BG001 **Title:** Gefapixant **Description:** Gefapixant: BID Subjects received one tablet twice daily for 4 weeks. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 64 #### Measurement **Group ID:** BG001 **Value:** 65 #### Measurement **Group ID:** BG002 **Value:** 129 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 22 #### Measurement **Group ID:** BG001 **Value:** 20 #### Measurement **Group ID:** BG002 **Value:** 42 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 52 #### Measurement **Group ID:** BG001 **Value:** 57 #### Measurement **Group ID:** BG002 **Value:** 109 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 34 #### Measurement **Group ID:** BG001 **Value:** 28 #### Measurement **Group ID:** BG002 **Value:** 62 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 1 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 4 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 21 #### Measurement **Group ID:** BG001 **Value:** 20 #### Measurement **Group ID:** BG002 **Value:** 41 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 62 #### Measurement **Group ID:** BG001 **Value:** 62 #### Measurement **Group ID:** BG002 **Value:** 124 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 1 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 86 #### Measurement **Group ID:** BG001 **Value:** 85 #### Measurement **Group ID:** BG002 **Value:** 171 **Class Title:** United States ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 5 **Upper Limit:** 9 **Value:** 6.7 #### Measurement **Group ID:** BG001 **Lower Limit:** 5 **Upper Limit:** 9 **Value:** 6.8 #### Measurement **Group ID:** BG002 **Lower Limit:** 5 **Upper Limit:** 9 **Value:** 6.75 **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ### Measure 5 **Description:** Subjects were instructed to select a number between 0 and 10 where 0 is no pain and 10 is the worst possible pain. The scale was completed by telephone (an interactive voice response system \[IVRS\]) every evening before bedtime. **Dispersion Type:** FULL_RANGE **Parameter Type:** MEAN **Title:** Numeric Pain Rating Scale (NPRS) **Unit of Measure:** units on a scale ## Results Section - More Information Module ### Certain Agreement **Other Details:** 60 days prior to the submission of any results, the PI shall submit to SPONSOR any proposed PUBLICATION, which period may be extended for an additional 30 days if requested by SPONSOR. If any Confidential Information should be redacted or patent applications relating to an Invention should be filed prior to PUBLICATION, then PUBLICATION will be delayed until patent application has been filed. Delay of a PUBLICATION shall not exceed 24 months from the date of such notice to the PI. **Restriction Type:** OTHER **Restrictive Agreement:** True ### Point of Contact **Email:** info@afferentpharma.com **Organization:** Afferent Pharmaceuticals **Phone:** 650-286-1276 **Title:** Clinical Development ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0 - **Spread:** - **Upper Limit:** 10 - **Value:** 5.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0 - **Spread:** - **Upper Limit:** 10 - **Value:** 4.9 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 23.12 - **Upper Limit:** - **Value:** 40.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 25.26 - **Upper Limit:** - **Value:** 41.0 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.39 - **Upper Limit:** - **Value:** 3.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.77 - **Upper Limit:** - **Value:** 4.1 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Subjects were instructed to select a number on a scale that best described their knee arthritis pain during the past 24 hours. The scale was between 0 and 10 where 0 was no pain and 10 was the worst possible pain. The scale was completed by telephone (an interactive voice response system \[IVRS\]) every evening before bedtime. **Dispersion Type:** Full Range **Parameter Type:** MEAN **Population Description:** Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores. **Reporting Status:** POSTED **Time Frame:** 2 Weeks **Title:** The Primary Efficacy Endpoint of This Study is the Weekly Average Daily NPRS (Average Pain) **Type:** PRIMARY **Unit of Measure:** units on a scale ##### Group **Description:** Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks. **ID:** OG000 **Title:** Sugar Pill ##### Group **Description:** Gefapixant: BID Subjects received one tablet twice daily for 4 weeks. **ID:** OG001 **Title:** Gefapixant #### Outcome Measure 2 **Description:** This is the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). This is a questionnaire that asks subjects to evaluate their pain, stiffness, and physical activities affecting their knee over the past 48 hours. Subjects evaluate their pain, stiffness and physical activities by selecting a number between 0 and 10 where 0 is no pain/no stiffness/no difficulty doing physical activities and 10 is extreme pain/extreme stiffness/extreme difficulty doing physical activities. The questionnaire was administered at Screening, Baseline and at the end of Week 4 by telephone (an interactive voice response system \[IVRS\]) before bedtime. The scores for each category are totaled (range is 0-100). A lower total score means less pain and a higher total score means greater pain. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores. **Reporting Status:** POSTED **Time Frame:** 4 Weeks **Title:** WOMAC Scores **Type:** SECONDARY **Unit of Measure:** units on a scale ##### Group **Description:** Sugar Pill: Placebo **ID:** OG000 **Title:** Sugar Pill ##### Group **Description:** Gefapixant: BID Subjects received one tablet twice daily for 4 weeks. **ID:** OG001 **Title:** Gefapixant #### Outcome Measure 3 **Description:** The SF-36 (acute version 2) was a 36 question survey administered at Baseline and at the end of study or early termination (Week 4). The questionnaire contained numerous domain scores to evaluate physical function, mental function, general health, bodily pain, social functioning and vitality. The question of interest for the analysis was question #1 regarding walking pain. Scores range from 0 - 100. A lower score means decreased pain while walking and a higher score means increased pain while walking. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores. **Reporting Status:** POSTED **Time Frame:** 4 Weeks **Title:** SF-36 **Type:** SECONDARY **Unit of Measure:** units on a scale ##### Group **Description:** Sugar Pill: Placebo **ID:** OG000 **Title:** Sugar Pill ##### Group **Description:** Gefapixant: BID Subjects received one tablet twice daily for 4 weeks. **ID:** OG001 **Title:** Gefapixant ### Participant Flow Module #### Group **Description:** Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks. **ID:** FG000 **Title:** Sugar Pill #### Group **Description:** Gefapixant: BID Subjects received one tablet twice daily for 4 weeks. **ID:** FG001 **Title:** Gefapixant #### Period **Title:** Overall Study ##### Withdraw **Type:** Adverse Event ###### Reason **Group ID:** FG000 **Number of Subjects:** 6 ###### Reason **Group ID:** FG001 **Number of Subjects:** 25 ##### Withdraw **Type:** Lack of Efficacy ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 86 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 85 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 76 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 58 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 10 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 27 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT00316979 **Brief Title:** Efficacy of rTMS in the Treatment of Patients With Migraine **Official Title:** Therapeutic Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Migraine Using Somatosensory Evoked High-Frequency Oscillations as a Parameter: A 3-year Study. #### Organization Study ID Info **ID:** rTMS_Migraine_VGHTPE #### Organization **Class:** OTHER_GOV **Full Name:** Taipei Veterans General Hospital, Taiwan ### Status Module #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2010-06-08 **Type:** ESTIMATED **Last Update Submit Date:** 2010-06-06 **Overall Status:** UNKNOWN #### Start Date **Date:** 2006-04 **Status Verified Date:** 2010-06 #### Study First Post Date **Date:** 2006-04-21 **Type:** ESTIMATED **Study First Submit Date:** 2006-04-20 **Study First Submit QC Date:** 2006-04-20 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** National Science Council, Taiwan #### Lead Sponsor **Class:** OTHER_GOV **Name:** Taipei Veterans General Hospital, Taiwan ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Migraine is a condition thought to be related to cortical hyperexcitability. Repetitive transcranial magnetic stimulation (rTMS) can modulate the cortical excitability by means of long-term potentiation or long-term depression. This study will will test the safety and efficacy of rTMS in the treatment of patients with Migraine. ### Conditions Module **Conditions:** - Migraine **Keywords:** - migraine - transcranial magnetic stimulation - repetitive transcranial magnetic stimulation - rTMS ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** Repetitive Transcranial Magnetic Stimulation (rTMS) **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** Reduction in days of migraine attack per month #### Secondary Outcomes **Measure:** The reduction in dosage of acute abortive medication **Measure:** The reduction of headache index ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age of 18-65 years * Diagnosed as migraine (with or without aura) * More than 4 attacks per month for at least 3 months prior to study * No preventive medication used * Must be able to sign permit Exclusion Criteria: * History of seizure or family history of seizures * Women in pregnancy or breast-feeding * Patient with medication overuse * Patient with other medical, psychologic, or surgical illness * Patient under preventive medications * Prior rTMS examination one month within **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** sjwang@vghtpe.gov.tw **Name:** Shuu-Jiun Wang, MD **Phone:** +886-2-28712121 **Phone Ext:** 2425 **Role:** CONTACT **Contact 2:** **Email:** kllai@vghtpe.gov.tw **Name:** Kuan-Lin Lai, MD **Phone:** +886-2-28712121 **Phone Ext:** 3185 **Role:** CONTACT #### Locations **Location 1:** **City:** Taipei **Contacts:** ***Contact 1:*** - **Email:** sjwang@vghtpe.gov.tw - **Name:** Shuu-Jiun Wang, MD - **Phone:** +886-2-28712121 - **Phone Ext:** 2425 - **Role:** CONTACT ***Contact 2:*** - **Email:** jlfuh@vghtpe.gov.tw - **Name:** Jong-Ling Fuh, MD - **Phone:** +886-2-28712121 - **Phone Ext:** 3256 - **Role:** CONTACT ***Contact 3:*** - **Name:** Shuu-Jiun Wang, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Taiwan **Facility:** Headache Center, Teipei Veterans General Hospital **Status:** RECRUITING **Zip:** 112 #### Overall Officials **Official 1:** **Affiliation:** Headache Center, Taipei Veterans General Hospital **Name:** Shuu-Jiun Wang, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Brighina F, Piazza A, Vitello G, Aloisio A, Palermo A, Daniele O, Fierro B. rTMS of the prefrontal cortex in the treatment of chronic migraine: a pilot study. J Neurol Sci. 2004 Dec 15;227(1):67-71. doi: 10.1016/j.jns.2004.08.008. **PMID:** 15546593 **Citation:** Lorenz J, Minoshima S, Casey KL. Keeping pain out of mind: the role of the dorsolateral prefrontal cortex in pain modulation. Brain. 2003 May;126(Pt 5):1079-91. doi: 10.1093/brain/awg102. **PMID:** 12690048 ## Annotation Section ### Unposted Annotation #### Event: RELEASE - Date: 2011-06-14 - Date Unknown: Unknown #### Event: RESET - Date: 2011-07-08 - Date Unknown: Unknown #### Event: RELEASE - Date: 2011-07-12 - Date Unknown: Unknown #### Event: RESET - Date: 2011-08-04 - Date Unknown: Unknown #### Event: RELEASE - Date: 2012-04-19 - Date Unknown: Unknown #### Event: RESET - Date: 2012-05-23 - Date Unknown: Unknown ## Derived Section ### Condition Browse Module - Ancestors - ID: D000051270 - Term: Headache Disorders, Primary - ID: D000020773 - Term: Headache Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M11852 - Name: Migraine Disorders - Relevance: HIGH - As Found: Migraine - ID: M9351 - Name: Headache - Relevance: LOW - As Found: Unknown - ID: M22529 - Name: Headache Disorders - Relevance: LOW - As Found: Unknown - ID: M26657 - Name: Headache Disorders, Primary - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008881 - Term: Migraine Disorders ### Misc Info Module #### Submission Tracking - Estimated Results First Submit Date: 2011-06-14 ##### Submission Infos - MCP Release N: Unknown - Release Date: 2011-06-14 - Reset Date: 2011-07-08 - Unrelease Date: Unknown - Unrelease Date Unknown: Unknown - MCP Release N: Unknown - Release Date: 2011-07-12 - Reset Date: 2011-08-04 - Unrelease Date: Unknown - Unrelease Date Unknown: Unknown - MCP Release N: Unknown - Release Date: 2012-04-19 - Reset Date: 2012-05-23 - Unrelease Date: Unknown - Unrelease Date Unknown: Unknown - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03032679 **Brief Title:** Pain and Impact of Chronic Pain on Function After Total Knee Replacements **Official Title:** Postoperative Pain Severity, Incidence Of Chronic Pain And Its Impact On Daily Function Following Total Knee Replacements (TKR) At A Tertiary Cancer Institute #### Organization Study ID Info **ID:** 1780 #### Organization **Class:** OTHER **Full Name:** Tata Memorial Centre ### Status Module #### Completion Date **Date:** 2020-08-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-10-08 **Type:** ACTUAL **Last Update Submit Date:** 2020-10-07 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-06-30 **Type:** ACTUAL #### Start Date **Date:** 2017-02-02 **Type:** ACTUAL **Status Verified Date:** 2020-10 #### Study First Post Date **Date:** 2017-01-26 **Type:** ESTIMATED **Study First Submit Date:** 2017-01-24 **Study First Submit QC Date:** 2017-01-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tata Memorial Centre #### Responsible Party **Investigator Affiliation:** Tata Memorial Centre **Investigator Full Name:** Dr Aparna Chatterjee **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** After Institutional Review Board approval, adult patients scheduled for total knee arthroplasty (TKA) will be enrolled into the study after obtaining informed consent over a 24 month period. Interim analyses of cases who have completed the 6 month follow up as on 31st October, 2017 will be analyzed as part of the co- principle investigator's thesis. All consenting patients will be assessed for pain preoperatively, the first 3 post-operative days, at 1, 4 and 6 months from the date of surgery. Pain scores will be assessed using the Numerical Rating Scale during the 3 postoperative days. Pain will be managed by the Acute Pain Service team as per standard protocols. The Brief pain inventory (BPI) (short form with translations, obtained with permission from MD Anderson), which assesses pain severity and its impact on daily functions will be administered to the patient in a language familiar to them, preoperatively, at 1, 4 and 6 months postoperatively. The Musculoskeletal Tumour Society Score (MSTS) which evaluates the functional condition (impairment) after completed tumour treatment will be estimated at the end of 6 months from the date of surgery The painDETECT questionnaire (PD-Q) a quick, simple and reliable screening tool to identify the likelihood of a neuropathic pain component in patients and validated in various languages including Hindi and Marathi will be administered preoperatively and at 1, 4 and 6 months after surgery. Details of postoperative chemotherapy and radiation will also be obtained from patient's notes and the electronic medical record. If the patient cannot follow up at the said intervals, the pain scores would be obtained telephonically and the BPI and PD-Q forms in prepaid envelopes would be given to them at discharge which they would have to duly fill in and post them to the given address at the appropriate intervals if they cannot visit the pain clinic. At the 6th month of follow up, they would be requested to visit the pain clinic for an assessment of MSTS score and completing the BPI and PD-Q. INCLUSION CRITERIA:- * Adult patients above 18 years of age, undergoing TKR * Literate: able to read and write in at least one of the following languages English, Hindi and Marathi * Willing to fill forms and post them and/or answer questions on phone EXCLUSION CRITERIA:- * Refusal of consent * Cognitively impaired * Revision TKRs (including cases with wound wash and nail spacer cementing) **Detailed Description:** INTRODUCTION:- A Total Knee Replacement (TKR) or arthroplasty (TKA) is a complex procedure that requires an Orthopedic Surgeon to make precise measurements and skillfully remove the diseased portions of the bone, in order to shape the remaining bone to accommodate the knee implant. Knee Replacement Surgery is most commonly performed in people with advanced osteoarthritis and should be considered when conservative treatments have been exhausted. Oncologic TKRs are different from the routine TKRs in a way that the former involves a wide local resection of the bone and soft tissues, ranging from 10 to 20 cm, resection of muscles like the head(s) of biceps femoris, the gastrocnemius muscle, the intermuscular septa, the joint capsule, etc. to ensure negative margins along with the complete resection of the tumour, followed by a reconstruction of almost the same length as that resected, to restore function. The most common indication for doing oncologic TKR is Osteogenic Sarcoma (OGS) of and around the knee joint. The distal femur and proximal tibia are among the most common sites for primary bone tumor. OGS is the most common bone cancer in the world in children and adolescents, and the eighth-most common form of childhood cancer, accounting for 4% of all childhood cancers worldwide. In India, the incidence varies from 4.7% to 11.6%, where this malignancy is associated with significant morbidity and mortality. Additional treatment involves chemotherapy which further delays the healing and recovery of the patient. Surgery is a known risk factor for development of Chronic Post Surgical Pain(CPSP) which as per the definition given by Macrae and Davies, is defined by * Pain developing after a surgical procedure. * Pain of at least 2 months' duration. * Other causes of pain excluded (e.g.- malignancy, infection, etc.). * Pain continuing from a pre-existing pain problem excluded. CPSP is a well known risk factor in many surgeries like (but not exclusive of)- * Mastectomy (Incidence of chronic pain = 11-57%) * Amputation (30-85%) * Inguinal hernia(5-63%) * Cholecystectomy (3-50%) CPSP develops after a surgical procedure or increases in intensity after the surgical procedure. Literature on TKR surgeries indicated for osteoarthritis, report that although many patients report a good outcome after their total knee replacement, at a time when recovery should have been achieved, about 10-34% of patients undergoing TKR for osteoarthritis report moderate to severe CPSP. In around 30% of patients with CPSP, the origin of CPSP might be neuropathic. Neuropathic pain is more severe and adversely affects the quality of life of patients. TKR on its own may cause neuropathic pain postoperatively due to local nerve damage, often to the infrapatellar branch of the saphenous nerve or due to local inflammation. Risk factors associated with the operation include increased duration of surgery and tourniquet time, revision surgery, TKA versus unicompartmental arthroplasty and intraoperative nerve damage. Oncologic TKRs are more extensive and include much morbid excisions, and consequently may be presumed to have a similar if not a greater incidence of CPSP. Some of the risk factors for CPSP include the following (but not exclusive of)- * Pain, moderate to severe, lasting more than 1 month * Repeat surgery * Younger age (adults) * Surgical approach with risk of nerve damage * Neurotoxic chemotherapy Preoperative pain is consistently found to be a predictor for persistent postsurgical pain, which might reflect an independent risk factor but could well be a manifestation of predisposing factors. Tata Memorial Hospital, a tertiary cancer institute is a 629 bedded hospital and conducts approximately 6000 surgeries per year out of which approximately 100 TKRs are performed per year. Analgesia peri-operatively is provided by an epidural infusion of a combination of local anaesthetic and an opioid or intravenous opioids with non-steroidal anti-inflammatory analgesics and paracetamol as appropriate. Postoperatively, if inserted, epidural analgesia is continued for up to 3-4 days to help mobilization \& physiotherapy. In the absence of an epidural, around the clock analgesics with or without an opioid administered by means of an Intravenous Patient Controlled Analgesia (IVPCA) device is instituted. These patients are visited by the acute pain service team to address pain issues for the first 3 postoperative days or sometimes longer. STUDY DESIGN:- Prospective and Observational study METHODS and MATERIALS:- After Institutional Review Board approval, adult patients scheduled for TKR surgeries will be enrolled into the study after obtaining their informed consent over a 24 month period. However, interim analyses of all cases who have completed the 6 month follow up as on 31st October, 2017 would be analyzed as part of the co- principle investigator's thesis. All consenting patients will be assessed for their pain preoperatively and for the first 3 post-operative days, and at 1, 4 and 6 months from the date of surgery. Pain scores will be assessed using the Numerical Rating Scale during the 3 days after surgery. Pain will be managed by the Acute Pain Service team as per the standard management protocols. The Brief pain inventory (BPI), (short form with translations, obtained with permission from MD Anderson), which assesses the severity of pain and the impact of pain on daily functions will be administered to the patient in the language familiar to them, preoperatively, at 1, 4 and 6 months postoperatively. The BPI is a useful instrument to assess the severity of pain and impact of pain on daily functions in patients with pain from chronic diseases, conditions such as cancer, osteoarthritis and low back pain, or with pain from acute conditions such as postoperative pain. The short form comprises of nine questions related to the severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. It has been widely used and validated in several languages the world over. The Musculoskeletal Tumour Society Score (MSTS) evaluates the functional condition (impairment) after completed tumour treatment will be estimated at the end of 6 months from the date of surgery. It is calculated on the basis of a standardized physical examination by the physician. This clinical examination assesses six criteria and differs slightly between the upper and lower limb. For the lower limb, the components are pain, function, emotional acceptance of the treatment outcome, need for walking aids, walking and gait. For all criteria, the estimate is made from bad to very good with parallel awarding of points (0 to 5). There is thus a numerical value for each of the six criteria. These six values are added and divided by the maximum possible number of points (30). The percentage value is obtained by multiplying the calculated point value by 100. The painDETECT questionnaire (PD-Q) is a quick, simple and reliable screening tool to identify the likelihood of a neuropathic pain component in patients with neuropathic pain. This questionnaire had been prepared by professionals and validated in various languages including Hindi and Marathi. Its sensitivity and specificity is higher than other screening questionnaires for neuropathic pain, including the Douleur Neuropathique 4 (DN4), Leeds Assessment of Neuropathic Symptoms and Signs (LANNS), and the Neuropathic Pain Questionnaire (NPQ) (Freynhagen et al 2006). The PD-Q has been used to identify neuropathic pain in patients with knee osteoarthritis (Ohtori et al 2012) and to identify sensory profiles in patients with diabetic neuropathy and postherpetic neuralgia (Baron et al 2009).This questionnaire will be administered tot he patients preoperatively , at 1, 4 and 6 months after surgery. Details of postoperative chemotherapy and radiation will also be obtained from patient's notes and the electronic medical record. If the patient cannot follow up at the said intervals, the pain scores would be obtained telephonically and the BPI and PD-Q forms in prepaid envelopes would be given to them at discharge which they would have to duly fill in and post them to the given address at the appropriate intervals if they cannot visit the pain clinic. At the 6th month of follow up, they would be requested to visit the pain clinic for an assessment of MSTS score and completing the BPI and PD-Q. MEASUREMENTS:- * All demographic, preoperative, intraoperative and postoperative data would be collected by the investigators. * Demographic data includes case no, age, sex, ASA (American Society of Anesthesiologists) grade. * Preoperative variables include pain score, preoperative analgesics, duration of use, and the dose. * Intraoperative variables include duration of surgery, tourniquet time, any nerve or muscle resection and length of bone resected. * Postoperative variables include median average and worst pain score for the first 3 postoperative days , 1, 4 and 6 months after surgery. * Analgesics administered postoperatively, dose \& dosing intervals, impact on daily functions as obtained from the BPI pre-operatively, 1, 4 and 6 months postoperatively. * The painDETECT score to identify the neuropathic component of pain if any, preoperatively and at 1, 4 and 6 months after surgery. * The MSTS score calculated by the physician and obtained from the patient's record at the 6th month after surgery. STATISTICAL ANALYSIS:- The above mentioned data will be presented as mean (sd), median (range), and frequency (percentage). Categorical data will be analyzed using the Chi-square test or Fisher Exact test (for binary data). Continuous variables will be analyzed using paired t test or Wilcoxon signed rank test as per distribution of data. Repeated measure ANOVA will be used for pain score analysis. Pearson correlation coefficients will be used for association. p-value \<0.05 will be considered statistical significant. ### Conditions Module **Conditions:** - Pain, Postoperative - Pain, Chronic - Osteogenic Sarcoma - Knee Arthropathy **Keywords:** - pain, acute, chronic, knee arthroplasty ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 139 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Non interventional study. Observational with questionnaires **Intervention Names:** - Other: Non interventional study **Label:** Single group of patients ### Interventions #### Intervention 1 **Arm Group Labels:** - Single group of patients **Description:** No intervention **Name:** Non interventional study **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Pain scores as per the numerical rating scale **Measure:** pain severity in the immediate post-operative period following oncologic TKRs **Time Frame:** First 3 postoperative days #### Secondary Outcomes **Description:** As assessed from the brief pain inventory **Measure:** the proportion of patients who continue to have pain at 4 and 6 months post surgery(CPSP) **Time Frame:** 4 and 6 months after surgery **Description:** Neuropathic component to be identified by using the pain Detect **Measure:** • To identify the type of pain (neuropathic component) persisting at 4 and 6 months after TKR **Time Frame:** 4 and 6 months from surgery **Description:** Brief pain inventory and the MSTS score to assess the interference of pain with daily function and how it compares with MSTS at 6 month **Measure:** Impact of the pain on daily function **Time Frame:** 4 and 6 months after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients above 18 years of age, undergoing TKR * Literate: able to read and write in at least one of the following languages English, Hindi and Marathi * Willing to fill forms and post them and/or answer questions on phone Exclusion Criteria: * Refusal of consent * Cognitively impaired * Revision knee arthroplasty (including cases with wound wash and nail spacer cementing) **Maximum Age:** 99 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult patients scheduled for total knee arthroplasty for osteogenic sarcoma ### Contacts Locations Module #### Locations **Location 1:** **City:** Mumbai **Country:** India **Facility:** Tata Memorial Centre **State:** Maharashtra **Zip:** 400012 #### Overall Officials **Official 1:** **Affiliation:** Professor **Name:** APARNA S CHATTERJEE, MD,FCARCSI **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Nguyen MP, Buckwalter JA, Miller BJ. Patterns of improvement following oncologic reconstructrion compared to total knee arthroplasty and revision knee arthroplasty. Iowa Orthop J. 2011;31:160-5. **PMID:** 22096436 **Citation:** Beswick AD, Wylde V, Gooberman-Hill R. Interventions for the prediction and management of chronic postsurgical pain after total knee replacement: systematic review of randomised controlled trials. BMJ Open. 2015 May 12;5(5):e007387. doi: 10.1136/bmjopen-2014-007387. **PMID:** 25967998 **Citation:** Haroutiunian S, Nikolajsen L, Finnerup NB, Jensen TS. The neuropathic component in persistent postsurgical pain: a systematic literature review. Pain. 2013 Jan;154(1):95-102. doi: 10.1016/j.pain.2012.09.010. **PMID:** 23273105 **Citation:** Ayers DC, Franklin PD, Ploutz-Snyder R, Boisvert CB. Total knee replacement outcome and coexisting physical and emotional illness. Clin Orthop Relat Res. 2005 Nov;440:157-61. doi: 10.1097/01.blo.0000185447.43622.93. **PMID:** 16239800 **Citation:** Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X. **PMID:** 16698416 **Citation:** Tunn PU, Pomraenke D, Goerling U, Hohenberger P. Functional outcome after endoprosthetic limb-salvage therapy of primary bone tumours--a comparative analysis using the MSTS score, the TESS and the RNL index. Int Orthop. 2008 Oct;32(5):619-25. doi: 10.1007/s00264-007-0388-8. Epub 2007 Aug 15. **PMID:** 17701173 **Citation:** Mathieson S, Lin C. painDETECT questionnaire. J Physiother. 2013 Sep;59(3):211. doi: 10.1016/S1836-9553(13)70189-9. No abstract available. **PMID:** 23896340 **Citation:** Jain P, Padole D, Bakshi S. Prevalence of acute neuropathic pain after cancer surgery: A prospective study. Indian J Anaesth. 2014 Jan;58(1):36-42. doi: 10.4103/0019-5049.126788. **PMID:** 24700897 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012509 - Term: Sarcoma - ID: D000018204 - Term: Neoplasms, Connective and Soft Tissue - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000018213 - Term: Neoplasms, Bone Tissue - ID: D000009372 - Term: Neoplasms, Connective Tissue ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Pain, Postoperative - ID: M29442 - Name: Chronic Pain - Relevance: HIGH - As Found: Chronic Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M15327 - Name: Sarcoma - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M15334 - Name: Osteosarcoma - Relevance: HIGH - As Found: Osteogenic Sarcoma - ID: M20350 - Name: Neoplasms, Connective and Soft Tissue - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M20359 - Name: Neoplasms, Bone Tissue - Relevance: LOW - As Found: Unknown - ID: M12317 - Name: Neoplasms, Connective Tissue - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: HIGH - As Found: Chronic - ID: T5284 - Name: Soft Tissue Sarcoma - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T4340 - Name: Osteosarcoma - Relevance: HIGH - As Found: Osteogenic Sarcoma ### Condition Browse Module - Meshes - ID: D000012516 - Term: Osteosarcoma - ID: D000059350 - Term: Chronic Pain - ID: D000010149 - Term: Pain, Postoperative ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05908279 **Acronym:** GAIT-PD **Brief Title:** Gait Control in Parkinson Disease **Official Title:** Flexible Control of Gait in Parkinson Disease: Effect of Task Instruction on the Exploitation of Redundancy in Speed Control. #### Organization Study ID Info **ID:** GAIT-PD #### Organization **Class:** OTHER **Full Name:** Université Catholique de Louvain ### Status Module #### Completion Date **Date:** 2027-10-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-06-18 **Type:** ACTUAL **Last Update Submit Date:** 2023-06-08 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-05-01 **Type:** ACTUAL **Status Verified Date:** 2023-06 #### Study First Post Date **Date:** 2023-06-18 **Type:** ACTUAL **Study First Submit Date:** 2023-05-25 **Study First Submit QC Date:** 2023-06-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Université Catholique de Louvain #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Previous work has shown that a statistical property of gait characterised by long-range autocorrelation functions is altered in Parkinson disease (PD). On the other hand it has been suggested that the same property is linked to the ability in healthy humans to co-regulate the amplitude and cadence of strides towards maintaining a constant speed. Here the investigators want to better understand why it is altered in PD by measuring the transitions between gait instructed by a metronome, and gait without metronome. The experimental conditions will allow the comparisons between these transitions across PD and healthy groups of volunteers, and assess differences based on statistical and computational modelling. The link with potential freezing episodes will also be studied to assess whether the statistical determinants of gait control in this population can be used as a proxy or predictor of the occurence of freezing episodes. ### Conditions Module **Conditions:** - Parkinson Disease ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with Parkinson's disease **Intervention Names:** - Other: Walking test - Other: Disease assessement **Label:** PD #### Arm Group 2 **Description:** Healthy volunteers **Intervention Names:** - Other: Walking test **Label:** Control ### Interventions #### Intervention 1 **Arm Group Labels:** - Control - PD **Description:** Walk with and without a metronome **Name:** Walking test **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - PD **Description:** Disease stage assessed by a doctor **Name:** Disease assessement **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Time between two consecutive heel strikes. Units are seconds. **Measure:** Stride cadence **Time Frame:** Measured during the entire experiment (an average of 4.5 years) **Description:** Distance between two consecutive heel strikes. Units are meters. **Measure:** Stride amplitude **Time Frame:** Measured during the entire experiment (an average of 4.5 years) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients and volunteers able to walk for 20mins and without other neurological disorders. Exclusion Criteria: * Patients or volunteers unable to walk for 20mins and with other neurological disorders. **Healthy Volunteers:** True **Maximum Age:** 99 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** One group of volunteers with previous diagnosis of Parkinson disease and one group of age and sex matched healthy volunteers. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** andre.mouraux@uclouvain.be **Name:** André Mouraux, PhD **Phone:** +32 2 764 54 47 **Role:** CONTACT **Contact 2:** **Email:** frederic.crevecoeur@uclouvain.be **Name:** Frederic Crevecoeur **Role:** CONTACT #### Locations **Location 1:** **City:** Louvain-la-Neuve **Contacts:** ***Contact 1:*** - **Email:** andre.mouraux@uclouvain.be - **Name:** Andre Mouraux, PhD - **Phone:** +32 2 764 54 47 - **Role:** CONTACT **Country:** Belgium **Facility:** Université catholique de Louvain **Status:** RECRUITING **Zip:** 1348 #### Overall Officials **Official 1:** **Affiliation:** Université Catholique de Louvain **Name:** Frederic Crevecoeur **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020734 - Term: Parkinsonian Disorders - ID: D000001480 - Term: Basal Ganglia Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009069 - Term: Movement Disorders - ID: D000080874 - Term: Synucleinopathies - ID: D000019636 - Term: Neurodegenerative Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M13213 - Name: Parkinson Disease - Relevance: HIGH - As Found: Parkinson's Disease - ID: M22494 - Name: Parkinsonian Disorders - Relevance: LOW - As Found: Unknown - ID: M25603 - Name: Ganglion Cysts - Relevance: LOW - As Found: Unknown - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M4774 - Name: Basal Ganglia Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M2217 - Name: Synucleinopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010300 - Term: Parkinson Disease ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02669979 **Brief Title:** Domiciliary Professional Oral Care for Dependent Elderly **Official Title:** Domiciliary Professional Oral Care for Dependent Elderly - Access to Improved Oral and General Health? #### Organization Study ID Info **ID:** KarolinskaACT #### Organization **Class:** OTHER **Full Name:** Karolinska Institutet ### Status Module #### Completion Date **Date:** 2017-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-08-13 **Type:** ACTUAL **Last Update Submit Date:** 2018-08-10 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-04 **Type:** ACTUAL #### Start Date **Date:** 2016-01 **Type:** ACTUAL **Status Verified Date:** 2018-08 #### Study First Post Date **Date:** 2016-02-01 **Type:** ESTIMATED **Study First Submit Date:** 2016-01-19 **Study First Submit QC Date:** 2016-01-29 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** The Swedish Research Council #### Lead Sponsor **Class:** OTHER **Name:** Karolinska Institutet #### Responsible Party **Investigator Affiliation:** Karolinska Institutet **Investigator Full Name:** Inger Wårdh **Investigator Title:** PhD Associate professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Today's increase of dentate elderly, many of them dependent, is a challenge, both according to the personal daily oral hygiene and dentistry. This is not only an oral problem, as research findings point to strong associations between oral and general health, even mortality. These findings are especially noticeable in elderly and frail individuals. Dental care is usually performed in stationary dental clinics where the patients are transported to receive treatment. Dependent elderly dental patients may present many obstacles to traditional dental care due to cognitive limitations or dementia, mobility or transport problems. An alternative is domiciliary dental care where the dental staff performs the treatment by a home visit, in the patients daily living environment. The ability to handle personal oral hygiene is often decreased in these patients and left to overburdened nursing staff that often also lack sufficient knowledge about oral health care, why prophylactic professional oral care is especially important. This type of care can with rather simple equipments be performed as domiciliary treatment of good quality, while more advanced dental care may present restrictions in the home environment. However, in the Swedish dental system with subsidized dental care for dependent and elderly patients, there are restrictions for the number of prophylactic oral care treatments. The levels vary in different counties and regions. The rationale for this is probably tradition and economy as scientific evidence is lacking. The aim with this project is to develop domiciliary professional oral care. The researchers will compare the effect of different regimens for domiciliary prophylactic professional oral care both according to content and frequency. The overall aim is to establish relevant recommendations for domiciliary prophylactic professional oral care. **Detailed Description:** Background: An increasing number of research publications point to the association between oral and general health. There are reports about associations between oral infections, coronary diseases, diabetes and respiratory tract infections but also between a high oral opportunistic micro flora and increased mortality in frail elderly individuals. It is important to develop oral care methods that effectively prevent the growth of an opportunistic micro flora and och oral diseases. Especially important is preventive methods in old and dependent individuals as these vulnerable patients groups have limited possibilities and access to relevant oral health care. Professional oral care have been seen as an effective method to prevent dental diseases as caries and periodontal problems in elderly but in the new National guidelines for dentistry there is pointed to that there are no scientific proof for the effect of professional oral care, besides ordinary daily oral care in grownups. This conclusion could not be translated to frail elderly who are dependent on help from the nursing staff to receive or perform daily oral hygiene. The effect of domiciliary oral care have to our knowledge, not been explored. This type of care can with rather simple equipments be performed with good quality, while more advanced dental care may present more restrictions in the home environment. However, in the Swedish dental system with subsidized dental care for dependent and elderly patients, there are restrictions for the number of prophylactic oral care treatments. The levels vary in different counties and regions. The rationale for this is probably tradition and economy as scientific evidence is lacking. Aim: The aim is to develop and evaluate domiciliary prophylactic professional oral care. The researchers will compare the effect of different regimens for domiciliary prophylactic professional oral care on oral health in dependent elderly, both according to content and frequency. The overall aim is to to establish relevant recommendations for domiciliary prophylactic professional oral care. Project plan: Design: The project is designed as a randomised, double blind, clinical study with two parallel study arms. Randomisation is performed at group level (ward unit), blind for the researchers and participants (allocation concealment). Data analysis will be made on individual level but presented at group level. Appliance for Ethical permission has been made and approved for the first part of the study that already is performed but it has to be completed with an approval for the continuing part of the study. Pilot study: Before the main clinical study started, a pilot study was performed in three months (half the time of the main study) to test the relevance of the study protocol, sample size but also the possible difference in oral health effects of hands-on-work including professional oral care compared to information and instruction. The pilot study was performed with 96 individuals included that randomly received professional oral care by a dental hygienist each month, information and re-instruction about oral care together with their daily care staff each month or served as a control. They all received baseline and effect registrations but with a selected number of variables that covered the purpose with the pilot study. Participants The main study is planned to include 366 (2 x150 + 18 % compensation for estimated drop outs) dependent elderly individual in nursing homes. Inclusion criteria: at least 10 natural or fixed teeth inclusively osseointegrated implants, non smokers, ability to cooperate for oral assessment in 5-10 minutes and able to answer the Oral Health Related Quality of Life formula. Exclusion criteria: edentulousness and full dentures, cognitive limitations that is an obstacle for cooperation, malignancies and/or immunosuppressive diseases, coagulation defects. Anticoagulants will be registered but not as an exclusion criteria. The participants are consecutively recruited and sorted into the ward research group after informed consent - eventually with help of an advocate, (the ward research group is decided by chance when the first participant in the ward is recruited). A control group without any professional oral care during 6 months, will not be included in the main study, as it is not seen as good ethics to collect data without offer any oral care. Besides this, "ordinary care", either from the elderly themselves or nursing staff, vary. This is a confounding factor in the project that as far as possible is controlled by giving the same recommendations about routines for daily oral care to all included wards and participants. In accordance with ethical rules, the participants can interrupt their participation without explanation and negative consequences. Sample size and power estimation: The sample size is based on a power calculation of the least amount of individuals in each group to detect a significant difference of 7 % concerning bleeding at probing (BoP) between the groups (cluster randomisation in blocks on ward level to diminish unbalance in number of individuals in each ward), with risks for Type-I and Type-II estimated to alpha =0.05 and beta =0.20. For the primary effect variable, BoP (17), 150 individuals in each group are required. Due to high mortality in the study group (about 30 % in a year) and drop out because of illness, the sample will be increased with 18%. Accordingly, the number of participants will be n=366 (183 in each group). When drop outs, data analysis is performed due to intention-to-treat method. Intervention: All involved wards, nursing staff and relatives will be informed by a meeting where the project is presented and explained. At this occasion, a questionnaire will be distributed to the nursing staff to explore their knowledge and opinion about oral health care. Standard rules for the daily oral hygiene during the study period will be set out. As far as possible, the oral care circumstances should be similar on each included study ward. Products containing chlorhexidine will be set out two weeks before the study start. At baseline all participants will have an oral assessment together with a medical report including drug use, delivered by a registered nurse. On a subgroup consisting of 100 individuals (50 in each study arm), the oral micro flora is measured through sampling collected from supra gingival plaque with sterile toothpicks. The total number of microorganisms growing and the proportion of a) lactobacilli and streptococcus mutans and b) opportunistic bacteria including Staphylococcus aureus and candida are calculated. As all participants is supposed to be eligible for free oral assessments at home and necessary dental care, their written oral care card will be updated with the routines that are actual during the study period. The exact performance of these routines will be established when the pilot study is evaluated. Intervention in the research groups is professional oral care with electric tooth brush (Braun Oral-B), "ordinary" fluoridated tooth paste (1100-1450 ppm NaF), and repeated oral care instruction to participants and staff (contact person) supra gingival depuration if necessary, fluor varnish and delivery of saliva stimulating and replacing products to participants that show a stimulated salivation less than 1,0 ml/minute. All groups are continued during a period of 12 months. If electric tooth brush not is tolerated, an ordinary suitable tooth brush, chosen by the dental hygienist, will be used. Group A receive treatment each month, Group B receive no additional treatment (control). Each participant is asked to brush their teeth every morning and evening with an "ordinary" fluoridated tooth paste (1100-1450 ppm NaF). Questions related to chewing ability and oral health related quality of life will be asked due to Geriatric Oral Health Assessment Index (GOHAI), as well as questions with the aim to evaluate how domiciliary professional oral care is experienced by the participants. Clinical registrations due to study protocol (see below: effect variables), are performed by calibrated dental staff (dentists or dental hygienists) at baseline, after three months and after six months in all three study groups. The dental staff will also have to get an opinion about the compliance of recommended routines and products with the help of questions to both the participants and the nursing staff. The exact construction of these questions will be made during the project period, as no validated formulas are available. A coordinator will be required to monitor the including researchers concerning their commitment to the study protocol and to handle unforeseeable events, like patient safety, complaints, complications. Any treatment complications that are suspected or reported, will be registred and the project leader act upon a relevant way. If any participant is in need of dental care besides what the project activities can supply, this will also be reported to and handled by the project leader. Effect variables: Primary effect variable: bleeding on probing (BoP) in the gingival sulcus on buccal surfaces concerning the teeth 13, 12, 11, 21, 23, and 33, 32, 31, 41, 43 or the nearest comparable teeth. The bleeding will be scored at four levels (0-3) due to Modified Sulcus Bleeding Index. The measurements are performed at baseline and after three and each third month in both study groups. Comparison will be made on group level. Secondary effect variables: Manifest caries is registred with the tooth as analysis unit DT Measurements are performed at baseline and each third month in both study groups. Oral hygiene: Mucosal and plaque index, MPS, will be used both for fixed teeth and and partial removable dentures. The measurements are performed at baseline and each third month in both study groups.. Oral micro flora: The oral micro flora is measured through sampling collected from the same teeth as above mentioned according to BoP. The measurements are performed at baseline and each six month in both groups on the sub sample of 50 in each group. Tertiary effect variables: Number of episodes with respiratory tract infections, pneumonia and use of antibiotics. Data is collected from a registered nurse. Measurements are performed at baseline and each six month in both groups. Oral Health Related Quality of Life will also be measured by GOHAI, at baseline and each six month. For the related nursing staff, two formulas will be used to measure knowledge about and attitudes to oral health, at baseline and each six month. Significance: Newly submitted data from professor Maude Wikström and her research group, inclusive main applicant Inger Wårdh, has pointed to that extensive oral hygiene routines may be effective in removing dental plaque but not opportunistic pathogens. This could probably be caused by oral dryness as the data also point to a need of stimulated flow at 1,0 ml/min before the pathogenic oral flora disappear, probably due to the self-cleaning effect of saliva. An important part of the professional oral health care would therefore be to supply with saliva stimulating or replacing products. Ongoing research also points to that we ought to use other products with the purpose to receive a higher pH-level in the oral cavity .It is lack of knowledge both according to content and frequency of professional oral care for dependent elderly and consequently neither how it ought to be subsidized from the government. However, in the first step it is important to create good routines for domiciliary professional oral care, which this project is able to do. The results will be published in scientific journals and also planned to be used in a PhD thesis and two master thesis. ### Conditions Module **Conditions:** - Dental Caries - Gingivitis **Keywords:** - elderly - oral care ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 200 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intervention in the research groups is professional oral care with tooth brush, "ordinary" fluoridated tooth paste (1100-1450 ppm NaF), and repeated oral care instruction to participants and staff (contact person) , supra gingival depuration if necessary. The group receive treatment each month. **Intervention Names:** - Other: Intervention **Label:** Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Care as usual. Common oral hygiene help administered by nursing staff. **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** Professional oral care **Name:** Intervention **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Number of episodes with respiratory tract infections, pneumonia and use of antibiotics. Data is collected from a registered nurse. Measurements are performed at baseline and each six month up to 12 months in both groups. **Measure:** Changes from baseline in episodes with respiratory tract infections each six month **Time Frame:** 12 months **Description:** Oral Health Related Quality of Life will be measured by the validated index GOHAI, Geriatric Oral Health Assessment Index. Measurements are performed at baseline and each six month up to 12 months in both groups. **Measure:** Changes from baseline in Oral Health Related Quality of Life, each six month **Time Frame:** 12 month **Description:** The related nursing staff will be evaluated by a questionnaire that deals with the knowledge about oral health. Measurements are performed at baseline and each six month up to 12 months in both groups. **Measure:** Changes from baseline in Knowledge within the nursing staff, each six months **Time Frame:** 12 months **Description:** The related nursing staff will be evaluated by an index that deals with attitudes, the nursing DCBS (Dental Coping Beliefs Scale), to oral health. Measurements are performed at baseline and each six month up to 12 months in both groups. **Measure:** Changes from baseline in attitudes within the nursing staff, each six months **Time Frame:** 12 months #### Primary Outcomes **Description:** Primary effect variable: bleeding on probing (BoP) in the gingival sulcus on buccal surfaces concerning the teeth 13, 12, 11, 21, 23, and 33, 32, 31, 41, 43 or the nearest comparable teeth. The bleeding will be scored at four levels (0-3) due to Modified Sulcus Bleeding Index. The measurements are performed at baseline and each third month up to 12 months in both study groups. Comparison will be made on group level. **Measure:** Changes from baseline in bleeding on probing (BoP) each third month **Time Frame:** 12 months #### Secondary Outcomes **Description:** Manifest caries is registered with the tooth as analysis unit DT (decayed teeth). Measurements are performed each third month up to 12 months in both study groups. **Measure:** Changes from baseline in caries each third month **Time Frame:** 12 months **Description:** Oral hygiene will be measured by Mucosal and plaque index. MPS, that will be used both for fixed teeth and and partial removable dentures. The measurements are performed at baseline and each third month up to 12 months in both study groups. The index is composed by a four level plaque score and a four level mucosal score that are added to a composed score in three levels: acceptable, unacceptable, bad **Measure:** Changes from baseline in Oral hygiene, each third month **Time Frame:** 12 months **Description:** Oral micro flora: The oral micro flora is measured through sampling collected from the same teeth as above mentioned according to BoP. The measurements are performed at baseline and each six month up to 12 months in both groups on the sub sample of 50 in each group. **Measure:** Changes from baseline in oral micro flora, each six month **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 10 or more natural teeth or fixed teeth inclusively osseointegrated implants * non smokers, * no or mild cognitive impairments Exclusion criteria: * severe cognitive impairments * edentulousness and full dentures * malignancies and/or immunosuppressive diseases, coagulation defects. Anticoagulants will be registered but not as an exclusion criteria. **Maximum Age:** 95 Years **Minimum Age:** 80 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Stockholm **Country:** Sweden **Facility:** Karolinsk institutet #### Overall Officials **Official 1:** **Affiliation:** Karolinska Institutet **Name:** Inger Wårdh, Assoc prof **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Data will be be published in scientific papers but not on individual level, only group level **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017001 - Term: Tooth Demineralization - ID: D000014076 - Term: Tooth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000007239 - Term: Infections - ID: D000005882 - Term: Gingival Diseases - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6928 - Name: Dental Caries - Relevance: HIGH - As Found: Dental Caries - ID: M9003 - Name: Gingivitis - Relevance: HIGH - As Found: Gingivitis - ID: M19339 - Name: Tooth Demineralization - Relevance: LOW - As Found: Unknown - ID: M16831 - Name: Tooth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M8994 - Name: Gingival Diseases - Relevance: LOW - As Found: Unknown - ID: M13419 - Name: Periodontal Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005891 - Term: Gingivitis - ID: D000003731 - Term: Dental Caries ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02682979 **Brief Title:** Continuity of the Therapeutic Limitation Code: Analysis of the Variables of Admission in the Emergency Service That Are Associated With a Therapeutic Limitation Upon Exit **Official Title:** Continuity of the Therapeutic Limitation Code: Analysis of the Variables of Admission in the Emergency Service That Are Associated With a Therapeutic Limitation Upon Exit #### Organization Study ID Info **ID:** CHUB-Therapeutic limitations #### Organization **Class:** OTHER **Full Name:** Brugmann University Hospital ### Status Module #### Completion Date **Date:** 2017-12-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-01-18 **Type:** ACTUAL **Last Update Submit Date:** 2018-01-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-12-01 **Type:** ACTUAL #### Start Date **Date:** 2016-02-01 **Type:** ACTUAL **Status Verified Date:** 2018-01 #### Study First Post Date **Date:** 2016-02-17 **Type:** ESTIMATED **Study First Submit Date:** 2016-02-11 **Study First Submit QC Date:** 2016-02-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Brugmann University Hospital #### Responsible Party **Investigator Affiliation:** Brugmann University Hospital **Investigator Full Name:** Murielle Surquin **Investigator Title:** Head of clinic **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Demographically, the geriatric population is expanding. It is also increasingly found in the emergency services.However, emergency services are not designed to accommodate these patients, whose needs are specific. This population is defined by complex physical and psychosocial needs, included in a comprehensive geriatric assessment too complex to be carried out in the emergency services. Many publications focused on ways to prevent potentially avoidable visits to geriatric patients in emergency services. People rely upon a therapeutic limitation code established for these patients to determine the intensity of the care that may be given to them. However, few geriatric patients arriving in the emergency services were already given such a code. As a consequence, the intensity of the care given to these emergency patients is influenced by the perception of the functional and cognitive status of the patient, even if part of this perception is incorrect. Moreover, it is also well established that the outcome of geriatric patients with severe pathologies at admission is often poor and that there is a need to find alternatives to the intensive treatment offered. The goal of this study will be to determine the prevalence of the presence of a therapeutic limitation code in geriatric patients at hospital admission / admission to the emergency department, and when they leave the hospital. This will be carried out for all geriatric patients residing or placed in nursing homes at the end of the hospitalization.The investigators postulate that establishing a therapeutic limitation code for these fragile patients, before they leave the hospital for a nursing home, would reduce the number of future admissions of these patients in the emergency department. **Detailed Description:** Demographically, the geriatric population is expanding. It is also increasingly found in the emergency services.However, emergency services are not designed to accommodate these patients, whose needs are specific. This population is defined by complex physical and psychosocial needs, included in a comprehensive geriatric assessment too complex to be carried out in the emergency services. The multidisciplinary care they need takes time. Several options are investigated worldwide to properly manage these fragile patients: * Scales of frailty and functional decline screening * Specialized care units: the Mobile Geriatric Team, the Emergency short-stay units, the acute care geriatric unit, the geriatric nurse liaison model, or a service specific geriatric emergency. Many publications focused on ways to prevent potentially avoidable visits to geriatric patients in emergency services. People rely upon a therapeutic limitation code established for these patients to determine the intensity of the care that may be given to them. However, few geriatric patients arriving in the emergency services were already given such a code. As a consequence, the intensity of the care given to these emergency patients is influenced by the perception of the functional and cognitive status of the patient, even if part of this perception is incorrect. Moreover, it is also well established that the outcome of geriatric patients with severe pathologies at admission is often poor and that there is a need to find alternatives to the intensive treatment offered. The goal of this study will be to determine the prevalence of the presence of a therapeutic limitation code in geriatric patients at hospital admission / admission to the emergency department, and when they leave the hospital. This will be carried out for all geriatric patients residing or placed in nursing homes at the end of the hospitalization.The investigators postulate that establishing a therapeutic limitation code for these fragile patients, before they leave the hospital for a nursing home, would reduce the number of future admissions of these patients in the emergency department. Furthermore, this study offers the prospective to establish in the future a systematic implementation of the therapeutic limitation code for geriatric patients residing in nursing homes, therefore anticipating the various issues specific to his population in the emergency department. ### Conditions Module **Conditions:** - Geriatrics **Keywords:** - therapeutic limitation code - emergency unit admittance ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 100 consecutive geriatric patients admitted in the Emergency Department of the Brugmann Hospital, Horta site, from 01/04/2015. **Intervention Names:** - Other: Medical files analysis **Label:** Geriatric patients ### Interventions #### Intervention 1 **Arm Group Labels:** - Geriatric patients **Description:** Retrospective analysis of the medical files according to medical, social and geriatric criteria. **Name:** Medical files analysis **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The medical files of the patients admitted in the emergency department of the hospital, from 01/04/2015, will be examined in order to determine if they had a therapeutic limitation code upon admittance. **Measure:** Prevalence of a therapeutic limitation code (hospital admittance) **Time Frame:** Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months) **Description:** The medical files of the patients admitted in the emergency department of the hospital, from 01/04/2015, will be examined in order to determine if received a therapeutic limitation code upon hospital discharge. **Measure:** Prevalence of a therapeutic limitation code (hospital discharge) **Time Frame:** Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months) #### Secondary Outcomes **Description:** Retrospective analysis of patient medical files. The investigators will evaluate if the social status of the patient is linked to a therapeutic limitation decision upon hospital discharge. **Measure:** social status **Time Frame:** Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months) **Description:** Retrospective analysis of patient medical files.The investigators will evaluate if the autonomy of the patient is linked to a therapeutic limitation decision upon hospital discharge. Patient autonomy is evaluated by the results of either of these two tests: the Sherpa test or the Katz scale. **Measure:** autonomy status **Time Frame:** Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months) **Description:** Retrospective analysis of patient medical files.The investigators will evaluate if the cognitive status of the patient is linked to a therapeutic limitation decision upon hospital discharge. The patient cognitive status is evaluated by the results of either the confusion assessment method or the mini mental state evaluation test. **Measure:** cognitive status **Time Frame:** Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months) **Description:** Retrospective analysis of patient medical files.The investigators will evaluate if the admission motive/established diagnosis is linked to a therapeutic limitation decision upon hospital discharge. **Measure:** diagnosis **Time Frame:** Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months) **Description:** Retrospective analysis of patient medical files.The investigators will evaluate if the hospitalisation length is linked to a therapeutic limitation decision upon hospital discharge. **Measure:** hospitalisation length **Time Frame:** Patients hopitalized from 01/04/2015 till present date (11 months) **Description:** Retrospective analysis of patient medical files.The investigators will evaluate if the nutrition status (albumine measurement) is linked to a therapeutic limitation decision upon hospital discharge. **Measure:** Albumine **Time Frame:** Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months) **Description:** Retrospective analysis of patient medical files.The investigators will evaluate if the hydration level (combined sodium and creatinine/urea measurement) is linked to a therapeutic limitation decision upon hospital discharge. **Measure:** Hydratation level **Time Frame:** Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months) **Description:** Retrospective analysis of patient medical files.The investigators will evaluate if an unintentional weigh loss is linked to a therapeutic limitation decision upon hospital discharge. **Measure:** Unintentional weigh loss **Time Frame:** Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months) **Description:** Retrospective analysis of patient medical files.The investigators will evaluate if the presence of comorbidities (dementia or severe cardiac decompensation or cancer or pneumonia or severe cardio-vascular diseases or hepatic insufficiency) is linked to a therapeutic limitation decision upon hospital discharge. **Measure:** Presence of comorbidities **Time Frame:** Patients hospitalized from 01/04/2015 till 11/02/2016 (11 months) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients admitted in the hospital via the emergency department and placed in a nursing home upon hospital discharge * Patients will an available global geriatric evaluation (either realized in the geriatric ward, either realized by the geriatric team) Exclusion Criteria: * if multiple hospitalizations occur during the study length, data related to the first hospitalization only will be analyzed. **Minimum Age:** 75 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - OLDER_ADULT **Study Population:** 100 consecutive geriatric patients admitted in the emergency department of the Brugmann Hospital, Horta site, from 01/04/2015 till 11/02/2016. ### Contacts Locations Module #### Locations **Location 1:** **City:** Brussels **Country:** Belgium **Facility:** CHU Brugmann **Zip:** 1020 #### Overall Officials **Official 1:** **Affiliation:** CHU Brugmann **Name:** Murielle Surquin, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** CHU Brugmann **Name:** Axelle Gregory, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available. **PMID:** 14044222 **Citation:** Folstein MF, Robins LN, Helzer JE. The Mini-Mental State Examination. Arch Gen Psychiatry. 1983 Jul;40(7):812. doi: 10.1001/archpsyc.1983.01790060110016. No abstract available. **PMID:** 6860082 **Citation:** Yesavage JA. Geriatric Depression Scale. Psychopharmacol Bull. 1988;24(4):709-11. No abstract available. **PMID:** 3249773 **Citation:** Clement JP, Nassif RF, Leger JM, Marchan F. [Development and contribution to the validation of a brief French version of the Yesavage Geriatric Depression Scale]. Encephale. 1997 Mar-Apr;23(2):91-9. French. **PMID:** 9264935 **Citation:** Goring H, Baldwin R, Marriott A, Pratt H, Roberts C. Validation of short screening tests for depression and cognitive impairment in older medically ill inpatients. Int J Geriatr Psychiatry. 2004 May;19(5):465-71. doi: 10.1002/gps.1115. **PMID:** 15156548 **Citation:** Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941. **PMID:** 2240918 **Citation:** Katz S. Assessing self-maintenance: activities of daily living, mobility, and instrumental activities of daily living. J Am Geriatr Soc. 1983 Dec;31(12):721-7. doi: 10.1111/j.1532-5415.1983.tb03391.x. **PMID:** 6418786 **Citation:** Katz PR, Karuza J, Kolassa J, Hutson A. Medical practice with nursing home residents: results from the National Physician Professional Activities Census. J Am Geriatr Soc. 1997 Aug;45(8):911-7. doi: 10.1111/j.1532-5415.1997.tb02958.x. **PMID:** 9256840 **Citation:** Katz PP, Yelin EH. Activity loss and the onset of depressive symptoms: do some activities matter more than others? Arthritis Rheum. 2001 May;44(5):1194-202. doi: 10.1002/1529-0131(200105)44:53.0.CO;2-6. **PMID:** 11352254 **Citation:** Katz PP, Morris A. Use of accommodations for valued life activities: prevalence and effects on disability scores. Arthritis Rheum. 2007 Jun 15;57(5):730-7. doi: 10.1002/art.22765. **PMID:** 17530671 **Citation:** Derouesne C, Poitreneau J, Hugonot L, Kalafat M, Dubois B, Laurent B. [Mini-Mental State Examination:a useful method for the evaluation of the cognitive status of patients by the clinician. Consensual French version]. Presse Med. 1999 Jun 12;28(21):1141-8. French. **PMID:** 10399508 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7796 - Name: Emergencies - Relevance: HIGH - As Found: Emergency - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004630 - Term: Emergencies ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00233779 **Brief Title:** Evaluation of Sirolimus-Eluting, Heparin-Coated CoCr Stent in the Treatment of de Novo Coronary Artery Lesions in Small Vessels(EVOLUTION) **Official Title:** Sirolimus-Eluting, Heparin-Coated Cobalt Chromium Balloon-Expandable Stent in the Treatment of Patients With de Novo Coronary Artery Lesions in Small Vessels (EVOLUTION) #### Organization Study ID Info **ID:** P03-7401 #### Organization **Class:** INDUSTRY **Full Name:** Cordis Corporation ### Status Module #### Completion Date **Date:** 2004-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2007-06-27 **Type:** ESTIMATED **Last Update Submit Date:** 2007-06-26 **Overall Status:** COMPLETED #### Start Date **Date:** 2003-10 **Status Verified Date:** 2007-06 #### Study First Post Date **Date:** 2005-10-06 **Type:** ESTIMATED **Study First Submit Date:** 2005-10-04 **Study First Submit QC Date:** 2005-10-04 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Cordis Corporation ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The objective of this study is to assess the performance and safety of a sirolimus-eluting, heparin-coated, cobalt chromium balloon-expandable stent (Small Vessel Stent) in patients with de novo native coronary artery lesions in small vessels as compared to historical data from small vessel patients in the RAVEL trial receiving the Sirolimus-eluting Bx VELOCITY™ stent. ### Conditions Module **Conditions:** - Coronary Artery Disease ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 52 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** SIROLIMUS-ELUTING, HEPARIN-COATED CoCr BALLOON-EXPANDABLE STENT **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** The primary endpoint is in-stent late loss as measured by quantitative coronary angiography (QCA) at 6 months post-procedure. **Time Frame:** 6 months post-procedure #### Secondary Outcomes **Measure:** In-lesion late loss as measured by QCA at 6 months post-procedure. **Time Frame:** 6 months post-procedure **Measure:** In-stent and in-lesion minimum lumen diameter (MLD) and percent diameter stenosis (%DS) by QCA post-procedure and at 6 months. **Time Frame:** Post-procedure and at 6 months **Measure:** Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used. **Measure:** Target Lesion Revascularization (TLR) at six and 12 months. **Time Frame:** 6 and 12 months **Measure:** Target Vessel Revascularization (TVR) at six and 12 months. **Time Frame:** 6 and 12 months **Measure:** Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days, 6 months and 12 months post-procedure. **Time Frame:** 30 days, 6 months and 12 months post-procedure **Measure:** Stent Lumen and Stent Obstruction Volume by Intravascular Ultrasound (IVUS) at post procedure and six months follow-up. **Time Frame:** post procedure and six months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. The patient must be minimum 18 years of age; 2. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III) OR patients with documented silent ischemia; 3 Treatment of one lesion in a native coronary artery. The treated lesion will be the one with the highest % diameter stenosis by visual estimate. Additional study stents may be used for procedural complications such as dissections. Multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. If other non-target vessels are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion; 4. The target lesion is \>/=2.0 mm and \</=2.5mm in diameter (visual estimate); 5. The target lesion can be covered with a single 18mm stent; 6. Target lesion stenosis is \>50% and \<100% (TIMI I) (visual estimate); Exclusion Criteria: 1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK\>2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment; 2. Target lesion is due to in-stent restenosis; 3. Ejection fraction 30%; 4. Totally occluded vessel (TIMI 0 level); 5. Impaired renal function (creatinine \> 3.0 mg/dL); **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Sao Paolo **Country:** Brazil **Facility:** Instituto Dante Pazzanese de Cardiologia #### Overall Officials **Official 1:** **Affiliation:** Instituto Dante Pazzanese de Cardiologia **Name:** J. E. Sousa, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003327 - Term: Coronary Disease - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6549 - Name: Coronary Disease - Relevance: LOW - As Found: Unknown - ID: M6546 - Name: Coronary Artery Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003324 - Term: Coronary Artery Disease ### Intervention Browse Module - Ancestors - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000000903 - Term: Antibiotics, Antineoplastic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000000935 - Term: Antifungal Agents - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000925 - Term: Anticoagulants - ID: D000005343 - Term: Fibrinolytic Agents - ID: D000050299 - Term: Fibrin Modulating Agents ### Intervention Browse Module - Browse Branches - Abbrev: FiAg - Name: Fibrinolytic Agents - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Micro - Name: Micronutrients ### Intervention Browse Module - Browse Leaves - ID: M9579 - Name: Heparin - Relevance: HIGH - As Found: Obesity - ID: M21960 - Name: Sirolimus - Relevance: HIGH - As Found: Included - ID: M6097 - Name: Chromium - Relevance: LOW - As Found: Unknown - ID: M46053 - Name: Calcium heparin - Relevance: LOW - As Found: Unknown - ID: M6265 - Name: Cobalt - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M6252 - Name: Clotrimazole - Relevance: LOW - As Found: Unknown - ID: M11796 - Name: Miconazole - Relevance: LOW - As Found: Unknown - ID: M4254 - Name: Antifungal Agents - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M4244 - Name: Anticoagulants - Relevance: LOW - As Found: Unknown - ID: M8473 - Name: Fibrinolytic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000020123 - Term: Sirolimus - ID: D000006493 - Term: Heparin ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00508079 **Brief Title:** Evaluating the Occurence of New and Progression of Existing Peripheral Venous Disease in Leg Veins **Official Title:** Incidence and Progression of Peripheral Venous Disease #### Organization Study ID Info **ID:** 1389 #### Organization **Class:** OTHER **Full Name:** University of California, San Diego #### Secondary ID Infos **ID:** R01HL084229-01A1 **Link:** https://reporter.nih.gov/quickSearch/R01HL084229-01A1 **Type:** NIH ### Status Module #### Completion Date **Date:** 2011-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2013-07-12 **Type:** ESTIMATED **Last Update Submit Date:** 2013-07-10 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2011-01 **Type:** ACTUAL #### Start Date **Date:** 2007-07 **Status Verified Date:** 2013-07 #### Study First Post Date **Date:** 2007-07-27 **Type:** ESTIMATED **Study First Submit Date:** 2007-07-25 **Study First Submit QC Date:** 2007-07-25 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Heart, Lung, and Blood Institute (NHLBI) #### Lead Sponsor **Class:** OTHER **Name:** University of California, San Diego #### Responsible Party **Investigator Affiliation:** University of California, San Diego **Investigator Full Name:** Dr. Michael H. Criqui **Investigator Title:** Distinguished Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Peripheral venous disease occurs when a vein becomes damaged or blocked. It can occur almost anywhere in the body, but is most common in the arms and legs. This study will examine people who participated in a previous venous disease study to evaluate changes in leg veins and venous disease status over a period of 11 years. **Detailed Description:** Peripheral venous disease is a general term for damage, defects, or blockage that occurs in the peripheral veins, which carry blood from the hands and feet back to the heart to receive oxygen. The most common cause of peripheral venous disease is a blood clot that blocks a vein. Varicose veins, which are swollen blood vessels near the surface of the skin, and chronic venous insufficiency, a condition in which blood in the leg veins does not drain properly, are two other common types of peripheral venous disease. From 1996 to 2000, the San Diego Population Study (SDPS) evaluated a group of individuals to gather information on the prevalence of venous disease. This current study will re-evaluate the SDPS participants to document changes that have occurred in their leg veins over the past 11 years, including any new venous disease and any progression of existing venous disease. Study researchers will also evaluate how venous disease relates to risk factors, symptoms, and quality of life issues. This study will enroll people who participated in the SDPS study. Each participant will attend one study visit. Study staff will conduct a 1-hour interview with each participant to collect information on their medical history, disease-related symptoms, risk factors for venous disease, family health history, health habits, and quality of life. Blood collection will occur, participant's leg veins will be examined and photographed, and blood flow in the legs will be measured with an ultrasound. ### Conditions Module **Conditions:** - Peripheral Vascular Diseases **Keywords:** - Venous Disease - Varicose Veins - Chronic Venous Insufficiency - PAD ### Design Module #### Bio Spec **Description:** Whole blood, serum, plasma **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT #### Enrollment Info **Count:** 1103 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Measure:** Incident Venous Disease **Time Frame:** Since previous visit (approximately 11 years) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participated in the SDPS study **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Previous participants from the San Diego Population Study ### Contacts Locations Module #### Locations **Location 1:** **City:** La Jolla **Country:** United States **Facility:** University of California San Diego **State:** California **Zip:** 92093 #### Overall Officials **Official 1:** **Affiliation:** University of California, San Diego **Name:** Michael H. Criqui, MD, MPH **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000050197 - Term: Atherosclerosis - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M17400 - Name: Vascular Diseases - Relevance: HIGH - As Found: Vascular Disease - ID: M29213 - Name: Peripheral Arterial Disease - Relevance: HIGH - As Found: Peripheral Vascular Disease - ID: M18894 - Name: Peripheral Vascular Diseases - Relevance: HIGH - As Found: Peripheral Vascular Disease - ID: M17435 - Name: Venous Insufficiency - Relevance: LOW - As Found: Unknown - ID: M20559 - Name: Disease Progression - Relevance: LOW - As Found: Unknown - ID: M17396 - Name: Varicose Veins - Relevance: LOW - As Found: Unknown - ID: M26188 - Name: Atherosclerosis - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014652 - Term: Vascular Diseases - ID: D000016491 - Term: Peripheral Vascular Diseases - ID: D000058729 - Term: Peripheral Arterial Disease ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06293079 **Brief Title:** The Effect of Hybrid Telerehabilitation-Based Structured Exercise Programs in Patients With Multiple Sclerosis **Official Title:** The Effect of Hybrid Telerehabilitation-Based Structured Exercise Programs on Gait, Functional Capacity, EMG Muscle Activation and Fatigue in Patients With Multiple Sclerosis #### Organization Study ID Info **ID:** BiruniUnive #### Organization **Class:** OTHER **Full Name:** Biruni University #### Secondary ID Infos **Domain:** Biruni University **ID:** Researcher **Type:** OTHER ### Status Module #### Completion Date **Date:** 2024-08-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-03-05 **Type:** ACTUAL **Last Update Submit Date:** 2024-03-01 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-02-12 **Type:** ACTUAL #### Start Date **Date:** 2023-08-30 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-03-05 **Type:** ACTUAL **Study First Submit Date:** 2024-02-16 **Study First Submit QC Date:** 2024-03-01 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Biruni University #### Responsible Party **Investigator Affiliation:** Biruni University **Investigator Full Name:** Guzin Kaya Aytutuldu **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of our study is to compare the effects of hybrid telerehabilitation (TR)-based exercise program applied in patients with MS, only TR-based exercise program and only clinical-based exercise program on walking speed, functional capacity, peripheral muscle saturation and fatigue. Forty-five individuals with MS with EDSS scores between 0-4 will be included in the study. The patients will be randomized into three groups: Group A, Group B, and Group C. Group A- Telerehabilitation group will be included in an aerobic and strengthening exercise program over the synchronized videoconference system with the physiotherapist 2 days a week for 8 weeks. Group B- Hybrid Telerehabilitation group will be included in the same exercise program 2 days a week for 2 weeks in the clinic, and will continue remotely over the synchronized videoconference system with the physiotherapist 2 days a week for 6 weeks. In Group C-Clinical Based Rehabilitation group, the same exercise program will be applied in the clinic 2 days a week for 8 weeks. In addition to aerobic and strengthening exercises, traditional breathing exercises and energy conservation techniques will be taught to all three groups within the scope of patient education Demographic and clinical information of all patients to be included in the study will be recorded with a "Case Evaluation Form". The gait speed of the patients will be evaluated with the Timed 25-step walking test, their functional capacity with the 6-minute walking test, their Quadriceps muscle activation will be tested with the EMG muscle activation, the fatigue will be evaluated with the "Modified Fatigue Impact Scale", and the Patient Satisfaction with the "Global Rating Scale". In addition, feasibility evaluation will be made by calculating the attendance rate of the patients to the programs. All data will be evaluated by statistical analysis methods. **Detailed Description:** Multiple Sclerosis (MS) is a chronic progressive disease that often leads to deterioration of health-related quality of life, including symptoms such as muscle weakness, extreme fatigue, gait disturbances, sensory problems, balance problems, and chronic pain, cognitive and motor impairments. Physiotherapy and rehabilitation programs that include aerobic and progressive resistance exercises in the treatment of functional disorders by controlling the symptoms of the disease increase the quality of life by improving aerobic capacity, but sustainability can be difficult due to difficulties in accessing the clinic. Following exercise programs with telerehabilitation (TR) methods improves cognitive function, mobility, balance, participation, and quality of life by increasing physical activity and reducing fatigue. However, the details of the frequency, duration, and the way the program is delivered are not known, and although the exercise methods applied with TR methods are found to be as effective as the practices performed in the clinic, the remote limited patient-therapist relationship creates potential problems for patients to follow up on the digital platform. The hybrid TR model, in which a certain part of the exercise program is carried out face-to-face, can provide a solution to these problems by increasing patient-therapist communication. To the best of our knowledge, there is no study examining the effectiveness of a rehabilitation program applied with the hybrid TR model for individuals with MS. The aim of our study is to compare the effects of hybrid telerehabilitation (TR)-based exercise program applied in patients with MS, only TR-based exercise program and only clinical-based exercise program on walking speed, functional capacity, peripheral muscle saturation and fatigue. Forty-five individuals with MS with EDSS scores between 0-4 will be included in the study. The patients will be randomized into three groups: Group A, Group B, and Group C. Group A- Telerehabilitation group will be included in an aerobic and strengthening exercise program over the synchronized videoconference system with the physiotherapist 2 days a week for 8 weeks. Group B- Hybrid Telerehabilitation group will be included in the same exercise program 2 days a week for 2 weeks in the clinic, and will continue remotely over the synchronized videoconference system with the physiotherapist 2 days a week for 6 weeks. In Group C-Clinical Based Rehabilitation group, the same exercise program will be applied in the clinic 2 days a week for 8 weeks. In addition to aerobic and strengthening exercises, traditional breathing exercises and energy conservation techniques will be taught to all three groups within the scope of patient education Demographic and clinical information of all patients to be included in the study will be recorded with a "Case Evaluation Form". The gait speed of the patients will be evaluated with the Timed 25-step walking test, their functional capacity with the 6-minute walking test, their Quadriceps muscle activation will be tested with the EMG muscle activation, the fatigue will be evaluated with the "Modified Fatigue Impact Scale", and the Patient Satisfaction with the "Global Rating Scale". In addition, feasibility evaluation will be made by calculating the attendance rate of the patients to the programs. All data will be evaluated by statistical analysis methods. The aim of this study is to investigate the effect of hybrid telerehabilitation program on walking speed, functional capacity, peripheral muscle activation and fatigue in patients with MS. For these purposes: * To increase compliance and participation of MS patients in exercises, * To prevent fatigue by increasing the functional capacity of MS patients who regularly participate in exercise programs, * To provide a sustainable program for exercise continuity for MS patients who have difficulty reaching the clinic and to examine its effects on fatigue, * To compare the effects of Telerehabilitation, Hybrid Telerehabilitation and the same exercise programs performed in the clinic on gait speed, functional capacity, peripheral muscle activation and fatigue, * To examine the statistical differences and relationships between the expected improvements in functional capacity, peripheral muscle activation and fatigue parameters, * To offer an innovative and effective treatment option to clinicians and experts working in the relevant field with the hybrid telerehabilitation model, which can be an alternative to traditional methods, * It is aimed to contribute to the literature in this field by transforming the results obtained because of the study into qualified scientific publications. ### Conditions Module **Conditions:** - Multiple Sclerosis **Keywords:** - telerehabilitation - exercise therapy - MS patients ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized Controlled Trial ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 45 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** An eight-week rehabilitation program will be implemented synchronously with the physiotherapist two days a week via video conferencing system. **Intervention Names:** - Other: Exercise Program **Label:** Telerehabilitation Group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The first two weeks of the eight-week program will be applied face to face in the clinic, and the six weeks will be applied synchronously with the physiotherapist via video conferencing system. **Intervention Names:** - Other: Exercise Program **Label:** Hybrid Telerehabilitation Group **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** An eight-week rehabilitation program will be implemented face to face in the clinic. **Intervention Names:** - Other: Exercise Program **Label:** Clinic Group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Clinic Group - Hybrid Telerehabilitation Group - Telerehabilitation Group **Description:** Structured rehabilitation program of the groups; Patient education consists of aerobic and strengthening exercises. An information brochure will be given to patients after the first evaluation about the program to be implemented. **Name:** Exercise Program **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Evaluation of Patient Satisfaction: Patient satisfaction will be evaluated with the Global Change Scale. Participants will be asked to express the difference in improvement in their health after treatment compared to before treatment. **Measure:** Global Rating of Change Scale **Time Frame:** 1minutes #### Primary Outcomes **Description:** The primary evaluation criterion is walking speed. The timed 25-step walking test will be used to evaluate walking speed. In T25FW, which evaluates lower extremity function, patients are asked to walk a distance of 7.62 m as quickly as possible, but without running and safely, and the completion time is recorded in seconds. The average of the two trials is recorded as the T25FW score. T25FW is the best-defined measurement method for measuring gait impairment in individuals with MS and for evaluating the walking speed of patients with gait impairment in the clinical setting **Measure:** Gait Speed **Time Frame:** 5 minutes **Description:** Functional capacity will be evaluated with a six-minute walk test. The six-minute walk test is a frequently used test that evaluates physical function and walking capacity in patients with MS. According to the principles of the American Thoracic Society, the 6-minute walk test should be performed in the clinic in a 30-meter, flat and hard corridor. The distance walked by the patient is calculated. Patients may stop or slow down if they feel dyspnea. These and similar explanations should be made to the patients. The Borg Dyspnea Scale level, saturation, pulse and blood pressure values should be recorded at the beginning and end of the test. **Measure:** Functional Capacity **Time Frame:** 6 minutes #### Secondary Outcomes **Description:** Rectus Femoris and Vastus lateralis muscle activation will be tested with surface EMG device(Myoplus 2 pro) During activation and relaxation of muscle; work average time, during rest; rest average time , average release time will be recorded. **Measure:** EMG muscle activation **Time Frame:** 5 minutes **Description:** Rectus Femoris and Vastus lateralis muscle activation will be tested with surface EMG device(Myoplus 2 pro) During activation and relaxation of muscle; peak torque will be recorded. **Measure:** EMG muscle activation **Time Frame:** 5 minutes **Description:** It is a fatigue scale frequently used in clinical and experimental studies. It evaluates the physical, cognitive and social effects of fatigue. It consists of a total of 21 questions. Each item is given a score between 0 and 4, and a low score indicates a low degree of fatigue. A Turkish validity and reliability study of the this scale has been conducted, and it will be used to determine the fatigue effect in our study **Measure:** Modified Fatigue Impact Scale **Time Frame:** 5 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * EDSS score of 0 - 4.0 * Having high-speed internet access via smartphone or computer * Getting at least 24 points from the Mini Mental Test * Being at Stage 3 or above according to the Functional Ambulation Scale. Exclusion Criteria: * Having hearing or vision problems. * Participating in any exercise program. * Having other accompanying neurological, cardiovascular or orthopedic disorders * A history of MS attacks or a change in medication in the last 6 months. * Being in a physical condition that cannot do the exercises. * Comorbid conditions that negatively affect oxygen transport (severe anemia, peripheral artery diseases, etc.) **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** guzinkaya14@gmail.com **Name:** Güzin Kaya Aytutuldu **Phone:** 05366265884 **Role:** CONTACT #### Locations **Location 1:** **City:** İstanbul **Contacts:** ***Contact 1:*** - **Email:** guzinkaya14@gmail.com - **Name:** Güzin Kaya Aytutuldu - **Phone:** 05366265884 - **Role:** CONTACT **Country:** Turkey **Facility:** Biruni University **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Biruni University **Name:** Guzin Kaya Aytutuldu **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Momsen AH, Ortenblad L, Maribo T. Effective rehabilitation interventions and participation among people with multiple sclerosis: An overview of reviews. Ann Phys Rehabil Med. 2022 Jan;65(1):101529. doi: 10.1016/j.rehab.2021.101529. Epub 2022 Jan 25. **PMID:** 33940247 **Citation:** Kjolhede T, Vissing K, Langeskov-Christensen D, Stenager E, Petersen T, Dalgas U. Relationship between muscle strength parameters and functional capacity in persons with mild to moderate degree multiple sclerosis. Mult Scler Relat Disord. 2015 Mar;4(2):151-8. doi: 10.1016/j.msard.2015.01.002. Epub 2015 Jan 12. **PMID:** 25787191 **Citation:** Latimer-Cheung AE, Pilutti LA, Hicks AL, Martin Ginis KA, Fenuta AM, MacKibbon KA, Motl RW. Effects of exercise training on fitness, mobility, fatigue, and health-related quality of life among adults with multiple sclerosis: a systematic review to inform guideline development. Arch Phys Med Rehabil. 2013 Sep;94(9):1800-1828.e3. doi: 10.1016/j.apmr.2013.04.020. Epub 2013 May 10. **PMID:** 23669008 **Citation:** Manjaly ZM, Harrison NA, Critchley HD, Do CT, Stefanics G, Wenderoth N, Lutterotti A, Muller A, Stephan KE. Pathophysiological and cognitive mechanisms of fatigue in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2019 Jun;90(6):642-651. doi: 10.1136/jnnp-2018-320050. Epub 2019 Jan 25. **PMID:** 30683707 **Citation:** Morris ME, Cantwell C, Vowels L, Dodd K. Changes in gait and fatigue from morning to afternoon in people with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2002 Mar;72(3):361-5. doi: 10.1136/jnnp.72.3.361. **PMID:** 11861697 **Citation:** Kos D, Kerckhofs E, Nagels G, D'hooghe MB, Ilsbroukx S. Origin of fatigue in multiple sclerosis: review of the literature. Neurorehabil Neural Repair. 2008 Jan-Feb;22(1):91-100. doi: 10.1177/1545968306298934. Epub 2007 Apr 4. **PMID:** 17409388 **Citation:** Rottoli M, La Gioia S, Frigeni B, Barcella V. Pathophysiology, assessment and management of multiple sclerosis fatigue: an update. Expert Rev Neurother. 2017 Apr;17(4):373-379. doi: 10.1080/14737175.2017.1247695. Epub 2016 Oct 21. **PMID:** 27728987 **Citation:** Tollar J, Nagy F, Toth BE, Torok K, Szita K, Csutoras B, Moizs M, Hortobagyi T. Exercise Effects on Multiple Sclerosis Quality of Life and Clinical-Motor Symptoms. Med Sci Sports Exerc. 2020 May;52(5):1007-1014. doi: 10.1249/MSS.0000000000002228. **PMID:** 31876670 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000020278 - Term: Demyelinating Autoimmune Diseases, CNS - ID: D000020274 - Term: Autoimmune Diseases of the Nervous System - ID: D000009422 - Term: Nervous System Diseases - ID: D000003711 - Term: Demyelinating Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M12060 - Name: Multiple Sclerosis - Relevance: HIGH - As Found: Multiple Sclerosis - ID: M15415 - Name: Sclerosis - Relevance: HIGH - As Found: Sclerosis - ID: M8364 - Name: Fatigue - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M22098 - Name: Demyelinating Autoimmune Diseases, CNS - Relevance: LOW - As Found: Unknown - ID: M22094 - Name: Autoimmune Diseases of the Nervous System - Relevance: LOW - As Found: Unknown - ID: M6909 - Name: Demyelinating Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009103 - Term: Multiple Sclerosis - ID: D000012598 - Term: Sclerosis ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05597579 **Brief Title:** Cognitive Impairments in Psychotic Disorders **Official Title:** The Timing of Cognitive Impairments in Psychotic Disorders #### Organization Study ID Info **ID:** 2974-16-SMC #### Organization **Class:** OTHER_GOV **Full Name:** Sheba Medical Center ### Status Module #### Completion Date **Date:** 2024-05-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2022-10-28 **Type:** ACTUAL **Last Update Submit Date:** 2022-10-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2023-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2020-02-12 **Type:** ACTUAL **Status Verified Date:** 2022-10 #### Study First Post Date **Date:** 2022-10-28 **Type:** ACTUAL **Study First Submit Date:** 2022-02-24 **Study First Submit QC Date:** 2022-10-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Sheba Medical Center #### Responsible Party **Investigator Affiliation:** Sheba Medical Center **Investigator Full Name:** Mark Weiser, MD, Principal Investigator **Investigator Title:** Head of Psychiatry **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Patients with Psychotic disorders (Schizophrenia, Bipolar disorder and Schizoaffective disorder) often suffer from significant cognitive impairments, however how these develop and change over time before and after the first psychotic break is unclear. While there are data by several groups, showing that many future patients have significant cognitive impairments years before the onset of psychosis, many future patients seem to be doing well before the manifestation of psychosis, and decline steeply in functioning after their first psychotic episode. Hence the timing of the onset of cognitive impairment in patients with psychotic disorders requires further exploration. The current study will investigate the timing of cognitive impairment by using IQ tests before and after the first psychotic break **Detailed Description:** In this study the investigators aim to use the DAPAR tests (A cognitive assessment which all 17 year old Jewish adolescents in Israel undergo to participate in mandatory military service), which measures intelligence, and is equivalent to the IQ test. The subjects will be persons who had their first psychotic break, at least one year following the DAPAR tests. As part of the study, the participants will re-take the DAPAR tests, after the onset of the psychotic illness. ### Conditions Module **Conditions:** - Psychotic Disorders - Cognitive Impairment **Keywords:** - Schizophrenia - Affective Disorders - IQ Tests - Psychotic Disorders - Cognition ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients diagnosed with psychotic disorder. **Intervention Names:** - Diagnostic Test: DAPAR Tests (IQ equivalent test) **Label:** Study Group #### Arm Group 2 **Description:** Healthy Controls **Intervention Names:** - Diagnostic Test: DAPAR Tests (IQ equivalent test) **Label:** Control Group ### Interventions #### Intervention 1 **Arm Group Labels:** - Control Group - Study Group **Description:** This study will compare DAPAR scores before and after the onset of the psychotic illness. **Name:** DAPAR Tests (IQ equivalent test) **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Cognitive changes in both groups (lowest 10 - highest 90) **Measure:** Changes in DAPAR (An Israeli cognitive test) scores **Time Frame:** 1 day (During recruitment visit) #### Secondary Outcomes **Description:** PANSS-6 (Positive and Negative Syndrome Scale - Abbrevieted) scores (lowest 0- highest 36) **Measure:** Psychotic Symptoms **Time Frame:** 1 day (During recruitment visit) **Description:** PSP (Personal and Social Performance Scale) Scores (lowest 0- highest 100) **Measure:** Social Functioning **Time Frame:** 1 day (During recruitment visit) **Description:** WAIS-III (Wechsler Adult Intelligence Scale) (4 specific sub-tests) **Measure:** Cognitive Functioning **Time Frame:** 1 day (During recruitment visit) **Description:** COPE (Assessing Coping Strategies) scores (lowest 0 - highest 90) **Measure:** Coping strategies **Time Frame:** 1 day (During recruitment visit) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria - Study Group: * Patients between the ages 27-18 who had first psychotic break in the last ten years, and more than a year from the date of the DAPAR tests. * Diagnoses of schizophrenia, Bipolar disorder or Schizoaffective disorder according to DSM-5 criteria. * Previous DAPAR tests at the age of 17. Inclusion Criteria - Control group: * Participants between the ages of 27-18. * No history of psychotic break. * Previous DAPAR tests at the age of 17. Exclusion Criteria - Both groups: * Participants who did not perform the full battery of the DAPAR tests. * Participants who have been appointed a guardian. Exclusion Criteria - Control group: - Participants who have a first-degree relative who suffers from a psychotic disorder. **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** The investigators will recruit patients treated in the psychiatric unit at the Sheba Medical Center and in other medical institutions throughout the country. Additionally, subjects will be recruited through internet advertisement of the study. All subjects will give informed consent. Control group will be recruited by matching for Age, Sex and socioeconomic status. recruitment will be preforemd by advertisement. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** noaz.cohen@sheba.gov.il **Name:** Noaz Cohen, MA **Phone:** 972-3-5303325 **Role:** CONTACT #### Locations **Location 1:** **City:** Ramat-Gan **Contacts:** ***Contact 1:*** - **Name:** Mark Weiser, MD - **Phone:** +972-3-5303773 - **Role:** CONTACT ***Contact 2:*** - **Name:** Mark Weiser, MD, Prof. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Israel **Facility:** Sheba Medical Center **Status:** RECRUITING **Zip:** 52621 #### Overall Officials **Official 1:** **Affiliation:** Sheba Medical Center **Name:** Mark Weiser, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003072 - Term: Cognition Disorders - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000019967 - Term: Schizophrenia Spectrum and Other Psychotic Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M29705 - Name: Cognitive Dysfunction - Relevance: HIGH - As Found: Cognitive Impairment - ID: M15376 - Name: Schizophrenia - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: HIGH - As Found: Psychotic Disorders - ID: M14473 - Name: Psychotic Disorders - Relevance: HIGH - As Found: Psychotic Disorders - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M6301 - Name: Cognition Disorders - Relevance: LOW - As Found: Unknown - ID: M21836 - Name: Neurocognitive Disorders - Relevance: LOW - As Found: Unknown - ID: M21838 - Name: Schizophrenia Spectrum and Other Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000060825 - Term: Cognitive Dysfunction - ID: D000001523 - Term: Mental Disorders - ID: D000011618 - Term: Psychotic Disorders ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04111679 **Acronym:** EnSEMbLE **Brief Title:** EffectS of prEferred Music on Laparoscopic performancE **Official Title:** The Effect of Preferred Music on Laparoscopic Performance #### Organization Study ID Info **ID:** MEC-2018-1134 #### Organization **Class:** OTHER **Full Name:** Erasmus Medical Center ### Status Module #### Completion Date **Date:** 2018-11-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-11-07 **Type:** ACTUAL **Last Update Submit Date:** 2019-11-05 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-11-30 **Type:** ACTUAL #### Start Date **Date:** 2018-06-01 **Type:** ACTUAL **Status Verified Date:** 2019-11 #### Study First Post Date **Date:** 2019-10-01 **Type:** ACTUAL **Study First Submit Date:** 2019-09-04 **Study First Submit QC Date:** 2019-09-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Erasmus Medical Center #### Responsible Party **Investigator Affiliation:** Erasmus Medical Center **Investigator Full Name:** Prof. dr. Gert-Jan Kleinrensink **Investigator Title:** Professor of anatomy **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The main objective is to investigate whether listening to recorded music has a positive effect on the execution of laparoscopic skills. Secondary objectives are to investigate the effects of music during surgical performance on blood pressure, mental workload and heart rate. Study design: This will be a 4-period 4-sequence 2-treatment crossover study, participants will be exposed to both control (noise cancelling headphones without music) and the intervention (preferred music via headphones) whilst performing a laparoscopic task in a box trainer. Every period consists of 5 repetitions of a laparoscopic peg transfer task. In total participants will perform in each condition 10 peg transfer tasks. Prior to the experiment, all participants practice the laparoscopic peg transfer task 20 times Study population: Healthy volunteering medicine students without laparoscopic experience. Intervention (if applicable): Participants will perform 2 periods of 5 laparoscopic peg transfer task whilst listening to preferred recorded music via headphones and 2 periods of 5 laparoscopic peg transfer tasks while wearing noise cancelling headphones without music (2 periods of 5 tasks). Main study parameters/endpoints: The primary endpoint is laparoscopic performance as defined by time of task completion Secondary endpoints are: laparoscopic task performance (path length, jerk, error score, economy of motion) vital parameters (heart rate, and post test blood pressure) and mental workload (SURG-TLX) ### Conditions Module **Conditions:** - Laparoscopic Surgery - Music - Surgical Education **Keywords:** - Surgical skill - Music - Laparoscopy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** This will be a 4-period 4-sequence 2-treatment crossover study, participants will be exposed to both control group (A), the silent group, and intervention group (B), the music group, whilst performing a laparoscopic task in a box trainer. Participants will be randomly assigned to a sequence that determines in which order they are being exposed to both auditory environments ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** During laparoscopic task performance; participants will wear a noise cancelling headphone that plays music that is chosen by the participant. **Intervention Names:** - Other: Music **Label:** Music **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** During laparoscopic task performance; participants will wear a noise cancelling headphone that does not play music. **Label:** No music **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Music **Description:** Participant selected music, applied using noise cancelling headphones **Name:** Music **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** It will be measured in seconds and calculated using data generated from motion analysis software. Each tasks starts, when the participants puts the tip of the grasper in a yellow square that is projected on the screen, after task completion the participant puts tip in the square again to finish the task. The time between start and finish is defined as the time to task completion. An average is calculated for both the 10 tasks in the intervention group and the 10 tasks in the control group. **Measure:** Time to task completion (s) **Time Frame:** This will be measured during the experimental session which will take up about 1 hour in total #### Secondary Outcomes **Description:** The total distance the tip of the instrument has travelled per task (mm) per task, it will be calculated using data generated from motion analysis software. Each tasks starts, when the participants puts the tip of the grasper in a yellow square that is projected on the screen, after task completion the participant puts tip in the square again to finish the task. An average is calculated for both the 10 tasks in the intervention group and the 10 tasks in the control group. **Measure:** Path length **Time Frame:** This will be measured during the experimental session which will take up about 1 hour in total **Description:** the rate of change of acceleration of the instrument tips (m/s3) per task. It will be calculated using data generated from motion analysis software. Each tasks starts, when the participants puts the tip of the grasper in a yellow square that is projected on the screen, after task completion the participant puts tip in the square again to finish the task. An average is calculated for both the 10 tasks in the intervention group and the 10 tasks in the control group. **Measure:** Normalized jerk **Time Frame:** This will be measured during the experimental session which will take up about 1 hour in total **Description:** Mental workload will be assessed using the Surgery task load index (SURG-TLX) this is a validated multidimensional, surgery-specific workload measure. The SURG-TLX is an adapted version of the National Aeronautics and Space Administration Task Load Index (NASA-TLX). In the SURG-TLX subjects rate six dimensions of workload i.e. situational stress, distractions, task complexity, physical demands, temporal demands and mental demands on visual analogue scales VAS ranging from 0-100 (0 = very low;100 = very high) the scores of these subscales are combined into a weighed average that results in a general score ranging from 0-100 (0 = very low; 100 = very high) After every period of 5 tasks a SURG-TLX questionnaire is completed. An average is calculated for both the two periods in the intervention group and the two periods in the control group. The averages of both the general score and the individual subscales will be reported. **Measure:** Mental workload **Time Frame:** This will be measured during the experimental session which will take up about 1 hour in total **Description:** Heart rate will be assessed prior to; and immediately after every period of laparoscopic tasks in beats per minute. Change in heart rate before and after each period of tasks is calculated. An average change will be calculated for both the two periods in the intervention group and the two periods in the control group **Measure:** Heart rate **Time Frame:** This will be measured during the experimental session which will take up about 1 hour in total **Description:** Systolic and diastolic pressure will be assessed prior to and immediately after every period of laparoscopic tasks in mmHg. Change in blood pressure before and after each period of tasks is calculated. An average change will be calculated for both the two periods in the intervention group and the two periods in the control group **Measure:** Blood pressure **Time Frame:** This will be measured during the experimental session which will take up about 1 hour in total **Description:** * Age (years) * Sex (male or female) * Dexterity (left- or right handed, ambidextrous) * Year of medical education: * The importance of music in daily life on a (10-point numeric rating scale) * Musical genres the subject listens to (classical, world music, rock, pop, techno, house, jazz, blues, disco, other) * Musical genres the subject listens to when studying: (classical, world music, rock, pop, techno, house, jazz, blues, disco, other) * choice of music during the experiment * Whether or not the subject plays or has played a musical instrument (never, in the past, currently) * Whether or not the subject plays or has played video games and to what extends (never, in the past, currently) This questionnaire will be completed before starting the practice session of 20 laparoscopic tasks. **Measure:** Participant's characteristics **Time Frame:** This will be measured during the experimental session which will take up about 1 hour in total ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: In order to be eligible to participate in this study a subject must meet all of the following criteria. * Age ≥ 18 years * Medicine students * Provision of written informed consent by the subject. A potential subject who meets any of the following criteria will be excluded from participation in this study: * Severe hearing impairment, defined as no verbal communication possible. * Severe visual impairment, defined as not able to see the monitor on which the laparoscopic task is projected. * Any physical handicap that impairs laparoscopic performance (unable to stand for 10 minutes, unable to hold and use both instruments. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Rotterdam **Country:** Netherlands **Facility:** Erasmus MC **State:** Zuid-Holland **Zip:** 3015 GD #### Overall Officials **Official 1:** **Affiliation:** Erasmus Medical Center **Name:** Gert-Jan Kleinrensink, Prof. Dr. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Oomens P, Fu VX, Kleinrensink VEE, Kleinrensink GJ, Jeekel J. The Effects of Preferred Music on Laparoscopic Surgical Performance: A Randomized Crossover Study. World J Surg. 2020 Aug;44(8):2614-2619. doi: 10.1007/s00268-020-05523-0. **PMID:** 32333159 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03925779 **Brief Title:** Conscious Sedation for Outpatient Colonoscopy **Official Title:** Dexmedetomidine Versus Propofol-Remifentanil Conscious Sedation for Outpatient Colonoscopy: A Prospective Randomized Double-blind Trial. #### Organization Study ID Info **ID:** 2019/3/15/9 #### Organization **Class:** OTHER **Full Name:** Menoufia University ### Status Module #### Completion Date **Date:** 2021-01-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-01-08 **Type:** ACTUAL **Last Update Submit Date:** 2021-01-07 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-12-31 **Type:** ACTUAL #### Start Date **Date:** 2019-06-15 **Type:** ACTUAL **Status Verified Date:** 2021-01 #### Study First Post Date **Date:** 2019-04-24 **Type:** ACTUAL **Study First Submit Date:** 2019-04-21 **Study First Submit QC Date:** 2019-04-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Menoufia University #### Responsible Party **Investigator Affiliation:** Menoufia University **Investigator Full Name:** Abd-Elazeem Abd-Elhameed Elbakry **Investigator Title:** Associate professor of anaesthesia **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Although colonoscopy is a mildly painful procedure, the pain and the procedure itself are distressful for most patients. This raises the attention for using different sedation regimens aiming at maintaining optimal sedation level with maintained airway and stable haemodynamics all through the procedure. The present study was scheduled to investigate the sedative efficacy of dexmedetomedine versus propofol-remifentanil for outpatient colonoscopy. **Detailed Description:** Eighty patients undergoing outpatient colonoscopy will be randomized into two equal groups. In Dexmedetomidine (DEX) group the patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure. In the PR group, propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min. If the patient complained of pain or discomfort, the infusion rates of dexmedetomidine (DEX group) or propofol-remifentanil (P-R group) will be increased. If the higher limit of the dose range of the study drugs reached, additional fentanyl 0.5 μg/kg i.v. boluses will be administered. Rescue medication consisting of propofol boluses of 0.5 mg/kg i.v. will be given if the previous protocol failed. Sedation score,haemodynamics, end-tidal carbon dioxide, oxygen saturation, total fentanyl, propofol bolus doses, patient and colonoscopist satisfaction and side effects will be recorded. ### Conditions Module **Conditions:** - Conscious Sedation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** A blinded investigator that was not involved in the anaesthetic management of the patients, collected the intra-operative and postoperative data. The patients and colonoscopist were blinded to group allocation. For blinding purposes, two drug infusion pumps were used in every patient where the infusion pumps and i.v. connection lines were concealed to avoid identification. **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 80 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure **Intervention Names:** - Drug: Dexmedetomidine **Label:** (Dexmedetomidine)Dex group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min. **Intervention Names:** - Drug: Propofol - Drug: Remifentanil **Label:** Propofol-Remifentanil (P-R) group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - (Dexmedetomidine)Dex group **Description:** dexmedetomidine sedation **Name:** Dexmedetomidine **Other Names:** - dexmedetomidine infusion **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Propofol-Remifentanil (P-R) group **Description:** propofol sedation **Name:** Propofol **Other Names:** - propofol infusion **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Propofol-Remifentanil (P-R) group **Description:** Remifentanil sedation **Name:** Remifentanil **Other Names:** - Remifentanil infusion **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Degree of sedation by Ramsay sedation score from 1 inadequate sedation to 6 excessive sedation. **Measure:** Sedation **Time Frame:** Perioperative #### Secondary Outcomes **Description:** Mean arterial blood pressure in mmHg **Measure:** Mean arterial blood pressure **Time Frame:** Perioperative **Description:** Heart rate in beats/minutes **Measure:** Heart rate **Time Frame:** Perioperative **Description:** Arterial oxygen saturation as a percentage of the total haemoglobin. **Measure:** Oxygen saturation **Time Frame:** Perioperative **Description:** Number of patients with hypotension **Measure:** Hypotension **Time Frame:** Perioperative **Description:** Number of patients with bradycardia **Measure:** Bradycardia **Time Frame:** Perioperative **Description:** Measured by visual analogue scale \[from 0 "no pain" to 10 "worst imaginable pain"\] **Measure:** Analgesia **Time Frame:** Perioperative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ASA I or II physical status * 18-65 years * Scheduled for elective colonoscopy Exclusion Criteria: * History of allergy to any of the study drugs * Alcohol or drug abuse. * Second and third-degree heart block. * Morbid obesity. * Pregnant and lactating women. * Psychiatric disorders. * Severe cardiac, respiratory, renal, and liver diseases **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Faculty of Medicine **State:** Shebin El-kom **Zip:** 32511 #### Overall Officials **Official 1:** **Affiliation:** Associate professor **Name:** Abd-Elazeem A Elbakry, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000006993 - Term: Hypnotics and Sedatives - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018712 - Term: Analgesics, Non-Narcotic - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000058647 - Term: Adrenergic alpha-2 Receptor Agonists - ID: D000000316 - Term: Adrenergic alpha-Agonists - ID: D000000322 - Term: Adrenergic Agonists - ID: D000018663 - Term: Adrenergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000018686 - Term: Anesthetics, Intravenous - ID: D000018681 - Term: Anesthetics, General - ID: D000000777 - Term: Anesthetics - ID: D000000701 - Term: Analgesics, Opioid - ID: D000009294 - Term: Narcotics ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M22662 - Name: Dexmedetomidine - Relevance: HIGH - As Found: Twice daily - ID: M18307 - Name: Propofol - Relevance: HIGH - As Found: COVID-19 - ID: M1696 - Name: Remifentanil - Relevance: HIGH - As Found: SARS- - ID: M10043 - Name: Hypnotics and Sedatives - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M20786 - Name: Analgesics, Non-Narcotic - Relevance: LOW - As Found: Unknown - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown - ID: M3668 - Name: Adrenergic alpha-Agonists - Relevance: LOW - As Found: Unknown - ID: M3673 - Name: Adrenergic Agonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M20766 - Name: Anesthetics, Intravenous - Relevance: LOW - As Found: Unknown - ID: M20761 - Name: Anesthetics, General - Relevance: LOW - As Found: Unknown - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown - ID: M12245 - Name: Narcotics - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000020927 - Term: Dexmedetomidine - ID: D000077208 - Term: Remifentanil - ID: D000015742 - Term: Propofol ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00081679 **Brief Title:** SES, Health Behaviors and CVD Among Vietnam-Era Twins #### Organization Study ID Info **ID:** 1247 #### Organization **Class:** OTHER **Full Name:** The Miriam Hospital #### Secondary ID Infos **ID:** R01HL072819 **Link:** https://reporter.nih.gov/quickSearch/R01HL072819 **Type:** NIH ### Status Module #### Completion Date **Date:** 2007-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2014-04-16 **Type:** ESTIMATED **Last Update Submit Date:** 2014-04-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2007-05 **Type:** ACTUAL #### Start Date **Date:** 2004-06 **Status Verified Date:** 2008-01 #### Study First Post Date **Date:** 2004-04-21 **Type:** ESTIMATED **Study First Submit Date:** 2004-04-19 **Study First Submit QC Date:** 2004-04-20 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Heart, Lung, and Blood Institute (NHLBI) #### Lead Sponsor **Class:** OTHER **Name:** The Miriam Hospital ### Description Module **Brief Summary:** To further characterize the nature of the association between socioeconomic status (SES), health behaviors and early cardiovascular disease in the Vietnam Era Twin (VET) Registry, a sample of over 4,000 twin pairs. **Detailed Description:** BACKGROUND: Cardiovascular disease (CVD) affects approximately 60,800,000 Americans each year, claiming the lives of nearly one million of these people (American Heart Association, 2001). CVD is likely to be complex in etiology, reflecting the combined effect of both genes and environment, as well as gene x gene and gene x environment interaction. Examination of environmental factors thought to affect CVD risk in the context of a genetically informative design can help elucidate the relative contribution of genetic and environmental factors and potentially aid in identifying environmental factors that may interact with genetic vulnerability in predicting CVD. Cardiovascular morbidity and mortality are over-represented among individuals in lower socioeconomic strata, as are behaviors that increase the likelihood of cardiovascular events, including smoking, heavy alcohol consumption and physical inactivity (Adler et al., 1994; Anderson \& Armstead, 1995). Thus, it is commonly assumed that socioeconomic status (SES) serves as an important environmental influence on health and health behaviors. Twin studies partition genetic and environmental variance and detect gene x environment interaction and provide a unique opportunity to study the association between SES and health. DESIGN NARRATIVE: The study will characterize the nature of the association between socioeconomic status (SES), health behaviors and cardiovascular disease (CVD) in the existing Vietnam Era Twin (VET) registry, a sample of over 4000 male twin pairs with a mean age of 51 in 1999. Specifically, the study will: 1) determine how strongly environmental factors contribute to individual differences in SES, health behaviors and CVD, relative to genetic factors; 2) examine whether measures of SES are associated with health behaviors and CVD mortality when controlling for concomitant genetic influences; and 3) investigate whether SES interacts with genetic vulnerabilities to predict health behaviors and CVD (gene x environment interaction). Using VETdatasets, the primary method of analysis will be twin structural equation modeling. ### Conditions Module **Conditions:** - Cardiovascular Diseases - Heart Diseases ### Design Module **Study Type:** OBSERVATIONAL ### Eligibility Module **Eligibility Criteria:** No eligibility criteria **Maximum Age:** 65 Years **Minimum Age:** 45 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** The Miriam Hospital **Name:** Jeanne McCaffery ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9419 - Name: Heart Diseases - Relevance: HIGH - As Found: Heart Disease ### Condition Browse Module - Meshes - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000006331 - Term: Heart Diseases ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00961779 **Brief Title:** Safety Study of NNZ-2566 in Healthy Female Subjects **Official Title:** A Phase I, Double-Blind, Randomized, Dose Escalation Study to Assess the Safety, Tolerability and PK of NNZ-2566 in Healthy Females, When Administered as a Loading Dose (10-Min), and as a Loading Dose Followed by a Maintenance Dose (72-Hr). #### Organization Study ID Info **ID:** Neu-2566-HV-004 #### Organization **Class:** INDUSTRY **Full Name:** Neuren Pharmaceuticals Limited ### Status Module #### Completion Date **Date:** 2010-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2014-10-07 **Type:** ESTIMATED **Last Update Submit Date:** 2014-10-03 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2010-08 **Type:** ACTUAL #### Start Date **Date:** 2010-03 **Status Verified Date:** 2014-10 #### Study First Post Date **Date:** 2009-08-19 **Type:** ESTIMATED **Study First Submit Date:** 2009-08-17 **Study First Submit QC Date:** 2009-08-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Neuren Pharmaceuticals Limited #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to obtain evidence of the safety of NNZ-2566 in healthy female volunteers and to determine the pharmacokinetics (PK) of NNZ-2566 in healthy female volunteers. **Detailed Description:** To obtain evidence of the safety of NNZ-2566 in healthy female volunteers, compared to placebo when administered as a 10 minute intravenous (i.v.) bolus infusion, and when administered as a 10-minute bolus infusion immediately followed by a continuous 72-hour maintenance infusion. To determine the blood pharmacokinetics (PK) of an intravenous dose of NNZ-2566 in healthy female volunteers when administered as a 10-minute bolus infusion, and when administered as a 10-minute bolus followed by a continuous 72-hour maintenance infusion. ### Conditions Module **Conditions:** - Brain Injuries, Traumatic ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 39 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Placebo **Label:** Placebo (Normal saline infusion) **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** NNZ-2566 reconstituted in bicarbonate buffer and normal saline. 6/8 subjects in each cohort (5 cohort in total) to receive NNZ-2566 experimental treatment. **Intervention Names:** - Drug: NNZ-2566 **Label:** NNZ-2566 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - NNZ-2566 **Description:** Glycyl-L-2-Methylprolyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials) for reconstitution with bicarbonate buffer and normal saline. **Name:** NNZ-2566 **Other Names:** - Experimental name: NNZ-2566 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo (Normal saline infusion) **Description:** Normal saline infusion **Name:** Placebo **Other Names:** - Sodium Chloride 0.9% Injection **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Incidence of AEs and SAEs **Time Frame:** Through to Day 7 post end of study drug infusion or until resolved ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged between 18 years and 50 years (inclusive). * Females only. * Weight 50 to 105 kg * BMI of 18 to 30 kg/m2. * General Health: Healthy, determined by a medical history with particular attention to: * a drug history identifying any known drug allergies and the presence of drug abuse; * any chronic use of medication; and * a thorough review of body systems. This will also be determined by having no clinically significant abnormal findings on physical examination, which includes an electrocardiogram (ECG), which in the opinion of the Investigator would jeopardize the safety of the subject or impact on the validity of the study results. * Venous Access: Volunteers with adequate venous access in their left and right arm to allow collection of blood samples and drug administration. * Language: Fluent in the English language. * Informed Consent: Have voluntarily given written informed consent to participate in this study. Exclusion Criteria: * Pregnant and lactating females are excluded from participating in the study. * History of allergy and/or hypersensitivity to any of the stated ingredients of the formulations. * History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease or hematological disorders. * Any history of asthma during the last 10 years. * A creatinine clearance of less than 75 mL/min. * Any predisposing condition that might interfere with the absorption, distribution, metabolism, and/or excretion of the investigational product. * History of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture or intravenous cannulation. * History of Hepatitis B, a positive test for Hepatitis B surface antigen, a history of Hepatitis C, a positive test for Hepatitis C antibody, a history of HIV infection or demonstration of HIV antibodies. * Pregnancy. * Any evidence of organ dysfunction, or any clinically significant clinical laboratory value, including a liver function test (LFT) \> 1.5 x upper limit of normal (ULN). * Difficulty abstaining from alcohol during the 48 hours prior to dose administration and until completion of blood sampling at exit assessment. * History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit, or positive urine drug screen for drugs of abuse. * Difficulty in abstaining from any prescription medications for 14 days prior to dose administration and for the duration of the study. * Difficulty in abstaining from over-the-counter (OTC) medications or herbal supplements for 14 days prior to dose administration and for the duration of the study, (with the exception of occasional analgesia, vitamin and other nutrient supplement use, at the discretion of the Investigator). * Difficulty in abstaining from food and/or beverages that contain caffeine or other xanthines, (e.g., coffee, tea, cola and chocolate) during the 24 hours prior to dose administration and whilst confined at the clinical study facility. * History of any psychiatric illness which may impair the ability to provide written informed consent. * Poor protocol compliers or those unlikely to attend. * Receipt of any drug as part of a research study within 30 days of initial dose administration in this study. * Standard blood donation (usually 550 mL) within the 12-week period before dose administration. * Unusual dietary habits and excessive or unusual vitamin intakes. * Vaccination or immunizations within 30 days of initial dose administration. * QT/QTc Exclusions i.e., a marked baseline prolongation of corrected QT interval \> 450 ms in two ECGs, or a history of risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome). **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Melbourne **Country:** Australia **Facility:** Nucleus Network **State:** Victoria **Zip:** 3004 #### Overall Officials **Official 1:** **Affiliation:** Neuren Pharmaceuticals Ltd **Name:** Douglas J Wilson, MB ChB, PhD **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000006259 - Term: Craniocerebral Trauma - ID: D000020196 - Term: Trauma, Nervous System - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5207 - Name: Brain Injuries - Relevance: HIGH - As Found: Brain Injury - ID: M628 - Name: Brain Injuries, Traumatic - Relevance: HIGH - As Found: Brain Injuries, Traumatic - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M9349 - Name: Craniocerebral Trauma - Relevance: LOW - As Found: Unknown - ID: M22023 - Name: Trauma, Nervous System - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001930 - Term: Brain Injuries - ID: D000070642 - Term: Brain Injuries, Traumatic ### Intervention Browse Module - Browse Branches - Abbrev: AA - Name: Amino Acids - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T5 - Name: Glutamic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06339879 **Brief Title:** Health Effects of Grain Foods in Adults **Official Title:** Health Effects of Grain Foods in Adults #### Organization Study ID Info **ID:** IRB-2023-1071 #### Organization **Class:** OTHER **Full Name:** Purdue University ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-04-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-02 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-18 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-04-01 **Type:** ACTUAL **Study First Submit Date:** 2023-12-11 **Study First Submit QC Date:** 2024-03-25 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Grain Food Foundation #### Lead Sponsor **Class:** OTHER **Name:** Purdue University #### Responsible Party **Investigator Affiliation:** Purdue University **Investigator Full Name:** Richard Mattes **Investigator Title:** Distinguished Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study will assess the effects of eating whole grain foods versus refined grain foods with different amounts of added sugar. It is hypothesized that a diet including grain products will have beneficial effects on taste hedonics, appetite, food/energy intake, body weight, blood pressure, acute and chronic glycemia and acute and chronic lipemia compared to customary diets controlling for added sugars, saturated fats and sodium. **Detailed Description:** This 16-week, randomized, controlled, parallel-arm, clinical trial will assess the effects of consuming four different categories of grain foods on taste hedonics, appetite, food/energy intake, body weight, and blood pressure as well as acute and longer-term glycemia and lipemia. It will also examine the effects of foods varying in grain/carbohydrate composition on the microbiome and microbiota functionality. One hundred and twenty adults will be recruited and randomly assigned to one of four intervention groups. These groups will be defined by the diets they are prescribed. All will be prescribed diets containing approximately 50%; 35% and 15% energy from carbohydrate, fat and protein, respectively. Grain foods will comprise 50% of the carbohydrate component (i.e., 25% of total energy). The grain foods will be assigned to one of four categories based on whole grain content and concentrations of added sugars. The grain foods meeting these criteria will have the following composition: Group 1 - High Whole Grain, Low Sugar 6 servings of whole grain and \<13% energy from added sugars. Group 2 - Low Whole Grain, Low Sugar 3 servings of whole grain and \<13% energy from added sugars. Group 3 - High Whole Grain, High Sugar 6 servings of whole grain and \>13% energy from added sugars. Group 4 - Low Whole Grain, High Sugar 3 servings of whole grain and \>13% energy from added sugars. Detailed Study Design The study measures and timing are outlined in the following table: Screening Week 1 Baseline Week 2 Week 5 Week 8 Week 11 Week 14 Fasting Blood X X X XX MTT X X X Weight X X X X X X Body Composition X X CGM X X X Intake X Hedonics (palatability) X X X Appetite X X X Activity X X X Blood Pressure X X X X X X Microbiota X X X X X Compliance X X X X X MTT = Meal Tolerance Test; DXA= Dual-energy X-ray Absorptiometry; CGM=Continuous glucose monitoring ### Conditions Module **Conditions:** - High Whole Grain and Low Sugar - Medium Whole Grain and Low Sugar - Low Whole Grain and Low Sugar - Low Whole Grain and High Sugar **Keywords:** - whole grain - refined grain - glycemia - appetite - food intake - microbiome - body weight - blood pressure - lipemia - hedonics ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Parallel assignment ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 6 servings of whole grain and \<13% energy from added sugars. **Intervention Names:** - Other: High Whole Grain, Low Sugar **Label:** High Whole Grain, Low Sugar **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** 3 servings of whole grain and \<13% energy from added sugars. **Intervention Names:** - Other: Low Whole Grain, Low Sugar **Label:** Low Whole Grain, Low Sugar **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** 6 servings of whole grain and \>13% energy from added sugars. **Intervention Names:** - Other: High Whole Grain, High Sugar **Label:** High Whole Grain, High Sugar **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Description:** 3 servings of whole grain and \>13% energy from added sugars. **Intervention Names:** - Other: Low Whole Grain, High Sugar **Label:** Low Whole Grain, High Sugar **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - High Whole Grain, Low Sugar **Description:** 6 servings of whole grain and \<13% energy from added sugars. **Name:** High Whole Grain, Low Sugar **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Low Whole Grain, Low Sugar **Description:** 3 servings of whole grain and \<13% energy from added sugars. **Name:** Low Whole Grain, Low Sugar **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - High Whole Grain, High Sugar **Description:** 6 servings of whole grain and \>13% energy from added sugars. **Name:** High Whole Grain, High Sugar **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Low Whole Grain, High Sugar **Description:** 3 servings of whole grain and \>13% energy from added sugars. **Name:** Low Whole Grain, High Sugar **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** blood sugar **Measure:** Glycemia **Time Frame:** 12 weeks #### Secondary Outcomes **Description:** ingestive sensations measured by VAS ratings **Measure:** Appetite **Time Frame:** 12 weeks **Description:** palatability **Measure:** Taste Hedonics **Time Frame:** 12 weeks **Description:** kcals **Measure:** Energy Intake **Time Frame:** 12 weeks **Description:** pounds **Measure:** Body Weight **Time Frame:** 12 weeks **Description:** mm mercury **Measure:** Systolic and Diastolic Blood Pressure **Time Frame:** 12 weeks **Description:** Blood lipids **Measure:** Lipemia **Time Frame:** 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * male and female; 21 to 60 years old; Hemoglobin A1c concentration between 5.7 and 6.4% * Prefer no use of medications, but if on medication, must have been on a stable dose for 3 months and plan to remain at the same dose for the duration of the trial. * low customary intake of whole grain foods (less than 2 servings per day) and high energy from added sugar (greater than 10% energy). Exclusion Criteria: * Grain or dairy sensitivities or allergies or celiac disease; sensitivity or allergy to other foods that would result in refusal to eat a class of foods. * smoker * intended weight loss or gain during the study period; intended change of activity level during the study period * use of blood thinners * prior gastrointestinal surgery. **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** georgej@purdue.edu **Name:** Judy George, BS **Phone:** 4654946192 **Role:** CONTACT **Contact 2:** **Email:** mattes@purdue.edu **Name:** Richard Mattes, PhD **Phone:** 7654940662 **Role:** CONTACT #### Locations **Location 1:** **City:** West Lafayette **Contacts:** ***Contact 1:*** - **Email:** mattes@purdue.edu - **Name:** Richard D Mattes, PhD - **Phone:** 765-494-0662 - **Role:** CONTACT ***Contact 2:*** - **Name:** Richard D Mattes, PhD, RD, MPH - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Purdue University **State:** Indiana **Status:** RECRUITING **Zip:** 17907 #### Overall Officials **Official 1:** **Affiliation:** Purdue University **Name:** Richard Mattes, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** deidentified data will be shared. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown - ID: M10000 - Name: Hyperlipidemias - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06334679 **Brief Title:** The Effect of Cold Gel Pack Application on Itching in Burn Patients in the Maturation Stage **Official Title:** The Effect of Cold Gel Pack Application on Itching in Burn Patients in the Maturation Stage: A Randomized Controlled Study #### Organization Study ID Info **ID:** zeynepersoz #### Organization **Class:** OTHER **Full Name:** Marmara University ### Status Module #### Completion Date **Date:** 2024-12-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-03-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-03-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-11-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-15 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-03-28 **Type:** ACTUAL **Study First Submit Date:** 2024-03-08 **Study First Submit QC Date:** 2024-03-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Marmara University #### Responsible Party **Investigator Affiliation:** Marmara University **Investigator Full Name:** Zeynep Ersöz **Investigator Title:** PhD Candidate **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Burn is a serious trauma that causes acute damage to the skin and subcutaneous tissues due to the effect of heat, electricity, radiation, physical, and chemical substances. It has been reported that the incidence of itching is high in burn patients during the maturation stage of wound healing. The literature suggests that in managing the symptom of itching, skin hydration support along with cold application methods can also be used. The integrity of the skin, the duration, frequency, characteristics, areas of itching, and identifying conditions that increase or decrease itching are important for managing itching. This study is planned to be conducted with a randomized controlled design to examine the effect of applying cold gel packs to burn areas of burn patients during the maturation stage on itching. This researcher's hypothesis is that burn patients who applied cold gel packs to burn areas during the maturation phase had lower itching severity (frequency, duration, intensity) than those who did not. **Detailed Description:** Patients will be assigned to one of two groups according to the block randomization list, given a sequence number according to the date and time of admission. In addition to the clinical routine application, cold gel pack application will be applied to the patients in Group 1, and the clinical routine application will continue for those in Group 2. To collect data, the Patient Diagnosis Form developed by the researcher in line with literature information, the Visual Analog Scale for Itching, the Bates-Jensen Wound Assessment Tool and the 12-Item Itching Severity Scale, whose validity and reliability analysis has been conducted, will be used. Calculation of the sample size of the study was made with the G.Power (v3.1.7) computer program. In the study of Joo et al., a total of 26 patient samples were used to represent the universe, assuming that the difference in two independent groups was considered statistically significant according to the itching degree averages of burn patients (α = 0.05 significance level and 95% power). During the research process, it was decided to include a total of 60 individuals in the sample, with 30 patients in Group-1 (Experiment) and 30 patients in Group-2 (Control), taking into account possible losses. ### Conditions Module **Conditions:** - Burns - Pruritus **Keywords:** - Burn - İtch/Pruritus - Cold Application - Maturation - Cold Gel Pack ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** It is a prospective interventional type two-group randomized controlled clinical study. Distribution according to the groups and layers to be assigned for each intervention; Group-1 (Experiment) was designed as clinical routine (liquid petroleum jelly) and cold gel pack, and Group-2 (Control) was designed as clinical routine (liquid petroleum jelly). ##### Masking Info **Masking:** SINGLE **Masking Description:** When cold application studies in the literature are examined, cold gel packs are placed in a sheath and contacted with the skin of the patients. Therefore, due to the nature of the application method to be used, patients and the researcher will not be considered blind. The evaluator will be considered blind in the analysis of the study. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Before the first application of the day, the "12-Item Itching Severity Scale" will be applied to evaluate the patient's daily itching. Before each application, itching severity will be evaluated with the Visual Analog Scale (VAS) for Itch at minute 0. Vital signs will be measured and recorded. Cold gel packs placed in a sterile cloth sheath will be placed in full contact with the burn areas and applied for 20 minutes. During the application, the skin will be checked every 30 seconds and 5 minutes, and the application will be interrupted in case of new pain, numbness, redness, pallor, chills, cold sensitivity and skin surface temperature ≤13 degrees Celsius. The temperature of the cold gel packs before and during application will be checked with a Digital Infrared Non-Contact Thermometer. Immediately after the application is completed, a 20-minute VAS for itching will be shown and they will be asked to evaluate the severity of the itching they feel instantly. **Intervention Names:** - Other: Cold Gel Packet Application **Label:** Group-1 (Clinical Routine (liquid vaseline) and Cold Gel Pack applied group) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Before the first application of the day, the "12-Item Itching Severity Scale" will be applied to evaluate the patient's daily itching. Before each application, the Visual Analog Scale (VAS) for Itch will be shown at minute 0 and they will be asked to evaluate the severity of itching they feel immediately. Vital signs will be measured and recorded. Liquid petroleum jelly, which is the routine practice of the clinic, will be applied by clinic nurses. Immediately after the application is completed, a 20-minute VAS for itching will be shown and they will be asked to evaluate the severity of itching they feel immediately. **Label:** Group-2: Clinical routine (liquid petroleum jelly) applied group (control) **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Group-1 (Clinical Routine (liquid vaseline) and Cold Gel Pack applied group) **Description:** Cold gel packs will be placed on the burn areas of the patients in the maturation phase and applied for 20 minutes. **Name:** Cold Gel Packet Application **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The scale consists of 12 questions. Questions 2, 3, 4, 5, 6, 7, 8 and 12 in the scale have two options, "yes" and "no", and the scoring changes as 1 or 0. The frequency of itching in the first question and itchy areas in the 11th question are marked and scored between 1 and 3. The 9th question, which evaluates the frequency of waking up from sleep due to itching, has 4 items and is scored between 0-3. The 10th question, which evaluates the severity of itching, has 5 items and is scored between 1-5. The score obtained from the scale is at least 3 and at most 22, and as the score increases, the level of being affected by itching also increases. Scores obtained as a result of the scale indicate mild itching between "3-6", moderate itching between "7-11" and severe itching between "12-22". **Measure:** Itching severity **Time Frame:** The itching severity of the patients was measured with the "12-Item Itching Severity Scale"; Before the first application, it will be evaluated a total of 5 times over 4 days, on the morning of the next day of application. **Description:** Visual Analog Scale (VAS).It is stated that Visual Analogue Scale (VAS) can be used to measure the severity of itching. VAS is a numerical and one-dimensional scale and is mostly used to obtain an objective result by evaluating the intensity and severity of itching. The scale is scored between 1-10. VAS is a scale that initially ranges from 0 "I have no itching" to 10 "I have very severe itching", with each interval corresponding to one centimeter and given a numerical value. On the scale, 0 points indicate no itching, 1-3 points indicate mild itching, 4-6 points indicate moderate itching, 7-8 points indicate severe itching, and 9 and above points indicate very severe itching. **Measure:** Itching grade **Time Frame:** itching grade will be evaluated instantly with the Visual Analog Scale (VAS) 0 minutes before each application and 20 minutes immediately after the application.The scale will be evaluated for 4 days with repeated measurements twice a day before and after ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Burn percentage is between 15-25% and 1st or 2nd degree burn areas are in the maturation phase (BatesJensen Wound Assessment Tool Scale score=1-13), * Describing itching in burn wounds in the last 24 hours, * Over 18 years of age, * Literate, * Oriented to person, place and time, * Having no vision, speech or communication problems, * Do not have any skin disease other than burns, * Patients whose vital signs are within physiological limits (Pulse: 60-100/min, Temperature: average 37 degrees Celsius, respiration 12-16/min, Blood Pressure: average 120/80). Exclusion Criteria: * Cold sensitivity/allergy, * Perineum, neck and inner wrist burn areas * Hypertrophic scar area, * Burn infection * Raynaud's disease, * Use of aspirin, anticoagulants, non-steriod anti-inflammatory drugs, * Evitamin and vasoactive agent use, * Peripheral vascular disease, * Connective tissue disease, * Diabetic neuropathy, * Use of a medication that will cause itching, * Patients participating in another study conducted at the clinic * Applying medical treatment in addition to the clinical routine due to itching, * Due to the fact that he was discharged in a shorter period of time than the average hospitalization day, the research process failure to complete, * Failure to comply with the monitoring process and conditions of the research, * It was determined as the person wanting to leave the study voluntarily. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** zeynepersoz08@gmail.com **Name:** Zeynep Ersoz **Phone:** 05553496718 **Role:** CONTACT **Contact 2:** **Email:** yergun@marmara.edu.tr **Name:** Yasemin Ergun **Phone:** 05057960394 **Role:** CONTACT #### Locations **Location 1:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Email:** zeynepersoz08@gmail.com - **Name:** Zeynep Ersoz - **Phone:** 05553496718 - **Role:** CONTACT ***Contact 2:*** - **Email:** gayetaylan@yahoo.com - **Name:** Gaye Filinte - **Phone:** 5339576333 - **Role:** CONTACT **Country:** Turkey **Facility:** Kartal Dr.Lütfi Kırdar City Hospital **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Joo SY, Kim JB, Cho YS, Cho YS, Seo CH. Effect of cold pack therapy for management of burn scar pruritus: A pilot study. Burns. 2018 Jun;44(4):1005-1010. doi: 10.1016/j.burns.2018.01.011. Epub 2018 Feb 13. **PMID:** 29422437 **Citation:** Stepien K, Reich A. The 12-Item Pruritus Severity Scale - Determining the Severity Bands. Front Med (Lausanne). 2020 Dec 17;7:614005. doi: 10.3389/fmed.2020.614005. eCollection 2020. **PMID:** 33392233 **Citation:** Reich A, Bozek A, Janiszewska K, Szepietowski JC. 12-Item Pruritus Severity Scale: Development and Validation of New Itch Severity Questionnaire. Biomed Res Int. 2017;2017:3896423. doi: 10.1155/2017/3896423. Epub 2017 Oct 2. **PMID:** 29098154 **Citation:** Stander S, Augustin M, Reich A, Blome C, Ebata T, Phan NQ, Szepietowski JC; International Forum for the Study of Itch Special Interest Group Scoring Itch in Clinical Trials. Pruritus assessment in clinical trials: consensus recommendations from the International Forum for the Study of Itch (IFSI) Special Interest Group Scoring Itch in Clinical Trials. Acta Derm Venereol. 2013 Sep 4;93(5):509-14. doi: 10.2340/00015555-1620. **PMID:** 23624777 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries - ID: D000012871 - Term: Skin Diseases - ID: D000012877 - Term: Skin Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M5326 - Name: Burns - Relevance: HIGH - As Found: Burn - ID: M14396 - Name: Pruritus - Relevance: HIGH - As Found: Pruritus - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M15680 - Name: Skin Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011537 - Term: Pruritus - ID: D000002056 - Term: Burns ### Intervention Browse Module - Browse Branches - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M13485 - Name: Petrolatum - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02185079 **Brief Title:** The Effect of Metrics Based Performance Based Progression in Provision of Labor Epidural Analgesia **Official Title:** The Effect of Metrics Based Performance Based Progression in Provision of Labor Epidural Analgesia on Clinical Performance and Clinical Outcome #### Organization Study ID Info **ID:** ECM4(i)06/05/2014 #### Organization **Class:** OTHER **Full Name:** Cork University Hospital ### Status Module #### Completion Date **Date:** 2017-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-07-17 **Type:** ACTUAL **Last Update Submit Date:** 2018-07-16 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-12 **Type:** ACTUAL #### Start Date **Date:** 2014-01 **Status Verified Date:** 2018-07 #### Study First Post Date **Date:** 2014-07-09 **Type:** ESTIMATED **Study First Submit Date:** 2014-07-05 **Study First Submit QC Date:** 2014-07-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cork University Hospital #### Responsible Party **Investigator Affiliation:** Cork University Hospital **Investigator Full Name:** Karthikeyan Kallidaikurichi Srinivasan **Investigator Title:** Specialist Registrar,Anaesthetics,Cork University Hospital **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Procedural skills are an important determinant of clinical outcomes for certain patient groups. Training for procedural skills in the medical profession is still largely based on an apprenticeship model. For example, trainees learning to perform epidural anaesthesia do so by "practicing" on patients under direct supervision by seniors (consultants or senior registrars/residents). Learning a complex and high risk procedural skill on patients is not ideal. As medical training moves from apprentice based to competency based training along and as for the number of clinical learning opportunities for trainees is less, it is necessary to develop a comprehensive training programme which enables effective and efficient learning without compromising on patient safety. Metrics-based performance based progression has shown to improve clinical performance not only in novices but also in experts. We envisage a standard methodology which could address the deficiencies in procedural training currently. This would entail development and validation of a set of metrics for a particular procedure, evaluation of a proficiency based progression training programme based on those metrics to and demonstration of improved clinical performance and clinical outcome associated with that programme. Although elements of this "end -end" approach have been demonstrated previously for various procedures, we propose to apply this methodology in its entirety to placement of a lumbar epidural catheter for analgesia for patients in labor. To date we have developed and are validating a set of metrics for this procedure. Proficiency based training leading to better procedural skills leading to better patient outcomes has not been studied so far. Epidural analgesia during labor lends itself as an excellent model for evaluating the whole process. It has a specific procedural skill which is closely linked to patient outcome which is measurable and occurs in finite time interval. The hypothesis of the study is that in novice anaesthetic trainees, training with metrics based performance based progression in addition to improving the clinical performance will also reduce the failure rates of labor epidural analgesia to 5% when compared to 25% achieved by conventional training. **Detailed Description:** This will be a prospective, randomized, double blind control study. Ethical committee approval and consent from both participating anaesthetist and patients will be obtained. Trainees will be recruited from Cork University Hospital. Anaesthetic trainees with less than 2 years of experience in anaesthesia and who has performed less than 50 epidurals in the preceding 2 years (not limited to labor epidurals) will be requested to participate in the study. The trainees will be randomized in to group 1 and group 2. In group 1, standardized conventional teaching and training for labor epidural analgesia will be used. In group 2, they will be trained by metrics based simulation to predetermined level of proficiency. Each trainee will then perform 10 labor epidural catheter insertions and the procedures will be video recorded with patients consent. Observers blinded to the groups will be used for the data collection, outcome assessment and analysis. Failure rate of epidural will be assessed based on the occurrence of one or more of the following events, 1. Inadequate analgesia at 45 minutes from start of epidural needle placement. 2. Resiting epidural or abandoning the procedure. 3. Accidental Dural puncture. 4. Supervisor take over. The primary end point of the study is to compare difference in epidural failure rates between the two groups. Secondary end point will include assessment of clinical performance using metrics based assessment by two blinded reviewers based on video recordings and patient satisfaction with epidural analgesia. In addition to demographic data of the patients, duration of labor, cervical dilation at the time of insertion of the catheter, length of catheter inserted, time of insertion of catheter, experience of the operator and position of the patient during epidural placement will be noted. Age, sex and anaesthesia experience of the trainees will also be collected. The estimated labor epidural failure rates for year 1 trainees is 25%.6 We hope to reduce the failure rate in interventional group to 5%. 48 procedures per group will be sufficient to show a statistically significant difference between the groups with p value of 0.05% and power of 80%. To allow for dropouts, 8 trainees per group will be recruited and each will perform 10 procedures making it a total of 80 procedures per group. ### Conditions Module **Conditions:** - Labor Pain **Keywords:** - labor - epidural ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 16 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm. Access to epidural simulator for 2 days will be given. **Intervention Names:** - Behavioral: Conventional training **Label:** Group C **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm as well.Trainees in this arm in addition will be subjected to training to proficiency based on the metrics developed for labor epidural catheter placement in a epidural simulator. **Intervention Names:** - Behavioral: Training to proficiency **Label:** Group M **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Group M **Description:** Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm as well.Trainees in this arm in addition will be trained to proficience based on the metrics developed for labor epidural catheter placement in a epidural simulator. **Name:** Training to proficiency **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Group C **Description:** Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm. Access to epidural simulator for 2 days will be given. **Name:** Conventional training **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Failure rate of epidural will be assessed based on the occurrence of one or more of the following events, 1. Inadequate analgesia at 45 minutes from start of epidural needle placement. 2. Resiting epidural or abandoning the procedure. 3. Accidental Dural puncture. 4. Supervisor take over. **Measure:** Epidural failure rate **Time Frame:** within 48 hours after completion of epidural #### Secondary Outcomes **Description:** assessment of clinical performance using metrics based assessment will be done by two blinded reviewers based on video recordings **Measure:** assessment of clinical performance using metrics based assessment **Time Frame:** within 36 months after aquiring the video of epidrual catheter insertion procedure **Description:** Patient will be asked to rate eidural as (a) satisfied, will want it again (b) Not satisfied - give reason in free text **Measure:** patient satisfaction with epidural analgesia **Time Frame:** within 48 hours of completion of insertion of labor epidural catheter ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Anaesthetic trainees with less than 2 years of experience in anaesthesia and who has performed less than 50 epidurals in the preceding 2 years (not limited to labor epidurals) will be requested to participate in the study. Exclusion Criteria: * No tmeeting inclusion criteria * Not consenting for study **Maximum Age:** 60 Years **Minimum Age:** 23 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cork,Ireland **Country:** Ireland **Facility:** Cork University Hospital **State:** Cork #### Overall Officials **Official 1:** **Affiliation:** Cork University Hospital **Name:** Karthikeyan Kallidaikurichi Srinivasan, FCARCSI,MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Kallidaikurichi Srinivasan K, Gallagher A, O'Brien N, Sudir V, Barrett N, O'Connor R, Holt F, Lee P, O'Donnell B, Shorten G. Proficiency-based progression training: an 'end to end' model for decreasing error applied to achievement of effective epidural analgesia during labour: a randomised control study. BMJ Open. 2018 Oct 15;8(10):e020099. doi: 10.1136/bmjopen-2017-020099. **PMID:** 30327396 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M26008 - Name: Labor Pain - Relevance: HIGH - As Found: Labor Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M20559 - Name: Disease Progression - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000048949 - Term: Labor Pain ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11767 - Name: Metronidazole - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05570279 **Acronym:** PLAN-A **Brief Title:** PLAN-A Data- Bio- and Plan- Bank Collection for SCCA in Denmark **Official Title:** PLAN-A - Data- Bio-and Plan-bank Collection in Patients Treated With Radiotherapy for Squamous Cell Carcinoma of the Anus in Denmark - a DACG Cooperation #### Organization Study ID Info **ID:** KFE-1523 #### Organization **Class:** OTHER **Full Name:** Aarhus University Hospital ### Status Module #### Completion Date **Date:** 2026-04-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2022-10-06 **Type:** ACTUAL **Last Update Submit Date:** 2022-10-05 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-04-01 **Type:** ESTIMATED #### Start Date **Date:** 2016-04-01 **Type:** ACTUAL **Status Verified Date:** 2022-10 #### Study First Post Date **Date:** 2022-10-06 **Type:** ACTUAL **Study First Submit Date:** 2018-12-26 **Study First Submit QC Date:** 2022-10-05 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Herlev Hospital **Class:** OTHER **Name:** Vejle Hospital #### Lead Sponsor **Class:** OTHER **Name:** Aarhus University Hospital #### Responsible Party **Investigator Affiliation:** Aarhus University Hospital **Investigator Full Name:** Karen-Lise Garm Spindler **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study is a prospective registration of treatment related-, toxicity-, Quality of life- and outcome data from patients treated in Denmark with radiotherapy for squamous cell carcinoma of the anus (SCCA), as a cooperation within the Danish Anal Cancer Group (DACG). Substudy one: A prospective biobank is collected with the purpose to identify predictive and prognostic markers for outcome. Substudy two: MRI scans are performed to investigate the rate of pelvic insufficience fractures at one year post chemoradiotherapy. ### Conditions Module **Conditions:** - Anal Cancer ### Design Module #### Bio Spec **Description:** Tissue from the primary tumor and pre-treatment and consecutive blood samples are collected for a prospective biomarker evaluation **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 600 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Rate of complete response to primary treatment as defined by clinical and radiological evaluation **Measure:** Complete clinical response **Time Frame:** 3 years #### Secondary Outcomes **Description:** The rate of treatment related adverse events (assessed by CTCAE v.4.0) related to bowel, skin, bladder and bone. **Measure:** Early toxicity evaluation by CTCAE **Time Frame:** 2 weeks after the last day of therapy **Description:** The rate of treatment related adverse events (assessed by CTCAE v.4.0) related to bowel, skin, bladder and bone. **Measure:** Late toxicity evaluation by CTCAE **Time Frame:** 1 and 3 years post treatment **Description:** European Organisation for Research and Treatment of Cancer (EORTC) quality of life (QoL) questionnaire (QLQ) C30 (core). The EORTC QLQ-CR29 is a tumor-specific health related QoL questionnaire module for CRC (colorectal cancer) patients, which is designed to complement the EORTC QLQ-C30 questionnaire. Patients are asked to indicate their symptoms during the past week(s). Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales. **Measure:** Quality of life assessed by the EORTC QoL questionaires **Time Frame:** 2 weeks, 1 and 3 years post therapy **Description:** Measurement of circulating tumor DNA (in copies per ML) **Measure:** Prognostic value of ctDNA **Time Frame:** At time of treatment completion, an average of 30 days, 1 and 3 years post therapy **Description:** Frequency of pelvic insufficience fractures at MRI scans **Measure:** Incidence of pelvis fractures **Time Frame:** 1 and 3 years post therapy ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥ 18 * Squamous cell carcinoma of the anus, and indication for curatively intended radiotherapy * Written and oral consent Exclusion Criteria: * Contraindication to blood sampling or MRI scans (substudy 1 and 2) * Other malignant disease within 5 years except from basal cell carcinomas **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** All patients eligible for radiotherapy for SCCA in Denmark will be offered inclusion. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** k.g.spindler@rm.dk **Name:** Karen-Lise G Spindler, DMSc, PhD **Phone:** +4591167244 **Phone Ext:** +4591167244 **Role:** CONTACT **Contact 2:** **Email:** k.g.spindler@rm.dk **Name:** Karen-Lise G Spindler, Professor **Phone:** +4591167244 **Phone Ext:** +4591167244 **Role:** CONTACT #### Locations **Location 1:** **City:** Aarhus **Country:** Denmark **Facility:** Aarhus University Hospital **Status:** RECRUITING **Zip:** 8000 **Location 2:** **City:** Herlev **Contacts:** ***Contact 1:*** - **Name:** Eva S Hansen - **Role:** CONTACT **Country:** Denmark **Facility:** Herlev Hospital **Status:** RECRUITING **Location 3:** **City:** Vejle **Country:** Denmark **Facility:** Vejle Hospital **Status:** RECRUITING **Zip:** 7100 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012004 - Term: Rectal Neoplasms - ID: D000015179 - Term: Colorectal Neoplasms - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000001004 - Term: Anus Diseases - ID: D000012002 - Term: Rectal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M5550 - Name: Carcinoma, Squamous Cell - Relevance: LOW - As Found: Unknown - ID: M4321 - Name: Anus Neoplasms - Relevance: HIGH - As Found: Anal Cancer - ID: M14846 - Name: Rectal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17890 - Name: Colorectal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M4320 - Name: Anus Diseases - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown - ID: T362 - Name: Anal Cancer - Relevance: HIGH - As Found: Anal Cancer ### Condition Browse Module - Meshes - ID: D000001005 - Term: Anus Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04952779 **Brief Title:** Regulatory Post Marketing Surveillance (rPMS) Study of Xultophy® (Insulin Degludec/Liraglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea **Official Title:** A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance (rPMS) Study of Xultophy® (Insulin Degludec / Liraglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea #### Organization Study ID Info **ID:** NN9068-4445 #### Organization **Class:** INDUSTRY **Full Name:** Novo Nordisk A/S #### Secondary ID Infos **Domain:** World Health Organization **ID:** 1111-1211-7084 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2024-07-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-07-11 **Type:** ACTUAL **Last Update Submit Date:** 2023-07-07 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2021-06-02 **Type:** ACTUAL **Status Verified Date:** 2023-07 #### Study First Post Date **Date:** 2021-07-07 **Type:** ACTUAL **Study First Submit Date:** 2021-06-28 **Study First Submit QC Date:** 2021-06-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Novo Nordisk A/S #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this study is to assess the safety and effectiveness of Xultophy® initiated according to label in adults with type 2 diabetes mellitus (T2DM) under routine clinical practice conditions. Participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 26 weeks. ### Conditions Module **Conditions:** - Diabetes Mellitus, Type 2 ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 750 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Korean adults with type 2 diabetes mellitus (T2DM) initiating Xultophy® under routine clinical practice and according to approved label in Korea. **Intervention Names:** - Drug: Xultophy® (insulin degludec/liraglutide) **Label:** Xultophy® ### Interventions #### Intervention 1 **Arm Group Labels:** - Xultophy® **Description:** Xultophy® is a fixed ratio combination of the long-acting basal insulin, insulin degludec, and the glucagon-like peptide 1 receptor agonist (GLP-1 RA), liraglutide, administered under the skin. Patients will be treated according to routine clinical practice at the discretion of the treating physician according to the label approved by MFDS. The assignment of the patient to Xultophy® is not decided in advance by the protocol but falls within current practice and the prescription of Xultophy® is clearly separated from the decision to include the patient in the study. **Name:** Xultophy® (insulin degludec/liraglutide) **Other Names:** - insulin degludec/liraglutide **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Count of events **Measure:** Incidence of Adverse Events (AEs) by preferred term **Time Frame:** baseline (Visit1, 0 week) to 26 weeks #### Secondary Outcomes **Description:** Plasma Glucose (PG) less than 54 mg/dL (3.0 mmol/L) **Measure:** Level 3 hypoglycaemia (severe) or level 2 hypoglycaemia **Time Frame:** Visit1 (0 week) to 26 weeks **Description:** Kilograms **Measure:** Change in body weight **Time Frame:** Visit 1 (0 week), Visit 3 (13 weeks) **Description:** kilograms **Measure:** Change in body weight **Time Frame:** Visit 1 (0 week), Visit 4 (26 weeks) **Description:** Units **Measure:** Change of Xultophy® dose **Time Frame:** Visit 1 (0 week), 13 weeks (Visit 3) **Description:** Units **Measure:** Change of Xultophy® dose **Time Frame:** Visit (0 week), Visit 4 (26 weeks) **Description:** Percentage **Measure:** Change in Glycosylated Haemoglobin (HbA1c) **Time Frame:** Visit 1 (0 week), Visit 3 (13 weeks) **Description:** Percentage **Measure:** Change in HbA1c **Time Frame:** Visit 1 (0 week), Visit 4 (26 weeks) **Description:** Percentage **Measure:** Individuals achieving HbA1c target less than 7.0 % **Time Frame:** Visit 1 (0 week), Visit 3 (13 weeks) **Description:** Percentage **Measure:** Individuals achieving HbA1c target less than 7.0 % **Time Frame:** Visit 1 (0 week), Visit 4 (26 weeks) **Description:** mg/dl **Measure:** Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG) **Time Frame:** Visit 1 (0 week), Visit 3 (13 weeks) **Description:** mg/dl **Measure:** Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG) **Time Frame:** Visit 1 (0 week), Visit 4 (26 weeks) **Description:** mg/dl **Measure:** Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG) **Time Frame:** Visit 1 (0 week), Visit 3 (13 weeks) **Description:** mg/dl **Measure:** Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG) **Time Frame:** Visit 1 (0 week), Visit 3 (26 weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * The decision to initiate treatment with commercially available Xultophy® has been made by the participant/Legally Acceptable Representative (LAR) and the study doctor before and independently from the decision to include the participant in this study. * Informed consent obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Male or female, age 19 years or older at the time of signing informed consent form. * Participants diagnosed (clinically) with T2DM and who is scheduled to start treatment with Xultophy® based on the clinical judgment of their treating physician as specified in the approved Korean-Prescribing information (local label). Exclusion Criteria: * Participants who are or have previously been on Xultophy® therapy. * Known or suspected hypersensitivity to Xultophy® (the active substance or any of the excipients). * Previous participation in this study. Participation is defined as having given informed consent in this study. * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. **Minimum Age:** 19 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Korean adults with type 2 diabetes mellitus (T2DM) initiating Xultophy® under routine clinical practice and according to approved label in Korea. ### Contacts Locations Module #### Locations **Location 1:** **City:** Daejeon **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **State:** Cheongsa-ro, Seo-gu **Zip:** 35220 **Location 2:** **City:** Cheonan **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **State:** Chungcheongnam-do **Zip:** 31151 **Location 3:** **City:** Busan **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 47354 **Location 4:** **City:** Busan **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 47392 **Location 5:** **City:** Busan **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 49267 **Location 6:** **City:** Daegu **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 42601 **Location 7:** **City:** Daejeon **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 302-120 **Location 8:** **City:** Daejeon **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 35220 **Location 9:** **City:** Daejeon **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 361-711 **Location 10:** **City:** Goyang **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 10326 **Location 11:** **City:** Gyeonggi-do **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 13620 **Location 12:** **City:** Gyeonggi-do **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 14754 **Location 13:** **City:** Gyeonggi-do **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 16499 **Location 14:** **City:** Gyeongsangnam-do **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 52727 **Location 15:** **City:** Hwasung-si **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 18450 **Location 16:** **City:** Incheon **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 22332 **Location 17:** **City:** Jeonju **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 561-712 **Location 18:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 01450 **Location 19:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 01830 **Location 20:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 04058 **Location 21:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 04551 **Location 22:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 06591 **Location 23:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 130711 **Location 24:** **City:** Uijeongbu **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 11759 **Location 25:** **City:** Ulsan **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 44686 **Location 26:** **City:** Ulsan **Country:** Korea, Republic of **Facility:** Novo Nordisk Investigational Site **Zip:** 682-060 #### Overall Officials **Official 1:** **Affiliation:** Novo Nordisk A/S **Name:** Clinical Transparency dept. 1452 **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** According to the Novo Nordisk disclosure commitment on novonordisk-trials.com **IPD Sharing:** YES **URL:** http://novonordisk-trials.com ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes Mellitus - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Diabetes Mellitus, Type 2 - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003924 - Term: Diabetes Mellitus, Type 2 ### Intervention Browse Module - Ancestors - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000097789 - Term: Glucagon-Like Peptide-1 Receptor Agonists - ID: D000054795 - Term: Incretins - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: Micro - Name: Micronutrients ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: HIGH - As Found: Day 1 - ID: M9043 - Name: Glucagon - Relevance: LOW - As Found: Unknown - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: HIGH - As Found: Day 1 - ID: M267475 - Name: Xultophy - Relevance: HIGH - As Found: Absolute Bioavailability - ID: M3401 - Name: Glucagon-Like Peptide-1 Receptor Agonists - Relevance: LOW - As Found: Unknown - ID: M26997 - Name: Glucagon-Like Peptide 1 - Relevance: LOW - As Found: Unknown - ID: M419 - Name: Liraglutide - Relevance: HIGH - As Found: Ascending - ID: M17768 - Name: Zinc - Relevance: LOW - As Found: Unknown - ID: M26073 - Name: Insulin, Long-Acting - Relevance: HIGH - As Found: Ligament - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown - ID: M27905 - Name: Incretins - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007328 - Term: Insulin - ID: C000557859 - Term: Insulin, Globin Zinc - ID: D000069450 - Term: Liraglutide - ID: D000049528 - Term: Insulin, Long-Acting - ID: C000629636 - Term: Xultophy ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05276479 **Brief Title:** Dietary Plant Hormone and Mental Health **Official Title:** Association Between Dietary Plant Hormone Intake and Mental Health #### Organization Study ID Info **ID:** ABA2022 #### Organization **Class:** OTHER **Full Name:** University of Bern ### Status Module #### Completion Date **Date:** 2022-08-01 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** NOT_YET_RECRUITING #### Last Update Post Date **Date:** 2022-03-31 **Type:** ACTUAL **Last Update Submit Date:** 2022-03-16 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2022-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2022-04-01 **Type:** ESTIMATED **Status Verified Date:** 2022-03 #### Study First Post Date **Date:** 2022-03-11 **Type:** ACTUAL **Study First Submit Date:** 2022-03-02 **Study First Submit QC Date:** 2022-03-02 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Bern #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this cross-sectional online study is to investigate the association between regular feeding behavior and stress, sleep as well as anxiety and depressive symptoms in healthy subjects. **Detailed Description:** The gut-microbiota-brain (GMB) axis has a multidirectional communication between the intestine, the microbiota, and the central nervous system (CNS). Over the past decade, there has been extensive research showing that the GMB axis has a profound influence not only on neurological disorders but also on neural development, activation of the neuroendocrine axis and neurotransmission, as well as modulation of complex human behaviors. Thus, the GBM-axis is involved in the regulation of stress, emotions, behaviour, and higher cognitive functions. As the GMB plays an essential role in human psychological functioning and mental health, the dietary manipulation of the microbiome may have direct effects on mental well-being, sleep, anxiety and depressive symptoms. ### Conditions Module **Conditions:** - Dietary Behavior - Stress - Sleep - Depression, Anxiety ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Healthy subjects aged 18-30 years **Intervention Names:** - Other: Anonymous online survey on dietary habits and mental health **Label:** Healthy subjects ### Interventions #### Intervention 1 **Arm Group Labels:** - Healthy subjects **Description:** Assessment of regular feeding behavior and mental health **Name:** Anonymous online survey on dietary habits and mental health **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Subjective life-quality will be measured with the short version of the World Health Organization Quality of Life questionnaire (WHOQOL-BREF,). The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely". For the present study only the three subscales (physical and psychological health, and social relationships) will be assessed. **Measure:** Quality of life **Time Frame:** At baseline **Description:** Overall depressive symptoms assessed with the Beck Depression Inventory II (BDI-II; Beck, A., Steer, R., Brown, G., 1996). Each answer is scored on a scale value of 0-3. Measures of 0-9 indicates that a person is not depressed, 10-18 indicates mild-moderate depression, 19-29 indicates moderate-severe depression and 30-63 indicates severe depression. **Measure:** Depression **Time Frame:** At baseline **Description:** Sleep quality is assessed with the Pittsburgh Sleep Quality Index (PSQI; Buysse, D., Reynolds, C., Monk, T., Berman, S., Kupfer, D.,1989). Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality. **Measure:** Sleep **Time Frame:** At baseline #### Secondary Outcomes **Description:** Anxiety symptoms will be assessed with the validated German version of the Beck Anxiety Inventory (Beck and Steer 1988). A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and; 26 - 63 as "Severe". **Measure:** Anxiety **Time Frame:** At baseline **Description:** Stress will be assessed with the Stress and Coping Inventory (SCI; Satow, 2012).The SCI is used to determine the current stress load and stress symptoms and to illustrate how to deal with stress using five coping strategies. It comprises 10 scales with 54 items: (A) Current stress load (1) Stress due to uncertainty, (2) Stress due to overload, (3) Stress due to loss and actual negative events, (4) Total stress: Total stress due to insecurity, threat, overload or loss in important areas of life, (5) Physical and psychological stress symptoms; (B) Stress coping (Coping) (1) Positive thinking, (2) Active stress coping, (3) Social support, (4) Keeping faith, (5) Increased alcohol and cigarette consumption. **Measure:** Stress and Coping **Time Frame:** At baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 18 to 30 Exclusion Criteria: * None **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** Healthy subjects ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** leila.soravia@upd.unibe.ch **Name:** Leila M Soravia, Prof. Dr. **Phone:** +41 31 930 91 11 **Role:** CONTACT **Contact 2:** **Email:** christelle.robert@ips.unibe.ch **Name:** Christelle AM Robert, Prof. Dr. **Phone:** +41 31 684 31 55 **Role:** CONTACT #### Locations **Location 1:** **City:** Bern **Country:** Switzerland **Facility:** University Hospital of Psychiatry, University of Bern **Zip:** 3000 #### Overall Officials **Official 1:** **Affiliation:** University Hospital of Psychiatry, University of Bern **Name:** Leila M Soravia, Prof. Dr. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00370279 **Brief Title:** Surgical Management of Pseudophakic and Aphakic Retinal Detachment; a Randomized Clinical Trial #### Organization Study ID Info **ID:** 8405 #### Organization **Class:** OTHER **Full Name:** Shahid Beheshti University of Medical Sciences ### Status Module #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2008-06-26 **Type:** ESTIMATED **Last Update Submit Date:** 2008-06-25 **Overall Status:** UNKNOWN #### Start Date **Date:** 2005-09 **Status Verified Date:** 2008-06 #### Study First Post Date **Date:** 2006-08-31 **Type:** ESTIMATED **Study First Submit Date:** 2006-08-30 **Study First Submit QC Date:** 2006-08-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Shahid Beheshti University of Medical Sciences ### Description Module **Brief Summary:** To compare the visual and anatomical outcomes and complications of four surgical techniques (1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy with encircling band, 4- triamcinolone assisted vitrectomy) for management of pseudophakic and aphakic retinal detachment ### Conditions Module **Conditions:** - Pseudophakic Retinal Detachment - Aphakic Retinal Detachment **Keywords:** - Pseudophakic retinal detachment, - Aphakic retinal detachment, - Scleral buckling, - Primary vitrectomy, - Proliferative vitreoretinopathy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** scleral buckling **Intervention Names:** - Procedure: scleral buckling, primary vitrectomy **Label:** 1 **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Primary vitrectomy without encircling band **Intervention Names:** - Procedure: scleral buckling, primary vitrectomy **Label:** 2 **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Primary vitrectomy with encircling band **Intervention Names:** - Procedure: scleral buckling, primary vitrectomy **Label:** 3 **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Description:** Triamcinolone assisted vitrectomy **Intervention Names:** - Procedure: scleral buckling, primary vitrectomy **Label:** 4 **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - 1 - 2 - 3 - 4 **Description:** Four different surgical techniques were performed(one in each arm); 1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy with encircling band, 4- triamcinolone assisted vitrectomy **Name:** scleral buckling, primary vitrectomy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** Retinal reattachment rate **Measure:** Visual acuity #### Secondary Outcomes **Measure:** Proliferative vitreoretinopathy **Measure:** Macular Pucker **Measure:** Anisometropia **Measure:** Choroidal detachment **Measure:** Reoperation ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Cases of pseudophakic and aphakic retinal detachment with PVR grade A or B Exclusion Criteria: * PVR grade C * History of surgery for RD * Signs of diabetic retinopathy, AMD, glaucoma and macular hole * History of ocular trauma * Giant retinal tear **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** hahmadieh@hotmail.com **Name:** Hamid Ahmadieh, MD **Phone:** +98 21 22585952 **Role:** CONTACT #### Locations **Location 1:** **City:** Tehran **Contacts:** ***Contact 1:*** - **Email:** hahmadieh@hotmail.com - **Name:** Hamid Ahmadieh, MD - **Phone:** +98 21 22585952 - **Role:** CONTACT **Country:** Iran, Islamic Republic of **Facility:** Hamid Ahmadieh, MD **Status:** RECRUITING **Zip:** 16666 #### Overall Officials **Official 1:** **Affiliation:** Ophthalmic Research Center of Shaheed Beheshti Medical University **Name:** Hamid Ahmadieh, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders - ID: D000012164 - Term: Retinal Diseases - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14998 - Name: Retinal Detachment - Relevance: HIGH - As Found: Retinal Detachment - ID: M20719 - Name: Vitreoretinopathy, Proliferative - Relevance: LOW - As Found: Unknown - ID: M6515 - Name: Conversion Disorder - Relevance: LOW - As Found: Unknown - ID: M7394 - Name: Dissociative Disorders - Relevance: HIGH - As Found: Detachment - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M14999 - Name: Retinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: T5871 - Name: Vitreoretinal Degeneration - Relevance: LOW - As Found: Unknown - ID: T1568 - Name: Conversion Disorder - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012163 - Term: Retinal Detachment - ID: D000004213 - Term: Dissociative Disorders ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M16975 - Name: Triamcinolone Acetonide - Relevance: LOW - As Found: Unknown - ID: M16974 - Name: Triamcinolone - Relevance: LOW - As Found: Unknown - ID: M237966 - Name: Triamcinolone hexacetonide - Relevance: LOW - As Found: Unknown - ID: M209573 - Name: Triamcinolone diacetate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00764179 **Acronym:** Proneonat **Brief Title:** Effects (Long Term Analysis) of an Hyperproteinic Nutrition on Neonates With Intra-uterine Growth Delay : a Prospective, Multicentric , Randomized, Double Blind Study ("Proneonat") **Official Title:** Effects (Long Term Analysis) of an Hyperproteinic Nutrition on Neonates With Intra-uterine Growth Delay : a Prospective, Multicentric , Randomized, Double Blind Study ("Proneonat") #### Organization Study ID Info **ID:** BRD/06/12-P #### Organization **Class:** OTHER **Full Name:** Nantes University Hospital ### Status Module #### Completion Date **Date:** 2015-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2016-10-05 **Type:** ESTIMATED **Last Update Submit Date:** 2016-10-04 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2015-06 **Type:** ACTUAL #### Start Date **Date:** 2008-03 **Status Verified Date:** 2016-10 #### Study First Post Date **Date:** 2008-10-01 **Type:** ESTIMATED **Study First Submit Date:** 2008-09-30 **Study First Submit QC Date:** 2008-09-30 **Why Stopped:** difficulties of recruitment, high number of patients lost to follow-up ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Nantes University Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Neonates with intra-uterine growth delay represent more than 2% of the 800 000 annual births in France. Studies have shown that milks enriched with protein allow to accelerate newborns growth. According to some papers, growth acceleration would have a favourable effect on psycho-motor development at age of 2 or 3. However, for other authors, this would not lead to any benefit and even an early hyperproteinic feeding would have bad long term consequences such as appearance of several diseases in the future adult (overweight, diabetes, arterial hypertension, renal function alteration).The main objective of this clinical trial is to check that an hyperproteinic feeding does not lead to any benefit on psycho-motor development at age of 2, compared with a milk containing same level of protein than milk proposed to newborns of normal weight. The secondary objectives of our clinical trial are to compare the effects of these two types of milk on renal function, arterial blood pressure, body composition, corpulence, food preferences, insulin resistance and intestinal integrity at age of 2. A sub study will also be realized to analyse the proteic turn over . This sub-study will be undertaken only with neonates of Nantes Hospital. ### Conditions Module **Conditions:** - Intra-uterine Growth Delay **Keywords:** - Neonates with intra-uterine growth delay ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 93 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** hyperproteinic milk **Intervention Names:** - Other: milk enriched in proteins (2.15 g/100ml) **Label:** 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Normoproteinic milk **Intervention Names:** - Other: milk with normal protein concentration (1.45g/100ml) **Label:** 2 **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - 1 **Description:** Neonates will drink the hyperproteinic milk until they reach the 25th of "Sempé and Pedron" curve (milk to be taken at least until 40 weeks of amenorrhoea or at maximum until 4 months of corrected age) **Name:** milk enriched in proteins (2.15 g/100ml) **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - 2 **Description:** Neonates will drink the normoproteinic milk until they reach the 25th of "Sempé and Pedron" curve (milk to be taken at least until 40 weeks of amenorrhoea or at maximum until 4 months of corrected age) **Name:** milk with normal protein concentration (1.45g/100ml) **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Quotient of psycho-motor development evaluated by the Brunet-Lezine test at age of 2 **Time Frame:** at 2 years old #### Secondary Outcomes **Measure:** Leptine, glycemia/insulin and pro-insulin blood level **Time Frame:** At age of 15 (+/- 2) days and at age of 2 years **Measure:** Plasmatic and urinary citrulline levels **Time Frame:** At age of 15 (+/- 2) days and at age of 2 years **Measure:** Micro-albuminuria, creatinine, urea, sodium and potassium urine levels **Time Frame:** At age of 15 (+/- 2) days and at age of 2 years **Measure:** Faecal floa, faecal calprotectine and other markers **Time Frame:** At age of 15 (+/- 2) days and at age of 2 years **Measure:** Arterial blood pressure, arterial elasticity, adiponectine, preferential food choices, kidney size **Time Frame:** at age of 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Neonates with intra-uterine growth delay (with weight \< 10th centile) * Aged \>34 weeks of amenorrhoea * For neonates \>38 weeks of amenorrhoea, weight \< 2500g * Mother's refusal of breast feeding * Informed consent signed by the 2 parents * Possibility to follow newborns until age of 2 Exclusion Criteria: * Subject not fulfilling inclusion criteria * Severe disease (syndrome and/or congenital abnormality, deficiency of metabolism at birth) **Maximum Age:** 39 Weeks **Minimum Age:** 34 Weeks **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Nantes **Country:** France **Facility:** Universitary Hospital **Zip:** 44093 #### Overall Officials **Official 1:** **Affiliation:** Nantes Universitary Hospital **Name:** Dominique DARMAUN, Professor **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Nantes Universitary Hospital **Name:** Dominique DARMAUN, Professor **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Nantes Universitary Hospital **Name:** Jean-Christophe ROZE, Professor **Role:** STUDY_CHAIR **Official 4:** **Affiliation:** Nantes Universitary Hospital **Name:** Clotilde DES ROBERT, Doctor **Role:** STUDY_CHAIR **Official 5:** **Affiliation:** AP-HM, "Hôpital de la conception- Marseille" **Name:** Umberto SIMEONI, Professor **Role:** STUDY_CHAIR **Official 6:** **Affiliation:** CHU of Poitiers **Name:** Régis HANKARD, Professor **Role:** STUDY_CHAIR **Official 7:** **Affiliation:** CHU of Bordeaux (Pellegrin-Tripode Hospital) **Name:** Eric DUMAS DE LA ROQUE, Doctor **Role:** STUDY_CHAIR **Official 8:** **Affiliation:** AP-HP (Paris - Robert Debré Hospital) **Name:** Olivier BAUD, Professor **Role:** STUDY_CHAIR ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24