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## Protocol Section ### Identification Module **NCT ID:** NCT01567579 **Brief Title:** An Evaluation of Routine Developmental Follow-Up in Infants and Children With Congenital Heart Disease **Official Title:** An Evaluation of Routine Developmental Follow-Up in Infants and Children With Congenital Heart Disease #### Organization Study ID Info **ID:** CHW 09/98, GC 896 #### Organization **Class:** OTHER **Full Name:** Medical College of Wisconsin ### Status Module #### Completion Date **Date:** 2021-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-11-30 **Type:** ACTUAL **Last Update Submit Date:** 2021-11-18 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-09 **Type:** ACTUAL #### Start Date **Date:** 2009-09 **Type:** ACTUAL **Status Verified Date:** 2021-11 #### Study First Post Date **Date:** 2012-03-30 **Type:** ESTIMATED **Study First Submit Date:** 2012-03-28 **Study First Submit QC Date:** 2012-03-29 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Children's Hospital and Health System Foundation, Wisconsin #### Lead Sponsor **Class:** OTHER **Name:** Medical College of Wisconsin #### Responsible Party **Investigator Affiliation:** Medical College of Wisconsin **Investigator Full Name:** Cheryl Brosig **Investigator Title:** Professor, Pediatrics, Cardiology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to understand how having a heart problem affects development,quality of life, and family life in young children and their families. Results for children and families with heart disease will be compared to children and families without heart disease. The investigators hope that this information may help us to support children and families better in the future. All children and families that are seen in the HHC Developmental Follow-Up Program will be asked if they would like to take part in this study. It is hypothesized that children with congenital heart disease will demonstrate developmental delays when compared to normative values. **Detailed Description:** Research suggests that children with congenital heart disease are at higher risk for neurodevelopmental and psychosocial problems. Routine developmental screening and early intervention have been suggested as strategies to identify and ameliorate these problems. The purpose of this study is to describe the developmental trajectory and psychosocial functioning of children referred to the Herma Heart Center Developmental Follow-Up Program for routine developmental assessment. The specific aims of this project are: 1. to summarize the results of developmental screening, quality of life, and family impact in subjects that have been evaluated in the HHC Developmental Follow-Up Program since its inception in 2007, 2. to evaluate longitudinal changes in the trajectory of development for subjects that undergo repeated developmental and psychosocial screening, 3. to characterize how subjects with congenital heart disease compare to normative data for the instruments utilized and samples of children with other chronic health conditions, and 4. to determine what factors predict variability in developmental outcomes i.e. demographic and clinical variables such as gender, race, socioeconomic status, diagnosis, type of surgery, and length of hospitalization among others. Because our research and the research of others have indicated that children with Congenital Heart Disease (CHD) are at higher risk for neurodevelopmental and psychosocial problems, the Herma Heart Center Developmental Follow-Up Program was created in 2007. All infants who have open-heart surgery within the first 30 days of life, and all children under the age of 3 years who have a cyanotic lesion are referred to the clinic. This study will utilize both retrospective chart review and prospective collection of data from new subjects entering the program. No additional procedures are required to participate in the research study. Participation in the research study involves granting permission for the research team to systematically analyze the data obtained during the HHC Developmental Follow-Up Program clinic visits that a child participates in and to aggregate these data with all subjects that have received these follow-up assessments. A sample size of 1000 subjects is needed to ensure adequate power to detect medium effect sizes for the multiple outcome measures that are proposed (assuming p = .05 and power = .80). Therefore, recruitment for the study will continue until a sample size of 1000 subjects is reached. Estimated recruitment duration is 7 years. There are no anticipated risks related to participation in this study. Descriptive analyses will be conducted to summarize characteristics of the sample and to determine the frequency of developmental/behavioral/emotional problems among children in the present sample. Correlation and regression analyses will be conducted to examine the relationships among demographic, clinical, and outcome variables. For children with multiple visits, longitudinal changes and the pattern of developmental trajectory for children with congenital heart disease will be examined. Results may point to possible areas for intervention to improve child and family psychosocial outcomes. ### Conditions Module **Conditions:** - Congenital Heart Defects **Keywords:** - congenital heart defects ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 928 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** test of developmental skills **Measure:** Bayley Scales of Infant and Toddler Development Third Edition **Time Frame:** every 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Referred to the Herma Heart Center (HHC)Developmental Follow-Up Clinic for assessment. Exclusion Criteria: * Non-English and Non-Spanish speaking families * Children with extremely complex co-morbidities **Maximum Age:** 18 Years **Minimum Age:** 6 Months **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** Children who have had congenital heart surgery, before the age of 1. ### Contacts Locations Module #### Locations **Location 1:** **City:** Milwaukee **Country:** United States **Facility:** Children's Hospital of Wisconsin **State:** Wisconsin **Zip:** 53226 #### Overall Officials **Official 1:** **Affiliation:** Medical College of Wisconsin **Name:** Cheryl L Brosig, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Medical College of Wisconsin **Name:** Laurel M Bear, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Soto CB, Olude O, Hoffmann RG, Bear L, Chin A, Dasgupta M, Mussatto K. Implementation of a routine developmental follow-up program for children with congenital heart disease: early results. Congenit Heart Dis. 2011 Sep-Oct;6(5):451-60. doi: 10.1111/j.1747-0803.2011.00546.x. Epub 2011 Jul 1. **PMID:** 21718458 **Citation:** Mussatto KA, Hoffmann RG, Hoffman GM, Tweddell JS, Bear L, Cao Y, Brosig C. Risk and prevalence of developmental delay in young children with congenital heart disease. Pediatrics. 2014 Mar;133(3):e570-7. doi: 10.1542/peds.2013-2309. Epub 2014 Feb 2. **PMID:** 24488746 **Citation:** Mussatto KA, Hoffmann R, Hoffman G, Tweddell JS, Bear L, Cao Y, Tanem J, Brosig C. Risk Factors for Abnormal Developmental Trajectories in Young Children With Congenital Heart Disease. Circulation. 2015 Aug 25;132(8):755-61. doi: 10.1161/CIRCULATIONAHA.114.014521. **PMID:** 26304667 **Citation:** Brosig CL, Bear L, Allen S, Hoffmann RG, Pan A, Frommelt M, Mussatto KA. Preschool Neurodevelopmental Outcomes in Children with Congenital Heart Disease. J Pediatr. 2017 Apr;183:80-86.e1. doi: 10.1016/j.jpeds.2016.12.044. Epub 2017 Jan 9. **PMID:** 28081891 **Citation:** Brosig CL, Bear L, Allen S, Simpson P, Zhang L, Frommelt M, Mussatto KA. Neurodevelopmental outcomes at 2 and 4 years in children with congenital heart disease. Congenit Heart Dis. 2018 Sep;13(5):700-705. doi: 10.1111/chd.12632. Epub 2018 Sep 6. **PMID:** 30191663 **Citation:** Jilek E, Shields A, Zhang L, Simpson P, Bear L, Martins SA, Mussatto KA, Brosig CL. Predictors of behavioural and emotional outcomes in toddlers with congenital heart disease. Cardiol Young. 2022 Aug;32(8):1216-1221. doi: 10.1017/S1047951121003942. Epub 2021 Sep 22. **PMID:** 34548125 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000018376 - Term: Cardiovascular Abnormalities - ID: D000000013 - Term: Congenital Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M9419 - Name: Heart Diseases - Relevance: HIGH - As Found: Heart Disease - ID: M9418 - Name: Heart Defects, Congenital - Relevance: HIGH - As Found: Congenital Heart Defects - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M20503 - Name: Cardiovascular Abnormalities - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006331 - Term: Heart Diseases - ID: D000006330 - Term: Heart Defects, Congenital ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01628679 **Brief Title:** Physiotherapy Intervention for Provoked Vulvar Vestibulodynia **Official Title:** Physiotherapy Intervention for Provoked Vulvar Vestibulodynia #### Organization Study ID Info **ID:** H11-01805 #### Organization **Class:** OTHER **Full Name:** University of British Columbia #### Secondary ID Infos **ID:** H11-01805 ### Status Module #### Completion Date **Date:** 2020-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-06-23 **Type:** ACTUAL **Last Update Submit Date:** 2020-06-20 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-03 **Type:** ACTUAL #### Start Date **Date:** 2012-08 **Type:** ACTUAL **Status Verified Date:** 2020-06 #### Study First Post Date **Date:** 2012-06-27 **Type:** ESTIMATED **Study First Submit Date:** 2012-02-12 **Study First Submit QC Date:** 2012-06-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of British Columbia #### Responsible Party **Investigator Affiliation:** University of British Columbia **Investigator Full Name:** Marcy Dayan **Investigator Title:** Registered Physiotherapist, Clinical Instructor Department of PhysicalTherapy **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Hypothesis: 1. Specific physiotherapy interventions will decrease pain, improve pelvic floor motor control, increase self efficacy, improve sexual function and decrease pain catastrophizing behaviour in women with provoked vulvar vestibulodynia. This study will look at specific physiotherapy treatment interventions to see if they decrease pain, improve pelvic floor motor control, increase self efficacy, improve sexual function and decrease pain catastophizing behaviour. Participants will fill out a questionnaire on their pain symptoms and complete standardized scales prior to starting treatment and after 4 sessions to determine change due to interventions. 2. A combination of physiotherapy, group educational sessions and group cognitive behavioural therapy will have better outcomes than physiotherapy alone. Results of physiotherapy intervention alone will be compared to results of those treated with physiotherapy, group educational sessions and group cognitive behavioural therapy at a separate treatment centre. Physiotherapy interventions and outcome measures are the same between both groups. Justification: Standard treatment is hard to identify as many approaches are taken, none with any evidence to support them. This study aims to look at specific techniques (pelvic floor coordination and relaxation exercises, education on female sexual response and pain pathophysiology education) to see if there is a benefit. ### Conditions Module **Conditions:** - Vulvodynia - Provoked Vulvar Vestibulodynia **Keywords:** - provoked - vulvar - vestibulodynia - vestibulitis ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 125 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Physical therapy treatment **Label:** physical therapy treatment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - physical therapy treatment **Description:** Subjects will be given pelvic floor motor control,proprioception and relaxation exercises. This will be with and without the use of external surface Electromyography (EMG) biofeedback. Education will also be given on pain management, female sexual response and vestibulodynia. Subjects will also practice inserting vaginal inserts of graduating diameter into their vaginas, practicing the skills learned in physical therapy sessions. **Name:** Physical therapy treatment **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Time frame: Following completion of data collection **Measure:** Upon completion of data analysis, establishment of the efficacy of pelvic floor physiotherapy for the treatment of Provoked Vulvar Vestibulodynia will be determined **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 40 years and under * diagnosis of provoked vulvar vestibulodynia Exclusion Criteria: * early menopause * have had a total or partial hysterectomy * are on estrogen suppression medication * have a primary arousal disorder * declined admission to the Multidisciplinary Vulvodynia Program at Vancovuer General Hospital **Maximum Age:** 40 Years **Minimum Age:** 16 Years **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Vancouver **Country:** Canada **Facility:** Dayan Physiotherapy and Pelvic Floor Clinic **State:** British Columbia **Zip:** V5Z 1H8 #### Overall Officials **Official 1:** **Affiliation:** Clinical Instructor, Dep't of Physical Therapy, Faculty of Medicine, University of British Columbia **Name:** Marcy L Dayan, BSc Rehab **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014845 - Term: Vulvar 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 - ID: D000014847 - Term: Vulvitis ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M28529 - Name: Vulvodynia - Relevance: HIGH - As Found: Vestibulodynia - ID: M27753 - Name: Vulvar Vestibulitis - Relevance: HIGH - As Found: Vestibulodynia - ID: M17588 - Name: Vulvar 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 - ID: T5878 - Name: Vulvar Vestibulitis Syndrome - Relevance: HIGH - As Found: Vestibulodynia ### Condition Browse Module - Meshes - ID: D000056650 - Term: Vulvodynia - ID: D000054515 - Term: Vulvar Vestibulitis ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05056779 **Brief Title:** Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis With Inadequate Response to or for Whom Cyclosporine A is Not Medically Advisable **Official Title:** A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis With Inadequate Response to or for Whom Cyclosporine A is Not Medically Advisable #### Organization Study ID Info **ID:** RD.06.SPR.201591 #### Organization **Class:** INDUSTRY **Full Name:** Galderma R&D #### Secondary ID Infos **ID:** 2021-002166-40 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2023-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-09-21 **Type:** ACTUAL **Last Update Submit Date:** 2023-09-18 **Overall Status:** WITHDRAWN #### Primary Completion Date **Date:** 2023-07 **Type:** ESTIMATED #### Start Date **Date:** 2023-01 **Type:** ESTIMATED **Status Verified Date:** 2021-09 #### Study First Post Date **Date:** 2021-09-27 **Type:** ACTUAL **Study First Submit Date:** 2021-09-15 **Study First Submit QC Date:** 2021-09-15 **Why Stopped:** The study data will not be utilized in the IND and is only being conducted in EU. ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Galderma R&D #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The primary objective of this study is to investigate the efficacy of nemolizumab administered in combination with topical background therapy (topical corticosteroids \[TCS\] with or without topical calcineurin inhibitors \[TCI\]) in adult participants with moderate-to-severe atopic dermatitis (AD) who are not adequately controlled with or are not advised to use oral cyclosporine A (CsA) for medical reasons. The secondary objective is to investigate the safety of nemolizumab in adult participants with moderate-to-severe AD who are not adequately controlled with or are not advised to use oral CsA for medical reasons. The study will be carried out in up to 70 different locations across Europe. ### Conditions Module **Conditions:** - Moderate-to-severe Atopic Dermatitis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Nemolizumab **Label:** Nemolizumab **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: CD14152 placebo **Label:** Placebo **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Nemolizumab **Description:** Participants will receive loading dose of 60 milligram (2×30 mg) subcutaneous (SC) injection of nemolizumab at baseline. Thereafter 30 mg nemolizumab will be administered via single SC injection once in 4 week (Q4W) up to week 12. **Name:** Nemolizumab **Other Names:** - CD14152 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Participants will receive loading dose of 60 mg (2×30 mg) SC injection of placebo at baseline. Thereafter 30 mg placebo will be administered via single SC injection Q4W up to week 12. **Name:** CD14152 placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity will be assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score can range from 0 to 72 with higher scores representing greater severity of atopic dermatitis. **Measure:** Proportion of Participants with Eczema Area and Severity Index-75 (EASI-75) (≥ 75% Improvement in EASI from Baseline) at Week 16 **Time Frame:** Week 16 **Description:** Pruritus NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. **Measure:** Proportion of Participants with an Improvement of Peak Pruritus Numeric Rating Scale (PP NRS) ≥ 4 at Week 16 **Time Frame:** Week 16 #### Secondary Outcomes **Description:** EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity will be assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score can range from 0 to 72 with higher scores representing greater severity of atopic dermatitis. **Measure:** Percent Change from Baseline in EASI at Each Visit Through Week 16 **Time Frame:** Baseline through week 16 **Description:** EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity will be assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score can range from 0 to 72 with higher scores representing greater severity of atopic dermatitis. EASI-50, EASI-75 and EASI-90 responders will be the participants who achieved \>=50%, \>=75% and \>=90% overall improvement in EASI score respectively from baseline to Week 16. **Measure:** Proportion of Participants with at Least 50%, 75%, or 90% Improvement from Baseline in Eczema Area and Severity Index (EASI-50, EASI-75, and EASI-90) at Each Visit Through Week 16 **Time Frame:** Baseline through week 16 **Description:** Pruritus NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. **Measure:** Percent Change From Baseline in Peak Pruritus Numeric Rating Scale (PP NRS) at Each Visit Through Week 16 **Time Frame:** Baseline through week 16 **Description:** Pruritus NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. **Measure:** Proportion of Participants with an Improvement of Peak Pruritus Numeric Rating Scale (PP NRS) ≥ 4 at Week 1, Week 2, and Each Visit Through Week 16 **Time Frame:** From Week 1 to Week 16 **Description:** Pruritus NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. **Measure:** Proportion of Participants with Peak Pruritus Numeric Rating Scale (PP NRS) < 2 at each Visit Through Week 16 **Time Frame:** Baseline through week 16 **Description:** IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used to evaluate the global severity of AD. Higher scores indicate worse outcome. **Measure:** Proportion of Participants with an Investigator's Global Assessment (IGA) Success (Defined as an IGA of 0 [Clear] or 1 [Almost clear] and a ≥ 2-Point Reduction from Baseline) at Each Visit Through Week 16 **Time Frame:** Baseline through week 16 **Description:** EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity will be assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score can range from 0 to 72 with higher scores representing greater severity of atopic dermatitis. **Measure:** Proportion of Participants with EASI-75 and improvement of PP NRS ≥ 4 at Each Visit Through Week 16 **Time Frame:** Baseline through week 16 **Description:** IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used to evaluate the global severity of AD. Higher scores indicate worse outcome. Pruritus NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. **Measure:** Proportion of Participants with IGA Success and Improvement of PP NRS ≥ 4 at each Visit Through Week 16 **Time Frame:** Baseline through week 16 **Description:** The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants will be asked the following questions in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicate worse outcome. **Measure:** Proportion of Participants with an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) ≥ 4 at Each Visit Through Week 16 **Time Frame:** Baseline through week 16 **Description:** The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants will be asked the following questions in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicate worse outcome. **Measure:** Percent Change from Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Each Visit Through Week 16 **Time Frame:** Baseline through week 16 **Description:** SCORAD is a clinical tool for assessing the severity and the extent of AD signs and symptoms. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). **Measure:** Percent Change from Baseline in SCORing Atopic Dermatitis (SCORAD) and It's Components at Each Visit Through Week 16 **Time Frame:** Baseline through week 16 **Measure:** Change from Baseline in Percent of Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Each Visit Through Week 16 **Time Frame:** Baseline through week 16 **Description:** EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity will be assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score can range from 0 to 72 with higher scores representing greater severity of atopic dermatitis. **Measure:** Proportion of Participants with Prior Cyclosporine A (CsA) Use Achieving EASI-75 at Each Visit Through Week 16 **Time Frame:** Baseline through week 16 **Description:** EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity will be assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score can range from 0 to 72 with higher scores representing greater severity of atopic dermatitis. **Measure:** Change from Baseline in Individual Components of the EASI (Averaged Across Body Regions) at Each Visit Through Week 16 **Time Frame:** Baseline through week 16 **Measure:** Change from Baseline in Atopic Dermatitis (AD)-Associated Pain Frequency Through Week 16 **Time Frame:** Baseline through week 16 **Measure:** Change from Baseline in Atopic Dermatitis (AD)-Associated Pain Intensity Through Week 16 **Time Frame:** Baseline through week 16 **Measure:** Incidence of Rescue Therapy Use Through Week 16 **Time Frame:** Baseline through week 16 **Measure:** Change from Baseline in Percentage of Itch-Free Days (Based on PP NRS = 0/1) Through Week 16 **Time Frame:** Baseline through week 16 **Description:** The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant will rate each question ranging from 0 (not at all) to 3 (very much) and score ranges from 0 to 30. A higher total score indicates a poorer quality of life (QoL). **Measure:** Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Each Visit Through Week 16 **Time Frame:** Baseline through week 16 **Description:** The POEM is a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life \[QOL\]). **Measure:** Change from Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Each Visit Through Week 16 **Time Frame:** Baseline through week 16 **Measure:** Number of Days Free of Topical Atopic Dermatitis (AD) Therapy From Baseline to Week 16 **Time Frame:** Baseline to Week 16 **Description:** Hospital Anxiety and Depression Scale (HADS) is a 14-question validated questionnaire completed by the participant for each subscale (i.e. depression and anxiety). Each question has a multiple choice answer which is scored between 0 and 3. Questions are identified as relating to anxiety (A) or depression (D) and a summation for each area is performed leading to a total score of 0 to 21 for each area. Scores of 0 to 7 are considered normal, 8 to 10 are borderline, and \>= 11 indicates clinical effects. **Measure:** Change from baseline in Hospital Anxiety and Depression Scale (HADS) for each subscale (ie, depression and anxiety) at each visit through Week 16 **Time Frame:** Baseline through week 16 **Description:** Hospital Anxiety and Depression Scale (HADS) is a 14-question validated questionnaire completed by the participant for each subscale (i.e. depression and anxiety). Each question has a multiple choice answer which is scored between 0 and 3. Questions are identified as relating to anxiety (A) or depression (D) and a summation for each area is performed leading to a total score of 0 to 21 for each area. Scores of 0 to 7 are considered normal, 8 to 10 are borderline, and \>= 11 indicates clinical effects. **Measure:** Proportion of Participants Reporting Hospital Anxiety and Depression Scale (HADS) anxiety Scores < 8 for those Reporting Scores ≥ 8 at Baseline at Each Visit Through Week 16 **Time Frame:** Baseline through week 16 **Description:** Hospital Anxiety and Depression Scale (HADS) is a 14-question validated questionnaire completed by the participant for each subscale (i.e. depression and anxiety). Each question has a multiple choice answer which is scored between 0 and 3. Questions are identified as relating to anxiety (A) or depression (D) and a summation for each area is performed leading to a total score of 0 to 21 for each area. Scores of 0 to 7 are considered normal, 8 to 10 are borderline, and \>= 11 indicates clinical effects. **Measure:** Proportion of Participants Reporting HADS depression Scores < 8 for Those Reporting Scores ≥ 8 at Baseline at Each Visit Through Week 16 **Time Frame:** Baseline through week 16 **Description:** The EQ-5D instrument is a validated questionnaire, completed by the participant that consists of 2 parts. The first part consists of 5 multiple choice QoL questions and the second is a 100 point visual analogue scale (VAS) with 0 being "Worst imaginable health state" and 100 being "Best imaginable health state". **Measure:** Change from Baseline in EuroQoL 5-Dimension (EQ-5D) at each visit through Week 16 **Time Frame:** Baseline through week 16 **Measure:** Incidence and Severity of Adverse Events (AEs), Including Adverse Events of Special Interest (AESIs), Treatment Emergent AEs (TEAEs), and serious AEs (SAEs) **Time Frame:** Baseline through week 24 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Chronic AD for at least 2 years before the screening visit and confirmed according to American Academy of Dermatology Consensus at the time of the screening visit. 2. EASI score ≥ 20 at both the screening and baseline visits. Participant with an EASI score of 18-19 at the screening visit only may be reevaluated once within 48 hours. 3. IGA score ≥ 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the screening and baseline visits. 4. AD involvement ≥ 10% of BSA at both the screening and baseline visits. 5. Documented history by a physician (within 6 months before the screening visit) of inadequate response to topical medications or use of systemic therapies for control of the disease. 6. Agree to apply a moisturizer throughout the study from the screening visit; agree to apply an authorized TCS, with or without TCI, from the screening visit and throughout the study as determined appropriate by the investigator. 7. Documented history of one of the following, where CsA treatment should not be continued/restarted or participant is not currently a candidate for CsA treatment: 1. Inadequate response to CsA with previous exposure (defined as flare of AD during CsA tapering from a maximum of 6 weeks of high dose \[5 mg/kg/day\] to maintenance dose \[2 to 3 mg/kg/day\] or a flare after a minimum of 3 months on maintenance dose). Flare is defined as increase in signs and/or symptoms leading to escalation of therapy (ie, increase in dose, switch to a higher-potency topical corticosteroids \[TCS\] or start of another systemic nonsteroidal immunosuppressive drug), or 2. Previous requirement for CsA at doses \> 5 mg/kg/day, or duration beyond those specified in the prescribing information (\> 1 year) 3. Intolerance and/or unacceptable toxicity (eg, elevated creatinine, elevated liver function tests, uncontrolled hypertension, paresthesia, headache, nausea, hypertrichosis) with previous CsA exposure 4. CsA is medically inadvisable due to medical contraindication, use of prohibited medications, risk of AEs (eg, serious infection) or toxicity (eg, renal or liver damage), or hypersensitivity to CsA or excipients, in the opinion of the investigator Acceptable documentation includes patient records with information on CsA prescription and treatment outcome, other prohibitive medications/medical history, or written documentation of the conversation with the participant's treating physician, if different than the investigator, as applicable. 8. Other protocol defined inclusion criteria could apply. Exclusion Criteria: 1. Body weight \< 30 kg. 2. One or more of the following criteria at screening or baseline: 1. Exacerbation of asthma requiring hospitalization in the preceding 12 months. 2. Asthma that has not been well controlled (i.e, symptoms occurring on \> 2 days per week, nighttime awakenings 2 or more times per week, or some interference with normal activities) during the preceding 3 months. 3. Asthma Control Test (ACT) ≤ 19 (only for subjects with a history of asthma). 4. Peak expiratory flow (PEF) \< 80% of the predicted value. 3. Current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis. 4. Positive serology results (hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\], hepatitis C \[HCV\] antibody with positive HCV RNA, or human immunodeficiency virus \[HIV\] antibody) at the screening visit. 5. Presence of confounding skin conditions that may interfere with study assessments. 6. Planned or expected major surgical procedure during the clinical study. 7. Other protocol defined exclusion criteria could apply. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012871 - Term: Skin Diseases - ID: D000012873 - Term: Skin Diseases, Genetic - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000017443 - Term: Skin Diseases, Eczematous - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7067 - Name: Dermatitis - Relevance: HIGH - As Found: Dermatitis - ID: M7655 - Name: Eczema - Relevance: HIGH - As Found: Atopic Dermatitis - ID: M7071 - Name: Dermatitis, Atopic - Relevance: HIGH - As Found: Atopic Dermatitis - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M15676 - Name: Skin Diseases, Genetic - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M19712 - Name: Skin Diseases, Eczematous - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: 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: D000003876 - Term: Dermatitis, Atopic - ID: D000003872 - Term: Dermatitis - ID: D000004485 - Term: Eczema ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M18961 - Name: Cyclosporine - Relevance: LOW - As Found: Unknown - ID: M6730 - Name: Cyclosporins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01789879 **Brief Title:** A Pharmacokinetic Evaluation of Levonorgestrel Implant and Antiretroviral Therapy **Official Title:** A Pharmacokinetic Evaluation of Levonorgestrel Implant and Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Based Antiretroviral Therapy in HIV-infected Ugandan Women #### Organization Study ID Info **ID:** 0022-14-EP #### Organization **Class:** OTHER **Full Name:** University of Nebraska #### Secondary ID Infos **ID:** 1R21HD074462-01 **Link:** https://reporter.nih.gov/quickSearch/1R21HD074462-01 **Type:** NIH ### Status Module #### Completion Date **Date:** 2015-03-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-09-01 **Type:** ACTUAL **Last Update Submit Date:** 2023-08-30 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2014-09-01 **Type:** ACTUAL #### Start Date **Date:** 2014-03-04 **Type:** ACTUAL **Status Verified Date:** 2023-08 #### Study First Post Date **Date:** 2013-02-12 **Type:** ESTIMATED **Study First Submit Date:** 2013-02-07 **Study First Submit QC Date:** 2013-02-08 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) **Class:** OTHER **Name:** Makerere University **Class:** OTHER **Name:** University of Liverpool #### Lead Sponsor **Class:** OTHER **Name:** University of Nebraska #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The use of hormone contraception poses a significant challenge for the estimated 16 million HIV-infected women of childbearing age. This is due to known drug interactions with antiretroviral therapy (medicines used to treat HIV) that may jeopardize contraception effectiveness. By evaluating the impact of antiretroviral therapy on a levonorgestrel subdermal implant, the most widely available hormone implant in low and middle-income countries, this study will translate its findings into an evidence-based approach to co-manage these important medications. The investigators hypothesize that women receiving nevirapine or efavirenz-based antiretroviral therapy will have a significant decrease in the mean levonorgestrel plasma concentration measured six months after the implant's insertion as compared to those women who are not taking antiretroviral therapy. Although the implant's efficacy may be retained initially, the investigators propose that a decrease in levonorgestrel concentrations in women receiving antiretroviral therapy may jeopardize the implant's effectiveness near the end of its intended duration of use (5 years). **Detailed Description:** Family planning services, including hormone contraceptives, are critical for HIV-infected women, in whom prevention of unintended pregnancy not only decreases maternal and child mortality, but also reduces the risk of mother-to-child HIV transmission. Similarly, antiretroviral therapy (ART) is a lifesaving intervention that improves the health and economic status of HIV-infected women throughout the world. Therefore, it is of significant public health importance to guide the appropriate use these essential medications. To this end, millions of HIV-infected women in low and middle income countries (LMIC) currently use or are gaining access to subdermal progestin-containing implants as a preferred method of long-acting reversible contraception. These implants are often combined with ART despite the lack of critically needed pharmacokinetic (PK) drug-interaction data to inform their safe and effective concomitant use. Highlighting this concern are several case reports of unintended pregnancy that occurred in patients with subdermal progestin-containing implants concurrently receiving non-nucleoside reverse transcriptase inhibitor (NNRTI)-based ART, the most commonly used ART in LMICs. While NNRTIs are known to significantly decrease oral pill progestin concentrations, no data are available to inform healthcare providers of the impact of NNRTIs on progestin concentrations following release from subdermal implants. To fill this critical gap in knowledge, the overall aim of this proposal is to conduct a PK study to evaluate the combination of a levonorgestrel (LNG) implant and NNRTI (nevirapine or efavirenz)-based ART in HIV-infected Ugandan women. The investigators propose that lower LNG concentrations will be observed in patients on NNRTI-based ART and although the implant's efficacy may be retained initially, this negative interaction will jeopardize implant effectiveness near the end of its intended duration of use (5 years). The specific aims of this project are (1) to characterize the PK of LNG released from a subdermal implant over one year in HIV-infected women with and without NNRTI-based ART and (2) to evaluate the potential for a bidirectional drug-interaction resulting from the long-term impact of chronic progestin exposure on antiretroviral concentrations. To achieve these aims, this study will enroll 20 HIV-infected women into each of three study groups: a control group not receiving ART and two treatment arms consisting of patients receiving nevirapine- or efavirenz- based ART. Using sparse PK sampling strategies, LNG, nevirapine or efavirenz concentrations will be measured over one-year and compared between and within groups, as appropriate. The LNG data will also be used to develop a PK model that will predict LNG disposition over the following three years of intended use, allowing for identification of the safe duration of LNG implant use in women on NNRTI-based ART. At the conclusion of this project, the first evidence-based medical knowledge will be available to guide the safe and effective concomitant use of subdermal LNG implants and NNRTIs, thereby improving management of reproductive health in millions of HIV-infected women worldwide. ### Conditions Module **Conditions:** - HIV - Contraception **Keywords:** - Levonorgestrel - Efavirenz - Nevirapine - Pharmacokinetics ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Levonorgestrel subdermal implant in subjects not yet receiving ART (control group) **Intervention Names:** - Drug: Levonorgestrel **Label:** Control group (no current ART) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Levonorgestrel subdermal implant in subjects receiving nevirapine-based ART **Intervention Names:** - Drug: Levonorgestrel - Drug: Nevirapine **Label:** NVP-based ART group **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Levonorgestrel subdermal implant in subjects receiving efavirenz-based ART **Intervention Names:** - Drug: Levonorgestrel - Drug: Efavirenz **Label:** EFV-based ART group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Control group (no current ART) - EFV-based ART group - NVP-based ART group **Description:** Levonorgestrel 2-rod subdermal implant (75mg/rod) placed on study day 0 after baseline evaluations and remains in place until the subject requests removal or for the duration of drug activity (currently approved for 5 years). **Name:** Levonorgestrel **Other Names:** - Jadelle - SinoImplant **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - NVP-based ART group **Description:** Nevirapine 200mg twice daily as part of a complete antiretroviral therapy regimen. Subjects will be on this therapy prior to entry in this study. **Name:** Nevirapine **Other Names:** - Viramune - NVP **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - EFV-based ART group **Description:** Efavirenz 600mg once daily as part of a complete antiretroviral therapy regimen. Subjects will be on this therapy prior to entry in this study. **Name:** Efavirenz **Other Names:** - Sustiva - Atripla - Stocrin - EFV **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Levonorgestrel plasma concentrations **Measure:** Levonorgestrel plasma concentrations **Time Frame:** 6 months and 1 year after implant #### Secondary Outcomes **Description:** Applies to subjects being treated with either efavirenz- or nevirapine-based antiretroviral therapy **Measure:** Non-nucleoside reverse transcriptase inhibitor (NNRTI) plasma concentrations **Time Frame:** Over 1 year (baseline, Months 1, 3, 6, 9, and 12) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. * Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * Women age 18 years or older * Diagnosed with HIV-1 infection * Desiring LNG subdermal implant as a contraceptive method * Subjects not yet eligible for ART (based on the Ugandan Treatment Guidelines); or subjects receiving nevirapine or efavirenz-based ART for a minimum of 1 month prior to screening Exclusion Criteria: * For patients currently on ART: HIV-1 RNA \> 400 copies/mL at screening visit * Serum hemoglobin \< 9.0 g/dl * Elevations in serum levels of alanine transaminase (ALT) above 5 times the upper limit of normal * Elevations in serum creatinine above 2.5 times the upper limit of normal * Use of drugs known to be contraindicated with levonorgestrel, nevirapine (NVP group only), or efavirenz (EFV group only) within 30 days of study entry. Due to the dynamic nature of drug interactions related to antiretroviral therapy, the study team will review all concomitant medications at screening based on the US Department of Health and Human Services drug interaction tables or the AIDS Clinical Trials Group Drug Interactions Database. * Currently pregnant or postpartum \<30 days at study entry * No concurrent use of other hormonal contraception is allowed during the study period **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Kampala **Country:** Uganda **Facility:** Infectious Diseases Institute #### Overall Officials **Official 1:** **Affiliation:** University of Nebraska **Name:** Kimberly K Scarsi, PharmD, MSc **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Scarsi KK*, Darin KM, Nakalema S, Back D, Byakika-Kibwika P, Else L, Dilly-Penchala S, Cohn S, Merry C, Lamorde M. Levonorgestrel implant + EFV-based ART: Unintended pregnancies and associated PK Data. Conference on Retroviruses and Opportunistic Infections. Seattle, WA. February 23-26, 2015. Abstract #85LB. **Citation:** Scarsi K, Lamorde M, Darin K, Penchala SD, Else L, Nakalema S, Byakika-Kibwika P, Khoo S, Cohn S, Merry C, Back D. Efavirenz- but not nevirapine-based antiretroviral therapy decreases exposure to the levonorgestrel released from a sub-dermal contraceptive implant. J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19484. doi: 10.7448/IAS.17.4.19484. eCollection 2014. **PMID:** 25393993 **Citation:** Scarsi KK, Darin KM, Nakalema S, Back DJ, Byakika-Kibwika P, Else LJ, Dilly Penchala S, Buzibye A, Cohn SE, Merry C, Lamorde M. Unintended Pregnancies Observed With Combined Use of the Levonorgestrel Contraceptive Implant and Efavirenz-based Antiretroviral Therapy: A Three-Arm Pharmacokinetic Evaluation Over 48 Weeks. Clin Infect Dis. 2016 Mar 15;62(6):675-682. doi: 10.1093/cid/civ1001. Epub 2015 Dec 8. **PMID:** 26646680 #### See Also Links **Label:** CID Open Access publication **URL:** http://cid.oxfordjournals.org/content/early/2016/01/01/cid.civ1001.full ## 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 - Ancestors - 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: D000000998 - Term: Antiviral Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000065688 - Term: Cytochrome P-450 CYP2C9 Inhibitors - ID: D000065607 - Term: Cytochrome P-450 Enzyme Inhibitors - ID: D000065689 - Term: Cytochrome P-450 CYP2C19 Inhibitors - ID: D000065695 - Term: Cytochrome P-450 CYP2B6 Inducers - ID: D000065693 - Term: Cytochrome P-450 Enzyme Inducers - ID: D000065701 - Term: Cytochrome P-450 CYP3A Inducers - 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: D000019380 - Term: Anti-HIV Agents - ID: D000044966 - Term: Anti-Retroviral Agents ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M19256 - Name: Levonorgestrel - Relevance: HIGH - As Found: SBRT - ID: M20935 - Name: Reverse Transcriptase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M340137 - Name: Efavirenz - Relevance: HIGH - As Found: See - ID: M25428 - Name: Anti-Retroviral Agents - Relevance: LOW - As Found: Unknown - ID: M245 - Name: Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination - Relevance: LOW - As Found: Unknown - ID: M21717 - Name: Nevirapine - Relevance: HIGH - As Found: Colon cancer - ID: M7951 - Name: Enzyme Inhibitors - 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 - ID: M30537 - Name: Cytochrome P-450 Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M6494 - Name: Contraceptive Agents - 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: M21350 - Name: Anti-HIV Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000098320 - Term: Efavirenz - ID: D000019829 - Term: Nevirapine - ID: D000016912 - Term: Levonorgestrel ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06307379 **Acronym:** BRONCHOPROEM **Brief Title:** Patient Reported Outcome and Experience Measures for Bronchoscopic Procedures **Official Title:** Patient Reported Outcome and Experience Measures for Bronchoscopic Procedures #### Organization Study ID Info **ID:** EC 23022 #### Organization **Class:** OTHER **Full Name:** Vitaz ### Status Module #### Completion Date **Date:** 2025-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-03-12 **Type:** ACTUAL **Last Update Submit Date:** 2024-03-11 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-13 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-03-12 **Type:** ACTUAL **Study First Submit Date:** 2023-10-09 **Study First Submit QC Date:** 2024-03-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Vitaz #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** 'Patient-reported outcomes' (PROMS) and 'patient-reported experiences' (PREMS) are increasingly important parameters in evaluating and adjusting clinical procedures and strategies in healthcare. Validated disease-specific PROMS related to bronchoscopic procedures are not available and examples in the medical literature are very scarce. **Detailed Description:** The potential usefulness of PROM/PREMS is multiple: 1. Quality improvement within the current clinical care structure 2. Monitoring the health status of the population 3. Contribution to decision-making regarding financing of care 4. Increase employee and patient involvement in clinical care pathways 5. Rationalize the deployment of medical personnel and resources 6. Integration of data in electronic patient files and registers ### Conditions Module **Conditions:** - Bronchial Diseases **Keywords:** - bronchoscopy - endoscopy - patient reported outcome measures ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Bronchoscopy under local anesthesia **Intervention Names:** - Other: no intervention **Label:** Bronchoscopy under local anesthesia #### Arm Group 2 **Description:** Bronchoscopy under anxiolysis **Intervention Names:** - Other: no intervention **Label:** Bronchoscopy under anxiolysis #### Arm Group 3 **Description:** Bronchoscopy under conscious sedation **Intervention Names:** - Other: no intervention **Label:** Bronchoscopy under conscious sedation #### Arm Group 4 **Description:** Bronchoscopy under general anesthesia **Intervention Names:** - Other: no intervention **Label:** Bronchoscopy under general anesthesia ### Interventions #### Intervention 1 **Arm Group Labels:** - Bronchoscopy under anxiolysis - Bronchoscopy under conscious sedation - Bronchoscopy under general anesthesia - Bronchoscopy under local anesthesia **Description:** only observational **Name:** no intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Procedure-related dyspnea scale (VAS) **Measure:** Procedure-related dyspnea scale (VAS) **Time Frame:** 24 hours **Description:** Procedure-related pain scale (VAS) **Measure:** Procedure-related pain scale (VAS) **Time Frame:** 24 hours **Description:** Procedure related cough scale (VAS) **Measure:** Procedure related cough scale (VAS) **Time Frame:** 24 hours **Description:** General patient satisfaction VAS scale **Measure:** General patient satisfaction **Time Frame:** 24 hours #### Secondary Outcomes **Description:** bleeding + grading; pneumothorax; hypoxaemia; hypercapnia; respiratory rate; heart rate. **Measure:** Procedure-related complications: **Time Frame:** 24 hours **Description:** paradoxical agitation; GCS; hypoxaemia; hypercapnia **Measure:** Sedation-related complications **Time Frame:** 24 hours **Description:** number of biopsies; histological diagnosis; DNA extraction. **Measure:** Diagnostic yield **Time Frame:** 30 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age above 18 years * Patient referred for diagnostic flexible bronchoscopy * Procedure performed in outpatient setting Exclusion Criteria: * Patient unable to adequately respond to the contents of the patient questionnaire. * Procedure performed in hospitalised setting * Patient with active pregnancy **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Out-of-hospital care ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jonas Yserbyt, MD,PhD **Phone:** +3237602327 **Role:** CONTACT #### Locations **Location 1:** **City:** Sint-Niklaas **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jonas Yserbyt - **Role:** CONTACT **Country:** Belgium **Facility:** VITAZ **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** MD **Name:** Jonas Yserbyt, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5258 - Name: Bronchial Diseases - Relevance: HIGH - As Found: Bronchial Diseases - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001982 - Term: Bronchial Diseases ### 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

## Protocol Section ### Identification Module **NCT ID:** NCT03215979 **Brief Title:** Use of Platelet-enriched Plasma During Auricular Reconstruction **Official Title:** Use of Platelet-enriched Plasma to Improve the Percentage of Integration of the Cutaneous Graft During Second Stage of Auricular Reconstruction in Children Aged 8-12 Years; A Controlled Clinical Trial #### Organization Study ID Info **ID:** 05-20-2017 #### Organization **Class:** OTHER_GOV **Full Name:** Hospital General Dr. Manuel Gea González ### Status Module #### Completion Date **Date:** 2018-12-10 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2018-02-22 **Type:** ACTUAL **Last Update Submit Date:** 2018-02-20 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2018-11-29 **Type:** ESTIMATED #### Start Date **Date:** 2017-06-29 **Type:** ACTUAL **Status Verified Date:** 2018-02 #### Study First Post Date **Date:** 2017-07-12 **Type:** ACTUAL **Study First Submit Date:** 2017-07-07 **Study First Submit QC Date:** 2017-07-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Hospital General Dr. Manuel Gea González #### Responsible Party **Investigator Affiliation:** Hospital General Dr. Manuel Gea González **Investigator Full Name:** Jorge Raúl Carrillo Córdova **Investigator Title:** Medical Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In this study investigators are trying to determine the benefits of using platelet enriched plasma during the second stage of auricular reconstruction. The intervention will be blinded to the surgeon and the surgical team. The main outcome will be the evaluation of the integration rate of the skin full thickness graft used to coat the auricular frame. ### Conditions Module **Conditions:** - Ear Cartilage - Platelets - Microtia-Anotia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In this arm, surgeon will be applying platelet enriched plasma(PEP) (5 ml) during the second stage procedure of auricular reconstruction. PEP will be infected in the temporal fascia used to cover the cartilage frame. **Intervention Names:** - Procedure: Platelet enriched plasma administration **Label:** PEP-Arm **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** This arm will be used as control. The surgeon will inject 0.9% saline solution (5ml) in a blinded basis. **Intervention Names:** - Procedure: Placebo Arm **Label:** Placebo-Arm **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - PEP-Arm **Description:** It is a blinded administration of platelet enriched plasma in the temporal fascia used to cover the auricular reconstruction frame, during the second stage of the procedure. The use of platelet enriched plasma is focused to improve the integration rate of the full-thickness split skin graft **Name:** Platelet enriched plasma administration **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Placebo-Arm **Description:** 5 ml of saline 0.9%will be applied in the temporal fascia as a placebo used to compare to the experimental group. **Name:** Placebo Arm **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Evaluation of the integration will be made on clinical basis, and evaluated by 3 experimented plastic surgeons. **Measure:** Integration rate (in percentage) of the full thickness split graft sued during the second stage of auricular reconstruction. **Time Frame:** evaluation will be at day 10 #### Secondary Outcomes **Description:** It refers to a deviation from the normal course of the pathology, 3 complications will be taken into account: infection, seroma and hematoma **Measure:** Complication **Time Frame:** evaluation will be at day 10 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Microtia Tanzer II-A * patients aged 8-12 years * Haemoglobin \> 10 gr/dL * History of first stage of auricular reconstruction Exclusion Criteria: * associated endocrinopathies * desnutrition (\<2.5 gr/ dL) **Maximum Age:** 12 Years **Minimum Age:** 8 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Mexico city **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jorge Raúl Carrillo-Córdova, M.D - **Phone:** 01 55 4000 3000 - **Phone Ext:** 1323 - **Role:** CONTACT **Country:** Mexico **Facility:** Hospital General "Dr. Manuel Gea González" **Status:** RECRUITING **Zip:** 4800 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004427 - Term: Ear Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases - ID: D000000013 - Term: Congenital Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M30605 - Name: Congenital Microtia - Relevance: HIGH - As Found: Microtia - ID: M7601 - Name: Ear Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: T3813 - Name: Microtia-Anotia - Relevance: HIGH - As Found: Microtia-Anotia ### Condition Browse Module - Meshes - ID: D000065817 - Term: Congenital Microtia ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01447979 **Acronym:** HomeCTR1_1 **Brief Title:** Feasibility Study of a Portable Artificial Pancreas System in Type 1 Diabetes Mellitus (T1DM) - Montpellier **Official Title:** Pilot Study 1 of Outpatient Control-to-Range - System and Monitoring Testing #### Organization Study ID Info **ID:** 2011-A01096-35 #### Organization **Class:** OTHER **Full Name:** University of Virginia #### Secondary ID Infos **Domain:** Juvenile Diabetes Research Foundation **ID:** JDRF 22-2011-649 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2012-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2012-11-29 **Type:** ESTIMATED **Last Update Submit Date:** 2012-11-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2012-04 **Type:** ACTUAL #### Start Date **Date:** 2012-03 **Status Verified Date:** 2012-11 #### Study First Post Date **Date:** 2011-10-06 **Type:** ESTIMATED **Study First Submit Date:** 2011-09-29 **Study First Submit QC Date:** 2011-10-05 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University Hospital, Montpellier **Class:** OTHER **Name:** University of Padova **Class:** OTHER **Name:** University of California, Santa Barbara #### Lead Sponsor **Class:** OTHER **Name:** University of Virginia #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** A single arm, single treatment study is proposed to assess the feasibility of a portable artificial pancreas system outside of a hospital based clinical research center. Adult T1DM patients will use a newly developed platform in conjunction with a subcutaneous insulin infusion pump and a continuous glucose monitor for 18 hours is quasi free conditions (hotel). **Detailed Description:** Automated closed-loop control (CLC), known as "artificial pancreas" (AP) can have tremendous impact on the health and lives of people with type 1 diabetes (T1D). Our inter-institutional and international research team has been on the forefront of CLC developments since the beginning of the JDRF Artificial Pancreas initiative in 2006. Thus far, we have conducted three closed-loop control clinical trials (totaling 60 subjects with T1D), which demonstrated significantly more time in an acceptable "target" blood glucose range during CLC, and significantly fewer hypoglycemic events during CLC compared to open loop. Our overall objective is to sequentially test, validate, obtain regulatory approval for, and deploy at home, a closed-loop Control-to-Range (CTR) system comprised of two algorithmic components: a Safety Supervision Module (SSM) and an automated Range Correction Module (RCM). The SSM will monitor the safety of the subject's continuous subcutaneous insulin infusion pump (CSII) to prevent hypoglycemia, and will also monitor the integrity of continuous glucose monitor (CGM) data for signal sensor deviations or loss of sensitivity. The RCM will be responsible for the optimal regulation of postprandial hyperglycemic excursions through correction boluses. The first phase to address our overall objective is a pilot study that will test the ability of a cell-phone-based system to (1) run CTR in an outpatient setting, and (2) be remotely monitored. Specifically, this pilot study entails a hybrid hotel/hospital design targeting adults with T1D that are experienced insulin pump users. Subjects will spend one night in a local hotel, during which the phone-based system will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur. Subjects will spend the following day in the hospital, where CTR will be activated, and challenged with meals and a CGM sensor replacement . Subjects will then spend a second night in the hotel for continued evaluation of remote system monitoring, along with outpatient testing of the CTR system run on the phone-based system. This series of admissions will address the first major hurdles that need to be overcome for home deployment of a closed loop CTR system: Specific Aim 1: The phone-based CTR system can be remotely monitored by nurses/physicians/technicians to confirm appropriate functioning outside of the hospital setting. Specific Aim 2: The CTR can be deployed outside of the hospital setting. ### Conditions Module **Conditions:** - Type 1 Diabetes Mellitus **Keywords:** - Artificial Pancreas - Insulin Pump - Continuous Glucose Monitor - Closed Loop ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 5 **Type:** ACTUAL **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** this is the only arm of the study, and concerns all patients. **Intervention Names:** - Device: portable artificial pancreas system with Control-To-Range algorithms **Label:** All patients **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - All patients **Description:** The investigators will test the new portable CTR system in CRC conditions for 10h followed by 18h of CTR in a hotel. **Name:** portable artificial pancreas system with Control-To-Range algorithms **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** we will estimate the frequency of failures (#failures/day) of each following system components: CGM communication, pump communication, insulin dose computation, user interface. **Measure:** estimation of the failure rates of system components **Time Frame:** length of admission (hour 42) #### Secondary Outcomes **Description:** number of CGM data point not received by the device divided by the total number of possible data points to be received. **Measure:** frequency analysis of lost or inaccurate CGM records **Time Frame:** length of admission (42 hours) **Description:** number of minutes the Control-To-Range system was functioning properly (computation of insulin infusion, and insulin actually delivered) divided by the maximum number of minutes the CTR system should have been active (as per protocol) **Measure:** percent time of active CTR **Time Frame:** length of admission (42h) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patient must be aged between 21 (inclusive) and 65 years old. The age of 21 has been chosen because this trial is supported by a US Foundation. * Patient must have been clinically diagnosed with Type 1 diabetes mellitus. For an individual to be enrolled at least one criterion from each list must be met: * Criteria for documented hyperglycemia (at least 1 must be met): * Fasting glucose ≥126 mg/dL - confirmed * Two-hour OGTT glucose ≥200 mg/dL - confirmed * HbA1c ≥6.5% documented - confirmed * Random glucose ≥200 mg/dL with symptoms * No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes * Criteria for requiring insulin at diagnosis (1 must be met): * Participant required insulin at diagnosis and continually thereafter * Participant did not start insulin at diagnosis but upon investigator review likely needed insulin (significant hyperglycemia that did not respond to oral agents) and did require insulin eventually and used continually * Participant did not start insulin at diagnosis but continued to be hyperglycemic, had positive islet cell antibodies - consistent with latent autoimmune diabetes in adults (LADA) and did require insulin eventually and used continually * Use of an insulin pump to treat his/her diabetes for at least 1 year * Actively using a carbohydrate \[CHO\] / insulin ratio for insulin bolus adjustments in order to keep blood glucose in a predefined range * Patient HbA1c is between 6.0% and 9% as measured with DCA2000 or equivalent device * Patient must demonstrate proper mental status and cognition for the study * Patient must be willing to avoid consumption of acetaminophen-containing products during the study interventions involving DexCom use * Patient must be affiliated or beneficiary of a social medical insurance * Patient has signed informed consent form prior to study entry Exclusion Criteria: * Diabetic ketoacidosis within the 6 months prior to enrollment * Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment * Pregnancy, breast feeding, or intention of becoming pregnant * Uncontrolled arterial hypertension (diastolic blood pressure \>90 mmHg and/or systolic blood pressure \>160 mmHg) * Conditions which may increase the risk of hypoglycemia such as uncontrolled coronary artery disease during the previous year (e.g. history of myocardial infarction, acute coronary syndrome, therapeutic coronary intervention, coronary bypass or stenting procedure, stable or unstable angina, episode of chest pain of cardiac etiology with documented EKG changes, or positive stress test or catheterization with coronary blockages \>50%), congestive heart failure, history of cerebrovascular event, seizure disorder, syncope, adrenal insufficiency, neurologic disease or atrial fibrillation * History of a systemic or deep tissue infection with methicillin-resistant staph aureus or Candida albicans * Use of a device that may pose electromagnetic compatibility issues and/or radiofrequency interference with the DexCom CGM (implantable cardioverter-defibrillator, electronic pacemaker, neurostimulator, intrathecal pump, and cochlear implants) * Anticoagulant therapy other than aspirin * Oral steroids * Medical condition requiring use of an acetaminophen-containing medication that cannot be withheld for the study admissions. * Psychiatric disorders that would interfere with study tasks (e.g. inpatient psychiatric treatment within 6 months prior to enrollment) * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * Known current or recent alcohol or drug abuse * Medical conditions that would make operating a CGM, cell phone, or insulin pump difficult (e.g. blindness, severe arthritis, immobility) * Any skin condition that prevents sensor or pump placement on the abdomen or arm (e.g. bad sunburn, pre-existing dermatitis, intertrigo, psoriasis, extensive scarring, cellulitis) * Impaired hepatic function measured as alanine aminotransferase or aspartate aminotransferase ≥three times the upper reference limit * Impaired renal function measured as creatinine \>1.2 times above the upper limit of normal * Uncontrolled microvascular (diabetic) complications (other than diabetic non-proliferative retinopathy), such as history of laser coagulation, proliferative diabetic retinopathy, known diabetic nephropathy (other than microalbuminuria with normal creatinine) or neuropathy requiring treatment * Active gastroparesis requiring current medical therapy * If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study * Uncontrolled thyroid disease * Known bleeding diathesis or dyscrasia * Known allergy to medical adhesives, components of the insulin pump insertion set or continuous glucose monitor sensor * Unwillingness to withhold dietary supplements two weeks prior to admission and for the duration of the study participation. * Unwillingness to withhold pramlintide, liraglutide and exenatide for the duration of the study intervention. * Patient is actively enrolled in another clinical trial or was part of study within 30 days or whose annual study income is over 4 500€ * Persons deprived of freedom, adults protected by law or vulnerable persons **Maximum Age:** 65 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Montpellier **Country:** France **Facility:** Centre d'Investigation Clinique CHU Montpellier **Zip:** 34000 #### Overall Officials **Official 1:** **Affiliation:** University of Montpellier Hospital **Name:** Eric Renard, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University of Virginia **Name:** Boris Kovatchev, PhD **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Kovatchev BP, Renard E, Cobelli C, Zisser HC, Keith-Hynes P, Anderson SM, Brown SA, Chernavvsky DR, Breton MD, Farret A, Pelletier MJ, Place J, Bruttomesso D, Del Favero S, Visentin R, Filippi A, Scotton R, Avogaro A, Doyle FJ 3rd. Feasibility of outpatient fully integrated closed-loop control: first studies of wearable artificial pancreas. Diabetes Care. 2013 Jul;36(7):1851-8. doi: 10.2337/dc12-1965. **PMID:** 23801798 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune 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 - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes Mellitus - ID: M7117 - Name: Diabetes Mellitus, Type 1 - Relevance: HIGH - As Found: Type 1 Diabetes Mellitus - 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 - 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: D000003920 - Term: Diabetes Mellitus - ID: D000003922 - Term: Diabetes Mellitus, Type 1 ### Intervention Browse Module - Ancestors - ID: D000005765 - Term: Gastrointestinal Agents ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: LOW - As Found: Unknown - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown - ID: M22554 - Name: Pancrelipase - Relevance: HIGH - As Found: Context - ID: M13114 - Name: Pancreatin - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000020799 - Term: Pancrelipase ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01295879 **Brief Title:** Vitamin D Repletion in Stone Formers With Hypercalciuria **Official Title:** Effect of Ergocalciferol Repletion on Urine Calcium Among Stone Formers With Vitamin D Deficiency and Hypercalciuria #### Organization Study ID Info **ID:** AAAF3346 #### Organization **Class:** OTHER **Full Name:** New York Presbyterian Hospital ### Status Module #### Completion Date **Date:** 2011-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2012-10-23 **Type:** ESTIMATED **Last Update Submit Date:** 2012-09-10 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2011-04 **Type:** ACTUAL #### Results First Post Date **Date:** 2012-10-23 **Type:** ESTIMATED **Results First Submit Date:** 2012-09-10 **Results First Submit QC Date:** 2012-09-10 #### Start Date **Date:** 2010-09 **Status Verified Date:** 2012-09 #### Study First Post Date **Date:** 2011-02-15 **Type:** ESTIMATED **Study First Submit Date:** 2011-02-14 **Study First Submit QC Date:** 2011-02-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** New York Presbyterian Hospital #### Responsible Party **Investigator Affiliation:** New York Presbyterian Hospital **Investigator Full Name:** David E. Leaf **Investigator Title:** Nephrology Fellow **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Vitamin D plays a critical role in maintaining bone health, as well as preventing cardiovascular disease, cancer, and various autoimmune diseases, such as diabetes. Vitamin D deficiency is very common in the United States and worldwide, and is now being increasingly recognized and treated. One group in which vitamin D deficiency may be particularly important is patients who have had kidney stones. These patients frequently have elevated levels of calcium in their urine, which is a common and important risk factor for calcium containing kidney stones. Because vitamin D increases absorption of calcium into the blood by the intestines, physicians may be reluctant to prescribe vitamin D therapy to patients with vitamin D deficiency if they also have kidney stones and high amounts of calcium in the urine. They are concerned about the possible risk of increasing the amount of calcium in the urine (and thereby increasing the risk of calcium stones occurring again). However, studies in patients without kidney stones, as well as studies in patients with high calcium levels in the urine, have demonstrated that giving vitamin D is effective and safe and does not increase calcium in the urine. Therefore, the investigators will study the effects of giving vitamin D on the amount of calcium in the urine in patients with a history of kidney stones and elevated calcium in the urine. The investigators will evaluate the safety of giving vitamin D to this particular group of patients. **Detailed Description:** The investigators plan to conduct a clinic-based interventional study of 30 patients followed at outpatient urology clinics associated with New York Presbyterian Hospital (NYPH). The intervention is supplementation with oral ergocalciferol 50,000 IU per week for 8 weeks, and each participant will serve as his/her own control. The formulation, dose, and duration of vitamin D therapy is reflective of that which is given in routine clinical practice to patients with vitamin D deficiency. The outcome is the change in urinary calcium excretion. ### Conditions Module **Conditions:** - Nephrolithiasis - Urolithiasis - Idiopathic Hypercalciuria - Vitamin D Deficiency - Disorder of Vitamin D **Keywords:** - Vitamin D insufficiency ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks **Intervention Names:** - Drug: Ergocalciferol **Label:** Ergocalciferol **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Ergocalciferol **Description:** Ergocalciferol 50,000 IU's orally per week, for 8 weeks **Name:** Ergocalciferol **Other Names:** - Vitamin D2 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Elevated values of urine calcium are a risk factor for recurrence of calcium kidney stones **Measure:** Change in 24 Hour Urine Calcium **Time Frame:** 8 weeks #### Secondary Outcomes **Description:** Elevated values of calcium oxalate supersaturation in the urine are a risk factor for recurrence of calcium kidney stones **Measure:** Change in 24 Hour Urine Supersaturation of Calcium Oxalate **Time Frame:** 8 weeks **Measure:** Recurrence of Kidney Stones **Time Frame:** 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * History of nephrolithiasis as per medical record * Urinary calcium excretion between 150 and 400 mg/day (measured within 3 months of study enrollment) * 25(OH)D deficiency or insufficiency (defined as a serum level \< 30 ng/ml) within 3 months of enrollment Exclusion Criteria: * Pregnant women, since the optimal dose of vitamin D supplementation in this population has not been rigorously studied. * Known uric acid, cystine, or struvite stone disease (because our intervention is predominantly aimed at patients with calcium stone disease). An exception to this is patients who have passed both uric acid and calcium stones, or patients who have passed stones of mixed composition (uric acid and calcium). * Hypercalcemia (serum calcium \> 10.4 mg/dL) at baseline * Acute stone event or gross hematuria (blood in the urine) within the past 2 months * Recent stone intervention within the past 1 month * Suspected or known secondary causes of hypercalciuria, such as primary hyperparathyroidism, sarcoidosis, hyperthyroidism, or malignancy (except nonmelanoma skin cancer) * Addition or dose change of medicines potentially affecting urinary calcium since the baseline 24hour urine collection (including diuretics, magnesium supplements, potassium supplements, potassium citrate, and vitamin D supplementation) **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 Presbyterian Hospital **State:** New York **Zip:** 10032 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001361 - Term: Avitaminosis - ID: D000003677 - Term: Deficiency Diseases - ID: D000044342 - Term: Malnutrition - ID: D000009748 - Term: Nutrition Disorders - 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: D000014545 - Term: Urinary Calculi - ID: D000002137 - Term: Calculi - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000007674 - Term: Kidney Diseases - ID: D000020924 - Term: Urological Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - 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: M10693 - Name: Kidney Calculi - Relevance: HIGH - As Found: Nephrolithiasis - ID: M27103 - Name: Urolithiasis - Relevance: HIGH - As Found: Urolithiasis - ID: M17295 - Name: Urinary Calculi - Relevance: LOW - As Found: Unknown - ID: M5399 - Name: Calculi - Relevance: LOW - As Found: Unknown - ID: M27126 - Name: Nephrolithiasis - Relevance: HIGH - As Found: Nephrolithiasis - ID: M17551 - Name: Vitamin D Deficiency - Relevance: HIGH - As Found: Vitamin D Deficiency - ID: M27341 - Name: Hypercalciuria - Relevance: HIGH - As Found: Hypercalciuria - ID: M4660 - Name: Avitaminosis - Relevance: LOW - As Found: Unknown - ID: M6879 - Name: Deficiency Diseases - Relevance: LOW - As Found: Unknown - ID: M25306 - Name: Malnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - 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: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M22659 - Name: Urological Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000052878 - Term: Urolithiasis - ID: D000053040 - Term: Nephrolithiasis - ID: D000007669 - Term: Kidney Calculi - ID: D000014808 - Term: Vitamin D Deficiency - ID: D000053565 - Term: Hypercalciuria ### Intervention Browse Module - Ancestors - ID: D000014815 - Term: Vitamins - ID: D000018977 - Term: Micronutrients - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000050071 - Term: Bone Density Conservation Agents - ID: D000077264 - Term: Calcium-Regulating Hormones and Agents ### Intervention Browse Module - Browse Branches - Abbrev: BDCA - Name: Bone Density Conservation Agents - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M17550 - Name: Vitamin D - Relevance: HIGH - As Found: Anti-tumor - ID: M6003 - Name: Cholecalciferol - Relevance: LOW - As Found: Unknown - ID: M5381 - Name: Calcium - Relevance: LOW - As Found: Unknown - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown - ID: M8026 - Name: Ergocalciferols - Relevance: HIGH - As Found: Anti-tumor - ID: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: T442 - Name: Cholecalciferol - Relevance: LOW - As Found: Unknown - ID: T479 - Name: Vitamin D3 - Relevance: LOW - As Found: Unknown - ID: T440 - Name: Calciferol - Relevance: HIGH - As Found: Anti-tumor - ID: T445 - Name: Ergocalciferol - Relevance: HIGH - As Found: Anti-tumor - ID: T478 - Name: Vitamin D2 - Relevance: HIGH - As Found: Interferon alfa-2a ### Intervention Browse Module - Meshes - ID: D000014807 - Term: Vitamin D - ID: D000004872 - Term: Ergocalciferols ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Ergocalciferol **Description:** Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks **ID:** EG000 **Other Num at Risk:** 29 **Serious Number At Risk:** 29 **Title:** Ergocalciferol **Frequency Threshold:** 0 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 29 **Units:** Participants ### Group **ID:** BG000 **Title:** Ergocalciferol **Description:** Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 27 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 2 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 12 **Value:** 48 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 7 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 22 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 29 **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 **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 **PI Sponsor Employee:** True ### Point of Contact **Email:** [email protected] **Organization:** Brigham and Women's Hospital **Phone:** 617-732-5951 **Title:** David E. Leaf, M.D., Renal Fellow ## 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:** 71 - **Upper Limit:** - **Value:** 2 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 3.5 - **Upper Limit:** - **Value:** -1 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Elevated values of urine calcium are a risk factor for recurrence of calcium kidney stones **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 8 weeks **Title:** Change in 24 Hour Urine Calcium **Type:** PRIMARY **Unit of Measure:** mg/day ##### Group **Description:** Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks **ID:** OG000 **Title:** Ergocalciferol #### Outcome Measure 2 **Description:** Elevated values of calcium oxalate supersaturation in the urine are a risk factor for recurrence of calcium kidney stones **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 8 weeks **Title:** Change in 24 Hour Urine Supersaturation of Calcium Oxalate **Type:** SECONDARY **Unit of Measure:** (unitless) ##### Group **Description:** Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks **ID:** OG000 **Title:** Ergocalciferol #### Outcome Measure 3 **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** 8 weeks **Title:** Recurrence of Kidney Stones **Type:** SECONDARY **Unit of Measure:** # of stone recurrences ##### Group **Description:** Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks **ID:** OG000 **Title:** Ergocalciferol ### Participant Flow Module #### Group **Description:** Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks **ID:** FG000 **Title:** Ergocalciferol #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 29 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 29 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT05776979 **Brief Title:** Post-Transplant Maintenance Therapy With Isatuximab Plus Lenalidomide for High-Risk Multiple Myeloma Patients **Official Title:** Post-Transplant Maintenance Therapy With Isatuximab Plus Lenalidomide for High-Risk Multiple Myeloma Patients #### Organization Study ID Info **ID:** 2022-0028 #### Organization **Class:** OTHER **Full Name:** M.D. Anderson Cancer Center #### Secondary ID Infos **Domain:** NCI-CTRP Clinical Trials Registry **ID:** NCI-2023-02219 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2024-02-01 **Type:** ACTUAL **Last Update Submit Date:** 2024-01-30 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-08-17 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2023-03-20 **Type:** ACTUAL **Study First Submit Date:** 2023-03-08 **Study First Submit QC Date:** 2023-03-08 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Sanofi #### Lead Sponsor **Class:** OTHER **Name:** M.D. Anderson Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** To learn if isatuximab can help to control highrisk MM when given in combination with lenalidomide after an autologous stem cell transplantation (ASCT). **Detailed Description:** Objectives: Primary Objectives 1. Compare progression-free survival at 3 years with historical control rate of 50%. Primary endpoint 1. Progression-free survival at 3 years, measured from the date of transplant to the date of progression or death. Secondary objectives: 1. Assess minimal residual disease (MRD) rate at 12 months after starting Isatuximab maintenance therapy 2. Assess overall best response rate (defined as the occurrence of VGPR or better and CR/sCR) before the 4th Isatuximab cycle, and at 12, 24, and 36 months after starting maintenance therapy 3. Assess MRD rate before 4th Isatuximab cycle and at 24 months after starting maintenance therapy 4. Assess duration of response (DOR) 5. Assess overall survival (OS) 6. Assess safety ### Conditions Module **Conditions:** - Multiple Myeloma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 61 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Both isatuximab and lenalidomide are FDA approved and commercially available for the treatment of relapsed or refractory MM (MM that has come back or stopped responding to treatment). Participants will begin taking the study drugs about 60-180 days after your ASCT. Participants may receive the study drugs for about 3 years. After that, participants will have follow-up visits 1 time a year for the 3 years after your last dose of study drugs **Intervention Names:** - Drug: Isatuximab - Drug: lenalidomide **Label:** isatuximab plus lenalidomide after an autologous stem cell transplantation (ASCT) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - isatuximab plus lenalidomide after an autologous stem cell transplantation (ASCT) **Description:** Given by vein over about 75 minutes **Name:** Isatuximab **Other Names:** - SAR650984 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - isatuximab plus lenalidomide after an autologous stem cell transplantation (ASCT) **Description:** Given by PO **Name:** lenalidomide **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5 **Time Frame:** through study completion; an average of 1 year. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Adult patients 18 to 70 years old, with newly diagnosed symptomatic (according to the revised 2014 IMWG criteria as summarized in Appendix A) myeloma. Patients must have measurable disease at diagnosis defined by any of the following: * Serum M-protein ≥1 g/dL (for IgA ≥0.5 g/dL) or urine M-protein ≥200 mg/24 hours * For oligosecretory myeloma, involved serum free light chain (FLC) level ≥10 mg/dL, provided serum FLC ratio is abnormal * For non-secretory myeloma, \> 1 focal lesions measurable by imaging 2. Subjects must have high-risk myeloma defined as followed: * R-ISS stage II or III patients (Appendix B) * ISS stage III (Appendix B) * ≥ 3 copies +1q21 in patients with ISS Stage II/III or R-ISS Stage II/III * Presence of del(17p) cytogenetic abnormality regardless of ISS/R-ISS Stage * Presence of at least 2 high-risk genetic abnormalities \[del(17p), t(4;14), t(14;16), t(14;20), +1q21\] regardless of ISS/R-ISS stage 3. English and non-English speaking patients are eligible. 4. Karnofsky performance score of at least 70% and/or ECOG PS ≤2 5. Underwent ASCT using a conditioning regimen consisting of Busulfan and Melphalan with adequate cell count recovery after transplant without the need for growth factor support or transfusions within 7 days from the lab test * Absolute neutrophil count (ANC) ≥1000 /µL * Hemoglobin ≥8 g/dL * Platelet count ≥50,000 /µL 6. Patients must have achieved partial response (PR) or better prior to starting maintenance therapy. 7. Adequate major organ system function as demonstrated by: * Serum creatinine clearance equal or more than 30 ml/min (calculated with Cockcroft- Gault formula). * Total bilirubin equal or less than 2.0 mg/dL (equal or less than 3.0 mg/dL for patients with Gilbert's disease). * ALT or AST equal or less than 3 times the upper normal for adults. 8. Patient or patient's legal representative, parent(s) or guardian should provide written Internal Review Board (IRB)-approved informed consent. 9. Female patients included must not be pregnant or lactating. Females of childbearing potential must have (before starting treatment) a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to and again within 24 hours prior to starting Isatuximab and with each cycle of study treatment. Females of childbearing potential must refrain from becoming pregnant and commit to either apply highly effective method of birth control (two reliable methods of birth control) or continue abstinence from heterosexual intercourse during study period and for at least 5 months after last dose of Isatuximab. Patients who receive Lenalidomide should continue to follow REVLIMID REMSTM requirements. 10. Men of reproductive potential must agree to follow accepted birth control methods and refrain from sperm donation for the duration of the study and for at least 5 months after last dose of Isatuximab. Patients who receive Lenalidomide should continue to follow REVLIMID REMSTM requirements. Exclusion Criteria 1. Progression of myeloma, as defined by the IMWG criteria (Appendix C), prior to initiation of maintenance therapy 2. Patients receiving any other investigational agents within 14 days or 5 half-lives of the investigational drug prior to initiation of study intervention. Exceptions can be granted after discussing with PI. 3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the study drugs. Hypersensitivity or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study intervention that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents. 4. Known hypersensitivity or desquamating rash to either thalidomide or lenalidomide. 5. Participants must not have an active infection requiring treatment. 6. Participants must not have an uncontrolled intercurrent illness including, but not limited to, an uncontrolled hypertension (systolic \>170, diastolic \>100 despite antihypertensive therapy), symptomatic congestive heart failure (Class III or IV as defined by the New York Heart Association (NYHA) functional classification system), acute coronary syndrome, liver cirrhosis, and/or cognitive impairments/psychiatric illness/social situations that would limit compliance with study requirements. PI is the final arbiter of this criterion. 7. Major surgery within 4 weeks before initiating study treatment. 8. HIV-positive patients and/or active hepatitis A, B or C infections. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Muzzaffar Qazilbash, MD **Phone:** (713) 745-3458 **Role:** CONTACT #### Locations **Location 1:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Muzaffar Qazilbash, MD - **Phone:** 713-745-3458 - **Role:** CONTACT ***Contact 2:*** - **Name:** Muzaffar Qazilbash, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** M D Anderson Cancer Center **State:** Texas **Status:** RECRUITING **Zip:** 77030 #### Overall Officials **Official 1:** **Affiliation:** M.D. Anderson Cancer Center **Name:** Muzzaffar Qazilbash, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** M D Anderson Cancer Center **URL:** http://www.mdanderson.org ## 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: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000020533 - Term: Angiogenesis Inhibitors - ID: D000043924 - Term: Angiogenesis Modulating Agents - ID: D000006133 - Term: Growth Substances - ID: D000006131 - Term: Growth Inhibitors - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1725 - Name: Lenalidomide - Relevance: HIGH - As Found: Respiratory - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M22318 - Name: Angiogenesis Inhibitors - Relevance: LOW - As Found: Unknown - ID: M9231 - Name: Growth Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077269 - Term: Lenalidomide ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01489579 **Brief Title:** Telephone Counseling for Tobacco Cessation **Official Title:** Evaluation of Brief, Structured, Telephone Counseling for Tobacco Cessation as Part of a Cardiovascular Risk Reduction Service #### Organization Study ID Info **ID:** CO-11-1660 #### Organization **Class:** OTHER **Full Name:** Kaiser Permanente ### Status Module #### Completion Date **Date:** 2015-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-03-18 **Type:** ACTUAL **Last Update Submit Date:** 2018-12-04 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2014-12 **Type:** ACTUAL #### Results First Post Date **Date:** 2019-03-18 **Type:** ACTUAL **Results First Submit Date:** 2016-12-07 **Results First Submit QC Date:** 2018-12-04 #### Start Date **Date:** 2011-11 **Status Verified Date:** 2018-12 #### Study First Post Date **Date:** 2011-12-09 **Type:** ESTIMATED **Study First Submit Date:** 2011-12-08 **Study First Submit QC Date:** 2011-12-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Kaiser Permanente #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to determine whether giving more structured information to patients over the phone about quitting tobacco helps to increase the chance that they will try to quit. The results of this study will help provide direction in developing a more standard way of helping patients to quit. Study Hypothesis: Brief, structured, telephone tobacco cessation counseling delivered by clinical pharmacy specialists will significantly increase the percentage of self-reported tobacco cessation attempts compared to usual care among patients enrolled in a cardiovascular risk reduction program. **Detailed Description:** While physician-delivered care may have the greatest impact on tobacco abstinence rates, recent data indicate that other health care providers such as nurses and pharmacists improve tobacco abstinence rates more than self-help and/or no intervention.5 Thus, pharmacists continue to expand their clinical practice areas to include smoking cessation interventions. A meta-analysis of studies involving pharmacist-delivered smoking cessation services found quit rates at 6 to12 months follow-up ranged from 14% to16%.6 The results of this meta-analysis demonstrate that pharmacists can successfully deliver tobacco-cessation interventions and the evidence strongly suggests they are effective in helping increase tobacco cessation rates. Proactive telephone counseling can be more effective at increasing tobacco abstinence rates than self-help or no intervention.5 Telephone counseling is an effective system to help increase tobacco abstinence rates for a variety of reasons. From the tobacco user's standpoint, there are no transportation inconveniences and fewer scheduling conflicts. In addition, receiving counseling in the privacy of one's own home provides treatment access to individuals who are less willing to seek out counseling. At Kaiser Permanente Colorado (KPCO), members with a history of CVD are enrolled in the Clinical Pharmacy Cardiac Risk Service (CPCRS). The CPCRS is a clinical pharmacy specialist-managed, physician-directed program which provides secondary prevention care to over 14,000 patients. Clinical care includes evaluating and treatment of major cardiovascular risk factors, including tobacco use, for members. Currently, CPCRS has no standard of care with regard to addressing tobacco use. Clinical pharmacy specialists working in CPCRS deliver tobacco cessation advice at their own discretion, through various methods. The purpose of this pilot study is to determine whether brief, structured, telephone tobacco cessation counseling delivered by a clinical pharmacy specialist increases the number of smoking cessation attempts compared to usual care. ### Conditions Module **Conditions:** - Tobacco Use Cessation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 192 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The patients in the Brief, structured, telephone tobacco cessation, BST, counseling group, will receive tobacco cessation counseling, intervention, by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources. **Intervention Names:** - Behavioral: Telephone Counseling for Tobacco Cessation **Label:** BST counseling group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices. These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendations **Intervention Names:** - Behavioral: Usual Care **Label:** Usual care group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - BST counseling group **Description:** The patients in the Brief, Structured, Telephone (BST) counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources ("Ready to quit" patient handout) **Name:** Telephone Counseling for Tobacco Cessation **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Usual care group **Description:** Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices. These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendations **Name:** Usual Care **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The proportion of patients in each group who report a tobacco cessation attempt during the follow-up telephone survey conducted three months following pharmacist contact **Measure:** The Percentage of Self-reported Tobacco Cessation Attempts Between Groups **Time Frame:** 3 months #### Secondary Outcomes **Description:** Information on COQL participation was obtained from a prevention department within KPCO that tracks these data. Report was provided to capture who from study had participated in the COQL within 3 months of pharmacist contact. **Measure:** The Proportion of Patients in Each Group Who Participate in the Colorado Quitline (COQL) Within Three Months of Pharmacist Contact **Time Frame:** 3 months **Description:** The proportion of patients who attend any KPCO tobacco cessation program(s)or webinar(s) within three months following contact. Classes include Stop Smoking the Basics and Freedom from Cigarettes. Webinars include Break Free and Freedom from Tobacco **Measure:** The Proportion of Patients Who Attend Any KPCO Tobacco Cessation Program(s)or Webinar(s) Within Three Months Following Contact. **Time Frame:** 3 months **Description:** The proportion of patients in each group who purchase tobacco cessation medication aids from KPCO pharmacies within three months following pharmacist contact. Medications include nicotine replacement therapy, bupropion, and varenicline **Measure:** The Proportion of Patients in Each Group Who Purchase Tobacco Cessation Medication Aids From KPCO Pharmacies Within Three Months Following Pharmacist Contact. **Time Frame:** 3 months **Description:** The proportion of patients in each group who report tobacco abstinence during the follow-up telephone survey conducted three months following pharmacist contact **Measure:** The Proportion of Patients in Each Group Who Report Tobacco Abstinence During at the Three Months Follow-up Telephone Survey **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Patients who meet the following criteria will be eligible for the study: * Enrolled in CPCRS at the time of counseling (12/11-02/12), * Current tobacco user as noted in KP HealthConnect as of the date of the routine CPCRS evaluation and counseling. For study purposes, tobacco use includes any use of cigarettes, pipe, cigars, snuff, and chew. * Continuous KPCO Denver/Boulder membership during study time period Exclusion Criteria: * Patients who meet any of the following criteria will not be enrolled in the study: * \<18 years of age, * Non-English speakers, * Deceased at time of survey, and/or * Unable to provide consent **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Aurora **Country:** United States **Facility:** Clinical Pharmacy Specialist, Clinical Pharmacy Cardiac Risk Service - Kaiser Permanente of Colorado **State:** Colorado **Zip:** 80011 #### Overall Officials **Official 1:** **Affiliation:** Kaiser Permanente **Name:** Alicia Cymbala, PharmD, BCPS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** BST Counseling Group **Deaths Num At Risk:** 64 **Description:** The patients in the BST counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources. AE's captured for patients who obtained lab data and had contact with clinical Pharmacist (120) **ID:** EG000 **Other Num at Risk:** 64 **Serious Number At Risk:** 64 **Title:** BST Counseling Group **Group ID:** EG001 **Title:** Usual Care Group **Deaths Num At Risk:** 56 **Description:** Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices. These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendations. AE's captured for patients who obtained lab data and had contact with clinical Pharmacist (120) **ID:** EG001 **Other Num at Risk:** 56 **Serious Number At Risk:** 56 **Title:** Usual Care Group **Frequency Threshold:** 0 **Time Frame:** 3 month follow up ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 64 **Group ID:** BG001 **Value:** 56 **Group ID:** BG002 **Value:** 120 **Units:** Participants ### Group **ID:** BG000 **Title:** BST Counseling Group **Description:** The patients in the BST counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources ("Ready to quit" patient handout. Brief, Structured, Telephone Counseling for Tobacco Cessation as Part of a Cardiovascular Risk Reduction Service: The patients in the BST counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counse ### Group **ID:** BG001 **Title:** Usual Care Group **Description:** Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices. These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendations. Usual Care: Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices. These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendatio ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 8.1 **Value:** 66.6 #### Measurement **Group ID:** BG001 **Spread:** 9.4 **Value:** 64.6 #### Measurement **Group ID:** BG002 **Spread:** 8.7 **Value:** 65.7 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 28 #### Measurement **Group ID:** BG001 **Value:** 16 #### Measurement **Group ID:** BG002 **Value:** 44 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 36 #### Measurement **Group ID:** BG001 **Value:** 40 #### Measurement **Group ID:** BG002 **Value:** 76 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 64 #### Measurement **Group ID:** BG001 **Value:** 56 #### Measurement **Group ID:** BG002 **Value:** 120 **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:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** [email protected] **Organization:** Kaiser Permanente **Phone:** 303-972-5384 **Title:** Alicia Cymbala ## 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 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 **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:** 3 **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:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 11 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** The proportion of patients in each group who report a tobacco cessation attempt during the follow-up telephone survey conducted three months following pharmacist contact **Parameter Type:** NUMBER **Population Description:** Reported not smoking at follow up survey **Reporting Status:** POSTED **Time Frame:** 3 months **Title:** The Percentage of Self-reported Tobacco Cessation Attempts Between Groups **Type:** PRIMARY **Unit of Measure:** participants ##### Group **Description:** The patients in the Brief, Structured, Telephone, BST, counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources **ID:** OG000 **Title:** BST Counseling Group ##### Group **Description:** Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices. These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendations **ID:** OG001 **Title:** Usual Care Group #### Outcome Measure 2 **Description:** Information on COQL participation was obtained from a prevention department within KPCO that tracks these data. Report was provided to capture who from study had participated in the COQL within 3 months of pharmacist contact. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Three control patients reported participation in the Colorado quitline **Reporting Status:** POSTED **Time Frame:** 3 months **Title:** The Proportion of Patients in Each Group Who Participate in the Colorado Quitline (COQL) Within Three Months of Pharmacist Contact **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** The patients in the Brief, Structured, Telephone, BST, counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources **ID:** OG000 **Title:** BST Counseling Group ##### Group **Description:** Pharmacists randomized to Usual Care will continue to provide interventions/procedures according to usual care practices. Interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists randomized to Usual Care were asked to continue their current approach for tobacco cessation **ID:** OG001 **Title:** Usual Care Group #### Outcome Measure 3 **Description:** The proportion of patients who attend any KPCO tobacco cessation program(s)or webinar(s) within three months following contact. Classes include Stop Smoking the Basics and Freedom from Cigarettes. Webinars include Break Free and Freedom from Tobacco **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** The proportion of patients who attend any KPCO tobacco cessation program(s)or webinar(s) within three months following contact. Classes include Stop Smoking the Basics and Freedom from Cigarettes. Webinars include Break Free and Freedom from Tobacco **Reporting Status:** POSTED **Time Frame:** 3 months **Title:** The Proportion of Patients Who Attend Any KPCO Tobacco Cessation Program(s)or Webinar(s) Within Three Months Following Contact. **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** The patients in the Brief, Structured, Telephone, BST, counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources **ID:** OG000 **Title:** BST Counseling Group ##### Group **Description:** The study arms were balanced on baseline characteristics except for the control arm having a higher median chronic disease score (P = 0.013) Sixteen subjects (9 and 7 in the control and intervention arms, respectively) did not complete the follow-up tele- phone survey, resulting in 104 subjects (47 and 57 in the control and intervention arm, respectively) available for the survey-based outcome analyses. Cigarettes were the predominate type of tobacco used. Fewer than half of the subjects reported ''Yes'' to baseline readiness to quit in the next 30 days. There were no statistically significant differences identified in the primary (P = 0.804) or secondary outcomes (all P \> 0.05) **ID:** OG001 **Title:** Usual Care Group #### Outcome Measure 4 **Description:** The proportion of patients in each group who purchase tobacco cessation medication aids from KPCO pharmacies within three months following pharmacist contact. Medications include nicotine replacement therapy, bupropion, and varenicline **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** 3 months **Title:** The Proportion of Patients in Each Group Who Purchase Tobacco Cessation Medication Aids From KPCO Pharmacies Within Three Months Following Pharmacist Contact. **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** The patients in the Brief, Structured, Telephone, BST, counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources **ID:** OG000 **Title:** BST Counseling Group ##### Group **Description:** The study arms were balanced on baseline characteristics except for the control arm having a higher median chronic disease score (P = 0.013) Sixteen subjects (9 and 7 in the control and intervention arms, respectively) did not complete the follow-up tele- phone survey, resulting in 104 subjects (47 and 57 in the control and intervention arm, respectively) available for the survey-based outcome analyses. Cigarettes were the predominate type of tobacco used. Fewer than half of the subjects reported ''Yes'' to baseline readiness to quit in the next 30 days. There were no statistically significant differences identified in the primary (P = 0.804) or secondary outcomes (all P \> 0.05) **ID:** OG001 **Title:** Usual Care Group #### Outcome Measure 5 **Description:** The proportion of patients in each group who report tobacco abstinence during the follow-up telephone survey conducted three months following pharmacist contact **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** 3 months **Title:** The Proportion of Patients in Each Group Who Report Tobacco Abstinence During at the Three Months Follow-up Telephone Survey **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** The patients in the Brief, Structured, Telephone, BST, counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources **ID:** OG000 **Title:** BST Counseling Group ##### Group **Description:** The study arms were balanced on baseline characteristics except for the control arm having a higher median chronic disease score (P = 0.013) Sixteen subjects (9 and 7 in the control and intervention arms, respectively) did not complete the follow-up tele- phone survey, resulting in 104 subjects (47 and 57 in the control and intervention arm, respectively) available for the survey-based outcome analyses. Cigarettes were the predominate type of tobacco used. Fewer than half of the subjects reported ''Yes'' to baseline readiness to quit in the next 30 days. There were no statistically significant differences identified in the primary (P = 0.804) or secondary outcomes (all P \> 0.05) **ID:** OG001 **Title:** Usual Care Group ### Participant Flow Module #### Group **Description:** Pharmacists randomized to Usual Care will continue to provide interventions/procedures according to usual care practices. Interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists randomized to Usual Care were asked to continue their current approach for tobacco cessation **ID:** FG000 **Title:** Usual Care Group #### Group **Description:** The patients in the BST counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources **ID:** FG001 **Title:** BST Counseling Group #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 56 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 64 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 47 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 57 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 9 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 7 **Pre-Assignment Details:** Seventy-two subjects did not obtain scheduled laboratory data or have contact with a clinical pharmacist during the study time period resulting in 120 subjects, 56 and 64 in the control and intervention groups, respectively, enrolled in the study. **Recruitment Details:** A total of 347 patients were identified as eligible for study participation study personnel contacted the patient by telephone approximately 2 weeks prior to her or his scheduled SOC encounter to describe the study and obtain verbal consent for enrollment. 192 were consented. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT05748379 **Brief Title:** Atraumatic Zirconia Abutment Versus Customized Composite Healing Abutment in Maxilla or Mandible. **Official Title:** Closure of a Guided Immediate Implant Placed in the Extraction Socket With Bone Augmentation in the Lateral Area of the Maxilla or Mandible, With a Temporary Composite Abutment vs With a Custom-made Zirconium Oxide Abutment. #### Organization Study ID Info **ID:** SIAAdenta #### Organization **Class:** OTHER **Full Name:** SIA Adenta ### Status Module #### Completion Date **Date:** 2024-12-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-02-28 **Type:** ACTUAL **Last Update Submit Date:** 2023-02-26 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2022-12-10 **Type:** ACTUAL #### Start Date **Date:** 2022-11-30 **Type:** ACTUAL **Status Verified Date:** 2023-02 #### Study First Post Date **Date:** 2023-02-28 **Type:** ACTUAL **Study First Submit Date:** 2023-01-11 **Study First Submit QC Date:** 2023-02-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** SIA Adenta #### Responsible Party **Investigator Affiliation:** SIA Adenta **Investigator Full Name:** Vitālijs Gnusins **Investigator Title:** Doctor of dental Surgery **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** 40 patients are included in the study, 20 patients in group 1 (=closure with composite material shaper; test group) and 20 patients in group 2 (=closure with custom-made zirconia oxide abutment; control group). Randomisation envelopes will be used for randomisation. Device under study: Straumann BLX, Roxolid® , SLActive® dental implants with a diameter of 3.5, 3.75, 4, 4.5 mm are used. Allogenic bone botiss maxgraft® cortical granules are used as graft material. Inclusion criteria: 1. Males and females at least 18 years of age or older. 2. One implant per patient. 3. Prior to any study-related activity, the subject must voluntarily sign informed consent, be willing and able to attend scheduled follow-up visits, and agree to the collection and analysis of pseudonymised data. 4. Lateral individual teeth (premolars and molars). 5. Class I extraction socket (intact buccal wall) or class II (1/3 of buccal wall). 6. The gingival contour of the tooth to be extracted - without recession. 7. Adjacent anterior teeth have no periodontal loss. 8. There are no implants in the adjacent teeth. 9. Non-traumatic tooth extraction, which results in intact walls of the socket. Exclusion criteria: 1. Deep occlusion (severe, class II). 2. The patient smokes a lot (more than 10 cigarettes per day). 3. Systemic disease (osteoporosis). 4. No initial stability has been achieved after the implant insertion procedure. **Detailed Description:** General Notes 40 patients are included in the study, 20 patients in group 1 (=closure with composite material shaper; test group) and 20 patients in group 2 (=closure with custom-made zirconia oxide abutment; control group). Randomisation envelopes will be used for randomisation. Device under study: Straumann BLX, Roxolid® , SLActive® dental implants with a diameter of 3.5, 3.75, 4, 4.5 mm are used. Allogenic bone botiss maxgraft® cortical granules are used as graft material. Inclusion criteria: 1. Males and females at least 18 years of age or older. 2. One implant per patient. 3. Prior to any study-related activity, the subject must voluntarily sign informed consent, be willing and able to attend scheduled follow-up visits, and agree to the collection and analysis of pseudonymised data. 4. Lateral individual teeth (premolars and molars). 5. Class I extraction socket (intact buccal wall) or class II (1/3 of buccal wall). 6. The gingival contour of the tooth to be extracted - without recession. 7. Adjacent anterior teeth have no periodontal loss. 8. There are no implants in the adjacent teeth. 9. Non-traumatic tooth extraction, which results in intact walls of the socket. Exclusion criteria: 1. Deep occlusion (severe, class II). 2. The patient smokes a lot (more than 10 cigarettes per day). 3. Systemic disease (osteoporosis). 4. No initial stability has been achieved after the implant insertion procedure. 4.2. Surgical Procedures and Recovery Phase (see Annexes No. 1 and 2) Group 1. Immediate implant placement and temporary closure of tapered implants with a custom-made composite shaper after tooth extraction with bone augmentation by using allogeneic bone. 1. Non-traumatic extraction. 2. Palatal position of tapered implant for premolars and centred position for molars (more commonly - in the septum) 3-4 mm below the buccal gum line or 1-2 mm below the bony protuberance. 3. For premolars, the implant is placed palatally 2-3 mm to the buccal bone wall, for molars 2-3 mm to the buccal and lingual wall. 4. Implant insertion. 5. "Jump distance" sealing with allogeneic bone. 6. Temporary closure with a composite shaper. 7. Cone beam computed tomography with Carestream machine. 8. Taking a photo. 9. Scan with 3Shape TRIOS4 scanner. After 3 months, a cone beam computed tomography is performed to evaluate changes in the crestal bone, the temporary restoration is screwed off and the presence/absence of bleeding is recorded. A digital impression is taken for a zirconium oxide crown made on Ti base and to assess soft tissue changes. The change in the buccal vertical bone level will be measured as the difference between the former and the new vertical distance from implant platform to the buccal alveolar crest. While the change in the buccal horizontal bone dimension will be measured as the difference between the former and the new horizontal distance between the implant and the outer surface of the buccal plate. Both measurements will be taken using CBCT, one immediately after the surgery and the other one 3 month later. Intraoral scans with 3Shape Trios4 dental scanner will be taken to compare soft tissue stability. Measurements will be taken before, immediately after the surgery and 3 month later. By using STL files it will be possible to compare soft tissue stability. Group 2. Immediate implant placement and temporary closure of tapered implant with a custom-made zirconium oxide abutment after tooth extraction with bone augmentation by using allogeneic bone. 1. Non-traumatic extraction. 2. Palatal position of tapered implant for premolars and centred position for molars (more commonly - in the septum) 3-4 mm below the buccal gum line or 1-2 mm below the bony protuberance. 3. For premolars, the implant is placed palatally 2-3 mm to the buccal bone wall, for molars 2-3 mm to the buccal and lingual wall. 4. Implant insertion. 5. "Jump distance" sealing with allogeneic bone. 6. Closure with a zirconium oxide abutment. 7. Cone beam computed tomography with Carestream machine. 8. Taking a photo. 9. Scan with 3Shape TRIOS4 scanner. After 3 months, a cone beam computed tomography is performed to evaluate changes in the crestal bone, the custom-made abutment is screwed off and the presence/absence of bleeding is recorded. A digital impression is taken for a zirconium oxide crown and to assess soft tissue changes. The change in the buccal vertical bone level will be measured as the difference between the former and the new vertical distance from implant platform to the buccal alveolar crest. While the change in the buccal horizontal bone dimension will be measured as the difference between the former and the new horizontal distance between the implant and the outer surface of the buccal plate. Both measurements will be taken using CBCT, one immediately after the surgery and the other one 3 month later. Intraoral scans with 3Shape Trios4 dental scanner will be taken to compare soft tissue stability. Measurements will be taken before, immediately after the surgery and 3 month later. By using STL files it will be possible to compare soft tissue stability. Evaluation Phase T1 (Basic): After the performance of final restoration: X-ray, photograph, scan, PD, BOP, RI. T2: Follow-up after 3 months: X-ray, photograph, scan, PD, BOP, RI. T3: Follow-up after a year: X-ray, photograph, scan, PD, BOP, RI. ### Conditions Module **Conditions:** - Dental Implants - Humans - Dental Implants, Single-Tooth - Male - Female - Osseointegration - Dental Anxiety - Guided Surgery ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Masking Description:** Each patient has their individual ID number **Who Masked:** - PARTICIPANT **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 44 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Immediate implant placement and temporary closure of tapered implants with a custom-made composite shaper after tooth extraction with bone augmentation by using allogeneic bone. **Intervention Names:** - Procedure: Kompozite closure **Label:** Kompozite closure **Type:** OTHER #### Arm Group 2 **Description:** Immediate implant placement and temporary closure of tapered implant with a custom-made zirconium oxide abutment after tooth extraction with bone augmentation by using allogeneic bone. **Intervention Names:** - Procedure: Individual abutment **Label:** Individual abutment **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Kompozite closure **Description:** Immediate implant placement and temporary closure of tapered implants with a custom-made composite shaper. **Name:** Kompozite closure **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Individual abutment **Description:** Immediate implant placement and temporary closure of tapered implant with a custom-made zirconium oxide abutment. **Name:** Individual abutment **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** To compare crystal bone stability CBCT will be taken before surgery. , immediately after surgery, after 3 month and a follow up after 1 year. The change in the buccal vertical bone level will be measured as the difference between the former and the new vertical distance from implant platform to the buccal alveolar crest. While the change in the buccal horizontal bone dimension will be measured as the difference between the former and the new horizontal distance between the implant and the outer surface of the buccal plate. Both measurements will be taken using CBCT, one immediately after the surgery and the other one 3 month later **Measure:** Stability of crestal bone **Time Frame:** Before surgery, immediately after surgery, 3 moth, 1 year follow up **Description:** Recession (REC) state of the gingival/mucosa border - registered by means of a periodontal probe from the incisal edge to the border of the medial, zenith and distal zones. There are taken scans with 3Shape Trios4 before surgery, immediately after, then 3 month and 1 year follow up to compare soft tissue stability **Measure:** The changes of stability of soft tissue **Time Frame:** Before surgery, immediately after surgery, 3 month, 1 year follow up **Description:** To compare implant position accuracy using surgical guide, the following two things will be compared: DICOM after the surgery witch contains information on the implant position in the bone and the STL file witch contains information on implant position before the surgery. There are taken cone beam computer tomography before and immediately after surgery, then 3 month and 1 year follow up. **Measure:** The change of position of implant using surgical guide **Time Frame:** Before surgery and immediately after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Males and females at least 18 years of age or older. 2. One implant per patient. 3. Prior to any study-related activity, the subject must voluntarily sign informed consent, be willing and able to attend scheduled follow-up visits, and agree to the collection and analysis of pseudonymised data. 4. Lateral individual teeth (premolars and molars). 5. Class I extraction socket (intact buccal wall) or class II (1/3 of buccal wall). 6. The gingival contour of the tooth to be extracted - without recession. 7. Adjacent anterior teeth have no periodontal loss. 8. There are no implants in the adjacent teeth. 9. Non-traumatic tooth extraction, which results in intact walls of the socket. Exclusion Criteria: 1. Deep occlusion (severe, class II). 2. The patient smokes a lot (more than 10 cigarettes per day). 3. Systemic disease (osteoporosis). 4. No initial stability has been achieved after the implant insertion procedure **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Vitālijs Gnusins, DDS **Phone:** +371 29993389 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Karlis Kibermanis **Phone:** 26176596 **Role:** CONTACT #### Locations **Location 1:** **City:** Riga **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Vitālijs Gnusins - **Phone:** 29993389 - **Role:** CONTACT **Country:** Latvia **Facility:** Adenta **State:** Latvija **Status:** RECRUITING **Zip:** LV-1045 #### Overall Officials **Official 1:** **Affiliation:** Riga Stradiņš University **Name:** Ģirts Šalms, Asoc.prof **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Alexopoulou M, Lambert F, Knafo B, Popelut A, Vandenberghe B, Finelle G. Immediate implant in the posterior region combined with alveolar ridge preservation and sealing socket abutment: A retrospective 3D radiographic analysis. Clin Implant Dent Relat Res. 2021 Feb;23(1):61-72. doi: 10.1111/cid.12974. Epub 2021 Jan 13. **PMID:** 33438320 **Citation:** Sanz-Martin I, Permuy M, Vignoletti F, Nunez J, Munoz F, Sanz M. A novel methodological approach using superimposed Micro-CT and STL images to analyze hard and soft tissue volume in immediate and delayed implants with different cervical designs. Clin Oral Implants Res. 2018 Oct;29(10):986-995. doi: 10.1111/clr.13365. Epub 2018 Sep 23. **PMID:** 30246362 **Citation:** Guidetti LG, Monnazzi MS, Piveta AC, Gabrielli MA, Gabrielli MF, Pereira Filho VA. Evaluation of single implants placed in the posterior mandibular area under immediate loading: a prospective study. Int J Oral Maxillofac Surg. 2015 Nov;44(11):1411-5. doi: 10.1016/j.ijom.2015.06.021. Epub 2015 Jul 18. **PMID:** 26194771 #### See Also Links **Label:** Customized sealing socket abutment (SSA) has been claimed to optimize the peri-implant hard and soft tissues in type 1 implant placement. **URL:** https://pubmed.ncbi.nlm.nih.gov/33438320/ **Label:** To study the hard and soft tissue volume after placing immediate (IMI) or delayed implants (DLI) with a triangular coronal macro-design (Test/T) or a conventional cylindrical design (Control/C). **URL:** https://pubmed.ncbi.nlm.nih.gov/30246362/ **Label:** The aim of this study was to evaluate the survival of single dental implants subjected to immediate function. Twelve patients with edentulous areas in the posterior mandible were included in the study. **URL:** https://pubmed.ncbi.nlm.nih.gov/26194771/ ## Derived Section ### 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: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04785079 **Brief Title:** Instrument Assisted Soft Tissue Mobilization Effect on Blood Flow **Official Title:** Qualification of Instrument Assisted Soft Tissue Mobilization Induced Hyperemia Using Musculoskeletal Ultrasound #### Organization Study ID Info **ID:** 2020-34 #### Organization **Class:** OTHER **Full Name:** Florida Gulf Coast University ### Status Module #### Completion Date **Date:** 2022-03-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-07-27 **Type:** ACTUAL **Last Update Submit Date:** 2022-07-26 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-03-01 **Type:** ACTUAL #### Start Date **Date:** 2020-08-01 **Type:** ACTUAL **Status Verified Date:** 2022-07 #### Study First Post Date **Date:** 2021-03-05 **Type:** ACTUAL **Study First Submit Date:** 2021-03-01 **Study First Submit QC Date:** 2021-03-03 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Thomas Zeller **Class:** UNKNOWN **Name:** Tyler Corbin **Class:** UNKNOWN **Name:** Alyssa Nieves #### Lead Sponsor **Class:** OTHER **Name:** Florida Gulf Coast University #### Responsible Party **Investigator Affiliation:** Florida Gulf Coast University **Investigator Full Name:** Dr. Rob Sillevis, **Investigator Title:** Assistent 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 is designed to evaluate the short term change in blood flow in the superficial human tissue layers after the application of 3 min Graston instrumented assisted soft tissue mobilization on the plantar aspect of the foot and the trapezius muscle. **Detailed Description:** Instrument assisted soft tissue mobilization (IASTM) is a commonly used physical therapy intervention. Graston ® technique is a form of IASTM that requires completion of a certification course and utilizes specific stainless-steel tools. IASTM has been found to improve range of motion, pain and patient reported function in pathological individuals. One method by which these improvements are thought to occur is by increasing blood flow. Increased blood flow brings nutrients and oxygen to the area and is thought to contribute to tissue remodeling. There is very limited research investigating blood flow changes following IASTM. In order to measure blood flow changes following IASTM, doppler ultrasound may be used. There are no studies to our knowledge quantifying changes in blood flow following IASTM using ultrasound. Power doppler approximates perfusion by detecting a frequency shift from movement of red blood cells and color is then encoded proportionally to the number of red blood cells. Power doppler imaging quantification (PDIQ) is a feature of musculoskeletal ultrasound (MSK) that compares the number of color pixels and the intensity of color within these pixels to grey scale pixels within a given image. The aim of this study is to determine if there is an increase in blood flow in the trapezius, plantar fascia and medial arch of the foot measured following IASTM. Blood flow was measured by using PDIQ ratio in the doppler setting of MSK ultrasound. ### Conditions Module **Conditions:** - Asymptomatic Condition **Keywords:** - Instrument assisted soft tissue mobilization - Musculoskeletal Ultrasound Imaging - Bood circulation - Perception ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Quasi-experimental study using a single group ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 35 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Pre and post Graston change in blood flow at the medial arch foot, plantar fascia, and the trapezius region **Intervention Names:** - Procedure: Graston Instrument assisted Soft tissue Mobilization **Label:** Graston effect medial arch, plantar fascia, and trapezius **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Graston effect medial arch, plantar fascia, and trapezius **Description:** Instrument assisted soft tissue mobilization using the Graston tool and technique for 3 minutes on each of the three locations **Name:** Graston Instrument assisted Soft tissue Mobilization **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** ultrasound images are used to calculate the ratio of color to grey scale pixels called the power doppler quantification ratio (PDIQ). **Measure:** GE LOGIQe ultrasound machine to measure maximum power doppler imaging quantification (PDIQ) ratios **Time Frame:** One day measure-First measure will be taken before the treatment intervention, immediate after the intervention and three minutes afterward. Total time for the experiment is 15 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * A-symptomatic individuals over the age of 18 Exclusion Criteria: * Anyone under 18 and anyone with any conditions contraindicated for IASTM including compromised tissue integrity, deep vein thrombosis (DVT), area of infection in the treatment area, or acute fracture. **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Fort Myers **Country:** United States **Facility:** Florida Gulf Coast University **State:** Florida **Zip:** 33965 ### 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 - Abbrev: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M28968 - Name: Asymptomatic Diseases - Relevance: HIGH - As Found: Asymptomatic Condition - ID: M9991 - Name: Hyperemia - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000058070 - Term: Asymptomatic Diseases ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02162979 **Brief Title:** Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's Disease **Official Title:** A Double-Blind, Placebo-Controlled, Cross-Over Study of Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's Disease #### Organization Study ID Info **ID:** 52031 #### Organization **Class:** OTHER **Full Name:** Loma Linda University ### Status Module #### Completion Date **Date:** 2009-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-03-30 **Type:** ACTUAL **Last Update Submit Date:** 2018-03-05 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2009-01 **Type:** ACTUAL #### Results First Post Date **Date:** 2014-07-22 **Type:** ESTIMATED **Results First Submit Date:** 2014-06-20 **Results First Submit QC Date:** 2014-06-20 #### Start Date **Date:** 2002-02 **Status Verified Date:** 2018-03 #### Study First Post Date **Date:** 2014-06-13 **Type:** ESTIMATED **Study First Submit Date:** 2007-12-26 **Study First Submit QC Date:** 2014-06-12 **Why Stopped:** Not enough subjects. ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Loma Linda University #### 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 study is to determine if Viagra is effective in reducing dyskinesias in patients with Parkinson's Disease. **Detailed Description:** Inclusion Criteria: 1. Diagnosis of idiopathic Parkinson's disease. 2. Age \> 40 years. 3. willingness and ability to comply with the study requirements and give informed consent. ### Conditions Module **Conditions:** - Parkinson's Disease **Keywords:** - Parkinson's disease - PD - dyskinesia - treatment - motor complications ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 2 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. **Intervention Names:** - Drug: sildenafil **Label:** Viagra **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. **Intervention Names:** - Drug: Placebo **Label:** Placebo comparator **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Viagra **Description:** sildenafil 50mg BID for 2 weeks **Name:** sildenafil **Other Names:** - Viagra **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo comparator **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Change in Duration of Dyskinesia. **Time Frame:** 2 weeks #### Secondary Outcomes **Description:** "on" time is the period in which the subject is symptom free. We will track the amount of time the subject is considered symptom free before and after treatment. This value will be represented as a percent change. **Measure:** Percent Change in "on" Time **Time Frame:** 4 weeks **Measure:** Change in Dose of Anti-parkinsonian Medications **Time Frame:** 7 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Diagnosis of idiopathic Parkinson's disease, Hoehn and Yahr stage 2.0 to 4.0. 2. Presence of drug-induced dyskinesias 3. Age\>40 years. 4. Willingness and ability to comply with the study requirements and give informed consent. Exclusion Criteria: 1. Atypical parkinsonian syndrome due to drugs, metabolic disorders, encephalitis, or degenerative diseases. 2. History of stereotaxic brain surgery. 3. Clinical history of dementia. 4. Known major psychiatric disorder, major depression, schizophrenia. Known alcoholism or substance dependence within previous 12 months. 5. History of major hematological, renal, or hepatic abnormalities. 6. Known coronary artery disease including angina or myocardial infarction within the last 6 months. Significant cardiovascular disease including cardiac failure, unstable angina or life-threatening arrhythmia within the last 6 months. 7. History of stroke within the last 6 months. 8. Abnormal EKG consistent with cardiac ischemia. 9. Treatment with nitrates. Nitrates or any NO donors in any dosage form (oral, sublingual, transdermal, inhalation, or aerosols). 10. Malignant hypertension or SBP . 180 or \<90, or DBP .110 or \<50. 11. History of priapism. 12. Known history of retinitis pigmentosa. 13. Positive pregnancy test. 14. History of bleeding disorder. 15. Patients with active peptic ulcer disease associated with bleeding. 16. Unwillingness to use adequate contraceptive methods if of childbearing potential. 17. Patients with medical or psychological condition or social circumstances that would impair their ability to participate in the study. 18. Use of Viagra or any experimental drugs within 30 days of screening visit. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Loma Linda **Country:** United States **Facility:** Loma Linda University **State:** California **Zip:** 92354 #### Overall Officials **Official 1:** **Affiliation:** Loma Linda University **Name:** David M. Swope, MD **Role:** PRINCIPAL_INVESTIGATOR ### 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 - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13213 - Name: Parkinson Disease - Relevance: HIGH - As Found: Parkinson's Disease - ID: M22574 - Name: Dyskinesias - Relevance: HIGH - As Found: Dyskinesia - 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 - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010300 - Term: Parkinson Disease - ID: D000020820 - Term: Dyskinesias ### Intervention Browse Module - Ancestors - ID: D000014665 - Term: Vasodilator Agents - ID: D000058986 - Term: Phosphodiesterase 5 Inhibitors - ID: D000010726 - Term: Phosphodiesterase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000064804 - Term: Urological Agents ### Intervention Browse Module - Browse Branches - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: Urol - Name: Urological Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M292 - Name: Sildenafil Citrate - Relevance: HIGH - As Found: Atrial Fibrillation - ID: M21320 - Name: Citric Acid - Relevance: LOW - As Found: Unknown - ID: M1837 - Name: Sodium Citrate - Relevance: LOW - As Found: Unknown - ID: M17412 - Name: Vasodilator Agents - Relevance: LOW - As Found: Unknown - ID: M29332 - Name: Phosphodiesterase 5 Inhibitors - Relevance: LOW - As Found: Unknown - ID: M13629 - Name: Phosphodiesterase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: T382 - Name: Citrate - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000068677 - Term: Sildenafil Citrate ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Viagra **Description:** subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. sildenafil: sildenafil 50mg BID for 2 weeks **ID:** EG000 **Title:** Viagra **Group ID:** EG001 **Title:** Placebo Comparator **Description:** subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. Placebo **ID:** EG001 **Title:** Placebo Comparator **Frequency Threshold:** 0 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 0 **Group ID:** BG001 **Value:** 0 **Group ID:** BG002 **Value:** 0 **Units:** Participants ### Group **ID:** BG000 **Title:** Viagra **Description:** subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. sildenafil: sildenafil 50mg BID for 2 weeks ### Group **ID:** BG001 **Title:** Placebo Comparator **Description:** subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. Placebo ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure **Category Title:** <=18 years **Category Title:** Between 18 and 65 years **Category Title:** >=65 years **Class Title:** ### Measure ### Measure **Category Title:** Female **Category Title:** Male **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Title:** Age, Categorical ### Measure 2 **Title:** Age, Continuous **Unit of Measure:** years ### Measure 3 **Title:** Sex: Female, Male ## Results Section - More Information Module ### Certain Agreement **PI Sponsor Employee:** True ### Point of Contact **Email:** [email protected] **Organization:** Loma Linda University **Phone:** 909-558-4908 **Title:** Tonya Hamilton, reszearch Compliance Auditor ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 #### Outcome Measure 2 #### Outcome Measure 3 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Reporting Status:** POSTED **Time Frame:** 2 weeks **Title:** Change in Duration of Dyskinesia. **Type:** PRIMARY ##### Group **Description:** subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. sildenafil: sildenafil 50mg BID for 2 weeks **ID:** OG000 **Title:** Viagra ##### Group **Description:** subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. Placebo **ID:** OG001 **Title:** Placebo Comparator #### Outcome Measure 2 **Description:** "on" time is the period in which the subject is symptom free. We will track the amount of time the subject is considered symptom free before and after treatment. This value will be represented as a percent change. **Reporting Status:** POSTED **Time Frame:** 4 weeks **Title:** Percent Change in "on" Time **Type:** SECONDARY ##### Group **Description:** subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. sildenafil: sildenafil 50mg BID for 2 weeks **ID:** OG000 **Title:** Viagra ##### Group **Description:** subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. Placebo **ID:** OG001 **Title:** Placebo Comparator #### Outcome Measure 3 **Reporting Status:** POSTED **Time Frame:** 7 weeks **Title:** Change in Dose of Anti-parkinsonian Medications **Type:** SECONDARY ##### Group **Description:** subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. sildenafil: sildenafil 50mg BID for 2 weeks **ID:** OG000 **Title:** Viagra ##### Group **Description:** subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. Placebo **ID:** OG001 **Title:** Placebo Comparator ### Participant Flow Module #### Group **Description:** subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. sildenafil: sildenafil 50mg BID for 2 weeks **ID:** FG000 **Title:** Viagra #### Group **Description:** subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. Placebo **ID:** FG001 **Title:** Placebo Comparator #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 **Pre-Assignment Details:** Documentation regarding the randomization of the two enrolled participants cannot be located. Therefore no meaningful data are available for entry in the data tables. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT06008379 **Brief Title:** A Study of 7MW3711 in Subjects With Advanced Solid Tumors **Official Title:** A Phase 1/2 Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 7MW3711 in Subjects With Advanced Solid Tumors #### Organization Study ID Info **ID:** 7MW3711-2023-CP102 #### Organization **Class:** INDUSTRY **Full Name:** Mabwell (Shanghai) Bioscience Co., Ltd. ### Status Module #### Completion Date **Date:** 2026-01-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-09-13 **Type:** ACTUAL **Last Update Submit Date:** 2023-09-11 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-08-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-08-28 **Type:** ACTUAL **Status Verified Date:** 2023-09 #### Study First Post Date **Date:** 2023-08-23 **Type:** ACTUAL **Study First Submit Date:** 2023-08-07 **Study First Submit QC Date:** 2023-08-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Mabwell (Shanghai) Bioscience Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** 7MW3711 is a antibody-drug conjugate(ADC) drected to a target wildly expressed on solid tumors. This is an open-label, multicenter, phase 1/2 study to evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 7MW3711 in subjects with advanced solid tumors. **Detailed Description:** Two parts are included in this study. The part of dose escalation and dose expansion(part 1) will enrolled subjects with advanced solid tumors and is to evaluate the safety and tolerability and to determine the maximum tolerated dose and/or the recommend pahse 2 dose(RP2D) of 7MW3711 in subjects with advanced solid tumors. The part of cohort expansion(part 2) will enrolled subejcts with selected advanced solid tumors and is to assess the preliminary efficacy of 7MW3711 in selected advanced solid tumors. ### Conditions Module **Conditions:** - Advanced Solid Tumor ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 164 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** all subjects enrolled in the part of dose escalation and dose expansion will receive 7MW3711 by introvenous infusion **Intervention Names:** - Drug: 7MW3711 for injection **Label:** dose escalation and dose expansion **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** all subjects enrolled in the part of cohort expansion will be treated by 7MW3711 will receive 7MW3711 by introvenous infusion **Intervention Names:** - Drug: 7MW3711 for injection **Label:** cohort expansion **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - dose escalation and dose expansion **Description:** IV administration of 7MW3711, Q3W, 3 weeks a cycle **Name:** 7MW3711 for injection **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - cohort expansion **Description:** IV administration of 7MW3711, the dosage regimen including dosage and dosing frequency for cohort expansion is conformed on basis of the data in part 1 **Name:** 7MW3711 for injection **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Incidence and seriousness of adverse events (AEs) and serious adverse events (SAEs) by CTCAE version 5.0. **Measure:** evaluation of the incidence of adverse events (AEs) (part 1) **Time Frame:** approximately up to 16 cycles, 21 days a cycle **Measure:** Identification of the MTD and /or RP2D of 7MW3711(part 1) **Time Frame:** from Day1 to Day21 in cycle1 of part 1 **Description:** ORR:defined as the proportion of patients who achieved a best overall response of completeresponse (CR) or partial response (PR) **Measure:** Overall response rate (ORR) evaluated by investigators based on RECIST version 1.1 in selected solid tumors. (part 2) **Time Frame:** approximately up to 2 years #### Secondary Outcomes **Description:** Maximum observed concentration(Cmax) **Measure:** evaluation of PK parameters of 7MW3711 **Time Frame:** approximately up to 2 years **Description:** the time to Cmax(tmax) **Measure:** evaluation of PK parameters of 7MW3711 **Time Frame:** approximately up to 2 years **Description:** half-live(t1/2) **Measure:** evaluation of PK parameters of 7MW3711 **Time Frame:** approximately up to 2 years **Description:** Area under the concentration-time curve(AUC) **Measure:** evaluation of PK parameters of 7MW3711 **Time Frame:** approximately up to 2 years **Description:** ORR:defined as the proportion of patients who achieved a best overall response of completeresponse (CR) or partial response (PR) based on RECIST version 1.1. **Measure:** overall response rate (ORR) (part1) **Time Frame:** approximately up to 1 years **Description:** DCR:defined as the proportion of subjects with CR, PR, and SD based on RECIST 1.1 criteria **Measure:** disease control rate(DCR) **Time Frame:** approximately up to 2 years **Description:** PFS:defined as time from the date of first administration to the date of first documented disease progression based on RECIST 1.1 criteria, or death due to any cause, whichever occurs first **Measure:** progression-free survival(PFS) **Time Frame:** approximately up to 2 years **Description:** TTR:defined as time from the date of first administration to the date of first documented CR or PR **Measure:** time to response (TTR) **Time Frame:** approximately up to 2 years **Description:** Frequency and percentage of subjects with positive anti-drug antibody after being treated by 7MW3711. **Measure:** evaluation of the immunogenicity of 7MW3711 **Time Frame:** approximately up to 2 years **Description:** Incidence and seriousness of adverse events (AEs) and serious adverse events (SAEs) by CTCAE version 5.0. **Measure:** evaluation of the incidence of adverse events (AEs) (part 2) **Time Frame:** approximately up to 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Life expectancy of at least 3 months as assessed by the Investigator. * Part 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor, progressive after last treatment received and who progressed on or after standard therapies or intolerant to approved therapies or who lack of effient standard therapies; part 2: Histologically or cytologically confirmed locally advanced or metastatic selected advanced solid tumors having progressed after at least one line of standard systermic therapy or intolerate standard therapies. * An archival tumor tissue sample(formalin-fixed paraffin-embedded (FFPE) tumor tissue block or at least 5 unstained slides) or a fresh tissue sample should be provided. If the tissue sample cannot be provided during dose escalation, enrollment into the study is allowed after discussion with the Investigator * Measurable or evaluable disease by RECIST v1.1. * Have adequate hematopoietic, renal and hepatic functions. * Men or women willing to use adequate contraceptive measures throughout the study Exclusion Criteria: * Have other prior malignancies within 3 years before the first administration. * Known central nervous system metastatic disease or carcinomatous meningitis except for treated and stable brain metastases. * Have significant, uncontrolled, or active cardiovascular disease. * Known history of COPD, or intestinal lung disease, or other respiratory diseases requring inpatient treatments within 4 weeks prior to first administration. * Have adverse events due to prior antitumor therapy not resolved to grade 1 or lower by NCI CTCAE V5.0. * have active infections requiring treatment within 14 weeks; have infection of HIV, active infection of HCV and HBV. * Prior treatment with an antibody drug conjugate (ADC) that consists of an topoisomerase I inhibitor. * Prior treatment with B7-H3 targeted agents. * have received chemotherapy, immunotherapy, curative radiation within 3 weeks prior to the first administration or targeted molecular within 2 weeks prior to first administration. have received Chinese patent medicine or Chinese herbs of anti-tumor indications within 1 weeks prior to the first administration. * Have received any systemic immunosuppressants within 2 weeks prior to the first administration except for topical corticosteroids. * Have received any other investigational drugs or medical device within 4 weeks prior to the first administration. * History of drug abuse including narcotic and psychiatric drugs within 12 months prior to screening. * Pregnant, or nursing females **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sun Lu, Doctor **Phone:** 021-22200000*3121 **Role:** CONTACT #### Locations **Location 1:** **City:** Zhengzhou **Contacts:** ***Contact 1:*** - **Name:** Qiming Wang - **Role:** CONTACT **Country:** China **Facility:** Henan Cancer Hospital **State:** Henan **Status:** NOT_YET_RECRUITING **Location 2:** **City:** Changsha **Contacts:** ***Contact 1:*** - **Name:** Yongzhong Luo - **Role:** CONTACT **Country:** China **Facility:** Hunan Cancer Hospital **State:** Hunan **Status:** NOT_YET_RECRUITING **Location 3:** **City:** Xuzhou **Contacts:** ***Contact 1:*** - **Name:** Liang Han - **Role:** CONTACT **Country:** China **Facility:** Xuzhou Central Hospital **State:** Jiangsu **Status:** NOT_YET_RECRUITING **Zip:** 221009 **Location 4:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sun Lu, Doctor - **Phone:** 021-22200000*3121 - **Role:** CONTACT **Country:** China **Facility:** The Lung Cancer Center of Shanghai Chest Hospital **State:** Shanghai **Status:** RECRUITING **Zip:** 2000043 **Location 5:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Zhengbo Song, Doctor - **Role:** CONTACT **Country:** China **Facility:** Zhejiang Cancer Hospital **State:** Zhejiang **Status:** NOT_YET_RECRUITING **Zip:** 310000 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02550379 **Brief Title:** Emotion Recognition Training for Young People **Official Title:** Emotion Recognition Training for Socially Anxious Adolescents: A Randomized Controlled Trial #### Organization Study ID Info **ID:** HS-15-41-Fitzgerald #### Organization **Class:** OTHER **Full Name:** University College Dublin ### Status Module #### Completion Date **Date:** 2016-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2016-11-09 **Type:** ESTIMATED **Last Update Submit Date:** 2016-11-08 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-03 **Type:** ACTUAL #### Start Date **Date:** 2015-09 **Status Verified Date:** 2016-11 #### Study First Post Date **Date:** 2015-09-15 **Type:** ESTIMATED **Study First Submit Date:** 2015-09-11 **Study First Submit QC Date:** 2015-09-11 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Bristol #### Lead Sponsor **Class:** OTHER **Name:** University College Dublin #### Responsible Party **Investigator Affiliation:** University College Dublin **Investigator Full Name:** Dr. Amanda Fitzgerald **Investigator Title:** Lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** While it has been hypothesised that individuals who experience social anxiety are more likely to misread facial emotions as threatening or disapproving, researchers have proposed that the difficulty may lie in decoding ambiguous facial expressions rather than identifying emotions which are expressed with greater intensity. Emotion recognition (ER) training provides a promising new avenue of research which may be beneficial in altering emotion processing biases which maintain or increase symptoms of mental health disorders. This study will examine the effectiveness of ER training in a community-based sample of young people (15-18 years) who report high levels of social anxiety. The intervention aims to alter emotion processing biases through a training procedure designed to promote the perception of happiness over disgust in ambiguous facial expressions which we hypothesise will subsequently reduce symptoms of social anxiety. The study design consists of two phases. During Phase 1 participants will complete a screening questionnaire. This questionnaire will include a measure of the affective, cognitive, and behavioural components of social anxiety in adolescence. Depending on their suitability (i.e. scoring above a cut-off on a standardised measure of social anxiety in Phase 1 of the study), participants may then be invited to take part in a 4-day computer-based emotion recognition training programme (Phase 2). The purpose of this phase is to see if ER training will help young people feel less worried or nervous in social situations by training them to interpret ambiguous facial expressions as expressing a positive emotion (happy rather than disgusted). Participants will be randomly assigned to either the intervention or placebo (inactive) group. Both groups will be asked to complete a 4-day programme involving one computer training session per day (each session takes approximately 20 minutes). Questionnaires will also be given to participants to complete before and after the intervention, along with a 2-week follow-up assessment. These will include questionnaires to measure social anxiety, depressive symptoms, and fear of negative evaluation. Each questionnaire will take approximately 15 minutes to complete. Participants will not know whether they have received the intervention or placebo training until after the intervention. **Detailed Description:** Social anxiety disorder (SAD) is among the most prevalent mental disorders in adolescence, 10% of females and 5% of males are diagnosed with SAD in adolescence. SAD is characterised by marked fear or anxiety about social situations in which the individual is exposed to possible scrutiny by others. SAD is associated with social isolation, poor social skills, low self-esteem, and future comorbid mental disorders. Social anxiety typically develops during adolescence, thus there is a need to detect and treat it early prior to the development of a clinically-diagnosed SAD. Most early interventions for social anxiety have used Cognitive Behavioural Therapy (CBT), which focuses on modifying explicit verbal cognitions. However, many adolescents do not have access to CBT and many finding it demanding. Research suggests that individuals who have high levels of social anxiety are more likely to misread facial emotions as threatening or disapproving, and researchers have proposed that the difficulty may lie in decoding low intensity facial expressions rather than identifying facial emotions which are expressed with greater intensity. In social anxiety, a bias towards perceiving ambiguous facial expressions as negative may give rise to avoidant behaviour and maintain or increase symptoms; therefore, this emotion processing bias may be a powerful bias for researchers to target with the aim of developing interventions to reduce symptoms. ER training provides a promising new line of research which may be beneficial in altering emotion processing biases which maintain or increase symptoms of mental health disorders. Research has shown that ER training may be effective in reducing depressive symptoms in analogue populations with high levels of depression and anger and aggressive behaviour in healthy adults and adolescent youth at high risk of criminal offending and delinquency. Present Study: This research tests the effectiveness of ER training in reducing social anxiety in adolescents. Given that the age of onset of social anxiety is adolescence, peaking in late teens, this research focuses on 15-18 year olds. Aims \& Objectives: To test the effectiveness of ER training in reducing social anxiety in adolescents. The intervention aims to alter emotion processing biases through a training procedure designed to promote the perception of happiness over disgust in ambiguous facial expressions which we hypothesise will subsequently reduce symptoms of social anxiety. Central Research Questions: Is ER training associated with: I. An increase in the perception of positive (happy) over negative (disgust) emotions in faces displaying ambiguous emotional expressions? II. A decrease in negative evaluations? III. A decrease in social anxiety? IV. A decrease in other forms of anxiety and/or symptoms of depression? PHASE 1: SCREENING FOR SOCIAL ANXIETY IN ADOLESCENTS Objective: To screen for sub-clinical levels of social anxiety in adolescents. School Sampling: Approximately 8 large second-level schools in Dublin will be randomly selected from the Department of Education and Skills 2012 published list of schools. Power Analysis: Using G\*Power 3.1, the sample size was determined as 111 based on the following parameters: a medium effect size of 0.3, alpha of 0.05, power of 0.8, a repeated measures within-between interaction: 2 (Randomization) X 3 (Pre, Post, Follow-up). Participants: Adolescents aged 15-18 years in second-level schools will be invited for the initial screening. Procedure: Adolescents must return parental and informed consent forms. Participants will be screened using the Social Phobia and Anxiety Inventory for Children (SPAI-C). Participants scoring above the cut-off of ≥18 will be invited to participate in the intervention (Phase 2). Approximately 440 second-level students across 8 schools will be invited to complete screening. With an approximate response rate of 50% (N=220), and using a cut-off of ≥18 120 will be identified (60 per condition). PHASE 2: RANDOMIZED CONTROL TRIAL Objective: To compare the effectiveness of ER to placebo training in reducing social anxiety. Participants: Adolescents from Phase 1 screening above a cut-off of ≥18 will be invited to participate in the intervention and will be randomly assigned to ER/placebo training. On the basis of screening, the PI will ensure group equivalence across ER versus placebo groups on key variables (e.g., age, gender, social anxiety) in advance of randomization. Post randomization, independent variables will be checked to ensure they are balanced across groups so as not to contaminate outcomes of the study. Procedure: Participants in both ER and placebo training groups will receive 4 training sessions over 4 consecutive days. The intervention will be performed on a laptop during school and delivered in a quiet room with the researcher present. Pre-intervention data will be collected on day 1 prior to training, post-intervention data will be collected on day 4 following training, with a follow-up assessment at 2-weeks post-intervention. Training Task: Participants will complete training over 4 consecutive days in schools. Each session will include a computerised training programme comprised of three phases, baseline, training, and test,which will take approximately 15 minutes to complete. A follow-up assessment will be completed two weeks post-intervention. During the 2-week follow-up assessment participants will complete a final assessment of emotion sensitivity using the test phase of the emotion recognition task. * Prototypical 'happy' and 'disgust' composite images generated from 40 individual faces (20 x male, 20 x female) showing a disgust facial expression, and the same 40 individuals showing a happy expression. * Prototypical images used as endpoints to generate a linear morph sequence that consists of images that change incrementally from unambiguously 'happy' to unambiguous 'disgust', with emotionally ambiguous images in the middle. The proposed research will include a sequence with 15 equally spaced images for each gender (male and female) for use as experimental stimuli. * Previous research by the University of Bristol has used stimuli portraying male faces only. The task stimuli for the current research will be matched to the participant's gender, i.e. female participants will complete a task which will include female face stimuli and male participants will complete a task which will include male face stimuli. * Baseline and test phases will consist of 45 trials, in which each of the stimuli from the morph sequence will be presented to the participant three times. The task will require the participant to make a forced choice judgement as to whether each face is displaying a happy or disgust expression. Images will be presented one at a time, in random order, for 150 milliseconds. Stimuli will be preceded by a fixation cross, which will be presented for a random period ranging from 1500 to 2500 milliseconds. Subsequent to presentation, and to prevent processing of after images, a backward mask of noise will be presented for 250 milliseconds, followed by a prompt asking the participant to respond. This will remain on screen until the participant makes response (i.e., a judgement of 'happy' or 'disgust'). * Trials in the training phase will be similar to trials in the baseline and test phases with respect to inter-trial interval and stimuli presentation, but with the addition of feedback subsequent to the participant's response. In the placebo condition, feedback will be based on the participant's baseline balance point. That is, responses will be classified as 'correct' if the participant identified images below the original balance point image as 'disgust' and above it as 'happy', and otherwise are classified as 'incorrect'. Feedback will be a message saying 'Correct / Incorrect! That face was disgust/happy'. In the training condition, feedback will be again based on the participant's baseline balance point, but the 'correct' classification will be shifted two morph steps towards the 'disgust' end of the continuum, so that the two images nearest the balance point that the participant would previously have classified as 'disgust' at baseline will be considered 'happy' when providing feedback. In each training block, each face from the 15 face continuum will be presented twice. The order of presentation will be randomized within each block. Three training blocks will be given to each participant, resulting in 90 training trials per session and a total of 360 training trials in total. Outcome Measures: Outcome measure will be administered to all participants in the RCT pre-intervention (baseline on day 1), post-intervention (day 4), and at 2-week follow-up, including: Emotion Sensitivity Measurement Accuracy assessed using baseline and test measurements at each ER/placebo training session. Social Phobia and Anxiety Inventory for Children (SPAI-C) The SPAI-C is a 26-item self-report instrument and has good psychometric properties with adolescent samples. The SPAI-C measures the somatic, cognitive, and behavioural aspects of social phobia in children and adolescents. Questions relate to how nervous the respondent feels when carrying out certain tasks and responses are rated on a 3-point scale from never, or hardly ever to most of the time, or always with higher scores indicating greater levels of social anxiety. Brief Fear of Negative Evaluations Scale - Revised (BFNE-R) Negative evaluations are an important aspect of social anxiety. The BFNE-R is a 12-item measure which assesses fear of negative evaluation. Items are responded to on a 5-point Likert scale from 0 to 4. The BFNE-R has shown high internal consistency and correlates well with the original BFNE. Screen for Child Anxiety Related Disorders (SCARED) Child Version The SCARED is used to screen for signs of anxiety disorders. The 41-item measure is used to measure anxiety, including panic, separation anxiety, generalised anxiety, social avoidance, and school phobia. It has shown high reliability with adolescents. Items are rated on a 3-point Likert scale. Internal consistencies have been shown to be high with adolescent samples. Depression Subscale of the Revised Child Anxiety and Depression Scale (RCADS) The RCADS is a 47-item self-report measure and has good psychometric properties with adolescent samples. The Depression Subscale contains 10 items. Items relating to the frequency with which depressive symptoms are experienced are rated on a 4-point Likert scale. Research Design: A mixed model 2 (Randomization) x 3 (Time) complex design combining between subjects and within subjects conditions will be employed. Each participant will be tested at pre-intervention, post-intervention, and 2-week follow-up. Independent Variables: Randomization (K=2; ER training/ Placebo) Time (K=3; Pre-intervention\[day 1\], Post-intervention \[day 4\], and Follow-up) Analyses: All analyses on change in social anxiety, anxiety, depression, and fear of negative evaluation will be conducted as intention-to-treat analyses. Descriptive statistics Chi-square analyses and ANOVAs Primary analyses will consist of two-way repeated ANOVAs 2 (Randomization) x 3 (Time) to test the variables under study. ### Conditions Module **Conditions:** - Anxiety - Depression **Keywords:** - Social Anxiety - Social Phobia - Depression - Emotion Recognition Training ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 115 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The placebo protocol consists of 3 phases, baseline, training, and test. The baseline phase consists of 45 trials which calculates the balance point at which the participant rates a face as 'happy' rather than 'disgusted' over a continuum of 15 faces ranging from happy through ambiguous to disgust. 3 training blocks are then administered with 30 trials per block. Behavioural feedback is given during training (correct/incorrect) based on the participant's balance point at baseline. A test phase is then administered which is identical to the baseline phase to reassess the participant's balance point. The task takes approximately 15 minutes to complete all 3 phases. **Intervention Names:** - Other: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** The ER training protocol consists of 3 phases, baseline, training, and test. The baseline phase consists of 45 trials which calculates the balance point at which the participant rates a face as 'happy' rather than 'disgusted' over a continuum of 15 faces ranging from happy through ambiguous to disgust. 3 training blocks are then administered with 30 trials per block. Behavioural feedback is given during training (correct/incorrect) based on the participant's balance point however this balance point is adjusted by 2 points on the 15 face continuum to train the participant to rate more faces as 'happy'. A test phase, identical to the baseline phase, is then administered to reassess the participant's balance point. The task takes approximately 15 minutes to complete all 3 phases. **Intervention Names:** - Behavioral: Intervention **Label:** Intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** Emotion Recognition Training **Name:** Intervention **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Placebo Training **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** A 26-item self-report questionnaire to measure social anxiety - Social Phobia and Anxiety Inventory for Children (SPAI-C; Biedel et al., 1998) **Measure:** Change from baseline in social anxiety at post-intervention **Time Frame:** Pre-intervention (day 1), post-intervention (day 4) #### Secondary Outcomes **Description:** A 26-item self-report questionnaire to measure social anxiety - Social Phobia and Anxiety Inventory for Children (SPAI-C; Biedel et al., 1998) **Measure:** Change from baseline in social anxiety at 2-week follow-up **Time Frame:** Pre-intervention (day 1), 2-week follow-up post-intervention **Description:** Emotion sensitivity measurement via shift in balance points across training sessions and at 2-week follow-up assessed using accuracy data from baseline and test phases of the ER/placebo training task **Measure:** Change from baseline in emotion sensitivity measurement at post-intervention and 2-week follow-up **Time Frame:** Pre-intervention (day 1), post-intervention (day 4), 2-week follow-up post-intervention **Description:** A 12-item self-report questionnaire to measure fear of negative evaluation - Brief Fear of Negative Evaluation Questionnaire -Revised (BFNE-R; Carleton et al., 2006) **Measure:** Change from baseline in fear of negative evaluation at post-intervention and 2-week follow-up **Time Frame:** Pre-intervention (day 1), post-intervention (day 4), and 2-week follow-up **Description:** A 41-item self-report screening tool for anxiety disorders including panic, separation anxiety, generalized anxiety, social avoidance, and school phobia - Screen for Child Anxiety Related Disorders Child Version (SCARED; Birmaher et al., 1999) **Measure:** Change from baseline in anxiety related disorders at post-intervention and 2-week follow-up **Time Frame:** Pre-intervention (day 1), post-intervention (week 4), and 2-week follow-up **Description:** A 10-item self-report subscale to assess the frequency of depressive symptoms - The Revised Child Anxiety and Depression Scale - Depression Subscale (RCADS; Chorpita et al., 2000) **Measure:** Change from baseline in depression symptoms at post-intervention and 2-week follow-up **Time Frame:** Pre-intervention (day 1), post-intervention (day 4), and 2-week follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: • Those who score above the cut-off on the SPAI-C Exclusion Criteria: * Those with a diagnosed mental health disorder * Those who are currently attending a mental health professional * Those scoring below the cut-off on the SPAI-C * Those who decline to participate * Those whose parents/guardians do not provide written consent **Healthy Volunteers:** True **Maximum Age:** 18 Years **Minimum Age:** 15 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** University College Dublin **Name:** Amanda Fitzgerald, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Adams S, Penton-Voak IS, Harmer CJ, Holmes EA, Munafo MR. Effects of emotion recognition training on mood among individuals with high levels of depressive symptoms: study protocol for a randomised controlled trial. Trials. 2013 Jun 1;14:161. doi: 10.1186/1745-6215-14-161. **PMID:** 23725208 **Citation:** Penton-Voak IS, Bate H, Lewis G, Munafo MR. Effects of emotion perception training on mood in undergraduate students: randomised controlled trial. Br J Psychiatry. 2012 Jul;201(1):71-2. doi: 10.1192/bjp.bp.111.107086. Epub 2012 Apr 26. **PMID:** 22539781 **Citation:** Penton-Voak IS, Thomas J, Gage SH, McMurran M, McDonald S, Munafo MR. Increasing recognition of happiness in ambiguous facial expressions reduces anger and aggressive behavior. Psychol Sci. 2013 May;24(5):688-97. doi: 10.1177/0956797612459657. Epub 2013 Mar 26. **PMID:** 23531485 **Citation:** Yoon KL, Zinbarg RE. Threat is in the eye of the beholder: social anxiety and the interpretation of ambiguous facial expressions. Behav Res Ther. 2007 Apr;45(4):839-47. doi: 10.1016/j.brat.2006.05.004. Epub 2006 Jun 23. **PMID:** 16797485 **Citation:** Button K, Lewis G, Penton-Voak I, Munafo M. Social anxiety is associated with general but not specific biases in emotion recognition. Psychiatry Res. 2013 Nov 30;210(1):199-207. doi: 10.1016/j.psychres.2013.06.005. Epub 2013 Jul 9. **PMID:** 23845415 **Citation:** Merikangas KR, He JP, Burstein M, Swanson SA, Avenevoli S, Cui L, Benjet C, Georgiades K, Swendsen J. Lifetime prevalence of mental disorders in U.S. adolescents: results from the National Comorbidity Survey Replication--Adolescent Supplement (NCS-A). J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):980-9. doi: 10.1016/j.jaac.2010.05.017. Epub 2010 Jul 31. **PMID:** 20855043 **Citation:** Wittchen HU, Fehm L. Epidemiology and natural course of social fears and social phobia. Acta Psychiatr Scand Suppl. 2003;(417):4-18. doi: 10.1034/j.1600-0447.108.s417.1.x. **PMID:** 12950432 **Citation:** Wittchen HU, Carter RM, Pfister H, Montgomery SA, Kessler RC. Disabilities and quality of life in pure and comorbid generalized anxiety disorder and major depression in a national survey. Int Clin Psychopharmacol. 2000 Nov;15(6):319-28. doi: 10.1097/00004850-200015060-00002. **PMID:** 11110007 **Citation:** American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Arlington, VA, American Psychiatric Association, 2013. **Citation:** Neil AL, Christensen H. Efficacy and effectiveness of school-based prevention and early intervention programs for anxiety. Clin Psychol Rev. 2009 Apr;29(3):208-15. doi: 10.1016/j.cpr.2009.01.002. Epub 2009 Jan 25. **PMID:** 19232805 **Citation:** Otto MW, Smits JA, Reese HE. Cognitive-behavioral therapy for the treatment of anxiety disorders. J Clin Psychiatry. 2004;65 Suppl 5:34-41. **PMID:** 15078117 **Citation:** Carleton RN, McCreary DR, Norton PJ, Asmundson GJ. Brief fear of negative evaluation scale-revised. Depress Anxiety. 2006;23(5):297-303. doi: 10.1002/da.20142. **PMID:** 16688736 **Citation:** Birmaher B, Brent DA, Chiappetta L, Bridge J, Monga S, Baugher M. Psychometric properties of the Screen for Child Anxiety Related Emotional Disorders (SCARED): a replication study. J Am Acad Child Adolesc Psychiatry. 1999 Oct;38(10):1230-6. doi: 10.1097/00004583-199910000-00011. **PMID:** 10517055 **Citation:** Crocetti E, Hale WW 3rd, Fermani A, Raaijmakers Q, Meeus W. Psychometric properties of the Screen for Child Anxiety Related Emotional Disorders (SCARED) in the general Italian adolescent population: a validation and a comparison between Italy and The Netherlands. J Anxiety Disord. 2009 Aug;23(6):824-9. doi: 10.1016/j.janxdis.2009.04.003. Epub 2009 Apr 23. **PMID:** 19427168 **Citation:** Chorpita BF, Yim L, Moffitt C, Umemoto LA, Francis SE. Assessment of symptoms of DSM-IV anxiety and depression in children: a revised child anxiety and depression scale. Behav Res Ther. 2000 Aug;38(8):835-55. doi: 10.1016/s0005-7967(99)00130-8. **PMID:** 10937431 **Citation:** Mathyssek CM, Olino TM, Hartman CA, Ormel J, Verhulst FC, Van Oort FV. Does the Revised Child Anxiety and Depression Scale (RCADS) measure anxiety symptoms consistently across adolescence? The TRAILS study. Int J Methods Psychiatr Res. 2013 Mar;22(1):27-35. doi: 10.1002/mpr.1380. Epub 2013 Mar 11. **PMID:** 23483654 **Citation:** Beidel DC, Turner SM, Morris The Social Phobia and Anxiety Inventory for Children (SPAI-C). Toronto, ON, Multi-Health Systems, 1998. **Citation:** Inderbitzen-Nolan H, Davies CA, McKeon ND. Investigating the construct validity of the SPAI-C: comparing the sensitivity and specificity of the SPAI-C and the SAS-A. J Anxiety Disord. 2004;18(4):547-60. doi: 10.1016/S0887-6185(03)00042-2. **PMID:** 15149713 **Citation:** Rawdon C, Murphy D, Motyer G, Munafo MR, Penton-Voak I, Fitzgerald A. An investigation of emotion recognition training to reduce symptoms of social anxiety in adolescence. Psychiatry Res. 2018 May;263:257-267. doi: 10.1016/j.psychres.2018.02.023. Epub 2018 Feb 8. **PMID:** 29602534 ## 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: M1117 - Name: Phobia, Social - Relevance: LOW - As Found: Unknown - ID: M13603 - Name: Phobic Disorders - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05919979 **Acronym:** IMS **Brief Title:** Effect of a Physical Exercise Session Performed During a 24-34 Hour Fasting Period on Energy Metabolism and Cognitive Function in Healthy Adults **Official Title:** Efecto de Una sesión de Ejercicio físico Realizada Durante un Periodo de Ayuno de 24-34 Horas Sobre el Metabolismo energético y la función Cognitiva en Adultos Sanos: Estudio Piloto #### Organization Study ID Info **ID:** GSD-2023-002 #### Organization **Class:** OTHER **Full Name:** Universidad de Granada ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-06 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-03 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-05-29 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2023-06-27 **Type:** ACTUAL **Study First Submit Date:** 2023-06-05 **Study First Submit QC Date:** 2023-06-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universidad de Granada #### Responsible Party **Investigator Affiliation:** Universidad de Granada **Investigator Full Name:** Guillermo Sanchez Delgado **Investigator Title:** Postdoctoral Researcher **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study explores the impact of high-intensity exercise during fasting on energy metabolism and cognitive function in healthy adults. Changes in respiratory exchange ratio, blood substances, and cognitive performance will be measured after 24 and 34 hours of fasting with and without exercise in a randomized crossover design. ### Conditions Module **Conditions:** - Energy Metabolism ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: 34-hour fasting in sedentary conditions - Behavioral: 34-hour fasting with high-intensity exercise **Label:** Fasting, then fasting+exercise **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Behavioral: 34-hour fasting in sedentary conditions - Behavioral: 34-hour fasting with high-intensity exercise **Label:** Fasting + Exercise, then fasting **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Fasting + Exercise, then fasting - Fasting, then fasting+exercise **Description:** Participants will fast for 34h after a standardized breakfast, refraining from physical activity. **Name:** 34-hour fasting in sedentary conditions **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Fasting + Exercise, then fasting - Fasting, then fasting+exercise **Description:** Participants will fast for 34h after a standardized breakfast, performing a high-intensity exercise session 6-10 hours aprox. after starting the fasting period. **Name:** 34-hour fasting with high-intensity exercise **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Measure:** Respiratory Exchange Ratio **Time Frame:** 24-hour after starting the fasting period #### Secondary Outcomes **Measure:** Respiratory Exchange Ratio **Time Frame:** 34-hour after starting the fasting period **Measure:** Serum insulin concentration **Time Frame:** 24-hour after starting the fasting period **Measure:** Serum insulin concentration **Time Frame:** 34-hour after starting the fasting period **Measure:** Serum glucose concentration **Time Frame:** 24-hour after starting the fasting period **Measure:** Serum glucose concentration **Time Frame:** 34-hour after starting the fasting period **Measure:** Dimensional Change Card Sort Test (NIH toolbox) **Time Frame:** 24-hour after starting the fasting period **Measure:** Dimensional Change Card Sort Test (NIH toolbox) **Time Frame:** 34-hour after starting the fasting period **Measure:** List Sorting Working Memory Test (NIH toolbox) **Time Frame:** 24-hour after starting the fasting period **Measure:** List Sorting Working Memory Test (NIH toolbox) **Time Frame:** 34-hour after starting the fasting period **Measure:** Flanker Test (NIH toolbox) **Time Frame:** 24-hour after starting the fasting period **Measure:** Flanker Test (NIH toolbox) **Time Frame:** 34-hour after starting the fasting period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-40 years old. * Body mass index: 18.5-30.0 Kg/m2. * Stable body weight (5kg range within the last 3 months) * Being able to consume all the food items provided as part of the study. * Not having change the time zone or have shifted sleeping hours equivalent to more than 3 hours on the previous 2 weeks. Exclusion Criteria: * Diagnosed with any chronic condition that, in the research team's opinion or based on the American College of Sports Medicine guidelines, could contraindicate the implementation of 34-hour fasting periods and/or high-intensity exercise. * Diagnosed with a chronic endocrine, digestive, rheumatic, neurological, cardiac, pulmonary, autoimmune, or infectious condition that affects energy metabolism. * Presenting any signs or symptoms of illness that, in the research team's opinion or based on the American College of Sports Medicine guidelines, could contraindicate the implementation of 34-hour fasting periods and/or high-intensity exercise. * Pregnant or breastfeeding. * Using medications or supplements that may alter energy metabolism. * Currently undergoing or having undergone any type of nutritional intervention or treatment in the past 3 months. * Engaging in more than 5 hours per week of habitual moderate-to-vigorous cycling. * Any other condition that, in the research team's opinion, discourages participation in the study. **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Guillermo Sanchez Delgado, PhD **Phone:** +34665186487 **Role:** CONTACT #### Locations **Location 1:** **City:** Granada **Contacts:** ***Contact 1:*** - **Name:** Guillermo Sanchez Delgado, PhD - **Role:** CONTACT **Country:** Spain **Facility:** Instiuto Mixto Universitario Deporte y Salud **Status:** RECRUITING **Zip:** 18007 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00523679 **Acronym:** SMART **Brief Title:** Symbicort SMART (Symbicort Maintenance And Reliever Therapy) **Official Title:** SMART (Symbicort Maintenance And Reliever Therapy): Reassure Program for Patients Using Symbicort Turbuhaler as Maintenance and Reliever Therapy in Korean Clinical Practice #### Organization Study ID Info **ID:** NIS-RKR-SYM-2007/1 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca ### Status Module #### Completion Date **Date:** 2008-07 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2009-07-13 **Type:** ESTIMATED **Last Update Submit Date:** 2009-07-10 **Overall Status:** COMPLETED #### Start Date **Date:** 2007-07 **Status Verified Date:** 2009-07 #### Study First Post Date **Date:** 2007-08-31 **Type:** ESTIMATED **Study First Submit Date:** 2007-08-29 **Study First Submit QC Date:** 2007-08-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AstraZeneca ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to investigate the extent of Symbicort use in patients prescribed Symbicort as maintenance and reliever therapy. ### Conditions Module **Conditions:** - Asthma **Keywords:** - Asthma - Symbicort - SMART - inhaler - compliance - Naturalistic - Observational ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 2000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Asthma patients prescribed Symbicort as maintenance and reliever therapy, according to the label, before inclusion in this program. Exclusion Criteria: * Since this programme intends to describe Symbicort use in routine clinical practice when prescribed as Symbicort maintenance and reliever therapy, there are no programme specific exclusion criteria, other than: involvement in the planning and conduct of the programme (applies to both AstraZeneca staff or staff at the investigational site) **Minimum Age:** 12 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Hospital Outpatient Clinics ### Contacts Locations Module #### Locations **Location 1:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Research Site **State:** Jongro-gu **Location 2:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Research Site **State:** Kangnam-gu **Location 3:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Research Site **State:** Songpa-gu #### Overall Officials **Official 1:** **Affiliation:** AstraZeneca Korea **Name:** Joon-Woo Bahn **Role:** STUDY_DIRECTOR ## 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: 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:** NCT04730479 **Acronym:** EPRAC **Brief Title:** Echography to Predict Radial Artery Catheterization Failure (EPRAC) **Official Title:** Ultrasound Prediction of Radial Arterial Catheterization Failure in Patients Undergoing Cardiac or Aortic Surgery: a Prospective Study #### Organization Study ID Info **ID:** RECHMPL20_0091 #### Organization **Class:** OTHER **Full Name:** University Hospital, Montpellier ### Status Module #### Completion Date **Date:** 2022-04-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-11-08 **Type:** ACTUAL **Last Update Submit Date:** 2022-11-04 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-04-06 **Type:** ACTUAL #### Start Date **Date:** 2021-04-15 **Type:** ACTUAL **Status Verified Date:** 2022-10 #### Study First Post Date **Date:** 2021-01-29 **Type:** ACTUAL **Study First Submit Date:** 2021-01-25 **Study First Submit QC Date:** 2021-01-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Montpellier #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In patients undergoing cardiac or aortic surgery, the placement of a radial KTA is sometimes difficult, the purpose of this study is to do an ultrasound in order to evaluate the diagnostic values of the internal diameter of the radial artery to predict the failure to install the radial KTA. **Detailed Description:** The Arterial Catheter (KTA) enables continuous measurement of invasive blood pressure in patients with accurate and reliable hemodynamic monitoring. Radial Artery Catheterization is the currently recommended placement site. In patients undergoing cardiac or aortic surgery, placement of a radial KTA is sometimes difficult, with a failure rate of around 15%. It is also a source of local complications and prolongation of the anesthetic duration. There is no predictive diagnostic test for failed radial KTA placement in anesthesia. Accurately predicting the failure of radial catheterization by echography will, in the future, make it possible to offer "at risk" patients an immediate catheterization in an other site as for example brachial site. ### Conditions Module **Conditions:** - Cardiac and Aortic Surgery **Keywords:** - ultrasonography - radial artery catheterization - probabilistic model - adult ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 330 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Failure to insert the radial KTA by the nurse anesthesiologist defined as follows: ≥ 3 punctures (by the nurse anesthetist) or need to change of doctor operator (nurse anesthesiologist to Anesthesiologist - Resuscitator) or change of puncture site (radial to radial contralateral or other site). All professionals involved are blinded to the echographic measures of the radial artery. **Measure:** Failure to insert a radial artery catheter (KTA) by the nurse anesthesiologists **Time Frame:** Day 1 #### Secondary Outcomes **Description:** Measured on echographic exam. Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient). Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician. **Measure:** Internal radial artery diameter **Time Frame:** Day 1 **Description:** Measured on echographic exam. Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient). Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician. **Measure:** External radial artery diameter **Time Frame:** Day 1 **Description:** Measured on echographic exam. Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient). Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician. **Measure:** Internal area of the radial artery **Time Frame:** Day 1 **Description:** Measured on echographic exam. Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient). Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician. **Measure:** External area of the radial artery **Time Frame:** Day 1 **Description:** Measured on echographic exam. Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient). Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician. **Measure:** Calcification of arterial wall (yes/no) **Time Frame:** Day 1 **Description:** Measured on echographic exam. Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient). Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician. **Measure:** Thickness of arteria wall **Time Frame:** Day 1 **Description:** Measured on echographic exam. Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient). Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician. **Measure:** Ratio between internal and external arteria diameter **Time Frame:** Day 1 **Description:** Age, sex, body mass index, ASA score, duration of preoperative fasting, cardiovascular risk factors, cardiovascular conditions, wrist circumference, pulse force of the radial, ulnar, and brachial arteries (no pulse / feeble pulse / normal pulse), mean arterial pressure at punction time, dose of vasopressants (ephedrine, neosynephrine, noradrenaline) at punction time **Measure:** Clinical characteristics at baseline **Time Frame:** Day 1 **Description:** Hematoma, dissection, thrombosis, ischemia, false aneuvrysm, infection, pain. **Measure:** Punction-related adverse events **Time Frame:** 6 months **Description:** delay between first pulse palpation and end of bandage on a functional catheter **Measure:** Duration of arterial punction **Time Frame:** Day 1 **Description:** duration of anaesthesia, duration of presence in surgery room, length of hospital stay **Measure:** Duration of patient management **Time Frame:** 28 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged from 18 years old * Be operated for a scheduled cardiac or aortic surgery * Be able to complete all the visits and follow the study procedures * Subjects must be covered by public health insurance Exclusion Criteria: * Patients protected by law or Absence of signed informed consent * Emergency Surgery Patient * Patient already with an arterial catheter * Patient with Radial Arterial Catheter Contraindication * Radial arterial catheter placed by an anesthesiologist nurse student **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult who have an scheduled cardiac or aortic surgery at Montpellier University Hospital ### Contacts Locations Module #### Locations **Location 1:** **City:** Montpellier **Country:** France **Facility:** University hospital of Montpellier **Zip:** 34295 #### Overall Officials **Official 1:** **Affiliation:** University hospital of Montpellier, Montpellier, France, 34295 **Name:** Jérôme PANIEGO **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02437279 **Acronym:** OpACIN **Brief Title:** Study to Identify the Optimal Adjuvant Combination Scheme of Ipilimumab and Nivolumab in Melanoma Patients **Official Title:** Feasibility Study to Identify the Optimal Adjuvant Combination Scheme of Ipilimumab and Nivolumab in Stage III Melanoma Patients #### Organization Study ID Info **ID:** N14OPC #### Organization **Class:** OTHER **Full Name:** The Netherlands Cancer Institute #### Secondary ID Infos **Domain:** BMS **ID:** CA209-278 **Type:** OTHER_GRANT **Domain:** CCMO register **ID:** NL51280.031.14 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2022-04-15 **Type:** ACTUAL **Last Update Submit Date:** 2022-04-14 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2018-06-28 **Type:** ACTUAL #### Start Date **Date:** 2016-11-24 **Type:** ACTUAL **Status Verified Date:** 2022-04 #### Study First Post Date **Date:** 2015-05-07 **Type:** ESTIMATED **Study First Submit Date:** 2015-04-13 **Study First Submit QC Date:** 2015-05-04 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Bristol-Myers Squibb #### Lead Sponsor **Class:** OTHER **Name:** The Netherlands Cancer Institute #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a two-arm Phase 1b feasibility trial consisting of 20 patients receiving the combination of ipilimumab+nivolumab, either adjuvant, or split neo-adjuvant and adjuvant. **Detailed Description:** Patients with stage III melanoma with palpable disease, naïve for CTLA-4/PD-1/PD-L1 immunotherapy, will be treated either post-surgery for 12 weeks with the combination of ipilimumab+nivolumab or in a split design for 6 weeks upfront surgery and for 6 weeks postsurgery. It is a two-arm Phase 1b feasibility trial consisting of 20 patients, 10 in each arm. At different timepoints tumor biopsies and blood for PBMCs will be taken for translational research. Also scans will be done on specific timepoints. The study will be held to determine safety, feasibility, and the immune-activating capacity of short-term combined neo-adjuvant and adjuvant ipilimumab + nivolumab. And to determine relapse free survival (RFS), any late adverse events, pharmacokinetics/pharmacodynamics, and the correlation between RFS and changes in neo-antigen specific T cell response. ### Conditions Module **Conditions:** - Stage III Skin Melanoma **Keywords:** - Palpable - Stage III - Skin melanoma - Ipilimumab - Nivolumab - Surgery ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Post-surgery infusion for 12 weeks with the combination of ipilimumab+nivolumab **Intervention Names:** - Procedure: Surgery of the tumor - Drug: Infusion with ipilimumab 3 mg/kg q3wks - Drug: Infusion with nivolumab 1 mg/kg q3wks **Label:** Arm A **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** A split design 6 weeks upfront surgery and 6 weeks post-surgery infusion with the combination of ipilimumab+nivolumab **Intervention Names:** - Procedure: Surgery of the tumor - Drug: Infusion with ipilimumab 3 mg/kg q3wks - Drug: Infusion with nivolumab 1 mg/kg q3wks **Label:** Arm B **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm A - Arm B **Name:** Surgery of the tumor **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Arm A - Arm B **Name:** Infusion with ipilimumab 3 mg/kg q3wks **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Arm A - Arm B **Name:** Infusion with nivolumab 1 mg/kg q3wks **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** To this purpose the immunogenic mutational load of each patient's melanoma will be determined by DNA and RNA sequencing from baseline biopsies (3x14g, 5ug tumor DNA). Proteasomal degradation and peptide presentation in HLA will be predicted in silico. MHC-tetramer staining containing the predicted peptides will be done as described before \[2\]. In addition, the effect of therapy on intratumoral T cell responses to obtain better insight into the mode of action of therapy will be analyzed. Identified neo-antigen specific T cells will be analyzed with respect to their phenotype and immunologic function (intracellular cytokine staining, lytic function as determined by CD107 staining, and coculture with APC presenting the cognate antigen). **Measure:** The alteration in magnitude of the neo-antigen specific T cell response in the time interval pre- to post-adjuvant therapy in peripheral blood **Time Frame:** 12 weeks from baseline **Measure:** Safety as measured by SUSARs. **Time Frame:** 12 weeks from baseline **Description:** To this purpose the immunogenic mutational load of each patient's melanoma will be determined by DNA and RNA sequencing from baseline biopsies (3x14g, 5ug tumor DNA). Proteasomal degradation and peptide presentation in HLA will be predicted in silico. MHC-tetramer staining containing the predicted peptides will be done as described before \[2\]. In addition, the effect of therapy on intratumoral T cell responses to obtain better insight into the mode of action of therapy will be analyzed. Identified neo-antigen specific T cells will be analyzed with respect to their phenotype and immunologic function (intracellular cytokine staining, lytic function as determined by CD107 staining, and coculture with APC presenting the cognate antigen). **Measure:** The alteration in breadth of the neo-antigen specific T cell response in the time interval pre- to post-adjuvant therapy in peripheral blood **Time Frame:** 12 weeks from baseline **Measure:** Feasibility as measured adherence to the timelines in the study protocol. **Time Frame:** 12 weeks from baseline #### Secondary Outcomes **Measure:** Recurrence Free Survival, as determined according to RECIST 1.1 criteria. **Time Frame:** Until progression, median 10 months. **Measure:** Rate of adverse events and late adverse events **Time Frame:** Until end of follow-up, median 3 years. **Measure:** Type of adverse events and late adverse events **Time Frame:** Until end of follow-up, median 3 years. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults at least 18 years of age * World Health Organization (WHO) Performance Status 0 or 1 * Histologically confirmed stage IIIB metastatic cutaneous melanoma, palpable disease (non-transit only) of the axilla or groin * Patient willing to undergo triple tumor biopsies during screening and in case of disease progression * No prior immunotherapy targeting CTLA-4, PD-1 or PD-L1 * No immunosuppressive medications within 6 months prior study inclusion * Presence of at least two of the defined HLA alleles (Table 1, see appendix) * Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109/L, Neutrophils ≥1.5x109/L, Platelets ≥100 x109/L, Hemoglobin ≥5.5 mmol/L, Creatinine ≤1.5x ULN, AST ≤1.5 x ULN, ALT ≤ 1.5 x ULN, Bilirubin ≤1.5 X ULN * normal LDH * Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug * Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of ipilimumab+nivolumab * Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product * Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception Exclusion Criteria: * Distantly metastasized melanoma * Subjects with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy * Prior CTLA-4 or PD-1/PD-L1 targeting immunotherapy * Radiotherapy prior or post surgery within this trial * Patients will be excluded if they are positive test for hepatitis B virus surface antigen (HBVsAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection * Patients will be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) * Allergies and Adverse Drug Reaction * History of allergy to study drug components * History of severe hypersensitivity reaction to any monoclonal antibody * Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events; * Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids; * Use of other investigational drugs before study drug administration 30 days and 5 half-times before study inclusion * Pregnant or nursing. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Amsterdam **Country:** Netherlands **Facility:** Netherlands Cancer Institute **State:** NH **Zip:** 1066CX #### Overall Officials **Official 1:** **Affiliation:** The Netherlands Cancer Institute **Name:** Christian Blank, MD PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Versluis JM, Reijers ILM, Rozeman EA, Menzies AM, van Akkooi ACJ, Wouters MW, Ch'ng S, Saw RPM, Scolyer RA, van de Wiel BA, Schilling B, Long GV, Blank CU. Neoadjuvant ipilimumab plus nivolumab in synchronous clinical stage III melanoma. Eur J Cancer. 2021 May;148:51-57. doi: 10.1016/j.ejca.2021.02.012. Epub 2021 Mar 15. **PMID:** 33735809 **Citation:** Rozeman EA, Hoefsmit EP, Reijers ILM, Saw RPM, Versluis JM, Krijgsman O, Dimitriadis P, Sikorska K, van de Wiel BA, Eriksson H, Gonzalez M, Torres Acosta A, Grijpink-Ongering LG, Shannon K, Haanen JBAG, Stretch J, Ch'ng S, Nieweg OE, Mallo HA, Adriaansz S, Kerkhoven RM, Cornelissen S, Broeks A, Klop WMC, Zuur CL, van Houdt WJ, Peeper DS, Spillane AJ, van Akkooi ACJ, Scolyer RA, Schumacher TNM, Menzies AM, Long GV, Blank CU. Survival and biomarker analyses from the OpACIN-neo and OpACIN neoadjuvant immunotherapy trials in stage III melanoma. Nat Med. 2021 Feb;27(2):256-263. doi: 10.1038/s41591-020-01211-7. Epub 2021 Feb 8. **PMID:** 33558721 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018358 - Term: Neuroendocrine Tumors - 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: D000009380 - Term: Neoplasms, Nerve Tissue - ID: D000018326 - Term: Nevi and Melanomas - ID: D000012878 - Term: Skin Neoplasms - ID: D000009371 - Term: Neoplasms by Site - 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 - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11528 - Name: Melanoma - Relevance: HIGH - As Found: Melanoma - ID: M3212 - Name: Melanoma, Cutaneous Malignant - Relevance: HIGH - As Found: Skin Melanoma - ID: M20495 - Name: Neuroendocrine Tumors - 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: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: M12448 - Name: Nevus, Pigmented - Relevance: LOW - As Found: Unknown - ID: M12446 - Name: Nevus - Relevance: LOW - As Found: Unknown - ID: M20470 - Name: Nevi and Melanomas - Relevance: LOW - As Found: Unknown - ID: M15681 - Name: Skin Neoplasms - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T4091 - Name: Neuroendocrine Tumor - Relevance: LOW - As Found: Unknown - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008545 - Term: Melanoma - ID: D000096142 - Term: Melanoma, Cutaneous Malignant ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000082082 - Term: Immune Checkpoint Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1854 - Name: Nivolumab - Relevance: HIGH - As Found: Prospective - ID: M1348 - Name: Ipilimumab - Relevance: HIGH - As Found: While - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077594 - Term: Nivolumab - ID: D000074324 - Term: Ipilimumab ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04337879 **Brief Title:** A Study of AL2846 Capsule Combined With Standard Chemotherapy Regimen in Subjects With Advanced Colorectal Cancer **Official Title:** A Phase Ib Study to Evaluate the Efficacy and Safety of AL2846 Capsule Combined With Chemotherapy (mFOLFOX6 or FOLFIRI)Versus Placebo Combined With Chemotherapy in Subjects With Advanced Colorectal Cancer #### Organization Study ID Info **ID:** AL2846-I-0004 #### Organization **Class:** INDUSTRY **Full Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ### Status Module #### Completion Date **Date:** 2020-12-31 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2020-07-21 **Type:** ACTUAL **Last Update Submit Date:** 2020-07-20 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2020-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2020-07-20 **Type:** ACTUAL **Status Verified Date:** 2020-01 #### Study First Post Date **Date:** 2020-04-08 **Type:** ACTUAL **Study First Submit Date:** 2020-04-06 **Study First Submit QC Date:** 2020-04-06 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a study to explore the safety, tolerance and efficacy of AL2846 capsules combined with mFOLFOLX6 or FOLFIRI standard chemotherapy regimen in subjects with advanced metastatic colorectal cancer. ### Conditions Module **Conditions:** - Advanced Colorectal Cancer ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 56 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** AL2846 capsule administered orally,once daily in 28-day cycle; oxaliplatin 85mg/ ㎡ administered intravenously (IV) on day 1, day 15 in 28-day cycle；calcium folate 400mg/ ㎡ IV on day 1, day 15 in 28-day cycle；5-fu 2800mg/ ㎡ IV on day 1, 2, 15, 16 in 28-day cycle. **Intervention Names:** - Drug: AL2846 - Drug: Calcium folate - Drug: 5-FU - Drug: Oxaliplatin **Label:** AL2846 + mFOLFOX6 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** AL2846 capsule administered orally,once daily in 28-day cycle; irinotecan 180mg/㎡ administered intravenously (IV) on day 1,15 in 28-day cycle; calcium folate 400mg/ ㎡ IV on day 1,15 in 28-day cycle; 5-fu 2800mg/ ㎡ IV on day 1, 2, 15, 16 days in 28-day cycle. **Intervention Names:** - Drug: AL2846 - Drug: Calcium folate - Drug: 5-FU - Drug: Irinotecan **Label:** AL2846 + FOLFIRI **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - AL2846 + FOLFIRI - AL2846 + mFOLFOX6 **Description:** AL2846 is a multi-target receptor tyrosine kinase inhibitor, which has obvious selectivity for c-met. **Name:** AL2846 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - AL2846 + FOLFIRI - AL2846 + mFOLFOX6 **Description:** Calcium folate 400mg/ ㎡ IV on day 1,15 in 28-day cycle **Name:** Calcium folate **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - AL2846 + FOLFIRI - AL2846 + mFOLFOX6 **Description:** 5-FU 2800mg/ ㎡ IV on day 1, 2, 15, 16 days in 28-day cycle. **Name:** 5-FU **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - AL2846 + mFOLFOX6 **Description:** Oxaliplatin 85mg/ ㎡ administered intravenously (IV) on day 1, day 15 in 28-day cycle. **Name:** Oxaliplatin **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - AL2846 + FOLFIRI **Description:** Irinotecan 180mg/㎡ administered intravenously (IV) on day 1,15 in 28-day cycle. **Name:** Irinotecan **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** PFS defined as the time from the first dose until the first documented progressive disease (PD) or death from any cause, based on investigator. **Measure:** Progression-free survival (PFS) **Time Frame:** up to 12 month #### Secondary Outcomes **Description:** Percentage of participants achieving complete response (CR) and partial response (PR). **Measure:** Overall response rate (ORR) **Time Frame:** up to 12 month **Description:** Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD). **Measure:** Disease control rate（DCR） **Time Frame:** up to 12 month **Description:** The time when the participants first achieved complete or partial remission to disease progression. **Measure:** Duration of response (DOR) **Time Frame:** up to 12 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: -1. Histologically confirmed advanced metastatic colorectal cancer. 2. Has received only first-line standard chemotherapy regimen for metastatic disease, and which was failed. 3. At least one measurable lesion. 4. Has received systemic chemotherapy, palliative radiotherapy or other anti-tumor therapy before first dose at least 4 weeks. 5.18 and 75 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months. 6. Adequate laboratory indicators. 7. No pregnant or breastfeeding women, and a negative pregnancy test. 8. Understood and signed an informed consent form. Exclusion Criteria: * 1. Diagnosed and/or treated additional malignancy within 5 years with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix. 2. Has received radiotherapy, chemotherapy and surgery before and less than 4 weeks from the first administration and less than 5 half-lives of oral targeted drugs after the completion of treatment. 3. Has multiple factors that affect oral medications. 4. Has gastroduodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases or other conditions judged by the investigator that may cause gastrointestinal bleeding or perforation. 5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 6. Has arterial or deep vein thrombosis events in 6 months. 7. Hypersensitivity to AL2846 or its excipient. 8. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear. 9. Has symptomatic brain metastases, spinal cord compression, and cancerous meningitis within 8 weeks,or brain or pia mater disease confirmed by CT or MRI examination before the first dose. 10.Has adverse events caused by previous therapy that did not recover to ≤ grade 1, with the exception of alopecia or ≥ grade 2 neurotoxicity caused by Oxaliplatin. 11. Subjects plan to receive FOLFIRI chemotherapy regimen with uridine diphosphate glucuronyltransferase homozygous variant or double hybrid variant. 12. Has drug abuse history that unable to abstain from or mental disorders. 13. Has any serious and/or uncontrolled disease. 14. Has received allogeneic organ transplants, hematopoietic stem cell transplants or bone marrow transplants. 15. Has participated in other clinical trials within 4 weeks before the first dose. 16. According to the investigators' judgment. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yunpeng Liu, Doctor **Phone:** 024-83282256 **Role:** CONTACT #### Locations **Location 1:** **City:** Shengyang **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yunpeng Liu, Doctor - **Role:** CONTACT ***Contact 2:*** - **Name:** Yunpeng Liu, Doctor - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** The First Hospital of China Medical University **State:** Liaoning **Status:** RECRUITING **Zip:** 110011 ## Derived Section ### Condition Browse Module - Ancestors - 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: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000012002 - Term: Rectal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17890 - Name: Colorectal Neoplasms - Relevance: HIGH - As Found: Colorectal Cancer - 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: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015179 - Term: Colorectal Neoplasms ### Intervention Browse Module - Ancestors - ID: D000077264 - Term: Calcium-Regulating Hormones and Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000970 - Term: Antineoplastic Agents - ID: D000059004 - Term: Topoisomerase I Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients - Abbrev: Hemat - Name: Hematinics - Abbrev: BDCA - Name: Bone Density Conservation Agents - Abbrev: Vi - Name: Vitamins - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M8600 - Name: Fluorouracil - Relevance: LOW - As Found: Unknown - ID: M1674 - Name: Oxaliplatin - Relevance: HIGH - As Found: Outcomes - ID: M1671 - Name: Irinotecan - Relevance: HIGH - As Found: Infection - ID: M5381 - Name: Calcium - Relevance: HIGH - As Found: Radiation - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown - ID: M2889 - Name: Tyrosine Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M29349 - Name: Topoisomerase I Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: T447 - Name: Folinic Acid - Relevance: LOW - As Found: Unknown - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: HIGH - As Found: Mitochondrial - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown - ID: T22 - Name: Tyrosine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077150 - Term: Oxaliplatin - ID: D000077146 - Term: Irinotecan - ID: D000002118 - Term: Calcium ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03101579 **Brief Title:** Intrathecal Pemetrexed for Recurrent Leptomeningeal Metastases From Non-small Cell Lung Cancer **Official Title:** Intrathecal Pemetrexed for Recurrent Leptomeningeal Metastasis From Non-small Cell Lung Cancer: A Prospective Pilot Clinical Trial #### Organization Study ID Info **ID:** IPRLM #### Organization **Class:** OTHER **Full Name:** The First Hospital of Jilin University ### Status Module #### Completion Date **Date:** 2019-01-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-03-19 **Type:** ACTUAL **Last Update Submit Date:** 2019-03-16 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-09-15 **Type:** ACTUAL #### Start Date **Date:** 2017-03-01 **Type:** ACTUAL **Status Verified Date:** 2019-03 #### Study First Post Date **Date:** 2017-04-05 **Type:** ACTUAL **Study First Submit Date:** 2017-03-23 **Study First Submit QC Date:** 2017-03-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The First Hospital of Jilin University #### Responsible Party **Investigator Affiliation:** The First Hospital of Jilin University **Investigator Full Name:** Zhenyu Pan **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** It has been proved that intrathecal chemotherapy is the main treatment strategy for leptomeningeal metastases. At present, the commonly used drugs for intrathecal chemotherapy include methotrexate, cytarabine, and liposomal cytarabine. In recent decades, no new effective drugs have been discovered for intrathecal chemotherapy. The recurrence of leptomeningeal metastases is inevitable even after aggressive treatment. There is no effective treatment for recurrent leptomeningeal metastases after comprehensive treatment which includes intrathecal methotrexate and/or cytarabine, central nervous system radiation therapy, systemic chemotherapy as well as tyrosine-kinase inhibitor drugs. The quality of life is extremely poor, and the patients always die in short time. Pemetrexed is a newer multitargeted antifolate which has shown activity in various tumors. It has higher effectiveness and safety, which has been used as the first-line treatment of non-small cell lung cancer. In animal studies, pemetrexed was demonstrated to suppress tumor growth completely in mice with two types of transplanted human colon xenografts resistant to methotrexate. Therefore, the purpose of the study is to evaluate the safety and feasibility of intrathecal pemetrexed in patients with recurrent leptomeningeal metastases from non-small cell lung cancer. **Detailed Description:** This is a single arm clinical trial. The objective of the study is patients with recurrent or progressive leptomeningeal metastases from non-small cell lung cancer after leptomeningeal metastases-related treatment. The regimen of pemetrexed (Alimta, Eli Lilly and Company) is 10/15/20 mg, plus dexamethasone 5 mg, twice per week for 2 weeks, followed by once per week for 2-4 weeks. Pemetrexed and dexamethasone are administrated by intrathecal injection via lumbar puncture. Folic acid and vitamin B12 are administered to reduce the frequency of myelosuppression. Folic acid 200-400 μg is administered orally once daily, prior to the first intrathecal pemetrexed, until 21 days after the last intrathecal pemetrexed. A single dose of vitamin B12 1000 μg is administered by intramuscular injection before the first intrathecal pemetrexed，once per 3 weeks. To detect the pharmacokinetics of intrathecal pemetrexed, the serum and cerebrospinal fluid samples are collected. These samples would be analyzed by spectrometer for drug concentration. ### Conditions Module **Conditions:** - Leptomeningeal Metastases **Keywords:** - Leptomeningeal metastasis - Recurrence - Intrathecal chemotherapy - Pemetrexed ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 13 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients were treated with intrathecal pemetrexed at dose escalation. The regimen of intrathecal pemetrexed is 10/15/20 mg, plus dexamethasone 5 mg, twice per week for 2 weeks, followed by once per week for 2-4 weeks. Pemetrexed is administrated by intrathecal injection via lumbar puncture. Folic acid 200-400 μg is administered orally once daily, prior to the first intrathecal pemetrexed, until 21 days after the last intrathecal pemetrexed. A single dose of vitamin B12 1000 μg is administered by intramuscular injection before the first intrathecal pemetrexed，once per 3 weeks. To detect the pharmacokinetics of intrathecal pemetrexed, the serum and cerebrospinal fluid samples are collected. These samples would be analyzed by spectrometer for drug concentration. **Intervention Names:** - Drug: Pemetrexed - Drug: Dexamethasone - Drug: Folic Acid - Drug: Vitamin B12 **Label:** Intra-pemetrexed **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intra-pemetrexed **Description:** Pemetrexed,10-15 mg, intrathecal injection via lumbar puncture, twice per week for 2 weeks, followed by once per week for 2-4 weeks. **Name:** Pemetrexed **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Intra-pemetrexed **Description:** Dexamethasone, 5 mg, intrathecal injection via lumbar puncture, simultaneously with pemetrexed, twice per week for 2 weeks, followed by once per week for 2-4 weeks. **Name:** Dexamethasone **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Intra-pemetrexed **Description:** Folic acid, 400 μg, oral, once per day, prior to the first intrathecal pemetrexed, until 21 days after the last intrathecal pemetrexed. **Name:** Folic Acid **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Intra-pemetrexed **Description:** A single dose of vitamin B12 1000 μg, intramuscular injection, before the first intrathecal pemetrexed. **Name:** Vitamin B12 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Adverse events (AEs) are evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE, version 3.0). Events of grade 3-5 are defined as moderate and severe adverse events. **Measure:** Incidence of severe adverse events **Time Frame:** Two months after the treatment. **Description:** A dose-limiting toxicity (DLT) was defined as grade 3 neurological toxicities (e.g. chemical meningitis) or other grade 4 toxicity. If more than two patients experienced a DLT, that level was considered too toxic. The maximal tolerated dose (MTD) was exceeded and an additional three patients should be treated at the next lower dose level. The MTD was defined as the dose where 0/3 or 1/6 patients experienced a DLT with at least two patients encountering DLT at the higher dose. **Measure:** Maximal tolerated dose **Time Frame:** From the beginning of the treatment until two months after the treatment. #### Secondary Outcomes **Description:** The RANO proposal for response criteria of leptomeningeal metastasis was used to assess the clinical response in this study. **Measure:** Clinical response rate **Time Frame:** One month after the treatment. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients diagnosed as leptomeningeal metastases from non-small cell lung cancer had been received comprehensive treatment, including intrathecal methotrexate and/or cytarabine, central nervous system radiation therapy, systemic chemotherapy as well as tyrosine-kinase inhibitor drugs. 2. Patients diagnosed with recurrent leptomeningeal metastases by positive cerebrospinal fluid cytological examination and persist aggravate symptoms for more than 1 week, or increased intracranial pressure (\>300 mmH2O). 3. No severe abnormal liver and kidney function; WBC≥2500/mm3, Plt≥60000/mm3; 4. No other severe chronic diseases; 5. No severe dyscrasia. 6. Signed informed consent form. Exclusion Criteria: 1. Patients with the clinical manifestation of nervous system failure including severe encephalopathy, grade III-IV white matter lesions confirmed by imaging examination, moderate or severe coma, and glasgow coma score less than 9 points; 2. Patients with severe nervous system injury related with treatment, such as chemical meningitis; 3. Patients who had accepted systemic chemotherapy within two weeks, or new molecular targeted therapeutic drug less than one months; 4. Patients with poor compliance, or for other reasons, the researchers considered unsuitable to participate in this clinical study. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Changchun **Country:** China **Facility:** The First Hospital of Jilin University **State:** Jilin **Zip:** 130021 #### Overall Officials **Official 1:** **Affiliation:** The First Hospital of Jilin University **Name:** Zhenyu Pan, Professor **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** McDonald AC, Vasey PA, Adams L, Walling J, Woodworth JR, Abrahams T, McCarthy S, Bailey NP, Siddiqui N, Lind MJ, Calvert AH, Twelves CJ, Cassidy J, Kaye SB. A phase I and pharmacokinetic study of LY231514, the multitargeted antifolate. Clin Cancer Res. 1998 Mar;4(3):605-10. **PMID:** 9533527 **Citation:** Taylor EC, Kuhnt D, Shih C, Rinzel SM, Grindey GB, Barredo J, Jannatipour M, Moran RG. A dideazatetrahydrofolate analogue lacking a chiral center at C-6, N-[4-[2-(2-amino-3,4-dihydro-4-oxo-7H-pyrrolo[2,3-d]pyrimidin-5- yl)ethyl]benzoyl]-L-glutamic acid, is an inhibitor of thymidylate synthase. J Med Chem. 1992 Nov 13;35(23):4450-4. doi: 10.1021/jm00101a023. **PMID:** 1447744 **Citation:** Adjei AA. Pharmacology and mechanism of action of pemetrexed. Clin Lung Cancer. 2004 Apr;5 Suppl 2:S51-5. doi: 10.3816/clc.2004.s.003. **PMID:** 15117425 **Citation:** Rinaldi DA, Burris HA, Dorr FA, Woodworth JR, Kuhn JG, Eckardt JR, Rodriguez G, Corso SW, Fields SM, Langley C, et al. Initial phase I evaluation of the novel thymidylate synthase inhibitor, LY231514, using the modified continual reassessment method for dose escalation. J Clin Oncol. 1995 Nov;13(11):2842-50. doi: 10.1200/JCO.1995.13.11.2842. **PMID:** 7595747 **Citation:** Yan J, Zhong N, Liu G, Chen K, Liu X, Su L, Singhal S. Usp9x- and Noxa-mediated Mcl-1 downregulation contributes to pemetrexed-induced apoptosis in human non-small-cell lung cancer cells. Cell Death Dis. 2014 Jul 3;5(7):e1316. doi: 10.1038/cddis.2014.281. **PMID:** 24991768 **Citation:** Ramirez JM, Ocio EM, San Miguel JF, Pandiella A. Pemetrexed acts as an antimyeloma agent by provoking cell cycle blockade and apoptosis. Leukemia. 2007 Apr;21(4):797-804. doi: 10.1038/sj.leu.2404599. Epub 2007 Feb 22. **PMID:** 17315026 **Citation:** Pan Z, Yang G, He H, Zhao G, Yuan T, Li Y, Shi W, Gao P, Dong L, Li Y. Concurrent radiotherapy and intrathecal methotrexate for treating leptomeningeal metastasis from solid tumors with adverse prognostic factors: A prospective and single-arm study. Int J Cancer. 2016 Oct 15;139(8):1864-72. doi: 10.1002/ijc.30214. Epub 2016 Jun 30. **PMID:** 27243238 **Citation:** Pan Z, Yang G, Cui J, Li W, Li Y, Gao P, Jiang T, Sun Y, Dong L, Song Y, Zhao G. A Pilot Phase 1 Study of Intrathecal Pemetrexed for Refractory Leptomeningeal Metastases From Non-small-cell Lung Cancer. Front Oncol. 2019 Aug 30;9:838. doi: 10.3389/fonc.2019.00838. eCollection 2019. **PMID:** 31544065 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000009385 - Term: Neoplastic Processes - ID: D000010335 - Term: Pathologic Processes - ID: D000008577 - Term: Meningeal Neoplasms - ID: D000016543 - Term: Central Nervous System Neoplasms - ID: D000009423 - Term: Nervous System Neoplasms - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: LOW - As Found: Unknown - ID: M12307 - Name: Neoplasm Metastasis - Relevance: HIGH - As Found: Metastases - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M28325 - Name: Meningeal Carcinomatosis - Relevance: HIGH - As Found: Leptomeningeal Metastasis - ID: M12330 - Name: Neoplastic Processes - 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 ### Condition Browse Module - Meshes - ID: D000009362 - Term: Neoplasm Metastasis - ID: D000055756 - Term: Meningeal Carcinomatosis ### Intervention Browse Module - Ancestors - ID: D000014815 - Term: Vitamins - ID: D000018977 - Term: Micronutrients - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000000932 - Term: Antiemetics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000005938 - Term: Glucocorticoids - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000018931 - Term: Antineoplastic Agents, Hormonal - ID: D000000970 - Term: Antineoplastic Agents - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000005493 - Term: Folic Acid Antagonists - ID: D000019384 - Term: Nucleic Acid Synthesis Inhibitors - ID: D000006397 - Term: Hematinics - ID: D000014803 - Term: Vitamin B Complex ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: AnEm - Name: Antiemetics - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M7102 - Name: Dexamethasone - Relevance: HIGH - As Found: Children - ID: M264 - Name: Pemetrexed - Relevance: HIGH - As Found: General - ID: M235549 - Name: Dexamethasone acetate - Relevance: LOW - As Found: Unknown - ID: M8618 - Name: Folic Acid - Relevance: HIGH - As Found: Behavioral Therapy - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M17548 - Name: Vitamin B 12 - Relevance: HIGH - As Found: Inclusion criteria - ID: M9934 - Name: Hydroxocobalamin - Relevance: LOW - As Found: Unknown - ID: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - Relevance: LOW - As Found: Unknown - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4251 - Name: Antiemetics - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M9047 - Name: Glucocorticoids - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M20966 - Name: Antineoplastic Agents, Hormonal - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M8619 - Name: Folic Acid Antagonists - Relevance: LOW - As Found: Unknown - ID: M9485 - Name: Hematinics - Relevance: LOW - As Found: Unknown - ID: T447 - Name: Folinic Acid - Relevance: LOW - As Found: Unknown - ID: T446 - Name: Folic Acid - Relevance: HIGH - As Found: Behavioral Therapy - ID: T451 - Name: Methylcobalamin - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown - ID: T476 - Name: Vitamin B12 - Relevance: HIGH - As Found: Inclusion criteria - ID: T441 - Name: Cobalamin - Relevance: LOW - As Found: Unknown - ID: T444 - Name: Cyanocobalamin - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000005492 - Term: Folic Acid - ID: D000014805 - Term: Vitamin B 12 - ID: D000003907 - Term: Dexamethasone - ID: D000068437 - Term: Pemetrexed ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00001879 **Brief Title:** Collections of Blood and Stool Samples in Patients With Acute Hepatitis **Official Title:** Collection of Blood and Stool Samples in Patients With Acute Hepatitis #### Organization Study ID Info **ID:** 990060 #### Organization **Class:** NIH **Full Name:** National Institutes of Health Clinical Center (CC) #### Secondary ID Infos **ID:** 99-H-0060 ### Status Module #### Completion Date **Date:** 2001-03 #### Expanded Access Info #### Last Update Post Date **Date:** 2024-03-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-03-21 **Overall Status:** COMPLETED #### Start Date **Date:** 1999-03 **Status Verified Date:** 2000-02 #### Study First Post Date **Date:** 2002-12-10 **Type:** ESTIMATED **Study First Submit Date:** 1999-11-03 **Study First Submit QC Date:** 2002-12-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NIH **Name:** National Heart, Lung, and Blood Institute (NHLBI) ### Description Module **Brief Summary:** Hepatitis is an inflammation of the liver. Hepatitis can be caused by an infection with a virus, but poisonous (toxic) substances can also cause it. Researchers have identified several of the viruses responsible for hepatitis, however some patients with hepatitis show no evidence of being infected with known hepatitis viruses. Researchers call conditions like this, seronegative hepatitis. It means that a patient has hepatitis but he/she does not have evidence in their blood of a viral infection. Seronegative hepatitis is often complicated by autoimmune disorders and associated severe disorders especially, fulminant hepatitis of childhood and post-hepatitis aplastic anemia. Researchers have attempted to identify the cause of these conditions but have been unsuccessful. Therefore, this study was developed to collect blood and stool samples from patients with seronegative hepatitis in order to help identify the virus responsible. **Detailed Description:** While several viruses have been identified as agents of liver inflammation, some proportion of cases of acute hepatitis are seronegative and show no evidence of prior infection with known hepatitis viruses A, B, C, or E. Seronegative acute hepatitis is often complicated by autoimmune phenomena or late severe consequences, especially fulminant hepatitis of childhood and post-hepatitis aplastic anemia. Efforts in the Hematology Branch to identify an infectious agent in these latter two syndromes have been unsuccessful, probably because they are immune-mediated and also accompanied by massive tissue destruction. We now propose systematic collection of blood and fecal samples from patients with seronegative acute hepatitis for purposes of virus identification research. Samples will be collected from patients in United States Army clinics; patient identifiers will be employed. ### Conditions Module **Conditions:** - Hepatitis **Keywords:** - Liver Disease - Novel Agents - Serum - Viruses - non-A,G Hepatitis - Seronegative Acute Hepatitis ### Design Module #### Enrollment Info **Count:** 200 **Study Type:** OBSERVATIONAL ### Eligibility Module **Eligibility Criteria:** Collection of blood samples. **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bethesda **Country:** United States **Facility:** National Heart, Lung and Blood Institute (NHLBI) **State:** Maryland **Zip:** 20892 ### References Module #### References **Citation:** Atillasoy E, Berk PD. Fulminant hepatic failure: pathophysiology, treatment, and survival. Annu Rev Med. 1995;46:181-91. doi: 10.1146/annurev.med.46.1.181. **PMID:** 7598455 **Citation:** Williams R. Classification, etiology, and considerations of outcome in acute liver failure. Semin Liver Dis. 1996 Nov;16(4):343-8. doi: 10.1055/s-2007-1007247. **PMID:** 9027947 ## 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 ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9592 - Name: Hepatitis A - Relevance: HIGH - As Found: Hepatitis - ID: M9591 - Name: Hepatitis - Relevance: HIGH - As Found: Hepatitis - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus 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: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable 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: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006506 - Term: Hepatitis A - ID: D000006505 - Term: Hepatitis ### Intervention Browse Module - Browse Branches - Abbrev: Hemat - Name: Hematinics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05437679 **Acronym:** CHARTER **Brief Title:** Characterization of Circulating Tumor Cells (CTCs) in High Risk and Early Metastatic Prostate Cancer Patients Using Parsortix® System **Official Title:** ANG-015 / MLU-3 (CHARTER Study): Characterization of Circulating Tumor Cells Isolated Using the Parsortix® System in High Risk and Early Metastatic Prostate Cancer Patients #### Organization Study ID Info **ID:** ANG-015 / MLU-3 #### Organization **Class:** INDUSTRY **Full Name:** Angle plc ### Status Module #### Completion Date **Date:** 2023-08-22 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-09-05 **Type:** ACTUAL **Last Update Submit Date:** 2023-08-31 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2023-08-22 **Type:** ACTUAL #### Start Date **Date:** 2022-07-05 **Type:** ACTUAL **Status Verified Date:** 2023-08 #### Study First Post Date **Date:** 2022-06-29 **Type:** ACTUAL **Study First Submit Date:** 2022-06-27 **Study First Submit QC Date:** 2022-06-27 **Why Stopped:** Futility (slow enrollment) ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** MidLantic Urology, LLC #### Lead Sponsor **Class:** INDUSTRY **Name:** Angle plc #### 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:** This study is designed to evaluate the presence and numbers of circulating tumor cells (CTCs) and cancer related gene expression levels in subjects with localized high-risk prostate cancer (HRLPC) and from subjects with non-metastatic disease experiencing biochemical recurrence and castration-resistance (BCRLPC and NMCRPC groups, respectively) who are about to undergo next generation imaging (NGI, such as Axumin® or PSMA PETCT). The investigators will also evaluate subjects with localized indolent prostate cancer who are on active surveillance (AS) as a control population. The CTC and gene expression results will be evaluated for association with disease state and progression and survival. **Detailed Description:** Patients who meet the eligibility criteria and provide written informed consent will be enrolled into the study. The four (4) groups of patients to be enrolled into the study will consist of: 1) men with low risk localized prostate cancer (LPC) on active surveillance (AS control group), 2) treatment naïve men with high risk LPC (HRLPC) who are 2 - 5 months out after having a radical prostatectomy, 3) treatment naïve men with biochemically recurrent LPC (BCRLPC) who are about to or have recently undergone next generation imaging \[NGI\] (i.e. Axumin® or PSMA PETCT), and men with non-metastatic castration resistant prostate cancer (NMCRPC) who are about to or have recently undergone NGI (i.e. Axumin® or PSMA PETCT). The goal is to enroll a total of 25 evaluable patients into each study group (HRLPC, BCRLPC, NMCRPC and AS) and collect up to \~29mL of blood from each patient as a single timepoint for evaluation. HRLPC patients will have blood draw 2 - 5 months following their radical prostatectomy procedure, BCRLPC and NMCRPC patients will have their blood drawn within 45 days prior to or after their scheduled NGI study and prior to initiation of a new treatment for their disease, and AS patients will have their blood drawn either after having a stable PSA for greater than 5 years or greater than 2 years after having a biopsy confirming low risk disease. All patients will be followed for up to 2 years after enrollment for disease progression and survival status. ### Conditions Module **Conditions:** - High Risk Prostate Carcinoma - Biochemically Recurrent Prostate Carcinoma - Castration-resistant Prostate Cancer - Prostate Cancer **Keywords:** - surveillance - circulating tumor cells - PETCT - PSMA - Axumin - Parsortix - next generation imaging ### Design Module #### Bio Spec **Description:** Whole blood samples will be collected, and the following will be isolated from the whole blood samples: serum, plasma, cells (e.g., CTCs, white blood cells, etc.), circulating cell free DNA, DNA and RNA from isolated cells, etc. **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 9 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with low or very low risk prostate cancer who have been on active surveillance for 5 or more years with a stable PSA or on active surveillance for 2 or more years with negative multiparametric MRI (mpMRI) or mpMRI with a fusion biopsy(ies) confirming low risk disease. **Intervention Names:** - Other: Blood collection **Label:** Active Surveillance (AS) Controls #### Arm Group 2 **Description:** Men with high-risk localized prostate cancer, defined as stage pT3a or Gleason score greater than or equal to 8 and/or pre-prostatectomy PSA of greater than or equal to 20 ng/mL. **Intervention Names:** - Other: Blood collection **Label:** High Risk Localized Prostate Cancer (HRLPC) #### Arm Group 3 **Description:** Systemic and/or hormonal treatment naive men with localized prostate cancer (pathological stages pT2, pT3a or pT4 with TNM N0 or N1 and M0 disease) who have clinical suspicion of biochemical recurrence 2 - 5 months following radical prostatectomy and are scheduled to undergo NGI (i.e., Axumin® or PSMA PETCT) within the next 45 days or have already undergone NGI within the past 45 days. **Intervention Names:** - Other: Blood collection **Label:** Biochemically Recurrent Localized Prostate Cancer (BCRLPC) #### Arm Group 4 **Description:** Patients with evidence of non-metastatic castration-resistant prostate cancer (i.e. localized prostate cancer patients with clinical symptoms of disease progression and/or evidence of a rising PSA following hormone therapy) who are scheduled to undergo NGI (i.e., Axumin® or PSMA PETCT) within the next 45 days or have already undergone NGI within the past 45 days and who have not started a new therapy for treatment of their castration-resistant prostate cancer. **Intervention Names:** - Other: Blood collection **Label:** Non-Metastatic Castration-Resistant Prostate Cancer (NMCRPC) ### Interventions #### Intervention 1 **Arm Group Labels:** - Active Surveillance (AS) Controls - Biochemically Recurrent Localized Prostate Cancer (BCRLPC) - High Risk Localized Prostate Cancer (HRLPC) - Non-Metastatic Castration-Resistant Prostate Cancer (NMCRPC) **Description:** Peripheral blood will be collected from each subject at a single time point and data will be collected from a review of each subject's medical records. **Name:** Blood collection **Other Names:** - Data collection **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The population of cells captured from the peripheral blood samples by the Parsortix system will be evaluated using cytological and/or immunofluorescent staining methods to determine the numbers and phenotypes of any rare cells present (e.g., epithelial and/or mesenchymal CTCs, megakaryocytes, etc. alone and/or in clusters). The numbers and phenotypes of any rare cells present will be evaluated for association with the patient disease state (e.g., study group), the presence of metastatic disease as determined by NGI, and disease progression and/or survival (for up to two years following enrollment). **Measure:** CTC number and phenotype **Time Frame:** Baseline **Description:** DNA and/or RNA will be isolated from the population of cells captured from the peripheral blood samples by the Parsortix system and will be evaluated using molecular methods (e.g. multiplex gene expression, mutational analysis, sequencing, etc.) to determine the genotype(s) of the harvested cells. The genotype(s) of any rare cells present will be evaluated for association with the patient disease state (e.g., study group), the presence of metastatic disease as determined by NGI, and disease progression and/or survival (for up to two years following enrollment). **Measure:** CTC genotype **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Males ≥ 18 years of age; * ECOG status of 0 - 2; * Signed informed consent; * HRLPC cohort (n=25): * Clinical diagnosis of HRLPC, defined as stage pT3a or Gleason score \>8 and/or pre-prostatectomy PSA \>20 ng/mL; * 2-5 months post-radical prostatectomy; * Treatment naïve (i.e. have not received any systemic and/or hormonal therapy since the time of their radical prostatectomy). * BCRLPC cohort (n=25): * Patients with localized prostate cancer (pathological stages pT2, pT3a, pT3b or pT4 with TNM N0 or N1 and M0 disease) who have clinical suspicion of biochemical recurrence following a radical prostatectomy; * Have been pre-authorized by insurance to undergo next generation imaging (NGI, such as Axumin® or PSMA PETCT) within the next 45 days or have already undergone NGI within the past 45 days; * Treatment naïve (i.e. have not received any systemic and/or hormonal therapy since the time of their radical prostatectomy). * NMCRPC cohort (n=25): * Patients with evidence of non-metastatic castration-resistant prostate cancer (i.e. localized prostate cancer patients with clinical symptoms of disease progression and/or evidence of a rising PSA following hormone therapy); * Have been pre-authorized by insurance to undergo NGI (i.e. Axumin® or PSMA PETCT) within the next 45 days or have already undergone NGI within the past 45 days; * Have not started a new therapy for the treatment of their castration-resistant prostate cancer. * Control cohort (n=25): * Patients with low or very low risk prostate cancer who have been on active surveillance (AS) for 5 or more years with a stable PSA or on active surveillance for 2 or more years with negative multiparametric magnetic resonance imaging (mpMRI) or mpMRI with a fusion biopsy confirming low risk disease. Exclusion Criteria: * Documented evidence of brain metastases; * ECOG status of 3 or greater; * Unable to provide informed consent or a high risk that the patient may not comply with the protocol requirements. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients being treated within MidLantic Urology's (MLU's) clinical network (located in southeast Pennsylvania), will be evaluated for eligibility and invited to participate in the study. ### Contacts Locations Module #### Locations **Location 1:** **City:** Bala-Cynwyd **Country:** United States **Facility:** MidLantic Urology **State:** Pennsylvania **Zip:** 19004 **Location 2:** **City:** Pottstown **Country:** United States **Facility:** MidLantic Urology **State:** Pennsylvania **Zip:** 19464 #### Overall Officials **Official 1:** **Affiliation:** MidLantic Urology, LLC **Name:** Jose G Moreno, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Data from this study will not be shared with other researchers. **IPD Sharing:** NO ### References Module #### References **Citation:** Moreno JG, Gomella LG. Evolution of the Liquid Biopsy in Metastatic Prostate Cancer. Urology. 2019 Oct;132:1-9. doi: 10.1016/j.urology.2019.06.006. Epub 2019 Jun 14. **PMID:** 31207303 **Citation:** Miller MC, Robinson PS, Wagner C, O'Shannessy DJ. The Parsortix Cell Separation System-A versatile liquid biopsy platform. Cytometry A. 2018 Dec;93(12):1234-1239. doi: 10.1002/cyto.a.23571. Epub 2018 Aug 14. **PMID:** 30107082 #### See Also Links **Label:** MidLantic Urology, LLC **URL:** https://midlanticurology.com/ **Label:** ANGLE plc **URL:** https://angleplc.com/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000005834 - Term: Genital Neoplasms, Male - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - 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 - ID: D000009362 - Term: Neoplasm Metastasis - ID: D000009385 - Term: Neoplastic Processes - ID: D000010335 - Term: Pathologic Processes ### 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: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M12305 - Name: Neoplastic Cells, Circulating - Relevance: HIGH - As Found: Circulating Tumor Cells - 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: 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 - ID: M12307 - Name: Neoplasm Metastasis - Relevance: LOW - As Found: Unknown - ID: M12330 - Name: Neoplastic Processes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000011471 - Term: Prostatic Neoplasms - ID: D000009360 - Term: Neoplastic Cells, Circulating ### 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:** NCT01112579 **Acronym:** DEFEAT-HF **Brief Title:** Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure **Official Title:** Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure #### Organization Study ID Info **ID:** DEFEAT-HF #### Organization **Class:** INDUSTRY **Full Name:** Medtronic Cardiac Rhythm and Heart Failure ### Status Module #### Completion Date **Date:** 2015-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2015-10-29 **Type:** ESTIMATED **Last Update Submit Date:** 2015-10-01 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2014-01 **Type:** ACTUAL #### Results First Post Date **Date:** 2015-10-29 **Type:** ESTIMATED **Results First Submit Date:** 2015-10-01 **Results First Submit QC Date:** 2015-10-01 #### Start Date **Date:** 2010-04 **Status Verified Date:** 2015-10 #### Study First Post Date **Date:** 2010-04-28 **Type:** ESTIMATED **Study First Submit Date:** 2010-04-16 **Study First Submit QC Date:** 2010-04-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Medtronic Cardiac Rhythm and Heart Failure #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to determine the feasibility of spinal cord stimulation (SCS) as a chronic therapy for systolic heart failure. ### Conditions Module **Conditions:** - Heart Failure ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 81 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: Medtronic PrimeADVANCED Neurostimulator **Label:** Treatment **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Device: Medtronic PrimeADVANCED Neurostimulator **Label:** Control **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment **Description:** Heart failure therapy **Name:** Medtronic PrimeADVANCED Neurostimulator **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Control **Description:** Medical management **Name:** Medtronic PrimeADVANCED Neurostimulator **Other Names:** - Medical management **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** Evaluate the Reduction in Left-ventricular End Systolic Volume Index (LVESVi) After 6 Months of Spinal Cord Stimulation (SCS) Therapy in the Treatment Arm Compared to the Control Arm. **Time Frame:** Baseline and 6 months #### Secondary Outcomes **Measure:** Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months **Time Frame:** Baseline and 6 Months **Measure:** Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months **Time Frame:** Baseline and 6 Months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Left Ventricular Ejection Fraction (LVEF) of 35 percent or less * New York Heart Association (NYHA) functional Class III at time of screening * QRS duration less than 120 milliseconds (ms) * Left Ventricular End Diastolic Diameter (LVEDD) of 55 millimeters (mm) to 80 mm as determined by echocardiography within the past 6 months * Receiving stable optimal medical therapy for heart failure prior to enrollment * Serum creatinine less than or equal to 3.0 milligrams per deciliter (mg/dL) * 18 years of age or older * Willing and able to comply with study procedures * Expected lifespan greater than 12 months beyond study enrollment as assessed by physician Exclusion Criteria: * Interruption of thromboprophylaxis (e.g., heparin, LMWH, warfarin, aspirin, dabigatran, clopidogrel) would pose an unacceptable health risk (e.g., patient with an abnormal bleeding time), as determined by physician * Polyneuropathy * Requires diathermy including shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy * Unable to perform an exercise capacity test * Pregnant or planning to become pregnant during this study * Currently enrolled or plans to enroll in another investigational device or drug study that may confound the results of this study * Had Coronary Artery Bypass Graft/Percutaneous Coronary Intervention/Bare Metal Stent (CABG/PCI/BMS) procedures within the past 90 days * Had a heart transplant * Has complete heart block * Had Acute Coronary Syndrome within the past 90 days * Has congenital heart disease with significant hemodynamic shunting * Has chemotherapy-induced heart failure * Has reversible cardiomyopathy * Has severe mitral regurgitation (greater than 60 percent regurgitant fraction or greater than 0.3 centimeters squared (cm2) regurgitant orifice area) * Has diagnosed unstable angina pectoris * Has unstable coronary artery disease * Has a Cardiac Resynchronization Therapy (CRT) device implanted and is receiving CRT therapy * Has a non-Medtronic Implantable Cardioverter Defibrillator (ICD), pacemaker, or any non-transvenous defibrillation lead * Has a Medtronic ICD whose sensing threshold cannot be programmed to 0.3mV or greater * Has an existing neurostimulator **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Miami **Country:** United States **State:** Florida **Location 2:** **City:** Indianapolis **Country:** United States **State:** Indiana **Location 3:** **City:** Allentown **Country:** United States **State:** Pennsylvania **Location 4:** **City:** Philadelphia **Country:** United States **State:** Pennsylvania **Location 5:** **City:** Burlington **Country:** United States **State:** Vermont **Location 6:** **City:** Spokane **Country:** United States **State:** Washington **Location 7:** **City:** Vancouver **Country:** Canada **State:** British Columbia **Location 8:** **City:** Victoria **Country:** Canada **State:** British Columbia **Location 9:** **City:** Prague **Country:** Czech Republic **Location 10:** **City:** Berlin **Country:** Germany **Location 11:** **City:** Herne **Country:** Germany **Location 12:** **City:** Rome **Country:** Italy **Location 13:** **City:** Groningen **Country:** Netherlands **Location 14:** **City:** Maastricht **Country:** Netherlands **Location 15:** **City:** Zwolle **Country:** Netherlands **Location 16:** **City:** Cape Town **Country:** South Africa **Location 17:** **City:** Johannesburg **Country:** South Africa **Location 18:** **City:** Gothenburg **Country:** Sweden **Location 19:** **City:** Stockholm **Country:** Sweden #### Overall Officials **Official 1:** **Affiliation:** Krannert Institute of Cardiology **Name:** Douglas P Zipes, M.D. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Charite Universitatsmedizin Berlin - Campus Charite Mitte **Name:** Heinz Theres, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Zipes DP, Neuzil P, Theres H, Caraway D, Mann DL, Mannheimer C, Van Buren P, Linde C, Linderoth B, Kueffer F, Sarazin SA, DeJongste MJL; DEFEAT-HF Trial Investigators. Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Systolic Heart Failure: The DEFEAT-HF Study. JACC Heart Fail. 2016 Feb;4(2):129-136. doi: 10.1016/j.jchf.2015.10.006. Epub 2015 Dec 9. Erratum In: JACC Heart Fail. 2018 Jun;6(6):542. **PMID:** 26682789 ## 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 - Abbrev: Rare - Name: Rare Diseases ### 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 - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Treatment **Description:** Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy **ID:** EG000 **Other Num Affected:** 19 **Other Num at Risk:** 42 **Serious Number Affected:** 30 **Serious Number At Risk:** 42 **Title:** Treatment **Group ID:** EG001 **Title:** Control **Description:** Medtronic PrimeADVANCED Neurostimulator: Medical management **ID:** EG001 **Other Num Affected:** 12 **Other Num at Risk:** 24 **Serious Number Affected:** 16 **Serious Number At Risk:** 24 **Title:** Control **Frequency Threshold:** 5 #### Other Events **Term:** Decompensated Heart Failure **Organ System:** Cardiac disorders **Source Vocabulary:** **Term:** Dyspepsia **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Adverse Drug Reaction **Organ System:** General disorders **Source Vocabulary:** **Term:** Device Stimulation Issue **Organ System:** General disorders **Source Vocabulary:** **Term:** Fatigue **Organ System:** General disorders **Source Vocabulary:** **Term:** Bronchitis **Organ System:** Infections and infestations **Source Vocabulary:** **Term:** Osteoarthritis **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** **Term:** Pain in Extremity **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** **Term:** Dizziness **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Dyspnoea **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** **Term:** Skin Reaction **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** **Term:** Orthostatic Hypotension **Organ System:** Vascular disorders **Source Vocabulary:** #### Serious Events **Term:** Anaemia **Organ System:** Blood and lymphatic system disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Atrial Fibrillation **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Atrial Tachycardia **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Bradycardia **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Cardiac Failure Acute **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Cardiac Failure Congestive **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Cardiac Perforation **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Cardiogenic Shock **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 24 **Num Events:** 2 **Term:** Decompensated Heart Failure **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 16 **Num At Risk:** 42 **Num Events:** 33 **Group ID:** EG001 **Num Affected:** 7 **Num At Risk:** 24 **Num Events:** 15 **Term:** Pericardial Effusion **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Ventricular Arrhythmia **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Ventricular Fibrillation **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Ventricular Tachycardia **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 24 **Num Events:** 3 **Term:** Abdominal Wall Haematoma **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Ascites **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Gastritis **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Gastrointestinal Haemorrhage **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Haemorrhoidal Haemorrhage **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Pancreatic Cyst **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Pancreatitis **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Vomiting **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 2 **Term:** Adverse Drug Reaction **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Arterial Restenosis **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Chest Pain **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 42 **Num Events:** 2 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Death **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Device Extrusion **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Device Inappropriate Shock Delivery **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Device Lead Damage **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Lead Dislodgement **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 42 **Num Events:** 3 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Sudden Cardiac Death **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 42 **Num Events:** 2 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Sudden Death **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Ischaemic Hepatitis **Organ System:** Hepatobiliary disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Bronchopneumonia **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Clostridium Difficile Colitis **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 3 **Term:** Endocarditis **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Gastroenteritis **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Implant Site Infection **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Pericarditis Infective **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Pneumonia **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 42 **Num Events:** 6 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 24 **Num Events:** 3 **Term:** Pyleonephritis **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Respiratory Tract Infection **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Septic Shock **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Upper Respiratory Tract Infection **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Urinary Tract Infection **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Femur Fracture **Organ System:** Injury, poisoning and procedural complications ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Toxicity to Various Agents **Organ System:** Injury, poisoning and procedural complications ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** International Normalised Ratio Increased **Organ System:** Investigations ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Dehydration **Organ System:** Metabolism and nutrition disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Gout **Organ System:** Metabolism and nutrition disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Hypoglycaemia **Organ System:** Metabolism and nutrition disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Hypokalaemia **Organ System:** Metabolism and nutrition disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 2 **Term:** Bursitis **Organ System:** Musculoskeletal and connective tissue disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Gouty Arthritis **Organ System:** Musculoskeletal and connective tissue disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Gallbladder Neoplasm **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Rectosigmoid Cancer Metastatic **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Cerebrovascular Accident **Organ System:** Nervous system disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Epilepsy **Organ System:** Nervous system disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Loss of Consiousness **Organ System:** Nervous system disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Presyncope **Organ System:** Nervous system disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Sciatica **Organ System:** Nervous system disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Syncope **Organ System:** Nervous system disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Renal Failure **Organ System:** Renal and urinary disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Renal Failure Acute **Organ System:** Renal and urinary disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Renal Failure Chronic **Organ System:** Renal and urinary disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Endometrial Atrophy **Organ System:** Reproductive system and breast disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Apnoea **Organ System:** Respiratory, thoracic and mediastinal disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Pneumonitis **Organ System:** Respiratory, thoracic and mediastinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Respiratory Depression **Organ System:** Respiratory, thoracic and mediastinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Dry Gangrene **Organ System:** Skin and subcutaneous tissue disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Aortic Dissection **Organ System:** Vascular disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Circulatory Collapse **Organ System:** Vascular disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Haematoma **Organ System:** Vascular disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Hypotension **Organ System:** Vascular disorders ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 42 **Num Events:** 2 **Group ID:** EG001 **Num At Risk:** 24 **Term:** Peripheral Arterial Occlusive Disease **Organ System:** Vascular disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 42 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 24 **Num Events:** 1 **Term:** Thrombosis **Organ System:** Vascular disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 42 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 24 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 42 **Group ID:** BG001 **Value:** 24 **Group ID:** BG002 **Value:** 66 **Units:** Participants ### Group **ID:** BG000 **Title:** Treatment **Description:** Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy ### Group **ID:** BG001 **Title:** Control **Description:** Medtronic PrimeADVANCED Neurostimulator: Medical management ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 11 **Value:** 58 #### Measurement **Group ID:** BG001 **Spread:** 11 **Value:** 66 #### Measurement **Group ID:** BG002 **Spread:** 12 **Value:** 61 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 10 #### Measurement **Group ID:** BG001 **Value:** 4 #### Measurement **Group ID:** BG002 **Value:** 14 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 32 #### Measurement **Group ID:** BG001 **Value:** 20 #### Measurement **Group ID:** BG002 **Value:** 52 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 3 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 3 **Class Title:** Canada #### Measurement **Group ID:** BG000 **Value:** 12 #### Measurement **Group ID:** BG001 **Value:** 10 #### Measurement **Group ID:** BG002 **Value:** 22 **Class Title:** Czech Republic #### Measurement **Group ID:** BG000 **Value:** 9 #### Measurement **Group ID:** BG001 **Value:** 5 #### Measurement **Group ID:** BG002 **Value:** 14 **Class Title:** Netherlands #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 5 #### Measurement **Group ID:** BG002 **Value:** 9 **Class Title:** Sweden #### Measurement **Group ID:** BG000 **Value:** 9 #### Measurement **Group ID:** BG001 **Value:** 3 #### Measurement **Group ID:** BG002 **Value:** 12 **Class Title:** United States #### Measurement **Group ID:** BG000 **Value:** 3 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 3 **Class Title:** Italy #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 2 **Class Title:** South Africa #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 1 **Class Title:** Germany **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:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** Randomized participants ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** [email protected] **Organization:** Medtronic Cardiac Rhythm and Heart Failure **Phone:** 1-800-328-2518 **Title:** DEFEAT-HF Clinical Team ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** -2.0 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 14.9 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.3 **P-Value Comment:** **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** 6.4 **Statistical Comment:** **Statistical Method:** ANCOVA **Tested Non-Inferiority:** False ### Outcome Measure 2 #### Analysis **CI Lower Limit:** -845.8 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 633.6 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.79 **P-Value Comment:** **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** -106.1 **Statistical Comment:** **Statistical Method:** ANCOVA **Tested Non-Inferiority:** False ### Outcome Measure 3 #### Analysis **CI Lower Limit:** -1.6 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 3.2 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.93 **P-Value Comment:** **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** 0.8 **Statistical Comment:** **Statistical Method:** ANCOVA **Tested Non-Inferiority:** False ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 16.0 - **Upper Limit:** - **Value:** 2.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 14.9 - **Upper Limit:** - **Value:** -3.6 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 994.0 - **Upper Limit:** - **Value:** -32.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1468.0 - **Upper Limit:** - **Value:** 73.8 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 4.1 - **Upper Limit:** - **Value:** 0.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 3.3 - **Upper Limit:** - **Value:** -0.2 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline and 6 months **Title:** Evaluate the Reduction in Left-ventricular End Systolic Volume Index (LVESVi) After 6 Months of Spinal Cord Stimulation (SCS) Therapy in the Treatment Arm Compared to the Control Arm. **Type:** PRIMARY **Unit of Measure:** mL/m2 ##### Group **Description:** Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy **ID:** OG000 **Title:** Treatment ##### Group **Description:** Medtronic PrimeADVANCED Neurostimulator: Medical management **ID:** OG001 **Title:** Control #### Outcome Measure 2 **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline and 6 Months **Title:** Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months **Type:** SECONDARY **Unit of Measure:** pg/mL ##### Group **Description:** Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy **ID:** OG000 **Title:** Treatment ##### Group **Description:** Medtronic PrimeADVANCED Neurostimulator: Medical management **ID:** OG001 **Title:** Control #### Outcome Measure 3 **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline and 6 Months **Title:** Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months **Type:** SECONDARY **Unit of Measure:** mL/kg/min ##### Group **Description:** Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy **ID:** OG000 **Title:** Treatment ##### Group **Description:** Medtronic PrimeADVANCED Neurostimulator: Medical management **ID:** OG001 **Title:** Control ### Participant Flow Module #### Group **Description:** Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy **ID:** FG000 **Title:** Treatment #### Group **Description:** Medtronic PrimeADVANCED Neurostimulator: Medical management **ID:** FG001 **Title:** Control #### Period **Title:** Overall Study ##### Withdraw **Type:** Missed Visit ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ##### Withdraw **Type:** Death ###### Reason **Group ID:** FG000 **Number of Subjects:** 0 ###### Reason **Group ID:** FG001 **Number of Subjects:** 2 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 42 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 24 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 41 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 21 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 1 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 3 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT00706979 **Brief Title:** A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers **Official Title:** A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers #### Organization Study ID Info **ID:** 1R01DA021619-01A1 **Link:** https://reporter.nih.gov/quickSearch/1R01DA021619-01A1 **Type:** NIH #### Organization **Class:** OTHER **Full Name:** Medical University of South Carolina #### Secondary ID Infos **ID:** 1R01DA021619-01A1 **Link:** https://reporter.nih.gov/quickSearch/1R01DA021619-01A1 **Type:** NIH ### Status Module #### Completion Date **Date:** 2010-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2011-12-09 **Type:** ESTIMATED **Last Update Submit Date:** 2011-11-07 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2010-10 **Type:** ACTUAL #### Results First Post Date **Date:** 2011-12-09 **Type:** ESTIMATED **Results First Submit Date:** 2011-11-07 **Results First Submit QC Date:** 2011-11-07 #### Start Date **Date:** 2008-09 **Status Verified Date:** 2010-10 #### Study First Post Date **Date:** 2008-06-30 **Type:** ESTIMATED **Study First Submit Date:** 2008-06-26 **Study First Submit QC Date:** 2008-06-26 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute on Drug Abuse (NIDA) #### Lead Sponsor **Class:** OTHER **Name:** Medical University of South Carolina #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** A sample of smokers who have no current plans to quit will be recruited for this study and randomized to one of two intervention conditions: 1. Practice Quit Attempt (PQA) aided by brief advice and self-help materials, or 2. PQA aided by advice and self-help materials plus nicotine replacement therapy (NRT). This study will test whether adding free nicotine replacement therapy to brief advice to undertake a practice quit attempt will motivate more smokers to make a serious attempt to stop smoking than brief advice without NRT. All treatments and assessments will be delivered via telephone and mailing. The primary outcome of interest is the incidence of a serious attempt to permanently stop smoking made over a six-month study period. Our specific hypotheses are as follows: Hypothesis 1: Helping smokers to make a practice quit attempt aided by NRT will result in a higher incidence of making a serious effort to quit smoking permanently, compared to an aided practice quit attempt without NRT. We also expect provision of NRT will increase point prevalence abstinence at 6 month follow-up. Hypothesis 2: This relationship between NRT-aided practice quit attempts and quit behaviors will be mediated by a) increased smoking related self efficacy, b) increased belief in the efficacy of NRT, c) fewer concerns about adverse events of NRT, d) increased social support for not smoking, and e) less withdrawal distress and craving during the practice quit attempt. ### Conditions Module **Conditions:** - Smoking - Smoking Cessation **Keywords:** - smoking - smoking cessation - nicotine replacement therapy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 849 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Practice Quit Attempt plus Nicotine Replacement Therapy **Intervention Names:** - Other: Practice Quit Attempt plus nicotine lozenge **Label:** 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Practice Quit Attempt only **Intervention Names:** - Behavioral: Practice Quit Attempt only **Label:** 2 **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - 1 **Description:** nicotine lozenge, 2 mg or 4 mg **Name:** Practice Quit Attempt plus nicotine lozenge **Other Names:** - Nicotine lozenge - Nicotine Replacement Therapy (NRT) **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - 2 **Description:** Practice Quit Attempts (PQA) message aided by brief advice and self-help materials **Name:** Practice Quit Attempt only **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome was an attempt to quit smoking for good. To distinguish from a PQA, we specifically asked participants if they tried to quit smoking with the intent of quitting for good. Quit attempts were defined as any self-defined attempt to quit for good. **Measure:** A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking **Time Frame:** From study enrollment through six month follow-up **Description:** Serious quit attempt of \>=24hrs, which fits the CDC's definition of a quit attempt. **Measure:** A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking **Time Frame:** From study enrollment through six month follow-up #### Secondary Outcomes **Measure:** Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days **Time Frame:** At any point during the study **Measure:** Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days **Time Frame:** At 6-month follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Current cigarette smoker of at least 10 cigarettes per day * Interested in quitting at some time * Not currently interested in quitting smoking * Access to telephone (home or work) for 6 month study period Exclusion Criteria: * Monthly cigar, pipe, or smokeless tobacco use * Current pregnancy or breastfeeding * Recent cardiovascular distress * Phenylketonuria (PKU) * Previous use of nicotine replacement therapy (gum, patch, lozenge, inhaler, or nasal spray) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Medical University of South Carolina **Name:** Matthew J Carpenter, Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Carpenter MJ, Hughes JR, Gray KM, Wahlquist AE, Saladin ME, Alberg AJ. Nicotine therapy sampling to induce quit attempts among smokers unmotivated to quit: a randomized clinical trial. Arch Intern Med. 2011 Nov 28;171(21):1901-7. doi: 10.1001/archinternmed.2011.492. **PMID:** 22123796 ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000005731 - Term: Ganglionic Stimulants - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018722 - Term: Nicotinic Agonists - ID: D000018679 - Term: Cholinergic Agonists - ID: D000018678 - Term: Cholinergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSSti - Name: Central Nervous System Stimulants ### Intervention Browse Module - Browse Leaves - ID: M12478 - Name: Nicotine - Relevance: HIGH - As Found: Prior to - ID: M4029 - Name: Central Nervous System Stimulants - Relevance: LOW - As Found: Unknown - ID: M20796 - Name: Nicotinic Agonists - Relevance: LOW - As Found: Unknown - ID: M20758 - Name: Cholinergic Agents - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000009538 - Term: Nicotine ### Misc Info Module #### Removed Countries - Country: United States - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Practice Quit Attempt Plus Nicotine Replacement Therapy **Description:** This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period. **ID:** EG000 **Other Num Affected:** 179 **Other Num at Risk:** 426 **Serious Number At Risk:** 426 **Title:** Practice Quit Attempt Plus Nicotine Replacement Therapy **Group ID:** EG001 **Title:** Practice Quit Attempt Only **Description:** This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA). **ID:** EG001 **Serious Number Affected:** 1 **Serious Number At Risk:** 423 **Title:** Practice Quit Attempt Only **Frequency Threshold:** 5 #### Other Events **Term:** Nausea/stomach upset (dyspepsia) **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Throat irritation **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** **Term:** Hiccups **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** **Term:** Heartburn **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** #### Serious Events **Term:** Death **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** We were notified of the death of a participant from bladder cancer in the control group(PQA Only group, did not receive nicotine replacement therapy) by the participant's wife. **Organ System:** Renal and urinary disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 426 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 423 **Num Events:** 1 **Time Frame:** Adverse events were collected in the Practice Quit Attempt (PQA) + Nicotine Replacement Therapy (NRT) group only. They were collected at every follow-up study visit, which included 5 time points over a 7.5 month (32 weeks) period. ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 426 **Group ID:** BG001 **Value:** 423 **Group ID:** BG002 **Value:** 849 **Units:** Participants ### Group **ID:** BG000 **Title:** Practice Quit Attempt Plus Nicotine Replacement Therapy **Description:** This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period. ### Group **ID:** BG001 **Title:** Practice Quit Attempt Only **Description:** This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA). ### 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:** 382 #### Measurement **Group ID:** BG001 **Value:** 389 #### Measurement **Group ID:** BG002 **Value:** 771 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 44 #### Measurement **Group ID:** BG001 **Value:** 34 #### Measurement **Group ID:** BG002 **Value:** 78 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 11.8 **Value:** 50.5 #### Measurement **Group ID:** BG001 **Spread:** 11.4 **Value:** 50.7 #### Measurement **Group ID:** BG002 **Spread:** 11.6 **Value:** 50.6 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 266 #### Measurement **Group ID:** BG001 **Value:** 279 #### Measurement **Group ID:** BG002 **Value:** 545 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 160 #### Measurement **Group ID:** BG001 **Value:** 144 #### Measurement **Group ID:** BG002 **Value:** 304 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 426 #### Measurement **Group ID:** BG001 **Value:** 423 #### Measurement **Group ID:** BG002 **Value:** 849 **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 **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 ### Point of Contact **Email:** [email protected] **Organization:** Medical University of South Carolina' **Phone:** 843-792-3974 **Title:** Matthew J. Carpenter ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** 1.1 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.4 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** A logistic regression model was used to examine the primary hypothesis that NRT-enhanced PQAs would yield a higher rate of any ever-occurring quit attempt. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.008 **P-Value Comment:** **Parameter Type:** Risk Ratio (RR) **Parameter Value:** 1.2 **Statistical Comment:** **Statistical Method:** Regression, Logistic **Tested Non-Inferiority:** False ### Outcome Measure 2 #### Analysis **CI Lower Limit:** 1.0 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.7 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** A logistic regression model was used to examine the secondary hypothesis that NRT-enhanced PQAs would yield a higher rate of 7 days of abstinence at some point during the study. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.09 **P-Value Comment:** **Parameter Type:** Risk Ratio (RR) **Parameter Value:** 1.3 **Statistical Comment:** **Statistical Method:** Regression, Logistic **Tested Non-Inferiority:** False ### Outcome Measure 3 #### Analysis **CI Lower Limit:** 1.1 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.5 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** A logistic regression model was used to examine the primary hypothesis that NRT-enhanced PQAs would yield a higher rate for the primary outcome of any 24hr quit attempt. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.004 **P-Value Comment:** **Parameter Type:** Risk Ratio (RR) **Parameter Value:** 1.3 **Statistical Comment:** **Statistical Method:** Regression, Logistic **Tested Non-Inferiority:** False ### Outcome Measure 4 #### Analysis **CI Lower Limit:** 0.9 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.6 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** A logistic regression model was used to examine the secondary hypothesis that NRT-enhanced PQAs would yield a higher rate for 7 days of abstinence at the six month follow-up. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.3 **P-Value Comment:** **Parameter Type:** Risk Ratio (RR) **Parameter Value:** 1.2 **Statistical Comment:** **Statistical Method:** Regression, Logistic **Tested Non-Inferiority:** False ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 208 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 168 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 82 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 63 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 185 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 143 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 68 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 57 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** The primary outcome was an attempt to quit smoking for good. To distinguish from a PQA, we specifically asked participants if they tried to quit smoking with the intent of quitting for good. Quit attempts were defined as any self-defined attempt to quit for good. **Parameter Type:** NUMBER **Population Description:** All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit. **Reporting Status:** POSTED **Time Frame:** From study enrollment through six month follow-up **Title:** A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking **Type:** PRIMARY **Unit of Measure:** participants ##### Group **Description:** This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period. **ID:** OG000 **Title:** Practice Quit Attempt Plus Nicotine Replacement Therapy ##### Group **Description:** This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA). **ID:** OG001 **Title:** Practice Quit Attempt Only #### Outcome Measure 2 **Parameter Type:** NUMBER **Population Description:** All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit. **Reporting Status:** POSTED **Time Frame:** At any point during the study **Title:** Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days **Type:** SECONDARY **Unit of Measure:** participants ##### Group **Description:** This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period. **ID:** OG000 **Title:** Practice Quit Attempt Plus Nicotine Replacement Therapy ##### Group **Description:** This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA). **ID:** OG001 **Title:** Practice Quit Attempt Only #### Outcome Measure 3 **Description:** Serious quit attempt of \>=24hrs, which fits the CDC's definition of a quit attempt. **Parameter Type:** NUMBER **Population Description:** All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit. **Reporting Status:** POSTED **Time Frame:** From study enrollment through six month follow-up **Title:** A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking **Type:** PRIMARY **Unit of Measure:** participants ##### Group **Description:** This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period. **ID:** OG000 **Title:** Practice Quit Attempt Plus Nicotine Replacement Therapy ##### Group **Description:** This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA). **ID:** OG001 **Title:** Practice Quit Attempt Only #### Outcome Measure 4 **Parameter Type:** NUMBER **Population Description:** All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit. **Reporting Status:** POSTED **Time Frame:** At 6-month follow-up **Title:** Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days **Type:** SECONDARY **Unit of Measure:** participants ##### Group **Description:** This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period. **ID:** OG000 **Title:** Practice Quit Attempt Plus Nicotine Replacement Therapy ##### Group **Description:** This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA). **ID:** OG001 **Title:** Practice Quit Attempt Only ### Participant Flow Module #### Group **Description:** This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period. **ID:** FG000 **Title:** Practice Quit Attempt Plus Nicotine Replacement Therapy #### Group **Description:** This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA). **ID:** FG001 **Title:** Practice Quit Attempt Only #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 426 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 423 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 426 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 423 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 **Pre-Assignment Details:** Participants were randomized to treatment group in a 1:1 ratio using a random number generator with block randomization before research staff made calls to initiate formal study enrollment. **Recruitment Details:** Participants were recruited from 1/2009 - 2/2010 via the internet from an email database of potential enrollees provided by a market research firm. Eligible participants were mailed an informed consent and asked to return a signed copy if they wished to participate. Research staff then made calls to initiate formal study enrollment. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT03427879 **Brief Title:** Effect of Flavonoids on Gut Permeability in Cyclists **Official Title:** Effect of Flavonoids on Gut Permeability in Cyclists #### Organization Study ID Info **ID:** 1010820 #### Organization **Class:** OTHER **Full Name:** Utah State University ### Status Module #### Completion Date **Date:** 2019-07-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-02-25 **Type:** ACTUAL **Last Update Submit Date:** 2021-02-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-05-15 **Type:** ACTUAL #### Start Date **Date:** 2018-09-14 **Type:** ACTUAL **Status Verified Date:** 2021-02 #### Study First Post Date **Date:** 2018-02-09 **Type:** ACTUAL **Study First Submit Date:** 2018-01-30 **Study First Submit QC Date:** 2018-02-02 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Utah State University #### Responsible Party **Investigator Affiliation:** Utah State University **Investigator Full Name:** Robert Ward **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this investigation is to test the hypothesis that chronic supplementation with a dairy-based beverage containing a mixture of blueberry, green tea, and cocoa flavonoids (non-nutritive natural plant compounds) will ameliorate exercise-related changes in gut permeability and inflammation. In a previous feeding study in humans, (NCT02728570) a high flavonoid diet (flavonoids at 340 mg/1000kcal) was effective in mitigating gut permeability and inflammation in overweight and obese adults compared to a low flavonoid diet (10mg/1000 kcal). To test this hypothesis, 20 trained cyclists will complete a randomized crossover study with supplementation for 2 weeks with a dairy-based sports beverage containing either a high flavonoid (approximately 620 mg) or low flavonoid (approximately 5mg) beverage. After the two week intervention, cyclists will complete a 1 hour cycling trial (45 min at 65% VO2 max then 15 minute time trial). The primary endpoints will be gut permeability as measured by plasma intestinal fatty acid binding protein (I-FABP) and the differential sugar test. Secondary endpoints will include gut inflammation (measured via fecal calprotectin), plasma cytokines (IL-6, IL-10 and TNFα) and plasma LPS. In addition, the distance completed in the time trial is a secondary endpoint. ### Conditions Module **Conditions:** - Gut Permeability, Gut Inflammation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 12 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects will consume 310 milliliters per day of a dairy-based, low flavonoid, sports nutrition recovery beverage 14 days. **Intervention Names:** - Drug: Low flavonoid beverage **Label:** Low flavonoid beverage **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Subjects will consume 310 milliliters per day of a dairy-based, high flavonoid, sports nutrition recovery beverage 14 days. **Intervention Names:** - Drug: High flavonoid beverage **Label:** High flavonoid beverage **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Low flavonoid beverage **Description:** A low flavonoid, sports nutrition recovery beverage will be prepared from milk (78%), sugar (8.6%), maltodextrin (8.6%), placebo blueberry powder (2.4%), alkalized cocoa powder (1.6%), and whey protein isolate (0.6%). The beverage will contain approximately 5mg flavonoids per serving. **Name:** Low flavonoid beverage **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - High flavonoid beverage **Description:** A high flavonoid, sports nutrition recovery beverage will be prepared from milk (78%), sugar (8.6%), maltodextrin (8.6%), blueberry powder (2.4%), cocoa powder (1.6%), green tea extract (0.1%) and whey protein isolate (0.6%). The beverage will contain approximately 620 mg flavonoids per serving. **Name:** High flavonoid beverage **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Measure of gut permeability from mouth to end of small intestine. Ratio of urinary lactulose to mannitol after subject consumes a beverage containing these sugars. Sugars in urine are measured by gas chromatography with flame ionization detection. **Measure:** Urinary lactulose:mannitol ratio by gas chromatography **Time Frame:** Three weeks **Description:** Marker of gut wall integrity. i-FABP is measure by enzyme-linked immunosorbent assay in plasma of subjects after the time trial. **Measure:** Plasma intestinal fatty acid binding protein (i-FABP) by ELISA **Time Frame:** Three weeks #### Secondary Outcomes **Description:** Secondary endpoint for intestinal inflammation. Calprotectin is measured in fecal samples by enzyme-linked immunosorbent assay. **Measure:** Fecal calprotectin by ELISA **Time Frame:** Three weeks **Description:** Secondary measure of gut permeability from mouth to end of colon. Ratio of urinary lactulose to mannitol after subject consumes a beverage containing these sugars. Sugars in urine are measured by gas chromatography with flame ionization detection. **Measure:** Urinary sucralose:mannitol ratio by gas chromatography **Time Frame:** Three weeks **Description:** One of four secondary endpoints for systemic inflammation. The cytokine, TNFa, is measured in plasma by enzyme-linked immunosorbent assay. **Measure:** Serum soluble tumor necrosis factor (TNFa) by ELISA **Time Frame:** Three weeks **Description:** One of four secondary endpoints for systemic inflammation. The cytokine, IL-6, is measured in plasma by enzyme-linked immunosorbent assay. **Measure:** Serum soluble interleukin-6 (IL-6) by ELISA **Time Frame:** Three weeks **Description:** One of four secondary endpoints for systemic inflammation. The cytokine, IL-10, is measured in plasma by enzyme-linked immunosorbent assay. **Measure:** Serum soluble interleukin-10 by ELISA **Time Frame:** Three weeks **Description:** One of four secondary endpoint for systemic inflammation. The bacterial cell wall product is measured in plasma by enzyme-linked immunosorbent assay. **Measure:** Serum endotoxin by ELISA. **Time Frame:** Three weeks **Description:** Subjects will complete a 15m time trial on a bike after each dietary intervention. The distance covered in each time trial will be measured by the computer on the exercise bike. **Measure:** Distance ridden in time trial **Time Frame:** One Day **Description:** Subjects will complete a 15m time trial on a bike after each dietary intervention. This measure is a subjective measure of the difficulty of the work. Subjects will provide the ratings orally during the time trial. **Measure:** Rating of perceived exertion by questionnaire. **Time Frame:** One Day ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female of any race or ethnicity between 18 to 49 years of age * Competed in a road race or triathlon in past 12 months * Free of chronic disease and GI conditions * Train at least 3 times per week, 1 hour at a time on average * Willing to prepare and consume provided pre-workout beverage daily * Maintain weight (no more/less than 5 kg change) * Willing to avoid consumption of high flavonoid foods/supplements, large dose vitamin and mineral supplements, and NSAIDs or other medications known to affect inflammation during study period * Willing to provide urine, stool, and blood samples Exclusion Criteria: * Age \<18 or \>50 years * Medical history of heart disease, hypertension, diabetes, Crohn's disease, IBS, colitis, celiac disease, inflammatory or autoimmune disease, and lactose intolerance * Uncontrolled hypertension: diastolic blood pressure \>95 mm Hg or systolic blood pressure \>160 mm Hg * For women: pregnancy, breast feeding or postpartum \<6 months * Food allergies or restrictions to treatment/placebo beverages * Chronic use of NSAIDs * Consumption of flavonoid supplements \<1 month prior to study start * Antibiotic use \<3 months prior to study start * Other conditions (medical, psychiatric, or behavioral) that may present a safety hazard to the participant or interfere with study participation, as determined by the principal investigators **Healthy Volunteers:** True **Maximum Age:** 49 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Logan **Country:** United States **Facility:** Center for Human Nutrition Studies **State:** Utah **Zip:** 84322 #### Overall Officials **Official 1:** **Affiliation:** Nutrition, Dietetics and Food Sciences, Utah State University **Name:** Robert E Ward, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## 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: Ot - Name: Other Dietary Supplements - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: T435 - Name: Whey Protein - Relevance: LOW - As Found: Unknown - ID: T312 - Name: Tea - Relevance: LOW - As Found: Unknown - ID: T79 - Name: Blueberry - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01553279 **Brief Title:** Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011) **Official Title:** A Phase III Open-label Randomised Study, to Evaluate the Immunogenicity and Safety of the Concomitant Administration of V419 (PR5I) Given at 2, 3 and 4 Months of Age With Two Types of Meningococcal Serogroup C Conjugate (MCC) Vaccines Given at 3 and 4 Months of Age, and Followed by the Administration at 12 Months of Age of a Combined Haemophilus Influenzae Type b-MCC Vaccine #### Organization Study ID Info **ID:** V419-011 #### Organization **Class:** INDUSTRY **Full Name:** MCM Vaccines B.V. #### Secondary ID Infos **ID:** 2011-002413-11 **Type:** EUDRACT_NUMBER **Domain:** MCMVaccBV Protocol ID **ID:** PRI01C **Type:** OTHER **Domain:** Merck Protocol Number **ID:** V419-011 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2013-09-27 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-03-28 **Type:** ACTUAL **Last Update Submit Date:** 2019-03-06 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2013-09-27 **Type:** ACTUAL #### Results First Post Date **Date:** 2019-03-28 **Type:** ACTUAL **Results First Submit Date:** 2019-01-30 **Results First Submit QC Date:** 2019-03-06 #### Start Date **Date:** 2012-03-30 **Type:** ACTUAL **Status Verified Date:** 2019-03 #### Study First Post Date **Date:** 2012-03-14 **Type:** ESTIMATED **Study First Submit Date:** 2012-03-07 **Study First Submit QC Date:** 2012-03-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** MCM Vaccines B.V. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The primary objectives of this study are to evaluate the immunogenicity and safety of concomitant administration of V419 (PR51) with 2 types of meningococcal serogroup C conjugate (MCC) vaccines to healthy infants at 3 and 4 months of age in terms of antibody seroprotection rate (SPR) to MCC. Participants also received a Haemophilus influenza type B (Hib)-MCC vaccination at 12 months of age. It was hypothesized that the SPR to MCC at 1 month post-dose 2 of either tetanus toxoid conjugated Meningo C (MCC-TT) or CRM197 conjugated Meningo C (MCC-CRM) vaccines would be acceptable when administered concomitantly with V419. ### Conditions Module **Conditions:** - Neisseria Meningitidis - Bacterial Infections - Virus Diseases ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 284 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age), followed by a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of a measles, mumps, and rubella (MMR) vaccine (at 12 months of age). **Intervention Names:** - Biological: V419 - Biological: PREVNAR 13® - Biological: MCC-TT - Biological: Hib-MCC - Biological: MMR Vaccine **Label:** V419 and MCC-TT **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age), followed by a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **Intervention Names:** - Biological: V419 - Biological: PREVNAR 13® - Biological: MCC-CRM - Biological: Hib-MCC - Biological: MMR Vaccine **Label:** V419 and MCC-CRM **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - V419 and MCC-CRM - V419 and MCC-TT **Description:** Diphtheria and Tetanus toxoids and acellular Pertussis adsorbed, inactivated Poliovirus, Haemophilus b conjugate \[meningococcal outer membrane protein complex\], and Hepatitis B \[recombinant\] vaccine administered via 0.5 mL intramuscular injection. **Name:** V419 **Other Names:** - PR51, VAXELIS® **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - V419 and MCC-CRM - V419 and MCC-TT **Description:** Pneumococcal conjugate vaccine (13-valent, adsorbed) administered via 0.5 mL intramuscular injection (routine vaccination). **Name:** PREVNAR 13® **Type:** BIOLOGICAL #### Intervention 3 **Arm Group Labels:** - V419 and MCC-TT **Description:** Meningococcal Group C polysaccharide conjugate vaccine to tetanus toxoid adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age **Name:** MCC-TT **Other Names:** - NEISVAC-C® **Type:** BIOLOGICAL #### Intervention 4 **Arm Group Labels:** - V419 and MCC-CRM **Description:** Meningococcal Group C conjugate vaccine to CRM-197 adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age **Name:** MCC-CRM **Other Names:** - MENJUGATE® **Type:** BIOLOGICAL #### Intervention 5 **Arm Group Labels:** - V419 and MCC-CRM - V419 and MCC-TT **Description:** Haemophilus type b and meningococcal Group C conjugate vaccine administered via 0.5 mL intramuscular injection. **Name:** Hib-MCC **Other Names:** - MENITORIX® **Type:** BIOLOGICAL #### Intervention 6 **Arm Group Labels:** - V419 and MCC-CRM - V419 and MCC-TT **Description:** Measles, mumps, and rubella vaccine (live) given via 0.5 mL intramuscular injection (routine vaccination). **Name:** MMR Vaccine **Other Names:** - M-M-RVAXPRO® **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** The acceptability (i.e., percentage of participants with anti-MCC Ab titre ≥1:8 dil) of the seroprotection rate (SPR) to MCC was determined 1 month after MCC-TT or MCC-CRM Dose 2. The SPR was considered acceptable if the lower bound of the 2-sided 95% CI was \>90%. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay. **Measure:** Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil One Month After MCC-TT or MCC-CRM (Part 1) **Time Frame:** Month 5 (1 month after MCC-TT/MCC-CRM Dose 2) #### Secondary Outcomes **Description:** The acceptability (i.e., percentage of participants with anti-PRP Ab titre ≥0.15 µg/mL) of the seroprotection rate (SPR) to Haemophilus influenza type b (Hib) was determined 1 month after the third dose of V419 in participants also treated with MCC-TT or MCC-CRM. The pooled (i.e., all V419-treated participants) SPR was considered acceptable if the lower bound of the 2-sided 95% CI was \>80%. Serum Ab levels were determined with radioimmunoassay (RIA). **Measure:** Percentage of Participants With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody (Ab) Titre ≥0.15 µg/mL One Month After V419 Dose 3 (Part 1) **Time Frame:** Month 5 (1 month after V419 Dose 3) **Description:** The percentage of participants with anti-MCC Ab titres ≥1:8 dil and ≥1:128 dil 1 month after MCC-TT or MCC-CRM Doses 1 and 2 was determined in participants also treated with V419. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay. **Measure:** Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1) **Time Frame:** Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2) **Description:** Anti-MCC antibody GMTs were determined 1 month after MCC-TT or MCC-CRM Doses 1 and 2 in participants also treated with V419. Serum antibody levels were assayed using the Meningo C rabbit complement serum bactericidal antibody (rSBA) assay. **Measure:** Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1) **Time Frame:** Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2) **Description:** The percentage of participants meeting Ab response rates for V14 antigens was determined after V114 Dose 3. Antibody response rate criteria for Haemophilus influenza Type B (PRP); hepatitis B (HBsAg); diphtheria; tetanus; and polio types 1, 2, and 3 are shown in the rows below. The percentage of seroresponders to pertussis seroresponders (pertussis toxoid \[PT\]; filamentous haemagglutinin (FHA); fimbrae types 2 and 3 \[FIM\]; and pertactin \[PRN\]) was determined as 1) if pre-vaccination Ab concentration \<lower limit of quantification (LLoQ) but post-vaccination Ab concentration ≥LLoQ; or 2) if pre-vaccination Ab concentration was ≥LLoQ but post-vaccination Ab concentration was ≥pre-immunization levels. Antibody titres were measured by RIA for PRP, enhanced chemiluminescence assay (ECi) for HBsAg, micrometabolic inhibition test (MIT) for diphtheria and poliovirus, and enzyme-linked immunosorbent assay (ELISA) for tetanus, PT, FHA, FIM, and PRN. **Measure:** Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1) **Time Frame:** Month 5 (1 month after V419 Dose 3) **Description:** The GMTs for PRP Ab titres were determined for each arm. Antibody titres for PRP were measured by radioimmunoassay (RIA). **Measure:** Antibody (Ab) Geometic Mean Titres (GMTs) for Haemophilus Influenza Type B (Polyribosylribitol Phosphate [PRP]) One Month After V114 Dose 3 (Part 2) **Time Frame:** Month 5 (1 month after V419 Dose 3) **Description:** The GMTs for HBsAg Ab titres were determined for each arm. Antibody titres for HBsAg were measured by enhanced chemiluminescence (ECi) assay. **Measure:** Antibody (Ab) Geometic Mean Titres (GMTs) for Hepatitis B Surface Antigen (HBsAg) One Month After V114 Dose 3 (Part 2) **Time Frame:** Month 5 (1 month after V419 Dose 3) **Description:** The GMTs for diphtheria Ab titres were determined for each arm. Antibody titres for diptheria were measured by enhanced micrometabolic inhibition test (MIT). **Measure:** Antibody (Ab) Geometic Mean Titres (GMTs) for Diptheria One Month After V114 Dose 3 (Part 2) **Time Frame:** Month 5 (1 month after V419 Dose 3) **Description:** The GMTs for tetanus Ab titres were determined for each arm. Antibody titres for tetanus were determined with enzyme-linked immunosorbent assay (ELISA). **Measure:** Antibody (Ab) Geometic Mean Titres (GMTs) for Tetanus One Month After V114 Dose 3 (Part 2) **Time Frame:** Month 5 (1 month after V419 Dose 3) **Description:** The GMTs for PT Ab titres were determined for each arm. Antibody titres for PT were measured with enzyme-linked immunosorbent assay (ELISA). **Measure:** Antibody (Ab) Geometic Mean Titres (GMTs) for Pertussis Toxoid (PT) One Month After V114 Dose 3 (Part 2) **Time Frame:** Month 5 (1 month after V419 Dose 3) **Description:** The GMTs for FHA were determined for each arm. Antibody titres for FHA were measured by enhanced chemiluminescence (ECi) assay. **Measure:** Antibody (Ab) Geometic Mean Titres (GMTs) for Filamentous Haemagglutinin (FHA) One Month After V114 Dose 3 (Part 2) **Time Frame:** Month 5 (1 month after V419 Dose 3) **Description:** The GMTs for PRN were determined for each arm. Antibody titres for PRN were measured by enhanced chemiluminescence (ECi) assay. **Measure:** Antibody (Ab) Geometic Mean Titres (GMTs) for Pertactin (PRN) One Month After V114 Dose 3 (Part 2) **Time Frame:** Month 5 (1 month after V419 Dose 3) **Description:** The GMTs for FIM were determined for each arm. Antibody titres for FIM were measured by enhanced chemiluminescence (ECi) assay. **Measure:** Antibody (Ab) Geometic Mean Titres (GMTs) for Fimbrae Types 2 and 3 (FIM) One Month After V114 Dose 3 (Part 2) **Time Frame:** Month 5 (1 month after V419 Dose 3) **Description:** The GMTs for polio types 1, 2, and 3 were determined for each arm. Antibody titres for polio types 1, 2, and 3 were measured by micrometabolic inhibition test (MIT). **Measure:** Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2) **Time Frame:** Month 5 (1 month after V419 Dose 3) **Description:** The percentage of participants with anti-Hib Ab titres ≥1:8 (1/dil) and ≥1:28 (1/dil) were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay. **Measure:** Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2) **Time Frame:** Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC) **Description:** Antibody GMTs were were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay. **Measure:** Antibody (Ab) Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Meningococcal Serogroup C (MCC) Vaccination (Part 2) **Time Frame:** Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC) **Description:** The percentage of participants with anti-PRP Ab titres ≥0.15 µg/mL and ≥1.0 µg/mL was determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA). **Measure:** Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2) **Time Frame:** Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2) **Description:** Anti-PRP Ab GMTs were determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA) and are expressed as µg/mL.. **Measure:** Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2) **Time Frame:** Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2) **Description:** An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. **Measure:** Percentage of Participants Experiencing an Adverse Event (AE) [Part 1] **Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination) **Description:** An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. As per protocol, all injection site AEs were considered vaccine-related. **Measure:** Percentage of Participants Experiencing an Injection Site (Vaccine-Related) Systemic Adverse Event (AE) [Part 1] **Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination) **Description:** The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling. **Measure:** Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1) **Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination) **Description:** The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs were any injection-site ISRs not considered solicited. **Measure:** Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1) **Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination) **Description:** The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling. **Measure:** Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1) **Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination) **Description:** The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs consisted of bruising, dermatitis, erythema, induration, mass, pain, rash, and warmth. **Measure:** Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1) **Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination) **Description:** The percentage of participants with solicited systemic AEs was determined for each arm. Solicited systemic AEs consisted of crying, decreased appetite, irritability, pyrexia, somnolence, and vomiting. **Measure:** Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1] **Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination) **Description:** The percentage of participants experiencing temperatures ≥38.0° Celsius (C), \>38.5° C, and \>39.5° C following any Part 1 vaccination was determined. **Measure:** Percentage of Participants Experiencing Increased Temperature [Part 1] **Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination) **Description:** An SAE is an event that results in death; is life-threatening; results in or prolongs hospitalization; is a congenital anomaly/birth defect; is a cancer; is an overdose; or is another important medical event that may jeopardize the participant. **Measure:** Percentage of Participants Experiencing a Serious Adverse Event (SAE) [Part 1] **Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy infant 46 to 74 days of age (both inclusive) * Parent(s)/legal representative able to comply will the study procedures Exclusion Criteria: * Is participating in a study with an investigational compound or device since birth * Has a history of congenital or acquired immunodeficiency * Has a history of leukemia, lymphoma, malignant melanoma or myeloproliferative disorder * Has a chronic illness that could interfere with study conduct or completion * Has hypersensitivity to any of the vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or contraindication to any of the study vaccines * Has a history, or mother has a history, of hepatitis B virus surface antigen (HBsAg) seropositivity * Has a coagulation disorder that contraindicate intramuscular injection * Has a history of vaccination with a hepatitis B, Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acellular or whole-cell), poliovirus, pneumococcal conjugate or polysaccharide, meningococcal serogroup C conjugate, measles, mumps, or rubella containing vaccine(s) * Has a history of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, invasive pneumococcal, meningococcal serogroup C, measles, mumps or rubella infection * Has received immune globulin, blood or blood-derived products, immunosuppressive agents systemic corticosteroids since birth * Has received vaccination with an inactivated (except influenza vaccine) or conjugated or live vaccine in the last 30 days or vaccination with an inactivated influenza vaccine in the last 14 days * Has received antipyretic, analgesic and non-steroidal anti-inflammatory medications in the last 48 hours * Has a febrile illness or body temperature ≥38.0°C in the last 24 hours **Healthy Volunteers:** True **Maximum Age:** 74 Days **Minimum Age:** 46 Days **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Merck Sharp & Dohme LLC **Name:** Medical Director **Role:** STUDY_DIRECTOR ### 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: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) 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: M4722 - Name: Bacterial Infections - Relevance: HIGH - As Found: Bacterial Infections - ID: M10295 - Name: Influenza, Human - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: HIGH - As Found: Virus Disease - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown - ID: T2646 - Name: Haemophilus Influenzae - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001424 - Term: Bacterial Infections - ID: D000014777 - Term: Virus Diseases ### 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: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown - ID: M412 - Name: Heptavalent Pneumococcal Conjugate Vaccine - Relevance: HIGH - As Found: Impedance - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069443 - Term: Heptavalent Pneumococcal Conjugate Vaccine ### Misc Info Module #### Removed Countries - Country: United Kingdom - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** All participants who received ≥1 dose of study medication are included. #### Event Groups **Group ID:** EG000 **Title:** V419 and MCC-TT **Deaths Num At Risk:** 142 **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** EG000 **Other Num Affected:** 140 **Other Num at Risk:** 142 **Serious Number Affected:** 6 **Serious Number At Risk:** 142 **Title:** V419 and MCC-TT **Group ID:** EG001 **Title:** V419 and MCC-CRM **Deaths Num At Risk:** 142 **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** EG001 **Other Num Affected:** 137 **Other Num at Risk:** 142 **Serious Number Affected:** 4 **Serious Number At Risk:** 142 **Title:** V419 and MCC-CRM **Frequency Threshold:** 2 #### Other Events **Term:** Constipation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 16.1 **Term:** Diarrhoea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 16.1 **Term:** Teething **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 16.1 **Term:** Vomiting **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 16.1 **Term:** Crying **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 16.1 **Term:** Injection site bruising **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 16.1 **Term:** Injection site erythema **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 16.1 **Term:** Injection site mass **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 16.1 **Term:** Injection site pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 16.1 **Term:** Injection site swelling **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 16.1 **Term:** Injection site warmth **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 16.1 **Term:** Irritability **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 16.1 **Term:** Pyrexia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 16.1 **Term:** Nasopharyngitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 16.1 **Term:** Rhinitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 16.1 **Term:** Contusion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 16.1 **Term:** Decreased appetite **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 16.1 **Term:** Somnolence **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 16.1 **Term:** Insomnia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA 16.1 **Term:** Cough **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 16.1 **Term:** Nasal congestion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 16.1 **Term:** Rhinorrhoea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 16.1 **Term:** Rash **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 16.1 #### Serious Events **Term:** Abdominal pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 16.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 142 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 142 **Num Events:** 1 **Term:** Crying **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 16.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 142 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 142 **Num Events:** 1 **Term:** Hypothermia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 16.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 142 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 142 **Term:** Croup infectious **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 16.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 142 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 142 **Term:** Gastroenteritis salmonella **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 16.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 142 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 142 **Num Events:** 1 **Term:** Gastroenteritis viral **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 16.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 142 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 142 **Num Events:** 1 **Term:** Respiratory syncytial virus bronchiolitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 16.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 142 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 142 **Term:** Sepsis neonatal **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 16.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 142 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 142 **Term:** Urinary tract infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 16.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 142 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 142 **Term:** Weight gain poor **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 16.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 142 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 142 **Term:** Choking **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 16.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 142 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 142 **Num Events:** 1 **Time Frame:** Up to 12.5 months (up to 14 days after the final dose of study medication) ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 142 **Group ID:** BG001 **Value:** 142 **Group ID:** BG002 **Value:** 284 **Units:** Participants ### Group **ID:** BG000 **Title:** V419 and MCC-TT **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). ### Group **ID:** BG001 **Title:** V419 and MCC-CRM **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 6.7 **Value:** 62.6 #### Measurement **Group ID:** BG001 **Spread:** 7.2 **Value:** 61.6 #### Measurement **Group ID:** BG002 **Spread:** 7.0 **Value:** 62.1 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 62 #### Measurement **Group ID:** BG001 **Value:** 67 #### Measurement **Group ID:** BG002 **Value:** 129 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 80 #### Measurement **Group ID:** BG001 **Value:** 75 #### Measurement **Group ID:** BG002 **Value:** 155 **Category Title:** Male **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:** Days ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** [email protected] **Organization:** Merck Sharp & Dohme Corp. **Phone:** 1-800-672-6372 **Title:** Senior Vice President, Global Clinical Development ## 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 ### Outcome Measure 11 ### Outcome Measure 12 ### Outcome Measure 13 ### Outcome Measure 14 ### Outcome Measure 15 ### Outcome Measure 16 ### Outcome Measure 17 ### Outcome Measure 18 ### Outcome Measure 19 ### Outcome Measure 20 ### Outcome Measure 21 ### Outcome Measure 22 ### Outcome Measure 23 ### Outcome Measure 24 ### Outcome Measure 25 ### Outcome Measure 26 ### Outcome Measure 27 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 97.0 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 95.0 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 99.1 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 95.9 - **Spread:** - **Upper Limit:** 99.9 - **Value:** 98.9 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 96.4 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 89.9 - **Spread:** - **Upper Limit:** 99.3 - **Value:** 96.4 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 102 - **Group ID:** OG001 - **Value:** 84 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 93.1 - **Spread:** - **Upper Limit:** 99.8 - **Value:** 98.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 75.0 - **Spread:** - **Upper Limit:** 91.5 - **Value:** 84.5 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 102 - **Group ID:** OG001 - **Value:** 84 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 97.0 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 95.0 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 99.1 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 121 - **Group ID:** OG001 - **Value:** 109 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 95.5 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 99.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 95.0 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 99.1 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 121 - **Group ID:** OG001 - **Value:** 109 **Units:** Participants #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1058.4 - **Spread:** - **Upper Limit:** 1729.6 - **Value:** 1353 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 201.5 - **Spread:** - **Upper Limit:** 403.1 - **Value:** 285.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1689.8 - **Spread:** - **Upper Limit:** 2425.9 - **Value:** 2024.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 847.5 - **Spread:** - **Upper Limit:** 1369.8 - **Value:** 1077.4 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 92.4 - **Spread:** - **Upper Limit:** 99.7 - **Value:** 97.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 95.6 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 93 - **Group ID:** OG001 - **Value:** 82 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 90.9 - **Spread:** - **Upper Limit:** 99.3 - **Value:** 96.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 89.7 - **Spread:** - **Upper Limit:** 99.2 - **Value:** 96.3 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 93 - **Group ID:** OG001 - **Value:** 82 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 97.1 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 96.5 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 125 - **Group ID:** OG001 - **Value:** 104 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 59.1 - **Spread:** - **Upper Limit:** 76.1 - **Value:** 68.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 64.5 - **Spread:** - **Upper Limit:** 82.1 - **Value:** 74.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 125 - **Group ID:** OG001 - **Value:** 104 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 97.0 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 96.5 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 122 - **Group ID:** OG001 - **Value:** 105 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 97.0 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 96.5 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 122 - **Group ID:** OG001 - **Value:** 105 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 94.6 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 99.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 95.2 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 100 - **Group ID:** OG001 - **Value:** 75 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 83.6 - **Spread:** - **Upper Limit:** 95.8 - **Value:** 91.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 81.5 - **Spread:** - **Upper Limit:** 96.1 - **Value:** 90.5 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 100 - **Group ID:** OG001 - **Value:** 74 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 88.7 - **Spread:** - **Upper Limit:** 98.4 - **Value:** 95.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 81.2 - **Spread:** - **Upper Limit:** 96.1 - **Value:** 90.4 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 100 - **Group ID:** OG001 - **Value:** 73 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 90.1 - **Spread:** - **Upper Limit:** 98.9 - **Value:** 96.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 88.8 - **Spread:** - **Upper Limit:** 99.2 - **Value:** 96.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 100 - **Group ID:** OG001 - **Value:** 75 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 96.8 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 96.2 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 114 - **Group ID:** OG001 - **Value:** 95 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 96.6 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 95.9 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 106 - **Group ID:** OG001 - **Value:** 89 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 96.0 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 95.1 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 90 - **Group ID:** OG001 - **Value:** 74 **Units:** Participants #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 4.7 - **Spread:** - **Upper Limit:** 8.83 - **Value:** 6.44 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 6.08 - **Spread:** - **Upper Limit:** 11.09 - **Value:** 8.21 **Title:** #### Outcome Measure 7 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 150.7 - **Spread:** - **Upper Limit:** 252.7 - **Value:** 195.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 186.3 - **Spread:** - **Upper Limit:** 329.3 - **Value:** 247.7 **Title:** #### Outcome Measure 8 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.165 - **Spread:** - **Upper Limit:** 0.237 - **Value:** 0.198 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.181 - **Spread:** - **Upper Limit:** 0.268 - **Value:** 0.22 **Title:** #### Outcome Measure 9 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.9 - **Spread:** - **Upper Limit:** 1.17 - **Value:** 1.03 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.82 - **Spread:** - **Upper Limit:** 1.1 - **Value:** 0.95 **Title:** #### Outcome Measure 10 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 117.2 - **Spread:** - **Upper Limit:** 147.6 - **Value:** 131.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 118.3 - **Spread:** - **Upper Limit:** 150.2 - **Value:** 133.3 **Title:** #### Outcome Measure 11 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 44.8 - **Spread:** - **Upper Limit:** 56.6 - **Value:** 50.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 43.7 - **Spread:** - **Upper Limit:** 57.4 - **Value:** 50.1 **Title:** #### Outcome Measure 12 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 73.2 - **Spread:** - **Upper Limit:** 111.7 - **Value:** 90.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 83.7 - **Spread:** - **Upper Limit:** 136.3 - **Value:** 106.8 **Title:** #### Outcome Measure 13 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 339.4 - **Spread:** - **Upper Limit:** 475.5 - **Value:** 401.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 363.2 - **Spread:** - **Upper Limit:** 537.2 - **Value:** 441.7 **Title:** #### Outcome Measure 14 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 164.9 - **Spread:** - **Upper Limit:** 277.7 - **Value:** 214 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 193.8 - **Spread:** - **Upper Limit:** 343.1 - **Value:** 257.9 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 114 - **Group ID:** OG001 - **Value:** 95 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 288.2 - **Spread:** - **Upper Limit:** 514.9 - **Value:** 385.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 290.6 - **Spread:** - **Upper Limit:** 552.3 - **Value:** 400.6 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 106 - **Group ID:** OG001 - **Value:** 89 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 370.2 - **Spread:** - **Upper Limit:** 681.4 - **Value:** 502.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 284.9 - **Spread:** - **Upper Limit:** 576 - **Value:** 405.1 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 90 - **Group ID:** OG001 - **Value:** 74 **Units:** Participants #### Outcome Measure 15 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 73.7 - **Spread:** - **Upper Limit:** 90.2 - **Value:** 83.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 30.4 - **Spread:** - **Upper Limit:** 51.0 - **Value:** 40.4 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 89 - **Group ID:** OG001 - **Value:** 94 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 30.2 - **Spread:** - **Upper Limit:** 51.4 - **Value:** 40.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 9.2 - **Spread:** - **Upper Limit:** 25.0 - **Value:** 16.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 89 - **Group ID:** OG001 - **Value:** 94 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 96.7 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 92.2 - **Spread:** - **Upper Limit:** 99.4 - **Value:** 97.3 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 111 - **Group ID:** OG001 - **Value:** 111 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 95.0 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 99.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 89.7 - **Spread:** - **Upper Limit:** 98.5 - **Value:** 95.5 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 111 - **Group ID:** OG001 - **Value:** 111 **Units:** Participants #### Outcome Measure 16 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 34.4 - **Spread:** - **Upper Limit:** 73.4 - **Value:** 50.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 5.9 - **Spread:** - **Upper Limit:** 12.9 - **Value:** 8.7 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 89 - **Group ID:** OG001 - **Value:** 94 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2597.4 - **Spread:** - **Upper Limit:** 4086.3 - **Value:** 3257.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 432.7 - **Spread:** - **Upper Limit:** 779.5 - **Value:** 580.8 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 111 - **Group ID:** OG001 - **Value:** 111 **Units:** Participants #### Outcome Measure 17 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 86.3 - **Spread:** - **Upper Limit:** 98.0 - **Value:** 93.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 88.6 - **Spread:** - **Upper Limit:** 98.7 - **Value:** 95.4 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 82 - **Group ID:** OG001 - **Value:** 87 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 43.5 - **Spread:** - **Upper Limit:** 65.9 - **Value:** 54.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 45.3 - **Spread:** - **Upper Limit:** 66.9 - **Value:** 56.3 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 82 - **Group ID:** OG001 - **Value:** 87 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 96.7 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 96.6 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 111 - **Group ID:** OG001 - **Value:** 111 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 95.0 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 99.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 96.6 - **Spread:** - **Upper Limit:** 100.0 - **Value:** 100.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 111 - **Group ID:** OG001 - **Value:** 111 **Units:** Participants #### Outcome Measure 18 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.81 - **Spread:** - **Upper Limit:** 1.45 - **Value:** 1.09 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.90 - **Spread:** - **Upper Limit:** 1.55 - **Value:** 1.18 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 82 - **Group ID:** OG001 - **Value:** 87 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 81.05 - **Spread:** - **Upper Limit:** 123.86 - **Value:** 100.19 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 101.11 - **Spread:** - **Upper Limit:** 144.80 - **Value:** 121.00 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 110 - **Group ID:** OG001 - **Value:** 106 **Units:** Participants #### Outcome Measure 19 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 95.0 - **Spread:** - **Upper Limit:** 99.8 - **Value:** 98.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 92.9 - **Spread:** - **Upper Limit:** 99.2 - **Value:** 97.2 **Title:** #### Outcome Measure 20 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 95.0 - **Spread:** - **Upper Limit:** 99.8 - **Value:** 98.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 92.0 - **Spread:** - **Upper Limit:** 98.8 - **Value:** 96.5 **Title:** #### Outcome Measure 21 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 62.9 - **Spread:** - **Upper Limit:** 78.4 - **Value:** 71.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 56.3 - **Spread:** - **Upper Limit:** 72.6 - **Value:** 64.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 54.9 - **Spread:** - **Upper Limit:** 71.3 - **Value:** 63.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 57.8 - **Spread:** - **Upper Limit:** 73.9 - **Value:** 66.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 42.9 - **Spread:** - **Upper Limit:** 59.9 - **Value:** 51.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 38.8 - **Spread:** - **Upper Limit:** 55.7 - **Value:** 47.2 **Title:** #### Outcome Measure 22 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2.9 - **Spread:** - **Upper Limit:** 11.7 - **Value:** 6.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 6.6 - **Spread:** - **Upper Limit:** 17.7 - **Value:** 11.3 **Title:** #### Outcome Measure 23 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 47.8 - **Spread:** - **Upper Limit:** 64.6 - **Value:** 56.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 37.4 - **Spread:** - **Upper Limit:** 54.3 - **Value:** 45.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 33.3 - **Spread:** - **Upper Limit:** 50.1 - **Value:** 41.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 37.4 - **Spread:** - **Upper Limit:** 54.3 - **Value:** 45.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 28.0 - **Spread:** - **Upper Limit:** 44.4 - **Value:** 35.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 20.9 - **Spread:** - **Upper Limit:** 36.3 - **Value:** 28.2 **Title:** #### Outcome Measure 24 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4.2 **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:** 0.7 **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:** 0.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2.1 **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:** 0.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.7 **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:** 2.1 **Title:** #### Outcome Measure 25 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 85.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 81.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 63.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 64.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 88.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 81.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 11.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 10.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 81.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 78.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 40.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 49.3 **Title:** #### Outcome Measure 26 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 11.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 10.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.0 **Title:** #### Outcome Measure 27 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.6 - **Spread:** - **Upper Limit:** 9.0 - **Value:** 4.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.8 - **Spread:** - **Upper Limit:** 7.1 - **Value:** 2.8 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** The acceptability (i.e., percentage of participants with anti-MCC Ab titre ≥1:8 dil) of the seroprotection rate (SPR) to MCC was determined 1 month after MCC-TT or MCC-CRM Dose 2. The SPR was considered acceptable if the lower bound of the 2-sided 95% CI was \>90%. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. **Reporting Status:** POSTED **Time Frame:** Month 5 (1 month after MCC-TT/MCC-CRM Dose 2) **Title:** Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil One Month After MCC-TT or MCC-CRM (Part 1) **Type:** PRIMARY **Unit of Measure:** Percentage of Participants ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 2 **Description:** The acceptability (i.e., percentage of participants with anti-PRP Ab titre ≥0.15 µg/mL) of the seroprotection rate (SPR) to Haemophilus influenza type b (Hib) was determined 1 month after the third dose of V419 in participants also treated with MCC-TT or MCC-CRM. The pooled (i.e., all V419-treated participants) SPR was considered acceptable if the lower bound of the 2-sided 95% CI was \>80%. Serum Ab levels were determined with radioimmunoassay (RIA). **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. **Reporting Status:** POSTED **Time Frame:** Month 5 (1 month after V419 Dose 3) **Title:** Percentage of Participants With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody (Ab) Titre ≥0.15 µg/mL One Month After V419 Dose 3 (Part 1) **Type:** SECONDARY **Unit of Measure:** Percentage of Participants ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT or MCC-CRM (at 3 and 4 months of age). **ID:** OG000 **Title:** V419 + MCC-TT/MCC-CRM #### Outcome Measure 3 **Description:** The percentage of participants with anti-MCC Ab titres ≥1:8 dil and ≥1:128 dil 1 month after MCC-TT or MCC-CRM Doses 1 and 2 was determined in participants also treated with V419. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. **Reporting Status:** POSTED **Time Frame:** Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2) **Title:** Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1) **Type:** SECONDARY **Unit of Measure:** Percentage of Participants ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 4 **Description:** Anti-MCC antibody GMTs were determined 1 month after MCC-TT or MCC-CRM Doses 1 and 2 in participants also treated with V419. Serum antibody levels were assayed using the Meningo C rabbit complement serum bactericidal antibody (rSBA) assay. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. **Reporting Status:** POSTED **Time Frame:** Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2) **Title:** Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1) **Type:** SECONDARY **Unit of Measure:** Titres ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 5 **Description:** The percentage of participants meeting Ab response rates for V14 antigens was determined after V114 Dose 3. Antibody response rate criteria for Haemophilus influenza Type B (PRP); hepatitis B (HBsAg); diphtheria; tetanus; and polio types 1, 2, and 3 are shown in the rows below. The percentage of seroresponders to pertussis seroresponders (pertussis toxoid \[PT\]; filamentous haemagglutinin (FHA); fimbrae types 2 and 3 \[FIM\]; and pertactin \[PRN\]) was determined as 1) if pre-vaccination Ab concentration \<lower limit of quantification (LLoQ) but post-vaccination Ab concentration ≥LLoQ; or 2) if pre-vaccination Ab concentration was ≥LLoQ but post-vaccination Ab concentration was ≥pre-immunization levels. Antibody titres were measured by RIA for PRP, enhanced chemiluminescence assay (ECi) for HBsAg, micrometabolic inhibition test (MIT) for diphtheria and poliovirus, and enzyme-linked immunosorbent assay (ELISA) for tetanus, PT, FHA, FIM, and PRN. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. **Reporting Status:** POSTED **Time Frame:** Month 5 (1 month after V419 Dose 3) **Title:** Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1) **Type:** SECONDARY **Unit of Measure:** Percentage of Participants ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 6 **Description:** The GMTs for PRP Ab titres were determined for each arm. Antibody titres for PRP were measured by radioimmunoassay (RIA). **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. **Reporting Status:** POSTED **Time Frame:** Month 5 (1 month after V419 Dose 3) **Title:** Antibody (Ab) Geometic Mean Titres (GMTs) for Haemophilus Influenza Type B (Polyribosylribitol Phosphate [PRP]) One Month After V114 Dose 3 (Part 2) **Type:** SECONDARY **Unit of Measure:** µg/mL ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 7 **Description:** The GMTs for HBsAg Ab titres were determined for each arm. Antibody titres for HBsAg were measured by enhanced chemiluminescence (ECi) assay. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. **Reporting Status:** POSTED **Time Frame:** Month 5 (1 month after V419 Dose 3) **Title:** Antibody (Ab) Geometic Mean Titres (GMTs) for Hepatitis B Surface Antigen (HBsAg) One Month After V114 Dose 3 (Part 2) **Type:** SECONDARY **Unit of Measure:** mIU/mL ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 8 **Description:** The GMTs for diphtheria Ab titres were determined for each arm. Antibody titres for diptheria were measured by enhanced micrometabolic inhibition test (MIT). **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. **Reporting Status:** POSTED **Time Frame:** Month 5 (1 month after V419 Dose 3) **Title:** Antibody (Ab) Geometic Mean Titres (GMTs) for Diptheria One Month After V114 Dose 3 (Part 2) **Type:** SECONDARY **Unit of Measure:** IU/mL ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 9 **Description:** The GMTs for tetanus Ab titres were determined for each arm. Antibody titres for tetanus were determined with enzyme-linked immunosorbent assay (ELISA). **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. **Reporting Status:** POSTED **Time Frame:** Month 5 (1 month after V419 Dose 3) **Title:** Antibody (Ab) Geometic Mean Titres (GMTs) for Tetanus One Month After V114 Dose 3 (Part 2) **Type:** SECONDARY **Unit of Measure:** IU/mL ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 10 **Description:** The GMTs for PT Ab titres were determined for each arm. Antibody titres for PT were measured with enzyme-linked immunosorbent assay (ELISA). **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. **Reporting Status:** POSTED **Time Frame:** Month 5 (1 month after V419 Dose 3) **Title:** Antibody (Ab) Geometic Mean Titres (GMTs) for Pertussis Toxoid (PT) One Month After V114 Dose 3 (Part 2) **Type:** SECONDARY **Unit of Measure:** EU/mL ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 11 **Description:** The GMTs for FHA were determined for each arm. Antibody titres for FHA were measured by enhanced chemiluminescence (ECi) assay. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. **Reporting Status:** POSTED **Time Frame:** Month 5 (1 month after V419 Dose 3) **Title:** Antibody (Ab) Geometic Mean Titres (GMTs) for Filamentous Haemagglutinin (FHA) One Month After V114 Dose 3 (Part 2) **Type:** SECONDARY **Unit of Measure:** EU/mL ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 12 **Description:** The GMTs for PRN were determined for each arm. Antibody titres for PRN were measured by enhanced chemiluminescence (ECi) assay. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. **Reporting Status:** POSTED **Time Frame:** Month 5 (1 month after V419 Dose 3) **Title:** Antibody (Ab) Geometic Mean Titres (GMTs) for Pertactin (PRN) One Month After V114 Dose 3 (Part 2) **Type:** SECONDARY **Unit of Measure:** EU/mL ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 13 **Description:** The GMTs for FIM were determined for each arm. Antibody titres for FIM were measured by enhanced chemiluminescence (ECi) assay. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. **Reporting Status:** POSTED **Time Frame:** Month 5 (1 month after V419 Dose 3) **Title:** Antibody (Ab) Geometic Mean Titres (GMTs) for Fimbrae Types 2 and 3 (FIM) One Month After V114 Dose 3 (Part 2) **Type:** SECONDARY **Unit of Measure:** EU/mL ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 14 **Description:** The GMTs for polio types 1, 2, and 3 were determined for each arm. Antibody titres for polio types 1, 2, and 3 were measured by micrometabolic inhibition test (MIT). **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. **Reporting Status:** POSTED **Time Frame:** Month 5 (1 month after V419 Dose 3) **Title:** Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2) **Type:** SECONDARY **Unit of Measure:** titre (1/dil) ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 15 **Description:** The percentage of participants with anti-Hib Ab titres ≥1:8 (1/dil) and ≥1:28 (1/dil) were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** All randomized and treated participants with data available, who had no protocol violations that could interfere with results, and received all Part 1 vaccinations are included. **Reporting Status:** POSTED **Time Frame:** Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC) **Title:** Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2) **Type:** SECONDARY **Unit of Measure:** Percentage of Participants ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 16 **Description:** Antibody GMTs were were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** All randomized and treated participants with data available, who had no protocol violations that could interfere with results, and received all Part 1 vaccinations are included. **Reporting Status:** POSTED **Time Frame:** Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC) **Title:** Antibody (Ab) Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Meningococcal Serogroup C (MCC) Vaccination (Part 2) **Type:** SECONDARY **Unit of Measure:** tire (1/dil) ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 17 **Description:** The percentage of participants with anti-PRP Ab titres ≥0.15 µg/mL and ≥1.0 µg/mL was determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA). **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. **Reporting Status:** POSTED **Time Frame:** Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2) **Title:** Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2) **Type:** SECONDARY **Unit of Measure:** Percentage of Participants ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 18 **Description:** Anti-PRP Ab GMTs were determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA) and are expressed as µg/mL.. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** GEOMETRIC_MEAN **Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. **Reporting Status:** POSTED **Time Frame:** Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2) **Title:** Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2) **Type:** SECONDARY **Unit of Measure:** µg/mL ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 19 **Description:** An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** All randomized participants who received ≥1 dose of study medication in Part 1 are included. **Reporting Status:** POSTED **Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination) **Title:** Percentage of Participants Experiencing an Adverse Event (AE) [Part 1] **Type:** SECONDARY **Unit of Measure:** Percentage of Participants ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 20 **Description:** An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. As per protocol, all injection site AEs were considered vaccine-related. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** All randomized participants who received ≥1 dose of study medication in Part 1 are included. **Reporting Status:** POSTED **Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination) **Title:** Percentage of Participants Experiencing an Injection Site (Vaccine-Related) Systemic Adverse Event (AE) [Part 1] **Type:** SECONDARY **Unit of Measure:** Percentage of Participants ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 21 **Description:** The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** All randomized participants who received ≥1 dose of study medication in Part 1 are included. **Reporting Status:** POSTED **Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination) **Title:** Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1) **Type:** SECONDARY **Unit of Measure:** Percentage of Participants ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 22 **Description:** The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs were any injection-site ISRs not considered solicited. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** All randomized participants who received ≥1 dose of study medication in Part 1 are included. **Reporting Status:** POSTED **Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination) **Title:** Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1) **Type:** SECONDARY **Unit of Measure:** Percentage of Participants ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 23 **Description:** The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** All randomized participants who received ≥1 dose of study medication in Part 1 are included. **Reporting Status:** POSTED **Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination) **Title:** Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1) **Type:** SECONDARY **Unit of Measure:** Percentage of Participants ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 24 **Description:** The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs consisted of bruising, dermatitis, erythema, induration, mass, pain, rash, and warmth. **Parameter Type:** NUMBER **Population Description:** All randomized participants who received ≥1 dose of study medication in Part 1 are included. **Reporting Status:** POSTED **Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination) **Title:** Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1) **Type:** SECONDARY **Unit of Measure:** Percentage of Participants ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 25 **Description:** The percentage of participants with solicited systemic AEs was determined for each arm. Solicited systemic AEs consisted of crying, decreased appetite, irritability, pyrexia, somnolence, and vomiting. **Parameter Type:** NUMBER **Population Description:** All randomized participants who received ≥1 dose of study medication in Part 1 are included. **Reporting Status:** POSTED **Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination) **Title:** Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1] **Type:** SECONDARY **Unit of Measure:** Percentage of Participants ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 26 **Description:** The percentage of participants experiencing temperatures ≥38.0° Celsius (C), \>38.5° C, and \>39.5° C following any Part 1 vaccination was determined. **Parameter Type:** NUMBER **Population Description:** All randomized participants who received ≥1 dose of study medication in Part 1 are included. **Reporting Status:** POSTED **Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination) **Title:** Percentage of Participants Experiencing Increased Temperature [Part 1] **Type:** SECONDARY **Unit of Measure:** Percentage of Participants ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM #### Outcome Measure 27 **Description:** An SAE is an event that results in death; is life-threatening; results in or prolongs hospitalization; is a congenital anomaly/birth defect; is a cancer; is an overdose; or is another important medical event that may jeopardize the participant. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** All randomized participants who received ≥1 dose of study medication in Part 1 are included. **Reporting Status:** POSTED **Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination) **Title:** Percentage of Participants Experiencing a Serious Adverse Event (SAE) [Part 1] **Type:** SECONDARY **Unit of Measure:** Percentage of Participants ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG000 **Title:** V419 and MCC-TT ##### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** OG001 **Title:** V419 and MCC-CRM ### Participant Flow Module #### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** FG000 **Title:** V419 and MCC-TT #### Group **Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). **ID:** FG001 **Title:** V419 and MCC-CRM #### Period **Title:** Part 1 (Infant Vaccinations) ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ##### Milestone **Type:** STARTED **Comment:** Number Randomized ###### Achievement **Group ID:** FG000 **Number of Subjects:** 142 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 142 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 140 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 141 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 1 #### Period **Title:** Interim Period ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ###### Reason **Group ID:** FG001 **Number of Subjects:** 2 ##### Withdraw **Type:** Lost to Follow-up ###### 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:** 140 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 141 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 137 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 139 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 2 #### Period **Title:** Period 2: Toddler Vaccinations ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 0 ###### Reason **Group ID:** FG001 **Number of Subjects:** 5 ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 3 ###### Reason **Group ID:** FG001 **Number of Subjects:** 2 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 137 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 139 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 134 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 132 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 7 **Recruitment Details:** Infant participants were enrolled at 11 study sites in the United Kingdom. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT01571479 **Brief Title:** The Feasibility and Safety of a Three-Port Laparoscopic Cholecystectomy Using a 2-mm Mini-Instrument **Official Title:** The Feasibility and Safety of a Three-Port Laparoscopic Cholecystectomy Using a 2-mm Mini-Instrument #### Organization Study ID Info **ID:** 2012-026 #### Organization **Class:** OTHER **Full Name:** Inje University ### Status Module #### Completion Date **Date:** 2012-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2012-04-05 **Type:** ESTIMATED **Last Update Submit Date:** 2012-04-03 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2011-04 **Type:** ACTUAL #### Start Date **Date:** 2010-04 **Status Verified Date:** 2012-04 #### Study First Post Date **Date:** 2012-04-05 **Type:** ESTIMATED **Study First Submit Date:** 2012-03-31 **Study First Submit QC Date:** 2012-04-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Inje University #### Responsible Party **Investigator Affiliation:** Inje University **Investigator Full Name:** Kwan Woo Kim **Investigator Title:** Haeundae paik hospital **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this study was to show that this technique is feasible, safe and easily reproducible and to evaluate the selection criteria for a three-port laparoscopic cholecystectomy using a 2-mm mini-port. **Detailed Description:** Since the first four-port laparoscopic cholecystectomy (LC) was reported in 1987, various surgical options for LC have been developed. Recently, single port LC (SPLC) has been increasingly performed to minimize tissue trauma, improve cosmesis and decrease postoperative pain for patients. Some surgeons suggest that the four- or three-port LC using mini-ports could be as safe, effective, economical and cosmetic as SPLC. For this reason, the investigators started M-LC for patients with benign gallbladder disease in April 2010. Prospectively collected data from 133 patients who underwent LC for benign gallbladder disease between April 2010 and April 2011 were retrospectively reviewed. The patient's selection for M-LC was determined by surgeon's judgment based on 'laparoscopic surgical view' after inserting the laparoscope in the operating room. ### Conditions Module **Conditions:** - Gallbladder Disease **Keywords:** - laparoscopic cholecystectomy - mini-instrument ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 133 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** M-LC is three-port laparoscopic cholecystectomy using a 2-mm mini-instrument. **Intervention Names:** - Procedure: 2- mini-instrument **Label:** 2-mm mini-instrument (M-LC) **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** C-LC is conventional three port laparoscopic cholecystectomy **Label:** conventional instrument(C-LC) **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - 2-mm mini-instrument (M-LC) **Description:** The patient was positioned in the supine position with the head and right side up. Under general anesthesia, pneumoperitoneum (12 mmHg) was established after an 11-mm port was placed through 11-mm transumbilical incision by the open method. A 10-mm 0-degree laparoscope was inserted through this umbilical port. A 5-mm trocar was then placed in the epigastric area, and the surgeon determined through 'laparoscopic surgical view' whether the 2-mm mini-instrument could be used as the right subcostal port . If the 2-mm mini-instrument could be used as the right subcostal port, a 2-mm trocar was inserted . If not, a 5-mm trocar was inserted for the right subcostal port. Therefore, this point is the unique difference between the two groups. **Name:** 2- mini-instrument **Other Names:** - micro-instrument **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** Number of participants with complications or open conversion to M-LC **Time Frame:** one year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * all patients required laparoscopic cholecystectomy for benign gallbladder diseases. Exclusion Criteria: * open cholecystectomy **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Busan **Country:** Korea, Republic of **Facility:** University of Inje College of Medicine, Haeundae Paik Hopsital **Zip:** 612-030 #### Overall Officials **Official 1:** **Affiliation:** University of Inje College of Medicine, Haeundae Paik Hopsital **Name:** kwan woo kim **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Aprea G, Coppola Bottazzi E, Guida F, Masone S, Persico G. Laparoendoscopic single site (LESS) versus classic video-laparoscopic cholecystectomy: a randomized prospective study. J Surg Res. 2011 Apr;166(2):e109-12. doi: 10.1016/j.jss.2010.11.885. Epub 2010 Dec 22. **PMID:** 21227454 **Citation:** Bisgaard T, Klarskov B, Trap R, Kehlet H, Rosenberg J. Microlaparoscopic vs conventional laparoscopic cholecystectomy: a prospective randomized double-blind trial. Surg Endosc. 2002 Mar;16(3):458-64. doi: 10.1007/s00464-001-9026-5. Epub 2001 Nov 16. **PMID:** 11928028 **Citation:** Chow A, Purkayastha S, Aziz O, Pefanis D, Paraskeva P. Single-incision laparoscopic surgery for cholecystectomy: a retrospective comparison with 4-port laparoscopic cholecystectomy. Arch Surg. 2010 Dec;145(12):1187-91. doi: 10.1001/archsurg.2010.267. **PMID:** 21173293 **Citation:** Curcillo PG 2nd, Wu AS, Podolsky ER, Graybeal C, Katkhouda N, Saenz A, Dunham R, Fendley S, Neff M, Copper C, Bessler M, Gumbs AA, Norton M, Iannelli A, Mason R, Moazzez A, Cohen L, Mouhlas A, Poor A. Single-port-access (SPA) cholecystectomy: a multi-institutional report of the first 297 cases. Surg Endosc. 2010 Aug;24(8):1854-60. doi: 10.1007/s00464-009-0856-x. Epub 2010 Feb 5. **PMID:** 20135180 **Citation:** Edwards C, Bradshaw A, Ahearne P, Dematos P, Humble T, Johnson R, Mauterer D, Soosaar P. Single-incision laparoscopic cholecystectomy is feasible: initial experience with 80 cases. Surg Endosc. 2010 Sep;24(9):2241-7. doi: 10.1007/s00464-010-0943-z. Epub 2010 Mar 3. **PMID:** 20198490 **Citation:** Elsey JK, Feliciano DV. Initial experience with single-incision laparoscopic cholecystectomy. J Am Coll Surg. 2010 May;210(5):620-4, 624-6. doi: 10.1016/j.jamcollsurg.2009.12.030. **PMID:** 20421017 **Citation:** Franklin ME Jr, Jaramillo EJ, Glass JL, Trevino JM, Berghoff KR. Needlescopic cholecystectomy: lessons learned in 10 years of experience. JSLS. 2006 Jan-Mar;10(1):43-6. **PMID:** 16709356 **Citation:** Gagner M, Garcia-Ruiz A. Technical aspects of minimally invasive abdominal surgery performed with needlescopic instruments. Surg Laparosc Endosc. 1998 Jun;8(3):171-9. **PMID:** 9649038 ## Annotation Section ### Unposted Annotation #### Event: RELEASE - Date: 2012-04-05 - Date Unknown: Unknown #### Event: RESET - Date: 2012-05-02 - Date Unknown: Unknown ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001660 - Term: Biliary Tract Diseases - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M8823 - Name: Gallbladder Diseases - Relevance: HIGH - As Found: Gallbladder Diseases - ID: M4946 - Name: Biliary Tract 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 ### Condition Browse Module - Meshes - ID: D000005705 - Term: Gallbladder Diseases ### 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 #### Submission Tracking - Estimated Results First Submit Date: 2012-04-05 ##### Submission Infos - MCP Release N: Unknown - Release Date: 2012-04-05 - Reset Date: 2012-05-02 - Unrelease Date: Unknown - Unrelease Date Unknown: Unknown - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04452279 **Brief Title:** Ocular Surface Disease Changes After iStent or iStent Inject Implantation With Phacoemulsification **Official Title:** Prospective Study of Ocular Surface Disease Changes After iStent or iStent Inject Trabecular Micro-Bypass Implantation With Cataract Surgery #### Organization Study ID Info **ID:** The OSD iStent Study #### Organization **Class:** OTHER **Full Name:** Vance Thompson Vision ### Status Module #### Completion Date **Date:** 2019-08-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-06-30 **Type:** ACTUAL **Last Update Submit Date:** 2020-06-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-03-01 **Type:** ACTUAL #### Start Date **Date:** 2018-05-01 **Type:** ACTUAL **Status Verified Date:** 2020-06 #### Study First Post Date **Date:** 2020-06-30 **Type:** ACTUAL **Study First Submit Date:** 2020-06-24 **Study First Submit QC Date:** 2020-06-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Vance Thompson Vision #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** This prospective interventional single-arm trial evaluates measures changes in ocular surface disease parameters in eyes with mild to moderate open-angle glaucoma (OAG) on 1-4 glaucoma medications who undergo phacoemulsification and trabecular micro-bypass stent(s) implantation (iStent or iStent inject). **Detailed Description:** This study enrolled eyes with mild to moderate open-angle glaucoma (OAG) on 1-4 glaucoma medications who were scheduled to undergo phacoemulsification cataract extraction and trabecular micro-bypass stent(s) implantation (iStent or iStent inject). Study participation entailed measurement of key ocular surface data through 3 months postoperative including Ocular Surface Disease Index score (OSDI), corneal/conjunctival staining (Oxford Schema), fluorescein tear break-up time (FTBUT), and conjunctival hyperemia (Efron Scale); these measures were collected alongside standard postoperative glaucoma evaluations such as number of glaucoma medications and intraocular pressure (IOP). ### Conditions Module **Conditions:** - Ocular Surface Disease - Glaucoma, Open-Angle **Keywords:** - ocular surface - dry eye - medication - quality of life ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 47 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Eyes will undergo phacoemulsification cataract surgery combined with iStent or iStent inject implantation according to standard clinical practice. From baseline through 3 months postoperatively, participants will complete subjective and objective assessments of ocular surface disease. **Intervention Names:** - Device: iStent or iStent inject implantation with concomitant cataract surgery **Label:** Ocular Surface Disease post-stenting **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Ocular Surface Disease post-stenting **Description:** Standard phacoemulsification cataract surgery followed by ab interno implantation of either iStent or iStent inject trabecular micro-bypass stent(s). Preoperatively and at specified visits through 3 months postoperative, patients will complete evaluations of their ocular surface disease (specifically OSDI score, hyperemia, corneal/conjunctival staining, and tear break-up time). **Name:** iStent or iStent inject implantation with concomitant cataract surgery **Other Names:** - iStent or iStent inject **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Difference between preoperative and Month 3 mean OSDI score **Measure:** Change in mean OSDI score **Time Frame:** 3 months **Description:** Difference between preoperative and Month 3 mean Efron score of conjunctival hyperemia **Measure:** Change in mean conjunctival hyperemia score **Time Frame:** 3 months **Description:** Difference between preoperative and Month 3 mean Oxford score of corneal/conjunctival hyperemia **Measure:** Change in mean corneal/conjunctival staining score **Time Frame:** 3 months **Description:** Difference between preoperative and Month 3 mean FTBUT in seconds **Measure:** Change in mean fluorescein tear break-up time (FTBUT) **Time Frame:** 3 months #### Secondary Outcomes **Description:** Difference between preoperative and Month 3 mean IOP in mmHg **Measure:** IOP change **Time Frame:** 3 months **Description:** Difference between preoperative and Month 3 mean number of glaucoma medications **Measure:** Medication change **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Mild to moderate primary open-angle glaucoma 2. Currently treated with ocular hypotensive medication 3. Primary open-angle, pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses 4. Subject scheduled to undergo cataract surgery in combination with one trabecular meshwork bypass stent 5. 22 years of age or older 6. Able and willing to attend scheduled follow-up exams for three months postoperatively 7. Able and willing to provide written informed consent on the IRB approved Informed Consent Form 8. Successful, uncomplicated cataract surgery 9. OSDI of 8 or more Exclusion Criteria: * 1. Primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma 2. Any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated: 1. Cataract surgery 2. Stent implantation 3. Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits) 3. Fellow eye actively enrolled in this trial 4. Current participation in any study, or participation within 30 calendar days of screening exam 5. Unsuccessful, complicated cataract surgery 6. OSDI of 7 or less **Minimum Age:** 22 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Sioux Falls **Country:** United States **Facility:** Vance Thompson Vision **State:** South Dakota **Zip:** 57108 #### Overall Officials **Official 1:** **Affiliation:** Vance Thompson Vision **Name:** Justin Schweitzer, OD, FAAO **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Schweitzer JA, Hauser WH, Ibach M, Baartman B, Gollamudi SR, Crothers AW, Linn JE, Berdahl JP. Prospective Interventional Cohort Study of Ocular Surface Disease Changes in Eyes After Trabecular Micro-Bypass Stent(s) Implantation (iStent or iStent inject) with Phacoemulsification. Ophthalmol Ther. 2020 Dec;9(4):941-953. doi: 10.1007/s40123-020-00290-6. Epub 2020 Aug 13. **PMID:** 32789800 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005901 - Term: Glaucoma - ID: D000009798 - Term: Ocular Hypertension - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M5638 - Name: Cataract - Relevance: LOW - As Found: Unknown - ID: M18040 - Name: Dry Eye Syndromes - Relevance: LOW - As Found: Unknown - ID: M10664 - Name: Keratoconjunctivitis Sicca - Relevance: LOW - As Found: Unknown - ID: M9013 - Name: Glaucoma - Relevance: LOW - As Found: Unknown - ID: M9014 - Name: Glaucoma, Open-Angle - Relevance: HIGH - As Found: Glaucoma, Open-Angle - ID: M10024 - Name: Hypertension - Relevance: LOW - As Found: Unknown - ID: M12731 - Name: Ocular Hypertension - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005902 - Term: Glaucoma, Open-Angle ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01754779 **Brief Title:** Treatment for Calcium Phosphate Kidney Stone Disease **Official Title:** Pharmacological Therapy for Calcium Phosphate Urolithiasis #### Organization Study ID Info **ID:** 032012-058 #### Organization **Class:** OTHER **Full Name:** University of Texas Southwestern Medical Center #### Secondary ID Infos **ID:** R21DK097476-01 **Link:** https://reporter.nih.gov/quickSearch/R21DK097476-01 **Type:** NIH ### Status Module #### Completion Date **Date:** 2023-02-16 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-04-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-03-07 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-02-16 **Type:** ACTUAL #### Results First Post Date **Date:** 2024-04-04 **Type:** ACTUAL **Results First Submit Date:** 2024-01-23 **Results First Submit QC Date:** 2024-03-07 #### Start Date **Date:** 2012-07 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2012-12-21 **Type:** ESTIMATED **Study First Submit Date:** 2012-12-14 **Study First Submit QC Date:** 2012-12-18 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) #### Lead Sponsor **Class:** OTHER **Name:** University of Texas Southwestern Medical Center #### Responsible Party **Investigator Affiliation:** University of Texas Southwestern Medical Center **Investigator Full Name:** Naim Maalouf **Investigator Title:** Associate Professor of Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The investigators will examine in two studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of Calcium Phosphate stone formers. **Detailed Description:** We will examine in two short-term placebo-controlled cross-over metabolic studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of CaP stone formers. The first study will be conducted in hypocitraturic CaP stone formers without hypercalciuria, and will compare the effects of potassium citrate, citric acid and placebo. The second study will be conducted in hypercalciuric CaP stone formers on a thiazide diuretic who require potassium supplementation, and will compare the effects of potassium chloride alone, potassium chloride + citric acid, and potassium citrate alone. Physicochemical assays will be applied in addition to computer-based stone risk prediction programs to assess risk of stone recurrence. ### Conditions Module **Conditions:** - Calcium Phosphate Kidney Stones **Keywords:** - calcium phosphate - urolithiasis - kidney stones - hypercalciuria ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 13 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) **Intervention Names:** - Dietary Supplement: Placebo - Dietary Supplement: Citric Acid - Dietary Supplement: Potassium Citrate **Label:** Placebo, then Citric Acid, then Potassium Citrate **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) **Intervention Names:** - Dietary Supplement: Placebo - Dietary Supplement: Citric Acid - Dietary Supplement: Potassium Citrate **Label:** Placebo, then Potassium Citrate, then Citric Acid **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) **Intervention Names:** - Dietary Supplement: Placebo - Dietary Supplement: Citric Acid - Dietary Supplement: Potassium Citrate **Label:** Potassium Citrate, then Placebo, then Citric Acid **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) **Intervention Names:** - Dietary Supplement: Placebo - Dietary Supplement: Citric Acid - Dietary Supplement: Potassium Citrate **Label:** Potassium Citrate, then Citric Acid, then Placebo **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) **Intervention Names:** - Dietary Supplement: Placebo - Dietary Supplement: Citric Acid - Dietary Supplement: Potassium Citrate **Label:** Citric Acid, then Potassium Citrate, then Placebo **Type:** EXPERIMENTAL #### Arm Group 6 **Description:** Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) **Intervention Names:** - Dietary Supplement: Placebo - Dietary Supplement: Citric Acid - Dietary Supplement: Potassium Citrate **Label:** Citric Acid, then Placebo, then Potassium Citrate **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Citric Acid, then Placebo, then Potassium Citrate - Citric Acid, then Potassium Citrate, then Placebo - Placebo, then Citric Acid, then Potassium Citrate - Placebo, then Potassium Citrate, then Citric Acid - Potassium Citrate, then Citric Acid, then Placebo - Potassium Citrate, then Placebo, then Citric Acid **Description:** 3 tablets twice daily of matching placebo during the placebo phase. **Name:** Placebo **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Citric Acid, then Placebo, then Potassium Citrate - Citric Acid, then Potassium Citrate, then Placebo - Placebo, then Citric Acid, then Potassium Citrate - Placebo, then Potassium Citrate, then Citric Acid - Potassium Citrate, then Citric Acid, then Placebo - Potassium Citrate, then Placebo, then Citric Acid **Description:** 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) **Name:** Citric Acid **Type:** DIETARY_SUPPLEMENT #### Intervention 3 **Arm Group Labels:** - Citric Acid, then Placebo, then Potassium Citrate - Citric Acid, then Potassium Citrate, then Placebo - Placebo, then Citric Acid, then Potassium Citrate - Placebo, then Potassium Citrate, then Citric Acid - Potassium Citrate, then Citric Acid, then Placebo - Potassium Citrate, then Placebo, then Citric Acid **Description:** 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) **Name:** Potassium Citrate **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** This variable represents a ratio of the calcium phosphate saturation in a given urine sample to the calcium phosphate saturation at the point of precipitation and hence this measure has no units. **Measure:** Urinary Calcium Phosphate Saturation **Time Frame:** 2 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Aim 1 * Hypocitraturic CaP stone formers * urine citrate \<320mg/d * elevated pH as 24-hr urine pH above 6.40 * \>21 years Aim 2 * Hypercalciuric CaP stone formers * 24hr urine calcium \>250mg/d in women and \>300mg/d in men prior to indapamide use * high pH as \>6.40 in the absence of urinary tract infection * \>21 years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Dallas **Country:** United States **Facility:** UT Southwestern Medical Center **State:** Texas **Zip:** 75390-8885 #### Overall Officials **Official 1:** **Affiliation:** UT Southwestern Medical Center **Name:** Naim M Maalouf, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Doizi S, Poindexter JR, Pearle MS, Blanco F, Moe OW, Sakhaee K, Maalouf NM. Impact of Potassium Citrate vs Citric Acid on Urinary Stone Risk in Calcium Phosphate Stone Formers. J Urol. 2018 Dec;200(6):1278-1284. doi: 10.1016/j.juro.2018.07.039. Epub 2018 Jul 20. **PMID:** 30036516 ## Document Section ### Large Document Module #### Large Docs - Date: 2018-02-21 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 378271 - Type Abbrev: Prot_SAP - Upload Date: 2024-01-22T18:04 - Date: 2018-04-23 - Filename: ICF_001.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 171715 - Type Abbrev: ICF - Upload Date: 2024-01-22T18:08 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002137 - Term: Calculi - ID: D000020763 - Term: Pathological Conditions, Anatomical - 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: D000052878 - Term: Urolithiasis - ID: D000014545 - Term: Urinary Calculi - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10693 - Name: Kidney Calculi - Relevance: HIGH - As Found: Kidney Stone - ID: M27103 - Name: Urolithiasis - Relevance: LOW - As Found: Unknown - ID: M17295 - Name: Urinary Calculi - Relevance: LOW - As Found: Unknown - ID: M5399 - Name: Calculi - Relevance: LOW - As Found: Unknown - ID: M27126 - Name: Nephrolithiasis - Relevance: HIGH - As Found: Kidney Stone - ID: M27341 - Name: Hypercalciuria - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney Diseases - 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 ### Condition Browse Module - Meshes - ID: D000007669 - Term: Kidney Calculi - ID: D000053040 - Term: Nephrolithiasis ### Intervention Browse Module - Ancestors - ID: D000000925 - Term: Anticoagulants - ID: D000065096 - Term: Calcium Chelating Agents - ID: D000002614 - Term: Chelating Agents - ID: D000064449 - Term: Sequestering Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000004232 - Term: Diuretics - ID: D000045283 - Term: Natriuretic Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000005100 - Term: Expectorants - ID: D000019141 - Term: Respiratory System Agents ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: BDCA - Name: Bone Density Conservation Agents - Abbrev: NaAg - Name: Natriuretic Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M5381 - Name: Calcium - Relevance: LOW - As Found: Unknown - ID: M21320 - Name: Citric Acid - Relevance: HIGH - As Found: Intravenous fluid - ID: M1837 - Name: Sodium Citrate - Relevance: HIGH - As Found: Intravenous fluid - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown - ID: M21334 - Name: Potassium Citrate - Relevance: HIGH - As Found: Calcification - ID: M4244 - Name: Anticoagulants - Relevance: LOW - As Found: Unknown - ID: M5860 - Name: Chelating Agents - Relevance: LOW - As Found: Unknown - ID: M7411 - Name: Diuretics - Relevance: LOW - As Found: Unknown - ID: M8243 - Name: Expectorants - Relevance: LOW - As Found: Unknown - ID: M21137 - Name: Respiratory System Agents - Relevance: LOW - As Found: Unknown - ID: T382 - Name: Citrate - Relevance: HIGH - As Found: Free ### Intervention Browse Module - Meshes - ID: D000019357 - Term: Potassium Citrate - ID: D000019343 - Term: Citric Acid - ID: D000077559 - Term: Sodium Citrate ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Placebo **Deaths Num At Risk:** 13 **Description:** Placebo tablets twice daily Placebo: Matching placebo for both aims. **ID:** EG000 **Other Num at Risk:** 13 **Serious Number At Risk:** 13 **Title:** Placebo **Group ID:** EG001 **Title:** Citric Acid **Deaths Num At Risk:** 13 **Description:** Citric acid tablets twice daily Citric Acid **ID:** EG001 **Other Num at Risk:** 13 **Serious Number At Risk:** 13 **Title:** Citric Acid **Group ID:** EG002 **Title:** Potassium Citrate **Deaths Num At Risk:** 13 **Description:** Potassium Citrate tablets twice daily Potassium Citrate **ID:** EG002 **Other Num at Risk:** 13 **Serious Number At Risk:** 13 **Title:** Potassium Citrate **Frequency Threshold:** 0 **Time Frame:** 5 weeks ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 2 **Group ID:** BG001 **Value:** 1 **Group ID:** BG002 **Value:** 2 **Group ID:** BG003 **Value:** 3 **Group ID:** BG004 **Value:** 3 **Group ID:** BG005 **Value:** 2 **Group ID:** BG006 **Value:** 13 **Units:** Participants ### Group **ID:** BG000 **Title:** Placebo, Then Citric Acid, Then Potassium Citrate **Description:** Placebo: 3 tablets twice daily of matching placebo during the placebo phase. Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) ### Group **ID:** BG001 **Title:** Placebo, Then Potassium Citrate, Then Citric Acid **Description:** Placebo: 3 tablets twice daily of matching placebo during the placebo phase. Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) ### Group **ID:** BG002 **Title:** Potassium Citrate, Then Placebo, Then Citric Acid **Description:** Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) Placebo: 3 tablets twice daily of matching placebo during the placebo phase. Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) ### Group **ID:** BG003 **Title:** Potassium Citrate, Then Citric Acid, Then Placebo **Description:** Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) Placebo: 3 tablets twice daily of matching placebo during the placebo phase. ### Group **ID:** BG004 **Title:** Citric Acid, Then Potassium Citrate, Then Placebo **Description:** Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) Placebo: 3 tablets twice daily of matching placebo during the placebo phase. ### Group **ID:** BG005 **Title:** Citric Acid, Then Placebo, Then Potassium Citrate **Description:** Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) Placebo: 3 tablets twice daily of matching placebo during the placebo phase. Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) ### Group **ID:** BG006 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 9.2 **Value:** 35.9 #### Measurement **Group ID:** BG001 **Value:** 34.8 #### Measurement **Group ID:** BG002 **Spread:** 27.9 **Value:** 49.2 #### Measurement **Group ID:** BG003 **Spread:** 24.5 **Value:** 41.4 #### Measurement **Group ID:** BG004 **Spread:** 11.8 **Value:** 45.6 #### Measurement **Group ID:** BG005 **Spread:** 1.3 **Value:** 35.6 #### Measurement **Group ID:** BG006 **Spread:** 15 **Value:** 41 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 2 #### Measurement **Group ID:** BG003 **Value:** 2 #### Measurement **Group ID:** BG004 **Value:** 3 #### Measurement **Group ID:** BG005 **Value:** 2 #### Measurement **Group ID:** BG006 **Value:** 11 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 #### Measurement **Group ID:** BG003 **Value:** 1 #### Measurement **Group ID:** BG004 **Value:** 0 #### Measurement **Group ID:** BG005 **Value:** 0 #### Measurement **Group ID:** BG006 **Value:** 2 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 #### Measurement **Group ID:** BG003 **Value:** 0 #### Measurement **Group ID:** BG004 **Value:** 2 #### Measurement **Group ID:** BG005 **Value:** 0 #### Measurement **Group ID:** BG006 **Value:** 2 **Class Title:** Black #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 2 #### Measurement **Group ID:** BG003 **Value:** 3 #### Measurement **Group ID:** BG004 **Value:** 1 #### Measurement **Group ID:** BG005 **Value:** 2 #### Measurement **Group ID:** BG006 **Value:** 11 **Class Title:** White #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 1 #### Measurement **Group ID:** BG003 **Value:** 1 #### Measurement **Group ID:** BG004 **Value:** 0 #### Measurement **Group ID:** BG005 **Value:** 0 #### Measurement **Group ID:** BG006 **Value:** 4 **Class Title:** Hispanic #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 1 #### Measurement **Group ID:** BG003 **Value:** 2 #### Measurement **Group ID:** BG004 **Value:** 3 #### Measurement **Group ID:** BG005 **Value:** 2 #### Measurement **Group ID:** BG006 **Value:** 8 **Class Title:** Non-Hispanic ### Measure #### Measurement **Group ID:** BG000 **Spread:** 0.13 **Value:** 1.66 #### Measurement **Group ID:** BG001 **Value:** 1.58 #### Measurement **Group ID:** BG002 **Spread:** 0.02 **Value:** 1.56 #### Measurement **Group ID:** BG003 **Spread:** 0.18 **Value:** 1.63 #### Measurement **Group ID:** BG004 **Spread:** 0.06 **Value:** 1.69 #### Measurement **Group ID:** BG005 **Spread:** 0.05 **Value:** 1.64 #### Measurement **Group ID:** BG006 **Spread:** 0.10 **Value:** 1.63 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 3.4 **Value:** 74.2 #### Measurement **Group ID:** BG001 **Value:** 89.0 #### Measurement **Group ID:** BG002 **Spread:** 18.0 **Value:** 70.3 #### Measurement **Group ID:** BG003 **Spread:** 16.0 **Value:** 56.7 #### Measurement **Group ID:** BG004 **Spread:** 11.0 **Value:** 91.4 #### Measurement **Group ID:** BG005 **Spread:** 7.4 **Value:** 53.8 #### Measurement **Group ID:** BG006 **Spread:** 18.5 **Value:** 71.6 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 2.8 **Value:** 26.9 #### Measurement **Group ID:** BG001 **Value:** 35.9 #### Measurement **Group ID:** BG002 **Spread:** 8.0 **Value:** 28.9 #### Measurement **Group ID:** BG003 **Spread:** 2.7 **Value:** 21.2 #### Measurement **Group ID:** BG004 **Spread:** 2.1 **Value:** 32.1 #### Measurement **Group ID:** BG005 **Spread:** 4.0 **Value:** 20.2 #### Measurement **Group ID:** BG006 **Spread:** 6.4 **Value:** 26.7 **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:** NUMBER **Title:** Race/Ethnicity, Customized **Unit of Measure:** participants ### Measure 4 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Height **Unit of Measure:** metres ### Measure 5 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Weight **Unit of Measure:** kg ### Measure 6 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Body mass index (BMI) **Unit of Measure:** kg/m^2 ## Results Section - More Information Module ### Certain Agreement **PI Sponsor Employee:** True ### Limitations and Caveats **Description:** The second study (in hypercalciuric Cap stone formers) was never conducted due to difficulties in recruitment and limited budget. ### Point of Contact **Email:** [email protected] **Organization:** UT Southwestern Medical Center **Phone:** 214/648-2954 **Title:** Dr. Naim Maalouf ## 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:** 1.07 - **Upper Limit:** - **Value:** 2.38 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.75 - **Upper Limit:** - **Value:** 1.97 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.96 - **Upper Limit:** - **Value:** 2.19 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** This variable represents a ratio of the calcium phosphate saturation in a given urine sample to the calcium phosphate saturation at the point of precipitation and hence this measure has no units. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 2 weeks **Title:** Urinary Calcium Phosphate Saturation **Type:** PRIMARY **Unit of Measure:** no units ##### Group **Description:** Placebo tablets twice daily Placebo: Matching placebo for both aims. **ID:** OG000 **Title:** Placebo ##### Group **Description:** Citric acid tablets twice daily Citric Acid **ID:** OG001 **Title:** Citric Acid ##### Group **Description:** Potassium Citrate tablets twice daily Potassium Citrate **ID:** OG002 **Title:** Potassium Citrate ### Participant Flow Module #### Group **Description:** Placebo: 3 tablets twice daily of matching placebo during the placebo phase. Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) **ID:** FG000 **Title:** Placebo, Then Citric Acid, Then Potassium Citrate #### Group **Description:** Placebo: 3 tablets twice daily of matching placebo during the placebo phase. Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) **ID:** FG001 **Title:** Placebo, Then Potassium Citrate, Then Citric Acid #### Group **Description:** Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) Placebo: 3 tablets twice daily of matching placebo during the placebo phase. Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) **ID:** FG002 **Title:** Potassium Citrate, Then Placebo, Then Citric Acid #### Group **Description:** Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) Placebo: 3 tablets twice daily of matching placebo during the placebo phase. **ID:** FG003 **Title:** Potassium Citrate, Then Citric Acid, Then Placebo #### Group **Description:** Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) Placebo: 3 tablets twice daily of matching placebo during the placebo phase. **ID:** FG004 **Title:** Citric Acid, Then Potassium Citrate, Then Placebo #### Group **Description:** Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) Placebo: 3 tablets twice daily of matching placebo during the placebo phase. Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) **ID:** FG005 **Title:** Citric Acid, Then Placebo, Then Potassium Citrate #### Period **Title:** First Intervention (1 Week) ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 1 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG004 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG005 **Number of Subjects:** 2 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 1 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG004 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG005 **Number of Subjects:** 2 ##### 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 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG004 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG005 **Number of Subjects:** 0 #### Period **Title:** Washout (1 Week) ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 1 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG004 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG005 **Number of Subjects:** 2 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 1 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG004 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG005 **Number of Subjects:** 2 ##### 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 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG004 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG005 **Number of Subjects:** 0 #### Period **Title:** Second Intervention (1 Week) ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 1 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG004 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG005 **Number of Subjects:** 2 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 1 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG004 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG005 **Number of Subjects:** 2 ##### 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 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG004 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG005 **Number of Subjects:** 0 #### Period **Title:** Washout (1 Week) ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 1 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG004 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG005 **Number of Subjects:** 2 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 1 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG004 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG005 **Number of Subjects:** 2 ##### 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 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG004 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG005 **Number of Subjects:** 0 #### Period **Title:** Third Intervention (1 Week) ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 1 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG004 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG005 **Number of Subjects:** 2 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 1 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG004 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG005 **Number of Subjects:** 2 ##### 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 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG004 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG005 **Number of Subjects:** 0 **Pre-Assignment Details:** Out of 41 patients who met inclusion criteria and were contacted for study enrollment, a total of 13 subjects agreed to enroll and were consented and each participant was evaluated during 3 phases in randomized order. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT01678079 **Acronym:** ENCAP **Brief Title:** Encapsulated Calcium Absorption in Pregnancy **Official Title:** Bioavailability and Acceptability of Enteric-Coated Microencapsulated Calcium During Pregnancy: A Randomized Crossover Trial in Bangladesh (Encapsulated Calcium Absorption in Pregnancy) #### Organization Study ID Info **ID:** 1000033463 #### Organization **Class:** OTHER **Full Name:** The Hospital for Sick Children ### Status Module #### Completion Date **Date:** 2013-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2014-11-18 **Type:** ESTIMATED **Last Update Submit Date:** 2014-11-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2013-06 **Type:** ACTUAL #### Start Date **Date:** 2013-02 **Status Verified Date:** 2014-11 #### Study First Post Date **Date:** 2012-09-03 **Type:** ESTIMATED **Study First Submit Date:** 2012-08-30 **Study First Submit QC Date:** 2012-08-31 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** International Centre for Diarrhoeal Disease Research, Bangladesh **Class:** OTHER **Name:** Baylor College of Medicine **Class:** OTHER **Name:** Johns Hopkins Bloomberg School of Public Health **Class:** UNKNOWN **Name:** Saving Lives at Birth **Class:** OTHER **Name:** Grand Challenges Canada **Class:** FED **Name:** United States Agency for International Development (USAID) **Class:** UNKNOWN **Name:** Government of Norway **Class:** OTHER **Name:** Bill and Melinda Gates Foundation **Class:** OTHER **Name:** World Bank #### Lead Sponsor **Class:** OTHER **Name:** The Hospital for Sick Children #### Responsible Party **Investigator Affiliation:** The Hospital for Sick Children **Investigator Full Name:** Daniel Roth **Investigator Title:** Staff Physician, Paediatric Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study will enroll at least 60 pregnant women in a randomized cross-over study in Dhaka, Bangladesh. Each participant will be randomized to one of 3 calcium doses: 500 mg, 1000 mg, 1500 mg elemental Ca per day. Each participant will undergo two calcium absorption tests, one with a micronutrient supplement powder containing non-encapsulated (non-coated) calcium and the other with a micronutrient supplement powder containing encapsulated calcium at the same dose. The absorption tests will be separated by a 2-week washout period. Fractional calcium absorption will be measured using the dual stable isotope method. For each test, the formulation will be administered orally for 9 days; on the 10th day, a 44Ca- labeled stable isotope will be given orally and a 42Ca-labeled stable isotope dose will be given intravenously. Urine will be collected for 48 hours to measure calcium absorption. ### Conditions Module **Conditions:** - Pregnancy **Keywords:** - Pregnancy - Micronutrient Powder - Calcium - Iron - Bangladesh ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 61 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Encapsulated Calcium **Intervention Names:** - Dietary Supplement: Encapsulated Calcium **Label:** Micronutrient Powder, Enteric-coated Calcium (500 mg/day) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Encapsulated Calcium **Intervention Names:** - Dietary Supplement: Encapsulated Calcium **Label:** Micronutrient Powder, Enteric-coated Calcium (1000 mg/day) **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Encapsulated Calcium **Intervention Names:** - Dietary Supplement: Encapsulated Calcium **Label:** Micronutrient Powder, Enteric-coated Calcium (1500 mg/day) **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Non-capsulated Calcium **Intervention Names:** - Dietary Supplement: Non-capsulated Calcium **Label:** Micronutrient Powder, Uncoated Calcium (500 mg/day) **Type:** ACTIVE_COMPARATOR #### Arm Group 5 **Description:** Non-capsulated Calcium **Intervention Names:** - Dietary Supplement: Non-capsulated Calcium **Label:** Micronutrient Powder, Uncoated Calcium (1000 mg/day) **Type:** ACTIVE_COMPARATOR #### Arm Group 6 **Description:** Non-capsulated Calcium **Intervention Names:** - Dietary Supplement: Non-capsulated Calcium **Label:** Micronutrient Powder, Uncoated Calcium (1500 mg/day) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Micronutrient Powder, Enteric-coated Calcium (1000 mg/day) - Micronutrient Powder, Enteric-coated Calcium (1500 mg/day) - Micronutrient Powder, Enteric-coated Calcium (500 mg/day) **Description:** The intervention is a multi-micronutrient powder containing enteric-coated calcium carbonate, in addition to ferrous fumarate (60 mg of elemental iron) and folic acid (400 µg). **Name:** Encapsulated Calcium **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Micronutrient Powder, Uncoated Calcium (1000 mg/day) - Micronutrient Powder, Uncoated Calcium (1500 mg/day) - Micronutrient Powder, Uncoated Calcium (500 mg/day) **Description:** The comparator/control intervention is a micronutrient powder containing non-coated calcium (500, 1000 or 1500 mg elemental calcium from calcium carbonate), ferrous fumarate (60 mg of elemental iron) and folic acid (400 µg). This product will be similar in Ca dose, appearance, taste and texture to the experimental formulation but will not include the enteric-coating. **Name:** Non-capsulated Calcium **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** The primary analysis will be a comparison of mean fractional absorption of the two calcium formulations (enteric-coated vs. non-coated). The secondary analysis will be a comparison of mean fractional absorption across different calcium doses (500, 1000, 1500 mg per day). **Measure:** Fractional Calcium Absorption **Time Frame:** Fractional calcium absorption during day 10-11 **Description:** The primary analysis will be a comparison of mean fractional absorption of the two calcium formulations (enteric-coated vs. non-coated). The secondary analysis will be a comparison of mean fractional absorption across different calcium doses (500, 1000, 1500 mg per day). **Measure:** Fractional Calcium Absorption **Time Frame:** Fractional calcium absorption during day 35-36 #### Secondary Outcomes **Description:** The palatability and acceptability of the microencapsulated and non-encapsulated calcium formulations will be surveyed to assess the following parameters using semi-quantitative measures (i.e. Organoleptic properties, such as taste, odour, texture and colour, and adherence to prescribed micronutrient regimen, and reasons for non-adherence) **Measure:** Palatability and Acceptability **Time Frame:** Baseline, +10/11 days, +35/36 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Women aged 18 to 30 years * Current residence in Dhaka at a fixed address * Plan to remain in Dhaka for at least 2 months from date of enrolment * Gestational age of 27 completed weeks ± 1 week, estimated based on the recalled first day of the last menstrual period (LMP) Exclusion Criteria: * Complicated medical or obstetric history, based on self-report or clinical assessment by physician (e.g., cardiovascular disease, uterine hemorrhage, placenta previa, threatened abortion, hypertension, preeclampsia, multiple gestation, diabetes, renal disease) * Higher risk pregnancy based on one or more of the following clinical findings at time of recruitment: * Severe anemia (hemoglobin \<70 g/L assessed by Hemocue) * Proteinuria (≥ 100 mg/dl based on urine dipstick) * Glycosuria (≥ 100 mg/dl based on urine dipstick) * Hypertension (systolic blood pressure, ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg) * Reported use of dietary supplements that contain \>500 mg of calcium per day and/or \>400 IU (10 mcg) of vitamin D per day * Reported use (chewing) of betel leaf, areca nut and lime (together referred to locally as paan) during pregnancy **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Baltimore **Country:** United States **Facility:** The Johns Hopkins Bloomberg School of Public Health **State:** Maryland **Zip:** 21213 **Location 2:** **City:** Houston **Country:** United States **Facility:** Baylor College of Medicine **State:** Texas **Location 3:** **City:** Dhaka **Country:** Bangladesh **Facility:** International Center for Diarrheal Disease Research **Location 4:** **City:** Toronto **Country:** Canada **Facility:** The Hospital for Sick Children **State:** Ontario **Zip:** M5G 1X8 #### Overall Officials **Official 1:** **Affiliation:** The Hospital for Sick Children **Name:** Daniel Roth, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** The Hospital for Sick Children **Name:** Stanley Zlotkin, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Roth DE, Pezzack B, Al Mahmud A, Abrams SA, Islam M, Aimone Phillips A, Baxter JA, Dimitris MC, Hawthorne KM, Ahmed T, Zlotkin SH. Bioavailability of enteric-coated microencapsulated calcium during pregnancy: a randomized crossover trial in Bangladesh. Am J Clin Nutr. 2014 Dec;100(6):1587-95. doi: 10.3945/ajcn.114.090621. Epub 2014 Oct 1. **PMID:** 25411294 ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000077264 - Term: Calcium-Regulating Hormones and Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000050071 - Term: Bone Density Conservation Agents ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Hemat - Name: Hematinics - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: BDCA - Name: Bone Density Conservation Agents - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M10533 - Name: Iron - Relevance: LOW - As Found: Unknown - ID: M5381 - Name: Calcium - Relevance: HIGH - As Found: Radiation - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M5382 - Name: Calcium Carbonate - Relevance: LOW - As Found: Unknown - ID: M5398 - Name: Calcium, Dietary - Relevance: HIGH - As Found: Radiation - ID: M225448 - Name: Ferrous fumarate - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: T447 - Name: Folinic Acid - Relevance: LOW - As Found: Unknown - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002136 - Term: Calcium, Dietary - ID: D000002118 - Term: Calcium ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05687279 **Brief Title:** Study on a Live-attenuated Respiratory Syncytial Virus Vaccine for Assessment of Safety, Transmissibility, and Genetic Stability of the Vaccine Virus Among Close Contacts in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA) **Official Title:** Phase II, Randomized, Observer-blind, Placebo-controlled, Multi-center Study of a Live Attenuated Respiratory Syncytial Virus Vaccine to Assess the Vaccine Virus' Transmissibility in Household or Daycare Center Settings, Shedding, and Genetic Stability, and to Describe the Immunogenicity and Safety of the Vaccine in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA) #### Organization Study ID Info **ID:** VAD00014 #### Organization **Class:** INDUSTRY **Full Name:** Sanofi #### Secondary ID Infos **Domain:** ICTRP **ID:** U1111-1278-3910 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2025-05-21 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-11 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2025-05-21 **Type:** ESTIMATED #### Start Date **Date:** 2023-02-06 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2023-01-18 **Type:** ACTUAL **Study First Submit Date:** 2023-01-06 **Study First Submit QC Date:** 2023-01-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Sanofi Pasteur, a Sanofi Company #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The primary purpose of the study is to assess the shedding, transmission, and genetic stability of the live-attenuated RSVt vaccine after each intranasal vaccination (56 days apart) in infants and toddlers 6 to \< 24 months of age. **Detailed Description:** The duration of each participant's participation is up to 8 months, including the 6 months safety follow-up phone call after the second study intervention administration for the pediatric participants The treatment administration for the pediatric participants will be on D01 and D57 (1 intranasal administration each). ### Conditions Module **Conditions:** - Respiratory Syncytial Virus Infection ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** Observer-blind: * Blinding for vaccine group assignment: participants, parents or legally acceptable representative (LAR), outcome assessors, investigators, laboratory personnel, Sponsor study staff * No blinding for study staff who prepare and administer the study interventions **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 80 **Type:** ACTUAL **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 2 intranasal administrations (56 days apart) of the RSVt vaccine at D01 and D57 **Intervention Names:** - Biological: RSVt Vaccine **Label:** RSVt Vaccine Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 2 intranasal administrations (56 days apart) of the placebo at D01 and D57 **Intervention Names:** - Other: Control Group **Label:** Control Group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - RSVt Vaccine Group **Description:** Pharmaceutical Form: Suspension of virus in a nasal spray Route of Administration: Intranasal **Name:** RSVt Vaccine **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Control Group **Description:** Pharmaceutical Form: Suspension of virus in a nasal spray Route of Administration: Intranasal **Name:** Control Group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Proportion of vaccinees infected with vaccine virus in the placebo group, defined as vaccine virus shedding, detected by quantitative reverse transcription polymerase chain reaction (qRT-PCR) **Measure:** Presence of vaccine virus **Time Frame:** Day 1 through Day 22 **Description:** Titer of vaccine virus shedding in nasal swabs, quantified by qRT-PCR Assay in all pediatric participants **Measure:** Change in the Geometric Mean Titers (GMTs) of vaccine virus shedding **Time Frame:** Day 1 through Day 71 **Description:** Number of differences detected in genetic sequence of NS2 segment of the vaccine virus compared to the reference strain vaccine virus isolates in the vaccine virus positive swabs from pediatric participants receiving placebo and ad hoc close contact participants **Measure:** Number of differences detected in genetic sequence of NS2 segment **Time Frame:** Approximately Day 1 through Day 85 #### Secondary Outcomes **Description:** RSV A serum Nab titers **Measure:** Geometric Mean Titers (GMTs) of RSV A serum neutralizing antibody (nAb) titers **Time Frame:** Day 1, Day 57 and Day 85 **Description:** RSV serum anti-F IgG ELISA antibody titers **Measure:** GMTs of RSV serum anti-F Immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) antibody titers up to 28 days after the second administration (D01, D57, and D85) **Time Frame:** Day 1, Day 57 and Day 85 **Description:** Number of participants experiencing immediate unsolicited systemic AEs **Measure:** Presence of immediate unsolicited systemic Adverse Events (AEs) **Time Frame:** Within 30 minutes after each vaccination administration **Description:** Number of participants reporting: * injection site reactions: pain, erythema and swelling * systemic reactions: fever, headache, malaise, myalgia, arthralgia and chills **Measure:** Presence of solicited injection site or systemic reactions **Time Frame:** Within 21 days after each vaccination administration **Description:** Number of participants experiencing unsolicited AEs **Measure:** Presence of unsolicited AEs **Time Frame:** Within 28 days after each vaccination administration **Description:** Number of participants experiencing AESIs **Measure:** Presence of adverse events of special interest (AESIs) **Time Frame:** Within 28 days after each vaccination administration **Description:** Number of participants experiencing MAAEs **Measure:** Presence of medically attended adverse events (MAAEs) **Time Frame:** Within 28 days after each vaccination administration **Description:** Number of participants experiencing SAEs **Measure:** Presence of serious adverse events (SAEs) **Time Frame:** From Day 1 until the end of the study (approximately 8 months) **Description:** Proportion of vaccinees infected with vaccine virus in the placebo group, defined as vaccine virus shedding, detected by quantitative reverse transcription polymerase chain reaction (qRT-PCR) **Measure:** Presence of vaccine virus at Day 64 through Day 71 **Time Frame:** Day 64 through Day 71 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged 6 months to \< 24 months on the day of inclusion (from the day of the 6 months after birth to the day before the 2nd birthday) * Participants who are healthy as determined by medical evaluation including medical history. * Born at full term of pregnancy (≥ 37 weeks) or born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator, based on the following definition: "Medically stable" refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention * Attends a daycare facility at least 3 days per week and 4 hours per day at which the participant would be in a contact group/playroom of at least one other child 6 to \< 24 months of age who will participate in this study or is a member of a household, which includes at least one other child 6 to \< 24 months of age who will participate in this study Exclusion Criteria: * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion * Any acute febrile illness in the past 48 hours that according to investigator judgment is significant enough to interfere with successful inoculation on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. * Probable or confirmed ongoing case of COVID-19 at the time of enrollment * Member of a household that contains an immunocompromised individual, including, but not limited to: * a person who is HIV infected * a person who has received chemotherapy within the 12 months prior to study enrollment * a person who has received (within the past 6 months) or is receiving (at the time of enrollment) immunosuppressant agents * a person living with a solid organ or bone marrow transplant * Member of a household that includes, or will include, an infant who is less than 6 months of age at the time of enrollment * Attends a daycare facility and shares a daycare room with infants less than 6 months of age, and parent/legally acceptable representative is unable or unwilling to suspend attendance at the daycare facility for 28 days following study intervention administration * Any need of supplemental oxygen therapy in a home or hospital setting at the time of enrollment. * Participant's mother previous receipt or planned administration of an investigational RSV vaccine or any monoclonal antibody (such as Infliximab) during pregnancy and/or breastfeeding. * Receipt or planned receipt of any of the following vaccines prior to or after the first study intervention administration: * any influenza vaccine within 7 days prior to and after, or any COVID-19 or inactivated vaccine or live-attenuated rotavirus vaccine within 14 days prior to and after, or * any live vaccine, other than rotavirus vaccine, within 28 days prior to and after * Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product (such as ribavirin or RSV Immunoglobulin (IG) or RSV monoclonal antibody) at the time of enrollment. * Receipt of immune globulins, blood or blood-derived products in the past 3 months * Receipt of intranasal and intra-ocular medications within 3 days prior to study enrollment * Receipt at the time of enrollment or previous receipt of salicylate (aspirin) or salicylate-containing products * Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure * Deprived of freedom in an emergency setting, or hospitalized involuntarily * Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial. **Healthy Volunteers:** True **Maximum Age:** 23 Months **Minimum Age:** 6 Months **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Norfolk **Country:** United States **Facility:** Meridian Clinical Research Norfolk Site Number : 8400003 **State:** Nebraska **Zip:** 68701 **Location 2:** **City:** Omaha **Country:** United States **Facility:** Velocity Clinical Research, Omaha Site Number : 8400001 **State:** Nebraska **Zip:** 68134 **Location 3:** **City:** Bayamón **Country:** Puerto Rico **Facility:** Investigational Site Number : 6300004 **Zip:** 00960 **Location 4:** **City:** Carolina **Country:** Puerto Rico **Facility:** Investigational Site Number : 6300002 **Zip:** 984 **Location 5:** **City:** Guayama **Country:** Puerto Rico **Facility:** Investigational Site Number : 6300003 **Zip:** 00784 **Location 6:** **City:** San Juan **Country:** Puerto Rico **Facility:** Investigational Site Number : 6300001 **Zip:** 00918 #### Overall Officials **Official 1:** **Affiliation:** Sanofi Pasteur, a Sanofi Company **Name:** Clinical Sciences & Operations **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014777 - Term: Virus Diseases - ID: D000007239 - Term: Infections - ID: D000018186 - Term: Pneumovirus Infections - ID: D000018184 - Term: Paramyxoviridae Infections - ID: D000018701 - Term: Mononegavirales Infections - ID: D000012327 - Term: RNA Virus Infections ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### 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: M20494 - Name: Respiratory Syncytial Virus Infections - Relevance: HIGH - As Found: Respiratory Syncytial Virus Infections - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20330 - Name: Paramyxoviridae Infections - Relevance: LOW - As Found: Unknown - ID: M20778 - Name: Mononegavirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000018357 - Term: Respiratory Syncytial Virus Infections ### 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 ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01150279 **Brief Title:** Exploring the Role of At-home Semi-Quantitative Pregnancy Tests for Medical Abortion Follow-up **Official Title:** Simplifying Medical Abortion Provision: Exploring the Role of At-home Semi-Quantitative Pregnancy Tests for Medical Abortion Follow-up #### Organization Study ID Info **ID:** 6.1.3 #### Organization **Class:** OTHER **Full Name:** Gynuity Health Projects ### Status Module #### Expanded Access Info #### Last Update Post Date **Date:** 2015-10-02 **Type:** ESTIMATED **Last Update Submit Date:** 2015-10-01 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2014-05 **Type:** ACTUAL #### Start Date **Date:** 2009-08 **Status Verified Date:** 2015-10 #### Study First Post Date **Date:** 2010-06-24 **Type:** ESTIMATED **Study First Submit Date:** 2010-05-13 **Study First Submit QC Date:** 2010-06-23 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Stanford University **Class:** UNKNOWN **Name:** Secretaría de Salud del Distrito Federal **Class:** UNKNOWN **Name:** Office National de la Famille et de la Population, Tunisia **Class:** UNKNOWN **Name:** Maternité de la Rabta, Tunisia **Class:** UNKNOWN **Name:** Clinique du Parc, Tunisia #### Lead Sponsor **Class:** OTHER **Name:** Gynuity Health Projects #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** This study will examine the feasibility, acceptability and usability of a semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) for at-home follow-up after early medical abortion using mifepristone+misoprostol. The study seeks to: 1. Assess the feasibility of using this test in lieu of standard one-week clinic-based follow up for determination of complete abortion status as part of normal service delivery. In Mexico, follow up will be in two weeks, as is standard care in that . 2. To determine if women using this test at home understand how to use it and can correctly interpret the results; is it practical. 3. Assess women's and provider's acceptability of using at-home pregnancy tests in lieu of clinic-based follow up for confirmation of complete medical abortion in the future. ### Conditions Module **Conditions:** - Medical Abortion **Keywords:** - medical abortion - Medical Abortion Follow Up Care ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1200 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Measure:** Percent of women who correctly interpreted their results (in U.S. and Vietnam only) **Time Frame:** 18 months #### Secondary Outcomes **Measure:** Percent of women who felt confident in using the test and would be willing to use it in place of clinic-based follow up in the future **Time Frame:** 18 months **Measure:** The proportion of times the provider believes that each participant correctly read her test result **Time Frame:** 18 months **Measure:** Percent of providers who were comfortable with the urine pregnancy test determining whether women need to return or not for clinic-based follow-up **Time Frame:** 18 months **Measure:** The proportion of times that the semi-quantitative test correctly identifies all on going pregnancies **Time Frame:** 18 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Women age greater than or equal to 18 years * Gestational age less than or equal to 63 days by last menstrual period (LMP), ultrasound or clinical assessment * Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up * Able to consent to study participation. Inclusion Criteria for Mexico: * Gestational age \<_ 70 days from LMP * Eligible for mifepristone- misoprostol medical abortion according to clinic guidelines * Willing to follow instructions of the provider regarding use of the at-home pregnancy test * Agrees to provide test results by phone to study coordinator on morning of schedule follow-up visit * Willing to provide an address and/or telephone number for purposes of follow-up * Agrees to return for standard follow-up visit * Wishes to participate in the study * Having easy access to a telephone and transportation * Able to consent to study participation Exclusion Criteria: * Women less than 18 years of age * Women not eligible for medical abortion services * Women unable to provide contact information * Women unable to sign the consent form Exclusion Criteria for Mexico: * Women not eligible for medical abortion services * Women unable to provide contact information * Women unable to sign the consent form **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** Women presenting to clinic seeking medical abortion ### Contacts Locations Module #### Locations **Location 1:** **City:** Palo Alto **Country:** United States **Facility:** Stanford University Hospital **State:** California **Location 2:** **City:** Sacramento **Country:** United States **Facility:** Planned Parenthood Mar Monte **State:** California **Location 3:** **City:** Chicago **Country:** United States **Facility:** Family Planning Associates Group - Washington **State:** Illinois **Location 4:** **City:** Chicago **Country:** United States **Facility:** Family Planning Associates- Elston **State:** Illinois **Location 5:** **City:** Mexico City **Country:** Mexico **Facility:** Hospital Materno Infantil Nicolas M. Cedillo **Location 6:** **City:** Ben Arous **Country:** Tunisia **Facility:** ONFP Ben Arous **Location 7:** **City:** Nabeul **Country:** Tunisia **Facility:** ONFP Nabeul **Location 8:** **City:** Sousse **Country:** Tunisia **Facility:** ONFP Sousse **Location 9:** **City:** Tunis **Country:** Tunisia **Facility:** Clinique du Parc **Location 10:** **City:** Tunis **Country:** Tunisia **Facility:** Maternite de la Rabta **Location 11:** **City:** Ho Chi Minh City **Country:** Vietnam **Facility:** HocMon District Hospital #### Overall Officials **Official 1:** **Affiliation:** Stanford University **Name:** Paul D Blumenthal, MD, MPH **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Gynuity Health Projects **Name:** Beverly Winikoff, MD, MPH **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Gynuity Health Investigator **Name:** Jennifer Blum, MPH **Role:** PRINCIPAL_INVESTIGATOR **Official 4:** **Affiliation:** Secretaría de Salud del Distrito Federal **Name:** Patricio Sanhueza Smith, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 5:** **Affiliation:** Office National de la Famille et de la Population **Name:** Rym Fayala, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 6:** **Affiliation:** Maternité de la Rabta **Name:** Ezzedine Sfar **Role:** PRINCIPAL_INVESTIGATOR **Official 7:** **Affiliation:** Clinique du Parc **Name:** Hella Chelli **Role:** PRINCIPAL_INVESTIGATOR **Official 8:** **Affiliation:** Gynuity Health Projects **Name:** Rasha Dabash, MPH **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Dabash R, Shochet T, Hajri S, Chelli H, Hassairi AE, Haleb D, Labassi H, Sfar E, Temimi F, Koenig L, Winikoff B. Self-administered multi-level pregnancy tests in simplified follow-up of medical abortion in Tunisia. BMC Womens Health. 2016 Jul 30;16:49. doi: 10.1186/s12905-016-0327-1. **PMID:** 27475998 **Citation:** Lynd K, Blum J, Ngoc NT, Shochet T, Blumenthal PD, Winikoff B. Simplified medical abortion using a semi-quantitative pregnancy test for home-based follow-up. Int J Gynaecol Obstet. 2013 May;121(2):144-8. doi: 10.1016/j.ijgo.2012.11.022. Epub 2013 Mar 7. **PMID:** 23477704 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04453579 **Brief Title:** Bariatric Surgery During Lockdown, Impact of COVID-19 on Physical and Mental Health **Official Title:** Was it Right to Stop Bariatric Surgery During COVID-19 Lockdown? #### Organization Study ID Info **ID:** UNRomeB #### Organization **Class:** OTHER **Full Name:** University of Rome Tor Vergata ### Status Module #### Completion Date **Date:** 2020-05-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-07-01 **Type:** ACTUAL **Last Update Submit Date:** 2020-06-29 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-05-04 **Type:** ACTUAL #### Start Date **Date:** 2020-03-09 **Type:** ACTUAL **Status Verified Date:** 2020-06 #### Study First Post Date **Date:** 2020-07-01 **Type:** ACTUAL **Study First Submit Date:** 2020-06-29 **Study First Submit QC Date:** 2020-06-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Rome Tor Vergata #### Responsible Party **Investigator Affiliation:** University of Rome Tor Vergata **Investigator Full Name:** Paolo Gentileschi **Investigator Title:** Head of Bariatric Unit **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** From the beginning of March 2020, lockdown regimens prevented patients with obesity from receiving bariatric surgery. Surgical emergencies and oncological procedures were the only operations allowed in public hospitals. Consequently, patients with morbid obesity were put in a stand-by situation. With the aim at exploring physical and psychological conditions of the investigators future bariatric surgery patients, the investigators built a Questionnaire concerning obesity and COVID-19. **Detailed Description:** Introduction: the investigators present an investigation about the impact of COVID-19 on individuals suffering from severe obesity that were in the waiting list for bariatric surgery. Worldwide and in Italy bariatric procedures are considered as elective surgery and therefore were interrupted during the lockdown. The patients are well-known victim of stigma, social discrimination and the majority of them is affected by maladaptive eating behaviors that are supposed to worsen due to the isolation, absence of healthcare check-up and alarming pandemic scenario.the investigators performed telephonic interview providing an ad hoc questionnaire with the aim to explore their emotional and physical status. Method: A total of 116 bariatric surgery candidates were approached using a telephonic interview during the Italian lockdown. ### Conditions Module **Conditions:** - Obese - Morbid Obesity **Keywords:** - Bariatric surgery - Covid-19 - Obesity - Mental health - Eating disorder ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 116 **Type:** ACTUAL **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 2 Weeks ### Arms Interventions Module #### Arm Group 1 **Description:** 116 patients were assessed during the Italian lockdown by means of a telephone interview performed by a trained researcher. The interview was composed of socio-demographic items (e.g. employed before and during the lockdown, own accommodation during lockdown etc.) and questions about physical and mental health in relation to the COVID-19 emergency **Intervention Names:** - Behavioral: Telephonic interview during the Italian lockdown. **Label:** 116 patients completed a survey ### Interventions #### Intervention 1 **Arm Group Labels:** - 116 patients completed a survey **Description:** The interview was composed of socio-demographic items lockdown, and dichotomous questions about physical and mental health in relation to the COVID-19 emergency **Name:** Telephonic interview during the Italian lockdown. **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** exploring physical and psychological conditions of our future bariatric surgery patients **Measure:** Psychological conditions **Time Frame:** 2 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Severe Obesity with BMI \> 35 kg/m2 Exclusion Criteria: * Alcoholism * Drug addiction **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** From March 9th to May 4th 2020, 116 bariatric surgery candidates were approached using a telephonic interview during the Italian lockdown. The interview was composed of socio-demographic items and dichotomous about physical and mental health in relation to the COVID-19 emergency. ### Contacts Locations Module #### Locations **Location 1:** **City:** Rome **Country:** Italy **Facility:** Michela Campanelli **State:** RM **Zip:** 00133 #### Overall Officials **Official 1:** **Affiliation:** University Hospital of Tor Vergata, Rome, Italy **Name:** paolo gentileschi, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese. **PMID:** 32064853 **Citation:** Sockalingam S, Leung SE, Cassin SE. The Impact of Coronavirus Disease 2019 on Bariatric Surgery: Redefining Psychosocial Care. Obesity (Silver Spring). 2020 Jun;28(6):1010-1012. doi: 10.1002/oby.22836. **PMID:** 32294297 ## 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 - ID: D000009765 - Term: Obesity - ID: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: COVID-19 - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M12702 - Name: Obesity, Morbid - Relevance: HIGH - As Found: Morbid Obesity - 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 - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 - ID: D000009767 - Term: Obesity, Morbid ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04205279 **Brief Title:** Reactive Balance Training for Fall Prevention **Official Title:** Reactive Balance Training for Fall Prevention: a Comparative Study of Three Different Perturbation Devices #### Organization Study ID Info **ID:** 2017-1069 #### Organization **Class:** OTHER **Full Name:** University of Illinois at Chicago ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2018-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2019-12-19 **Type:** ACTUAL **Study First Submit Date:** 2019-12-11 **Study First Submit QC Date:** 2019-12-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Illinois at Chicago #### Responsible Party **Investigator Affiliation:** University of Illinois at Chicago **Investigator Full Name:** Tanvi Bhatt **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 objective of this pilot study is to evaluate and compare the effect of three different perturbation based training devices on the reactive balance control among healthy young adults, healthy older adults, and neurologically impaired stroke individuals. Furthermore, the project aims to determine the feasibility and tolerability of 30-minutes of perturbation training using the SureFooted Trainer. Overall, the project directs to find out the long term effect of training on fall risk reduction and fall prevention. This study investigates the effects of perturbation training (slip and trip) based on the principles of motor learning. Perturbations in the form of slips and trips induced by the three different types of perturbation devices will displace the center of mass outside the base of support and challenge the stability, thereby inducing a fall and demand compensatory strategies in order to prevent it. Such perturbation training would train the motor system to improve stability control and vertical limb support. The project design aims to examine the ability of the central nervous system to mitigate the interference in stability control (if any) that is induced by opposing types of perturbations. The hypothesis of this study if supported by the results, will provide the difference in motor learning with training on three different perturbation devices. Furthermore, it would help to determine which of the three training devices is the most effective in developing defense mechanisms necessary to reduce fall-risk among community-living older adults and the neurological population. **Detailed Description:** About 34% of the community-dwelling older population experience a detrimental fall each year. Moreover, 40% of the individuals who suffer from pathological conditions such as stroke experience falls. Age-related changes and post-stroke impairments often lead to impaired balance and gait that are highly associated with falls. Most of these falls have been reported to occur during dynamic and complex activities such as walking, reaching out for objects that are a part of daily living. There are various clinical balance tests used to evaluate the balance in individuals suffering from a stroke. However, most of the tests measure only the static balance ability while performing voluntary/ self-generated activities. Hence, these measures fail to determine the reactive balance control or compensatory strategies used to recover from unexpected perturbations. Perturbation induced by various perturbation based devices such as Activestep treadmill, a motorized, custom-designed free-sliding over-ground walkway that aims to cause a loss of balance by presenting a threat to stability, thereby, challenging the reactive balance response of an individual. This interventional paradigm has now been widely used to quality and trains reactive balance control in older adults and neurologically affected populations. Previously studied along with emerging researches and numerous ongoing clinical trials focusing on perturbation training using a treadmill and overground walking, have already indicated its effectiveness in reducing fall risk. Literature states that more than half of the elderly population did not experience any fall after the first exposure of a novel slip during over-ground walking. However, the efficacy of a newly introduced equipment, Surefooted Trainer, which is a customized, moveable slippery platform where an individual walks safely along protected by a harness, has not yet been explored. Surefooted Trainer consists of the platform which causes slip-like perturbations and obstacles which cause trip-perturbation. Further, both the Activestep and Surefooted Trainer are more compact and can be easily installed in clinical settings. While the Activestep is a treadmill based system the Surefooted Trainer is an overground walkway perturbation system. The study aims to establish feasibility and tolerability for 30 minutes of the Surefooted Trainer first and then gather pilot data for assessing the efficacy of these three perturbation training systems. The perturbation training paradigm is based on the principle that the central nervous system adapts and learns from previous experience of perturbation and employs motor learning to prospective perturbation induced loss of balance. This helps to reduce the number of falls and improves dynamic stability in the laboratory setting which is later translated to real-life situations. The dose and intensity necessary to induce motor learning are not clearly known and therefore, the purpose of this study is to compare the results of perturbation training on three devices and identify the most effective training protocol with immediate and long term effects on the fall reduction. If the results from this study seem to be promising, it could help in translating the most beneficial protocol for clinical treatment for older adults and stroke population. To determine the long term effects in the community-dwelling, the study will monitor the physical activity of the elderly and stroke population during community ambulation. The aim of the study is to compare the effect of perturbation training between ActiveStep treadmill, a custom-designed over-ground walkway and the Sure-footed Trainer among healthy young adults, older adults, and neurologically impaired stroke survivors both immediately post-training and in long term on reduction in fall rate. Furthermore, to establish feasibility and tolerability of 30-minute training using Surefooted Trainer and then assess the efficacy of these three perturbation training systems. ### Conditions Module **Conditions:** - Healthy Young - Healthy Aging - Stroke **Keywords:** - Reactive balance - Virtual reality training - Surefooted platform ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Controlled design to compare the effect of three different perturbation based training devices on the reactive balance control among healthy young adults, healthy older adults and person with stroke. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects randomly assigned to the treadmill training, would undergo either a stance or walking perturbation training protocol. The stroke subjects and older adults would be assigned to either the stance or walking perturbation training protocol. All the participants would be asked to perform voluntary stepping, backward and forward with both limbs pre and post perturbation training. Also, all the participants would perform walking trials with head mounted virtual reality system under three conditions: ice, beach and crowd. **Intervention Names:** - Other: Experimental: Treadmill training **Label:** Treadmill training **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Subjects randomly assigned to overground slip will be made to walk at their comfortable natural walking speeds either for 5-8 trials on the instrumented walkway (7 m 1.5 m) at their self-selected preferred speed. All the participants would perform walking trials with head mounted virtual reality system under three conditions: ice, beach and crowd. After establishing baseline walking ability, a slip will be introduced without warning which will comprise the baseline slip test followed by a trip in the form of the trip plate. This is followed by a block of 8 trials for slip training, block of 8 trials for trip training and then the mixed block consisting of slip and trip trials interspersed with walking trials. Slips and trips could be induced under either of the limbs. **Intervention Names:** - Other: Experimental: Overground training **Label:** Overground training **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Subjects randomly assigned to Surefooted (Surefooted LLC) would be donned a safety harness and instructed that "when you experience slip-like or trip-like movements, try to keep walking on the platform". Subjects would undergo 4-minute training block on each of the 6 different conditions. The first 3 training blocks would be unidirectional perturbation (either slip or trip) followed by 3 training blocks of mixed directional perturbations while the subjects are walking on the platform. 3 surface conditions- slippery (vinyl surface plate), normal friction with obstacles (surface plate with 6" tall structures embedded), and a foam surface with obstacles embedded would be used. **Intervention Names:** - Other: Experimental: Surefooted training **Label:** Surefooted training **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treadmill training **Description:** Participants will be given thirteen slips and thirteen trips in stance and walking, followed by two slips and two trips at a higher intensity (posttest). Subjects would be consented if they would like to undergo fMRI pre and post-training. Participants not willing to undergo imaging would not be excluded. Three day training consisting of blocks of five consecutive gait-slips at varying intensities will be provided. Individuals with stroke would undergo an additional session (total 4 training sessions over 4 weeks (1session/week) since these individuals get easily fatigued and also might need more training sessions with sufficient rest interval to induce reactive adaptation. Training at a specific level will persist until the subjects show a recovery step response in at least 3/5 trials in a single block. Once subjects successfully adapt to this level, the perturbation intensity will be increased until they show a recovery response in at least 3/5 trials. **Name:** Experimental: Treadmill training **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Overground training **Description:** Slips and trips could be induced under either of the limbs. The specialized walkway consists of two sliding platforms, each of which is mounted on two rows of low friction linear bearings (friction coefficient = 0.02). The base plate of each platform is bolted separately onto the top of a force platform embedded in the floor. An electronic-mechanical latch system is used to control the 2 states of the support platform; that is, the "locked" state for regular walking and the "release" state to initiate slipping are carefully controlled. The sliding top of the platform is released after the heel strike (vertical force to exceed 2% of the body weight). The slip distance would be adjusted between 30 to 60 centimeters depending upon the different population and their physical capacity. **Name:** Experimental: Overground training **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Surefooted training **Description:** During the first minute of each block, subjects would experience no perturbations followed by 3 minutes of single or multi-directional perturbations. A one minute break between each condition would be provided. Subject's fatigue would be assessed by Fatigue severity scale to determine the tolerability of 30 minute training protocol. The expected duration to complete the test would be a maximum of 1 hour including the preparation and training time. **Name:** Experimental: Surefooted training **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Stability is defined by both the position of a person's center-of-mass (COM) with respect to his or her base-of-support (BOS) and it's velocity. **Measure:** Change in Stability gain or loss **Time Frame:** Baseline (1st novel slip, week 1) and at Immediate post-training (after repeated perturbation training session, week 1) **Description:** The inability to provide timely limb support due to insufficient amount of upward impulse generated from the ground reactive force can cause limb collapse, as characterized by the quotient of amount and rate of hip descent (Vhip/Zhip) measured from hip height and lead to an eventual fall. **Measure:** Change in Limb support gain or loss **Time Frame:** Baseline (1st novel slip, week 1) and Immediate post-training (after repeated perturbation training session, week 1) **Description:** Perturbation is induced successfully and safely to reproduce inadvertent falls in a protective laboratory environment. Falls will be measured by the amount of body weight supported by the full-body harness system and measured by a load cell attached to this system. Instability of the body's COM and poor limb support prior to touchdown of the recovery step account for 90\~100% of subsequent falls (occurring \~500ms later) in both sit-to-stand-slip and in gait-slip, in the laboratory settings. Intervention consists of repeated perturbation training to induce a change in the laboratory induced falls immediately post-training and examine it's retention after the initial training session. **Measure:** Change in laboratory-induced falls **Time Frame:** Baseline (1st novel slip, week 1) and Immediate post-training (after repeated perturbation training session, week 1) **Description:** Real life falls are measured to determine if training effect can be translated into everyday real life setting. **Measure:** Number of Real life falls **Time Frame:** prospective post-training over next 12 months (total falls tracked and reported at 12 months post-training will be compared between groups) #### Secondary Outcomes **Description:** the deviation of the Center of mass relative to the sagittal plane **Measure:** Center of mass excursion angle **Time Frame:** Baseline (natural walking) (Week 1), and Virtual reality walking trials at week 1 **Description:** The peak excursion of the COM perpendicular to the walking direction **Measure:** Medio-Lateral excursion of center of mass **Time Frame:** Baseline (natural walking) (Week 1), and Virtual reality walking trials at week 1 **Description:** The total number of steps and distance for each day will be calculated by patient's wearable sensor and their assistive device sensor. This parameter will be used to analyze improvement in physical activity of the patient and decrease reliance on the assistive device. **Measure:** Change in Number of steps **Time Frame:** One month before pretest till prospectively 12 months post training ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Healthy Young participants * Age group: 18-55 years. * Absence of any acute or chronic neurological, cardiopulmonary, musculoskeletal or systemic diagnosis. * No recent major surgery (\< 6 months) or hospitalization (\< 3 months) * Not on any sedative drugs. * Can understand and communicate in English Healthy older adults * Age group: 56-90 years. * Absence of any acute or chronic neurological, cardiopulmonary, musculoskeletal or systemic diagnosis. * No recent major surgery (\< 6 months) or hospitalization (\< 3 months) * Not on any sedative drugs. * Ability to walk with or without an assistive device for 10 meters * Can understand and communicate in English * Berg balance scale score \<45/56. Persons with stroke * Age group: 18-90 years. * Absence of any acute or chronic neurological diagnosis except stroke (self reported) * Onset of stroke (\> 6 months) * Absence of any cardiopulmonary, musculoskeletal or systemic diagnosis. * No recent major surgery (\< 6 months) or hospitalization (\< 3 months) * Not on any sedative drugs. * Ability to walk with or without an assistive device for 10 meters * Can understand and communicate in English Exclusion Criteria: Healthy subject: * Subjects will not proceed with the test if any of the following occurs at baseline measurement: 1) HR \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age), 2) systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during resting), and 3) oxygen saturation (measured by pulse oximeter) during resting \< 95%. * Body weight more than 250 lbs. Healthy Older adults: * Individuals with heel bone density with a T-score \< -2, is classified as osteoporotic and will be excluded. * Individuals with mild cognitive impairment (Mini-mental State Exam score \< 25/30) will be excluded. * Subjects will not proceed with the test if any of the following occurs at baseline measurement: 1) HR \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age), 2) systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during resting), and 3) oxygen saturation (measured by pulse oximeter) during resting \< 95%. * 6 minute walk test. Subjects will also be screened out if on the 6 minute walk test they complain of shortness of breath or uncontrolled pain (\> 3/10 on VAS) or pulse oxygen drops \< 92% or are unable to achieve the age-specified minimal ambulation distance. * Body weight more than 250 lbs. Persons with stroke: * Individuals with heel bone density with a T-score \< -2, is classified as osteoporotic and will be excluded. * Individuals with mild cognitive impairment (Mini-mental State Exam score \< 25/30) will be excluded. * Subjects will not proceed with the test if any of the following occurs at baseline measurement: 1) HR \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age), 2) systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during resting), and 3) oxygen saturation (measured by pulse oximeter) during resting \< 95%. * 6 minute walk test. Subjects will also be screened out if on the 6 minute walk test they complain of shortness of breath or uncontrolled pain (\> 3/10 on VAS) or pulse oxygen drops \< 92% or are unable to achieve the age-specified minimal ambulation distance. * Body weight more than 250 lbs. **Healthy Volunteers:** True **Maximum Age:** 90 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Shamali Dusane, MPT **Phone:** 3123552735 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Lakshmi Kannan, MS PT **Phone:** 3124133175 **Role:** CONTACT #### Locations **Location 1:** **City:** Chicago **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Tanvi S Bhatt, PhD - **Phone:** 312-355-4443 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Lakshmi Kannan, MS - **Phone:** 3124133175 - **Role:** CONTACT **Country:** United States **Facility:** University of Illinois at Chicago **State:** Illinois **Status:** RECRUITING **Zip:** 60612 #### Overall Officials **Official 1:** **Affiliation:** University of Illinois at Chicago **Name:** Tanvi Bhatt, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M22306 - Name: Stroke - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03377179 **Brief Title:** A Study of ABC294640 (Yeliva ®) Alone and in Combination With Hydroxychloroquine Sulfate in Treatment of Patients With Advanced Cholangiocarcinoma **Official Title:** A Phase I/IIA Study of ABC294640 Alone and in Combination With Hydroxychloroquine Sulfate in the Treatment of Patients With Advanced, Unresectable Intra-hepatic, Perihilar and Extra-Hepatic Cholangiocarcinoma #### Organization Study ID Info **ID:** ABC-108 #### Organization **Class:** INDUSTRY **Full Name:** RedHill Biopharma Limited ### Status Module #### Completion Date **Date:** 2022-06-21 **Type:** ACTUAL #### Disp First Post Date **Date:** 2023-04-04 **Type:** ACTUAL **Disp First Submit Date:** 2023-03-30 #### Expanded Access Info **Has Expanded Access:** True **Status For NCT ID:** AVAILABLE #### Last Update Post Date **Date:** 2023-04-04 **Type:** ACTUAL **Last Update Submit Date:** 2023-03-30 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-06-21 **Type:** ACTUAL #### Start Date **Date:** 2018-03-07 **Type:** ACTUAL **Status Verified Date:** 2023-03 #### Study First Post Date **Date:** 2017-12-19 **Type:** ACTUAL **Study First Submit Date:** 2017-12-01 **Study First Submit QC Date:** 2017-12-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** RedHill Biopharma Limited #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** ABC-108 is a single-arm Phase IIA clinical study of ABC294640 (Yeliva ®, opaganib) alone and in combination with hydroxychloroquine sulfate (HCQ) in the treatment of cholangiocarcinoma (CCA). In Part 1 of this clinical study, all participants will be receiving ABC294640 and in Part 2 all participants will be receiving ABC294640 and HCQ to explore the drugs activity signal in CCA. The study drug, ABC294640 is an orally available inhibitor of the enzyme sphingosine kinase-2 (SK2). SK2 is an innovative target for anti-cancer therapy because of its critical role in sphingolipid metabolism, which is known to regulate tumor cell death and proliferation. ABC294640 also inhibits proliferation and induces apoptosis of cholangiocarcinoma cell lines. Furthermore, in a recent Phase I trial, ABC294640 demonstrated clinical activity in CCA patients. HCQ, is an orally available, FDA approved therapy for the treatment of malaria as well as discoid and systemic lupus erythematosus and rheumatoid arthritis. It is also known as an inhibitor of autophagy, a pro-survival mechanism utilized by many cancers. Evidence indicates that inhibition of autophagy can increase the therapeutic activity of ABC294640 in CCA. In Part 1 of this study, ABC294640 will be continuously administrated orally, twice a day, in 28 day cycles. In Part 2, ABC294640 and HCQ will be continuously administrated orally (the safe and tolerable will be determined in the study) in 28 day cycles. Administration of drug/s in both parts of the study will continue until disease progression, unacceptable toxicity or voluntary withdrawal initiated by the participants or physician. **Detailed Description:** This is an open-label clinical study to explore the activity signal of ABC294640 and of ABC294640 and HCQ in adult subjects who have been diagnosed with unresectable cholangiocarcinoma either intra- perhilar or extra-hepatic. The study will be conducted at 5 sites in the USA. For Part 1, a maximum of 39 participants evaluable for efficacy will be enrolled in the study. Eligible participants will receive ABC294640, 500 mg twice a day, continuously administered in 28 day cycles. Part 2 will be a single-arm Phase IIA study identical to Part 1 but treatment will consist of both ABC294640 together with HCQ. Additionally, Part 2, will consist of two phases: Phase I: accelerate HCQ dose-escalation run-in starting with a HCQ dose of 200 mg QD (once a day). Based on safety results, patient cohorts will be expanded, and dosing will continue to 200 mg BID (twice a day), 400 mg BID and 600 BID. At the end of Part2, Phase I, it will be determined what is the safe and tolerable HCQ dose for Phase II. For Part 2, up to 15 patients evaluable for safety and tolerability will be enrolled in Phase I component of Part 2; and 20 patients evaluable for efficacy in the Phase II component of Part 2. All eligible participants will receive ABC294640, 500 mg BID in addition to the determined HCQ dose, continuously administered in 28 day cycles. In addition to physical, neurological and eye exams (eye exams only for participants receiving HCQ), blood and urine samples will be routinely collected for safety and to determine response to the study drugs. Participants will be radiographically assessed for disease status every 2 cycles of treatment. Tumor biopsies, when accessible, will be obtained within 21 days prior to the beginning of treatment and again on the beginning of the second treatment cycle. All participants will be followed every 2 months for progression and survival for a maximum of 24 months after the last patient has been entered to the study. Follow up procedures may include physical examination, laboratory work and radiographic tumor assessment. ### Conditions Module **Conditions:** - Cholangiocarcinoma - Cholangiocarcinoma Non-resectable - Cholangiocarcinoma, Perihilar - Cholangiocarcinoma, Extrahepatic - Cholangiocarcinoma, Intrahepatic **Keywords:** - Clinical Trial, Phase II - Multicenter Trials - Clinical Study - Clinical Trials, Non-Randomized - Oral capsule - Single arm - Anti-cancer - Anti-inflammatory - ABC294640 - Yeliva ® - opaganib - Hydroxychloroquine Sulfate - HCQ - Autophagy ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Part 1- single-arm Phase IIA study, all participants receiving ABC294640, continuously administered in 28 day cycles, until disease progression, unacceptable toxicity or voluntary withdrawal Enrollment in a two-stage design: 12 participants will be accrued, if none of those patients respond, registration will halt. If one or more patients respond, additional 27 patients evaluable for efficacy will be enrolled. Part 2- identical to Part 1 with the exceptions: co-treatment of both ABC294640 and HCQ and study will consist of two phases: Phase I, a hybrid accelerate dose escalation run-in starting at HCQ dose of 200 mg QD. Based on safety results, patient cohorts will be expanded and dosing will escalate up to 600 mg BID. Phase II, treatment with ABC294640 and HCQ at the Phase I determined dose. Up to 15 participants evaluable for safety and tolerability will be accrued in Phase I and 20 participants evaluable for efficacy in Phase II, Part 2. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 65 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Part 1: All participants will be receiving ABC294640, 500 mg twice a day (BID), continuously in 28 day cycles Part 2: All participants will be receiving ABC294640, 500 mg twice a day (BID) and HCQ at a determined level, continuously in 28 day cycles **Intervention Names:** - Drug: ABC294640 - Drug: Hydroxychloroquine Sulfate 200 MG **Label:** ABC294640 +/- HCQ treatment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - ABC294640 +/- HCQ treatment **Description:** Two 250 mg capsules of ABC294640 will be taken twice daily **Name:** ABC294640 **Other Names:** - yeliva - opaganib **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - ABC294640 +/- HCQ treatment **Description:** HCQ tablets will be taken at a dose that will be determined **Name:** Hydroxychloroquine Sulfate 200 MG **Other Names:** - HCQ **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Tumor biopsies, when accessible, will be obtained and will be assessed for tumor signaling proteins (c-Myc, pAKT, SK2). Peripheral Blood Mononuclear Cells (PBMC) for c-Myc will be collected within 1 hour prior to the pre- and posttreatment biopsies (or at the scheduled time of biopsy if not performed). **Measure:** Determine the effect of treatment with ABC294640 alone or in combination with HCQ on pharmacodynamic markers that are associated with the mechanism of action of the drug. **Time Frame:** Within 21 days prior to treatment and on the beginning of the second cycle of treatment (approximately a month) **Description:** Serum ctDNA be assessed for mutational status and development of new mutations. **Measure:** Serial measurement of circulating tumor DNA (ctDNA) **Time Frame:** Prior to treatment till the end of study (assessed at screening, beginning of cycle three of treatment and every 8 weeks thereafter, up to 24 months) #### Primary Outcomes **Description:** To determine the response rate (RR) of CCA defined as objective responses (OR), i.e. complete and partial responses (CR, PR) plus stable disease (SD) of at least 4 months to treatment with ABC294640. **Measure:** Part1 - Determine Response Rate **Time Frame:** At least 4 months **Description:** To determine the Durable Disease Control Rate (DDCR) of CCA defined as Disease Control Rate (DCR) of at least 4 months duration to treatment with ABC294640 and HCQ **Measure:** Part 2 - Determine the Durable Disease Control Rate **Time Frame:** At least 4 months #### Secondary Outcomes **Description:** A physical exam which will include weight measurment in kilograms will be performed in screening and on the beginning of each cycle of treatment till 30 day post treatment. **Measure:** Physical exam to include eye exams (the latter only for patients enrolled in Part 2) to measure safety and tolerability of ABC294640 alone and in combination with HCQ **Time Frame:** From screening phase, during beginning of each cycle of treatment, till 30 days after the end of treatment (an estimated median of 5 months) **Description:** A general neurological exam will be performed in screening and on the beginning of each cycle of treatment till 30 day post treatment. **Measure:** A general neurological exam to measure safety and tolerability of ABC294640 alone and in combination with HCQ **Time Frame:** From screening phase, during beginning of each cycle of treatment, till 30 days after the end of treatment (an estimated median of 5 months) **Description:** HADS (Hospital Anxiety and Depression Scale) questionnaire will be utilized to monitor any alterations in the participant's anxiety and depression levels. **Measure:** HADS score for depression and anxiety to measure safety and tolerability of ABC294640 alone and in combination with HCQ **Time Frame:** From screening, during each cycle of treatment, till the end of treatment (an estimated median of 4 months). Patient diaries will be filled on a daily basis during treatment. **Description:** ECOG (Eastern Cooperative Oncology Group) performance score to the participant's performance status and how it is impacting the daily living abilities. **Measure:** ECOG performance score to measure safety and tolerability of ABC294640 alone and in combination with HCQ **Time Frame:** From screening, during each cycle of treatment, till the end of treatment (an estimated median of 4 months). Patient diaries will be filled on a daily basis during treatment. **Description:** MMSE (Mini-Mental State Examination) questionnaire will be utilized for evaluating the mental state of the participants. **Measure:** MMSE score to measure safety and tolerability of ABC294640 alone and in combination with HCQ **Time Frame:** From screening, during each cycle of treatment, till the end of treatment (an estimated median of 4 months). Patient diaries will be filled on a daily basis during treatment. **Description:** Participants will be asked to fill a daily diary to record the drug administration and any side effects that they may experience. **Measure:** Daily diary entries to aid in asessing safety and tolerability of ABC294640 alone and in combination with HCQ **Time Frame:** From screening, during each cycle of treatment, till the end of treatment (an estimated median of 4 months). Patient diaries will be filled on a daily basis during treatment. **Description:** Adverse events will be graded according to the revised NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE version 4.03) to measure the safety and tolerability of treatment with ABC294640 alone and in combination with HCQ in patients with unresectable CCA. **Measure:** Number of treatment-related Adverse Events alone and in combination with HCQ **Time Frame:** From screening till the 30 days after the end of treatment (an estimated median of 5 months) **Description:** To determine the pharmacokinetics of ABC294640 (Part 1) and of ABC294640 and HCQ (Part 2) in the first 12 patients by measuring Maximum Plasma Concentration (Cmax) of ABC294640 and HCQ **Measure:** The Maximum Plasma Concentration (Cmax) of ABC294640 and of HCQ **Time Frame:** From the first day of treatment until the beginning of second cycle of treatment (on day 1, 15, 28 approximately) **Description:** To determine the pharmacokinetics of ABC294640 (Part 1) and of ABC294640 and HCQ (Part 2) in the first 12 patients by measuring the Area Under the Curve (AUC) of ABC294640 and of HCQ which reflects the body exposure to drug after administration of a dose of the drug. **Measure:** The Area Under the Curve (AUC) of ABC294640 (Part 1) and of ABC294640 and HCQ (Part 2) **Time Frame:** From the first day of treatment until the beginning of second cycle of treatment (on day 1, 15, 28 approximately) **Measure:** Determine the progression free survival (PFS) **Time Frame:** Every 2 months for a maximum of 24 months after the last participant has been entered to the study **Description:** Determine Disease Control Rate (DCR) = complete response (CR)+ partial response (PR) + stable disease (SD) **Measure:** Determine Disease Control Rate (DCR=CR+PR+SD) **Time Frame:** Every 2 months for a maximum of 24 months after the last participant has been entered to the study **Measure:** Determine the overall survival (OS) **Time Frame:** Every 2 months for a maximum of 24 months after the last participant has been entered to the study ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients with histologically confirmed intrahepatic, perihilar or extra-hepatic CCA. 2. Patients with no more than 2 prior treatments with systemic anti-neoplastic therapy for CCA. 3. The tumor is unresectable and not amenable to curative therapy. 4. One or more tumors measurable on CT scan per RECIST 1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0- 1. 6. Life expectancy of at least 3 months. 7. Age ≥18 years. 8. Signed, written IRB-approved informed consent. 9. A negative pregnancy test (if female). 10. Acceptable liver and renal function: * Bilirubin ≤ 1.5 times upper limit of normal (CTCAE Grade 2 baseline) * AST (SGOT), ALT (SGPT) ≤ 2.5 x upper limit of normal (ULN), * Serum creatinine ≤ 1.5 X ULN (CTCAE Grade 1 baseline) * Albumin \> 3.0 g/dL 11. Acceptable hematologic status: * Absolute neutrophil count ≥1000 cells/mm3 * Platelet count ≥75,000 (plt/mm3) (CTCAE Grade 1 baseline) * Hemoglobin ≥ 9 g/dL 12. Acceptable blood sugar control: - Fasting glucose value ≤ 160 mg/dL (CTCAE Grade 1 baseline) 13. Urinalysis: No clinically significant abnormalities. 14. Prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 1.5 X ULN after correction of nutritional deficiencies that may have contributed to prolonged PT/PTT. 15. For men and women of child-producing potential, willingness to use effective contraceptive methods during the study. If female (or female partner of male patient), was either not of childbearing potential (defined as postmenopausal for ≥ 1 year or surgically sterile \[bilateral tubal ligation, bilateral oophorectomy or hysterectomy\]) or practicing one of the following medically acceptable methods of birth control and agreed to continue with the regimen throughout the duration of the study: * Oral, implantable or injectable contraceptives for 3 consecutive months before the baseline/randomization visit. * Total abstinence from sexual intercourse (≥ 1 complete menstrual cycle before the baseline/randomization visit). * Intrauterine device. * Double barrier method (condoms, sponge, diaphragm or vaginal ring with spermicidal jellies or cream Exclusion Criteria: 1. \>2 previous systemic anti-neoplastic regimens for CCA. 2. Previously having received ABC294640 or HCQ (or chloroquine) for the treatment of a malignancy. 3. New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG. 4. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. 5. Pregnant or nursing women. NOTE: If a woman became pregnant or suspects she is pregnant while participating in this study, she must inform her treating physician immediately. 6. Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within 28 days prior to study entry. Patients who had received any antineoplastic therapy \> 28 days prior to starting treatment with ABC294640 and HCQ must have recovered from the reversible effects of prior antineoplastic therapy (with the exception of alopecia and Grade 1 neuropathy). 7. Unwillingness or inability to comply with procedures required in this protocol. 8. Known infection with human immunodeficiency virus. 9. Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor. 10. Patients who were currently receiving any other investigational agent. 11. Patients who were receiving drugs that were sensitive substrates of CYP450 1A2, 3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of all major CYP450 isozymes that could not have been stopped at least 7 days or 5 half-lives (whichever was longer) before starting treatment with ABC294640, could not have been replaced with another appropriate medication or not given for the duration of the clinical study must be discussed with the Medical Monitor in order to determine eligibility for the study. 12. Patients who are taking warfarin, apixaban, argatroban or rivaroxaban. 13. If the patient is to receive HCQ, pre-existing retinopathy. 14. Known history of G-6-PD Deficiency, porphyria or psoriasis. 15. History of macular degeneration, visual field changes, retinal disease, or cataracts that would interfere with funduscopic eye examinations. 16. History of allergic reactions attributed to compounds of similar chemical or biologic composition to HCQ. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Phoenix **Country:** United States **Facility:** Mayo Clinic Cancer Center **State:** Arizona **Zip:** 85054 **Location 2:** **City:** Atlanta **Country:** United States **Facility:** Emory University **State:** Georgia **Zip:** 30322 **Location 3:** **City:** Rochester **Country:** United States **Facility:** Mayo Clinic Cancer Center **State:** Minnesota **Zip:** 55905 **Location 4:** **City:** Houston **Country:** United States **Facility:** MD Anderson Cancer Center **State:** Texas **Zip:** 77030 **Location 5:** **City:** Salt Lake City **Country:** United States **Facility:** Huntsman Cancer Institute, University of Utah **State:** Utah **Zip:** 84103 #### Overall Officials **Official 1:** **Affiliation:** Mayo Clinic **Name:** Mitesh Borad, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Ding X, Chaiteerakij R, Moser CD, Shaleh H, Boakye J, Chen G, Ndzengue A, Li Y, Zhou Y, Huang S, Sinicrope FA, Zou X, Thomas MB, Smith CD, Roberts LR. Antitumor effect of the novel sphingosine kinase 2 inhibitor ABC294640 is enhanced by inhibition of autophagy and by sorafenib in human cholangiocarcinoma cells. Oncotarget. 2016 Apr 12;7(15):20080-92. doi: 10.18632/oncotarget.7914. **PMID:** 26956050 **Citation:** Beljanski V, Knaak C, Smith CD. A novel sphingosine kinase inhibitor induces autophagy in tumor cells. J Pharmacol Exp Ther. 2010 May;333(2):454-64. doi: 10.1124/jpet.109.163337. Epub 2010 Feb 23. **PMID:** 20179157 **Citation:** French KJ, Zhuang Y, Maines LW, Gao P, Wang W, Beljanski V, Upson JJ, Green CL, Keller SN, Smith CD. Pharmacology and antitumor activity of ABC294640, a selective inhibitor of sphingosine kinase-2. J Pharmacol Exp Ther. 2010 Apr;333(1):129-39. doi: 10.1124/jpet.109.163444. Epub 2010 Jan 8. **PMID:** 20061445 **Citation:** Britten CD, Garrett-Mayer E, Chin SH, Shirai K, Ogretmen B, Bentz TA, Brisendine A, Anderton K, Cusack SL, Maines LW, Zhuang Y, Smith CD, Thomas MB. A Phase I Study of ABC294640, a First-in-Class Sphingosine Kinase-2 Inhibitor, in Patients with Advanced Solid Tumors. Clin Cancer Res. 2017 Aug 15;23(16):4642-4650. doi: 10.1158/1078-0432.CCR-16-2363. Epub 2017 Apr 18. **PMID:** 28420720 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000230 - Term: Adenocarcinoma - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M20426 - Name: Cholangiocarcinoma - Relevance: HIGH - As Found: Cholangiocarcinoma - ID: M20430 - Name: Klatskin Tumor - Relevance: HIGH - As Found: Cholangiocarcinoma, Perihilar - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - 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: T755 - Name: Bile Duct Cancer - Relevance: HIGH - As Found: Cholangiocarcinoma - ID: T3241 - Name: Klatskin Tumor - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000018281 - Term: Cholangiocarcinoma - ID: D000018285 - Term: Klatskin Tumor ### Intervention Browse Module - Ancestors - ID: D000000962 - Term: Antimalarials - ID: D000000981 - Term: Antiprotozoal Agents - ID: D000000977 - Term: Antiparasitic Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000018501 - Term: Antirheumatic Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents ### Intervention Browse Module - Browse Leaves - ID: M9940 - Name: Hydroxychloroquine - Relevance: HIGH - As Found: Rare disease - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4280 - Name: Antimalarials - Relevance: LOW - As Found: Unknown - ID: M4298 - Name: Antiprotozoal Agents - Relevance: LOW - As Found: Unknown - ID: M4294 - Name: Antiparasitic 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: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000006886 - Term: Hydroxychloroquine ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02149979 **Brief Title:** Closure of Skin Incision Using CO2 Laser **Official Title:** Closure of Skin Incision Using CO2 Laser #### Organization Study ID Info **ID:** Katzir #1 #### Organization **Class:** OTHER **Full Name:** Tel Aviv University ### Status Module #### Completion Date **Date:** 2009-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2014-05-29 **Type:** ESTIMATED **Last Update Submit Date:** 2014-05-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2008-01 **Type:** ACTUAL #### Start Date **Date:** 2007-03 **Status Verified Date:** 2014-05 #### Study First Post Date **Date:** 2014-05-29 **Type:** ESTIMATED **Study First Submit Date:** 2014-05-25 **Study First Submit QC Date:** 2014-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Avraham Katzir #### Responsible Party **Investigator Affiliation:** Tel Aviv University **Investigator Full Name:** Avraham Katzir **Investigator Title:** Head of the applied physics group **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to evaluate the safety and effectiveness of using Temperature Controlled Laser Soldering System for soft tissue bonding. **Detailed Description:** Skin incisions can be closed by a variety of method which create temporary approximation of the wound edges until natural healing process ensue and reach a phase, where it is closed and can sustain the daily tensile forces. The wound closure devices include sutures, staples, tapes, tissue adhesives. The Applied Physics group at the Tel Aviv University has developed a Temperature Controlled CO2 Laser Soldering system for soft tissue bonding. This system includes features that make laser soldering suitable for clinical use. The Temperature Controlled Laser Soldering System is composed of CO2 fiberoptic laser device, Infrared fiber-optic radiometer, a computerized temperature control program, propriety grip device (Clamps) and concentrated Human Albumin as a soldering agent. ### Conditions Module **Conditions:** - Wound **Keywords:** - Incision - Wound Closure - Laser Tissue Soldering ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### 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:** Efficacy and safety of Temperature Controlled Laser Soldered wound incisions closure **Intervention Names:** - Device: Temperature Controlled Laser Soldering **Label:** Temperature Controlled Laser Soldering **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Temperature Controlled Laser Soldering **Description:** This study had a prospective within-subject design. Patients allocated to laparoscopic cholecystectomy procedure were enrolled. After the completion of the laparoscopic cholecystectomy surgical procedure, 4 trocar port sites were randomly either sutured or laser soldered by employing the temperature-controlled laser soldering system. **Name:** Temperature Controlled Laser Soldering **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** Primary study endpoint will be to establish the safety of using the Temperature Controlled Laser Soldering System for skin bonding and wounds closure. Safety will be established by paucity of serious adverse events and adverse events. **Time Frame:** 3 months #### Secondary Outcomes **Measure:** Re-intervention: A subject is scored a success (1) if he had No Re-intervention by 3 months; otherwise he is scored a failure (0). **Time Frame:** 3 months **Measure:** Wound dehiscence of at least 50% of wound length **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male/Female age 18-65. * Subject is scheduled for laparoscopic cholecystectomy surgery. * Subject able to comprehend and sign informed consent for participation in this study. * Ability to comply with the study procedures and follow-up visits Exclusion Criteria: * Subject has a history of hypertrophic or keloid scar formation * Subject is a pregnant and/or nursing woman * Subject has a known allergy to blood products * Subject is suffering from a bleeding disorders or using anticoagulant medications * Subject is suffering from hepatic or renal disorder * Subject is suffering from rheumatic and / or collagen disorder * Subject is using steroids * Subject is suffering from immunosuppressive disorder * Subject is suffering from Ischemic Heart Disease (IHD) * Subject is suffering from neoplastic disorder * Subject who has had an active illness within 4 weeks of study enrollment * Subject is participating in another study for an investigational drug and/or device within 3 months of study enrollment * Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Afula **Country:** Israel **Facility:** Department of Surgery B, "HaEmek" Medical Center **Zip:** 18341 **Location 2:** **City:** Afula **Country:** Israel **Facility:** Haemek Medical Center **Zip:** 18341 #### Overall Officials **Official 1:** **Affiliation:** Department of Surgery B, "HaEmek" Medical Center, Afula, **Name:** Doron Kopelman, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** The applied physics group, Tel Aviv University **Name:** Abraham Katzir, PhD **Role:** STUDY_CHAIR **Official 3:** **Affiliation:** The applied physics group, Tel Aviv University **Name:** David Simhon, MD, PhD **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Simhon D, Halpern M, Brosh T, Vasilyev T, Ravid A, Tennenbaum T, Nevo Z, Katzir A. Immediate tight sealing of skin incisions using an innovative temperature-controlled laser soldering device: in vivo study in porcine skin. Ann Surg. 2007 Feb;245(2):206-13. doi: 10.1097/01.sla.0000232554.13719.10. **PMID:** 17245173 **Citation:** Simhon D, Brosh T, Halpern M, Ravid A, Vasilyev T, Kariv N, Katzir A, Nevo Z. Closure of skin incisions in rabbits by laser soldering: I: Wound healing pattern. Lasers Surg Med. 2004;35(1):1-11. doi: 10.1002/lsm.20074. **PMID:** 15278922 **Citation:** Brosh T, Simhon D, Halpern M, Ravid A, Vasilyev T, Kariv N, Nevo Z, Katzir A. Closure of skin incisions in rabbits by laser soldering II: Tensile strength. Lasers Surg Med. 2004;35(1):12-7. doi: 10.1002/lsm.20073. **PMID:** 15278923 **Citation:** Simhon D, Ravid A, Halpern M, Cilesiz I, Brosh T, Kariv N, Leviav A, Katzir A. Laser soldering of rat skin, using fiberoptic temperature controlled system. Lasers Surg Med. 2001;29(3):265-73. doi: 10.1002/lsm.1118. **PMID:** 11573230 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M1112 - Name: Surgical Wound - Relevance: HIGH - As Found: Incision - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000072836 - Term: Surgical Wound ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04346979 **Brief Title:** Telerehabilitation-based Yoga and Mindfulness Home Program in Postmenopausal Women Having Social Isolation **Official Title:** The Effect of Telerehabilitation Based Yoga and Mindfulness Home Program on Psychological Resilience, Body Awareness and Physical Activity in Postmenopausal Women Having Social Isolation #### Organization Study ID Info **ID:** 0001 #### Organization **Class:** OTHER **Full Name:** Istinye University ### Status Module #### Completion Date **Date:** 2020-11-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-09-16 **Type:** ACTUAL **Last Update Submit Date:** 2022-09-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-10-01 **Type:** ACTUAL #### Start Date **Date:** 2020-08-01 **Type:** ACTUAL **Status Verified Date:** 2022-09 #### Study First Post Date **Date:** 2020-04-15 **Type:** ACTUAL **Study First Submit Date:** 2020-04-13 **Study First Submit QC Date:** 2020-04-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istinye University #### Responsible Party **Investigator Affiliation:** Istinye University **Investigator Full Name:** Yasemin Çırak **Investigator Title:** Physiotherapist, PhD, 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:** In the postmenopausal period when the woman spent 1/3 of her life; Due to the lack of estrogen, some physical and psychological changes occur. These changes may cause some problems. For women who perceive menopause as the first step of old age, loss of physical strength, energy, attraction and fertility, menopause can also lead to anxiety. In addition to these, they are among the emotional changes in the menopausal period in symptoms such as hypersensitivity to events, fatigue, and insomnia. Sometimes it can even be seen in psychological disorders such as melancholy and depression. The new coronavirus pneumonia (COVID-19), which appeared in Wuhan in December 2019, started to appear in different countries soon after. All countries have taken measures to prevent the spread of this virus. To this end, Turkey remains at home on March 21, 2020, and has commissioned social isolation measures. Studies investigating the effects of social isolation show that psychological and physical problems occur in individuals. Studies have shown that yoga and mindfulness programs have an impact on people's anxiety, depression, and the ability to control themselves. The purpose of this study; To investigate the effectiveness of telerehabilitation based yoga and mindfulness programs on psychological resilience, physical awareness and physical activity in postmenopausal women in social isolation due to the COVID-19 outbreak. Using telerehabilitation-based home programs aims to use an innovative model. ### Conditions Module **Conditions:** - Telerehabilitation **Keywords:** - Postmenopausal - Yoga - Mindfulness - COVID-19 - Social Isolation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Telerehabilitation based yoga and mindfulness training will be given to the study group. **Intervention Names:** - Other: Telerehabilitation-Based **Label:** Study Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Yoga and mindfulness training will be provided by sending a video recording to the control group. **Intervention Names:** - Other: Video-Based **Label:** Control Group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Study Group **Description:** 25 volunteers postmenopausal women who are at home during the social isolation process due to the coronavirus outbreak will be included in this group. Online yoga and mindfulness protocol was created for individuals who will participate in the study. Each training protocol was planned as 30 minutes for 3 days a week for 6 weeks. It was planned to start the protocol with warm-up exercises and finish with cooling exercises. Respiratory exercise was added to the training protocol. Individuals were asked to participate in the study via telerehabilitation system and aimed to do their exercises with a physiotherapist. **Name:** Telerehabilitation-Based **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Control Group **Description:** 25 volunteers postmenopausal women who are at home during the social isolation process due to the coronavirus outbreak will be included in this group. Online yoga and mindfulness protocol was created for individuals who will participate in the study. Each training protocol was planned as 30 minutes for 3 days a week for 6 weeks. It was planned to start the protocol with warm-up exercises and finish with cooling exercises. The respiratory exercise was added to the training protocol. Video recordings containing only yoga and mindfulness training were sent to individuals. The participants were supervised by the researcher. **Name:** Video-Based **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The scale was used to measure the psychological resilience of individuals and Smith et al. (2008) were developed by. It is a 5-point Likert type, 6-item self-reporting style measurement tool. After the items in the scale and reverse coded are translated, the high scores indicate high psychological soundness. **Measure:** The Brief Resilience Scale **Time Frame:** 2 week **Description:** Nottingham Health Profile was created in England in 1985 to evaluate the quality of life-related to health. The Nottingham Health Profile is a general quality of life questionnaire that assesses the level of individuals health problems and how they affect their daily life activities. **Measure:** Nottingham Health Profile **Time Frame:** 2 week **Description:** Mindful Attention Awareness Scale developed by Brown and Ryan (2003) is a 15-item scale that measures the general tendency to be aware of and be mindful of instant experiences in daily life. It has a single factor structure and gives a single total score. High scores from the scale indicate that conscious awareness is high. It is a 6-point Likert type scale. **Measure:** Mindful Attention Awareness Scale **Time Frame:** 2 week **Description:** It is a questionnaire consisting of four subgroups (changes in body process, sleep-wake cycle, prediction at the onset of the disease, prediction of body responses) and a total of 18 expressions aimed at determining the normal or abnormal sensitivity level of the body composition. The participant is asked to score from one to seven figures for each statement. In the survey, the ratings are made as total points. A high score indicates that body sensitivity is better. **Measure:** The Body Awareness Questionnaire **Time Frame:** 2 week **Description:** It, developed by Richards in 1987, is a 6-item scale that evaluates the depth of night sleep, falling asleep, frequency of waking, awakening when awakened, the quality of sleep and the level of noise in the environment. Each item is evaluated on the chart between 0 and 100 with a visual analog scale technique. "0-25" score obtained from the scale indicates very poor sleep, and the "76-100" score indicates very good sleep. Scale total score is evaluated over 5 items, and item 6 evaluating the noise level in the environment is excluded from the total score assessment. As the score of the scale increases, the sleep quality of the patients also increases. **Measure:** Richard-Campbell Sleep Questionnaire **Time Frame:** 2 week **Description:** The participant, who is on the non-dominant side, will be asked to create a support surface from the elbow with the lower arm, place the other hand on the waist, and build a bridge by lifting the hip and knee. The time that the balance is maintained will be recorded. **Measure:** Lateral bridge test **Time Frame:** 2 week **Description:** It is applied functionally both for the balance of the individual and for measuring the amount of dynamic reach. The individual is asked to lie down as long as he/she can lie down without going over the heel and hip flexion. **Measure:** Functional reach test **Time Frame:** 2 week **Description:** It consists of 21 questions used to evaluate the emotional situation. Each question is graded between 0-3 and a high score indicates that depressive symptoms increase. 10-16 points indicate mild depressive symptoms, 17-29 points indicate moderate depressive symptoms and 30-63 points indicate severe depressive symptoms. **Measure:** Beck Depression Scale **Time Frame:** 2 week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being physically or perceptually competent to exercise, * No spinal pathology or deformity, * Volunteering to participate in the study, * Not having menstruation for at least 12 months * Hormonally, surgically induced or natural menopause-confirmed women Exclusion Criteria: * Those with serious heart disease (aortic stenosis, angina, hypertrophic cardiac myopathy, arrhythmia, pacemaker) * Those with inflammatory or systemic disease malignancy * Psychological dysfunction * Those who use corticosteroids **Gender Based:** True **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 45 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Istinye University ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M2561 - Name: COVID-19 - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05358379 **Brief Title:** A Study to Investigate CYC140, in Subjects With Advanced Solid Tumors and Lymphoma **Official Title:** A Phase 1/2, Open-label, Multicenter Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CYC140, an Oral PLK1 Inhibitor, in Subjects With Advanced Solid Tumors and Lymphoma #### Organization Study ID Info **ID:** CYC140-101 #### Organization **Class:** INDUSTRY **Full Name:** Cyclacel Pharmaceuticals, Inc. ### Status Module #### Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-02-07 **Type:** ACTUAL **Last Update Submit Date:** 2024-02-06 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-08 **Type:** ESTIMATED #### Start Date **Date:** 2022-04-14 **Type:** ACTUAL **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2022-05-03 **Type:** ACTUAL **Study First Submit Date:** 2022-04-19 **Study First Submit QC Date:** 2022-04-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Cyclacel Pharmaceuticals, Inc. #### 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 2-part, phase 1/2, open-label, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, pharmacogenomics, and efficacy of CYC140 administered orally daily. This study consists of Phase 1 and Phase 2 components in subjects with advanced solid tumors and lymphoma who have progressed despite having standard therapy or for which no standard therapy exists. **Detailed Description:** Phase 1 part of the study will consist of a dose-escalation and a dose-finding component. Phase 2 will enroll subjects with locally advanced, recurrent, or metastatic, histologically confirmed advanced solid tumors or lymphoma, who have failed all standard therapies or for whom standard therapy does not exist, into 8 groups: Group 1: Bladder cancer Group 2: Breast cancer: Triple-negative breast cancer (TNBC) Group 3: Lung cancer (non-small cell lung cancer \[NSCLC\] and small cell lung cancer \[SCLC\]) Group 4: Hepatocellular carcinoma (HCC) and biliary tract cancer (BTC) Group 5: Metastatic colorectal cancer (mCRC) including KRAS-mutated mCRC Group 6: B-cell lymphoma including diffuse large B-cell lymphoma (DLBCL) Group 7: T-cell lymphoma (cutaneous T-cell lymphoma \[CTCL\] and peripheral T-cell lymphoma \[PTCL\]) Group 8: Basket cohort: tumor types that are suspected to have a related mechanism of action but are not included in previous groups including, esophageal, prostate, ovarian and pancreatic cancers ### Conditions Module **Conditions:** - Solid Tumor, Adult Lymphoma ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL **Intervention Model Description:** Dose escalation in Phase 1 part ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 330 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Phase 1 = CYC140 administered orally in escalating doses starting at 5mg QD M-F week 1 to 3 for 3 weeks of a 4 week cycle. Subsequent cohorts will escalate in dose and schedule until optimized phase 2 dose and schedule is achieved. **Intervention Names:** - Drug: CYC140 **Label:** Phase 1 Dose Escalation **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Phase 2 = Recommended CYC140 phase 2 dose and schedule administered orally in 28-day cycles. **Intervention Names:** - Drug: CYC140 **Label:** Phase 2 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Phase 1 Dose Escalation - Phase 2 **Description:** CYC140 is a highly selective, orally- and intravenously- available, ATP-competitive inhibitor of PLK1. **Name:** CYC140 **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Pharmacodynamic response to CYC140 will be assessed by mRNA sequencing of blood samples to determine differential expression of PLK1 target genes (including MYC, PLK1, CDKN1A) relative to baseline. **Measure:** Pharmacodynamics **Time Frame:** 6 months **Description:** Genomic alterations will be assessed by next generation sequencing (NGS) at baseline and various time points during treatment with CYC140 in order to investigate the relationship between genetic alterations in CYC140 related pathways and response to CYC140. Parameters of genetic variations (DNA mutations) and copy number variations using plasma cell-free DNA derived from peripheral blood will be assessed. **Measure:** Pharmacogenomics **Time Frame:** 24 months #### Primary Outcomes **Description:** The incidence rate of dose-limiting toxicities (first cycle only) at each dose level **Measure:** Maximum tolerated dose **Time Frame:** 6 months **Description:** Assessment of response criteria according to RESIST, Lugano or mSWAT. **Measure:** Overall Response Rate (ORR) **Time Frame:** 18 months #### Secondary Outcomes **Description:** Type, frequency, and severity of adverse drug reactions **Measure:** Adverse events **Time Frame:** 24 months **Description:** CYC140 plasma concentrations **Measure:** AUC **Time Frame:** 6 months **Description:** CYC140 plasma concentrations **Measure:** Cmax **Time Frame:** 6 months **Description:** CYC140 plasma concentrations **Measure:** Tmax **Time Frame:** 6 months **Description:** CYC140 plasma concentrations **Measure:** T1/2 **Time Frame:** 6 months **Description:** To evaluate the disease control rate (DCR) in subjects receiving CYC140. **Measure:** Disease Control Rate **Time Frame:** 24 months **Description:** To evaluate the duration of response (DOR) in subjects receiving CYC140. **Measure:** Duration of Response **Time Frame:** 24 months **Description:** To evaluate progression-free survival (PFS) in subjects receiving CYC140. **Measure:** Progression-free Survival **Time Frame:** 24 months **Description:** To evaluate overall survival (OS) in subjects receiving CYC140. **Measure:** Overall Survival **Time Frame:** 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Males or females aged ≥ 18 years. 2. Subjects with histological- or cytological-confirmed, advanced cancer who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists 1. For Phase 1, all tumor types may be enrolled 2. For Phase 2, subjects will be enrolled as per the study design section above 3. ECOG performance status of 0-2. 4. Subjects who relapsed post-autologous or post-allogeneic transplant are eligible. Post-transplant subjects must be without active fungal disease or significant acute graft-versus-host disease 5. Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to starting the study drug. Both males and females must agree to use effective birth control during the study (prior to the first dose and for 6 months after the last dose) if conception is possible during this interval. 6. Subjects must be able to swallow and retain orally administered medication and not have any clinically significant GI abnormalities that may alter the absorption, such as malabsorption syndrome or major resection of the stomach or bowels. 7. Able to agree to and sign the informed consent and to comply with the protocol. Exclusion Criteria: 1. Subjects with a history of brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases. Subjects with treated brain metastases that are asymptomatic and have been clinically stable for at least 4 weeks will be eligible. 2. Subjects who have not received vaccines for severe acute respiratory syndrome-corona virus-2 (SARS-COV-2) and have suspected signs and symptoms of the novel coronavirus infection (COVID-19) or have confirmed COVID-19. 3. Subjects with a history of another primary malignancy, other than: 1. In situ carcinomas, e.g., breast, cervix, and prostate 2. Locally excised nonmelanoma skin cancer 3. No evidence of disease from another primary cancer for 2 or more years and has not taken any anti-cancer treatment in 2 years. 4. Any other clinically significant acute or chronic medical or psychiatric condition or any laboratory abnormality that may increase the risk associated with study drug administration or may interfere with the interpretation of study results. 5. Diseases that significantly affect GI absorption of CYC140. 6. Subjects who have impaired cardiac function or clinically significant cardiac disease. 7. Presence of active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment 8. Presence of an active infection requiring intravenous antibiotics 9. Presence of known history of human immunodeficiency virus-1/2 with uncontrolled viral load and on medications that may interfere with metabolism 10. Presence of active hepatitis B virus (HBV) or hepatitis C virus (HCV). 11. Chemotherapy, biologic therapy, targeted therapy, immunotherapy, extended-field radiotherapy, or investigational agents within 5 half-lives or 3 weeks (whichever is shorter) prior to administration of first dose of study drug on Day 1 or have not recovered from the side effects of such therapy. 12. Major surgery/surgical therapy for any cause within 4 weeks of the first dose **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mark H Kirschbaum, MD **Phone:** 626-316-3394 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Julius Huang, PhD **Role:** CONTACT #### Locations **Location 1:** **City:** Duarte **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Miguel Villalona-Calero, MD - **Role:** CONTACT **Country:** United States **Facility:** City of Hope **State:** California **Status:** RECRUITING **Zip:** 91010 **Location 2:** **City:** Pittsburgh **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Julie Urban - **Role:** CONTACT **Country:** United States **Facility:** UPMC Hillman Cancer Center **State:** Pennsylvania **Status:** RECRUITING **Zip:** 15232 **Location 3:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Meng Gao - **Role:** CONTACT **Country:** United States **Facility:** MD Anderson Cancer Center **State:** Texas **Status:** RECRUITING **Zip:** 77030 **Location 4:** **City:** Seoul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Do-Youn Oh, Prof. MD - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Seoul National University Hospital **Status:** RECRUITING **Location 5:** **City:** Barcelona **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Elena Garralda Cabanas, MD - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Universitario Vall d'Hebron **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - 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: M11220 - Name: Lymphoma - Relevance: HIGH - As Found: Lymphoma - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - 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: T3543 - Name: Lymphosarcoma - Relevance: HIGH - As Found: Lymphoma ### Condition Browse Module - Meshes - ID: D000008223 - Term: Lymphoma ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04151979 **Brief Title:** MRI for the Diagnosis of Placenta Accreta Spectrum **Official Title:** MRI for the Diagnosis of Placenta Accreta Spectrum #### Organization Study ID Info **ID:** PAS001 #### Organization **Class:** OTHER **Full Name:** Peking University Third Hospital ### Status Module #### Completion Date **Date:** 2019-12-31 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2019-11-05 **Type:** ACTUAL **Last Update Submit Date:** 2019-11-01 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2019-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2015-01-01 **Type:** ACTUAL **Status Verified Date:** 2019-10 #### Study First Post Date **Date:** 2019-11-05 **Type:** ACTUAL **Study First Submit Date:** 2019-10-24 **Study First Submit QC Date:** 2019-11-01 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Peking University Third Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Placenta Accreta Spectrum (PAS) is a disease associated with abnormal placental adhesion and invasion. In recent years, the incidence of PAS has increased significantly, which can cause massive postpartum hemorrhage, hysterectomy,and even maternal mortality. The research team of Peking university third hospital developed the ultrasound rating scale in china at first to conduct preliminary assessment of the PAS risk which can identify the severity of cases. In a basis of ultrasound, plan to explore the MRI for the the investigators diagnosis of PAS according to some specific PAS features, like the the uneven signal intensity , the myometrial discontinuity, and black band on T2 image, and finally established a MRI scoring system of PAS. MRI score system of PAS can reduce the subjective difference of the clinician's visual reading, and assist the clinician to assess the risk of sever PAS further, and conduct perioperative preparation to reduce the risk of maternal morbidity and mortality to achieve a better clinical outcome. **Detailed Description:** Placenta Accreta Spectrum (PAS) is a disease associated with abnormal placental adhesion and invasion. In recent years, the incidence of PAS has increased significantly, and the main risk is high hysterectomy rate,massive postpartum hemorrhage, and even maternal mortality in women at childbearing age. The research team of Peking university third hospital developed the ultrasound rating scale in china at first to conduct preliminary assessment of the PAS risk which can identify the severity of cases and guide the junior hospitals to transfer. Peking University third hospital is in the leading position in the preoperative diagnosis of PAS currently. Magnetic resonance imaging (MRI) has become a common method for preoperative evaluation for sever cases. MRI can provide a map of the placenta and PAS features, like the uterus enlarged significantly, the uneven signal intensity , the myometrial discontinuity, and black band on T2 image. It has a high diagnostic value. At present, only Lim and Ueno reported MRI scoring system for PAS. Due to the small sample size and the limitation of the research methods, a widely applicable rating scale has not been established. MRI score system of PAS can reduce the subjective difference of the clinician's visual reading, and assist the clinician to assess the risk of sever PAS further, and conduct perioperative preparation to reduce the risk of maternal morbidity and mortality and achieve a better clinical outcome. ### Conditions Module **Conditions:** - Placenta Accreta **Keywords:** - placenta accreta spectrum - MRI - score scale - diagnosis ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** diagnose as PAS through clinical observation or specimen pathology after surgery **Measure:** Rate of PAS diagnosed **Time Frame:** one week after surgery #### Secondary Outcomes **Description:** The blood loss volume during the 24 hours after surgery **Measure:** Blood loss volume(ml) **Time Frame:** 24 hours after surgery **Description:** Number of patients who were performed hysterectomy/Number of patients with PAS **Measure:** Rate of hysterectomy **Time Frame:** two weeks after surgery **Description:** The number of patients who delivered between 28 to 36+6 weeks/Number of patients with PAS **Measure:** Rate of preterm labor **Time Frame:** two weeks after surgery **Description:** the volume of blood transfusion **Measure:** Blood transfusion volume(ml) **Time Frame:** two weeks after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients diagnosed as scarred uterus(with a history of cesarean section) 2. "ultrasound score" of PAS≥ 6 points who undergo MRI 3. Terminate pregnancy or childbirth in Peking university third hospital. - Exclusion Criteria: 1. Patients who didn't undergo MRI 2. Patients who didn't deliver the baby in PUTH - **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** The patients who have risk factors of PAS, undergo "ultrasound scoring" and MRI ,finally delivered in Peking university third hospital. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Lian Chen **Phone:** +8613811748746 **Role:** CONTACT #### Locations **Location 1:** **City:** Peking **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Lian Chen - **Phone:** +8613811748746 - **Role:** CONTACT **Country:** China **Facility:** Peking University Third Hospital **State:** Beijing **Status:** RECRUITING **Zip:** 100191 #### Overall Officials **Official 1:** **Affiliation:** Peking University Third Hospital **Name:** YangYu Zhao, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007744 - Term: Obstetric Labor Complications - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000010922 - Term: Placenta Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13811 - Name: Placenta Accreta - Relevance: HIGH - As Found: Placenta Accreta - ID: M10764 - Name: Obstetric Labor Complications - 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: M13812 - Name: Placenta Diseases - Relevance: LOW - As Found: Unknown - ID: T4583 - Name: Placenta Disorder - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010921 - Term: Placenta Accreta ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06361979 **Brief Title:** SHR-A1811 Combined With Bevacizumab in HER2-positive Breast Cancer With Brain Metastases **Official Title:** A Single-arm, Exploratory Clinical Study of SHR-A1811 Combined With Bevacizumab in the Treatment of HER2-positive Breast Cancer With Brain Metastases #### Organization Study ID Info **ID:** A1811 #### Organization **Class:** OTHER **Full Name:** Tongji Hospital ### Status Module #### Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-04-12 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-08 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-04-12 **Type:** ACTUAL **Study First Submit Date:** 2024-04-08 **Study First Submit QC Date:** 2024-04-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Huihua Xiong #### Responsible Party **Investigator Affiliation:** Tongji Hospital **Investigator Full Name:** Huihua Xiong **Investigator Title:** Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aimed to evaluate the use of SHR-A1811 and bevacizumab in HER2-positive Breast Cancer with brain metastases ### Conditions Module **Conditions:** - Breasr Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: SHR-A1811 - Drug: Bevacizumab **Label:** ARM1 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - ARM1 **Description:** SHR-A1811: intravenous **Name:** SHR-A1811 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - ARM1 **Description:** Bevacizumab:intravenous **Name:** Bevacizumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** CNS-ORR was defined as percentage of participants with CNS response assessed by the investigator according to RANO-BM criteria **Measure:** CNS-ORR **Time Frame:** Up to 2 years #### Secondary Outcomes **Description:** PFS was defined as the time from first dose to first documented disease progression (PD) or death from any cause, whichever occurred first **Measure:** PFS **Time Frame:** up to 2 years **Description:** ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR assessed by the investigator according to RECIST version 1.1 **Measure:** ORR **Time Frame:** Up to 2 years **Description:** Proportion of participants experienced adverse events during the study period **Measure:** AE **Time Frame:** Up to 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. ≥18 years old; 2. Pathologically confirmed HER2-positive breast cancer; 3. At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment; 4. More than 2 weeks from last systemic treatment; patients with new brain lesions after craniocerebral surgery were admitted if no radiotherapy was performed. 5. Prior HER2-target treatment, endocrine therapy and chemotherapy was allowed; 6. Adequate function of major organs- Exclusion Criteria: 1. Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor; 2. Previous treatment with bevacizumab; 3. Participated in other drug clinical trials within 4 weeks before admission; 4. History of clinically significant lung disease； 5. Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years. 6. According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.). 7. Any other conditions that researchers believe that patients are unsuitable for this study. - **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Xiong huihua **Phone:** 13886073988 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology **Name:** Xiong huihua **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009369 - Term: Neoplasms - ID: D000016543 - Term: Central Nervous System Neoplasms - ID: D000009423 - Term: Nervous System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### 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 - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12307 - Name: Neoplasm Metastasis - Relevance: LOW - As Found: Unknown - ID: M5209 - Name: Brain Neoplasms - Relevance: HIGH - As Found: Brain Metastases - 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 ### Condition Browse Module - Meshes - ID: D000001932 - Term: Brain Neoplasms ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000020533 - Term: Angiogenesis Inhibitors - ID: D000043924 - Term: Angiogenesis Modulating Agents - ID: D000006133 - Term: Growth Substances - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000006131 - Term: Growth Inhibitors ### 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: HIGH - As Found: Non- - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M22318 - Name: Angiogenesis Inhibitors - Relevance: LOW - As Found: Unknown - ID: M9231 - Name: Growth Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000068258 - Term: Bevacizumab ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00656279 **Brief Title:** Intensive Dietary Education to Lower Serum Phosphorus in Patients With Chronic Kidney Disease **Official Title:** Intensive Patient Education Using the Phosphorus Point System© Tool to Improve Serum Phosphorus Levels in Patients With Chronic Kidney Disease #### Organization Study ID Info **ID:** SMH07-377 #### Organization **Class:** OTHER **Full Name:** Unity Health Toronto ### Status Module #### Completion Date **Date:** 2009-07 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2013-05-09 **Type:** ESTIMATED **Last Update Submit Date:** 2013-05-07 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2009-07 **Type:** ACTUAL #### Start Date **Date:** 2008-04 **Status Verified Date:** 2013-05 #### Study First Post Date **Date:** 2008-04-11 **Type:** ESTIMATED **Study First Submit Date:** 2008-04-07 **Study First Submit QC Date:** 2008-04-07 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Unity Health Toronto #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** A low phosphorus diet is recommended for patients with chronic kidney disease who exhibit high levels of phosphorus. The purpose of this study is to determine the effects of a more intensive, innovative dietary phosphorus educational intervention on reducing serum phosphorus levels, as well as improving dietary adherence, dietary satisfaction and phosphorus knowledge level in patients with chronic kidney disease. **Detailed Description:** High serum phosphorus concentration (hPhos) commonly occurs in chronic kidney disease (CKD) secondary to declining renal function. hPhos increases the risk of developing metastatic calcification, secondary hyperparathyroidism, renal osteodystrophy and cardiovascular complications. Patients with hPhos are advised to restrict their dietary phosphorus intake to 800-1000mg/d, as per National Kidney Foundations'Kidney Disease Quality Outcomes Initiative (KDOQI). Adherence to a phosphorus restricted diet is often challenging for CKD patients, as they may be required to follow various dietary restrictions, and there is significant quantities of hidden phosphorus in processed foods. This randomized controlled trial is designed to compare the effectiveness of more intensive phosphorus education (IPE) using the innovative Phosphorus Point System Tool© versus standard phosphorus education (SPE) using the Choose/Avoid list on 1) serum phosphorus levels (primary outcome) 2) dietary adherence, dietary knowledge and satisfaction in patients with pre-dialysis CKD. We hypothesize that patients receiving IPE will have lower serum phosphorus than those receiving SPE. Fifty patients attending a pre-dialysis CKD clinic with serum phosphorus \> 1.49 mmol/L will be randomly assigned to IPE or SPE and followed over 12 weeks. Serum phosphorus, dietary intakes using the 5-pass repeat 24-hour dietary recall method, dietary knowledge and satisfaction by validated questionnaires, will be measured at baseline, 6 weeks and 12 weeks. The study's findings on the impact of more intensive innovative dietary phosphorus education in patients with pre-dialysis CKD will serve towards developing best practice of care and potentially reduce long-term complications. ### Conditions Module **Conditions:** - Chronic Kidney Disease **Keywords:** - chronic kidney disease - predialysis - hyperphosphatemia - dietary intervention - intensive dietary education - low phosphorus diet ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 24 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intensive dietary phosphorus education **Intervention Names:** - Behavioral: Intensive dietary phosphorus education **Label:** 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Standard dietary education consists of the dietitian assessing laboratory values and dietary intake and providing dietary education for abnormal values using handouts developed for specific nutrients. **Label:** 2 **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - 1 **Description:** Intensive dietary phosphorus education will be completed using the Phosphorus Point System Tool, a booklet listing phosphorus points for food items based on the phosphorus content. Patients will be allotted a maximum of 32-40 phosphorus points daily. Points consumed will be tracked by the patients via daily tracking sheets which require patients to list the phosphorus food items consumed, the number of points, and the time and amount of phosphate binders. Patients in this group will also receive intensive education about phosphorus additives. As a part of the program that supports the tool, patients will receive weekly telephone calls for the first 6 weeks to address any questions about the tool and find phosphorus point values of foods not listed within the tool. **Name:** Intensive dietary phosphorus education **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Measure:** Serum phosphorus **Time Frame:** baseline, week 6, week 12 #### Secondary Outcomes **Measure:** Dietary adherence **Time Frame:** baseline, week 6, week 12 **Measure:** Dietary satisfaction **Time Frame:** baseline, week 6, week 12 **Measure:** Phosphorus management knowledge-level **Time Frame:** baseline, week 6, week 12 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ≥ 18 years old * Patient with pre-dialysis CKD attending the Progressive Renal Disease Clinic (PRDC) at St. Michael's Hospital * Six-month mean serum phosphorus \> 1.35 mmol/L * Able to provide informed consent Exclusion Criteria: * Currently on dialysis * Current malignancy * Inability to use Phosphorus Point System (PPS) Tool **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Toronto **Country:** Canada **Facility:** St. Michael's Hospital Progressive Renal Disease Clinic **State:** Ontario **Zip:** M5B 1W8 #### Overall Officials **Official 1:** **Affiliation:** St. Michael's Hospital & University of Toronto **Name:** Pauline Darling, PhD **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 - 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: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic 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: M27783 - Name: Hyperphosphatemia - Relevance: LOW - As Found: Unknown - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: HIGH - As Found: Chronic Kidney 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: 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: D000007674 - Term: Kidney Diseases - ID: D000051436 - Term: Renal Insufficiency, Chronic ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04540679 **Brief Title:** Self-Management Across the Care Continuum **Official Title:** An Integrated Self-Management Service Delivery Model for Persons With SCI Across the Care Continuum #### Organization Study ID Info **ID:** 115501 #### Organization **Class:** OTHER **Full Name:** Lawson Health Research Institute ### Status Module #### Completion Date **Date:** 2021-04-29 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** NOT_YET_RECRUITING #### Last Update Post Date **Date:** 2020-09-07 **Type:** ACTUAL **Last Update Submit Date:** 2020-09-01 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2021-04-29 **Type:** ESTIMATED #### Start Date **Date:** 2020-09-01 **Type:** ESTIMATED **Status Verified Date:** 2020-09 #### Study First Post Date **Date:** 2020-09-07 **Type:** ACTUAL **Study First Submit Date:** 2020-08-25 **Study First Submit QC Date:** 2020-09-01 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** ForaHealthyMe Inc **Class:** OTHER **Name:** University Health Network, Toronto **Class:** UNKNOWN **Name:** Spinal Cord Injury Ontario **Class:** OTHER **Name:** The Craig H. Neilsen Foundation #### Lead Sponsor **Class:** OTHER **Name:** Lawson Health Research Institute #### Responsible Party **Investigator Affiliation:** Lawson Health Research Institute **Investigator Full Name:** Dalton Wolfe **Investigator Title:** Scientist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Persons with spinal cord injury (SCI) face many challenges as they transition from inpatient care to outpatients and on into the community. With shorter lengths of stay and barriers to coordinating care between SCI specialists and community service providers, the development of self-management skills are an integral part in the effective community reintegration, proper healthcare utilization, management of secondary complications as well as independence and community participation. Based on the best available behaviour change theory, this initiative utilizes an online e-health Platform as a key component of a novel care service delivery model to enhance the development of effective self-management skills. This Platform will be provided to participants receiving care in the inpatient or outpatient programs at Parkwood Institute with the potential to continue its use in the community. Participants will complete surveys prior to, during and following use of the e-health solution. These will assess feasibility, usability, usage analytics and several patient-reported outcomes including self-management-related outcomes, healthcare utilization and prevalence of secondary complications. This platform is especially relevant to our current state of dealing with COVID-19 and the challenges it presents for clinicians and their patients in that it will provide an online solution during a time of physical isolation as well as providing access to tools and resources as people transition back to their home communities following specialized rehabilitation services. **Detailed Description:** Participants using the e-health solution (called Parkwood VIP4SCI) will have access to features that connect them directly with their clinician(s) such as Virtual calling (initiated by the clinician), Messaging (email) and Scheduling/Calendar features. Platform use will be supported by a "VIP Coach. The clinician, coach and patient participants will also be able to use the e-health solution to create and monitor progress associated with self-management goals and also use embedded educational resources. These resources will also support the patients in best meeting their goals in a timely manner. User Manuals for both the Client (i.e. Patient) and Provider (i.e. Clinician) are provided and contain screenshots and descriptive text that outline all the features of the intervention. Patient participants will either be inpatients or outpatients, whereas healthcare team participants will consist of any provider assigned to the patient participant's circle of care at Parkwood Institute. The patient participants can choose to have their caregiver also access the platform - however, due to technical limitations, only 1 account is provided for the patient/caregiver dyad. Health care provider participants will have access to the platform for a specific patient at any time that patient is in the "Platform access" group as described below. The inpatient participants will be randomly allocated to 1 of 2 groups - either 1) "Platform access" or 2) "Standard care" with delayed access to the platform. In the "Standard care" group, the platform will be provided 6 weeks after inpatient discharge with support provided by the VIP coach. Those in the "Platform access" group will receive access within 2 weeks of admission to the inpatient or outpatient team at Parkwood Institute. For those patients transitioning from inpatient to outpatient care, their access to the platform will be guided by which group they were originally assigned to in addition to their needs and discharge circumstances as some of these patients may or may not be picked up by the Parkwood Outpatient team. The criteria influencing this will continue to be guided by the clinical team as per standard care. Participants seen by the outpatient team that were previously enrolled as inpatients in the "Standard care" group will be able to access the platform after 6 weeks of outpatient therapy with VIP coach support only, while those in the "Platform access" group can continue to use the platform with their outpatient health care providers. Patient participants will complete surveys at specific time points throughout the study including measures at baseline (within 2 weeks of admission), discharge from inpatient program (or 6 weeks from admission for outpatients) and then 6 weeks after that. In the case of the "Standard care" group, there will be an additional follow-up survey to assess outcome measures 6 weeks after they have been provided access to the platform. The outcome measures will assess feasibility, usability, usage analytics and several patient-reported outcomes including self-management-related outcomes, healthcare utilization and prevalence of secondary complications. ### Conditions Module **Conditions:** - Spinal Cord Injuries **Keywords:** - online platform - self-management - e-health - care transitions ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** prospective experimental trial with two sets of participants a) Inpatients being randomized to one of two groups with pre-post assessments and b) outpatients being non-randomized with pre-post assessments ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patient will receive standard inpatient care and provided access to the platform 6 weeks after inpatient discharge with support provided by the VIP coach. **Intervention Names:** - Other: VIP4SCI **Label:** Inpatient - Standard Care Delayed Platform **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patient will be provided access to the platform within 2 weeks of admission to the inpatient program **Intervention Names:** - Other: VIP4SCI **Label:** Inpatient - Platform Access **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Patient will be provided access to the platform within 2 weeks of admission to the outpatient program. If patient is transitioning from the inpatient program, their access to the platform will be guided by which group they were originally assigned to (i.e. if a 6 week delay is applicable). **Intervention Names:** - Other: VIP4SCI **Label:** Outpatient - Platform Access **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Inpatient - Platform Access - Inpatient - Standard Care Delayed Platform - Outpatient - Platform Access **Description:** Technology-enabled self-management \& rehabilitation solution **Name:** VIP4SCI **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Feasibility will be assessed across 4 subdomains (a) acceptance, b) demand, c) practicality, and d) limited efficacy) by the average scores from a set of 5 point likert-style questions relating to each sub-domain as part of a customized feasibility survey based on the Bowen et al feasibility framework (Am J Prev Med. 2009 May; 36(5): 452-457). The overall feasibility will be represented by the average score across all of the sub-domains. **Measure:** Feasibility of the use of the platform across 4 sub-domains including a) acceptance, b) demand, c) practicality, and d) limited efficacy **Time Frame:** 6 weeks after admission/enrollment (inpatient/outpatient platform access groups), discharge (or 6 weeks after admission if outpatient), and 6 weeks after being provided access to the platform (if Standard Care group) #### Secondary Outcomes **Description:** This will be assessed using 4 questions from the Social Roles \& Activities - Ability to Participate Short Form 10a which is a subscale in the SCI Quality of Life (SCI-QOL) 1.0 Measurement Tool (Tulsky et al., J Spinal Cord Med. May, 2015; 38(3): 257-269). This is a patient-reported outcome measure involving 5-point, likert-based questions. **Measure:** Social Roles & Activities - Ability to Participate **Time Frame:** Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up **Description:** This will be assessed using 1 question from the Independence Short Form 8a which is a subscale in the SCI Quality of Life (SCI-QOL) 1.0 Measurement Tool (Tulsky et al., J Spinal Cord Med. May, 2015; 38(3): 257-269). This is a patient-reported outcome measure involving 5-point, likert-based questions. **Measure:** Independence **Time Frame:** Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up **Description:** This will be assessed using 3 questions from the Pressure Ulcers Form 12a which is a subscale in the SCI Quality of Life (SCI-QOL) 1.0 Measurement Tool (Tulsky et al., J Spinal Cord Med. May, 2015; 38(3): 257-269). This is a patient-reported outcome measure involving 5-point, likert-based questions. **Measure:** Pressure Ulcer **Time Frame:** Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up **Description:** This will be assessed using 3 questions from the Pain Interference Form 10a which is a subscale in the SCI Quality of Life (SCI-QOL) 1.0 Measurement Tool (Tulsky et al., J Spinal Cord Med. May, 2015; 38(3): 257-269). This is a patient-reported outcome measure involving 5-point, likert-based questions. **Measure:** Pain Interference **Time Frame:** Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up **Description:** This will be assessed using 1 question from the Pain Behaviour Form which is a subscale in the SCI Quality of Life (SCI-QOL) 1.0 Measurement Tool (Tulsky et al., J Spinal Cord Med. May, 2015; 38(3): 257-269). This is a patient-reported outcome measure involving 5-point, likert-based questions. **Measure:** Pain Behaviour **Time Frame:** Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up **Description:** This will be assessed using 3 questions from the Resilience Short Form 8a which is a subscale in the SCI Quality of Life (SCI-QOL) 1.0 Measurement Tool (Tulsky et al., J Spinal Cord Med. May, 2015; 38(3): 257-269). This is a patient-reported outcome measure involving 5-point, likert-based questions. **Measure:** Resilience **Time Frame:** Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up **Description:** This will be assessed using the Secondary Conditions Scale which involves 4-point, likert-based questions to indicate the degree to which a specific condition is a "problem" (Kalpakjian et al., J Spinal Cord Med. 2007; 30: 62-70). There are 16 questions, each one addressing a different condition (e.g., bowel dysfunction, bladder dysfunction, diabetes, etc) that are common in persons with spinal cord injury. **Measure:** Impact of Secondary Conditions **Time Frame:** Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up **Description:** This will be assessed using the Mobile Application Rating Scale which is a series of 5-point likert-based questions across 6 sub-domains including (a) engagement, (b) functionality, (c) aesthetics, (d) information quality, (e) subjective quality and (f) perceived impact (Stoyanov et al., JMIR Mhealth Uhealth 2015;3(1):e27). **Measure:** Quality of Mobile Application **Time Frame:** 6 weeks after admission/enrollment (inpatient/outpatient platform access groups), discharge (or 6 weeks after admission if outpatient), and 6 weeks after being provided access to the platform (if Standard Care group) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria - For patient participants: * \>18 years old * Has a spinal cord injury * Admitted to SCI inpatients/outpatients at Parkwood Institute for comprehensive Rehabilitation Care (not short stay) * Has reliable high-speed internet access and device * Intact cognitive function Inclusion Criteria - For caregiver participants: - Have been identified by the patient participant as someone who they would like to participate in a caregiver role Inclusion Criteria - For health care provider participants: - Part of the health care team for a patient participant Exclusion Criteria - For patient participants only: * \<18 years old * No spinal cord injury * No access to reliable internet access or device * Impaired cognitive function **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Dalton Wolfe, PhD **Phone:** 519-685-4292 **Phone Ext:** 42957 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Heather Askes, BSc **Phone:** 519-685-4292 **Phone Ext:** 42940 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Lawson Health Research Institute **Name:** Dalton Wolfe, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013118 - Term: Spinal Cord Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - 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: M15916 - Name: Spinal Cord Injuries - Relevance: HIGH - As Found: Spinal Cord Injury - ID: M15915 - Name: Spinal Cord 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: M22023 - Name: Trauma, Nervous System - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013119 - Term: Spinal Cord Injuries ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03413579 **Acronym:** CIMAHOPE **Brief Title:** Evaluate Efficacy of the Association Nimotuzumab(HR3) /Cisplatin-Vinorelbine on Patients With Cervical Carcinom **Official Title:** Multicenter Randomised Double-blind Study to Compare HR3 or Placebo in Combination With Cisplatin-navelbine for Patients With Cervical Carcinoma, Followed in Case of Progression by a Second Line. #### Organization Study ID Info **ID:** CIMA-I3-05D143-01 #### Organization **Class:** INDUSTRY **Full Name:** El Kendi Pharmaceuticals Manufacturing Company ### Status Module #### Completion Date **Date:** 2021-02 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-08-25 **Type:** ACTUAL **Last Update Submit Date:** 2021-08-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-03 **Type:** ACTUAL #### Start Date **Date:** 2015-11 **Type:** ACTUAL **Status Verified Date:** 2020-03 #### Study First Post Date **Date:** 2018-01-29 **Type:** ACTUAL **Study First Submit Date:** 2018-01-11 **Study First Submit QC Date:** 2018-01-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** El Kendi Pharmaceuticals Manufacturing Company #### 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 objective of the present study is to estimate the overall survival of patients with cervical cancer after the administration of monoclonal antibody (mAb) Nimotuzumab (hR3) in combination with chemotherapy of first intention. Patients will be randomized in two parallel treatment groups. The first group will receive a dose of 200 mg of monoclonal antibody anti-hR3 (weekly during 18 weeks), combined with a chemotherapy (6 cycles, every 21 days of Cisplatin 70mg/m2, Vinorelbine 60 mg/m2 (Per Os) at D1 and D8 and then 80mg / m2. The second group will receive a placebo in combination with the same chemotherapy regimen as the first group. At the end of the first intention chemotherapy treatment, a dose of maintenance of Nimotuzumab will be administered at the dose of 200mg every 14 days until progression. A second chemotherapy in the second intention is proposed, this one is based on Carboplatin ( CBP) in an AUC (area under curve) of 6, and Paclitaxel (Txl) in 175 mg / m2 / BSA (body surface area ) in drip of 3 hours, every 3 weeks, concomitant with the administration of hR3, every 14 days, until a limit of toxicity or an ECOG (Eastern Cooperative Oncology Group) status superior to 3, appears. **Detailed Description:** The objective of the present study is to assess the overall survival of patients after administration of Nimotuzumab hR3 monoclonal antibodies (combined with a chemotherapy) in the treatment of patients with cervix epithelial tumors as first-line treatment. The patients included will be divided into two treatment groups. The first group receive a 200 mg dose of hR3 monoclonal antibody (weekly for 18 weeks), and chemotherapy (6 cycles, every 21 days: Cisplatin (CDDP) 70 mg / m2 on day 1, Vinorelbine 60 mg / m2 on day 1 and day 8) and then 80mg / m2. The second group receive a placebo in addition to the listed chemotherapy. After the first line , a 200mg dose of hR3 monoclonal antibodies will be given every 14 days until progress. A second -line chemotherapy is proposed, this is based on Carboplatin (CBP) at AUC of 6, and Paclitaxel (Txl) 175 mg / m2 / SC as 3 hour infusion, every 3 weeks, concomitant with the administration of hR3, every 14 days, until a toxicity limit or an ECOG status greater than 3 appears. The survival overall will be considered as the main variable of the response and survival without progression from the antitumor response, the toxicity assessment and the quality of life will be the secondary variables. In addition, the effects may arise during treatment will be identified, and tumor biopsy markers such as, EGF-R and HPV will be determined and those of p53, Ki67 and Bcl-2 by immunohistochemistry (IHC). It is expected to achieve a difference in survival between the treatment groups of 6.5 vs 10.5 months (0.278 vs 0.62) in favor of the group with mAb hR3. ### Conditions Module **Conditions:** - Cervical Cancer **Keywords:** - Cervix - Oncology, - hR3, - Nimotuzumab, - Chemotherapy, - Survival - Monoclonal antibody - RECIST - Cisplatin - Vinorelbine - Paclitaxel - Carboplatine - Randomisation - Placebo - cancer - cimahope ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 37 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Injection of 200 mg of Nimotuzumab (weekly during 18 weeks), in combination with chemotherapy (6 cycles, every 21 days: 70 mg / m2 Cisplatin and Vinorelbine 60 mg / m2 (Per Os) at day 1 and day 8. The objective of the present study is to assess the overall survival of patients after administration of Nimotuzumab hR3 monoclonal antibodies (combined with a chemotherapy) in the treatment of patients with cervix epithelial tumors as first-line treatment. After the first line , a 200mg dose of hR3 monoclonal antibodies will be given every 14 days until progress. A second -line chemotherapy is proposed, this is based on Carboplatin (CBP) at AUC of 6, and Paclitaxel (Txl) 175 mg / m2 / SC as 3 hour infusion, every 3 weeks, concomitant with the administration of hR3, every 14 days, until a toxicity limit or an ECOG status greater than 3 appears. **Intervention Names:** - Biological: Nimotuzumab ( h-R3) **Label:** Nimotuzumab **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Injection of the Placebo in the same procedures (weekly during 18 weeks), in combination with chemotherapy (6 cycles, every 21 days: 70 mg / m2 Cisplatin and Vinorelbine 60 mg / m2 (Per Os) at day 1 and day 8. After the first line , a 200mg dose of hR3 monoclonal antibodies will be given every 14 days until progress. A second -line chemotherapy is proposed, this is based on Carboplatin (CBP) at AUC of 6, and Paclitaxel (Txl) 175 mg / m2 / SC as 3 hour infusion, every 3 weeks, concomitant with the administration of hR3, every 14 days, until a toxicity limit or an ECOG status greater than 3 appears. **Intervention Names:** - Other: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Nimotuzumab **Description:** Humanized monoclonal antibody **Name:** Nimotuzumab ( h-R3) **Other Names:** - CIMAHOPE **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Placebo **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Overall survival in patients who received hR3 mAb treatment combined with Chemotherapy **Time Frame:** Calculated from patient randomisation to death (36 months) #### Secondary Outcomes **Measure:** Antitumor Response **Time Frame:** up to 24months (every 3 months) **Measure:** Duration of response **Time Frame:** from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months **Measure:** Time to progression **Time Frame:** Time from randomization until objective tumor progression assessed up to 60 months **Measure:** Progression-free survival **Time Frame:** Time from randomization until disease progression or death, assessed up to 60 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients aged between 18 to 75, including both limits. * Patients who give their written consent to participate to the study. * Chemonaive patients with local cervical cancer and / or persistent or recurrent metastatic disease with measurable disease (RECIST criteria) by a physical examination (scanner or MRI). A confirmation by biopsy is necessary in case there is a single lesion less than 2 cm. * Patients who had pelvic CT + radiotherapy may also be included in the study (concomitant chemotherapy as a radiotherapy stabilizer). * Patients having a histopathological report: epidermoid carcinoma, adenocarcinoma, adenosquamous carcinoma and / or clear cells carcinoma. * Patients with an ECOG score between 0-2 * Patients with a life expectancy greater than six months. * Patients with Left Ventricular Ejection Fraction (LVEF) ≥50%, through Echocardiography. * Patients with normal function of organs and bone marrow, defined by the following parameters: * Haemoglobin ≥ 9 g / dL * White Blood cell ≥ 4000 /mm3 * Absolute neutrophil count≥ 1500 /mm3 * Platelet count≥ 100000 /mm3 * Total bilirubin up to 1.5 the upper limit of normal (ULN) * Albumin ≥ 2 g/dL (3,5 - 5,0 g /dl) * Serum Glutamopyruvate Transférase (SGPT) and SErum Glutamooxaloacetate Transferase (SGTO) \< or = 2.5 ULN * Serum creatinine within the normal limits and the calculation of glomerular filtration according to Cockcroft formula ≥ 60ml and according to MDRD formula for patients whose age is 70 years ≥ 60ml . Glomerular filtration will be performed only on clinical discretion for patients suspected to have a kidney problem. (The normal laboratory values will be appropriate to the techniques and equipment used in the place where they are done). * The determination or expression of EGF-R (epidermal growth factor receptor), p53, Ki67 and Bcl-2 by immuno-histochemistry in the primary tumor before treatment integrated in a paraffin block. The results are not an inclusion criterion, but will be evaluated as an indicator of prognostic response in the final assessment. Exclusion Criteria: * Pregnant or breastfeeding patients * Patients with small cells and / or neuroendocrine cervical cancer. * Patients receiving another onco-specific drug, for other clinical trial, * Patients with a history of allergy attributed to chemical or biological compounds similar to the monoclonal antibody being evaluated or to chemotherapeutic agents. * Patients having uncontrolled intercurrent diseases, including active infections, symptomatic congestive heart failure , unstable angina, cardiac arrhythmia, decompensated diabetes, uncontrolled hypertension and psychiatric disorders. * Patients having a second tumor . Excepting for those receiving appropriate therapy for skin cancer (basal or squamous) * Previous or concomitant malignancy with exception for non-melanoma skin carcinomas * Patients having special conditions or circumstances that could significantly limit the complete follow up of the study **Gender Based:** True **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Algiers **Country:** Algeria **Facility:** Centre Pierre et Marie Curie (CPMC) **Location 2:** **City:** Annaba **Country:** Algeria **Facility:** CAC Annaba **Location 3:** **City:** Batna **Country:** Algeria **Facility:** CAC Batna **Location 4:** **City:** Blida **Country:** Algeria **Facility:** CHU Frantz Fanon **Location 5:** **City:** Tizi Ouzou **Country:** Algeria **Facility:** CHU Sidi Belloua #### Overall Officials **Official 1:** **Affiliation:** El Kendi, Part of MS Pharma, Manufacturing Company **Name:** Mohamed MECHETI, MD. **Role:** STUDY_DIRECTOR ## 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: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M5830 - Name: Uterine Cervical Neoplasms - Relevance: HIGH - As Found: Cervical Cancer - ID: M20559 - Name: Disease Progression - Relevance: LOW - As Found: Unknown - 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: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: LOW - As Found: Unknown - ID: M6182 - Name: Cisplatin - Relevance: LOW - As Found: Unknown - ID: M288889 - Name: Nimotuzumab - Relevance: HIGH - As Found: Post-transplant - ID: M18650 - Name: Carboplatin - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M1710 - Name: Vinorelbine - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000501466 - Term: Nimotuzumab ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04612179 **Brief Title:** Post-Market Registry to Evaluate the Safety and Efficacy of the The SUPRAFLEX CRUZ™ Sirolimus Eluting Coronary Stent System in the Treatment of an Octo- and Nonagenerian All-Comer Patient Cohort With Coronary Artery Disease - the Cruz Senior Study **Official Title:** Post-Market Registry to Evaluate the Safety and Efficacy of the The SUPRAFLEX CRUZ™ Sirolimus Eluting Coronary Stent System in the Treatment of an Octo- and Nonagenerian All-Comer Patient Cohort With Coronary Artery Disease - the Cruz Senior Study #### Organization Study ID Info **ID:** Cruz-Senior #### Organization **Class:** OTHER **Full Name:** IHF GmbH - Institut für Herzinfarktforschung ### Status Module #### Completion Date **Date:** 2025-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-03-06 **Type:** ACTUAL **Last Update Submit Date:** 2024-03-05 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2021-06-23 **Type:** ACTUAL **Status Verified Date:** 2023-03 #### Study First Post Date **Date:** 2020-11-02 **Type:** ACTUAL **Study First Submit Date:** 2020-10-30 **Study First Submit QC Date:** 2020-10-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** IHF GmbH - Institut für Herzinfarktforschung #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Prospective, multi-centre, open-label, single-armed, non-interventional observational clinical investigation designed to enrol 2000 octo- and nonagenerian all-comer patients with coro-nary artery disease in up to 37 sites in Germany, Switzerland and Austria. Patients underwent PCI using at least one Supraflex Cruz Sirolimus Eluting stent as per current practice and will be followed up for 12 months. **Detailed Description:** This is a prospective, multicentre, open-label, single-armed, non-interventional observa-tional clinical investigation in aged patients (≥80 years) undergoing PCI using at least one Supraflex sirolimus eluting stent as per current practice. The registry is an observational study and patient's participation in this study has no impact on his or her indication for treatment, diagnostics, or therapy. Subjects are supposed to be treated according to cur-rent guidelines and the site's internal directives. Inclusion in the registry is completely independent of the medical treatment. All products used for the medical treatment should be administered as stated in their SmPCs (Sum-mary of Product Characteristics) and/or Instructions for Use (IFU). Treatment pattern and treatment initiation, continuation, or changes are solely at the discretion of the physician and the patient. There will be no attempt to influence the treatment patterns of any indi-vidual treating physician. All drug subscriptions applied will be in the usual standard of care. Participation in the registry will in no way influence payment or reimbursement for any treatment received by subjects during the study. The study will be conducted about 37 sites in Germany, Switzerland and Austria and 2000 subjects will be included. A total study duration of about 39 months is assumed, of which about 18 months account for enrolment and 12 months for the follow-up. Eligible are all patients with chronic- (CCS) or acute- Non-ST-elevation coronary syndrome (NSTE-ACS) and target lesion suitable for PCI with drug-eluting stent (see section 6.3 for detailed eligibility criteria) undergoing PCI using at least one SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system as per current practice, who will visit consecutively a partici-pating investigation site. It is planned to enroll about 2000 patients in total. Following discharge, patients will be treated according to clinical routine/guidelines. Hence, no study-specific pre-planned procedures will be performed. To assess the primary endpoint, all patients will receive telephone calls at 6 and 12 months following index procedure and will be interviewed by means of a standardized patient interview by the investigation sites. On-site monitoring will be performed (about 1.5 visits per site; risk-based approach). Dur-ing on-site monitoring, the monitor will verify patient informed consent documentation and perform source data verification against the patient's medical records. In addition, an attempt will be made to check the consecutiveness of patient enrolment at the site, fully respecting privacy and personal data of subjects who are not enrolled in the registry and consequently have not given informed consent. Data will be captured at three time points: * Baseline (e.g. site and patient characteristics, index procedure, events, etc.), * 6-months FU (e.g. vital status, endpoint-related events, quality of life, adverse events, etc.) and * 12-months FU (e.g. vital status, endpoint-related events, quality of life, adverse events, etc.) ### Conditions Module **Conditions:** - Coronary Disease **Keywords:** - CAD - PCI - Cruz Stent - CCS - NSTE-ACS ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 2000 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 12 Months ### Arms Interventions Module #### Arm Group 1 **Description:** All-comer patients (≥80 years) affected by acute coronary syn-drome (NSTE-ACS), stabile angina, or silent angina, who qualify for percutaneous coronary intervention (PCI) according to ESC-treatment guidelines and physicians' clinical routine estimation. **Intervention Names:** - Device: The SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system **Label:** All Comer Patients ### Interventions #### Intervention 1 **Arm Group Labels:** - All Comer Patients **Description:** Investigational device: SUPRAFLEX CRUZ™ Sirolimus eluting Coronary Stent System The SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system consists of a balloon ex-pandable Sirolimus eluting stent, premounted on a stent delivery system. The active pharmaceutical ingredient in the SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent is Sirolimus (also known as Rapamycin). The SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system is indicated for improving coronary luminal diameter in patients with symptomatic Ischemic heart disease due to discrete de-novo stenotic lesions and in-stent restenotic lesions in native coronary arter-ies with a reference vessel diameter of 2.00 mm to 4.50 mm. **Name:** The SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Device Oriented Composite Endpoint (DOCE as per ARC2) at 12 months defined as compo-site of cardiovascular death, myocardial infarction (MI) not clearly attributable to a non-target vessel and clinically driven target lesion revascularization (TLR) **Measure:** Device Oriented Composite Endpoint **Time Frame:** 12 month #### Secondary Outcomes **Description:** All death, cardiovascular death and non-cardiovascular death rate **Measure:** All death **Time Frame:** 6 and 12 month **Description:** All MI rate at 6 months and 12 months **Measure:** All MI rate **Time Frame:** 6 and 12 month **Description:** Rate of TV-MI and MI not clearly attributable to non-target vessel at 6 months and at 12 months **Measure:** Rate of TV-MI and MI not **Time Frame:** 6 and 12 month **Description:** Clinically indicated TLR rate at 6 months and 12 months. **Measure:** Clinically indicated TLR **Time Frame:** 6 and 12 month **Description:** All TLR rate at 6 months and at 12 months. **Measure:** All TLR rate **Time Frame:** 6 months and at 12 months. **Description:** All Target Vessel Revascularization (TVR) rate at 6 months and at 12 months. **Measure:** Target Vessel Revascularization (TVR **Time Frame:** 6 months and at 12 months. **Description:** All revascularization rate at 6 months and at 12 months. **Measure:** revascularization rate **Time Frame:** 6 months and at 12 months. **Description:** Stent Thrombosis rate at 6 months and at 12 months (ARC2). **Measure:** Stent Thrombosis **Time Frame:** 6 months and at 12 months **Description:** Device success defined as deployment of the stents without system failure or device-related complication **Measure:** Device success **Time Frame:** 12 month **Description:** Lesion success defined as the attainment of \< 50 % residual stenosis of the target le-sions post-PCI. **Measure:** Lesion success **Time Frame:** 12 month **Description:** Procedure success defined as all lesion successfully treated without the occurrence of DOCE during the hospital stay. **Measure:** Procedure success **Time Frame:** 12 month **Description:** Major Bleeding (BARC 3 to 5). **Measure:** Major Bleeding **Time Frame:** 12 month **Description:** Seattle Angina Questionnaire (SAQ) at 6 months **Measure:** SAQ **Time Frame:** 6 months **Description:** Quality of life at 6- and 12-months as measured by PROMIS-29 questionnaire **Measure:** Quality of life PROMIS **Time Frame:** 6- and 12-months **Description:** Geriatric Assessment Questionnaire: Barthel-Index **Measure:** Geriatric Assessment - Bartel Index **Time Frame:** baseline **Description:** Geriatric Assessment Questionnaire: Timed up - and Go Test **Measure:** Geriatric Assessment - Times up and Go Test **Time Frame:** baseline **Description:** Geriatric Assessment Questionnaire: Minimal Mental Status Test **Measure:** Geriatric Assessment - Minimal Mental Status Test **Time Frame:** baseline **Description:** Geriatric Assessment Questionnaire: G8 Questionnaire **Measure:** Geriatric Assessment - G8 Questionnaire **Time Frame:** baseline **Description:** Geriatric Assessment Questionnaire: general living condition **Measure:** Geriatric Assessment - General Living conditions **Time Frame:** baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Written consent received from the patient or a legal repre-sentative after the information has been provided. 2. ≥ 80 years of age. 3. De-novo or re-stenotic significant stenosis in at least one cor-onary vessel. 4. Patients with NSTE-ACS, unstable angina, stable angina, silent ischemia (no limitation of the number of treated lesions and vessels: planned staged procedures are allowed within 3 months using Supraflex Cruz only). 5. Target lesion suitable for PCI with SUPRAFLEX CRUZ™ Siroli-mus eluting coronary stent system with diameter between 2.0 and 4.5 mm 6. Total lesion length should be from 6-120 mm Exclusion Criteria: 1. Patients with ST-elevation myocardial infarction (STE-ACS) 2. Hemodynamic instability or cardiogenic shock 3. Known hypersensitivity or contraindication to any component of the study stent or the eluting drug, to media contrast, to dual antiplatelet therapy (DAPT) medication required by cur-rent practice 4. Any co-morbid condition with life expectancy \< 1 year or that may result in protocol non-compliance 5. Patients who are participating in another drug or device inves-tigational study, which has not reached its primary endpoint 6. Patients under judicial protection, tutorship or curatorship **Maximum Age:** 99 Years **Minimum Age:** 80 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - OLDER_ADULT **Study Population:** All-comer patients (≥80 years) affected by acute coronary syn-drome (NSTE-ACS), stabile angina, or silent angina, who qualify for percutaneous coronary intervention (PCI) according to ESC-treatment guidelines and physicians' clinical routine estimation. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** David M Leistner, Prof. **Phone:** +49-(30) 450 - 513725 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Sebastian T Diebold, PhD **Phone:** +49 621 59577 214 **Role:** CONTACT #### Locations **Location 1:** **City:** Berlin **Contacts:** ***Contact 1:*** - **Name:** Arash Haghikia, MD - **Role:** CONTACT **Country:** Germany **Facility:** Charité Berlin **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Charite University, Berlin, Germany **Name:** David M Leistner, Prof **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - 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: HIGH - As Found: Coronary Disease - ID: M6546 - Name: Coronary Artery Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M19506 - Name: Myocardial Ischemia - Relevance: HIGH - As Found: Coronary Artery Disease - 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 - ID: D000017202 - Term: Myocardial Ischemia - ID: D000003327 - Term: Coronary 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 ### 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: M21960 - Name: Sirolimus - Relevance: HIGH - As Found: Included - ID: M353695 - Name: Temsirolimus - Relevance: LOW - As Found: Unknown - ID: M2827 - Name: MTOR Inhibitors - 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 ### Intervention Browse Module - Meshes - ID: D000020123 - Term: Sirolimus ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01460979 **Brief Title:** Efficacy,Tolerability,Safety of Temsirolimus in Women With Platinum-refractory Ovarian Carcinoma or Advanced Endometrial Carcinoma **Official Title:** Activity, Tolerability, Safety of Temsirolimus in Women With Ovarian Cancer Who Progressed During Previous Platinum Chemotherapy or Within 6 Months After Therapy or Advanced Endometrial Carcinoma #### Organization Study ID Info **ID:** AGO-GYN 8 #### Organization **Class:** OTHER **Full Name:** AGO Study Group ### Status Module #### Completion Date **Date:** 2015-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2016-02-29 **Type:** ESTIMATED **Last Update Submit Date:** 2016-02-26 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2015-06 **Type:** ACTUAL #### Start Date **Date:** 2011-10 **Status Verified Date:** 2016-02 #### Study First Post Date **Date:** 2011-10-27 **Type:** ESTIMATED **Study First Submit Date:** 2011-10-25 **Study First Submit QC Date:** 2011-10-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** AGO Study Group #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to determine the activity, tolerability and safety of Temsirolimus in women with ovarian cancer who progressed during the previous platinum chemotherapy alternatively within 6 months from completion of therapy or advanced endometrial carcinoma. ### Conditions Module **Conditions:** - Genital Diseases, Female - Ovarian Diseases - Ovarian Neoplasms - Endometrial Neoplasms **Keywords:** - Ovarian Cancer - Endometrial Carcinoma - Temsirolimus ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 47 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Temsirolimus **Label:** Temsirolimus **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Temsirolimus **Description:** 25mg weekly intravenous until progression **Name:** Temsirolimus **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** progression-free survival **Time Frame:** after 4 months for ovarian cancer and 6 months for endometrial carcinoma after study entry #### Secondary Outcomes **Measure:** rate and duration of stable diseases according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and Gynecologic Cancer Intergroup (GCIG)-criteria for ovarian cancer **Time Frame:** every 8 weeks until progression **Measure:** progression-free survival according to RECIST 1.1 and cancer antigen 125 (CA 125) (for ovarian cancer) (biological progression-free survival (PFSbio)) **Time Frame:** every 8 weeks until progression **Measure:** overall survival **Time Frame:** weekly until progression; thereafter every 8 weeks **Measure:** safety and toxicity, i.e. type, frequency, severity and duration of adverse reactions **Time Frame:** weekly until progression; thereafter every 8 weeks **Measure:** quality of life according to European Organisation for Research and Treatment of Cancer (EORTC) questionaires "QLQ C30", "QLQ OV28" and "QLQ-EN24" **Time Frame:** every 8 weeks **Measure:** rate and duration of stable diseases according to RECIST-criteria for endometrial cancer **Time Frame:** every 8 weeks until progression ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Women ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 * Before performance of study specific actions or assessment the patient has to be informed, has signed the written consent and is willing to follow the requirements concerning treatment and follow-up.Comment: Procedures which are according to common clinical routine and having been performed before having given written informed consent may be used for the purpose of screening procedures or initial medical assessment as long as these procedures follow the protocol. * Required: negative pregnancy test in fertile women Stratum A - Ovarian Cancer: * Histologically confirmed Ovarian Cancer * Platin-refractory relapsed disease: progression within a platin-based chemotherapy or within 6 months after completion of a platin-based chemotherapy * Prior treatment with a taxane-based scheme * minimum of one measurable or non-measurable tumor lesion(according to RECIST 1.1 criteria) * Not more than 2 previous chemotherapies or cytostatic therapies (i.e. monoclonal antibodies, cytokines, signal transduction inhibitors) Stratum B - Endometrian Cancer: * Histologically confirmed Endometrian Cancer * Advanced (International Federation of Gynaecology and Obstetrics (FIGO) III or IV) or relapsed diseases not amenable to potentially curative treatment with local surgery and/or radiation therapy * Prior endocrine therapy is allowed * Prior adjuvant chemotherapy is allowed * Minimum of one measurable or non-measurable tumor lesion(according to RECIST 1.1 criteria) Exclusion Criteria: * ECOG \> 2 * Prior therapy with mammalian target of rapamycin (mTOR) -Inhibitor * Cytostatic therapy (i.e. monoclonal antibodies, cytokines, signal transduction inhibitors), cytotoxical chemotherapy or endocrine therapy or radiation at the same time * Current or recent treatment with another study drug and/or participation in another clinical study within 28 days prior to first dose of study treatment * Chemotherapy or cytostatic therapy (i.e. monoclonal antibodies, cytokines, signal transduction inhibitors) or radiation within 28 days prior to start of study treatment * Known or supposed hypersensitivity compared to study medication * Acute or chronical infection * Second malignancy which influences the prognosis of the patient * Inadequate renal function (Creatinin \> 1.5 x Upper Limit of Normal (ULN)) * Inadequate liver function (aspartate transaminase (AST), alanine transaminase (ALT), gamma-Glutamyl transpeptidase (GGT) \> 2.5 x ULN or \> 5.0 x ULN in the presence of liver metastasis; Bilirubin \> 1.5 x ULN) * Platelets \< 100.000 /μl; Absolute Neutrophil Count (ANC) \< 1.500 /μl * Cachectic patients with weight \< 45kg * Patients who need parenteral nutrition * Patients with ileus within the last 28 days * One of the following diseases within 12 months prior to first study treatment: myocardial infarction, severe/unstable angina, bypass surgery of the coronar- or peripheral vessels, symptomatic heart insufficiency, cerebrovascular insult, transient ischemic attack (TIA), pulmonary embolism, deep venous thrombosis, other thromboembolic events * Current treatment with Cytochrome P450 3A4 (CYP3A4) -Inhibitors (i.e. protease inhibitors, antimycotics, calcium channel blocker, macrolide antibiotics, Cimetidine) or -inductors (i.e. Carbamazepin, Phenobarbital, Phenytoin, Rifampicin, amber) * Uncontrolled hypertension (\> 150/100 mmHg despite optimal medicinal treatment) * Current cardiac arrhythmias (Common Terminology Criteria for Adverse Events of National Cancer Institute (NCI CTCAE) grade ≥ 2), atrial fibrillation, prolongation of QTc \> 470 msec * Left ventricular ejection fraction (LVEF) ≤ 50% defined by echocardiogram * NCI CTCAE grade 3 hemorrhage within 4 weeks prior to beginning of treatment * Symptoms which indicate brain metastases, spinal cord compression or give new indications for brain- or leptomeningeal metastases * Human immunodeficiency virus (HIV) positive or manifested Acquired Immune Deficiency Syndrome (AIDS-disease) * Patients with other severe diseases who represent an inadequate risk for study participation Applicable only for patients with no hysterectomy and/or bilateral adnexectomy prior to start of study. * lactation * potential fertile women without adequate contraception (potential fertile women must use one of the following adequate contraception: complete abstinence, intrauterine spiral or another method with a failure quote \< 1% per year) * life expectancy \< 3 months * neurological or psychiatric diseases or drugs or alcohol abuse which suppose no adequate comprehension and consequently no effective consent to study participation or no acceptable compliance during the study * predictable problems with the compliance to appointments for examinations **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Ulm **Country:** Germany **Facility:** Universitätsklinikum Ulm **State:** Baden-Württemberg **Zip:** 89075 **Location 2:** **City:** Erlangen **Country:** Germany **Facility:** Universität Erlangen-Nürnberg **State:** Bayern **Zip:** 91054 **Location 3:** **City:** München **Country:** Germany **Facility:** Klinikum rechts der Isar der Technischen Universität **State:** Bayern **Zip:** 81675 **Location 4:** **City:** Frankfurt am Main **Country:** Germany **Facility:** Klinikum der J. W. Goethe-Universität **State:** Hessen **Zip:** 60590 **Location 5:** **City:** Marburg **Country:** Germany **Facility:** Universitätsklinikum Gießen-Marburg, Standort Marburg **State:** Hessen **Zip:** 35043 **Location 6:** **City:** Offenbach **Country:** Germany **Facility:** Klinikum Offenbach **State:** Hessen **Zip:** 63069 **Location 7:** **City:** Greifswald **Country:** Germany **Facility:** Universitätsklinikum Greifswald der Ernst-Moritz-Arndt-Universität **State:** Mecklenburg Vorpommern **Zip:** 17475 **Location 8:** **City:** Göttingen **Country:** Germany **Facility:** Klinikum Göttingen, Georg-August-Universität **State:** Niedersachsen **Zip:** 37075 **Location 9:** **City:** Hannover **Country:** Germany **Facility:** Gynäkologisch-onkologische Praxis **State:** Niedersachsen **Zip:** 30177 **Location 10:** **City:** Hannover **Country:** Germany **Facility:** Medizinische Hochschule Hannover **State:** Niedersachsen **Zip:** 30625 **Location 11:** **City:** Essen **Country:** Germany **Facility:** Universitätsklinikum Essen **State:** Nordrhein-Westfalen **Zip:** 45122 **Location 12:** **City:** Essen **Country:** Germany **Facility:** Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH **State:** Nordrhein-Westfalen **Zip:** 45136 **Location 13:** **City:** Solingen **Country:** Germany **Facility:** Städt. Klinikum Solingen gGmbH **State:** Nordrhein-Westfalen **Zip:** 42653 **Location 14:** **City:** Dresden **Country:** Germany **Facility:** Universitätsklinikum Carl Gustav Carus **State:** Sachsen **Zip:** 01307 **Location 15:** **City:** Kiel **Country:** Germany **Facility:** Universitätsklinikum Schleswig-Holstein, Campus Kiel **State:** Schleswig-Holstein **Zip:** 24105 **Location 16:** **City:** Berlin **Country:** Germany **Facility:** Charité, Campus Virchow Klinikum **Zip:** 13353 **Location 17:** **City:** Bremen **Country:** Germany **Facility:** GYNAEKOLOGICUM Bremen **Zip:** 28211 **Location 18:** **City:** Hamburg **Country:** Germany **Facility:** Universitätsklinikum Hamburg-Eppendorf **Zip:** 20251 #### Overall Officials **Official 1:** **Affiliation:** AGO Study Group (Study Group of the Arbeitsgemeinschaft Gynaekologische Onkologie) **Name:** Günter Emons, Professor **Role:** STUDY_CHAIR ### References Module #### See Also Links **Label:** Final publication **URL:** http://www.ncbi.nlm.nih.gov/pubmed/26731724 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000014594 - Term: Uterine Neoplasms - ID: D000005833 - Term: Genital Neoplasms, Female - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000014591 - Term: Uterine Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000000291 - Term: Adnexal Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000006058 - Term: Gonadal Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M8943 - Name: Genital Diseases, Female - Relevance: HIGH - As Found: Genital Diseases, Female - ID: M19235 - Name: Endometrial Neoplasms - Relevance: HIGH - As Found: Endometrial Carcinoma - ID: M12974 - Name: Ovarian Neoplasms - Relevance: HIGH - As Found: Ovarian Neoplasms - ID: M1704 - Name: Carcinoma, Ovarian Epithelial - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: HIGH - As Found: Genital Diseases - ID: M12972 - Name: Ovarian Diseases - Relevance: HIGH - As Found: Ovarian Diseases - 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: 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: M17339 - Name: Uterine 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: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M3643 - Name: Adnexal Diseases - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M9163 - Name: Gonadal Disorders - Relevance: LOW - As Found: Unknown - ID: T4352 - Name: Ovarian Cancer - Relevance: LOW - As Found: Unknown - ID: T4354 - Name: Ovarian Epithelial Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000009369 - Term: Neoplasms - ID: D000016889 - Term: Endometrial Neoplasms - ID: D000010051 - Term: Ovarian Neoplasms - ID: D000091662 - Term: Genital Diseases - ID: D000010049 - Term: Ovarian Diseases - ID: D000005831 - Term: Genital Diseases, Female ### Intervention Browse Module - Ancestors - ID: D000047428 - Term: Protein Kinase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - 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: D000000970 - Term: Antineoplastic Agents - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000000903 - Term: Antibiotics, Antineoplastic - ID: D000000935 - Term: Antifungal Agents ### 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: M21960 - Name: Sirolimus - Relevance: HIGH - As Found: Average - ID: M353695 - Name: Temsirolimus - Relevance: HIGH - As Found: Average - ID: M2827 - Name: MTOR Inhibitors - Relevance: HIGH - As Found: Average - ID: M25820 - Name: Protein Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - 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: 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 ### Intervention Browse Module - Meshes - ID: D000020123 - Term: Sirolimus - ID: C000401859 - Term: Temsirolimus - ID: D000091203 - Term: MTOR Inhibitors ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03924479 **Brief Title:** Respiratory Muscle Function in Heart Failure **Official Title:** Respiratory Muscle-mediated Neural and Cardiovascular Consequences in Heart Failure With Preserved Ejection Fraction #### Organization Study ID Info **ID:** 17-007785 #### Organization **Class:** OTHER **Full Name:** Mayo Clinic ### Status Module #### Completion Date **Date:** 2024-03-21 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-03-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-03-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-03-21 **Type:** ACTUAL #### Start Date **Date:** 2018-11-28 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2019-04-23 **Type:** ACTUAL **Study First Submit Date:** 2019-02-04 **Study First Submit QC Date:** 2019-04-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mayo Clinic #### Responsible Party **Investigator Affiliation:** Mayo Clinic **Investigator Full Name:** Thomas P. Olson, M.S., Ph.D. **Investigator Title:** Principal Investigator **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 is being done because investigators are trying to determine how respiratory muscle and lung function influence the exercise responses in heart failure and healthy participants. Further, the heart failure patients will participate in an intervention to improve their respiratory muscle function to determine if this improves exercise capacity. **Detailed Description:** The participants enrolled in this study will be asked to make 4 or 9 separate study visits. Healthy participants will perform 4 study visits and heart failure participants will perform 9 study visits. During study visit 1, the participants will be asked to get a DEXA bone scan, perform pulmonary function tests, and exercise on a stationary bike at maximal exertion while breathing into a mouth piece. During the exercise test, a iodine-based dye will be injected via a venous catheter in the arm. Also, a thin balloon will be inserted through the nose into the esophagus. During study visit 2, the participants will breathe the same way they did during exercise, but will be seated and not exercising. A thin balloon will be inserted through the nose into the esophagus. During study visits 3 and 4, the participants will perform different respiratory muscle workouts at rest that will be at different intensities ranging from very easy to moderate for \~10 minutes. An iodine-based dye will be injected via a venous catheter in the arm. The participant's with heart failure will then perform 8 weeks of breathing muscle training at home. After 3 weeks of breathing muscle training, the participants will return for study visit 5 where the training load will be adjusted. Following the 8 weeks of breathing muscle training, the heart failure participants will perform the same 4 study visits as outlined above. ### Conditions Module **Conditions:** - Heart Failure, Diastolic **Keywords:** - heart failure preserved ejection fraction - exercise - respiratory muscle ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The breathing muscle training will consist of 7 sessions per week (1 per day) for 8 weeks. Each training session will consist of breathing \~15 times each minute for 30 minutes at 40% of maximal breathing muscle strength, while using the breathing muscle trainer. During the inhalation, participants will be instructed to inhale as fast as they can, while exhalations will be performed at the participants discretion. **Intervention Names:** - Device: PowerBreathe (Breathing muscle training) **Label:** Breathing muscle training **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The breathing muscle training will consist of 7 sessions per week (1 per day) for 8 weeks. Each training session will consist of breathing \~15 times each minute for 30 minutes at 2%% of maximal breathing muscle strength, while using the breathing muscle trainer. During the inhalation, participants will be instructed to inhale as fast as they can, while exhalations will be performed at the participants discretion. **Intervention Names:** - Device: PowerBreathe (Breathing muscle training) **Label:** Sham breathing muscle training **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Breathing muscle training - Sham breathing muscle training **Description:** The breathing muscle breathing training will consist of using the PowerBreathe training for 8 weeks. The PowerBreathe is an inspiratory pressure threshold trainer.The valve blocks the airflow until the threshold pressure is achieved by breathing in forcefully into the device. **Name:** PowerBreathe (Breathing muscle training) **Other Names:** - PowerBreathe Device **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Breathing muscle oxygen uptake between heart failure and healthy participants **Measure:** Breathing muscle oxygen cost **Time Frame:** Year 1 **Description:** Breathing muscle blood flow between heart failure and healthy participants **Measure:** Respiratory muscle blood flow **Time Frame:** Year 1 **Description:** Respiratory muscle workout-induced increases in systolic and diastolic blood pressure between heart failure and healthy participants **Measure:** Systolic and diastolic blood pressure **Time Frame:** Year 1 **Description:** Breathing muscle oxygen uptake from pre to post-breathing muscle training in heart failure participants **Measure:** Breathing muscle oxygen cost **Time Frame:** Year 2 **Description:** Breathing muscle blood flow rom pre to post-breathing muscle training in heart failure participants **Measure:** Respiratory muscle blood flow **Time Frame:** Year 2 **Description:** Respiratory muscle workout-induced increases in systolic and diastolic blood pressure from pre to post-breathing muscle training in heart failure participants **Measure:** Systolic and diastolic blood pressure **Time Frame:** Year 2 ### Eligibility Module **Eligibility Criteria:** Healthy subjects: Adults (≥21 years of age) in the absence of a history of HFpEF or HFrEF, pulmonary, neurologic, orthopedic, or other diseases affecting the neuromuscular system. Controls will be matched for age and sex. All HFpEF patients will be managed by their primary care physician or cardiologist with additional review and oversight by Dr. Borlaug (Co-Investigator) prior to enrollment to ensure adequacy of inclusion and exclusion criteria and that participation in exercise testing and resistance exercise training is safe. Inclusion Criteria for HFpEF, includes: * Clinical diagnosis of HFpEF. * Patients with a history stable (no medication changes in past 6 weeks (w/duration of diagnosis \>6 months). * New York Heart Association class I-III. * Current non-smokers with \<15 pack year history. * Non-pregnant women, and individuals who are able to exercise (i.e. without orthopedic limitations or neuromuscular disorders). Exclusion Criteria for all subjects, includes: * history of dangerous arrhythmias * body mass index \>35 kg/m2 * current smokers and/or smoking history \>15 pack years * pregnant women * uremia, history of allergy to iodides * impaired renal function * creatinine value greater than or equal to 1.3 mg/dL (via clinical record within the past 6 months) * diagnosis of liver disease * individuals who are not able to engage in exercise **Healthy Volunteers:** True **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Rochester **Country:** United States **Facility:** Mayo Clinic in Rochester **State:** Minnesota **Zip:** 55905 #### Overall Officials **Official 1:** **Affiliation:** Mayo Clinic **Name:** Thomas P Olson **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Mayo Clinic Clinical Trials **URL:** https://www.mayo.edu/research/clinical-trials ## 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: M27580 - Name: Heart Failure, Diastolic - Relevance: HIGH - As Found: Heart Failure, Diastolic - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure - ID: D000054144 - Term: Heart Failure, Diastolic ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05165979 **Brief Title:** Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Moderate and Severe COVID-19 Patients in Brazil **Official Title:** Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Moderate and Severe COVID-19 Patients in Brazil #### Organization Study ID Info **ID:** Pos-COVID Brasil 1 #### Organization **Class:** OTHER **Full Name:** Hospital Moinhos de Vento ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-11-07 **Type:** ACTUAL **Last Update Submit Date:** 2023-11-03 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-04-01 **Type:** ESTIMATED #### Start Date **Date:** 2021-12-21 **Type:** ACTUAL **Status Verified Date:** 2023-11 #### Study First Post Date **Date:** 2021-12-21 **Type:** ACTUAL **Study First Submit Date:** 2021-12-20 **Study First Submit QC Date:** 2021-12-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hospital Moinhos de Vento #### 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 present prospective cohort study aims to assess factors associated with of one-year health-related quality of life and physical, cognitive and mental health outcomes among adult survivors of hospitalization for COVID-19. Adult patients requiring hospitalization due to COVID-19 disease will be followed through structured and centralized telephone interviews performed at 3, 6, 9 and 12 months after enrollment. ### Conditions Module **Conditions:** - COVID-19 - Quality of Life - Disability Physical - Disabilities Mental ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 650 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Hospitalized COVID-19 patients **Intervention Names:** - Other: Hospitalization due to COVID-19 **Label:** Hospitalized COVID-19 patients ### Interventions #### Intervention 1 **Arm Group Labels:** - Hospitalized COVID-19 patients **Description:** Hospitalization due to COVID-19 **Name:** Hospitalization due to COVID-19 **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The outcome will be assessed using the Brazilian version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. **Measure:** One-year utility score of health related quality of life **Time Frame:** The outcome will be assessed 12 months after enrollment. #### Secondary Outcomes **Description:** The outcome will be assessed using the Brazilian version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health). **Measure:** Utility score of health related quality of life at 3, 6, and 9 months **Time Frame:** The outcome will be assessed at 3, 6, and 9 months after enrollment. **Description:** Incidence of all-cause mortality **Measure:** Incidence of all-cause mortality **Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. **Description:** Incidence of major cardiovascular events (composite endpoint of non-fatal stroke, non-fatal acute myocardial infarction, or cardiovascular death) **Measure:** Incidence of major cardiovascular events **Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. **Description:** Incidence of all-cause rehospitalizations **Measure:** Incidence of rehospitalizations **Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. **Description:** Prevalence of prolonged COVID-19 symptoms defined as presence of dyspnea, cough, fatigue, muscular weakness, chest discomfort, joint pain, anosmia, hair loss, brain fog, insomnia, among others) **Measure:** Prevalence of prolonged COVID-19 symptoms **Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. **Description:** Prevalence of cognitive dysfunction as assessed by the Telephone Interview for Cognitive Status (TICS-m; scores ranging from 0 to 50 with lower scores indicating worse cognition). **Measure:** Prevalence of cognitive dysfunction **Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. **Description:** Prevalence of anxiety and depression symptoms as assessed by the Hospital Anxiety and Depression Scale (anxiety and depression scores range from 0 to 21, with higher scores indicating worse symptoms). **Measure:** Prevalence of anxiety and depression symptoms **Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. **Description:** Prevalence of posttraumatic stress disorder symptoms as assessed by the Impact Event Scale-6 (scores range from 0 to 24 with higher scores indicating worse symptoms). **Measure:** Prevalence of posttraumatic stress disorder symptoms **Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. **Description:** Physical functional status as assessed by the modified Barthel index (score ranges from 0 to 100; higher scores indicate less functional dependence). **Measure:** Physical functional status **Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. **Description:** The outcome will be assessed using the Lawton \& Brody Instrumental Activities of Daily Living Scale (the score ranges from 0 to 8, with higher scores indicating less dependence). **Measure:** Instrumental Activities of Daily Living **Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. **Description:** Incidence of return to work or study among patients that were working or studying at the moment of hospitalization. **Measure:** Incidence of return to work or study **Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. **Description:** Incidence of new symptomatic COVID-19 infection defined as recurrence of COVID-19-related symptoms with a positive PCR test for SARS-CoV-2 90 days after the index infection. **Measure:** Incidence of new symptomatic COVID-19 infection **Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥18 years; * Symptomatic COVID-19 disease within the last 14 days; * Positive polymerase chain reaction (PCR) test for SARS-CoV-2 within the last 14 days; * Need of hospitalization (duration ≥ 48 hours). Exclusion Criteria: * Severe comorbidity with life expectancy less than 3 months; * Death during hospitalization; * Absence of telephone contact; * Absence of proxy for patients with communication difficulties; * Refusal or withdrawal of agreement to participate; * Previous enrollment in the study. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult patients survivors of hospitalization due to proven COVID-19 disease. ### Contacts Locations Module #### Locations **Location 1:** **City:** Belo Horizonte **Country:** Brazil **Facility:** Hospital das clínicas da UFMG **State:** MG **Location 2:** **City:** Belo Horizonte **Country:** Brazil **Facility:** Hospital Emydio Germano **State:** MG **Location 3:** **City:** Belo Horizonte **Country:** Brazil **Facility:** Hospital Metropolitano Célio de Castro **State:** MG **Location 4:** **City:** Belo Horizonte **Country:** Brazil **Facility:** Instituto Horizonti **State:** MG **Location 5:** **City:** Campo Grande **Country:** Brazil **Facility:** Hospital do Coração de Mato Grosso do Sul **State:** MS **Location 6:** **City:** Curitiba **Country:** Brazil **Facility:** Santa Casa de Curitiba **State:** PR **Location 7:** **City:** Londrina **Country:** Brazil **Facility:** Hospital Universitário de Londrina **State:** PR **Location 8:** **City:** Ponta Grossa **Country:** Brazil **Facility:** Hospital universitário de Ponta Grossa **State:** PR **Location 9:** **City:** Porto Alegre **Country:** Brazil **Facility:** Hospital moinhos de Vento **State:** Rio Grande Do Sul **Location 10:** **City:** Porto Velho **Country:** Brazil **Facility:** Cemetron **State:** RO **Location 11:** **City:** Canoas **Country:** Brazil **Facility:** Hospital Universitário de Canoas **State:** RS **Location 12:** **City:** Guaíba **Country:** Brazil **Facility:** Hospital Nelson Cornetet **State:** RS **Location 13:** **City:** Passo Fundo **Country:** Brazil **Facility:** Hospital das Clínicas de Passo Fundo **State:** RS **Location 14:** **City:** Passo Fundo **Country:** Brazil **Facility:** Hospital São Vicente de Paulo **State:** RS **Location 15:** **City:** Porto Alegre **Country:** Brazil **Facility:** Fundação Universitária Instituto de Cardiologia **State:** RS **Location 16:** **City:** Porto Alegre **Country:** Brazil **Facility:** Hospital de Clínicas de Porto Alegre **State:** RS **Location 17:** **City:** Porto Alegre **Country:** Brazil **Facility:** Hospital Ernesto Dornelles **State:** RS **Location 18:** **City:** Porto Alegre **Country:** Brazil **Facility:** Hospital Vila Nova **State:** RS **Location 19:** **City:** Itapetininga **Country:** Brazil **Facility:** Hospital Leo Orsi **State:** SP **Location 20:** **City:** Ribeirão Preto **Country:** Brazil **Facility:** Hospital Beneficência Portuguesa de Ribeirão Preto **State:** SP **Location 21:** **City:** São Paulo **Country:** Brazil **Facility:** Hospital Alemão Oswaldo Cruz **State:** SP **Location 22:** **City:** São Paulo **Country:** Brazil **Facility:** Hospital Beneficência Portuguesa de São Paulo **State:** SP **Location 23:** **City:** São Paulo **Country:** Brazil **Facility:** Hospital do Coração **State:** SP **Location 24:** **City:** São Paulo **Country:** Brazil **Facility:** Hospital SEPACO **State:** SP #### Overall Officials **Official 1:** **Affiliation:** Hospital Moinhos de Vento **Name:** Regis G Rosa, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** The authors encourage interested parties to contact the corresponding author with data sharing requests, including for access to additional unpublished data. **IPD Sharing:** UNDECIDED ## 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 - Abbrev: BXM - Name: Behaviors and Mental Disorders ### 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 - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05619679 **Brief Title:** A Clinical Practice Snapshot on Pediatric Kidney Transplantation **Official Title:** A Clinical Practice Snapshot on Pediatric Kidney Transplantation Healthcare in Europe #### Organization Study ID Info **ID:** PKT.Clinical.Snapshot #### Organization **Class:** OTHER **Full Name:** Radboud University Medical Center ### Status Module #### Completion Date **Date:** 2023-06-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-12-05 **Type:** ACTUAL **Last Update Submit Date:** 2023-12-03 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-06-30 **Type:** ACTUAL #### Start Date **Date:** 2022-01-10 **Type:** ACTUAL **Status Verified Date:** 2023-11 #### Study First Post Date **Date:** 2022-11-17 **Type:** ACTUAL **Study First Submit Date:** 2022-11-09 **Study First Submit QC Date:** 2022-11-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Radboud University Medical Center #### 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 is to create an overview of the similarities and differences in daily practice among the different centers performing pediatric kidney transplantation in Europe. For this purpose, a Clinical Practice Snapshot will be used to provide insight in the current approaches. **Detailed Description:** In order to create an overview of the current care for pediatric kidney transplant (PKT) recipients a clinical practice snapshot was developed. All participating centers were asked to answer 6 clinical questions on their last 30 transplanted patients. Patient characteristics, donor charactertistics, use of stents, immunosuppressive medication and renal function are compared between centers. ### Conditions Module **Conditions:** - Kidney Transplant Failure **Keywords:** - Kidney transplantation ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 410 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Kidney transplantation **Name:** Kidney Transplantation **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Functioning graft **Measure:** Graft survival **Time Frame:** at end of follow-up at least one month **Description:** Living or deceased donor **Measure:** Donor type **Time Frame:** At transplantation #### Secondary Outcomes **Description:** Immunosuppressive medication at discharge after transplant **Measure:** Immunosuppressants prescribed at discharge **Time Frame:** 2 weeks **Description:** Viral infections after transplantations **Measure:** Number of infections **Time Frame:** end of follow-up, at least one month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Kidney received \<18 years * at least one month of follow-up * transplantation and follow-up in dedicated PKT center Exclusion Criteria: * combined transplantation **Maximum Age:** 18 Years **Minimum Age:** 0 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** All pediatric kidney recipients that were transplanted in one of the participating centers and followed up for at least one month ### Contacts Locations Module #### Locations **Location 1:** **City:** Nijmegen **Country:** Netherlands **Facility:** Radboud University Medical Center **Zip:** 6500HB ### IPD Sharing Statement Module **Description:** Researchers from centers that contributed can request anonymized data **Info Types:** - ICF **IPD Sharing:** YES ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06122779 **Acronym:** AURORA-HFpEF **Brief Title:** Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) **Official Title:** A Phase 2A, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) #### Organization Study ID Info **ID:** CV029-1001 #### Organization **Class:** INDUSTRY **Full Name:** Bristol-Myers Squibb #### Secondary ID Infos **ID:** 2023-505919-21 **Type:** EUDRACT_NUMBER **Domain:** WHO **ID:** U1111-1292-8451 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2025-01-22 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-23 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-01-22 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-07 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2023-11-08 **Type:** ACTUAL **Study First Submit Date:** 2023-11-03 **Study First Submit QC Date:** 2023-11-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Bristol-Myers Squibb #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF). ### Conditions Module **Conditions:** - Heart Failure **Keywords:** - BMS-986435 - MYK-224 - Pharmacokinetics - Pharmacodynamics - Safety - HFpEF ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 48 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: BMS-986435 **Label:** BMS-986435 **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Other: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - BMS-986435 **Description:** Specified dose on specified days **Name:** BMS-986435 **Other Names:** - MYK-224 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Specified dose on specified days **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Incidence of treatment emergent adverse events (TEAEs) **Time Frame:** Up to approximately 15 weeks **Measure:** Incidence of serious adverse events (SAEs) **Time Frame:** Up to approximately 15 weeks **Measure:** Incidence of AEs leading to treatment discontinuation **Time Frame:** Up to approximately 10 weeks #### Secondary Outcomes **Measure:** Summary of plasma concentrations of MYK-224 **Time Frame:** Up to approximately 15 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria - Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability. Exclusion Criteria * Participants must not have a known diagnosis of obstructive or genetic hypertrophic cardiomyopathy or infiltrative/storage disorder such as cardiac amyloidosis, or any other acute or serious condition that could interfere with assessments during the study or may pose a risk to the participant. * Other protocol-defined Inclusion/Exclusion criteria apply. **Maximum Age:** 90 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** BMS Study Connect Contact Center www.BMSStudyConnect.com **Phone:** 855-907-3286 **Role:** CONTACT **Contact 2:** **Name:** First line of the email MUST contain NCT # and Site #. **Role:** CONTACT #### Locations **Location 1:** **City:** Birmingham **Contacts:** ***Contact 1:*** - **Name:** Pankaj Arora, Site 0002 - **Role:** CONTACT **Country:** United States **Facility:** University of Alabama at Birmingham **State:** Alabama **Status:** RECRUITING **Zip:** 35233 **Location 2:** **City:** Miami **Contacts:** ***Contact 1:*** - **Name:** Sander Fernandez, Site 0003 - **Role:** CONTACT **Country:** United States **Facility:** Infinite Clinical Research **State:** Florida **Status:** RECRUITING **Zip:** 33133-4223 **Location 3:** **City:** Atlanta **Contacts:** ***Contact 1:*** - **Name:** Alanna Morris, Site 0014 - **Role:** CONTACT **Country:** United States **Facility:** Emory Heart and Vascular Center **State:** Georgia **Status:** NOT_YET_RECRUITING **Zip:** 30322-1013 **Location 4:** **City:** Atlanta **Country:** United States **Facility:** Local Institution - 0048 **State:** Georgia **Status:** WITHDRAWN **Zip:** 30322-1013 **Location 5:** **City:** Chicago **Contacts:** ***Contact 1:*** - **Name:** Ravi B Patel, Site 0004 - **Role:** CONTACT **Country:** United States **Facility:** Bluhm Cardiovascular Institute of Northwestern **State:** Illinois **Status:** RECRUITING **Zip:** 60611-5969 **Location 6:** **City:** Hazel Crest **Contacts:** ***Contact 1:*** - **Name:** Suhail Khadra, Site 0005 - **Phone:** 708-798-8522 - **Role:** CONTACT **Country:** United States **Facility:** Chicago Medical Research, LLC **State:** Illinois **Status:** RECRUITING **Zip:** 60429-2196 **Location 7:** **City:** Indianapolis **Contacts:** ***Contact 1:*** - **Name:** Site 0029 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0029 **State:** Indiana **Status:** NOT_YET_RECRUITING **Zip:** 46260-1992 **Location 8:** **City:** Indianapolis **Country:** United States **Facility:** Local Institution - 0045 **State:** Indiana **Status:** WITHDRAWN **Zip:** 46260-1992 **Location 9:** **City:** Saint Louis **Contacts:** ***Contact 1:*** - **Name:** Harvey Serota, Site 0028 - **Phone:** 314-741-0911 - **Role:** CONTACT **Country:** United States **Facility:** St. Louis Heart and Vascular **State:** Missouri **Status:** RECRUITING **Zip:** 63136-6111 **Location 10:** **City:** Saint Louis **Country:** United States **Facility:** Local Institution - 0043 **State:** Missouri **Status:** WITHDRAWN **Zip:** 63136 **Location 11:** **City:** New York **Contacts:** ***Contact 1:*** - **Name:** Parag Goyal, Site 0008 - **Role:** CONTACT **Country:** United States **Facility:** Weill Cornell Medicine **State:** New York **Status:** RECRUITING **Zip:** 10065-4805 **Location 12:** **City:** Oklahoma City **Country:** United States **Facility:** Local Institution - 0041 **State:** Oklahoma **Status:** WITHDRAWN **Zip:** 73135-2607 **Location 13:** **City:** Oklahoma City **Contacts:** ***Contact 1:*** - **Name:** Naeem Tahirkheli, Site 0016 - **Phone:** 405-628-6865 - **Role:** CONTACT **Country:** United States **Facility:** South Oklahoma Heart Research **State:** Oklahoma **Status:** RECRUITING **Zip:** 73135-2607 **Location 14:** **City:** Tullahoma **Contacts:** ***Contact 1:*** - **Name:** Dinesh Gupta, Site 0001 - **Phone:** 931-461-2663 - **Role:** CONTACT **Country:** United States **Facility:** Tennessee Center for Clinical Trials **State:** Tennessee **Status:** RECRUITING **Zip:** 37388-8260 **Location 15:** **City:** Dallas **Contacts:** ***Contact 1:*** - **Name:** Ambarish Pandey, Site 0036 - **Phone:** 214-645-8000 - **Role:** CONTACT **Country:** United States **Facility:** University of Texas Southwestern Medical Center **State:** Texas **Status:** RECRUITING **Zip:** 75390 **Location 16:** **City:** Houston **Contacts:** ***Contact 1:*** - **Name:** Amin Karim, Site 0015 - **Phone:** 281-944-3610 - **Role:** CONTACT **Country:** United States **Facility:** Angiocardiac Care of Texas - PA - PPDS **State:** Texas **Status:** RECRUITING **Zip:** 77025-5253 **Location 17:** **City:** Houston **Country:** United States **Facility:** Local Institution - 0051 **State:** Texas **Status:** WITHDRAWN **Zip:** 77025-5253 **Location 18:** **City:** Toronto **Contacts:** ***Contact 1:*** - **Name:** Gordon Moe, Site 0037 - **Phone:** 4168645319 - **Role:** CONTACT **Country:** Canada **Facility:** Medicus MFC Inc. **State:** Ontario **Status:** RECRUITING **Zip:** M4P 1E4 **Location 19:** **City:** Toronto **Contacts:** ***Contact 1:*** - **Name:** Site 0030 - **Role:** CONTACT **Country:** Canada **Facility:** Local Institution - 0030 **State:** Ontario **Status:** NOT_YET_RECRUITING **Zip:** M5S 1B2 **Location 20:** **City:** Toronto **Country:** Canada **Facility:** Local Institution - 0040 **State:** Ontario **Status:** WITHDRAWN **Zip:** M5S 1B2 **Location 21:** **City:** Trois-Rivieres **Contacts:** ***Contact 1:*** - **Name:** Site 0035 - **Role:** CONTACT **Country:** Canada **Facility:** Local Institution - 0035 **State:** Quebec **Status:** NOT_YET_RECRUITING **Zip:** G9A 1Y1 **Location 22:** **City:** Napoli **Contacts:** ***Contact 1:*** - **Name:** Site 0019 - **Role:** CONTACT **Country:** Italy **Facility:** Local Institution - 0019 **State:** Campania **Status:** NOT_YET_RECRUITING **Zip:** 80131 **Location 23:** **City:** Melegnano **Contacts:** ***Contact 1:*** - **Name:** Site 0022 - **Role:** CONTACT **Country:** Italy **Facility:** Local Institution - 0022 **State:** Lombardia **Status:** NOT_YET_RECRUITING **Zip:** 20077 **Location 24:** **City:** Milano **Contacts:** ***Contact 1:*** - **Name:** Site 0023 - **Role:** CONTACT **Country:** Italy **Facility:** Local Institution - 0023 **State:** Lombardia **Status:** NOT_YET_RECRUITING **Zip:** 20162 **Location 25:** **City:** Milano **Country:** Italy **Facility:** Local Institution - 0033 **State:** Lombardia **Status:** WITHDRAWN **Zip:** 20162 **Location 26:** **City:** San Donato Milanese **Country:** Italy **Facility:** Local Institution - 0050 **State:** Lombardia **Status:** WITHDRAWN **Zip:** 20097 **Location 27:** **City:** Foggia **Country:** Italy **Facility:** Local Institution - 0027 **State:** Puglia **Status:** WITHDRAWN **Zip:** 71100 **Location 28:** **City:** Foggia **Contacts:** ***Contact 1:*** - **Name:** Site 0038 - **Role:** CONTACT **Country:** Italy **Facility:** Local Institution - 0038 **State:** Puglia **Status:** NOT_YET_RECRUITING **Zip:** 71100 **Location 29:** **City:** Massa **Country:** Italy **Facility:** Local Institution - 0052 **State:** Toscana **Status:** WITHDRAWN **Zip:** 54100 **Location 30:** **City:** Pisa **Contacts:** ***Contact 1:*** - **Name:** Site 0017 - **Role:** CONTACT **Country:** Italy **Facility:** Local Institution - 0017 **State:** Toscana **Status:** NOT_YET_RECRUITING **Zip:** 56124 **Location 31:** **City:** Bergamo **Contacts:** ***Contact 1:*** - **Name:** Site 0009 - **Role:** CONTACT **Country:** Italy **Facility:** Local Institution - 0009 **Status:** NOT_YET_RECRUITING **Zip:** 24127 **Location 32:** **City:** Lublin **Contacts:** ***Contact 1:*** - **Name:** Site 0020 - **Role:** CONTACT **Country:** Poland **Facility:** Local Institution - 0020 **State:** Lubelskie **Status:** NOT_YET_RECRUITING **Zip:** 20-954 **Location 33:** **City:** Lódz **Contacts:** ***Contact 1:*** - **Name:** Site 0013 - **Role:** CONTACT **Country:** Poland **Facility:** Local Institution - 0013 **State:** Lódzkie **Status:** NOT_YET_RECRUITING **Zip:** 92-213 **Location 34:** **City:** Bialystok **Contacts:** ***Contact 1:*** - **Name:** Site 0031 - **Role:** CONTACT **Country:** Poland **Facility:** Local Institution - 0031 **State:** Podlaskie **Status:** NOT_YET_RECRUITING **Zip:** 15-276 **Location 35:** **City:** Bialystok **Country:** Poland **Facility:** Local Institution - 0044 **State:** Podlaskie **Status:** WITHDRAWN **Zip:** 15-276 **Location 36:** **City:** Krakow **Country:** Poland **Facility:** Local Institution - 0006 **Status:** WITHDRAWN **Zip:** 30-082 **Location 37:** **City:** Lublin **Country:** Poland **Facility:** Local Institution - 0049 **Status:** WITHDRAWN **Zip:** 20-954 **Location 38:** **City:** Oswiecim **Country:** Poland **Facility:** Local Institution - 0024 **Status:** WITHDRAWN **Zip:** 51162 **Location 39:** **City:** Hospitalet de Llobregat **Contacts:** ***Contact 1:*** - **Name:** Josep Comin, Site 0012 - **Phone:** 34932483123 - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Universitario de Bellvitge **State:** Barcelona **Status:** RECRUITING **Zip:** 08907 **Location 40:** **City:** Majadahonda **Contacts:** ***Contact 1:*** - **Name:** Pablo García Pavia, Site 0025 - **Phone:** +34911917297 - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Universitario Puerta de Hierro - Majadahonda **State:** Madrid **Status:** RECRUITING **Zip:** 28222 **Location 41:** **City:** Majadahonda **Country:** Spain **Facility:** Local Institution - 0047 **State:** Madrid **Status:** WITHDRAWN **Zip:** 28222 **Location 42:** **City:** El Palmar **Contacts:** ***Contact 1:*** - **Name:** Domingo Pascual-Figal, Site 0021 - **Phone:** +34968369662 - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Universitario Virgen de La Arrixaca **State:** Murcia **Status:** RECRUITING **Zip:** 30120 **Location 43:** **City:** El Palmar **Country:** Spain **Facility:** Local Institution - 0039 **State:** Murcia **Status:** WITHDRAWN **Zip:** 30120 **Location 44:** **City:** Malaga **Contacts:** ***Contact 1:*** - **Name:** José Manuel García Pinilla, Site 0032 - **Phone:** +34951032349 - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Universitario Virgen de la Victoria **State:** Málaga **Status:** RECRUITING **Zip:** 29010 **Location 45:** **City:** Malaga **Country:** Spain **Facility:** Local Institution - 0042 **State:** Málaga **Status:** WITHDRAWN **Zip:** 29010 **Location 46:** **City:** Madrid **Contacts:** ***Contact 1:*** - **Name:** Pau Llacer Iborra, Site 0026 - **Phone:** 34913368923 - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Universitario Ramon y Cajal **Status:** RECRUITING **Zip:** 28034 **Location 47:** **City:** Madrid **Country:** Spain **Facility:** Local Institution - 0034 **Status:** WITHDRAWN **Zip:** 28034 **Location 48:** **City:** Sevilla **Contacts:** ***Contact 1:*** - **Name:** Antonio Reyes Dominguez, Site 0018 - **Phone:** 34955015777 - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Nuestra Señora de Valme **Status:** RECRUITING **Zip:** 41014 **Location 49:** **City:** Sevilla **Country:** Spain **Facility:** Local Institution - 0046 **Status:** WITHDRAWN **Zip:** 41014 **Location 50:** **City:** Valencia **Contacts:** ***Contact 1:*** - **Name:** Julio Nuñez Villota, Site 0010 - **Phone:** +34961973520 - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Clinico Universitario de Valencia **Status:** RECRUITING **Zip:** 46010 #### Overall Officials **Official 1:** **Affiliation:** Bristol-Myers Squibb **Name:** Bristol-Myers Squibb **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** See Plan Description **Description:** BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html **Info Types:** - STUDY_PROTOCOL - SAP - CSR **IPD Sharing:** YES **Time Frame:** See Plan Description **URL:** https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html ### References Module #### See Also Links **Label:** BMS Clinical Trial Information **URL:** https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html **Label:** BMS Clinical Trial Patient Recruiting **URL:** https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06122779 ## 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 ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M258342 - Name: Sulconazole - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00037479 **Brief Title:** Brain Imaging and Retreatment Study of Persistent Lyme Disease **Official Title:** PET and MRI Imaging of Persistent Lyme Encephalopathy #### Organization Study ID Info **ID:** R01NS038636 **Link:** https://reporter.nih.gov/quickSearch/R01NS038636 **Type:** NIH #### Organization **Class:** NIH **Full Name:** National Institute of Neurological Disorders and Stroke (NINDS) ### Status Module #### Expanded Access Info #### Last Update Post Date **Date:** 2005-12-07 **Type:** ESTIMATED **Last Update Submit Date:** 2005-12-06 **Overall Status:** COMPLETED #### Start Date **Date:** 1999-12 **Status Verified Date:** 2005-12 #### Study First Post Date **Date:** 2002-05-20 **Type:** ESTIMATED **Study First Submit Date:** 2002-05-17 **Study First Submit QC Date:** 2002-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NIH **Name:** National Institute of Neurological Disorders and Stroke (NINDS) ### Description Module **Brief Summary:** The purpose of this study is to determine whether patients with persistent memory problems after Lyme disease benefit from an additional longer course of IV antibiotic therapy; to use modern brain imaging technology to determine whether the problem in the central nervous system is primarily one of poor blood flow or one of impaired nerve cell functioning; and to try to identify biological markers prior to treatment that will identify patients who are more or less likely to respond to the study treatment. **Detailed Description:** Some people with a history of Lyme disease continue to have problems despite having received "textbook duration" antibiotic therapy. When memory, attention, or thinking problems persist, the syndrome is called persistent Lyme disease (PLD). This study seeks to answer critical scientific questions about the treatment and cause of PLD symptoms. This 24-week treatment study will evaluate each patient's response to treatment using neuropsychological testing and state-of-the-art brain imaging. The brain tests include neuropsychological testing of memory and attention, brain imaging (MRI and PET scans) to look at blood flow in the brain and nerve cell structure and metabolism, a neurological exam, and studies of the fluid that surrounds the brain (cerebrospinal fluid). The treatment involves 10 weeks of either intravenous antibiotic called ceftriaxone (also known as Rocephin) or intravenous placebo (inactive substance). After the first visit to Columbia Presbyterian Medical Center, the remaining treatments will be done in the patient's home. Patients will be screened over the phone and in person to confirm study eligibility. ### Conditions Module **Conditions:** - Lyme Disease - Lyme Neuroborreliosis **Keywords:** - neurologic Lyme disease - Lyme disease - ceftriaxone - Rocephin - PET scans - Lyme encephalopathy - neuroborreliosis - borreliosis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 65 **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** ceftriaxone **Type:** DRUG ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Eligible participants must: * Be 18-65 years old * Have persistent problems with memory, verbal fluency, or attention after having contracted Lyme disease. * Be able to travel to New York for 4-5 evaluations over the course of one year. Travel costs for participants in need may be partially or fully reimbursable. * Have had a history of well-documented Lyme disease using the CDC's clinical criteria and a current positive IgG Western blot or PCR. * Have received, at some point in the past at least 3 weeks of IV antibiotic therapy for Lyme disease. Exclusion Criteria: Ineligible from participation are people with the following: * Other major medical or neurologic problems * Smoke more than 10 cigarettes a day * Uncontrolled high blood pressure * Allergy to ceftriaxone (Rocephin) * History of marked cocaine abuse Twenty healthy subjects are also being sought for the study. **Healthy Volunteers:** True **Maximum Age:** 65 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:** Columbia Presbyterian Medical Center **State:** New York **Zip:** 10032 #### Overall Officials **Official 1:** **Affiliation:** Columbia University, College of Physicians and Surgeons, Lyme Disease Research Program **Name:** Brian Fallon, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** Columbia's Lyme disease research studies website **URL:** http://www.columbia-lyme.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000016905 - Term: Gram-Negative Bacterial Infections - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections - ID: D000001899 - Term: Borrelia Infections - ID: D000013145 - Term: Spirochaetales Infections - ID: D000017282 - Term: Tick-Borne Diseases - ID: D000079426 - Term: Vector Borne Diseases - ID: D000020806 - Term: Central Nervous System Bacterial Infections - ID: D000002494 - Term: Central Nervous System Infections - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M11190 - Name: Lyme Disease - Relevance: HIGH - As Found: Lyme Disease - ID: M22602 - Name: Lyme Neuroborreliosis - Relevance: HIGH - As Found: Lyme Neuroborreliosis - ID: M5177 - Name: Borrelia Infections - 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: 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: M19577 - Name: Tick-Borne Diseases - Relevance: LOW - As Found: Unknown - ID: M2054 - Name: Vector Borne Diseases - Relevance: LOW - As Found: Unknown - ID: M22561 - Name: Central Nervous System Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M5743 - Name: Central Nervous System Infections - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008193 - Term: Lyme Disease - ID: D000020852 - Term: Lyme Neuroborreliosis ### Intervention Browse Module - Ancestors - ID: D000097911 - Term: Third Generation Cephalosporins - ID: D000097902 - Term: Beta Lactam Antibiotics - ID: D000000900 - Term: Anti-Bacterial 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 ### Intervention Browse Module - Browse Leaves - ID: M5693 - Name: Ceftriaxone - Relevance: HIGH - As Found: Antimicrobial - ID: M5760 - Name: Cephalosporins - Relevance: LOW - As Found: Unknown - ID: M3453 - Name: Third Generation Cephalosporins - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M10789 - Name: Lactams - Relevance: LOW - As Found: Unknown - ID: M25772 - Name: beta-Lactams - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M3444 - Name: Beta Lactam Antibiotics - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002443 - Term: Ceftriaxone ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06075979 **Brief Title:** Correlation Between Microbial Infection and Lumbar Degenerative Disease Based on High-throughput Gene Sequencing **Official Title:** The First Affiliated Hospital of Shandong First Medical University #### Organization Study ID Info **ID:** High-throughput gene #### Organization **Class:** OTHER **Full Name:** Qianfoshan Hospital ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-04-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-01 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-02 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2023-10-10 **Type:** ACTUAL **Study First Submit Date:** 2023-09-18 **Study First Submit QC Date:** 2023-10-04 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** HaoxuanZhang #### Responsible Party **Investigator Affiliation:** Qianfoshan Hospital **Investigator Full Name:** HaoxuanZhang **Investigator Title:** Associate professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Lumbar degenerative disease is one of the most common diseases in orthopedic and spinal surgery. The pathogenesis of lumbar degenerative disease is still unclear, mainly including aging degeneration and biomechanical hypothesis. In our previous research work，the investigators took lumbar disc tissue from patients who underthe investigatorsnt surgical treatment for lumbar degenerative diseases. The investigators found that some patients had low-toxic bacterial infection in the intervertebral disc tissue. Combined with literature and previous studies, it is suggested that microbial infection plays a role in lumbar degenerative diseases. The investigators suggest that microbial infection may be closely related to the occurrence and development of lumbar degenerative diseases, which may cause or even accelerate the degeneration of lumbar intervertebral disc tissue. The current research difficulties are as follows: 1. Low sensitivity and specificity of microbial analysis; 2. It is difficult to distinguish the colonization infection of intervertebral disc tissue microorganisms from the contamination of foreign substances. In view of this, this study intends to use the high-throughput gene sequencing technology of infectious pathogens based on nano single molecule sequencing, double verification of blood samples and intervertebral disc tissue samples, to identify the microbial status of degenerative lumbar disc tissue, and to explore the correlation between lumbar degenerative disease and microbial infection, identifying relevant susceptible microorganisms, which is expected to study the pathogenesis of this susceptible microorganism in the future, and provide new ideas and approaches for the prevention, control and treatment of lumbar degenerative diseases. **Detailed Description:** This study intends to use the high-throughput gene sequencing technology of infectious pathogens based on nano single molecule sequencing, double verification of blood samples and intervertebral disc tissue samples, to identify the microbial status of degenerative lumbar disc tissue, and to explore the correlation between lumbar degenerative disease and microbial infection, identifying relevant susceptible microorganisms, which is expected to study the pathogenesis of this susceptible microorganism in the future, and provide new ideas and approaches for the prevention, control and treatment of lumbar degenerative diseases.This clinical study has a funding of 50000 RMB. ### Conditions Module **Conditions:** - Lumbar Degenerative Diseases - Gene Product Sequence Variation **Keywords:** - lumbar degenerative diseases - high-throughput gene sequencing - microbial infection ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients undergoing surgery for lumbar disc herniation **Intervention Names:** - Other: Lumbar disc herniation - Other: Lumbar spinal stenosis **Label:** Lumbar disc herniation group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients undergoing surgery for lumbar spinal stenosis **Intervention Names:** - Other: Lumbar disc herniation - Other: Lumbar spinal stenosis **Label:** Lumbar spinal stenosis group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Lumbar disc herniation group - Lumbar spinal stenosis group **Description:** Patients undergoing surgery for lumbar disc herniation **Name:** Lumbar disc herniation **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Lumbar disc herniation group - Lumbar spinal stenosis group **Description:** Patients undergoing surgery for lumbar spinal stenosis **Name:** Lumbar spinal stenosis **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Modic degeneration of the vertebral endplate in the lumbar spine refers to a common abnormal signal change in the endplate and subendplate bone on lumbar magnetic resonance imaging after excluding tumors and tuberculosis. It reflects the microscopic changes in tissue biochemistry within the endplate and the manifestations of endplate degeneration. Modic and other scholars have conducted detailed research on it and classified it into three types based on the signal level and pathological and biochemical changes on MRI, as shown in Figure 1. Type I (edema type): Low signal on T1WI, high signal on T2WI, and cracks in the endplate can be found in the granulation tissue of new blood vessels in the bone marrow; Type II (fatty type): High signal on T1WI, equal or slightly high signal on T2WI, adjacent bone marrow tissue replaced by adipocytes, and end plate rupture; Type III (sclerotic type): Low signal on T1WI and T2WI, with sclerosis changes in the endplate and subchondral bone. **Measure:** Classification of endplate degeneration in lumbar magnetic resonance imaging - Modic classification **Time Frame:** 3 years **Description:** The Pfirmmann grading system based on sagittal T2WI of lumbar magnetic resonance imaging is a semi quantitative evaluation method for the degree of lumbar disc degeneration, which can display the morphological changes of lumbar disc degeneration. It is currently a widely used and highly recognized grading system for evaluating the degree of lumbar disc degeneration. This grading system was proposed by Pfirmmann in 2001, which evaluates the level of lumbar disc degeneration based on indicators such as signal intensity, disc shape, and intervertebral space changes in the midsagittal position of the T2WI sequence. **Measure:** Classification of intervertebral disc degeneration -Pfirrmann classification **Time Frame:** 3 years **Description:** Collect blood samples from patients before surgery and intervertebral disc tissue after decompression during surgery. Send blood samples and intervertebral disc tissue samples to bacterial culture analysis for microbial species and drug sensitivity, and conduct smear observation, aerobic and anaerobic environment culture identification. The VitekII Compact fully automated microbial identification and drug sensitivity analysis system (BioMerieux, Marcy Ioile, France) was used for bacterial identification and sensitivity testing of commonly used clinical drugs, and the paper diffusion method (K-B method) was used to increase sensitivity testing of commonly used antibiotics such as levofloxacin, polymyxin B, cefoperazone/sulbactam, minocycline, and vancomycin. **Measure:** General bacterial culture and identification **Time Frame:** 3 years **Description:** Collect blood samples from patients before surgery, and collect intervertebral disc tissue from patients after decompression during surgery using sterile collection tubes. To ensure the comprehensive identification of microbial species, this study plans to simultaneously sequence RNA and DNA using the TIAAmp MicroRNA and DNA Extraction Kit (Beijing Tiangen Biochemical Technology Co., Ltd., China), and extract RNA and DNA from blood samples and intervertebral disc tissue samples according to the instructions in the manual. For microbial data analysis, use the Sanger method to map the sequencing results in BWA; Convert data to bam format using SAMtools; After using the built-in script of the software for filtering, use IGV software to process the mapping data; Assemble consistent sequences using SAMTools and BCFtools; Visualize using IGV software; Verify the sequencing accuracy of Nanopore MinION by comparing consistent sequences and Sanger method reference sequences. **Measure:** High throughput gene sequencing and drug sensitivity analysis of infectious pathogens **Time Frame:** 3 years #### Secondary Outcomes **Description:** The visual analog scale (VAS) is used for pain assessment. It is widely used in clinical practice in China, and the basic method is to use a vernier ruler with a length of about 10cm, marked with 10 scales on one side, with both ends marked as "0" and "10" respectively. A score of 0 indicates painlessness, and a score of 10 represents the most severe pain that cannot be tolerated. **Measure:** VAS **Time Frame:** 3 years **Description:** The Japanese Orthopaedic Association Scores (JOA) is a neurological function scoring system recommended by the Japanese Orthopaedic Association, which includes four parts: upper limb motor function, lower limb motor function, sensory and bladder function, with a total score of 29 points. The lower the score, the more severe the neurological dysfunction. **Measure:** JOA **Time Frame:** 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients in the experimental group, aged 18 to 85 years old, have symptoms and imaging data that support the diagnosis of lumbar degenerative diseases (including lumbar disc herniation, lumbar spinal stenosis, and lumbar spondylolisthesis). * Patients who undergo strict conservative treatment for 3 months before surgery have no significant improvement in symptoms; The control group of patients had no significant lumbar disc degeneration evaluated by imaging, but needed surgical decompression and fusion intervention due to trauma causing lumbar fractures, lumbar tumors, scoliosis. * The disc organizer can be obtained during surgery. Exclusion Criteria: * Lumbar degenerative diseases combined with infectious diseases. * Lumbar degenerative diseases combined with mental diseases. * Lumbar degenerative diseases combined with metal allergy. **Healthy Volunteers:** True **Maximum Age:** 85 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Hao-Xuan Zhang, Ph.D/MD **Phone:** +8615275105665 **Role:** CONTACT #### Locations **Location 1:** **City:** Jinan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hao-Xuan Zhang, Ph.D/MD - **Phone:** +8615275105665 - **Role:** CONTACT **Country:** China **Facility:** Hao-Xuan Zhang **State:** Shandong **Status:** RECRUITING **Zip:** 250000 #### Overall Officials **Official 1:** **Affiliation:** The First Affiliated Hospital of Shandong First Medical University **Name:** Hao-Xuan Zhang, Ph.D/MD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01316679 **Brief Title:** An Analysis of Urinary Proteases as Biomarkers for Hepatocellular Carcinoma-101423 **Official Title:** An Analysis of Urinary Proteases as Biomarkers for Hepatocellular Carcinoma-101423 #### Organization Study ID Info **ID:** Urinary Biomarkers 101423 #### Organization **Class:** OTHER **Full Name:** Vanderbilt University Medical Center ### Status Module #### Completion Date **Date:** 2013-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-04-12 **Type:** ACTUAL **Last Update Submit Date:** 2017-04-10 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2013-01 **Type:** ACTUAL #### Start Date **Date:** 2011-03 **Type:** ACTUAL **Status Verified Date:** 2017-04 #### Study First Post Date **Date:** 2011-03-16 **Type:** ESTIMATED **Study First Submit Date:** 2011-03-15 **Study First Submit QC Date:** 2011-03-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Vanderbilt University Medical Center #### Responsible Party **Investigator Affiliation:** Vanderbilt University Medical Center **Investigator Full Name:** David L Gorden **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Specific urine proteases or groups of these enzymes can be reliable biomarkers and an effective gauge of response to therapy in patients with hepatocellular carcinoma. ### Conditions Module **Conditions:** - Hepatocellular Carcinoma - Liver Disease **Keywords:** - HCC - Liver Disease without HCC ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 87 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with known HCC **Label:** group A #### Arm Group 2 **Description:** Patients with liver disease but no HCC **Label:** Group B #### Arm Group 3 **Description:** Control; patients with no known liver disease or HCC **Label:** Group C ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Ability and willingness to provide written informed consent * Must be between 18-90 years of age at the time of consent * Ability to provide urine specimen at protocol-defined timepoints * Must have treatment interventions planned that are directly related to liver disease (excluding those assigned to group 3-Controls) Exclusion Criteria: * Suspected inability, e.g. unwillingness to comply with study procedures or unwillingness to provide written consent **Healthy Volunteers:** True **Maximum Age:** 90 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients will be recruited from Vanderbilt internal medicine, hepatology, hepatobiliary surgery, and general surgery clinics. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000000230 - Term: Adenocarcinoma - ID: D000008113 - Term: Liver Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M9613 - Name: Carcinoma, Hepatocellular - Relevance: HIGH - As Found: Hepatocellular Carcinoma - ID: M11107 - Name: Liver Diseases - Relevance: HIGH - As Found: Liver Disease - 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: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M11113 - Name: Liver 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 ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000006528 - Term: Carcinoma, Hepatocellular - ID: D000008107 - Term: Liver Diseases ### Intervention Browse Module - Browse Branches - Abbrev: Hemat - Name: Hematinics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03828279 **Acronym:** HGR **Brief Title:** Global Registry to Gather Data on Natural History of Patients With Hereditary Angioedema Type I and II **Official Title:** The Global Registry on Hereditary Angioedema Type I and II #### Organization Study ID Info **ID:** HAERegistry #### Organization **Class:** OTHER **Full Name:** HAE Global Registry Foundation ### Status Module #### Completion Date **Date:** 2023-12-31 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2019-02-05 **Type:** ACTUAL **Last Update Submit Date:** 2019-02-03 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2019-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2017-10-01 **Type:** ACTUAL **Status Verified Date:** 2019-01 #### Study First Post Date **Date:** 2019-02-04 **Type:** ACTUAL **Study First Submit Date:** 2019-01-23 **Study First Submit QC Date:** 2019-01-31 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** HAE Global Registry Foundation #### 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 this international hereditary angioedema (HAE) register is to collect homogeneous clinical and laboratory data on patients with HAE type I and II gathering better information on the natural course of the disease and detecting therapeutic options to manage it. **Detailed Description:** It is an international multicenter disease registry, the principal investigator at each center is responsible for competent ethic committee/institutional review board approval and for identifying co-investigators, who collect patients' informed consent and insert patients' data. Participating patients own their data. Upon acceptance of the informed consent, the treating physician transfers data of the case report form (CRF) to a specifically designed electronic support (eCRF) and the patients enter data on attacks. Physicians at center fill-in the eCRF with data for demography, diagnosis, prophylaxis and associated diseases. Plasma levels of C1 inhibitor antigen and function and of C4 antigen document laboratory diagnostic criteria. Each patient has a national identifier code. Patients fill-in attack reports that encompass duration, severity and treatment of each angioedema episode. C1 inhibitor coding gene (SERPING1) genotype is entered according to the last Hugo nomenclature. Yearly update of information is recommended, patients with follow up above two years are moved in a separate area and excluded from analysis. Each patient prospectively fills data on attacks. On a specific informed consent, the patient can agree on storing biological material (plasma and nucleic acids) for research purposes. The data processor is an innovative start-up (Cloud-R s.r.l. Milan, Italy) that manages all data according to a specific contract and in compliance with current regulation on sensitive data security and processing. The Registry, delivered in the mode of Registry-as-a-Service (RaaS), is designed following General Data Protection Regulation (GDPR) guidelines, and issues regular software and infrastructure enhancements as a part of the normal operational mode. The system generates statistics of aggregated anonymized data following the participating centers' hierarchy levels and Global Registry governance rules. Patients supply data on attacks either on paper support or using a Web form or a mobile application. These data will flow into a staging area for physician validation before being considered valid for statistics. For each entry the system updates in real-time all the statistics and dashboards. The platform has configurable functionalities to support data quality management. It provides data format validation, integration to external qualified libraries, alerts, dashboards, automatic index calculations, advanced filters and queries, data change log. This open architecture, allows integration of the system, via standard API's, to external or sub-registries, registries, biobanks and clinical bioinformatics tools, i.e. for specific trial studies leveraging a specific cluster of patients already present in the Global Registry. An independent non-profit foundation (HGRF) made of representatives of patients' associations is in charge for funding and delegates all the management to the HAE Global Registry Board (HGRB). The HGRB is in charge for operational, assisted by the HAE Global Registry Scientific Committee (HGRSC) for topics of competence. No registry member, center, group or board can access the entire set of data. All registry members, as single or group, can propose studies based on aggregated data by addressing the request to the HGRSC. Analysis and studies of data at local centers can occur at any time. Members of HGRB and HGRSC are elected to be representative of different cultural and geographic backgrounds. Their offices have a two-year term with no more than one consecutive renewal. Angioedema centers can join the Registry upon request to the HGRB . The registry quality control system periodically checks Registry entries and compliance of eCRF with the source data. For each information, the system will grant traceability of time and author. ### Conditions Module **Conditions:** - Hereditary Angioedema Type I and II **Keywords:** - angioedema - disease registry - C1 inhibitor - anti bradykinin treatments ### Design Module #### Bio Spec **Description:** Sodium Citrate samples are collected form patients for testing plasma levels of C1 inhibitor antigen and function and C4 antigen. Cells are collected for DNA extraction and detection of mutations in SERPING1 **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 220 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Year ### Arms Interventions Module #### Arm Group 1 **Description:** Patients were diagnosed as C1 inhibitor HAE type I when functional and antigenic C1 inhibitor were ≤ 50% of normal **Intervention Names:** - Diagnostic Test: functional and antigenic C1 inhibitor **Label:** hereditary angioedema type I #### Arm Group 2 **Description:** Patients were diagnosed as type II when functional C1 inhibitor was ≤50% and antigenic was \>50% of normal **Intervention Names:** - Diagnostic Test: functional and antigenic C1 inhibitor **Label:** hereditary angioedema type II ### Interventions #### Intervention 1 **Arm Group Labels:** - hereditary angioedema type I - hereditary angioedema type II **Description:** Diagnosis of HAE is based on personal and/or family history of angioedema and on C1 inhibitor functional or antigenic plasma levels ≤50% of normal. **Name:** functional and antigenic C1 inhibitor **Other Names:** - genetic analysis **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Number of angioedema events **Measure:** Number of angioedema events **Time Frame:** Through study completion, an average of 5 years **Description:** Time in hours of presence of angioedema symptoms **Measure:** Time of angioedema events **Time Frame:** Through study completion, an average of 5 years **Description:** Number of severe, moderate, mild angioedema symptoms based on a three point scale patient reported outcome **Measure:** Severity of angioedema events **Time Frame:** through study completion, an average of 5 years #### Secondary Outcomes **Description:** Number and type of comorbidities recorded according to the International Classification of Diseases 9 codes **Measure:** Comorbidities **Time Frame:** Through study completion , an average of 5 years **Description:** Incidence of comorbidities emerging in patients exposed to specific treatments **Measure:** Treatment-Emergent comorbidities **Time Frame:** Through study completion , an average of 5 years **Description:** Hours of presence of angioedema symptoms during specific long term prophylaxis **Measure:** Treatment efficacy **Time Frame:** Through study completion , an average of 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients diagnosed with HAE type I and II with signed informed consent * laboratory diagnostic criteria documenting plasma levels of C1 inhibitor antigen and function and of C4 antigen Exclusion Criteria: * patients without HAE type I and II * patients without documented laboratory diagnostic criteria * patients not capable to give informed consent **Healthy Volunteers:** True **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** patients diagnosed with HAE type I and II and followed by a referral center for angioedema ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** marco cicardi, MD **Phone:** +39 0239042516 **Role:** CONTACT #### Locations **Location 1:** **City:** Milan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** marco cicardi, M.D. - **Phone:** +3950319829 - **Role:** CONTACT **Country:** Italy **Facility:** ASST FBF Sacco **Status:** RECRUITING **Zip:** 20157 #### Overall Officials **Official 1:** **Affiliation:** HAE Global Registry Foundation **Name:** marco cicardi, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** to be a member of the HAERegistry and have the approval of the HGRSC to analyze data **Description:** All registry members, as single or group, can propose studies based on aggregated anonymized data by addressing the request to the HAE Global Registry Scientific Committee (HGRSC) **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** entire study period ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014581 - Term: Urticaria - ID: D000017445 - Term: Skin Diseases, Vascular - ID: D000012871 - Term: Skin Diseases - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases - ID: D000081208 - Term: Hereditary Complement Deficiency Diseases - ID: D000081207 - Term: Primary Immunodeficiency Diseases - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000007153 - Term: Immunologic Deficiency Syndromes ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4127 - Name: Angioedema - Relevance: HIGH - As Found: Angioedema - ID: M27584 - Name: Angioedemas, Hereditary - Relevance: HIGH - As Found: Hereditary Angioedema - ID: M28606 - Name: Hereditary Angioedema Types I and II - Relevance: HIGH - As Found: Hereditary Angioedema Types I and II - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M17330 - Name: Urticaria - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M19714 - Name: Skin Diseases, Vascular - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: 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 - ID: M6879 - Name: Deficiency Diseases - Relevance: LOW - As Found: Unknown - ID: M2286 - Name: Hereditary Complement Deficiency Diseases - Relevance: LOW - As Found: Unknown - ID: M10199 - Name: Immunologic Deficiency Syndromes - Relevance: LOW - As Found: Unknown - ID: M2285 - Name: Primary Immunodeficiency Diseases - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: T2734 - Name: Hereditary Angioedema - Relevance: HIGH - As Found: Hereditary Angioedema ### Condition Browse Module - Meshes - ID: D000000799 - Term: Angioedema - ID: D000054179 - Term: Angioedemas, Hereditary - ID: D000056829 - Term: Hereditary Angioedema Types I and II ### 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 - Abbrev: VaDiAg - Name: Vasodilator Agents ### Intervention Browse Module - Browse Leaves - ID: M26365 - Name: Complement C1 Inhibitor Protein - Relevance: HIGH - As Found: Biometry - ID: M5197 - Name: Bradykinin - Relevance: LOW - As Found: Unknown - ID: M10725 - Name: Kininogens - Relevance: LOW - As Found: Unknown - ID: M6392 - Name: Complement System Proteins - Relevance: LOW - As Found: Unknown - ID: M6401 - Name: Complement C1 Inactivator Proteins - 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 ### Intervention Browse Module - Meshes - ID: D000050718 - Term: Complement C1 Inhibitor Protein ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00210379 **Brief Title:** Phase II Study of Combined Modality Treatment in Primary Testicular Non-Hodgkin's Lymphoma **Official Title:** A Phase II Study of CHOP + Rituximab, With Intrathecal Methotrexate Followed by Radiotherapy in Patients With Primary Testicular Non-Hodgkin's Lymphoma #### Organization Study ID Info **ID:** IELSG10 #### Organization **Class:** OTHER **Full Name:** International Extranodal Lymphoma Study Group (IELSG) ### Status Module #### Completion Date **Date:** 2007-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2009-07-22 **Type:** ESTIMATED **Last Update Submit Date:** 2009-07-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2004-11 **Type:** ACTUAL #### Start Date **Date:** 2000-11 **Status Verified Date:** 2009-07 #### Study First Post Date **Date:** 2005-09-21 **Type:** ESTIMATED **Study First Submit Date:** 2005-09-13 **Study First Submit QC Date:** 2005-09-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** International Extranodal Lymphoma Study Group (IELSG) #### Responsible Party **Old Name Title:** International Extranodal Lymphoma Study Group (IELSG) **Old Organization:** IELSG ### Description Module **Brief Summary:** The primary objective assess the clinical activity of combination doxorubicin-containing chemotherapy plus monoclonal antibody anti-CD20 (Rituximab) plus intrathecal prophylactic chemotherapy and loco-regional radiotherapy in primary localised testicular DLCL and to assess the toxicity of this therapeutic strategy ### Conditions Module **Conditions:** - Lymphoma, B Cell ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 64 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** rituximab **Type:** DRUG #### Intervention 2 **Name:** CHOP **Type:** DRUG #### Intervention 3 **Name:** intrathecal methotrexate **Type:** DRUG #### Intervention 4 **Name:** radiotherapy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** Disease-free survival **Measure:** Progression-free survival **Measure:** Event-free survival #### Secondary Outcomes **Measure:** Overall survival will be a secondary end-point because post-relapse therapy is not specified in this protocol and is expected to be highly variable ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. age = 18 years. 2. ECOG performance status 0-2 3. Histologically proven primary testicular CD20-positive diffuse large B-cell non-Hodgkin's lymphoma, untreated 4. Ann Arbor stage IE or IIE. Bilateral testicular involvement at presentation will not be considered stage IV. In these patients the final Ann Arbor stage will be determined by the extent of nodal involvement. 5. Bidimensionally measurable or evaluable disease. Patients who have had all disease removed by surgery are eligible. 6. Adequate bone marrow reserve (ANC \> 1.000/L, Plt \> 100.000/L) 7. Cardiac ejection fraction ≥ 50% by MUGA scan or echocardiography 8. No previous therapy with monoclonal antibody anti-CD20. 9. No psychiatric illness that precludes understanding concepts of the trial or signing informed consent 10. No other major life-threatening illnesses that may preclude chemotherapy 11. Have given written informed consent prior to any program-specific screening procedure, with the understanding that the consent may be withdrawn by the patient at any time without prejudice Exclusion Criteria: 1. impairment of renal function (creatinine \> 2 mg/dl) or liver function (bilirubin \> 2 mg/dl) unless due to lymphoma involvement 2. HIV positive patients 3. evolutive malignancy within 5 years with the exception of localized non-melanomatous skin cancer **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bellinzona **Country:** Switzerland **Facility:** Oncology Institute of Southern Switzerland (IOSI) **Zip:** 6500 #### Overall Officials **Official 1:** **Affiliation:** International Extranodal Lymphoma Study Group **Name:** Andreas Sarris, MD **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland (IOSI) **Name:** Emanuele Zucca, MD **Role:** STUDY_CHAIR **Official 3:** **Affiliation:** Radiation Oncology. Princess Margareth Hospital. Toronto **Name:** Mary Gospodarowicz, MD **Role:** STUDY_CHAIR **Official 4:** **Affiliation:** Hematology Division. Ospedale San Giovanni Battista. Torino **Name:** Umberto Vitolo, MD **Role:** STUDY_CHAIR ### References Module #### See Also Links **Label:** Click here for more information about this study **URL:** http://www.ielsg.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - 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: M11220 - Name: Lymphoma - Relevance: HIGH - As Found: Lymphoma - ID: M18828 - Name: Lymphoma, B-Cell - Relevance: HIGH - As Found: Lymphoma, B-Cell - ID: M11222 - Name: Lymphoma, Non-Hodgkin - Relevance: HIGH - As Found: Non-Hodgkin Lymphoma - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - 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: T3543 - Name: Lymphosarcoma - Relevance: HIGH - As Found: Lymphoma - ID: T640 - Name: B-cell Lymphoma - Relevance: HIGH - As Found: Lymphoma, B-Cell ### Condition Browse Module - Meshes - ID: D000008223 - Term: Lymphoma - ID: D000008228 - Term: Lymphoma, Non-Hodgkin - ID: D000016393 - Term: Lymphoma, B-Cell ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018501 - Term: Antirheumatic Agents - ID: D000000020 - Term: Abortifacient Agents, Nonsteroidal - ID: D000000019 - Term: Abortifacient Agents - ID: D000012102 - Term: Reproductive Control Agents - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000003879 - Term: Dermatologic Agents - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000005493 - Term: Folic Acid Antagonists - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000019384 - Term: Nucleic Acid Synthesis Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M11703 - Name: Methotrexate - Relevance: HIGH - As Found: Breast Cancer - ID: M373 - Name: Rituximab - Relevance: HIGH - As Found: Healthy - ID: M1346 - Name: Antineoplastic Agents, Immunological - 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: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M7074 - Name: Dermatologic Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M8619 - Name: Folic Acid Antagonists - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: T447 - Name: Folinic Acid - Relevance: LOW - As Found: Unknown - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069283 - Term: Rituximab - ID: D000008727 - Term: Methotrexate ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05321979 **Brief Title:** Long-term Extension Study to Evaluate MBA-P01 in Subjects With Moderate to Severe Glabellar Lines **Official Title:** Open-label, Single Group, Multi-center, Repeat-dose Long-term Extension Study to Evaluate the Long-term Safety and Efficacy of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines #### Organization Study ID Info **ID:** MT14-KR21GBL1202 #### Organization **Class:** INDUSTRY **Full Name:** Medy-Tox ### Status Module #### Completion Date **Date:** 2023-05-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-01-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-01-12 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-05-30 **Type:** ACTUAL #### Start Date **Date:** 2022-02-07 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2022-04-11 **Type:** ACTUAL **Study First Submit Date:** 2022-03-23 **Study First Submit QC Date:** 2022-04-04 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Medytox Korea #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study is intended to evaluate long-term safety and efficacy of MBA-P01 in treatment of glabellar lines. ### Conditions Module **Conditions:** - Glabellar Frown Lines ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 253 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** MBA-P01 will be injected into GL: **Intervention Names:** - Drug: MBA-P01 **Label:** MBA-P01 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - MBA-P01 **Description:** MBA-P01 will be injected into the Glabellar line. **Name:** MBA-P01 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Incidence rate of treatment-emergent adverse events (TEAEs), adverse drug reactions (ADRs), serious adverse events (SAEs) and adverse event of special interest (AESI), when MBA-P01 is administered in repeated treatments. **Time Frame:** Through study completion, an average of 1 year **Measure:** Incidence rate of TEAE, ADR, SAE and AESI of each cycle **Time Frame:** Through each cycle, an average of 3 months **Measure:** The change of laboratory test and vital sign **Time Frame:** Through study completion, an average of 1 year **Measure:** The result of anti-drug-andibodies (ADA) and neutralizing antibodies **Time Frame:** Through study completion, an average of 1 year #### Secondary Outcomes **Description:** Proportion of paricipants achieving at least a 2-grade improvement from reatreatment day and a grade 0 (none) or 1 (mild) in GL severity\* as assessed by investigator \*GL severity: 0=none, 1=mild, 2=moderate, 3=severe **Measure:** Investigator-rated improvement rate of glabellar lines (GL) at maximum frown at week 4, week 8 and 12 of each cycle **Time Frame:** at week 4, week 8 and 12 of each cycle **Description:** Proportion of participants who were grade 2 (moderate) on retreatment day and achieving grade 0 (none) or 1 (mild) at week 4, week 8 and 12 in GL severity\* as assessed by investigator \*GL severity: 0=none, 1=mild, 2=moderate, 3=severe **Measure:** Investigator-rated improvement rate of GL at rest at week 4, week 8 and 12 of each cycle **Time Frame:** at week 4, week 8 and 12 of each cycle **Description:** Proportion of participants achieving at least a 2-grade improvement from reatreatment day and a grade 0 (none) or 1 (mild) in GL severity\* as assessed by participant \*GL severity: 0=none, 1=mild, 2=moderate, 3=severe **Measure:** Participant-rated improvement rate of GL at frown at week 4, week 8 and 12 of each cycle **Time Frame:** at week 4, week 8 and 12 of each cycle **Description:** Proportion of participants who were grade 2 (moderate) on retreatment day and achieving grade 0 (none) or 1 (mild) at week 4, week 8 and 12 in GL severity\* as assessed by participant \*GL severity: 0=none, 1=mild, 2=moderate, 3=severe **Measure:** Participant-rated improvement rate of GL at rest at week 4, week 8 and 12 of each cycle **Time Frame:** at week 4, week 8 and 12 of each cycle **Description:** Participant evaluate the level of safisfaction by 7-grade score **Measure:** Participant-rated satisfaction rate of GL at rest at week 4, week 8 and 12 of each cycle **Time Frame:** at week 4, week 8 and 12 of each cycle **Measure:** Time to retreatment **Time Frame:** Through study completion, an average of 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients who completed the phase III trial (MT14-KR20GBL309) * Patients who were capable of understanding and complying with the protocol and have signed the informed consent form voluntarily Exclusion Criteria: * Patients who have received other procedures which may affect glabellar lines within 6 months (except of MBA-P01 or BOTOX® treated in phase III trial, MT14-KR20GBL309) * Female patients who are pregnant or lactating. Female patients of childbearing age who have a plan to get pregnant during the study period. * Patient who do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.) * Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening * Patients who are not eligible for this study based on the judgment of an investigator **Maximum Age:** 65 Years **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Chung-Ang Univ. Hospital **State:** Dongjak-gu **Zip:** 06973 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05172479 **Acronym:** PASSEM **Brief Title:** Prognostic Accuracy of qSOFA, SIRS, and EWSs for In-hospital Mortality in Emergency Department **Official Title:** Prognostic Accuracy of qSOFA Score, SIRS Criteria, and EWSs for In-hospital Mortality Among Adult Patients Presenting With Suspected Infection to the Emergency Department (PASSEM): Protocol for an International Multicentre Prospective External Validation Cohort Study #### Organization Study ID Info **ID:** ACH-2 #### Organization **Class:** OTHER_GOV **Full Name:** Aseer Central Hospital ### Status Module #### Completion Date **Date:** 2023-09-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-09-13 **Type:** ACTUAL **Last Update Submit Date:** 2023-09-10 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-09-11 **Type:** ACTUAL #### Start Date **Date:** 2021-12-12 **Type:** ACTUAL **Status Verified Date:** 2023-09 #### Study First Post Date **Date:** 2021-12-29 **Type:** ACTUAL **Study First Submit Date:** 2021-12-03 **Study First Submit QC Date:** 2021-12-11 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Armed Force Hospital Southern Region-Khamis Mushayt (AFHSR-KM) **Class:** UNKNOWN **Name:** King Khalid University (KKU) #### Lead Sponsor **Class:** OTHER_GOV **Name:** Aseer Central Hospital #### Responsible Party **Investigator Affiliation:** Aseer Central Hospital **Investigator Full Name:** Abdullah M Algarni **Investigator Title:** Family medicine consultant **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Early identification of a patient with infection who may develop sepsis is of utmost importance. Unfortunately, this remains elusive because no single clinical measure or test can reflect complex pathophysiological changes in patients with sepsis. However, multiple clinical and laboratory parameters indicate impending sepsis and organ dysfunction. Screening tools using these parameters can help identify the condition, such as SIRS, quick SOFA (qSOFA), National Early Warning Score (NEWS), or Modified Early Warning Score (MEWS). The 2016 SCCM/ESICM task force recommended using qSOFA, while the 2021 Surviving Sepsis Campaign strongly recommended against its use compared with SIRS, NEWS, or MEWS as a single screening tool for sepsis or septic shock. We hypothesised that qSOFA has greater prognostic accuracy than SIRS and EWS (NEWS/NEWS2/MEWS). **Detailed Description:** Over the past decade, medical advances in sepsis continued to focus on sepsis as a prevalent condition that accounts for 10% of admissions to intensive care units (ICUs) and is associated with a 10-20% in-hospital mortality rate. Standardised protocols and physician awareness have significantly improved survival, but mortality rates remain between 20% and 36%, with \~270,000 deaths annually in the United States. However, of patients with sepsis, 80% are treated in an emergency department (ED), and the remainder develops sepsis during hospitalisation with other conditions. In 2016, the Society of Critical Care Medicine/European Society of Intensive Care Medicine (SCCM/ESICM) task force redefined sepsis based on organ dysfunction and mortality prediction. Sepsis now is defined as life-threatening organ dysfunction caused by dysregulated host response to infection. This definition emphasises the complexity of the disease that cannot be explained by infection or body response to it. Acute change in Sequential Organ Failure Assessment (SOFA) score ≥2 indicates sepsis-related organ dysfunction, a predictor of excess in-hospital mortality. Systemic Inflammatory Response Syndrome (SIRS) and "severe sepsis" terms were omitted from the most recent definition. SIRS has been criticised for its poor specificity, while "severe sepsis" may underestimate sepsis's seriousness. A subset of patients may develop septic shock with underlying profound organ dysfunction and excess mortality. Clinically, septic shock is defined as persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mm Hg and serum lactate level ≥ 2 mmol/L (18 mg/dL) despite adequate volume resuscitation. Early identification of a patient with infection who may develop sepsis is of utmost importance. Unfortunately, this remains elusive because no single clinical measure or test can reflect complex pathophysiological changes in patients with sepsis. However, multiple clinical and laboratory parameters indicate impending sepsis and organ dysfunction. Screening tools using these parameters can help identify the condition, such as SIRS, quick SOFA (qSOFA), National Early Warning Score (NEWS), or Modified Early Warning Score (MEWS). The 2016 SCCM/ESICM task force recommended using qSOFA, while the 2021 Surviving Sepsis Campaign strongly recommended against its use compared with SIRS, NEWS, or MEWS as a single screening tool for sepsis or septic shock. We hypothesised that qSOFA has greater prognostic accuracy than SIRS and EWS (NEWS/NEWS2/MEWS). ### Conditions Module **Conditions:** - Sepsis - Septic Shock **Keywords:** - Sepsis - Septic shock - qSOFA - SIRS - EWS - NEWS - NEWS2 - MEWS - Emergency department ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 3274 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Adult patients with suspected infection and a qSOFA score ≥ 2 at the triage in the ED who are planned for hospitalization **Intervention Names:** - Diagnostic Test: Measurement of qSOFA score **Label:** Positive qSOFA #### Arm Group 2 **Description:** Adult patients with suspected infection and a qSOFA score \< 2 at the triage in the ED who are planned for hospitalization **Intervention Names:** - Diagnostic Test: Measurement of qSOFA score **Label:** Negative qSOFA #### Arm Group 3 **Description:** Adult patients with suspected infection and a SIRS criteria ≥ 2 at the triage in the ED who are planned for hospitalization **Intervention Names:** - Diagnostic Test: Measurement of SIRS criteria **Label:** Positive SIRS #### Arm Group 4 **Description:** Adult patients with suspected infection and a SIRS criteria \< 2 at the triage in the ED who are planned for hospitalization **Intervention Names:** - Diagnostic Test: Measurement of SIRS criteria **Label:** Negative SIRS #### Arm Group 5 **Description:** Adult patients with suspected infection and a NEWS ≥ 5 or red score (i.e., a score of 3 in any one parameter) at the triage in the ED who are planned for hospitalization **Intervention Names:** - Diagnostic Test: Measurement of NEWS **Label:** Positive NEWS #### Arm Group 6 **Description:** Adult patients with suspected infection and a NEWS \< 5 at the triage in the ED who are planned for hospitalization **Intervention Names:** - Diagnostic Test: Measurement of NEWS **Label:** Negative NEWS #### Arm Group 7 **Description:** Adult patients with suspected infection and a NEWS2 ≥ 5 or red score (i.e., a score of 3 in any one parameter) at the triage in the ED who are planned for hospitalization **Intervention Names:** - Diagnostic Test: Measurement of NEWS2 **Label:** Positive NEWS2 #### Arm Group 8 **Description:** Adult patients with suspected infection and a NEWS2 \< 5 at the triage in the ED who are planned for hospitalization **Intervention Names:** - Diagnostic Test: Measurement of NEWS2 **Label:** Negative NEWS2 #### Arm Group 9 **Description:** Adult patients with suspected infection and a MEWS ≥ 5 at the triage in the ED who are planned for hospitalization **Intervention Names:** - Diagnostic Test: Measurement of MEWS **Label:** Positive MEWS #### Arm Group 10 **Description:** Adult patients with suspected infection and a MEWS \< 5 at the triage in the ED who are planned for hospitalization **Intervention Names:** - Diagnostic Test: Measurement of MEWS **Label:** Negative MEWS ### Interventions #### Intervention 1 **Arm Group Labels:** - Negative qSOFA - Positive qSOFA **Description:** At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's qSOFA score. **Name:** Measurement of qSOFA score **Other Names:** - quick Sequential Organ Failure Assessment (qSOFA) **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - Negative SIRS - Positive SIRS **Description:** At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's SIRS criteria. **Name:** Measurement of SIRS criteria **Other Names:** - Systemic inflammatory response syndrome (SIRS) **Type:** DIAGNOSTIC_TEST #### Intervention 3 **Arm Group Labels:** - Negative NEWS - Positive NEWS **Description:** At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's NEWS. **Name:** Measurement of NEWS **Other Names:** - National Early Warning Score (NEWS) **Type:** DIAGNOSTIC_TEST #### Intervention 4 **Arm Group Labels:** - Negative NEWS2 - Positive NEWS2 **Description:** At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's NEWS2. **Name:** Measurement of NEWS2 **Other Names:** - National Early Warning Score 2 (NEWS2) **Type:** DIAGNOSTIC_TEST #### Intervention 5 **Arm Group Labels:** - Negative MEWS - Positive MEWS **Description:** At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's MEWS. **Name:** Measurement of MEWS **Other Names:** - Modified Early Warning Score (MEWS) **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Mortality rate during hospitalization of patient **Measure:** In-hospital mortality **Time Frame:** 30 days #### Secondary Outcomes **Description:** Number of participants admitted to an intensive care unit **Measure:** Intensive care unit admission **Time Frame:** 30 days **Description:** Stay in intensive care unit \>72 hours **Measure:** Length of stay in the intensive care unit **Time Frame:** 30 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Adult patients (age ≥18 years), 2. Suspected infection (based on the opinion of the emergency physician), 3. Planned for hospitalization, 4. Willing to give oral informed consent (if required by recruiting center's IRB). Exclusion Criteria: 1. Presentation to ED is not due to infection (e.g., autoimmune diseases, myocardial infarction, stroke, venous thromboembolism, trauma, intoxication ... etc.), 2. Pregnancy, 3. Transferred from another hospitals, 4. Code status is "Do-Not-Resuscitate" (DNR) 5. Elective admission through ED 6. Initial diagnosis of infection in the ED was not confirmed after finishing of the recruitment and follow-up phase. **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** All consecutive adult patients (age ≥18 years) presenting to the ED with suspected infection who planned to be hospitalized and willing to give informed consent (if required by recruiting center IRB) are eligible. A presumptive diagnosis of infection will be judged based on the opinion of the emergency physician upon the initial patient presentation to the ED. We will exclude patients with evidence of other causes of presentation to the ED other than infection (e.g., autoimmune diseases, myocardial infarction, trauma, ...etc.), pregnant ladies, those who transferred from other hospitals, those not planned for hospitalization, or those who admitted electively to the hospital through ED. We will also exclude patients whose initial diagnosis of infection in the ED was not confirmed after the recruitment and follow-up. ### Contacts Locations Module #### Locations **Location 1:** **City:** Ar Rifā' **Country:** Bahrain **Facility:** Bahrain Defence Force Hospital **State:** Southern Governorate **Zip:** 947 **Location 2:** **City:** Muharraq **Country:** Bahrain **Facility:** King Hamad University Hospital **Location 3:** **City:** Kuwait **Country:** Kuwait **Facility:** Amiri Hospital **Location 4:** **City:** Muscat **Country:** Oman **Facility:** Armed Forces Hospital Oman **Zip:** 111 **Location 5:** **City:** Doha **Country:** Qatar **Facility:** Hamad Medical Corporation **Location 6:** **City:** Abha **Country:** Saudi Arabia **Facility:** Aseer Central Hospital (ACH) **State:** Aseer Province **Zip:** 62523 **Location 7:** **City:** Khamis Mushait **Country:** Saudi Arabia **Facility:** Armed Force Hospital Southern Region-Khamis Mushayt (AFHSR-KM) **State:** Aseer Province **Zip:** 62413 **Location 8:** **City:** Dammam **Country:** Saudi Arabia **Facility:** King Fahad Specialist Hospital **State:** Eastern Province **Zip:** 32253 **Location 9:** **City:** Dhahran **Country:** Saudi Arabia **Facility:** Johns Hopkins Aramco Healthcare **State:** Eastern Province **Zip:** 34465 **Location 10:** **City:** Jubail **Country:** Saudi Arabia **Facility:** Royal Commission Hospital in Jubail **State:** Eastern Province **Zip:** 31961 **Location 11:** **City:** Jeddah **Country:** Saudi Arabia **Facility:** King Abdulaziz University Hospital **State:** Makkah Al Mukarramah Province **Zip:** 22252 **Location 12:** **City:** Jeddah **Country:** Saudi Arabia **Facility:** King Fahd Armed Forces Hospital **State:** Makkah Al Mukarramah Province **Zip:** 23311 **Location 13:** **City:** Arar **Country:** Saudi Arabia **Facility:** North Medical Tower **State:** Northern Borders Province **Zip:** 73241 **Location 14:** **City:** Riyadh **Country:** Saudi Arabia **Facility:** King Abdullah bin Abdulaziz University Hospital (KAAUH) **State:** Riyadh Province **Zip:** 11564 **Location 15:** **City:** Riyadh **Country:** Saudi Arabia **Facility:** King Fahad Medical City (KFMC) **State:** Riyadh Province **Zip:** 12231 **Location 16:** **City:** Riyadh **Country:** Saudi Arabia **Facility:** King Saud Medical City (KSMC) **State:** Riyadh Province **Zip:** 12746 **Location 17:** **City:** Riyadh **Country:** Saudi Arabia **Facility:** Sulaiman Al-Habib Hospital **Location 18:** **City:** Kocaeli **Country:** Turkey **Facility:** Kocaeli University Hospital **Zip:** 41380 **Location 19:** **City:** Abu Dhabi **Country:** United Arab Emirates **Facility:** Sheikh Shakhbout Medical City **Location 20:** **City:** Dubai **Country:** United Arab Emirates **Facility:** Rashid Hospital #### Overall Officials **Official 1:** **Affiliation:** Aseer Central Hospital (ACH) **Name:** Abdullah M Algarni, MBBS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Algarni AM, Alfaifi MS, Al Bshabshe AA, Omair OM, Alsultan MA, Alzahrani HM, Alali HE, Alsabaani AA, Alqarni AM, Alghanem SA, Al Mufareh BS, Almemari AM, Sindi AA, Ozturan IU, Alhadhira AA, Shujaa AS, Alotaibi AH, Awladthani MM, Alsaad AA, Almarshed AA, AlQahtani AM, Harris TR, Alyahya BA, Assiri SA, Abuzeyad FH, Kazim SN, Al-Fares AA, Almazroua FY, Marzook NT, Basri AA, Elsafti AM, Alalshaikh AS, Ozturan CA, Alawad YI, AlOmari A, Alkhateeb MA, Farooq MM, AlMutairi LA, Alasfour MM, Al Haber MI, Umar UA, Bokhary NH, Alqahtani SF, Almutairi A, Alyahya HF, Alzahrani WS, Alsalmi F, Omair AM, Alasmari FM, Alfifi SY, Al-Nujimi MS, Foroutan F. Prognostic accuracy of qSOFA score, SIRS criteria, and EWSs for in-hospital mortality among adult patients presenting with suspected infection to the emergency department (PASSEM) Multicenter prospective external validation cohort study protocol. PLoS One. 2024 Jan 17;19(1):e0281208. doi: 10.1371/journal.pone.0281208. eCollection 2024. **PMID:** 38232095 #### See Also Links **Label:** Protocol preprint **URL:** https://www.medrxiv.org/content/10.1101/2022.03.19.22272537v1 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000018805 - Term: Sepsis - ID: D000007239 - Term: Infections - ID: D000018746 - Term: Systemic Inflammatory Response Syndrome - ID: D000007249 - Term: Inflammation - ID: D000012769 - Term: Shock ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections ### Condition Browse Module - Browse Leaves - ID: M7796 - Name: Emergencies - Relevance: HIGH - As Found: Emergency - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M15580 - Name: Shock, Septic - Relevance: HIGH - As Found: Septic Shock - ID: M15577 - Name: Shock - Relevance: LOW - As Found: Unknown - ID: M20864 - Name: Sepsis - Relevance: LOW - As Found: Unknown - ID: M16869 - Name: Toxemia - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M20818 - Name: Systemic Inflammatory Response Syndrome - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012772 - Term: Shock, Septic - ID: D000004630 - Term: Emergencies ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05966779 **Brief Title:** Physical Therapy in Lipedema Surgery **Official Title:** Physical Therapy Intervention in the Immediate Postoperative Phase of Lipedema Surgery #### Organization Study ID Info **ID:** OE36/2023 #### Organization **Class:** OTHER **Full Name:** University of Alcala ### Status Module #### Completion Date **Date:** 2023-07-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-08-01 **Type:** ACTUAL **Last Update Submit Date:** 2023-07-20 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-07-12 **Type:** ACTUAL #### Start Date **Date:** 2023-07-01 **Type:** ACTUAL **Status Verified Date:** 2023-07 #### Study First Post Date **Date:** 2023-08-01 **Type:** ACTUAL **Study First Submit Date:** 2023-07-20 **Study First Submit QC Date:** 2023-07-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Alcala #### Responsible Party **Investigator Affiliation:** University of Alcala **Investigator Full Name:** Ester Cerezo-Téllez **Investigator Title:** PhD., 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 goal of this observational study or clinical trial is to know evaluate the effects of a modified Complete Decongestive Therapy protocol using the Godoy Method in the postoperative period following lipedema surgery. The main question it aims to answer are: * if the treatment is effective on pain reduction, edema resorption, mobility improvement in short term and follow-up at 90 days * if the treatment is effective on preventing complications of these participants after surgery Participants have been treated in the lasts years and authors recover information of the effects of the treatment. Researchers will compare sub-groups of participants depending on the number of physical therapy sessions received **Detailed Description:** Background: Lipedema is an adipose tissue disorder in women, with an abnormal fat deposition in lower limbs and occasionally upper limbs. The patients present pain, bruising, heaviness, and mobility impairment. It affects them physically and psychologically. Purpose: This study aims to evaluate the effects of a modified CDT protocol using the Godoy Method in the postoperative period following lipedema surgery. Outcomes: pain (VAS), edema resorption, complications, mobility and patient satisfaction. A descriptive statistical analysis will be performed using means and standard deviation (quantitative outcomes) and percentages (dichotomous and categorical outcomes). An inferential analysis will be carried out using paired and unpaired T-tests as One-way and repeated measures ANOVA to search for differences between quantitative outcomes. Pearson chi-square will also be used to relate dichotomous and categorical variables in a transversal analysis. All missing values will be excluded from the analysis. In all cases, a P\<0.05 value and a 95% confidence interval will be determined forstatistical significance. All statistical analysis will be performed using the Stata® version 14.2 package for MS Windows® version 10. ### Conditions Module **Conditions:** - Assessment - Lipedema - Vascular Diseases - Dermatologic Complication **Keywords:** - Lipedema, physical therapy,liposuction,complications,treatment,assessment ### Design Module #### Design Info **Observational Model:** ECOLOGIC_OR_COMMUNITY **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 293 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A complete physical therapy assessment was done. All sociodemographic data were recruited as well as body mass index (BMI), the month of intervention, kind of surgery, extracted liters, psychological treatment, physical therapy sessions, pain, mobility, complications (seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema), compression, smoking, satisfaction with the treatment received. A modified CDT physical therapy protocol, based on Godoy's Method, was applied to all study participants. This protocol comprised of 1. Cervical Stimuli 15min 2. MLD based on Godoy 3. Mechanical lymphatic drainage with RA Godoy® device 4. Compression therapy with multilayer and multicomponent bandages during the mechanical lymphatic drainage. 5. Skin care - before and after the bandages- and therapeutic education. 6. Put on compression garments 7. Active movement if possible. **Intervention Names:** - Other: modified CDT physical therapy protocol, based on Godoy's Method **Label:** modified CDT physical therapy protocol, based on Godoy's Method ### Interventions #### Intervention 1 **Arm Group Labels:** - modified CDT physical therapy protocol, based on Godoy's Method **Description:** modified CDT physical therapy protocol **Name:** modified CDT physical therapy protocol, based on Godoy's Method **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** VAS **Measure:** Pain VAS scale **Time Frame:** 2018-2022 #### Secondary Outcomes **Description:** lower limb edema is measured **Measure:** edema resorption - volume **Time Frame:** 2018-2022 **Description:** seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema **Measure:** complications reported - binary outcome **Time Frame:** 2018-2022 **Description:** 1- dependent to move/no improvement, 2-somewhat dependent/minor to medium improvement, 3- independent marked improvement **Measure:** mobility - scale **Time Frame:** 2018-2022 **Description:** binary outcome **Measure:** patient satisfaction **Time Frame:** 2018-2022 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * female subject who underwent a lipedema surgery * recommendation of the surgeon to receive physical therapy Exclusion Criteria: * unilateral surgery * lack of data in the clinical history * only 1-2 physical therapy sessions **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** females from undergon a surgical proceeding for lipedema in two private hospitals in Madrid and were treated in a private physical therapy center. After surgery they were recommended to receive CDT by their surgeons. All participants received the same physical therapy treatment. The study was approved by the Clinical Research Committee of Hospital Universitario Principe de Asturias (CEIm 36/2023). ### Contacts Locations Module #### Locations **Location 1:** **City:** Alcalá de Henares **Country:** Spain **Facility:** Ester Cerezo Tellez **State:** Madrid **Zip:** 28823 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000003240 - Term: Connective Tissue Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M17400 - Name: Vascular Diseases - Relevance: HIGH - As Found: Vascular Disease - ID: M30472 - Name: Lipedema - Relevance: HIGH - As Found: Lipedema - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014652 - Term: Vascular Diseases - ID: D000065134 - Term: Lipedema ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01407679 **Acronym:** AliCLE **Brief Title:** Efficacy and Safety of Oral Alitretinoin (Toctino®) in the Treatment of Patients With Cutaneous Lupus Erythematosus **Official Title:** Efficacy and Safety of Oral Alitretinoin (Toctino®) in the Treatment of Patients With Cutaneous Lupus Erythematosus: A Multicentre, Open-Label, Prospective Pilot Study #### Organization Study ID Info **ID:** UKM 10_0019 #### Organization **Class:** OTHER **Full Name:** University Hospital Muenster ### Status Module #### Completion Date **Date:** 2014-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2016-06-01 **Type:** ESTIMATED **Last Update Submit Date:** 2016-05-30 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2014-04 **Type:** ACTUAL #### Start Date **Date:** 2011-08 **Status Verified Date:** 2016-05 #### Study First Post Date **Date:** 2011-08-02 **Type:** ESTIMATED **Study First Submit Date:** 2011-08-01 **Study First Submit QC Date:** 2011-08-01 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Basilea Pharmaceutica International Ltd #### Lead Sponsor **Class:** OTHER **Name:** University Hospital Muenster #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** To evaluate the therapeutic effect of oral alitretinoin (Toctino®) in the treatment of CLE with respect to proportion of responders based on the Revised Cutaneous Lupus Disease Area and Severity Index (RCLASI) activity score for skin lesions at baseline and after 24 weeks of treatment or at the latest assessment for patients who withdrew prematurely. Response is defined as a reduction of 50% in the total RCLASI compared to the baseline value ("RCLASI 50"). ### Conditions Module **Conditions:** - Lupus Erythematosus, Cutaneous **Keywords:** - cutaneous lupus erythematosus - discoid lupus erythematosus - subacute cutaneous lupus erythematosus - lupus erythematosus tumidus ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 7 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Alitretinoin **Label:** Alitretinoin **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Alitretinoin **Description:** 1 capsule Alitretinoin 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur **Name:** Alitretinoin **Other Names:** - Alitretinoin 30 mg soft capsules - Alitretinoin 10 mg soft capsules **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Response is defined as a reduction of 50% in the total RCLASI activity for skin lesions, compared to the baseline value ("RCLASI 50") **Measure:** Primary efficacy outcome is the response rate at week 24 or at the latest assessment for patients who withdrew prematurely. **Time Frame:** Week 24 or at the latest assessment for patients who withdrew prematurely. #### Secondary Outcomes **Measure:** Proportion of patients with RCLASI 50 at week 12 of treatment. **Time Frame:** Week 12 of treatment **Measure:** Proportion of patients with at least partial response at end of therapy (with regard to RCLASI activity score for skin lesions). **Time Frame:** End of therapy (up to 24 weeks) **Measure:** Patient's global assessment and VAS for itch and pain 12 weeks after the beginning of treatment. **Time Frame:** 12 weeks after the beginning of treatment **Measure:** Number of Participants with Adverse Events (AEs) and their severity. **Time Frame:** 24 weeks of treatment + 5 weeks of follow up **Measure:** Patient's global assessment and VAS for itch and pain at the end of therapy. **Time Frame:** End of therapy (up to 24 weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * A clinical and histological diagnosis of CLE (DLE, SCLE, LET) who failed to respond to topical corticosteroids; * Total RCLASI activity score of skin lesions \>6 (at least 3 points in at least 2 locations); * At least one primary but preferably 2 methods of contraception; Exclusion Criteria: * Systemic Lupus Erythematosus (SLE) with major systemic organ involvement, e.g. clinical significant renal involvement, requiring systemic medical treatment for the disease; * Clinically significant illness that may influence the outcome of the study in the four weeks before and during the study; * Active severe infection diseases, including chronic or localized; * Patients with hepatic insufficiency (AST, ALT \> 2.5 x ULN), severe renal failure (creatinine clearance \< 60ml/min), or hypercholesterolemia characterized by: 1. Fasting triglyceridemia \> 1.5 x upper limit of normal (ULN) 2. Fasting total cholesterol \> 1.5 x ULN 3. Fasting low-density lipoprotein (LDL) cholesterol \> 1.5x ULN * Patients with known hypersensitivity to other retinoids or vitamin A derivatives, or to any study medication component, especially soybean oil and partly hydrogenated soybean oil; * Patients with cardiovascular risk factors that would exclude a starting dose of 30 mg of alitretinoin; * Topical corticosteroids within 14 days prior to dosing; * Patients treated with any systemic or topical retinoids within 4 weeks before start of study treatment; * Drugs with a potential for drug-drug interaction, such as systemic tetracyclines, ketoconazole, or St. John"s Wort within 1 week, or receiving systemic itraconazole within 2 weeks, before start of study treatment; * Initiation or change in the dose of any current systemic medication for the treatment of CLE/SLE prior to the study (time depending on drug class and half-life); * Treatment with immunosuppressive drugs for other reasons, 4 weeks prior and within the study; * Concomitant medication with drugs with a known photosensitizing potential, e.g. tetracyclines, griseofulvin, thiazides, furosemide, sulfonamides or tolbutamide; * Drugs associated to CLE-induction: terbinafine, hydrochlorothiazide, diltiazem, verapamil, nifedipine, nitrendipine, fluorouracil, penicillamine, infliximab, adalimumab, etanercept, pantoprazole; 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 #### Locations **Location 1:** **City:** Mannheim **Country:** Germany **Facility:** Department of Dematology, University Hospital **State:** Baden-Wuerttemberg **Zip:** 68167 **Location 2:** **City:** Muenchen **Country:** Germany **Facility:** Department of Dermatology, Ludwig-Maximilians University **State:** Bayern **Zip:** 80337 **Location 3:** **City:** Muenster **Country:** Germany **Facility:** Department of Dermatology, University Hospital **State:** Westfalen **Zip:** 48149 #### Overall Officials **Official 1:** **Affiliation:** Department of Dermatology, University Hospital Muenster, Muenster, Germany **Name:** Annegret Kuhn, Prof. Dr. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11175 - Name: Lupus Erythematosus, Cutaneous - Relevance: HIGH - As Found: Cutaneous Lupus Erythematosus - ID: M11176 - Name: Lupus Erythematosus, Discoid - Relevance: LOW - As Found: Unknown - ID: M11177 - Name: Lupus Erythematosus, Systemic - Relevance: HIGH - As Found: Lupus Erythematosus - 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 - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T1683 - Name: Cutaneous Lupus Erythematosus - Relevance: HIGH - As Found: Cutaneous Lupus Erythematosus ### Condition Browse Module - Meshes - ID: D000008180 - Term: Lupus Erythematosus, Systemic - ID: D000008178 - Term: Lupus Erythematosus, Cutaneous ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000003879 - Term: Dermatologic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1834 - Name: Alitretinoin - Relevance: HIGH - As Found: Weaning From Mechanical Ventilation - ID: M7074 - Name: Dermatologic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077556 - Term: Alitretinoin ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05177679 **Brief Title:** Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption **Official Title:** Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption #### Organization Study ID Info **ID:** 21066 #### Organization **Class:** OTHER **Full Name:** University of Illinois at Urbana-Champaign ### Status Module #### Completion Date **Date:** 2026-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-04-27 **Type:** ACTUAL **Last Update Submit Date:** 2023-04-26 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2022-06-23 **Type:** ACTUAL **Status Verified Date:** 2023-04 #### Study First Post Date **Date:** 2022-01-04 **Type:** ACTUAL **Study First Submit Date:** 2021-11-02 **Study First Submit QC Date:** 2021-12-14 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Northeastern University **Class:** OTHER **Name:** University of Georgia #### Lead Sponsor **Class:** OTHER **Name:** University of Illinois at Urbana-Champaign #### 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 aim of this study is to test the casual relationship between carotenoid supplementation, cognitive function, and achievement over a school-year. The central hypothesis is that, relative to the waitlist placebo group, children receiving the carotenoid supplement will exhibit greater gains in cognitive function and achievement. **Detailed Description:** This clinical trial will be a randomized placebo-controlled double-blind trial to examine the effects of carotenoid supplementation on cognitive control, hippocampal-dependent relational memory, and academic achievement among pre-adolescents over one school year (i.e. 9-months). ### Conditions Module **Conditions:** - Cognitive Change - Achievement - Macular Pigmentation **Keywords:** - Lutein - Zeaxanthin - Carotenoids - Child - Spatial memory - Hippocampus - Academic success - Cognition ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized, placebo-controlled, double-blind trial. ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 288 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The active supplementation group participants will be asked to consume a daily carotenoid supplement for 9 months. **Intervention Names:** - Dietary Supplement: Active supplement **Label:** Active Supplement **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The placebo control group participants will be asked to consume a placebo supplement for 9 months. **Intervention Names:** - Dietary Supplement: Placebo control **Label:** Placebo Control **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Active Supplement **Description:** Carotenoid supplement comprised of 10mg lutein and 2mg zeaxanthin. **Name:** Active supplement **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Placebo Control **Description:** Placebo control supplement **Name:** Placebo control **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Changes in accuracy (%) between groups using a computerized flanker task. **Measure:** Attentional Accuracy **Time Frame:** 9 months (Baseline vs Follow-up) **Description:** Changes in reaction time (ms) between groups using a computerized flanker task. **Measure:** Attentional Reaction Time **Time Frame:** 9 months (Baseline vs Follow-up) **Description:** Spatial memory task accuracy **Measure:** Hippocampal-dependent Relational memory **Time Frame:** 9 months (Baseline vs Follow-up) **Description:** Kaufman Test of Academic and Educational Achievement II (KTEA III) composite or comprehensive academic achievement score. The scores are standard scores with a minimum score of 40 and a maximum score of 160 where a higher score indicates a better outcome. **Measure:** Composite Academic Achievement **Time Frame:** 9 months (Baseline vs Follow-up) #### Secondary Outcomes **Description:** Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer. **Measure:** Macular Pigment Optical Density **Time Frame:** 9 months (Baseline vs Follow-up) **Description:** Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task. **Measure:** Attentional Resource Allocation **Time Frame:** 9 months (Baseline vs Follow-up) **Description:** Changes in P3 event related potential latency (ms) between groups using a computerized flanker task. **Measure:** Attentional Processing Speed **Time Frame:** 9 months (Baseline vs Follow-up) **Description:** Assessed as Mass subtest standard scores on the KTEA III. The scores are standard scores with a minimum score of 40 and a maximum score of 160 where a higher score indicates a better outcome. **Measure:** Math **Time Frame:** 9 months (Baseline vs Follow-up) **Description:** Assessed as Reading subtest standard scores on the KTEA III. The scores are standard scores with a minimum score of 40 and a maximum score of 160 where a higher score indicates a better outcome. **Measure:** Reading **Time Frame:** 9 months (Baseline vs Follow-up) **Description:** Assessed as Written Language subtest standard scores on the KTEA III. The scores are standard scores with a minimum score of 40 and a maximum score of 160 where a higher score indicates a better outcome. **Measure:** Written Language **Time Frame:** 9 months (Baseline vs Follow-up) **Description:** Assessed as Reading Fluency subtest standard scores on the KTEA III. The scores are standard scores with a minimum score of 40 and a maximum score of 160 where a higher score indicates a better outcome. **Measure:** Reading Fluency **Time Frame:** 9 months (Baseline vs Follow-up) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Child assent and parent/guardian consent * 8-10 years of age * No lutein supplementation within 6-months prior to enrollment (exception of multivitamins containing less than 1 mg lutein/day) * Absence of learning disability (parent-reported) * Tanner scale score ≤ 2 * 20/20 or corrected vision Exclusion Criteria: * Non-assent of child or non-consent of guardian * Above/below 8-10 years of age * Lutein supplementation within 6-months prior to enrollment (including multivitamins containing more than 1 mg lutein/day) * Identified learning disability (parent-reported) * Tanner scale score \> 2 * Not 20/20 or uncorrected vision **Healthy Volunteers:** True **Maximum Age:** 10 Years **Minimum Age:** 8 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Naiman Khan, PhD **Phone:** 217-300-2197 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Ginger Reeser, MS **Phone:** 217-244-8442 **Role:** CONTACT #### Locations **Location 1:** **City:** Urbana **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Naiman Khan, PhD - **Phone:** 217-300-2197 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Ginger Reeser, MS - **Phone:** 217-244-8442 - **Role:** CONTACT **Country:** United States **Facility:** University of Illinois Urbana-Champaign **State:** Illinois **Status:** RECRUITING **Zip:** 61801 #### Overall Officials **Official 1:** **Affiliation:** University of Illinois Urbana-Champaign **Name:** Naiman Khan, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Cannavale CN, Keye SA, Rosok L, Martell S, Holthaus TA, Reeser G, Raine LB, Mullen SP, Cohen NJ, Hillman CH, Hammond BR, Renzi-Hammond L, Khan NA. Enhancing children's cognitive function and achievement through carotenoid consumption: The Integrated Childhood Ocular Nutrition Study (iCONS) protocol. Contemp Clin Trials. 2022 Nov;122:106964. doi: 10.1016/j.cct.2022.106964. Epub 2022 Oct 15. **PMID:** 36252934 ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M5592 - Name: Carotenoids - Relevance: LOW - As Found: Unknown - ID: T407 - Name: Lutein - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03790579 **Brief Title:** Dietary Acid Load During Pregnancy and Gestational Diabetes Mellitus **Official Title:** Is There Any Effect of Maternal Dietary Acid Load During Pregnancy on Arising Gestational Diabetes Mellitus? #### Organization Study ID Info **ID:** Hacettepe Nutrition #### Organization **Class:** OTHER **Full Name:** Hacettepe University ### Status Module #### Completion Date **Date:** 2014-10-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-01-02 **Type:** ACTUAL **Last Update Submit Date:** 2018-12-29 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2014-09-05 **Type:** ACTUAL #### Start Date **Date:** 2014-01-05 **Type:** ACTUAL **Status Verified Date:** 2018-12 #### Study First Post Date **Date:** 2018-12-31 **Type:** ACTUAL **Study First Submit Date:** 2018-12-28 **Study First Submit QC Date:** 2018-12-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hacettepe University #### Responsible Party **Investigator Affiliation:** Hacettepe University **Investigator Full Name:** F. Gülhan Samur **Investigator Title:** Professor doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Dietary habits resembling Western style, rich in animal protein and poor in fruit and vegetables, increase the body acid load, a predictor of type 2 diabetes risk. Recently, the studies related to relationships between dietary acid load and insulin resistance has become a growing interest but there are only a few study conducted with gestational diabetes mellitus (GDM). Therefore, the aim of this study was to evaluate the potential relationship between dietary acid load in second trimester, blood lipid profiles and GDM. **Detailed Description:** This cross-sectional study conducted with 40 women with GDM diagnosed with two-step 100g oral glucose tolerance test and 40 healthy women, aged 21-41 years, between weeks of 14-28 of pregnancy, who attended the Department of Obstetrics and Gynecology of Gulhane Training and Research Hospital. Participants with polycystic ovary syndrome, chronic diseases, pre-GDM, or multiple pregnancies were excluded. Sociodemographic information was recorded via questionnaire and anthropometrics of women were measured. Blood samples were taken after an overnight fasting. Dietary information was obtained by mean intakes of a 3-day food records (2 weekdays and 1 weekend day) and analyzed via nutrition analysis software. According to the data obtained from software analysis, animal protein (g/day) to potassium (g/day) ratio (AP/K), potential renal acid load (PRAL; mEq/day) score and net endogenous acid production (NEAP; mEq/day) were calculated from established algorithms to estimate dietary acid load. All nutrients were age and energy- adjusted before being introduced into the equation and tertiles of the scores were used for statistical analysis. ANOVA, ANCOVA and Logistic regression test were used. The study plan was approved by the Hospital\&#39;s Ethics Committee. ### Conditions Module **Conditions:** - Diabetes, Gestational - Dietary Habits **Keywords:** - Gestational diabetes mellitus - Dietary acid load - Pregnancy ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 80 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** We randomly selected the 40 pregnant women diagnosed GDM by two-step procedure based on Carpenter-Coustan criteria at this hospital. The diagnosis of GDM was confirmed if at least 2 of 4 glucose levels exceed based on Carpenter-Coustan criteria: fasting ≥ 95 mg/dL (5.3 mmol/L), 1 hour ≥ 180 mg/dL ( 10.0 mmol/L), 2 hour ≥ 155 mg/dL (8.6 mmol/L), and 3 hour ≥ 140 mg/dL (7.8 mmol/L). **Label:** Women with gestational diabetes #### Arm Group 2 **Description:** We also randomly selected 40 healthy pregnant with normal serum glucose levels ≤129 mg/dL (7.2 mmol/L) after GCT. **Label:** Healthy women ### Outcomes Module #### Primary Outcomes **Description:** According to the data obtained from software analysis, animal protein (g/day) to potassium (g/day) ratio (AP/K), potential renal acid load (PRAL; mEq/day) score and net endogenous acid production (NEAP; mEq/day) were calculated from established algorithms to estimate dietary acid load. **Measure:** Dietary acid load **Time Frame:** 24-28. weeks of pregnancy ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Singleton pregnancy, * Aged in 20-40 years, * Gestational age 24-28 weeks, * Non-history of acute or chronic diseases. Exclusion Criteria: * History of GDM, * Type 1 and 2 diabetes mellitus, * Preeclampsia, * Polycystic ovary syndrome, * Thyroid disease * Parathyroid disease, * Metabolic bone disease, * Kidney disease, * Abnormal liver function, * Multiple pregnancy * Extreme values of energy intake in their dietary records (\<1500 and \>4000 kkal). **Gender Based:** True **Healthy Volunteers:** True **Maximum Age:** 41 Years **Minimum Age:** 21 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** In this observational cross-sectional study, 40 women with GDM and 40 healthy pregnant between 21-41 years in age, in their 24-28th gestational week applied to Gulhane Education and Research Hospital were recruited. This study must recruit 40 women for each group to have 80% study power with 5% type I error level to detect a clinically significant difference. ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Hacettepe University **Name:** Gülhan SAMUR, Professor **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Mehmet Akif Ersoy University **Name:** Gözde EDE, MSci **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Della Guardia L, Thomas MA, Cena H. Insulin Sensitivity and Glucose Homeostasis Can Be Influenced by Metabolic Acid Load. Nutrients. 2018 May 15;10(5):618. doi: 10.3390/nu10050618. **PMID:** 29762478 **Citation:** Jayedi A, Shab-Bidar S. Dietary acid load and risk of type 2 diabetes: A systematic review and dose-response meta-analysis of prospective observational studies. Clin Nutr ESPEN. 2018 Feb;23:10-18. doi: 10.1016/j.clnesp.2017.12.005. Epub 2017 Dec 23. **PMID:** 29460782 **Citation:** Williams RS, Kozan P, Samocha-Bonet D. The role of dietary acid load and mild metabolic acidosis in insulin resistance in humans. Biochimie. 2016 May;124:171-177. doi: 10.1016/j.biochi.2015.09.012. Epub 2015 Sep 10. **PMID:** 26363101 **Citation:** Gaede J, Nielsen T, Madsen ML, Toft U, Jorgensen T, Overvad K, Tjonneland A, Hansen T, Allin KH, Pedersen O. Population-based studies of relationships between dietary acidity load, insulin resistance and incident diabetes in Danes. Nutr J. 2018 Oct 6;17(1):91. doi: 10.1186/s12937-018-0395-1. **PMID:** 30292239 **Citation:** Saraf-Bank S, Tehrani H, Haghighatdoost F, Moosavian SP, Azadbakht L. The acidity of early pregnancy diet and risk of gestational diabetes mellitus. Clin Nutr. 2018 Dec;37(6 Pt A):2054-2059. doi: 10.1016/j.clnu.2017.09.020. Epub 2017 Oct 3. **PMID:** 29054469 **Citation:** Miki A, Hashimoto Y, Tanaka M, Kobayashi Y, Wada S, Kuwahata M, Kido Y, Yamazaki M, Fukui M. Urinary pH reflects dietary acid load in patients with type 2 diabetes. J Clin Biochem Nutr. 2017 Jul;61(1):74-77. doi: 10.3164/jcbn.16-118. Epub 2017 Jul 1. **PMID:** 28751813 **Citation:** Kiefte-de Jong JC, Li Y, Chen M, Curhan GC, Mattei J, Malik VS, Forman JP, Franco OH, Hu FB. Diet-dependent acid load and type 2 diabetes: pooled results from three prospective cohort studies. Diabetologia. 2017 Feb;60(2):270-279. doi: 10.1007/s00125-016-4153-7. Epub 2016 Nov 17. **PMID:** 27858141 **Citation:** Williams RS, Heilbronn LK, Chen DL, Coster AC, Greenfield JR, Samocha-Bonet D. Dietary acid load, metabolic acidosis and insulin resistance - Lessons from cross-sectional and overfeeding studies in humans. Clin Nutr. 2016 Oct;35(5):1084-90. doi: 10.1016/j.clnu.2015.08.002. Epub 2015 Aug 12. **PMID:** 26299332 **Citation:** Akter S, Eguchi M, Kuwahara K, Kochi T, Ito R, Kurotani K, Tsuruoka H, Nanri A, Kabe I, Mizoue T. High dietary acid load is associated with insulin resistance: The Furukawa Nutrition and Health Study. Clin Nutr. 2016 Apr;35(2):453-459. doi: 10.1016/j.clnu.2015.03.008. Epub 2015 Mar 27. **PMID:** 25863769 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital 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 - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes Mellitus - ID: M19012 - Name: Diabetes, Gestational - Relevance: HIGH - As Found: Gestational Diabetes Mellitus - 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 - 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 ### Condition Browse Module - Meshes - ID: D000016640 - Term: Diabetes, Gestational - ID: D000003920 - Term: Diabetes Mellitus ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04376879 **Brief Title:** Predicting the Need for Intubation in Hospitalised COVID-19 Patients (PRED ICU COVID19) **Official Title:** Predicting the Need for Intubation in Hospitalised COVID-19 Patients (PRED ICU COVID19) #### Organization Study ID Info **ID:** 2020-A01076-33 #### Organization **Class:** OTHER **Full Name:** Central Hospital, Nancy, France ### Status Module #### Completion Date **Date:** 2021-05-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-09-10 **Type:** ACTUAL **Last Update Submit Date:** 2021-09-02 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-05-31 **Type:** ACTUAL #### Start Date **Date:** 2020-05-16 **Type:** ACTUAL **Status Verified Date:** 2021-08 #### Study First Post Date **Date:** 2020-05-06 **Type:** ACTUAL **Study First Submit Date:** 2020-05-04 **Study First Submit QC Date:** 2020-05-05 ### 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:** One of the main challenges of the health crisis caused by the COVID-19 epidemic is the availability of beds in intensive care units (ICUs) and, more importantly, the need for invasive mechanical ventilation (IVM) because the ICUs are currently reserved for intubated patients. The experiences of both China and Italy indicate that a certain number of COVID-19 patients will require mechanical ventilation. However, the limited number of resuscitation beds and ventilators requires strict use of these scarce resources. As a significant proportion about 5% to 10%, of patients initially admitted to hospital with COVID-19 will require ventilation, it is essential to anticipate their need for resuscitation to improve the rare resource of beds and ventilator shortages in intensive care units. The hypothesis of the study is that, in proven or suspected hospitalised and oxygen-requiring COVID-19 patients, an early predictive clinical score, calculated over the three first days of admission may allow for an earlier identification of patients who will require intubation and transfer to an intensive care unit for orotracheal intubation ### Conditions Module **Conditions:** - COVID-19 ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 301 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Cohort for the creation of clinical-biological score to predict the risk of intubation in COVID-19 **Intervention Names:** - Other: Data monitoring for 48h within the first 24 hours of admission for COVID-19 **Label:** Step 1: creation of the score #### Arm Group 2 **Description:** Cohort for the validation of clinical-biological score to predict the risk of intubation in COVID-19 **Intervention Names:** - Other: Data monitoring for 48h within the first 24 hours of admission for COVID-19 **Label:** Step 2: validation of the score ### Interventions #### Intervention 1 **Arm Group Labels:** - Step 1: creation of the score - Step 2: validation of the score **Description:** The admission variables and those constituting the predictive score (blood pressure, temperature, oxygenotherapy, biological analysis...) will be collected for 48 hours after enrolment (i.e within the first 24 hours of admission ) **Name:** Data monitoring for 48h within the first 24 hours of admission for COVID-19 **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Primary outcome measure for the creation of the predictive score **Measure:** the number of intubations in COVID-19 patients initially hospitalised in wards **Time Frame:** up to 1 month #### Secondary Outcomes **Description:** Secondary endpoints for validation of the predictive score **Measure:** the number of intubations in COVID-19 patients initially hospitalised in wards. **Time Frame:** up to 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Proven or expected COVID-19 patients hospitalised in a non-intensive care unit for less than 24 hours, * Patients requiring oxygen therapy, * Age ≥ 18 years old. Exclusion Criteria: * Patients who are opposed to taking part in the study and who are opposed to the collection and use of the data that the study aims to collect., * Patients who can not be intubated for medical reasons, * Pregnant women, parturient women or nursing mothers , * Adult person subject to a legal protection measure (guardianship, curatorship, judicial safeguard), * Adults person who is unable to give consent and who is not subject to a legal protection measure, * Persons deprived of their liberty by a judicial or administrative decision, * Persons subject to psychiatric care under duress. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Proven or expected COVID-19 patients hospitalised in a non-intensive care unit for less than 24 hours ### Contacts Locations Module #### Locations **Location 1:** **City:** Colombes **Country:** France **Facility:** Louis Mourier hospital (AP-HP) **Zip:** 92700 **Location 2:** **City:** Vandœuvre-lès-Nancy **Country:** France **Facility:** Brabois Hospital (CHRU de Nancy) **Zip:** 54500 #### Overall Officials **Official 1:** **Affiliation:** CHRU de NANCY **Name:** Antoine KIMMOUN, MD-PhD **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** AP-HP, Louis Mourier Hospital **Name:** Jean Damien RICARD, MD-PhD **Role:** STUDY_CHAIR **Official 3:** **Affiliation:** Institut National de Recherche en Informatique et en Automatique **Name:** Julie JOSSE, PhD **Role:** STUDY_CHAIR **Official 4:** **Affiliation:** CHRU de NANCY **Name:** Patrick ROSSIGNOL, MD-PhD **Role:** STUDY_CHAIR ## 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 - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05240079 **Acronym:** CARDIASENS_2 **Brief Title:** Evaluation of a New System for Heart Rate and SpO2 Measurement. **Official Title:** Evaluation of Concordance Between the Measurements Obtained by an Acquisition System of Physiological Parameters (Heart Rate/SpO2) Via a Teleconsultation Camera System With Reference to Standard Acquisition Measurements #### Organization Study ID Info **ID:** 2021-A02217-34 #### Organization **Class:** OTHER **Full Name:** Central Hospital, Nancy, France ### Status Module #### Completion Date **Date:** 2023-11-15 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** NOT_YET_RECRUITING #### Last Update Post Date **Date:** 2022-02-15 **Type:** ACTUAL **Last Update Submit Date:** 2022-02-10 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2023-09-15 **Type:** ESTIMATED #### Start Date **Date:** 2022-03-15 **Type:** ESTIMATED **Status Verified Date:** 2021-11 #### Study First Post Date **Date:** 2022-02-15 **Type:** ACTUAL **Study First Submit Date:** 2022-01-19 **Study First Submit QC Date:** 2022-02-10 ### 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:** Caducy is a new medical device that is able to estimate physiological number such as heart rate and SpO2 via laptop or computer camera. The goal of this study is to evaluate the concordance of Caducy system in reference to gold standard which is a heart rate monitor and an oximeter pod linked to a station of acquisition regardless the human variability. The Caducy system measurement via camera is made by filming the visage of the patient during 1 minute. ### Conditions Module **Conditions:** - Telemedicine **Keywords:** - Telemedicine - Heart rate - photoplethysmography ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: Heart rate measurement with Caducy system (twice). SpO2 measurement with Caducy system (Twice). **Label:** Patients **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients **Description:** Heart rate and SpO2 measurement with Caducy (the visage of the subject is filmed 30 seconds and 1 minute with a camera) and heart rate and SpO2 measurement with gold standard (heart rate monitor and oximeter pod linked to an acquisition station). The procedure is repeated twice. **Name:** Heart rate measurement with Caducy system (twice). SpO2 measurement with Caducy system (Twice). **Other Names:** - Heart rate measurement with gold standard system (twice). SpO2 measurement with gold standard system (twice). **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Heart rate (bpm) taken with gold standart Heart rate (bpm) calculated by CADUCY **Measure:** Caducy's heart rate measurement compared to standard **Time Frame:** through study completion, an average of 6 month #### Secondary Outcomes **Description:** Blood oxygen saturation (%) taken by gold standard Blood oxygen saturation (%) calculated by CADUCY **Measure:** Caducy's SpO2 measurement compared to standard **Time Frame:** through study completion, an average of 6 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Be 18 years of age or over. * Patient affiliated to a social security scheme. * Having received complete information on the organization of the research. * Able to understand the requirements of the trial and having signed a free and informed consent prior to entering the study * Patient taken care of by the CUMSAPA (Centre Universitaire de Médecine du Sport et Activité Physique Adaptées) service for an PFT (pulmonary function test), stress test, consultation of adapted physical activity or other functional explorations carried out by the service. * Patient having carried out a preliminary clinical examination. Exclusion Criteria: * Acute phenomenon contra-indicating the performance of an PFT, stress test or other functional exploration. * Person with tremors at the time of clinical examination (Parkinson, spasms...) * People who cannot present the palms of both hands (amputation). * Woman of childbearing age who does not have effective contraception. * Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code: Pregnant woman, parturient or nursing mother, Minor (non-emancipated), Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice), Person of full age unable to express consent * Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01693679 **Brief Title:** Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis #### Organization Study ID Info **ID:** Telbivudine #### Organization **Class:** OTHER **Full Name:** Sun Yat-sen University ### Status Module #### Expanded Access Info **Last Known Status:** ACTIVE_NOT_RECRUITING #### Last Update Post Date **Date:** 2012-09-26 **Type:** ESTIMATED **Last Update Submit Date:** 2012-09-24 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2014-04 **Type:** ESTIMATED #### Start Date **Date:** 2012-09 **Status Verified Date:** 2012-09 #### Study First Post Date **Date:** 2012-09-26 **Type:** ESTIMATED **Study First Submit Date:** 2012-09-20 **Study First Submit QC Date:** 2012-09-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Shao-quan Zhang #### Responsible Party **Investigator Affiliation:** Sun Yat-sen University **Investigator Full Name:** Shao-quan Zhang **Investigator Title:** Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** • To estimate renoprotective efficacy of Telbivudine treated patients with HBV-related liver cirrhosis. ### Conditions Module **Conditions:** - HBV-related Liver Cirrhosis **Keywords:** - Tebivudine eGFR non-Tebivudine ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Telbivudine team,Telbivudine,600mg/d,oral,60 patients. non-Tebivudine team,Lamivudine,100mg/d,oral,20 patients.Adefovir,10mg/d,oral,20 patients.Enecavir,0.5mg/d,oral,20 patients. **Intervention Names:** - Drug: Telbivudine, Lamivudine, Adefovir ,Enecavir **Label:** antiviral drug **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - antiviral drug **Description:** investigational Telbivudine,600mg,daily,oral.comparator Lamivudine,100mg daily, oral,Adefovir,10mg,daily,oral,Enecavir,0.5mg,daily,oral. **Name:** Telbivudine, Lamivudine, Adefovir ,Enecavir **Other Names:** - no. **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** No. **Measure:** Change from Baseline in glomerular filtration rate and Serum creatinine at 96 weeks **Time Frame:** May 2014 #### Secondary Outcomes **Description:** No. **Measure:** Change from Baseline in ALT normalization rate,• The rate of complications,• Percentage of participants with HBeAg loss & HBeAg seroconversion and Percentage of subjects achieving HBV DNA<300copies/mL at96 weeks **Time Frame:** May 2014 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Subjects eligible for enrolment in the study must meet all of the following criteria: * Aged between 18-75 years (inclusive). * Male or female. * Subjects with positive HBsAg for more than 6 months and anti-HBs negative regardless of HBeAg status , HBV DNA ≥2×103 IU/ml * Subjects with HBV-related liver cirrhosis, including compensated cirrhosis and decompensated, but only Child-Pugh A or B. * The ablility to understand and sign a written informed consent prior to any study related procedure and comply with the requirements of the study. Exclusion Criteria: * Subjects meeting any of the following criteria must not be enrolled in the study * Subjects with non-HBV cirrhosis * Co-infection with HAV/HCV/HDV/ HIV * Subjects who take nucleosides within 6 months * Kidney injury due to non-HBV factors * Inability to comply with study requirements as determined by the study investigator * Patients with very low GFR, who may need dialysis or renal transplantation **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000008107 - Term: Liver Diseases - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11103 - Name: Liver Cirrhosis - Relevance: HIGH - As Found: Liver Cirrhosis - ID: M8485 - Name: Fibrosis - Relevance: HIGH - As Found: Cirrhosis - 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 ### Condition Browse Module - Meshes - ID: D000008103 - Term: Liver Cirrhosis - ID: D000005355 - Term: Fibrosis ### Intervention Browse Module - Ancestors - 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: D000000998 - Term: Antiviral Agents - ID: D000000890 - Term: Anti-Infective Agents - 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 - Abbrev: Hemat - Name: Hematinics ### Intervention Browse Module - Browse Leaves - ID: M21243 - Name: Lamivudine - Relevance: HIGH - As Found: Plane - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown - ID: M4314 - Name: Antiviral Agents - Relevance: LOW - As Found: Unknown - ID: M219518 - Name: Adefovir - Relevance: HIGH - As Found: IV bolus - ID: M1879 - Name: Telbivudine - Relevance: HIGH - As Found: 3 times per day - ID: M20935 - Name: Reverse Transcriptase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - 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: D000019259 - Term: Lamivudine - ID: C000053001 - Term: Adefovir - ID: D000077712 - Term: Telbivudine ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05312879 **Acronym:** AMPLITUDE **Brief Title:** Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Proteinuric Kidney Disease Mediated Proteinuric Kidney Disease **Official Title:** A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Adult and Pediatric Subjects With APOL1-mediated Proteinuric Kidney Disease #### Organization Study ID Info **ID:** VX21-147-301 #### Organization **Class:** INDUSTRY **Full Name:** Vertex Pharmaceuticals Incorporated #### Secondary ID Infos **ID:** 2021-004762-35 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Start Date **Date:** 2022-03-30 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2022-04-06 **Type:** ACTUAL **Study First Submit Date:** 2022-03-28 **Study First Submit QC Date:** 2022-03-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Vertex Pharmaceuticals Incorporated #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease. ### Conditions Module **Conditions:** - Proteinuric Kidney Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 466 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will be randomized to receive different dose levels of VX-147. **Intervention Names:** - Drug: VX-147 **Label:** Phase 2: VX-147 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive placebo matched to VX-147. **Intervention Names:** - Drug: Placebo **Label:** Phase 2: Placebo **Type:** PLACEBO_COMPARATOR #### Arm Group 3 **Description:** Participants will receive VX-147 with the dose to be based on the outcome of Phase 2. **Intervention Names:** - Drug: VX-147 **Label:** Phase 3: VX-147 **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Participants will receive placebo matched to VX-147. **Intervention Names:** - Drug: Placebo **Label:** Phase 3: Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Phase 2: VX-147 - Phase 3: VX-147 **Description:** Tablets for oral administration. **Name:** VX-147 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Phase 2: Placebo - Phase 3: Placebo **Description:** Tablets for oral administration. **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Percent Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48 (Assessed at the Week 48 Interim Analysis) **Time Frame:** From Baseline at Week 48 **Measure:** Estimated Glomerular Filtration Rate (eGFR) Slope Assessed at the Week 48 Interim Analysis **Time Frame:** From Baseline Through >= Week 48 **Measure:** eGFR Slope Assessed at Study Completion **Time Frame:** From Baseline Through Study Completion (Approximately 2 Years After the Last Participant Enrolls) #### Secondary Outcomes **Measure:** Time to Composite Clinical Outcome of a Sustained Decline of >=30 Percent (%) in eGFR, the Onset of end-stage Kidney Disease or Death **Time Frame:** From Baseline Through Study Completion (Approximately 2 Years After the Last Participant Enrolls) **Measure:** Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs) **Time Frame:** Day 1 Through Study Completion (Approximately 2 Years After the Last Participant Enrolls) **Measure:** Maximum Plasma Concentration (Cmax) of VX-147 **Time Frame:** Day 1 and Week 40 **Measure:** Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-147 **Time Frame:** Day 1 and Week 40 **Measure:** Observed Pre-dose Plasma Concentration (Ctrough) of VX-147 **Time Frame:** Day 1 up to Week 40 **Measure:** Acceptability Tablet Formulation of VX-147 in Pediatric Participants using the Convenience Domain of the Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 **Time Frame:** Day 1 and Week 48 ### Eligibility Module **Eligibility Criteria:** Key Inclusion Criteria: * APOL1 genotype of G1/G1, G2/G2, or G1/G2 * Proteinuric kidney disease Key Exclusion Criteria: * Solid organ or bone marrow transplant * Uncontrolled hypertension * History of diabetes mellitus * Known underlying cause of kidney disease including but not limited to sickle cell disease Other protocol defined Inclusion/Exclusion criteria apply. **Maximum Age:** 65 Years **Minimum Age:** 10 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Medical Information **Phone:** 617-341-6777 **Role:** CONTACT #### Locations **Location 1:** **City:** Fairhope **Country:** United States **Facility:** Nephrology Associates **State:** Alabama **Status:** RECRUITING **Zip:** 36532 **Location 2:** **City:** Huntsville **Country:** United States **Facility:** Nephrology Consultants, LLC **State:** Alabama **Status:** RECRUITING **Zip:** 35805 **Location 3:** **City:** Mesa **Country:** United States **Facility:** AKDHC Medical Research Service LLC - Banner Desert Office **State:** Arizona **Status:** RECRUITING **Zip:** 85202 **Location 4:** **City:** Phoenix **Country:** United States **Facility:** AKDHC Medical Research Service LLC **State:** Arizona **Status:** WITHDRAWN **Zip:** 85016 **Location 5:** **City:** Little Rock **Country:** United States **Facility:** Cardiology and Medicine Clinic, P.A. **State:** Arkansas **Status:** RECRUITING **Zip:** 72204 **Location 6:** **City:** Little Rock **Country:** United States **Facility:** University of Arkansas for Medical Sciences **State:** Arkansas **Status:** RECRUITING **Zip:** 72205 **Location 7:** **City:** Fresno **Country:** United States **Facility:** The Medical Research Group, Inc **State:** California **Status:** RECRUITING **Zip:** 93720 **Location 8:** **City:** Granada Hills **Country:** United States **Facility:** Renal Consultants Medical Group **State:** California **Status:** RECRUITING **Zip:** 91344 **Location 9:** **City:** Los Angeles **Country:** United States **Facility:** Eastside Clinical Research Associates **State:** California **Status:** RECRUITING **Zip:** 90022 **Location 10:** **City:** Los Angeles **Country:** United States **Facility:** Kaiser Permanente - Los Angeles Medical Center **State:** California **Status:** RECRUITING **Zip:** 90027 **Location 11:** **City:** Los Angeles **Country:** United States **Facility:** Cedars-Sinai Medical Center **State:** California **Status:** RECRUITING **Zip:** 90048 **Location 12:** **City:** Los Angeles **Country:** United States **Facility:** UCLA Division of Nephrology **State:** California **Status:** RECRUITING **Zip:** 90095 **Location 13:** **City:** Orange **Country:** United States **Facility:** UCI Center for Clinical Research **State:** California **Status:** RECRUITING **Zip:** 92868 **Location 14:** **City:** Sacramento **Country:** United States **Facility:** Kaiser Permanente, Sacramento **State:** California **Status:** RECRUITING **Zip:** 95825 **Location 15:** **City:** San Francisco **Country:** United States **Facility:** UCSF School of Medicine **State:** California **Status:** RECRUITING **Zip:** 94143 **Location 16:** **City:** Torrance **Country:** United States **Facility:** Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center **State:** California **Status:** RECRUITING **Zip:** 90502 **Location 17:** **City:** Victorville **Country:** United States **Facility:** Kidney and Hypertension Center **State:** California **Status:** RECRUITING **Zip:** 92395 **Location 18:** **City:** Bloomfield **Country:** United States **Facility:** Greater Hartford Nephrology **State:** Connecticut **Status:** RECRUITING **Zip:** 06002 **Location 19:** **City:** Middlebury **Country:** United States **Facility:** Nephrology & Hypertension Associates, PC **State:** Connecticut **Status:** RECRUITING **Zip:** 06762 **Location 20:** **City:** New Haven **Country:** United States **Facility:** Yale University **State:** Connecticut **Status:** RECRUITING **Zip:** 06510 **Location 21:** **City:** Washington **Country:** United States **Facility:** Children's National Hospital **State:** District of Columbia **Status:** RECRUITING **Zip:** 20010 **Location 22:** **City:** Washington **Country:** United States **Facility:** The George Washington University Medical Faculty Associates - Kidney Disease & Hypertension **State:** District of Columbia **Status:** RECRUITING **Zip:** 20037 **Location 23:** **City:** Bay Pines **Country:** United States **Facility:** Bay Pines Healthcare System **State:** Florida **Status:** RECRUITING **Zip:** 33744 **Location 24:** **City:** Bradenton **Country:** United States **Facility:** Nova Clinical Research, LLC **State:** Florida **Status:** RECRUITING **Zip:** 34209 **Location 25:** **City:** Brandon **Country:** United States **Facility:** Clinical Research of Brandon, LLC **State:** Florida **Status:** RECRUITING **Zip:** 33511-5937 **Location 26:** **City:** Coral Gables **Country:** United States **Facility:** AMR-Miami **State:** Florida **Status:** RECRUITING **Zip:** 33134 **Location 27:** **City:** Coral Gables **Country:** United States **Facility:** Horizon Research Group, LLC **State:** Florida **Status:** RECRUITING **Zip:** 33134 **Location 28:** **City:** Coral Springs **Country:** United States **Facility:** South Florida Nephrology Group PA, Research Div. **State:** Florida **Status:** RECRUITING **Zip:** 33071 **Location 29:** **City:** Delray Beach **Country:** United States **Facility:** Delray Physician Care Center **State:** Florida **Status:** RECRUITING **Zip:** 33445 **Location 30:** **City:** Gainesville **Country:** United States **Facility:** North Florida/South Georgia Veterans Health System **State:** Florida **Status:** RECRUITING **Zip:** 32608 **Location 31:** **City:** Gainesville **Country:** United States **Facility:** University of Florida, Shands Hospital **State:** Florida **Status:** RECRUITING **Zip:** 32610 **Location 32:** **City:** Hallandale Beach **Country:** United States **Facility:** Velocity Clinical Research - Hallandale Beach **State:** Florida **Status:** RECRUITING **Zip:** 33009 **Location 33:** **City:** Hialeah **Country:** United States **Facility:** Qway Research **State:** Florida **Status:** RECRUITING **Zip:** 33010 **Location 34:** **City:** Hollywood **Country:** United States **Facility:** Elixia Pines, LLC **State:** Florida **Status:** COMPLETED **Zip:** 33024 **Location 35:** **City:** Lauderdale Lakes **Country:** United States **Facility:** South Florida Research Institute **State:** Florida **Status:** RECRUITING **Zip:** 33313 **Location 36:** **City:** Miami **Country:** United States **Facility:** Total Research Group, LLC **State:** Florida **Status:** RECRUITING **Zip:** 33126 **Location 37:** **City:** Miami **Country:** United States **Facility:** Cordova Research Institute **State:** Florida **Status:** RECRUITING **Zip:** 33155 **Location 38:** **City:** Miami **Country:** United States **Facility:** MedBio Trials **State:** Florida **Status:** WITHDRAWN **Zip:** 33180 **Location 39:** **City:** Orlando **Country:** United States **Facility:** Elixia Central **State:** Florida **Status:** RECRUITING **Zip:** 32806 **Location 40:** **City:** Orlando **Country:** United States **Facility:** Omega Research Orlando, LLC **State:** Florida **Status:** RECRUITING **Zip:** 32808 **Location 41:** **City:** Sanford **Country:** United States **Facility:** Mid Florida Kidney and Hypertension Care, PL **State:** Florida **Status:** RECRUITING **Zip:** 32771 **Location 42:** **City:** Tampa **Country:** United States **Facility:** Genesis Clinical Research **State:** Florida **Status:** COMPLETED **Zip:** 33603 **Location 43:** **City:** Tampa **Country:** United States **Facility:** Elixia Tampa, LLC **State:** Florida **Status:** ACTIVE_NOT_RECRUITING **Zip:** 33618 **Location 44:** **City:** Atlanta **Country:** United States **Facility:** Emory School of Medicine - Renal Division **State:** Georgia **Status:** RECRUITING **Zip:** 30308 **Location 45:** **City:** Atlanta **Country:** United States **Facility:** Advanced Clinical Research of Atlanta **State:** Georgia **Status:** RECRUITING **Zip:** 30309 **Location 46:** **City:** Atlanta **Country:** United States **Facility:** Morehouse School of Medicine, Grady Memorial Hospital **State:** Georgia **Status:** RECRUITING **Zip:** 30310 **Location 47:** **City:** Atlanta **Country:** United States **Facility:** Children's Healthcare of Atlanta - Center for Advanced Pediatrics **State:** Georgia **Status:** RECRUITING **Zip:** 30322 **Location 48:** **City:** Atlanta **Country:** United States **Facility:** Fides Clinical Research **State:** Georgia **Status:** RECRUITING **Zip:** 30342 **Location 49:** **City:** Augusta **Country:** United States **Facility:** Medical College of Georgia (MCG) **State:** Georgia **Status:** RECRUITING **Zip:** 30912-3140 **Location 50:** **City:** Brunswick **Country:** United States **Facility:** Coastal Medical Research **State:** Georgia **Status:** ACTIVE_NOT_RECRUITING **Zip:** 31520 **Location 51:** **City:** Columbus **Country:** United States **Facility:** Clincept - Warm Springs **State:** Georgia **Status:** RECRUITING **Zip:** 31904 **Location 52:** **City:** Columbus **Country:** United States **Facility:** Renal Associates, LLC **State:** Georgia **Status:** RECRUITING **Zip:** 31904 **Location 53:** **City:** Decatur **Country:** United States **Facility:** Atlanta VA Healthcare System **State:** Georgia **Status:** RECRUITING **Zip:** 30033 **Location 54:** **City:** East Point **Country:** United States **Facility:** Southeast Kidney Associates **State:** Georgia **Status:** RECRUITING **Zip:** 30344 **Location 55:** **City:** Fayetteville **Country:** United States **Facility:** Javara Inc./Privia Medical Group Georgia, PLLC **State:** Georgia **Status:** RECRUITING **Zip:** 30214 **Location 56:** **City:** Lawrenceville **Country:** United States **Facility:** Georgia Nephrology **State:** Georgia **Status:** RECRUITING **Zip:** 30046 **Location 57:** **City:** Savannah **Country:** United States **Facility:** Javara Inc./Privia Medical Group Georgia, LLC **State:** Georgia **Status:** RECRUITING **Zip:** 31406 **Location 58:** **City:** Tyrone **Country:** United States **Facility:** Inova Clinical Trials and Research Center **State:** Georgia **Status:** RECRUITING **Zip:** 30290 **Location 59:** **City:** Evergreen Park **Country:** United States **Facility:** NANI Research LLC **State:** Illinois **Status:** RECRUITING **Zip:** 60805 **Location 60:** **City:** Palos Hills **Country:** United States **Facility:** Essential Concepts Research Solutions **State:** Illinois **Status:** RECRUITING **Zip:** 60465 **Location 61:** **City:** Indianapolis **Country:** United States **Facility:** Indiana University **State:** Indiana **Status:** RECRUITING **Zip:** 46202 **Location 62:** **City:** Mishawaka **Country:** United States **Facility:** Nephrology Physicians, LLC **State:** Indiana **Status:** COMPLETED **Zip:** 46545 **Location 63:** **City:** Iowa City **Country:** United States **Facility:** University of Iowa **State:** Iowa **Status:** RECRUITING **Zip:** 52242 **Location 64:** **City:** Kansas City **Country:** United States **Facility:** University of Kansas Medical Center **State:** Kansas **Status:** RECRUITING **Zip:** 66160 **Location 65:** **City:** Overland Park **Country:** United States **Facility:** Premier Clinical Research **State:** Kansas **Status:** COMPLETED **Zip:** 66210 **Location 66:** **City:** Baton Rouge **Country:** United States **Facility:** Renal Associates of Baton Rouge **State:** Louisiana **Status:** RECRUITING **Zip:** 70808 **Location 67:** **City:** Metairie **Country:** United States **Facility:** East Jefferson General Hospital **State:** Louisiana **Status:** RECRUITING **Zip:** 70006 **Location 68:** **City:** New Orleans **Country:** United States **Facility:** Louisiana State University Health Sciences Center LSUHSC **State:** Louisiana **Status:** RECRUITING **Zip:** 70112 **Location 69:** **City:** New Orleans **Country:** United States **Facility:** University Medical Center - New Orleans **State:** Louisiana **Status:** RECRUITING **Zip:** 70112 **Location 70:** **City:** New Orleans **Country:** United States **Facility:** Ochsner Medical Center - New Orleans **State:** Louisiana **Status:** RECRUITING **Zip:** 70121 **Location 71:** **City:** Shreveport **Country:** United States **Facility:** Northwest Louisiana Nephrology, LLC - Shreveport **State:** Louisiana **Status:** RECRUITING **Zip:** 71101 **Location 72:** **City:** Annapolis **Country:** United States **Facility:** Javara Inc./Privia Medical Group, LLC MidAtlantic - Main Research Site **State:** Maryland **Status:** RECRUITING **Zip:** 21401 **Location 73:** **City:** Baltimore **Country:** United States **Facility:** University of Maryland Medical Center **State:** Maryland **Status:** COMPLETED **Zip:** 21201 **Location 74:** **City:** Baltimore **Country:** United States **Facility:** Johns Hopkins Hospital **State:** Maryland **Status:** RECRUITING **Zip:** 21287 **Location 75:** **City:** Gaithersburg **Country:** United States **Facility:** Kaiser Permanente, Mid-Atlantic **State:** Maryland **Status:** RECRUITING **Zip:** 20879 **Location 76:** **City:** Silver Spring **Country:** United States **Facility:** Javara Inc./Privia Medical Group, LLC MidAtlantic-Silver Spring, MD **State:** Maryland **Status:** RECRUITING **Zip:** 20901 **Location 77:** **City:** Boston **Country:** United States **Facility:** Tufts Medical Center **State:** Massachusetts **Status:** RECRUITING **Zip:** 02111 **Location 78:** **City:** Boston **Country:** United States **Facility:** Boston Medical Center **State:** Massachusetts **Status:** RECRUITING **Zip:** 02118 **Location 79:** **City:** Boston **Country:** United States **Facility:** Beth Israel Deaconess Medical Center **State:** Massachusetts **Status:** RECRUITING **Zip:** 02215 **Location 80:** **City:** Springfield **Country:** United States **Facility:** Renal and Transplant Associates of New England, PC **State:** Massachusetts **Status:** COMPLETED **Zip:** 01107 **Location 81:** **City:** West Springfield **Country:** United States **Facility:** Kidney Care and Transplant Services of New England **State:** Massachusetts **Status:** RECRUITING **Zip:** 01089 **Location 82:** **City:** Ann Arbor **Country:** United States **Facility:** University of Michigan Health System - A. Alfred Taubman Health Care Center - Nephrology Clinic **State:** Michigan **Status:** RECRUITING **Zip:** 48109 **Location 83:** **City:** Detroit **Country:** United States **Facility:** Henry Ford Hospital **State:** Michigan **Status:** RECRUITING **Zip:** 48202 **Location 84:** **City:** Flint **Country:** United States **Facility:** AA Medical Research Center **State:** Michigan **Status:** RECRUITING **Zip:** 48504 **Location 85:** **City:** Lansing **Country:** United States **Facility:** Sparrow Clinical Research Institute **State:** Michigan **Status:** RECRUITING **Zip:** 48912 **Location 86:** **City:** Roseville **Country:** United States **Facility:** St. Clair Nephrology Research **State:** Michigan **Status:** COMPLETED **Zip:** 48066 **Location 87:** **City:** Saint Clair Shores **Country:** United States **Facility:** Center for Advanced Kidney Research **State:** Michigan **Status:** RECRUITING **Zip:** 48081 **Location 88:** **City:** Edina **Country:** United States **Facility:** InterMed Consultants **State:** Minnesota **Status:** RECRUITING **Zip:** 55435 **Location 89:** **City:** Minneapolis **Country:** United States **Facility:** Minneapolis VA Healthcare System **State:** Minnesota **Status:** RECRUITING **Zip:** 55417 **Location 90:** **City:** Columbus **Country:** United States **Facility:** Nephrology Associates, P.C. **State:** Mississippi **Status:** RECRUITING **Zip:** 39705 **Location 91:** **City:** Grenada **Country:** United States **Facility:** University of Mississippi **State:** Mississippi **Status:** RECRUITING **Zip:** 38901 **Location 92:** **City:** Tupelo **Country:** United States **Facility:** Nephrology and Hypertension Associates, LTD **State:** Mississippi **Status:** RECRUITING **Zip:** 38801 **Location 93:** **City:** Saint Louis **Country:** United States **Facility:** Center for Specialized Medicine - SSM Health Saint Louis University Hospital **State:** Missouri **Status:** RECRUITING **Zip:** 63104 **Location 94:** **City:** Saint Louis **Country:** United States **Facility:** Washington University Saint Louis **State:** Missouri **Status:** RECRUITING **Zip:** 63130 **Location 95:** **City:** Saint Louis **Country:** United States **Facility:** St. Louis Heart and Vascular, P.C. **State:** Missouri **Status:** RECRUITING **Zip:** 63136 **Location 96:** **City:** Las Vegas **Country:** United States **Facility:** Nevada Kidney Disease and Hypertension Centers **State:** Nevada **Status:** WITHDRAWN **Zip:** 89106 **Location 97:** **City:** Las Vegas **Country:** United States **Facility:** DaVita Clinical Research **State:** Nevada **Status:** RECRUITING **Zip:** 89107 **Location 98:** **City:** Hackensack **Country:** United States **Facility:** Hackensack University Medical Center **State:** New Jersey **Status:** RECRUITING **Zip:** 07601 **Location 99:** **City:** Newark **Country:** United States **Facility:** Rutgers New Jersey Medical School **State:** New Jersey **Status:** RECRUITING **Zip:** 07103 **Location 100:** **City:** Albuquerque **Country:** United States **Facility:** New Mexico VA Healthcare System **State:** New Mexico **Status:** RECRUITING **Zip:** 87108 **Location 101:** **City:** Albuquerque **Country:** United States **Facility:** Renal Medicine Associates **State:** New Mexico **Status:** COMPLETED **Zip:** 87109 **Location 102:** **City:** Bronx **Country:** United States **Facility:** Albert Einstein Hospital - Montefiore Medical Center **State:** New York **Status:** RECRUITING **Zip:** 10461-1900 **Location 103:** **City:** Bronx **Country:** United States **Facility:** Kidney Medical Associates, PLLC **State:** New York **Status:** COMPLETED **Zip:** 10461 **Location 104:** **City:** Bronx **Country:** United States **Facility:** Montefiore Medical Center **State:** New York **Status:** RECRUITING **Zip:** 10467 **Location 105:** **City:** Bronx **Country:** United States **Facility:** James J. Peters VA Medical Center **State:** New York **Status:** RECRUITING **Zip:** 10468 **Location 106:** **City:** Brooklyn **Country:** United States **Facility:** SUNY Downstate Health Sciences University **State:** New York **Status:** RECRUITING **Zip:** 11203 **Location 107:** **City:** Flushing **Country:** United States **Facility:** Nephrology Associates, P.C. - Queens **State:** New York **Status:** RECRUITING **Zip:** 11365 **Location 108:** **City:** Great Neck **Country:** United States **Facility:** Zucker School of Medicine at Hofstra/Northwell **State:** New York **Status:** RECRUITING **Zip:** 11021 **Location 109:** **City:** Laurelton **Country:** United States **Facility:** Clinical Research Development Associates LLC **State:** New York **Status:** RECRUITING **Zip:** 11413 **Location 110:** **City:** New York **Country:** United States **Facility:** VA New York Harbor Healthcare System **State:** New York **Status:** RECRUITING **Zip:** 10010 **Location 111:** **City:** New York **Country:** United States **Facility:** New York University Grossman School of Medicine **State:** New York **Status:** RECRUITING **Zip:** 10016 **Location 112:** **City:** New York **Country:** United States **Facility:** The Rogosin Institute - The Rogosin Kidney Center **State:** New York **Status:** RECRUITING **Zip:** 10021 **Location 113:** **City:** New York **Country:** United States **Facility:** Icahn School of Medicine at Mount Sinai **State:** New York **Status:** RECRUITING **Zip:** 10029 **Location 114:** **City:** New York **Country:** United States **Facility:** Columbia University - Division of Nephrology **State:** New York **Status:** RECRUITING **Zip:** 10032 **Location 115:** **City:** New York **Country:** United States **Facility:** NYC Health + Hospital/Harlem **State:** New York **Status:** RECRUITING **Zip:** 10037 **Location 116:** **City:** Cary **Country:** United States **Facility:** North Carolina Nephrology P.A. - Cary Office **State:** North Carolina **Status:** RECRUITING **Zip:** 27511 **Location 117:** **City:** Chapel Hill **Country:** United States **Facility:** UNC Clinical and Translational Research Center **State:** North Carolina **Status:** RECRUITING **Zip:** 27599-7155 **Location 118:** **City:** Charlotte **Country:** United States **Facility:** Metrolina Nephrology Associates **State:** North Carolina **Status:** RECRUITING **Zip:** 28208 **Location 119:** **City:** Durham **Country:** United States **Facility:** DUHS Children's Health Center T0909 **State:** North Carolina **Status:** RECRUITING **Zip:** 27710 **Location 120:** **City:** Greenville **Country:** United States **Facility:** Eastern Nephrology Associates - Greenville Office **State:** North Carolina **Status:** RECRUITING **Zip:** 27834 **Location 121:** **City:** Jacksonville **Country:** United States **Facility:** Eastern Nephrology Associates - Jacksonville Office **State:** North Carolina **Status:** RECRUITING **Zip:** 28546 **Location 122:** **City:** Kinston **Country:** United States **Facility:** Eastern Nephrology Associates - Kinston Office **State:** North Carolina **Status:** RECRUITING **Zip:** 28504 **Location 123:** **City:** New Bern **Country:** United States **Facility:** Eastern Nephrology Associates - New Bern Office **State:** North Carolina **Status:** RECRUITING **Zip:** 28562 **Location 124:** **City:** Wilmington **Country:** United States **Facility:** Eastern Nephrology Associates - Wilmington Office **State:** North Carolina **Status:** RECRUITING **Zip:** 28401 **Location 125:** **City:** Winston-Salem **Country:** United States **Facility:** Brookview Hills Research Associates **State:** North Carolina **Status:** COMPLETED **Zip:** 27103 **Location 126:** **City:** Cincinnati **Country:** United States **Facility:** Cincinnati VA Medical Center **State:** Ohio **Status:** COMPLETED **Zip:** 45220 **Location 127:** **City:** Cleveland **Country:** United States **Facility:** University Hospitals Cleveland Medical Center **State:** Ohio **Status:** RECRUITING **Zip:** 44106 **Location 128:** **City:** Cleveland **Country:** United States **Facility:** Cleveland Clinic **State:** Ohio **Status:** RECRUITING **Zip:** 44195 **Location 129:** **City:** Columbus **Country:** United States **Facility:** Ohio State University **State:** Ohio **Status:** RECRUITING **Zip:** 43201 **Location 130:** **City:** Philadelphia **Country:** United States **Facility:** Thomas Jefferson University **State:** Pennsylvania **Status:** ACTIVE_NOT_RECRUITING **Zip:** 19107 **Location 131:** **City:** Philadelphia **Country:** United States **Facility:** Temple University Hospital **State:** Pennsylvania **Status:** RECRUITING **Zip:** 19140 **Location 132:** **City:** Philadelphia **Country:** United States **Facility:** Einstein Medical Center (NDKD) **State:** Pennsylvania **Status:** RECRUITING **Zip:** 19141 **Location 133:** **City:** Pittsburgh **Country:** United States **Facility:** Children's Hospital of Pittsburgh of UPMC **State:** Pennsylvania **Status:** RECRUITING **Zip:** 15224 **Location 134:** **City:** East Providence **Country:** United States **Facility:** Lifespan Clinical Research Center **State:** Rhode Island **Status:** RECRUITING **Zip:** 02915 **Location 135:** **City:** Charleston **Country:** United States **Facility:** Medical University of South Carolina **State:** South Carolina **Status:** RECRUITING **Zip:** 29425 **Location 136:** **City:** Columbia **Country:** United States **Facility:** Columbia Nephrology Associates, PA **State:** South Carolina **Status:** RECRUITING **Zip:** 29203 **Location 137:** **City:** Spartanburg **Country:** United States **Facility:** Carolina Nephrology, PA **State:** South Carolina **Status:** RECRUITING **Zip:** 29306 **Location 138:** **City:** Chattanooga **Country:** United States **Facility:** Southeast Renal Research Institute **State:** Tennessee **Status:** RECRUITING **Zip:** 37404 **Location 139:** **City:** Nashville **Country:** United States **Facility:** Meharry Medical College **State:** Tennessee **Status:** RECRUITING **Zip:** 37208 **Location 140:** **City:** Nashville **Country:** United States **Facility:** Vanderbilt University Medical Center, Nephrology Clinical Trials Center **State:** Tennessee **Status:** RECRUITING **Zip:** 37232 **Location 141:** **City:** Arlington **Country:** United States **Facility:** Dallas Renal Group - Arlington **State:** Texas **Status:** RECRUITING **Zip:** 76002 **Location 142:** **City:** Arlington **Country:** United States **Facility:** Arlington Nephrology **State:** Texas **Status:** COMPLETED **Zip:** 76015 **Location 143:** **City:** Dallas **Country:** United States **Facility:** Baylor Scott & White Research Institute **State:** Texas **Status:** RECRUITING **Zip:** 75204 **Location 144:** **City:** Dallas **Country:** United States **Facility:** Dallas Renal Group - 2 **State:** Texas **Status:** RECRUITING **Zip:** 75230 **Location 145:** **City:** Dallas **Country:** United States **Facility:** Nephrotex Research Group **State:** Texas **Status:** RECRUITING **Zip:** 75231 **Location 146:** **City:** Dallas **Country:** United States **Facility:** Dallas Renal Group - 1 **State:** Texas **Status:** RECRUITING **Zip:** 75237 **Location 147:** **City:** Dallas **Country:** United States **Facility:** Dallas Nephrology Associates - Dallas Landry Office **State:** Texas **Status:** RECRUITING **Zip:** 75246 **Location 148:** **City:** Dallas **Country:** United States **Facility:** UT Southwestern Medical Center **State:** Texas **Status:** RECRUITING **Zip:** 75390 **Location 149:** **City:** El Paso **Country:** United States **Facility:** Davita Clinical Research - El Paso **State:** Texas **Status:** RECRUITING **Zip:** 79925 **Location 150:** **City:** Fort Worth **Country:** United States **Facility:** Cook Children's Medical Center **State:** Texas **Status:** RECRUITING **Zip:** 76104 **Location 151:** **City:** Houston **Country:** United States **Facility:** Ronald Ralph MD PA **State:** Texas **Status:** RECRUITING **Zip:** 77054-2101 **Location 152:** **City:** Houston **Country:** United States **Facility:** Prolato Clinical Research Center **State:** Texas **Status:** RECRUITING **Zip:** 77054 **Location 153:** **City:** Houston **Country:** United States **Facility:** Houston Medical Research Institute, LLC **State:** Texas **Status:** COMPLETED **Zip:** 77074 **Location 154:** **City:** Houston **Country:** United States **Facility:** Clinical Research Strategies - Romano North Main Office **State:** Texas **Status:** COMPLETED **Zip:** 77090 **Location 155:** **City:** Houston **Country:** United States **Facility:** Southwest Houston Research, Ltd **State:** Texas **Status:** RECRUITING **Zip:** 77099 **Location 156:** **City:** Lewisville **Country:** United States **Facility:** North Texas Kidney Disease Associates **State:** Texas **Status:** RECRUITING **Zip:** 75057 **Location 157:** **City:** Lubbock **Country:** United States **Facility:** Texas Tech University Health Sciences Center **State:** Texas **Status:** RECRUITING **Zip:** 79430 **Location 158:** **City:** San Antonio **Country:** United States **Facility:** San Antonio Kidney **State:** Texas **Status:** WITHDRAWN **Zip:** 78229 **Location 159:** **City:** San Antonio **Country:** United States **Facility:** University of Texas Health San Antonio **State:** Texas **Status:** COMPLETED **Zip:** 78229 **Location 160:** **City:** San Antonio **Country:** United States **Facility:** San Antonio Kidney **State:** Texas **Status:** RECRUITING **Zip:** 78251 **Location 161:** **City:** Shenandoah **Country:** United States **Facility:** Kidney Specialists of N Houston, PLLC **State:** Texas **Status:** RECRUITING **Zip:** 77384 **Location 162:** **City:** The Woodlands **Country:** United States **Facility:** Renal Physicians of Montgomery County, PA **State:** Texas **Status:** RECRUITING **Zip:** 77384 **Location 163:** **City:** Webster **Country:** United States **Facility:** Tranquil Clinical Research **State:** Texas **Status:** RECRUITING **Zip:** 77598 **Location 164:** **City:** Charlottesville **Country:** United States **Facility:** University of Virginia Health - Nephrology Clinical Research Center **State:** Virginia **Status:** RECRUITING **Zip:** 22908 **Location 165:** **City:** Norfolk **Country:** United States **Facility:** TKS Research, P.L.L.C. **State:** Virginia **Status:** RECRUITING **Zip:** 23504 **Location 166:** **City:** Norfolk **Country:** United States **Facility:** York Clinical Research, LLC **State:** Virginia **Status:** RECRUITING **Zip:** 23504 **Location 167:** **City:** Richmond **Country:** United States **Facility:** Richmond VAMC **State:** Virginia **Status:** RECRUITING **Zip:** 23249 **Location 168:** **City:** Richmond **Country:** United States **Facility:** Virginia Commonwealth University - Division of Nephrology **State:** Virginia **Status:** RECRUITING **Zip:** 23298 **Location 169:** **City:** Virginia Beach **Country:** United States **Facility:** Nephrology Associates of Tidewater, LTD **State:** Virginia **Status:** COMPLETED **Zip:** 23454 **Location 170:** **City:** Seattle **Country:** United States **Facility:** University of Washington Medical Center **State:** Washington **Status:** RECRUITING **Zip:** 98195 **Location 171:** **City:** Wauwatosa **Country:** United States **Facility:** Milwaukee Nephrologists, SC **State:** Wisconsin **Status:** RECRUITING **Zip:** 53226 **Location 172:** **City:** Woluwe-Saint-Lambert **Country:** Belgium **Facility:** Cliniques Universitaires Saint-Luc **State:** Brussels **Status:** RECRUITING **Location 173:** **City:** Leuven **Country:** Belgium **Facility:** University Hospital Leuven **Status:** RECRUITING **Location 174:** **City:** Belo Horizonte **Country:** Brazil **Facility:** Santa Casa de Misericórdia de Belo Horizonte **Status:** RECRUITING **Location 175:** **City:** Curitiba **Country:** Brazil **Facility:** Instituto Pro-Renal **Status:** RECRUITING **Location 176:** **City:** Curitiba **Country:** Brazil **Facility:** PUC Trials - Unidade Epicenter **Status:** RECRUITING **Location 177:** **City:** Fortaleza **Country:** Brazil **Facility:** Hospital Universitário Valter Cantídio **Status:** RECRUITING **Location 178:** **City:** Goiania **Country:** Brazil **Facility:** Federal University of Goiás (UFG) **Status:** RECRUITING **Location 179:** **City:** Juiz de Fora **Country:** Brazil **Facility:** Cmip-Centro Mineiro de Pesquisa Ltda **Status:** RECRUITING **Location 180:** **City:** Juiz De Fora **Country:** Brazil **Facility:** Galileo Medical Research Ltda **Status:** RECRUITING **Location 181:** **City:** Porto Alegre **Country:** Brazil **Facility:** Irmandade da Santa Casa de Misericórdia de Porto Alegre **Status:** RECRUITING **Location 182:** **City:** Porto Alegre **Country:** Brazil **Facility:** UFRS - Hospital de Clínicas **Status:** RECRUITING **Location 183:** **City:** Ribeirao Preto **Country:** Brazil **Facility:** Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo **Status:** RECRUITING **Location 184:** **City:** Rio de Janeiro **Country:** Brazil **Facility:** Hospital São Lucas **Status:** RECRUITING **Location 185:** **City:** Rio de Janeiro **Country:** Brazil **Facility:** Hospital Universitário Pedro Ernesto **Status:** RECRUITING **Location 186:** **City:** Rio de Janeiro **Country:** Brazil **Facility:** Pedro Ernesto University Hospital **Status:** RECRUITING **Location 187:** **City:** Salvador **Country:** Brazil **Facility:** CSB Group of Nephrology Brazil **Status:** RECRUITING **Location 188:** **City:** Salvador **Country:** Brazil **Facility:** Federal University of Bahia **Status:** RECRUITING **Location 189:** **City:** São José do Rio Preto **Country:** Brazil **Facility:** Fundação Faculdade Regional de Medicina de São José do Rio Preto **Status:** RECRUITING **Location 190:** **City:** São Paulo **Country:** Brazil **Facility:** Hospital do Rim - Fundação Oswaldo Ramos - Ambulatorio NEFRITE **Status:** RECRUITING **Location 191:** **City:** São Paulo **Country:** Brazil **Facility:** University of Sao Paulo **Status:** RECRUITING **Location 192:** **City:** Montreal **Country:** Canada **Facility:** Recherche GCP Research **Status:** COMPLETED **Location 193:** **City:** Toronto **Country:** Canada **Facility:** Women's College Hospital **Status:** RECRUITING **Location 194:** **City:** Atlántico **Country:** Colombia **Facility:** Clinica de La Costa S.A.S **Status:** RECRUITING **Location 195:** **City:** Bogota **Country:** Colombia **Facility:** Solano & Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia - UNIENDO **Status:** RECRUITING **Location 196:** **City:** Cali **Country:** Colombia **Facility:** Fundación Valle Del Lili **Status:** RECRUITING **Location 197:** **City:** Cartagena **Country:** Colombia **Facility:** Centro Cardiovascular Aristides Sotomayor Santa Lucía SAS IPS **Status:** RECRUITING **Location 198:** **City:** Medellín **Country:** Colombia **Facility:** Fundación Hospitalaria San Vicente de Paul **Status:** RECRUITING **Location 199:** **City:** Créteil **Country:** France **Facility:** Hopital Henri Mondor **Status:** RECRUITING **Location 200:** **City:** Grenoble **Country:** France **Facility:** CHU Grenoble Alpes - Hôpital Nord Michallon **Status:** RECRUITING **Location 201:** **City:** Le Kremlin Bicêtre **Country:** France **Facility:** Hôpital Bicêtre AP-HP **Status:** RECRUITING **Location 202:** **City:** Limoges **Country:** France **Facility:** CHU Dupuytren 2 **Status:** RECRUITING **Location 203:** **City:** Marseille **Country:** France **Facility:** Hôpital de la Conception, Centre de néphrologie et transplantation rénale **Status:** RECRUITING **Zip:** 13385 **Location 204:** **City:** Paris **Country:** France **Facility:** Ambroise Paré Hospital **Status:** RECRUITING **Location 205:** **City:** Paris **Country:** France **Facility:** Hopitaux Universitaires Est Parisien - Hopital Tenon **Status:** RECRUITING **Location 206:** **City:** Paris **Country:** France **Facility:** Service de Nephrologie - Hopital Universitaire Necker **Status:** RECRUITING **Location 207:** **City:** Paris **Country:** France **Facility:** Université Paris-Descartes / Hôpital Européen Georges Pompidou **Status:** RECRUITING **Location 208:** **City:** Saint-Ouen **Country:** France **Facility:** AURA Nord Saint Ouen **Status:** RECRUITING **Location 209:** **City:** Toulouse **Country:** France **Facility:** Centre Hospitalier Universitaire CHU de Toulouse Hopital de Rangueil **Status:** RECRUITING **Location 210:** **City:** Accra **Country:** Ghana **Facility:** University of Ghana Medical School **Status:** RECRUITING **Location 211:** **City:** Cantonments **Country:** Ghana **Facility:** The Bank Hospital **Status:** RECRUITING **Location 212:** **City:** Kumasi **Country:** Ghana **Facility:** Komfo Anokye Teaching Hospital **Status:** RECRUITING **Location 213:** **City:** Amsterdam **Country:** Netherlands **Facility:** University of Amsterdam **Status:** COMPLETED **Location 214:** **City:** Amadora **Country:** Portugal **Facility:** Unidade Autónoma de Nefrologia **Status:** RECRUITING **Location 215:** **City:** Lisboa **Country:** Portugal **Facility:** Department of Nephrology and Renal Transplant **Status:** RECRUITING **Location 216:** **City:** Lisboa **Country:** Portugal **Facility:** Hospital Curry Cabral **Status:** RECRUITING **Location 217:** **City:** Loures **Country:** Portugal **Facility:** Hospital Beatriz Angelo **Status:** RECRUITING **Location 218:** **City:** Rio Piedras **Country:** Puerto Rico **Facility:** Alliance, School of Medicine **Status:** RECRUITING **Zip:** 00935 **Location 219:** **City:** San Juan **Country:** Puerto Rico **Facility:** GCM Medical Group, PSC **Status:** COMPLETED **Zip:** 00917 **Location 220:** **City:** Barcelona **Country:** Spain **Facility:** Hospital Clinic de Barcelona **Status:** RECRUITING **Location 221:** **City:** Barcelona **Country:** Spain **Facility:** Hospital Universitari Vall d'Hebron **Status:** RECRUITING **Location 222:** **City:** Córdoba **Country:** Spain **Facility:** Reina Sofia University Hospital **Status:** RECRUITING **Location 223:** **City:** Madrid **Country:** Spain **Facility:** Hospital Universitario 12 de Octubre **Status:** RECRUITING **Location 224:** **City:** Seville **Country:** Spain **Facility:** Hospital Universitario Virgen Macarena **Status:** RECRUITING **Location 225:** **City:** Birmingham **Country:** United Kingdom **Facility:** FutureMeds Birmingham **Status:** RECRUITING **Location 226:** **City:** Birmingham **Country:** United Kingdom **Facility:** University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital **Status:** RECRUITING **Location 227:** **City:** Carshalton **Country:** United Kingdom **Facility:** Epsom and St Helier University Hospitals NHS Trust - St Helier Hospital - South West SW Thames Institute for Renal Research **Status:** RECRUITING **Location 228:** **City:** Leicester **Country:** United Kingdom **Facility:** University Hospitals of Leicester NHS Trust - Leicester General Hospital **Status:** RECRUITING **Location 229:** **City:** London **Country:** United Kingdom **Facility:** Barts Health NHS Trust, The Royal London Hospital **Status:** RECRUITING **Location 230:** **City:** London **Country:** United Kingdom **Facility:** Guy's & St Thomas NHS Foundation Trust, Guy's Hospital **Status:** RECRUITING **Location 231:** **City:** London **Country:** United Kingdom **Facility:** Royal Free NHS Trust **Status:** RECRUITING **Location 232:** **City:** London **Country:** United Kingdom **Facility:** St George's University Hospitals NHS Foundation Trust **Status:** RECRUITING **Location 233:** **City:** Manchester **Country:** United Kingdom **Facility:** Manchester Royal Infirmary **Status:** RECRUITING **Location 234:** **City:** Manchester **Country:** United Kingdom **Facility:** The Medicines Evaluation Unit **Status:** RECRUITING **Location 235:** **City:** Nottingham **Country:** United Kingdom **Facility:** Nottingham University Hospital **Status:** RECRUITING **Location 236:** **City:** Southwark **Country:** United Kingdom **Facility:** King's College Hospital NHS Foundation Trust - Guthrie Clinic **Status:** RECRUITING ### IPD Sharing Statement Module **Description:** Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing **IPD Sharing:** NO ## 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: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Kidney Disease - 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 ### Condition Browse Module - Meshes - ID: D000007674 - Term: Kidney Diseases ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00246779 **Brief Title:** A Study of the Effect of Blinding in a Trial of Blood Filtration During Heart Surgery **Official Title:** Transfusion Reduction and Modified Ultrafiltration After Cardiopulmonary Bypass (TRAM Trial) - A Pilot Feasibility Trial #### Organization Study ID Info **ID:** Grant NA 5565 #### Organization **Class:** OTHER **Full Name:** Ottawa Heart Institute Research Corporation ### Status Module #### Completion Date **Date:** 2007-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-09-27 **Type:** ACTUAL **Last Update Submit Date:** 2019-09-25 **Overall Status:** COMPLETED #### Start Date **Date:** 2005-11 **Status Verified Date:** 2019-09 #### Study First Post Date **Date:** 2005-10-30 **Type:** ESTIMATED **Study First Submit Date:** 2005-10-27 **Study First Submit QC Date:** 2005-10-27 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Heart and Stroke Foundation of Ontario #### Lead Sponsor **Class:** OTHER **Name:** Ottawa Heart Institute Research Corporation ### Description Module **Brief Summary:** Cardiac surgery is a major consumer of blood products worldwide. The nature of the surgery when the heart-lung machine is used, is such that the patient's blood is significantly diluted by intravenous fluids. This dilution further compounds the blood's ability to form blood clots to seal the wound, thus increasing bleeding after surgery. The problem of this dilution is particularly severe in patients with low body weight, of whom a large percentage are women undergoing heart surgery. As a result, in this population there is an increased risk of needing a blood transfusion during and after surgery. The effects of this dilution can be potentially reversed by filtering the blood and removing the fluid after the principal part of the procedure has been completed through a process referred to as modified ultrafiltration (MUF). This procedure has been shown to be effective in several small clinical studies, however the interpretation of the results has been complicated by the fact that the studies were not "blinded". In other words, because the physicians and surgeons making the decisions about blood transfusions knew what treatment the patients received (i.e. MUF or not) it may have biased their judgement and affected the validity of the findings of the studies. The investigators believe that MUF may be a useful procedure to limit blood transfusions, particularly in patients of low body size, and weight undergoing heart surgery. This can only be demonstrated in a large clinical trial, and in the best case scenario, in a trial in which total blinding has been undertaken. However, blinding in this manner is quite difficult to achieve and it is necessary first to demonstrate that this is possible. Further, as the trial will involve several heart centers, it is essential to demonstrate that the relatively complex study interventions can be carried out in each of the centers in a reproducible manner. With this data in hand, the investigators will be able to submit for funding at a later date for a very large trial to determine if MUF decreases the need for blood transfusions in heart surgery patients. The investigators will also be able to determine the effect of this in terms of helping conserve blood as a benefit to the blood-banking agency (the Canadian Blood Service). **Detailed Description:** The demographic of the cardiac surgery population has progressively changed such that there is a greater proportion of older patients and females who by virtue of their co-morbidities and smaller average size have an increased risk of receiving blood products during and after surgery. Cardiopulmonary bypass (CPB) is the major contributing factor to this adverse event, as the technique is not only associated with coagulation and platelet abnormalities, but also by necessity, significant hemodilution as a consequence of the pump prime and the cardioplegia solution used to induce cardiac arrest. The hemodilution and the resultant decreased hematocrit (Hct) may trigger transfusion by the surgical team and there is evidence that platelet and coagulation function may be further compromised, resulting in worsening of postoperative bleeding. Modified ultrafiltration (MUF), a technique commonly utilized in pediatric cardiac surgery to reverse the effects of hemodilution after CPB, utilizes a circuit with an inflow attached to the aortic cannula, an ultrafiltration device, and outflow of the hemoconcentrated product directed back into the right atrium. Although MUF has been demonstrated to be effective at increasing the Hct, this technique has not received general acceptance as a blood conservation technology in the adult cardiac surgery population for several reasons. First, the necessary prolongation of the operative time with MUF may be perceived to be inconvenient by the operating staff and this may dissuade their use of this technique. Second, the results from the limited adult trials utilizing MUF, though positive in terms of blood conservation, have not shown changes of a magnitude that would routinely impact standard of care. It is possible that the perceived benefits of MUF in these trials have been less than impressive primarily due to the inclusion of patients at low risk of bleeding and the lack of blinding, thus contributing to the concern of treatment bias. Finally, none of these trials have been blinded and thus treatment bias may have contributed to the results. We believe that ultimately the use of MUF in this target population must be tested in a double-blind randomized controlled trial. However, the logistics of carrying out a trial of this magnitude must be established beforehand in a pilot trial that convincingly demonstrates the feasibility of blinding of this operative intervention, as well as the reproducibility of the model in several clinical centers. We are proposing to carry out a two phase multi-centre (University of Ottawa Heart Institute \[OHI\], Kingston General Hospital, Royal Victoria Hospital, University Hospital London) randomized controlled trial to evaluate the feasibility of an experimental model testing MUF versus a "sham" circuit in low-body weight (= 65 kg) patients at high risk to receive transfusion. In Phase I (n = 16 patients - 4 patients/center), the model will be optimized, and in Phase II (n = 64 patients - 16 patients/center) the project will be expanded and the blinding tested. The primary outcome will involve the success of blinding of the treating physicians (surgeon, anesthetist, and intensivist) in Phase II as measured by a novel Blinding Index. The information derived on the study model will be used to support a proposal in the subsequent definitive multi-center trial for which we will seek funding in the following year (n = 278/group). The primary outcome of the definitive trial will address the mean number of units of blood transfused in patients treated with or without MUF. There is also evidence in an animal model of the benefit of MUF to limit neurologic injury related to cardiac surgery. This aspect has not been assessed in a clinical model and therefore we intend to address this by evaluating the impact of MUF on early and late neurocognitive dysfunction related to CPB as a secondary outcome in the definitive trial. The proposed pilot and the definitive trial have the potential to address the role of MUF in adult cardiac surgery as a blood conservation technology. The potential application has significant implications as the procedure is inexpensive, easily teachable and physiologically sound. Further, it has very considerable relevance to women undergoing heart surgery due to their relative small body weight and increased current transfusion risk. As such, we believe that the magnitude of the findings from these trials will greatly impact current care in cardiac surgery worldwide. ### Conditions Module **Conditions:** - Heart Diseases **Keywords:** - transfusion - cardiac surgery - modified ultrafiltration - Cardiopulmonary bypass ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 78 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** Modified ultrafiltration **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** Success of intraoperative blinding as determined by Blinding Index #### Secondary Outcomes **Measure:** Compliance **Measure:** Screening and recruitment rates **Measure:** Confirmation of safety **Measure:** Establishing feasibility of multi-center approach **Measure:** Collection of data for power calculation of final trial **Measure:** Determination of frequency of anti-fibrinolytic use ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult cardiac surgery patients with weight ≤ 65 kg or body surface area (BSA) \< 1.7 m2 Exclusion Criteria: * Emergency surgery * Abciximab (Reopro™) use \< 7 days * Inability to obtain consent * Age \< 18 years * Patients undergoing off-pump surgery * Preoperative anemia **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Kingston **Country:** Canada **Facility:** Kingston General Hospital **State:** Ontario **Zip:** K7L 2V7 **Location 2:** **City:** London **Country:** Canada **Facility:** University Hospital **State:** Ontario **Zip:** N6A 5A5 **Location 3:** **City:** Ottawa **Country:** Canada **Facility:** University of Ottawa Heart Institute **State:** Ontario **Zip:** K1Y 4W7 **Location 4:** **City:** Montreal **Country:** Canada **Facility:** Royal Victoria Hospital **State:** Quebec **Zip:** H3A 1A1 #### Overall Officials **Official 1:** **Affiliation:** University of Ottawa **Name:** Fraser D Rubens, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University of Ottawa **Name:** Howard J. Nathan, MD **Role:** STUDY_CHAIR **Official 3:** **Affiliation:** University of Ottawa **Name:** Thierry Mesana, MD **Role:** STUDY_CHAIR **Official 4:** **Affiliation:** University of Ottawa **Name:** Phil Wells, MD **Role:** STUDY_CHAIR ### References Module #### References **Citation:** Boodhwani M, Hamilton A, de Varennes B, Mesana T, Williams K, Wells GA, Nathan H, Dupuis JY, Babaev A, Wells P, Rubens FD. A multicenter randomized controlled trial to assess the feasibility of testing modified ultrafiltration as a blood conservation technology in cardiac surgery. J Thorac Cardiovasc Surg. 2010 Mar;139(3):701-6. doi: 10.1016/j.jtcvs.2009.11.056. **PMID:** 20176212 #### See Also Links **Label:** Pubmed.gov link **URL:** https://www.ncbi.nlm.nih.gov/pubmed/20176212 ## Derived Section ### Condition Browse Module - Ancestors - 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: M9419 - Name: Heart Diseases - Relevance: HIGH - As Found: Heart Disease ### Condition Browse Module - Meshes - ID: D000006331 - Term: Heart Diseases ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04268979 **Brief Title:** Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator **Official Title:** Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator Intervention for Neuro-Oncology Couples #### Organization Study ID Info **ID:** MCC 19731 #### Organization **Class:** OTHER **Full Name:** H. Lee Moffitt Cancer Center and Research Institute ### Status Module #### Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-02 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-01 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-12 **Type:** ESTIMATED #### Start Date **Date:** 2020-02-13 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2020-02-13 **Type:** ACTUAL **Study First Submit Date:** 2020-02-11 **Study First Submit QC Date:** 2020-02-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** H. Lee Moffitt Cancer Center and Research Institute #### 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 determine if family caregivers of neuro-oncology patients feel less burdened by utilizing the Electronic Social Network Assessment Program (eSNAP) + the Caregiver Navigator. ### Conditions Module **Conditions:** - Brain Cancer **Keywords:** - Neuro Oncology ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 225 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** eSNAP intervention plus questionnaires **Intervention Names:** - Behavioral: eSNAP - Behavioral: Caregiver Navigator **Label:** eSNAP & Caregiver Navigator **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants randomly assigned to the waitlist control condition will only complete questionnaires during the 8-week study period. After the 8 weeks, they will then have access to the eSNAP, including completion of questionnaires and 8 weeks of Caregiver Navigator sessions as needed. **Label:** Waitlist Control Condition **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - eSNAP & Caregiver Navigator **Description:** eSNAP is a web based tool that quickly collects and organizes social support information entered by Family Caregivers (FCGs) into visualizations of the size, quality, and function of support networks. Visualizations can help FCGs catalogue support resources and present them in a new way, which may make them more salient and remind FCGs of their availability. **Name:** eSNAP **Other Names:** - Electronic Social Network Assessment Program **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - eSNAP & Caregiver Navigator **Description:** The Caregiver Navigator will have social work training and will help Family Caregivers (FCGs) identify and leverage informal and formal social support, including enrolling or directing FCGs to services. **Name:** Caregiver Navigator **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Caregiver well being will be measured using the Generalized Anxiety Disorder 7 Item Scale (GAD-7). The GAD-7 measures anxiety scoring 0-3 points per item, with a total score range 0-21,with a higher score meaning more anxiety. **Measure:** Family Caregiver Well-Being Using GAD-7 Scale **Time Frame:** 8 weeks per participant **Description:** Caregiver well being will be measured using the Personal Health Questionnaire Depression 8 Item Scale Scale (PHQ 8). The PHQ 8 measures depression scoring 0-3 points per item, with a total score range of 0-24, with the higher score meaning more depression. **Measure:** Family Caregiver Well-Being using PHQ-8 Scale **Time Frame:** 8 weeks per participant **Description:** Caregiver well being will be measured using the Zarit Burden Interview. The Zarit Burden Interview measures burden scoring 0-4 points per item, with a total score range of 0-48, with the higher score meaning more burden. **Measure:** Family Caregiver Well-Being Using Zarit Burden Interview **Time Frame:** 8 weeks per participant **Description:** Neuro patients well being will be measured using the Generalized Anxiety Disorder 7 Item Scale (GAD-7). The GAD-7 measures anxiety scoring 0-3 points per item, with a total score range 0-21,with a higher score meaning more anxiety. **Measure:** Neuro Patients Well-Being Using GAD-7 Scale **Time Frame:** 8 weeks per participant **Description:** Neuro patients well being will be measured using the Personal Health Questionnaire Depression 8 Item Scale Scale (PHQ 8). The PHQ 8 measures depression scoring 0-3 points per item, with a total score range of 0-24, with the higher score meaning more depression. **Measure:** Neuro Patients Well-Being using PHQ-8 Scale **Time Frame:** 8 weeks per participant **Description:** Neuro patients well being will be measured using Neuro-Qol (Neuro Quality of Life) which will be using T scores where the lower values represent worse outcomes. **Measure:** Neuro Patients Well-Being using NeuroQol **Time Frame:** 8 weeks per participant ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * English-speaking/reading/writing * Able to complete questionnaires (including by proxy) * Family Caregivers (FCGs) must self-identify as being a primary FCG of a patient with a primary brain tumor, secondary (metastatic) brain tumor, or leptomeningeal disease diagnosis. A primary caregiver is a family member, friend, or other unpaid person who provides at least some care for a patient at home. * Patients must be diagnosed with new or recurrent primary brain tumor, a secondary (metastatic) brain tumor or leptominingeal disease within the last 9 months, receiving at least some evaluation and/or care at Moffitt (i.e. at least one appointment), have a prognosis of at least 9 months Exclusion Criteria: * Patients may not participate without a consenting FCG, but FCGs may participate without a consenting patient * Patients and FCGs who are experiencing acute distress will be excluded from enrollment and referred directly to social work, per Moffitt policy. **Healthy Volunteers:** True **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Deanna Witte **Phone:** 813-745-2875 **Role:** CONTACT #### Locations **Location 1:** **City:** Tampa **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Margaret Byrne, PhD - **Phone:** 813-745-5569 - **Role:** CONTACT ***Contact 2:*** - **Name:** Margaret Byrne, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Peter Forsyth, MD - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** Moffitt Cancer Center **State:** Florida **Status:** RECRUITING **Zip:** 33612 #### Overall Officials **Official 1:** **Affiliation:** Moffitt Cancer Center **Name:** Margaret Byrne, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Reblin M, Ketcher D, McCormick R, Barrios-Monroy V, Sutton SK, Zebrack B, Wells KJ, Sahebjam S, Forsyth P, Byrne MM. A randomized wait-list controlled trial of a social support intervention for caregivers of patients with primary malignant brain tumor. BMC Health Serv Res. 2021 Apr 17;21(1):360. doi: 10.1186/s12913-021-06372-w. **PMID:** 33865382 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000016543 - Term: Central Nervous System Neoplasms - ID: D000009423 - Term: Nervous System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5209 - Name: Brain Neoplasms - Relevance: HIGH - As Found: Brain Cancer - 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 ### Condition Browse Module - Meshes - ID: D000001932 - Term: Brain Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00129779 **Brief Title:** Assessment of the Effects of an Intermediate Care Package in Preventing Hospitalisation of Patients With COPD **Official Title:** A Randomised Control Trial Assessing the Effects of an Intermediate Care Package in Preventing Hospitalisation of Elderly Patients With Chronic Obstructive Pulmonary Disease (COPD) #### Organization Study ID Info **ID:** NHLICX3038 #### Organization **Class:** OTHER **Full Name:** Imperial College London ### Status Module #### Completion Date **Date:** 2006-08 #### Expanded Access Info #### Last Update Post Date **Date:** 2015-06-08 **Type:** ESTIMATED **Last Update Submit Date:** 2015-06-04 **Overall Status:** COMPLETED #### Start Date **Date:** 2003-12 **Status Verified Date:** 2008-05 #### Study First Post Date **Date:** 2005-08-12 **Type:** ESTIMATED **Study First Submit Date:** 2005-08-11 **Study First Submit QC Date:** 2005-08-11 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** The Health Foundation #### Lead Sponsor **Class:** OTHER **Name:** Imperial College London ### Description Module **Brief Summary:** Chronic obstructive pulmonary disease (COPD) is a term used for the conditions of chronic bronchitis and emphysema, diseases that are very common among the elderly and diseases that account for up to15% of all general medical admissions to National Health Service Hospitals. In a recent report on emergency admissions to acute hospitals in London, the King's Fund concluded that taking better care of elderly patients with COPD could reduce pressures on acute hospitals, and suggested that identification of vulnerable patients with lung disease and "pro-active," rather than "reactive," management might reduce the chances of hospitalisation. In this study, the investigators wish to compare a group of patients with COPD who are managed in the normal way, with another group of patients with COPD who receive all interventions known to be of some benefit to those with this condition. This will include a pulmonary rehabilitation programme, intensive education regarding self care, targeted advice to their general practitioners regarding how best to manage COPD, and regular contact with specialist respiratory nurses who will support the patients in their own homes by a combination of home visits and telephone contact. The value of such a comprehensive intervention will be studied, in terms of both its ability to reduce admissions to the hospital and its impact on quality of life. **Detailed Description:** One hundred twenty-two patients over the age of 50 with COPD, admitted to Charing Cross Hospital in 2000-2004 with an acute exacerbation of their condition will be recruited and randomised to routine and opportunistic care (n= 61) vs study care package (n=61) for 2 years. The patients randomised to the study package will take part in an initial pulmonary rehabilitation programme of 8 sessions of physical therapy and education (2 sessions a week for 4 weeks). Health related quality of life will be measured in the intervention and routine care groups using validated instruments (SF-36 and Canadian Respiratory Diseases Questionnaire). This will be followed by a baseline home visit and assessment from an experienced specialist respiratory nurse (Grade G), followed by monthly telephone calls and a home visit every 3 months. Each interview and visit will be a structured intervention addressing specific issues related to the management of COPD, with four possible specific outcomes including history taking; measurement of vital signs; discussion of treatment; appropriate vaccination and discussing and reinforcing self-management education. At the end of the 2 year study period the routine care and intervention groups will be compared for the following outcomes: number of admissions to hospital for exacerbations of COPD; number of unplanned visits to a general practitioner (with those initiated by study nurse identified separately); measures of quality of life (SF-36; CRDQ). ### Conditions Module **Conditions:** - COPD **Keywords:** - COPD ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE #### Enrollment Info **Count:** 122 **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** Intermediate care package **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Measure:** Number of hospital admissions for exacerbations of COPD #### Secondary Outcomes **Measure:** Number of unplanned visits to a general practitioner **Measure:** Measures of quality of life (SF-36; Canadian Respiratory Disease Questionnaire [CRDQ]) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients over the age of 50 with COPD * Admitted to Charing Cross Hospital in 2000-2004 with an acute exacerbation of COPD Exclusion Criteria: * Significant co-morbidity including severe heart disease and cancer * Any condition that would preclude participation in the physical therapy component of a pulmonary rehabilitation programme, including musculoskeletal diseases **Maximum Age:** 90 Years **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** London **Country:** United Kingdom **Facility:** Respiratory Medicine, NHLI at Charing Cross Hospital **Zip:** W6 8RF #### Overall Officials **Official 1:** **Affiliation:** Imperial College London **Name:** Martyn R Partridge, MD FRCP **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** The burden of lung disease. British Thoracic Society, London, 2001. **Citation:** King's Fund report - 'Managing the pressure' by Michael Damiani and Jennifer Dixon. King's Fund, London 2002 **Citation:** Gravil JH, Al-Rawas OA, Cotton MM, Flanigan U, Irwin A, Stevenson RD. Home treatment of exacerbations of chronic obstructive pulmonary disease by an acute respiratory assessment service. Lancet. 1998 Jun 20;351(9119):1853-5. doi: 10.1016/s0140-6736(97)11048-0. **PMID:** 9652670 **Citation:** Cockcroft A, Bagnall P, Heslop A, Andersson N, Heaton R, Batstone J, Allen J, Spencer P, Guz A. Controlled trial of respiratory health worker visiting patients with chronic respiratory disability. Br Med J (Clin Res Ed). 1987 Jan 24;294(6566):225-8. doi: 10.1136/bmj.294.6566.225. **PMID:** 3101821 **Citation:** Lacasse Y, Wong E, Guyatt GH, King D, Cook DJ, Goldstein RS. Meta-analysis of respiratory rehabilitation in chronic obstructive pulmonary disease. Lancet. 1996 Oct 26;348(9035):1115-9. doi: 10.1016/S0140-6736(96)04201-8. **PMID:** 8888163 **Citation:** British Thoracic Society Standards of Care Subcommittee on Pulmonary Rehabilitation. Pulmonary rehabilitation. Thorax. 2001 Nov;56(11):827-34. doi: 10.1136/thorax.56.11.827. No abstract available. **PMID:** 11641505 **Citation:** Parrott S, Godfrey C, Raw M, West R, McNeill A. Guidance for commissioners on the cost effectiveness of smoking cessation interventions. Thorax. 1998 Dec;53 Suppl 5 Pt 2(Suppl 5):S1-38. No abstract available. **PMID:** 10226676 **Citation:** Raw M, McNeill A, Watt J, Raw D. National smoking cessation services at risk. BMJ. 2001 Nov 17;323(7322):1140-1. doi: 10.1136/bmj.323.7322.1140. No abstract available. **PMID:** 11711385 **Citation:** Gallefoss F, Bakke PS. Impact of patient education and self-management on morbidity in asthmatics and patients with chronic obstructive pulmonary disease. Respir Med. 2000 Mar;94(3):279-87. doi: 10.1053/rmed.1999.0749. **PMID:** 10783940 **Citation:** BTS guidelines for the management of chronic obstructive pulmonary disease. The COPD Guidelines Group of the Standards of Care Committee of the BTS. Thorax. 1997 Dec;52 Suppl 5(Suppl 5):S1-28. No abstract available. **PMID:** 9474238 **Citation:** Pauwels RA, Buist AS, Calverley PM, Jenkins CR, Hurd SS; GOLD Scientific Committee. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) Workshop summary. Am J Respir Crit Care Med. 2001 Apr;163(5):1256-76. doi: 10.1164/ajrccm.163.5.2101039. No abstract available. **PMID:** 11316667 **Citation:** Sridhar M, Taylor R, Dawson S, Roberts NJ, Partridge MR. A nurse led intermediate care package in patients who have been hospitalised with an acute exacerbation of chronic obstructive pulmonary disease. Thorax. 2008 Mar;63(3):194-200. doi: 10.1136/thx.2007.077578. Epub 2007 Sep 27. **PMID:** 17901162 ## Annotation Section ### Unposted Annotation #### Event: RELEASE - Date: 2020-01-08 - Date Unknown: Unknown #### Event: RESET - Date: 2020-01-17 - Date Unknown: Unknown #### Event: RELEASE - Date: 2020-01-17 - Date Unknown: Unknown #### Event: RESET - Date: 2020-01-28 - Date Unknown: Unknown ## Derived Section ### 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: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M23449 - Name: Pulmonary Disease, Chronic Obstructive - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Misc Info Module #### Submission Tracking - Estimated Results First Submit Date: 2020-01-08 ##### Submission Infos - MCP Release N: Unknown - Release Date: 2020-01-08 - Reset Date: 2020-01-17 - Unrelease Date: Unknown - Unrelease Date Unknown: Unknown - MCP Release N: Unknown - Release Date: 2020-01-17 - Reset Date: 2020-01-28 - Unrelease Date: Unknown - Unrelease Date Unknown: Unknown - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00415779 **Acronym:** ZANTE **Brief Title:** ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer **Official Title:** Phase I Study of the Combination of Zoledronic Acid and Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer #### Organization Study ID Info **ID:** ZANTE #### Organization **Class:** OTHER **Full Name:** National Cancer Institute, Naples #### Secondary ID Infos **ID:** EUDRACT 2006-000426-31 ### Status Module #### Completion Date **Date:** 2009-07 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2010-02-24 **Type:** ESTIMATED **Last Update Submit Date:** 2010-02-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2008-12 **Type:** ACTUAL #### Start Date **Date:** 2006-07 **Status Verified Date:** 2010-02 #### Study First Post Date **Date:** 2006-12-25 **Type:** ESTIMATED **Study First Submit Date:** 2006-12-22 **Study First Submit QC Date:** 2006-12-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** National Cancer Institute, Naples #### Responsible Party **Old Name Title:** Francesco Perrone, Director Clinical Trials Unit **Old Organization:** National Cancer Institute Naples, Italy ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This phase I trial is studying the side effects and best dose of docetaxel when given with zoledronic acid in patients with bone metastasis from prostate cancer that has not responded to hormone therapy. **Detailed Description:** Docetaxel has been used alone and in combination with other anti-cancer therapies in the treatment of hormone refractory metastatic prostate cancer. Zoledronic acid has been used in the treatment of bone metastasis from prostate cancer. This is a study of the combination of these two agents. The Zante study will test a dose escalation of docetaxel in association with a predetermined dose of zoledronic acid (2 mg), given every 14 days for a minimum of 6 and maximum of 12 cycles. Sequence A: Docetaxel on day 1 and zoledronic acid on day 2 Sequence B: Zoledronic acid on day 1 and docetaxel on day 2 Patients are enrolled sequentially in cohorts of 3 for each dose level, and a maximum of 36 patients will be enrolled. ### Conditions Module **Conditions:** - Metastatic Prostate Cancer **Keywords:** - hormone refractory - bone metastasis - chemotherapy - biphosphonates ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** given IV in subsequent cohorts of patients at 30, 40, or 50mg/m2 **Name:** docetaxel **Type:** DRUG #### Intervention 2 **Description:** 2 mg IV every 2 weeks **Name:** zoledronic acid **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** to determine the maximum tolerated dose and dose limiting toxicity of docetaxel in the two treatment schedules **Time Frame:** every 2 weeks for up to 3 cycles #### Secondary Outcomes **Measure:** to determine the recommended docetaxel dose when combined with zoledronic acid for phase II studies **Time Frame:** every 2 weeks for 6 cycles **Measure:** to determine which administration sequence of the combination permits a higher dosage of docetaxel **Time Frame:** every 2 weeks for 6 weeks **Measure:** to describe the toxicity of the combination of the two drugs **Time Frame:** every 2 weeks **Measure:** to describe the effects of the combination of the two drugs on biologic parameters: angiogenetic factors, cytokines, differential neuroendocrine markers, serum markers of osteolysis **Time Frame:** every 12 weeks **Measure:** to describe the antitumor activity of the two drug association **Time Frame:** every 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Written informed consent * Hormone refractory prostate cancer * Stage IV disease with bone metastasis * No immunotherapy, hormonal therapy or radiotherapy within the previous month * Performance status \< or = 2 (ECOG) * Serum creatinine \< 1.5 mg/100ml * Serum bilirubin \< or = 1.25 x UNL (upper normal limit) (or \< or = 1.5 x UNL in the presence of hepatic metastases); SGOT e SGPT \< or = 1.5 x UNL (or \< or = 2.5 x UNL in presence of hepatic metastases) * Left ventricular ejection fraction \> or = 50% (measured by cardiac ultrasound or MUGA scan) * Neutrophils \> 1500/mm3; platelets \>100000/mm3; hemoglobin \>10 g/100 ml· Life expectancy of at least 3 months Exclusion Criteria: * Previous malignancies with the exception of radically treated epithelioma * Previous chemotherapy * Comorbidities that would, in the Investigator's opinion, contraindicate the use of the drugs in the study * Uncontrolled Diabetes * Severe cardiac arrhythmias, severe uncontrolled congestive heart failure, severe ischemic cardiac disease or myocardial infarction within the previous 6 months * severe infection * cerebral metastasis * Pre-existing motor or sensory neurotoxicity \> or = grade 2 according to CTC (Common Toxicity Criteria). **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Napoli **Country:** Italy **Facility:** Istituto Nazionale dei Tumori **Zip:** 80131 **Location 2:** **City:** Rionero in Vulture **Country:** Italy **Facility:** Ospedale Oncologico Regionale C.R.O.B. - Basilicata #### Overall Officials **Official 1:** **Affiliation:** Experimental Pharmacology, National Cancer Institute Naples **Name:** Michele Caraglia, M.D. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Experimental Pharmacology, National Cancer Institute Naples **Name:** Alfredo Budillon, M.D. **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** National Cancer Institute Naples, Italy; Director Clinical Trials Unit **Name:** Francesco Perrone, M.D., Ph.D **Role:** PRINCIPAL_INVESTIGATOR **Official 4:** **Affiliation:** Medical Oncology B, National Cancer Institute Naples **Name:** R. Vincenzo Iaffaioli, M.D **Role:** PRINCIPAL_INVESTIGATOR **Official 5:** **Affiliation:** Medical Oncology B, National Cancer Institute Naples **Name:** Gaetano Facchini, M.D. **Role:** PRINCIPAL_INVESTIGATOR **Official 6:** **Affiliation:** Clinical Trials Unit, National Cancer Institute Naples **Name:** Alessandro Morabito, M.D. **Role:** PRINCIPAL_INVESTIGATOR ## 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: M12307 - Name: Neoplasm Metastasis - 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 - Ancestors - 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: D000050071 - Term: Bone Density Conservation Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: BDCA - Name: Bone Density Conservation Agents ### Intervention Browse Module - Browse Leaves - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M1668 - Name: Docetaxel - Relevance: HIGH - As Found: Physical - ID: M1699 - Name: Zoledronic Acid - Relevance: HIGH - As Found: Lymphoblastic - ID: M7346 - Name: Diphosphonates - 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 ### Intervention Browse Module - Meshes - ID: D000077211 - Term: Zoledronic Acid - ID: D000077143 - Term: Docetaxel ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02183779 **Acronym:** REFRAIN **Brief Title:** PORH and Response to Cold in Raynaud's Phenomenon. **Official Title:** Rôle Des Acides Epoxy-eicosatriénoïques et du Monoxyde d'Azote Dans l'hyperhémie Post-occlusive cutanée Digitale et la réponse cutanée au Froid Dans le phénomène de Raynaud Primaire #### Organization Study ID Info **ID:** DCIC 14 02 #### Organization **Class:** OTHER **Full Name:** University Hospital, Grenoble ### Status Module #### Completion Date **Date:** 2017-06 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2015-12-09 **Type:** ESTIMATED **Last Update Submit Date:** 2015-12-08 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2016-10 **Type:** ESTIMATED #### Start Date **Date:** 2014-06 **Status Verified Date:** 2015-12 #### Study First Post Date **Date:** 2014-07-08 **Type:** ESTIMATED **Study First Submit Date:** 2014-07-01 **Study First Submit QC Date:** 2014-07-02 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Grenoble #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The main objective of the study is to determine if implication of epoxy-eicosatriénoïc acids (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with Raynaud phenomena and healthy volunteers, by studying hyperaemic postocclusive response after microinjection of fluconazole and L-NMMA at the dorsal side of the fingers. **Detailed Description:** The main objective of the study is to determine if implication of epoxy-eicosatriénoïques acids (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with Raynaud phenomena and healthy volunteers, by studying hyperaemic postocclusive response after microinjection of fluconazole and L-NMMA at the dorsal side of the fingers. Healthy controls and patients will undergo 3 visits ### Conditions Module **Conditions:** - Raynaud Disease - Hyperemia - Cold **Keywords:** - post-occlusive hyperaemia - laser-speckle contrast imaging - epoxyeicosatrienoic acid - nitrous oxide ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** patients with reynaud phenomena **Intervention Names:** - Procedure: post-occlusive hyperemia - Procedure: cooling box - Drug: L-NMMA and Fluconazole dermic injection **Label:** Reynaud **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Healthy volunteers **Intervention Names:** - Procedure: post-occlusive hyperemia - Procedure: cooling box - Drug: L-NMMA and Fluconazole dermic injection **Label:** Healthy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Healthy - Reynaud **Name:** post-occlusive hyperemia **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Healthy - Reynaud **Name:** cooling box **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Healthy - Reynaud **Name:** L-NMMA and Fluconazole dermic injection **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** post-occlusive hyperemia amplitude (maximal amplitude in % of maximal vasodilatation and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) **Measure:** post occlusive hyperemia amplitude **Time Frame:** day 1 #### Secondary Outcomes **Description:** post-occlusive hyperemia amplitude (maximal amplitude in % of maximal vasodilatation and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) treated with anesthetic **Measure:** post occlusive hyperemia amplitude with anesthetic treatment **Time Frame:** day1 **Description:** cold-induced vasoconstriction amplitude (maximal amplitude in % of basal and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) **Measure:** cold-induced vasoconstriction amplitude **Time Frame:** day 2 **Description:** cold-induced vasoconstriction amplitude (maximal amplitude in % of basal and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) with anesthetic local treatment **Measure:** cold-induced vasoconstriction amplitude with anesthetic treatment **Time Frame:** day 2 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Neither raynaud's phenomenon or chronic disease for healthy volunteers * Raynaud's phenomenon without connective tissue disease for patients in the group "Raynaud" Exclusion Criteria: * History of axillary dissection , trauma or surgery * History of thromboembolic disease or thrombophilia * Minor or law-protected major * Exclusion period in another study * No affiliation to medicare * Pregnant, parturient or breasting woman * Concomitant serious disease: progressive cancer, liver failure, history of myocardial infarction less than 5 years, angor * Smoking in the 6 last months * Person deprived of liberty by a legal or administrative decision, person under legal protection * Maximal annual indemnification reached. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jean-Luc CRACOWSKI, MD-PhD **Phone:** +33476769260 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Matthieu ROUSTIT, PharmD-PhD **Phone:** +33476769260 **Role:** CONTACT #### Locations **Location 1:** **City:** GRENOBLE cedex9 **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jean-Luc CRACOWSKI, MD-PhD - **Phone:** 33476769260 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** PARIS Adeline, PharmD-PhD - **Phone:** 33476767383 - **Role:** CONTACT ***Contact 3:*** - **Name:** Jean-Luc CRACOWSKI, MD-PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Centre d'investigation clinique CIC1406 **Status:** RECRUITING **Zip:** 38043 #### Overall Officials **Official 1:** **Affiliation:** INSERM + University Hospital Grenoble **Name:** Jean-Luc CRACOWSKI, MD-PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000090122 - Term: Livedoid Vasculopathy - ID: D000013927 - Term: Thrombosis - ID: D000016769 - Term: Embolism and Thrombosis - ID: D000016491 - Term: Peripheral Vascular Diseases - ID: D000017445 - Term: Skin Diseases, Vascular - ID: D000012871 - Term: Skin 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: BC14 - Name: Heart and Blood Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M9991 - Name: Hyperemia - Relevance: HIGH - As Found: Hyperemia - ID: M14772 - Name: Raynaud Disease - Relevance: HIGH - As Found: Raynaud's Disease - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M2750 - Name: Livedoid Vasculopathy - Relevance: LOW - As Found: Unknown - ID: M16686 - Name: Thrombosis - Relevance: LOW - As Found: Unknown - ID: M7784 - Name: Embolism - Relevance: LOW - As Found: Unknown - ID: M19128 - Name: Embolism and Thrombosis - Relevance: LOW - As Found: Unknown - ID: M29213 - Name: Peripheral Arterial Disease - Relevance: LOW - As Found: Unknown - ID: M18894 - Name: Peripheral Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M19714 - Name: Skin Diseases, Vascular - Relevance: LOW - As Found: Unknown - ID: T3486 - Name: Livedoid Vasculopathy - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006940 - Term: Hyperemia - ID: D000011928 - Term: Raynaud Disease ### Intervention Browse Module - Ancestors - ID: D000000935 - Term: Antifungal Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000058888 - Term: 14-alpha Demethylase Inhibitors - ID: D000065607 - Term: Cytochrome P-450 Enzyme Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000065088 - Term: Steroid Synthesis Inhibitors - ID: D000006727 - Term: Hormone Antagonists - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000065688 - Term: Cytochrome P-450 CYP2C9 Inhibitors - ID: D000065689 - Term: Cytochrome P-450 CYP2C19 Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: Resp - Name: Respiratory System Agents ### Intervention Browse Module - Browse Leaves - ID: M12546 - Name: Nitrous Oxide - Relevance: LOW - As Found: Unknown - ID: M18296 - Name: Fluconazole - Relevance: HIGH - As Found: Acute Lymphoblastic Leukemia - ID: M12507 - Name: Nitric Oxide - Relevance: LOW - As Found: Unknown - ID: M21301 - Name: omega-N-Methylarginine - 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: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M30537 - Name: Cytochrome P-450 Enzyme Inhibitors - 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: D000015725 - Term: Fluconazole ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00092079 **Brief Title:** A Study of MK0217A and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227) **Official Title:** A 15-Week, Double-Blind, Randomized, Active-Controlled, Multi-Center Study With 24-Week Extension to Evaluate the Safety, Tolerability, Efficacy of Alendronate 70 mg Plus Vitamin D3 2800 IU Combination Tablet in Men and Postmenopausal Women With Osteoporosis #### Organization Study ID Info **ID:** 0217A-227 Extension #### Organization **Class:** INDUSTRY **Full Name:** Merck Sharp & Dohme LLC #### Secondary ID Infos **ID:** 2004_021 ### Status Module #### Completion Date **Date:** 2004-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2014-11-11 **Type:** ESTIMATED **Last Update Submit Date:** 2014-11-07 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2004-11 **Type:** ACTUAL #### Start Date **Date:** 2004-01 **Status Verified Date:** 2014-11 #### Study First Post Date **Date:** 2004-09-24 **Type:** ESTIMATED **Study First Submit Date:** 2004-09-21 **Study First Submit QC Date:** 2004-09-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Merck Sharp & Dohme LLC #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** The purpose of this study is to test the safety, tolerability, and effectiveness of an investigational drug and dietary supplement to reduce the risk of vitamin D insufficiency and deficiency during treatment of osteoporosis in men and postmenopausal women. ### Conditions Module **Conditions:** - Osteoporosis - Vitamin D Deficiency ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 652 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 24 weeks **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Safety and tolerability; primary parameter assessed is the proportion of patients who develop hypercalcuria ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Men or postmenopausal women who are osteoporotic Exclusion Criteria: * Vitamin D deficiency * Other disease of bone or mineral metabolism * Digestive disease causing malabsorption * Other medical conditions that are not adequately treated **Maximum Age:** 90 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Merck Sharp & Dohme LLC **Name:** Medical Monitior **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Recker R, Lips P, Felsenberg D, Lippuner K, Benhamou L, Hawkins F, Delmas PD, Rosen C, Emkey R, Salzmann G, He W, Santora AC. Alendronate with and without cholecalciferol for osteoporosis: results of a 15-week randomized controlled trial. Curr Med Res Opin. 2006 Sep;22(9):1745-55. doi: 10.1185/030079906x120913. **PMID:** 16968578 **Citation:** Binkley N, Ringe JD, Reed JI, Ljunggren O, Holick MF, Minne HW, Liu M, Lamotta A, West JA, Santora AC. Alendronate/vitamin D3 70 mg/2800 IU with and without additional 2800 IU vitamin D3 for osteoporosis: results from the 24-week extension of a 15-week randomized, controlled trial. Bone. 2009 Apr;44(4):639-47. doi: 10.1016/j.bone.2008.05.002. Epub 2008 May 15. **PMID:** 19185560 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001851 - Term: Bone Diseases, Metabolic - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000008659 - Term: Metabolic Diseases - ID: D000001361 - Term: Avitaminosis - ID: D000003677 - Term: Deficiency Diseases - ID: D000044342 - Term: Malnutrition - ID: D000009748 - Term: Nutrition Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12947 - Name: Osteoporosis - Relevance: HIGH - As Found: Osteoporosis - ID: M17551 - Name: Vitamin D Deficiency - Relevance: HIGH - As Found: Vitamin D Deficiency - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M5130 - Name: Bone Diseases, Metabolic - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M4660 - Name: Avitaminosis - Relevance: LOW - As Found: Unknown - ID: M6879 - Name: Deficiency Diseases - Relevance: LOW - As Found: Unknown - ID: M25306 - Name: Malnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010024 - Term: Osteoporosis - ID: D000014808 - Term: Vitamin D Deficiency ### Intervention Browse Module - Ancestors - ID: D000077264 - Term: Calcium-Regulating Hormones and Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000014815 - Term: Vitamins - ID: D000018977 - Term: Micronutrients - ID: D000050071 - Term: Bone Density Conservation Agents ### Intervention Browse Module - Browse Branches - Abbrev: BDCA - Name: Bone Density Conservation Agents - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M17550 - Name: Vitamin D - Relevance: HIGH - As Found: 2.5 - ID: M6003 - Name: Cholecalciferol - Relevance: HIGH - As Found: 2.5 - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: M21353 - Name: Alendronate - Relevance: HIGH - As Found: Botox - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M5381 - Name: Calcium - Relevance: LOW - As Found: Unknown - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown - ID: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - Relevance: LOW - As Found: Unknown - ID: T442 - Name: Cholecalciferol - Relevance: HIGH - As Found: 2.5 - ID: T479 - Name: Vitamin D3 - Relevance: HIGH - As Found: 2.5 - ID: T440 - Name: Calciferol - Relevance: HIGH - As Found: 2.5 ### Intervention Browse Module - Meshes - ID: D000002762 - Term: Cholecalciferol - ID: D000014807 - Term: Vitamin D - ID: D000019386 - Term: Alendronate ### Misc Info Module #### Removed Countries - Country: United States - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01576679 **Brief Title:** Safety and Efficacy of the Use of Tissue Plasminogen Activator (tPA) in Intra-Abdominal Collections in Children - A Prospective Study **Official Title:** A Double Blind, Randomized Controlled Trial Examining the Efficacy of the Use of Tissue Plasminogen Activator (tPA) in Intra-abdominal Collections in Children - a Prospective Study #### Organization Study ID Info **ID:** 1000029136 #### Organization **Class:** OTHER **Full Name:** The Hospital for Sick Children ### Status Module #### Completion Date **Date:** 2017-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-06-27 **Type:** ACTUAL **Last Update Submit Date:** 2019-06-25 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2016-05 **Type:** ACTUAL #### Start Date **Date:** 2012-03 **Type:** ACTUAL **Status Verified Date:** 2019-06 #### Study First Post Date **Date:** 2012-04-12 **Type:** ESTIMATED **Study First Submit Date:** 2012-04-10 **Study First Submit QC Date:** 2012-04-11 **Why Stopped:** very slow accrual. ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The Hospital for Sick Children #### Responsible Party **Investigator Affiliation:** The Hospital for Sick Children **Investigator Full Name:** Bairbre Connolly **Investigator Title:** Project Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The objective of this study is to establish the efficacy of tPA when used in pediatric intra-abdominal abscesses immediately after percutaneous drainage, irrespective of the ultrasound appearance or consistency of the drained fluid. **Detailed Description:** The use of tPA in pediatric abdominal abscesses is poorly defined. The indications are somewhat subjective and the dosage guidelines vary between institutions. Some studies have suggested that it be administered at, or soon after, the time of drainage if the ultrasound appearance of the collection is complex and/or septated, or if the initial aspirated contents are thick and viscous. Both criteria are difficult to accurately define and implement. In many instances, when there is minimal ongoing drainage despite follow-up ultrasound appearances suggesting a significant residual collection, tPA is administered several days following the initial procedure. The purpose of this study is to establish the efficacy of tPA in the initial treatment of all pediatric intra-abdominal abcesses and a standardized manner in which it can be used. This may eventually lead to a change in practice in the management of this patient population. ### Conditions Module **Conditions:** - Intra-abdominal Abscess **Keywords:** - intra-abdominal - abscess - tPA - alteplase - cathflo ### 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:** 28 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** tissue Plasminogen Activator **Intervention Names:** - Drug: Cathflo (Alteplase) **Label:** tPA **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Saline **Intervention Names:** - Drug: Saline **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - tPA **Name:** Cathflo (Alteplase) **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Name:** Saline **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome is the length of time (in hours) the drain remains insitu. For the primary outcome the individual abscess will be the unit of measurement; if there are multiple abscesses (up to a maximum of three) in the one patient each abscess will receive the same treatment. In the case of more than one drain being inserted in a single patient, the length of time that each drain remains in situ will be recorded individually. **Measure:** Length of time the drain remains insitu **Time Frame:** up to 2 weeks #### Secondary Outcomes **Measure:** Documentation of any adverse event **Time Frame:** up to 2 weeks **Measure:** The length of hospital stay **Time Frame:** up to 2 months **Measure:** Rate of resolution of abscess **Time Frame:** up to 2 weeks **Measure:** Return of clinical parameters to normal **Time Frame:** up to 2 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. All patients under the age of 18 years with intra-abdominal bacterial abscesses requiring percutaneous drain insertion (including transrectal drains). 2. Drain(s) must be inserted within the 23hrs prior to enrollment in the study. 3. The underlying diagnosis of the condition will not affect the enrollment of the patient unless it is detailed within the exclusion criteria (section 4.1.2). 4. Patients and parents must have signed informed consent to participate in the study. Exclusion Criteria:1. 1. Pancreatic abscess (not bacterial in nature) 2. Known coagulation impairment 3. Known central nervous system tumor or abscesses 4. Arteriovenous malformation 5. Aneurysm or history of central nervous system bleeding 6. Hypersensitivity to tPA 7. Recent administration of an investigational drug (within previous 30 days) 8. Pregnancy 9. Breast-feeding 10. Fulminant hepatic failure 11. Proven fistula (as it will alter the drainage time) or any abscess secondary to Crohn's Disease (because fistula existence cannot be excluded) 12. Necrotizing enterocolitis 13. Children requiring 4 or more drains **Maximum Age:** 18 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Toronto **Country:** Canada **Facility:** The Hospital for Sick Children **State:** Ontario **Zip:** M5G1X8 #### Overall Officials **Official 1:** **Affiliation:** The Hospital for Sick Children **Name:** Bairbre Connolly, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013492 - Term: Suppuration - ID: D000007239 - Term: Infections - ID: D000007249 - Term: Inflammation - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M37 - Name: Abscess - Relevance: HIGH - As Found: Abscess - ID: M20845 - Name: Abdominal Abscess - Relevance: HIGH - As Found: Abdominal Abscess - ID: M16273 - Name: Suppuration - 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: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000038 - Term: Abscess - ID: D000018784 - Term: Abdominal Abscess ### Intervention Browse Module - Ancestors - ID: D000005343 - Term: Fibrinolytic Agents - ID: D000050299 - Term: Fibrin Modulating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: FiAg - Name: Fibrinolytic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M13848 - Name: Plasminogen - Relevance: LOW - As Found: Unknown - ID: M13849 - Name: Tissue Plasminogen Activator - Relevance: HIGH - As Found: Bearing - ID: M8473 - Name: Fibrinolytic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000010959 - Term: Tissue Plasminogen Activator ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02750579 **Brief Title:** Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes? **Official Title:** Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes? #### Organization Study ID Info **ID:** 2016-A00379-42 #### Organization **Class:** OTHER **Full Name:** Assistance Publique Hopitaux De Marseille ### Status Module #### Completion Date **Date:** 2018-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-04-09 **Type:** ACTUAL **Last Update Submit Date:** 2018-04-06 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-04 **Type:** ACTUAL #### Start Date **Date:** 2016-09-05 **Type:** ACTUAL **Status Verified Date:** 2018-04 #### Study First Post Date **Date:** 2016-04-25 **Type:** ESTIMATED **Study First Submit Date:** 2016-04-21 **Study First Submit QC Date:** 2016-04-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assistance Publique Hopitaux De Marseille #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Percutaneous coronary intervention (PCI) is the cornerstone of the care of intermediate and high-risk non ST-elevation acute coronary syndromes (NSTE ACS). Revascularization reduces the rate of cardiovascular death and recurrent myocardial infarction in this clinical setting. The recommendation regarding the timing of intervention in this clinical setting is derived from old trials and has a weak level of evidence. In fact, there are no conclusive randomized trials in the contemporary era providing guidance on the optimal timing of intervention. In addition, the optimal timing of this critical intervention has not been studied since the development of new P2Y12-ADP receptor antagonists and the controversy surrounding the use of pretreatment with a P2Y12-ADP receptor antagonist before intervention. Early intervention in intermediate and high-risk non ST-elevation ACS is not well validated to date. In addition, the recent changes in the use of pretreatment with P2Y12-ADP receptor antagonists may impact on the potential benefit of an early intervention. Based on these evidences, we hypothesize that with the current protocols of care without pretreatment with a P2Y12-ADP receptor antagonist, an early PCI (\<2 hours) would be superior to a delayed (between 12 to 72 hours) PCI in the setting of intermediate or high-risk non-ST elevation acute coronary syndrome to prevent cardiovascular death and ischemic recurrences. ### Conditions Module **Conditions:** - Acute Coronary Syndrome ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 740 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** control group: Percutaneous coronary intervention for revascularization delayed intervention (12 to 72 hours) **Intervention Names:** - Procedure: Percutaneous coronary intervention for revascularization **Label:** Control group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** experimental group: early Percutaneous coronary intervention for revascularization intervention (\<2 hours) **Intervention Names:** - Procedure: Percutaneous coronary intervention for revascularization **Label:** experimental group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Control group - experimental group **Description:** Percutaneous coronary intervention for revascularization with anticoagulant and antiplatelet therapy (routine care) **Name:** Percutaneous coronary intervention for revascularization **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** compare the efficacy defined by the rate of recurrent ischemic events at 1 month of 2 therapeutic strategies: an immediate (\<2 hours) versus a delayed (12-72 hours) intervention for intermediate and high-risk non ST-elevation acute coronary syndrome compare the efficacy defined by the rate of cardiovascular death and/or recurrent ischemic events at 1 month of 2 therapeutic strategies: an immediate (\<2 hours) versus a delayed (12-72 hours) intervention for intermediate and high-risk non ST-elevation acute coronary syndrome **Measure:** recurrent ischemic events **Time Frame:** 1 month **Description:** compare the efficacy defined by the rate of cardiovascular death at 1 month of 2 therapeutic strategies: an immediate (\<2 hours) versus a delayed (12-72 hours) intervention for intermediate and high-risk non ST-elevation acute coronary syndrome **Measure:** cardiovascular death **Time Frame:** 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Must not be of child-bearing potential (1 year post-menopausal, contraceptive use or surgically sterile); * Subject with a non-ST-segment elevation ACS defined by the presence of at least 2 of the following criteria: symptoms of myocardial ischemia, electrocardiographic ST-segment abnormalities (depression or transient elevation of at least 0.1 mV) or T-wave inversion in at least in 2 contiguous leads, or an elevated cardiac troponin value (above the upper limit of normal) ; * Subject requiring intervention according to physician's judgment including the following criteria subject with one of the following risk factor defining intermediate and high risk ACS: diabetes mellitus, kidney failure, reduced LVEF, early post infarction angina, recent PCI, prior CABG or a GRACE risk score \>109, recurrent symptoms or ischaemia on non-invasive testing (2); * Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital; Exclusion Criteria: * - Minors or pregnant or breast-feeding women; * Subject with low risk ACS; * Subject with very high-risk ACS: refractory angina, severe heart failure, life-threatening ventricular arrhythmias, hemodynamic instability requiring immediate intervention; * Subject with thrombolytic therapy during the preceding 24 hours; * Subject with bleeding diathesis; * Subject with Upstream treatment by a GPIIb/IIIa inhibitor; * Subject under chronic anticoagulant; * Subject participating in another research protocol; * Subject not agreeing to participate; * Subject with contraindication to or under chronic P2Y12 receptor antagonists therapy (clopidogrel, ticagrelor and prasugrel); * Present with ST-segment elevation myocardial infarction (STEMI) at the time of entry or randomization into the study defined as follows: * ST-segment elevation myocardial infarction is defined as a history of chest discomfort or ischemic symptoms of \>20 minutes duration at rest ≤14 days prior to entry into the study with one of the following present on at least one ECG prior to randomization: 1. ST-segment elevation ≥1 mm in two or more contiguous ECG leads. 2. New or presumably new left bundle branch block (LBBB). 3. ST-segment depression ≥1 mm in two anterior precordial leads (V1 through V4) with clinical history and evidence suggestive of true posterior infarction. * Have cardiogenic shock (systolic blood pressure \<90 mm Hg associated with clinical evidence of end-organ hypoperfusion, or subjects requiring vasopressors to maintain systolic blood pressure over 90 mm Hg and associated with clinical evidence of end-organ hypoperfusion); * Have New York Heart Association (NYHA) Class IV congestive heart failure (CHF). **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Marseille **Country:** France **Facility:** Assistance Publique Hopitaux de Marseille **Zip:** 13015 #### Overall Officials **Official 1:** **Affiliation:** assistance Public Hopitaux de Marseille **Name:** Laurent Bonello, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Lemesle G, Laine M, Pankert M, Boueri Z, Motreff P, Paganelli F, Baumstarck K, Roch A, Kerbaul F, Puymirat E, Bonello L. Optimal Timing of Intervention in NSTE-ACS Without Pre-Treatment: The EARLY Randomized Trial. JACC Cardiovasc Interv. 2020 Apr 27;13(8):907-917. doi: 10.1016/j.jcin.2020.01.231. **PMID:** 32327087 **Citation:** Lemesle G, Laine M, Pankert M, Puymirat E, Bonello L. Great expectations. Lancet. 2018 Jan 27;391(10118):306. doi: 10.1016/S0140-6736(18)30096-5. Epub 2018 Jan 31. No abstract available. **PMID:** 29413039 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - 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: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M27545 - Name: Acute Coronary Syndrome - Relevance: HIGH - As Found: Acute Coronary Syndrome - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - 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: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000054058 - Term: Acute Coronary Syndrome - ID: D000013577 - Term: Syndrome ### Intervention Browse Module - Browse Branches - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4244 - Name: Anticoagulants - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06083779 **Brief Title:** Early Detection of Endometrial Cancer Using Plasma Cell-free DNA Fragmentomics **Official Title:** A Prospective Study of Early Detection of Endometrial Cancer Using Plasma Cell-free DNA Fragmentomics #### Organization Study ID Info **ID:** SYSKY-2023-848-01 #### Organization **Class:** OTHER **Full Name:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Status Module #### Completion Date **Date:** 2024-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-10-16 **Type:** ACTUAL **Last Update Submit Date:** 2023-10-09 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-01-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-08-01 **Type:** ACTUAL **Status Verified Date:** 2023-08 #### Study First Post Date **Date:** 2023-10-16 **Type:** ACTUAL **Study First Submit Date:** 2023-10-09 **Study First Submit QC Date:** 2023-10-09 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Nanjing Geneseeq Technology Inc. #### Lead Sponsor **Class:** OTHER **Name:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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:** The purpose of this study is to enable non-invasive early detection of endometrial cancer in high-risk populations through the establishment of a multimodal machine learning model using plasma cell-free DNA fragmentomics. Plasma cell-free DNA from early stage endometrial cancer patients and healthy individuals will be subjected to whole-genome sequencing. Five different feature types, including Fragment Size Distribution, nucleosome features, SBS Signatures, BreakPoint Motif , and Copy Number Variation will be assessed to generate this model. **Detailed Description:** Currently, there is no international consensus on the standard for endometrial cancer screening. The Expert Committee on Endometrial Cancer Screening in China released the "Expert Consensus on Endometrial Cancer Screening and Early Diagnosis (Draft)" in 2017, recommending the use of endometrial brushes for endometrial sampling and the use of endometrial cytology for slide preparation. Transvaginal ultrasound (TVS) can be used as an initial assessment and auxiliary method for endometrial cytology screening for endometrial cancer. For women without clinical symptoms, the routine method of endometrial cancer screening is mainly TVS to monitor endometrial thickness. Although TVS has high sensitivity, its specificity is very low, with a low positive predictive value (PPV) and a high false-positive rate, making it unable to distinguish between benign and malignant endometrial changes. There are also certain operator subjective judgments and instrument-related errors. For women with clinical symptoms, patients need endometrial cytology testing, that is, invasive endometrial sampling with an endometrial brush, followed by cytological slide preparation. Suspicious malignant tumor cells or malignant tumor cells should immediately undergo hysteroscopy and segmental diagnostic curettage to obtain endometrial biopsy tissue, and further clinical treatment should be carried out based on the pathological results. Due to the need to go deep into the uterus, the sampling failure rate for nulliparous women is as high as 20%, and the sampling failure rate for multiparous women is 8%. Whether it is endometrial cytology or hysteroscopic biopsy, which is close to the invasive operation of abortion, it will bring a lot of pain and economic burden to women. Moreover, there are currently no specific and sensitive tumor markers available for the diagnosis and follow-up of endometrial cancer. Therefore, it is urgent to develop a non-invasive, efficient screening detection method. In short, the space for early screening of endometrial cancer is vast, and liquid biopsy is non-invasive, convenient and easy to accept. It is an important technical means for early screening research of endometrial cancer, and has great potential to improve the performance of early screening of endometrial cancer. In order to further verify the application value of cfDNA-based fragmentomics in early screening of endometrial cancer and better screen the high-risk population of endometrial cancer in China, this study intends to analyze the characteristics of five cfDNA fragments based on low-depth whole-genome sequencing technology (WGS), and integrate artificial intelligence machine learning technology to establish a prediction model for early screening of endometrial cancer based on cfDNA. ### Conditions Module **Conditions:** - Endometrial Cancer **Keywords:** - Endometrial Cancer - Early Stage - Plasma Cell-free DNA - Fragmentomic assay ### Design Module #### Bio Spec **Description:** Plasma Cell-free DNA **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 216 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** the 108 patients with early to mid-stage endometrial cancer, more than 50% were in FIGO stages I/II. **Intervention Names:** - Genetic: low-depth whole-genome sequencing technology **Label:** Patients with endometrial cancer #### Arm Group 2 **Description:** 108 healthy people **Intervention Names:** - Genetic: low-depth whole-genome sequencing technology **Label:** healthy people ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients with endometrial cancer - healthy people **Description:** the characteristics of five cfDNA fragments based on low-depth whole-genome sequencing technology (WGS) **Name:** low-depth whole-genome sequencing technology **Type:** GENETIC ### Outcomes Module #### Primary Outcomes **Description:** The area under curve of the model for the ultrasensitive early detection of endometrial cancer would be evaluate **Measure:** Area under curve of the model for detecting endometrial cancer **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age minimum 18 years * Patients diagnosed with early to mid-stage endometrial cancer (more than 50% are in FIGO stages I/II) through histological and/or cytological examination. * Ability to understand and the willingness to sign a written informed consent document * Participants can obtain comprehensive clinical and pathological information. * Non-cancer controls are sex- and age-matched individuals without presence of any tumors or nodules or any other severe chronic diseases through systematic screening Exclusion Criteria: * Participants must not be pregnant or breastfeeding * Participants must not have prior cancer histories or a second non-endometrial malignancy * Participants must not have had any form of cancer treatment before enrollment or plasma collection, including surgery, chemotherapy, radiotherapy, targeted therapy and immunotherapy * Participants must not present medical conditions of fever or have acute or immunological diseases that required treatment 14 days before plasma collection * Participants who underwent organ transplant or allogenic bone marrow or hematopoietic stem cell transplantation * Participants with clinically important abnormalities or conditions unsuitable for blood collection * Any other disease or clinical condition of participants that the researcher believes may affect the compliance of the protocol, or affect the patient's signing of the informed consent form (ICF), which is not suitable to participate in this clinical trial. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Approximately 108 early to mid-stage endometrial cancer patients and 108 non-cancer controls ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Bingzhong Zhang, MD **Phone:** 13925063030 **Phone Ext:** 86 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Bingzhong Zhang, MD - **Phone:** 13925063030 - **Phone Ext:** 86 - **Role:** CONTACT **Country:** China **Facility:** The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University **State:** Guangdong **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University **Name:** Bingzhong Zhang, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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: 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: M19235 - Name: Endometrial Neoplasms - Relevance: HIGH - As Found: Endometrial 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: 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: D000016889 - Term: Endometrial Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04704479 **Brief Title:** Russian Current and Expiratory Muscle Training in COPD Patients **Official Title:** Influence of Russian Current and Expiratory Muscle Training on Expiratory Efficiency in Patients With Chronic Obstructive Pulmonary Disease #### Organization Study ID Info **ID:** P.T.REC/012/002924 #### Organization **Class:** OTHER **Full Name:** Cairo University ### Status Module #### Completion Date **Date:** 2022-04 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** ACTIVE_NOT_RECRUITING #### Last Update Post Date **Date:** 2022-03-31 **Type:** ACTUAL **Last Update Submit Date:** 2022-03-15 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2022-03 **Type:** ESTIMATED #### Start Date **Date:** 2021-03-15 **Type:** ACTUAL **Status Verified Date:** 2022-03 #### Study First Post Date **Date:** 2021-01-11 **Type:** ACTUAL **Study First Submit Date:** 2021-01-01 **Study First Submit QC Date:** 2021-01-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Hassan Mohamed Hassan **Investigator Title:** researcher **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:** Respiratory muscles are essential to alveolar ventilation. In COPD, these muscles work against increased mechanical loads due to airflow limitation and geometrical changes of the thorax derived from pulmonary hyperinflation. Respiratory muscle fibers show several degrees of impairment in cellular and subcellular structures which translates, from the functional point of view, to a loss of strength (capacity to generate tension) and an increased susceptibility to failure in the face of a particular load. Expiratory Muscle Training was recommended to strengthen expiratory muscles and minimize exacerbations in addition to delaying deterioration with better functional capacity. Neuromuscular electrical stimulation (NMES) is emerging as a new rehabilitation modality for muscle strengthening that does not evoke dyspnea to obtain a benefit in patients who are unable to participate in a traditional rehabilitation program **Detailed Description:** Chronic Obstructive Pulmonary Disease (COPD) remains the fourth leading cause of chronic morbidity and mortality at the global level, and it represents a major problem for public health. It is known that expiratory muscles are usually activated at the end of expiration in COPD patients during rest, or weight-bearing breathing to compensate weakness of inspiratory muscle and lung hyperinflation by time, expiratory muscle fatigue and weakness take place and more lung deterioration affecting COPD patient functional capacity occur. The efficacy of pulmonary rehabilitation on chronic obstructive pulmonary disease (COPD) patients has been demonstrated in many studies. Although pulmonary rehabilitation is a multi-dimensional therapy, respiratory muscle training and strengthening appears to be its most effective component, expiratory muscle training improves functional exercise capacity as assessed by timed walking distance, and decreases dyspnea during daily living activities, resulting in a better health-related quality of life in patients with COPD. Russian current is a medium frequency current, which was developed for improving muscle strength. There is limited literature on the effect of Russian current in improving strength of respiratory muscles. Thus, a need arises which addresses this perspective for new management strategies ### Conditions Module **Conditions:** - Chronic Obstructive Pulmonary Disease **Keywords:** - expiratory muscles - dyspnea - electrical stimulation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Russian current will be applied over the participant expiratory muscles in addition to application of EMT for more enhancement and strengthening of the expiratory muscles. **Intervention Names:** - Device: Russian current - Device: EMT **Label:** combined Russian and EMT **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** the participant receives EMT only over the whole study period **Intervention Names:** - Device: EMT **Label:** EMT only **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - combined Russian and EMT **Description:** For application of Russian current, 2 channels with 2 electrodes each will positioned on the oblique muscles and rectus abdominis motor points using wet spongy pads to enhance electrical activity. Russian current will be a carrier frequency 2500 Hz with frequency of 5 Hz for 5 minutes of muscular conditioning, 40 Hz for 10 minutes for training of slow contraction muscular fibers and 120 Hz for 5 minutes for training of fast contraction muscular fibers with On time (contraction time) 4 secs and Off time (relaxation time) 2 secs. The contraction phase will be at time of patient's expiration while relaxation will be at time of patient's inspiration **Name:** Russian current **Other Names:** - NMES **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - EMT only - combined Russian and EMT **Description:** patients in both groups trained 3 times a week, each session consisting of 1/2 h by the end of sessions. Initially, repeated cycles of 3 min of work followed by 2 min of rest were conducted (total work- time 18 min). The length of work intervals was increased on a weekly basis while rest periods were shortened to obtain a total work time of 30 min in the last week of the program. The valve opening pressure was continuously monitored at the mouthpiece to ensure the achievement of the target pressure. Patients will receive EMT with a threshold expiratory muscle trainer (Threshold; HealthScan), started breathing through the expiratory port of the threshold muscle trainer at a resistance equal to 15% of their Pemax for 1 week. The resistance will then increase incrementally, 5 to 10% each session, to reach 60% of their baseline Pemax at the end of the first month then continued at 60% of the Pemax, will be adjusted weekly to the new Pemax achieved **Name:** EMT **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** It is used to measure MEP with a pressure manometer. Measurements are usually made with patients in a sitting position and with a nose clip, Patients perform a maximal expiratory effort and sustain it for 1 to 2 seconds. The maneuver should be repeated 3 to 8 times, and the highest value recorded is used for analysis. The value obtained from the best of at least three efforts, measured at 2-min intervals, was used. Measurements will be obtained from TLC which yield higher values than those obtained of measurements from FRC **Measure:** Maximum expiratory pressure **Time Frame:** 10 weeks #### Secondary Outcomes **Description:** Modified Borg scale to determine degree of dyspnea and level of improvement in COPD patients. it is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during during six-minute walk testing (6MWT), 0 referred to no breathing difficulties while 10 referred to maximal difficulty of breathing **Measure:** dyspnea assessment **Time Frame:** 10 weeks **Description:** 6 min. walking test.The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. **Measure:** functional capacity **Time Frame:** 10 weeks **Description:** to assess progression of lung disease, decline in functional status, and gauge effectiveness of pulmonary rehabilitation. Patient-completed questionnaire assessing globally the impact of COPD (cough, sputum, dyspnea, chest tightness) on health status. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. The self-administered questionnaire consists of eight items assessing various manifestations of COPD aiming to provide a simple quantified measure of HRQoL **Measure:** COPD Assessment Test **Time Frame:** 10 weeks **Description:** Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry. its normal value is 80% to 120% **Measure:** forced vital capacity **Time Frame:** 10 weeks **Description:** Forced expiratory volume in the first second (FEV1) is the maximum amount of air that the subject can forcibly expel during the first-second following maximal inhalation. Its normal value is 80% or greater **Measure:** Forced expiratory volume in the first second **Time Frame:** 10 weeks **Description:** Maximal Voluntary Ventilation (MVV) is a spirometry test that measures the largest volume that can be moved into and out of the lungs during a 10-15 second interval with voluntary effort. it reflect respiratory muscle endurance. In the normal subject MVV is about 15 to 20 times the resting minute volume. **Measure:** maximal voluntary ventilation **Time Frame:** 10 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Men with stage II COPD Patients * aged from 55 to 65 years' old * FEV1/FVC less than 70% (Patients of moderate COPD (Stage II- GOLD criteria) (Rabe et al, 2019) * BMI 25.0-29.9 kg/m2 (Pre-obesity) * Tobacco smokers * No history of infections or symptom exacerbations in the previous two months before the study * Did not participate in any selective exercise program for the respiratory muscles before Exclusion Criteria: * Women * Acute exacerbation that requires a change in pharmacological management or hospitalization * An open injury affecting the application of surface electrodes of russian current * Asthmatic patient. * Implanted pacemaker * Patients with chest infection. * Patients with pleural diseases. * Primary valvular disease * History of spontaneous pneumothorax * Clinically significant peripheral vascular disease * Severe anemia * BMI more than 29.9 kg/m2 * Previous lung surgery * Long-term oxygen treatment * Patients with chronic renal failure. * Any cognitive impairment that interferes with prescribed exercise procedures * Musculoskeletal or neurological limitation to physical exercise * Any patient enrolled in an anther research study for at least 30 days **Maximum Age:** 65 Years **Minimum Age:** 55 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Giza **Country:** Egypt **Facility:** Cairo University **Zip:** 11432 #### Overall Officials **Official 1:** **Affiliation:** Cairo University **Name:** Hassan M Habib, Master **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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: 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: M7591 - Name: Dyspnea - Relevance: LOW - As Found: Unknown - 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: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008171 - Term: Lung Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000029424 - Term: Pulmonary Disease, Chronic Obstructive ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05419479 **Brief Title:** Switch Maintenance in Pancreatic **Official Title:** Phase Ib/II Open-Label, Multicenter, Randomized Study Evaluating the Safety and Efficacy of 'Switch Maintenance' Combination Immunotherapy Using AB154, AB122, and APX005M in Patients With Metastatic Pancreatic Cancer #### Organization Study ID Info **ID:** 22-141 #### Organization **Class:** OTHER **Full Name:** Dana-Farber Cancer Institute ### Status Module #### Completion Date **Date:** 2028-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-01-18 **Type:** ACTUAL **Last Update Submit Date:** 2024-01-16 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-01-31 **Type:** ESTIMATED #### Start Date **Date:** 2022-11-30 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2022-06-15 **Type:** ACTUAL **Study First Submit Date:** 2022-06-10 **Study First Submit QC Date:** 2022-06-10 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Arcus Biosciences, Inc. **Class:** OTHER **Name:** Lustgarten Foundation #### Lead Sponsor **Class:** OTHER **Name:** James Cleary, MD, PhD #### Responsible Party **Investigator Affiliation:** Dana-Farber Cancer Institute **Investigator Full Name:** James Cleary, MD, PhD **Investigator Title:** Sponsor Investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study is being done to test the safety and effectiveness of combining domvanalimab (AB154), zimberelimab (AB122), and APX005M with pancreatic cancer that has spread to other parts of body. This research study involves immunotherapy. Immunotherapy triggers the body's immune system to fight cancer cells. The names of the study drugs involved in this study are: * Domvanalimab (also known as AB154) * Zimberelimab (also known as AB122) * APX005M **Detailed Description:** This is an open-label, Phase 1b/2, multicenter, randomized study evaluating the safety and efficacy of 'switch maintenance' combination immunotherapy (domvanalimab) zimberelimab and APX005M versus 'continuous maintenance' in patients with metastatic pancreatic cancer following 4-6 months of FOLFIRINOX The names of the study drugs involved in this study are: * Domvanalimab (also known as AB154) * Zimberelimab (also known as AB122) * APX005M The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will be randomized into one of two groups: * Arm A will receive domvanalimab, zimberelimab, and APX005M every two weeks through an infusion. * Arm B will receive leucovorin, fluorouracil, and irinotecan every two weeks through an infusion If you are in Arm B and the drugs stop working, participants may receive the drugs given in Arm A. Participants will receive study treatment as long the disease does not worsen or there are no serious side effects for a maximum of 26 cycles (2 years) and will be followed for 12 months after the discontinue the study drugs. It is expected that about 46 people will take part in this research study. This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of an investigational drug or drugs and also tries to define the appropriate dose of the investigational drug(s) to use for further studies. Phase II clinical trials test the safety and effectiveness of an investigational drug or drugs to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved domvanalimab, zimberelimab, or APX005M as a treatment for any disease. drug regimen. ### Conditions Module **Conditions:** - Pancreatic Cancer - Adenocarcinoma of the Pancreas - Squamous Cell Carcinoma of Pancreas - Adenosquamous Carcinoma of the Pancreas **Keywords:** - Pancreatic Cancer - Adenocarcinoma of the Pancreas - Squamous Cell Carcinoma of Pancreas - Adenosquamous Carcinoma of the Pancreas ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 46 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The lead-in dose de-escalation cohort (Phase 1b) will enroll 6 patients (up to 12 patients in 2 dose levels if needed; 6 patients per DL) to receive zimberelimab, domvanalimab, and APX005M **Intervention Names:** - Drug: ZIMBERELIMAB - Drug: DOMVANALIMAB - Drug: APX005M **Label:** LEAD-IN: DOSE DE-ESCALATION **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will be randomly assigned to one of two groups Arm A will receive domvanalimab, zimberelimab, and APX005M every two weeks through an infusion. **Intervention Names:** - Drug: ZIMBERELIMAB - Drug: DOMVANALIMAB - Drug: APX005M **Label:** ARM A: ZIMBERELIMAB + DOMVANALIMAB + APX005M **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Arm B will receive leucovorin, fluorouracil, and irinotecan every two weeks through an infusion **Intervention Names:** - Drug: FOLFIRI **Label:** ARM B: FOLFIRI **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Description:** Participants in Arm B (control arm) who experience disease progression (as defined by RECIST v1.1) will be given the option to crossover and receive domvanalimab + zimberelimab, + APX005M in the second-line setting, provided they meet eligibility criteria **Intervention Names:** - Drug: ZIMBERELIMAB - Drug: DOMVANALIMAB - Drug: APX005M **Label:** CROSSOVER: ZIMBERELIMAB + DOMVANALIMAB + APX005M **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - ARM A: ZIMBERELIMAB + DOMVANALIMAB + APX005M - CROSSOVER: ZIMBERELIMAB + DOMVANALIMAB + APX005M - LEAD-IN: DOSE DE-ESCALATION **Description:** Via IV on two days per cycle, dosage per protocol **Name:** ZIMBERELIMAB **Other Names:** - AB 122 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - ARM A: ZIMBERELIMAB + DOMVANALIMAB + APX005M - CROSSOVER: ZIMBERELIMAB + DOMVANALIMAB + APX005M - LEAD-IN: DOSE DE-ESCALATION **Description:** Via IV on two days per cycle, dosage per protocol **Name:** DOMVANALIMAB **Other Names:** - AB 154 **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - ARM A: ZIMBERELIMAB + DOMVANALIMAB + APX005M - CROSSOVER: ZIMBERELIMAB + DOMVANALIMAB + APX005M - LEAD-IN: DOSE DE-ESCALATION **Description:** Via IV on two days per cycle, dosage per protocol **Name:** APX005M **Other Names:** - CD40 **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - ARM B: FOLFIRI **Description:** every two weeks through an infusion at a dose determined by physician **Name:** FOLFIRI **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Toxicity assessments will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 **Measure:** Dose-limiting toxicities-Phase 1 **Time Frame:** 28 Days **Description:** PFS is defined as the time from registration to the Crossover Arm to the earlier of progression or death due to any cause. The PFS2 distribution will be calculated and plotted using the Kaplan-Meier method **Measure:** Switch Maintenance-Progression Free Survival **Time Frame:** baseline up to 38 months #### Secondary Outcomes **Description:** Tumor reassessment with baseline CT scan and restaging scans will occur every 8 weeks using RECIST v1.1 **Measure:** Objective Response Rate (ORR) **Time Frame:** Every 8 weeks up to 38 Months **Description:** Tumor reassessment with baseline CT scan and restaging scans will occur every 8 weeks using RECIST v1.1 **Measure:** Disease Control Rate **Time Frame:** Every 8 weeks up to 38 Months **Description:** The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause. Participants without events reported are censored at the last disease evaluation). **Measure:** Duration of Response (DoR) **Time Frame:** Baseline up to 38 Months **Description:** Progression-Free Survival (PFS) is defined as the time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation **Measure:** Progression Free Survival **Time Frame:** baseline up to 38 months **Description:** Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive **Measure:** Overall Survival **Time Frame:** baseline up to 38 months **Description:** Toxicity assessments will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 **Measure:** Number of Participants With Treatment-Related Adverse Events **Time Frame:** Up to 38 Months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants must have histologically confirmed pancreatic cancer (adenocarcinoma, squamous, or adenosquamous histologies) that is metastatic and for which standard curative or palliative measures do not exist or are no longer effective. Locally advanced patients are not eligible. * Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. * Participants must have received 8-12 cycles (4-6 months) of first-line FOLFIRINOX or modified FOLFIRINOX with stable disease or better. * Age ≥18 years. Because no dosing or adverse event data are currently available on the use of domvanalimab + zimberelimab + APX005M in participants \<18 years of age, children are excluded from this study. * ECOG performance status ≤1 * Participants must have adequate organ and marrow function as defined below: * leukocytes ≥3,000/mcL * absolute neutrophil count ≥1,500/mcL * platelets ≥100,000/mcL * total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except in patients with documented Gilbert's syndrome, who must have a total bilirubin ≤ 3 x ULN * AST(SGOT)/ALT(SGPT) ≤ 2.5 x institution's upper limit of normal (ULN) for patients with no concurrent liver metastases, OR ≤ 5.0 x institution's ULN for patients with concurrent liver metastases creatinine OR glomerular filtration rate (GFR) creatinine ≤ 2 x ULN OR GFR measured by calculated creatinine clearance (CrCl) \> 45 mL/min. CrCl can be calculated using the Cockroft-Gault method. * Hemoglobin (Hgb) \>9.0 g/dL * Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. If a participant has brain or meningeal metastases, the participant must meet the following criteria: * Have no evidence of progression by neurologic symptoms or sign for at least 4 weeks prior to the first dose. * Metastatic brain lesions do not require immediate intervention. * Carcinomatous meningitis is excluded regardless of clinical stability. * Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better. * Participants must be willing to undergo a pre-treatment fresh tumor biopsy. * Participants must be willing to undergo an on-treatment tumor biopsy (if medically feasible). * Participants must have archival tissue available for analysis, which will be used for correlative studies if a pretreatment biopsy reveals necrotic tissue. * The effects of domvanalimab, zimberelimab, and APX005M on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (See Section 5.6) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of domvanalimab, zimberelimab, or APX005M administration. * Women of childbearing potential (WOCBP), defined as not surgically sterilized and between menarche and 1-year post menopause, must have a negative serum pregnancy test within 7 days prior to the first dose of investigational therapies and a negative urine (or serum) pregnancy test within 3 days prior to the first dose of investigational therapies. * WOCBP must agree to use highly effective methods of contraception from the time of consent, through the duration of study treatment, and 5 months after the last dose of investigational therapies. * Male participants with WOCBP sexual partners must agree to use highly effective methods of contraception, and to refrain from donating sperm from the time of consent through the duration of study treatment and 7 months after the last dose of investigational therapies. Contraceptive requirements may be extended depending on local regulatory requirements. * Female participants must not be breast feeding and must not breast-feed a baby while on treatment and for up to 7 months after the last dose of investigational therapies. * Ability to understand and the willingness to sign a written informed consent document. * Willing and able to comply with the requirements and restrictions in this protocol. * Eligibility Criteria for Stage 2 (Crossover Stage) * Patients must meet all of the criteria used for Stage 1. * Patients allocated to the control arm (Arm B) during Stage 1 have the ability to initiate Stage 2 treatment within 4 weeks after experiencing disease progression per RECIST v1.1 while receiving control treatment * Availability of a tumor specimen from on-treatment biopsy during Expansion Phase. If this is not available, willingness to undergo biopsy prior to initiation of Crossover Phase. * Exclusion Criteria (for both Stage 1 and Stage 2) * Patients who have evidence of disease progression on FOLFIRINOX. * Participants who have had cytotoxic chemotherapy, radiotherapy, within 2 weeks prior to the first dose of study medication or those who have not recovered to ≤ CTCAE Grade 1 or baseline from adverse events due to agents administered more than 2 weeks earlier. Exceptions include alopecia of any grade and Grade ≤ 2 peripheral neuropathy. * Participants who have received any other investigational agents for pancreatic cancer. * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies, or allergic reactions attributed to compounds of similar chemical or biologic composition to domvanalimab, zimberelimab, APX005M, or other agents used in study. * Prior treatment with any of the protocol-specified study treatments, with the exception of chemotherapy. * Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies (including anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-TIGIT, and CD40 agonist therapeutic antibodies) * Patients with endocrine or acinar pancreatic carcinoma are not eligible for the study. * Known dihydropyrimidine dehydrogenase deficiency. * Known germline BRCA1 or BRCA2 mutation(s). * Participants who have undergone major surgery 28 days prior to initiating protocol therapy. Participants must have sufficiently recovered from adverse events caused by the procedure as judged by the treating investigator. Placement of central venous access catheter (e.g., port or similar) is not considered a major surgical procedure. * Participants must not have a history of human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV), except for the following: * Participants with anti-HepB core antibody but with undetectable HepB virus deoxyribonucleic acid (DNA) and negative for HepB surface antigen * Participants with resolved or treated hepatitis C virus (HCV) (i.e., HCV antibody positive but undetectable HCV RNA) * Participants must not have a history of primary immunodeficiency. * Active autoimmune disease, history of autoimmune disease, or concurrent administration of immune suppressive medications. Participants must not have a known or suspected history of an autoimmune disorder within 3 years of the first dose of investigational agent, including but not limited to: systemic lupus erythematosus, scleroderma, inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, sarcoidosis, or autoimmune hepatitis. Exceptions include participants with Type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement, skin disorders such as alopecia or vitiligo, not requiring systemic therapy, resolved childhood asthma/atopy, or conditions not expected to recur in the absence of an external trigger are eligible. Patients with a history of Hashimoto syndrome within 3 years of the first dose of investigational agent, which resolved to hypothyroidism alone. * Prior allogeneic bone marrow transplantation or solid organ transplantation. * Participants must not receive concurrent or prior use of an immunosuppressive agent within 14 days prior to the first dose of investigational agent. Exceptions include: * Systemic steroids at physiologic doses (equivalent to dose of ≤ 10 mg oral prednisone) are permitted. * Intranasal, inhaled, topical, intra-articular, and ocular corticosteroids with minimal systemic absorption are permitted. * Patients with a condition with anticipated use of systemic steroids above the equivalent of 10 mg prednisone are excluded. * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. * Patients must not have received a live attenuated vaccine within 28 days before the first dose of investigational agent, and patients, if enrolled, should not receive live vaccines during the study or for 180 days after the last dose of investigational agent. Prior COVID-19 infection and/or COVID-19 vaccination is permitted. * Known hereditary or acquired coagulopathy (e.g., hemophilia, von Willebrand disease, cancer-associated diffuse intravascular coagulation) * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of investigational therapy), clinically significant cardiovascular disease, unstable angina pectoris, cardiac arrhythmia, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or psychiatric illness/social situations that would limit compliance with study requirements. * Participants with a history of a clinically relevant second primary malignancy within the past 2 years. Exceptions include: resected basal and squamous cell carcinomas of the skin and completely resected carcinoma in situ of any type. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** James Cleary, MD, PhD **Phone:** 617-632-6073 **Role:** CONTACT #### Locations **Location 1:** **City:** Boston **Contacts:** ***Contact 1:*** - **Name:** James Cleary, MD, PhD - **Phone:** 617-632-6073 - **Role:** CONTACT ***Contact 2:*** - **Name:** James Cleary, MD, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Dana Farber Cancer Institute **State:** Massachusetts **Status:** RECRUITING **Zip:** 02115 #### Overall Officials **Official 1:** **Affiliation:** Dana-Farber Cancer Institute **Name:** James Cleary, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Contact the Belfer Office for Dana-Farber Innovations (BODFI) at [email protected] **Description:** The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research. **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES **Time Frame:** Data can be shared no earlier than 1 year following the date of publication ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000018307 - Term: Neoplasms, Squamous Cell - 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 - ID: D000018193 - Term: Neoplasms, Complex and Mixed ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M13110 - Name: Pancreatic Neoplasms - Relevance: HIGH - As Found: Pancreatic Cancer - ID: M5550 - Name: Carcinoma, Squamous Cell - Relevance: HIGH - As Found: Squamous Cell Carcinoma - ID: M3585 - Name: Adenocarcinoma - Relevance: HIGH - As Found: Adenocarcinoma - ID: M20342 - Name: Carcinoma, Adenosquamous - Relevance: HIGH - As Found: Adenosquamous Carcinoma - 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: M20451 - Name: Neoplasms, Squamous Cell - 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: HIGH - As Found: Pancreatic Cancer ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000002294 - Term: Carcinoma, Squamous Cell - ID: D000000230 - Term: Adenocarcinoma - ID: D000010190 - Term: Pancreatic Neoplasms - ID: D000018196 - Term: Carcinoma, Adenosquamous ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M6191 - Name: Leucovorin - Relevance: LOW - As Found: Unknown - ID: M8600 - Name: Fluorouracil - Relevance: LOW - As Found: Unknown - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M1671 - Name: Irinotecan - 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:** NCT01224379 **Acronym:** Topping-off **Brief Title:** Comparison of Standard Fusion With "Topping Off"-System in Lumbar Spine **Official Title:** Clinical Trial of the Efficacy of Hybrid Systems(Topping Off)in Comparison to the Conventional Spondylodesis in Fusion-surgery in the Lumbal Spine: a Prospective, Randomised Study #### Organization Study ID Info **ID:** Uni-Köln-1223 #### Organization **Class:** OTHER **Full Name:** University of Cologne #### Secondary ID Infos **Domain:** University of Cologne **ID:** Uni-Köln-1223 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2012-10 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** NOT_YET_RECRUITING #### Last Update Post Date **Date:** 2010-10-20 **Type:** ESTIMATED **Last Update Submit Date:** 2010-10-19 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2012-07 **Type:** ESTIMATED #### Start Date **Date:** 2011-01 **Status Verified Date:** 2010-09 #### Study First Post Date **Date:** 2010-10-20 **Type:** ESTIMATED **Study First Submit Date:** 2010-10-19 **Study First Submit QC Date:** 2010-10-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Cologne #### Responsible Party **Old Name Title:** University of Cologne **Old Organization:** Medizinische Fakultät der Universität zu Köln ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** Does a new "topping-off" device lead to a better clinical outcome compared to standard fusion? Does this device prevent the development of adjacent instability? Does radiological adjacent instability correlate with clinical outcome? **Detailed Description:** Primary efficacy endpoint: The baseline and follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline of the SF-36 (Short-Form-36)-Measured Outcome regarding the Physical Component Summary (PCS). Key secondary endpoint(s): 1. Mental Component Summary (MCS) and individual dimensions and subscales of the SF-36 2. Individual dimensions of the Oswestry Disability Index (ODI) 3. Time until radiological adjacent instability and comparison to the clinical outcome 4. Capacity of work at the time of surgery and after surgery, time until return to work Assessment of safety: 1. Treatment complication in control and intervention groups (SAE-management) 2. A rating committee will provide consistency of the procedure and the assessment of data (e.g. by intraoperative photos, surgery reports, x-rays) to minimize bias ### Conditions Module **Conditions:** - Spondylolisthesis - Erosive Osteochondrosis in L2-S1 **Keywords:** - Lumbar spine - fusion - adjacent instability - topping-off. ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The intervention group will receive a "topping off" system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion). **Intervention Names:** - Device: Topping off system **Label:** Arm1: "topping off" system **Type:** OTHER #### Arm Group 2 **Description:** The control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis) **Intervention Names:** - Device: monosegmental PLIF **Label:** Arm 2: monosegmental PLIF **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm1: "topping off" system **Description:** The intervention group will receive a "topping off" system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion). **Name:** Topping off system **Other Names:** - Topping off **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Arm 2: monosegmental PLIF **Description:** The control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis) **Name:** monosegmental PLIF **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Primary efficacy endpoint: The baseline and follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline of the SF-36 (Short-Form-36)-Measured Outcome regarding the Physical Component Summary (PCS). **Measure:** SF36 **Time Frame:** 6 Month #### Secondary Outcomes **Description:** 1. Mental Component Summary (MCS) and individual dimensions and subscales of the SF-36 follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline **Measure:** 1.Mental Component Summary (MCS) and individual dimensions and subscales of the Mental Component Summary (MCS) and individual dimensions and subscales of SF-36 **Time Frame:** 6 weeks **Description:** Assessment of safety: 1. Treatment complication in control and intervention groups (SAE-management) 2. A rating committee will provide consistency of the procedure and the assessment of data (e.g. by intraoperative photos, surgery reports, x-rays) to minimize bias **Measure:** Safety **Time Frame:** all time **Description:** Individual dimensions of the Oswestry Disability Index (ODI) follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline **Measure:** Individual dimensions of the Oswestry Disability Index (ODI) **Time Frame:** 6weeks **Description:** Time until radiological adjacent instability and comparison to the clinical outcome follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline **Measure:** Time until radiological adjacent instability and comparison to the clinical outcome **Time Frame:** 6 weeks **Description:** Capacity of work at the time of surgery and after surgery, time until return to work follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline **Measure:** Capacity of work at the time of surgery and after surgery, time until return to work **Time Frame:** 6 weeks ### Eligibility Module **Eligibility Criteria:** Key inclusion criteria: 1. Male or female \>30 years of age 2. Lumbar spine pathology with indication for monosegmental PLIF 3. Radiological signs of a degeneration of the adjacent segment without instability Key exclusion criteria: 1. Radiological signs of existing instability of the adjacent segment 2. Normal endplates and no disc desiccation in MRI in the adjacent seg-ment 3. Previous surgery of the lumbar spine - **Minimum Age:** 30 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jan Siewe, Dr. **Phone:** +49-221-478-87294 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Margarete Wicharz **Phone:** +49-221-478-87294 **Role:** CONTACT #### Locations **Location 1:** **City:** Cologne **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jan Siewe, Dr. - **Phone:** +49-221-478-87294 - **Role:** CONTACT ***Contact 2:*** - **Name:** Jan Siewe, Dr. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Germany **Facility:** University of Cologne, Department of Orthopedics& traumasurgery **Zip:** 50931 #### Overall Officials **Official 1:** **Affiliation:** University of Cologne **Name:** Jan Siewe, Dr. **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Siewe J, Otto C, Knoell P, Koriller M, Stein G, Kaulhausen T, Eysel P, Zarghooni K, Franklin J, Sobottke R. Comparison of standard fusion with a "topping off" system in lumbar spine surgery: a protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2011 Oct 18;12:239. doi: 10.1186/1471-2474-12-239. **PMID:** 22008088 #### See Also Links **Label:** Related Info **URL:** http://orthopaedie.uk-koeln.de/forschung ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013169 - Term: Spondylolysis - ID: D000055009 - Term: Spondylosis - ID: D000013122 - Term: Spinal Diseases - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15963 - Name: Spondylolisthesis - Relevance: HIGH - As Found: Spondylolisthesis - ID: M28008 - Name: Osteochondrosis - Relevance: HIGH - As Found: Osteochondrosis - ID: M15964 - Name: Spondylolysis - Relevance: LOW - As Found: Unknown - ID: M27993 - Name: Spondylosis - Relevance: LOW - As Found: Unknown - ID: M15919 - Name: Spinal Diseases - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: T4302 - Name: Osteochondrosis - Relevance: HIGH - As Found: Osteochondrosis ### Condition Browse Module - Meshes - ID: D000013168 - Term: Spondylolisthesis - ID: D000055034 - Term: Osteochondrosis ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06139679 **Brief Title:** Improvement In Left Ventricular Diameter After Closure Of ASD With Fenestrated Patch: A Cross-sectional Study **Official Title:** Improvement In Left Ventricular Diameter After Closure Of Atrial Septal Defect With Fenestrated Patch: A Cross-sectional Study #### Organization Study ID Info **ID:** 1148/110/3/XII/2021 #### Organization **Class:** OTHER_GOV **Full Name:** Dr. Soetomo General Hospital ### Status Module #### Completion Date **Date:** 2022-11-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-11-18 **Type:** ACTUAL **Last Update Submit Date:** 2023-11-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-08-31 **Type:** ACTUAL #### Start Date **Date:** 2022-03-01 **Type:** ACTUAL **Status Verified Date:** 2023-11 #### Study First Post Date **Date:** 2023-11-18 **Type:** ACTUAL **Study First Submit Date:** 2023-11-02 **Study First Submit QC Date:** 2023-11-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Dr. Soetomo General Hospital #### Responsible Party **Investigator Affiliation:** Dr. Soetomo General Hospital **Investigator Full Name:** dr. Heroe Soebroto, Sp.B, Sp.BTKV, Subsp.JPK(K) **Investigator Title:** MD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Introduction: The presence of pulmonary hypertension (PH) in atrial septal defect (ASD) poses a clinical challenge on whether or not to close the defect. Closing the defect increases the risk of low cardiac output syndrome (LCOS), while leaving the defect open may eventually lead to irreparable shunt reversal, hypoxemia, and death. The implementation of a fenestrated patch may halt LCOS while adding volume to the left heart. Methods: this is an analytical observational study involving patients with ostium secundum defect with PH who were operated on in Dr. Soetomo Hospital between January 2017 and October 2021. The aim of this study is to evaluate the improvement in left ventricular size during both systole and diastole. **Detailed Description:** Atrial septal defect (ASD) is one of the most common congenital heart diseases. It is typically characterized by a left-to-right shunt which results in volume overload of the right ventricle and overcirculation of the pulmonary vascularization (le Gloan et al., 2018). This may further result in arrhythmia, right ventricular dysfunction, and pulmonary hypertension (PH). Pulmonary hypertension is caused by endothelial dysfunction, remodelling of the pulmonary vascularization, which increases pulmonary vascular resistance, and eventually causes shunt reversal into right-to-left (Eisenmenger's syndrome). At this point, closure of the defect is contraindicated. Small LV, although less extensively studied than dilated LV, also implies impaired LV function. Small LV means less tolerance to volume overload, which in turn impairs cardiac output and presents higher risk of heart failure and mortality (Saito et al., 2021). ASD closure in cases with severe pulmonary hypertension (PH) presents a clinical challenge. Complete closure may cause pulmonary hypertensive crisis and low cardiac output syndrome; however, if left untreated, the disease progresses, the pulmonary vascular resistance increases, which may also lead to Eisenmenger's syndrome and shunt reversal. Today, this condition is treated with fenestrated closure, either with patch or fenestrated septal occluder. The fenestration is hypothesized to provide protective effect against pulmonary hypertensive crisis because it allows blood to flow from right to left heart. The added volume into the left heart is then, hypothesized, to provide volume training for the left heart, mainly in the case of small LV. Therefore, this study aims to evaluate the effect of fenestrated closure compared to non- fenestrated closure to the left ventricular size at systole and diastole. ### Conditions Module **Conditions:** - Atrial Septal Defect **Keywords:** - Left Ventricle Diameter - Atrial septal defect closure - Fenestrated patch ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 21 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with ASD who underwent surgical closure of ASD with fenestrated patch **Intervention Names:** - Procedure: ASD closure with fenestrated/non-fenestrated patch **Label:** Fenestrated #### Arm Group 2 **Description:** Patients with ASD who underwent surgical closure of ASD with non-fenestrated patch **Intervention Names:** - Procedure: ASD closure with fenestrated/non-fenestrated patch **Label:** Non-fenestrated ### Interventions #### Intervention 1 **Arm Group Labels:** - Fenestrated - Non-fenestrated **Description:** A PTFE patch is used to surgically close the interatrial defect. If closure with fenestrated patch is deemed necessary, a small opening is created on the patch **Name:** ASD closure with fenestrated/non-fenestrated patch **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The change in left ventricular diameter during both systole and diastole is measured preoperatively and postoperatively **Measure:** Improvement in left ventricular diameter during systole and diastole **Time Frame:** January 2017 - October 2021 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with ASD secundum and pulmonary hypertension with complete preoperative and postoperative echocardiography (LVIDd and LVIDs) data * Patients with ASD secundum and pulmonary hypertension with complete preoperative but incomplete postoperative echocardiography (LVIDd and LVIDs) data, but willing to present upon invitation to complete missing postoperative data Exclusion Criteria: * Patients with ASD secundum and pulmonary hypertension who are unwilling to participate in the study, or in a condition that prevents the patient to present for echocardiographic evaluation * Patients with incomplete medical records **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients with ASD secundum with pulmonary hypertension of all age groups who underwent surgical closure of ASD in Dr. Soetomo General Academic Hospital within January 2017 - October 2021 ### Contacts Locations Module #### Locations **Location 1:** **City:** Surabaya **Country:** Indonesia **Facility:** Dr. Soetomo General Academic Hospital **State:** East Java #### Overall Officials **Official 1:** **Affiliation:** Department of Thoracic, Cardiac, and Vascular Surgery, Dr. Soetomo General Hospital, Surabaya, Indonesia **Name:** Heroe Soebroto **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006330 - Term: Heart Defects, Congenital - ID: D000018376 - Term: Cardiovascular Abnormalities - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000006331 - Term: Heart Diseases - ID: D000000013 - Term: Congenital Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9432 - Name: Heart Septal Defects, Atrial - Relevance: HIGH - As Found: Atrial Septal Defect - ID: M9431 - Name: Heart Septal Defects - Relevance: HIGH - As Found: Septal Defect - ID: M9418 - Name: Heart Defects, Congenital - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M20503 - Name: Cardiovascular Abnormalities - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006343 - Term: Heart Septal Defects - ID: D000006344 - Term: Heart Septal Defects, Atrial ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00056979 **Brief Title:** Monoclonal Antibody Conditioning for Allogeneic Stem Cell Transplantation of Patients With Inherited Metabolic Storage Diseases **Official Title:** Anti-CD45 (YTH-24 & YTH 54) and ANTI-CD52 (CAMPATH-1H) Monoclonal Antibody Conditioning Regimen for Allogeneic Stem Cell Transplantation of Patients With Inherited Metabolic Storage Diseases #### Organization Study ID Info **ID:** H11909 #### Organization **Class:** OTHER **Full Name:** Baylor College of Medicine #### Secondary ID Infos **ID:** MAID ### Status Module #### Completion Date **Date:** 2003-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2015-09-23 **Type:** ESTIMATED **Last Update Submit Date:** 2015-09-21 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2003-06 **Type:** ACTUAL #### Start Date **Date:** 2002-06 **Status Verified Date:** 2015-09 #### Study First Post Date **Date:** 2003-03-27 **Type:** ESTIMATED **Study First Submit Date:** 2003-03-26 **Study First Submit QC Date:** 2003-03-26 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** The Methodist Hospital Research Institute #### Lead Sponsor **Class:** OTHER **Name:** Baylor College of Medicine #### Responsible Party **Investigator Affiliation:** Baylor College of Medicine **Investigator Full Name:** Robert Krance **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Description Module **Brief Summary:** This study treats patients with an inherited disease that prevents the body from making a specific protein or enzyme needed for the body's metabolism. Lack of this enzyme causes accumulation of harmful or toxic substances in the body, which leads to deterioration and failure of organs such as the brain or the heart. This disease can be fatal. Some patients with inherited metabolic storage disease may benefit from an allogeneic stem cell transplant ('allogeneic' means that the stem cells come from another person). Stem cells are created in the bone marrow. They mature into different types of blood cells that are needed including red blood cells, white blood cells, and platelets. Stem cells, when transplanted, can make a new blood system. Donor stem cells can make the protein or enzyme patients with this disease cells cannot. The donor cells may prevent further accumulation of toxic substances. It is hoped that the donor cells can prevent or stop the disease from progressing. This research study uses a new pre-treatment combination of two drugs, Anti-CD45 and CAMPATH-1H. Anti-CD45 and CAMPATH-1H are antibodies against certain types of blood cells. CAMPATH-1H is particularly important because it stays active in the body for a long time after infusion, which means it may work longer at preventing GVHD symptoms. In addition to antibodies, patients will receive Fludarabine, which is a chemotherapy drug. Fludarabine kills bone marrow cells and is given to reduce the bone marrow cells so that donor stem cells may 'take.' **Detailed Description:** Fludarabine will be given as a daily IV (intravenous, by vein) infusion for a total of 5 days. CAMPATH-1H will be given as a daily 4-hour IV (intravenous, by vein) infusion for three days. Anti-CD45 will be given as a daily 6-hour IV infusion over the next 4 days. Then patients will have a one-day rest period before receiving the stem cell transplant. To help prevent the body from rejecting the transplant, patients will also receive the drug FK506, starting two days before the transplant and continuing for three months. If there is no GVHD, the amount of FK506 patients are taking will be reduced by 20% every 2 weeks until this medication is stopped. ### Conditions Module **Conditions:** - Inherited Metabolic Storage Diseases **Keywords:** - Metabolic diseases ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 2 **Type:** ACTUAL **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Fludarabine will be given as a daily IV (intravenous, by vein) infusion for a total of 5 days. CAMPATH-1H will be given as a daily 4-hour IV (intravenous, by vein) infusion for three days. Anti-CD45 will be given as a daily 6-hour IV infusion over the next 4 days. To help prevent body from rejecting the transplant, the drug FK506 will be given, starting two days before the transplant and continuing for three months. **Intervention Names:** - Drug: CAMPATH-1H - Drug: Anti-CD45 - Drug: FK506 - Drug: Fludarabine **Label:** Fludarabine, CAMPATH-1H , Anti-CD45, FK506 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Fludarabine, CAMPATH-1H , Anti-CD45, FK506 **Name:** CAMPATH-1H **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Fludarabine, CAMPATH-1H , Anti-CD45, FK506 **Name:** Anti-CD45 **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Fludarabine, CAMPATH-1H , Anti-CD45, FK506 **Name:** FK506 **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Fludarabine, CAMPATH-1H , Anti-CD45, FK506 **Name:** Fludarabine **Type:** DRUG ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: * Patients with inherited metabolic storage diseases of all ages are eligible. * Diagnosis of inherited metabolic storage disease confirmed by standard biochemical and genetic studies in consultation with the Department of Genetics at the Baylor College of Medicine * Inherited metabolic storage diseases which may be stabilized or improved by stem cell transplantation include: Hurler, Hunter, Maroteaux-Lamy, Sly, Wolman, Gaucher, Farber, Nieman-Pick, Mannosidosis, Aspartylglucosaminuria, Fucosidosis, Neuronal Ceroid-Lipofuscinosis, Metachromatic Leukodystrophy, Globoid Cell Leukodystrophy, and Adrenoleukodystrophy * Availability of an HLA matched or mismatched (up to one haplotype) donor who is not an obligate carrier for the inherited condition or an unrelated HLA matched stem cell donor. Fully matched is defined as 6/6 match by high resolution DR based DNA typing. * Female patients of childbearing age must have a negative pregnancy test and be willing to use an effective means of birth control. Exclusion criteria: * Patients with a life expectancy (\<6 weeks) limited by diseases other than inherited metabolic storage disease * Patients with advanced inherited metabolic storage disease, which has not been stabilized or improved by hematopoietic stem cell transplantation. * Patients with symptomatic cardiac disease, or evidence of significant cardiac disease by echocardiogram (i.e., shortening fraction \<25%) * Patients with severe renal disease (Creatinine \>2 x normal for age) * Patients with known allergy to rat serum products * Patients with a Karnofsky or Lansky score \<50%. * Patients with a severe infection that on evaluation by the Principal Investigator precludes ablative chemotherapy or successful transplantation * Patients with severe personality disorder or mental illness or neuropsychological evaluation indicating too much damage for the transplant to be of benefit. * Patients with documented HIV positivity. * Patients with grade III-IV liver toxicity not related to metabolic storage disease. **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Houston **Country:** United States **Facility:** Texas Children's Hospital **State:** Texas **Location 2:** **City:** Houston **Country:** United States **Facility:** The Methodist Hospital **State:** Texas #### Overall Officials **Official 1:** **Affiliation:** Baylor College of Medicine **Name:** Malcolm K Brenner, MD **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11639 - Name: Metabolic Diseases - Relevance: HIGH - As Found: Storage Disease ### Condition Browse Module - Meshes - ID: D000008659 - Term: Metabolic Diseases ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000074322 - Term: Antineoplastic Agents, Immunological ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: LOW - As Found: Unknown - ID: M283230 - Name: Fludarabine - Relevance: HIGH - As Found: Comparison - ID: M18950 - Name: Tacrolimus - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M225513 - Name: Fludarabine phosphate - Relevance: LOW - As Found: Unknown - ID: M1347 - Name: Alemtuzumab - Relevance: HIGH - As Found: PAP - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000024352 - Term: Fludarabine - ID: D000074323 - Term: Alemtuzumab ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02712879 **Acronym:** SPO **Brief Title:** Moderate Bleeding in Cardiac Surgery Post Operative **Official Title:** Bleeding Moderate Postoperative Cardiac Surgery and Prognostic Implications Anemia and Postoperative Transfusion: Prospective, Observational, Descriptive. #### Organization Study ID Info **ID:** UF9695 #### Organization **Class:** OTHER **Full Name:** University Hospital, Montpellier ### Status Module #### Completion Date **Date:** 2016-06-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-04-20 **Type:** ACTUAL **Last Update Submit Date:** 2022-04-19 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-06-30 **Type:** ACTUAL #### Start Date **Date:** 2016-03-11 **Type:** ACTUAL **Status Verified Date:** 2022-04 #### Study First Post Date **Date:** 2016-03-18 **Type:** ESTIMATED **Study First Submit Date:** 2016-03-04 **Study First Submit QC Date:** 2016-03-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Montpellier #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the drainage system to define moderate bleeding postoperative cardiac surgery and define the population. **Detailed Description:** Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the drainage system to define moderate bleeding postoperative cardiac surgery and define the population. Secondary objectives: To evaluate the kinetics of moderate SPORT and its impact on anemia and postoperative transfusion. To evaluate the prognostic impact of the SPO moderate in terms of post-operative complications. Determine predictors of moderate SPO. ### Conditions Module **Conditions:** - Heart Surgery ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 303 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Hourly blood loss in drains during the first twelve hours **Measure:** Evolution of blood loss per hour drains **Time Frame:** Hourly blood loss in drains during the first twelve hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients in the postoperative intensive care in cardiac surgery Exclusion Criteria: * Patients who received a heart transplant, a heart surgery beating, cardiac support establishment of long duration, or have a disease that alters the coagulation. **Maximum Age:** 90 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** patients admitted to intensive care after surgery for heart surgery ### Contacts Locations Module #### Locations **Location 1:** **City:** Montpellier **Country:** France **Facility:** UHMontpellier **Zip:** 34700 #### Overall Officials **Official 1:** **Affiliation:** University Hospital, Montpellier **Name:** Marine SAOUR, CCA **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## 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 - Abbrev: BC15 - Name: Blood and Lymph Conditions ### Condition Browse Module - Browse Leaves - ID: M9556 - Name: Hemorrhage - Relevance: HIGH - As Found: Bleeding - ID: M4070 - Name: Anemia - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006470 - Term: Hemorrhage ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01514279 **Acronym:** IMPACT **Brief Title:** Ideas Moving Parents and Adolescents to Change Together (IMPACT) **Official Title:** Targeting Obesity and Blood Pressure in Urban Youth(Consortium Title: Childhood Obesity Prevention and Treatment Research [COPTR] and Site Project Name IMPACT (Ideas Moving Parents and Adolescents to Change Together). #### Organization Study ID Info **ID:** IMPACT-1-5U01HL103622-02 #### Organization **Class:** OTHER **Full Name:** Case Western Reserve University #### Secondary ID Infos **ID:** 5U01HL103622-02 **Link:** https://reporter.nih.gov/quickSearch/5U01HL103622-02 **Type:** NIH ### Status Module #### Completion Date **Date:** 2017-01-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-08-25 **Type:** ACTUAL **Last Update Submit Date:** 2020-08-13 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-01-21 **Type:** ACTUAL #### Results First Post Date **Date:** 2020-08-25 **Type:** ACTUAL **Results First Submit Date:** 2020-07-22 **Results First Submit QC Date:** 2020-08-13 #### Start Date **Date:** 2011-02-01 **Type:** ACTUAL **Status Verified Date:** 2020-08 #### Study First Post Date **Date:** 2012-01-23 **Type:** ESTIMATED **Study First Submit Date:** 2011-12-20 **Study First Submit QC Date:** 2012-01-17 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Heart, Lung, and Blood Institute (NHLBI) #### Lead Sponsor **Class:** OTHER **Name:** Case Western Reserve University #### Responsible Party **Investigator Affiliation:** Case Western Reserve University **Investigator Full Name:** Elaine Borawski **Investigator Title:** Angela Bowen Williamson Professor of Community Nutrition, Director, Prevention Research Center for Healthy Neighborhoods **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The National Heart, Lung, and Blood Institute (NHLBI) of the National Institute of Health (NIH) has sponsored a consortium of four sites across the United States, entitled Childhood Obesity Prevention and Treatment Research (COPTR). Each site has its own protocol. Case Western Reserve/Cleveland's project is entitled "Targeting Obesity and Blood Pressure in Urban Youth". The site name is IMPACT (Ideas Moving Parents and Adolescents to Change Together). The project assesses the effects of three interventions on Body Mass Index(BMI) in overweight and obese urban 5th-8th grade youth: a cognitive-behavioral intervention (HealthyChange), a systems improvement intervention (SystemsChange), and an education-only intervention (Tools4Change). In addition the study assesses the potential additional impact of a school-community based intervention on outcomes. The project has two phases: a formative phase (including focus groups and a pilot) and the main trial. The main trial will take place over approximately four years. **Detailed Description:** The IMPACT trial will involve a 3-arm randomized controlled trial of three behavioral and educational interventions: (1) HealthyCHANGE, a behavioral approach focusing on building skills and increasing intrinsic motivation (based on cognitive-behavioral theory with motivational interviewing components); (2) SystemCHANGE, an innovative behavioral approach focusing on system re-design of the family environment and daily routines (based on social-ecological and personal process improvement theories); and (3) education-only (representing usual care, called Tools4CHANGE). In the main trial, approximately half of the children will also be in schools that take part in the We Run This City (WRTC)Marathon program, a school-based fitness program administered by the YMCA, and half will be in schools that do not take part in the WRTC program. This study will assess the impact of the interventions on the main trial's (1) primary outcome, Change in Body Mass Index (BMI). (2) secondary outcomes including diet, physical activity, sedentary behavior, sleep, blood pressure, cardiovascular risk, body composition, fitness, and quality of life (3) mediators including : child's self-efficacy, social support, motivation, family problem solving ability, systems thinking, and self-regulation;(4) moderators including: socioeconomic status, demographic factors, environmental factors, personal and psychosocial characteristics of child and parent. ### Conditions Module **Conditions:** - Overweight - Obese **Keywords:** - Overweight - Obese - Over Nutrition - Nutrition Disorders - Body weight - Signs and Symptoms ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 360 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. **Intervention Names:** - Behavioral: HealthyCHANGE **Label:** HealthyCHANGE **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines **Intervention Names:** - Behavioral: SystemCHANGE **Label:** SystemCHANGE **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **Label:** Tools4CHANGE **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - HealthyCHANGE **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **Name:** HealthyCHANGE **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - SystemCHANGE **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **Name:** SystemCHANGE **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** BMI slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without BMI values post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. **Measure:** Slope of Body Mass Index (BMI) **Time Frame:** Baseline, 12 mos, 24 mos and 36 mos #### Secondary Outcomes **Description:** Annualized change in calories per day. Dietary intake slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. **Measure:** Dietary Intake- Calories Per Day **Time Frame:** Baseline, 12 mos, 24 mos and 36 mos **Description:** Annualized change in blood pressure measures using the slope of 3 year trajectory. Blood pressure slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood pressure readings post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. **Measure:** Blood Pressure **Time Frame:** Baseline, 12 mos, 24 mos and 36 mos **Description:** Annualized change in physical activity measures of moderate to vigorous minutes per day and bed rest/sedentary minutes per day as measured by accelerometer. Physical activity slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without accelerometer readings post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. **Measure:** Physical Activity **Time Frame:** [Baseline, 12 mos, 24 mos and 36 mos] **Description:** The results reflect the annualized change in adolescent sleep wake scale and pediatric daytime sleepiness scale. The items of the adolescent sleep wake scale are recoded to have a minimum of 0 and maximum value of 5, in which a higher scores for both the individual items and the overall sum score indicate a better outcome. The items of the pediatric daytime sleepiness are recoded to have a minimum of 0 and maximum value of 4, in which a lower score for both the individual items and the overall sum score indicates a better outcome. Sleep slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without post-baseline measures. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. **Measure:** Sleep **Time Frame:** [Baseline, 12 mos, 24 mos and 36 mos] **Description:** Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slopes of fasting glucose, HDL cholesterol, LDL cholesterol, and total cholesterol over 3 years reported. **Measure:** Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol **Time Frame:** Baseline, 12 mos, 24 mos and 36 mos **Description:** The annualized change in body composition measures over 3 years. Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in slope of BMI percentile over time reported. **Measure:** Body Composition- BMI Percentile **Time Frame:** Baseline, 12 mos, 24 mos and 36 mos **Description:** The annualized change in pacer laps completed during PACER test over 3 years. PACER test slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without PACER test measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. **Measure:** Fitness **Time Frame:** Baseline, 12 mos, 24 mos and 36 mos **Description:** The annualized change in perceived stress over 3 years. Participants are asked to rate individual scale items on their perception of how often they feel specific stressors on a scale from 0 (never) to 4 (very often). Individual scale items are summed for a total score. Higher scores indicate higher perceived frequency of stressors, therefore higher perceived stress. Outcomes are reported as the mean of the slope estimates for total perceived stress score over 3 years (from baseline to 36 months). The perceived stress slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without stress scores post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. **Measure:** Quality of Life- Perceived Stress **Time Frame:** [Baseline, 12 mos, 24 mos and 36 mos] **Description:** The annualized change of percent of calories from fat over 3 years. Percent calories from fat slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. **Measure:** Dietary Intake- Percent Calories From Fat **Time Frame:** Baseline, 12 months, 24 months, 36 months **Description:** The annualized change in the number of fruit and vegetable servings per day over 3 years. Serving slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. **Measure:** Dietary Intake- Fruit and Vegetable Servings **Time Frame:** Baseline, 12 months, 24 months, 36 months **Description:** The annualized change in sodium intake (mg) per day over 3 years. Sodium intake slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. **Measure:** Dietary Intake- Sodium **Time Frame:** Baseline, 12 months, 24 months, 36 months **Description:** Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slope of glycated Hemoglobin A1c over 3 years reported. **Measure:** Cardiometabolic Factors- Hemoglobin A1c **Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos] **Description:** Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slope of high-sensitivity C-reactive protein over 3 years reported. **Measure:** Cardiometabolic Factors- High-sensitivity C-reactive Protein **Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos] **Description:** Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slope of insulin over 3 years reported. **Measure:** Cardiometabolic Factors- Insulin **Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos] **Description:** Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slope of HOMA-IR over 3 years reported. **Measure:** Cardiometabolic Factors- HOMA-IR **Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos] **Description:** The annualized change in body composition measures over 3 years. Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in slope of waist-to-height ratio over time reported. The weight-to-heigh ratio compares the child's waist circumference (cm) to their height (cm). **Measure:** Body Composition- Waist-to-height Ratio **Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos] **Description:** The annualized change in body composition measures over 3 years. Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in slope of waist circumference (cm) over time reported. **Measure:** Body Composition- Waist Circumference **Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos] **Description:** The annualized change in body composition measures over 3 years. Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in slope of body fat percentage over time reported. Body fat percentage calculated using Stevens equation. **Measure:** Body Composition- Percent Body Fat **Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos] ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Students entering the 6th grade who are found at the standard school screenings to be overweight or obese * (BMI 85th- 94th percentile or \> 95th percentile for age/sex respectively) Exclusion Criteria: * Taking medications that alter appetite or weight (e.g. glucocorticoids, metformin, insulin, Risperidone (Risperdal), Olanzapine (Zyprexa), Clozapine(Clozaril), Quetiapine (Seroquel), Ziprasidone (Geodon), Carbamazepine (Tegretol), Valproic acid (Depakote/Depakene/Depacon), Aripiprazole (Abilify), Orlistat (Xenical), Sibutramine (Meridia), Phentermine, Diethylproprion (Tenuate), Topirimate (Topamax), glitazones (thiazolidinediones) * Inability to understand English * Stage 2 hypertension or stage 1 hypertension with end organ damage (left ventricular hypertrophy, microalbuminuria) * Severe behavioral problems that preclude group participation (as reported by parent/guardian) * Child involvement in another weight management program * Family expectation to move from the region within 1 year * The presence of a known medical condition that itself causes obesity (e.g., Prader-Willi syndrome) or interfere with HbA1C ( sickle cell disease) **Maximum Age:** 15 Years **Minimum Age:** 11 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Cleveland **Country:** United States **Facility:** Case Western Reserve University **State:** Ohio **Zip:** 44106 #### Overall Officials **Official 1:** **Affiliation:** Case Western Reserve University **Name:** Elaine A Borawski, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Case Western Reserve University **Name:** Shirley M Moore, RN, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Conducted in conjunction with the Research Coordinating Unit (UNC Chapel Hill) of the COPTR Consortium. **IPD Sharing:** YES ### References Module #### References **Citation:** Moore SM, Borawski EA, Cuttler L, Ievers-Landis CE, Love TE. IMPACT: a multi-level family and school intervention targeting obesity in urban youth. Contemp Clin Trials. 2013 Nov;36(2):574-86. doi: 10.1016/j.cct.2013.08.009. Epub 2013 Sep 2. **PMID:** 24008055 **Citation:** JaKa MM, Wood C, Veblen-Mortenson S, Moore SM, Matheson D, Stevens J, Atkins L, Michie S, Adegbite-Adeniyi C, Olayinka O, Po'e EK, Kelly AM, Nicastro H, Bangdiwala SI, Barkin SL, Pratt C, Robinson TN, Sherwood NE. Applying the Behavior Change Technique Taxonomy to Four Multicomponent Childhood Obesity Interventions. West J Nurs Res. 2021 May;43(5):468-477. doi: 10.1177/0193945920954782. Epub 2020 Sep 10. **PMID:** 32909523 **Citation:** Truesdale KP, Matheson DM, JaKa MM, McAleer S, Sommer EC, Pratt CA. Baseline diet quality of predominantly minority children and adolescents from households characterized by low socioeconomic status in the Childhood Obesity Prevention and Treatment Research (COPTR) Consortium. BMC Nutr. 2019 Sep 9;5:38. doi: 10.1186/s40795-019-0302-y. eCollection 2019. **PMID:** 32153951 **Citation:** Cui Z, Truesdale KP, Robinson TN, Pemberton V, French SA, Escarfuller J, Casey TL, Hotop AM, Matheson D, Pratt CA, Lotas LJ, Po'e E, Andrisin S, Ward DS. Recruitment strategies for predominantly low-income, multi-racial/ethnic children and parents to 3-year community-based intervention trials: Childhood Obesity Prevention and Treatment Research (COPTR) Consortium. Trials. 2019 May 28;20(1):296. doi: 10.1186/s13063-019-3418-0. **PMID:** 31138278 **Citation:** Moore SM, Borawski EA, Love TE, Jones S, Casey T, McAleer S, Thomas C, Adegbite-Adeniyi C, Uli NK, Hardin HK, Trapl ES, Plow M, Stevens J, Truesdale KP, Pratt CA, Long M, Nevar A. Two Family Interventions to Reduce BMI in Low-Income Urban Youth: A Randomized Trial. Pediatrics. 2019 Jun;143(6):e20182185. doi: 10.1542/peds.2018-2185. **PMID:** 31126971 ## Document Section ### Large Document Module #### Large Docs - Date: 2012-03-30 - Filename: Prot_SAP_ICF_000.pdf - Has ICF: True - Has Protocol: True - Has SAP: True - Label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Size: 1406255 - Type Abbrev: Prot_SAP_ICF - Upload Date: 2020-07-22T11:59 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight ### 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: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M26186 - Name: Overweight - Relevance: HIGH - As Found: Overweight - ID: M30155 - Name: Pediatric Obesity - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000050177 - Term: Overweight ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** HealthyCHANGE **Deaths Num At Risk:** 118 **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** EG000 **Other Num at Risk:** 118 **Serious Number Affected:** 30 **Serious Number At Risk:** 118 **Title:** HealthyCHANGE **Group ID:** EG001 **Title:** SystemCHANGE **Deaths Num At Risk:** 123 **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** EG001 **Other Num at Risk:** 123 **Serious Number Affected:** 29 **Serious Number At Risk:** 123 **Title:** SystemCHANGE **Group ID:** EG002 **Title:** Tools4CHANGE **Deaths Num At Risk:** 119 **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **ID:** EG002 **Other Num at Risk:** 119 **Serious Number Affected:** 28 **Serious Number At Risk:** 119 **Title:** Tools4CHANGE **Frequency Threshold:** 5 #### Serious Events **Term:** Cardiac event **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** Any event related to the cardiovascular system **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 118 **Num Events:** 5 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 123 **Num Events:** 1 **Group ID:** EG002 **Num Affected:** 3 **Num At Risk:** 119 **Num Events:** 3 **Term:** Diabetic event **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** Any event related to diabetes **Organ System:** Endocrine disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 118 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 123 **Num Events:** 2 **Group ID:** EG002 **Num At Risk:** 119 **Term:** Diabetes-related complications **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Endocrine disorders ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 118 **Num Events:** 2 **Group ID:** EG001 **Num At Risk:** 123 **Group ID:** EG002 **Num At Risk:** 119 **Term:** Surgery **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 118 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 123 **Group ID:** EG002 **Num At Risk:** 119 **Term:** Cancer diagnosis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 118 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 123 **Num Events:** 1 **Group ID:** EG002 **Num At Risk:** 119 **Term:** Hospitalization **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 118 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 123 **Num Events:** 1 **Group ID:** EG002 **Num At Risk:** 119 **Term:** Hospitalization **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 118 **Num Events:** 5 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 123 **Num Events:** 3 **Group ID:** EG002 **Num Affected:** 4 **Num At Risk:** 119 **Num Events:** 4 **Term:** Immune system disorder diagnosis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Immune system disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 118 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 123 **Num Events:** 1 **Group ID:** EG002 **Num At Risk:** 119 **Term:** Immune system disorder complications **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Immune system disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 118 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 123 **Num Events:** 1 **Group ID:** EG002 **Num At Risk:** 119 **Term:** Event resulting in injury or poisoning **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** Non-study related events only **Organ System:** Injury, poisoning and procedural complications ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 118 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 123 **Num Events:** 2 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 119 **Num Events:** 2 **Term:** Nervous system event **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 118 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 123 **Num Events:** 1 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 119 **Num Events:** 2 **Term:** Childbirth **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Pregnancy, puerperium and perinatal conditions ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 118 **Num Events:** 3 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 123 **Num Events:** 3 **Group ID:** EG002 **Num Affected:** 4 **Num At Risk:** 119 **Num Events:** 4 **Term:** Pregnancy complications **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Pregnancy, puerperium and perinatal conditions ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 118 **Num Events:** 2 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 123 **Num Events:** 1 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 119 **Num Events:** 2 **Term:** Psychiatric event **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 118 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 123 **Num Events:** 1 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 119 **Num Events:** 1 **Term:** Event related to reproductive system **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Reproductive system and breast disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 118 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 123 **Num Events:** 2 **Group ID:** EG002 **Num At Risk:** 119 **Term:** Respiratory event **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 118 **Num Events:** 3 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 123 **Num Events:** 1 **Group ID:** EG002 **Num Affected:** 3 **Num At Risk:** 119 **Num Events:** 3 **Term:** Housefire **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Social circumstances ##### Stats **Group ID:** EG000 **Num At Risk:** 118 **Group ID:** EG001 **Num At Risk:** 123 **Group ID:** EG002 **Num Affected:** 2 **Num At Risk:** 119 **Num Events:** 2 **Term:** Surgery **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Surgical and medical procedures ##### Stats **Group ID:** EG000 **Num Affected:** 7 **Num At Risk:** 118 **Num Events:** 7 **Group ID:** EG001 **Num Affected:** 8 **Num At Risk:** 123 **Num Events:** 8 **Group ID:** EG002 **Num Affected:** 5 **Num At Risk:** 119 **Num Events:** 5 **Time Frame:** 3 years ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 118 **Group ID:** BG001 **Value:** 123 **Group ID:** BG002 **Value:** 119 **Group ID:** BG003 **Value:** 360 **Units:** Participants ### Group **ID:** BG000 **Title:** HealthyCHANGE **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. ### Group **ID:** BG001 **Title:** SystemCHANGE **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. ### Group **ID:** BG002 **Title:** Tools4CHANGE **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. ### Group **ID:** BG003 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 0.56 **Value:** 11.58 #### Measurement **Group ID:** BG001 **Spread:** 0.59 **Value:** 11.59 #### Measurement **Group ID:** BG002 **Spread:** 0.56 **Value:** 11.51 #### Measurement **Group ID:** BG003 **Spread:** 0.57 **Value:** 11.56 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 66 #### Measurement **Group ID:** BG001 **Value:** 73 #### Measurement **Group ID:** BG002 **Value:** 69 #### Measurement **Group ID:** BG003 **Value:** 208 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 52 #### Measurement **Group ID:** BG001 **Value:** 50 #### Measurement **Group ID:** BG002 **Value:** 50 #### Measurement **Group ID:** BG003 **Value:** 152 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 5 #### Measurement **Group ID:** BG002 **Value:** 5 #### Measurement **Group ID:** BG003 **Value:** 14 **Category Title:** Non-Hispanic White #### Measurement **Group ID:** BG000 **Value:** 91 #### Measurement **Group ID:** BG001 **Value:** 92 #### Measurement **Group ID:** BG002 **Value:** 93 #### Measurement **Group ID:** BG003 **Value:** 276 **Category Title:** Non-Hispanic Black #### Measurement **Group ID:** BG000 **Value:** 17 #### Measurement **Group ID:** BG001 **Value:** 24 #### Measurement **Group ID:** BG002 **Value:** 18 #### Measurement **Group ID:** BG003 **Value:** 59 **Category Title:** Hispanic #### Measurement **Group ID:** BG000 **Value:** 5 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 2 #### Measurement **Group ID:** BG003 **Value:** 8 **Category Title:** Multi-racial #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 1 #### Measurement **Group ID:** BG003 **Value:** 3 **Category Title:** Other **Class Title:** Child's Race/Ethnicity ### Measure #### Measurement **Group ID:** BG000 **Value:** 118 #### Measurement **Group ID:** BG001 **Value:** 123 #### Measurement **Group ID:** BG002 **Value:** 119 #### Measurement **Group ID:** BG003 **Value:** 360 **Class Title:** United States ### Measure #### Measurement **Group ID:** BG000 **Spread:** 4.78 **Value:** 27.25 #### Measurement **Group ID:** BG001 **Spread:** 5.12 **Value:** 27.36 #### Measurement **Group ID:** BG002 **Spread:** 4.71 **Value:** 26.80 #### Measurement **Group ID:** BG003 **Spread:** 4.87 **Value:** 27.14 **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/Ethnicity, Customized **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ### Measure 5 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Body mass index **Unit of Measure:** kg/m^2 ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** [email protected] **Organization:** School of Medicine, Case Western Reserve University **Phone:** 216)368-1024 **Title:** Dr. Elaine Borawski, PhD ## 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 ### Outcome Measure 11 ### Outcome Measure 12 ### Outcome Measure 13 ### Outcome Measure 14 ### Outcome Measure 15 ### Outcome Measure 16 ### Outcome Measure 17 ### Outcome Measure 18 ### Outcome Measure 19 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.363 - **Upper Limit:** - **Value:** 0.821 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.129 - **Upper Limit:** - **Value:** 1.083 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 1.318 - **Upper Limit:** - **Value:** 0.952 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 226.65 - **Upper Limit:** - **Value:** 12.49 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 211.04 - **Upper Limit:** - **Value:** 6.99 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 250.44 - **Upper Limit:** - **Value:** 24.03 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 3.319 - **Upper Limit:** - **Value:** 1.245 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 3.075 - **Upper Limit:** - **Value:** 1.130 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 2.787 - **Upper Limit:** - **Value:** 0.886 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.796 - **Upper Limit:** - **Value:** -0.136 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.726 - **Upper Limit:** - **Value:** -0.074 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 2.378 - **Upper Limit:** - **Value:** -0.162 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 9.206 - **Upper Limit:** - **Value:** -1.450 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 8.063 - **Upper Limit:** - **Value:** -2.044 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 8.095 - **Upper Limit:** - **Value:** -2.028 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 8.228 - **Upper Limit:** - **Value:** -2.335 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 8.063 - **Upper Limit:** - **Value:** -2.044 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 6.645 - **Upper Limit:** - **Value:** -2.132 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 10.123 - **Upper Limit:** - **Value:** -3.370 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 7.486 - **Upper Limit:** - **Value:** -4.619 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 8.493 - **Upper Limit:** - **Value:** -3.523 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 16.365 - **Upper Limit:** - **Value:** 10.501 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 14.561 - **Upper Limit:** - **Value:** 13.052 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 16.961 - **Upper Limit:** - **Value:** 11.022 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 8.937 - **Upper Limit:** - **Value:** -1.061 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 9.755 - **Upper Limit:** - **Value:** -1.552 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 7.749 - **Upper Limit:** - **Value:** -1.184 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.350 - **Upper Limit:** - **Value:** -0.239 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.618 - **Upper Limit:** - **Value:** -0.361 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 2.089 - **Upper Limit:** - **Value:** -0.273 **Title:** #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.864 - **Upper Limit:** - **Value:** -0.146 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 3.805 - **Upper Limit:** - **Value:** -0.520 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 3.135 - **Upper Limit:** - **Value:** -0490 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 3.433 - **Upper Limit:** - **Value:** -0.300 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.526 - **Upper Limit:** - **Value:** -0.600 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 2.906 - **Upper Limit:** - **Value:** -0.385 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.915 - **Upper Limit:** - **Value:** -1.449 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 7.295 - **Upper Limit:** - **Value:** -1.970 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 6.645 - **Upper Limit:** - **Value:** -2.357 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 9.500 - **Upper Limit:** - **Value:** -2.409 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 8.280 - **Upper Limit:** - **Value:** -3.651 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 7.201 - **Upper Limit:** - **Value:** -2.94 **Title:** #### Outcome Measure 7 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 3.821 - **Upper Limit:** - **Value:** -1.375 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.552 - **Upper Limit:** - **Value:** -0.258 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 3.225 - **Upper Limit:** - **Value:** -1.082 **Title:** #### Outcome Measure 8 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.640 - **Upper Limit:** - **Value:** 1.084 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 3.663 - **Upper Limit:** - **Value:** 0.533 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 3.491 - **Upper Limit:** - **Value:** 1.715 **Title:** #### Outcome Measure 9 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.620 - **Upper Limit:** - **Value:** 0.313 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.769 - **Upper Limit:** - **Value:** -0.049 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 2.491 - **Upper Limit:** - **Value:** -0.026 **Title:** #### Outcome Measure 10 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.905 - **Upper Limit:** - **Value:** 0.139 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.589 - **Upper Limit:** - **Value:** -0.050 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.360 - **Upper Limit:** - **Value:** -0.055 **Title:** #### Outcome Measure 11 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.239 - **Upper Limit:** - **Value:** -0.061 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.234 - **Upper Limit:** - **Value:** -0.050 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.360 - **Upper Limit:** - **Value:** -0.055 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.276 - **Upper Limit:** - **Value:** 0.013 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.263 - **Upper Limit:** - **Value:** 0.008 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.253 - **Upper Limit:** - **Value:** -0.008 **Title:** #### Outcome Measure 12 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 425.79 - **Upper Limit:** - **Value:** -0.42 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 409.34 - **Upper Limit:** - **Value:** 26.46 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 446.28 - **Upper Limit:** - **Value:** 39.15 **Title:** #### Outcome Measure 13 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.210 - **Upper Limit:** - **Value:** -0.040 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.304 - **Upper Limit:** - **Value:** -0.021 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.093 - **Upper Limit:** - **Value:** -0.017 **Title:** #### Outcome Measure 14 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.163 - **Upper Limit:** - **Value:** -0.013 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.141 - **Upper Limit:** - **Value:** -0.002 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.123 - **Upper Limit:** - **Value:** -0.0185 **Title:** #### Outcome Measure 15 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 4.761 - **Upper Limit:** - **Value:** 0.772 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 6.875 - **Upper Limit:** - **Value:** 0.406 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 4.568 - **Upper Limit:** - **Value:** 0.228 **Title:** #### Outcome Measure 16 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.003 - **Upper Limit:** - **Value:** 0.032 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.281 - **Upper Limit:** - **Value:** 0.037 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 1.009 - **Upper Limit:** - **Value:** 0.004 **Title:** #### Outcome Measure 17 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.023 - **Upper Limit:** - **Value:** -0.003 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.017 - **Upper Limit:** - **Value:** 0.002 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.020 - **Upper Limit:** - **Value:** -0.001 **Title:** #### Outcome Measure 18 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 3.584 - **Upper Limit:** - **Value:** 1.814 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.839 - **Upper Limit:** - **Value:** 2.339 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 3.288 - **Upper Limit:** - **Value:** 2.200 **Title:** #### Outcome Measure 19 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.376 - **Upper Limit:** - **Value:** -0.246 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.889 - **Upper Limit:** - **Value:** 0.299 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 2.170 - **Upper Limit:** - **Value:** -0.044 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** BMI slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without BMI values post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline, 12 mos, 24 mos and 36 mos **Title:** Slope of Body Mass Index (BMI) **Type:** PRIMARY **Unit of Measure:** kg/m^2/year ##### Group **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG000 **Title:** HealthyCHANGE ##### Group **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG001 **Title:** SystemCHANGE ##### Group **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **ID:** OG002 **Title:** Tools4CHANGE #### Outcome Measure 2 **Description:** Annualized change in calories per day. Dietary intake slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline, 12 mos, 24 mos and 36 mos **Title:** Dietary Intake- Calories Per Day **Type:** SECONDARY **Unit of Measure:** kcal/d/year ##### Group **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG000 **Title:** HealthyCHANGE ##### Group **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG001 **Title:** SystemCHANGE ##### Group **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **ID:** OG002 **Title:** Tools4CHANGE #### Outcome Measure 3 **Description:** Annualized change in blood pressure measures using the slope of 3 year trajectory. Blood pressure slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood pressure readings post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline, 12 mos, 24 mos and 36 mos **Title:** Blood Pressure **Type:** SECONDARY **Unit of Measure:** mmHg/year ##### Group **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG000 **Title:** HealthyCHANGE ##### Group **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG001 **Title:** SystemCHANGE ##### Group **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **ID:** OG002 **Title:** Tools4CHANGE #### Outcome Measure 4 **Description:** Annualized change in physical activity measures of moderate to vigorous minutes per day and bed rest/sedentary minutes per day as measured by accelerometer. Physical activity slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without accelerometer readings post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** [Baseline, 12 mos, 24 mos and 36 mos] **Title:** Physical Activity **Type:** SECONDARY **Unit of Measure:** minutes/day/year ##### Group **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG000 **Title:** HealthyCHANGE ##### Group **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG001 **Title:** SystemCHANGE ##### Group **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **ID:** OG002 **Title:** Tools4CHANGE #### Outcome Measure 5 **Description:** The results reflect the annualized change in adolescent sleep wake scale and pediatric daytime sleepiness scale. The items of the adolescent sleep wake scale are recoded to have a minimum of 0 and maximum value of 5, in which a higher scores for both the individual items and the overall sum score indicate a better outcome. The items of the pediatric daytime sleepiness are recoded to have a minimum of 0 and maximum value of 4, in which a lower score for both the individual items and the overall sum score indicates a better outcome. Sleep slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without post-baseline measures. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** [Baseline, 12 mos, 24 mos and 36 mos] **Title:** Sleep **Type:** SECONDARY **Unit of Measure:** score on a scale/year ##### Group **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG000 **Title:** HealthyCHANGE ##### Group **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG001 **Title:** SystemCHANGE ##### Group **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **ID:** OG002 **Title:** Tools4CHANGE #### Outcome Measure 6 **Description:** Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slopes of fasting glucose, HDL cholesterol, LDL cholesterol, and total cholesterol over 3 years reported. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline, 12 mos, 24 mos and 36 mos **Title:** Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol **Type:** SECONDARY **Unit of Measure:** mg/dL/year ##### Group **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG000 **Title:** HealthyCHANGE ##### Group **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG001 **Title:** SystemCHANGE ##### Group **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **ID:** OG002 **Title:** Tools4CHANGE #### Outcome Measure 7 **Description:** The annualized change in body composition measures over 3 years. Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in slope of BMI percentile over time reported. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline, 12 mos, 24 mos and 36 mos **Title:** Body Composition- BMI Percentile **Type:** SECONDARY **Unit of Measure:** BMI percentile/year ##### Group **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG000 **Title:** HealthyCHANGE ##### Group **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG001 **Title:** SystemCHANGE ##### Group **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **ID:** OG002 **Title:** Tools4CHANGE #### Outcome Measure 8 **Description:** The annualized change in pacer laps completed during PACER test over 3 years. PACER test slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without PACER test measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline, 12 mos, 24 mos and 36 mos **Title:** Fitness **Type:** SECONDARY **Unit of Measure:** laps completed/year ##### Group **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG000 **Title:** HealthyCHANGE ##### Group **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG001 **Title:** SystemCHANGE ##### Group **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **ID:** OG002 **Title:** Tools4CHANGE #### Outcome Measure 9 **Description:** The annualized change in perceived stress over 3 years. Participants are asked to rate individual scale items on their perception of how often they feel specific stressors on a scale from 0 (never) to 4 (very often). Individual scale items are summed for a total score. Higher scores indicate higher perceived frequency of stressors, therefore higher perceived stress. Outcomes are reported as the mean of the slope estimates for total perceived stress score over 3 years (from baseline to 36 months). The perceived stress slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without stress scores post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** [Baseline, 12 mos, 24 mos and 36 mos] **Title:** Quality of Life- Perceived Stress **Type:** SECONDARY **Unit of Measure:** scores on a scale/year ##### Group **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG000 **Title:** HealthyCHANGE ##### Group **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG001 **Title:** SystemCHANGE ##### Group **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **ID:** OG002 **Title:** Tools4CHANGE #### Outcome Measure 10 **Description:** The annualized change of percent of calories from fat over 3 years. Percent calories from fat slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline, 12 months, 24 months, 36 months **Title:** Dietary Intake- Percent Calories From Fat **Type:** SECONDARY **Unit of Measure:** percent/year ##### Group **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG000 **Title:** HealthyCHANGE ##### Group **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG001 **Title:** SystemCHANGE ##### Group **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **ID:** OG002 **Title:** Tools4CHANGE #### Outcome Measure 11 **Description:** The annualized change in the number of fruit and vegetable servings per day over 3 years. Serving slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline, 12 months, 24 months, 36 months **Title:** Dietary Intake- Fruit and Vegetable Servings **Type:** SECONDARY **Unit of Measure:** number of servings/day/year ##### Group **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG000 **Title:** HealthyCHANGE ##### Group **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG001 **Title:** SystemCHANGE ##### Group **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **ID:** OG002 **Title:** Tools4CHANGE #### Outcome Measure 12 **Description:** The annualized change in sodium intake (mg) per day over 3 years. Sodium intake slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline, 12 months, 24 months, 36 months **Title:** Dietary Intake- Sodium **Type:** SECONDARY **Unit of Measure:** mg/day/year ##### Group **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG000 **Title:** HealthyCHANGE ##### Group **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG001 **Title:** SystemCHANGE ##### Group **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **ID:** OG002 **Title:** Tools4CHANGE #### Outcome Measure 13 **Description:** Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slope of glycated Hemoglobin A1c over 3 years reported. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos] **Title:** Cardiometabolic Factors- Hemoglobin A1c **Type:** SECONDARY **Unit of Measure:** % glycated/year ##### Group **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG000 **Title:** HealthyCHANGE ##### Group **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG001 **Title:** SystemCHANGE ##### Group **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **ID:** OG002 **Title:** Tools4CHANGE #### Outcome Measure 14 **Description:** Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slope of high-sensitivity C-reactive protein over 3 years reported. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos] **Title:** Cardiometabolic Factors- High-sensitivity C-reactive Protein **Type:** SECONDARY **Unit of Measure:** mg/L/year ##### Group **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG000 **Title:** HealthyCHANGE ##### Group **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG001 **Title:** SystemCHANGE ##### Group **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **ID:** OG002 **Title:** Tools4CHANGE #### Outcome Measure 15 **Description:** Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slope of insulin over 3 years reported. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos] **Title:** Cardiometabolic Factors- Insulin **Type:** SECONDARY **Unit of Measure:** uU/mL/year ##### Group **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG000 **Title:** HealthyCHANGE ##### Group **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG001 **Title:** SystemCHANGE ##### Group **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **ID:** OG002 **Title:** Tools4CHANGE #### Outcome Measure 16 **Description:** Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slope of HOMA-IR over 3 years reported. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos] **Title:** Cardiometabolic Factors- HOMA-IR **Type:** SECONDARY **Unit of Measure:** score on a scale/year ##### Group **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG000 **Title:** HealthyCHANGE ##### Group **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG001 **Title:** SystemCHANGE ##### Group **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **ID:** OG002 **Title:** Tools4CHANGE #### Outcome Measure 17 **Description:** The annualized change in body composition measures over 3 years. Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in slope of waist-to-height ratio over time reported. The weight-to-heigh ratio compares the child's waist circumference (cm) to their height (cm). **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos] **Title:** Body Composition- Waist-to-height Ratio **Type:** SECONDARY **Unit of Measure:** ratio/year ##### Group **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG000 **Title:** HealthyCHANGE ##### Group **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG001 **Title:** SystemCHANGE ##### Group **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **ID:** OG002 **Title:** Tools4CHANGE #### Outcome Measure 18 **Description:** The annualized change in body composition measures over 3 years. Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in slope of waist circumference (cm) over time reported. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos] **Title:** Body Composition- Waist Circumference **Type:** SECONDARY **Unit of Measure:** cm/year ##### Group **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG000 **Title:** HealthyCHANGE ##### Group **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG001 **Title:** SystemCHANGE ##### Group **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **ID:** OG002 **Title:** Tools4CHANGE #### Outcome Measure 19 **Description:** The annualized change in body composition measures over 3 years. Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in slope of body fat percentage over time reported. Body fat percentage calculated using Stevens equation. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos] **Title:** Body Composition- Percent Body Fat **Type:** SECONDARY **Unit of Measure:** percent/year ##### Group **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG000 **Title:** HealthyCHANGE ##### Group **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** OG001 **Title:** SystemCHANGE ##### Group **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **ID:** OG002 **Title:** Tools4CHANGE ### Participant Flow Module #### Group **Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** FG000 **Title:** HealthyCHANGE #### Group **Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. **ID:** FG001 **Title:** SystemCHANGE #### Group **Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. **ID:** FG002 **Title:** Tools4CHANGE #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 118 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 123 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 119 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 107 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 110 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 114 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 11 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 13 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 5 **Recruitment Details:** Participants were recruited between May 2012 and January 2014 as part of an existing BMI and blood pressure screening program in the local school district. Participants were randomly assigned to 1 of 3 intervention study arms within 37 days of the baseline clinical visit once recruited. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT02523079 **Acronym:** CBT-INSOMNIA **Brief Title:** Cognitive Behavioral Therapy for Insomnia Among Different Types of Shift Workers **Official Title:** Cognitive Behavioral Therapy for Insomnia Among Different Types of Shift Workers #### Organization Study ID Info **ID:** 34627 #### Organization **Class:** OTHER **Full Name:** Finnish Institute of Occupational Health #### Secondary ID Infos **Domain:** Finnish Work Environment Fund **ID:** 114391 **Type:** OTHER_GRANT **Domain:** The Ethics Committees of the Hospital District of Helsinki and Uusimaa, Finland **ID:** 53/13/03/00/15 **Type:** REGISTRY **Domain:** NordForsk **ID:** 74809 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2020-06-30 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** ACTIVE_NOT_RECRUITING #### Last Update Post Date **Date:** 2019-04-16 **Type:** ACTUAL **Last Update Submit Date:** 2019-04-15 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2019-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2015-01-01 **Type:** ACTUAL **Status Verified Date:** 2019-04 #### Study First Post Date **Date:** 2015-08-14 **Type:** ESTIMATED **Study First Submit Date:** 2015-07-01 **Study First Submit QC Date:** 2015-08-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Finnish Work Environment Fund **Class:** UNKNOWN **Name:** NordForsk **Class:** OTHER **Name:** City of Helsinki **Class:** UNKNOWN **Name:** City of Turku, Occupational Health Centre **Class:** UNKNOWN **Name:** Finnair Health Services **Class:** OTHER **Name:** Aava Medical Centre **Class:** UNKNOWN **Name:** Fazer Health Services #### Lead Sponsor **Class:** OTHER **Name:** Finnish Institute of Occupational Health #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of the study is to compare the implementation and effectiveness of group and self-help based cognitive behavioral treatment for insomnia (CBT-I) delivered by occupational health services (OHS) in a randomized and controlled design (RCT) among different types of shift workers. **Detailed Description:** Because of irregular sleep-wake pattern shift work is a challenge in the screening and treatment of chronic insomnia. Earlier results has showed that CBT-I delivered by trained nurses of OHS may be effective treatment also among workers with irregular work hours. The aim of the present study is to compare the implementation and effectiveness of OHS delivered group and self-help based CBT-I in a RCT design among different types of shift work. Participants (n=90-120) are shift workers with insomnia disorder that has lasted at least three months. The participants are randomized to a) group-based CBT-I (6 group sessions); or b) mainly computerized self-help CBT-I (an individual session before and after the intervention) delivered by a trained OHS nurse or psychologist; or c) control group given a sleep hygiene intervention (1 individual session). Outcomes are assessed using a sleep diary, questionnaires, actigraphy and cognitive performance tests. To study the effect of CBT-I program at molecular level, blood samples of participants will be collected at baseline and at the end of the program for genetic analyses. The measurements are conducted at five time points for a period of two years. The investigators expect to find that both group and self-help based CBT-I among different types of shift workers are effective low-intensity treatments of chronic insomnia compared to control intervention. Through the training of OHS or general medical practitioners and by computerised self-help interventions the investigators may have better chance to make CBT-I more accessible to a larger number of insomniacs also with different types of working hours. Additionally, it may be possible to decrease chronic insomnia and unfavourably consequences of insomnia to the health and performance capacity in shift workers. ### Conditions Module **Conditions:** - Chronic Insomnia - Cognitive Behavioral Therapy - Sleep Disorders, Circadian Rhythm - Sleep Disorders, Shift-Work ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 83 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Includes 6 group sessions (90 minutes each). The groups are led by trained psychologist or nurse of occupational health services. The manualized treatment is based on the general CBT-I model and includes components such as sleep hygiene, relaxation, stimulus control, sleep restriction and cognitive restructuring. In addition, participants receive information on how to schedule sleep, wake and light based on circadian principles while working differently timed shifts. **Intervention Names:** - Behavioral: Cognitive Behavioral Group Therapy for Insomnia **Label:** Cognitive Behavioral Group Therapy for Insomnia **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Mainly computerized self-help intervention. Includes an individual session before and after the intervention (30 minutes each) led by trained psychologist or nurse of occupational health services. The self-help treatment is based on the general CBT-I model and includes components such as sleep hygiene, relaxation, stimulus control, sleep restriction and cognitive restructuring. In addition, participants receive information on how to schedule sleep, wake and light based on circadian principles while working differently timed shifts. **Intervention Names:** - Behavioral: Cognitive Behavioral Self-help Therapy for Insomnia **Label:** Cognitive Behavioral Self-help Therapy for Insomnia **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Includes one individual session (60 minutes) led by trained psychologist or nurse of occupational health services. The intervention is based on sleep hygiene guidance. **Intervention Names:** - Behavioral: Sleep Hygiene Guidance **Label:** Sleep Hygiene Guidance **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Cognitive Behavioral Group Therapy for Insomnia **Name:** Cognitive Behavioral Group Therapy for Insomnia **Other Names:** - Group-based CBT-I **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Cognitive Behavioral Self-help Therapy for Insomnia **Name:** Cognitive Behavioral Self-help Therapy for Insomnia **Other Names:** - Self-help CBT-I **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Sleep Hygiene Guidance **Name:** Sleep Hygiene Guidance **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** Personality traits (Big Five facets) **Measure:** Short Five (S5) Personality traits (NEO-PRI-R) **Time Frame:** Baseline #### Primary Outcomes **Measure:** Changes over the measurement points in Insomnia Severity Index (ISI) **Time Frame:** Baseline, immediately after intervention and 3-, 6-, 12- and 24-month follow-ups #### Secondary Outcomes **Measure:** Changes over the measurement points in sleep diary **Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups **Measure:** Changes over the measurement points in Sleep Hygiene Practice Scale **Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups **Measure:** Changes over the measurement points in actigraphy **Time Frame:** Baseline, immediately after intervention and 6-month follow-up **Measure:** Changes over the measurement points in Shirom-Melamed Burnout Measure (SMBM) **Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups **Measure:** Changes over the measurement points in Generalized Anxiety Disorder (GAD-7) **Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups **Measure:** Changes over the measurement points in Beck Depression Inventory **Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups **Measure:** Changes over the measurement points in a single-item measure of stress symptoms **Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups **Measure:** Changes over the measurement points in Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) **Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups **Measure:** Changes over the measurement points in Penn State Worry Questionnaire (PSWQ) **Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups **Measure:** Changes over the measurement points in Sense of Coherence **Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups **Description:** Finnish version of the RAND 36 item Health Survey **Measure:** Changes over the measurement points in RAND SF-36 **Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups **Measure:** Changes over the measurement points in Work Ability Index **Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups **Measure:** Changes over the measurement points in Own recovery evaluation **Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups **Measure:** Changes over the measurement points in Work Cognitive Failure Scale (WCFS) **Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups **Measure:** Changes over the measurement points in computerized cognitive performance tests **Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups **Description:** Genetic analyses **Measure:** Changes over the measurement points in blood samples **Time Frame:** Baseline and 6-month follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Chronic Insomnia (F51.0) * Difficulty initiating and/or maintaining sleep for ≥ 30 minutes and/or the use of sleep promoting medicine on three or more nights per week for at least 3 months * Motivation to treat insomnia with non-pharmacological methods * Full-time shift work (at least 10 % of shifts are morning, evening and/or night shifts) * Fluent Finnish (due to interventions) Exclusion Criteria: * Non-assessed or untreated somatic or mental illness which may explain insomnia * Planned changes in the work (for example retirement) **Maximum Age:** 60 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Helsinki **Country:** Finland **Facility:** City of Helsinki, Occupational Health Centre **State:** Uusimaa **Zip:** 00099 **Location 2:** **City:** Helsinki **Country:** Finland **Facility:** Aava Medical Centre **Zip:** 00240 **Location 3:** **City:** Helsinki **Country:** Finland **Facility:** Finnair Health Services **Zip:** 01053 **Location 4:** **City:** Turku **Country:** Finland **Facility:** City of Turku, Occupational Health Centre **Zip:** 20500 **Location 5:** **City:** Vantaa **Country:** Finland **Facility:** Fazer Health Services **Zip:** 01230 ### References Module #### References **Citation:** Jarnefelt H, Harma M, Sallinen M, Virkkala J, Paajanen T, Martimo KP, Hublin C. Cognitive behavioural therapy interventions for insomnia among shift workers: RCT in an occupational health setting. Int Arch Occup Environ Health. 2020 Jul;93(5):535-550. doi: 10.1007/s00420-019-01504-6. Epub 2019 Dec 18. Erratum In: Int Arch Occup Environ Health. 2020 Mar 3;: **PMID:** 31853633 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020919 - Term: Sleep Disorders, Intrinsic - ID: D000020920 - Term: Dyssomnias - ID: D000009422 - Term: Nervous System Diseases - ID: D000001523 - Term: Mental Disorders - ID: D000009461 - Term: Neurologic Manifestations - ID: D000021081 - Term: Chronobiology Disorders - ID: D000009784 - Term: Occupational Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC24 - Name: Occupational Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M22007 - Name: Sleep Disorders, Circadian Rhythm - Relevance: HIGH - As Found: Sleep Disorders, Circadian Rhythm - ID: M22242 - Name: Parasomnias - Relevance: HIGH - As Found: Sleep Disorders - ID: M10356 - Name: Sleep Initiation and Maintenance Disorders - Relevance: HIGH - As Found: Insomnia - ID: M15696 - Name: Sleep Wake Disorders - Relevance: HIGH - As Found: Sleep Disorders - ID: M22654 - Name: Sleep Disorders, Intrinsic - Relevance: LOW - As Found: Unknown - ID: M22655 - Name: Dyssomnias - 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: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M22703 - Name: Chronobiology Disorders - Relevance: LOW - As Found: Unknown - ID: M12719 - Name: Occupational Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007319 - Term: Sleep Initiation and Maintenance Disorders - ID: D000012893 - Term: Sleep Wake Disorders - ID: D000020447 - Term: Parasomnias - ID: D000020178 - Term: Sleep Disorders, Circadian Rhythm ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00760279 **Brief Title:** An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates **Official Title:** An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates Pediatric Pharmacology Research Unit, Children's Hospital of Michigan #### Organization Study ID Info **ID:** PPRU10820 #### Organization **Class:** NIH **Full Name:** Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ### Status Module #### Expanded Access Info #### Last Update Post Date **Date:** 2008-09-26 **Type:** ESTIMATED **Last Update Submit Date:** 2008-09-25 **Overall Status:** COMPLETED #### Start Date **Date:** 2005-09 **Status Verified Date:** 2008-09 #### Study First Post Date **Date:** 2008-09-26 **Type:** ESTIMATED **Study First Submit Date:** 2008-09-25 **Study First Submit QC Date:** 2008-09-25 ### Sponsor Collaborators Module #### Collaborators **Class:** NETWORK **Name:** Pediatric Pharmacology Research Units Network **Class:** OTHER **Name:** Children's Hospital of Michigan #### Lead Sponsor **Class:** NIH **Name:** Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of IV azithromycin in preterm neonates and confirm that the pharmacokinetics of azithromycin is similar in the 24-\<32 week and 32-\<37 week neonate. The dose of 10 mg/kg has been chosen on the basis of previous pediatric pharmacokinetic studies. **Detailed Description:** In vitro studies with azithromycin show good inhibitory activity against U. urealyticum. Pharmacokinetic studies of azithromycin in older children show better tolerance, higher tissue concentration, fewer side effects, and fewer drug interactions, when compared to erythromycin. Thus far, there have been no published data on the pharmacokinetic profile of azithromycin in neonates including low birth weight infants. However, the clinical pharmacology profile suggests a substantial therapeutic advantage of this drug in the newborn. To date, there are no data on the PK profile of IV Azithromycin from whence rational dosing can be derived. ### Conditions Module **Conditions:** - Ureaplasma - Bacterial Infection **Keywords:** - Bacterial infection - Azithromycin ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 16 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** Azithromycin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Safety: Patients will be monitored for clinical adverse events and have standard hematology labs drawn within 72 hours of study entry. Liver function tests, renal function tests and standard chemistries will be drawn prior to and at the end of the study. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. 24 to 37 weeks gestational age 2. postnatal age 0 to 30 days 3. May require therapy with antibiotics/anti-infectives 4. Have baseline Hematology labs available (hemoglobin, hematocrit, white blood cell and differential and platelet count), which have been obtained within the previous 72 hours, as part of their standard of care 5. Signed informed consent by the parent or guardian Exclusion Criteria: 1. Clinically significant hepatic disease (ALT or AST twice the normal value) 2. Clinically significant anemia (hemoglobin \< 10 gm %) 3. Neutropenia (absolute neutrophil count \< 500 cells/mm3) 4. Clinically significant renal disease \[Creatinine clearance twice the normal value, as calculated by the Schwartz formula : Length in cms x k (a constant) / S.Cr (Values for the constant are given in Appendix 1)\] 5. Cardiac rhythm abnormalities 6. Critically ill patients 7. Patients who are on or expected to be on the following concurrent medications carbamazepine, phenytoin, theophylline, digoxin, warfarin, ergot alkaloids, triazolam, cyclosporine, terfenadine, hexobarbital and antacids. **Maximum Age:** 30 Days **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Detroit **Country:** United States **Facility:** Wayne State **State:** Michigan **Zip:** 48201 **Location 2:** **City:** Cleveland **Country:** United States **Facility:** Rainbow Babies and Children's Hospital **State:** Ohio **Zip:** 44106-6010 #### Overall Officials **Official 1:** **Affiliation:** Wayne State **Name:** Elias Tessema, M.D. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Wayne State **Name:** David Edwards, Pharm.D. **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Wayne State **Name:** Jacob Aranda, M.D., Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007239 - Term: Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses ### 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 ### 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: M4722 - Name: Bacterial Infections - Relevance: HIGH - As Found: Bacterial Infections - ID: M25869 - Name: Premature Birth - 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 ### Condition Browse Module - Meshes - ID: D000001424 - Term: Bacterial Infections ### Intervention Browse Module - Ancestors - ID: D000000900 - Term: Anti-Bacterial 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 ### Intervention Browse Module - Browse Leaves - ID: M20132 - Name: Azithromycin - Relevance: HIGH - As Found: 20 minutes - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017963 - Term: Azithromycin ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02528279 **Acronym:** REPLAMO **Brief Title:** Relapses in Plasmodium Ovale and Efficacy of Artemether-lumefantrine for Mixed Species and Non-falciparum Malaria **Official Title:** Prospective Assessment of Relapse Characteristics of Plasmodium Ovale and Antimalarial Treatment Efficacy of Artemether-lumefantrine for Mixed Species and Non-falciparum Malaria in Gabon #### Organization Study ID Info **ID:** Rep001 #### Organization **Class:** OTHER **Full Name:** Albert Schweitzer Hospital ### Status Module #### Completion Date **Date:** 2016-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-01-25 **Type:** ESTIMATED **Last Update Submit Date:** 2017-01-24 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-10 **Type:** ACTUAL #### Start Date **Date:** 2014-10 **Status Verified Date:** 2017-01 #### Study First Post Date **Date:** 2015-08-19 **Type:** ESTIMATED **Study First Submit Date:** 2015-04-28 **Study First Submit QC Date:** 2015-08-18 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Medical University of Vienna #### Lead Sponsor **Class:** OTHER **Name:** Albert Schweitzer Hospital #### Responsible Party **Investigator Affiliation:** Albert Schweitzer Hospital **Investigator Full Name:** Michael Ramharter **Investigator Title:** Assoc. Prof., MD, MSc **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Malaria is a protozoan infection transmitted by anopheline mosquitoes. The most severe forms are caused by Plasmodium (P) falciparum and to a much lesser extent by P. vivax. Although the interest in research on malaria has increased during the last years, yet little research is conducted on the "neglected" malaria species P. ovale and P. malariae. P. ovale being first described in 1922, it still remains unclear whether it displays dormant pre-erythrocytic liver stages, so called hypnozoites, or not. Primaquine, the only marketed drug with liver stage activity at present, can cause severe hemolysis in glucose-6-phosphate dehydrogenase (G6PD) deficient persons and methemoglobinemia. Because G6PD is widely spread in Central Africa, it is important to explore whether additional intake of liver-active medication is really needed and on this account further research to investigating new treatment options with liver stage activity should be conducted. While, due to widespread resistance, treatment recommendations for P. falciparum and mixed infections have switched from chloroquine to the safer applicable artemisinin-based combination therapies (ACTs), World Health Organization (WHO) guidelines still suggest chloroquine as first line treatment for P. malariae and P. ovale mono infections. Further studies assessing alternative treatment options are largely missing. Summing up the current situation for both topics shows the need for further research. Therefore this study aims to assess the evidence and characterize the frequency of relapses in P. ovale infections with respect to differences between its subspecies as well as the effectiveness of the ACT artemether-lumefantrine in P. malariae and P. ovale mono- and mixed infections. **Detailed Description:** Although P. ovale hypnozoites have never been demonstrated by biological experiments and findings in the literature about relapses are controversial, a 14 days primaquine standard therapy is recommended for every patient suffering from P. ovale infection. As there is no clear evidence of relapses of P. ovale it is of importance to conclusively analyze clinical evidence for its relapse potential to evaluate the necessity for further anti-relapse treatment options. Moreover, summarizing the actual situation shows the need for further evaluation of the clinical use of ACTs in non-falciparum infections: * Firstly, molecular diagnostic methods indicate that P. malariae and P. ovale are more prevalent than previously thought. In many settings malaria is treated on clinical suspicion. Diagnosis by microscopy is difficult if parasitemia is low and differentiation of species requires experience. This leads to the assumption that P. malariae and P. ovale infections are already blindly treated with the common ACTs recommended for P. falciparum malaria. The evaluation of artemisinin based combination therapies for non-falciparum malaria is therefore essential. * Secondly, combination therapies have proven to be protective for the emergence of resistant parasites and in Asia combination therapy could even reduce resistance. As chloroquine-resistant P. malariae parasites have been reported, a combination therapy should be implemented in order to stop the emergence and spread of further resistance. Additionally, artemisinins can, in contrast to chloroquine, reduce transmissibility by their gametocytocidal activity. A uniform treatment algorithm for all four Plasmodium species would simplify and facilitate treatment of malaria. With the reduction of chloroquine use in settings of poor quality diagnosis, the risk of fatal treatment failure due to wrongly administered chloroquine to chloroquine-resistant P. falciparum would be decreased. Finally, if no 8-aminoquinoline treatment was necessary for P. ovale infections, this could improve the safety and compliance of treatment. The study is designed as an open label prospective study with a within group design. Patients enrolled will receive oral artemether-lumefantrine tablets as a 6 dose regimen over 3 consecutive days (Day 0, 1 and 2). Dosage depends on the patient's weight is according to the manufacturers recommendations. Patients will be followed for 42 days. If P. ovale is diagnosed at baseline, a one-year follow-up will be conducted every second week. Parasite density, expressed as the number of parasites per microliter (µl) of blood, will be measured regularly to determine parasite clearance time (PCT). Blood smears preparation, staining, examination and interpretation will be done according to the Lambaréné method. Thick and thin blood films for parasite count and species diagnosis should be obtained and examined at screening on D0 to confirm inclusion/exclusion criteria. Thick blood films will be examined every 24h following first dose administration and until the parasites have cleared. Thick and thin blood films will be also examined on Days 7, 14, 21, 28, 35 and 42 or on any other day if the patient spontaneously returns. For participants with P. ovale infection at baseline, reading of thick and thin blood films will be continued every second week for up to one year. In case of reappearance of parasites, Coartem will be administered again and Follow-up will be continued as scheduled. Diagnosis of P. ovale will be effected by PCR. Furthermore, genotyping studies will be used to differentiate a new infection from relapse or recrudescence and to confirm microscopic diagnosis of species. Plasma samples will be collected and stored for further pharmacokinetic analysis 7 days after treatment initiation. To determine the efficacy clinically, body temperature and clinical signs and symptoms of malaria will be assessed. Safety assessments include physical examination, vital signs and hematology. Adverse Events and Serious Adverse Events will be ascertained. The investigator or his / her staff will notify the Independent Ethics Committee of all Serious Adverse Events as soon as possible and in accordance with local regulations. ### Conditions Module **Conditions:** - Malaria **Keywords:** - Plasmodium ovale - relapse - artemether-lumefantrine - mixed species malaria - non-falciparum malaria ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will receive the study drug combination artemether-lumefantrine (Coartem®) orally as a 6 dose regimen for three consecutive days. Tablets are available as a fixed dose combination of 20mg artemether plus 120mg lumefantrine. The dosing will be based on the body weight and follow the manufacturer's recommendations: Body weight 5-14kg: 1 tablet; Body weight 15-24kg: 2 tablets; Body weight 25-34kg: 3 tablets; Body weight \> 34kg: 4 tablets; The respective amount of tablets is to be taken at hours 0, 8, 24, 36, 48 and 60 with fatty food. **Intervention Names:** - Drug: Coartem **Label:** Coartem **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Coartem **Description:** Patients will receive the study drug combination artemether-lumefantrine (Coartem®) orally as a 6 dose regimen for three consecutive days. Tablets are available as a fixed dose combination of 20mg artemether plus 120mg lumefantrine. The dosing will be based on the body weight and follow the manufacturer's recommendations: Body weight 5-14kg: 1 tablet; Body weight 15-24kg: 2 tablets; Body weight 25-34kg: 3 tablets; Body weight \> 34kg: 4 tablets; The respective amount of tablets is to be taken at hours 0, 8, 24, 36, 48 and 60 with fatty food. **Name:** Coartem **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Adequate clinical and parasitological response on Day 28 **Measure:** Adequate clinical and parasitological response (WHO criteria for antimalarial drug trials) **Time Frame:** 28 days #### Secondary Outcomes **Measure:** Parasite clearance time **Time Frame:** 7 days **Measure:** Fever clearance time **Time Frame:** 7 days **Description:** Evidence and characterization of duration and frequency of relapses due to Plasmodium ovale after day 28. This is a disctinct outcome measure from the primary outcome and will be presented seperately. **Measure:** Reappearance of P. ovale parasitemia **Time Frame:** from day 29 - 2 years of follow up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female patients older than 1 year * Presence of uncomplicated malaria infection confirmed by: fever or history of fever in the previous 3 days, and positive microscopy of P. malariae, P. ovale or mixed infection with parasite density \> 10 - 200000/µl of blood * Residence in vicinity and no travel plans for the next 6 months * Written informed consent by the patient or the legal representative and where possible, patient assent will be sought. If the patient/parent/guardian is unable to write, witnessed consent is permitted according to local ethical considerations. Exclusion Criteria: * Presence of P. falciparum monoinfection * Presence of severe malaria (clinical WHO criteria) * Presence of other febrile conditions * Known history of hypersensitivity, allergic or adverse reactions to artemether or lumefantrine * Intake of any antimalarials or antibiotics with known antimalarial activity in the past 72 hours * Intake of an 8-aminoquinoline antimalarial or atovaquone-proguanil in preceding 28 days * Pregnant women in first trimenon **Minimum Age:** 1 Year **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Lambaréné **Country:** Gabon **Facility:** Centre de Recherches Médicales de Lambaréné, Hôpital Albert Schweitzer **State:** Moyen-Ogooué **Zip:** 118 **Location 2:** **City:** Fougamou **Country:** Gabon **Facility:** Centre de Recherches Médicales de Ngounié **State:** Ngounié **Zip:** 113 #### Overall Officials **Official 1:** **Affiliation:** Centre de Recherches Médicales de Lambaréné **Name:** Michael Ramharter, Prof. **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Planche T, Krishna S, Kombila M, Engel K, Faucher JF, Ngou-Milama E, Kremsner PG. Comparison of methods for the rapid laboratory assessment of children with malaria. Am J Trop Med Hyg. 2001 Nov;65(5):599-602. doi: 10.4269/ajtmh.2001.65.599. **PMID:** 11716121 **Citation:** Richter J, Franken G, Mehlhorn H, Labisch A, Haussinger D. What is the evidence for the existence of Plasmodium ovale hypnozoites? Parasitol Res. 2010 Nov;107(6):1285-90. doi: 10.1007/s00436-010-2071-z. Epub 2010 Oct 5. **PMID:** 20922429 **Citation:** Maguire JD, Sumawinata IW, Masbar S, Laksana B, Prodjodipuro P, Susanti I, Sismadi P, Mahmud N, Bangs MJ, Baird JK. Chloroquine-resistant Plasmodium malariae in south Sumatra, Indonesia. Lancet. 2002 Jul 6;360(9326):58-60. doi: 10.1016/S0140-6736(02)09336-4. **PMID:** 12114045 **Citation:** Greenwood BM, Bradley AK, Greenwood AM, Byass P, Jammeh K, Marsh K, Tulloch S, Oldfield FS, Hayes R. Mortality and morbidity from malaria among children in a rural area of The Gambia, West Africa. Trans R Soc Trop Med Hyg. 1987;81(3):478-86. doi: 10.1016/0035-9203(87)90170-2. **PMID:** 3318021 **Citation:** Perandin F, Manca N, Calderaro A, Piccolo G, Galati L, Ricci L, Medici MC, Arcangeletti MC, Snounou G, Dettori G, Chezzi C. Development of a real-time PCR assay for detection of Plasmodium falciparum, Plasmodium vivax, and Plasmodium ovale for routine clinical diagnosis. J Clin Microbiol. 2004 Mar;42(3):1214-9. doi: 10.1128/JCM.42.3.1214-1219.2004. **PMID:** 15004078 **Citation:** Groger M, Veletzky L, Lalremruata A, Cattaneo C, Mischlinger J, Zoleko-Manego R, Endamne L, Klicpera A, Kim J, Nguyen T, Flohr L, Remppis J, Matsiegui PB, Adegnika AA, Agnandji ST, Kremsner PG, Mordmuller B, Mombo-Ngoma G, Ramharter M. Prospective Clinical Trial Assessing Species-Specific Efficacy of Artemether-Lumefantrine for the Treatment of Plasmodium malariae, Plasmodium ovale, and Mixed Plasmodium Malaria in Gabon. Antimicrob Agents Chemother. 2018 Feb 23;62(3):e01758-17. doi: 10.1128/AAC.01758-17. Print 2018 Mar. **PMID:** 29311086 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011528 - Term: Protozoan Infections - ID: D000010272 - Term: Parasitic Diseases - ID: D000007239 - Term: Infections - ID: D000096724 - Term: Mosquito-Borne Diseases - ID: D000079426 - Term: Vector Borne Diseases - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### 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: M11280 - Name: Malaria - Relevance: HIGH - As Found: Malaria - ID: M14850 - Name: Recurrence - Relevance: HIGH - As Found: Relapse - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14388 - Name: Protozoan Infections - Relevance: LOW - As Found: Unknown - ID: M13185 - Name: Parasitic Diseases - Relevance: LOW - As Found: Unknown - ID: M3255 - Name: Mosquito-Borne Diseases - Relevance: LOW - As Found: Unknown - ID: M2054 - Name: Vector Borne Diseases - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T3571 - Name: Malaria - Relevance: HIGH - As Found: Malaria ### Condition Browse Module - Meshes - ID: D000008288 - Term: Malaria - ID: D000012008 - Term: Recurrence ### Intervention Browse Module - Ancestors - ID: D000000962 - Term: Antimalarials - ID: D000000981 - Term: Antiprotozoal Agents - ID: D000000977 - Term: Antiparasitic 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 ### Intervention Browse Module - Browse Leaves - ID: M1936 - Name: Lumefantrine - Relevance: LOW - As Found: Unknown - ID: M1827 - Name: Artemether - Relevance: LOW - As Found: Unknown - ID: M1867 - Name: Artemether, Lumefantrine Drug Combination - Relevance: HIGH - As Found: Ivermectin - ID: M4280 - Name: Antimalarials - Relevance: LOW - As Found: Unknown - ID: M4298 - Name: Antiprotozoal Agents - Relevance: LOW - As Found: Unknown - ID: M4294 - Name: Antiparasitic Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077611 - Term: Artemether, Lumefantrine Drug Combination ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03191279 **Brief Title:** First Aid by Laypersons - Effect on Mortality and Length of Stay **Official Title:** Førstehjelp Gjort av Lekfolk-effekt på dødelighet og behandlingsforløp (First Aid by Laypersons - Effect on Mortality and Length of Stay) #### Organization Study ID Info **ID:** 2016/1760 #### Organization **Class:** OTHER **Full Name:** University of Tromso ### Status Module #### Completion Date **Date:** 2021-08 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** NOT_YET_RECRUITING #### Last Update Post Date **Date:** 2017-06-19 **Type:** ACTUAL **Last Update Submit Date:** 2017-06-15 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2020-08 **Type:** ESTIMATED #### Start Date **Date:** 2018-08 **Type:** ESTIMATED **Status Verified Date:** 2017-06 #### Study First Post Date **Date:** 2017-06-19 **Type:** ACTUAL **Study First Submit Date:** 2017-05-03 **Study First Submit QC Date:** 2017-06-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University Hospital of North Norway **Class:** UNKNOWN **Name:** Norsk Folkehjelp **Class:** UNKNOWN **Name:** Nasjonal kompetansetjeneste for traumatologi (NKT-Traume) #### Lead Sponsor **Class:** OTHER **Name:** University of Tromso #### 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 study aims to assess the effect of first aid from bystanders on survival, admission length, and need of ICU-stay for trauma victims. **Detailed Description:** All ambulance services in Norway will be invited to participate. In the participating ambulance services, the personnel of first unit to reach the scene of accident for any emergency response to trauma will register what first aid measures (if any) are indicated and have been performed by the bystanders on the scene up til the point where the ambulance arrives. Hospital data for each case will be retrieved. Those patients who did receive correct first aid will then be compared to those patients who did not receive first aid, and those where first aid was attempted but not correct for differences in share of survivors, length of hospital stay, and need for admission to ICU. ### Conditions Module **Conditions:** - Wounds and Injury - First Aid - Bystander - Trauma **Keywords:** - Wounds and injury - Trauma - First aid - Bystander - Laypersons ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1400 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patient has received first aid according to local guidelines for all indicated first aid measures from bystanders on scene of accident when the first ambulance arrives **Intervention Names:** - Procedure: First aid **Label:** First aid correct #### Arm Group 2 **Description:** Bystanders have attempted first aid for indicated first aid measures, but measures have been incorrectly performed according to local guidelines **Intervention Names:** - Procedure: First aid **Label:** First aid attempted #### Arm Group 3 **Description:** Indicated first aid measures have not been carried out when the first ambulance arrives on scene **Label:** No first aid ### Interventions #### Intervention 1 **Arm Group Labels:** - First aid attempted - First aid correct **Description:** Open airway (head tilt, chin lift), recovery position, staunch of bleeding, prevention of hypothermia, cooling of burn, CPR **Name:** First aid **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** If patients with indicated measures receiving first aid from bystanders, given for each measure and combined **Measure:** Whether patients received first aid from bystanders **Time Frame:** At time of inclusion **Description:** If first aid measures was indicated, given for each measure and combined **Measure:** Whether first aid measures were indicated for the patient **Time Frame:** At time of inclusion #### Primary Outcomes **Description:** Length of hospital stay after injury, in days **Measure:** Admission length **Time Frame:** 3 months after inclusion **Description:** 30-day survival, starting from day of injury **Measure:** Survival **Time Frame:** 1 month after inclusion **Description:** Whether patient is admitted to ICU during admission **Measure:** Need of ICU stay **Time Frame:** 3 months after inclusion #### Secondary Outcomes **Description:** Length of ICU stay if patient was admitted to ICU, in days **Measure:** Length of ICU stay **Time Frame:** 3 months after inclusion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All emergency response calls to trauma (drownings and hangings included) Exclusion Criteria: * No injury to patient * Non-traumatic condition * Poisonings **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** All patients who has sustained an injury and where the EMS has been alerted and initiated an emergency response ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Håkon Kvåle Bakke, MD, PhD **Phone:** +4795182294 **Role:** CONTACT #### Locations **Location 1:** **City:** Tromso **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Håkon Bakke, MD, PhD - **Phone:** +4795182294 - **Role:** CONTACT **Country:** Norway **Facility:** UNN Tromsø **Zip:** 9037 ### IPD Sharing Statement Module **Description:** No plan of sharing IDP **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Wounds and Injuries ### Condition Browse Module - Meshes - ID: D000014947 - Term: Wounds and Injuries ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04189679 **Acronym:** METABO-ICI **Brief Title:** Identification of a Predictive Metabolic Signature of Response to Immune Checkpoint Inhibitors in Non-Small Cell Lung Carcinoma **Official Title:** : Identification of a Predictive Metabolic Signature of Response to Immune Checkpoint Inhibitors in Non-Small Cell Lung Carcinoma #### Organization Study ID Info **ID:** 38RC19.133 #### Organization **Class:** OTHER **Full Name:** University Hospital, Grenoble #### Secondary ID Infos **Domain:** ID RCB **ID:** 2019-A01255-52 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2023-01-27 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-01-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-01-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-01-27 **Type:** ACTUAL #### Start Date **Date:** 2020-01-03 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2019-12-06 **Type:** ACTUAL **Study First Submit Date:** 2019-10-03 **Study First Submit QC Date:** 2019-12-05 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Grenoble #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Immune checkpoints inhibitors (ICI) are becoming new standards of care for Non-Small Cell Lung Carcinoma (NSCLC) treatment. To date, no powerful predictive biomarker of response has been found. The investigators hypothesize that metabolomics profile could represent a potent biomarker of response to ICI **Detailed Description:** Immune checkpoints inhibitors (ICI) are becoming new standards of care for Non-Small Cell Lung Carcinoma (NSCLC) treatment, both as first and second line of treatment. To date, no powerful predictive biomarker of response has been found. It has been recently shown that microbiota composition could dictate the ability of patients to respond to ICI. Since, the microbiota produces circulating metabolites that will subsequently act on immune system, the investigators hypothesized that metabolic signature, reflecting microbiota function, could represent a predictive biomarker of response to ICI. Primary objective is to identify baseline metabolic signature (metabolomics analysis by Mass spectrometry) associated to ICI response. Secondary objectives are to link metabolic signature with microbiota composition (metagenomics analysis RNA 16S) and immune profile, and altogether with clinic response to ICI. Profile evolution (metabolic, metagenomics and immune) will be also analyzed at 2-month post ICI initiation and at tumor progression, if any. In order to do so, the investigators thus plan to enroll 60 NSCLC patients treated by ICI as 1st, 2nd or 3rd line of treatment in CHUGA in 18 months. Blood as well feces will be collected prior to, and at 2 month following ICI treatment initiation as well as at progression. Will be excluded from this study, patients that have received antibiotic or corticotherapy 2 or 4 weeks before ICI initiation, respectively. ### Conditions Module **Conditions:** - Non Small Cell Lung Cancer **Keywords:** - Metabolomic - Microbiota ### Design Module #### Bio Spec **Description:** Meta-genomic signature of intestinal flora **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 62 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 20 patients in first line of treatment **Intervention Names:** - Other: Immune signature in serum associated to the metabolic signature - Genetic: Meta-genomic signature of intestinal flora **Label:** First line #### Arm Group 2 **Description:** 40 patients in second and third line of treatment **Intervention Names:** - Other: Immune signature in serum associated to the metabolic signature - Genetic: Meta-genomic signature of intestinal flora **Label:** Second or third line ### Interventions #### Intervention 1 **Arm Group Labels:** - First line - Second or third line **Description:** Immune signature in serum associated to the metabolic signature **Name:** Immune signature in serum associated to the metabolic signature **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - First line - Second or third line **Description:** Meta-genomic signature of intestinal flora **Name:** Meta-genomic signature of intestinal flora **Type:** GENETIC ### Outcomes Module #### Primary Outcomes **Description:** To identify the link of the change from baseline of Metabolic signature in serum (metabolomics analysis performed using a Mass spectrometry) and the ICI response at 6 months or at the tumoral progression **Measure:** Identification of the change from baseline Metabolic signature as predictive factor of the ICI response at 6 months or at the tumoral progression **Time Frame:** baseline, 6 months or tumoral progression #### Secondary Outcomes **Description:** To identify the link between the Meta-genomic signature of intestinal flora (microbiota composition analysed by RNA 16 S) with the Immune signature in serum and the metabolic signature at 6 months or at the tumoral progression **Measure:** Identification of the link between the Meta-genomic and immune signatures and the metabolic signature at 6 months or at the tumoral progression **Time Frame:** 6 months or tumoral progression **Description:** To identify the link between the Meta-genomic signature of intestinal flora with the Immune signature in serum and the ICI response at 6 months or at the tumoral progression **Measure:** Identification of the link between the Meta-genomic and immune signatures and ICI response at 6 months or at the tumoral progression **Time Frame:** 6 months or tumoral progression **Description:** To describe the change from baseline of the Meta-genomic signature at 2 months or at the tumoral progression **Measure:** Description of the profile change of Meta-genomic signature **Time Frame:** 2 months or tumoral progression **Description:** To describe the change from baseline of the Immune signature at 2 months or at the tumoral progression **Measure:** Description of the profile change of Immune signature at 2 months or at the tumoral progression **Time Frame:** Baseline and 2 months or tumoral progression **Description:** To identify the link between the profile change from baseline of meta-genomic signature and the ICI response at 2 months or at the tumoral progression **Measure:** Identification of the link between the profile change of meta-genomic signature and the ICI response at 2 months or at the tumoral progression **Time Frame:** Baseline and (2 months or tumoral progression) **Description:** To identify the link between the profile change from baseline of immune signature and the ICI response at 2 months or at the tumoral progression **Measure:** Identification of change of immune signature and the ICI response at 2 months or at the tumoral progression **Time Frame:** Baseline and (2 months or tumoral progression) **Description:** To describe of the overall survival under ICI at 6 months or at the tumoral progression **Measure:** Description of overall survival under ICI at 6 months or at the tumoral progression **Time Frame:** 6 months or tumoral progression **Description:** To describe the survival without progression under ICI at 6 months or at the tumoral progression **Measure:** Description of the survival without progression under ICI at 6 months or at the tumoral progression **Time Frame:** 6 months or tumoral progression ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * NSCLC diagnosis * Patient treated by a ICI in first, second or third line of treatment, or by the combination of chemotherapy and IPCI in first line of treatment * Patient with at least one measurable lesion as defined by RECIST Exclusion Criteria: * Patient treated with antibiotic treatment within 2 weeks before the start of ICI or corticosteroids (\>20 mg per day) within 4 weeks before the start of ICI **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study cohort will include NSCLC patients treated by ICI as 1st, 2nd or 3rd line of treatment in Grenoble University Hospital (France) in 18 months. 60 NSCLC patients are anticipated to be enrolled in the study. ### Contacts Locations Module #### Locations **Location 1:** **City:** La Tronche **Country:** France **Facility:** University Hospital, Grenoble **State:** Isère **Zip:** 38700 #### Overall Officials **Official 1:** **Affiliation:** University Hospital, Grenoble **Name:** Anne-Claire Toffart, Dr **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Medicine University, Grenoble **Name:** Dalil Hannani, PhD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009369 - Term: Neoplasms - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Carcinoma - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Non-Small Cell Lung Carcinoma - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - 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: D000002289 - Term: Carcinoma, Non-Small-Cell Lung - ID: D000008175 - Term: Lung Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01380379 **Brief Title:** Self-Defense Training in Women With Trauma **Official Title:** A Pilot Study of Self-Defense Training in Women With Trauma #### Organization Study ID Info **ID:** SU-04152011-7701 #### Organization **Class:** OTHER **Full Name:** Stanford University #### Secondary ID Infos **ID:** 20776 ### Status Module #### Completion Date **Date:** 2015-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-02-01 **Type:** ESTIMATED **Last Update Submit Date:** 2016-12-07 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2013-08 **Type:** ACTUAL #### Results First Post Date **Date:** 2017-02-01 **Type:** ESTIMATED **Results First Submit Date:** 2016-10-11 **Results First Submit QC Date:** 2016-12-07 #### Start Date **Date:** 2011-04 **Status Verified Date:** 2016-12 #### Study First Post Date **Date:** 2011-06-27 **Type:** ESTIMATED **Study First Submit Date:** 2011-05-18 **Study First Submit QC Date:** 2011-06-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Stanford University #### Responsible Party **Investigator Affiliation:** Stanford University **Investigator Full Name:** Jennifer Keller **Investigator Title:** Senior Research Scholar **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Previous research has shown that self-defense training can lead to gains in women's assertiveness, self-esteem, self-efficacy, and physical competence, and decreases in anxiety, helplessness, fear, and avoidant behaviors. However, most of this research has been conducted with healthy women who had not previously experienced physical or sexual violence. The investigators believe that women with such trauma histories require additional care because of potential triggering symptoms. As such, the investigators are mindful of the potential for triggering trauma symptoms and will work with the women so that they feel safe and comfortable in their participation. This pilot study aims to examine whether similar psychological gains from self-defense training are made in women who have previous experiences of physical and/or sexual violence. **Detailed Description:** There is a high rate of violence against women in the United States. For example, at least 1 in 6 women will experience an attempted or completed rape in their lifetime (Tjaden \& Thoenees, 2000). The high physical, emotional, economic and social costs of such violence are staggering. In particular, there can be a serious impact on mental health, with both immediate and long-term consequences (e.g., Coker et al., 2000). The aim of this project is to examine the psychological benefits of a class, which incorporates psychological and physical self-defense skills, for women who have been the victim of sexual or physical violence. A small literature suggests that women who take self-defense classes have increases in general self-efficacy and self-esteem (e.g.,Ozer and Bandura, 1990). This project is focusing on women who already have a history of physical or sexual violence. The investigators hypothesize that women who already have such a history of violence will benefit from a self-defense class that incorporates psychoeducation and brief psychology treatments in order to successfully participate in such a class and that ultimately it will improve their psychological well-being. Potential participants will first do a short phone screening to see whether they may be eligible for the study. If so, they will be brought into the clinic for a full eligibility assessment. Eligibility Procedures: Before entering the study, participants will participate in an eligibility interview. This will consist of a psychiatric interview (e.g., portions of the SCID and psychiatric rating scales), trauma history (e.g. CAPS), and physical health assessment. Participants will either need approval from their primary care physician to participate in the physical self-defense portion of the study or have a brief physical exam will a physician on the research team. If the participant is eligible for the study, they will be added to the list of participants. Once an adequate number of participants have been screened and determine eligible for the study, they will participate in the group for 8 weeks. Participants will fill out a series of questionnaires pre- and post- the course. Each set of questionnaires should take less than 1 hour to complete. In addition, the investigators conducted a 6-month post-class, follow up assessment. Self-defense class: The self-defense program is an eight week curriculum that meets once per week for 2.5 hours per session. The course which involves three components. The first component is a psycho-educational component which provides current basic information about physical and sexual assaults and also skill building, such as assertiveness, communication skills, and boundary setting. The second component of each class is physical resistance techniques which offers ample training. This includes information about basic targets, punches, and kicks, as well as breaking out of holds and other resistance skills. The third component of each class includes a supportive psychotherapy debriefing session. Following participation in the self-defense class all participants will be required to come for an in-person, debriefing interview. ### Conditions Module **Conditions:** - Depression - Anxiety - Stress Disorders, Post-Traumatic **Keywords:** - physical violence - sexual violence ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### 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:** Women will participate in a therapeutic group which covers education, skills, and empowerment activities. **Intervention Names:** - Behavioral: Life skills and self-defense training **Label:** Life skills and self-defense training **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Life skills and self-defense training **Description:** 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing. **Name:** Life skills and self-defense training **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** General self-efficacy (Schwartz and Jerusalem, 1993) is a measure of one's perceived self-competence. Scores are summed across 10 items, and range between 10-40, where higher scores reflect a stronger sense of personal competence. **Measure:** Change in Self-efficacy From Baseline to Post-treatment **Time Frame:** Change in GSE from baseline to 8 weeks #### Secondary Outcomes **Description:** Measured by the Rathus Assertiveness Schedule (Rathus, 1973). Rathus Assertiveness Scale is a 30-item scale assessing assertive behavior in a variety of situations. Each item is rated on a 6-point Likert scale from +3 (very characteristic of me) to -3 (very uncharacteristic of me). Total scores range from +90, which is equivalent of very assertive behavior to -90, which is equivalent to very unassertive behavior. The positive change indicates an increase in assertive behavior. **Measure:** Change in Assertiveness Between Baseline and Post-intervention **Time Frame:** Change in assertiveness from baseline to post-class (8 weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Women ages 21-65 years 2. History of physical and/or sexual violence, with subsequent interpersonal or psychological distress (e.g., depression or anxiety) related to this history. Exclusion Criteria: 1. Substance abuse in the past 6 months 2. Significant medical conditions that would preclude safe participation in the study 3. High levels of depression with significant suicide risk 4. Pregnant women 5. Active symptoms of psychosis or psychiatric instability 6. History of assaultive behavior or is judged to be at potential risk to assault others. **Maximum Age:** 65 Years **Minimum Age:** 21 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Stanford **Country:** United States **Facility:** Stanford University School of Medicine **State:** California **Zip:** 94305 #### Overall Officials **Official 1:** **Affiliation:** Stanford University **Name:** Jennifer Keller **Role:** PRINCIPAL_INVESTIGATOR ## 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 ### Condition Browse Module - Browse Leaves - ID: M16103 - Name: Stress Disorders, Post-Traumatic - Relevance: HIGH - As Found: Stress Disorders, Post-Traumatic - 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: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - 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 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Life Skills and Self-defense Training **Description:** Women will participate in a therapeutic group which covers education, skills, and empowerment activities. Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing. **ID:** EG000 **Other Num Affected:** 1 **Other Num at Risk:** 8 **Serious Number At Risk:** 8 **Title:** Life Skills and Self-defense Training **Frequency Threshold:** 0 #### Other Events **Term:** Dissociation during class **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 9 **Units:** Participants ### Group **ID:** BG000 **Title:** Life Skills and Self-defense Training **Description:** Women will participate in a therapeutic group which covers education, skills, and empowerment activities. Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing. ### Measure #### Measurement **Group ID:** BG000 **Spread:** 9.6 **Value:** 46.38 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 9 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 4 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 5 **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 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Gender **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:** Region of Enrollment **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** [email protected] **Organization:** Stanford University **Phone:** 650-724-0070 **Title:** Dr. Jennifer Keller ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### 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:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** <.01 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** Single group comparison pre-post change score, compared to a value of 0 (no change) **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### 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:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** <.04 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 5.8 - **Upper Limit:** - **Value:** 23.38 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 3.0 - **Upper Limit:** - **Value:** 29.63 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 34.6 - **Upper Limit:** - **Value:** -24.88 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 33.85 - **Upper Limit:** - **Value:** -15.88 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** General self-efficacy (Schwartz and Jerusalem, 1993) is a measure of one's perceived self-competence. Scores are summed across 10 items, and range between 10-40, where higher scores reflect a stronger sense of personal competence. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** The data is the change in general self efficacy from baseline to post-class, with higher scores indicating a greater increase in self-efficacy **Reporting Status:** POSTED **Time Frame:** Change in GSE from baseline to 8 weeks **Title:** Change in Self-efficacy From Baseline to Post-treatment **Type:** PRIMARY **Unit of Measure:** units on a scale ##### Group **Description:** Women will participate in a therapeutic group which covers education, skills, and empowerment activities. Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing. **ID:** OG000 **Title:** Life Skills and Self-defense Training #### Outcome Measure 2 **Description:** Measured by the Rathus Assertiveness Schedule (Rathus, 1973). Rathus Assertiveness Scale is a 30-item scale assessing assertive behavior in a variety of situations. Each item is rated on a 6-point Likert scale from +3 (very characteristic of me) to -3 (very uncharacteristic of me). Total scores range from +90, which is equivalent of very assertive behavior to -90, which is equivalent to very unassertive behavior. The positive change indicates an increase in assertive behavior. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Change in assertiveness from baseline to post-class (8 weeks) **Title:** Change in Assertiveness Between Baseline and Post-intervention **Type:** SECONDARY **Unit of Measure:** units on a scale ##### Group **Description:** Women will participate in a therapeutic group which covers education, skills, and empowerment activities. Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing. **ID:** OG000 **Title:** Life Skills and Self-defense Training ### Participant Flow Module #### Group **Description:** Women will participate in a therapeutic group which covers education, skills, and empowerment activities. Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing. **ID:** FG000 **Title:** Life Skills and Self-defense Training #### Period **Title:** Overall Study ##### Withdraw **Type:** Pregnancy ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 9 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 8 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 1 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT04596579 **Brief Title:** SARS-CoV-2 (COVID-19) Immune Surveillance Among a Population Based Sample of Adults in Florida **Official Title:** SARS-CoV-2 Immune Surveillance Among a Population Based Sample of Adults in Florida #### Organization Study ID Info **ID:** MCC-20635 #### Organization **Class:** OTHER **Full Name:** H. Lee Moffitt Cancer Center and Research Institute ### Status Module #### Completion Date **Date:** 2021-07-25 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-10-03 **Type:** ACTUAL **Last Update Submit Date:** 2022-09-30 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-07-25 **Type:** ACTUAL #### Start Date **Date:** 2020-10-17 **Type:** ACTUAL **Status Verified Date:** 2022-09 #### Study First Post Date **Date:** 2020-10-22 **Type:** ACTUAL **Study First Submit Date:** 2020-10-16 **Study First Submit QC Date:** 2020-10-16 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Merck Sharp & Dohme LLC #### Lead Sponsor **Class:** OTHER **Name:** H. Lee Moffitt Cancer Center and Research Institute #### 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 overall goal of this study is to understand the immune response (IgG) to SARS-CoV-2 to fill critical knowledge gaps in the natural history of this virus and to inform the development of future infection mitigation efforts. The study team aims to assess the prevalence of circulating IgG antibodies to SARS-CoV-2 and the factors associated with sero-prevalence. These data will be used to estimate the total population that has been exposed to the virus (asymptomatic and symptomatic), the proportion of the population that may be protected by natural immunity, and the proportion that is susceptible. Data obtained from this research will be shared with the Florida Department of Health. ### Conditions Module **Conditions:** - Coronavirus Infection **Keywords:** - COVID -19 - SARC-CoV-2 ### Design Module #### Design Info **Observational Model:** ECOLOGIC_OR_COMMUNITY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1135 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Up to 300 participants age 18-34 who received an invitation by mail and are free of fever at time of interview. **Intervention Names:** - Diagnostic Test: SARS-CoV-2 Antibody Analysis - Diagnostic Test: Weck-cel Swab Collection - Behavioral: Web Based Questionnaire **Label:** Participants age 18-34 #### Arm Group 2 **Description:** Up to 300 Participants age 35-54 who received an invitation by mail and are free of fever at time of interview. **Intervention Names:** - Diagnostic Test: SARS-CoV-2 Antibody Analysis - Diagnostic Test: Weck-cel Swab Collection - Behavioral: Web Based Questionnaire **Label:** Participants age 35-54 #### Arm Group 3 **Description:** Up to 300 participants age 35-54 who received an invitation by mail and are free of fever at time of interview. **Intervention Names:** - Diagnostic Test: SARS-CoV-2 Antibody Analysis - Diagnostic Test: Weck-cel Swab Collection - Behavioral: Web Based Questionnaire **Label:** Participants age 55-64 #### Arm Group 4 **Description:** Up to 300 participants age 35-54 who received an invitation by mail and are free of fever at time of interview. **Intervention Names:** - Diagnostic Test: SARS-CoV-2 Antibody Analysis - Diagnostic Test: Weck-cel Swab Collection - Behavioral: Web Based Questionnaire **Label:** Participants 65 and over ### Interventions #### Intervention 1 **Arm Group Labels:** - Participants 65 and over - Participants age 18-34 - Participants age 35-54 - Participants age 55-64 **Description:** 10 ml of blood will be drawn for antibody analysis. Participants who test SARCS-CoV-2 positive will be invited to participate in follow-up antibody testing at 4 weeks and at 3 months. **Name:** SARS-CoV-2 Antibody Analysis **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - Participants 65 and over - Participants age 18-34 - Participants age 35-54 - Participants age 55-64 **Description:** A Weck-cel swab will be used to collect secretions from the mucosal epithelium **Name:** Weck-cel Swab Collection **Type:** DIAGNOSTIC_TEST #### Intervention 3 **Arm Group Labels:** - Participants 65 and over - Participants age 18-34 - Participants age 35-54 - Participants age 55-64 **Description:** A brief web enabled questionnaire will be administered to collect information related to demographics, SARS-CoV-2 exposure history, past symptoms, comorbidities associates with increased infection and disease risk, as well as immunosuppression status and use to immunosuppressive medications. **Name:** Web Based Questionnaire **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** All participants who respond to study invitation letter will be tested for SARS-CoV-2 antibodies after completing a web-based questionnaire. **Measure:** Percentage of Participants who test positive for SARS-CoV-2 antibodies at first visit **Time Frame:** At study start **Description:** Participants who tested positive for SARS-CoV-2 antibodies at first study visit will be tested for antibodies to SARS-CoV-2 again at 4 weeks. **Measure:** Percentage of Participants who test positive for SARS-CoV-2 antibodies at second visit **Time Frame:** At 4 weeks **Description:** Participants who tested positive for SARS-CoV-2 antibodies at second study visit will be tested for antibodies to SARS-CoV-2 again at 3 months. **Measure:** Percentage of Participants who test positive for SARS-CoV-2 antibodies at third visit **Time Frame:** At 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Resident of Hillsborough County, Florida * 18 years of age or older * Currently not exhibiting symptoms of SARS-CoV-2 infection **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Community Sample ### Contacts Locations Module #### Locations **Location 1:** **City:** Tampa **Country:** United States **Facility:** Moffitt Cancer Center **State:** Florida **Zip:** 33612 #### Overall Officials **Official 1:** **Affiliation:** Moffitt Cancer Center **Name:** Anna R Giuliano, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### See Also Links **Label:** Moffitt Cancer Center's Clinical Trials Website **URL:** https://moffitt.org/clinical-trials-research/clinical-trials ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000014777 - Term: Virus Diseases - ID: D000007239 - Term: Infections ### 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: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: HIGH - As Found: Coronavirus Infection - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales 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 ### Condition Browse Module - Meshes - ID: D000018352 - Term: Coronavirus Infections ### 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: Program - ID: M10184 - Name: Immunoglobulins - 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 ### Intervention Browse Module - Meshes - ID: D000000906 - Term: Antibodies ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03423979 **Acronym:** EVEREST-I **Brief Title:** Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter **Official Title:** Evaluation of Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter in the Treatment of Moderate-to-Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia #### Organization Study ID Info **ID:** PR1051 #### Organization **Class:** INDUSTRY **Full Name:** Urotronic Inc. ### Status Module #### Completion Date **Date:** 2024-03-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-07-03 **Type:** ACTUAL **Last Update Submit Date:** 2023-06-14 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2019-06-04 **Type:** ACTUAL #### Results First Post Date **Date:** 2023-07-03 **Type:** ACTUAL **Results First Submit Date:** 2023-05-10 **Results First Submit QC Date:** 2023-06-14 #### Start Date **Date:** 2017-12-19 **Type:** ACTUAL **Status Verified Date:** 2023-06 #### Study First Post Date **Date:** 2018-02-06 **Type:** ACTUAL **Study First Submit Date:** 2018-01-30 **Study First Submit QC Date:** 2018-02-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Urotronic Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is Unapproved Device:** True **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** A prospective, non-randomized study. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The post-treatment follow-up visit can be up to 5 years. The objective of the study is to evaluate the safety and efficacy of the Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System in the treatment of BPH. **Detailed Description:** A prospective, non-randomized, multi-center study. The study will enroll up to 85 subjects to be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. Subjects will be followed up post-treatment at Foley removal, and up to 1 year. The subjects may choose to be followed-up annually for 5 years or until study close, whichever comes first. Study device is Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System. Study primarily outcomes are measured by 1). Change in IPSS score at 3-month post-procedure follow-up; 2). Major device or procedure related complications at 3-month post-procedure follow-up. ### Conditions Module **Conditions:** - Benign Prostatic Hyperplasia - Benign Prostatic Hypertrophy **Keywords:** - BPH ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** treatment group - treated with Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 80 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Optilume™ BPH Prostatic DCB treatment procedure **Intervention Names:** - Device: Optilume™ BPH Prostatic DCB Dilation Catheter - Drug: Paclitaxel **Label:** Optilume™ BPH Prostatic DCB Dilation Catheter **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Optilume™ BPH Prostatic DCB Dilation Catheter **Description:** BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU). **Name:** Optilume™ BPH Prostatic DCB Dilation Catheter **Other Names:** - BPH Prostatic DCB **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Optilume™ BPH Prostatic DCB Dilation Catheter **Description:** paclitaxel will release to adjacent tissue after the balloon inflated in the urethra **Name:** Paclitaxel **Other Names:** - drug coated balloon **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The proportion of subjects experiencing at least a 40% improvement in International Prostate Symptom Score (IPSS) scores from baseline to 3 months. The IPSS contains the well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH symptoms. The first seven questions in the IPSS address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency, and scored on a 6-point scale (0 to 5). The IPSS can be interpreted as follows: 0-7 mildly symptomatic, 8-19 moderately symptomatic, and 20-35 severely symptomatic. **Measure:** Therapeutic Responder at 3 Months **Time Frame:** 90 days **Description:** The proportion of subjects reporting a composite of device/procedure related severe urinary retention (lasting \>14 days), unresolved stress urinary incontinence, or bleeding requiring transfusion. **Measure:** Major Device/Procedure Related Complications **Time Frame:** 90 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Male subject \> 50 years of age who has moderate-to-severe LUTS (IPSS score of ≥ 13) and is a candidate for interventional therapy 2. LUTS felt to be secondary to an enlarged prostate (henceforth termed LUTS/BPH) 3. Peak urinary flow rate (Qmax) ≥ 5 mL/sec and ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml 4. Post-void residual (PVR) ≤ 250 ml 5. Prostate volume 20 - 80 gm as determined by TRUS 6. Prostatic urethra length is 35 - 55 mm as determined by TRUS 7. Able to complete the study protocol in the opinion of the investigator Exclusion Criteria: 1. Interested in maintaining fertility and unwilling to use protected sex for the first 30 days post treatment 2. Unwilling to abstain or use protected sex for ninety (90) days post treatment if sexual partner is of child bearing potential 3. Presence of a penile implant or stent(s) in the urethra or prostate 4. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate 5. PSA \> 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is \> 4 ng/ml and ≤ 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the investigator via additional tests including digital rectal exam (DRE) and/or biopsy 6. Confirmed or suspected malignancy of prostate or bladder 7. Active or history of epididymitis within the past 3 months 8. Previous pelvic irradiation or radical pelvic surgery 9. Documented active urinary tract infection (UTI) by culture or bacterial prostatitis within last year documented by culture (UTI is defined as \>100,000 colonies per ml urine from midstream clean catch or catheterization specimen) 10. Visible hematuria with subject urine sample without known contributing factor 11. Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function 12. Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms 13. Use of beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week prior to treatment unless there is documented evidence of stable dosing for last 6 months (no dose changes) 14. Use of alpha blockers, antidepressants, anticholinergics, androgens, daily tadalafil or gonadotropin-releasing hormonal analogs (prescribed for BPH) within 3 weeks prior to treatment 15. Use of 5-alpha reductase inhibitor within 6 months prior to treatment 16. Incidence of spontaneous urinary retention within 6 months prior to baseline assessment 17. Post-void residual volume \> 250 ml or catheter dependent bladder drainage 18. Overactive bladder (OAB) or urge incontinence 19. Known poor detrusor muscle function (e.g. Qmax \< 5 ml/sec) 20. Current bladder stones or prostatic calculi 21. Biopsy of prostate within 30 days prior to procedure or planned within 30 days following the procedure 22. History of cancer in non-genitourinary system which is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years 23. History of clinically significant comorbidities or presence of unstable conditions (e.g. cardiovascular, lung, renal \[serum creatinine \> 2.0 mg/dl\], hepatic, bleeding disorders, or metabolic impairment) that may confound the results of the study or have a risk to subject per investigator's opinion 24. Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study quality of life questionnaires 25. Expected life expectancy \< one year 26. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the follow-up requirements 27. Currently enrolled in or plan to enroll in another investigational clinical trial for any disease except for observational only study 28. In the opinion of the investigator, it is not in the subject's best interest to participate in the study 29. Current treatment with anti-coagulants (e.g., warfarin or enoxaparin) or anti-platelet medications other than aspirin (e.g., clopidogrel) 30. Anatomy, e.g. presence of false passage or size of meatus, is not suitable for treatment in this study 31. Device that corresponds with the subject's prostate size per the IFU is not available 32. Intravesical prostatic protrusion (IPP) \> 1 cm 33. Current uncontrolled diabetes (hemoglobin A1c \> 7%) 34. Unable or unwilling to provide all the protocol-required semen samples 35. Sensitivity to paclitaxel, on medication that may have negative interaction with paclitaxel, or contraindicated for systemic paclitaxel **Gender Based:** True **Gender Description:** Based on biological sex **Minimum Age:** 50 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Santiago De Los Caballeros **Country:** Dominican Republic **Facility:** Union Medica Hospital **State:** Santiago **Location 2:** **City:** Santo Domingo Oeste **Country:** Dominican Republic **Facility:** Urolaser SRL **State:** Santo Domingo **Location 3:** **City:** La Romana **Country:** Dominican Republic **Facility:** Centro Medico Dr. Canela, SRL **Location 4:** **City:** Panama City, **Country:** Panama **Facility:** Consultorios Royal Center **State:** Urbanización Marbella Ciudad De Panamá **Location 5:** **City:** Ciudad de Panamá **Country:** Panama **Facility:** Centro Especializado San Fernando #### Overall Officials **Official 1:** **Affiliation:** Urotronic Inc. **Name:** Jill Moland **Role:** STUDY_DIRECTOR ## Document Section ### Large Document Module #### Large Docs - Date: 2022-03-25 - Filename: Prot_001.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 2744200 - Type Abbrev: Prot - Upload Date: 2023-06-14T16:39 - Date: 2018-07-19 - Filename: SAP_002.pdf - Has ICF: False - Has Protocol: False - Has SAP: True - Label: Statistical Analysis Plan - Size: 295705 - Type Abbrev: SAP - Upload Date: 2023-06-14T16:40 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000011469 - Term: Prostatic Diseases - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - 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: BC23 - Name: Symptoms and General Pathology - Abbrev: BC04 - Name: Neoplasms ### Condition Browse Module - Browse Leaves - ID: M14334 - Name: Prostatic Hyperplasia - Relevance: HIGH - As Found: Prostatic Hyperplasia - ID: M10016 - Name: Hyperplasia - Relevance: HIGH - As Found: Hyperplasia - ID: M10035 - Name: Hypertrophy - Relevance: HIGH - As Found: Hypertrophy - ID: M12307 - Name: Neoplasm Metastasis - Relevance: LOW - As Found: Unknown - ID: M7292 - Name: Dilatation, Pathologic - Relevance: LOW - As Found: Unknown - ID: M29464 - Name: Lower Urinary Tract Symptoms - Relevance: LOW - As Found: Unknown - ID: M14333 - Name: Prostatic Diseases - 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: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011470 - Term: Prostatic Hyperplasia - ID: D000006965 - Term: Hyperplasia - ID: D000006984 - Term: Hypertrophy ### 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 ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M231 - Name: Albumin-Bound Paclitaxel - 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 ### Intervention Browse Module - Meshes - ID: D000017239 - Term: Paclitaxel ### Misc Info Module #### Submission Tracking ##### First MCP Info ###### Post Date - Date: 2023-06-07 - Type: ACTUAL - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Optilume™ BPH Prostatic DCB Dilation Catheter **Deaths Num Affected:** 3 **Deaths Num At Risk:** 80 **Description:** Optilume™ BPH Prostatic DCB treatment procedure Optilume™ BPH Prostatic DCB Dilation Catheter: BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU). Paclitaxel: paclitaxel will release to adjacent tissue after the balloon inflated in the urethra **ID:** EG000 **Other Num Affected:** 43 **Other Num at Risk:** 80 **Serious Number Affected:** 22 **Serious Number At Risk:** 80 **Title:** Optilume™ BPH Prostatic DCB Dilation Catheter **Frequency Threshold:** 5 #### Other Events **Term:** Hematuria **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 21.1 **Term:** Urinary Retention **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 21.1 **Term:** Urinary Incontinence **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 21.1 **Term:** Dysuria **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 21.1 **Term:** Ejaculation Disorder **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Reproductive system and breast disorders **Source Vocabulary:** MedDRA 21.1 **Term:** Urinary Tract Infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 21.1 #### Serious Events **Term:** Urinary Incontinence **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 21.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 80 **Num Events:** 2 **Term:** Hematuria **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 21.1 ##### Stats **Group ID:** EG000 **Num Affected:** 7 **Num At Risk:** 80 **Num Events:** 7 **Term:** Urethral Stenosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 21.1 ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 80 **Num Events:** 4 **Term:** Urinary Retention **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 21.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 80 **Num Events:** 1 **Term:** Cerebrovascular Accident **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 21.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 80 **Num Events:** 2 **Term:** Anesthetic Complication (Pulmonary) **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 21.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 80 **Num Events:** 1 **Term:** Complication of Device Removal **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 21.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 80 **Num Events:** 1 **Term:** Stress Urinary Incontinence **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 21.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 80 **Num Events:** 1 **Term:** Intervertebral Disc Protrusion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 21.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 80 **Num Events:** 1 **Term:** Intestinal Obstruction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 21.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 80 **Num Events:** 1 **Term:** Urethral Perforation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 21.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 80 **Num Events:** 1 **Term:** Rectal Perforation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 21.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 80 **Num Events:** 1 **Term:** COVID-19 **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 21.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 80 **Num Events:** 1 **Time Frame:** 3 years ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 80 **Units:** Participants ### Group **ID:** BG000 **Title:** Optilume™ BPH Prostatic DCB Dilation Catheter **Description:** Optilume™ BPH Prostatic DCB treatment procedure Optilume™ BPH Prostatic DCB Dilation Catheter: BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU). Paclitaxel: paclitaxel will release to adjacent tissue after the balloon inflated in the urethra ### Measure #### Measurement **Group ID:** BG000 **Spread:** 7.8 **Value:** 65.8 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 80 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 10 **Category Title:** Black/African Origin #### Measurement **Group ID:** BG000 **Value:** 2 **Category Title:** Caucasian #### Measurement **Group ID:** BG000 **Value:** 68 **Category Title:** Hispanic/Latino **Class Title:** Race/Ethnicity ### Measure #### Measurement **Group ID:** BG000 **Spread:** 13.2 **Value:** 35.9 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 10 **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/Ethnicity, Customized **Unit of Measure:** Participants ### Measure 4 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Prostate Volume (g) **Unit of Measure:** grams ### Measure 5 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Presence of Intravesical Prostatic Protrusion **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement ### Limitations and Caveats **Description:** Interim review of safety data lead to refinement of device sizing and appropriate device size selection based on prostate dimensions for the final 30 subjects enrolled. Safety information reported for full cohort, as no pre-specified sub-analyses were planned. ### Point of Contact **Email:** [email protected] **Organization:** Urotronic, Inc **Phone:** (763) 285-7489 **Title:** Vice President of Clinical Affairs ## 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:** 65 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** The proportion of subjects experiencing at least a 40% improvement in International Prostate Symptom Score (IPSS) scores from baseline to 3 months. The IPSS contains the well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH symptoms. The first seven questions in the IPSS address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency, and scored on a 6-point scale (0 to 5). The IPSS can be interpreted as follows: 0-7 mildly symptomatic, 8-19 moderately symptomatic, and 20-35 severely symptomatic. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** In the primary analysis, a worst-case approach was used where those missing 3 month IPSS scores were imputed as non-responders **Reporting Status:** POSTED **Time Frame:** 90 days **Title:** Therapeutic Responder at 3 Months **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Optilume™ BPH Prostatic DCB treatment procedure Optilume™ BPH Prostatic DCB Dilation Catheter: BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU). Paclitaxel: paclitaxel will release to adjacent tissue after the balloon inflated in the urethra **ID:** OG000 **Title:** Optilume™ BPH Prostatic DCB Dilation Catheter #### Outcome Measure 2 **Description:** The proportion of subjects reporting a composite of device/procedure related severe urinary retention (lasting \>14 days), unresolved stress urinary incontinence, or bleeding requiring transfusion. **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** 90 days **Title:** Major Device/Procedure Related Complications **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Optilume™ BPH Prostatic DCB treatment procedure Optilume™ BPH Prostatic DCB Dilation Catheter: BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU). Paclitaxel: paclitaxel will release to adjacent tissue after the balloon inflated in the urethra **ID:** OG000 **Title:** Optilume™ BPH Prostatic DCB Dilation Catheter ### Participant Flow Module #### Group **Description:** Optilume™ BPH Prostatic DCB treatment procedure Optilume™ BPH Prostatic DCB Dilation Catheter: BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU). Paclitaxel: paclitaxel will release to adjacent tissue after the balloon inflated in the urethra **ID:** FG000 **Title:** Optilume™ BPH Prostatic DCB Dilation Catheter #### Period **Title:** Overall Study ##### Withdraw **Type:** Death ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 80 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 79 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 1 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT03218579 **Acronym:** microbiome **Brief Title:** Endoscopic Assessment and Prediction of Microbiome-modifying Interventions **Official Title:** Endoscopic Assessment and Prediction of Microbiome-modifying Interventions #### Organization Study ID Info **ID:** TASMC-12-ZH-658-CTIL #### Organization **Class:** OTHER_GOV **Full Name:** Tel-Aviv Sourasky Medical Center ### Status Module #### Completion Date **Date:** 2020-12-30 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2017-07-21 **Type:** ACTUAL **Last Update Submit Date:** 2017-07-18 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2019-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2013-02-01 **Type:** ACTUAL **Status Verified Date:** 2017-07 #### Study First Post Date **Date:** 2017-07-14 **Type:** ACTUAL **Study First Submit Date:** 2017-07-13 **Study First Submit QC Date:** 2017-07-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Weizmann Institute of Science #### Lead Sponsor **Class:** OTHER_GOV **Name:** Tel-Aviv Sourasky Medical Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The investigators would like to examine the extent of gut microbiome rehabilitation in healthy people after the consumption of antibiotics. Outcomes of probiotic treatment versus bacteriotherapy will be compared. **Detailed Description:** The investigators would like to examine the extent of rehabilitation of the composition and functioning of the intestinal bacteria in healthy people after the consumption of antibiotics. Since the digestive mocus enables the connection between the host and the bacteria that live within it, the investigators would like to characterize the microbiome in the different areas along the digestive system - before antibiotic treatment and after rehabilitation by probiotic treatment versus bacteriotherapy. ### Conditions Module **Conditions:** - Gut Microbiome - Antibiotic Side Effect **Keywords:** - microbiome - intestinal bacteria ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 45 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** No intervention after antibiotic treatment. **Label:** No intervention **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Probiotic treatment after antibiotic treatment. **Intervention Names:** - Dietary Supplement: Probiotic treatment **Label:** Probiotic microbiome rehabilitation **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Bacteriotherapy after antibiotic treatment. **Intervention Names:** - Biological: Bacteriotherapy **Label:** Bacteriotherapy microbiome rehabilitation **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Probiotic microbiome rehabilitation **Description:** 4 weeks of probiotic treatment after 7 days of antibiotics (Metronidazole+Ciprofloxacin) **Name:** Probiotic treatment **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Bacteriotherapy microbiome rehabilitation **Description:** Bacteriotherapy (autologous fecal microbiota transplantation) after 7 days of antibiotics (Metronidazole+Ciprofloxacin) **Name:** Bacteriotherapy **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** stool samples **Measure:** Microbiome composition **Time Frame:** 1 year #### Secondary Outcomes **Description:** Gastrointestinal tract biopsies **Measure:** Microbiome composition **Time Frame:** 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy volunteers * Age: 18 years and up * Gender: women and men Exclusion Criteria: * Pregnancy * Age under 18 years * antibiotic treatment 3 months prior to enrollment * Viral Hepatitis * HIV positive **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Noya Horowitz, PhD **Phone:** 97236974297 **Role:** CONTACT #### Locations **Location 1:** **City:** Tel Aviv **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Zamir Halpern, MD - **Phone:** 6974282 - **Role:** CONTACT ***Contact 2:*** - **Name:** Zamir Halpern, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Niv Zmora, MD - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Eran Elinav, M.D. Ph.D. A. - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Eran Segal, Prof. - **Role:** SUB_INVESTIGATOR **Country:** Israel **Facility:** Department of Gastroentherology **Status:** RECRUITING **Zip:** 64239 #### Overall Officials **Official 1:** **Affiliation:** Tel-Aviv Sourasky Medical Center **Name:** Zamir Halpern, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### 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: M6176 - Name: Ciprofloxacin - 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: M11767 - Name: Metronidazole - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02043379 **Brief Title:** Post-bypass Prophylactic IVIG in Infants and Neonates **Official Title:** Intravenous Immunoglobulin for Early Prevention of Cardiopulmonary Bypass Induced Hypogammaglobulinemia in Infants and Neonates #### Organization Study ID Info **ID:** F13114002 #### Organization **Class:** OTHER **Full Name:** University of Alabama at Birmingham #### Secondary ID Infos **Domain:** UAB Institutional Reveiw Board **ID:** F13114002 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2015-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-04-13 **Type:** ACTUAL **Last Update Submit Date:** 2017-03-01 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2015-06 **Type:** ACTUAL #### Results First Post Date **Date:** 2017-04-13 **Type:** ACTUAL **Results First Submit Date:** 2016-10-14 **Results First Submit QC Date:** 2017-03-01 #### Start Date **Date:** 2014-05 **Status Verified Date:** 2017-03 #### Study First Post Date **Date:** 2014-01-23 **Type:** ESTIMATED **Study First Submit Date:** 2014-01-14 **Study First Submit QC Date:** 2014-01-21 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Grifols Biologicals, LLC #### Lead Sponsor **Class:** OTHER **Name:** University of Alabama at Birmingham #### Responsible Party **Investigator Affiliation:** University of Alabama at Birmingham **Investigator Full Name:** Jeffrey Alten, MD **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study protocol is to determine if administering Intravenous Immunoglobulin (IVIG) for treatment of cardiopulmonary bypass (CPB) induced hypogammaglobulinemia in the early post-operative period can impact post-surgical outcomes (i.e., infection, fluid overload, and associated morbidities). **Detailed Description:** The intense post-CPB systemic inflammatory response syndrome (SIRS) is well described in neonates and infants. Increased production and release of pro-inflammatory cytokines, including Tumor Necrosis Factor, Interleukin1-B, and Interleukin-6 may suppress myocardial contractility, induce capillary leak, and activate complement and the clotting cascade - together leading to potential organ injury and death. SIRS is also frequently accompanied by impairment of the humoral immune response. One potential reason for this acquired immunodeficiency after cardiac surgery is the removal of immunoglobulins (Ig)s from the vascular space into other compartments where they are either sequestered or lost from the body altogether. We recently demonstrated that such Ig depletion from the intravascular compartment occurs in neonates following cardiac surgery. In a retrospective study of 53 children \<3 months of age, we showed that plasma Immunoglobulin G (IgG) concentration drops precipitously after cardiac surgery and does not return to preoperative levels by 7 days; 51% of patients had hypogammaglobulinemia. An important question is whether post-CPB low IgG has clinical consequence. IgG plays an essential role in the humoral immune system, activating complement and inducing the phagocytic system to neutralize pathogens. IgG deficiency is a known risk factor for infections in other pediatric populations. We were the first to demonstrate that post-CPB hypogammaglobulinemia is associated with worse clinical outcomes, including increased secondary infections (37% vs.12% in those without low IgG, p\<0.05). These novel findings are paramount in that they identify a potential modifiable risk factor to improve outcomes after pediatric cardiac surgery with CPB. Additionally, low IgG is accompanied by fluid overload and prolonged mechanical ventilation. Igs constitute an important component of plasma oncotic pressure, so hypogammaglobulinemia may exacerbate anasarca, prolonging postoperative convalescence and increasing the morbidities associated with increased ICU length of stay.9 Igs have an increasingly recognized role in modulating the innate immune response. Present use of IVIG exceeds mere antibody replacement and extends to the treatment of autoimmune and inflammatory conditions. In fact, more than 75% of IVIG use in the U.S. today is for the treatment of inflammatory conditions, where proposed mechanisms include reduction of pro-inflammatory cytokine and adhesion molecule expression, superantigen neutralization, restoration of glucocorticoid responsiveness, and blockade of complement fragment deposition. It is plausible that IVIG could benefit neonates after cardiac surgery not only via restoration of humoral opsonization capacity, but also as a modulator of innate immunity and SIRS. According to this model, tissue injury, CPB, and shock trigger SIRS, leading to hypogammaglobulinemia and resultant increased susceptibility to inflammatory dysregulation which might be ameliorated via administration of IVIG. In an adult study, IVIG failed to benefit postoperative cardiac patients with severe SIRS. However, the dose of IVIG given was relatively small compared with that typically given for autoimmune and inflammatory conditions. Neonates and infants may be more susceptible to the harmful effects of acquired hypogammaglobulinemia than adults as they may be unable to generate adequate quantities of antibodies in response to pathogens, relying mainly on maternal Igs until around the 4th to 6th month of life. In addition, they display an exaggerated inflammatory response to CPB as compared with older children and adults, so they might stand to benefit more from IVIG as an immunomodulator. Because of the increased vulnerability to acquired infection and other morbidities in the setting of hypogammaglobulinemia as result of enhanced SIRS and immune dysfunction, it is feasible that normalization of IgG concentration in the neonatal and infant population may improve clinical outcomes via restoration of the humoral immune system, modulation of the innate immune system, and restoration of intravascular oncotic pressure. The appropriate IgG level threshold for treatment and optimal plasma IgG level to target after administration of IVIG are presently unknown. ### Conditions Module **Conditions:** - Hypogammaglobulinemia - Congenital Heart Disease **Keywords:** - congenital heart disease - Cardiopulmonary Bypass - Hypogammaglobulinemia ### 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:** 50 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose and will be administered per hospital standards for IVIG administration. **Intervention Names:** - Drug: IVIG **Label:** IVIG **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. This infusion will be administered as if the subject is receiving IVIG according to hospital policy. **Intervention Names:** - Other: Placebo **Label:** Normal Saline **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - IVIG **Description:** Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **Name:** IVIG **Other Names:** - Gamunex **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Normal Saline **Description:** If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **Name:** Placebo **Other Names:** - Normal Saline **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The primary endpoint of this study is incidence of post-operative infections through hospital discharge **Measure:** Post-Operative Infections **Time Frame:** until Hospital Discharge, an average of 30 days **Description:** Any positive culture or treatment for culture negative sepsis within 1 week of surgery **Measure:** Post-operative Infection **Time Frame:** within 1 week of surgery **Description:** Any positive blood culture during the post-operative period until hospital discharge **Measure:** Blood Stream Infection **Time Frame:** until Hospital Discharge, an average of 30 days **Measure:** Blood Stream Infection Within 1 Week of Surgery **Time Frame:** 7 days #### Secondary Outcomes **Description:** Plasma albumin will be assessed at 24 and 48 hours. **Measure:** Post-operative Plasma Albumin **Time Frame:** up to 48 hours post CPB **Description:** The following fluid overload variables will be assessed in milliliters per kilogram at 0-24 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload. The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg. **Measure:** Fluid Overload Variables **Time Frame:** 0-24 hours post-CPB **Description:** The average admit, 12 hour, 24 hour, and 48 hour post-operative inotrope score will be calculated excluding Milrinone. To calculate the inotrope score the following formula was used: (Epinephrine/Norepinephrine dose in mcg/kg/min x 100) + (Dopamine dose in mcg/kg/min x 1) + (Phenylephrine dose in mcg/kg/min x 10) + (Vasopressin dose unit/kg/hr x 60/10000). The higher the inotrope score the more cardiac support the subject requires. There is not a "normal" scale or range used for this calculation. **Measure:** Post-operative Inotrope Score **Time Frame:** first 48 hours post-CPB **Description:** Alive, ventilator free days will be recorded at hospital discharge. **Measure:** Respiratory Variables **Time Frame:** until Hospital Discharge, an average of 30 days **Description:** From admit post-operative to the Pediatric cardiac intensive care unit until discharge from the hospital in days. **Measure:** Hospital Discharge **Time Frame:** Approximately 1 month **Description:** Plasma Immunoglobulin levels will be checked pre-operatively, 12 hours post-op and 5 days post-op **Measure:** Plasma Immunoglobulins **Time Frame:** 5 days post-op **Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. **Measure:** Interferon-gamma Plasma Cytokine Levels **Time Frame:** Pre-operative to 48 hours post-operative **Description:** Immunoglobulin concentration will be measured from chest tube every 4 hours for first 12 hours post-operative and then 24 hours post-operative. **Measure:** Immunoglobulin Concentration in Chest Tube Drainage **Time Frame:** 24 hours post-op **Description:** Incidence of mortality from admit to Pediatric cardiac intensive care unit post-operatively until hospital discharge . **Measure:** Mortality **Time Frame:** Approximately 1 month **Description:** The length of stay in the pediatric cardiac intensive care unit from admit post-operative until either discharge home, discharge to another unit/hospital/care facility, or death. This value is calculated in hours. Admit post-operative is recorded as hour 0. **Measure:** Intensive Care Unit Length of Stay **Time Frame:** 1 month **Description:** The following fluid overload variables will be assessed at 0-24 hours, 25-48 hours, and 0-48 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload.The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg. **Measure:** Fluid Overload Variables **Time Frame:** 0-48 hours post-CPB **Description:** Time until first extubation in hours **Measure:** Respiratory Variables **Time Frame:** until extubation, an average of 2 days **Description:** Total time duration of post-operative length of mechanical ventilation until hospital discharge **Measure:** Respiratory Variables **Time Frame:** until extubation, an average of 2 days **Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. **Measure:** Interleukin-10 Plasma Cytokine Levels **Time Frame:** pre-operative through 48 hours post-operative **Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. **Measure:** Interleukin-12p70 Plasma Cytokine Levels **Time Frame:** pre-operative through 48 hours post-operative **Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. **Measure:** Interleukin-1b Plasma Cytokine Levels **Time Frame:** pre-operative through 48 hours post-operative **Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. **Measure:** Interleukin-6 Plasma Cytokine Levels **Time Frame:** pre-operative through 48 hours post-operative **Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. **Measure:** Interleukin-8 Plasma Cytokine Levels **Time Frame:** pre-operative through 48 hours post-operative **Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. **Measure:** Tumor Necrosis Factor Plasma Cytokine Levels **Time Frame:** pre-operative through 48 hours post-operative **Description:** Immunoglobulin concentration will be measured from chest tube and peritoneal drain every 4 hours for first 12 hours post-operative and 24 hours post-operative. **Measure:** Immunoglobulin Concentration in Peritoneal Dialysis Drainage **Time Frame:** 24 hours post-op **Description:** Pre-operative and 48 hour post-operative maximum creatinine recorded. **Measure:** Serum Creatinine **Time Frame:** 48 hours **Measure:** Lactic Acid **Time Frame:** pre-operative through 24 hours post-operative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Infants \<6 months old * Successfully weaned off cardiopulmonary bypass after cardiac surgery Exclusion Criteria: * Requirement of extra corporeal membrane oxygenation in the operating room * Known immune deficiency * Current Do Not Resuscitate or limitation of care order * Current enrollment in another interventional clinical study * Refusal of parental consent **Maximum Age:** 6 Months **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Birmingham **Country:** United States **Facility:** Children's of Alabama **State:** Alabama **Zip:** 35233 #### Overall Officials **Official 1:** **Affiliation:** University of Alabama at Birmingham Pediatric Cardiac Critical Care **Name:** Jeffrey Alten, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** IPD will not be shared with other individuals **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000018376 - Term: Cardiovascular Abnormalities - ID: D000000013 - Term: Congenital Abnormalities - ID: D000001796 - Term: Blood Protein Disorders - ID: D000006402 - Term: Hematologic Diseases - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007153 - Term: Immunologic Deficiency Syndromes - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M9419 - Name: Heart Diseases - Relevance: HIGH - As Found: Heart Disease - ID: M9418 - Name: Heart Defects, Congenital - Relevance: HIGH - As Found: Congenital Heart Disease - ID: M3711 - Name: Agammaglobulinemia - Relevance: HIGH - As Found: Hypogammaglobulinemia - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M20503 - Name: Cardiovascular Abnormalities - 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: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic 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: D000006331 - Term: Heart Diseases - ID: D000006330 - Term: Heart Defects, Congenital - ID: D000000361 - Term: Agammaglobulinemia ### 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: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M19117 - Name: Immunoglobulins, Intravenous - Relevance: HIGH - As Found: Microliters - ID: M8836 - Name: gamma-Globulins - Relevance: LOW - As Found: Unknown - ID: M20191 - Name: Rho(D) Immune Globulin - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000016756 - Term: Immunoglobulins, Intravenous ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** IVIG **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** EG000 **Other Num at Risk:** 30 **Serious Number At Risk:** 30 **Title:** IVIG **Group ID:** EG001 **Title:** Normal Saline **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** EG001 **Other Num at Risk:** 20 **Serious Number At Risk:** 20 **Title:** Normal Saline **Frequency Threshold:** 0 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 30 **Group ID:** BG001 **Value:** 20 **Group ID:** BG002 **Value:** 50 **Units:** Participants ### Group **ID:** BG000 **Title:** IVIG **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. ### Group **ID:** BG001 **Title:** Normal Saline **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Value:** 30 #### Measurement **Group ID:** BG001 **Value:** 20 #### Measurement **Group ID:** BG002 **Value:** 50 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **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 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 6 **Upper Limit:** 50.75 **Value:** 9 #### Measurement **Group ID:** BG001 **Lower Limit:** 6.25 **Upper Limit:** 79.5 **Value:** 47 #### Measurement **Group ID:** BG002 **Lower Limit:** 6 **Upper Limit:** 74.75 **Value:** 11.5 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 14 #### Measurement **Group ID:** BG001 **Value:** 8 #### Measurement **Group ID:** BG002 **Value:** 22 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 16 #### Measurement **Group ID:** BG001 **Value:** 12 #### Measurement **Group ID:** BG002 **Value:** 28 **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:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **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:** 8 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 10 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 22 #### Measurement **Group ID:** BG001 **Value:** 18 #### Measurement **Group ID:** BG002 **Value:** 40 **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 **Lower Limit:** 3.17 **Upper Limit:** 3.99 **Value:** 3.45 #### Measurement **Group ID:** BG001 **Lower Limit:** 3.04 **Upper Limit:** 4.52 **Value:** 3.85 #### Measurement **Group ID:** BG002 **Lower Limit:** 3.13 **Upper Limit:** 4.09 **Value:** 3.51 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 37 **Upper Limit:** 39 **Value:** 38 #### Measurement **Group ID:** BG001 **Lower Limit:** 37 **Upper Limit:** 39.75 **Value:** 38.5 #### Measurement **Group ID:** BG002 **Lower Limit:** 37 **Upper Limit:** 39 **Value:** 38 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 3 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 3 **Class Title:** 1 #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 5 #### Measurement **Group ID:** BG002 **Value:** 7 **Class Title:** 2 #### Measurement **Group ID:** BG000 **Value:** 7 #### Measurement **Group ID:** BG001 **Value:** 8 #### Measurement **Group ID:** BG002 **Value:** 15 **Class Title:** 3 #### Measurement **Group ID:** BG000 **Value:** 12 #### Measurement **Group ID:** BG001 **Value:** 4 #### Measurement **Group ID:** BG002 **Value:** 16 **Class Title:** 4 #### Measurement **Group ID:** BG000 **Value:** 6 #### Measurement **Group ID:** BG001 **Value:** 3 #### Measurement **Group ID:** BG002 **Value:** 9 **Class Title:** 5 ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 73.5 **Upper Limit:** 120.3 **Value:** 105.5 #### Measurement **Group ID:** BG001 **Lower Limit:** 68 **Upper Limit:** 122.3 **Value:** 91.5 #### Measurement **Group ID:** BG002 **Lower Limit:** 70.5 **Upper Limit:** 120 **Value:** 97.5 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 42.5 **Upper Limit:** 70 **Value:** 52 #### Measurement **Group ID:** BG001 **Lower Limit:** 44.5 **Upper Limit:** 78.5 **Value:** 56 #### Measurement **Group ID:** BG002 **Lower Limit:** 44.5 **Upper Limit:** 70 **Value:** 53.5 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 5 #### Measurement **Group ID:** BG001 **Value:** 5 #### Measurement **Group ID:** BG002 **Value:** 10 **Class Title:** Yes #### Measurement **Group ID:** BG000 **Value:** 25 #### Measurement **Group ID:** BG001 **Value:** 15 #### Measurement **Group ID:** BG002 **Value:** 40 **Class Title:** No **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:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Age, Continuous **Unit of Measure:** days ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 5 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Weight **Unit of Measure:** kilograms ### Measure 6 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Gestational Age **Unit of Measure:** weeks ### Measure 7 **Description:** The Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery) Congenital Heart Surgery Mortality Categories. The STAT Mortality Categories range from 1 to 5 with higher values indicating greater risk of mortality associated with operations for congenital heart disease **Parameter Type:** NUMBER **Title:** STAT category **Unit of Measure:** participants ### Measure 8 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Cardiopulmonyar bypass time **Unit of Measure:** minutes ### Measure 9 **Dispersion Type:** INTER_QUARTILE_RANGE **Parameter Type:** MEDIAN **Title:** Aortic cross clamp time **Unit of Measure:** minutes ### Measure 10 **Description:** Subjects requiring mechanical ventilation in the pre-operative period for either respiratory or cardiac support. **Parameter Type:** NUMBER **Title:** Intubated Pre-operatively **Unit of Measure:** subjects ## Results Section - More Information Module ### Certain Agreement **PI Sponsor Employee:** True ### Point of Contact **Email:** [email protected] **Organization:** UAB Pediatric Cardiac Critical Care Medicine **Phone:** (205) 975-3123 **Title:** Jeffrey Alten, MD ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### 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:** **Non-Inferiority Comment:** We used alpha level of 0.05 and power of 0.8 to calculate the sample size necessary to detect a meaningful clinical difference for our primary endpoint. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 1 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Chi-squared **Tested Non-Inferiority:** ### 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:** **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 1 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Chi-squared **Tested Non-Inferiority:** ### Outcome Measure 3 #### 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:** **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.38 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Chi-squared **Tested Non-Inferiority:** ### Outcome Measure 4 #### 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:** **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.26 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Chi-squared **Tested Non-Inferiority:** ### Outcome Measure 5 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** 24 hour post-CPB albumin **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.42 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** #### 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:** 48 hour post CPB albumin **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.06 **P-Value Comment:** a p-value of \<0.05 represents the threshold for test signficance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** ### Outcome Measure 6 #### 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:** **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.52 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 7 #### 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:** Admit Inotrope Score **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.81 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 12 hours post-operative inotrope score **Non-Inferiority Comment:** power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.82 **P-Value Comment:** a p value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 24 hours post-operative inotrope score **Non-Inferiority Comment:** power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.9 **P-Value Comment:** a p value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 48 hours post-operative inotrope score **Non-Inferiority Comment:** power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.23 **P-Value Comment:** a p-value of \<0.05 represents the threshold for statistical signficance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 8 #### 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:** **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.49 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 9 #### 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:** **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.79 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 10 #### 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:** pre-operative IgG level **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.32 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** #### 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:** 12 hours post-operative IgG level **Non-Inferiority Comment:** power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.36 **P-Value Comment:** a p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** post-operative day 3 (72 hours) IgG level **Non-Inferiority Comment:** power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** <0.01 **P-Value Comment:** p-value of \<0.05 represents the threshold for statistical signficance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** post-operative day 5 (120 hours) IgG level **Non-Inferiority Comment:** power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** <0.01 **P-Value Comment:** p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 11 #### 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:** pre-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.60 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 0 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.06 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 4 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.06 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 12 hours post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.33 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 24 hours post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.05 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 48 hours post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.83 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 12 #### 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:** 0 hour levels **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.27 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 4 hour level **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.34 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 8 hour level **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.14 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 12 hour level **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.13 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 24 hour level **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.02 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 13 #### 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:** **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 1 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Chi-squared **Tested Non-Inferiority:** ### Outcome Measure 14 #### 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:** **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.4 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 15 #### 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:** 0-48 hours post-CPB **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.09 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 0-24 hours post CPB **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.52 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 16 #### 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:** **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.72 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 17 #### 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:** **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.63 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 18 #### 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:** pre-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.41 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 0 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.34 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 4 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.47 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 12 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.42 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 24 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.82 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 48 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.44 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 19 #### 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:** pre-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.28 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 0 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.37 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 4 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.42 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 12 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.31 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 24 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.38 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 48 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.4 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 20 #### 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:** pre-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.1 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 0 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.12 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 4 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.51 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 12 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.27 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 24 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.88 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 48 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.38 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 21 #### 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:** pre-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.35 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 0 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.39 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 4 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.58 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 12 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.36 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 24 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.61 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 48 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.38 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 22 #### 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:** pre-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.1 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 0 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.02 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 4 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.34 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 12 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.35 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 24 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.67 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 48 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.47 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 23 #### 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:** pre-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.46 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 0 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.04 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 4 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.14 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 12 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.82 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 24 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.9 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 48 hour post-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.78 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 24 #### 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:** 0 hour level **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.37 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 4 hour level **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.47 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 8 hour level **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.47 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 12 hour level **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.79 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### 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:** 24 hour level **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.04 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 25 #### 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:** pre-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.43 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** #### 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:** max **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.68 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** ### Outcome Measure 26 #### 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:** pre-operative **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.87 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** #### 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:** 24 hour post-operative max **Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.79 **P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 21 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 14 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 - **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:** 25 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 17 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 - **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:** 25 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 19 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 - **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:** 27 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 20 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.74 - **Upper Limit:** - **Value:** 3.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.67 - **Upper Limit:** - **Value:** 4.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.57 - **Upper Limit:** - **Value:** 3.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.52 - **Upper Limit:** - **Value:** 3.6 **Title:** #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.6 - **Spread:** - **Upper Limit:** 74 - **Value:** 30 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 34.4 - **Spread:** - **Upper Limit:** 87 - **Value:** 58.1 **Title:** #### Outcome Measure 7 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.23 - **Spread:** - **Upper Limit:** 7.95 - **Value:** 5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 3.15 - **Spread:** - **Upper Limit:** 6.6 - **Value:** 4.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.25 - **Spread:** - **Upper Limit:** 7.68 - **Value:** 5.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 3 - **Spread:** - **Upper Limit:** 8 - **Value:** 5.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.3 - **Spread:** - **Upper Limit:** 7.3 - **Value:** 5.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 3.18 - **Spread:** - **Upper Limit:** 6.93 - **Value:** 5.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.08 - **Spread:** - **Upper Limit:** 7.83 - **Value:** 6.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 1 - **Spread:** - **Upper Limit:** 6.25 - **Value:** 2 **Title:** #### Outcome Measure 8 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 21.1 - **Spread:** - **Upper Limit:** 26.3 - **Value:** 24.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 21.6 - **Spread:** - **Upper Limit:** 27 - **Value:** 25.5 **Title:** #### Outcome Measure 9 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 11.25 - **Spread:** - **Upper Limit:** 35 - **Value:** 22 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 7.25 - **Spread:** - **Upper Limit:** 34.75 - **Value:** 22 **Title:** #### Outcome Measure 10 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 226.1 - **Upper Limit:** - **Value:** 487 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 230.5 - **Upper Limit:** - **Value:** 414 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 183 - **Upper Limit:** - **Value:** 496 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 272 - **Upper Limit:** - **Value:** 569 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 243 - **Upper Limit:** - **Value:** 837 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 215.4 - **Upper Limit:** - **Value:** 508 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 213 - **Upper Limit:** - **Value:** 839 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 212.3 - **Upper Limit:** - **Value:** 585 **Title:** #### Outcome Measure 11 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.7 - **Spread:** - **Upper Limit:** 4.5 - **Value:** 2.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2.5 - **Spread:** - **Upper Limit:** 7.7 - **Value:** 3.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.3 - **Spread:** - **Upper Limit:** 4.2 - **Value:** 2.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 3.4 - **Spread:** - **Upper Limit:** 12.4 - **Value:** 6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2.2 - **Spread:** - **Upper Limit:** 4.1 - **Value:** 2.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 3 - **Spread:** - **Upper Limit:** 16 - **Value:** 6.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2 - **Spread:** - **Upper Limit:** 4.5 - **Value:** 2.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2.6 - **Spread:** - **Upper Limit:** 10.4 - **Value:** 6.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.3 - **Spread:** - **Upper Limit:** 3.2 - **Value:** 2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2.7 - **Spread:** - **Upper Limit:** 11.5 - **Value:** 5.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.4 - **Spread:** - **Upper Limit:** 3.2 - **Value:** 2.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2.3 - **Spread:** - **Upper Limit:** 5.2 - **Value:** 3.4 **Title:** #### Outcome Measure 12 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 23.3 - **Spread:** - **Upper Limit:** 73.6 - **Value:** 50.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 39.4 - **Spread:** - **Upper Limit:** 117.5 - **Value:** 62.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 79.4 - **Spread:** - **Upper Limit:** 250.7 - **Value:** 154.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 111 - **Spread:** - **Upper Limit:** 291.2 - **Value:** 161.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 122.3 - **Spread:** - **Upper Limit:** 308.6 - **Value:** 195.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 150.6 - **Spread:** - **Upper Limit:** 448.1 - **Value:** 227.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 155.3 - **Spread:** - **Upper Limit:** 316.3 - **Value:** 233.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 202.4 - **Spread:** - **Upper Limit:** 447.2 - **Value:** 226.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 471 - **Spread:** - **Upper Limit:** 916.4 - **Value:** 614.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 190.1 - **Spread:** - **Upper Limit:** 578 - **Value:** 268.7 **Title:** #### Outcome Measure 13 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 - **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:** 27 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 18 **Title:** #### Outcome Measure 14 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 141.3 - **Spread:** - **Upper Limit:** 536.6 - **Value:** 357.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 106.0 - **Spread:** - **Upper Limit:** 575.8 - **Value:** 189.6 **Title:** #### Outcome Measure 15 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.6 - **Spread:** - **Upper Limit:** 74 - **Value:** 30 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 34.4 - **Spread:** - **Upper Limit:** 87 - **Value:** 58.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -35.53 - **Spread:** - **Upper Limit:** 41.55 - **Value:** 7.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -0.4 - **Spread:** - **Upper Limit:** 43.85 - **Value:** 34.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 13.9 - **Spread:** - **Upper Limit:** 85.25 - **Value:** 46.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 36.8 - **Spread:** - **Upper Limit:** 114.73 - **Value:** 77 **Title:** #### Outcome Measure 16 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 18.5 - **Spread:** - **Upper Limit:** 88.1 - **Value:** 46 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 18 - **Spread:** - **Upper Limit:** 93.2 - **Value:** 43 **Title:** #### Outcome Measure 17 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 29.9 - **Spread:** - **Upper Limit:** 165 - **Value:** 62.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 23.3 - **Spread:** - **Upper Limit:** 153.5 - **Value:** 59 **Title:** #### Outcome Measure 18 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1 - **Spread:** - **Upper Limit:** 3.2 - **Value:** 1.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 1.1 - **Spread:** - **Upper Limit:** 3 - **Value:** 1.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 37.5 - **Spread:** - **Upper Limit:** 91.7 - **Value:** 54.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 52.5 - **Spread:** - **Upper Limit:** 216.5 - **Value:** 124 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 6.4 - **Spread:** - **Upper Limit:** 25.3 - **Value:** 10.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 7.9 - **Spread:** - **Upper Limit:** 56.7 - **Value:** 20.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2.7 - **Spread:** - **Upper Limit:** 7.9 - **Value:** 4.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 5.5 - **Spread:** - **Upper Limit:** 20.9 - **Value:** 10.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.2 - **Spread:** - **Upper Limit:** 3.6 - **Value:** 1.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2 - **Spread:** - **Upper Limit:** 6.7 - **Value:** 4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.8 - **Spread:** - **Upper Limit:** 2.3 - **Value:** 1.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 1.2 - **Spread:** - **Upper Limit:** 9.8 - **Value:** 2.3 **Title:** #### Outcome Measure 19 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.2 - **Spread:** - **Upper Limit:** 0.2 - **Value:** 0.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.2 - **Spread:** - **Upper Limit:** 0.6 - **Value:** 0.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.2 - **Spread:** - **Upper Limit:** 0.3 - **Value:** 0.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.3 - **Spread:** - **Upper Limit:** 2.1 - **Value:** 0.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.3 - **Spread:** - **Upper Limit:** 0.5 - **Value:** 0.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.3 - **Spread:** - **Upper Limit:** 3.5 - **Value:** 0.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.3 - **Spread:** - **Upper Limit:** 0.8 - **Value:** 0.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.4 - **Spread:** - **Upper Limit:** 2 - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.2 - **Spread:** - **Upper Limit:** 0.5 - **Value:** 0.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.3 - **Spread:** - **Upper Limit:** 1.6 - **Value:** 0.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.2 - **Spread:** - **Upper Limit:** 0.3 - **Value:** 0.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.2 - **Spread:** - **Upper Limit:** 0.8 - **Value:** 0.4 **Title:** #### Outcome Measure 20 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.1 - **Spread:** - **Upper Limit:** 0.2 - **Value:** 0.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.1 - **Spread:** - **Upper Limit:** 0.7 - **Value:** 0.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.2 - **Spread:** - **Upper Limit:** 0.4 - **Value:** 0.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.3 - **Spread:** - **Upper Limit:** 0.4 - **Value:** 0.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.3 - **Spread:** - **Upper Limit:** 0.6 - **Value:** 0.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.4 - **Spread:** - **Upper Limit:** 0.6 - **Value:** 0.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.3 - **Spread:** - **Upper Limit:** 0.5 - **Value:** 0.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.2 - **Spread:** - **Upper Limit:** 0.3 - **Value:** 0.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.2 - **Spread:** - **Upper Limit:** 0.5 - **Value:** 0.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.3 - **Spread:** - **Upper Limit:** 1.4 - **Value:** 0.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.2 - **Spread:** - **Upper Limit:** 0.6 - **Value:** 0.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.2 - **Spread:** - **Upper Limit:** 0.4 - **Value:** 0.3 **Title:** #### Outcome Measure 21 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.1 - **Spread:** - **Upper Limit:** 5.5 - **Value:** 2.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 1.4 - **Spread:** - **Upper Limit:** 7.6 - **Value:** 3.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 6.6 - **Spread:** - **Upper Limit:** 16.2 - **Value:** 10.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 9.9 - **Spread:** - **Upper Limit:** 30.7 - **Value:** 17.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 23.6 - **Spread:** - **Upper Limit:** 46.5 - **Value:** 32.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 33.8 - **Spread:** - **Upper Limit:** 84.9 - **Value:** 52.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 29.6 - **Spread:** - **Upper Limit:** 64.8 - **Value:** 43.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 36.6 - **Spread:** - **Upper Limit:** 86.6 - **Value:** 49.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 15.6 - **Spread:** - **Upper Limit:** 50.4 - **Value:** 26.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 24.2 - **Spread:** - **Upper Limit:** 81.3 - **Value:** 40.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 9.4 - **Spread:** - **Upper Limit:** 21.5 - **Value:** 15.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 10.5 - **Spread:** - **Upper Limit:** 24.8 - **Value:** 15.5 **Title:** #### Outcome Measure 22 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 14.4 - **Spread:** - **Upper Limit:** 22.7 - **Value:** 18.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 12.8 - **Spread:** - **Upper Limit:** 23.4 - **Value:** 17.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 58.8 - **Spread:** - **Upper Limit:** 131 - **Value:** 76.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 99.9 - **Spread:** - **Upper Limit:** 255.5 - **Value:** 163 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 63.6 - **Spread:** - **Upper Limit:** 162.3 - **Value:** 116.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 71 - **Spread:** - **Upper Limit:** 214.8 - **Value:** 147.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 36.7 - **Spread:** - **Upper Limit:** 131 - **Value:** 67.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 50 - **Spread:** - **Upper Limit:** 132 - **Value:** 90 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 40.3 - **Spread:** - **Upper Limit:** 61.7 - **Value:** 47.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 33.4 - **Spread:** - **Upper Limit:** 112.8 - **Value:** 46 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 24.6 - **Spread:** - **Upper Limit:** 59.8 - **Value:** 33.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 23.6 - **Spread:** - **Upper Limit:** 64.7 - **Value:** 38.2 **Title:** #### Outcome Measure 23 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.9 - **Spread:** - **Upper Limit:** 3.4 - **Value:** 2.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2.4 - **Spread:** - **Upper Limit:** 4 - **Value:** 2.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2.2 - **Spread:** - **Upper Limit:** 3.8 - **Value:** 2.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2.5 - **Spread:** - **Upper Limit:** 6.4 - **Value:** 4.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2.6 - **Spread:** - **Upper Limit:** 5.6 - **Value:** 3.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 3.7 - **Spread:** - **Upper Limit:** 7.6 - **Value:** 5.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2.2 - **Spread:** - **Upper Limit:** 3.4 - **Value:** 3.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2.7 - **Spread:** - **Upper Limit:** 5.5 - **Value:** 4.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2.2 - **Spread:** - **Upper Limit:** 3.4 - **Value:** 2.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 3 - **Spread:** - **Upper Limit:** 5 - **Value:** 3.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2 - **Spread:** - **Upper Limit:** 3.2 - **Value:** 2.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2.1 - **Spread:** - **Upper Limit:** 4.8 - **Value:** 3.5 **Title:** #### Outcome Measure 24 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 18.8 - **Spread:** - **Upper Limit:** 52.1 - **Value:** 33.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 11.5 - **Spread:** - **Upper Limit:** 144.3 - **Value:** 101.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 45.6 - **Spread:** - **Upper Limit:** 263.3 - **Value:** 136.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 114.5 - **Spread:** - **Upper Limit:** 384.2 - **Value:** 201.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 193.4 - **Spread:** - **Upper Limit:** 446.8 - **Value:** 279.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 84.4 - **Spread:** - **Upper Limit:** 513.2 - **Value:** 221.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 143.1 - **Spread:** - **Upper Limit:** 510.2 - **Value:** 387.33 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 149.4 - **Spread:** - **Upper Limit:** 434.3 - **Value:** 300.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 598.3 - **Spread:** - **Upper Limit:** 2181.1 - **Value:** 1613.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 170.4 - **Spread:** - **Upper Limit:** 984.2 - **Value:** 366.9 **Title:** #### Outcome Measure 25 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.15 - **Upper Limit:** - **Value:** 0.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.17 - **Upper Limit:** - **Value:** 0.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.28 - **Upper Limit:** - **Value:** 0.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.38 - **Upper Limit:** - **Value:** 0.7 **Title:** #### Outcome Measure 26 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.65 - **Upper Limit:** - **Value:** 1.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.75 - **Upper Limit:** - **Value:** 1.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 4 - **Upper Limit:** - **Value:** 5.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 4.54 - **Upper Limit:** - **Value:** 5.4 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** The primary endpoint of this study is incidence of post-operative infections through hospital discharge **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** until Hospital Discharge, an average of 30 days **Title:** Post-Operative Infections **Type:** PRIMARY **Unit of Measure:** subjects ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 2 **Description:** Any positive culture or treatment for culture negative sepsis within 1 week of surgery **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** within 1 week of surgery **Title:** Post-operative Infection **Type:** PRIMARY **Unit of Measure:** Subjects ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 3 **Description:** Any positive blood culture during the post-operative period until hospital discharge **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** until Hospital Discharge, an average of 30 days **Title:** Blood Stream Infection **Type:** PRIMARY **Unit of Measure:** subjects ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 4 **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** 7 days **Title:** Blood Stream Infection Within 1 Week of Surgery **Type:** PRIMARY **Unit of Measure:** subjects ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 5 **Description:** Plasma albumin will be assessed at 24 and 48 hours. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** up to 48 hours post CPB **Title:** Post-operative Plasma Albumin **Type:** SECONDARY **Unit of Measure:** g/dL ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 6 **Description:** The following fluid overload variables will be assessed in milliliters per kilogram at 0-24 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload. The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg. **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** 0-24 hours post-CPB **Title:** Fluid Overload Variables **Type:** SECONDARY **Unit of Measure:** mililiters/kilogram ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 7 **Description:** The average admit, 12 hour, 24 hour, and 48 hour post-operative inotrope score will be calculated excluding Milrinone. To calculate the inotrope score the following formula was used: (Epinephrine/Norepinephrine dose in mcg/kg/min x 100) + (Dopamine dose in mcg/kg/min x 1) + (Phenylephrine dose in mcg/kg/min x 10) + (Vasopressin dose unit/kg/hr x 60/10000). The higher the inotrope score the more cardiac support the subject requires. There is not a "normal" scale or range used for this calculation. **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** first 48 hours post-CPB **Title:** Post-operative Inotrope Score **Type:** SECONDARY **Unit of Measure:** inotropic score ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 8 **Description:** Alive, ventilator free days will be recorded at hospital discharge. **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** until Hospital Discharge, an average of 30 days **Title:** Respiratory Variables **Type:** SECONDARY **Unit of Measure:** days ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 9 **Description:** From admit post-operative to the Pediatric cardiac intensive care unit until discharge from the hospital in days. **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** Approximately 1 month **Title:** Hospital Discharge **Type:** SECONDARY **Unit of Measure:** days ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 10 **Description:** Plasma Immunoglobulin levels will be checked pre-operatively, 12 hours post-op and 5 days post-op **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 5 days post-op **Title:** Plasma Immunoglobulins **Type:** SECONDARY **Unit of Measure:** mg/dL ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 11 **Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** Pre-operative to 48 hours post-operative **Title:** Interferon-gamma Plasma Cytokine Levels **Type:** SECONDARY **Unit of Measure:** pg/mL ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 12 **Description:** Immunoglobulin concentration will be measured from chest tube every 4 hours for first 12 hours post-operative and then 24 hours post-operative. **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** 24 hours post-op **Title:** Immunoglobulin Concentration in Chest Tube Drainage **Type:** SECONDARY **Unit of Measure:** mg/dL ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 13 **Description:** Incidence of mortality from admit to Pediatric cardiac intensive care unit post-operatively until hospital discharge . **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Approximately 1 month **Title:** Mortality **Type:** SECONDARY **Unit of Measure:** subjects ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 14 **Description:** The length of stay in the pediatric cardiac intensive care unit from admit post-operative until either discharge home, discharge to another unit/hospital/care facility, or death. This value is calculated in hours. Admit post-operative is recorded as hour 0. **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** 1 month **Title:** Intensive Care Unit Length of Stay **Type:** SECONDARY **Unit of Measure:** hours ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 15 **Description:** The following fluid overload variables will be assessed at 0-24 hours, 25-48 hours, and 0-48 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload.The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg. **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** 0-48 hours post-CPB **Title:** Fluid Overload Variables **Type:** SECONDARY **Unit of Measure:** militers/kilogram ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 16 **Description:** Time until first extubation in hours **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** until extubation, an average of 2 days **Title:** Respiratory Variables **Type:** SECONDARY **Unit of Measure:** hours ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 17 **Description:** Total time duration of post-operative length of mechanical ventilation until hospital discharge **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** until extubation, an average of 2 days **Title:** Respiratory Variables **Type:** SECONDARY **Unit of Measure:** hours ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 18 **Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** pre-operative through 48 hours post-operative **Title:** Interleukin-10 Plasma Cytokine Levels **Type:** SECONDARY **Unit of Measure:** pg/mL ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 19 **Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** pre-operative through 48 hours post-operative **Title:** Interleukin-12p70 Plasma Cytokine Levels **Type:** SECONDARY **Unit of Measure:** pg/mL ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 20 **Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** pre-operative through 48 hours post-operative **Title:** Interleukin-1b Plasma Cytokine Levels **Type:** SECONDARY **Unit of Measure:** pg/mL ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 21 **Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** pre-operative through 48 hours post-operative **Title:** Interleukin-6 Plasma Cytokine Levels **Type:** SECONDARY **Unit of Measure:** pg/mL ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 22 **Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** pre-operative through 48 hours post-operative **Title:** Interleukin-8 Plasma Cytokine Levels **Type:** SECONDARY **Unit of Measure:** pg/dL ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 23 **Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** pre-operative through 48 hours post-operative **Title:** Tumor Necrosis Factor Plasma Cytokine Levels **Type:** SECONDARY **Unit of Measure:** pg/dL ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 24 **Description:** Immunoglobulin concentration will be measured from chest tube and peritoneal drain every 4 hours for first 12 hours post-operative and 24 hours post-operative. **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** 24 hours post-op **Title:** Immunoglobulin Concentration in Peritoneal Dialysis Drainage **Type:** SECONDARY **Unit of Measure:** mg/dL ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 25 **Description:** Pre-operative and 48 hour post-operative maximum creatinine recorded. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 48 hours **Title:** Serum Creatinine **Type:** SECONDARY **Unit of Measure:** mg/dL ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline #### Outcome Measure 26 **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** pre-operative through 24 hours post-operative **Title:** Lactic Acid **Type:** SECONDARY **Unit of Measure:** mmol/L ##### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** OG000 **Title:** IVIG ##### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** OG001 **Title:** Normal Saline ### Participant Flow Module #### Group **Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. **ID:** FG000 **Title:** IVIG #### Group **Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. **ID:** FG001 **Title:** Normal Saline #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 30 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 20 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 30 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 20 ##### 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:** NCT01559779 **Acronym:** AB-CD-10 **Brief Title:** Effect of Gastric Bypass Surgery on Pancreatic Islets and Incretin Function **Official Title:** The Effect of Gastric Bypass Surgery on the Beta- and Alpha Cells Secretory Function and the Insulinotropic Effect of the Incretin Hormones #### Organization Study ID Info **ID:** AB-CD-10 #### Organization **Class:** OTHER **Full Name:** Hvidovre University Hospital ### Status Module #### Completion Date **Date:** 2012-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2014-06-10 **Type:** ESTIMATED **Last Update Submit Date:** 2014-06-09 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2012-07 **Type:** ACTUAL #### Start Date **Date:** 2010-11 **Status Verified Date:** 2014-06 #### Study First Post Date **Date:** 2012-03-21 **Type:** ESTIMATED **Study First Submit Date:** 2012-03-19 **Study First Submit QC Date:** 2012-03-20 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Copenhagen #### Lead Sponsor **Class:** OTHER **Name:** Hvidovre University Hospital #### Responsible Party **Investigator Affiliation:** Hvidovre University Hospital **Investigator Full Name:** Carsten Dirksen **Investigator Title:** MD PhD student **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study aims at describing the acute and subacute changes after Roux-en-Y (RYGB) gastric bypass in insulin secretion from the beta cell and glucagon secretion from the alpha cell as well as the stimulatory effect of the incretins on the pancreatic islets. RYGB is a bariatric procedure that changes the gastrointestinal anatomy and has been demonstrated to cause remission of type 2 diabetes shortly after the operation, before any significant weight loss. The altered transit of nutrient through the gastrointestinal tract after the operation is thought to play a key role in this remission and studies have shown significant changes in the secretion of gut hormones, namely the incretin hormone glucagon-like peptide-1 (GLP-1). However it is unknown whether the secretory function of the pancreatic islets as well as the stimulatory effect of the incretin hormones is changes postoperatively. ### Conditions Module **Conditions:** - Obesity **Keywords:** - Obesity - Roux-en-Y gastric bypass - Incretin hormones - Beta cell function ### Design Module #### Bio Spec **Description:** Plasma and serum specimens are retained **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 11 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Morbidly obese subjects with normal glucose tolerance undergoing gastric bypass surgery **Label:** Normal glucose tolerance ### Outcomes Module #### Primary Outcomes **Description:** Change in first and second phase insulin response, disposition index, and acute insulin secretion in response to a non-glucose stimulus **Measure:** Change in beta cell function **Time Frame:** Before and 1 week and 3 months after surgery **Description:** Change in first and second phase insulin response during GLP-1 and GIP infusion compared to saline **Measure:** Insulinotropic effect of incretin hormones **Time Frame:** Before and 1 week and 3 months after surgery #### Secondary Outcomes **Description:** Change in glucagon secretion in response to glucose and non-glucose stimuli **Measure:** Change in alpha cell function **Time Frame:** Before and 1 week and 3 months after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Normal glucose tolerance * Age \> 18 years * BMI \> 40 or \> 35 if combined with hypertension or obstructive sleep apnoea * Caucasian * Normal hemoglobinaemia * Signed informed consent Exclusion Criteria: * Major psychiatric disorder * Alcohol or drug abuse * Major hearth or pulmonary disease * Previous major abdominal disease (e.g. peritonitis, large hernia) * Pregnancy/lactation * Treatment with GLP-1 analogs **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Subjects are recruited from the population undergoing gastric bypass surgery at Hvidovre Hospital ### Contacts Locations Module #### Locations **Location 1:** **City:** Hvidovre **Country:** Denmark **Facility:** Dpt. of Endocrinology (215) at Hvidovre Hospital **State:** Copenhagen **Zip:** 2650 #### Overall Officials **Official 1:** **Affiliation:** Hvidovre University Hospital **Name:** Carsten Dirksen, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Dirksen C, Bojsen-Moller KN, Jorgensen NB, Jacobsen SH, Kristiansen VB, Naver LS, Hansen DL, Worm D, Holst JJ, Madsbad S. Exaggerated release and preserved insulinotropic action of glucagon-like peptide-1 underlie insulin hypersecretion in glucose-tolerant individuals after Roux-en-Y gastric bypass. Diabetologia. 2013 Dec;56(12):2679-87. doi: 10.1007/s00125-013-3055-1. Epub 2013 Sep 19. **PMID:** 24048673 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: HIGH - As Found: Obesity - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009765 - Term: Obesity ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M27905 - Name: Incretins - Relevance: LOW - As Found: Unknown - ID: M8866 - Name: Gastric Inhibitory Polypeptide - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04149379 **Brief Title:** Hyperbaric Oxygen Therapy After Stroke - PILOT **Official Title:** Hyperbaric Oxygen Therapy After Cerebral Infarction - PILOT #### Organization Study ID Info **ID:** 305476 #### Organization **Class:** INDUSTRY **Full Name:** Norwegian Underwater Intervention (NUI) ### Status Module #### Completion Date **Date:** 2021-12-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2020-04-27 **Type:** ACTUAL **Last Update Submit Date:** 2020-04-23 **Overall Status:** WITHDRAWN #### Primary Completion Date **Date:** 2021-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2020-04-20 **Type:** ESTIMATED **Status Verified Date:** 2020-04 #### Study First Post Date **Date:** 2019-11-04 **Type:** ACTUAL **Study First Submit Date:** 2019-10-29 **Study First Submit QC Date:** 2019-10-30 **Why Stopped:** Because of the economic consequences of the COVID-19 pandemic 2020 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Western Norway University of Applied Sciences **Class:** OTHER **Name:** Helse-Bergen HF #### Lead Sponsor **Class:** INDUSTRY **Name:** Norwegian Underwater Intervention (NUI) #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this pilot study is to establish more information about hyperbaric oxygen therapy for this group of patients, and give us more information of how to initiate the best possible main study. Can we find any indications that support the use of this therapy for patients suffering from chronic disability after cerebral infarction? Can we improve physical and cognitive function. **Detailed Description:** This is a pilot project including 6 patients for one session of 20 treatments of hyperbaric oxygen therapy. The objective is to establish knowledge of HBO for this group of patients in a Norwegian context, so that we can prepare for the main study afterwards, including about 60-70 patients. We need to know how to optimize the administrative and technical systems for the larger study. We want to collect feedback from the patients undergoing the pilot study. We want more information about the treatment table, if 20 treatments are enough, if 2,4 bar pressure is adequate. The treatment table is based on existing research, and is considered safe. The patients are to be treated at table 14/90, at 2,4 Absolute atmospheres, and daly 90 minutes of oxygen inhalation (medical oxygen). ### Conditions Module **Conditions:** - Cerebral Stroke **Keywords:** - Stroke - Hyperbaric oxygen ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Single subject SSED ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** One group of 6 patients undergoing 20 sessions of hyperbaric therapy at table 14/90. **Intervention Names:** - Drug: Hyperbaric oxygen **Label:** Treatment group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment group **Description:** 20 sessions of hyperbaric therapy in a pressure chamber at 2,4 absolute atmospheres, 90 minutes per day of breathing 100% medical oxygen through an own mask. Table 14/90. **Name:** Hyperbaric oxygen **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The project's physiotherapist and ergo therapist from Western Norway University of Applied Sciences (HVL) are responsible for examining physical function and the participant's ability to acquire and use knowledge, as well as function in everyday living activities (ADL). Three measurements are made before starting treatment (establishing a baseline), where the third measurement is done on the same day as treatment starts to eliminate changes in test results as a result of learning the tests. Measurements are also made immediately after the end of treatment, as well as follow-up measurements after 6 and 12 months. Descriptions below. **Measure:** Improved physical and cognitive function in activities of daily living. **Time Frame:** 0+6+12 months after end of treatment period **Description:** This test is very widely used to provide a quick and validated test of strength, balance and coordination. The test has a roof effect, so it is not suitable for capturing very small and subtle self-perceived disturbances in function. The test is very sensitive to change in the target group. **Measure:** Short Physical Performance Battery (SPPB) **Time Frame:** 0+6+12 months after end of treatment period **Description:** There is a recognized and validated connection between general function and health and grip strength, as well as between grip strength and life span. Grip strength changes as other function changes. **Measure:** Grip strength **Time Frame:** 0+6+12 months after end of treatment period **Description:** A major problem after stroke and in many brain disorders is fatigue. Fatigue leads to reduced foxing and thus loss of function. The test is believed to be able to detect changes that are relevant to everyday life function and social participation. **Measure:** Fatigue Severity Scale (FSC) **Time Frame:** 0+6+12 months after end of treatment period **Description:** COPM is designed to help people identify and prioritize activity problems, as well as evaluate activity performance and satisfaction with activity execution. In an interview, the person is asked to describe activities they consider important but find it difficult to perform. Among the aforementioned challenges, the person is asked to prioritize a maximum of five activities he / she wants to be able to perform better after the end of treatment. Then, the person is asked to score the current performance and satisfaction with the current performance of priority activities. The score scale is from 1-10 where 10 indicates very good workmanship or high satisfaction. After the interview, partial scores for execution (COPM-U) and satisfaction (COPM-T) are calculated. A change score of 3 points is considered a clinically important change. COPM has shown good measurement properties, among other things for participants with stroke and the elderly. **Measure:** Canadian Occupational Performance Measure (COPM) **Time Frame:** 0+6+12 months after end of treatment period **Description:** ARAT is a tool designed to assess motor function in the arm after stroke. The tasks in the test reflect daily activities and the patient's ability to perform them. The test contains 19 sub-tasks in which different grips (five-finger grips, cylinder grips, tweezers grips), as well as gross motor skills are specifically assessed. In each of the 19 tasks, a score is given from 0-3, where high scores indicate good arm function. The total score (0-57) is the sum of the sub-scores. The test has shown promising measurement properties. For participants in the chronic and subacute phase after stroke, a change of 5.7 points (10%) is considered clinically important. Norwegian guidelines will be used in the study. **Measure:** Action Research Arm Test (ARAT) **Time Frame:** 0+6+12 months after end of treatment period **Description:** NHPT is a simple test of fine motor skills that is recommended, among other things, for participants with stroke. Scoring is based on the time the patient spends in placing and removing nine small pieces in nine holes. Total time (maximum 50 seconds) and total number of pins are indicated. The test has shown satisfactory reliability and validity. **Measure:** Nine Hole Peg Test (NHPT) **Time Frame:** 0+6+12 months after end of treatment period ### Eligibility Module **Eligibility Criteria:** Inlcution criteria: * No age restriction * Suffered from ischemic stroke (cerebral infarction) 6-12 months before inclusion. * Stable phase after standard rehabilitation * Measurable physical function failure and / or reduced ADL function. * Sufficient physical function / mobility to be able to move into / out of the pressure chamber with the help of only one person (Tender). Patients to participate in the study must be physically, mentally and cognitively fit for pressure chamber treatment. They must be able to stand for their own help, move with support, and be able to follow instructions. This is ensured by discretionary assessment after observation and interview with the patient. Exclusion criteria: * Claustrophobia * Psychosis, severe anxiety * Inability to equalize pressure in the middle ear * Severe COPD and asthma, pathological lung sounds * Hypertension (Blood pressure \> 140/90 mmHg) * Pregnancy * Hernia * Earlier fractures, or suspected fractures in the face * Ongoing chemotherapy * Previous treatment with Bleomycin * Aphasia that prevents necessary communication * Cognitive failure that prevents necessary co-operation in the pressure chamber. * Previous or current pneumothorax, other lung injury * Increased risk of pneumothorax * Known or suspected injury to the chest * Marfan syndrome * Homocystinuria * Family history of pneumothorax * Chronic lung disease (COPD, Emphysema, Asthma eller cystic fibrosis) * Tuberculosis **Maximum Age:** 99 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bergen **Country:** Norway **Facility:** NUI **State:** Hordaland **Zip:** 5165 #### Overall Officials **Official 1:** **Affiliation:** Western Norway University of Applied Sciences **Name:** Tobba T Südmann, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Heyboer M 3rd, Sharma D, Santiago W, McCulloch N. Hyperbaric Oxygen Therapy: Side Effects Defined and Quantified. Adv Wound Care (New Rochelle). 2017 Jun 1;6(6):210-224. doi: 10.1089/wound.2016.0718. **PMID:** 28616361 **Citation:** Plafki C, Peters P, Almeling M, Welslau W, Busch R. Complications and side effects of hyperbaric oxygen therapy. Aviat Space Environ Med. 2000 Feb;71(2):119-24. **PMID:** 10685584 **Citation:** Mu J, Ostrowski RP, Soejima Y, Rolland WB, Krafft PR, Tang J, Zhang JH. Delayed hyperbaric oxygen therapy induces cell proliferation through stabilization of cAMP responsive element binding protein in the rat model of MCAo-induced ischemic brain injury. Neurobiol Dis. 2013 Mar;51:133-43. doi: 10.1016/j.nbd.2012.11.003. Epub 2012 Nov 10. **PMID:** 23146993 **Citation:** Mathieu D, Marroni A, Kot J. Tenth European Consensus Conference on Hyperbaric Medicine: recommendations for accepted and non-accepted clinical indications and practice of hyperbaric oxygen treatment. Diving Hyperb Med. 2017 Mar;47(1):24-32. doi: 10.28920/dhm47.1.24-32. Erratum In: Diving Hyperb Med. 2017 Jun;47(2):131-132. **PMID:** 28357821 **Citation:** Al-Waili NS, Butler GJ, Beale J, Abdullah MS, Hamilton RW, Lee BY, Lucus P, Allen MW, Petrillo RL, Carrey Z, Finkelstein M. Hyperbaric oxygen in the treatment of patients with cerebral stroke, brain trauma, and neurologic disease. Adv Ther. 2005 Nov-Dec;22(6):659-78. doi: 10.1007/BF02849960. **PMID:** 16510383 **Citation:** Efrati S, Ben-Jacob E. Reflections on the neurotherapeutic effects of hyperbaric oxygen. Expert Rev Neurother. 2014 Mar;14(3):233-6. doi: 10.1586/14737175.2014.884928. Epub 2014 Jan 29. **PMID:** 24471697 **Citation:** Rosario ER, Kaplan SE, Khonsari S, Vazquez G, Solanki N, Lane M, Brownell H, Rosenberg SS. The Effect of Hyperbaric Oxygen Therapy on Functional Impairments Caused by Ischemic Stroke. Neurol Res Int. 2018 Oct 9;2018:3172679. doi: 10.1155/2018/3172679. eCollection 2018. **PMID:** 30402285 **Citation:** Wang W, Osenbroch P, Skinnes R, Esbensen Y, Bjoras M, Eide L. Mitochondrial DNA integrity is essential for mitochondrial maturation during differentiation of neural stem cells. Stem Cells. 2010 Dec;28(12):2195-204. doi: 10.1002/stem.542. **PMID:** 20954243 **Citation:** Efrati S, Fishlev G, Bechor Y, Volkov O, Bergan J, Kliakhandler K, Kamiager I, Gal N, Friedman M, Ben-Jacob E, Golan H. Hyperbaric oxygen induces late neuroplasticity in post stroke patients--randomized, prospective trial. PLoS One. 2013;8(1):e53716. doi: 10.1371/journal.pone.0053716. Epub 2013 Jan 15. **PMID:** 23335971 **Citation:** Godman CA, Chheda KP, Hightower LE, Perdrizet G, Shin DG, Giardina C. Hyperbaric oxygen induces a cytoprotective and angiogenic response in human microvascular endothelial cells. Cell Stress Chaperones. 2010 Jul;15(4):431-42. doi: 10.1007/s12192-009-0159-0. Epub 2009 Dec 1. **PMID:** 19949909 **Citation:** Vila JF, Balcarce PE, Abiusi GR, Dominguez RO, Pisarello JB. Improvement in motor and cognitive impairment after hyperbaric oxygen therapy in a selected group of patients with cerebrovascular disease: a prospective single-blind controlled trial. Undersea Hyperb Med. 2005 Sep-Oct;32(5):341-9. **PMID:** 16457083 #### See Also Links **Label:** The effects of combined hyperbaric oxygen therapy on patients with post-stroke depression **URL:** https://www.jstage.jst.go.jp/article/jpts/27/5/27_jpts-2014-730/_article/-char/ja/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - 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: M22306 - Name: Stroke - Relevance: HIGH - As Found: Stroke - ID: M5793 - Name: Cerebral Infarction - Relevance: LOW - As Found: Unknown - ID: M10282 - Name: Infarction - Relevance: LOW - As Found: Unknown - ID: M5810 - Name: Cerebrovascular Disorders - 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: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020521 - Term: Stroke ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03403179 **Brief Title:** Functional Remediation for Bipolar Disorder **Official Title:** A Pilot Study of Functional Remediation for Bipolar Disorder: Feasibility and Preliminary Efficacy #### Organization Study ID Info **ID:** HUM00113668 #### Organization **Class:** OTHER **Full Name:** University of Michigan ### Status Module #### Completion Date **Date:** 2018-12-20 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-02-28 **Type:** ACTUAL **Last Update Submit Date:** 2019-02-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-12-10 **Type:** ACTUAL #### Start Date **Date:** 2017-11-17 **Type:** ACTUAL **Status Verified Date:** 2019-02 #### Study First Post Date **Date:** 2018-01-18 **Type:** ACTUAL **Study First Submit Date:** 2018-01-11 **Study First Submit QC Date:** 2018-01-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Michigan #### Responsible Party **Investigator Affiliation:** University of Michigan **Investigator Full Name:** Sagar Parikh **Investigator Title:** Professor of Psychiatry **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Bipolar Disorder is a major mood disorder with periodic mood episodes that may be very distressing, both to the individual and to others. When ill, the person is at particular risk for disruptions to social and occupational functioning, physical health, and even premature death. When not in an episode, individuals with BD may still be feeling well but have ongoing neurobiological processes, as well as the psychological sequelae from illness episodes, that can lead to subtle neurocognitive impairment that impedes overall functioning. This study is a test of an existing, published intervention that ameliorates deficits in functioning in euthymic bipolar individuals. ### Conditions Module **Conditions:** - Bipolar Disorder **Keywords:** - Cognition - Cognitive Remediation - Mood Disorder - Functional Impairment - Psychosocial intervention ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** This study is a single center, open-label, outpatient clinical trial with no randomization or blinding. The Barcelona Functional Remediation for Bipolar Disorder (FR) Program will be tested over a 21-week period using 30 participants split into two equal cohorts. The study will evaluate the feasibility and preliminary efficacy of the intervention. ##### 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:** Functional Remediation: The functional remediation program consists of 21 weekly sessions, each lasting 90 min. This intervention addresses neurocognitive issues such as attention, memory and executive functions, but it focuses even more on enhancing functioning in daily routine. The content of the intervention is based on ecological tasks to be performed in two settings, in the clinic as well as at home. Participants will be trained with exercises for memory, attention, problem solving and reasoning, multitasking and organization in order to improve their functional outcome. Most of the techniques are based on paper-and-pencil tasks and group activities. **Intervention Names:** - Other: Functional Remediation **Label:** Receiving Psychosocial Intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Receiving Psychosocial Intervention **Description:** Functional Remediation: The functional remediation program consists of 21 weekly sessions, each lasting 90 min. This intervention addresses neurocognitive issues such as attention, memory and executive functions, but it focuses even more on enhancing functioning in daily routine. The content of the intervention is based on ecological tasks to be performed in two settings, in the clinic as well as at home. Participants will be trained with exercises for memory, attention, problem solving and reasoning, multitasking and organization in order to improve their functional outcome. Most of the techniques are based on paper-and-pencil tasks and group activities. **Name:** Functional Remediation **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Feasibility will be determined by a composite of ability to recruit and deliver the treatment intervention to both cohorts of participants, with adequate delivery of the intervention as measured by completion of the manual's objectives. **Measure:** Feasibility **Time Frame:** 30 weeks **Description:** Acceptability of the intervention will be measured by use of the Satisfaction with Therapy and Therapist Scale. **Measure:** Acceptability (Subject Satisfaction) **Time Frame:** 30 weeks **Description:** Measured by percentage of subjects who complete the intervention. **Measure:** Acceptability (Subject completion) **Time Frame:** 30 weeks #### Secondary Outcomes **Description:** The Functioning Assessment Short Test (FAST) is an interviewer-administered scale for disability due to psychiatric illness, used both pre-and post-completion. The instrument has 24 items capturing 6 domains of functioning: (1) Autonomy (2) Occupational Functioning (3) Cognitive Functioning (4) Financial Issues (5) Relationships (6) Leisure Time. Scores above 11 identify at least mild functional impairment. Impact of the intervention on change in FAST score will be examined. **Measure:** Functional Impact **Time Frame:** 30 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * diagnosis of bipolar I or II disorder (BD), as determined by a structured diagnostic interview * at least three months of clinical remission (euthymia or minimal symptoms), based on the phone screen assessing mood episodes in the prior three months * score greater than 11 on a measure of everyday functioning (FAST; described in measures section) indicating at least mild impairment * use of a standard bipolar mood-stabilizing medication at the same, adequate dose (according to CANMAT treatment guidelines) for at least 3 months prior to screening, with ability to continue that dose during the study. Exclusion Criteria: * history of neurological illness or injury (e.g., stroke, brain tumor) * documented intellectual disability * inability to provide written informed consent * substance dependence within last 3 months or substance abuse in last 30 days * inability to complete the six-month intervention * received ECT in the past 12 months **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Ann Arbor **Country:** United States **Facility:** University of Michigan Depression Center **State:** Michigan **Zip:** 48109 #### Overall Officials **Official 1:** **Affiliation:** University of Michigan **Name:** Sagar Parikh, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000068105 - Term: Bipolar and Related Disorders - ID: D000019964 - Term: Mood 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: M4996 - Name: Bipolar Disorder - Relevance: HIGH - As Found: Bipolar Disorder - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M226 - Name: Bipolar and 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: D000001714 - Term: Bipolar Disorder ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02103179 **Acronym:** VEGF ECC **Brief Title:** VEGF Signaling Promotes Cell Growth and Metastasis in Extrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway (ECC) **Official Title:** VEGF Signaling Promotes Cell Growth and Metastasis in Extrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway #### Organization Study ID Info **ID:** k0113011-2013ECC #### Organization **Class:** OTHER **Full Name:** First Affiliated Hospital, Sun Yat-Sen University ### Status Module #### Completion Date **Date:** 2014-09 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** ACTIVE_NOT_RECRUITING #### Last Update Post Date **Date:** 2014-04-03 **Type:** ESTIMATED **Last Update Submit Date:** 2014-03-31 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2014-04 **Type:** ESTIMATED #### Start Date **Date:** 2006-07 **Status Verified Date:** 2014-03 #### Study First Post Date **Date:** 2014-04-03 **Type:** ESTIMATED **Study First Submit Date:** 2014-03-31 **Study First Submit QC Date:** 2014-03-31 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Guangdong Province, Department of Science and Technology #### Lead Sponsor **Class:** OTHER **Name:** First Affiliated Hospital, Sun Yat-Sen University #### Responsible Party **Investigator Affiliation:** First Affiliated Hospital, Sun Yat-Sen University **Investigator Full Name:** Ming Kuang,MD,PhD **Investigator Title:** MD,PhD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The investigators study the VEGF signaling in ECC cell lines,patients and its mechanism in ECC growth, proliferation and apoptosis. **Detailed Description:** Several studies have documented the elevated expression of VEGF, VEGFR1 and VEGFR2 in cancer cell lines. Another study observed a sequential elevation of VEGF in low-grade dysplasia, high-grade dysplasia and early stage liver cancer. Clinical analyses have discovered the high expression of VEGF is correlated with tumor progression, vascular invasion, distal metastasis and poor prognosis. However, few studies have been conducted to investigate the VEGF signaling in ECC cells and its possible mechanism in regulating ECC growth.Therefore,we try to clarify the mechanism of VEGF signal in ECC growth,proliferation and apoptosis. ### Conditions Module **Conditions:** - Extrahepatic Cholangiocarcinoma **Keywords:** - Extrahepatic cholangiocarcinoma - ECC - VEGF signaling ### Design Module #### Bio Spec **Description:** Cut tissue into small pieces (\~2 mm2)and wash in drops of saline (1x PBS). Place pieces individually into LN2 in Styrofoam cup. Transfer pieces into LN2-cooled 1.5 mL cryovial. Pour out excess LN2 from vial, then seal and keep in LN2 until freezer storage. **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Extrahepatic cholangiocarcinoma patients treated by surgical treatment **Intervention Names:** - Procedure: surgical treatment **Label:** ECC patients ### Interventions #### Intervention 1 **Arm Group Labels:** - ECC patients **Description:** all the patients in the study must have been treated by the surgery at the first time and have been confirmed as 'complete section' by the post-surgery radiological image. **Name:** surgical treatment **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** the sections would be collected as previously described.Western blot,immunohistochemistry,PCR would be conducted to find out the variation between the normal liver tissue and tumor,tumor and meta(if have). **Measure:** the variation of the quantity of VEGF signal pathway genes in normal liver tissue,peri tumor,tumor and metastasis. **Time Frame:** the day when conducting surgery (day 1) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Extrahepatic cholangiocarcinoma patients diagnosed through biopsy; two or more dynamic imagine with a diagnosis of Extrahepatic cholangiocarcinoma 2. Child-Pugh A or B 3. well preserved renal and hematopoietic Function 4. receive surgical therapy 5. achieve complete section accessed by contrast-enhanced CT Exclusion Criteria: 1. incomplete section 2. remote metastasis 3. Child-Pugh C 4. combination with other hepatobiliary disease 5. suffer from other tumors concurrently or in last five years **Maximum Age:** 80 Years **Minimum Age:** 16 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Extrahepatic cholangiocarcinoma patients underwent surgical therapy ### Contacts Locations Module #### Locations **Location 1:** **City:** Guangzhou **Country:** China **Facility:** First Affiliated Hospital, Sun Yat-Sen University **State:** Guangdong **Zip:** 510000 #### Overall Officials **Official 1:** **Affiliation:** First Affiliated Hospital, Sun Yat-Sen University **Name:** Ming Kuang, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009369 - Term: Neoplasms - ID: D000000230 - Term: Adenocarcinoma - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12307 - Name: Neoplasm Metastasis - Relevance: LOW - As Found: Unknown - ID: M20426 - Name: Cholangiocarcinoma - Relevance: HIGH - As Found: Extrahepatic Cholangiocarcinoma - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - 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: T755 - Name: Bile Duct Cancer - Relevance: HIGH - As Found: Cholangiocarcinoma ### Condition Browse Module - Meshes - ID: D000018281 - Term: Cholangiocarcinoma ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03984279 **Acronym:** APIR-TDM **Brief Title:** Comparison of Sequential Fluoroscopy Guidance With Spiral Guidance in Terms of Safety, Effectiveness, Speed and Radiation in Interventional Chest-abdomen-pelvic Procedures **Official Title:** Comparison of the Study Was to Compare Sequential Fluoroscopy Guidance With Spiral Guidance in Terms of Safety (Number of Major Complications), Effectiveness (Number of Targets Reached), Speed (Procedural Time) and Radiation (DLP) in Interventional Chest-abdomen-pelvic Procedures. #### Organization Study ID Info **ID:** P/2018/362 #### Organization **Class:** OTHER **Full Name:** Centre Hospitalier Universitaire de Besancon ### Status Module #### Completion Date **Date:** 2018-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-07-23 **Type:** ACTUAL **Last Update Submit Date:** 2019-07-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-12-31 **Type:** ACTUAL #### Start Date **Date:** 2018-01-17 **Type:** ACTUAL **Status Verified Date:** 2019-05 #### Study First Post Date **Date:** 2019-06-12 **Type:** ACTUAL **Study First Submit Date:** 2019-05-27 **Study First Submit QC Date:** 2019-06-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Centre Hospitalier Universitaire de Besancon #### 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 was to compare sequential fluoroscopy guidance with spiral guidance in terms of safety (number of major complications), effectiveness (number of targets reached), speed (procedural time) and radiation (DLP) in interventional chest-abdomen-pelvic procedures. ### Conditions Module **Conditions:** - Body Interventional procédures With CT ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 385 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control **Label:** Sequentiel group (SEQ) #### Arm Group 2 **Intervention Names:** - Other: Patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control **Label:** Siral group (SPI) ### Interventions #### Intervention 1 **Arm Group Labels:** - Sequentiel group (SEQ) - Siral group (SPI) **Description:** Not applicable, all patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control on a period of 1 year will be taken into account **Name:** Patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Comparison between the 2 groups **Measure:** number of major complications **Time Frame:** All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account **Description:** Comparison between the 2 groups **Measure:** number of targets reached **Time Frame:** All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account **Description:** Comparison between the 2 groups **Measure:** Dose Length Product (DLP) **Time Frame:** All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account #### Secondary Outcomes **Description:** Comparison between the 2 groups **Measure:** number of controls required to place the needle **Time Frame:** All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * adult patients (\> 18 years), * indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control Exclusion Criteria: * MRI contra indication * persons referred to in Articles L1121-5 to L1121-8 of the French Public Health Code **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patient with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control ### Contacts Locations Module #### Locations **Location 1:** **City:** Besançon **Country:** France **Facility:** Centre Hospitalier Universitaire **Zip:** 25000 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00274079 **Brief Title:** SPIRIVA in Ususal Care **Official Title:** A Randomised, Double-blind, Parallel Group, 12 Week Study, Comparing the Effect of Once Daily Tiotropium Lactose Capsule With Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD), naïve to Anticholinergic Agents in Addition to Receiving Their Usual COPD Care #### Organization Study ID Info **ID:** 205.276 #### Organization **Class:** INDUSTRY **Full Name:** Boehringer Ingelheim ### Status Module #### Completion Date **Date:** 2003-10 #### Expanded Access Info #### Last Update Post Date **Date:** 2013-11-01 **Type:** ESTIMATED **Last Update Submit Date:** 2013-10-31 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2003-10 **Type:** ACTUAL #### Start Date **Date:** 2002-10 **Status Verified Date:** 2013-10 #### Study First Post Date **Date:** 2006-01-10 **Type:** ESTIMATED **Study First Submit Date:** 2006-01-09 **Study First Submit QC Date:** 2006-01-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Boehringer Ingelheim ### Description Module **Brief Summary:** The objective of the study is to determine the effect on lung function when either SPIRIVA once daily or placebo once daily is added to the usual therapy (care) of COPD patients naïve to anticholinergic agents managed in primary care. Previous studies have been in both hospital in and outpatients, with washout of some respiratory medications, this is the first study to be conducted in General Practice, the drug's anticipated environment. Data from this study, including the adverse event monitoring, and post study findings on physical examination, will be used to extend the safety database. Health Resource Utilisation (HRU) data will be recorded to be use with data from other sources for economic analysis of COPD treatment. **Detailed Description:** Anticholinergic drugs are currently indicated for all severities of COPD, due to the dominance of cholinergic tone in the pathological process of the disease. SPIRIVA is a new long acting anticholinergic, which has showed the benefits of improved lung function, dyspnoea, health status and less exacerbations compared to ipratropium, salmeterol and placebo in secondary care (hospital setting). The study will determine if the same effect is seen on the on lung function and dyspnoea when either SPIRIVA or placebo is added to the usual therapy /care of COPD patients naïve to anticholinergic agents managed in primary care. The one year placebo and active controlled studies have confirmed efficacy and safety. No evidence of tolerance to the bronchodilator effects of tiotropium has been seen. Consistent improvements of health outcomes were also demonstrated. In the one-year studies, statistically significantly fewer patients in the tiotropium groups experienced exacerbations, or were hospitalised for exacerbations. Additionally, time to first exacerbation was increased. This suggests that moderate and severe exacerbations are reduced in-patients treated with tiotropium. The mechanism underlying this is not known, but may be associated with sustained airway opening. The study will involve five visits to the GP surgery over a period of 14 weeks. Patient will attend for an initial visit to have the study information given to them and obtain their written consent. At the subsequent screening visit a physical examination including ECG together with an assessment of lung function will be performed. Once eligibility to the study is confirmed, and after completion of a 14 day 'run-in' period, patients will start treatment with a daily inhalation from the HandiHaler device of either SPIRIVA or placebo, this in addition to their usual COPD therapy. Throughout the 12 week treatment period, patients will be required to inhale their study treatment medication (each morning) and complete a diary card. Patients will be required to return to the surgery after 2 and 6 weeks, with the final visit at 12 weeks for lung function testing, assessment of symptoms using the Oxygen Cost Diagram (OCD), Health Resources Utilisation (HRU) and any adverse events. On completion of the 12 week treatment period, a full physical examination will be repeated. Adverse event monitoring including COPD exacerbations will take place throughout the study. Study Hypothesis: Based on previous studies on COPD patients who were not on long acting beta agonists (LABAs), the standard deviation (SD) for trough FEV1 was 215 ml and an effect of 130 ml was seen on mean trough FEV1 with tiotropium. It is assumed that 20% of primary care managed COPD patients will be using LABAs as part of their usual care. The effect of tiotropium on mean trough FEV1 in the study population is expected to be lower than the 130 ml seen in previous studies. Placebo is not expected to have any effect on mean trough FEV1. Assuming an SD of 235ml, a total of 348 patients (174 per group) is adequate to detect a difference of 100 ml in mean trough FEV1 response between treatments with at the least 95% power at the 2.5% level of significance (one-sided) using a two group t-test. To be considered complete, a patient must complete all primary efficacy data for all study visits as specified in the protocol without violations of the protocol so significant as to obscure the response to treatment. Comparison(s): Usual care for COPD ### Conditions Module **Conditions:** - Pulmonary Disease, Chronic Obstructive ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 395 **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** SPIRIVA **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Trough Forced Expiratory Volume in one second (FEV1) response determined at the end of the 12- week treatment period **Time Frame:** week 12 #### Secondary Outcomes **Measure:** Trough FEV1 response after 2 and 6 weeks **Time Frame:** week 2, week 6 **Measure:** Trough Forced Vital Capacity (FVC) response after 2, 6 and 12 weeks **Time Frame:** week 2, week 6, week 12 **Measure:** Dyspnoea measured by the Oxygen Cost Diagram (OCD **Time Frame:** week 12 **Measure:** Weekly mean number per day of occasions when Short Acting β2 Agonist (SABA) therapy was used **Time Frame:** week 12 **Measure:** Percentage compliance with study medication as assessed by inhalation capsule counts **Time Frame:** week 12 **Measure:** Adverse events **Time Frame:** week 12 **Measure:** Seated pulse rate and blood pressure **Time Frame:** week 12 **Measure:** Physical examination **Time Frame:** week 12 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Prior to participation in the study all patients must sign and date an informed consent consistent with ICH-GCP guidelines. * Male or female patients 40 years of age or older. * Patients with a diagnosis of COPD according to BTS criteria..A stable disease state with airway obstruction of FEV1 between 30- 65% of predicted normal value and FEV1 /FVC\<70% pre bronchodilators. * Predicted normal values will be calculated according to ECCS: * For height measured in metres * Males: FEV1 predicted (L) = 4.30 X (Ht in mts) - 0.029 X (Age in yrs) - 2.49 * Females:FEV1 predicted (L) = 3.95 X (Ht in mts) - 0.025 X (Age in yrs) - 2.60 * For height measured in inches * Males: FEV1 predicted (L) = 4.30 X (Ht in inches/39.37) - 0.029 X (Age in yrs) - 2.49 * Females:FEV1 predicted (L) = 3.95 X (Ht in inches/39.37) - 0.025 X (Age in yrs) - 2.60 * Maintained on a stable respiratory medication for 4 weeks prior to visit 1 (no changes in respiratory medication oral dosage). * Currently taking salbutamol or terbutaline MDI or DPI. * Patient must be able to inhale medication through the HandiHaler? * Patients must be able to perform technically acceptable pulmonary function tests in accordance with ATS criteria and must be able to maintain records (Patient Daily Record) during the study period as required in the protocol. * Patients must be current or ex-smokers with a smoking history of more than 10 pack years. * Pack Years = Number of cigarettes/day 20 (Patients who have never smoked cigarettes must be excluded.) NOTE: An exacerbation of COPD requiring treatment occurring within the four week period prior to screening visit 1 will mean that screening should be postponed for at least four weeks. Therefore, the patient should have duration of at least 4 weeks free of exacerbations. Exclusion Criteria: * Patients with significant diseases, other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study. * Patients who have taken inhaled anticholinergics in the previous 12 months. Patients that have been treated with inhaled anticholinergics (via nebuliser or metered dose inhaler) due to an exacerbation for a time period no longer than 7 days may be included. * Patients with an upper respiratory tract infection or exacerbation of COPD requiring treatment in the four weeks prior to the screening visit (visit 1) or during the two-week run-in period. Patients with a recent history (i.e., six months or less) of myocardial infarction. * Any unstable or life threatening cardiac arrhythmia requiring intervention or a change in drug therapy within the last year. * Patients with known active tuberculosis. * Patients who have a history of thoracotomy with pulmonary resection or have planned lung transplantation or lung volume reduction surgery. * Patients with a history of asthma, cystic fibrosis, bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease. * Patients who are being treated with antihistamines (H1 receptor antagonists) for asthma or excluded allergic conditions. * Patients with a history of cancer in the last five years; Basal cell tumours or patients whose length of time in remission is greater than five years can be included. * Patient with known hypersensitivity to atropine, and other anticholinergic drugs or lactose or any previous adverse reaction to anticholinergic drugs that resulted in withdrawal of the anticholinergic compound. * Patients using oral corticosteroid medication at unstable doses (i.e. Patients have been on a stable dose for less than 6 weeks prior to randomisation) or at doses in excess of the equivalent of 10mg o **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Aberdeen **Country:** United Kingdom **Facility:** Foresterhill Healthcentre **Location 2:** **City:** Airdrie **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** ML6 0JU **Location 3:** **City:** Atherstone **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** CV9 1EU **Location 4:** **City:** Barry **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** CF63 4HP **Location 5:** **City:** Bath **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** BA1 2SR **Location 6:** **City:** Bath **Country:** United Kingdom **Facility:** The Beehive Surgery, Bath **Zip:** BA2 1NH **Location 7:** **City:** Bath **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** BA2 4BY **Location 8:** **City:** Bedworth **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** CV6 4DD **Location 9:** **City:** Bellshill **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** ML4 1DQ **Location 10:** **City:** Bexhill-on-Sea **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** TN40 1JJ **Location 11:** **City:** Bexhill **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** TN39 5JB **Location 12:** **City:** Biggar **Country:** United Kingdom **Facility:** Health Centre **Zip:** ML12 6BE **Location 13:** **City:** Bradford Upon Avon **Country:** United Kingdom **Facility:** Bradford Health Centre **Zip:** BA15 1DQ **Location 14:** **City:** Bristol **Country:** United Kingdom **Facility:** Pembroke Road Surgery **Zip:** BS8 3EU **Location 15:** **City:** Cardiff **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** CF4 4UJ **Location 16:** **City:** Chapelhall **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** ML6 8SR **Location 17:** **City:** Coatbridge **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** ML5 3AP **Location 18:** **City:** Coatbridge **Country:** United Kingdom **Facility:** Coatbridge Health Centre **Zip:** ML5 3AP **Location 19:** **City:** Corsham **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** SN13 8NA **Location 20:** **City:** Corsham **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** SN13 9DL **Location 21:** **City:** Coventry **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** CV5 6EU **Location 22:** **City:** Doncaster **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** DN1 2EG **Location 23:** **City:** Garston **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** WD **Location 24:** **City:** Glasgow **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** G3 8YJ **Location 25:** **City:** Glasgow **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** G41 3YA **Location 26:** **City:** Glasgow **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** G44 3DH **Location 27:** **City:** Glasgow **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** G46 8NY **Location 28:** **City:** Glenboig **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** ML5 2RY **Location 29:** **City:** Gorseinon **Country:** United Kingdom **Facility:** Princess Street Surgery **Zip:** SA4 4US **Location 30:** **City:** Hamilton **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** ML3 0NQ **Location 31:** **City:** Haverfordwest **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** SA61 1RN **Location 32:** **City:** Heywood **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** OL10 4NH **Location 33:** **City:** Holt **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** NR25 6BH **Location 34:** **City:** Kingswood **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** BS15 2NJ **Location 35:** **City:** Leamington Spa **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** CV32 4RA **Location 36:** **City:** Leicester **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** LE3 9ED **Location 37:** **City:** Melksham **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** SN12 6UN **Location 38:** **City:** Plymouth **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** PL6 6HP **Location 39:** **City:** Radstock **Country:** United Kingdom **Facility:** St Chads Surgery **Zip:** BA3 2UH **Location 40:** **City:** Rutherglen **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** G73 2PQ **Location 41:** **City:** Sheffield **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** S3 9DA **Location 42:** **City:** Soham **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** CB7 5JD **Location 43:** **City:** Wishaw **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site **Zip:** ML2 7BQ **Location 44:** **City:** Woking **Country:** United Kingdom **Facility:** Boehringer Ingelheim Investigational Site #### Overall Officials **Official 1:** **Affiliation:** Boehringer Ingelheim Ltd./Bracknell **Name:** Boehringer Ingelheim Study Coordinator **Role:** STUDY_CHAIR ### References Module #### References **Citation:** Freeman D, Lee A, Price D. Efficacy and safety of tiotropium in COPD patients in primary care--the SPiRiva Usual CarE (SPRUCE) study. Respir Res. 2007 Jul 2;8(1):45. doi: 10.1186/1465-9921-8-45. **PMID:** 17605774 ## 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 - ID: D000008173 - Term: Lung Diseases, Obstructive ### 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: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M23449 - Name: Pulmonary Disease, Chronic Obstructive - Relevance: HIGH - As Found: Pulmonary Disease, Chronic Obstructive - 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: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008171 - Term: Lung Diseases - 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: D000010276 - Term: Parasympatholytics - ID: D000018680 - Term: Cholinergic Antagonists - ID: D000018678 - Term: Cholinergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: AntiConv - Name: Anticonvulsants ### Intervention Browse Module - Browse Leaves - ID: M20760 - Name: Cholinergic Antagonists - Relevance: LOW - As Found: Unknown - ID: M416 - Name: Tiotropium Bromide - Relevance: HIGH - As Found: IBI - ID: M5241 - Name: Bromides - Relevance: LOW - As Found: Unknown - 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: M13189 - Name: Parasympatholytics - Relevance: LOW - As Found: Unknown - ID: M20758 - Name: Cholinergic Agents - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069447 - Term: Tiotropium Bromide ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02086279 **Brief Title:** AMH Levels Change During Treatment With GnRh Agonist **Official Title:** AMH Levels Change During Treatment With GnRh Agonist: A Prospective Observational Study. #### Organization Study ID Info **ID:** AMHunderGnRH #### Organization **Class:** OTHER **Full Name:** University Magna Graecia ### Status Module #### Completion Date **Date:** 2014-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2014-11-25 **Type:** ESTIMATED **Last Update Submit Date:** 2014-11-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2014-10 **Type:** ACTUAL #### Start Date **Date:** 2014-03 **Status Verified Date:** 2014-11 #### Study First Post Date **Date:** 2014-03-13 **Type:** ESTIMATED **Study First Submit Date:** 2014-03-09 **Study First Submit QC Date:** 2014-03-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Magna Graecia #### Responsible Party **Investigator Affiliation:** University Magna Graecia **Investigator Full Name:** Fulvio Zullo **Investigator Title:** Full Professor Obstetric Gynecology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** To evaluate the variation of AMH levels in women undergoing treatment with GnRHa, and to assess whether this variation correlates with changes in the antral and pre-antral follicle ultrasonographic count (AFC). **Detailed Description:** The anti Mullerian hormone (AMH) is a glycoprotein produced by granulosa cells of antral and preantral ovarian follicles. Several studies have shown that the AMH levels provide a reliable indication of the size of the growing follicles pool (1). AMH is now commonly used as a biomarker for improving the ovarian reserve in women of reproductive age because it is related with outcomes of assisted reproduction cycles, chances of pregnancy and distance from menopause (2-4). For several years GnRH agonists have been used for the purpose of preserving fertility in the course of chemotherapy in young women with cancer (5). Their effectiveness, however, isn't 100% and there is the need to monitor the ovarian reserve in the course of treatment in these young women. With the administration of GnRHa, the FSH levels (the most used hormone for improve the ovarian reserve, although it is less reliable and less manageable because of its intra-cyclic variations) cannot be used to measure the residual ovarian function due to the physiological reduction of gonadotropins induced by the treatment. AMH levels, conversely, are relatively stable both during the menstrual cycle (6) and during administration of the contraceptive pill (7,8), suggesting the gonadotrophin independence of this molecule. AMH could therefore be a useful biomarker of ovarian reserve in the course of GnRHa treatment. The use of GnRHa for fertility preservation during chemotherapy is controversial because of inconclusive outcome data on fertility (9) and because the mechanism by which GnRHa may act to preserve fertility is unknown. The major function of GnRHa is to suppress the production of pituitary gonadotrophins, acting indirectly on the ovarian follicles, not exposing growing follicles to the toxicity of chemotherapy and thus protecting the future ovarian function. Determine the effect of GnRHa on AMH serum level is an essential step to determine both the effectiveness of the treatment in terms of preservation of fertility and the reliability of this marker for ovarian reserve in cancer patients treated with GnRHa. Up to now, the published studies have shown extremely contrasting data. Considered that GnRHa is largely used in non-oncological patients for preoperative pharmacological preparation in various benign gynecological conditions, it is possible to exploit the high number of patients with these characteristics for the non-invasive assessment of analogue effect on the AMH levels. ### Conditions Module **Conditions:** - Uterine Fibroids - Endometriosis - Endometriosis of Uterus - Pelvic Pain **Keywords:** - AMH levels - Ovarian reserve - GnRH analogue - Ovarian reserve after GnRH analogue - Ovarian reserve modification - Antral follicle count - Antral follicle count after GnRH analogue ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 67 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with uterine myoma, endometriosis, fibromatous uterus, chronic pelvic pain in list for surgery are usually pharmacologically treated by administration of GnRHa, 11.25 mg at 21° day of the menstrual cycle and repeated after 3 months to reduce pain symptoms, menstrual blood loss, uterine or fibroids vascularization and size, during the months spent on surgery waiting list. Patients enrolled will be subjected to valuation of ovarian reserve: specifically, serum levels of AMH and antral follicle count (AFC) between 1 and 4 days of the menstrual cycle will be measured at study entry and at 1, 3 and 6 months after the administration of the first vial of GnRH-a **Intervention Names:** - Drug: GnRH analogue **Label:** GnRH analogue **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - GnRH analogue **Description:** Patients with uterine myoma, endometriosis, fibromatous uterus, chronic pelvic pain in list for laparoscopic surgery or laparotomy are usually pharmacologically treated by administration of GnRHa, 11.25 mg at 21° day of the menstrual cycle and repeated after 3 months. This treatment is part of our preoperative routine in order to reduce pain symptoms, menstrual blood loss, uterine or fibroids vascularization and size, during the months spent on surgery waiting list. Patients who will satisfy inclusion and exclusion criteria will be enrolled in this study protocol and will be subjected to valuation of ovarian reserve: specifically, serum levels of AMH and antral follicle count (AFC) between first and fourth days of the menstrual cycle will be measured. **Name:** GnRH analogue **Other Names:** - Gonadotropin-releasing hormone analogue **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** AMH levels change before and after GnRHa **Time Frame:** At study entry and at 1, 3 and 6 months after the administration of the first vial of GnRH-a #### Secondary Outcomes **Measure:** Preantral and antral follicles **Time Frame:** At study entry and at 1, 3 and 6 months after the administration of the first vial of GnRH-a **Measure:** Correlation between AMH levels and preantral and antral follicles count **Time Frame:** At study entry and at 1,3 and 6 months after the first vial of GnRH ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients waiting for surgery for benign conditions such as uterine fibroids and endometriosis, undergoing preoperative treatment with two consecutive doses of GnRHa at a dose of 11.25 every three months * 18 to 45 years aged patients * Regular menstrual intervals between 22 and 35 days * Expressed written consent for the study entry Exclusion Criteria: * Patients who do not consent to pharmacological preparation with GnRHa * Estrogen-progestin therapy in the 2 months before enrollment * Autoimmune diseases, chronic , metabolic, systemic and endocrine disorders, including hyperandrogenism, hyperprolactinemia, diabetes mellitus and thyroid disease. * Hypogonadotropic hypogonadism * Majors clinical conditions **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Catanzaro **Country:** Italy **Facility:** Chair of Obstetrics and Gynecology - University division - UMG **State:** CZ **Zip:** 88100 #### Overall Officials **Official 1:** **Affiliation:** Magna Graecia University of Catanzaro **Name:** Fulvio Zullo **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - 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 - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009379 - Term: Neoplasms, Muscle Tissue - ID: D000018204 - Term: Neoplasms, Connective and Soft Tissue - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000014591 - Term: Uterine Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M19918 - Name: Pelvic Pain - Relevance: HIGH - As Found: Pelvic Pain - ID: M10901 - Name: Leiomyoma - Relevance: HIGH - As Found: Uterine Fibroids - ID: M25846 - Name: Myofibroma - Relevance: LOW - As Found: Unknown - ID: M7877 - Name: Endometriosis - Relevance: HIGH - As Found: Endometriosis - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M30012 - Name: Adenomyosis - Relevance: HIGH - As Found: Endometriosis of Uterus - 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 - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - 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: M17339 - Name: Uterine Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007889 - Term: Leiomyoma - ID: D000004715 - Term: Endometriosis - ID: D000062788 - Term: Adenomyosis - ID: D000017699 - Term: Pelvic Pain ### 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: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000006728 - Term: Hormones ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03715179 **Acronym:** OSO **Brief Title:** Observational Study of Ostomy Consumers **Official Title:** Observational Study of Ostomy Consumers #### Organization Study ID Info **ID:** 5878-O #### Organization **Class:** INDUSTRY **Full Name:** Hollister Incorporated ### Status Module #### Completion Date **Date:** 2025-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-07 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-03 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-02 **Type:** ESTIMATED #### Start Date **Date:** 2018-10-04 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2018-10-23 **Type:** ACTUAL **Study First Submit Date:** 2018-10-19 **Study First Submit QC Date:** 2018-10-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Hollister Incorporated #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this longitudinal prospective observational study is to collect electronic Patient Reported Outcome (ePRO) data over a 5-year period directly from people living with an ostomy and their caregivers (participants were re-consented with version 3 of the Protocol in 2020 which indicated a study duration of 5 years). Research participants will be asked to self-report on the ostomy pouching systems they typically use and other various aspects of living with an ostomy and/or caring for an individual living with an ostomy. **Detailed Description:** This longitudinal prospective observational study is designed as an ePRO registry to collect data from consumers with an ostomy (ileostomy, colostomy, or urostomy) in the United States, Canada, and United Kingdom. An ePRO registry provides a relevant data source founded on the patient's voice. As such, an ePRO registry will be invaluable for prospective observational research aiming to investigate associations of ostomy pouching systems (inclusive of accessories) with peristomal skin health, participant QoL, caregiver burden, product satisfaction, and Healthcare Resource Utilization (HRU). Information from this registry will inform and guide industry healthcare providers and payers in decision-making and subsequent research that factors in the patient and caregiver perspectives. The current study does not test any specific a priori hypotheses. ### Conditions Module **Conditions:** - Ostomy ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 600 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 5 Years ### Arms Interventions Module #### Arm Group 1 **Description:** Individuals living with an ostomy and their caregivers. Participants use their own ostomy pouching systems per their clinician's standard of care **Intervention Names:** - Device: Ostomy Pouching System **Label:** Standard of Care ### Interventions #### Intervention 1 **Arm Group Labels:** - Standard of Care **Description:** An ostomy pouching system is a medical device that provides a means for the collection of effluent from a surgically diverted biological system (colon, ileum, bladder), specifically from a stoma. No intervention is administered during the course of this study. **Name:** Ostomy Pouching System **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** To collect prospective observational data through a patient reported outcome (PRO) registry that will serve as a platform to conduct multiple analyses. **Measure:** To create a patient reported outcomes registry of ostomy consumers **Time Frame:** 5 years #### Secondary Outcomes **Description:** To identify and characterize ostomy specific outcomes for the purposes of hypothesis generation. **Measure:** Ostomy specific outcomes **Time Frame:** 5-years **Description:** To identify and characterize product specific outcomes related to the ostomy specific outcomes. **Measure:** Product specific outcomes **Time Frame:** 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Is at least 18 years of age; any self-reported gender 2. Has a single Ileostomy, Colostomy, or Urostomy 3. Is able to provide an informed consent for study participation with no cognitive impairment that would hinder the ability to provide informed consent or provide self-reported data 4. Is willing and able to complete a once per month online questionnaire about life with an ostomy, or has a proxy who can enter data on their behalf 5. Are able to respond themselves or appoint a caregiver as a proxy to respond to online computer questionnaires in English, French Canadian, or Spanish Caregivers will be entered into this study only if they meet all of the following criteria: 1. Is at least 18 years of age; any self-reported gender 2. Is an informal supporter (such as a relative, friend, or neighbor) of the care recipient 3. Provides support to the care recipient in some capacity (such as ordering supplies or pouch changes) on average at least once per week Exclusion Criteria: 1. Has more than one stoma 2. Has a single stoma that has been reversed or closed **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Sponsor-curated customer databases and printed EC/IRB approved advertisements targeted to ostomy product consumers in the United States, Canada, and United Kingdom that may be distributed by clinicians, mail, website, conferences and other consumer contacts. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Manager Global Clinical Affairs **Phone:** +18479321845 **Role:** CONTACT #### Locations **Location 1:** **City:** Libertyville **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Renee Malandrino, MSN RN CWOCN - **Phone:** 847-996-3061 - **Role:** CONTACT **Country:** United States **Facility:** Hollister Incorporated **State:** Illinois **Status:** RECRUITING **Zip:** 60048 #### Overall Officials **Official 1:** **Affiliation:** Hollister Incorporated **Name:** Renee Malandrino, MSN RN CWOCN **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Colwell JC, Pittman J, Raizman R, Salvadalena G. A Randomized Controlled Trial Determining Variances in Ostomy Skin Conditions and the Economic Impact (ADVOCATE Trial). J Wound Ostomy Continence Nurs. 2018 Jan/Feb;45(1):37-42. doi: 10.1097/WON.0000000000000389. **PMID:** 29300287 **Citation:** International Organization for Standardization. ISO 14155:2011: Clinical investigation of medical devices for human subjects - Good clinical practice. **Citation:** ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2008 Feb;17(2):200-8. doi: 10.1002/pds.1471. No abstract available. **PMID:** 17868186 **Citation:** Scientific and Clinical Abstracts From WOCNext(R) 2022: Fort Worth, Texas diamond June 5-8, 2022. J Wound Ostomy Continence Nurs. 2022 May-Jun 01;49(3 Suppl 1):S1-S99. doi: 10.1097/WON.0000000000000882. No abstract available. **PMID:** 35639023 ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T120 - Name: Cola - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06088979 **Acronym:** spiriTED **Brief Title:** A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 75 Years of Age With Thyroid Eye Disease **Official Title:** A Multicenter Phase 2b Randomized, Double-Masked, Placebo-Controlled Dose-Ranging Study of TOUR006 in Participants With Thyroid Eye Disease #### Organization Study ID Info **ID:** TOUR006-T01 #### Organization **Class:** INDUSTRY **Full Name:** Tourmaline Bio, Inc. ### Status Module #### Completion Date **Date:** 2026-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-04-11 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-10 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-02 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-19 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2023-10-18 **Type:** ACTUAL **Study First Submit Date:** 2023-10-03 **Study First Submit QC Date:** 2023-10-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Tourmaline Bio, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** Phase 2b trial of TOUR006 in Thyroid Eye Disease (TED) to evaluate 20mg and 50mg doses against placebo given by a subcutaneous injection every eight weeks to TED patients who are in the active inflammatory phase of disease. ### Conditions Module **Conditions:** - Thyroid Eye Disease **Keywords:** - TED - Graves' Disease - Thyroid Eye Disease - Exophthalmos - Eye Diseases - Thyroid Diseases - Graves' Ophthalmopathy - Hyperthyroidism ### 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:** 81 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In part A of the study, participants will receive a total of three 20 mg subcutaneous injections: 1 injection every 8 weeks (Day 1, Week 8, Week 16) followed by treatment in part B of the study based on proptosis response and rescue therapy use. **Intervention Names:** - Drug: TOUR006 - 20 MG **Label:** TOUR006 - 20 MG **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In part A of the study, participants will receive a total of three 50 mg subcutaneous injections: 1 injection every 8 weeks (Day 1, Week 8, Week 16) followed by treatment in part B of the study based on proptosis response and rescue therapy use. **Intervention Names:** - Drug: TOUR006 - 50 MG **Label:** TOUR006 - 50 MG **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** In part A of the study, participants will receive a total of three Placebo subcutaneous injections: 1 injection every 8 weeks (Day 1, Week 8, Week 16) followed by treatment in part B of the study based on proptosis response and rescue therapy use. **Intervention Names:** - Other: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - TOUR006 - 20 MG **Description:** TOUR006 20 MG **Name:** TOUR006 - 20 MG **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Placebo **Name:** Placebo **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - TOUR006 - 50 MG **Description:** TOUR006 - 50 MG **Name:** TOUR006 - 50 MG **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Percentage of participants achieving a proptosis response defined as a ≥2 mm reduction in proptosis from baseline in the study eye without deterioration [≥2 mm increase] of proptosis in the fellow eye and without need for rescue therapy/intervention). **Time Frame:** 20 weeks #### Secondary Outcomes **Measure:** Percentage of participants achieving a proptosis response with 20mg TOUR006 administered SC every 8 weeks or 50mg TOUR006 administered SC every 8 weeks. **Time Frame:** 72 weeks **Measure:** Percentage of participants attaining a complete or near complete response on the 7-point Clinical Activity Score (CAS). **Time Frame:** 72 weeks **Measure:** Percentage of participants attaining ≥1 grade decrease in diplopia. **Time Frame:** 72 weeks **Measure:** Incidence of Treatment Emergent Adverse Events by severity and Serious Adverse Events through Week 72. **Time Frame:** 72 weeks **Measure:** Mean change from baseline in serum trough concentration of TOUR006. **Time Frame:** 72 weeks **Measure:** Mean change from baseline in serum TSI. **Time Frame:** 72 weeks **Measure:** Percentage of participants with anti-drug antibodies. **Time Frame:** 72 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Clinical diagnosis of Graves' disease associated with moderate to severe active TED * Onset of active TED symptoms within approximately 12 months * Proptosis (exophthalmos) ≥3 mm above the normal range (based upon race and gender) for the study eye * CAS ≥4 (on the 7-item scale) for the study eye * Presence of thyroid stimulating immunoglobulin (TSI) above the upper limit of normal Additional inclusion criteria are defined in the study protocol. Exclusion Criteria: * Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision * Any previous treatment with teprotumumab or other agent that inhibits the IGF-1 receptor * History of systemic steroid (oral or IV) use with a cumulative dose equivalent to ≥1 g of methylprednisolone for the treatment of TED. Previous oral steroid use with a cumulative dose of \<1 g methylprednisolone (or equivalent dosage for other systemic corticosteroid) for the treatment of TED is allowed if the corticosteroid is discontinued at least 6 weeks before screening. * Systemic (oral or IV) corticosteroid use for conditions other than TED within 3 months before screening. * Any major illness/condition or evidence of an unstable clinical condition that, in the investigator's judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study * Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participant's participation in the study * Pregnant or lactating Additional exclusion criteria are defined in the study protocol. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Tourmaline Bio **Phone:** 347-773-2627 **Role:** CONTACT #### Locations **Location 1:** **City:** Pasadena **Country:** United States **Facility:** Site - 0116 **State:** California **Status:** RECRUITING **Zip:** 91107 **Location 2:** **City:** San Diego **Country:** United States **Facility:** Site - 0114 **State:** California **Status:** RECRUITING **Zip:** 92108 **Location 3:** **City:** Aurora **Country:** United States **Facility:** Site - 0101 **State:** Colorado **Status:** RECRUITING **Zip:** 80045 **Location 4:** **City:** Miami **Country:** United States **Facility:** Site - 0103 **State:** Florida **Status:** RECRUITING **Zip:** 33174 **Location 5:** **City:** Louisville **Country:** United States **Facility:** Site - 0108 **State:** Kentucky **Status:** RECRUITING **Zip:** 40202 **Location 6:** **City:** Livonia **Country:** United States **Facility:** Site - 0112 **State:** Michigan **Status:** RECRUITING **Zip:** 48152 **Location 7:** **City:** Chapel Hill **Country:** United States **Facility:** Site - 0104 **State:** North Carolina **Status:** RECRUITING **Zip:** 27517 **Location 8:** **City:** Houston **Country:** United States **Facility:** Site - 0106 **State:** Texas **Status:** RECRUITING **Zip:** 77004 **Location 9:** **City:** Morgantown **Country:** United States **Facility:** Site - 0113 **State:** West Virginia **Status:** RECRUITING **Zip:** 26506 **Location 10:** **City:** Amman **Country:** Jordan **Facility:** Site - 0401 **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Tourmaline Bio **Name:** Clinical Trials **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004700 - Term: Endocrine System Diseases - ID: D000015785 - Term: Eye Diseases, Hereditary - ID: D000006111 - Term: Graves Disease - ID: D000005094 - Term: Exophthalmos - ID: D000009916 - Term: Orbital Diseases - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000006042 - Term: Goiter - ID: D000006980 - Term: Hyperthyroidism - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M8271 - Name: Eye Diseases - Relevance: HIGH - As Found: Eye Disease - ID: M9214 - Name: Graves Disease - Relevance: LOW - As Found: Unknown - ID: M10031 - Name: Hyperthyroidism - Relevance: LOW - As Found: Unknown - ID: M16718 - Name: Thyroid Diseases - Relevance: HIGH - As Found: Thyroid - ID: M26148 - Name: Graves Ophthalmopathy - Relevance: HIGH - As Found: Thyroid Eye Disease - ID: M8237 - Name: Exophthalmos - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M18339 - Name: Eye Diseases, Hereditary - Relevance: LOW - As Found: Unknown - ID: M12845 - Name: Orbital Diseases - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M9147 - Name: Goiter - 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: D000005128 - Term: Eye Diseases - ID: D000049970 - Term: Graves Ophthalmopathy - ID: D000013959 - Term: Thyroid Diseases ### Misc Info Module - Version Holder: 2024-05-24