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## Protocol Section
### Identification Module
**NCT ID:** NCT06438068
**Brief Title:** Influence of Modern Colon Hydrotherapy on Intestinal Transit
**Official Title:** Influence of Modern Colon Hydrotherapy on Intestinal Transit
#### Organization Study ID Info
**ID:** UComplutenseMadrid Fasisifer3
#### Organization
**Class:** OTHER
**Full Name:** Universidad Complutense de Madrid
### Status Module
#### Completion Date
**Date:** 2024-07-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-26
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Universidad Complutense de Madrid
#### Responsible Party
**Investigator Affiliation:** Universidad Complutense de Madrid
**Investigator Full Name:** Isidro Fernández López
**Investigator Title:** PhD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A randomised and controlled trial, in which the effect of Modern Colon Hydrotherapy is evaluated in the gastrointestinal transit of subjects with functional constipation
**Detailed Description:** The aim of the present randomized randomised and controlled trial is to evaluate the effect of Modern Colon Hydrotherapy in the gastrointestinal transit of subjects with functional constipation.
Two intervention groups were used, to which this type of treatment was applied and to which the intake of a product with prebiotic and prebiotic properties or a placebo was added, depending on the assigned group.
### Conditions Module
**Conditions:**
- Constipation - Functional
- Hydrotherapy
- Functional Colonic Diseases
**Keywords:**
- constipation
- internal hydrotherapy
- Radiopaque Media
- Functional Colonic Diseases
### 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:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Colonic cleansing through 3 interventions of Modern Colon Hydrotherapy. In addition, a daily intake of a product with prebiotic and prebiotic properties for 30 days.
**Intervention Names:**
- Other: Modern Colon Hydrotherapy plus probiotic product intake
**Label:** Modern Colon Hydrotherapy plus probiotic product intake
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Colonic cleansing through 3 interventions of Modern Colon Hydrotherapy. In addition, a daily intake of a placebo for 30 days.
**Intervention Names:**
- Other: Modern Colon Hydrotherapy plus probiotic product intake
**Label:** Modern Colon Hydrotherapy plus placebo intake
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Modern Colon Hydrotherapy plus placebo intake
- Modern Colon Hydrotherapy plus probiotic product intake
**Description:** Colonic cleansing through 3 interventions of Modern Colon Hydrotherapy separated by 48 hours. In addition, a daily intake of a product with prebiotic and prebiotic properties for 30 days.
**Name:** Modern Colon Hydrotherapy plus probiotic product intake
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** intestinal transit using radiopaque markers
**Measure:** intestinal transit
**Time Frame:** 7 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients between 20 and 60 years of age with functional constipation of more than 5 years of evolution.
Exclusion Criteria:
* Taking any type of antibiotic in the last month
* Taking prebiotics or probiotics products in the last month.
* Taking laxatives in the last month.
* Undergoing any medicinal treatment
* Pregnancy
* Subject with a history of current gastrointestinal pathology or disorder such as: acute colon pathology, acute haemorrhagic colitis, suspected digestive perforation, recent abdominal surgery, severe arterial hypertension, abdominal hernia, colon neoplasia, history of cardiac syncope, renal failure, liver cirrhosis, epilepsy, severe psychiatric illness (psychosis), necrosis due to abdominal irradiation, severe anaemia, severe neurovegetative lability.
**Maximum Age:** 60 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Isidro Fernández-López, PhD.
**Phone:** 34625598970
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Madrid
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Isidro Fernández-López, PhD.
- **Phone:** +34625598970
- **Role:** CONTACT
***Contact 2:***
- **Name:** David Granizo-Bermejo, Mr.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Universidad Complutense de Madrid
#### Overall Officials
**Official 1:**
**Affiliation:** Universidad Complutense de Madrid
**Name:** Isidro Fernández-López, PhD.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012817
- Term: Signs and Symptoms, Digestive
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M6472
- Name: Constipation
- Relevance: HIGH
- As Found: Constipation
- ID: M6336
- Name: Colonic Diseases
- Relevance: HIGH
- As Found: Colonic Diseases
- ID: M6337
- Name: Colonic Diseases, Functional
- Relevance: HIGH
- As Found: Functional Colonic Diseases
- ID: M15622
- Name: Signs and Symptoms, Digestive
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003108
- Term: Colonic Diseases
- ID: D000003109
- Term: Colonic Diseases, Functional
- ID: D000003248
- Term: Constipation
### 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: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06438055
**Brief Title:** Clinical Treatment of Refractory Breast Cancer Based on Organoid Drug Sensitivity Results
**Official Title:** Clinical Treatment of Refractory Breast Cancer Based on Organoid Drug Sensitivity Results
#### Organization Study ID Info
**ID:** TJBCPDO01
#### Organization
**Class:** OTHER
**Full Name:** Tianjin Medical University Cancer Institute and Hospital
### Status Module
#### Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Kingbio Medical (Beijing) Co., Ltd.
#### Lead Sponsor
**Class:** OTHER
**Name:** Tianjin Medical University Cancer Institute and Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study aims to enroll refractory breast cancer patients. Patient-derived organoid will be established, and drug sensitivity test will be conducted to intervene in the selection of clinical treatment plans. Efficacy evaluation and prognosis analysis will also be conducted. It is hoped that this study will provide a basis for the development of personalized treatment plans.
**Detailed Description:** Forty patients with refractory breast cancer who met the inclusion criteria were enrolled in the study after signing an informed consent form. Tumor samples were obtained through clinical puncture, and qualified samples were subjected to organoid modeling. Perform drug sensitivity test on the established breast cancer organoids. The drugs used are all that have been marketed and applied in clinical practice. According to the results of organoid drug sensitivity analysis, the patient received a treatment plan with relatively sensitive drugs. Follow up prognostic data and relevant clinical information of enrolled patients, conduct statistical analysis on the consistency between drug sensitivity test results and patient treatment response, and evaluate the clinical effectiveness of treatment plans guided by organoid drug sensitivity results.
### Conditions Module
**Conditions:**
- Refractory Breast Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All patients will be included in a single-arm. Participants will undergo biopsy of tumor tissue for subsequent organoid generation and drug sensitivity tests.
**Intervention Names:**
- Other: Chemotherapy and targeted-therapy guided by organoid drug sensitivity test
**Label:** Organoid-Guided therapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Organoid-Guided therapy
**Description:** This study conducts drug sensitivity tests on various clinically approved drugs. The most sensitive drug for the patient is selected for treatment. This study aims to evaluate the clinical effectiveness of treatment plans guided by organoid drug sensitivity tests.
**Name:** Chemotherapy and targeted-therapy guided by organoid drug sensitivity test
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Percentage of patient's measurable disease who have achieved either complete response (CR) or partial response (PR) according to RECIST 1.1.
**Measure:** Objective Response Rate
**Time Frame:** 1-2 years
#### Secondary Outcomes
**Description:** The time from initiation of treatment to the occurrence of disease progression or death.
**Measure:** Progressive free survival
**Time Frame:** 1-2 years
**Description:** The time from the date of randomization to the date of death for any cause. Patients will be followed until their date of death or until final database closure.
**Measure:** Overall survival time
**Time Frame:** 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Female, aged ≥ 18 years and ≤ 75 years old;
2. Breast cancer confirmed by histology or cytology;
3. One of the following two conditions shall be met: a) Operable breast cancer: Recurrent progression during adjuvant therapy; or the time from initial treatment to the onset of disease progression is less than or equal to 2 years; b) Non-operable breast cancer: patients who have changed two line treatment plans within 6 months;
4. Being able to obtain sufficient fresh tissue specimens for organoid establishment through puncture;
5. Expected survival time ≥ 3 months;
6. The patient voluntarily joined this study and signed an informed consent form (ICF), with good compliance and cooperation in follow-up.
Exclusion Criteria:
1. Pregnant and lactating women;
2. Patients who have clinically significant (i.e. active) heart disease (such as congestive heart failure, symptomatic coronary artery disease, arrhythmia, etc.) or myocardial infarction within the past 12 months;
3. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
4. The researchers believe that patients are not suitable for inclusion.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yehui Shi, PhD
**Phone:** +8618622221183
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Tianjin Cancer Hospital
**Name:** Yehui Shi, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Cao W, Chen HD, Yu YW, Li N, Chen WQ. Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020. Chin Med J (Engl). 2021 Mar 17;134(7):783-791. doi: 10.1097/CM9.0000000000001474.
**PMID:** 33734139
**Citation:** Lei S, Zheng R, Zhang S, Chen R, Wang S, Sun K, Zeng H, Wei W, He J. Breast cancer incidence and mortality in women in China: temporal trends and projections to 2030. Cancer Biol Med. 2021 May 18;18(3):900-9. doi: 10.20892/j.issn.2095-3941.2020.0523. Online ahead of print.
**PMID:** 34002584
**Citation:** Potter DA, Herrera-Ponzanelli CA, Hinojosa D, Castillo R, Hernandez-Cruz I, Arrieta VA, Franklin MJ, Yee D. Recent advances in neoadjuvant therapy for breast cancer. Fac Rev. 2021 Jan 4;10:2. doi: 10.12703/r/10-2. eCollection 2021.
**PMID:** 33659921
**Citation:** Loibl S, Poortmans P, Morrow M, Denkert C, Curigliano G. Breast cancer. Lancet. 2021 May 8;397(10286):1750-1769. doi: 10.1016/S0140-6736(20)32381-3. Epub 2021 Apr 1. Erratum In: Lancet. 2021 May 8;397(10286):1710.
**PMID:** 33812473
**Citation:** Gralow JR, Burstein HJ, Wood W, Hortobagyi GN, Gianni L, von Minckwitz G, Buzdar AU, Smith IE, Symmans WF, Singh B, Winer EP. Preoperative therapy in invasive breast cancer: pathologic assessment and systemic therapy issues in operable disease. J Clin Oncol. 2008 Feb 10;26(5):814-9. doi: 10.1200/JCO.2007.15.3510.
**PMID:** 18258991
**Citation:** Seidlitz T, Merker SR, Rothe A, Zakrzewski F, von Neubeck C, Grutzmann K, Sommer U, Schweitzer C, Scholch S, Uhlemann H, Gaebler AM, Werner K, Krause M, Baretton GB, Welsch T, Koo BK, Aust DE, Klink B, Weitz J, Stange DE. Human gastric cancer modelling using organoids. Gut. 2019 Feb;68(2):207-217. doi: 10.1136/gutjnl-2017-314549. Epub 2018 Apr 27.
**PMID:** 29703791
**Citation:** Eiraku M, Watanabe K, Matsuo-Takasaki M, Kawada M, Yonemura S, Matsumura M, Wataya T, Nishiyama A, Muguruma K, Sasai Y. Self-organized formation of polarized cortical tissues from ESCs and its active manipulation by extrinsic signals. Cell Stem Cell. 2008 Nov 6;3(5):519-32. doi: 10.1016/j.stem.2008.09.002.
**PMID:** 18983967
**Citation:** Romero-Calvo I, Weber CR, Ray M, Brown M, Kirby K, Nandi RK, Long TM, Sparrow SM, Ugolkov A, Qiang W, Zhang Y, Brunetti T, Kindler H, Segal JP, Rzhetsky A, Mazar AP, Buschmann MM, Weichselbaum R, Roggin K, White KP. Human Organoids Share Structural and Genetic Features with Primary Pancreatic Adenocarcinoma Tumors. Mol Cancer Res. 2019 Jan;17(1):70-83. doi: 10.1158/1541-7786.MCR-18-0531. Epub 2018 Aug 31.
**PMID:** 30171177
**Citation:** Li M, Izpisua Belmonte JC. Organoids - Preclinical Models of Human Disease. N Engl J Med. 2019 Feb 7;380(6):569-579. doi: 10.1056/NEJMra1806175. No abstract available.
**PMID:** 30726695
**Citation:** Sachs N, de Ligt J, Kopper O, Gogola E, Bounova G, Weeber F, Balgobind AV, Wind K, Gracanin A, Begthel H, Korving J, van Boxtel R, Duarte AA, Lelieveld D, van Hoeck A, Ernst RF, Blokzijl F, Nijman IJ, Hoogstraat M, van de Ven M, Egan DA, Zinzalla V, Moll J, Boj SF, Voest EE, Wessels L, van Diest PJ, Rottenberg S, Vries RGJ, Cuppen E, Clevers H. A Living Biobank of Breast Cancer Organoids Captures Disease Heterogeneity. Cell. 2018 Jan 11;172(1-2):373-386.e10. doi: 10.1016/j.cell.2017.11.010. Epub 2017 Dec 7.
**PMID:** 29224780
**Citation:** Dekkers JF, Whittle JR, Vaillant F, Chen HR, Dawson C, Liu K, Geurts MH, Herold MJ, Clevers H, Lindeman GJ, Visvader JE. Modeling Breast Cancer Using CRISPR-Cas9-Mediated Engineering of Human Breast Organoids. J Natl Cancer Inst. 2020 May 1;112(5):540-544. doi: 10.1093/jnci/djz196.
**PMID:** 31589320
**Citation:** Chen P, Zhang X, Ding R, Yang L, Lyu X, Zeng J, Lei JH, Wang L, Bi J, Shao N, Shu D, Wu B, Wu J, Yang Z, Wang H, Wang B, Xiong K, Lu Y, Fu S, Choi TK, Lon NW, Zhang A, Tang D, Quan Y, Meng Y, Miao K, Sun H, Zhao M, Bao J, Zhang L, Xu X, Shi Y, Lin Y, Deng C. Patient-Derived Organoids Can Guide Personalized-Therapies for Patients with Advanced Breast Cancer. Adv Sci (Weinh). 2021 Nov;8(22):e2101176. doi: 10.1002/advs.202101176. Epub 2021 Oct 4.
**PMID:** 34605222
**Citation:** Chica-Parrado MR, Godoy-Ortiz A, Jimenez B, Ribelles N, Barragan I, Alba E. Resistance to Neoadjuvant Treatment in Breast Cancer: Clinicopathological and Molecular Predictors. Cancers (Basel). 2020 Jul 22;12(8):2012. doi: 10.3390/cancers12082012.
**PMID:** 32708049
**Citation:** Drost J, Clevers H. Organoids in cancer research. Nat Rev Cancer. 2018 Jul;18(7):407-418. doi: 10.1038/s41568-018-0007-6.
**PMID:** 29692415
**Citation:** Norman M, Rivers C, Lee YB, Idris J, Uney J. The increasing diversity of functions attributed to the SAFB family of RNA-/DNA-binding proteins. Biochem J. 2016 Dec 1;473(23):4271-4288. doi: 10.1042/BCJ20160649.
**PMID:** 27888239
**Citation:** Hashimoto T, Matsuda K, Kawata M. Scaffold attachment factor B (SAFB)1 and SAFB2 cooperatively inhibit the intranuclear mobility and function of ERalpha. J Cell Biochem. 2012 Sep;113(9):3039-50. doi: 10.1002/jcb.24182.
**PMID:** 22566185
**Citation:** Hutter K, Lohmuller M, Jukic A, Eichin F, Avci S, Labi V, Szabo TG, Hoser SM, Huttenhofer A, Villunger A, Herzog S. SAFB2 Enables the Processing of Suboptimal Stem-Loop Structures in Clustered Primary miRNA Transcripts. Mol Cell. 2020 Jun 4;78(5):876-889.e6. doi: 10.1016/j.molcel.2020.05.011.
**PMID:** 32502422
**Citation:** Hammerich-Hille S, Bardout VJ, Hilsenbeck SG, Osborne CK, Oesterreich S. Low SAFB levels are associated with worse outcome in breast cancer patients. Breast Cancer Res Treat. 2010 Jun;121(2):503-9. doi: 10.1007/s10549-008-0297-6. Epub 2009 Jan 10.
**PMID:** 19137425
**Citation:** Zhen H, Yao Y, Yang H. SAFB2 Inhibits the Progression of Breast Cancer by Suppressing the Wnt/beta-Catenin Signaling Pathway via NFAT5. Mol Biotechnol. 2023 Sep;65(9):1465-1475. doi: 10.1007/s12033-022-00649-z. Epub 2023 Jan 18.
**PMID:** 36652182
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M10018
- Name: Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06438042
**Brief Title:** Prevention of Pressure Ulcers in Patients at High Risk of Developping Pressure Ulcers Using the Low-pressure Motorized Air Support Mattress With XTECH®25 Control Unit
**Official Title:** Prevention of Pressure Ulcers in Patients at High Risk of Developping Pressure Ulcers Using the Low-pressure Motorized Air Support Mattress With XTECH®25 Control Unit
#### Organization Study ID Info
**ID:** 2023-A01556-39
#### Organization
**Class:** INDUSTRY
**Full Name:** SYSTAM
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-01
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Clin-Experts
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** SYSTAM
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of the study is to determine the clinical value of using a a low air pressure motorised therapeutic mattress in the prevention of pressure injury (PI) in patients at medium to high risk.
This study is noncomparative, observational study.
Patients older than 18 years of age, with a high risk of PI, without PI, lying more than 20 hours a day on a XTECH®25 mattress will be included. The study will be conducted in nursing homes, and in long-stay geriatrics department.
Patients are followed up for 35 days. The use of the XTECH®25 mattress is associated with the usual PI prevention measures. The primary outcome is the percentage of patients who developed between day 0 and day 35 at least one PI of at least stage 2 on the sacrum, spine, or heel. Secondary endpoints are patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety.
### Conditions Module
**Conditions:**
- Pressure Ulcer
**Keywords:**
- Prevention
- Pressure ulcer
- Low air pressure motorised mattress
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Device: Use of a powered low air pressure motorised therapeutic mattress that combines the motorised and static technologies
**Label:** Patients in nursing homes or long-stay geriatrics department
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patients in nursing homes or long-stay geriatrics department
**Description:** Patients with a high risk of pressure injury, without pressure injury, lying more than 20 hours a day, will ly a on a XTECH®25 mattress
**Name:** Use of a powered low air pressure motorised therapeutic mattress that combines the motorised and static technologies
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Percentage of patients who developed at least one stage 2 PI of the sacrum, backbone, or heel (areas of support when lying down)
**Measure:** Percentage of patients who developed at least one stage 2 pressure injury
**Time Frame:** 35 days after installation on the mattress (at day 35)
#### Secondary Outcomes
**Measure:** Percentage of patients who developed a o pressure injury (any stage), other than those of the sacrum, backbone, or heel between
**Time Frame:** 35 days after installation on the mattress (at day 35)
**Description:** On a scale from 0 (not satisfied at all) to 4 (very satisfied)
**Measure:** Assessment by the patient (or family or staff in the case of incapacity) of the comfort of the mattress (general comfort, stability)
**Time Frame:** 35 days after installation on the mattress (at day 35)
**Description:** On a scale from 0 (not satisfied at all) to 4 (very satisfied)
**Measure:** Assessment by the nursing staff with the use of the mattress (implementation, cleaning maintenance turning, changing to a sitting position)
**Time Frame:** 35 days after installation on the mattress (at day 35)
**Description:** On a scale from 1 (constantly moist) to 4 rarely moist
**Measure:** Assessment of the degree of maceration
**Time Frame:** On a scale from 1 (constantly moist) to 4 rarely moist
**Description:** By collecting any adverse event or mattress malfunction during the follow up
**Measure:** Assessment of mattress safety
**Time Frame:** At day 35
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patient over 18 years old
* Patient with high risk of developing pressure ulcers (clinical judgment and a score \<= 12 on the Braden scale (6 (maximum risk) to 23 (no risk))
* Patient without pressure injury on the day of inclusion
* Patient up lying more than 20 hours a day on XTECH®25 mattress
* Patient with a weight \< 200 kg
* Patient (or a trusted third party) having been informed of the study and agreeing to participate
Exclusion Criteria:
* Patient at end of life (estimated life expectancy less than 6 months)
* Patient discharge from the establishment expected within two months
* Participants will be excluded from the study if they meet the following combination of criteria indicative of malnutrition according to the 2021 Haute Autorité de la Santé guidelines (Participants must meet at least one phenotypic criterion and one etiological criterion to be considered malnourished and therefore ineligible for inclusion in the study) :
A) One or more of the following phenotypic criteria:
1. Significant unintentional weight loss: A weight loss of ≥ 5% within 1 month or ≥ 10% within 6 months
2. Low Body Mass Index (BMI): BMI \< 18.5 kg/m² for individuals under 70 years old, BMI \< 21 kg/m² for individuals aged 70 years and older
3. Reduced Muscle Mass
4. Evident reduction in muscle mass AND
B) One of the following etiological criteria:
1. Inadequate nutritional intake:
2. Nutritional intake less than 50% of the energy requirements for more than one week
3. Reduced food intake for more than two weeks
4. Presence of Disease or Stress Metabolism
5. Acute or chronic illness, or any condition causing metabolic stress that increases energy requirements .
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients in nursing homes or long-stay geriatrics department
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Renaud URBINELLI
**Phone:** 0756882093
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Multiple Locations
**Country:** France
**Facility:** Multiples locations
#### Overall Officials
**Official 1:**
**Affiliation:** Hôpital ROSCHILD
**Name:** Sylvie MEAUME
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000012883
- Term: Skin Ulcer
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M6870
- Name: Pressure Ulcer
- Relevance: HIGH
- As Found: Pressure Ulcer
- ID: M17206
- Name: Ulcer
- Relevance: HIGH
- As Found: Ulcer
- ID: M15686
- Name: Skin Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003668
- Term: Pressure Ulcer
- ID: D000014456
- Term: Ulcer
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06438029
**Brief Title:** The Effect of Disaster Training on the Perception of Disaster Response Competence
**Official Title:** The Effect of Education Given to Nursing Students on Their Perceptions of Disaster Response Competence: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** FU-SBF-FU-02
#### Organization
**Class:** OTHER
**Full Name:** Firat University
### Status Module
#### Completion Date
**Date:** 2024-12-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-11-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-10-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** FATOŞ UNCU
#### Responsible Party
**Investigator Affiliation:** Firat University
**Investigator Full Name:** FATOŞ UNCU
**Investigator Title:** assistant professor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Due to the increase in disasters, humanity is facing an increasing threat to life and property. Disasters occur with little warning and can last for hours or months. Existing literature reveals that most nurses are not prepared for a disaster in the community. Continuous preparedness requires the involvement of staff and nursing students in the development, review and implementation of the disaster plan. The development of ongoing, easily accessible, engaging and realistic educational programmes is best for the acquisition of skills and competence. An experimental study with pretest-posttest control group The project is planned to be conducted with the fourth grade students of the Department of Nursing, Faculty of Health Sciences, Fırat University in a randomised controlled study model with pre-test-post-test control group. The population of the study will consist of the fourth year students of the Department of Nursing, Faculty of Health Sciences, Fırat University. The sample will consist of 90 students with 0.05 error, 0.95 confidence interval, 0.95 confidence interval, 0.6 effect size and 0.80 representation power of the universe with the power analysis. These students will be divided into 45 experimental and 45 control groups. In the first stage of the study, the experimental and control group students were asked to complete the "Personal Information Form" and '' Disaster response self-efficacy scale" will be filled. In the second stage of the research, the students in the experimental group will be given a detailed and planned training programme. After the training, the students
**Detailed Description:** Natural disasters, which cause a large number of casualties, increase the workload and lead to disability of individuals, have always been an important public health problem. Natural disasters are unpredictable and often sudden events that cause great destruction and loss of life and severe psychological symptoms for survivors. Disaster preparedness refers to all previous action plans and efforts to establish a disaster response system before a disaster occurs. To be prepared, nurses need to have sufficient knowledge and skills to minimise the negative effects of a disaster, including trauma, infectious diseases, physical and psychological distress. However, there is evidence that most nurses do not feel adequately prepared for a disaster in the community. In a study in which the general knowledge levels of nurses in developing countries about disaster preparedness were evaluated, the knowledge and skills of nurses especially in the Asia-Pacific Region about disasters were found to be inadequate. In another study, it was reported that Iranian nurses had inadequate knowledge about disaster preparedness.
Despite the increasing number of disasters all over the world and the warnings of international nursing organisations and the World Health Organisation about the preparedness of nurses for disasters, it is seen that the training of nurses for disasters is inadequate and studies on this subject are limited.
### Conditions Module
**Conditions:**
- Public Health Nursing
**Keywords:**
- Natural disasters
- Nursing students
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This research is a randomised control study with pretest-posttest design.
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** Randomisation method will be used to determine how the experimental and control groups will be separated at the beginning of the study (13). As the randomisation method, "simple randomisation method" was chosen in order to provide equal number of samples in two groups. Randomisation will be performed using https://www.randomizer.org/ website in computer environment. According to the randomisation outputs, the individuals to be included in the experimental and control groups will be listed. Columns between 1-90 will be created in the system. Patients will be randomly assigned to the groups by considering the numbers 1 and 2 in the columns (nursing education group 1 and control group 2).
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The forms used in the study were collected by the researcher through face-to-face interviews in seminar halls in schools. Firstly, the students in the experimental group will be trained on disaster and disaster response. The trainings were organised as a total of four sessions with a two-week interval of twenty minutes in each session. Personal Information Form and Disaster Intervention Self-Efficacy Scale were filled as pre-test in the seminar halls of the schools under the supervision of the researcher.
**Intervention Names:**
- Other: Education group
- Other: control group
**Label:** Education group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Personal Information Form and Disaster Response Self-Efficacy Scale will be applied to the students in the control group as a pre-test. No training will be given to the control group. In the last stage of the research, the Disaster Response Self-Efficacy Scale will be applied to the control group as a post-test and the data collection process will be terminated. After the last test was applied to the groups, training materials will be given to the people who demanded from the control group.
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Education group
**Description:** the students in the experimental group will be trained on disaster and disaster response
**Name:** Education group
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Education group
**Description:** the students in the experimental group will be trained on disaster and disaster response
**Name:** control group
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The scale is a 5-point Likert type and consists of a total of 19 items and 3 sub-dimensions (On-site rescue competence, Disaster psychological nursing competence, Nature of the role undertaken in disaster and adaptation competence). The scale is answered as having no self-confidence (1 point), basically no self-confidence (2 points), some self-confidence (3 points), basically self-confident (4 points) and full self-confidence (5 points). The scale score is calculated by summing the answers to the questions. A high score from the scale indicates high disaster response self-efficacy. In the Turkish validity and reliability study of the scale, the Cronbach alpha coefficient was found to be 0.96.
**Measure:** Disaster response self-efficacy scale:
**Time Frame:** 3 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Being a 4th year Nursing Student
* Want to participate in the research voluntarily
Exclusion Criteria:
* Student wants to leave the study
* Incomplete filling of survey forms
**Healthy Volunteers:** True
**Maximum Age:** 25 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Fatoş Uncu, PhD
**Phone:** 04242370000
**Phone Ext:** 4574
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Tayyip Çapkur, Lisans
**Phone:** 04242370000
**Phone Ext:** 4574
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Elazığ
**Country:** Turkey
**Facility:** Firat University
**Zip:** 23119
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06438016
**Brief Title:** Stress Management Training for Nursing Professionals in a Tertiary Care Center in Nepal
**Official Title:** Exploring the Efficiency of Stress Management Training Programs in Reducing Stress Levels Within Nursing Professionals in a Tertiary Care Center in Nepal
#### Organization Study ID Info
**ID:** 205/2024
#### Organization
**Class:** OTHER
**Full Name:** Dhulikhel Hospital
### Status Module
#### Completion Date
**Date:** 2024-09-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Dhulikhel Hospital
#### Responsible Party
**Investigator Affiliation:** Dhulikhel Hospital
**Investigator Full Name:** Rebecca Makaju Shrestha
**Investigator Title:** Psychologist
**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 clinical trial is to learn if stress management programs can help alleviate existing and prevent future symptoms of stress in nursing professionals working in a tertiary care center in Nepal.
Researchers will compare the treatment group (exposed to stress management training) to the control group (not exposed to stress management training) to see if
1. Stress management sessions lead to reduction of levels of stress among nurses at tertiary level hospital in Nepal.
2. To compare the pre and post training stress levels among participants of intervention and control group
Participants will Fill out the Depression, Anxiety and Stress Scale 21 and the Perceived Stress Scale before either being exposed to a 4-session stress management training (treatment group) or not being exposed to such training (control). All participants (both groups) will fill out the Depression, Anxiety and Stress Scale 21 and the Perceived Stress Scale for pre-post comparative measure.
**Detailed Description:** This study will aim to explore the effectiveness of a stress management program in nursing professionals in a community teaching hospital in Nepal. A 4-day stress management training program will be conducted and pre and post-training stress levels will be measured using the Perceived Stress Scale (PSS) and the Stress-Subscale of the Depression, Anxiety and Stress Scale-21 (DASS-21) one week prior to and after the training program. This experimental pre-post double arm study will involve 86 participants - all nursing staff from the Dhulikhel Hospital. Participants will be divided into 2 groups - treatment and control. The treatment group will be further divided into 2 groups of 20-25. The stress management training program will be held across 4 weeks with both groups receiving one training course each week (eg. Week 1 - session 1; Week 2 - session 2). Both questionnaires will be distributed again to both groups, 1 month after the last stress management session (1 - month follow up) .The control group whilst not being subjected to the Stress management training during the study period, will obtain the training upon study completion.
### Conditions Module
**Conditions:**
- Mental Health
**Keywords:**
- Stress; Stress Management; Nursing; Nepal
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Treatment group will obtain stress management whilst the control will not. The control group will obtain stress management one month upon study completion
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 86
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in this group will be provided with a demographic questionnaire, the DASS-21 and the PSS one week prior to and after the stress management training. The treatment group will be sub-divided into 2 groups of 20-25 participants and subjected to a 4-session stress management training program over the course of 4-weeks (one 40 minute session each week). The DASS and the PSS will be administered to this group one week and one month post completion of the final stress management training session.
**Intervention Names:**
- Other: Stress Management Training
**Label:** Stress Management Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** This control group will fill out the DASS-21 and PSS with the treatment group prior to the treatment group commencing stress management and will also fill out the DASS-21 and PSS upon completion of the treatment group's stress management training. This group will however not obtain stress management training during the study. Training will be provided upon study completion.
**Label:** Control Group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Stress Management Group
**Description:** The intervention will comprise of 4 sessions delivered over 4 weeks. The training session will be structured as follows: Session 1 - Psychoeducation relating to stress and its effects. Session 2 - Behavioral techniques to cope with stress 1, Session 3 - Cognitive techniques to cope with stress and Session 4- Behavioral techniques to cope with stress. Both verbal and written means will be used to provide this training.
**Name:** Stress Management Training
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The DASS-21 is a 21-item tool measuring signs and symptoms of depression, anxiety and stress. The DASS-21 displays good to excellent internal consistency. Previous studies have reported a Cronbach's α ranging from 0.82 - 0.90 for Depression, .74 - .83 for Anxiety, and 82 - .87 for Stress. The DASS-21 has also been validated in Nepal with good reliability for each subscale, with Cronbach's alphas 0.79 for Anxiety, 0.91 for Stress, and 0.93 for Depression.
**Measure:** Depression Anxiety Stress Scale - 21
**Time Frame:** One week prior to 4-week intervention, one week and one month post-intervention.
**Description:** The PSS displays good internal consistency with a Cronbach's α ranging from 0.74 - 0.91. A Nepali version of the PSS has also been evaluated yielding validity, strong overall internal consistency (Cronbach's α = 0.95) and inter-rater reliability (ICC = 0.96).
**Measure:** Perceived Stress Scale
**Time Frame:** One week prior to 4-week intervention, one week and one month post-intervention.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Nurses employed at the Dhulikhel Hospital
* Minimum one year work experience
* Minimum qualification certificate level of nursing
* Fluent in spoken and written English
Exclusion Criteria:
* Nurses with the post of nurse manager and above
* Nursing Students
* History having undergone stress management training in the past
* Absent for one or more sessions
* Incidence of a major stressful/critical life event during the study (e.g., divorce, death, and other critical events)
**Maximum Age:** 65 Years
**Minimum Age:** 8 Years
**Sex:** FEMALE
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Rebecca Makaju Shrestha, Psychology
**Phone:** 9820114531
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Subasna Shrestha, MN
**Phone:** 9849294785
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Dhulikhel
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Rebecca Shrestha, MClinPsych
- **Phone:** 9820114531
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Subasna Shrestha, MN
- **Phone:** 9849294785
- **Role:** CONTACT
***Contact 3:***
- **Name:** Rebecca Shrestha, MClinPsych
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Subasna Shrestha, MN
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Nepal
**Facility:** Dhulikhel Hospital
**State:** Kavrepalanchowk
**Zip:** 45200
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Behzadi S, Alizadeh Z, Samani NK, Ghasemi A, Fereidouni Z, Rostami K. Effect of stress management on job stress of intensive care unit nurses in hospitals affiliated to the University of Medical Sciences. Archivos Venezolanos de Farmacología y Terapéutica. 2021;40(8):824-7.
**Citation:** Hakim RM, Walton LM, Schwartz JJ, Futrell SM, Zaaeed N, Raigangar VL. Nepali Version of the Ten-Item Perceived Stress Scale: Translation and Validation Study for Bhutanese Refugees. In2023 Combined Sections Meeting (CSM) 2023 Feb 25. APTA.
**Citation:** Lee EH. Review of the psychometric evidence of the perceived stress scale. Asian Nurs Res (Korean Soc Nurs Sci). 2012 Dec;6(4):121-7. doi: 10.1016/j.anr.2012.08.004. Epub 2012 Sep 18.
**PMID:** 25031113
**Citation:** Thapa DK, Visentin D, Kornhaber R, Cleary M. Psychometric properties of the Nepali language version of the Depression Anxiety Stress Scales (DASS-21). Nurs Open. 2022 Nov;9(6):2608-2617. doi: 10.1002/nop2.959. Epub 2021 Jun 23.
**PMID:** 34161668
**Citation:** Zanon C, Brenner RE, Baptista MN, Vogel DL, Rubin M, Al-Darmaki FR, Goncalves M, Heath PJ, Liao HY, Mackenzie CS, Topkaya N, Wade NG, Zlati A. Examining the Dimensionality, Reliability, and Invariance of the Depression, Anxiety, and Stress Scale-21 (DASS-21) Across Eight Countries. Assessment. 2021 Sep;28(6):1531-1544. doi: 10.1177/1073191119887449. Epub 2020 Jan 9.
**PMID:** 31916468
**Citation:** Pahlavanzadeh S, Asgari Z, Alimohammadi N. Effects of stress management program on the quality of nursing care and intensive care unit nurses. Iran J Nurs Midwifery Res. 2016 May-Jun;21(3):213-8. doi: 10.4103/1735-9066.180376.
**PMID:** 27186196
**Citation:** Chaabane S, Chaabna K, Bhagat S, Abraham A, Doraiswamy S, Mamtani R, Cheema S. Perceived stress, stressors, and coping strategies among nursing students in the Middle East and North Africa: an overview of systematic reviews. Syst Rev. 2021 May 5;10(1):136. doi: 10.1186/s13643-021-01691-9.
**PMID:** 33952346
**Citation:** Dutton S, Kozachik SL. Evaluating the Outcomes of a Web-Based Stress Management Program for Nurses and Nursing Assistants. Worldviews Evid Based Nurs. 2020 Feb;17(1):32-38. doi: 10.1111/wvn.12417. Epub 2020 Jan 8.
**PMID:** 31912984
**Citation:** Mimura C, Griffiths P. The effectiveness of current approaches to workplace stress management in the nursing profession: an evidence based literature review. Occup Environ Med. 2003 Jan;60(1):10-5. doi: 10.1136/oem.60.1.10.
**PMID:** 12499451
**Citation:** Ducharme F, Dubé V, Lévesque L, Saulnier D, Giroux F. An online stress management training program as a supportive nursing intervention for family caregivers of an elderly person. Canadian Journal of Nursing Informatics. 2011 Jun;6(2):1-9.
**Citation:** Edwards D, Burnard P. A systematic review of stress and stress management interventions for mental health nurses. J Adv Nurs. 2003 Apr;42(2):169-200. doi: 10.1046/j.1365-2648.2003.02600.x.
**PMID:** 12670386
**Citation:** Sailaxmi G, Lalitha K. Impact of a stress management program on stress perception of nurses working with psychiatric patients. Asian J Psychiatr. 2015 Apr;14:42-5. doi: 10.1016/j.ajp.2015.01.002. Epub 2015 Feb 7.
**PMID:** 25703040
**Citation:** Lary A, Borimnejad L, Mardani-Hamooleh M. The Impact of a Stress Management Program on the Stress Response of Nurses in Neonatal Intensive Care Units: A Quasi-Experimental Study. J Perinat Neonatal Nurs. 2019 Apr/Jun;33(2):189-195. doi: 10.1097/JPN.0000000000000396.
**PMID:** 31021944
**Citation:** Alkhawaldeh JMA, Soh KL, Mukhtar FBM, Peng OC, Anshasi HA. Stress management interventions for intensive and critical care nurses: A systematic review. Nurs Crit Care. 2020 Mar;25(2):84-92. doi: 10.1111/nicc.12489. Epub 2019 Dec 15.
**PMID:** 31840391
**Citation:** Izdebski Z, Kozakiewicz A, Bialorudzki M, Dec-Pietrowska J, Mazur J. Occupational Burnout in Healthcare Workers, Stress and Other Symptoms of Work Overload during the COVID-19 Pandemic in Poland. Int J Environ Res Public Health. 2023 Jan 30;20(3):2428. doi: 10.3390/ijerph20032428.
**PMID:** 36767797
**Citation:** Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
**PMID:** 7726811
**Citation:** Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
**PMID:** 6668417
**Citation:** Yazdani M, Rezaei S, Pahlavanzadeh S. The effectiveness of stress management training program on depression, anxiety and stress of the nursing students. Iran J Nurs Midwifery Res. 2010 Fall;15(4):208-15.
**PMID:** 22049282
**Citation:** Pahlevani M, Ebrahimi M, Radmehr S, Amini F, Bahraminasab M, Yazdani M. Effectiveness of stress management training on the psychological well-being of the nurses. J Med Life. 2015;8(Spec Iss 4):313-318.
**PMID:** 28316750
**Citation:** Kumar N, Jin Y. Impact of nurses' emotional labour on job stress and emotional exhaustion amid COVID-19: The role of instrumental support and coaching leadership as moderators. J Nurs Manag. 2022 Oct;30(7):2620-2632. doi: 10.1111/jonm.13818. Epub 2022 Oct 11.
**PMID:** 36181253
**Citation:** Woo T, Ho R, Tang A, Tam W. Global prevalence of burnout symptoms among nurses: A systematic review and meta-analysis. J Psychiatr Res. 2020 Apr;123:9-20. doi: 10.1016/j.jpsychires.2019.12.015. Epub 2020 Jan 22.
**PMID:** 32007680
**Citation:** Hersch RK, Cook RF, Deitz DK, Kaplan S, Hughes D, Friesen MA, Vezina M. Reducing nurses' stress: A randomized controlled trial of a web-based stress management program for nurses. Appl Nurs Res. 2016 Nov;32:18-25. doi: 10.1016/j.apnr.2016.04.003. Epub 2016 Apr 9.
**PMID:** 27969025
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06438003
**Brief Title:** Improving Healthy Living Opportunities: Laurel HARVEST
**Official Title:** Improving Healthy Living Opportunities: Laurel HARVEST
#### Organization Study ID Info
**ID:** 64602
#### Organization
**Class:** OTHER
**Full Name:** University of Kentucky
#### Secondary ID Infos
**Domain:** USDA NIFA
**ID:** 2022-68015-36497
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2025-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-03
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-01-27
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Makenzie Barr-Porter
#### Responsible Party
**Investigator Affiliation:** University of Kentucky
**Investigator Full Name:** Makenzie Barr-Porter
**Investigator Title:** Assistant Professor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this pre-post intervention study is to understand how community-engaged approaches to policy, systems, and environmental approaches can work to improve fruit and vegetable consumption and food security status among an Appalachian Kentucky community. The main approaches taken will be to employ a Community Advisory Board to define our target population of need, and appropriate intervention strategies. The investigators aim to understand if nutrition-based programming and food system approaches for lower-income, single-parent households, and multi-generational households can improve health. Participants will engage in annual data collection to assess dietary quality and food security status.
### Conditions Module
**Conditions:**
- Health Knowledge, Attitudes, Practice
- Obesity
**Keywords:**
- Health Equity
- Food Insecurity
- Rural
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 281
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Specialized services
**Intervention Names:**
- Behavioral: Special Services
**Label:** Laurel County
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Extension services as usual
**Intervention Names:**
- Other: Services as Usual
**Label:** Pike County
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Laurel County
**Description:** Community members will complete data collection at the extension office or community partner location. Extension cooking classes and helping to make raised bed gardens along with other area happenings will be offered to participants throughout the year with check-ins and reminders. Data will be collected from study participants (regardless of the intervention decided) , at two time points, to include survey, dietary recall, and carotenoid scanner.
**Name:** Special Services
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Pike County
**Description:** Community members will receive extension services as usual with Data collection on participants at two time points to assess changes in rates of food insecurity, dietary quality, and overall health conditions.
**Name:** Services as Usual
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Food Security Status will be measured at each time point by the 10-item United States Department of Agriculture (USDA) Household Food Security Module. The questionnaire includes ten questions pertaining to food security that were designed to assess an individual's ability to obtain food directly to ensure having enough healthy food to eat. The questions include items such as not having enough money to purchase food, inability to afford nutritious food, and skipping meals due to lack of sufficient money. Answer choices include often, sometimes, never, and don't know. Items will be scored Food security status is assigned as follows: raw score zero-High food security among adults, raw score 1-2-Marginal food security, raw score 3-5-Low food security, raw score 6-10-Very low food security. For some reporting purposes, the food security status of the first two categories in combination will be described as food secure and the latter two as food insecure.
**Measure:** change in food security
**Time Frame:** Baseline (year 1) and year 3
**Description:** The Healthy Eating Index is a measurement that can capture changes in the thirteen dietary components outlined in the Dietary Guidelines for Americans. A maximum score-5 or 10 points- can be reached for each dietary component, depending on the component. Points are awarded when the amounts consumed meets the standard for a particular dietary component. Amounts that do not meet the standard get fewer points, with zero being the minimum score, and the maximum total Healthy Eating Index score is 100.
**Measure:** change in total Healthy Eating Index scores
**Time Frame:** Baseline (year 1) and year 3
**Description:** 30 item questionnaire to collect self-reported behaviors pertaining to five domains: diet, physical activity, food safety, food security and food resource management. The response options for each question are based on a Likert scale. Each question is scored with higher scores indicating greater frequency of the behavior in question.
**Measure:** Change in Food and Physical Activity Questionnaire (FPAQ)
**Time Frame:** Baseline (year 1) and year 3
**Description:** the VEGGIE METER™ will be used to measure dermal carotenoids using non-invasive RS Spectroscopy. Carotenoids are a biological marker of fruit and vegetable consumption. This non-invasive measurement of dermal carotenoids has been validated against the standard of serum carotenoids in adults. To obtain the measurement, a subject places their pointer finger into the machine for 20 seconds while their finger is squeezed. Three replicates will be taken per person at 20 seconds per replicate. The VEGGIE METER™ scores dermal carotenoids on a scale of 0-850 with higher scores indicating higher intake.
**Measure:** change in carotenoids
**Time Frame:** Baseline (year 1) and year 3
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Resident of Laurel of Pike County
* Over 18 years of age
Exclusion Criteria:
* Pregnancy
* Non-English speaking
* Plans to move out of the counties within the next three years
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Lexington
**Country:** United States
**Facility:** University of Kentucky
**State:** Kentucky
**Zip:** 40506
#### Overall Officials
**Official 1:**
**Affiliation:** University of Kentucky
**Name:** Makenzie Barr-Porter, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Document Section
### Large Document Module
#### Large Docs
- Date: 2023-02-14
- Filename: ICF_000.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 330508
- Type Abbrev: ICF
- Upload Date: 2024-06-03T10:47
## Derived Section
### 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: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M5592
- Name: Carotenoids
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437990
**Brief Title:** Arteriovenous Loop Graft for Free Functional Gracilis Transfer in Brachial Plexus Surgery
**Official Title:** Pilot Study of Arteriovenous Loop Graft for Free Functional Gracilis Transfer in Brachial Plexus Injured Patients With Insufficient Flow of Donor Artery
#### Organization Study ID Info
**ID:** 652/2556(EC4)
#### Organization
**Class:** OTHER
**Full Name:** Siriraj Hospital
### Status Module
#### Completion Date
**Date:** 2024-07-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2024-04-30
**Type:** ACTUAL
#### Start Date
**Date:** 2015-11-19
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Siriraj Hospital
#### Responsible Party
**Investigator Affiliation:** Siriraj Hospital
**Investigator Full Name:** Panai Laohaprasitiporn, MD
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Free functional muscle transfer (FFMT) using the gracilis muscle as a donor muscle has become a standard treatment for reconstructing late-onset brachial plexus injuries. Successful implementation of this procedure relies on the availability of functional donor vessels in the injured limb to supply the muscle flap. However, some brachial plexus injuries are accompanied by subclavian or axillary artery injuries, which compromise the viability of the muscle flap due to insufficient vascular supply. To address this, arteriovenous (AV) loop grafts have been employed to extend donor vessels to the flap and have been utilized in various body regions, including the upper extremity. Despite their widespread use, AV loop grafts have not been previously utilized in FFMT for late-onset brachial plexus injuries with concurrent subclavian or axillary artery injuries. This study aimed to assess the feasibility of this surgical approach and report the long-term outcomes of the procedure.
### Conditions Module
**Conditions:**
- Brachial Plexus Injury
**Keywords:**
- brachial plexus injury
- brachial plexus palsy
- free functional muscle transfer
- arteriovenous loop graft
- subclavian artery injury
- axillary artery injury
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Late-onset brachial plexus injury patient with concomitant subclavian or axillary artery injury
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 10
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** A saphenous vein graft was used to create an arteriovenous loop from the common carotid artery to the external jugular vein, providing vascular supply for a free functional gracilis muscle flap in patients with late-onset brachial plexus injury.
**Intervention Names:**
- Procedure: Arteriovenous loop graft
**Label:** Arteriovenous loop graft
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Arteriovenous loop graft
**Description:** Using saphenous vein graft to create an arteriovenous loop from the common carotid artery to the external jugular vein, providing vascular supply for a free functional gracilis muscle flap in patients with late-onset brachial plexus injury with concomitant subclavian or axillary artery injury.
**Name:** Arteriovenous loop graft
**Other Names:**
- AV loop graft
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Survival of the flap after the surgery
**Measure:** Viability of the flap
**Time Frame:** 1 month
#### Secondary Outcomes
**Description:** Medical Research Council (MRC) grading for motor power assessment
**Measure:** Motor power
**Time Frame:** 12 months, 18 months
**Description:** Bleeding, infection, blood transfusion, stroke, embolism, thrombosis
**Measure:** Complications
**Time Frame:** 1 month
**Description:** Total operative time including flap revision surgery or other related complications
**Measure:** Operative time
**Time Frame:** 1 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age equal or more than 20 years old
* Patients with brachial plexus injury with depletion of blood flow to the injured limb which confirmed by abnormal computed tomography arteriogram
Exclusion Criteria:
* Patients who had sufficient thoraco-acromial or thoraco-dorsal artery blood flow for standard free functional muscle transfer operation without the need of an AV loop graft
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Bangkoknoi
**Country:** Thailand
**Facility:** Faculty of Medicine Siriraj Hospital, Mahidol University
**State:** Bangkok
**Zip:** 10700
#### Overall Officials
**Official 1:**
**Affiliation:** Siriraj Hospital
**Name:** Panai Laohaprasitiporn, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M13157
- Name: Paralysis
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437977
**Acronym:** neoR-TORCH
**Brief Title:** Neoadjuvant Therapy of SBRT Sequencial With Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC Patients(neoR-TORCH)
**Official Title:** Neoadjuvant Therapy of SBRT Sequencial With Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC Patients: A Multicenter, Openlabel, Randomized, Phase III Trial
#### Organization Study ID Info
**ID:** IS24056
#### Organization
**Class:** OTHER
**Full Name:** Shanghai Chest Hospital
### Status Module
#### Completion Date
**Date:** 2029-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Shanghai Chest Hospital
#### Responsible Party
**Investigator Affiliation:** Shanghai Chest Hospital
**Investigator Full Name:** Xuwei Cai
**Investigator Title:** Director
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This is a randomized, controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of SBRT sequencial with Toripalimab and chemotherapy versus Toripalimab and chemotherapy for subjects with resectable, stage II-III NSCLC.
**Detailed Description:** Subjects who meet all the inclusion criteria but do not meet any exclusion criteria are randomized into two groups at a ratio of 1:1: according to the stratification factors as below:
* Disease stage: II vs IIIA vs IIIB
* PD-L1 status: PD-L1 expression ≥1% vs. PD-L1 \<1% or not evaluable
* Pathological type: non-squamous cell carcinoma vs. squamous cell carcinoma Neoadjuvant therapy should be started within 1 week after randomization. Stereotactic body radiation therapy (SBRT) will be given for primary lung tumor, 24Gy/3fractions, sequential toripalimab IV 240 mg Q3W will be given combined with platinum-based doublet drug chemotherapy for three cycles in the preoperative neoadjuvant therapy period for trial group; the controlled group receive toripalimab IV 240 mg Q3W combined with platinum-based doublet drug chemotherapy for three cycles in the preoperative neoadjuvant therapy period. Every 3 weeks of treatment is regarded as one cycle, in which combined therapy is given in the first day of every cycle.
All the subjects will receive preoperative radiological and surgical evaluation 4-6 weeks after neoadjuvant therapy.
After 3 cycles of preoperative neoadjuvant therapy, all the subjects who still have surgical indications will receive radical excision based on the surgical operation criteria of the World Association for Lung Cancer Research within 4-6 weeks after 3 cycles of preoperative neoadjuvant therapy. The pTNM will be staged in accordance with AJCC Cancer Staging Manual (version 8). All the specimens taken during the operation will be evaluated by local pathologists for the surgical margin. The tumor tissue samples collected from subjects during the study will be submitted to the authorized central laboratory for blinded evaluation of pathological response and translational research.
All the subjects who have completed the radical operation will receive one cycle of postoperative adjuvant therapy, i.e., Toripalimab IV 240 mg/placebo + platinum-based doublet drug chemotherapy in 30 days after the operation. Then it will proceed to consolidation treatment period three weeks after adjuvant therapy; In the consolidation treatment period, Toripalimab IV 240 mg/placebo is given in each cycle of every 3 weeks for a total of 13 cycles . Adverse events (AEs) will be monitored throughout the study, and the severity will be graded to the guidelines listed in National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 or above. The safety will be followed up in the subjects who have received study treatment and discontinued the drug prematurely. All the subjects will be followed up for overall survival, until death, withdrawal of informed consent or end of study
### Conditions Module
**Conditions:**
- Stage II-III Non-small Cell Lung Cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Parallel
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 478
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants receive SBRT for primary lung tumor, sequential receive totally 4 cycles of Toripalimab combined with platinum doublet chemotherapy during perioperative period ; participants receive consolidation therapy of Toripalimab Intervention: SBRT: 24Gy/3fractions; Drug: 4cycles(Toripalimab IV 240mg + platinum-based doublet chemotherapy)+13 cycles(Toripalimab IV 240mg); Biological: Toripalimab
**Intervention Names:**
- Radiation: SBRT
- Drug: Toripalimab
**Label:** Experimental
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participantsreceive totally 4 cycles of Toripalimab combined with platinum doublet chemotherapy during perioperative period ; participants receive consolidation therapy of Toripalimab Intervention: Drug: 4cycles(Toripalimab IV 240mg + platinum-based doublet chemotherapy)+13 cycles(Toripalimab IV 240mg); Biological: Toripalimab
**Intervention Names:**
- Drug: Toripalimab
**Label:** Active Comparator
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental
**Description:** SBRT. 24Gy/3fractions Toripalimab 240 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1;Drug: Cisplatin 75 mg/m\^2 by IV infusion Q3W, given on cycle day 1;Drug: Corboplatin AUC 5 by IV infusion Q3W, given on cycle day 1;Drug: Pemetrexed 500 mg/m\^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.Drug:Paclitaxel 175 mg/m\^2 by IV infusion Q3W;Drug:Docetaxel 60-75 mg/m\^2 by IV infusion Q3W
**Name:** SBRT
**Type:** RADIATION
#### Intervention 2
**Arm Group Labels:**
- Active Comparator
- Experimental
**Description:** Toripalimab 240 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1;Drug: Cisplatin 75 mg/m\^2 by IV infusion Q3W, given on cycle day 1;Drug: Corboplatin AUC 5 by IV infusion Q3W, given on cycle day 1;Drug: Pemetrexed 500 mg/m\^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.Drug:Paclitaxel 175 mg/m\^2 by IV infusion Q3W;Drug:Docetaxel 60-75 mg/m\^2 by IV infusion Q3W
**Name:** Toripalimab
**Other Names:**
- Toripalimab IV 240mg + platinum-based doublet chemotherapy
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Event Free Survival (EFS):EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined either by biopsy assessed by central pathologist or by imaging using RECIST 1.1 assessed by BICR.
**Measure:** 2-year Event Free Survival Rate
**Time Frame:** 2 years
**Description:** Pathological Complete Response (pCR) Rate :pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
**Measure:** pCR rate
**Time Frame:** up to 7 weeks after neoadjuvant
#### Secondary Outcomes
**Description:** Major Pathological Response (mPR) Rate.mPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes in neoadjuvant therapy
**Measure:** Major Pathological Response
**Time Frame:** up to 7 weeks after neoadjuvant
**Measure:** Lymph node downstaging rate
**Time Frame:** up to 7 weeks after neoadjuvant
**Measure:** Perioperative complications
**Time Frame:** 90 days after the last administration
**Description:** Adverse event (AE), abnormal laboratory examination, serious adverse event (SAE) related with the study drug judged using NCI-CTCAE V5.0; surgical feasibility: percentage of procedure delay or cancellation, change of surgical approach, operation time
**Measure:** Treatment associated adverse events
**Time Frame:** 90 days after the last administration
**Description:** EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined either by biopsy assessed by central pathologist or by imaging using RECIST 1.1 assessed by investigator
**Measure:** EFS
**Time Frame:** up to 3 years
**Description:** DFS is defined as the time from postoperation until radiographic disease progression, , local or distant recurrence, or death due to any cause
**Measure:** Disease-free survival (DFS)
**Time Frame:** up to 3 years
**Description:** OS is defined as the time from randomization until death from any cause.
**Measure:** Overall survival (OS)
**Time Frame:** up to 3 years
**Measure:** R0 resection rate
**Time Frame:** up to 7 weeks after neoadjuvant
**Measure:** Surgical Completion Rate
**Time Frame:** up to 7 weeks after neoadjuvant
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Aged 18 -75 years, regardless of gender；
2. ECOG score 0-1;
3. Treatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (N2) (AJCC staging system, version 8) NSCLC ;
4. Measurable lesions based on the response evaluation criteria in solid tumors version 1.1;
5. Tumor tissue specimens available for pathological diagnosis, detection of PD-L1 expression and biomarkers prior to randomization ;
6. According to the doctor's judgment, lung function can meet the requirements of pneumonectomy;
7. Confirming the absence of EGFR/ALK sensitive gene mutations through molecular pathological diagnosis of the organization;
8. Good organ function:
Bone marrow function: absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L, hemoglobin ≥9 g/dL; Liver function: total bilirubin ≤ 1.5 × ULN, ALT and AST ≤ 1.5 × ULN; Renal function: serum creatinine ≤ 1.5 × ULN or serum creatinine clearance rate ≥ 60 mL/min; blood urea nitrogen ≤ 200mg/L;
9. Having sufficient understanding of this study and being willing to sign the informed consent form; 10. For female subjects of childbearing age, the serum pregnancy test should be negative within 3 days before receiving the first dose (cycle 1, day 1).
Exclusion Criteria:
1. Have locally advanced unresectable or metastatic disease; unresectable includes unresectable stage III non-small cell lung cancer as defined by the Multidisciplinary Diagnosis and Treatment Consensus (2019 edition), including partial stages IIIA and IIIB and all stage IIIC, N2: single station mediastinal lymph nodes with short diameter≥3cm or N2: multi-station mediastinal metastasis with lymph node fusion and the short diameter of lymph node ≥2cm on CT, T4 invading esophagus, heart, aorta, pulmonary veins and all the N3;
2. NSCLC involving superior sulcus, large cell neuroendocrine carcinoma (LCNEC), sarcomatoid tumor;
3. Participants with known EGFR sensitive mutations or ALK translocation, EGFR and ALK mutation status needs to be identified for the subjects with non-squamous cell carcinoma;
4. Previous treatment with systemic antitumor therapy for early NSCLC, including investigational product;
5. History of (non-infectious) pneumonitis/interstitial lung disease requiring steroid treatment, or ongoing pneumonitis/interstitial lung disease requiring steroid treatment;
6. Active tuberculosis；
7. Active infection requiring systemic treatment；
8. Subjects with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose; controlled type I diabetes;
9. Uncontrolled active hepatitis B (defined as positive hepatitis B surface antigen \[HBsAg\] in screening period with HBV-DNA detected higher than the upper limit of normal at the clinical laboratory of the study center); (the subjects with HBV-DNA assay \<500 IU/mL within 28 days prior to randomization who have received local standard antiviral therapy for at least 14 days and are willing to receive antiviral therapy continuously during the study can be enrolled); active hepatitis C (defined as positive hepatitis C surface antibody \[HCsAb\] in screening period and positive HCV-RNA);
10. Known human immunodeficiency virus (HIV) infection (known positive HIV antibody);
11. Vaccination of live vaccine within 30 days prior to the first dose. Including but not limited to the following: parotitis, rubella, measles, varicella/ herpes zoster (varicella), yellow fever, Rabies, Bacille Calmette-Guérin (BCG) and typhoid vaccine (inactivated virus vaccine allowed);
12. ≥ grade 2 peripheral neuropathy；
13. Previous use of PD-1/PD-L1 agent or the drug acting on another targeted T cell receptor (e.g., CTLA-4, OX-40);
14. Severe allergic reaction to other monoclonal antibodies;
15. History of serious allergy to Pemetrexed, paclitaxel or docetaxel, cisplatin, carboplatin or its preventive medications;
16. Known serious or uncontrolled pre-existing diseases; including but not limited to cardiovascular events with hemodynamic instability, symptomatic cerebrovascular events, and hepatic cirrhosis above Child-Pugh A within 6 months;
17. History or current evidence of any disease, therapy or abnormal laboratory examination that may confuse the study results, interfere with subject's participation in the full course of the study or not meet the best interest of subject's participation in the study, as judged by investigators;
18. Other malignant tumors within 5 years prior to the first dose, except non-small cell lung cancer. The malignant tumors with negligible risk of metastasis or death (e.g., expected disease-free survival \> 5 years) and expected to achieve radical outcomes after treatment (e.g., sufficiently treated carcinoma in situ of cervix, basal or squamous cell skin cancer, ductal carcinoma in situ treated for radical surgery) can be excluded.
**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:** Xuwei Cai
**Phone:** 02122200000
**Role:** CONTACT
### IPD Sharing Statement Module
**Description:** yes
**IPD Sharing:** YES
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002283
- Term: Carcinoma, Bronchogenic
- ID: D000001984
- Term: Bronchial Neoplasms
- ID: D000008175
- Term: Lung Neoplasms
- ID: D000012142
- Term: Respiratory Tract Neoplasms
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M11172
- Name: Lung Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M5546
- Name: Carcinoma, Non-Small-Cell Lung
- Relevance: HIGH
- As Found: Non-Small Cell Lung Cancer
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- 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
### 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: M6182
- Name: Cisplatin
- Relevance: LOW
- As Found: Unknown
- ID: M1668
- Name: Docetaxel
- Relevance: LOW
- As Found: Unknown
- ID: M264
- Name: Pemetrexed
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437964
**Brief Title:** Prophylactic Antibiotics in Endoscopic Secondary Prevention of Gastroesophageal Variceal Bleeding
**Official Title:** The Use of Prophylactic Antibiotics in the Endoscopic Secondary Prevention of Cirrhotic Patients With Gastroesophageal Variceal Bleeding
#### Organization Study ID Info
**ID:** 2024-0629
#### Organization
**Class:** OTHER
**Full Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-25
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Prophylactic antibiotics like third-generation cephalosporin is recommended for acute gastroesophageal variceal bleeding (GVB). Endoscopic sequential therapy is an option in the secondary prevention of acute gastroesophageal variceal bleeding (GVB). However, the value of prophylactic antibiotics in the endoscopic secondary prevention of GVB is still unclear. It's assumed that the procedure of needle puncture under endoscopy will cause iatrogenic variceal bleeding. Besides, the surface of intraluminal varices is nonsterile, and injection of sclerosing agent or tissue adhesive will put patients at a risk of bacteremia. As a result, it's rational to use antibiotics prophylactically in the endoscopic sequential therapy of GVB. While giving antibotics in all patients might cause abuse of antibiotics. In clinical practice now, the prophylactic administration of antibiotics is quite subjective. We observe that quite a lot of cirrhotic patients had no infection after endoscopic secondary prevention for gastroesophageal variceal bleeding, even they have not been administed prophylactic antibiotics. In this non-inferiority trial, we are aimed to evaluate whether no value of prophylactic antibiotics will increase the postoperative infection or not, in the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding.
### Conditions Module
**Conditions:**
- Gastroesophageal Variceal Bleeding
- Cirrhosis, Liver
- Endoscopic Secondary Prevention
- Prophylactic Antibiotics
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 224
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: No use of prophylactic antibiotics
**Label:** Intravenous infusion of 2.0g ceftriaxone before endoscopic therapy
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Other: No use of prophylactic antibiotics
**Label:** No use of prophylactic antibiotics before endoscopic therapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intravenous infusion of 2.0g ceftriaxone before endoscopic therapy
- No use of prophylactic antibiotics before endoscopic therapy
**Description:** In the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding, do not use any antibiotics before the endoscopic operation.
**Name:** No use of prophylactic antibiotics
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** have fever and increased inflammation marker within one day afer the endoscopic operation
**Measure:** Post-operation infection
**Time Frame:** 19 months
#### Secondary Outcomes
**Description:** have gastroesophageal variceal bleeding within 4 week after the endoscopic operation
**Measure:** Post-operation 4-week rebleeding
**Time Frame:** 19 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Cirrhotic patients with a history of gastroesophageal variceal bleeding that are readmitted for endoscopic secondary prevention, and are willing to sign an informed consent form.
Exclusion Criteria:
1. Allergy to penicillin or cephalosporin.
2. The patient is unwilling to sign the informed consent form.
3. Already have concurrent infection before the endoscopic operation.
4. Already have fever (body temperature ≥ 37.5 ℃) before the endoscopic operation.
5. Have granulocyte deficiency (neutrophil count below 0.5 \* 10 \^ 9/L) before the endoscopic operation.
6. Have malignant tumors before the endoscopic operation.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Hangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Meng Xue, Ph.D
- **Phone:** +86 13958123617
- **Role:** CONTACT
**Country:** China
**Facility:** The 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009385
- Term: Neoplastic Processes
- ID: D000009369
- Term: Neoplasms
- ID: D000010335
- Term: Pathologic Processes
- ID: D000005355
- Term: Fibrosis
- ID: D000008107
- Term: Liver Diseases
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M9556
- Name: Hemorrhage
- Relevance: HIGH
- As Found: Bleeding
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: HIGH
- As Found: Secondary
- ID: M11103
- Name: Liver Cirrhosis
- Relevance: HIGH
- As Found: Cirrhosis, Liver
- ID: M12330
- Name: Neoplastic Processes
- Relevance: LOW
- As Found: Unknown
- ID: M8485
- Name: Fibrosis
- Relevance: LOW
- As Found: Unknown
- ID: M11107
- Name: Liver Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009362
- Term: Neoplasm Metastasis
- ID: D000008103
- Term: Liver Cirrhosis
- ID: D000006470
- Term: Hemorrhage
### Intervention Browse Module - Ancestors
- 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: M4222
- Name: Anti-Bacterial Agents
- Relevance: HIGH
- As Found: Physician
- ID: M5693
- Name: Ceftriaxone
- Relevance: LOW
- As Found: Unknown
- ID: M4224
- Name: Antibiotics, Antitubercular
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000000900
- Term: Anti-Bacterial Agents
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437951
**Brief Title:** to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics of DWP14012 Injection
**Official Title:** A Randomized, Double-blind, Placebo-controlled, Single/Multiple-dose, Phase 1 Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics After Intravenous DWP14012 Injection in Healthy Participants
#### Organization Study ID Info
**ID:** DW_DWJ1521104
#### Organization
**Class:** INDUSTRY
**Full Name:** Daewoong Pharmaceutical Co. LTD.
### Status Module
#### Completion Date
**Date:** 2025-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Daewoong Pharmaceutical Co. LTD.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy participants
### Conditions Module
**Conditions:**
- Erosive Gastroesophageal Reflux Disease
### 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:** 40
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** IV injection of test drugs by dose group
**Intervention Names:**
- Drug: Fexuprazan Injection
**Label:** Part1_test group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** IV injection of test drugs by dose group
**Intervention Names:**
- Drug: Fexuprazan Injection placebo
**Label:** Part1_placebo group
**Type:** PLACEBO_COMPARATOR
#### Arm Group 3
**Description:** All Participants take IV injection of test drugs
**Intervention Names:**
- Drug: Fexuprazan Injection_part 2
**Label:** Part2
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** In the case of test group, take IV injection in the period 1 and take a tablet in the period 2
**Intervention Names:**
- Drug: Fexuprazan Injection_part 3
- Drug: Fexuprazan tablet
**Label:** Part3_test group
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** In the case of reference group, take a tablet in the period 1 and take IV injection in the period 2
**Intervention Names:**
- Drug: Fexuprazan Injection_part 3
- Drug: Fexuprazan tablet
**Label:** Part3_reference group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Part1_test group
**Description:** 20/40/80 mg
**Name:** Fexuprazan Injection
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Part1_placebo group
**Description:** 20/40/80 mg
**Name:** Fexuprazan Injection placebo
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Part2
**Description:** 20mg
**Name:** Fexuprazan Injection_part 2
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Part3_reference group
- Part3_test group
**Description:** 40mg
**Name:** Fexuprazan Injection_part 3
**Type:** DRUG
#### Intervention 5
**Arm Group Labels:**
- Part3_reference group
- Part3_test group
**Description:** 40mg
**Name:** Fexuprazan tablet
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** 1. Blood and urinary concentrations of Fexuprazan by part
**Measure:** PK of Fexuprazan
**Time Frame:** 0 and 72hour
**Description:** 1. Blood and urinary concentrations of metabolite by part
**Measure:** PK of metabolite
**Time Frame:** 0 and 72hour
**Description:** pH monitoring
**Measure:** PD of Fexuprazan
**Time Frame:** up to 15days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Healthy adult volunteers aged 19 to 50 at the time of screening tests
2. Those who weigh more than 50.0 kg, 90.0 kg or less, and have a BMI of 18.5 or more and 29.9 or less at the time of screening inspection BMI (kg/m2) = Weight (kg) / {Height (m)}2
3. In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in surgical infertility (bilateral ovarian obstruction, hysterectomy, bilateral ovarian resection, etc.)
4. A person who voluntarily decides to participate after hearing and fully understanding the detailed explanation of this clinical trial and agrees in writing before a screening procedure
5. A person who is suitable for this test when judging the tester by physical examination, clinical laboratory examination, questionnaire, etc
Exclusion Criteria:
1. Clinically significant hepatomegaly (severe liver disorder, viral hepatitis, etc.), kidney (severe renal disorder, etc.), nervous system, immune system, respiratory system, digestive system, endocrine system, blood and tumor, cardiovascular system (heart failure, Torsades de points, etc.), urinary system, mental system (fever disorder, obsessive compulsive disorder, etc.), sexual dysfunction, etc
2. A person who has a history of gastrointestinal diseases (such as Crohn's disease, ulcers, gastritis, gastritis, gastroesophageal reflux disease, etc.) or surgery (except simple appendectomy or hernia) that may affect the safety, pharmacokinetics and pharmacodynamic evaluation of clinical medicines
3. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
4. A person who has been tested positive for Helicobacter pylori
5. Those who have anatomical impairments in insertion and maintenance of the pH meter catheter etc
**Healthy Volunteers:** True
**Maximum Age:** 50 Years
**Minimum Age:** 19 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sujong Lee, Ph.D
**Phone:** 027408910
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Seoul National University College of Medicine and Hospital
**Name:** Injin zhang, Ph.D
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000015154
- Term: Esophageal Motility Disorders
- ID: D000003680
- Term: Deglutition Disorders
- ID: D000004935
- Term: Esophageal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
### Condition Browse Module - Browse Leaves
- ID: M8880
- Name: Gastroesophageal Reflux
- Relevance: HIGH
- As Found: Gastroesophageal Reflux
- ID: M17874
- Name: Esophageal Motility Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M17875
- Name: Esophageal Spasm, Diffuse
- Relevance: LOW
- As Found: Unknown
- ID: M6882
- Name: Deglutition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M8085
- Name: Esophageal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005764
- Term: Gastroesophageal Reflux
### Intervention Browse Module - Ancestors
- ID: D000005765
- Term: Gastrointestinal Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M350719
- Name: Fexuprazan
- Relevance: HIGH
- As Found: Reverse Total Shoulder Arthroplasty
- ID: M8881
- Name: Gastrointestinal Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000634065
- Term: Fexuprazan
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437938
**Brief Title:** The Effects of Dietary Supplements on Glycemic Control, Body Composition and Hepatic Fat Content in People With Prediabetes
**Official Title:** The Effects of Dietary Supplements on Glycemic Control, Body Composition and Hepatic Fat Content in People With Prediabetes: a Randomized, Double-blind, Placebo-controlled Pilot Study
#### Organization Study ID Info
**ID:** 1543/2023
#### Organization
**Class:** OTHER
**Full Name:** Medical University of Vienna
### Status Module
#### Completion Date
**Date:** 2025-08-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-05-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-25
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** BIOGENA GmbH
#### Lead Sponsor
**Class:** OTHER
**Name:** Medical University of Vienna
#### Responsible Party
**Investigator Affiliation:** Medical University of Vienna
**Investigator Full Name:** Michael Leutner
**Investigator Title:** Priv.Doz. Dr.med.univ.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This clinical study aims to explore the effects of 3 dietary supplements on metabolic parameters, liver fat content, and body composition in individuals with prediabetes. Prediabetes refers to a condition where blood sugar levels are higher than normal but not high enough for a diabetes diagnosis. The study will last for three months, during which participants will either take a dietary supplement or a placebo. Five groups will be studied, including placebo groups. Blood tests will assess glucose and lipid metabolism parameters, adipokines, and liver and kidney function. Liver stiffness and fat content will also be measured using elastography. Additionally, body composition will be assessed, and participants' psychological state, quality of life, eating habits and sports habits will be evaluated using questionnaires.
### Conditions Module
**Conditions:**
- PreDiabetes
**Keywords:**
- Prediabetes
- Dietary supplements
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Corresponding to dietary supplement groups B and C
**Intervention Names:**
- Other: Placebo group 1: Placebo capsules corresponding to DiaPhyt® Formula 3.0/Berberin Phytoactive Gold
**Label:** Placebo group 1
**Type:** PLACEBO_COMPARATOR
#### Arm Group 2
**Description:** Corresponding to dietary supplement A
**Intervention Names:**
- Other: Placebo group 2: Placebo powder corresponding to Wasabi leaf powder
**Label:** Placebo group 2
**Type:** PLACEBO_COMPARATOR
#### Arm Group 3
**Description:** Wasabi leaf powder
**Intervention Names:**
- Dietary Supplement: Dietary supplement A: Wasabi leaf powder (product of BIOGENA GmbH & Co KG)
**Label:** Dietary supplement group A
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Berberin Phytoactive Gold
**Intervention Names:**
- Dietary Supplement: Dietary supplement B: Berberin Phytoactive Gold (product of BIOGENA GmbH & Co KG)
**Label:** Dietary supplement group B
**Type:** PLACEBO_COMPARATOR
#### Arm Group 5
**Description:** DiaPhyt® Formula 3.0
**Intervention Names:**
- Dietary Supplement: Dietary supplement C: DiaPhyt® Formula 3.0 (product of BIOGENA GmbH & Co KG)
**Label:** Dietary supplement group C
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dietary supplement group A
**Description:** To be taken according to the information in the study protocol/patient information leaflet.
**Name:** Dietary supplement A: Wasabi leaf powder (product of BIOGENA GmbH & Co KG)
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Dietary supplement group B
**Description:** To be taken according to the information in the study protocol/patient information leaflet.
**Name:** Dietary supplement B: Berberin Phytoactive Gold (product of BIOGENA GmbH & Co KG)
**Type:** DIETARY_SUPPLEMENT
#### Intervention 3
**Arm Group Labels:**
- Dietary supplement group C
**Description:** To be taken according to the information in the study protocol/patient information leaflet.
**Name:** Dietary supplement C: DiaPhyt® Formula 3.0 (product of BIOGENA GmbH & Co KG)
**Type:** DIETARY_SUPPLEMENT
#### Intervention 4
**Arm Group Labels:**
- Placebo group 1
**Description:** To be taken according to the information in the study protocol/patient information leaflet.
**Name:** Placebo group 1: Placebo capsules corresponding to DiaPhyt® Formula 3.0/Berberin Phytoactive Gold
**Type:** OTHER
#### Intervention 5
**Arm Group Labels:**
- Placebo group 2
**Description:** To be taken according to the information in the study protocol/patient information leaflet.
**Name:** Placebo group 2: Placebo powder corresponding to Wasabi leaf powder
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** time in range measured with continuous glucose monitoring system
**Measure:** changes in the time in range
**Time Frame:** 2 weeks at baseline before start of the dietary supplement, 2 weeks during the last 2 weeks of the 3 month dietary supplement ingestion phase
#### Secondary Outcomes
**Description:** HbA1c (glycated haemoglobin) values
**Measure:** changes in HbA1c values
**Time Frame:** baseline, after 3 months
**Description:** fasting glucose concentration
**Measure:** changes in fasting glucose concentration
**Time Frame:** baseline, after 3 months
**Description:** fasting insulin concentration
**Measure:** changes in fasting insulin concentration
**Time Frame:** baseline, after 3 months
**Description:** fasting c-peptide concentration
**Measure:** changes in fasting c-peptide concentration
**Time Frame:** baseline, after 3 months
**Description:** HOMA-IR calculated as fasting insulin level (micro-units per milliliter) multiplied by the fasting blood glucose level (milligrams per deciliter), dividing the result by 405
**Measure:** changes in HOMA-IR
**Time Frame:** baseline, after 3 months
**Description:** HDL, LDL, triglycerides, total cholesterol, apolipoprotein B, chylomicrons
**Measure:** changes in parameters of lipid metabolism
**Time Frame:** baseline, after 3 months
**Description:** hepatic fat content
**Measure:** changes in the hepatic fat content
**Time Frame:** baseline, after 3 months
**Description:** hepatic fibrosis amount
**Measure:** changes in the hepatic fibrosis amount
**Time Frame:** baseline, after 3 months
**Description:** GGT (gamma-glutamyltransferase), GOT (AST, aspartate transaminase), GPT (ALT, alanine transaminase), alkaline phosphatase
**Measure:** changes in parameters of hepatic function
**Time Frame:** baseline, after 3 months
**Description:** bilirubin
**Measure:** changes in bilirubin concentrations
**Time Frame:** baseline, after 3 months
**Description:** weight
**Measure:** changes in the weight
**Time Frame:** baseline, after 3 months
**Description:** BMI calculated as weight in kilograms divided by the square of height in meters
**Measure:** changes in the BMI
**Time Frame:** baseline, after 3 months
**Description:** fat free mass, fat mass
**Measure:** changes in the anthropometric parameters
**Time Frame:** baseline, after 3 months
**Description:** adiponectin, leptin
**Measure:** changes in adipokine levels
**Time Frame:** baseline, after 3 months
**Description:** depressive, anxiety and stress-related symptoms assessed using the Depression-Anxiety-Stress Scale
**Measure:** changes in depressive, anxiety and stress-related symptoms
**Time Frame:** baseline, after 3 months
**Description:** quality of life assessed using the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire
**Measure:** changes in quality of life
**Time Frame:** baseline, after 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* willingness and ability to provide written informed consent and comply with all study requirements,
* age between 40 and 80 years
* prediabetes with a HbA1c level between 5,7-6,4%
* no antidiabetic treatment prior to the inclusion in the study
* BMI between 25 and 35 kg/m2
* fasting glucose of 100-125mg/dl
* in the case of women of childbearing potential, providing a negative pregnancy test at inclusion and once a month until the end of the study
Exclusion Criteria:
* failure to provide written informed consent and/or failure to comply with the study requirements
* age \<40 years
* HbA1c outside of the set range
* significant impairments of hepatic and/or renal function
* clinically significant abnormalities in medical history, routine laboratory screening, or in physical examination
* allergies against any of the components of the dietary supplements or the placebo
* type 1 diabetes mellitus, latent autoimmune diabetes in adults, maturity-onset diabetes of the young, gestational diabetes
* pregnancy, lactation
* concurrent treatment with any antidiabetic drug
* concurrent treatment with drugs/dietary supplements that have proven interactions with dietary supplements included in our study
**Maximum Age:** 80 Years
**Minimum Age:** 40 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Michael Leutner
**Phone:** 0140400
**Phone Ext:** 20690
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Vienna
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Michael Leutner, Priv.Doz. Dr.med.univ.
- **Phone:** 0140400
- **Phone Ext:** 20690
- **Role:** CONTACT
***Contact 2:***
- **Name:** Dorota Sluková, Dr.med.univ.
- **Role:** SUB_INVESTIGATOR
**Country:** Austria
**Facility:** Medical University of Vienna
**Status:** RECRUITING
**Zip:** 1090
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000006943
- Term: Hyperglycemia
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14117
- Name: Prediabetic State
- Relevance: HIGH
- As Found: Prediabetes
- ID: M20295
- Name: Glucose Intolerance
- Relevance: HIGH
- As Found: Prediabetes
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9994
- Name: Hyperglycemia
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011236
- Term: Prediabetic State
- ID: D000018149
- Term: Glucose Intolerance
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437925
**Brief Title:** Effects of Probiotic Ayran on Gingivitis
**Official Title:** Effects of the Use of Probiotics Ayran on Gingival Inflammation: An Experimental Gingivitis Study
#### Organization Study ID Info
**ID:** Cukurova University-1
#### Organization
**Class:** OTHER
**Full Name:** Cukurova University
### Status Module
#### Completion Date
**Date:** 2023-06-15
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-04-15
**Type:** ACTUAL
#### Start Date
**Date:** 2023-01-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Cukurova University
#### Responsible Party
**Investigator Affiliation:** Cukurova University
**Investigator Full Name:** Cenk Haytac
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Objectives: This study investigates the effects of daily consumption of probiotic ayran drink on gingival inflammation and the development of experimental gingivitis.
Methods: A total of 54volunteer students were included in the present randomized, double-blind, placebo-controlled trial.The participants were divided randomly into two groups; The Control group consisted of 27 participants who consumed placebo ayran, while the 27 participants of the Test group consumed probiotic ayran (containing Lactobacillus acidophilus and Bifidobacterium bifidum) for 42 days twice a day.After 42 days, mechanical plaque control was interrupted for 5 days. The clinical parameters of gingivitis; Plaque index (PI), gingival index (GI), probing bleeding (BOP), probing depth (PPD) were recorded at baseline, day 42 (beginning of experimental gingivitis) and day 47 (the end of experimental gingivitis). At the same time points, gingival crevicular fluid had been collected for analysis of matrix metalloproteinase - 8 (MMP-8).
**Detailed Description:** The most used and studied probiotics in the periodontal literature are lactobacillus and bifidobacterium. The current study aims to observe the effects of daily ayran consumption containing a probiotic combination of Lactobacillus acidophilus and Bifidobacterium bifidum on plaque development and gingival inflammation in an experimental gingivitis model of healthy individuals. The null hypothesis of this study using of probiotics has no additional benefit for periodontal health.
This study evaluates the effects of daily consumption of ayran containing a probiotic combination of Lactobacillus Acidophilus and Bifidobacterium Bifidum on plaque development and gingival status in healthy individuals with experimental gingivitis.
### Conditions Module
**Conditions:**
- Gingivitis
- Probiotics
- Inflamed Gums
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 54
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The participants in this experimental group will use probiotic containing ayran for 42 days and then will be subjected to 5 days of experimental gingivitis.
**Intervention Names:**
- Dietary Supplement: probiotic ayran drink
**Label:** Probiotic ayran drink
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The participants in this control group will use control ayran without probiotics for 42 days and then will be subjected to 5 days of experimental gingivitis.
**Intervention Names:**
- Dietary Supplement: Placebo ayran drink
**Label:** Placebo ayran drink
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Probiotic ayran drink
**Description:** The test group has received probiotic ayran drink for 6 weeks
**Name:** probiotic ayran drink
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Placebo ayran drink
**Description:** The control group has received placebo ayran drink for 6 weeks
**Name:** Placebo ayran drink
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** PI was scored from 0 to 5 according to the color change obtained with the Mira-2 solution
**Measure:** Plaque index
**Time Frame:** Plaque index will be recorded at baseline, at day 42 and 47
**Description:** GI is graded by visual assessment and mechanical stimulation of the gingival tissues, scoring the gingival condition according to the criteria
**Measure:** Gingival index
**Time Frame:** Gingival index will be recorded at baseline, at day 42 and 47
**Description:** The probing bleeding (BOP) index was determined by the presence/absence of bleeding ≈30 seconds after probing
**Measure:** Bleeding on probing
**Time Frame:** BOP will be recorded at baseline, at day 42 and 47
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Systemic healthy
* Subjects with gingivitis defined as a BOP sites ≥ 10% and PD ≤ 3 mm
* No radiographic bone loss
* Non-smoking participants
Exclusion Criteria:
* History of using antibiotics or anti-inflammatory drugs or probiotic preparations or food supplements in the last 6 months,
* Undergoing orthodontic treatment,
* Active carious lesions
* Mouth breathing
* History of allergy for milk or fermented milk products.
* Taking medications affecting the gingiva and/or oral mucosa
**Healthy Volunteers:** True
**Maximum Age:** 25 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Adana
**Country:** Turkey
**Facility:** Cukurova University Faculty of Dentistry
#### Overall Officials
**Official 1:**
**Affiliation:** Professor Doctor
**Name:** Cenk Haytac, phd
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** The data will be shared upon request
**Description:** The data will be shared upon request
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
**Time Frame:** The data is ready and can be shared for two years
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007239
- Term: Infections
- ID: D000005882
- Term: Gingival Diseases
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
### Condition Browse Module - Browse Leaves
- ID: M10293
- Name: Inflammation
- Relevance: LOW
- As Found: Unknown
- ID: M9003
- Name: Gingivitis
- Relevance: HIGH
- As Found: Gingivitis
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8994
- Name: Gingival Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13419
- Name: Periodontal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12019
- Name: Mouth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005891
- Term: Gingivitis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437912
**Brief Title:** Effectiveness of Botulinum Toxin A in Preventing Scar Formation and Initial Exploration of "Optimal Concentration"
**Official Title:** Effectiveness of Botulinum Toxin A in Preventing Scar Formation and Initial Exploration of "Optimal
#### Organization Study ID Info
**ID:** MR-37-23-008382
#### Organization
**Class:** OTHER
**Full Name:** Dezhou Hospital Qilu Hospital of Shandong University
### Status Module
#### Completion Date
**Date:** 2024-03-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-10-10
**Type:** ACTUAL
#### Start Date
**Date:** 2023-03-23
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Dezhou Hospital Qilu Hospital of Shandong 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:** Each year, millions of burn, trauma, or surgical patients worldwide suffer from scarring that severely affects their quality of life and social functioning. In order to prevent and treat diseases related to abnormal scar hyperplasia, clinicians and researchers have adopted various methods, such as scar grinding, surgical resection, drug injection in scar tissue, cryotherapy, laser and so on. However, these methods can not effectively inhibit the abnormal proliferation of scars and improve the adverse effects of existing scars on patients. To date, there is no accepted gold standard for the effective treatment and improvement of abnormal scar tissue.
**Detailed Description:** Through a large number of literature review and preliminary experiments, we summarized and found the following problems: a. The latest research on prevention of scar formation by botulinum toxin type A is only aimed at surgical wounds from the wound type, and there is no research on the scar prevention effect of trauma wounds. b. From the point of view of the study site, there is no study on the effect of scar prevention only on the head, neck, chest and other parts of the body. c. For the research results of botulinum toxin type A in the prevention of scarring, the current research focuses on the effectiveness of botulinum toxin type A at a certain concentration, and does not compare the effects of botulinum toxin type A at various concentrations.Therefore, in order to explore the "optimal concentration" of botulinum toxin type A to prevent scar formation; To explore the effect of botulinum toxin A on scar prevention of traumatic wounds and surgical incisions. To explore the effect of botulinum toxin A on scar prevention in other parts of the body in addition to effective prevention of head, neck and chest scar, We intend to focus on the effectiveness and "optimal concentration" of botulinum toxin type A to prevent scarring, to determine the effect of this means on scar prevention, to provide new ideas for botul
### Conditions Module
**Conditions:**
- Scar
**Keywords:**
- scar prevention
- botulinum toxin type A
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 50
**Type:** ACTUAL
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Botulinum toxin type A (BTXA) was injected into both sides of the knife edge immediately after operation, the injection volume was 1U/0.1ml per point, the interval between the injection points on the same side of the knife edge was 1cm, and the distance of each injection point from the knife edge was 0.5cm. It was injected only once immediately after operation.
**Intervention Names:**
- Drug: Botulinum toxin type A
**Label:** Injection 1 U / 0.1ml BTXA
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Botulinum toxin type A (BTXA) was injected into both sides of the knife edge immediately after operation, the injection volume was 2.5U/0.1ml per point, the interval between the injection points on the same side of the knife edge was 1cm, and the distance of each injection point from the knife edge was 0.5cm. It was injected only once immediately after operation.
**Intervention Names:**
- Drug: Botulinum toxin type A
**Label:** Injection 2.5U / 0.1ml BTXA
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Botulinum toxin type A (BTXA) was injected into both sides of the knife edge immediately after operation, the injection volume was 5U/0.1ml per point, the interval between the injection points on the same side of the knife edge was 1cm, and the distance of each injection point from the knife edge was 0.5cm. It was injected only once immediately after operation.
**Intervention Names:**
- Drug: Botulinum toxin type A
**Label:** Injection 5U / 0.1ml BTXA
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Injection 0.9%Nacl Immediately after operation 0.9%Nacl was injected on both sides of the knife edge, the injection volume per point was 0.1ml, the interval between each injection point on the same side of the knife edge was 1cm, and each injection point was away from the knife edge 0.5cm. It was injected only once immediately after operation.
**Intervention Names:**
- Drug: Botulinum toxin type A
**Label:** Injection 0.9%Nacl
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Injection 0.9%Nacl
- Injection 1 U / 0.1ml BTXA
- Injection 2.5U / 0.1ml BTXA
- Injection 5U / 0.1ml BTXA
**Description:** Eligible patients were randomly assigned to the experimental group and the control group. Patients in the experimental group will be randomized to receive injections of 1 U,2.5 U, and 5 U botulinum toxin type A,Patients in the control group received an injection of 0.9% Nacl
**Name:** Botulinum toxin type A
**Other Names:**
- 0.9%Nacl
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The mSBSES included width (0 = scar enlargement prominent and \> 2 mm, 1 = presence of scar enlargement ≤ 2 mm, 2 = no scar widening), height (0 = marked scar uplift, 1 = presence of scar uplift, 2 = no scar uplift), color (0 = scar significantly redder than surrounding, 1 = scar redder than surrounding and 2 = scar the same color as or lighter than surrounding skin), The visibility of the incision line (0 = marked incision line, 1 = presence of incision line, 2 = absence of incision line) was objectively assessed separately in non-chronological order, with overall scar values varying from 0 to 8, with higher scores indicating better scar appearance.
**Measure:** The modified Stony Brook Scar Evaluation Scale
**Time Frame:** Postoperative 7 days, 15 days, 1 month, 3 months, 6 months
#### Secondary Outcomes
**Description:** Patient Satisfaction Scale (1=dissatisfied, 2=slightly satisfied, 3=satisfied, and 4=very satisfied). They were also asked to assess their levels of pain (0=no pain, 1=mild, 2=moderate, 3=severe, 4=very painful) and pruritus (0=no itch, 1=mild, 2=moderate, 3=severe, 4=very itchy) at the incision site. The totals varied between 0-8, where lower scores indicated more positive subjective patient perceptions.
**Measure:** Patient satisfaction and perceptions represented secondary outcome measures in this study
**Time Frame:** Postoperative 7 days, 15 days, 1 month, 3 months, 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Patients with emergency trauma and skin swellings, with clear consciousness, no mental retardation or cognitive difficulties, agree to participate in this study, 12≤ age ≤ 65 years old
Exclusion Criteria:
Allergic to botulinum toxin type A;Pregnant, lactating women, patients who plan to get pregnant in the near future;Patients taking retinoic acid, synthetic steroids, amino glycosides antibiotics, calcium channel blockers, cyclosporine and cholinesterase inhibitors; 4 Neuromuscular diseases: such as myasthenia gravis, Lambert-Eaton syndrome, multiple sclerosis;5. Patients with cardiovascular diseases, kidney diseases, liver and other basic diseases; 6 Patients with infection at the injection site; 7 Expect unrealistic patients.
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 12 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Dezhou
**Country:** China
**Facility:** Qilu Hospital of Shandong University Dezhou Hospital
**State:** Shandong
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005355
- Term: Fibrosis
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M6160
- Name: Cicatrix
- Relevance: HIGH
- As Found: Scar
- ID: M8485
- Name: Fibrosis
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002921
- Term: Cicatrix
### Intervention Browse Module - Ancestors
- ID: D000065087
- Term: Acetylcholine Release Inhibitors
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000018678
- Term: Cholinergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000009465
- Term: Neuromuscular Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: VaDiAg
- Name: Vasodilator Agents
### Intervention Browse Module - Browse Leaves
- ID: M5183
- Name: Botulinum Toxins
- Relevance: HIGH
- As Found: Evaluating
- ID: M21257
- Name: Botulinum Toxins, Type A
- Relevance: HIGH
- As Found: Weight loss
- ID: M250193
- Name: abobotulinumtoxinA
- Relevance: HIGH
- As Found: Weight loss
- ID: M3473
- Name: Acetylcholine
- 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: D000001905
- Term: Botulinum Toxins
- ID: D000019274
- Term: Botulinum Toxins, Type A
- ID: C000542869
- Term: abobotulinumtoxinA
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437899
**Acronym:** LA vs SA
**Brief Title:** Evaluation of Efficacy and Patient Satisfaction of Local Anaesthesia Versus Sedoanalgesia for Botox (R) Injection in the Urinary Bladder for the Treatment of Idiopathic Overactive Bladder
**Official Title:** Evaluation of Efficacy and Patient Satisfaction Using Local Anaesthesia Versus Sedoanalgesia for Intradetrusor Botulinum-Toxin A Injection for the Treatment of Idiopathic Overactive Bladder: a Randomized Controlled Non-inferiority Trial
#### Organization Study ID Info
**ID:** 21346
#### Organization
**Class:** OTHER
**Full Name:** Hospital LKH Hochsteiermark - Leoben
#### Secondary ID Infos
**Domain:** AUB - Arbeitsgemeinschaft für Urogynäkologie Österreich
**ID:** AUB
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2026-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-30
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospital LKH Hochsteiermark - Leoben
#### 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:** Patients with symptoms of overactive bladder suffer from frequent micturition, urinary incontinence and recurrent urinary tract infections. Intravesical injections with botulinum toxin A can be used as a second-line therapy for this purpose.
Intravesical botulinum toxin A injections can be performed under general anesthesia, regional anesthesia, sedoanalgesia and local anesthesia. Which form of anesthesia is used varies greatly from region to region.
As these patients are often elderly and morbid, the lowest-risk and least stressful anesthesia method should be used. The lowest-risk anesthesia method that can be used is local anesthesia. Currently, there are no guidelines that describe the use of standardized protocols for local anesthesia.
The aim of this study is to show that the use of local anesthesia in this context is not inferior to the use of sedoanalgesia.
All patients with overactive bladder symptoms who fulfill the inclusion criteria and present at the Urogynecology Outpatient Clinic of the Department of Gynecology and Obstetrics at the LKH Hochsteiermark in Leoben within 24 months will be invited to participate in the study.
The main outcome measure is pain, secondary outcome measures are quality of life, patient satisfaction, incontinence score, operation time and length of stay in the recovery room, acceptance of repeating the procedure under local anesthesia, satisfaction with the type of anesthesia method, side effects/complications and duration of inpatient stay.
The study will be randomized into 2 arms (local anesthesia/sedoanalgesia) with a 1:1 ratio to carry out the intravesical injection with botulinum toxin A.
**Detailed Description:** Urinary urgency symptoms with frequent micturition, urinary incontinence, nocturia and recurrent urinary tract infections are typical complaints of women with symptoms of an overactive bladder. The level of suffering is usually very high. Social withdrawal, depressive moods, frequent antibiotic use and financial burdens due to the increased need for incontinence products can be the result. In accordance with the guideline-based treatment of idiopathic overactive bladder, intravesical injection of botulinum toxin A can be offered after unsuccessful conservative first-line and second-line treatment. Intravesical injection of botulinum toxin A has been approved for the treatment of idiopathic overactive bladder in Austria since 2013. Botulinum toxin A is a registered drug in Austria and is used for injection into the detrusor with 100IE according to its approval indication.
Intravesical botulinum toxin A injections can be performed under general anesthesia, regional anesthesia, sedoanalgesia and local anesthesia. Which form of anesthesia is used varies greatly from region to region. The effectiveness of botulinum toxin A is limited in time. Injections are repeated on average after 6-12 months. Patients are often older and often have comorbidities. Due to this and the potential need for repeated applications, the procedure should be performed under general and regional anesthesia. The use of local anesthesia, as one of the anesthesia methods mentioned, is considered to be very low-risk and the least stressful overall.
Comparing the use of local anesthesia with the use of sedoanalgesia to perform the botulinum toxin A injection is equivalent to comparing two guideline-compliant standard treatments. The confirmation of our hypothesis, namely that performing the procedure under local anesthesia is equivalent to performing it under sedoanalgesia (non-inferiority study), could serve to optimize the treatment of overactive bladder patients and contribute to an increase in the level of health protection by strengthening the role of local anesthesia in the context of this procedure as an efficient option with the elimination of all anesthetic risks and as a first-choice procedure.
All patients with overactive bladder symptoms who fulfill the inclusion criteria and present at the Urogynecology Outpatient Clinic of the Department of Gynecology and Obstetrics at the LKH Hochsteiermark in Leoben within 24 months will be invited to participate in the study.
The following examinations are carried out on all patients before inclusion, in accordance with the examination standard of our department:
* Medical history: age, micturition frequency day/night, urinary leakage, sexuality, amount drunk, frequency of urinary tract infections, previous treatments for incontinence, parity, secondary diseases (diabetes mellitus, obesity, arterial hypertension, central nervous diseases, etc), previous gynecological operations, medication
* Urogynecological examination
* Urinalysis (midstream urine)
* Urodynamics with stress test
* Micturition protocol (will be scanned)
* Standardized questionnaires to assess incontinence symptoms and quality of life
This is an open prospective randomized controlled non-inferiority study. Patients participating in the study will be randomized into 2 arms (local anesthesia/sedoanalgesia) with a 1:1 ratio. Randomization will be done electronically (www.randomizer.at).
The sample design was calculated based on a non-inferiority study with pain score evaluation as the primary endpoint.
A sample size of 39 per group, including expected drop-outs (approximately 3 per group) results in a required number of participants of 84.
### Conditions Module
**Conditions:**
- Overactive Bladder
**Keywords:**
- overactive bladder
- botulinum toxin A
- local anaesthesia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 84
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: intravesical botulinum toxin A injection unter local anaesthesia
**Label:** local anaesthesia
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Drug: intravesical botulinum toxin A injection unter local anaesthesia
**Label:** sedoanalagesia
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- local anaesthesia
- sedoanalagesia
**Description:** Arm1: Botulinum toxin A injection under local anesthesia according to standard protocol:
Retrograde filling of the empty urinary bladder with a 1:1 mixture of 50 ml lidocaine 1% mixed with 50 ml sodium bicarbonate 8.4%, leave the local anesthetic mixture in the bladder for 15 minutes.
Transurethral, intravesical injection of a total of 100IE botulinum toxin A dissolved in 10 ml NaCl 0.9% into the detrusor at 10 points using a rigid 70 degree cystoscope
Arm 2: botulinum toxin A injection in sedoanalgesia according to the anesthesia standard protocol:
Intravenous administration of remifentanil (0.05-0.15µg/kg/min) and propofol. Transurethral, intravesical injection of a total of 100IE botulinum toxin A dissolved in 10ml NaCl 0.9% into the detrusor.
**Name:** intravesical botulinum toxin A injection unter local anaesthesia
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The numeric rating scale is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and ten meaning "the worst pain imaginable".
**Measure:** pain assessed by numeric rating scale
**Time Frame:** twentyfour hours
#### Secondary Outcomes
**Description:** The postoperative anaesthesia questionnaire is a tool used to assess a patient's experience with anesthesia following surgery. It aims to gather information about the patient's perceptions of anesthesia-related outcomes and any adverse effects they may have experienced. It collects direct feedback from patients about their subjective experiences, including satisfaction and any discomfort or complications. Common sections and questions are about preoperative information, intraoperative experience, postoperative symptoms and overall satisfaction. Questions are answered with "yes" or "no".
**Measure:** patient satisfaction assessed with postoperative anaesthesia questionnaire
**Time Frame:** twentyfour hours
**Description:** The King's Health Questionnaire is a disease specific, self-administered questionnaire designed to assess the impact of urinary incontinence on quality of life in women. The questions in this questionnaire are to be answered using a 0-4 scale, with zero meaning "not applicable" and four meaning "very accurate".
**Measure:** quality of life assessed with King's Health Questionnaire
**Time Frame:** three and twelve months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Women with a minimum age of 18 years; no maximum age
* Unsuccessful conservative first and second-line treatment of OAB (defined as: completed pelvic floor/bladder training, local estrogenization of the vagina, at least one anticholinergic or ß3-mimetic oral therapy)
* Good German language skills
Exclusion Criteria:
* Pregnant women, breastfeeding women (no indication for approval)
* Women unable to give informed consent
* Refusal to participate in the study
**Gender Based:** True
**Gender Description:** All individuals with anatomical organs of a woman
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Leoben
**Country:** Austria
**Facility:** LKH Hochsteiermark
**Zip:** 8700
### IPD Sharing Statement Module
**Description:** The important and interesting data are published in a journal as part of the publication.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Subramanian B, Shastri N, Aziz L, Gopinath R, Karlekar A, Mehta Y, Sharma A, Bapat JS, Jain P, Jayant A, Samra T, Perera A, Agarwal A, Shetty V, Bhatnagar S, Pandya ST, Jain P. ASSIST - Patient satisfaction survey in postoperative pain management from Indian subcontinent. J Anaesthesiol Clin Pharmacol. 2017 Jan-Mar;33(1):40-47. doi: 10.4103/joacp.JOACP_245_16.
**PMID:** 28413271
**Citation:** Smith I, Avramov MN, White PF. A comparison of propofol and remifentanil during monitored anesthesia care. J Clin Anesth. 1997 Mar;9(2):148-54. doi: 10.1016/S0952-8180(96)00240-1.
**PMID:** 9075041
**Citation:** Barba M, Lazar T, Cola A, Marino G, Manodoro S, Frigerio M. Learning Curve of Botulinum Toxin Bladder Injection for the Treatment of Refractory Overactive Bladder. Int J Womens Health. 2022 Jan 4;14:1-7. doi: 10.2147/IJWH.S345454. eCollection 2022.
**PMID:** 35018123
**Citation:** Schurch B, Reitz A, Tenti G. Electromotive drug administration of lidocaine to anesthetize the bladder before botulinum-A toxin injections into the detrusor. Spinal Cord. 2004 Jun;42(6):338-41. doi: 10.1038/sj.sc.3101593.
**PMID:** 15007374
**Citation:** Faure Walker N, Macpherson F, Tasleem A, Rampal T. Interventions to improve tolerability of local anesthetic intradetrusor Botulinum toxin injections: A systematic review. Neurourol Urodyn. 2023 Jan;42(1):23-32. doi: 10.1002/nau.25061. Epub 2022 Oct 23.
**PMID:** 36378811
**Citation:** Cox L, Cameron AP. OnabotulinumtoxinA for the treatment of overactive bladder. Res Rep Urol. 2014 Jul 21;6:79-89. doi: 10.2147/RRU.S43125. eCollection 2014.
**PMID:** 25157339
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001745
- Term: Urinary Bladder Diseases
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000059411
- Term: Lower Urinary Tract Symptoms
- 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
### Condition Browse Module - Browse Leaves
- ID: M27167
- Name: Urinary Bladder, Overactive
- Relevance: HIGH
- As Found: Overactive Bladder
- ID: M5026
- Name: Urinary Bladder 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
- ID: M29464
- Name: Lower Urinary Tract Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M22659
- Name: Urological Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000053201
- Term: Urinary Bladder, Overactive
### Intervention Browse Module - Ancestors
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000065087
- Term: Acetylcholine Release Inhibitors
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000018678
- Term: Cholinergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000009465
- Term: Neuromuscular Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
### Intervention Browse Module - Browse Branches
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: ChanBlk
- Name: Channel Blockers
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Analg
- Name: Analgesics
- Abbrev: VaDiAg
- Name: Vasodilator Agents
### Intervention Browse Module - Browse Leaves
- ID: M11014
- Name: Lidocaine
- Relevance: LOW
- As Found: Unknown
- ID: M1696
- Name: Remifentanil
- Relevance: LOW
- As Found: Unknown
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M5183
- Name: Botulinum Toxins
- Relevance: HIGH
- As Found: Evaluating
- ID: M21257
- Name: Botulinum Toxins, Type A
- Relevance: HIGH
- As Found: F-18
- ID: M250193
- Name: abobotulinumtoxinA
- Relevance: HIGH
- As Found: F-18
- ID: M18307
- Name: Propofol
- Relevance: LOW
- As Found: Unknown
- ID: M4109
- Name: Anesthetics, Local
- Relevance: LOW
- As Found: Unknown
- ID: M3473
- Name: Acetylcholine
- 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: D000001905
- Term: Botulinum Toxins
- ID: D000019274
- Term: Botulinum Toxins, Type A
- ID: C000542869
- Term: abobotulinumtoxinA
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437886
**Brief Title:** High-dose Opioid Versus Opioid-sparing Anaesthesia in Cardiac Surgery
**Official Title:** Postoperative Recovery After Cardiac Surgery A Randomised Controlled Trial of High-dose Opioid Versus Opioid-sparing Anaesthesia
#### Organization Study ID Info
**ID:** 2024-2323
#### Organization
**Class:** OTHER
**Full Name:** Chinese Academy of Medical Sciences, Fuwai Hospital
### Status Module
#### Completion Date
**Date:** 2024-07-22
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2024-07-22
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-22
**Type:** ACTUAL
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Chinese Academy of Medical Sciences, Fuwai Hospital
#### Responsible Party
**Investigator Affiliation:** Chinese Academy of Medical Sciences, Fuwai Hospital
**Investigator Full Name:** Yan Fuxia
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** BACKGROUND In cardiac surgery, high-dose opioids contributes to adverse events associated with poor postoperative outcomes. There is growing evidence that nerve block-based opioid-sparing protocols may reduce perioperative opioid consumption with equally analgesia management and consequently improve patient's postoperative recovery.
OBJECTIVE To determine whether opioid-sparing anaesthesia based on pecto-intercostal fascial block and rectus sheath block (PIFB and RSB) could improve early postoperative recovery after cardiac surgery.
DESIGN A randomised controlled trial. SETTING A tertiary hospital. PATIENTS Eighty 45-70 years old patients undergoing cardiac surgery were enrolled. Key exclusion criteria included extubation failure within 24 hours postoperatively, contraindication to interventions or drugs and a history of chronic pain or chronic opioid use.
INTERVENTIONS Eligible patients were randomised at a 1 : 1 ratio to receive either PIFB and RSB-based opioid-sapring anaesthesia (intervention group) or opioid-based anaesthesia (control group).
MAIN OUTCOME MEASURES The primary outcome was the global score of the 15-item Quality of Recovery (QoR-15) questionnaire at 24 h after surgery. Secondary outcomes included recovery-related time, postoperative pain score and rescue analgesia, health-related quality of life, the incidence of postoperative adeverse events and chronic pain.
### Conditions Module
**Conditions:**
- Cardiac Surgery Patients
### 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:** 80
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: pecto-intercostal fascial block and rectus sheath block
**Label:** pecto-intercostal fascial block and rectus sheath block-based opioid-sparing anesthesia
**Type:** EXPERIMENTAL
#### Arm Group 2
**Label:** high-dose opiod traditional anesthesia
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- pecto-intercostal fascial block and rectus sheath block-based opioid-sparing anesthesia
**Description:** Bilateral PIFB and RSB was conducted after anesthetic induction in a supine position guided by ultrasound guidance. PIFB was conducted at the T2 to T5 levels under ultrasound guidance. The needle was inserted into the pecto-interfacial plane using an in-plane approach. Needle tip location was verified by ventral movement of the parietal pleura upon injection of 1-2 ml 0.9% saline. Each side received 20 ml 0.3% ropivacaine containing 2.5 mg dexamethasone. Bilateral RSB was conducted after the PIFB and the needle was inserted into the plane between the rectus abdominal muscle and its posterior sheath using an in-plane approach. Needle tip location was verified by ventral movement of the parietal pleura upon injection of 1-2 ml 0.9% saline. After verifying needle placement, 15 ml 0.3% ropivacaine containing 2.5 mg dexamethasone was delivered to each side.
**Name:** pecto-intercostal fascial block and rectus sheath block
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** the global score of the 15-item Quality of Recovery (QoR-15) questionnaire
**Time Frame:** at 24 hours postoperatively
#### Secondary Outcomes
**Description:** Postoperatvie pain was evaluated using an 11-point visual analogue scale (VAS) (0 = no pain, 10 = worst pain possible).
**Measure:** QoR-15, postoperative pain assessment
**Time Frame:** QoR-15 at 72 hours, postoperative pain assessment at 24 hours and 72 hours.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Male or female adult patients aged 45 to 70 years, awaiting elective cardiac surgery, and American Society of Anaesthesiologists physical status classes II or III were eligible.
Exclusion Criteria:
Patients with severe pulmonary, liver or renal dysfunction, contraindications to punctral or local anesthetic drugs, and inablity to communicate or refuse to enrollment.
**Maximum Age:** 70 Years
**Minimum Age:** 45 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Beijing
**Country:** China
**Facility:** Fuwai hospital
### IPD Sharing Statement Module
**Description:** Data availuable by sending email to corresponding authors
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M7102
- Name: Dexamethasone
- Relevance: LOW
- As Found: Unknown
- ID: M235549
- Name: Dexamethasone acetate
- Relevance: LOW
- As Found: Unknown
- ID: M1700
- Name: Ropivacaine
- Relevance: LOW
- As Found: Unknown
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437873
**Brief Title:** Long-term Survival Outcomes of Total Thyroidectomy and Radioactive Iodine Therapy in Unilateral T3/T4 FTC
**Official Title:** Long-term Survival Outcomes of Total Thyroidectomy and Radioactive Iodine Therapy in Unilateral T3/T4 Follicular Thyroid Carcinoma:A Retrospective Propensity Score-Matched Study
#### Organization Study ID Info
**ID:** DezhouH_2024_001
#### Organization
**Class:** OTHER
**Full Name:** Dezhou Hospital Qilu Hospital of Shandong University
### Status Module
#### Completion Date
**Date:** 2024-05-25
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2020-12-31
**Type:** ACTUAL
#### Start Date
**Date:** 2000-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Dezhou Hospital Qilu Hospital of Shandong University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study aims to thoroughly examine survival disparities in patients with T3 or T4 stage follicular thyroid carcinoma (FTC) as classified by the AJCC staging system. It compares outcomes between those who underwent total thyroidectomy (TT) and those who did not, and assesses the influence of radioactive iodine therapy (RAIT) on the survival of patients without TT. Utilizing the SEER database, a retrospective study identified patients diagnosed with T3 or T4 FTC, categorizing them into two cohorts: those treated with TT and those who were not (No-TT). The No-TT group was further analyzed to determine the impact of RAIT on patient survival. Propensity score matching (PSM) was applied to adjust for confounding variables. Survival analysis, including Kaplan-Meier survival curves and Landmark analysis, was conducted to evaluate the effects of surgical intervention and RAIT on overall survival (OS) and cancer-specific survival (CSS).
### Conditions Module
**Conditions:**
- Follicular Thyroid Cancer
- SEER Database Analysis
**Keywords:**
- Retrospective analysis, follicular thyroid carcinoma, total thyroidectomy, long-term survival outcomes.
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 2957
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with T3 or T4 stage follicular thyroid carcinoma who underwent total thyroidectomy
**Intervention Names:**
- Procedure: Total Thyroidectomy (TT)
**Label:** Total Thyroidectomy (TT) Group
#### Arm Group 2
**Description:** Patients with T3 or T4 stage follicular thyroid carcinoma who did not undergo total thyroidectomy.
**Label:** No Total Thyroidectomy (No-TT) Group
#### Arm Group 3
**Description:** Patients in the No-TT group who received radioactive iodine therapy.
**Intervention Names:**
- Radiation: Radioactive iodine treatment(RAIT)
**Label:** Radioactive Iodine Therapy (RAIT) Group
#### Arm Group 4
**Description:** Patients in the No-TT group who did not receive radioactive iodine therapy.
**Label:** No Radioactive Iodine Therapy (No-RAIT) Group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Total Thyroidectomy (TT) Group
**Description:** TT:Surgical removal of the entire thyroid gland.
**Name:** Total Thyroidectomy (TT)
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Radioactive Iodine Therapy (RAIT) Group
**Description:** RAIT:Administration of radioactive iodine to eliminate remaining thyroid tissue or cancer cells.
**Name:** Radioactive iodine treatment(RAIT)
**Type:** RADIATION
### Outcomes Module
#### Primary Outcomes
**Description:** Time from diagnosis until death from any cause.
**Measure:** Overall Survival (OS)
**Time Frame:** Up to 10 years post-diagnosis
**Description:** Time from diagnosis to death specifically from follicular thyroid carcinoma.
**Measure:** Cancer-Specific Survival (CSS)
**Time Frame:** Up to 10 years post-diagnosis
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:1.The primary site code C73.9, denoting the thyroid gland;2.The International Classification of Diseases for Oncology, Third Edition (ICD-O-3) histology types comprising 8330 (Follicular adenocarcinoma, NOS), 8331 (Follicular adenocarcinoma well differentiated), 8332 (Follicular adenocarcinoma trabecular), 8335 (Follicular carcinoma, minimally invasive), and 8339 (Follicular thyroid carcinoma (FTC), encapsulated angioinvasive).
Exclusion Criteria:(1). Absence of T stage information or designation as T1, T2; (2). Missing surgery codes; (3). Cases not verified by histopathological analysis; (4). FTC not being the initial malignancy diagnosed in the patient; (5). Unknown survival duration or survival less than one month; (6). Presence of bilateral tumors.
**Healthy Volunteers:** True
**Maximum Age:** 85 Years
**Minimum Age:** 5 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** The SEER database was established in 1973, serves as a public database and research resource developed by the National Cancer Institute (NCI) of the United States. It encompasses data covering approximately 30% of the U.S. population. The dataset for this retrospective study was obtained from the SEER Research Data, encompassing information from 17 registries as of November 2022, which includes cases recorded between the years 2000 and 2020.
### Contacts Locations Module
#### Overall Officials
**Official 1:**
**Affiliation:** Qilu hospital of Shandong University Dezhou hospital
**Name:** Tao Zhang, MD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** Researchers seeking access to the IPD must submit a methodologically sound proposal. Requests should be directed to the principal investigator and will be evaluated on the basis of scientific merit and ethical considerations.
**Description:** De-identified individual participant data (IPD) will be shared with researchers upon reasonable request.
**Info Types:**
- STUDY_PROTOCOL
- SAP
**IPD Sharing:** YES
**Time Frame:** Data will be available beginning 6 months after publication of the main study results and will be accessible for a period of 5 years.
### References Module
#### References
**Citation:** Daniels GH. Follicular Thyroid Carcinoma: A Perspective. Thyroid. 2018 Oct;28(10):1229-1242. doi: 10.1089/thy.2018.0306. Epub 2018 Aug 21. No abstract available.
**PMID:** 30039751
**Citation:** Barbesino G, Goldfarb M, Parangi S, Yang J, Ross DS, Daniels GH. Thyroid lobe ablation with radioactive iodine as an alternative to completion thyroidectomy after hemithyroidectomy in patients with follicular thyroid carcinoma: long-term follow-up. Thyroid. 2012 Apr;22(4):369-76. doi: 10.1089/thy.2011.0198. Epub 2012 Mar 2.
**PMID:** 22385290
**Citation:** Bal C, Satapathy S, Tupalli A, Ballal S. Propensity Score Matched Outcome Analysis of Lobar Ablation Versus Completion Thyroidectomy in Low-Risk Differentiated Thyroid Cancer Patients: Median Follow-Up of 11 Years. Thyroid. 2022 Oct;32(10):1220-1228. doi: 10.1089/thy.2022.0234. Epub 2022 Sep 22.
**PMID:** 35983596
**Citation:** Choi JB, Lee SG, Kim MJ, Kim TH, Ban EJ, Lee CR, Lee J, Kang SW, Jeong JJ, Nam KH, Chung WY, Park CS. Oncologic outcomes in patients with 1-cm to 4-cm differentiated thyroid carcinoma according to extent of thyroidectomy. Head Neck. 2019 Jan;41(1):56-63. doi: 10.1002/hed.25356. Epub 2018 Dec 10.
**PMID:** 30536465
**Citation:** Sugino K, Nagahama M, Kitagawa W, Ohkuwa K, Uruno T, Matsuzu K, Suzuki A, Tomoda C, Hames KY, Akaishi J, Masaki C, Ito K. Risk Stratification of Pediatric Patients with Differentiated Thyroid Cancer: Is Total Thyroidectomy Necessary for Patients at Any Risk? Thyroid. 2020 Apr;30(4):548-556. doi: 10.1089/thy.2019.0231. Epub 2020 Mar 11.
**PMID:** 31910105
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004700
- Term: Endocrine System Diseases
- 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: All
- Name: All Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M16723
- Name: Thyroid Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M16718
- Name: Thyroid Diseases
- Relevance: HIGH
- As Found: Thyroid
- ID: M20409
- Name: Adenocarcinoma, Follicular
- Relevance: HIGH
- As Found: Follicular Thyroid Cancer
- ID: M3585
- Name: Adenocarcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- 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: T5650
- Name: Thyroid Cancer, Follicular
- Relevance: HIGH
- As Found: Follicular Thyroid Cancer
### Condition Browse Module - Meshes
- ID: D000018263
- Term: Adenocarcinoma, Follicular
- ID: D000013959
- Term: Thyroid Diseases
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M10488
- Name: Iodine
- Relevance: LOW
- As Found: Unknown
- ID: M229695
- Name: Cadexomer iodine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437860
**Brief Title:** Nutritional Intervention for Sustaining Health (NURISH) Trial
**Official Title:** Nutritional Intervention for Sustaining Health (NURISH) Trial: Examining the Effects of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) on Cognitive Performance, Metabolic Health, and Nutrient Status.
#### Organization Study ID Info
**ID:** NURISH
#### Organization
**Class:** OTHER
**Full Name:** University of Illinois at Urbana-Champaign
### Status Module
#### Completion Date
**Date:** 2027-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-03
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Illinois at Urbana-Champaign
#### Responsible Party
**Investigator Affiliation:** University of Illinois at Urbana-Champaign
**Investigator Full Name:** Naiman Khan
**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 goal of this clinical trial is to learn if increasing adherence to a Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet pattern improves brain and heart health relative to a healthy control diet in middle-aged adults.The main questions it aims to answer are:
Does the MIND diet improve cognitive performance and heart health relative to a control diet?
Researchers will compare the MIND diet group to a control (a healthy diet that does not match the MIND diet) to see if the MIND provides more benefit to health.
Participants will:
Consume one meal that follows the MIND diet or a control meal every day for 3 months Visit the lab before and after the 3 months of meals for tests. Keep a record of the food they eat during the study.
**Detailed Description:** The purpose of this study is to understand how a healthy diet is related to thinking ability and heart health. Participants will be asked to consume a microwaveable study meal or prepackaged smoothie every day for 12 weeks. These meals will be delivered to participant homes using Daily Harvest meal delivery service. The study meals and smoothies will follow either a dietary pattern thought to improve brain and heart health (MIND), or a control diet, and will include foods commonly found in grocery stores. Participants will not know which diet they are assigned to (active or control). Participants will also be asked to follow simple dietary guidance on a healthy diet in addition to the meals provided. Participants will complete a series of online forms or surveys. Additionally, participants will come to 4 in-person laboratory visits to complete several computer-based tests of memory and attention while wearing an EEG cap. Participants will also be asked to complete an eye test, a heart rate and blood pressure assessment, a bone and body scan called DXA, and a blood draw at the beginning of the study and again at the end of the 12-week diet period.
### Conditions Module
**Conditions:**
- Cognitive Change
- Metabolic Syndrome, Protection Against
- Diet, Healthy
**Keywords:**
- Executive function
- MIND
- Dietary pattern
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 72
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in the active MIND diet group will be asked to consume one ready-to-eat meal per day from Daily Harvest® meal delivery service. The treatment meals will follow MIND diet guidelines and include leafy green vegetables, nuts, legumes, whole grains, berries, and extra virgin olive oil.
**Intervention Names:**
- Other: MIND Diet
**Label:** MIND Diet
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants in the control diet group will be asked to consume one ready-to-eat meal per day from Daily Harvest® meal delivery service. The Control group will receive daily meals that are isocaloric with the active/experimental meals but will follow a general diet based on the average American diet and Dietary Guidelines for Americans (i.e., vegetables, fruits, nuts, whole grains, and unsaturated fats).
**Intervention Names:**
- Other: Control Diet
**Label:** Control Diet
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MIND Diet
**Description:** Daily meals designed to increase adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) dietary pattern.
**Name:** MIND Diet
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Control Diet
**Description:** Daily meals designed to increase fruit, vegetable, and whole grain intake consistent with a healthy American diet.
**Name:** Control Diet
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Changes in accuracy (%) between groups using a computerized flanker task.
**Measure:** Attentional Accuracy
**Time Frame:** 12 weeks (Baseline vs Follow-Up)
**Description:** Changes in reaction time (ms) between groups using a computerized flanker task.
**Measure:** Attentional Reaction Time
**Time Frame:** 12 weeks (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:** 12 weeks (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:** 12 weeks (Baseline vs Follow-Up)
**Description:** Changes in fasting blood glucose concentration (mg/dL) between groups.
**Measure:** Fasting Blood Glucose
**Time Frame:** 12 weeks (Baseline vs Follow-Up)
**Description:** Changes in fasting blood triglyceride concentration (mg/dL) between groups.
**Measure:** Fasting Blood Triglycerides
**Time Frame:** 12 weeks (Baseline vs Follow-Up)
**Description:** Changes in fasting blood HDL concentration (mg/dL) between groups.
**Measure:** Fasting Blood HDL
**Time Frame:** 12 weeks (Baseline vs Follow-Up)
**Description:** Changes in systolic and diastolic blood pressure (mmHg) between groups.
**Measure:** Blood Pressure
**Time Frame:** 12 weeks (Baseline vs Follow-Up)
**Description:** Changes in waist circumference (cm) between groups.
**Measure:** Waist Circumference
**Time Frame:** 12 weeks (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:** 12 weeks (Baseline vs Follow-Up)
**Description:** Changes in visceral adipose tissue (g) between groups using Dual X-ray Absorptiometry.
**Measure:** Visceral Adipose Tissue
**Time Frame:** 12 weeks (Baseline vs Follow-Up)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 45-64 years of age
* 20/20 or corrected vision
* No food allergies or intolerances
* Not pregnant, lactating, or have given birth in the past 12 months
* Do not smoke, use tobacco, or abuse drugs
* Absence of liver or gastrointestinal diseases (i.e., primary biliary cirrhosis or gallbladder disease, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers), hepatitis, HIV, and cancer
* Not currently taking oral hypoglycemic agents, or insulin
* No history of malabsorptive or bariatric surgery
* Cognitively intact with no prior diagnosis of neurological disease (i.e., mild cognitive impairment, Alzheimer's disease, vascular dementia, and/or Asperger's syndrome)
* Able to consume the study meals
* Not enrolled in another dietary, exercise, or medication study during the study
Exclusion Criteria:
* Non-consent of participant
* Above 64 or below 45 years of age
* Vision not 20/20 or corrected
* Food allergies or intolerances
* Pregnant, lactating, or have given birth in the past 12 months
* Smoke, use tobacco, or abuse drugs
* Prior diagnosis of liver or gastrointestinal disease (i.e., primary biliary cirrhosis or gallbladder disease, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers), hepatitis, HIV, or cancer
* Currently taking oral hypoglycemic agents or insulin
* History of malabsorptive or bariatric surgery
* Cognitively impaired and/or prior diagnosis of neurological disease (i.e., mild cognitive impairment, Alzheimer's disease, vascular dementia, and/or Asperger's syndrome)
* Unable to consume the study meals
* Concurrent enrollment in another dietary, exercise, or medication study
**Healthy Volunteers:** True
**Maximum Age:** 64 Years
**Minimum Age:** 45 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Naiman Khan, PhD
**Phone:** 217 300 1667
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Illinois Urbana-Champaign
**Name:** Naiman Khan, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007333
- Term: Insulin Resistance
- ID: D000006946
- Term: Hyperinsulinism
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M23005
- Name: Metabolic Syndrome
- Relevance: HIGH
- As Found: Metabolic Syndrome
- ID: M10370
- Name: Insulin Resistance
- Relevance: LOW
- As Found: Unknown
- ID: M9997
- Name: Hyperinsulinism
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000024821
- Term: Metabolic Syndrome
### Intervention Browse Module - Browse Branches
- Abbrev: HB
- Name: Herbal and Botanical
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T242
- Name: Olive
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437847
**Brief Title:** Assessment of the Need to Use Short Cognitive Tests for French General Practitioners/Family Doctors
**Official Title:** Assessment of the Need to Use Short Cognitive Tests for French General Practitioners/Family Doctors
#### Organization Study ID Info
**ID:** IRBN632024/CHUSTE
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de Saint Etienne
### Status Module
#### Completion Date
**Date:** 2024-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Centre Hospitalier Universitaire de Saint Etienne
#### 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 prevalence of cognitive disorders is constantly increasing, with 1.2 million patients affected in France in 2016. Dementia is currently the seventh leading cause of death. In the absence of available treatment, systematic screening is not recommended. However, cognitive evaluation is recommended to maintain a level of autonomy for the patient at home. Targeted screening is the responsibility of the general practitioner. The latest recommendations from the HAS (2011) highlight the use of the MMSE as a first-line approach, there are no recommendations regarding short tests. Early cognitive assessment is limited by the time required to perform the tests and the knowledge about the available tools. The Codex is a short test, its sensitivity (92%) and specificity (85%) place it among the most discriminatory scores. It is underutilized in France. The objective of this thesis is to assess the training needs of general practitioners in short tests.
### Conditions Module
**Conditions:**
- Cognitive Disorder
**Keywords:**
- Cognitive evaluation
- Short Test
- General Practitioners
- Codex, Training
- Formation
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Questionnaire assessing the use of cognitive tests.
**Name:** Questionnaire
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Assessment of the need to use short cognitive tests
**Measure:** Quantitative questionnaire 1
**Time Frame:** Month : 1, 3, 6
#### Secondary Outcomes
**Description:** Assessment of the expectation regarding a project of training general practitioners to use the Codex tool (Sum = 4 or 5: = CODEX normal ; Sum = 0, 1, 2 or 3 = CODEX abnormal)
**Measure:** Quantitative questionnaire 2
**Time Frame:** Month : 1, 3, 6
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* General practitioners of the AURA Region, in activity, university supervisor or not, trained or not trained in geriatrics.
Exclusion Criteria:
* General practitioners with exclusive practices in pediatrics, gynecology, aesthetics, rehabilitation, and homeopathy.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** General practitioners of the AURA Region will be included.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Angèle FOURNIER, resident
**Phone:** (0)6.95.37.34.22
**Phone Ext:** +33
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Saint-Étienne
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Angèle FOURNIER, resident
- **Role:** CONTACT
***Contact 2:***
- **Name:** Angèle FOURNIER, resident
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Antonin ZOUBIAN, MD
- **Role:** SUB_INVESTIGATOR
**Country:** France
**Facility:** Chu de Saint-Etienne
**Zip:** 42055
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000019965
- Term: Neurocognitive 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: M6301
- Name: Cognition Disorders
- Relevance: HIGH
- As Found: Cognitive Disorders
- ID: M29705
- Name: Cognitive Dysfunction
- Relevance: HIGH
- As Found: Cognitive Disorders
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000060825
- Term: Cognitive Dysfunction
- ID: D000003072
- Term: Cognition Disorders
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437834
**Brief Title:** Increasing Men's Engagement in Preventive Healthcare Through an Enhanced Cocoon Vaccination Strategy
**Official Title:** Increasing Men's Engagement in Preventive Healthcare Through an Enhanced Cocoon Vaccination Strategy
#### Organization Study ID Info
**ID:** STUDY20240200
#### Organization
**Class:** OTHER
**Full Name:** University Hospitals Cleveland Medical Center
### Status Module
#### Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Randy Vince, MD
#### Responsible Party
**Investigator Affiliation:** University Hospitals Cleveland Medical Center
**Investigator Full Name:** Randy Vince, MD
**Investigator Title:** Physician
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to understand if offering a high touch engagement with healthcare center catered to men and bedside vaccine access in a birthing center increases men's engagement in preventive healthcare. The main questions it aims to answer are:
Does access to vaccinations and overall health education for men lead to increased uptake of vaccines? Does access to vaccinations and overall health education for men lead to increased engagement in overall healthcare of male identifying support persons.
Researchers will compare three arms (one that receives information only, one that receives information and an offer of vaccines at bedside, and one that receives higher level of engagement from patient liaisons as well as the offer of vaccines at bedside) to see if there is a difference in vaccine uptake and engagement in healthcare
Participants will complete two survey and one interview.
**Detailed Description:** The goal of this project is to understand whether the combination of vaccination access and connection to services tailored for men improves vaccination rates among men and engagement in healthcare. Additionally, this project aims to understand variations in effectiveness between low-touch and high-touch approaches. To achieve these goals, the project has two specific aims:
Aim 1: Assess the effectiveness of cocoon vaccination interventions on a continuum of minimum to high-touch in terms of vaccination completion and healthcare engagement. After refinement of the intervention materials and study materials based on engagement with community members, representatives of the priority population, interested parties including birthing parents, the initiative will roll out in three randomly timed clusters, one that includes low-touch information only, another that includes bedside vaccinations in addition to the low-touch information, and a third that includes bedside vaccinations and high-touch connection to the UH Cutler Center for Men through the Joe Team. Male-identifying individuals will be recruited and enrolled to complete two surveys, one at baseline and another four weeks after enrollment) to assess vaccination completion and healthcare engagement.
Aim 2: Examine the factors that impact uptake of vaccination and healthcare engagement after a cocoon vaccination intervention. Factors that impact intervention uptake will be assessed through the two surveys and semi-structured interviews with a subsample of survey participants. Additionally, contextual factors related to the implementation of the intervention, such as hours of operation for high touch connections/vaccine distribution will be assessed. By understanding the factors that impact intervention uptake, we will assess the barriers and facilitators of this strategy.
Hypothesis. This pilot study will examine whether implementing a cocoon vaccination strategy that provides access to vaccinations and overall health education for men leads to increased uptake of vaccines and engagement in overall healthcare of male identifying support persons. Additionally, it will assess the factors that impact intervention uptake. We anticipate that vaccination rates and engagement with healthcare will be highest among male visitors at the Ahuja Medical Center who receive the vaccination offer at bedside and the high-touch healthcare navigation information relative to those who are only offered information on health care or those who are offered bedside vaccines and information.
### Conditions Module
**Conditions:**
- Vaccines
- Preventive Medicine
**Keywords:**
- cocoon vaccination
- men's health
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 450
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** all male-identifying visitors in the birthing center will receive an information sheet about the importance of vaccinations and preventive healthcare for men.
**Intervention Names:**
- Other: Information Sheet
**Label:** Information-Only
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** all male-identifying visitors in the birthing center at the birthing center will receive the information sheet about vaccinations and preventive healthcare, and the offer of influenza and Tdap vaccinations at bedside in the birthing center.
**Intervention Names:**
- Other: Information Sheet
- Drug: Vaccines
**Label:** Bedside Vaccines plus Information
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** all male-identifying visitors in the birthing center will receive the information sheet, the offer to receive influenza and Tdap vaccinations at bedside in the birthing center, as well as a high-touch connection to healthcare navigation supports.
**Intervention Names:**
- Other: Information Sheet
- Other: High-touch connect
- Drug: Vaccines
**Label:** Bedside Vaccines plus High-touch connection
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Bedside Vaccines plus High-touch connection
- Bedside Vaccines plus Information
- Information-Only
**Description:** Information sheet describing the importance of vaccines and preventive care as well as contact information for patient navigators.
**Name:** Information Sheet
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Bedside Vaccines plus High-touch connection
**Description:** Engagement with a patient navigator.
**Name:** High-touch connect
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Bedside Vaccines plus High-touch connection
- Bedside Vaccines plus Information
**Description:** Offer of receiving TDap and Influenza vaccine
**Name:** Vaccines
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Self-report of receipt of Influenza vaccine
**Measure:** Number of participants who received Influenza Vaccine
**Time Frame:** One-month post consent
#### Secondary Outcomes
**Description:** Self-report of receipt of TDap vaccine
**Measure:** Number of participants who received TDap Vaccine
**Time Frame:** One-month post consent
**Description:** Self-report of enrollment in Men's Health Center that includes patient navigation
**Measure:** Number of participant who enrolled in Patient Navigation
**Time Frame:** One-month post consent
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
- Adult Partner of birthing person at a birthing center who identifies as male-identifying
Exclusion Criteria:
-Under the age of 18; does not identify as a man.
**Gender Based:** True
**Gender Description:** Identifies as Male
**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:** Sarah Koopman Gonzalez, PhD
**Phone:** 216-368-5755
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University Hospitals Cleveland Medical Center
**Name:** Randy Vince, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### 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: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437821
**Brief Title:** Comparative Effect of Graston Technique and Petrissage Technique on Tight Trapezius Muscles in Young Adults
**Official Title:** Comparative Effect of Graston Technique and Petrissage Technique on Tight Trapezius Muscles in Young Adults
#### Organization Study ID Info
**ID:** MSRSW/Batch-Fall22/717
#### Organization
**Class:** OTHER
**Full Name:** Superior University
### Status Module
#### Completion Date
**Date:** 2024-10-29
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-05-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-11-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Superior University
#### Responsible Party
**Investigator Affiliation:** Superior University
**Investigator Full Name:** Muhammad Naveed Babur
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This research aims to contribute valuable insights into the potential benefits of incorporating the portable wedge device into preventive or therapeutic interventions for calf-related musculoskeletal issues. By combining economical, ergonomic principles and user-friendly features, the proposed device offers individuals a convenient and efficient means to enhance their calf flexibility, ultimately mitigating strain and reducing spasms.
**Detailed Description:** Developing and successfully integrating a portable wedge device could mark a significant breakthrough in preventive and rehabilitative care for musculoskeletal problems associated with the calf region. This innovative device can enhance the overall well-being and musculoskeletal health of individuals suffering from such issues, providing a more effective and convenient treatment solution.
### Conditions Module
**Conditions:**
- Trapezius Muscle Strain
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 46
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Diagnostic Test: Petrissage
**Label:** Petrissage
**Type:** OTHER
#### Arm Group 2
**Intervention Names:**
- Other: Graston Technique
**Label:** Graston Technique
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Petrissage
**Description:** The calf muscles will receive a firm, deep-circulation massage with fingertip pressure
**Name:** Petrissage
**Type:** DIAGNOSTIC_TEST
#### Intervention 2
**Arm Group Labels:**
- Graston Technique
**Description:** The calf muscles will receive a firm, deep-circulation massage with fingertip pressure
**Name:** Graston Technique
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** A pain scale is a method used to quantify the level of discomfort a person is experiencing. It assesses a person's level of pain intensity on a scale from 0 to 10. The scale rates a person's level of discomfort at a particular moment and goes from '0', indicating no pain, to '10,' representing the worst pain imaginable. This simple yet efficient method is widely used to help healthcare professionals evaluate and treat pain.
**Measure:** Numeric Pain Rating Scale (NPRS)
**Time Frame:** 12 Months
**Description:** To evaluate a patient's functional status, ten questions are asked about their condition, including pain, personal care, lifting, reading, headaches, focus, job, driving, sleeping, and recreation. Each category is scored from 0 to 5, where 0 indicates "No pain" and 5 indicates "Worst imaginable pain." The score can be multiplied by two to get a percentage score, with a maximum score of fifty.
**Measure:** Neck disability index (NDI)
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male and female patients diagnosed with Trapezius tightness
* Age above 18-30
* Presence of active trigger points in the upper trapezius muscle
* Participants who are volunteer for the study
* Patients who suffer from shoulder pain and stiffness due to bad posture
Exclusion Criteria:
* History of whiplash injury
* History of head, neck, cervical spine or shoulder surgery
* History of cervical radiculopathy
* Diagnosed fibromyalgia and myopathy
* History of cancer
* Pregnancy Myofascial therapy within the past month
* Contraindication of dry needling and instrument-assisted soft tissue mobilization technique
**Maximum Age:** 30 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Lahore
**Country:** Pakistan
**Facility:** Faqraj Sharif Hospital (Trust) Physiotherapy and Orthopedic Department and Orian ABA Pakistan (Physiotherapy Department)
**State:** Punjab
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437808
**Brief Title:** Optimizing Football Training: Integrating Portable Force Plates for Advanced Performance Analysis
**Official Title:** Optimizing Football Training at Multan Sports Complex: Integrating Portable Force Plates for Advanced Performance Analysis
#### Organization Study ID Info
**ID:** MSRSW/Batch-Fall22/716
#### Organization
**Class:** OTHER
**Full Name:** Superior University
### Status Module
#### Completion Date
**Date:** 2024-09-29
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-05-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-10-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Superior University
#### Responsible Party
**Investigator Affiliation:** Superior University
**Investigator Full Name:** Muhammad Naveed Babur
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Optimizing Football Training at Multan Sports Complex: Integrating Portable Force Plates for Advanced Performance Analysis," aims to enhance football training through innovative technology. Under the supervision of Dr. Junaid Gondal, this MS Rehabilitation Science project explores the use of portable force plates to provide real-time data on players' biomechanics, enabling personalized training programs that improve performance and reduce injury risks.
**Detailed Description:** The research adopts a randomized control trial design, involving 30 male football players aged 18-35. Participants are divided into intervention and control groups, with the former using portable force plates during training. Data analysis will be conducted using IBM SPSS. This study underscores the significance of advanced performance analysis in football training, advocating for the integration of cutting-edge technology to refine training methods and enhance athletic performance at the Multan Sports Complex.
### Conditions Module
**Conditions:**
- Injury;Sports
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 30
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Combination Product: Training with Portable Force Plates Integration
**Label:** Training with Portable Force Plates Integration
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Other: Standard Training
**Label:** Standard Training
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Training with Portable Force Plates Integration
**Description:** This group will undergo football training sessions that incorporate the use of portable force plates. These devices will measure ground reaction forces and provide real-time data on players' movements, balance, and pressure points. The data collected will be used to create personalized training programs aimed at optimizing performance and reducing the risk of injuries.
**Name:** Training with Portable Force Plates Integration
**Type:** COMBINATION_PRODUCT
#### Intervention 2
**Arm Group Labels:**
- Standard Training
**Description:** This group will continue with the existing football training regimen without the use of portable force plates. Training will follow the traditional methods used at the Multan Sports Complex, focusing on physical conditioning, technical skills, and tactical awareness without the advanced biomechanical analysis provided by the force plates.
**Name:** Standard Training
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Rate of perceived exertion (RPE) is used to measure how hard your body works during physical activity. It runs from 0 - 10, using numbers to rate how much effort an activity takes
**Measure:** RPE Scale
**Time Frame:** 12 Months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male football players at Multan Sports Complex
* aged 18-35
* willing to consent.
Exclusion Criteria:
* Female players
* unregistered players
* those with unstable medical conditions.
**Healthy Volunteers:** True
**Maximum Age:** 35 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Multān
**Country:** Pakistan
**Facility:** Multan Sports Complex
**State:** Punjab
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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: M4570
- Name: Athletic Injuries
- Relevance: HIGH
- As Found: Injury;Sports
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001265
- Term: Athletic Injuries
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437795
**Brief Title:** Effectiveness of Dry Needling Versus Cupping Therapy for Pain in Piriformis Syndrome
**Official Title:** Effectiveness of Dry Needling Versus Cupping Therapy for Pain in Piriformis Syndrome
#### Organization Study ID Info
**ID:** MSRSW/Batch-Fall22/715
#### Organization
**Class:** OTHER
**Full Name:** Superior University
### Status Module
#### Completion Date
**Date:** 2024-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-05-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-11-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Superior University
#### Responsible Party
**Investigator Affiliation:** Superior University
**Investigator Full Name:** Muhammad Naveed Babur
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study aims to compare the effectiveness of two popular therapeutic interventions, dry needling and cupping therapy, in alleviating pain associated with Piriformis Syndrome. Piriformis Syndrome is a neuromuscular disorder caused by the compression or irritation of the sciatic nerve by the piriformis muscle, leading to buttock pain and radiating numbness.
**Detailed Description:** The study will recruit participants diagnosed with Piriformis Syndrome and will randomly assign them to receive either dry needling or cupping therapy over a specific period. The primary outcome will be the reduction in pain intensity measured by standardized pain assessment tools. Secondary outcomes will include improvements in functional mobility and quality of life. By analyzing the efficacy and patient-reported outcomes of both therapies, the study aims to provide evidence-based recommendations for clinicians treating Piriformis Syndrome.
### Conditions Module
**Conditions:**
- Piriformis Syndrome
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 80
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Diagnostic Test: Dry Needling Group
**Label:** Dry Needling Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Other: Cupping Therapy Group
**Label:** Cupping Therapy Group
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dry Needling Group
**Description:** Participants in this group will receive dry needling therapy. This involves inserting thin needles into trigger points in the piriformis muscle to relieve pain and muscle tension. The therapy will be administered twice a week for 4 weeks, with each session lasting approximately 30 minutes.
**Name:** Dry Needling Group
**Type:** DIAGNOSTIC_TEST
#### Intervention 2
**Arm Group Labels:**
- Cupping Therapy Group
**Description:** Participants in this group will receive cupping therapy. This involves placing cups on the skin to create suction, which is believed to improve blood flow and reduce muscle tension. The therapy will be administered twice a week for 4 weeks, with each session lasting approximately 30 minutes.
**Name:** Cupping Therapy Group
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Participants will rate their pain on a scale from 0 (no pain) to 10 (worst possible pain) at the beginning and end of the study.
**Measure:** Visual Analog Scale (VAS)
**Time Frame:** 12 Months
**Description:** This tool assesses the degree of disability in performing daily activities. Quality of life improvements measured by the SF-36 Health Survey, which evaluates physical and mental health status.
**Measure:** Oswestry Disability Index (ODI)
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults aged between 18 to 65 years.
* Diagnosed with piriformis syndrome.
* Experiencing chronic pain for at least 3 months.
* Willingness to comply with the study protocol and attend all therapy sessions.
Exclusion Criteria:
* Recent surgery on the lower back or hip.
* Presence of systemic diseases affecting muscle function (e.g., multiple sclerosis, rheumatoid arthritis).
* Pregnant or breastfeeding women.
* Use of anticoagulant medication or having a bleeding disorder.
* Participating in another clinical trial simultaneously
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Lahore
**Country:** Pakistan
**Facility:** Ghurkee Hospital
**State:** Punjab
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020426
- Term: Sciatic Neuropathy
- ID: D000020422
- Term: Mononeuropathies
- ID: D000010523
- Term: Peripheral Nervous System Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000009408
- Term: Nerve Compression Syndromes
- ID: D000009437
- Term: Neuralgia
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000017699
- Term: Pelvic Pain
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M28404
- Name: Piriformis Muscle Syndrome
- Relevance: HIGH
- As Found: Piriformis Syndrome
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M22222
- Name: Sciatic Neuropathy
- Relevance: LOW
- As Found: Unknown
- ID: M22218
- Name: Mononeuropathies
- Relevance: LOW
- As Found: Unknown
- ID: M13432
- Name: Peripheral Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12352
- Name: Nerve Compression Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M5853
- Name: Charcot-Marie-Tooth Disease
- Relevance: LOW
- As Found: Unknown
- ID: M18092
- Name: Hereditary Sensory and Motor Neuropathy
- Relevance: LOW
- As Found: Unknown
- ID: M12381
- Name: Neuralgia
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M19918
- Name: Pelvic Pain
- Relevance: LOW
- As Found: Unknown
- ID: T4568
- Name: Piriformis Syndrome
- Relevance: HIGH
- As Found: Piriformis Syndrome
- ID: T1081
- Name: Charcot-Marie-Tooth Disease
- Relevance: LOW
- As Found: Unknown
- ID: T2761
- Name: Hereditary Motor and Sensory Neuropathy
- Relevance: LOW
- As Found: Unknown
- ID: T2766
- Name: Hereditary Neuropathy With Liability to Pressure Palsies
- Relevance: LOW
- As Found: Unknown
- ID: T5067
- Name: Roussy Levy Syndrome
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000055958
- Term: Piriformis Muscle Syndrome
- ID: D000013577
- Term: Syndrome
### Intervention Browse Module - Browse Branches
- Abbrev: Antipy
- Name: Antipyretics
- Abbrev: Analg
- Name: Analgesics
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M2340
- Name: Acetaminophen
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437782
**Acronym:** HLQ-Diabete
**Brief Title:** Exploration of Health Literacy in Diabetes in Reunion Island and France
**Official Title:** Exploration of Health Literacy in Diabetes in Reunion Island and Metropolitan France
#### Organization Study ID Info
**ID:** 2017/CHU/13
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de la Réunion
### Status Module
#### Completion Date
**Date:** 2025-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Centre Hospitalier Universitaire de la Réunion
#### 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 goal of this observational study is to identify the health literacy profile of diabetic patients in Reunion Island and France in order to obtain information to improve access to information, therapeutic education and to health service. The main question\[s\] it aims to answer \[is/are\]:
Participants will complete the Health Literacy Questionnaire (HLQ) once.
### Conditions Module
**Conditions:**
- Diabetes type1
- Diabetes Type 2
- Diabetes, Gestational
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 1350
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: Questionnaire completion
**Label:** type 1 diabetes closed loop
#### Arm Group 2
**Intervention Names:**
- Other: Questionnaire completion
**Label:** type 2 diabetes
#### Arm Group 3
**Intervention Names:**
- Other: Questionnaire completion
**Label:** Gestational diabetes
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Gestational diabetes
- type 1 diabetes closed loop
- type 2 diabetes
**Description:** HLQ (Health Literacy questionnaire) will be completed by all included patients once.
**Name:** Questionnaire completion
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** HLQ (Health literacy questionnaire) is completed once. The algorithm produces unweighted scores for each of the 9 scales of the HLQ. The final score for each scale is an average score across all the questions that form that scale. The HLQ does not provide one overall summative score; rather it gives you nine separate scores that indicate a person's strengths and needs in relation to their health literacy.
**Measure:** Health literacy profiles in Reunion Island
**Time Frame:** at inclusion
#### Secondary Outcomes
**Description:** HLQ (Health literacy questionnaire) is completed once. Health literacy profile in patients treated on Reunion Island et France will be described.
The algorithm produces unweighted scores for each of the 9 scales of the HLQ. The final score for each scale is an average score across all the questions that form that scale. The HLQ does not provide one overall summative score; rather it gives you nine separate scores that indicate a person's strengths and needs in relation to their health literacy.
**Measure:** Health literacy profiles in Reunion Island and France
**Time Frame:** at inclusion
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Patient with type 1, 2 or gestational diabetes taken care in hospital
Exclusion Criteria:
* Patient unable to understand and respect study procedures
* Patient with cognitive disorder
* Patient with serious acute complication due to diabetes within 15 days before inclusion
* Stroke history with neurologic consequences
* Other specific types of diabetes : chronic calcific pancreatitis, iatrogenic, other secondary diabetes, rare monogenic or genetic diabetes due to insulin resistance
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients with type 1 diabetes (strict insulin dependence, or anti-GAD, anti-IA2, and/or anti-ZnT8 + antibodies) with a hybrid closed-loop insulin therapy system for at least 3 months , diabetes of type 2 (non-insulin-dependent or insulin-requiring, with negative anti-GAD, anti-IA2, and/or anti-ZnT8 Ab if diabetes has been diagnosed for less than 5 years at the time of insulin therapy), or diabetes during pregnancy: gestational diabetes (diabetes diagnosed during pregnancy according to the diagnostic criteria of French recommendations), or pre-existing diabetes (known or not) with pregnancy.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Anna FLAUS
**Phone:** +262262905610
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Xavier DEBUSSCHE
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Saint-Denis
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Anna FLAUS
- **Role:** CONTACT
***Contact 2:***
- **Name:** Anna FLAUS, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Réunion
**Facility:** CHU de La Réunion
**Zip:** 97400
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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
- 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: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- 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: M19012
- Name: Diabetes, Gestational
- Relevance: HIGH
- As Found: Diabetes, Gestational
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes
- ID: M7119
- Name: Diabetes Mellitus, Type 2
- Relevance: HIGH
- As Found: Diabetes Type 2
- ID: M7117
- Name: Diabetes Mellitus, Type 1
- Relevance: HIGH
- As Found: Diabetes Type 1
- 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
- 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
- ID: D000003924
- Term: Diabetes Mellitus, Type 2
- ID: D000003922
- Term: Diabetes Mellitus, Type 1
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437769
**Brief Title:** The Effect of Reiki on Cesarean During Hospitalization
**Official Title:** The Effect of Reiki Applied to Women Who Have Been Hospitalized by Cesarean During the Hospitalization Process on Anxiety, Depression, Comfort and Breastfeeding
#### Organization Study ID Info
**ID:** 2024/236
#### Organization
**Class:** OTHER
**Full Name:** Ondokuz Mayıs University
### Status Module
#### Completion Date
**Date:** 2024-08-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-03
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ondokuz Mayıs University
#### Responsible Party
**Investigator Affiliation:** Ondokuz Mayıs University
**Investigator Full Name:** Sümeyye BAL
**Investigator Title:** Director
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** To determine the effect of reiki applied to women who have been hospitalized by cesarean during the hospitalization process on anxiety, depression, comfort and breastfeeding
Method: The study will be completed in a randomized controlled manner with a total of 60 women, 30 in the experimental group and 30 in the control group. Women in the experimental group Reiki therapy will be applied to the participants for 30 minutes while they lie down with their eyes closed. Research data will be collected with the Comfort Scale, Hospital anxiety and depression scale and bristol breastfeeding points and will be recorded
**Detailed Description:** Design and Settings: This randomized controlled experimental study will conducted in the post operative room of the, Turkey between the dates of June 2024 and August 2024
### Conditions Module
**Conditions:**
- Cesarean Section Complications
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** . Reiki therapy will be applied to the participants for 30 minutes while they lie down with their eyes closed. A total of 4 sessions of Reiki application will be applied to the intervention group at the 4th hour, 8th hour, 24th hour and 28th hour after the cesarean section. Reiki application will be applied at the 4th hour after the cesarean section. Comfort, anxiety, depression and breastfeeding symptoms after the 4th session will be recorded.
**Intervention Names:**
- Other: reiki
**Label:** Reiki
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** will provided with standard midwifery care.
**Label:** control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Reiki
**Description:** effect of reiki application to women who have been hospitalized by ceserean during the hospitlalization process on anxiety depression comfort and breastfeesing
**Name:** reiki
**Other Names:**
- control group
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Hospital Anxiety and Depression Scale;Hospital anxiety depression scale, to screen anxiety and depression in people with physical illnesses.
has been prepared. It consists of 14 items.
**Measure:** anxiety and depression
**Time Frame:** immediately after intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* volunteering
* be over 18 years old
* Not having a diagnosed psychiatric disease
* no communication problems
* No drug sensitivity or allergy
* women who have had a cesarean section
Exclusion Criteria:
* Having a diagnosed psychiatric illness
* no communication problems
* Being under 18 years of age
* not volunteering to participate in the research
* drug sensitivity and allergy
* women who gave birth normally
**Healthy Volunteers:** True
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sümeyye BAL, Ph.D
**Phone:** 05434276696
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Ondokuz Mayıs University
**Name:** Sümeyye BAL, Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
## 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: M7061
- Name: Depressive Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M7058
- Name: Depression
- Relevance: LOW
- As Found: Unknown
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437756
**Brief Title:** Effects of Theraband Resistance Training on Muscle Strength in Coronary Artery Diseases
**Official Title:** Effects of Theraband Resistance Training on Muscle Strength in Coronary Artery Diseases
#### Organization Study ID Info
**ID:** REC/01808 Zunaira Shaukat
#### Organization
**Class:** OTHER
**Full Name:** Riphah International University
### Status Module
#### Completion Date
**Date:** 2024-07-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Riphah International University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** To compare the effects of Theraband Resistance Training with Conventional Resistance Training on muscle strength in coronary artery diseases
### Conditions Module
**Conditions:**
- Coronary Artery Disease
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 38
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: Theraband resistance training
**Label:** Theraband resistance training
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Other: Conventional Resistance Training
**Label:** Conventional Resistance Training
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Theraband resistance training
**Description:** Three sessions of 30 minutes each was used to complete the intervention over the course of six weeks (two sets of 12 repetitions). The participants were warmed up by stretching for 10 minutes before each session Participants were advised to take 5 mins rest before moving to next movement if they would feel fatigued after one movement. Thera-Band was utilized in only three different colors for the workouts.
**Name:** Theraband resistance training
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Conventional Resistance Training
**Description:** The intervention was carried out over the course of six weeks in three sessions of 30 minutes each (two sets of 12 repetitions). The participants were warmed up by stretching for 10 minutes before each session. The resistance-training program was performed with Universal weights.
**Name:** Conventional Resistance Training
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** If testing techniques are consistent, handheld dynamometry is a valid approach to assess the strength state and change in strength status. Hand-held dynamometry can be a reliable assessment technique when practiced by a single experienced tester
**Measure:** Hand Held Dynamometer
**Time Frame:** 6 week
**Description:** The Modified Borg Dyspnea Scale is numerical rating scale ranging from 0 to 10 and is used to measure dyspnea that patient report during sub-maximal exercise and is regularly administered during six-minute walk test. Changes from the baseline will be measured
**Measure:** Modified BORG Scale
**Time Frame:** 6 week
**Description:** It is a self-administered questionnaire for assessing the degree and severity of fatigue/tiredness in epidemiological populations, both clinical and non-clinical. The Chadler Fatigue Scale (CFS) was originally perceived as comprising two subscales that evaluate fatigue in the physical and mental domains. Items are rated on a 4-point Likert scale (0 = better than usual, 1 = no more than usual, 2 = worse than usual, 3 = much worse than usual), with higher scores indicating greater fatigue. Changes from the baseline are measured
**Measure:** Chadler Fatigue Scale
**Time Frame:** 6 week
**Description:** Changes from the baseline, Body Mass Index can be define as statistical index utilizing an individuals height and weight to give an estimation of muscle versus fat in female and male of all ages. It is determined by taking an individual weight in kilograms, separated by their height in meters squared, or BMI = weight (in kg)/height (in m square).
**Measure:** 6 Min walk test (Distance in meters)
**Time Frame:** 6 week
**Description:** The 30-Second Sit to Stand Test evaluates older people's leg strength and endurance using a foldable chair without arms. Participants stand with feet positioned back from knees, arms crossed, and arms crossed. The examiner counts stand within 30 seconds, determining the score.
**Measure:** The 30 Second Sit to Stand Test(30SSST) for lower limb strength
**Time Frame:** 6 week
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participants having a documented diagnosis of CAD, confirmed by a medical professional.
* Individuals with a history of myocardial infarction (heart attack), angina, or evidence of significant coronary artery stenosis.
* Stable CAD who were not experiencing acute coronary events, such as recent heart attacks or unstable angina.
* Patients who were able to perform exercises with TheraBand.
* Reduced muscle strength of upper limb/lower limb
Exclusion Criteria:
* Patients over the age of 75 years.
* Exclude individuals with a recent history of Theraband resistance training.
* Severe cardiovascular complications such as heart failure with reduced ejection fraction, severe arrhythmias, or uncontrolled hypertension.
* Patients with unstable conditions or cardiac episodes.
* Individuals who had undergone major cardiovascular surgery (e.g., coronary artery bypass grafting) within the last six months.
* Ejection fraction \< 40%
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Muhammad Iqbal Tariq, PhD*
**Phone:** 03338236752
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Islamabad
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Muhammad Iqbal Tariq, PhD*
- **Phone:** 03338236752
- **Role:** CONTACT
***Contact 2:***
- **Name:** Zunaira Shaukat
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Pakistan
**Facility:** Al Nafees Medical Hospital
**State:** Federal
**Status:** RECRUITING
**Zip:** 44000
#### Overall Officials
**Official 1:**
**Affiliation:** Riphah International University
**Name:** Muhammad Iqbal Tariq, PhD*
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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: 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: M6549
- Name: Coronary Disease
- 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
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437743
**Acronym:** SIMONE
**Brief Title:** Monitoring Nociception Using NoL Index to Reduce Opioid-Related Complications in Laparoscopic Abdominal Surgery
**Official Title:** Monitoring Nociception Using NoL Index and Its Implications in Reducing Opioid-Related Complications in Laparoscopic Abdominal Surgery
#### Organization Study ID Info
**ID:** SIMONE001
#### Organization
**Class:** NETWORK
**Full Name:** Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon
### Status Module
#### Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** NETWORK
**Name:** Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study aims to determine if optimal intraoperative nociception monitoring using the NoL index can reduce postoperative complications related to opioid use in laparoscopic abdominal surgery. The hypothesis is that guided nociception monitoring decreases opioid-related complications and improves postoperative outcomes.
**Detailed Description:** The study is a prospective, observational cohort study conducted across multiple centers. It aims to evaluate the impact of intraoperative nociception monitoring on postoperative opioid-related complications. The study will involve two groups of patients undergoing laparoscopic abdominal surgery: one group with visible NoL monitoring and another with non-visible NoL monitoring.
### Conditions Module
**Conditions:**
- Postoperative Opioid-related Complications
**Keywords:**
- Nociception, NoL Index, Opioids, Postoperative Complications, Laparoscopic Surgery
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 282
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients in this group will undergo laparoscopic abdominal surgery with the nociception level (NoL) monitor visible to the anesthesiologist. The NoL monitor provides an estimation of nociception through a multi-parameter sensor placed on the patient's finger. The anesthesiologist will adjust the doses of analgesic drugs based on the values observed on the NoL monitor, aiming to maintain the values between 10 and 25 during the surgery.
**Intervention Names:**
- Device: Nociception Level (NoL) Monitor
**Label:** NoL Visible
#### Arm Group 2
**Description:** Patients in this group will undergo laparoscopic abdominal surgery with the NoL monitor not visible to the anesthesiologist. The monitor will still be in place and collecting data, but its values will not be displayed during the surgery. The anesthesiologist will manage analgesia based on standard hemodynamic parameters such as heart rate and blood pressure, without access to the NoL values. The intervention includes the same standard anesthetic protocol as the NoL Visible group.
**Intervention Names:**
- Device: Nociception Level (NoL) Monitor
**Label:** NoL Not Visible
### Interventions
#### Intervention 1
**Arm Group Labels:**
- NoL Not Visible
- NoL Visible
**Description:** The NoL Monitor (PMD-200) is a multi-parameter sensor device placed on the patient's finger to estimate nociception levels during surgery. It provides continuous, real-time feedback to the anesthesiologist on the patient's nociception, assisting in the optimization of analgesic drug administration. The monitor integrates parameters such as heart rate variability, skin conductance, and other physiological signals to compute the NoL index, which ranges from 0 to 100, with target values between 10 and 25 for optimal nociception management.
**Name:** Nociception Level (NoL) Monitor
**Other Names:**
- PMD-200
**Type:** DEVICE
### Outcomes Module
#### Other Outcomes
**Description:** Patient satisfaction with pain management will be assessed using a standardized questionnaire. The goal is to compare satisfaction levels between the NoL visible group and the standard monitoring group.
**Measure:** Patient Satisfaction with Pain Management
**Time Frame:** At 48 hours postoperatively
#### Primary Outcomes
**Description:** The primary outcome measure will evaluate the incidence of postoperative opioid-related complications in patients undergoing laparoscopic abdominal surgery. Complications include nausea, vomiting, respiratory depression, and opioid-induced hyperalgesia. The study aims to determine if the use of the NoL monitor to guide intraoperative analgesia reduces these complications compared to standard hemodynamic monitoring.
**Measure:** Reduction in Postoperative Opioid-Related Complications
**Time Frame:** From the end of surgery up to 48 hours postoperatively
#### Secondary Outcomes
**Description:** This secondary outcome measure will assess the total amount of opioids administered during surgery. The comparison will be made between the group with visible NoL monitoring and the group with standard hemodynamic monitoring.
**Measure:** Intraoperative Opioid Consumption
**Time Frame:** During the surgical procedure
**Description:** Postoperative pain levels will be measured using the Visual Analog Scale (VAS) at various time points post-surgery. The study will compare pain scores between the two groups to evaluate the effectiveness of NoL-guided analgesia.
**Measure:** Postoperative Pain Scores
**Time Frame:** At 1, 6, 12, 24, and 48 hours postoperatively
**Description:** This secondary outcome will measure the duration of hospital stay from admission to discharge following surgery. The aim is to determine if NoL-guided analgesia affects the length of hospitalization.
**Measure:** Length of Hospital Stay
**Time Frame:** From admission to discharge, up to 7 days postoperatively
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 18 years
* Scheduled for laparoscopic abdominal surgery
* Undergoing balanced general anesthesia
* ASA physical status I-III
* Signed informed consent
Exclusion Criteria:
* Refusal to participate
* Communication barriers
* Multimodal, opioid-free, or regional epidural anesthesia
* ASA IV or V
* Pregnant or breastfeeding women
* Open or emergency abdominal surgery
* Post-surgery transfer to ICU or Recovery Unit
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study population includes adult patients scheduled for elective laparoscopic abdominal surgery at participating hospitals. The population will consist of individuals who meet the inclusion criteria and have consented to participate in the study.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Cristian Aragón-Benedí, M.D, Ph.D
**Phone:** +34625408866
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Ana Pascual-Bellosta, M.D, Ph.D, Prof.
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Miguel Servet University Hospital
**Name:** Ana Pascual-Bellosta, M.D, Ph.D, Prof.
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Miguel Servet University Hospital
**Name:** Cristian Aragón-Benedí, M.D, Ph.D
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**Description:** There is no plan to make individual participant data (IPD) available to other researchers for this study.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Analg
- Name: Analgesics
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
- ID: M4854
- Name: Benzocaine
- Relevance: LOW
- As Found: Unknown
- ID: T433
- Name: Tannic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437730
**Brief Title:** Comparison of INIT and Dry Needling on Trigger Points in Knee OA
**Official Title:** Comparison of Integrated Neuromuscular Inhibition Technique and Dry Needling on Trigger Points in Patient With Knee Osteoarthritis
#### Organization Study ID Info
**ID:** RiphahIU Iqra Iftikhar
#### Organization
**Class:** OTHER
**Full Name:** Riphah International University
### Status Module
#### Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-10-12
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Riphah International University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of the study is to compare the effects of Integrated Neuromuscular Inhibition Technique and Dry Needling on Functional Disability, Pain and Range of Motion. A randomized control trial will be conducted at Wah General Hospital Taxila. The sample size is 36 calculated through G-Power but I recruited 50. The participants were divided into two interventional groups each having 18 participants. Tools used in this study are Goniometer, NPRS, WOMAC, and Self structured Questionnaire. Data will be collected before and immediately after the application of interventions. Data will be analyzed through SPSS.
**Detailed Description:** Knee osteoarthritis (OA) is also known as degenerative joint disease, in which there is progressive loss of articular cartilage due to wear and tear. Knee osteoarthritis can be classified into two types, primary and secondary. Primary osteoarthritis is defined as degeneration of articular cartilage without any underlying cause. Secondary osteoarthritis can be caused due to either an abnormal amount of forces placed across the joint in a result of post-traumatic cause or due to abnormal articular cartilage, for example Rheumatoid arthritis. The prevalence of knee OA is higher as compared to other types of OA. As with increasing age and longer lifetime and higher average weight of population the incidence of knee OA increases, particularly in obese women. Women have a greater prevalence (42.1%) than do men (31.2%). There are different grades of knee OA. In Grade 1 There is a swelling of articular cartilage along with mild fibrillation in superficial zone. In Grade 2 Small portion of cartilage is lost and fibrillation occurs in deeper zone and clusters of chondrocytes begun to form. In Grade 3 formation of chondrons occurs and vertical fissures have advanced into middle zone. Early OA changes affects the superficial and middle zone of cartilage. There are different risk factors for developing Knee OA that includes age, Female Gender, Menopause, heredity, repetitive micro and macro trauma, alcohol and tobacco use and joint surgery. Some risk factors are modifiable and some are non-modifiable. Modifiable factors include: any trauma, occupation, weight, muscle weakness or imbalance, Prolonged standing and repetitive knee bending. Non-modifiable risk factors include Gender - females, Age, Genetics and Race. There can be different causes of knee OA including family history, obesity, age, diabetes, systemic inflammatory mediators, lower limb alignment, trauma and inflammation by metabolic syndrome. Diagnosis of Knee OA is mainly based on symptoms and X-rays according to Kellgren and Lawrence system for classification of Osteoarthritis. The Knee OA most common symptom is pain around knee joint, Pain can be of different nature such as dull, intermittent or sharp. Pain intensity can also vary from mild to moderate to severe. The Range of motion can also be decreased in knee OA. Other symptoms include grinding and popping sounds. Swelling, locking and giving way of the knee can also be seen in later stages. Inconsistencies are observed, in which they explain presence of Myofascial trigger points in surrounding muscles around knee. Studies showed treatment of trigger points will cause reduction in pain and improvement in functional capacity in Knee OA patients. There are different techniques to treat trigger points e.g. Dry needling and Integrated neuromuscular inhibition technique.
Study reported that there's significant reduction in pain and disability along with improved ROM in Knee Osteoarthritis patients who received Integrated Neuromuscular Inhibition Technique combined with Conventional treatment.
Another study conducted on Effect of Integrated Neuromuscular Inhibition Technique on Iliotibial Band Tightness in Osteoarthritis of Knee and their study concluded that there is a significant effect of Integrated Neuromuscular Inhibition Technique on iliotibial band tightness in osteoarthritis of knee.
Study was done to check effect of Dry needling in an exercise program for older adults with knee OA, The study concluded Despite the pain intensity and disability clinically relevant improvement for both DN and Sham-DN combined with exercise, 6 sessions of DN added to a therapeutic exercise program for older adults with KO did not seem to improve pain intensity and functionality.
Study conducted on Dry needling versus INIT on upper trapezius myofascial trigger points. According to study findings DN was more effective than INIT on management of upper trapezius active myofascial trigger points.
Proper evidence behind comparative effect of INIT and DN on trigger points in knee OA patient is sparse and there are less number of studies with limited methodological design on these techniques. This study will contribute to compare the ef-fects of INIT and Dry Needling on Functional Disability, Pain and ROM in patients with knee OA, and to check whether which technique is more effective in treating trigger points in Knee Osteoarthritis patients
### Conditions Module
**Conditions:**
- Knee Osteoarthritis
**Keywords:**
- Trigger Points,
- Knee Osteoarthritis,
- Dry Needling,
- Integrated Neuromuscular Inhibition Technique,
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 36
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** MTrPs points will be released with ischemic compression, position of ease will be acquired, and in the last METs will be performed. Ischemic compression applied through thumb on trigger point present in any muscle around the knee joint.
**Intervention Names:**
- Other: Integrated Neuromuscular Inhibition Technique:
**Label:** Group: 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Dry needle will be targeting trigger points (TrPs) using in-and-out techniques such as 'pistoning' or 'sparrow pecking'. 0.25x25mm needle is inserted.
**Intervention Names:**
- Other: Dry needling:
**Label:** Group: 2
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group: 1
**Description:** MTrPs points will be released with ischemic compression, position of ease will be acquired, and in the last METs will be performed. Ischemic compression applied through thumb on trigger point present in any muscle around the knee joint. Compression will be increased gradually until first resistance will feel and maintained until it resolves, further increases then until no tissue resistance will be felt under thumb. This process is maintained for 30sec and repeated 3-5 times per session. Positional release technique: after applying pressure on trigger point, patient will acquire position of ease that is maintained for 20 sec whether its extension or flexion of knee. This process is repeated 3-5 times per session. Muscle Energy Technique will be applied on the muscle in which isometric contraction is maintained for 7-10sec against 20-25% strength. After completion of muscular contraction, the limb is moved away for muscular stretch and then position is maintained for 30 seconds
**Name:** Integrated Neuromuscular Inhibition Technique:
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Group: 2
**Description:** Dry needle will be targeting trigger points (TrPs) using in-and-out techniques such as 'pistoning' or 'sparrow pecking'. 0.25x25mm needle is inserted.
For vastus laterals patient is supine line with knee extended performing an isometric quadriceps contraction, maintaining a clean technique by using gloves and performing an alcohol wipe down bracket the tissue to be treated and inserting needle with direct approach towards the femur, performing pistoning. For vastus medialis patient is supine line with 30 degrees of knee flexion. A headless 0.25x25mm needle fixed between the fingers of non-dominant hand and inserted perpendicularly to the MTrPs with metacarpophalangeal flexion extension of 1st and 2nd fingers of dominant hand. For Gastrocnemius patient is prone lying and bolstered supported slight knee bend, for the upper part anterior medial approach is used and center of muscle belly slight medial anterior approach is used.
**Name:** Dry needling:
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The WOMAC pain score is a numerical score that measures pain, stiffness, and functional limitations. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function.
**Measure:** Western Ontario and McMaster Universities Arthritis Index
**Time Frame:** 6th day
**Description:** The numeric pain rating scale is a scale for self-report of pain intensity. It is an 11-point scale, where 0 means no pain and 10 means the worst possible pain.
**Measure:** Numeric Pain Rating Scale
**Time Frame:** 6th day
**Description:** A goniometer is a device used in physical therapy to measure a joint's range of motion. It is essentially a protractor with two arms extending from it, used to measure a joint's range of motion.. There are two "arms" one that is stationary and one that is movable-that are hinged together. Each is positioned at specific points on the body with the center of the goniometer aligned at the joint of interest. The goniometer can be used to measure many joints such as the knee, hip, shoulder, or wrist.
**Measure:** Goniometer:
**Time Frame:** 6th day
**Description:** It is a common method of classifying the severity of Osteoarthritis using five grades
The grades are as follows:
Grade 0 (none): definite absence of x-ray changes of osteoarthritis Grade 1 (doubtful): doubtful joint space narrowing and possible osteophytic lipping Grade 2 (minimal): definite osteophytes and possible joint space narrowing Grade 3 (moderate): moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends Grade 4 (severe): large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends.
**Measure:** Kellgren and Lawrence system for classification of Osteoarthritis:
**Time Frame:** 6th day
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Osteoarthritis Grade-1 to 2 Positive jump sign Vastus medialis(75.43%), Vastus laterals(65.78%), Gastrocnemius
Exclusion Criteria:
* Patient with history of RA or any autoimmune disorder Any systematic Illness Patient with Varicose vein Post traumatic, Post-Surgical and Post fractured
**Maximum Age:** 60 Years
**Minimum Age:** 40 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Imran Amjad, PhD
**Phone:** 03324390125
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rawalpindi
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lal Gul Khan, MScPT
- **Phone:** 03002146287
- **Role:** CONTACT
***Contact 2:***
- **Name:** Iqra Iftikhar, MSPT
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Pakistan
**Facility:** Wah General Hospital,
**State:** Punjab
**Status:** RECRUITING
**Zip:** 44000
#### Overall Officials
**Official 1:**
**Affiliation:** Riphah International University
**Name:** Lal Gul Khan, MScPT
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Hsu H, Siwiec RM. Knee Osteoarthritis. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507884/
**PMID:** 29939661
**Citation:** Lespasio MJ, Piuzzi NS, Husni ME, Muschler GF, Guarino A, Mont MA. Knee Osteoarthritis: A Primer. Perm J. 2017;21:16-183. doi: 10.7812/TPP/16-183.
**PMID:** 29035179
**Citation:** Heidari B. Knee osteoarthritis diagnosis, treatment and associated factors of progression: part II. Caspian J Intern Med. 2011 Summer;2(3):249-55.
**PMID:** 24049581
**Citation:** Favero M, Ramonda R, Goldring MB, Goldring SR, Punzi L. Early knee osteoarthritis. RMD Open. 2015 Aug 15;1(Suppl 1):e000062. doi: 10.1136/rmdopen-2015-000062. eCollection 2015.
**PMID:** 26557380
**Citation:** Ejaz F, Safdar M, Ejaz H. Comparative Effectiveness of Integrated Neuromuscular Inhibition Technique Along with Conventional Treatment Vs Conventional Treatment Alone in Patients of Knee Osteoarthritis. Pakistan Journal of Medical & Health Sciences. 2023;17(01):859-.
**Citation:** Albin SR, Koppenhaver SL, MacDonald CW, Capoccia S, Ngo D, Phippen S, Pineda R, Wendlandt A, Hoffman LR. The effect of dry needling on gastrocnemius muscle stiffness and strength in participants with latent trigger points. J Electromyogr Kinesiol. 2020 Dec;55:102479. doi: 10.1016/j.jelekin.2020.102479. Epub 2020 Oct 9.
**PMID:** 33075711
**Citation:** Muraja S, Markulinčić B. FRI0597-HPR The effect of physical therapy on functional status and synovial perfusion in patients with knee osteoarthritis. Annals of the Rheumatic Diseases. 2013;72(Suppl 3):A578-A.
**Citation:** Mayoral O, Salvat I, Martin MT, Martin S, Santiago J, Cotarelo J, Rodriguez C. Efficacy of myofascial trigger point dry needling in the prevention of pain after total knee arthroplasty: a randomized, double-blinded, placebo-controlled trial. Evid Based Complement Alternat Med. 2013;2013:694941. doi: 10.1155/2013/694941. Epub 2013 Mar 27.
**PMID:** 23606888
**Citation:** Chavan SE, Shinde S. Effect of Integrated Neuromuscular Inhibition Technique on Iliotibial Band Tightness in Osteoarthritis of Knee
**Citation:** Sanchez-Romero EA, Pecos-Martin D, Calvo-Lobo C, Ochoa-Saez V, Burgos-Caballero V, Fernandez-Carnero J. Effects of dry needling in an exercise program for older adults with knee osteoarthritis: A pilot clinical trial. Medicine (Baltimore). 2018 Jun;97(26):e11255. doi: 10.1097/MD.0000000000011255.
**PMID:** 29952993
**Citation:** Abdelaziz YM, Abulkasem ST, Yamny AA. Dry Needling Versus Integrated Neuromuscular Inhibition Technique on Upper Trapezius Myofascial Trigger Points. Egypt J Appl Sci. 2020;35:45-56.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001168
- Term: Arthritis
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000012216
- Term: Rheumatic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M22168
- Name: Osteoarthritis, Knee
- Relevance: HIGH
- As Found: Knee Osteoarthritis
- ID: M12926
- Name: Osteoarthritis
- Relevance: HIGH
- As Found: Osteoarthritis
- ID: M4476
- Name: Arthritis
- Relevance: LOW
- As Found: Unknown
- ID: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15045
- Name: Rheumatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6323
- Name: Collagen Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010003
- Term: Osteoarthritis
- ID: D000020370
- Term: Osteoarthritis, Knee
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M3777
- Name: Ethanol
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437717
**Brief Title:** Role of Nanoemulsified Sesame Oil in Post-operative Care After Endoscopic Sinus Surgery
**Official Title:** Role of Nanoemulsified Sesame Oil in Post-operative Care After Endoscopic Sinus Surgery
#### Organization Study ID Info
**ID:** MS.20.5.1134
#### Organization
**Class:** OTHER
**Full Name:** Mansoura University
### Status Module
#### Completion Date
**Date:** 2024-03-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-01
**Type:** ACTUAL
#### Start Date
**Date:** 2022-12-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Mansoura University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The goal of our thesis is to design, develop and characterize a novel thermodynamically stable NE by spontaneous method intended for topical use. Subsequently, appraisal of nanoemulsified sesame oil formulation has been performed on the post-operative symptoms in CRS patients who have undergone ESS (endoscopic sinus surgery) combined with different types of nasal irrigation which may affect formulation efficacy.
### Conditions Module
**Conditions:**
- Chronic Rhinosinusitis (Diagnosis)
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: application of different topical nasal solutions
**Label:** only normal saline as nasal irrigation
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Other: application of different topical nasal solutions
**Label:** normal saline as nasal irrigation followed by sesame oil nasal drops
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Intervention Names:**
- Other: application of different topical nasal solutions
**Label:** only Ringer's lactate solution as nasal irrigation
**Type:** ACTIVE_COMPARATOR
#### Arm Group 4
**Intervention Names:**
- Other: application of different topical nasal solutions
**Label:** Ringer's lactate solution as nasal irrigation followed by sesame oil nasal drops
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Ringer's lactate solution as nasal irrigation followed by sesame oil nasal drops
- normal saline as nasal irrigation followed by sesame oil nasal drops
- only Ringer's lactate solution as nasal irrigation
- only normal saline as nasal irrigation
**Description:** each group receives a type of nasal solution to detect if there is a difference in the outcomes in chronic rhinosinusitis patients
**Name:** application of different topical nasal solutions
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** Sinonasal Outcome Test 22 (SNOT-22)
**Time Frame:** weekly for three months
**Measure:** Lund-Kennedy endoscopic grading system
**Time Frame:** once monthly for three months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patient age between 18 and 60 years old.
2. chronic rhinosinusitis patients who have undergone endoscopic sinus surgery.
Exclusion Criteria:
1. Patients with history of allergy for sesame seed derivatives.
2. Patients with chronic diseases which affecting the process of healing (uncontrolled DM, renal failure and hepatic failure).
3. Patients with nasal granulomas.
4. Patients with invasive fungal rhinosinusitis.
5. Smokers.
6. Patients with history of radio and/or chemotherapy exposure.
7. Patients with systemic diseases affecting integrity of nasal mucosa (e.g. CF, scleroderma, Sjogren syndrome ...).
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Mansoura
**Country:** Egypt
**Facility:** Mansoura University
**State:** Dakahliya
**Zip:** 35511
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012220
- Term: Rhinitis
- ID: D000012141
- Term: Respiratory Tract Infections
- ID: D000007239
- Term: Infections
- ID: D000012852
- Term: Sinusitis
- ID: D000010254
- Term: Paranasal Sinus Diseases
- ID: D000009668
- Term: Nose Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000010038
- Term: Otorhinolaryngologic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M3269
- Name: Rhinosinusitis
- Relevance: HIGH
- As Found: Rhinosinusitis
- ID: M15049
- Name: Rhinitis
- 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: M15657
- Name: Sinusitis
- Relevance: LOW
- As Found: Unknown
- ID: M13167
- Name: Paranasal Sinus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12604
- Name: Nose Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12961
- Name: Otorhinolaryngologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T5183
- Name: SeSAME Syndrome
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000096825
- Term: Rhinosinusitis
### 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: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437704
**Brief Title:** Effects of Brain Training Games on Cognitive Function and Quality of Life in MCI
**Official Title:** The Effects of Brain Training Games on Cognitive Function and Quality of Life Among Older Adults With Mild Cognitive Impairment
#### Organization Study ID Info
**ID:** Lylas Ali
#### Organization
**Class:** OTHER
**Full Name:** Riphah International University
### Status Module
#### Completion Date
**Date:** 2024-10-16
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-10-16
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Riphah International University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The study aims to determine the effects of brain training games on cognitive function and Quality of life among older adults with MCI.
**Detailed Description:** The study aims to determine the effects of brain training games on cognitive function and Quality of life among older adults with MCI.This study will assess the efficacy of Brain training games. Lumosity on the cognitive function and Quality of life among older adults with MCI .Beyond cognitive rehabilitation, this intervention holds promise as a cost-effective approach to delay, maintain, or even improve cognitive decline associated with the aging process.
### Conditions Module
**Conditions:**
- Mild Cognitive Impairment
**Keywords:**
- Cognition
- Aging
- Quality of life
- Brain training games
### 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:** 44
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Brain training game (Lumosity)
**Intervention Names:**
- Other: Brain training game Lumosity
**Label:** Experimental
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Simulation game (Simcity buildit)
**Intervention Names:**
- Other: Simulation game simcity buildit
**Label:** Control
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental
**Description:** . Group A, the experimental group will be trained using five selected games i.e. Speed Match, Memory Matrix, Tidal treasure, Ebb and Flow and Lost in Migration from Lumosity for a period of 30 sessions , 30 min/ day over the span of 6 weeks.
**Name:** Brain training game Lumosity
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Control
**Description:** Group B, the active control will be trained for the same number of sessions using a simulation game, SimCity Build it, for a period of 30 sessions , 30 min/ day over the span of 6 weeks.
**Name:** Simulation game simcity buildit
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Brief cognitive function assessment is done using MoCA Questionnaire which consist of 12 items, that is to say visuospatial, executive functioning, short-term memory, attention or concentration, working memory, language, and lastly orientation. The total score of this Questionnaire is 30. As per grading system, the score of 26 to 30 represent normal cognition, score of 18 to 25 denotes mild cognitive impairment and score of 10-17 signifies moderate cognitive impairment. Lastly, score of less than 10 embodies severe cognitive impairment. The inter-rater reliability or ICC value is 0.96 (95% CI: 0.91-0.98). Cronbach's alpha is 0.79 and AUC of 0.89 (95% CI: 0.83-0.95).
**Measure:** Montreal Cognitive Assessment Scale
**Time Frame:** 6 weeks
**Description:** Trail making test is a brief paper and pencil test used to screen for any cognitive impairment with the test scored by how long does it takes for a person to complete it. In part A of the test, the patient draw lines to join numbered circles from 1-to 25, connecting them in ascending order. The average score for completing this test is 29 seconds, whereas the rule of thumb suggests a typical score of 90 seconds. A score of greater than 78 seconds indicates deficiency. In part B of the test, the patient connect the circles alternating between numbers from 1 to 13 and letters from A to L. The average score is 75 seconds, with score of greater than 273 seconds representing deficiency. The rule of thumb for this test is a typical score of 3 minutes. The retest reliability for part A is between 0.76 and 0.89 and for part B it lies between 0.86 and 0.94. The Cronbach's alpha for this neuropsychological test is 0.90.
**Measure:** Trail Making Test A and B
**Time Frame:** 6 weeks
**Description:** WHO-QOL BREIF questionnaire is a 26 items tool for measuring quality of life. It address four domains of quality of life which includes physical health comprising of 7 items, psychological health having 6 items, social relationships 3 items, and environmental health encompassing 8 items; it also contains QOL and general health items. Each item in the questionnaire is scored on a 5 point ordinal scale; from 1 to 5.The scores are then transformed linearly to a 0 to 100 scale where 0 score represents the worst of health and maximum score of 100 indicates best possible state of health. The Cronbach's alpha coefficient for this questionnaire is 0.86 and the ICC value is 0.74. The CVI score is within the range of 0.78 to 1.00
**Measure:** World Health Organization Quality of Life Brief Version (WHO-QOL BREF) Questionnaire:
**Time Frame:** 6 weeks
**Description:** IPAQ is a self-reported tool for the assessment of level of physical activity. It evaluates the duration of physical activity in the last 7 days in the domains of job related physical activity, transportation , house chores and house maintenance, caring for family, recreational activities, sport, and leisure-time physical activity as well as time spent sitting. The score is recorded in the form of MET minutes. The total minutes per week spent on each activity type, that is walking (3.3 METs), doing moderate (4.0 METs) or vigorous physical activity (8.0 METs) are calculated and converted into MET-minutes. The sum of total MET-minutes for each activity determine the level of total physical activity. The questionnaire has an excellent test-retest reliability for physical activity (ICC = 0.84-1.00) as well as an exceptional concurrent validity: ρ = 0.71
**Measure:** International Physical Activity Questionnaire (IPAQ);
**Time Frame:** 6 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Older adults of age \>50 years and above
* Both male and female
* Education level matriculation at least
* Mild cognitive impairment ( MOCA score of 18-25)
* Active independent individuals with normal hearing and normal or corrected-to-normal vision.
Exclusion Criteria:
* Moderate to severe cognitive impairment
* Diagnosed case of dementia, depression or other mental issues.
* Current plans to move to another city.
**Maximum Age:** 80 Years
**Minimum Age:** 50 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Arshad Nawaz Malik, PhD
**Phone:** 03334503754
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Islamabad
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Arshad Nawaz Malik, PhD
- **Phone:** 03334503754
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Lylas Ali, MS-NMPT*
- **Phone:** 03045195505
- **Role:** CONTACT
***Contact 3:***
- **Name:** Lylas Ali, MS-NMPT*
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Pakistan
**Facility:** Riphah International University, Gulberg Green Campus
**State:** Punjab
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Riphah International University Islamabad
**Name:** Arshad Nawaz Malik, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003072
- Term: Cognition Disorders
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: 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: M29705
- Name: Cognitive Dysfunction
- Relevance: HIGH
- As Found: Mild Cognitive Impairment
- ID: M6301
- Name: Cognition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
### Condition Browse Module - Meshes
- ID: D000060825
- Term: Cognitive Dysfunction
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437691
**Brief Title:** Effect of Stent Placement on Short Term Survival of Left Sided Obstructive Colorectal Cancers Comparison of Bridge-To-Surgery Versus Emergency Surgery Approaches
**Official Title:** Effect of Stent Placement on Short Term Survival of Left Sided Obstructive Colorectal Cancers. Comparison of Bridge-To-Surgery Versus Emergency Surgery Approaches
#### Organization Study ID Info
**ID:** StentSurv
#### Organization
**Class:** OTHER
**Full Name:** Kanuni Sultan Suleyman Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-02-20
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-02-20
**Type:** ACTUAL
#### Start Date
**Date:** 2016-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Yasir Musa Kesgin, MD
#### Responsible Party
**Investigator Affiliation:** Kanuni Sultan Suleyman Training and Research Hospital
**Investigator Full Name:** Yasir Musa Kesgin, MD
**Investigator Title:** MD
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this observational study is to determine effect of stent placement on survival results in first three years in a patient who applied to the emergency department with obstruction due to colorectal cancer. Eligible patients divided into two groups. Group A includes patients underwent emergency surgery directly. Patients underwent elective surgery following stent placement as bridge-to-surgery. Patients underwent elective surgery following bridge-to-surgery stent placement were accepted as Group B.
**Detailed Description:** Patients who applied to emergency department of a single tertiary referral center between January 2016 and December 2020 and diagnosed as left sided obstructive colorectal cancer were included in this retrospective study. All patients were equal or older than 18 years and histopathologically found to have primary colorectal malignant neoplasms.
Patients were excluded from the analysis if they met any of the following criteria:
* Who underwent emergency surgery due to unsuccessful stent application intervention or stent-related complications developed,
* Those with middle and lower rectum tumors or received neoadjuvant treatment,
* Perforation,
* Who underwent subtotal or total colectomy (as a result of colon ischemia in the cecum, microperforation, etc.),
* Recurrent disease patients
* Patients have metastasis
### Conditions Module
**Conditions:**
- Colorectal Cancer
**Keywords:**
- Obstructive Colorectal Cancer, Colorectal Emergencies, Self Expandable Metallic Stents
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 65
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients underwent emergency surgery directly after coming to emergency department due to left sided obstructive colorectal cancer
**Label:** Group A - Emergency Surgery Group
#### Arm Group 2
**Description:** Left sided obstructive colorectal cancer patients underwent elective surgery following decompression via self-expandable metallic stent placement.
**Intervention Names:**
- Procedure: Self-Expandable Metallic Stent Placement
**Label:** Group B - Stent Group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group B - Stent Group
**Name:** Self-Expandable Metallic Stent Placement
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** The survival time of patient after being diagnosed as colorectal cancer after coming to emergency department
**Measure:** Overall Survival
**Time Frame:** 3 years
**Description:** The local or systemic recurrence free time period of patient after being diagnosed as colorectal cancer after coming to emergency department
**Measure:** Disease Free Survival
**Time Frame:** 3 years
#### Secondary Outcomes
**Description:** Death of patient in postoperative first three months
**Measure:** Mortality
**Time Frame:** 90 days
**Description:** Postoperative complications of patients that have a Clavien-Dindo Score greater than or equal to 3
**Measure:** Serious complications
**Time Frame:** 90 days
**Description:** Patients that found a chance for fully minimally invasive surgery for resection of colorectal cancer
**Measure:** Minimally invasive surgery
**Time Frame:** 90 days
**Description:** Patients that have a end colostomy at the end of surgical resection of colorectal cancer
**Measure:** End colostomy rate
**Time Frame:** 90 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* All patients were equal or older than 18 years and histopathologically found to have primary colorectal malignant neoplasms and diagnosed as left sided (descending colon, sigmoid colon and upper rectum) obstructive colorectal cancer were included
Exclusion Criteria:
* Who underwent emergency surgery due to unsuccessful stent placement intervention
* Who underwent emergency surgery due to stent-related complications
* Those with middle and lower rectum tumors
* Those received neoadjuvant treatment,
* Patients have perforation,
* Who underwent subtotal or total colectomy (as a result of colon ischemia in the cecum, microperforation, etc.),
* Who has a recurrent disease or metastasis.
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients come to emergency department and diagnosed as left sided obstructive colorectal cancer
### Contacts Locations Module
#### Overall Officials
**Official 1:**
**Affiliation:** Bakırköy Dr. Sadi Konuk Training and Research Hospital
**Name:** Ahmet Sürek
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**Description:** The datasets generated and analysed during the current study are not publicly available due to institutional policies but are available from the contact person on reasonable request.
**IPD Sharing:** NO
## 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
- 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: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M7796
- Name: Emergencies
- Relevance: HIGH
- As Found: Emergency
- 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: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System 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
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015179
- Term: Colorectal Neoplasms
- ID: D000004630
- Term: Emergencies
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437678
**Brief Title:** Phase II Study of Liposomal Irinotecan for Advanced Refractory Gastric Cancer
**Official Title:** A Single-Center, Prospective Phase II Clinical Study of Liposomal Irinotecan Monotherapy for Third-Line and Beyond Recurrent/Refractory Advanced Gastric Cancer
#### Organization Study ID Info
**ID:** IRB-2024-498
#### Organization
**Class:** OTHER
**Full Name:** Zhejiang Cancer Hospital
### Status Module
#### Completion Date
**Date:** 2026-02-28
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-02-28
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-27
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Zhejiang Cancer Hospital
#### Responsible Party
**Investigator Affiliation:** Zhejiang Cancer Hospital
**Investigator Full Name:** Xiangdong Cheng
**Investigator Title:** Chief physician
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** To evaluate the objective response rate (ORR) and disease control rate (DCR) of liposomal irinotecan monotherapy in the treatment of recurrent/refractory advanced gastric cancer.
**Detailed Description:** This study is a single-arm, single-center, prospective clinical trial aimed at evaluating the efficacy and safety of liposomal irinotecan monotherapy in the treatment of recurrent/refractory advanced gastric cancer. The study targets patients with locally advanced, recurrent, or metastatic/previous treatment-refractory adenocarcinoma of the stomach or gastroesophageal junction. The primary endpoints of the study are objective response rate (ORR) and disease control rate (DCR). It plans to enroll 50 patients with locally advanced, recurrent, or metastatic/previous treatment-refractory adenocarcinoma of the stomach or gastroesophageal junction. Subjects will sign informed consent and undergo screening for eligibility before enrollment. Subjects will receive the following treatment: Liposomal Irinotecan Hydrochloride Injection (Ⅱ) 56.5mg/m2 every 2 weeks. Safety visits will be conducted on Day 1 of each treatment cycle, at the end of the study treatment, and 30 days (±7 days) after the end of the study treatment. Imaging assessments will be performed according to RECIST 1.1 criteria, including chest CT, enhanced CT scans of the abdomen and pelvis, or chest CT plain scan plus abdominal/pelvic MRI scan for patients allergic to contrast agents. Suspected cases of brain metastases will require brain enhanced MRI or enhanced CT. Bone scan examination will be conducted if bone metastases are suspected clinically or radiologically. Patients who discontinue treatment due to reasons other than radiological progression during the treatment period will undergo imaging examination at the end of treatment unless it has been conducted within 28 days. Subjects will undergo survival follow-up every 3 months after the end of treatment to collect and record survival status and subsequent anti-tumor treatment until death or loss to follow-up.
### Conditions Module
**Conditions:**
- Gastric Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Liposomal Irinotecan Hydrochloride
**Label:** Recurrent/Refractory Advanced Gastric Cancer
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Recurrent/Refractory Advanced Gastric Cancer
**Description:** Liposomal Irinotecan Hydrochloride Injection (Ⅱ) 56.5mg/m2 every 2 weeks
**Name:** Liposomal Irinotecan Hydrochloride
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** After treatment, the proportion of cancer patients whose tumors have shrunk to a predetermined value and can maintain the minimum time limit requirement is the sum of the complete response (CR) and partial response (PR) ratios.
**Measure:** Objective response rate (ORR)
**Time Frame:** through study completion, an average of 1 year
**Description:** The percentage of evaluable cases in cancer patients who have improved their condition (CR+PR) and stabilized their condition (SD) after treatment.
**Measure:** Disease Control Rate (DCR)
**Time Frame:** through study completion, an average of 1 year
#### Secondary Outcomes
**Description:** The time between the date of enrollment and death caused by any reason.
**Measure:** OS (Overall survival)
**Time Frame:** Assessed up to 60 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients voluntarily join this study and sign an informed consent form;
* Age ≥18 years and ≤75 years;
* Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma;
* CT or biopsy-confirmed recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;
* Previously received at least one line of standard first- and second-line therapy (e.g., chemotherapy, targeted therapy), and experienced disease progression or intolerance;
* Interval of ≥4 weeks since previous chemotherapy, immunotherapy, or radiotherapy;
* Expected survival of ≥12 weeks;
* ECOG performance status score of 0-2;
* Normal major organ function, meeting the following criteria:
1. Hematologic criteria:
(No blood transfusion or blood products, and no use of G-CSF or other hematopoietic growth factors within 14 days) Absolute neutrophil count ≥1.5×10\^9/L; Platelets ≥80×10\^9/L; Hemoglobin ≥80 g/L.
2. Biochemical criteria:
Total bilirubin \<1.5×ULN; ALT and AST ≤2.5×ULN (without liver metastasis) / ALT and AST ≤5×ULN (with liver metastasis); Serum creatinine ≤1.5×ULN or creatinine clearance \>50 ml/min (Male: creatinine clearance = ((140 - age) × weight) / (72 × serum creatinine); Female: creatinine clearance = ((140 - age) × weight) / (72 × serum creatinine) × 0.85; weight in kg; serum creatinine in mg/mL).
3. Urine protein (semi-quantitative method) less than 2+;
4. Normal coagulation function (including INR, APTT, PT, FIB).
* Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to use effective contraception during the study and for 120 days after the last dose. Male participants with partners of childbearing potential must be surgically sterilized or agree to use effective contraception during the study and for 120 days after the last dose.
Exclusion Criteria:
* Having a history of or currently suffering from other malignant tumors;
* Previous or current use of irinotecan drugs;
* Having any chronic or significant disease deemed intolerable to treatment (e.g., severe heart disease, uncontrolled hypertension, significant liver or kidney dysfunction, etc.);
* History of gastrointestinal perforation, abdominal abscess, or recent (within 3 months) bowel obstruction, or imaging or clinical symptoms indicating the presence of bowel obstruction;
* Significant clinically relevant bleeding symptoms or a clear tendency to bleed within 3 months before the first dose of the study drug, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis; if fecal occult blood is positive at baseline, retesting is allowed. If retesting remains positive, a gastroscopy is required (unless gastroscopy has been performed within the past 3 months to exclude these conditions);
* Currently undergoing treatment for an active infection (e.g., requiring antibacterial, antiviral, or antifungal therapy);
* Active hepatitis (Hepatitis B: HBsAg positive and HBV DNA ≥500 IU/ml; Hepatitis C: HCV antibody positive and HCV RNA \> upper limit of normal);
* Congenital or acquired immunodeficiency (e.g., HIV infection);
* Suffering from a mental illness that could interfere with consent or follow-up;
* Having any active autoimmune disease or a history of autoimmune disease with a risk of recurrence;
* Planned or previous organ or allogeneic bone marrow transplantation;
* Currently having interstitial pneumonia or interstitial lung disease, a history of interstitial pneumonia or interstitial lung disease requiring steroid treatment, or a screening CT showing active pneumonia or severe lung dysfunction; active tuberculosis;
* Currently using or recently used immunosuppressive drugs or systemic corticosteroids for immunosuppressive purposes;
* Received an attenuated live vaccine within 28 days before the first dose of the study drug, or requires such a vaccine during the treatment period or within 60 days after the last dose;
* Known allergy to any study drug or excipients;
* Breastfeeding women.
**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:** Xiangdong Cheng
**Phone:** 13968032995
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Li Yuan
**Phone:** 15558103169
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hangzhou
**Country:** China
**Facility:** Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
**State:** Zhejiang
#### Overall Officials
**Official 1:**
**Affiliation:** Zhejiang Cancer Hospital
**Name:** Xiangdong Cheng
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- 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: D000013272
- Term: Stomach Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14850
- Name: Recurrence
- Relevance: LOW
- As Found: Unknown
- ID: M16064
- Name: Stomach Neoplasms
- Relevance: HIGH
- As Found: Gastric Cancer
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16062
- Name: Stomach Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T5486
- Name: Stomach Cancer
- Relevance: HIGH
- As Found: Gastric Cancer
### Condition Browse Module - Meshes
- ID: D000013274
- Term: Stomach Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000059004
- Term: Topoisomerase I Inhibitors
- ID: D000059003
- Term: Topoisomerase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- 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: M1671
- Name: Irinotecan
- Relevance: HIGH
- As Found: Emission
- ID: M29349
- Name: Topoisomerase I Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000077146
- Term: Irinotecan
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437665
**Brief Title:** Tech-wise Driver (Technology Acceptance of Targeted ADAS for Older Adults)
**Official Title:** The Tech-wise Driver: Exploring the Sustained Efficacy and Technology Acceptance of Targeted ADAS for Older Drivers
#### Organization Study ID Info
**ID:** R5570A12
#### Organization
**Class:** OTHER
**Full Name:** Western University, Canada
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Western University, Canada
#### Responsible Party
**Investigator Affiliation:** Western University, Canada
**Investigator Full Name:** Liliana Alvarez Jaramillo
**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 tech-wise driver: Exploring the sustained efficacy and technology acceptance of targeted ADAS for older drivers A significant percentage of road traffic fatalities registered in Canada occurred among older adults. According to the studies, the Advanced Driver Assistance Systems (ADAS) can enhance the safety and mitigate the age-related declines of older drivers. Whether sustained use results in declines in driving performance in older drivers relying on ADAS remains largely unexplored. This is problematic given emerging evidence on ADAS use by older drivers. Furthermore, exploring changes in ADAS technology acceptance in relation to sustained use can inform the correlation between perceived safety and intention to use.
The investigators hypothesize that, compared to driving simulator training alone, lane departure warning (LDW), cruise control (CC), and forward proximity warning (FPW) technology will result in a sustained decrease of critical driving errors in this population; and that exposure to the technology will increase participants' perceived usability and ease of use. To achieve this goal, the investigators will explore the determination of sustained efficacy, establish the impact of technology exposure, evaluate the concurrent validity of a computerized model of driving error type and severity using trained occupational therapy in-vehicle evaluation as the criterion, when evaluating older drivers 'performance.
Our findings may significantly impact the ability of older drivers to choose in-vehicle technologies, and our study will be the first to assess the criterion validity of a simulator-derived computerized model against the findings of an evaluator-based functional assessment.
**Detailed Description:** The driving simulator will be used to collect data on drivers in driving scenarios that include situations that may be more challenging for some drivers, e.g., pedestrian stepping into a crosswalk, a vehicle pulling out of a parking spot, a vehicle suddenly changing lanes. Vehicle data and gaze data will be collected for drivers along with images from the simulated environment. The simulator will measure driving performance through metrics generated from the simulator, e.g. pedal (i.e., gas and brake) reaction time, vehicle velocity, headway distance/time, etc.
Participants: Licensed older drivers (≥65 years of age) will be included in this study. Participants will be excluded if they have neurological or psychiatric conditions that would preclude full participation in driving activity, or if they take medications that may have a sustained negative impact on their mental and/or physical functioning during driving.
Sample Size: A sample size of n=68 will be recruited to achieve 80% power to detect a medium effect size of .50 based on a two-sided significance test with a significance level of 0.05.
Procedure:
1. Interested potential participants will reach to the team, using the information distributed during recruitment.
2. Upon confirm eligibility criteria, the first session will be scheduled.
3. Participants will receive a parking pass to park on the premises.
4. The first session will take approximately 1 hr to complete.
5. The objective of the study will be reviewed with each participant and they will be shown the simulator.
2.b. Participants will complete a battery of paper and pencil and computer tests. Of these tests, the first will be vision screening testing to make sure they meet inclusion criteria. Visual acuity (monocular and binocular) will be assessed via Snellen vision charts; visual acuity, peripheral fields, contrast sensitivity, color discrimination, depth perception, lateral phorias and vertical phorias will be assessed via the Optec 5000® Visual Analyzer (Stereo Optical Company, Inc., Chicago, IL). After vision screening, participants will complete an intake form. This is a standardized intake form adapted by the research team which will collect the following information: age, gender, preferred method of contact information for scheduling purposes, self-identified ethnicity, level of education, occupation, and medications. The questions regarding ethnic origin and population group are based on Statistics Canada updated standards.
2.c. Driving History and Habits: The participants will complete several tests germane to their driving history. First, participants will complete a driving history form adapted by the research team (based on Ali et al., 2014). The form will collect information in three sections. Section one will include age at which participants obtained their first license, type of vehicle participants normally drive, whether participants have been involved in a motor vehicle crash and previous use of ADAS technology. Second, participants will complete the computer-based Useful Field of View (UFOV). The UFOV is a standardized test which assesses visual perception and attention (Edwards et al., 2005). This test has shown to be correlated with driving performance among older drivers. The UFOV consists of three subtests that assess attention, divided attention, and selective attention. Finally, the participants will complete the Comprehensive Trail Making Test (CTMT), a normed test in which participants are presented with a standardized set of five visual search and sequencing tasks using pen and paper (Reynolds, 2002).
Rapid Pace Walk Administration: A physical assessment involving walking at a brisk pace, potentially used to evaluate gait and mobility, which can impact a person's ability to operate pedals and controls in a vehicle.
Finger to Nose Administration: A motor coordination test where the participant touches their nose with their finger, assessing fine motor skills and coordination relevant for tasks like steering and operating switches while driving.
Adelaide Self-Efficacy Driving Scale: A self-report questionnaire assessing the participant's confidence and perceived ability in various driving situations, helping to understand their subjective assessment of their driving skills.
Modified Simulator Sickness Questionnaire: A questionnaire measuring symptoms of simulator sickness or discomfort experienced during driving simulation sessions, important for evaluating the usability and comfort of simulation-based assessments.
Driving Simulation Evaluation Form: A structured form or checklist used to evaluate the participant's performance and behavior during driving simulation scenarios, providing objective data on driving skills and behaviors.
Manchester Driving Behavior Questionnaire: A questionnaire assessing self-reported driving behaviors and attitudes, offering insights into the participant's driving style, risk perception, and adherence to traffic rules.
The post-assessment tests generally involve reassessing specific aspects measured during the baseline assessment or evaluating any changes or improvements following interventions or training.
2.d. Following these tests, participants will complete their simulation drives. The investigators will employ a clinical driving simulator (DriveSafety Inc., Salt Lake City, UT). Prior to each drive, participants will be exposed to an acclimation drive. Acclimation drives are part of a mitigation protocol aimed at reducing the likelihood of participants experiencing discomfort caused by simulation. Such drives last no longer than 7 minutes, and slowly introduce the participant to the simulation, starting with simple maneuvers (e.g., accelerate ad stop) and progressively introducing more complex maneuvers (e.g. turning).
2.e. Each Participants will then complete a randomized 15-minute drive. Participants will then take part in three sets of four training sessions in which the ADAS will be simulated (experimental group) or a training script will be provided (control). After each set of four drives, a simulator assessment post-test will be completed with the final post-test also including the battery of clinical assessments. Available routes will be randomly allocated and counterbalanced across participants. All drives will be recorded (frontal view of the driver as well as simulated drive). Once a participant has completed all drives, the recordings will be sent to a blinded trained evaluator (occupational therapist and driving rehabilitation specialist). The study will use a high-fidelity clinical driving simulator (DriveSafety Inc) configured with three 19 inch flat-panel displays; 110-degree field of view; 1920 x 1080 pixels/screen. Raw files will be used to develop and compute the model for comparison. The drive using the simulator will be recorded (mp4). This will allow the post-drive evaluation of the number and type of driving errors conducted by the research team. In addition to recording the simulation drive, a camera located in the simulator records the face of the driver to enable scoring of visual scanning errors. All video files are stored in the password protected research drive connected to the simulator computer in the research lab, and only accessible to members of this research team. There will also be a stereo camera attached to the simulator for collecting gaze information of the driver. This camera is connected to a computer running gaze analysis software and records only the gaze directions (as vector in the 3D space of the camera) and head direction (also a vector in the 3D space of the camera). This data is numeric and will be stored using the identifier assigned to the participant; no images are collected from this camera. Prior to and after each drive, the Adapted Motion Sickness Questionnaire will be used to monitor for any signs of simulator sickness. If a participant scores over 5 in any of the items, the session will be suspended, the participants remunerated and provided with access to water, ginger ale, crackers, and cool room. No further drives will be attempted to avoid any risk of increasing simulator sickness.
2.f. After the driving session, the research team will thank the participant and provide remuneration.
3.In order to give the team access to the driving simulator metrics of each drive, a password protected One Drive folder within Western's license will be used. Only deidentified driving simulator data will be uploaded to the One Drive.
### Conditions Module
**Conditions:**
- Older Adults
- Driving
- Simulator
**Keywords:**
- Simulator driving, ADAS, Older Adults
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** The parallel model involves comparing two distinct groups, in this case, older drivers (≥65 years of age), who are randomly assigned to either receive ADAS-integrated driver simulation training or driving-simulator training alone. This model allows for a direct comparison between the two groups regarding the effectiveness of the targeted ADAS intervention on driving performance.
##### Masking Info
**Masking:** NONE
**Masking Description:** Masking, also known as blinding, refers to the practice of concealing information about the intervention assignment from certain parties involved in a study to reduce bias. In the described study, the masking applies to the Outcomes Assessor, who is an independent blinded occupational therapist responsible for evaluating the driving performance of participants. This means that the Outcomes Assessor will not be aware of which group (ADAS-integrated driver simulation training or driving-simulator training alone) each participant belongs to during the assessment process, helping to ensure an unbiased evaluation of the study outcomes.
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 68
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The intervention administered in this study is ADAS-integrated driver simulation training. Participants in this arm will undergo training sessions using a high-fidelity driving simulator equipped with Lane Departure Warning (LDW), Cruise Control (CC), and Forward Proximity Warning (FPW) technologies. These technologies are designed to assist older drivers (≥65 years of age) in improving their driving performance and reducing critical driving errors. The training will simulate real-world driving scenarios to help participants become familiar with and effectively use these ADAS features.
**Intervention Names:**
- Behavioral: The intervention name in this study is ADAS-integrated driver simulation training.
**Label:** ADAS-integrated driver simulation training
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ADAS-integrated driver simulation training
**Description:** The intervention involves providing older drivers (≥65 years of age) with training sessions utilizing a high-fidelity driving simulator. This training focuses on the integration and use of Lane Departure Warning (LDW), Cruise Control (CC), and Forward Proximity Warning (FPW) technologies, collectively referred to as ADAS. The training is designed to familiarize participants with these advanced driver assistance systems, enabling them to effectively utilize these features while driving.
**Name:** The intervention name in this study is ADAS-integrated driver simulation training.
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** This outcome aims to assess the sustained efficacy of a targeted Advanced Driver Assistance Systems (ADAS) intervention comprising Lane Departure Warning (LDW), Cruise Control (CC), and Forward Proximity Warning (FPW) technologies on the driving performance of older drivers (≥65 years). The study compares the performance of participants who receive ADAS-integrated driver simulation training against those who undergo driving-simulator training alone. The primary focus is on measuring the decrease in critical driving errors, as evaluated by an independent blinded occupational therapist, across post-test intervals.
**Measure:** Number of driving errors
**Time Frame:** The study will span over a 12-week period, encompassing pre-test, post-test 1, and post-test 2 assessments.
**Description:** The blinded evaluator will record type pf driving errors, to establish if there is a decrease in the number of critical driving errors (i.e. those requiring physical intervention from an instructor).
**Measure:** Type of driving errors
**Time Frame:** The study will span over a 12-week period, encompassing pre-test, post-test 1, and post-test 2 assessments.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Must be 65 years of age or older.
* Must hold a valid driver's license.
Exclusion Criteria:
* Neurological or psychiatric conditions that would preclude driving
* Use of psychotropic medications that may have a sustained negative impact on mental and/or physical functioning
**Healthy Volunteers:** True
**Minimum Age:** 65 Years
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437652
**Brief Title:** An AI Algorithm for Lymphocyte Focus Score of Minor Salivary Gland Biopsy Samples for Diagnosing Sjogren's Syndrome
**Official Title:** An Artificial Intelligence Algorithm for Lymphocyte Focus Score in Whole Slide Images of Minor Salivary Gland Biopsy Samples for Diagnosing Sjogren's Syndrome : a Blinded Clinical Validation and Deployment Study
#### Organization Study ID Info
**ID:** SYSKY-2023-915-01
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
### Status Module
#### Completion Date
**Date:** 2024-09-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-10-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
#### Responsible Party
**Investigator Affiliation:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
**Investigator Full Name:** Moyingqian
**Investigator Title:** Director
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this research is to discover an artificial intelligence (AI) algorithm for lymphocyte focus score in whole slide images of labial minor salivary gland (SG) biopsy samples for diagnosing Sjogren's Syndrome, in order to enhance the precision of pathological interpretation of labial minor SG biopsy samples in patients with suspected Sjogren's syndrome and aid clinicians make an accurate diagnose. A remote AI-assisted pathological interpretation platform for lymphocyte focus score in labial SG will be built for the global based on the research results. The research will propose the AI-assisted pathological interpretation of lymphocyte focus score in labial minor SG biopsy samples in the future guidelines for the diagnosis and treatment of Sjogren's syndrome.
The research will：
1. Develop and debug the AI algorithm for lymphocyte focus score in whole slide images of labial minor SG biopsy samples for diagnosing Sjogren's Syndrome;
2. Internal test of the AI algorithm;
3. Clinical validation of the AI algorithm with blind method in multiple centers; 4）Built a remote AI-assisted pathological interpretation platform for lymphocyte focus score in labial SG for the global and Explore its clinical application.
**Detailed Description:** 1. Develop and debug the AI algorithm for lymphocyte focus score in whole slide images of labial minor SG biopsy samples for diagnosing Sjogren's Syndrome; A total of 200 H\&E staining slides of labial minor SG biopsy samples are collected from Sun Yat-sen Memorial Hospital of Sun Yat-sen University and scanned into digital pathological images. The ground truth of gland tissue area and lymphocyte foci numbers in each image is interpreted by three senior pathologists with over 5 years of related experience.
2. Internal test of the AI algorithm; A total of 500 additional digital pathological images of labial gland biopsy tissues are collected from Sun Yat-sen Memorial Hospital of Sun Yat-sen University. The ground truth of gland tissue area and lymphocyte foci numbers in each images is interpreted by three senior pathologists with over 5 years of related experience. The AI algorithm's accuracy, specificity, sensitivity, positive predictive value and negative predictive value in evaluating the area of labial gland and the number of lymphocyte foci are calculated. Comparison of whether the image meets the criteria for Sjögren's syndrome (focus score greater than 1) is also conducted between the AI algorithm and the ground truth.
3. Clinical validation of the AI algorithm with blind method in multiple centers; A total of 600 additional digital pathological images of labial gland biopsy tissues are collected from six external centers. The ground truth of gland tissue area and lymphocyte foci numbers in each images is interpreted by three senior pathologists with over 5 years of related experience. The AI algorithm's accuracy, specificity, sensitivity, positive predictive value and negative predictive value in evaluating the area of labial gland and the number of lymphocyte foci are calculated. Comparison of whether the image meets the criteria for Sjögren's syndrome (focus score greater than 1) is also conducted between the AI algorithm and the ground truth.
4）Built a remote AI-assisted pathological interpretation platform for lymphocyte focus score in labial SG for the global and Explore its clinical application.
Digital pathological images of labial gland biopsy tissue can be uploaded to the Labial Gland Pathological Focus Score Remoting platform. AI-assisted pathological interpretation on gland tissue area, lymphocyte foci numbers, and whether meeting the criteria for Sjögren's syndrome (focus score greater than 1) is compared with the ground truth.
### Conditions Module
**Conditions:**
- Sjogren's Syndrome
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 1000
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** The ground truth of gland tissue area and lymphocyte foci numbers in consecutive images is interpreted by three senior pathologists with over 5 years of related experience. The focal score is determined by the gland tissue area and the number of lymphocyte foci. AI-assisted interpretation is compared with ground truth.
**Measure:** The accuracy of pathological interpretation of focal index of labial gland tissue
**Time Frame:** during the procedure
#### Secondary Outcomes
**Description:** AI-assisted interpretation is compared with ground truth.
**Measure:** The precision of pathological interpretation regarding the area of glandular tissue and the count of lymphocyte foci in labial gland tissue.
**Time Frame:** during the procedure
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* The original format of digital pathological images of labial gland biopsy tissue from patients with suspected Sjögren's Syndrome uploaded to the designated platform.
Exclusion Criteria:
1. Overlapping layers of cells due to excessively thick sections;
2. Excessive tissue defects caused by incomplete sectioning or poor staining on slides;
3. Absence of labial gland;
4. Insufficient clarity in the image.
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The suspected SjS patients presenting with ocular dryness and/or oral dryness, as determined by the American-European Consensus Group (AECG) questions
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ying-Qian Mo, Dr.
**Phone:** 00861356497192
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Guangzhou
**Country:** China
**Facility:** Ying-Qian Mo
**State:** Guangdong
**Status:** RECRUITING
**Zip:** 510120
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000001172
- Term: Arthritis, Rheumatoid
- ID: D000001168
- Term: Arthritis
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000012216
- Term: Rheumatic Diseases
- ID: D000014987
- Term: Xerostomia
- ID: D000012466
- Term: Salivary Gland Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000015352
- Term: Dry Eye Syndromes
- ID: D000007766
- Term: Lacrimal Apparatus Diseases
- ID: D000005128
- Term: Eye Diseases
- ID: D000003240
- Term: Connective Tissue Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M15664
- Name: Sjogren's Syndrome
- Relevance: HIGH
- As Found: Sjogren's Syndrome
- ID: M4476
- Name: Arthritis
- Relevance: LOW
- As Found: Unknown
- ID: M4480
- Name: Arthritis, Rheumatoid
- Relevance: LOW
- As Found: Unknown
- ID: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15045
- Name: Rheumatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6323
- Name: Collagen Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17724
- Name: Xerostomia
- Relevance: LOW
- As Found: Unknown
- ID: M15285
- Name: Salivary Gland Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12019
- Name: Mouth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- 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: M10786
- Name: Lacrimal Apparatus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6464
- Name: Connective Tissue Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012859
- Term: Sjogren's Syndrome
- ID: D000013577
- Term: Syndrome
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437639
**Brief Title:** MEXIDOL® Sequential Therapy of Patients With Primary Open-angle Glaucoma (POAG)
**Official Title:** Prospective, Open, Comparative, Randomized Study of the Efficacy and Safety Evaluation of the Mexidol® Sequential Therapy of Patients With Primary Open-angle Glaucoma (POAG)
#### Organization Study ID Info
**ID:** MexidolPOAG2024
#### Organization
**Class:** INDUSTRY
**Full Name:** Pharmasoft
### Status Module
#### Completion Date
**Date:** 2024-02-02
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-11-29
**Type:** ACTUAL
#### Start Date
**Date:** 2023-09-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Pharmasoft
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Hypothesis: The use of neurocytoprotectors helps restore the functional activity of mitochondria, improve the nervous activity of the retina and optic nerve, and stabilize the glaucomatous process.
**Detailed Description:** Hypothesis: Mexidol® allows to optimize POAG therapy by reducing mitochondrial dysfunction and stabilizing glaucomatous optic neuropathy by improving the functional activity of mitochondria and its energy-producing function
### Conditions Module
**Conditions:**
- Primary Open-Angle Glaucoma (POAG)
**Keywords:**
- Glaucoma
- Primary Open-Angle Glaucoma (POAG)
- Glaucomatous Optic Neuropathy (GON)
- Mitochondrial Dysfunction
- Neuroprotection
- Mexidol
- Ethylmethylhydroxypyridine Succinate
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 80
**Type:** ACTUAL
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Mexidol IV 300 mg for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 8 weeks
**Intervention Names:**
- Drug: Mexidol
**Label:** Main (Mexidol and standard therapy)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** IOP normalizing therapy
**Label:** Control (standard therapy)
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Main (Mexidol and standard therapy)
**Description:** Neurocytoprotector
**Name:** Mexidol
**Other Names:**
- Ethylmethylhydroxypyridine Succinate
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Enzyme status of lymphocytes (Succinate dehydrogenase and Glycerophosphate dehydrogenase)
**Measure:** Degree of expression of mitochondrial dysfunction
**Time Frame:** 90 days
**Description:** Cytomorphodensitometry (number of mitochondria, their optical density, number of granules and deposits in the mitochondria of lymphocytes)
**Measure:** Dynamics of the structural and functional characteristics of mitochondria
**Time Frame:** 90 days
#### Secondary Outcomes
**Description:** Dynamics of index of mean deviation (MD) of retinal photosensitivity \[Static Automated Perimetry (SAP)\]
**Measure:** Аssessment of differential light sensitivity of the retina
**Time Frame:** 90 days
**Description:** The average thickness of retinal nerve fibers (RNFL) of the peripapillary zone in four quadrants was studied using the Fast RNFL Thickness program and the thickness of the retinal ganglion cell complex (GCC-Ganglion Cell Complex protocol)
**Measure:** Structural and topographic changes in the layer of nerve fibers and the retinal ganglion [Optical Coherence Tomography (OCT) parameters]
**Time Frame:** 90 days
**Description:** Adverse events related to Mexidol
**Measure:** Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
**Time Frame:** 90 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* An advanced stage of POAG in one or two eyes
* Hypotonic-compensated intraocular pressure (IOP)
Exclusion Criteria:
* Degenerative diseases of the central nervous system, diabetes mellitus
* Primary mitochondrial dysfunction
* A history of surgical interventions and damage to the organ of vision
* Acute or chronic inflammatory or hereditary degenerative eye diseases (anterior and posterior sections)
* Decompensation of concomitant somatic diseases
* Taking antioxidants/nootropic drugs 6 months before inclusion in the study
* Hypersensitivity to ethylmethylhydroxypyridine succinate or to any of the excipients
**Maximum Age:** 65 Years
**Minimum Age:** 50 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Tyumen
**Country:** Russian Federation
**Facility:** Tyumen Scientific Center of the Russian Academy of Sciences
**Zip:** 625026
## Derived Section
### Condition Browse Module - Ancestors
- 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: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M9013
- Name: Glaucoma
- Relevance: HIGH
- As Found: Glaucoma
- ID: M9014
- Name: Glaucoma, Open-Angle
- Relevance: HIGH
- As Found: Primary Open Angle Glaucoma
- ID: M12832
- Name: Optic Nerve Diseases
- Relevance: LOW
- As Found: Unknown
- 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
### Condition Browse Module - Meshes
- ID: D000005901
- Term: Glaucoma
- ID: D000005902
- Term: Glaucoma, Open-Angle
### Intervention Browse Module - Ancestors
- ID: D000000975
- Term: Antioxidants
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000020011
- Term: Protective Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000010975
- Term: Platelet Aggregation Inhibitors
- ID: D000011619
- Term: Psychotropic Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: PlAggInh
- Name: Platelet Aggregation Inhibitors
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M249938
- Name: Emoxypine succinate
- Relevance: HIGH
- As Found: Karenitecin
- ID: M4292
- Name: Antioxidants
- Relevance: LOW
- As Found: Unknown
- ID: M21869
- Name: Protective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M13865
- Name: Platelet Aggregation Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M14474
- Name: Psychotropic Drugs
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000070020
- Term: Emoxypine succinate
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437626
**Acronym:** MIR
**Brief Title:** MEXIDOL® Sequential Therapy of Patients With Acute Cerebral Failure
**Official Title:** Prospective International Multicenter Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety Evaluation of the Mexidol® Sequential Therapy of Patients in the Acute and Early Recovery Periods of Ischemic Stroke
#### Organization Study ID Info
**ID:** MexidolMIR2023
#### Organization
**Class:** INDUSTRY
**Full Name:** Pharmasoft
#### Secondary ID Infos
**Domain:** Ministry of Health, Russian Federation
**ID:** PHS-APIS-004-MEX-SOL-TAB
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2023-08-18
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-08-18
**Type:** ACTUAL
#### Start Date
**Date:** 2019-11-18
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Pharmasoft
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Cerebral stroke is one of the most pressing clinical and social problems of modern medicine. According to WHO estimates, acute cerebral failure rank second among all causes of death. Optimizing the treatment of such conditions remains an urgent problem in neurology and rehabilitation.
**Detailed Description:** Hypothesis: The addition of neurocytoprotectors to standard therapy in the acute and early recovery periods of Ischemic Stroke helps improve the results of further rehabilitation and reduce the severity of neurological deficit. The multimodal mechanism of action allows Mexidol® to realize a whole range of clinical effects, primarily such as anti-ischemic, vegetotropic, anti-amnestic, nootropic, anxiolytic, anticonvulsant, etc.).
### Conditions Module
**Conditions:**
- Ischemic Stroke, Acute
**Keywords:**
- Ischemic Stroke
- Acute Stroke
- Cerebral stroke
- Acute Cerebrovascular Accident
- ACVA
- Acute cerebral failure
- Neuroprotection
- Mexidol
- Ethylmethylhydroxypyridine Succinate
### 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:** 304
**Type:** ACTUAL
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Mexidol IV 500 mg 2 times a day for 10 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
**Intervention Names:**
- Drug: Mexidol
**Label:** Main (Mexidol and standard therapy)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Placebo and standard therapy according to a scheme similar to the main group
**Intervention Names:**
- Other: Placebo
**Label:** Control (Placebo and standard therapy)
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Main (Mexidol and standard therapy)
**Description:** Neurocytoprotector
**Name:** Mexidol
**Other Names:**
- Ethylmethylhydroxypyridine Succinate
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Control (Placebo and standard therapy)
**Description:** Placebo therapy
**Name:** Placebo
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The Modified Rankin Scale (mRS) \[6 point scale: min value 0, max value 5, higher scores mean a worse outcome\]
**Measure:** Measures the degree of disability or dependence in the daily activities
**Time Frame:** 71 days
#### Secondary Outcomes
**Description:** The National Institutes of Health Stroke Scale (NIHSS) \[43 point scale: min value 0, max value 42, higher scores mean a worse outcome\]
**Measure:** Quantifying stroke severity
**Time Frame:** 71 days
**Description:** The Rivermead index \[16 point scale: min value 0, max value 15, higher scores mean a better outcome\]
**Measure:** Dynamics of level of mobility
**Time Frame:** 71 days
**Description:** The Montreal Cognitive Assessment (MoCA test) \[31 point scale: min value 0, max value 30, higher scores mean a better outcome\]
**Measure:** Dynamics of cognitive status
**Time Frame:** 71 days
**Description:** The Hospital Anxiety and Depression Scale (HADS) \[43 point scale: min value 0, max value 42, higher scores mean a worse outcome\]
**Measure:** Reduction in anxiety
**Time Frame:** 71 days
**Description:** Adverse events related to Mexidol
**Measure:** Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
**Time Frame:** 71 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Acute Ischemic Stroke confirmed by neuroimaging methods (CT, MRI)
* Modified Rankin Scale, mRS ≥ 3
* National Institutes of Health Stroke Scale: 9 ≤ NIHSS ≤ 15
Exclusion Criteria:
* Repeated or hemorrhagic stroke;
* Traumatic brain injury with severe neurological symptoms and cognitive impairment;
* Patients who have undergone thrombolytic therapy or thrombectomy;
* History of clinically significant allergic reactions, hypersensitivity and/or intolerance to any component of the study drug or placebo;
* Parkinson's disease, parkinsonism, multiple sclerosis, epilepsy, degenerative diseases of the central nervous system (CNS), history of dementia of the Alzheimer's type;
* BMI (Body Mass Index) \> 35
* Systemic autoimmune diseases or vascular collagenoses requiring previous or current treatment with systemic corticosteroid drugs, cytostatics;
* Malignant neoplasms within the last 5 years;
* Need to use drugs prohibited in this study;
* Having a positive result of a rapid test for IgM antibodies to the SARS-CoV-2 virus;
* Need for surgical intervention;
* History of alcohol or drug addiction;
* Positive result of at least one of the following tests: blood test for HIV, syphilis, hepatitis B and C;
* Pregnancy or lactation period;
* Participation of the patient in any clinical trial less than 3 months before the start of the present one.
**Maximum Age:** 75 Years
**Minimum Age:** 40 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Almaty
**Country:** Kazakhstan
**Facility:** Almaty City Hospital № 7
**Zip:** 050006
**Location 2:**
**City:** Kazan
**Country:** Russian Federation
**Facility:** Tatarstan Republican Clinical Hospital
**Zip:** 410064
**Location 3:**
**City:** Kazan
**Country:** Russian Federation
**Facility:** Interregional Clinical Diagnostic Center
**Zip:** 420101
**Location 4:**
**City:** Kazan
**Country:** Russian Federation
**Facility:** Kazan City Hospital № 7
**Zip:** 420103
**Location 5:**
**City:** Kemerovo
**Country:** Russian Federation
**Facility:** Kemerovo City Clinical Hospital № 11
**Zip:** 650014
**Location 6:**
**City:** Krasnodar
**Country:** Russian Federation
**Facility:** Research Institute - Regional Clinical Hospital № 1
**Zip:** 350086
**Location 7:**
**City:** Moscow
**Country:** Russian Federation
**Facility:** Federal Center for Brain and Neurotechnology
**Zip:** 117997
**Location 8:**
**City:** Moscow
**Country:** Russian Federation
**Facility:** Russian National Research Medical University n.a. N. I. Pirogov
**Zip:** 117997
**Location 9:**
**City:** Rostov-on-Don
**Country:** Russian Federation
**Facility:** Rostov State Medical University
**Zip:** 344022
**Location 10:**
**City:** Saint Petersburg
**Country:** Russian Federation
**Facility:** Alexandrovskaya Hospital
**Zip:** 193312
**Location 11:**
**City:** Saint Petersburg
**Country:** Russian Federation
**Facility:** St. Petersburg Clinical Hospital № 26
**Zip:** 196247
**Location 12:**
**City:** Saint Petersburg
**Country:** Russian Federation
**Facility:** National Medical Research Center n.a. V. A. Almazov
**Zip:** 197341
**Location 13:**
**City:** Saint Petersburg
**Country:** Russian Federation
**Facility:** City Hospital № 40 of Kurortny District
**Zip:** 197706
**Location 14:**
**City:** Samara
**Country:** Russian Federation
**Facility:** Samara Regional Clinical Hospital n.a. V. D. Seredavin
**Zip:** 443095
**Location 15:**
**City:** Ulyanovsk
**Country:** Russian Federation
**Facility:** Central Clinical Medical and Sanitary Unit n.a. V. A. Egorov
**Zip:** 432026
**Location 16:**
**City:** Voronezh
**Country:** Russian Federation
**Facility:** Voronezh Regional Clinical Hospital № 1
**Zip:** 394066
**Location 17:**
**City:** Vsevolozhsk
**Country:** Russian Federation
**Facility:** Vsevolozhsk Clinical Interdistrict Hospital
**Zip:** 188643
**Location 18:**
**City:** Yaroslavl
**Country:** Russian Federation
**Facility:** Yaroslavl Clinical Hospital № 2
**Zip:** 150030
**Location 19:**
**City:** Tashkent
**Country:** Uzbekistan
**Facility:** The first clinic of the Tashkent Medical Academy
**Zip:** 100109
## 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
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10543
- Name: Ischemia
- Relevance: HIGH
- As Found: Ischemic
- ID: M22306
- Name: Stroke
- Relevance: HIGH
- As Found: Stroke
- ID: M2400
- Name: Ischemic Stroke
- Relevance: HIGH
- As Found: Ischemic Stroke
- 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
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020521
- Term: Stroke
- ID: D000083242
- Term: Ischemic Stroke
- ID: D000007511
- Term: Ischemia
### Intervention Browse Module - Ancestors
- ID: D000000975
- Term: Antioxidants
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000020011
- Term: Protective Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000010975
- Term: Platelet Aggregation Inhibitors
- ID: D000011619
- Term: Psychotropic Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: PlAggInh
- Name: Platelet Aggregation Inhibitors
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M249938
- Name: Emoxypine succinate
- Relevance: HIGH
- As Found: Karenitecin
- ID: M4292
- Name: Antioxidants
- Relevance: LOW
- As Found: Unknown
- ID: M21869
- Name: Protective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M13865
- Name: Platelet Aggregation Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M14474
- Name: Psychotropic Drugs
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000070020
- Term: Emoxypine succinate
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437613
**Brief Title:** "Effects of Passive Static Stretching of 30 Seconds Versus 60 Seconds on the Hamstring Flexibility in Adults With Hamstring Tightness.
**Official Title:** "Effects of Passive Static Stretching of 30 Seconds Versus 60 Seconds on the Hamstring Flexibility in Adults With Hamstring Tightness.
#### Organization Study ID Info
**ID:** FUI/CTR/2024/9
#### Organization
**Class:** OTHER
**Full Name:** Foundation University Islamabad
### Status Module
#### Completion Date
**Date:** 2024-06-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2023-11-20
**Type:** ACTUAL
#### Start Date
**Date:** 2023-07-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Foundation University Islamabad
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study is a randomised controlled trial and the purpose of this study is to determine the effects of Passive Static Stretching of 30 seconds versus 60 seconds on the Hamstring Flexibility in adults with Hamstring Tightness.
The study is conducted in Rehabilitation department of Fauji Foundation Hospital on the sample of 38 participants. Hamstring flexibility will be evaluated at the beginning by Active knee extension test.
The subjects will be randomized into two group by sealed envelope method. Baseline assessment would be done by using tools of SLR and modified knee extension test and then final assessment will be done after 4 weeks.
**Detailed Description:** The purpose of this study is to determine the effects of passive static stretching on hamstring flexibility in adults with hamstring tightness" adults (age : 18-45 years ) by using
1. Goniometer
2. Straight leg raise (SLR)
3. Passive Hip Flexion Test(PHFT)
4. Active Knee Extension Test( AKET)
5. Modified Knee Extension Test(MKET) Data will be collected before and after the intervention protocol for each participant.
Data collection procedure:The subjects will be advised of the training session schedule following the baseline assessment. Pre and post intervention scores will be recorded.
### Conditions Module
**Conditions:**
- Hamstring Flexibility
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized Controlled Trial
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 32
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Week 1 Passive Hip Flexion Test Straight leg Raise Modified Knee Extension Test Passive Static Stretching 3-4 reps 3-5 second hold in each activity Week 2 Passive Hip Flexion Test Straight leg Raise Modified Knee Extension Test Passive Static Stretching 3-4 reps 3-5 second hold in each activity
Week 3 Passive Hip Flexion Test Straight leg Raise Modified Knee Extension Test Passive Static Stretching 3-4 reps 3-5 second hold in each activity
Week 4 Passive Hip Flexion Test Straight leg Raise Modified Knee Extension Test Passive Static Stretching 3-4 reps 3-5 second hold in each activity
**Intervention Names:**
- Procedure: Passive Static Stretching exercises for 30 seconds
**Label:** Group 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Week 1 Passive Hip Flexion Test Straight leg Raise Modified Knee Extension Test Passive Static Stretching 3-4 reps 3-5 second hold in each activity Week 2 Passive Hip Flexion Test Straight leg Raise Modified Knee Extension Test Passive Static Stretching 3-4 reps 3-5 second hold in each activity Week 3 Passive Hip Flexion Test Straight leg Raise Modified Knee Extension Test Passive Static Stretching 3-4 reps 3-5 second hold in each activity
Week 4 Passive Hip Flexion Test Straight leg Raise Modified Knee Extension Test Passive Static Stretching 3-4 reps 3-5 second hold in each activity
**Intervention Names:**
- Procedure: Passive Static Stretching exercises for 60 seconds
**Label:** Group 2
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group 1
**Description:** Intervention includes Following Tests
1. Passive Hip Flexion Test(PHFT)
2. Straight Leg Raises(SLR)
3. Modified Knee Extension Test(MKET)
**Name:** Passive Static Stretching exercises for 30 seconds
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Group 2
**Description:** Intervention includes Following Tests
1. Passive Hip Flexion Test(PHFT)
2. Straight Leg Raises(SLR)
3. Modified Knee Extension Test(MKET)
**Name:** Passive Static Stretching exercises for 60 seconds
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Numeric Pain Rating Scale has a scale of 0-10 or 0-100 points and can be given verbally or in writing.
**Measure:** Pain intensity
**Time Frame:** 4 weeks
**Description:** Goniometer will be used
**Measure:** Range of motion
**Time Frame:** 4 weeks
**Description:** Physical Function will be assessed using Oswestry disability Questionairre
**Measure:** Physical Function
**Time Frame:** 4 weeks
**Description:** Using Inclinometer
**Measure:** Lumbar range of motion
**Time Frame:** 4 Weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria:
* Adults age ranging from 18-45 years
* Both males and females are included in the study
* Individuals with 90 degree hip flexion having a minimum reduction of 15 degrees in knee extension position.
Exclusion criteria :
* Old adults
* Individuals suffering from any acute or chronic co-morbidities of musculoskeletal, neurologic, cardiovascular or systemic origin
* Post-surgical cases
* Hamstring strain or any other dysfunction in past two years.
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Imran Malik, MS-MSKPT*
**Phone:** +92 355877619
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rawalpindi
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sana Khalid, DPT,MSNMPT,PHD*
- **Phone:** 03444218174
- **Role:** CONTACT
**Country:** Pakistan
**Facility:** Foundation University College of Physical Therapy
**State:** Punjab
**Status:** RECRUITING
**Zip:** 4000
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437600
**Acronym:** MAGIC
**Brief Title:** Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis
**Official Title:** Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis (MAGIC): A Multicenter, Prospective, Open-label, Blinded Endpoint, Randomized Controlled Trial
#### Organization Study ID Info
**ID:** SYSKY-2024-337-01
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
### Status Module
#### Completion Date
**Date:** 2029-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2029-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Shenzhen Hospital of Southern Medical University
#### 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
### Description Module
**Brief Summary:** A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial that aims to evaluate the effect of immediate angioplasty (with or without stenting) for acute ischemic stroke (AIS) with severe intracranial atherosclerotic stenosis (ICAS) in improving the 90-day functional outcome.
**Detailed Description:** This study is a multicenter, prospective, open-label, blinded endpoint, randomized controlled trial designed to evaluate the effect of immediate angioplasty (with or without stenting) for AIS with severe ICAS. The primary outcome is the proportion of patients with a 90-day modified Rankin scale (mRS) of 0-2.
Study intervention: (1) Participants in the experimental group will undergo immediate angioplasty (with or without stenting), and will receive the best medical treatment (BMM) after the procedure. (2) Participants in the control group will receive BMM alone.
This study is anticipated to enroll 418 participants, with 209 participants in each group (1:1 ratio).
### Conditions Module
**Conditions:**
- Stroke, Acute Ischemic
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 418
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive immediate angioplasty (with or without stenting) for the culprit vessel and the target residual stenosis should be less than 30%. All participants will receive the best medical management (BMM).
**Intervention Names:**
- Procedure: Immediate angioplasty
**Label:** The experimental group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will receive BMM alone.
**Label:** The control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- The experimental group
**Description:** See arm/group descriptions.
**Name:** Immediate angioplasty
**Type:** PROCEDURE
### Outcomes Module
#### Other Outcomes
**Description:** Symptomatic intracranial hemorrhage within 36 hours (according to Heidelberg criteria).
**Measure:** SAFETY OUTCOME: Symptomatic intracranial hemorrhage
**Time Frame:** 24 (±12) hours
**Description:** Mortality at 90 days.
**Measure:** SAFETY OUTCOME: Mortality
**Time Frame:** 90(±7) days
**Description:** Any intracranial hemorrhage within 36 hours (according to Heidelberg criteria).
**Measure:** SAFETY OUTCOME: Any intracranial hemorrhage
**Time Frame:** 24 (±12) hours
#### Primary Outcomes
**Description:** The proportion of the mRS 0-2 at 90 days.
**Measure:** The modified Rankin Scale (mRS) 0-2
**Time Frame:** 90(±7) days
#### Secondary Outcomes
**Description:** The proportion of the mRS of 0-1 at 90 days.
**Measure:** The mRS 0-1
**Time Frame:** 90(±7) days
**Description:** The proportion of the mRS of 0-3 at 90 days.
**Measure:** The mRS 0-3
**Time Frame:** 90(±7) days
**Description:** The distribution of the mRS at 90 days.
**Measure:** The shift analysis of the mRS distribution
**Time Frame:** 90(±7) days
**Description:** The change of NIHSS from baseline to 7 days or discharge (whichever comes first).
**Measure:** The change of National Institute of Health Stroke Scale (NIHSS)
**Time Frame:** 7(±1) days or discharge, whichever came first
**Description:** The value of quality of life (EQ-5D-5L) at 90 days.
**Measure:** The quality of life
**Time Frame:** 90(±7) days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Aged 18 years or older.
2. Diagnosed with AIS and baseline NIHSS ≥6.
3. Pre-stroke mRS ≤2, or mRS \>2 but not related to neurological disease (e.g., amputation, blindness).
4. Time from symptom onset to randomization within 24 hours; the onset time refers to "Last Known Well" (LKW).
5. NCCT/DWI-MRI ASPECTS ≥6.
6. CTA, MRA, or DSA confirmed severe ICAS (70-99%) of the intracranial segment of the internal carotid artery, or M1 or M2 segment of the middle cerebral artery, and is presumed to be responsible for the stroke.
7. Signed informed consent.
Exclusion Criteria:
1. Normal diameter of the culprit vessel \<2.0 mm.
2. Hemorrhagic stroke within the past 90 days.
3. Stroke is caused by cerebral vasculitis, arterial inflammatory stenosis, vasospasm, dissection, perforating arteriopathy, and internal capsule warning syndrome.
4. Severe calcification at the site of stenosis, where target residual stenosis \<30% could not be achieved.
5. Stroke caused by cardioembolic origin, but those with only atrial fibrillation but no clear evidence of cardiac thrombosis could still be included in the study.
6. Coagulation disorder with INR\>1.7, use of new oral anticoagulants within the last 48 hours from screening, or use of low molecular weight heparin within the last 24 hours from screening.
7. Known genetic or acquired bleeding disposition with anticoagulation factor deficiency.
8. Platelet count \<50×10\^9/L.
9. Intracranial hemorrhage confirmed by CT or MRI.
10. Women who are pregnant or breastfeeding.
11. Participation in other clinical trials.
12. Known severe renal insufficiency with glomerular filtration rate \<30 ml/min or blood creatinine \>220 μmol/L (2.5 mg/dl).
13. Severe allergy to contrast (non-mild rash allergy) or absolute contraindication to iodine contrast.
14. Aortic dissection.
15. Intracranial tumors or arteriovenous malformations.
16. Previous parenchymal organ surgery or biopsy in the last 1 month.
17. Any active bleeding or recent bleeding (gastrointestinal, urinary tract bleeding, etc.) in the last 1 month.
18. SBP\>185 mmHg or DBP\>110 mmHg refractory to treatment.
19. Anticipated life expectancy \<3 months (e.g., malignancy, severe cardiopulmonary disease, etc.).
20. Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Xinguang Yang, MD
**Phone:** 86-20-81332619
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Xiongjun He, MD, PhD
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Guangzhou
**Contacts:**
***Contact 1:***
- **Name:** Yang Xinguang, Ph.D
- **Phone:** 86-20-81332619
- **Role:** CONTACT
***Contact 2:***
- **Name:** Yamei Tang, M.D., PhD.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
**State:** Guangdong
**Zip:** 510120
**Location 2:**
**City:** Shenzhen
**Country:** China
**Facility:** Shenzhen Hospital of Southern Medical University
**State:** Guangdong
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## 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
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10543
- Name: Ischemia
- Relevance: HIGH
- As Found: Ischemic
- ID: M22306
- Name: Stroke
- Relevance: HIGH
- As Found: Stroke
- ID: M2400
- Name: Ischemic Stroke
- Relevance: HIGH
- As Found: Stroke, Acute Ischemic
- ID: M6475
- Name: Constriction, Pathologic
- 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
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020521
- Term: Stroke
- ID: D000083242
- Term: Ischemic Stroke
- ID: D000007511
- Term: Ischemia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437587
**Brief Title:** Effects of Appropriate Technology for Home-based Rehabilitation in Patients With Post-stroke Physical Dysfunction
**Official Title:** Effects of Appropriate Technology for Home-based Rehabilitation in Patients With Post-stroke Physical Dysfunction
#### Organization Study ID Info
**ID:** HMUDQ20231116205
#### Organization
**Class:** OTHER
**Full Name:** Harbin Medical University
### Status Module
#### Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Harbin Medical University
#### Lead Sponsor
**Class:** OTHER
**Name:** Xi Chen
#### Responsible Party
**Investigator Affiliation:** Harbin Medical University
**Investigator Full Name:** Xi Chen
**Investigator Title:** researcher
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to assess the effect of S-HRAT to improve patients' motor function and activities of daily living.
**Detailed Description:** Limb dysfunction is the primary disability factor among stroke patients. However, due to various factors, most stroke survivors do not receive sufficient rehabilitation training after discharge. Home-based rehabilitation appropriate technology (S-HRAT） training could be a strategy to meet the patients' requirements for rehabilitation after hospital discharge. This study aims to assess the effect of a nursing intervention based on Cox's Interaction Model of Client Health Behavior (IMCHB) with the application of S-HRAT to improve patients' motor function and activities of daily living.
In this pilot trial, 36 stroke survivors with limb dysfunction will be screened for inclusion before hospital discharge and randomly assigned to the experimental or control group with their informed consent. The control group(n=18) will receive the usual care provided by the hospital. The experimental group(n=18) will receive usual care and an 8-week S-HRAT training program. This nursing interventions use Cox's IMCHB as a theoretical framework that consists of rehabilitation exercises and the provision of health information. Baseline assessments will be conducted on the day before hospital discharge, and outcomes will be assessed at 8 weeks and 12 weeks after discharge. The primary outcome is change in motor function 8 weeks after discharge, and the secondary outcomes include the activities of daily living, anxiety, depression, exercise adherence, and patient satisfaction.
This study is the first of its kind conducted in China to use Cox's IMCHB as a framework to guide the development of the S-HRAT training program. Our pilot will determine if such an approach is feasible and effective in enhancing motor function and improving the activities of daily living post-stroke after discharge.
### Conditions Module
**Conditions:**
- Stroke
**Keywords:**
- home-based rehabilitation
- appropriate technology
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** Due to the nature of the intervention, it is impossible to blind the researcher of the intervention who will deliver the intervention. Therefore, the participants and the outcome assessor will be blinded. The outcome assessor will be blinded to the allocation throughout the study and will independently assess all outcomes at T0, T1, and T2 for both groups.
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 36
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Home-based rehabilitation appropriate technology (S-HRAT) training
**Intervention Names:**
- Other: Home-based rehabilitation appropriate technology (S-HRAT) training
**Label:** intervention group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Routine discharge instructions
**Label:** control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- intervention group
**Description:** The S-HRAT training instruction consists of two phases: in-hospital training and post-discharge remote home training. Based on the S-HRAT list, we select individualized home rehabilitation training exercises for the participants and conduct five offline training instruction sessions one week before discharge to ensure that the participants master the correct method for each exercise and clarify precautions. At discharge, participants will receive an S-HRAT brochures, which will include detailed text, pictures and video demonstrations of exercises, to visualize the rehabilitation instructions and make them easy to understand. Participants learn how to use the S-HRAT booklet and follow a daily training program to complete the prescribed content. They will be asked to record a video of their training and send it to the researcher via WeChat for monitoring purposes and feedback.
**Name:** Home-based rehabilitation appropriate technology (S-HRAT) training
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The motor function of the patients is measured using the Motor Assessment Scale (MAS) for stroke. MAS is methodologically simple, targeted, and easily generalizable for motor function assessment in stroke patients, as well as reliable and valid. The scale consists of nine items, each of which is scored from 0 to 6 out of 48, with the ninth item not scoring. Higher scores indicate better motor function.
**Measure:** Motor Function
**Time Frame:** baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
**Description:** Balance was measured using the Berg Balance Scale (BBS). The scale consists of 14 items, including sitting to standing, standing independently, walking independently, and standing to sit, and each item is scored on five functional levels: 0, 1, 2, 3, and 4. A score of 4 indicates that the action under examination can be performed normally. In contrast, a score of 0 indicates that it cannot be performed or requires significant assistance. The total possible score is 56, with higher scores indicating better balance.
**Measure:** Balance
**Time Frame:** baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
#### Secondary Outcomes
**Description:** The Modified Barthel Index(MBI) is used to measure the activity of daily living. The scale consists of ten items, including eating, bathing, grooming, dressing, toileting, bed and chair transfers, walking on level ground, walking up and downstairs, bowel control, and urinary control. The possible score ranges from 0 to 100, and a higher score means greater independence
**Measure:** Activity of Daily Living
**Time Frame:** baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
**Description:** The Functional Exercise Adherence Scale for Stroke Patients (questionnaire of exercise adherence, EAQ) developed by Chinese author Beilei Lin in 2013 was used to assess patients' adherence to rehabilitation exercises. The scale consists of three dimensions: physical participation in exercise, monitoring of exercise effects, and active adherence to seeking exercise advice. Each item is scored using a Likert scale ranging from 0 to 4, with a total score ranging from 14 to 56. A higher score indicates a higher level of exercise adherence.
**Measure:** Exercise Adherence
**Time Frame:** baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
**Description:** The Nursing Job Satisfaction Questionnaire (Client Satisfaction Test, CST) was developed by Bear Bowers based on the IMCHB model and comprises 12 items across six domains: emotional support, health information, decision control, professional skills, service accessibility, and overall satisfaction. The rating method employs a scale of 1 to 5 points, representing five options "very satisfied," "quite satisfied," "not sure," "not too satisfied," and "very dissatisfied." The total scale thus ranges from 12 to 60 points. A higher score on the scale indicates a higher level of patient satisfaction.
**Measure:** Patient Satisfaction
**Time Frame:** baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
**Description:** The Chinese version of the Hospital Anxiety and Depression Scale (HADS) is employed to assess the anxiety and depression levels of patients. The HADS is a frequently used instrument for assessing the severity of anxiety and depression in patients. It is a 14-item instrument comprising two subscales: anxiety (HADS-A, 7 items) and depression (HADS-D, 7 items). Each item is rated on a 4-point Likert scale, ranging from 0 for "no problem" to 3 for "severe problem," with higher scores indicating higher levels of anxiety and depression.
**Measure:** Anxiety and Depression
**Time Frame:** baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age≥18;
* Patients diagnosed with cerebrovascular disease who have cerebral infarction or cerebral hemorrhage based on cranial CT or MRI and meet the diagnostic criteria;
* Patients are in the non-acute phase, meaning between two weeks and six months after the onset of the disease;
* Patients with limb dysfunction.
Exclusion Criteria:
* Return to a hospital or rehabilitation facility after discharge;
* The patient has a history of mental illness and dyslexia;
* Patients have a combination of serious, life-threatening conditions.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
## 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
### Condition Browse Module - Browse Leaves
- ID: M22306
- Name: Stroke
- Relevance: HIGH
- As Found: Stroke
- 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: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437574
**Brief Title:** Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer
**Official Title:** Lowering Cholesterol in Prostate Cancer to Target Rapamycin-Insensitive Companion Of MTOR (TORC2) in T-Cell Surface Glycoprotein CD8 Alpha Chain (CD8+) Lymphocytes
#### Organization Study ID Info
**ID:** STUDY00003290
#### Organization
**Class:** OTHER
**Full Name:** Cedars-Sinai Medical Center
#### Secondary ID Infos
**ID:** R01CA280060
**Link:** https://reporter.nih.gov/quickSearch/R01CA280060
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2028-05-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-02-29
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Cancer Institute (NCI)
#### Lead Sponsor
**Class:** OTHER
**Name:** Cedars-Sinai Medical Center
#### Responsible Party
**Investigator Affiliation:** Cedars-Sinai Medical Center
**Investigator Full Name:** Hyung L. Kim, MD
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** To test the hypothesis that intensive cholesterol lowering (iCL) therapy has anti-tumor immune modulating activity, the investigators will conduct an open-label, single-arm phase II trial in prostate cancer patients who are in active surveillance and undergoing a planned surveillance biopsy in 3-6 months. Eligible patients will initiate iCL with Vytorin®(group 1, 2, and 3), an FDA-approved combination of ezetimibe and simvastatin used to lower atherogenic low density lipoprotein cholesterol (LDL-C) or Ezetimibe (group 4). Starting dose will be determined by current statin use and LDL-C levels. Dose modifications of VYTORIN will be employed with the goal of achieving LDL-C \<70 mg/dl. Dose adjustment is not allowed for ezetimibe.
### Conditions Module
**Conditions:**
- Prostate Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 140
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Single arm with dual agents (ezetimibe and simvastatin) target the two primary sources of cholesterol, absorption in the gut and synthesis in the liver. These 2 agents are available in a single pill that is FDA approved and sold under the trade name, Vytorin.
**Intervention Names:**
- Drug: Vytorin
**Label:** Intensive Lipid Lowering
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intensive Lipid Lowering
**Description:** Vytorin is a drug combination (Ezetimibe and Simvastatin) that targets the two primary sources of cholesterol, absorption in the gut and synthesis in the liver.
**Name:** Vytorin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Our primary hypothesis is that maximum cholesterol lowering will increase CD8+ memory T cells and increase CD8+ T cell infiltration into prostate tissue. Change in CD8+ T cells in the prostate from baseline to 3 to 6 months is the primary endpoint.
**Measure:** Pre/Post-change in percent prostate infiltrating CD8+ T lymphocytes.
**Time Frame:** 3 to 6 months of cholesterol-lowering intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. At least one Atherosclerotic Cardiovascular Disease (ASCVD) risk factor, such as:
1. ≥ 50 years of age
2. Hypertension
3. Hypercholesterolemia
4. Diabetes
5. Current or former smoker
6. First-degree family history of any cardiovascular heart disease
7. BMI \> 25
8. On hypertension treatment, statin, and/or aspirin therapy
4. Patients with clinically localized prostate cancer. That is Low or intermediate risk prostate cancer defined as:
1. Pre-operative PSA (Prostate Specific Antigen) 20.0 ng/ml
2. Clinical stage T1c or cT2
3. Gleason score 3+3 or 3+4 or 4+3
5. Patients on AS with plans for surveillance biopsy
6. No previous treatment for prostate cancer with radiotherapy, chemotherapy, or hormonal therapy
7. Ability to take oral medication and be willing to adhere to once daily, oral Vytorin or ezetimibe.
8. Agree to avoid consumption of grapefruit and grapefruit juice ≥ one quart per day throughout study duration.
Exclusion Criteria:
1. Current use of medications contraindicated for use with a statin such as strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone).
2. Current use of medications contraindicated for use with ezetimibe (i.e., gemfibrozil, cyclosporine, or danazol).
3. History of allergic or severe reaction to a either study agent.
4. History of moderate or severe myalgia with statin use.
5. Acute liver failure or decompensated cirrhosis
6. Already on maximum VYTORIN dose (10/80)
7. Already on a PCSK9 inhibitor
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Amy Hoang
**Phone:** 310-423-1542
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Laura Sarmiento
**Phone:** 310-423-4295
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Cedars-Sinai Medical Center
**Name:** Hyung Kim, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005834
- Term: Genital Neoplasms, Male
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000005832
- Term: Genital Diseases, Male
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000011469
- Term: Prostatic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14335
- Name: Prostatic Neoplasms
- Relevance: HIGH
- As Found: Prostate Cancer
- ID: M8946
- Name: Genital Neoplasms, Male
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8944
- Name: Genital Diseases, Male
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14333
- Name: Prostatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011471
- Term: Prostatic Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000000924
- Term: Anticholesteremic Agents
- ID: D000000960
- Term: Hypolipidemic Agents
- ID: D000000963
- Term: Antimetabolites
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000057847
- Term: Lipid Regulating Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Lipd
- Name: Lipid Regulating Agents
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
### Intervention Browse Module - Browse Leaves
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
- ID: M450
- Name: Ezetimibe, Simvastatin Drug Combination
- Relevance: HIGH
- As Found: Strap
- ID: M21713
- Name: Simvastatin
- Relevance: LOW
- As Found: Unknown
- ID: M21960
- Name: Sirolimus
- Relevance: LOW
- As Found: Unknown
- ID: M409
- Name: Ezetimibe
- Relevance: LOW
- As Found: Unknown
- ID: M353695
- Name: Temsirolimus
- Relevance: LOW
- As Found: Unknown
- ID: M2827
- Name: MTOR Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M340819
- Name: polysaccharide-K
- Relevance: LOW
- As Found: Unknown
- ID: M4243
- Name: Anticholesteremic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4278
- Name: Hypolipidemic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
- ID: M28883
- Name: Lipid Regulating Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000069499
- Term: Ezetimibe, Simvastatin Drug Combination
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437561
**Brief Title:** Report of Ten Cases of Venous Aneurysm in Extremities
**Official Title:** Venous Aneurysm: a Case Series and Review of Literature
#### Organization Study ID Info
**ID:** 114099
#### Organization
**Class:** OTHER
**Full Name:** Golestan University of Medical sciences
### Status Module
#### Completion Date
**Date:** 2024-03-15
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-31
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-03-11
**Type:** ACTUAL
#### Start Date
**Date:** 2024-02-13
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Golestan University of Medical sciences
#### Responsible Party
**Investigator Affiliation:** Golestan University of Medical sciences
**Investigator Full Name:** Pezhman Kharazm, MD
**Investigator Title:** Vascular Surgeon
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Venous aneurysms are not common in general, but because of the inherent risk of thrombosis in aneurysms, their timely diagnosis and treatment are recommended in most of the current sources. Ten cases of venous aneurysms were diagnosed and managed in our vascular surgery department from October 2018 to January 2024. Patient information was extracted from their files retrospectively.
**Detailed Description:** A vascular aneurysm is defined as the focal dilatation of a vessel. Aneurysm is classically used for arterial dilatations, although dilatations can occur in any part of the vascular system including veins. Venous aneurysms are not common in general, but with the increase in the use of duplex ultrasound, the number of cases diagnosed with venous aneurysms has recently increased. Venous aneurysms are more common in the lower limbs, and in the lower limbs, the involvement of the deep venous system is much more than the superficial venous system. According to reports, 77% of venous aneurysms are present in the lower limbs, of which 57% are in the deep venous system and 1.5% in the superficial venous system.
Considering their rarity, venous aneurysms may cause diagnostic challenges in some cases.
The importance of these aneurysms, especially in the lower limbs, which inherently have relative stasis due to the opposite flow direction of gravity, is that by creating venous stasis and whirlwind blood flow inside the aneurysm, they increase the susceptibility to clotting. Also, due to dysfunction of the pigeon nest valves, they cause chronic venous insufficiency. Although clot formation and subsequent pulmonary embolism are more common in deep venous aneurysms, cases of pulmonary embolism secondary to superficial venous aneurysms of the lower limbs have also been reported.
Complications caused by chronic venous insufficiency are more common in aneurysms that occur at the main junctions of superficial and deep veins, including saphenous femoral and saphenous popliteal junctions.
Considering the possible complications mentioned about venous aneurysms, these aneurysms need treatment, regardless of their location, and although in the superficial system, surgical resection is the most commonly recommended method, other surgical methods such as aneurysmectomy and primary repair, resection, and graft interposition, and also endovascular methods have been used. Of course, in case of insufficiency in the venous system, specific treatment of the cause of insufficiency (such as stripping of the large saphenous vein) is necessary in addition to the treatment of the aneurysm.
Regarding the follow-up after the treatment of aneurysms of the superficial system, most articles have recommended short-term treatment with anticoagulants and control of the superficial and deep systems through color doppler.
In this case series, we present 10 cases of venous aneurysms and discuss their presentation, diagnosis, and management.
### Conditions Module
**Conditions:**
- Venous Aneurysm Nos
- Arteriovenous Malformations
- Vascular Diseases
**Keywords:**
- aneurysm
- venous malformation
- vascular surgery
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 10
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** different clinical presentations of extremity venous aneurysms and their prevalence
**Measure:** clinical presentation of extremity venous aneurysms
**Time Frame:** 6 years
**Description:** prevalence of extremity venous aneurysms in different ages
**Measure:** age distribution of extremity venous aneurysms
**Time Frame:** 6 years
**Description:** prevalence of extremity venous aneurysms in upper vs. lower limbs as well as left side vs. right side
**Measure:** location distribution of extremity venous aneurysms
**Time Frame:** 6 years
**Description:** prevalence of extremity venous aneurysms in both sexes
**Measure:** sex distribution of extremity venous aneurysms
**Time Frame:** 6 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
• Clinical diagnosis of venous aneurysm
Exclusion Criteria:
• Patient's non-consent
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** all patients with extremity venous aneurysm since 2018 to 2024
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Gorgan
**Country:** Iran, Islamic Republic of
**Facility:** Pezhman Kharazm, MD
**State:** Golestan
**Zip:** 4917956808
### IPD Sharing Statement Module
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
- ANALYTIC_CODE
**IPD Sharing:** YES
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000054079
- Term: Vascular Malformations
- ID: D000018376
- Term: Cardiovascular 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: M4113
- Name: Aneurysm
- Relevance: HIGH
- As Found: Aneurysm
- ID: M12
- Name: Congenital Abnormalities
- Relevance: HIGH
- As Found: Malformations
- ID: M17400
- Name: Vascular Diseases
- Relevance: HIGH
- As Found: Vascular Disease
- ID: M4473
- Name: Arteriovenous Malformations
- Relevance: HIGH
- As Found: Arteriovenous Malformations
- ID: M27558
- Name: Vascular Malformations
- Relevance: LOW
- As Found: Unknown
- ID: M20503
- Name: Cardiovascular Abnormalities
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000783
- Term: Aneurysm
- ID: D000014652
- Term: Vascular Diseases
- ID: D000001165
- Term: Arteriovenous Malformations
- ID: D000000013
- Term: Congenital Abnormalities
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437548
**Brief Title:** Epidural Stimulation for Upper Extremity Function
**Official Title:** Spinal Cord Stimulation for Reanimation After Nervous System Injury
#### Organization Study ID Info
**ID:** 2024P000185
#### Organization
**Class:** OTHER
**Full Name:** Brigham and Women's Hospital
### Status Module
#### Completion Date
**Date:** 2027-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Brigham and Women's Hospital
#### Responsible Party
**Investigator Affiliation:** Brigham and Women's Hospital
**Investigator Full Name:** Yi Lu, MD PhD
**Investigator Title:** Director of Neurosurgical Trauma, Associate Professor of Neurosurgery
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Restoring upper extremity function in patients with cervical spinal cord injury is extremely important for patients' independence and quality of life.
At present, there are limited options for hand or arm reanimation in this patient population. Nerve transfer is one such option that can partially restore the natural movement of hand or arm function in select patients.
The investigators are interested in understanding whether recovery of hand or arm motor function after nerve transfer can be augmented by cervical epidural spinal cord stimulation.
**Detailed Description:** The study will enroll up to 20 participants in a single arm prospective clinical study. Potential participants will have already had a nerve transfer surgery more than 6 months prior to enrollment and will have also completed post-nerve transfer physical /occupational neurorehabilitation.
At baseline, upper extremity muscle strength, muscle force and nerve health with needle electromyography and neuroimaging will be tested.
Patients will undergo percutaneous (temporary) spinal cord stimulator leads placement in the cervical supralesional spine region.
Week 0-4: Weekly testing of motor function and muscle contraction force with the stimulation turned on versus turned off will be performed. Stimulation parameters for each target upper extremity muscle will also be documented.
Temporary leads will be removed after approximately 4 weeks.
At the last research visit at approximately 6-7 weeks post leads placement muscle strength/force will be assessed to determine the duration of the stimulation effect (if it is sustained). To assess any improvement of nerve health, neuroimaging and electromyography will also be performed.
### Conditions Module
**Conditions:**
- Spinal Cord Injury Cervical
- Tetraplegia
**Keywords:**
- spinal
- cord
- stimulation
- percutaneous
- peripheral
- nerve
- transfer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Percutaneous temporary spinal cord stimulator. Parameters for upper extremity motor function will be assessed with the stimulation turned on and off. Muscle strength and force will be assessed with the stim turned on and off.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All participants will undergo baseline muscle strength and force assessments. Participants will also answer questionnaires on pain and quality of life. An optional nerve health assessment with needle electromyography and neuroimaging may be performed.
Participants will undergo clinically indicated percutaneous (temporal) cervical epidural leads placement.
Weeks 0-4 post-leads placement: during weekly visits upper extremity muscle strength and force will be assessed, pain and quality of life questionnaires will be completed (1 research visit per week)
At approximately 28 days temporary leads will be removed.
At the last visit, muscle strength and force in upper extremity muscle groups will be assessed, participants will complete pain and quality of life questionnaires. Participants may choose to undergo an optional nerve health assessment with needle electromyography and neuroimaging.
**Intervention Names:**
- Device: Percutaneous spinal cord stimulation
**Label:** Percutaneous spinal cord stimulation
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Percutaneous spinal cord stimulation
**Description:** The parameters of percutaneous cervical spinal cord stimulation leads will be adjusted for optimal upper extremity motor function.
**Name:** Percutaneous spinal cord stimulation
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Change in Medical Research Council (MRC) grade of recipient nerve transfer muscle group with spinal cord stimulation activated. MRC ranges from 0 (no visible muscle contraction) to 5 (normal muscle strength against full resistance). A larger number represents a better outcome.
**Measure:** Nerve transfer recipient muscle strength
**Time Frame:** 0-6 weeks
#### Secondary Outcomes
**Description:** Change in muscle force generated by recipient nerve transfer muscle group with spinal cord stimulation activated. Muscle force is measured with a hand-held dynamometer. This is measured in Newtons, with a larger number meaning greater force and a better outcome.
**Measure:** Nerve transfer recipient muscle force
**Time Frame:** 0-6 weeks
**Description:** Change in neck and upper extremity pain measured with the Numeric Rating Scale (NRS). NRS scale ranges from 0 (No pain) to 10 (worst possible pain), with a lower number representing a better outcome. A positive change in NRS from baseline to follow-up visits suggests improvement of pain.
**Measure:** Neck and upper extremity pain
**Time Frame:** 0-6 weeks
**Description:** Optimized amplitude of percutaneous stimulation for each upper extremity muscle for voluntary hand/arm motor function will be documented. Amplitude is measured in miliAmperes.
**Measure:** Amplitude of percutaneous stimulation
**Time Frame:** 0-4 weeks
**Description:** Optimized frequency of percutaneous stimulation for each upper extremity muscle for voluntary hand/arm motor function will be documented. Frequency is measured in Hz (Hertz).
**Measure:** Frequency of percutaneous stimulation
**Time Frame:** 0-4 weeks
**Description:** Optimized pulse width of percutaneous stimulation for each upper extremity muscle for voluntary hand/arm motor function will be documented. Pulse width is measured in microseconds.
**Measure:** Pulse width of percutaneous stimulation
**Time Frame:** 0-4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥18 years and ≤65
* Provides informed consent
* History of upper extremity nerve transfer \> 6 months prior to enrollment
* Completion of standard post-nerve transfer occupational therapy
* Baseline upper extremity strength of \< 5/5 grade with the MRC
* Scheduled to undergo a cervical spinal cord stimulation procedure for chronic pain refractory to first line therapy
* Willing and able to adhere to the study protocol
Exclusion Criteria:
* Central nervous system (CNS) malignancy
* A contraindication to the SCS procedure
* Diagnosis that precludes the patient from full participation in the protocol
* A functional implanted device (pacemaker, vagus nerve device, baclofen pump)
* Botulinum toxin injection in upper extremity muscles \< 6 months prior to enrollment
* For female participants, current/planned pregnancy (females of childbearing age will be asked to take a pregnancy test on the day of the intervention)
* Other factors that prevent participation in the opinion of the surgeon-principal investigator
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Benjamin R. Johnston, MD PhD
**Phone:** (617) 525-7378
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Joshua I. Chalif, MD PhD
**Phone:** (617) 525-7378
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Brigham and Women's Hospital
**Name:** Yi Lu, MD PhD
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**Description:** Individual participant data will not be shared with researchers outside of the study, except as required de-identified data for publication purposes.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Bertelli JA, Ghizoni MF. Nerve transfers for restoration of finger flexion in patients with tetraplegia. J Neurosurg Spine. 2017 Jan;26(1):55-61. doi: 10.3171/2016.5.SPINE151544. Epub 2016 Aug 5.
**PMID:** 27494781
**Citation:** Fox IK. Nerve Transfers in Tetraplegia. Hand Clin. 2016 May;32(2):227-42. doi: 10.1016/j.hcl.2015.12.013. Epub 2016 Mar 10.
**PMID:** 27094894
**Citation:** Lu DC, Edgerton VR, Modaber M, AuYong N, Morikawa E, Zdunowski S, Sarino ME, Sarrafzadeh M, Nuwer MR, Roy RR, Gerasimenko Y. Engaging Cervical Spinal Cord Networks to Reenable Volitional Control of Hand Function in Tetraplegic Patients. Neurorehabil Neural Repair. 2016 Nov;30(10):951-962. doi: 10.1177/1545968316644344. Epub 2016 May 18.
**PMID:** 27198185
**Citation:** Barra B, Conti S, Perich MG, Zhuang K, Schiavone G, Fallegger F, Galan K, James ND, Barraud Q, Delacombaz M, Kaeser M, Rouiller EM, Milekovic T, Lacour S, Bloch J, Courtine G, Capogrosso M. Epidural electrical stimulation of the cervical dorsal roots restores voluntary upper limb control in paralyzed monkeys. Nat Neurosci. 2022 Jul;25(7):924-934. doi: 10.1038/s41593-022-01106-5. Epub 2022 Jun 30.
**PMID:** 35773543
**Citation:** Greiner N, Barra B, Schiavone G, Lorach H, James N, Conti S, Kaeser M, Fallegger F, Borgognon S, Lacour S, Bloch J, Courtine G, Capogrosso M. Recruitment of upper-limb motoneurons with epidural electrical stimulation of the cervical spinal cord. Nat Commun. 2021 Jan 19;12(1):435. doi: 10.1038/s41467-020-20703-1.
**PMID:** 33469022
**Citation:** Powell MP, Verma N, Sorensen E, Carranza E, Boos A, Fields DP, Roy S, Ensel S, Barra B, Balzer J, Goldsmith J, Friedlander RM, Wittenberg GF, Fisher LE, Krakauer JW, Gerszten PC, Pirondini E, Weber DJ, Capogrosso M. Epidural stimulation of the cervical spinal cord for post-stroke upper-limb paresis. Nat Med. 2023 Mar;29(3):689-699. doi: 10.1038/s41591-022-02202-6. Epub 2023 Feb 20.
**PMID:** 36807682
## 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
- ID: D000010243
- Term: Paralysis
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M15916
- Name: Spinal Cord Injuries
- Relevance: HIGH
- As Found: Spinal Cord Injury
- ID: M14632
- Name: Quadriplegia
- Relevance: HIGH
- As Found: Tetraplegia
- ID: M22023
- Name: Trauma, Nervous System
- Relevance: LOW
- As Found: Unknown
- 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: M13157
- Name: Paralysis
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013119
- Term: Spinal Cord Injuries
- ID: D000011782
- Term: Quadriplegia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437535
**Brief Title:** Role of Vaspin in Pathophysiology of Pre-eclampsia
**Official Title:** The Pathophysiological Role of Vaspin and Apoptosis in Pre-eclamptic Obese Women
#### Organization Study ID Info
**ID:** vaspin and pre-eclampsia
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2025-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assiut University
#### Responsible Party
**Investigator Affiliation:** Assiut University
**Investigator Full Name:** Aya Ali Ibrahim Sayed
**Investigator Title:** principal investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** * To investigate the possible role of vaspin and apoptosis in pre-eclamptic obese women .
* To compare the serum as well as placental level of vaspin in normotensive and severe pre-eclamptic obese women.
* To compare the serum as well as placental level of vaspin in normotensive normal body weight and severe pre-eclamptic obese women women .
* To compare placental apoptosis marker Bcl2 in normotensive and severe pre-eclamptic obese women .
* To compare placental apoptosis marker Bcl2 in normotensive normal body weight and severe pre-eclamptic obese women .
* Correlation between vaspin and apoptosis in pre-eclamptic obese women .
* Correlation between vaspin level and apoptosis marker with patient demographic data(Age -parity).
**Detailed Description:** • Pre-eclampsia(PE) is defined as new onset hypertension after 20 weeks gestation with evidence of maternal organ or uteroplacental dysfunction or proteinuria. The majority of maternal deaths related to PE can be avoided by providing timely and effective care and delivery to high-risk women. Thus, optimization of health care for women during pregnancy to prevent and treat PE . PE classified clinically to mild and severe sub types as Pregnant women with BP≥160/110 mmHg and proteinuria ≥3+ reading on dipstick are classified as having severe PE while pregnant women with systolic blood pressure of 140 -159 mmHg, diastolic blood pressure of 90-109 mmHg, and proteinuria ≥1+ reading on dipstick are classified as having mild PE.. Vaspin, a member of adipokines was first isolated from the visceral adipose tissue of the rat abdominal obesity model (OLETF). It belongs to the serine protease inhibitors and acts through a protein G-coupled receptor - GRP78. Vaspin has also found in the liver, pancreas, cerebrospinal fluid, hypothalamus, intestine, and lungs.it has pleiotropic functions that include regulating inflammatory response, insulin resistance and the development of obesity. Vaspin like other adipokines including leptin and adiponectin can affect the female reproduction system like ovary. Vaspin expression was detected in another reproductive component, the placenta. In humans, vaspin was localized in cytotrophoblasts and syncytiotrophoblasts in first-trimester placentas, but only in syncytiotrophoblasts in third-trimester placentas. Apoptosis plays a critical role in the homeostasis regulation of normal placental development. However, excessive placental apoptosis leads to placental dysfunction, which may consequence in pregnancy disorders such as preeclampsia. vaspin acts as an antiapoptotic agent in ovary by attenuating the tumor necrosis factor (TNF-α)-induced apoptosis by promoting autophagy also has been shown to inhibit macrophage apoptosisAnti apoptotic effects of vaspin have also been described in human osteoblast cells by upregulation of the expression of BCL2 and downregulation of BAX through the Mitogen-activated kinase (MAP3/1)pathway and Protein kinase B(AKT) pathway.
### Conditions Module
**Conditions:**
- Pre-Eclampsia
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 75
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** will include 25 women with normal weight and normal blood pressure .
**Label:** Group 1
#### Arm Group 2
**Description:** :will include 25 obsese women with normal blood pressure.
**Label:** Group2
#### Arm Group 3
**Description:** : will include 25 obese women with confirmed diagnosis of severe preeclampsia .
**Label:** Group 3
### Outcomes Module
#### Primary Outcomes
**Description:** - measure level of vaspin in serum as well as its level in placenta in patients with pre-eclampsia and women with normal pregnancy
**Measure:** vaspin level in serum and placenta
**Time Frame:** one year
**Description:** measure level of gene expression of apoptotic marker bcl2 by PCR in placenta in patients with preeclampsia and women with normal pregnancy
**Measure:** level of bcl2 expression in placenta
**Time Frame:** one year
**Description:** correlation between level of vaspin and bcl2 gene expression in patients of preeclamsia and women with normal pregnancy
**Measure:** vaspin and bcl2
**Time Frame:** one year
#### Secondary Outcomes
**Description:** Correlation between vaspin level and bcl2 level with patient demographic data(Age -parity).
**Measure:** vapin level and bcl2 level and patient demographic data
**Time Frame:** one year
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria:
* Pregnant women who will come to hospital for termination of pregnancy .
* Confirmed diagnosis of preeclampsia for study groups.
* Control group will include Normotensive pregnant women.
* Age group 18-35 years.
* gestional age at termination of pregnancy : group 1\&2 : from 38 to 40 weeks group 3:terminatin of pregnancy regardless of gestional age
Exclusion Criteria:
* Pregnant women who do not consent to participate.
* Diabeteic patients .
* History of pre-gestional hypertension.
* History of chronic renal disease.
**Gender Based:** True
**Maximum Age:** 35 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
**Study Population:** Pregnant women who will come for termination of pregnancy
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Aya ali ibrahim sayed, master
**Phone:** +20 010096908832
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Mahmoud Raafat Abdel-fadeil, professor
**Phone:** +20 01001644429
**Role:** CONTACT
### References Module
#### References
**Citation:** Bergman L, Torres-Vergara P, Penny J, Wikstrom J, Nelander M, Leon J, Tolcher M, Roberts JM, Wikstrom AK, Escudero C. Investigating Maternal Brain Alterations in Preeclampsia: the Need for a Multidisciplinary Effort. Curr Hypertens Rep. 2019 Aug 2;21(9):72. doi: 10.1007/s11906-019-0977-0.
**PMID:** 31375930
**Citation:** Fondjo LA, Sarpong D, Owiredu WKBA, Opoku S, Adu-Bonsaffoh K, Teviu E. Effect of magnesium sulfate treatment on mediators of endothelial dysfunction and electrolytes in mild and severe preeclampsia: A case-control study. Health Sci Rep. 2023 Apr 26;6(5):e1232. doi: 10.1002/hsr2.1232. eCollection 2023 May.
**PMID:** 37123551
**Citation:** Kurowska P, Mlyczynska E, Dawid M, Jurek M, Klimczyk D, Dupont J, Rak A. Review: Vaspin (SERPINA12) Expression and Function in Endocrine Cells. Cells. 2021 Jul 6;10(7):1710. doi: 10.3390/cells10071710.
**PMID:** 34359881
**Citation:** Kurowska P, Mlyczynska E, Dawid M, Opydo-Chanek M, Dupont J, Rak A. In Vitro Effects of Vaspin on Porcine Granulosa Cell Proliferation, Cell Cycle Progression, and Apoptosis by Activation of GRP78 Receptor and Several Kinase Signaling Pathways Including MAP3/1, AKT, and STAT3. Int J Mol Sci. 2019 Nov 19;20(22):5816. doi: 10.3390/ijms20225816.
**PMID:** 31752432
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000046110
- Term: Hypertension, Pregnancy-Induced
- 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: 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: BC14
- Name: Heart and Blood Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M7633
- Name: Eclampsia
- Relevance: HIGH
- As Found: Eclampsia
- ID: M14106
- Name: Pre-Eclampsia
- Relevance: HIGH
- As Found: Pre-Eclampsia
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M10024
- Name: Hypertension
- Relevance: LOW
- As Found: Unknown
- ID: M25635
- Name: Hypertension, Pregnancy-Induced
- 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: T2019
- Name: Eclampsia
- Relevance: HIGH
- As Found: Eclampsia
### Condition Browse Module - Meshes
- ID: D000004461
- Term: Eclampsia
- ID: D000011225
- Term: Pre-Eclampsia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437522
**Brief Title:** A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
**Official Title:** A Phase II Clinical Trial To Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (Non-nasopharyngeal Carcinoma) and Other Solid Tumors
#### Organization Study ID Info
**ID:** BL-B01D1-204-02
#### Organization
**Class:** INDUSTRY
**Full Name:** Sichuan Baili Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Sichuan Baili Pharmaceutical Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 monoclonal antibody combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) and other solid tumors.
### Conditions Module
**Conditions:**
- Head and Neck Squamous Cell Carcinoma
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 52
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants receive BL-B01D1 + PD-1 monoclonal antibody as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
**Intervention Names:**
- Drug: BL-B01D1
- Drug: PD-1 monoclonal antibody
**Label:** Study treatment
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Study treatment
**Description:** Administration by intravenous infusion for a cycle of 3 weeks.
**Name:** BL-B01D1
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Study treatment
**Description:** Administration by intravenous infusion for a cycle of 3 weeks.
**Name:** PD-1 monoclonal antibody
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
**Measure:** Objective Response Rate (ORR)
**Time Frame:** Up to approximately 24 months
**Description:** The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1.
**Measure:** Recommended Phase II Dose (RP2D)
**Time Frame:** Up to approximately 24 months
#### Secondary Outcomes
**Description:** Progression-free survival (PFS) as assessed by BIRC is defined as the time between the date subjects are randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
**Measure:** Progression-free survival (PFS)
**Time Frame:** Up to approximately 24 months
**Description:** Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.
**Measure:** Disease Control Rate (DCR)
**Time Frame:** Up to approximately 24 months
**Description:** Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.
**Measure:** Duration of Response (DOR)
**Time Frame:** Up to approximately 24 months
**Description:** TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.
**Measure:** Treatment Emergent Adverse Event (TEAE)
**Time Frame:** Up to approximately 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Subject volunteered to participate in the study and signed an informed consent;
2. Male or female aged ≥18 years and ≤75 years;
3. Expected survival time ≥3 months;
4. ECOG score 0-1;
5. Patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) and other solid tumors confirmed by histopathology and/or cytology;
6. Patients must provide a documented tumor tissue specimen of the primary or metastatic tumor within 3 years for PD-L1 testing and other testing;
7. At least one measurable lesion meeting the RECIST v1.1 definition was required;
8. No blood transfusion and no use of cell growth factors and/or platelet-raising drugs within 14 days before screening, and the organ function level must meet the requirements;
9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
10. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.
Exclusion Criteria:
1. Prior treatment with an ADC drug with TOP I inhibitors as a toxin;
2. Before the first delivery within four weeks or five half-life used anti-tumor treatment; Palliative radiotherapy was given within 2 weeks before the first dose;
3. Received any previous systemic antitumor regimen for solid tumors such as recurrent or metastatic head and neck squamous cell carcinoma;
4. Had received immunotherapy and developed ≥ grade 3 irAE or ≥ grade 2 immune-related myocarditis;
5. Use of an immunomodulatory drug within 14 days before the first dose of study drug;
6. Systemic corticosteroids were required within 2 weeks before the first dose of the study;
7. Has a history of severe disease of heart head blood-vessel;
8. Active autoimmune and inflammatory diseases;
9. Other malignant tumors that progressed or required treatment within 3 years before the first dose;
10. With ILD requiring steroid treatment, current ILD, or suspected ILD at screening;
11. Presence of: a) poorly controlled diabetes mellitus before study treatment; b) poorly controlled hypertension; c) history of hypertensive crisis or hypertensive encephalopathy;
12. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
13. Patients with active central nervous system metastasis;
14. Patients with pleural effusion, pericardial effusion or ascites with clinical symptoms or requiring repeated drainage;
15. Had allergic history to recombinant humanized antibody or human-mouse chimeric antibody or to any of BL-B01D1's excipients;
16. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
17. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
18. Active infection requiring systemic therapy;
19. Had participated in another clinical trial within 4 weeks before the first dose;
20. Who have a history of psychotropic drug abuse and cannot abstain from it or have mental disorders;
21. Other circumstances that the investigator deemed inappropriate for participation in the trial.
**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:** Sa Xiao, PHD
**Phone:** 15013238943
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Name:** Chaosu Hu
- **Role:** CONTACT
***Contact 2:***
- **Name:** Chaosu Hu
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Dongmei Ji
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Fudan University Shanghai Cancer Center
**State:** Shanghai
#### Overall Officials
**Official 1:**
**Affiliation:** Fudan University
**Name:** Chaosu Hu
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Fudan University
**Name:** Dongmei Ji
**Role:** PRINCIPAL_INVESTIGATOR
## 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: D000006258
- Term: Head and Neck Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M14850
- Name: Recurrence
- Relevance: LOW
- As Found: Unknown
- ID: M5550
- Name: Carcinoma, Squamous Cell
- Relevance: HIGH
- As Found: Squamous Cell Carcinoma
- ID: M1689
- Name: Squamous Cell Carcinoma of Head and Neck
- Relevance: HIGH
- As Found: Head and Neck Squamous Cell 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: M9348
- Name: Head and Neck Neoplasms
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000002294
- Term: Carcinoma, Squamous Cell
- ID: D000077195
- Term: Squamous Cell Carcinoma of Head and Neck
### 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: M4230
- Name: Antibodies, Monoclonal
- Relevance: HIGH
- As Found: Chemotherapy
- ID: M4225
- Name: Antibodies
- Relevance: HIGH
- As Found: Given
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000000906
- Term: Antibodies
- ID: D000000911
- Term: Antibodies, Monoclonal
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437509
**Brief Title:** A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer
**Official Title:** A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer
#### Organization Study ID Info
**ID:** BL-B01D1-204-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Sichuan Baili Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Sichuan Baili Pharmaceutical Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 monoclonal antibody combination therapy in patients with extensive-stage small cell lung cancer.
### Conditions Module
**Conditions:**
- Extensive-stage Small-cell Lung Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants receive BL-B01D1 + PD-1 monoclonal antibody as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
**Intervention Names:**
- Drug: BL-B01D1
- Drug: PD-1 monoclonal antibody
**Label:** Study treatment
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Study treatment
**Description:** Administration by intravenous infusion for a cycle of 3 weeks.
**Name:** BL-B01D1
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Study treatment
**Description:** Administration by intravenous infusion for a cycle of 3 weeks.
**Name:** PD-1 monoclonal antibody
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
**Measure:** Objective Response Rate (ORR)
**Time Frame:** Up to approximately 24 months
**Description:** The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1.
**Measure:** Recommended Phase II Dose (RP2D)
**Time Frame:** Up to approximately 24 months
#### Secondary Outcomes
**Description:** Progression-free survival (PFS) as assessed by BIRC is defined as the time between the date subjects are randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
**Measure:** Progression-free survival (PFS)
**Time Frame:** Up to approximately 24 months
**Description:** Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.
**Measure:** Disease Control Rate (DCR)
**Time Frame:** Up to approximately 24 months
**Description:** Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.
**Measure:** Duration of Response (DOR)
**Time Frame:** Up to approximately 24 months
**Description:** TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.
**Measure:** Treatment Emergent Adverse Event (TEAE)
**Time Frame:** Up to approximately 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Subject volunteered to participate in the study and signed an informed consent;
2. Male or female aged ≥18 years and ≤75 years;
3. Expected survival time ≥3 months;
4. ECOG score 0-1;
5. Newly diagnosed patients with extensive-stage small cell lung cancer confirmed by histopathology and / or cytology;
6. A archived tumor tissue sample or fresh tissue sample of the primary or metastatic lesion must be provided within 3 years;
7. At least one measurable lesion meeting the RECIST v1.1 definition was required;
8. No blood transfusion and no use of cell growth factors and/or platelet-raising drugs within 14 days before screening, and the organ function level must meet the requirements;
9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
10. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.
Exclusion Criteria:
1. Prior use of ADC drug therapy with small molecule toxins as topoisomerase I inhibitors;
2. Prior treatment with any systemic anti-tumor regimen for extensive-stage small cell lung cancer;
3. Pathology suggested small cell carcinoma containing non-small cell carcinoma components;
4. Subjects had used immunomodulatory drugs within 14 days before the first use of the study drug ;
5. Screening the history of severe cardiovascular and cerebrovascular diseases in the first half of the year ;
6. QT interval prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia ;
7. Active autoimmune diseases and inflammatory diseases ;
8. Receiving long-term systemic corticosteroid therapy or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy prior to the first dose;
9. Other malignancies that have progressed or require treatment within 5 years prior to the first dose;
10. Have ILD requiring steroid therapy, or currently have ILD, or suspected ILD at screening;
11. Prior to initiation of study treatment, there were: a) poorly controlled diabetes mellitus; b) with severe complications of diabetes; c) glycosylated hemoglobin levels of 8% or more; d) hypertension that is poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy;
12. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening; Except for infusion set-related thrombosis;
13. Concurrent pulmonary disease leading to severe clinical impairment of respiratory function;
14. Patients with active central nervous system metastases;
15. Patients with large serosal effusions, or symptomatic serosal effusions, or poorly controlled serosal effusions;
16. History of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any excipient component of the experimental drug;
17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
18. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
19. Severe infection within 4 weeks prior to first dose of study drug; Lung infection or active lung inflammation within 4 weeks;
20. Have participated in another clinical trial within 4 weeks prior to the first dose;
21. Have a history of psychotropic substance abuse and cannot be abstained from or have a history of severe neurological or psychiatric disorders;
22. Imaging examination showed that the tumor had invaded or encapsulated the large blood vessels in the chest;
23. Severe and non-healing wounds, ulcers, or fractures within 4 weeks prior to signing the informed policy;
24. Clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing the informed policy;
25. Subjects who are scheduled to receive or receive a live vaccine within 28 days prior to the first dose;
26. Other conditions that the investigator considers unsuitable to participate in this clinical trial.
**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:** Sa Xiao, PHD
**Phone:** 15013238943
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Name:** Caicun Zhou
- **Role:** CONTACT
**Country:** China
**Facility:** Shanghai East Hospital
**State:** Shanghai
#### Overall Officials
**Official 1:**
**Affiliation:** Shanghai East Hospital
**Name:** Caicun Zhou, PHD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012142
- Term: Respiratory Tract Neoplasms
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000002283
- Term: Carcinoma, Bronchogenic
- ID: D000001984
- Term: Bronchial Neoplasms
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11172
- Name: Lung Neoplasms
- Relevance: HIGH
- As Found: Lung Cancer
- ID: M28323
- Name: Small Cell Lung Carcinoma
- Relevance: HIGH
- As Found: Small Cell Lung Cancer
- ID: M5534
- Name: Carcinoma
- 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
- ID: M5540
- Name: Carcinoma, Bronchogenic
- Relevance: LOW
- As Found: Unknown
- ID: M5260
- Name: Bronchial Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: T5271
- Name: Small Cell Lung Cancer
- Relevance: HIGH
- As Found: Small Cell Lung Cancer
### Condition Browse Module - Meshes
- ID: D000008175
- Term: Lung Neoplasms
- ID: D000055752
- Term: Small Cell Lung Carcinoma
### 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: M4230
- Name: Antibodies, Monoclonal
- Relevance: HIGH
- As Found: Chemotherapy
- ID: M4225
- Name: Antibodies
- Relevance: HIGH
- As Found: Given
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000000906
- Term: Antibodies
- ID: D000000911
- Term: Antibodies, Monoclonal
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437496
**Brief Title:** 68Ga-AAZTA-093 PET/CT: First-in-human Study
**Official Title:** 68Ga-AAZTA-093 PET/CT: First-in-human Study in Patients With Prostate Cancer
#### Organization Study ID Info
**ID:** FirstAHFujian-68Ga-AAZTA-093
#### Organization
**Class:** OTHER
**Full Name:** First Affiliated Hospital of Fujian Medical University
### Status Module
#### Completion Date
**Date:** 2024-10-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** First Affiliated Hospital of Fujian Medical University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** 68Ga-AAZTA-093 is a novel radiotracer targeting prostate-specific membrane antigen (PSMA). In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-093 PET/CT in patients with prostate cancer.
**Detailed Description:** Prostate cancer (PCa) is one of the most common malignancies worldwide in men. Prostate specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. Various low molecular weight radiopharmaceuticals targeting PSMA such as PSMA-11, PSMA-617 for 68Ga- or 177Lu- labeling have been developed. 68Ga-AAZTA-093, a novel radiopharmaceutical targeting PSMA, with the urea fragment of a conjugate that employs the AAZTA chelator for labeling with 68Ga(III). This pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-093 PET/CT and compared with 68Ga-PSMA-11 and 68Ga-PSMA-617 PET/CT in the same group of prostate cancer patients.
### Conditions Module
**Conditions:**
- Malignant Neoplasm of Prostate
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Drug: 68Ga-AAZTA-093 Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-AAZTA-093. Tracer doses of 68Ga-AAZTA-093 will be used to image lesions of prostate cancer by PET/CT.
**Intervention Names:**
- Drug: 68Ga-AAZTA-093
**Label:** 68Ga-AAZTA-093 PET/ CT
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Drug: 68Ga-PSMA-11/68Ga-PSMA-617 Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-PSMA-11/68Ga-PSMA-617. Tracer doses of 68Ga-PSMA-11/68Ga-PSMA-617 will be used to image lesions of prostate cancer by PET/CT.
**Intervention Names:**
- Drug: 68Ga-PSMA-11//68Ga-PSMA-617
**Label:** 68Ga-PSMA-11/68Ga-PSMA-617 PET/ CT
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 68Ga-AAZTA-093 PET/ CT
**Description:** Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-AAZTA-093. Tracer doses of 68Ga-AAZTA-093 will be used to image lesions of prostate cancer by PET/CT.
**Name:** 68Ga-AAZTA-093
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- 68Ga-PSMA-11/68Ga-PSMA-617 PET/ CT
**Description:** Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-PSMA-11//68Ga-PSMA-617. Tracer doses of 68Ga-PSMA-11/68Ga-PSMA-617 will be used to image lesions of prostate cancer by PET/CT.
**Name:** 68Ga-PSMA-11//68Ga-PSMA-617
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** Sensitivity and Specificity of 68Ga-AAZTA-093 for prostate cancer in comparison with 68Ga-PSMA-11/68Ga-PSMA-617 PET/CT.
**Measure:** Diagnostic value
**Time Frame:** through study completion, an average of 3 months
**Description:** Compare the SUV of tumors between 68Ga-AAZTA-093 PET/CT and 68Ga-PSMA-11/68Ga-PSMA-617 PET/CT.
**Measure:** SUV of tumors
**Time Frame:** through study completion, an average of 3 months
#### Primary Outcomes
**Description:** The safety will be assessed by the number and percentage of patients with adverse events; Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
**Measure:** Safety evaluation
**Time Frame:** Within 7 days following PET/CT
#### Secondary Outcomes
**Description:** Calculate the absorbed dose of 68Ga-AAZTA-093 in normal organs.
**Measure:** Dosimetry data
**Time Frame:** through study completion, an average of 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* confirmed treated or untreated prostate cancer patients;
* 68Ga-AAZTA-093 and 68Ga-PSMA-11/68Ga-PSMA-617 PET/CT within 1 week;
* signed written consent.
Exclusion Criteria:
* known allergy against PSMA;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
**Maximum Age:** 90 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Weibing Miao, MD
**Phone:** 86-0591-87981618
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Guochang Wang, MD
**Phone:** 86-0591-87981619
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Fuzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Guochang Wang, MD
- **Phone:** 86-0591-87981619
- **Role:** CONTACT
**Country:** China
**Facility:** Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
**State:** Fujian
**Status:** RECRUITING
**Zip:** 350005
## Derived Section
### Condition Browse Module - Ancestors
- 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
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14335
- Name: Prostatic Neoplasms
- Relevance: HIGH
- As Found: Malignant Neoplasm of Prostate
- 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: D000009369
- Term: Neoplasms
- ID: D000011471
- Term: Prostatic Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000019275
- Term: Radiopharmaceuticals
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M352637
- Name: Gallium 68 PSMA-11
- Relevance: HIGH
- As Found: Ketorolac
- ID: M21258
- Name: Radiopharmaceuticals
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000718244
- Term: Gallium 68 PSMA-11
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437483
**Brief Title:** Effects of Sustained Natural Apophyseal Glides Combined With Kinesiotaping in Patients With Chronic Mechanical Neck Pain: A Randomised Controlled Trial
**Official Title:** Effects of Sustained Natural Apophyseal Glides Combined With Kinesiotaping in Patients With Chronic Mechanical Neck Pain: A Randomised Controlled Trial
#### Organization Study ID Info
**ID:** FUI/CTR/2024/7
#### Organization
**Class:** OTHER
**Full Name:** Foundation University Islamabad
### Status Module
#### Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-05-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-11-10
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Foundation University Islamabad
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study is a randomized controlled trial and its purpose is to determine the combined effects of sustained natural apophyseal glides and kinesiotaping on pain, range of motion and neck disability in patients with chronic mechanical neck pain.
**Detailed Description:** This study aims to determine the combined effects of sustained natural apophyseal glides and kinesiotaping in chronic mechanical neck pain patients of age range 18-40. Outcome variables are pain, range of motion and functional disability of neck which will be determined by using the following respective data collection tools:
1. Numeric pain rating scale
2. Inclinometer
3. Neck Disability Index
Participants of interest will be approached and explained about the research. They will be randomly allocated in to two groups. Informed written consent will be taken. The intervention protocol will be comprised of six sessions over a 2-week period (3 sessions per week on alternate days). Outcome measures will be assessed at baseline and after 2 weeks. Data will be analyzed and interpreted using SPSS.
### Conditions Module
**Conditions:**
- Neck Pain
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized Controlled Trial
##### Masking Info
**Masking:** SINGLE
**Masking Description:** In this study, participants are blinded to their assigned treatment groups.
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 42
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in this group will receive Sustained Natural Apophyseal Glides followed by Kinesiotaping in addition to the conventional treatment. This arm of the study will assess the synergistic effects of SNAGs and kinesiotape.
**Intervention Names:**
- Procedure: Sustained Natural Apophyseal Glides
- Procedure: Kinesiotaping
- Procedure: Conventional Treatment
**Label:** Group A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants in group B will receive Sustained Natural Apophyseal Glides along with the conventional treatment.
**Intervention Names:**
- Procedure: Sustained Natural Apophyseal Glides
- Procedure: Conventional Treatment
**Label:** Group B
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group A
- Group B
**Description:** SNAGs:
Therapist will apply an antero-superior accessory glide to the superior spinous process of the involved motion segment (between C3 to C7) by pushing it towards the direction of eyeball at approximately a 45 degree angle, using the thumb. The other thumb will reinforce the glide. Painless accessory glide will be maintained and subject will slowly turn their head towards the painful or restricted side (that elicited symptoms) and sustain the position for a few seconds. In case of symptom-free, the subject will apply overpressure at the end of restricted range of motion. The glide will be maintained till the head returns to the midline.
Each session will consist of three sets of six to ten repetitions.
**Name:** Sustained Natural Apophyseal Glides
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Group A
**Description:** Kinesiotaping (KT):
Subject will be in comfortable sitting position. Neck of the subject will be thoroughly cleaned with alcohol and sterile gauze pads before the application of Kinesiotape.The layers of KT will be applied in the form of two strips i.e. "Y strip" and "I strip". and applied over the neck in a position of cervical flexion and contralateral rotation and, pasted up and over either ridge of the spine covering the cervical muscles.It extends from T1-T2 to either side of C1-C2.The second layer is I-strip:The overlaying I-strip will be placed perpendicular to the Y-strip, It will be stretched from the both ends, and the middle portion of the tape will be applied first after which tension is released and ends are applied without tension.
**Name:** Kinesiotaping
**Type:** PROCEDURE
#### Intervention 3
**Arm Group Labels:**
- Group A
- Group B
**Description:** Hot pack (moist heat) and TENS will be applied, each for 10 minutes.
**Name:** Conventional Treatment
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** It will be documented by using Numeric Pain Rating Scale (NPRS) which is a self- rated scale of 0-10 points where the participants rate their pain verbally or in writing."0" shows no pain whereas "10" represents worst pain. According to guidelines, NPRS scale categorizes pain into no pain (0), mild pain (1-3), moderate pain (4-7) and severe pain (8-10).
**Measure:** Pain intensity
**Time Frame:** 2 weeks
**Description:** The range of motion for flexion, extension, and side bending will be documented using a Inclinometer, positioned on the vertex of the head. For rotation, it will be placed on the forehead. Inclinometer demonstrates good Intraclass Correlation Coeffecient (ICC) value of 0.770-0.982.
**Measure:** Cervical Range of Motion
**Time Frame:** 2 weeks
**Description:** It will be documented by using Neck Disability Index (NDI) which consists of 10 questions addressing various aspects of neck functions to assess the impact of neck pain on a person's daily life. A total score ranges between 0 and 50 with higher scores indicating a high level of disability. Each question contains six answer choices, scored from 0 (no disability) to 5 (complete disability). All sections are then totaled.The scores on NDI are typically classified as: 0-4 (no disability), 5-14 (mild disability), 15-24 (moderate disability), 25-34 (severe disability), above 34 (complete disability).
**Measure:** Functional Disability of Neck
**Time Frame:** 2 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Mechanical Neck Pain
* Age range: 18-40 years
* Both males and females
* Having pain from at least last 3 months (chronic)
* Pain score greater than 3 on NPRS
* Pain and limitation on neck moverment
Exclusion criteria :
* Recent surgery of spine, Temporomandibular joint or shoulder in the previous 12 months.
* Open wound around neck.
* History of traumatic injuries or fractures in the cervical spine.
* History of neurological and cardiac pathologies.
* History of some serious pathologies (e.g., malignancy, inflammatory disorder etc.).
* History of cervical or shoulder neurological movement disorder.
* Cervical spondylolisthesis, cervical radiculopathy, and spinal stenosis.
* Vascular syndromes such as basilar insufficiency.
* Diagnosed psychiatric disorders such as anxiety and depression.
* Interventions including medications, exercise or physical therapy in the last 3 months.
* Any other condition that contraindicates kinesiotaping such as skin sensitivity.
**Maximum Age:** 40 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Fatima Riaz, MS-MSKPT
**Phone:** 0347-0051283
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rawalpindi
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ali Bin Asim, MS-OMPT
- **Phone:** 03135088144
- **Role:** CONTACT
**Country:** Pakistan
**Facility:** Foundation University College of Physical Therapy
**State:** Punjab
**Status:** RECRUITING
**Zip:** 460000
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M21485
- Name: Neck Pain
- Relevance: HIGH
- As Found: Neck Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000019547
- Term: Neck Pain
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M3777
- Name: Ethanol
- Relevance: LOW
- As Found: Unknown
- ID: M16204
- Name: Sulfamethazine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437470
**Brief Title:** Effect of Blood Flow Restriction Technique After Anterior Cruciate Ligament Reconstruction
**Official Title:** Combined Effect Of Blood Flow Restriction Technique And Conventional Physical Therapy Program After Anterior Cruciate Ligament Reconstruction
#### Organization Study ID Info
**ID:** P.T.REC/012/005176
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2025-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Cairo University
#### Responsible Party
**Investigator Affiliation:** Cairo University
**Investigator Full Name:** Mostafa Ahmed Ali Abed
**Investigator Title:** Assistant Lecturer of Physical Therapy for Musculoskeletal System Disorders and its Surgery, Faculty of Physical Therapy, Cairo University
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The purpose of this study will be to evaluate the effect of adding BFR (using 80% of LOP) to the conventional physical therapy program on knee function, functional test, balance, quadriceps and hamstrings muscles strength, thigh muscle girth and knee effusion in rehabilitation after ACLR.
**Detailed Description:** Anterior cruciate ligament (ACL) injury is one of the most common knee injuries especially in the age range 20 to 29 years. It is commonly seen during sport activities including jumping, pivoting or during contact with the other players (Khalil et al., 2023).
Quadriceps and hamstrings muscle weakness and atrophy are commonly seen after Anterior cruciate ligament reconstruction (ACLR) mainly due to weight bearing limitation in the early stage of rehabilitation (Barber-Westin and Noyes 2019 and Hughes et al., 2019). Recent rehabilitation protocols focused on range of motion (ROM) exercises and increased muscle activation in the early post-operative phase to minimize complications such as joint stiffness and muscle weakness (Myer et al., 2006 and Patterson et al., 2019a).
It is recommended by the American College of Sports Medicine to use 60% to 70% of one repetition maximum (1 RM) to increase muscle strength and 70% to 80% of 1 RM to increase muscle size. However, using these percentage of loads in the early post-operative phase after ACLR may not be applicable (Barber-Westin and Noyes 2019). Therefore, therapists considered it is necessary to find a safe exercise protocol designed to increase muscle strength and mass to be used in the early post-operative phase. One of these protocols is the blood flow restriction training (BFRT) (Patterson et al., 2019a).
The BFRT is a technique that restricts arterial and venous circulation in the working muscles during exercise (Scott et al., 2015). This technique uses a pneumatic tourniquet system that applies external pressure to the most proximal part of the arm or the thigh. Cuff inflation causes compression on the vascular structures under the cuff leading to occlusion of the venous return and restriction of the arterial blood flow to the distal part of the limb. This intentionally induced ischemic environment results in a state of hypoxia within the distal muscles (Manini and Clark 2009). In such environment, muscle strength and hypertrophy can be reached by smaller external loads such as 20% or 30% of 1RM (Loenneke et al., 2012a). This makes the BFRT applicable in the early post-operative phase of rehabilitation without stressing the knee joint, thus protecting the graft and minimizing the risk of increasing any associated injuries in cartilage or meniscus (Loenneke et al., 2012b and Arve et al., 2020).
The BFRT is beneficial for many groups such as geriatrics and those with degenerative joint diseases, ligamentous injury and inflammatory diseases (Hughes et al., 2017). Early BFRT research designs used general measures to calculate cuff pressures, such as setting pressure relative to systolic blood pressure, thigh circumference, or random pressures which is probably inaccurate especially with change in limb circumference or body position (Takano et al., 2005 and Loenneke et al., 2015). A study performed by (Khalil et al., 2023) used the portable doppler ultrasound device to calculate limb occlusion pressure (LOP) of dorsalis pedis artery while manually inflating the restriction cuff. This procedure is operator dependent and may lead to some errors, especially in determining the exact location of the artery.
Recent research recommends the use of individualized BFRT where the percentage of occlusion of the vascular structures is determined automatically for each individual separately (Scott et al., 2015).
Previous studies concluded that BFRT after ACLR was effective in improving knee extension and flexion torques, pain, and balance (Spada et al., 2022, Bobes et al., 2020 and Jung et al., 2022) A recent systematic review performed by (Colapietro et al., 2023) found that limited studies included functional testing of the knee joint after BFRT which will be covered in this study using the latest wireless version of AirBands produced by VALD performance company which possesses the ability to automatically calculate LOP for each participant alone as recommended by the guidelines of Australian Institute of Sport.
Up to the authors' knowledge, there was no study has investigated the effect of blood flow restriction (BFR) using 80% of LOP combined with the conventional physical therapy program on knee function and balance compared to the conventional physical therapy program alone after ACLR.
### Conditions Module
**Conditions:**
- Anterior Cruciate Ligament Injuries
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** A triple-blinded randomized controlled trial will be conducted, ensuring that participants, the research assistant (who serves as the examiner for all participants) and the statistician are blinded to the treatment group.
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** participants will receive the conventional physical therapy program while using non-inflated cuff as a sham treatment during exercising.
**Intervention Names:**
- Other: blood flow restriction technique
**Label:** conventional physical therapy program
**Type:** SHAM_COMPARATOR
#### Arm Group 2
**Description:** participants will receive the conventional physical therapy program with the use of BFR cuff which will be inflated to reach 80% of limb occlusive pressure
**Intervention Names:**
- Other: blood flow restriction technique
**Label:** blood flow restriction combined to conventional physical therapy program
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- blood flow restriction combined to conventional physical therapy program
- conventional physical therapy program
**Description:** All participants in the control group will receive the conventional physical therapy program with the use non-inflated cuff as a sham treatment during exercising.
All participants in the intervention group will receive the conventional physical therapy program combined to blood flow restriction to 80% of limb occlusive pressure by using blood flow restriction cuff.
**Name:** blood flow restriction technique
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** will be assessed by the Arabic version of the knee outcome survey-activities for daily living scale.
It encompasses six questions addressing restrictions in daily activities caused by symptoms like pain, swelling, and instability, and eight questions evaluating difficulties in functional tasks such as walking, stair climbing, and sitting or standing up from a chair.
Each question is rated on a 6-point Likert scale.
Scores range from 0 to 70, with higher scores indicating better functional capacity.
**Measure:** knee function
**Time Frame:** after 3 months of intervention
**Description:** will be assessed by the single leg hop test
**Measure:** knee functional test
**Time Frame:** after 3 months of intervention
**Description:** will be assessed by the Y balance test for the lower quarter
**Measure:** balance
**Time Frame:** after 3 months of intervention
**Description:** will be assessed by the hand held dynamometer
**Measure:** quadriceps and hamstring muscles strength
**Time Frame:** after 3 months of intervention
#### Secondary Outcomes
**Description:** will be assessed by a non-elastic measuring tape
**Measure:** Thigh muscle girth
**Time Frame:** baseline then 3 months after intervention
**Description:** will be assessed by a non-elastic measuring tape
**Measure:** Knee effusion
**Time Frame:** baseline then 3 months after intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Aged from 18-35 years.
2. Underwent an ACLR semitendinosus autograft one-week post-operative
3. Willingness to participate in the intervention and subsequent assessment.
4. BMI from 18.5 to 29.9 kg/m2.
Exclusion Criteria:
1. Insecure graft fixation (due to bone quality, suspension).
2. Active infection.
3. Postsurgical excess knee swelling that may limit exercise performance.
4. ACLR using bone tendon bone (BTB) graft.
5. Any cardiovascular disease such as hypertension.
6. Any lower limb trauma.
7. Hip and ankle pathology.
8. BMI more than 30 kg/m2
**Maximum Age:** 35 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mostafa A Abed, asst. lec.
**Phone:** 00201062051106
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Prof. of PT for Musculoskeletal System Disorders and its Surgery, Faculty of PT, Cairo University
**Name:** Enas F Youssef, Professor
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** Lec. of PT for Musculoskeletal System Disorders and its Surgery, Faculty of PT, Cairo University
**Name:** Dina S Abd Allah, lecturer
**Role:** STUDY_DIRECTOR
**Official 3:**
**Affiliation:** Asst. prof. of orthopedic surgery, Cairo University
**Name:** Ahmed S Elkalyoby, Asst. prof
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007718
- Term: Knee Injuries
- ID: D000007869
- Term: Leg Injuries
- 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: M601
- Name: Anterior Cruciate Ligament Injuries
- Relevance: HIGH
- As Found: Anterior Cruciate Ligament Injuries
- ID: M10738
- Name: Knee Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M10881
- Name: Leg Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000070598
- Term: Anterior Cruciate Ligament Injuries
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437457
**Brief Title:** Comparison of Gd-EOB-DTPA-enhanced MRI and Contrast-enhanced Ultrasound for Measuring Tumor Size of Solitary Hepatocellular Carcinoma ≤ 5cm:A Retrospective Study
**Official Title:** Comparison of CE-MRI and CEUS for Measuring Tumor Size of HCC
#### Organization Study ID Info
**ID:** 2023-RE-117
#### Organization
**Class:** OTHER
**Full Name:** Anhui Medical University
### Status Module
#### Completion Date
**Date:** 2024-05-20
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-05-01
**Type:** ACTUAL
#### Start Date
**Date:** 2019-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Anhui Medical University
#### Responsible Party
**Investigator Affiliation:** Anhui Medical University
**Investigator Full Name:** Kunyuan Jiang
**Investigator Title:** Anhui Medical University
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Knowing the tumor size before operation is of great significance to the choice of treatment methods of surgeons and the prognosis of patients. In this study, two commonly used imaging methods( CE-MRI/CEUS) were selected to measure and compare the tumor size before operation, in order to determine which measurement method is more accurate.
**Detailed Description:** A total of 194 patients who met the inclusion criteria from January 2019 through May 2024 were included. Taken pathological results as the gold standard, Paired T-test and Bland-Altman analisis were conducted to assess the correlation and mean absolute error between the measured tumor sizes obtained from CE-MRI/CEUS and pathological results.
### Conditions Module
**Conditions:**
- HCC - Hepatocellular Carcinoma
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 194
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The patients who underwent CEUS before liver resection
**Intervention Names:**
- Radiation: ceus
**Label:** CEUS
#### Arm Group 2
**Description:** The patients who underwent CE-MRI before liver resection
**Intervention Names:**
- Radiation: ceus
**Label:** CE-MRI
### Interventions
#### Intervention 1
**Arm Group Labels:**
- CE-MRI
- CEUS
**Description:** MRI was performed by using a superconducting magnet scanner operated at 3.0 T (GE discovery MR750w, USA) and the CEUS examination (Mindray, China), ultrasound was performed first in B-mode to identify the suspicious lesions and then switched to contrast mode prior to the injection of the contrast medium.
**Name:** ceus
**Type:** RADIATION
### Outcomes Module
#### Primary Outcomes
**Description:** the performance of Gd-EOB-DTPA-enhanced MRI (CE-MRI) and Contrast-enhanced Ultrasound (CEUS) in measuring tumor size of solitary hepatocellular carcinoma (HCC) ≤5cm.
**Measure:** measuring HCC diameter
**Time Frame:** Jaunary 2019 - May 2024
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. had no anti-HCC therapy before imaging examinations.
2. at least had one examination of Gd-EOB-DTPA-enhanced MRI and CEUS 2 weeks before surgery and confirmed as one single HCC.
3. If the patient had both imaging tests, the time interval between two examinations was less than 1 weeks.
4. both radiological and pathological results recorded the maximum tumor diameter.
Exclusion Criteria:
1. had anti-HCC therapy before imaging examinations.
2. had no examination of Gd-EOB-DTPA-enhanced MRI or CEUS 2 weeks before surgery .
3. had no radiological or pathological results recorded the maximum tumor diameter.
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** The patients who underwent liver resection from January 2019 to May 2024 were included.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Hefei
**Country:** China
**Facility:** Anhui Provincial Hospital
**State:** Anhui
**Zip:** 230001
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## 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
- ID: D000008107
- Term: Liver 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: 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: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11107
- Name: Liver Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000006528
- Term: Carcinoma, Hepatocellular
### 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: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437444
**Brief Title:** Asthma Crisis in Paediatrics: Impact of a Care Pathway in Primary and Hospital Care
**Official Title:** Asthma Crisis in Paediatrics: Impact of a Care Pathway in Primary and Hospital Care
#### Organization Study ID Info
**ID:** 2021111010
#### Organization
**Class:** OTHER_GOV
**Full Name:** Basque Health Service
### Status Module
#### Completion Date
**Date:** 2026-05-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-05-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-07
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Health Department of the Basque Government
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Basque Health Service
#### Responsible Party
**Investigator Affiliation:** Basque Health Service
**Investigator Full Name:** Marta Montejo Fernandez
**Investigator Title:** Pediatrician
**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 aims to evaluate the effect of the implementation of the new Asthma Care Pathway in the Basque Healthcare Service for the improvement of care for children with asthma attacks and the reduction of variability between professionals and care settings in this care practice. Asthma is the most common chronic disease in children and has a major impact on people's quality of life. The Asthma Care Pathway is a structured multidisciplinary care plan that details the essential steps in the care of patients with mild-moderate asthma attacks and the coordinated practice of the agents involved as dictated by the evidence. This pathway will include quality indicators of compliance with diagnostic criteria, assessment of severity and prescription of drugs, as well as the experience of families and professionals, which have been collected in meetings designed for this purpose.
The study consists in a mixed methods implementation trial with two phases:
1. Phase I: a quantitative evaluation will be carried out to assess implementation outcomes at the professional level through a pretest-posttest quasi-experimental study with paired control group, with a ratio of 1:2. The primary outcome variable will be the overall percentage of bronchodilator treatment with a spacer chamber in children diagnosed with mild-moderate asthma attacks. We will also include as outcomes to be measured the registration rate of the Pulmonary Score, the recording rate of the assessment of persistent asthma symptoms, and the rate of initiation of background treatment in children with persistent asthma symptoms. These variables will be analysed using differences in pre- and post-intervention outcome measures between the intervention and control groups.
2. Phase II: A qualitative evaluation will be carried out through a structured process with discussion groups focused on the identification of the main barriers and facilitators for the provision of recommended clinical practice related to asthmatic crisis in mild-moderate cases established by the Asthma Care Pathway. A purposive sample of paediatricians stratified by level of care and service organisations will be recruited to ensure that all views are represented in the discussion groups. The structured script will be designed with questions to explore each of the domains of the Theoretical Domains Framework (TDF).
The study will be carried out mainly in two integrated healthcare organizations (IHO), which are made up of two primary care areas and the paediatric reference hospital emergency department of both areas, as well as the hospitalisation, intensive care and paediatric pneumology departments of said hospital, to extend in the future the Asthma Care Pathway to the rest of the Basque Health Service IHOs.
### Conditions Module
**Conditions:**
- Asthma in Children
- Implementation Science
- Inappropriate Prescribing
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Quasi-experimental pre-post cluster trial with control group
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 249
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All the primary care and hospital pediatricians of the two Integrated Hospital Organizations (IHO) (Barakaldo-Sestao and Ezkerraldea-Enkarterri-Cruces) where the care pathway will be implemented. 83 participants in total.
**Intervention Names:**
- Behavioral: The implementation strategy to encourage the adoption of the Care Pathway
**Label:** Asthma Care Pathway group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Primary care and hospital pediatricians of other IHOs where the care pathway is not implemented, but with similar characteristics to those in the experimental group, and with a proportion of 1:2. 166 participants in total.
**Label:** Control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Asthma Care Pathway group
**Description:** 1. Dissemination of the most novel aspects of the agreed Care Pathway via corporate mail.
2. Audit \& Feedback (A\&F) data reports, sent every two weeks, to each paediatrician on the rate of prescription of bronchodilators administered with a spacer chamber, together with the rates of the other indicators established in the pathway, in their health centre and in the rest of the centres in the participating health areas.
3. Interactive training sessions, in which epidemiological data and data on the health, economic and social impact of asthma attacks were presented, together with data on other indicators associated with the care pathway, and key messages on current treatment recommendations based on the latest clinical practice.
4. Distribution of reminder posters in paediatrics consultations, PEDs and health centers.
**Name:** The implementation strategy to encourage the adoption of the Care Pathway
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The overall percentage of bronchodilator treatment with a spacer chamber in children diagnosed with mild-moderate asthma attacks.
**Measure:** Percentage of bronchodilator treatment
**Time Frame:** from baseline to 12 months and 24 months
#### Secondary Outcomes
**Description:** Rate of Pulmonary Score registration in children diagnosed with mild-moderate asthma attacks, at all levels of care.
**Measure:** Pulmonary Score registration
**Time Frame:** from baseline to 12 months and 24 months
**Description:** Rate of assessment and recording of persistent asthma symptoms in children diagnosed with mild-moderate asthma attacks by ussing the PACT form (Pediatric Asthma Control Tool).
**Measure:** Assessment and recording of persistent asthma symptoms.
**Time Frame:** from baseline to 12 months and 24 months
**Description:** Rate of initiation of background treatment in children who have been assessed and registered with persistent asthma symptoms.
**Measure:** Initiation of background treatment in children with persistent asthma symptoms
**Time Frame:** from baseline to 12 months and 24 months
### Eligibility Module
**Eligibility Criteria:** Eligibility for professionals:
* Primary Care paediatricians and nurses
* Paediatricians and nurses in the Paediatric Emergency Department
* Paediatricians and nurses on the inpatient ward
* Paediatric Intensive Care paediatricians and nurses
* Paediatric Pneumology paediatricians and nurses
Eligibility for patients:
- Patients between 2 and 14 years with an acute episode of asthma; defined as an episode of wheezing and a previous diagnosis of asthma or with a previous episode of wheezing, or a first episode in a child older than 2 years with a personal/family history of atopy and/or with an objective response to bronchodilators as assessed by the Pulmonary Score, that have being attended between the 05/07/2024 and the 05/07/2025.
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Alvaro Sanchez Perez
**Phone:** (+34)946006673
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Barakaldo
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Alvaro Sanchez Perez
- **Phone:** (+34)946006673
- **Role:** CONTACT
**Country:** Spain
**Facility:** Primary Care Research Unit of Bizkaia
**State:** Bizkaia
**Status:** RECRUITING
**Zip:** 48903
### IPD Sharing Statement Module
**Access Criteria:** Since data supporting the present study will mostly concern routine data retrieved from the electronic health record of the Basque Health Service-Osakidetza, it will be only shared on justified request to the study guarantors (proposals should be directed to the Responsible Party). It will only be shared with researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
**Description:** Individual participant data will be shared that underlie results reported in the publication, after deidentification.
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
**Time Frame:** Starting 6 months after the publication of results
## 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
### Intervention Browse Module - Browse Branches
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M5269
- Name: Bronchodilator Agents
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437431
**Acronym:** GALICE
**Brief Title:** Glenzocimab in Anterior Stroke With Large Ischemic Core Eligible for Endovascular Therapy
**Official Title:** Glenzocimab in Anterior Stroke With Large Ischemic Core Eligible for Endovascular Therapy
#### Organization Study ID Info
**ID:** JDS_2023_13
#### Organization
**Class:** NETWORK
**Full Name:** Fondation Ophtalmologique Adolphe de Rothschild
### Status Module
#### Completion Date
**Date:** 2028-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** NETWORK
**Name:** Fondation Ophtalmologique Adolphe de Rothschild
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Until recently, acute ischemic stroke (AIS) patients with a baseline large infarct core have been generally excluded from clinical trials of endovascular therapy (EVT). A first multicenter randomized trial (Rescue Japan Limit trial) found a significant benefit of EVT in AIS patients with large infarct core (DWI-ASPECTS of 3-5). Another non-randomized multicenter prospective study found a positive association of EVT with 3-month outcome in AIS patients with a baseline CTP ischemic core volume \>70mL. More recently, 2 additional randomized trials were published. They both confirmed a strong efficacy of EVT in patients with large infarct core. However, even with EVT, the proportion of good outcome (3-month mRS score of 0-3), remains low in these highly severe AIS patients ranging from 8-30%. Almost 75% of EVT-treated patients are still severely disabled or dead at 3 months. In experimental studies, we and others described the pathophysiological features of the downstream microvascular thrombosis (DMT) in AIS setting highlighting its immediate occurrence and the pivotal role of platelet activation and aggregation. In recent clinical studies, it has been shown that, even with a complete angiographic recanalization after EVT, up to 40% of patients presented no-reflow (NR), a failure of downstream microvascular reperfusion, visible on perfusion imaging performed after EVT. Some clinical studies reported the clinical impact of NR after successful EVT. We found that DMT participated to the development of neurovascular lesions in AIS with both an early ischemic lesion growth risk evolving towards a delayed hemorrhagic transformation (HT) and vasogenic edema risks and therefore worse outcome. Our results suggested that an antiplatelet therapy infused early in AIS patients could reduce both the ischemic lesion but also the risk of delayed vasogenic edema and HT. Platelet glycoprotein VI (GPVI) is a key receptor for collagen and fibrin and plays a major role in platelet activation, platelet recruitment and thrombosis. Furthermore, inhibition of the GPVI does not impair haemostasis and subjects with a genetic or acquired GPVI deficiency are not prone to excessively bleed.
Glenzocimab is a monoclonal antibody directed against the GPVI. It has been developed as an immediate antiplatelet agent with minimal bleeding risk for treating AIS. The ACTIMIS trial, a phase IB/IIA clinical study that assessed for the first time the glenzocimab IV infusion in AIS patients found very promising safety data including a significant reduce of symptomatic HT (1% vs. 7.8%) and mortality rates (7.8% vs. 18.7%), especially in severe AIS patients. Our hypothesis is that IV glenzocimab infusion would improve good functional outcome in large ischemic core AIS patients treated with EVT by reducing the DMT, ischemic lesion growth, and the HT rate.
### Conditions Module
**Conditions:**
- Acute Ischemic Stroke
### 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:** 304
**Type:** ESTIMATED
**Phases:**
- PHASE2
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: glenzocimab
**Label:** glenzocimab
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: placebo
**Label:** placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- glenzocimab
**Description:** Two vials (2x500 mg) of glenzocimab should be administered concomitantly for eligible patients for a total dose of 1g of glenzocimab as an IV infusion over 6 hours, with 1/4 of the dose administered by a 15-minutes bolus and 3/4 of the dose administered by 5h45minutes continuous infusion.
**Name:** glenzocimab
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- placebo
**Description:** Placebo of glenzocimab is 0.9% NaCl for IV administration. It is supplied for clinical trial use in vials of 50 mL. Two vials of placebo should be administered concomitantly for eligible patients. The administration scheme will be the same as in the experimental arm.
**Name:** placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Functional outcome at 3 months will be assessed with the modified Rankin Scale (mRS) score dichotomized 0 to 3 versus 4 to 6, collected by phone by trained certified professionals and blinded to the treatment allocation and centralized.
In case of loss of follow-up and impossibility to obtain mRS from the patient or his family at three month, a mRS score from the patient medical record (e.g. follow-up neurologist consultation, report of the rehabilitation hospitalization etc...) will be used if it is more or less 1 month from the 3-month protocol follow-up date.
**Measure:** proportion of good functional outcome at 3 months.
**Time Frame:** Month 3
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age \>18 years old
* Acute ischemic stroke due to an isolated proximal anterior large vessel occlusion (M1 and M2 segment of the middle cerebral artery, terminal internal carotid artery (TICA))
* Indication of EVT within the time window of 0 to 24 hours in participants treated with or without intravenous thrombolysis.
* Presenting with a baseline infarct core volume assessed on the MRI (DWI sequence) or CT scan with an ASPECTS\<6
* Woman \<49 years old must have a negative serum/urine pregnancy test at baseline
Exclusion Criteria:
* Possible tandem occlusion on the baseline imaging, potentially requiring stenting
* Significant pre-stroke disability (mRS\>2)
* Patients under or needing immediate dual anti-platelet therapy (DAPT) within the first 24 hours after the cessation of glenzocimab or placebo infusion
* Significant mass effect with midline shift as confirmed on CT/MRI
* Gastrointestinal or urinary tract haemorrhage in previous 21 days
* Patient with intracranial haemorrhage
* Platelet count \<100 000 mm3
* Known hypersensitivity to glenzocimab or to any of the excipients
* Known hypersensitivity to the gadolinium used for the brain MRI perfusion, or one of its excipients
* Known Severe renal insufficiency (Grades 4-5) with a glomerular filtration rate \< 30mL/Min/1.73m2
* Patients receiving anticoagulants within the last 24 hours and:
* For heparin, an elevated aPTT -greater than upper limit of normal for laboratory
* For vitamin K antagonists (ex: warfarin), an INR \>1.7;
* For direct thrombin inhibitors or direct factor Xa inhibitors, a plasmatic dosage of the drug greater than upper limit of normal for laboratory
* Pregnant or breastfeeding woman
* Participation in another interventional clinical investigational drug or medical device trial within 30 days prior to the inclusion.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10543
- Name: Ischemia
- Relevance: HIGH
- As Found: Ischemic
- ID: M22306
- Name: Stroke
- Relevance: HIGH
- As Found: Stroke
- ID: M2400
- Name: Ischemic Stroke
- Relevance: HIGH
- As Found: Acute Ischemic Stroke
- 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
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020521
- Term: Stroke
- ID: D000083242
- Term: Ischemic Stroke
- ID: D000007511
- Term: Ischemia
### Intervention Browse Module - Ancestors
- ID: D000000925
- Term: Anticoagulants
### Intervention Browse Module - Browse Branches
- Abbrev: AnCoag
- Name: Anticoagulants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M266316
- Name: Glenzocimab
- Relevance: HIGH
- As Found: Basophil Activation
- ID: M4244
- Name: Anticoagulants
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000711868
- Term: Glenzocimab
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437418
**Brief Title:** Association of Biliary Tract Disorders in Chronic Kidney Disease Patients and Its Related Risk Factors
**Official Title:** Association of Biliary Tract Disorders in Chronic Kidney Disease Patients and Its Related Risk Factors
#### Organization Study ID Info
**ID:** Gallbladder dysfunction in CKD
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assiut University
#### Responsible Party
**Investigator Affiliation:** Assiut University
**Investigator Full Name:** rehab Mohamed Mohamed
**Investigator Title:** resident doctor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Our aim in this cross-sectional study is to determine the frequency and aspects of gallbladder dysfunction and the related risk factors in pre-ESRD and hemodialysis patients.
**Detailed Description:** Biliary tract disorders including cholelithiasis, cholecystitis, and other diseases of the biliary tract, are one of the most prevalent medical issues in the digestive system, posing a myriad of challenges for health workers and patients. Gallbladder dysfunction is the most frequent cause of symptomatic and complicated biliary tract disorders. Although gallbladder dysfunction is a common condition in Middle East countries, data on the incidence of end-stage renal disease (ESRD) are limited. The occurrence of gallbladder dysfunction in patients fed with low-protein diets suggests that gallbladder stones formation is affected by dietary protein content. Also the lithogenic composition changes of bile, increased nucleation tendency, and impaired motility of gallbladder are important factors in ESRD patients. It has been reported that chronic kidney disease (CKD) patients on regular hemodialysis (HD) have increased bile cholesterol levels and an increased bile saturation index. In addition, the gallbladder is innervated by the autonomic nervous system, which malfunctions in uremia, and it has been shown that gallbladder stasis might cause increased stone formation. In some studies, the prevalence of gallbladder dysfunction has been shown to increase in patients undergoing hemodialysis (HD) treatment for ESRD. So, we focused in this study to try to find association of gallbladder dysfunction in pre-dialysis ESRD and HD patient in comparison to normal renal function individuals.
### Conditions Module
**Conditions:**
- CKD
- Gall Bladder Dysfunction
**Keywords:**
- CKD
- gall bladder dysfunction
- gall bladder ejection fraction
- hemodialysis
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 108
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Gallbladder dysfunction in pre-dialysis CKD patients.
**Intervention Names:**
- Diagnostic Test: abdominal ultrasonography.
**Label:** Group I
#### Arm Group 2
**Description:** Gallbladder dysfunction in end stage CKD patients on dialysis.
**Intervention Names:**
- Diagnostic Test: abdominal ultrasonography.
**Label:** Group II
#### Arm Group 3
**Description:** Gallbladder dysfunction in normal renal function participants (control group).
**Intervention Names:**
- Diagnostic Test: abdominal ultrasonography.
**Label:** Control Group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control Group
- Group I
- Group II
**Description:** Evaluate the gallbladder ejection fraction (EF)
**Name:** abdominal ultrasonography.
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluate the gallbladder ejection fraction (EF) which will be calculated by following formula. (EF = (fasting gallbladder volume (FV) - residual gallbladder volume (RV)) / fasting gallbladder volume (FV)x 100) EF = (FV - RV) / FV x 100
**Measure:** Gallbladder dysfunction in CKD patients
**Time Frame:** measuring fasting gallbladder volume (FV) after 10 overnight hours fasting and the residual gallbladder volume (RV) after 30 minutes after standard fixed meal
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients who are diagnosed as CKD with eGFR according to Cockcroft-Gault Equation, whatever they are on regular hemodialysis or pre-dialysis without history of previous gallbladder dysfunction with normal renal function individuals.
Exclusion Criteria:
* Patients who are younger than 18 years.
* Patients who are diabetic.
* Patients who have body mass index (BMI) more than 30.
* Patients who have family history of gallbladder disorder.
**Maximum Age:** 85 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** individuals visiting outpatient clinics of nephrology, GIT and internal medicine in Assiut hospitals.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Rehab Mohamed Mohamed Eltayeb, M.B.B.CH.
**Phone:** 01016644593
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Assiut
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Rehab Mohamed Mohamed Eltayeb Ahmed, M.B.B.CH.
- **Phone:** 01016644593
- **Role:** CONTACT
**Country:** Egypt
**Facility:** faculty of medicine Assiut university
## 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
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10698
- Name: Kidney Diseases
- Relevance: HIGH
- As Found: Kidney Disease
- ID: M4946
- Name: Biliary Tract Diseases
- Relevance: HIGH
- As Found: Biliary Tract Disorders
- 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: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001660
- Term: Biliary Tract Diseases
- ID: D000007674
- Term: Kidney Diseases
- ID: D000051436
- Term: Renal Insufficiency, Chronic
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437405
**Brief Title:** Resistance Exercise Plus Vinegar Ingestion on Biomarkers in Healthy Adults
**Official Title:** The Effects of a 12-Week Resistance Exercise Program Plus Vinegar Ingestion on Biomarkers of Intestinal Permeability, Cognition, and Mood State in Healthy Adults
#### Organization Study ID Info
**ID:** STUDY00019774
#### Organization
**Class:** OTHER
**Full Name:** Arizona State University
### Status Module
#### Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-10-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Arizona State University
#### Responsible Party
**Investigator Affiliation:** Arizona State University
**Investigator Full Name:** Carol Johnston
**Investigator Title:** Professor and Associate Dean
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Given its capacity to stimulate exercise-induced neuroplasticity at lower doses compared to aerobic exercise, resistance exercise has become the top-recommended rehabilitation approach for individuals with neurocognitive impairments. Despite a large body of evidence supporting its application in the context of cognition, little work has been done to investigate the role of resistance exercise in modifying the structure and function of the microbiota-gut-brain axis. Likewise, despite a general understanding of the benefits of short chain fatty acids such as acetate for the gut-brain axis, the impact of exogenous acetic acid has not been sufficiently examined in the context of the intestinal barrier. While self-reported mood disturbance responds favorably to vinegar ingestion, it is currently unknown if these effects are also associated with changes in intestinal permeability.
**Detailed Description:** Existing resistance exercise interventions have produced promising outcomes indicating favorable shifts in microbial composition, intestinal barrier integrity, and serum biomarkers of inflammation. These changes appear to be particularly pronounced in individuals experiencing greater enhancements in lean mass, implying a crucial role for the hypertrophic effects of the exercise protocol. Given the current knowledge surrounding age-related cognitive decline and the pathophysiology of neurological and psychiatric disorders, it seems that many of the mechanisms significantly influenced by resistance exercise could contribute to reducing the risk or, at the very least, delaying the onset of these conditions. Considering the observed neuroplastic and neuroprotective effects of resistance exercise on the brain, it is plausible to hypothesize that the mitigation of excessive intestinal permeability and subsequent neuroinflammation may further support overall brain function. Given the potential for vinegar to enhance these outcomes, investigating the combined effects of exercise and vinegar ingestion may provide valuable insights into how lifestyle interventions can effectively promote cognitive and mental health. Therefore, the purpose of this work is to assess whether the combination of resistance exercise and vinegar ingestion elicits more favorable shifts in gut barrier function, cognition, and mental health compared to resistance exercise alone. This investigation aims to demonstrate the potential efficacy of this integrated approach in fostering long-team health outcomes.
### Conditions Module
**Conditions:**
- LPS
- Mood Disorders
- Cognitive Change
**Keywords:**
- vinegar
- resistance training
- strength
- depression
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** 12-week randomized controlled trial preceded by a 3-week control period
##### Masking Info
**Masking:** SINGLE
**Masking Description:** participants will be randomly assigned to the liquid vinegar group or the vinegar pill group (control)
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 2 tablespoons of liquid apple cider vinegar (5% acidity) diluted in one cup of water twice daily with meals providing 1.5g acetic acid.
**Intervention Names:**
- Dietary Supplement: Vinegar liquid
**Label:** Liquid vinegar
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** one apple cider vinegar tablet (0.022g acetic acid) daily.
**Intervention Names:**
- Dietary Supplement: vinegar pill
**Label:** Vinegar pill
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Liquid vinegar
**Description:** one pill daily
**Name:** Vinegar liquid
**Other Names:**
- Vinegar pill
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Vinegar pill
**Description:** One pill daily
**Name:** vinegar pill
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** measured indirectly via LPS binding protein
**Measure:** Lipopolysaccharide
**Time Frame:** 12 weeks
**Description:** measured via Profile of Mood States (POMS) questionnaire
**Measure:** Depression
**Time Frame:** 12 weeks
**Description:** measured using Trail Making Test
**Measure:** Cognitive change
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. premenopausal (for those assigned female at birth)
2. willing and able to participate in moderate to vigorous exercise as determined by the ACSM Health/Fitness Facility Preparticipation Screening Questionnaire
3. sedentary (defined as a score \<14 on the Godin-Shepard Leisure Time Physical Activity Questionnaire (GSLTQ))
4. equipped with access to a complete gym
5. available for all lab visits (at weeks 0, 3, 9, and 15)
Exclusion Criteria:
1. antibiotic use within the past three months
2. prebiotic, probiotic, or high-dose antioxidant supplementation within the past month
3. regular engagement in moderate to vigorous exercise
4. following a vegetarian diet
5. presence of any medical/psychiatric disease
6. presence of any gastrointestinal disorder such as irritable bowel syndrome, inflammatory bowel disease, Crohn's disease, diverticulitis/diverticulosis, etc.
7. actively pregnant or breastfeeding
**Healthy Volunteers:** True
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Carol Johnston, PhD
**Phone:** 6024962539
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Phoenix
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Carol S Johnston, PhD
- **Phone:** 602-965-2539
- **Role:** CONTACT
**Country:** United States
**Facility:** 850 PBC
**State:** Arizona
**Status:** RECRUITING
**Zip:** 85004
### IPD Sharing Statement Module
**Description:** There is no plan to share data beyond study investigators.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7061
- Name: Depressive Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M7058
- Name: Depression
- Relevance: LOW
- As Found: Unknown
- ID: M21835
- Name: Mood Disorders
- Relevance: HIGH
- As Found: Mood Disorders
- 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: D000019964
- Term: Mood Disorders
### 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
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M21319
- Name: Acetic Acid
- Relevance: HIGH
- As Found: Socioeconomic
- ID: M303111
- Name: Retinol acetate
- 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: T436
- Name: Acetic Acid
- Relevance: HIGH
- As Found: Socioeconomic
### Intervention Browse Module - Meshes
- ID: D000019342
- Term: Acetic Acid
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437392
**Brief Title:** Evaluation of Sarcopenia and Related Factors in Patients Diagnosed With Psoriatic Arthritis
**Official Title:** Evaluation of Sarcopenia and Related Factors in Patients Diagnosed With Psoriatic Arthritis
#### Organization Study ID Info
**ID:** 10026356
#### Organization
**Class:** OTHER
**Full Name:** Ankara City Hospital Bilkent
### Status Module
#### Completion Date
**Date:** 2024-08-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-08-20
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-06-20
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ankara City Hospital Bilkent
#### Responsible Party
**Investigator Affiliation:** Ankara City Hospital Bilkent
**Investigator Full Name:** Gonca Canan Doğan Tosun
**Investigator Title:** Medical Doctor (Physical Medicine and Rehabilitation)
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of the study is identify the prevalence of sarcopenia and its associated factors in patients with psoriatic arthritis. Furthermore, we aimed to investigate the predictive contribution of USG in diagnosing sarcopenia by assessing the thickness of the rectus femoris, vastus intermedius, and quadriceps muscles in patients with psoriatic arthritis.
**Detailed Description:** After being informed about study and potential risk, all patient and giving written informed consent will undergo screnneing determite eligibility for study entire. Participants who agree to take part in the study and sign the informed consent form will be divided into two groups: patients and healthy volunteers. The patients will undergo a rheumatological examination, and sarcopenia screening will be conducted for both groups. Additionally, the quadriceps muscle thickness of both groups will be measured.
### Conditions Module
**Conditions:**
- Psoriatic Arthritis
**Keywords:**
- rheumatic disease
- sarcopenia
- ultrasonography
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 102
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Psoriatic arthritis patient
**Label:** Psoriatic arthritis
#### Arm Group 2
**Description:** Healthy Volunteer
**Label:** Healthy volunteer
### Outcomes Module
#### Primary Outcomes
**Description:** muscle strength measurement:Hand grip strength is a parameter used to assess sarcopenia. Therefore, the hand grip strength of participants will be measured. A Jamar hydraulic hand dynamometer (FEI®, model 5030J1, USA) will be used for measuring muscle strength.For the hand grip strength measurement, participants will be seated with back support, with the shoulder in adduction, the elbow at 90 degrees flexion, the forearm and wrist in neutral and supported
**Measure:** Grip strength
**Time Frame:** 1 day
**Description:** Participants are instructed to walk at a normal pace on a flat 6-meter surface (including the first 1 meter for acceleration, 4 meters for the walking test area, and the last 1 meter for deceleration). Those who take longer than 5 seconds to complete the 4 meters (walking speed \<0.8 m/s) are evaluated as having low physical performance.
**Measure:** 4 m gait speed test
**Time Frame:** 1 day
**Description:** The SARQoL (Sarcopenia Quality of Life) questionnaire consists of 55 items and 22 questions, organized into seven different domains of quality of life: physical and mental health, locomotion, body composition, functionality, daily living activities, leisure activities, and fears.
**Measure:** Quality of life in sarcopenia scale (SARQoL)
**Time Frame:** 1 day
**Description:** It is a test that assesses the participants' balance and walking. It includes 9 questions for balance and 7 questions for walking. Each response is scored between 0 and 2 points.
**Measure:** Tinetti balance and walking test
**Time Frame:** 1 day
**Description:** It is a scale developed to identify cases of anxiety disorders and depression in patients in non-psychiatric hospital clinics. Both contain seven intertwined items.
**Measure:** Hospital Anxiety and Depression Scale
**Time Frame:** 1 day
**Description:** This is a questionnaire that assesses the quality of life of patients diagnosed with psoriatic arthritis. It addresses pain, fatigue, skin problems, ability to perform work and/or leisure activities, functional capacity, discomfort, sleep disturbances, embarrassment from appearance, social participation, and depression.In this test, patients receive a score between 0 and 10.
**Measure:** PSAID12
**Time Frame:** 1 day
**Description:** In the method where tenderness and swelling in 28 joints are recorded, known as the Disease Activity Score (DAS 28), global pain assessment score is used along with CRP (C-Reactive Protein) or ESR (Erythrocyte Sedimentation Rate) values. Scores of 2.6 or lower are considered remission, while scores between 2.6 and 3.2 indicate low disease activity, scores between 3.2 and 5.1 indicate moderate disease activity, and scores above 5.1 indicate high disease activity.
**Measure:** DAS 28
**Time Frame:** 1 day
**Description:** The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score consists of six questions in the form of a visual analog scale (VAS) related to the five main symptoms of Ankylosing Spondylitis over the past week: fatigue, spinal pain, peripheral joint pain/swelling, localized tenderness, and morning stiffness. A final score between 0 and 10 is obtained. A BASDAI score of 4 or higher is considered indicative of active disease.
**Measure:** BASDAI
**Time Frame:** 1 day
**Description:** The Disease Activity Index for Psoriatic Arthritis (DAPSA) score involves a joint examination of the patient. 68 joints are assessed for tenderness, and 66 joints for swelling. The numbers of tender and swollen joints are determined. The physician evaluates the patient's overall pain during examination and scores it out of 10. The patient's Visual Analog Scale (VAS) value is also recorded. The CRP value is noted.
The score is then calculated simply by summing up all these values (number of tender joints + number of swollen joints + physician's assessment of overall pain + VAS + CRP).
A score between 0 and 4 indicates remission, 5 to 14 indicates low disease activity, 15 to 27 indicates moderate disease activity, and a score greater than 28 indicates high disease activity.
**Measure:** DAPSA
**Time Frame:** 1 day
**Description:** The Psoriasis Area Severity Index (PASI) evaluates both the severity and extent of psoriasis lesions on four body regions: the scalp, arms, trunk, and legs. It assesses the percentage of body surface area affected by lesions (A=area score; 1=\<10%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89%, 6=90-100%) and the severity of erythema (E), induration (I), and desquamation (D), each scored from 0 to 4.
PASI scores range from 0 to 72, with higher scores indicating more severe disease.
**Measure:** PASI
**Time Frame:** 1 day
**Description:** All participants included in the study will undergo sonographic examination using the Logiq 9 (GE, USA) ultrasound device and a high-frequency 7-12 MHz linear probe available in our clinic. The distance between the bilateral spina iliaca anterior superior and the upper pole of the patella of the participants' dominant and non-dominant extremities will be measured, and the distal 1/3 will be marked. The measurement will be taken in a seated upright position. Care will be taken to avoid compression during the measurement. After ensuring there is no compression in the subcutaneous fat tissue and muscle, an axial image will be recorded. The thickness of the subcutaneous fat tissue, vastus intermedius, rectus femoris, and total quadriceps will be measured three times, and the average of these measurements will be recorded.
**Measure:** ultrasonography
**Time Frame:** 1 day
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Diagnosed with psoriatic arthritis according to CASPAR criteria at least 1 year ago
* Between 18 and 65 years old
* Normal cognitive functions
* Agrees to participate in the study
* No changes in medical treatment for psoriatic arthritis in the last 3 months
Exclusion Criteria:
* Those with neurological diseases
* Those with hip dysplasia
* Those with upper and lower extremity deformities
* Those with upper and lower extremity joint arthroplasty
* Those with arthritis and deformities in the hands
* Those with lumbar stabilization
* Those with cognitive impairment preventing participation in the study
* Those with body weight beyond the device\'s measurement capacity
* Those who do not agree to participate in the study
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients between the ages of 18-65, who were diagnosed with psoriatic arthritis at least one year ago according to the CASPAR criteria, and healthy controls, who visited Ankara Bilkent City Hospital Physical Medicine and Rehabilitation Department, were included.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Tuba Güler, Assoc Prof
**Phone:** +905052841036
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Gonca Canan Dogan Tosun, Medical Doctor
**Phone:** +905383760095
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Ankara
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Gonca Canan DOGAN TOSUN, Medical Dovtor
- **Phone:** 05383760095
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Ankara Bilkent City Hospital Physical Therapy an Rehabilitation Hospital
**State:** Bilkent-Cankaya
**Status:** RECRUITING
**Zip:** 06800
#### Overall Officials
**Official 1:**
**Affiliation:** Ankara Bilkent City Hospital
**Name:** Gonca Canan Dogan Tosun, Medical Doctor
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Ankara City Hospital Bilkent
**Name:** Tuba Güler, Assoc Prof
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169. Erratum In: Age Ageing. 2019 Jul 1;48(4):601.
**PMID:** 30312372
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000009133
- Term: Muscular Atrophy
- ID: D000020879
- Term: Neuromuscular Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000001284
- Term: Atrophy
- ID: D000020763
- Term: Pathological Conditions, Anatomical
- ID: D000025242
- Term: Spondylarthropathies
- ID: D000025241
- Term: Spondylarthritis
- ID: D000013166
- Term: Spondylitis
- ID: D000013122
- Term: Spinal Diseases
- ID: D000001847
- Term: Bone Diseases
- ID: D000011565
- Term: Psoriasis
- ID: D000017444
- Term: Skin Diseases, Papulosquamous
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC01
- Name: Infections
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4476
- Name: Arthritis
- Relevance: HIGH
- As Found: Arthritis
- ID: M28396
- Name: Sarcopenia
- Relevance: HIGH
- As Found: Sarcopenia
- ID: M18178
- Name: Arthritis, Psoriatic
- Relevance: HIGH
- As Found: Psoriatic Arthritis
- ID: M15045
- Name: Rheumatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6323
- Name: Collagen Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4589
- Name: Atrophy
- Relevance: LOW
- As Found: Unknown
- ID: M12090
- Name: Muscular Atrophy
- Relevance: LOW
- As Found: Unknown
- ID: M22619
- Name: Neuromuscular Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
- ID: M23036
- Name: Spondylarthropathies
- Relevance: LOW
- As Found: Unknown
- ID: M15961
- Name: Spondylitis
- Relevance: LOW
- As Found: Unknown
- ID: M23035
- Name: Spondylarthritis
- 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: M14422
- Name: Psoriasis
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19713
- Name: Skin Diseases, Papulosquamous
- Relevance: LOW
- As Found: Unknown
- ID: T5412
- Name: Spondylarthropathy
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001168
- Term: Arthritis
- ID: D000015535
- Term: Arthritis, Psoriatic
- ID: D000055948
- Term: Sarcopenia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437379
**Brief Title:** Infection Control Measures for Patients Undergoing Percutaneous Nephrolithotomy
**Official Title:** Effect of Teaching Protocol on Nurse's Knowledge and Practice Regarding Infection Control Measures for Patients Undergoing Percutaneous Nephrolithotomy
#### Organization Study ID Info
**ID:** Infection Control Measures
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2025-01-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-17
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assiut University
#### Responsible Party
**Investigator Affiliation:** Assiut University
**Investigator Full Name:** Kamilia Farouk Abdel Fattah Osman
**Investigator Title:** Nursing specialist
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** To evaluate the effect of implementing teaching protocol on nurse's knowledge and practice regarding infection control measures for patients undergoing Percutaneous Nephrolithotomy.
**Detailed Description:** Percutaneous Nephrolithotomy (PCNL) is a surgery to remove kidney stones that are too large to pass on their own. Percutaneous" means that the procedure occurs through the skin. "Nephrolithotomy" means the removal of a calculus (kidney stone) from a kidney . Percutaneous Nephrolithotomy is typically recommended when kidney stones are larger than 0.8 inch (2 centimeters) in diameter. . Percutaneous Nephrolithotomy (PCNL) has altered dramatically the management of urolithiasis. In fact, these treatment modalities have nearly 99% success rates for treatment of upper urinary tract stones. . There were several complications related to Percutaneous Nephrolithotomy such as fever (23%) and bleeding necessitating transfusion (12%). Extravasation was seen in 7% of patients and transient ureteral obstruction in 6%. The complications limit surgical outcome of PCNL. Infection remains the most common complication arising from this procedure and some patients develop septicemia and septic shock, resulting in increased mortality and morbidity. So, the success of the Percutaneous Nephrolithotomy depends on the maintenance of infection control precautions. This is why investigator looked at this study. Knowledge of the nurse of percutaneous nephrolithotomy care was of crucial importance and had an impact on nurse's practice. The main goal of care was to prevent infection undergoing the percutaneous nephrolithotomy The nurses' role preventing infection for patient undergoing (PCNL) and mainly maintain the sterile field and after operation safety removing (PPE), washing instruments used during operation all of that resulting in positive surgical outcomes Infection control is an important concern for health care professionals specially nurses. Nurses have higher risk for both self-acquiring and transmitting infections to other patients infection control practices form the backbone of nurse's. Nurses has the distinctive opportunity to reduce hospital - acquired infections by utilizing the skills and knowledge about infection control measures, they can facilitate patient recovery while minimizing complications related to infections. Compliance with infection control and sterile technique principles will be prevent nosocomial infections in the operating room, and the patient's hospital stay being shorter and a reduced cost for the medical aids and hospitals . the investigators searched for this topic in many sites such as PubMed Central, Research Gate, and Science.gov.The current topic was not covered in the previous studies. Previous studies did not include specific point about this topic but include general point about PCNL and this strong rational for this study. This study will be carried out to evaluate the knowledge and practice about standard precautions and infection control measures and to explore education needs of nurses.
Generally, programs of healthcare education vary greatly in their contents and approaches .Various forms of visual aids are currently used in healthcare education including illustrations such as photographs and animations such as computer -generated clips and video clips.
### Conditions Module
**Conditions:**
- Urological Nursing
- Kidney Stone
**Keywords:**
- PCNL
- infection control
- nurses
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** To evaluate the effect of implementing teaching protocol on nurse's knowledge and practice regarding infection control measures for patients undergoing Percutaneous Nephrolithotomy.
##### Masking Info
**Masking:** NONE
**Masking Description:** nurse working in urology department
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 30
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Effect of Teaching Protocol on Nurse's Knowledge and Practice regarding Infection Control Measures for Patients undergoing Percutaneous Nephrolithotomy
**Intervention Names:**
- Behavioral: Infection control
**Label:** effect of infection control on patient outcomes undergoing PCNL
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- effect of infection control on patient outcomes undergoing PCNL
**Description:** To evaluate the effect of implementing teaching protocol on nurse's knowledge and practice regarding infection control measures for patients undergoing Percutaneous Nephrolithotomy.
**Name:** Infection control
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** use infection control technique to reduce infection in patient undergoing PCNL
**Measure:** teach nurses new measures to reduce infection in patient undergoing PCNL by applying infection control measure
**Time Frame:** one year
#### Secondary Outcomes
**Description:** reduce patient length of hospital stay
**Measure:** reduce the patients hospital stay postoperative
**Time Frame:** one year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1- Nursing Staff providing nursing care services for patient undergoing PNL (pre-intra-post) operative care.
Exclusion Criteria:
1. Head nurses
2. Nurses refused to participate in the study
**Maximum Age:** 65 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Assiut
**Country:** Egypt
**Facility:** Faculty of Nursing
**Zip:** 088
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Babjuk M, Burger M, Capoun O, Cohen D, Comperat EM, Dominguez Escrig JL, Gontero P, Liedberg F, Masson-Lecomte A, Mostafid AH, Palou J, van Rhijn BWG, Roupret M, Shariat SF, Seisen T, Soukup V, Sylvester RJ. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (Ta, T1, and Carcinoma in Situ). Eur Urol. 2022 Jan;81(1):75-94. doi: 10.1016/j.eururo.2021.08.010. Epub 2021 Sep 10.
**PMID:** 34511303
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000053040
- Term: Nephrolithiasis
- 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
- ID: D000002137
- Term: Calculi
- ID: D000020763
- Term: Pathological Conditions, Anatomical
### 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: HIGH
- As Found: Infection
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10693
- Name: Kidney Calculi
- Relevance: HIGH
- As Found: Kidney Stone
- ID: M27126
- Name: Nephrolithiasis
- Relevance: LOW
- As Found: Unknown
- ID: M5399
- Name: Calculi
- 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: M27103
- Name: Urolithiasis
- Relevance: LOW
- As Found: Unknown
- ID: M17295
- Name: Urinary Calculi
- 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: D000007239
- Term: Infections
- ID: D000007669
- Term: Kidney Calculi
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437366
**Acronym:** HeartMathsub
**Brief Title:** Nurse-Led Heart Math Training Program With Substance Use Disorder
**Official Title:** Effectiveness of a Nurse-Led Heart Math Training Program on Resilience , Sense of Coherence, and Emotional Adjustment in Patients With Substance Use Disorder
#### Organization Study ID Info
**ID:** 100.a
#### Organization
**Class:** OTHER
**Full Name:** Alexandria University
### Status Module
#### Completion Date
**Date:** 2024-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Alexandria 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:** Substance use disorders (SUDs) pose significant challenges to individuals' psychological well-being, resilience, and emotional adjustment. These disorders often lead to detrimental effects on physical health, mental health, and overall quality of life, creating a critical need for effective interventions that can support recovery and enhance emotional resilience. One promising approach is the implementation of nurse-led HeartMath training programs. These programs utilize evidence-based techniques to improve emotional regulation, increase resilience, and foster a sense of coherence, which is the ability to perceive life as comprehensible, manageable, and meaningful.
**Detailed Description:** The HeartMath training program, developed by the HeartMath Institute, focuses on teaching individuals self-regulation skills that promote heart-brain coherence. This state of coherence has been associated with improved cognitive function, emotional stability, and physical health. By integrating this training into the care of patients with SUDs, nurses can play a pivotal role in addressing the complex emotional and psychological needs of this population.
Brief About the Training Program
The nurse-led HeartMath training program consists of several key components designed to enhance resilience, sense of coherence, and emotional adjustment:
Heart-Focused Breathing Techniques: Patients are taught specific breathing techniques that help synchronize heart and brain activity, leading to a state of physiological coherence.
Emotional Regulation Skills: The training includes exercises that help individuals recognize and shift from negative to positive emotional states, thereby improving emotional stability and reducing stress.
Biofeedback Technology: Participants use HeartMath biofeedback devices that provide real-time feedback on their heart rhythm patterns, enabling them to monitor and improve their coherence levels.
Resilience-Building Exercises: The program incorporates activities and practices aimed at enhancing personal resilience, such as positive visualization and the cultivation of gratitude and appreciation.
Individual and Group Sessions: The training is delivered through a combination of individual coaching and group workshops, providing both personalized support and a sense of community.
### Conditions Module
**Conditions:**
- Substance Abuse
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The HeartMath training program, developed by the HeartMath Institute, focuses on teaching individuals self-regulation skills that promote heart-brain coherence. This state of coherence has been associated with improved cognitive function, emotional stability, and physical health. By integrating this training into the care of patients with SUDs, nurses can play a pivotal role in addressing the complex emotional and psychological needs of this population.
**Intervention Names:**
- Behavioral: Nurse-Led Heart Math Training Program
**Label:** nurse-led HeartMath training program on patients with substance use disorder
**Type:** EXPERIMENTAL
#### Arm Group 2
**Label:** Non-experimental patients with substance use disorder
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- nurse-led HeartMath training program on patients with substance use disorder
**Description:** he nurse-led HeartMath training program consists of several key components designed to enhance resilience, sense of coherence, and emotional adjustment:
Heart-Focused Breathing Techniques: Patients are taught specific breathing techniques that help synchronize heart and brain activity, leading to a state of physiological coherence.
Emotional Regulation Skills: The training includes exercises that help individuals recognize and shift from negative to positive emotional states, thereby improving emotional stability and reducing stress.
**Name:** Nurse-Led Heart Math Training Program
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Patients with substance use disorder who participate in a nurse-led HeartMath training program will show a statistically significant increase in resilience, as measured by the Connor-Davidson Resilience Scale (CD-RISC), compared to those who do not participate in the program.
**Measure:** Patients with substance use disorder who participate in a nurse-led HeartMath training program
**Time Frame:** three months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* substance abuse for at least one month
Exclusion Criteria:
* out side hospital
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Alexandria
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** mohamed H atta
- **Phone:** 2026609088
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Alexandria university
**State:** Al Iskandariyah
**Status:** RECRUITING
**Zip:** 21913
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000064419
- Term: Chemically-Induced Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC25
- Name: Substance Related Disorders
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M21837
- Name: Substance-Related Disorders
- Relevance: HIGH
- As Found: Substance Use Disorders
- ID: M30302
- Name: Chemically-Induced 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: D000019966
- Term: Substance-Related Disorders
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437353
**Brief Title:** Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib as First-line and Maintenance Therapy for Newly Diagnosed High-risk Ovarian Cancer
**Official Title:** Sorafenib Combined With Carboplatin/Paclitaxel and Sorafenib Combined With Olaparib as First-line and Maintenance Therapy for Newly Diagnosed High-risk Ovarian Cancer: a Single-arm, Multicenter, Exploratory Clinical Study
#### Organization Study ID Info
**ID:** 2024 No. 047
#### Organization
**Class:** OTHER
**Full Name:** Anhui Provincial Cancer Hospital
### Status Module
#### Completion Date
**Date:** 2027-10-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-10-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-25
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Hutchison Medipharma Limited
#### Lead Sponsor
**Class:** OTHER
**Name:** Anhui Provincial Cancer Hospital
#### Responsible Party
**Investigator Affiliation:** Anhui Provincial Cancer Hospital
**Investigator Full Name:** Bai-Rong Xia
**Investigator Title:** Director of Gynecological Surgery
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this type of clinical trial study is to evaluate the safety and efficacy of Surufatinib combined with Carboplatin/Paclitaxel and Surufatinib combined with Olaparib as first-line and maintenance therapy for newly diagnosed high-risk ovarian cancer
**Detailed Description:** Patients will have tests and exams to see if they are eligible for the clinical trial.
First-line chemotherapy regimen:
Paclitaxel/Carboplatin(repeat every 3 weeks, total of 6 cycles):
* Paclitaxel: 175 mg/m², intravenous infusion, on day 1.
* Carboplatin: AUC 5, intravenous infusion, on day 1.
* For patients aged ≥70 years or those with comorbidities, the paclitaxel dose can be adjusted to 135 mg/m².
Surufatinib(repeat every 3 weeks, total of 5 cycles):
* Surufatinib is not used during the first postoperative cycle.
* Starting from the second postoperative cycle, surufatinib is administered at a dose of 250 mg once daily, taken continuously.
Maintenance Therapy Regimen:
HRD-positive Patients:
* Surufatinib: 250 mg once daily, taken continuously.
* Olaparib: 300 mg twice daily, with doses taken 12 hours apart. Olaparib can be used for a maximum of 2 years.
HRD-negative or HRD Status Unknown Patients:
* Surufatinib: 250 mg once daily, taken continuously.
Treatment continues until the patient experiences disease progression or meets other criteria for discontinuation of the study treatment as specified in the protocol.
### Conditions Module
**Conditions:**
- Ovarian Cancer
**Keywords:**
- Antiangiogenic
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** First-line chemotherapy regimen:
* Paclitaxel: 175 mg/m², intravenous infusion, on day 1.
* Carboplatin: AUC 5, intravenous infusion, on day 1.
* Surufatinib：250 mg once daily, taken continuously.
Maintenance Therapy Regimen:
* Surufatinib: 250 mg once daily, taken continuously.
* Olaparib: 300 mg twice daily.
**Intervention Names:**
- Drug: Paclitaxel
**Label:** First-line and maintenance therapy regimen
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- First-line and maintenance therapy regimen
**Description:** First-line chemotherapy regimen:
* Paclitaxel: 175 mg/m², intravenous infusion, on day 1.
* Carboplatin: AUC 5, intravenous infusion, on day 1.
* Surufatinib：250 mg once daily, taken continuously.
Maintenance Therapy Regimen:
* Surufatinib: 250 mg once daily, taken continuously.
* Olaparib: 300 mg twice daily.
**Name:** Paclitaxel
**Other Names:**
- Surufatinib
- Carboplatin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Progression-free survival on first-line and maintenance therapy with Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib
**Measure:** Progression free survival
**Time Frame:** 12-month
#### Secondary Outcomes
**Description:** ORR is defined as the proportion of participants achieving Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST (v.1.1). Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of diameters (SoD) of target lesions
**Measure:** Overall Response Rate (ORR
**Time Frame:** 3-month
**Description:** the percentage of patients with complete response, partial response, and stable disease for more than 4 weeks in which response can be evaluated
**Measure:** Disease control rate
**Time Frame:** 3-month
**Description:** the date of enrollment to the date of death from any cause
**Measure:** Overall survival
**Time Frame:** 3-years
**Description:** Adverse medical events in clinical trial subjects treated with Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib
**Measure:** Adverse event
**Time Frame:** 3-month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age: 18-75 years old (≥18, ≤75)
2. Patients with newly diagnosed FIGO stage III or IV high-grade serous ovarian cancer, high-grade endometrioid carcinoma, primary peritoneal cancer, and/or fallopian tube cancer with high-risk factors for recurrence. High-risk recurrence is defined as follows:
* FIGO stage III with non-R0 resection;
* FIGO stage IV;
* Presence of ascites at initial diagnosis.
3. Patients who have undergone primary debulking surgery (PDS) for ovarian cancer.
4. ECOG performance status score: 0-2.
5. Postoperative administration time ≤12 weeks.
6. Expected survival of at least 3 months.
7. Major organ function within 7 days prior to treatment meets the following criteria:
* Hemoglobin (HB) ≥90 g/L;
* Absolute neutrophil count (ANC) ≥1.5×10⁹/L;
* Platelets (PLT) ≥100×10⁹/L.
8. Biochemical parameters must meet the following standards:
* Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN);
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, or ≤5×ULN if liver metastases are present;
* Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60 ml/min.
9. Women of childbearing potential must use effective contraception.
10. Subjects must voluntarily join the study and sign the informed consent form (ICF).
11. Subjects are expected to have good compliance and the ability to follow up on efficacy and adverse reactions as required by the protocol.
Exclusion Criteria:
1. Previous treatment with anti-angiogenic drugs such as apatinib, sorafenib, anlotinib, bevacizumab, or other anti-angiogenic therapies.
2. Pregnant or breastfeeding women.
3. Patients who have previously participated in other clinical trials that have not yet concluded.
4. Patients with evidence or history of significant bleeding tendencies or events within 3 months before enrollment (bleeding \>30 mL, accompanied by hematemesis, melena, or hematochezia), hemoptysis (≥5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke and/or transient ischemic attack) within 12 months.
5. Patients with uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).
6. Patients with grade I or higher myocardial ischemia or infarction, arrhythmias (including QTc ≥480 ms), or ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification).
7. Patients with active or uncontrolled severe infections (≥CTC AE grade 2).
8. Patients with renal failure requiring hemodialysis or peritoneal dialysis.
9. Patients with a history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or those with a history of organ transplantation.
10. Patients with persistent proteinuria (≥++) on two consecutive urine tests, and confirmed 24-hour urine protein \>1.0 g.
11. Patients with psychiatric disorders, including epilepsy, dementia, severe depression, mania, etc.
12. Patients with any signs or history of bleeding disorders, regardless of severity; patients who experienced any bleeding or hemorrhagic event ≥CTCAE grade 3 within 4 weeks before enrollment; patients with unhealed wounds, ulcers, or fractures.
13. Patients who had arterial or venous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism, within the past 6 months.
14. Patients with symptomatic brain metastases or those whose symptoms have been controlled for less than 2 months.
15. Patients with a history of substance abuse that cannot be relinquished or those with psychiatric disorders.
16. Patients with difficulty swallowing or known absorption disorders affecting drug intake.
17. Patients allergic to treatment drugs sorafenib or paclitaxel/carboplatin.
18. Any other condition that the researcher deems unsuitable for enrollment.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Bai-Rong Xia, Doctor
**Phone:** 18604516165
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hefei
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Bai-Rong Xia, MD
- **Phone:** 18604516165
- **Role:** CONTACT
**Country:** China
**Facility:** Anhui Cancer Hospital
**State:** Anhui
**Status:** RECRUITING
**Zip:** 230001
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000010049
- Term: Ovarian Diseases
- ID: D000000291
- Term: Adnexal 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: D000005833
- Term: Genital Neoplasms, Female
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000091662
- Term: Genital Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000006058
- Term: Gonadal Disorders
- 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: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12974
- Name: Ovarian Neoplasms
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: M1704
- Name: Carcinoma, Ovarian Epithelial
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M7863
- Name: Endocrine Gland Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12972
- Name: Ovarian Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M3643
- Name: Adnexal 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: M8945
- Name: Genital Neoplasms, Female
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- 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: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: T4352
- Name: Ovarian Cancer
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: T4354
- Name: Ovarian Epithelial Cancer
- Relevance: HIGH
- As Found: Ovarian Cancer
### Condition Browse Module - Meshes
- ID: D000010051
- Term: Ovarian Neoplasms
- ID: D000077216
- Term: Carcinoma, Ovarian Epithelial
### 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: M18650
- Name: Carboplatin
- Relevance: HIGH
- As Found: System
- ID: M233003
- Name: Olaparib
- Relevance: LOW
- As Found: Unknown
- ID: M22318
- Name: Angiogenesis Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M1680
- Name: Sorafenib
- 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
- ID: D000016190
- Term: Carboplatin
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437340
**Brief Title:** Life Satisfaction of Fathers of Children With Cerebral Palsy
**Official Title:** Determinants of Life Satisfaction Levels of Fathers of Children With Cerebral Palsy
#### Organization Study ID Info
**ID:** KAEU-T.ATAHAN-003
#### Organization
**Class:** OTHER
**Full Name:** Kirsehir Ahi Evran Universitesi
### Status Module
#### Completion Date
**Date:** 2024-05-15
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-05-10
**Type:** ACTUAL
#### Start Date
**Date:** 2023-06-06
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Kirsehir Ahi Evran Universitesi
#### Responsible Party
**Investigator Affiliation:** Kirsehir Ahi Evran Universitesi
**Investigator Full Name:** Atahan TURHAN
**Investigator Title:** Dr. Lecturer
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to examine the determinants of life satisfaction among fathers of children diagnosed with Cerebral Palsy.
### Conditions Module
**Conditions:**
- Cerebral Palsy
- Father-Child Relations
- Life Satisfaction
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 122
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Sociodemographic information included gender, age, height, and weight of the children and their fathers. In addition, clinical information about the children, such as duration of physical therapy and type of disability, was recorded.
**Measure:** Sociodemographic Data
**Time Frame:** 20week
**Description:** Life satisfaction level was assessed using the Satisfaction with Life Scale. The scale has a total of 5 items. Participants are asked to rate each item from 1 to 7. The scores obtained from each item can range from 1 to 7, and the total score can range from 1 to 35. The higher the score obtained from the scale, the higher the life satisfaction.
**Measure:** Satisfaction with Life
**Time Frame:** 20week
**Description:** The Gross Motor Function Classification System (GMFCS) was used to assess the level of gross motor function in children with Cerebral Palsy (CP). GMFCS is a system that classifies the gross motor function levels of children with CP in the same age groups from 1 to 5. Level 1 represents the highest level of function and level 5 represents the lowest level. A higher level represents a lower level of function.
**Measure:** Gross Motor Function
**Time Frame:** 20week
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* to be literate and to have no communication problems
* to be the father of a child with Cerebral Palsiy (CP) and no other medical diagnosis (aged between 1-18 years)
* to have a child with CP who regularly receives physiotherapy and rehabilitation
* to live in the same house with his wife and child/children
* to be willing to participate in the study
Exclusion Criteria:
* to care for individuals in need of care (such as disabled, elderly, chronically ill) additionally to the child with CP
* to have a chronic disorder (such as neurological, rheumatologic, psychiatric disorder) that would affect life satisfaction.
**Healthy Volunteers:** True
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** MALE
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Patients admitted to the Physical Medicine and Rehabilitation Outpatient Clinic with a diagnosis of cerebral palsy were examined by a physiatrist. Children diagnosed with cerebral palsy and their fathers who met the inclusion criteria and agreed to participate in the study were included.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Kirsehir
**Country:** Turkey
**Facility:** Atahan TURHAN
**State:** Merkez
**Zip:** 40100
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000001925
- Term: Brain Damage, Chronic
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5796
- Name: Cerebral Palsy
- Relevance: HIGH
- As Found: Cerebral Palsy
- ID: M13157
- Name: Paralysis
- Relevance: LOW
- As Found: Unknown
- ID: M5207
- Name: Brain Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M5202
- Name: Brain Damage, Chronic
- 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: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002547
- Term: Cerebral Palsy
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437327
**Brief Title:** Comparison of Effectiveness Between Active Release Technique and Hold Relax Technique in Patients With Piriformis Syndrome
**Official Title:** Comparison of Effectiveness Between Active Release Technique and Hold Relax Technique in Patients With Piriformis Syndrome
#### Organization Study ID Info
**ID:** FUI/CTR/2024/10
#### Organization
**Class:** OTHER
**Full Name:** Foundation University Islamabad
### Status Module
#### Completion Date
**Date:** 2024-06-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2023-11-20
**Type:** ACTUAL
#### Start Date
**Date:** 2023-07-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Foundation University Islamabad
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study is a randomized controlled trial and the purpose of this study is to compare the effects between active release technique and hold relax technique in patients with Piriformis syndrome.
**Detailed Description:** The purpose of this study is to compare the effects between active release technique and hold relax technique in patients with piriformis syndrome pain, range of motion, and functional disability, in adults (age: 25-55 years)
1. Numeric pain rating scale
2. Goniometer
3. Oswestry Disability Questionairre Data will be collected before and after the intervention protocol for each participant.
Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Pre and post-intervention scores will be recorded.
### Conditions Module
**Conditions:**
- Piriformis Syndrome
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized Controlled Trial
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Hot pack for 10 minutes Interferential Current (IFC) for 10 minutes Active release technique is applied (patient is prone lying with knee flexed, Pressure is applied on taut band and patient is asked to move the leg in internal rotation to achieve maximal lengthening) Repetitions 5 to 7 times hold for 5 to 20 seconds
**Intervention Names:**
- Procedure: Electrotherapy
- Procedure: Active release technique
**Label:** Experimiental Group 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Hot pack for 10 minutes Interferential Current (IFC) for 10 minutes Hold relax technique This technique is applied while the patient is in supine lying with one leg crossed over the other Patient is instructed to contract the piriformis against the manual resistance for 5 to 10 secs Then 15 secs of passive stretch is given repetitions x 5 times
**Intervention Names:**
- Procedure: Electrotherapy
- Procedure: Hold relax technique
**Label:** Experimental Group 2
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental Group 2
- Experimiental Group 1
**Description:** Hot pack for 10 minutes Interferential Current (IFC) for 10 minutes
**Name:** Electrotherapy
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Experimiental Group 1
**Description:** Active release technique is applied (patient is prone lying with knee flexed, Pressure is applied on taut band and patient is asked to move the leg in internal rotation to achieve maximal lengthening) Repetitions 5 to 7 times hold for 5 to 20 seconds
**Name:** Active release technique
**Type:** PROCEDURE
#### Intervention 3
**Arm Group Labels:**
- Experimental Group 2
**Description:** This technique is applied while the patient is in supine lying with one leg crossed over the other Patient is instructed to contract the piriformis against the manual resistance for 5 to 10 secs Then 15 secs of passive stretch is given repetitions x 5 times
**Name:** Hold relax technique
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Numeric Pain Rating Scale (NPRS): ICC (0.93-0.96).It has a scale of 0-10 or 0-100 points and can be given verbally or in writing.
**Measure:** Pain intensity
**Time Frame:** 2 weeks
**Description:** Physical Function will be measured using Oswestry disability Questionnaire
**Measure:** Physical Function using Oswestry disability Questionnaire
**Time Frame:** 2 weeks
**Description:** Hip internal rotation using Goniometer
**Measure:** Hip internal rotation range of motion
**Time Frame:** 2 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria:
* Gender: Both male and female
* Individuals aged 25-55 years
* Tenderness to palpation over sciatic foramen
* Positive FAIR Test.
Exclusion criteria :
* History of hip, pelvic, or Femoral fractures.
* Malignancies.
* Avascular necrosis of Femoral head.
* Inflammatory conditions (e.g. Rheumatoid Arthritis)
**Maximum Age:** 55 Years
**Minimum Age:** 25 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mohammad Ali, MS-MSKPT*
**Phone:** 03415161695
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rawalpindi
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Furqan Hassan, MS-OMPT,PHD*
- **Phone:** 03334056768
- **Role:** CONTACT
**Country:** Pakistan
**Facility:** Foundation University College of Physical Therapy
**State:** Punjab
**Status:** RECRUITING
**Zip:** 46000
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020426
- Term: Sciatic Neuropathy
- ID: D000020422
- Term: Mononeuropathies
- ID: D000010523
- Term: Peripheral Nervous System Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000009408
- Term: Nerve Compression Syndromes
- ID: D000009437
- Term: Neuralgia
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000017699
- Term: Pelvic Pain
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M28404
- Name: Piriformis Muscle Syndrome
- Relevance: HIGH
- As Found: Piriformis Syndrome
- ID: M22222
- Name: Sciatic Neuropathy
- Relevance: LOW
- As Found: Unknown
- ID: M22218
- Name: Mononeuropathies
- Relevance: LOW
- As Found: Unknown
- ID: M13432
- Name: Peripheral Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12352
- Name: Nerve Compression Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M5853
- Name: Charcot-Marie-Tooth Disease
- Relevance: LOW
- As Found: Unknown
- ID: M18092
- Name: Hereditary Sensory and Motor Neuropathy
- Relevance: LOW
- As Found: Unknown
- ID: M12381
- Name: Neuralgia
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M19918
- Name: Pelvic Pain
- Relevance: LOW
- As Found: Unknown
- ID: T4568
- Name: Piriformis Syndrome
- Relevance: HIGH
- As Found: Piriformis Syndrome
- ID: T1081
- Name: Charcot-Marie-Tooth Disease
- Relevance: LOW
- As Found: Unknown
- ID: T2761
- Name: Hereditary Motor and Sensory Neuropathy
- Relevance: LOW
- As Found: Unknown
- ID: T2766
- Name: Hereditary Neuropathy With Liability to Pressure Palsies
- Relevance: LOW
- As Found: Unknown
- ID: T5067
- Name: Roussy Levy Syndrome
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000055958
- Term: Piriformis Muscle Syndrome
- ID: D000013577
- Term: Syndrome
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437314
**Brief Title:** Effect of an Intervention Based on Back School in an Aquatic Environment on Non-specific Low Back Pain
**Official Title:** Effect of an Intervention Based on Back School in an Aquatic Environment on Non-specific Low Back Pain: Randomized Controlled Trial
#### Organization Study ID Info
**ID:** EE acuático
#### Organization
**Class:** OTHER
**Full Name:** University of Vigo
### Status Module
#### Completion Date
**Date:** 2025-01-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Vigo
#### Responsible Party
**Investigator Affiliation:** University of Vigo
**Investigator Full Name:** Pablo Hernandez-Lucas
**Investigator Title:** PhD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** A controlled and randomized clinical trial will be conducted, in which scores on dependent variable measures will be compared before and after the intervention, both in the experimental group (EG) (individuals who will attend the in an aquatic program based on the back school) and in the control group (CG) (individuals who will not attend the in an aquatic program based on the back school). The experimental procedure will follow the recommendations of the CONSORT and TidIER guidelines. The study protocol will be approved by the Research Ethics Committee of the University of Vigo. This study will be conducted under the Declaration of Helsinki (2013 version). Participants will sign a written informed consent after being informed of the benefits and risks of the research. Participants in the EG will participate in an aquatic program based on the back school. This program will follow the recommendations of the biopsychosocial model of chronic pain and will be conducted in an aquatic environment. The intervention will be carried out by physiotherapists in a sports center. The duration of the intervention will be six weeks, with a frequency of two sessions per week, totaling 12 sessions of 45 minutes each. Of all the sessions, 10 will have a practical focus and the other two will have a theoretical focus.
### Conditions Module
**Conditions:**
- Low Back Pain
- Exercise
- Healthy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 65
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will undertake a back school-based program. This program will follow the recommendations of the biopsychosocial model of chronic pain and will be conducted in an aquatic environment. The intervention will be carried out by physiotherapists in a sports center. The duration of the intervention will be six weeks, with a frequency of two sessions per week, totaling 12 sessions of 45 minutes each. Of all the sessions, 10 will have a practical focus (centered on trunk exercises) and the other two will have a theoretical focus (providing education on pain and risk factors for low back pain).
**Intervention Names:**
- Behavioral: Aquatic program based on the back school
**Label:** Aquatic program based on the back school
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** They will continue with their usual lifestyle.
**Label:** Control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Aquatic program based on the back school
**Description:** Participants will undertake a back school-based program. This program will follow the recommendations of the biopsychosocial model of chronic pain and will be conducted in an aquatic environment. The intervention will be carried out by physiotherapists in a sports center. The duration of the intervention will be six weeks, with a frequency of two sessions per week, totaling 12 sessions of 45 minutes each. Of all the sessions, 10 will have a practical focus (centered on trunk exercises) and the other two will have a theoretical focus (providing education on pain and risk factors for low back pain).
**Name:** Aquatic program based on the back school
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score).
**Measure:** Visual Analogue Scale.
**Time Frame:** Through study completion, an average of 2 months.
**Description:** The Roland Morris Disability Questionnaire Scoring (RMQ) is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total RMQ score ranging from 0 to 24; higher scores represent higher levels of pain-related disability.
**Measure:** Roland Morris Disability Questionnaire.
**Time Frame:** Through study completion, an average of 2 months.
**Description:** Short-Form Health Survey (SF-36) was used to measure quality of life.The SF-36 explores people's physical and mental health. It consists of 36 items that assessed eight dimensions of health status: social function, physical function, emotional role, physical role, mental health, vitality, physical pain, and general health. Scores ranged from 0 (worst health status) to 100 (best health status).
**Measure:** Short-Form Health Survey-36.
**Time Frame:** Through study completion, an average of 2 months.
**Description:** This scale measures kinesiophobia. The total scale score ranges from 11 to 44, where 11 means no kinesiophobia and 44 means severe kinesiophobia.
**Measure:** Tampa Scale Of Kinesiophobia.
**Time Frame:** Through study completion, an average of 2 months.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18-65 years of age. With non-specific low back pain for at least three months, with pain intensity (30-70 on a VAS).
Exclusion Criteria:
* History of cancer, spine infection, rheumatologic diseases, history of spine fracture, history of trauma, red flag signs including unwanted weight loss (exceeding 10 percent of the total body weight) in the past six months and fever, history of psychological disease and history of spine surgery, radiculopathy, anatomical and congenital disturbance.
* Missing more than two Back School sessions.
* Not being able to attend the measurement sessions.
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Pontevedra
**Country:** Spain
**Facility:** Beone Sport center
**Zip:** 36003
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M4714
- Name: Back Pain
- Relevance: HIGH
- As Found: Back Pain
- ID: M19433
- Name: Low Back Pain
- Relevance: HIGH
- As Found: Low Back Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001416
- Term: Back Pain
- ID: D000017116
- Term: Low Back Pain
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437301
**Brief Title:** End Tidal CO2 and Masks: Is There a Correlation?
**Official Title:** End Tidal CO2 and Masks: Is There a Correlation?
#### Organization Study ID Info
**ID:** 2021-057
#### Organization
**Class:** OTHER
**Full Name:** CHRISTUS Health
### Status Module
#### Completion Date
**Date:** 2022-03-16
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2021-12-31
**Type:** ACTUAL
#### Start Date
**Date:** 2021-07-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-07
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** CHRISTUS Health
#### Responsible Party
**Investigator Affiliation:** CHRISTUS Health
**Investigator Full Name:** Peter Richman, MD
**Investigator Title:** Professor and Research Director
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** In light of the ongoing COVID-19 pandemic, wearing a mask has become a universal standard as an attempt to reduce the spread of COVID-19. As of 2020, more than half of all U.S. states have implemented a state wide mandated mask policy. There are many schools of thought regarding the benefits and risks of donning a mask to prevent the spread of COVID-19. There is an unproven theory among some that wearing a mask interferes with our natural respiratory function, causing hypoxia, altered mental status and other various health issues. This dangerous perception has led some to believe wearing a mask is harmful, and encourages against wearing a mask in public. This theory, recently refuted by a study investigating oxygen levels while participants wore masks, performed in 2020 encouraged increased compliance with wearing masks. Another study, preformed by evaluated whether gas exchange abnormalities occurred with the use of surgical masks in subjects with and without lung function impairment. The conclusions of the study showed that regardless of lung function impairment, the presence of surgical masks did not impact gas exchange. Additionally, a more recent study concluded that the presence of a facemask did not have a significant change in physiologic parameters while during exercise. Although there is evidentiary support that facemasks do not negatively affect oxygen status and physiologic capacity, there is not strong evidence examining the relationship between ETCO2 and facemasks. The relationship between ETCO2 and facemasks is one of importance because mild decreases in oxygen have much less dangerous effects compared to the effects of rapid accumulations of carbon dioxide. Increases in end tidal carbon dioxide lead to confusion, acidosis and in severe cases, respiratory distress and failure. A study performed in 1989 showed that hypercapnia has greater increases in blood pressure, minute ventilation and sympathetic nerve activity than hypoxia.
In this newly proposed study, healthy volunteers will all wear the same type of three layer surgical mask. Their end tidal carbon dioxide will be measured while at rest without a mask, while resting with a mask and then after walking 100 meters in the mask. While previous studies have focused on changes in oxygen, there is a lack of research dedicated to analyzing end tidal carbon dioxide. This study will hope to show evidence supporting that there is no increase in end tidal carbon dioxide while wearing a mask.
### Conditions Module
**Conditions:**
- End Tidal Carbon Dioxide (ETCO2)
**Keywords:**
- Hypoxia
- Respiratory Disease
- Surgical Mask
- Physiologic Capacity
- Oxygen
- Sympathetic Nerve Activity
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** This study is a prospective, controlled study involving healthy adult volunteers all of whom are resident and faculty physicians, or other medical staff. There will be no financial compensation.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 31
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Subjects will have their baseline end tidal carbon dioxide measured while at rest and without a mask.
**Intervention Names:**
- Other: Baseline measure of ETCO2 without mask
**Label:** Baseline ETCO2 without mask
**Type:** OTHER
#### Arm Group 2
**Description:** The second measurement will also occur at rest, but while subjects are wearing a mask.
**Intervention Names:**
- Other: Baseline ETCO2 with mask
**Label:** Baseline ETCO2 with mask
**Type:** OTHER
#### Arm Group 3
**Description:** Lastly, end tidal carbon dioxide will be measured after each participant walks 200 meters, with a surgical mask.
**Intervention Names:**
- Other: ETCO2 after 200 meter walk with mask
**Label:** ETCO2 after 200 meter walk with mask
**Type:** OTHER
#### Arm Group 4
**Description:** Lastly, end tidal carbon dioxide will be measured after each participant walks 200 meters, without a surgical mask.
**Intervention Names:**
- Other: ETCO2 after 200 meter walk without mask
**Label:** ETCO2 after 200 meter walk without mask
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Baseline ETCO2 without mask
**Description:** Baseline
**Name:** Baseline measure of ETCO2 without mask
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Baseline ETCO2 with mask
**Description:** Mask
**Name:** Baseline ETCO2 with mask
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- ETCO2 after 200 meter walk with mask
**Description:** 200 meter walk and mask
**Name:** ETCO2 after 200 meter walk with mask
**Type:** OTHER
#### Intervention 4
**Arm Group Labels:**
- ETCO2 after 200 meter walk without mask
**Description:** 200 meter walk
**Name:** ETCO2 after 200 meter walk without mask
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The primary objective of this study is to evaluate if there are changes present with non-invasive end tidal carbon dioxide measurement while wearing a mask.
**Measure:** Change in end tidal carbon dioxide while wearing a mask.
**Time Frame:** Measured immediately after mask was put on.
#### Secondary Outcomes
**Description:** The secondary objective is to assess possible changes in end tidal carbon dioxide while walking moderate distances (200 meters) while wearing a mask.
**Measure:** Change in end tidal carbon dioxide while wearing a mask and walking a moderate distance.
**Time Frame:** Measured a time = 0 seconds after walk was completed.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Healthy individuals between the ages of 18 and 75
* Consent to participate in this study
* Resident and ancillary staff
Exclusion Criteria:
* Patients
* Inability or refusal consent
* Inability to walk the predetermined distance
* History of lung disease
* History of significant cardiac disease
* People under the age of 18 and over the age of 75
**Healthy Volunteers:** True
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Corpus Christi
**Country:** United States
**Facility:** CHRISTUS Health-Texas A&M Spohn Emergency Medicine Residency
**State:** Texas
**Zip:** 78405
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Chan NC, Li K, Hirsh J. Peripheral Oxygen Saturation in Older Persons Wearing Nonmedical Face Masks in Community Settings. JAMA. 2020 Dec 8;324(22):2323-2324. doi: 10.1001/jama.2020.21905.
**PMID:** 33125030
**Citation:** Barbeito-Caamano C, Bouzas-Mosquera A, Peteiro J, Lopez-Vazquez D, Quintas-Guzman M, Varela-Cancelo A, Martinez-Ruiz D, Yanez-Wonenburger JC, Pineiro-Portela M, Vazquez-Rodriguez JM. Exercise testing in COVID-19 era: Clinical profile, results and feasibility wearing a facemask. Eur J Clin Invest. 2021 Apr;51(4):e13509. doi: 10.1111/eci.13509. Epub 2021 Feb 15.
**PMID:** 33548060
**Citation:** Samannan R, Holt G, Calderon-Candelario R, Mirsaeidi M, Campos M. Effect of Face Masks on Gas Exchange in Healthy Persons and Patients with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2021 Mar;18(3):541-544. doi: 10.1513/AnnalsATS.202007-812RL. No abstract available.
**PMID:** 33003954
#### See Also Links
**Label:** What U.S. States Require Masks In Public?
**URL:** https://masks4all.co/what-states-require-masks/
**Label:** Adverse Effects of Prolonged Mask Use among Healthcare Professionals during COVID-19
**URL:** https://clinmedjournals.org/articles/jide/journal-of-infectious-diseases-and-epidemiology-jide-6-130.php?jid=jide
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
### Condition Browse Module - Browse Leaves
- ID: M4185
- Name: Hypoxia
- Relevance: LOW
- As Found: Unknown
- ID: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437288
**Brief Title:** Hematoporphyrin Photodynamic Therapy for Esophageal Cancer
**Official Title:** Therapeutic Effectiveness of Hematoporphyrin Injection Based Photodynamic Therapy in Post-Treatment Recurrent or Residual Superficial Esophageal Cancer: A Prospective, Single-Arm, Multicentric Study
#### Organization Study ID Info
**ID:** 2024-FXY-183
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2027-12-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-04-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sun Yat-sen University
#### Responsible Party
**Investigator Affiliation:** Sun Yat-sen University
**Investigator Full Name:** Jian-jun Li
**Investigator Title:** Prefessor, Endoscopy Department Administrative Director
**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 clinical trial is to evaluate the effectiveness of photodynamic therapy using hematoporphyrin injection in treating recurrent or residual superficial esophageal cancer. The primary purpose is to assess the ability of this intervention to achieve complete response in these patients.
The main question it aims to answer is:
- What is the complete response rate at day 28 post-treatment with PDT using hematoporphyrin injection in patients with recurrent or residual superficial esophageal cancer? There is no comparison group in this single-arm study.
Participants will:
* Be adults aged 18-80 with recurrent or residual superficial esophageal cancer after prior treatment.
* Receive an intravenous infusion of hematoporphyrin injection at a dose of 3mg/kg over 60 minutes.
* Undergo 630nm laser irradiation 48-72 hours after the infusion.
* Be assessed for complete response at day 28 post-treatment, as well as progression-free survival, overall survival, swallowing function, quality of life, and adverse events throughout the study.
### Conditions Module
**Conditions:**
- Esophageal Cancer
- Photodynamic Therapy
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Single-Stage Phase II Clinical Trials
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 198
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Receive an intravenous infusion of hematoporphyrin injection at a dose of 3mg/kg over 60 minutes.
Undergo 630nm laser irradiation 48-72 hours after the infusion.
**Intervention Names:**
- Drug: photodynamic therapy
**Label:** photodynamic therapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- photodynamic therapy
**Description:** Receive an intravenous infusion of hematoporphyrin injection
**Name:** photodynamic therapy
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The proportion of patients showing a complete disappearance of the tumor following the treatment, as assessed by EUS on day 28
**Measure:** The complete response rate evaluated by endoscopic ultrasound (EUS)
**Time Frame:** 28 days after the treatment.
#### Secondary Outcomes
**Description:** Length of time during and after the treatment of a disease, in which a patient lives with the disease but it does not get worse.
**Measure:** Progression free survival
**Time Frame:** 3 years
**Description:** length of time from the start of the treatment until the death of the patient, regardless of the cause.
**Measure:** Overall survival
**Time Frame:** 3 years
**Description:** Adverse events of the treatment.
**Measure:** Adverse events
**Time Frame:** 1 month after the treatment
**Description:** EORTC QLQ-C30 () is a 30-item questionnaire that assesses the quality of life of cancer patients.
**Measure:** Quality of life evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30)
**Time Frame:** 0.5 year; 1 year; 3 year
**Description:** Stooler's dysphagia grading is a clinical method used to categorize the severity of swallowing difficulties in patients with esophageal disorders, including esophageal cancer. It is based on the patient's ability to swallow liquids, semi-solids, and solids.
**Measure:** Stooler's dysphagia grading
**Time Frame:** 0.5 year; 1 year; 3 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult patients aged 18-80 with recurrent or residual superficial esophageal cancer after prior treatment.
Exclusion Criteria:
* Known hypersensitivity, severe comorbidities, pregnancy, etc.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jianjun Li, Doctor
**Phone:** 02087343009
**Phone Ext:** 02087343009
**Role:** CONTACT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000006258
- Term: Head and Neck Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000004935
- Term: Esophageal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14850
- Name: Recurrence
- Relevance: LOW
- As Found: Unknown
- ID: M8088
- Name: Esophageal Neoplasms
- Relevance: HIGH
- As Found: Esophageal Cancer
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M9348
- Name: Head and Neck Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8085
- Name: Esophageal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T2141
- Name: Esophageal Cancer
- Relevance: HIGH
- As Found: Esophageal Cancer
### Condition Browse Module - Meshes
- ID: D000004938
- Term: Esophageal Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M9502
- Name: Hematoporphyrins
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437275
**Brief Title:** The Degree of Knowledge and Attitude of Egyptian Physicians Regarding Emergency Treatment of Traumatic Dental Injuries
**Official Title:** The Degree of Knowledge and Attitude of Egyptian Physicians Regarding Emergency Treatment of Traumatic Dental Injuries: Cross Sectional Study
#### Organization Study ID Info
**ID:** knowloedge and attitude
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Cairo University
#### Responsible Party
**Investigator Affiliation:** Cairo University
**Investigator Full Name:** Nour Ziad Al-Tabbaa
**Investigator Title:** Principal investigator - Dr. Nour Ziad Al-Tabbaa
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study intends to evaluate physicians' fundamental knowledge and attitude regarding the management of TDIs in Egypt. A convenience sample of physicians will be enrolled in this cross-sectional study, and they will be asked to complete a validated questionnaire. The questionnaire includes demographic questions, two case scenarios involving crown fractures and the avulsion of permanent teeth, and self-evaluation questions.
**Detailed Description:** Several epidemiological studies continue to show significant levels of dental trauma in many countries. In industrialized countries, about one in five children experience a traumatic dental injury (TDI) to permanent teeth before leaving school.
Primary care providers (e.g., family physicians, pediatricians, emergency medicine physicians and nurses) can play an important role in offering primary care following dentofacial trauma, especially for rural populations with limited access to dentists.
Several global studies indicate that physicians and even pediatricians lacked the emergency management knowledge to deal with traumatic dental injuries (TDIs). Emphasizing the fact that medical students are not well educated or trained to manage TDIs.
To the best of our knowledge, no study has been conducted in Egypt to investigate physicians' knowledge and attitudes addressing traumatic dental injury.
### Conditions Module
**Conditions:**
- Traumatic Dental Injuries
**Keywords:**
- Traumatic dental injuries
- awareness
- knowledge
- attitude
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 290
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Questionnaire for the degree of knowledge and attitude of Egyptian physicians regarding emergency treatment of traumatic dental injuries.
**Name:** Questionnaire for the degree of knowledge and attitude
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluate Egyptian physicians knowledge and attitude regarding the management of dental trauma using questionnaire
**Measure:** The degree of knowledge and attitude of Egyptian physicians.
**Time Frame:** 2 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Physicians who accept to participate.
Exclusion Criteria:
Physicians who refuse to participate.
**Healthy Volunteers:** True
**Minimum Age:** 25 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Participants are family medicine, pediatricians, emergency doctors and other specialties in Cairo and Ain Shams University in Egypt.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Nour Al-Tabbaa, Master
**Phone:** +966551970003
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Cairo
**Contacts:**
***Contact 1:***
- **Name:** Rasha Adel, phd
- **Phone:** 00201111511145
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Cairo University
**State:** Al Manial
#### Overall Officials
**Official 1:**
**Affiliation:** Cairo University
**Name:** Sherien Badr, Professor
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** evaluate physicians' fundamental knowledge and attitude regarding the management of TDIs in Egypt.
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Al-Haj Ali SN, Farah RI, Alhariqi S. Knowledge and Attitudes of Saudi Medical Students about Emergency Management of Traumatic Dental Injuries. Int J Environ Res Public Health. 2022 Oct 31;19(21):14249. doi: 10.3390/ijerph192114249.
**PMID:** 36361130
**Citation:** Al Barkhati S, Al Mullahi A. Knowledge and Awareness of Emergency Medical Physicians on the Management of Traumatic Dental Avulsion at Sultan Qaboos University Hospital. Sultan Qaboos Univ Med J. 2023 Nov;23(4):479-484. doi: 10.18295/squmj.5.2023.030. Epub 2023 Nov 30.
**PMID:** 38090234
**Citation:** Sari MBD, Sari E, Bal C, Aksoy M. Evaluation of the knowledge level of pediatricians on dental trauma and their awareness of the ToothSOS mobile application: A cross sectional study. Dent Traumatol. 2024 Apr;40(2):195-203. doi: 10.1111/edt.12895. Epub 2023 Oct 18.
**PMID:** 37849392
**Citation:** Raoof M, Vakilian A, Kakoei S, Manochehrifar H, Mohammadalizadeh S. Should medical students be educated about dental trauma emergency management? A study of physicians and dentists in Kerman Province, Iran. J Dent Educ. 2013 Apr;77(4):494-501.
**PMID:** 23576595
**Citation:** Iyer SS, Panigrahi A, Sharma S. Knowledge and Awareness of First Aid of Avulsed Tooth among Physicians and Nurses of Hospital Emergency Department. J Pharm Bioallied Sci. 2017 Apr-Jun;9(2):94-98. doi: 10.4103/jpbs.JPBS_343_16.
**PMID:** 28717331
## 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: BC26
- Name: Wounds and Injuries
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M7796
- Name: Emergencies
- Relevance: HIGH
- As Found: Emergency
- ID: M17685
- Name: Wounds and Injuries
- Relevance: HIGH
- As Found: Injury
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004630
- Term: Emergencies
- ID: D000014947
- Term: Wounds and Injuries
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437262
**Brief Title:** Antibacterial Effect and Substantivity of a New Chlorhexidine and Cymenol Gel on Oral Biofilm and Saliva
**Official Title:** Randomized Clinical Trial on the Immediate Antibacterial Effect and Substantivity of a Single Application of a New Chlorhexidine Gel on Oral Biofilm and Saliva
#### Organization Study ID Info
**ID:** 2021-CE161
#### Organization
**Class:** OTHER
**Full Name:** University of Santiago de Compostela
### Status Module
#### Completion Date
**Date:** 2023-07-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-06-30
**Type:** ACTUAL
#### Start Date
**Date:** 2022-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Lacer, S.A.
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Santiago de Compostela
#### Responsible Party
**Investigator Affiliation:** University of Santiago de Compostela
**Investigator Full Name:** Inmaculada Tomás
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The objective of this project was to compare the immediate antimicrobial effect and in situ substantivity of a new 0.20% chlorhexidine (CHX) gel and cymenol with the current CHX gel formulation on dental plaque biofilm and salivary flora up to 7 hours after a single application.
### Conditions Module
**Conditions:**
- Healthy
- Saliva
- Biofilms
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 30
**Type:** ACTUAL
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants underwent a single application of the 0.20% CHX gel. Samples were collected in basal conditions (i.e., before application) and at 5 minutes, 1 hour, 3 hours, 5 hours and 7 hours after application.
**Intervention Names:**
- Drug: 0.20% CHX gel on saliva
- Drug: 0.20% CHX gel on oral biofilm
**Label:** 0.20% CHX gel
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Participants underwent a single application of the 0.20% CHX + Cymenol gel. Samples were collected in basal conditions (i.e., before application) and at 5 minutes, 1 hour, 3 hours, 5 hours and 7 hours after application.
**Intervention Names:**
- Drug: 0.20% CHX and Cymenol gel on saliva
- Drug: 0.20% CHX and Cymenol gel on oral biofilm
**Label:** 0.20% CHX and Cymenol gel
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 0.20% CHX gel
**Description:** In vivo application of a gel on the vestibular and palatal/lingual gingival mucosa of both arches at minute 0 for posterior saliva collection at different time-points.
**Name:** 0.20% CHX gel on saliva
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- 0.20% CHX and Cymenol gel
**Description:** In vivo application of a gel on the vestibular and palatal/lingual gingival mucosa of both arches at minute 0 for posterior saliva collection at different time-points.
**Name:** 0.20% CHX and Cymenol gel on saliva
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- 0.20% CHX gel
**Description:** Ex vivo application of a gel on the glass disks of the removable intraoral appliance at minute 0 for subsequent one-by-one disk removal from the device at different time-points.
**Name:** 0.20% CHX gel on oral biofilm
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- 0.20% CHX and Cymenol gel
**Description:** Ex vivo application of a gel on the glass disks of the removable intraoral appliance at minute 0 for subsequent one-by-one disk removal from the device at different time-points.
**Name:** 0.20% CHX and Cymenol gel on oral biofilm
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 5 minutes
**Measure:** Intragel bacterial viability: baseline vs 5 minutes
**Time Frame:** Baseline vs 5 minutes
**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 1 hour
**Measure:** Intragel bacterial viability: baseline vs 1 hour
**Time Frame:** Baseline vs 1 hour
**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 3 hours
**Measure:** Intragel bacterial viability: baseline vs 3 hours
**Time Frame:** Baseline vs 3 hours
**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 5 hours
**Measure:** Intragel bacterial viability: baseline vs 5 hours
**Time Frame:** Baseline vs 5 hours
**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 7 hours
**Measure:** Intragel bacterial viability: baseline vs 7 hours
**Time Frame:** Baseline vs 7 hours
**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 1 hour
**Measure:** Intragel bacterial viability: 5 minutes vs 1 hour
**Time Frame:** 5 minutes vs 1 hour
**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 3 hours
**Measure:** Intragel bacterial viability: 5 minutes vs 3 hours
**Time Frame:** 5 minutes vs 3 hours
**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 5 hours
**Measure:** Intragel bacterial viability: 5 minutes vs 5 hours
**Time Frame:** 5 minutes vs 5 hours
**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 7 hours
**Measure:** Intragel bacterial viability: 5 minutes vs 7 hours
**Time Frame:** 5 minutes vs 7 hours
**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) at baseline: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
**Measure:** Intergel bacterial viability at baseline: 0.20% CHX gel vs 0.20% CHX and cymenol gel
**Time Frame:** Baseline
**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 5 minutes: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
**Measure:** Intergel bacterial viability after 5 min: 0.20% CHX gel vs 0.20% CHX and cymenol gel
**Time Frame:** 5 minutes
**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 1 hour: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
**Measure:** Intergel bacterial viability after 1 hour: 0.20% CHX gel vs 0.20% CHX and cymenol gel
**Time Frame:** 1 hour
**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 3 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
**Measure:** Intergel bacterial viability after 3 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel
**Time Frame:** 3 hours
**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 5 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
**Measure:** Intergel bacterial viability after 5 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel
**Time Frame:** 5 hours
**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 7 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
**Measure:** Intergel bacterial viability after 7 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel
**Time Frame:** 7 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Systemically healthy volunteers
* Age between 20-45 years
* Presence of minimum 24 permanent teeth
* No evidence of gingivitis or periodontitis (CPITN= 0)
* No presence of untreated caries at the start of the study
Exclusion Criteria:
* Smoker or ex-smoker
* Presence of dental protheses or orthodontic appliances
* Antibiotic treatment and/or routine use of oral antiseptics in the previous three months
* Presence of any systemic disease that could alter saliva production or composition
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Santiago de Compostela
**Country:** Spain
**Facility:** University of Santiago de Compostela
**State:** A Coruña
**Zip:** 15782
#### Overall Officials
**Official 1:**
**Affiliation:** University of Santiago de Compostela, Spain
**Name:** Inmaculada Tomás, Prof
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Derm
- Name: Dermatologic Agents
### Intervention Browse Module - Browse Leaves
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M5953
- Name: Chlorhexidine
- Relevance: LOW
- As Found: Unknown
- ID: M344731
- Name: Chlorhexidine gluconate
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437249
**Brief Title:** Children's Dental Anxiety in Relation to Parental Dental Anxiety, Child's Age and Gender and Caries Experience
**Official Title:** Children's Dental Anxiety in Relation to Parental Dental Anxiety, Child's Age and Gender and Caries Experience (Cross Sectional Study)
#### Organization Study ID Info
**ID:** children dental anxiety
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Cairo University
#### Responsible Party
**Investigator Affiliation:** Cairo University
**Investigator Full Name:** Ghadeer Jaafar Ali Jawad
**Investigator Title:** Principal Investigator Ghadeer Jaafar Ali
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Determine the relation of of Children's dental anxiety to Parental Dental anxiety, child's age and gender and caries experience will be obtained through written questionnaires (ACDAS) and (CDAS) to the child and parents of children aged 6-8 years old in the clinic.
**Detailed Description:** 1. Soft copies of the Abeer children dental anxiety SCALE (ACDAS) Questionnaire and Corah Dental Anxiety Scale (CDAS) Questionnaire.
2. The child's age and gender will be recorded first.
3. Level of anxiety will be recorded by using Heart rate using fingertip pulse oximeter.
4. Dental caries experiences will record by using Dental caries indices (DMF and def)
5. Child dental anxiety will be evaluated from (ACDAS) Questionnaire: The first part is child self-report part, the operator will be answered by ticking the box that corresponds to child dental anxiety, 1 (happy), 2 (Ok), 3 (Scared). The second part about the cognitive part with five questions: three of them answered with (Yes, No) and the other two questions answered with score, 1 (happy), 2 (Ok), 3 (Scared)
6. Parents dental anxiety will be evaluated from (CDAS) Questionnaire. the parents will answer by ticking the answer. The final scores, \&gt;9 (Mild anxiety), 9-12 (Moderate anxiety), 13-14 (High anxiety), 15-20 (Sever anxiety).
7. Results will be analyzed by the statistician.
8. Data handling will be supervised by the supervisors.
### Conditions Module
**Conditions:**
- Child Dental Anxiety
**Keywords:**
- Parental dental anxiety
- Child dental anxiety
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 74
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 1 Month
### Outcomes Module
#### Primary Outcomes
**Description:** Using Abeer children dental anxiety SCALE Questionnaire Score score 1 happy 2 Ok 3 Scared
**Measure:** Child dental anxiety
**Time Frame:** Two months
**Description:** record Heart rate number using fingertip pulse oximeter
**Measure:** Level of anxiety
**Time Frame:** Two months
**Description:** Using dental caries indices ( Decayed Missed Filling and Decayed Exposed to extraction Filling ) in mixed dentition
**Measure:** Caries experience
**Time Frame:** Two months
#### Secondary Outcomes
**Description:** Using Corah Dental Anxiety Scale Questionnaire Score a = 1, b = 2, c = 3, d = 4, e = 5 Total possible = 20
* \< 9 = mild
* 9 - 12 = moderate anxiety
* 13 - 14 = high anxiety
* 15 - 20 = severe anxiety (or phobia) higher score means worse
**Measure:** Parental dental anxiety
**Time Frame:** Two months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Children range in age from 6-8 years old.
2. First dental visit.
3. Accompanied by their parents.
4. Both male and female included.
Exclusion Criteria:
1. Children with Physical or mental disabilities.
2. Children who refuse to participate.
**Healthy Volunteers:** True
**Maximum Age:** 8 Years
**Minimum Age:** 6 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** 1. Gender: Male and Female.
2. Age: 6-8 years old
* in Pediatric Clinic in Pediatric Dentistry and Dental Public Health Department-faculty of Dentistry, Cairo University, Egypt.
* parents will be interviewed by the examiner and the questionnaire will be filled.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ghadeer Jawad, Master
**Phone:** 00201220262599
**Phone Ext:** +97333323874
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Cairo
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Rasha l Adel, PHD
- **Phone:** 00201111511145
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Cairo University
**State:** Almanial
**Zip:** Egypt
#### Overall Officials
**Official 1:**
**Affiliation:** Cairo University
**Name:** Ola Mustafa, professor
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** evaluate the relation between the parental dental anxiety, child age and gender and caries experience on child dental anxiety in a group of Egyptian children.
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Coric A, Banozic A, Klaric M, Vukojevic K, Puljak L. Dental fear and anxiety in older children: an association with parental dental anxiety and effective pain coping strategies. J Pain Res. 2014 Aug 20;7:515-21. doi: 10.2147/JPR.S67692. eCollection 2014.
**PMID:** 25187737
**Citation:** Corah NL, Gale EN, Illig SJ. Assessment of a dental anxiety scale. J Am Dent Assoc. 1978 Nov;97(5):816-9. doi: 10.14219/jada.archive.1978.0394.
**PMID:** 31377
**Citation:** Al-Namankany A, Ashley P, Petrie A. The development of a dental anxiety scale with a cognitive component for children and adolescents. Pediatr Dent. 2012 Nov-Dec;34(7):e219-24.
**PMID:** 23265158
**Citation:** Aditya PVA, Prasad MG, Nagaradhakrishna A, Raju NS, Babu DN. Comparison of effectiveness of three distraction techniques to allay dental anxiety during inferior alveolar nerve block in children: A randomized controlled clinical trial. Heliyon. 2021 Sep 29;7(9):e08092. doi: 10.1016/j.heliyon.2021.e08092. eCollection 2021 Sep.
**PMID:** 34632153
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4324
- Name: Anxiety Disorders
- Relevance: HIGH
- As Found: Anxiety
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001008
- Term: Anxiety Disorders
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437236
**Brief Title:** Comparative Study Between Intravenous Granisetron and Ondansetron on Their Effect on Hemodynamics and Shivering After Spinal Anesthesia in Elective Cesarean Delivery
**Official Title:** Comparative Study Between Intravenous Granisetron and Ondansetron on Their Effect on Hemodynamics and Shivering After Spinal Anesthesia in Elective Cesarean Delivery : A Randomized Double-Blind Study
#### Organization Study ID Info
**ID:** soh-Med-24-04-012MS
#### Organization
**Class:** OTHER
**Full Name:** Sohag University
### Status Module
#### Completion Date
**Date:** 2024-12-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-10
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sohag University
#### Responsible Party
**Investigator Affiliation:** Sohag University
**Investigator Full Name:** Mohamed Abdelrady Abdelaziz
**Investigator Title:** resident at Anesthesiology, Surgical Intensive Care and Pain Medicine department
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Spinal anesthesia is commonly used in cesarean section surgeries . The most important adverse effects of spinal anesthesia are hypotension and bradycardia caused by sympathetic blockade, with an incidence of about 55-100% . However, blocking the venous return by the gravid uterus increases the risk of hypotension. Spinal anesthesia-induced hypotension is commonly associated with uncomfortable symptoms, such as shivering , nausea and vomiting, in the mother. Prolonged maternal hypotension may lead to serious maternal adverse effects, such as cardiovascular collapse, loss of consciousness, apnea, and aspiration of gastric contents. In addition, uteroplacental blood flow decreases in cases of sustained hypotension and detrimental neonatal effects, such as fetal acidosis and fetal death, may occur. Preventing spinal anesthesia-induced hypotension during cesarean section is essential for the well-being of both the mother and neonate.
Also, Shivering often happens after spinal anesthesia. Shivering is an unconscious and rhythmic movement involving several groups of muscles. The increase of muscle activity generates the elevation of oxygen consumption, lactic acidosis, and carbon dioxide production In recent years, researchers have focused on the effects of the Bezold-Jarisch reflex (BJR) . This reflex includes a triad of bradycardia, hypotension, and apnea. Researchers have suggested that serotonin and 5-hydroxytryptamine 3 (5-HT3) receptors play an important role in the occurrence of the BJR after spinal anesthesia . The 5-HT3 receptors are present in the heart, lung, and spine. Diminished venous return caused by spinal anesthesia stimulates the cardiac chemoreceptors, and parasympathetic activity increases, which results in bradycardia and hypotension . Studies have suggested that the use of 5-HT3 antagonists may attenuate spinal anesthesia-induced hypotension, thus inhibiting peripheral vasodilatation, alleviating the BJR, and increasing venous return to the heart . Ondansetron is a commonly used 5-HT3 receptor antagonist, and its peak plasma concentration occurs within 30 min following IV injection. Granisetron is a new 5-HT3 receptor antagonist, and the onset of action occurs 30 min following its IV administration \[
### Conditions Module
**Conditions:**
- Hemodynamic Instability and Shivering
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** will receive ondansetron 4mg diluted in normal saline,The total volume of the solution infused will kept at 10 mL.
After preloading, patients in the respective group will receive the infusion of the study drug over 1 minute just 5 minutes before performing the subarachnoid block.
**Intervention Names:**
- Drug: ondansetron
**Label:** Group A
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** will receive granisetron 1mg diluted in normal saline.The total volume of the solution infused will kept at 10 mL.
After preloading, patients in the respective group will receive the infusion of the study drug over 1 minute just 5 minutes before performing the subarachnoid block.
**Intervention Names:**
- Drug: granisetron
**Label:** group B
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group A
**Description:** Group A will receive ondansetron 4mg diluted in normal saline,The total volume of the solution infused will kept at 10 mL.
After preloading, patients in the respective group will receive the infusion of the study drug over 1 minute just 5 minutes before performing the subarachnoid block
**Name:** ondansetron
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- group B
**Description:** Group B will receive granisetron 1mg diluted in normal saline.The total volume of the solution infused will kept at 10 mL.
After preloading, patients in the respective group will receive the infusion of the study drug over 1 minute just 5 minutes before performing the subarachnoid block
**Name:** granisetron
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** a comparison of change in Blood pressure among groups
**Measure:** Blood pressure mesurment in mmhg
**Time Frame:** 6 months
#### Secondary Outcomes
**Description:** will include detect difference among groups incidece of shivering or not
**Measure:** incidece of shivering or not
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* All parturient who underwent elective caesarean delivery under spinal anesthesia will be included in this study
Exclusion Criteria:
* 1. Patient refusal 2. Patient with significant neurological , psychological disease 3. patient known allergy to ondansetron or granisetron, 4. patients receiving serotonin agonists or antagonists, 5. patient ischemic heart disease, chronic hypertension or pregnancy induced hypertension
**Gender Based:** True
**Healthy Volunteers:** True
**Sex:** FEMALE
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** mohamed A A, resident
**Phone:** 01030026022
**Role:** CONTACT
**Contact 2:**
**Name:** fawzy A B, assistant professor
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Sohag
**Country:** Egypt
**Facility:** Sohag university Hospital
**Status:** RECRUITING
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Lee JE, George RB, Habib AS. Spinal-induced hypotension: Incidence, mechanisms, prophylaxis, and management: Summarizing 20 years of research. Best Pract Res Clin Anaesthesiol. 2017 Mar;31(1):57-68. doi: 10.1016/j.bpa.2017.01.001. Epub 2017 Jan 8.
**PMID:** 28625306
**Citation:** Kinsella SM, Tuckey JP. Perioperative bradycardia and asystole: relationship to vasovagal syncope and the Bezold-Jarisch reflex. Br J Anaesth. 2001 Jun;86(6):859-68. doi: 10.1093/bja/86.6.859.
**PMID:** 11573596
**Citation:** Ortiz-Gomez JR, Palacio-Abizanda FJ, Morillas-Ramirez F, Fornet-Ruiz I, Lorenzo-Jimenez A, Bermejo-Albares ML. The effect of intravenous ondansetron on maternal haemodynamics during elective caesarean delivery under spinal anaesthesia: a double-blind, randomised, placebo-controlled trial. Int J Obstet Anesth. 2014 May;23(2):138-43. doi: 10.1016/j.ijoa.2014.01.005. Epub 2014 Feb 4.
**PMID:** 24631057
**Citation:** Yeoh SB, Leong SB, Heng AS. Anaesthesia for lower-segment caesarean section: Changing perspectives. Indian J Anaesth. 2010 Sep;54(5):409-14. doi: 10.4103/0019-5049.71037.
**PMID:** 21189878
## Derived Section
### Intervention Browse Module - Ancestors
- ID: D000000932
- Term: Antiemetics
- ID: D000001337
- Term: Autonomic Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000005765
- Term: Gastrointestinal Agents
- ID: D000000982
- Term: Antipruritics
- ID: D000003879
- Term: Dermatologic Agents
- ID: D000058831
- Term: Serotonin 5-HT3 Receptor Antagonists
- ID: D000012702
- Term: Serotonin Antagonists
- ID: D000018490
- Term: Serotonin Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
### Intervention Browse Module - Browse Leaves
- ID: M19588
- Name: Ondansetron
- Relevance: HIGH
- As Found: Mental health
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M20020
- Name: Granisetron
- Relevance: HIGH
- As Found: Neuroblastoma
- ID: M4251
- Name: Antiemetics
- Relevance: LOW
- As Found: Unknown
- ID: M8881
- Name: Gastrointestinal Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7074
- Name: Dermatologic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M15512
- Name: Serotonin
- Relevance: LOW
- As Found: Unknown
- ID: M29246
- Name: Serotonin 5-HT3 Receptor Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000017294
- Term: Ondansetron
- ID: D000017829
- Term: Granisetron
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437223
**Brief Title:** Study of Xiflam™ Treatment in Patients Post COVID-19 Infection Suffering From What is Known as Long COVID (LC)
**Official Title:** A Phase 2 Study to Compare the Efficacy and Safety of Orally Administered Xiflam™ Therapy With Orally Administered Placebo in Patients With Ocular and Systemic Manifestations of Post COVID Sequelae Known as "Long" COVID
#### Organization Study ID Info
**ID:** IFX-LC001
#### Organization
**Class:** INDUSTRY
**Full Name:** Inflammx Therapeutics Inc
### Status Module
#### Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-12
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Inflammx Therapeutics 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:** The primary objective of this study is to evaluate the safety and efficacy of Xiflam versus Placebo in patients who present with signs and symptoms of Long COVID.
Xiflam (n=10) or placebo (n=5) will be administered orally once a day (QD) for 12 weeks.
**Detailed Description:** This is a Phase 2a randomized, masked, placebo-controlled clinical trial to evaluate the safety and efficacy of Xiflam for use in patients with signs/symptoms of Long COVID. Patients will be randomized to Xiflam the study drug (n=10) or Placebo (n=5). Both Xiflam and Placebo will be taken once daily by mouth for 12 weeks.
I. Baseline Screening Visit After obtaining informed consent and before treatment is initiated, an initial study visit will be conducted in person to confirm subject eligibility. Subjects will be asked complete a baseline questionnaire to assess signs and symptom severity. During this screening visit, a baseline blood sample will be obtained to determine any changes over time in any of the measured parameters. These include biomarkers of inflammation. Additional study procedures occurring during the baseline/screening phase of this study are outlined in the protocol. Patients who are found not to meet inclusion criteria, will not be entered into the treatment Phase of the study.
### Conditions Module
**Conditions:**
- Long COVID
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** Phase 2 randomized, masked, placebo-controlled clinical trial
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 15
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** IFX-LC001 Tonabersat tablets 40mg tablets or placebo Take two tablets once per day
**Intervention Names:**
- Drug: Tonabersat
**Label:** Experimental
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** IFX-LC001Tonabersat tablets 40mg tablets or placebo Take two tablets once per day
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental
**Description:** Tonabersat 40mg. Two tablets per day
**Name:** Tonabersat
**Other Names:**
- Xiflam
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Placebo 40mg, Two tablets per day
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** Incidence and severity of ocular and systemic treatment emergent adverse events (TEAE)
**Measure:** Safety Endpoint
**Time Frame:** 12 weeks
#### Primary Outcomes
**Description:** Primary outcomes are change from baseline for signs and symptoms measured by a Visual Analogue Scale (VAS) instrument. Reporting done by the patient on a 0-100 scale. Scale measures severity from none (0) to severe (100) for multiple signs and symptoms, for the different systems involved in this disease state (see below)
1. General health
2. Neurological signs/symptoms
3. Ocular signs/symptoms
4. Respiratory signs/symptoms
5. Gastrointestinal signs/symptoms
6. Cardiovascular signs/symptoms
7. Musculoskeletal signs/symptoms
8. Dermatological signs/symptoms
9. Mental Health signs/symptoms
10. Miscellaneous signs/symptoms which may not be captured above.
Since Long COVID is a multi-system disease, patients will only score on the severity scale of the signs/symptoms which are of clinical significance to that particular patient.
**Measure:** Primary Endpoint
**Time Frame:** 12 weeks
#### Secondary Outcomes
**Description:** Complete Blood Count (CBC) including biomarkers of inflammation Physical Examination including electrocardiogram (EKG)
Change in laboratory values including inflammatory markers, e.g., C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), Antinuclear Antibody (ANA)
**Measure:** Secondary Endpoint
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Have tested positive for COVID-19 irrespective of variant or timeframe.
2. Developed signs and symptoms of the disease as described by the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO).
3. Have recovered from the infection (tested negative for COVID-19).
4. Following negative COVID-19 testing, continued to demonstrate signs/symptoms which were not pre-existing. The signs/symptoms must have persisted for 12 weeks or more.
5. Have had a persistent recurrence of a disease state (e.g., posterior uveitis, extreme fatigue etc.) that occurred following COVID-19 infection.
6. Female subjects must be:
1. Women of non-child-bearing potential, or
2. Women of child-bearing potential with a negative pregnancy test at screening, must agree to use approved methods of contraception for the duration of the study and refrain from breastfeeding for the duration of the study.
7. Males with female partners of child-bearing potential must agree to use approved methods of contraception and agree to refrain from donating sperm for the duration of the study.
8. Willing and able to give informed consent and to comply with the study procedures and assessments.
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following exclusion criteria apply:
1. No proof of having tested positive for COVID-19 infection at any time.
2. Presence of an active ocular/systemic disease that in the opinion of the Investigator existed prior to COVID-19 infection and is not likely a LC related condition.
3. Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization.
4. History of laser therapy in the macular region.
5. Any ocular or systemic condition that in the opinion of the Investigator is not LC related (e.g., pre-existing cataract) that may require surgery or medical intervention during the study period.
6. Participation in any systemic experimental treatment or any other systemic investigational new drug within 90 days prior to the start of study treatment.
7. Any screening laboratory value (hematology, serum chemistry or urinalysis) that in the opinion of the Investigator is clinically significant and not suitable for study participation.
8. Known hypersensitivity to Xiflam™ or excipients.
9. Known history of alcohol and/or drug abuse within 12 months prior to Visit 1 Screening that, in the opinion of the Investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject.
**Minimum Age:** 21 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yasmin Massoudi
**Phone:** (781) 647-1431
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Tate Valerio
**Phone:** (781) 647-1431
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Waltham
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yasmin Massoudi
- **Phone:** 781-647-1431
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Tate Valerio
- **Phone:** (781) 647-1431
- **Role:** CONTACT
***Contact 3:***
- **Name:** Peter Chang, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Massachusetts Eye Research and Surgery Institution (MERSI)
**State:** Massachusetts
**Status:** RECRUITING
**Zip:** 02451
#### Overall Officials
**Official 1:**
**Affiliation:** Massachusetts Eye Research and Surgery Institution (MERSI)
**Name:** Peter Chang, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000086382
- Term: COVID-19
- 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: D000094025
- Term: Post-Infectious Disorders
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### 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: Rare
- Name: Rare Diseases
### 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: M3013
- Name: Post-Acute COVID-19 Syndrome
- Relevance: HIGH
- As Found: Long COVID
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M13904
- Name: Pneumonia
- Relevance: LOW
- As Found: Unknown
- ID: M13914
- Name: Pneumonia, Viral
- 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: M3014
- Name: Post-Infectious Disorders
- 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: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000094024
- Term: Post-Acute COVID-19 Syndrome
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437210
**Brief Title:** Evaluation of Treatment With Viusid in Post-COVID-19 Syndrome
**Official Title:** Evaluation of Treatment With Viusid in Post-COVID-19 Syndrome
#### Organization Study ID Info
**ID:** VIUSID_POSTCOVID_CO_2022
#### Organization
**Class:** INDUSTRY
**Full Name:** Catalysis SL
### Status Module
#### Completion Date
**Date:** 2024-03-15
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-31
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-15
**Type:** ACTUAL
#### Start Date
**Date:** 2022-02-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Catalysis SL
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Reports of long-lasting symptoms of COVID-19 are increasing, but little is known about the prevalence of risk factors or whether it is possible to predict a prolonged course at disease onset. Prolonged COVID is characterized on the basis of symptoms such as fatigue, headache, dyspnea, and anosmia present for weeks, with older age, high body mass index, and female sex being more susceptible.
Accordingly, and in the absence of specific treatments, the present study seeks to establish a treatment protocol for Post-COVID syndrome through the application of the dietary supplement VIUSID, due to its anti-inflammatory and immunomodulatory effect, thus helping to reduce and/or control the symptoms of the syndrome.
**Detailed Description:** Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2e) is the pathogen responsible for the 2019 coronavirus disease pandemic (COVID-19), which has caused global health care crises and overstretched health care resources, Scientific and clinical evidence is evolving on the subacute and long-term effects of COVID-19, which can affect multiple organ systems. As the population of patients recovering from COVID-19 grows, it is critical to establish an understanding of the healthcare issues surrounding them. COVID-19 is now recognized as a multi-organ disease with a broad spectrum of manifestations.
Early reports suggest residual effects of SARS-CoV-2c infection, such as fatigue, dyspnea, chest pain, cognitive impairment, arthralgia and impaired quality of life. Cellular damage, a robust innate immune response with inflammatory cytokine production and a procoagulant state induced by SARS-CoV-2 infection may contribute to these sequelae. Survivors of previous coronavirus infections, including the 2003 SARS epidemic and the 2012 Middle East Respiratory Syndrome (MERS) outbreak, have demonstrated a similar set of persistent symptoms, reinforcing concerns about clinically significant sequelae of COVID-19.
Some countries use several drugs to treat coronavirus. In one of its documents, the Spanish Society of Medicine mentions the recommendations of the protocol developed for the treatment of COVID-19. Specific antiviral treatment requires drugs such as lopinavir/ritonavir administered orally. This drug is indicated to help control human immunodeficiency virus (HIV) infection. It is only administered orally 0 in concomitant treatment with interferon beta-lb. In this case Betaferon is recommended, which is indicated for the treatment of multiple sclerosis. Interferons are proteins produced by the body that help fight against attacks on the immune system, such as viral infections. Lopinavir / ritonavir can also be used in combination with an alpha-2B interferon, such as Intron A, which modifies the immune system response of the patient. the body's immune system to help fight infections and serious illnesses.
Viusid (Catalysis Laboratories, Madrid, Spain) is a nutritional supplement with recognized antioxidant and immunomodulatory properties that have beneficial effects on clinical outcomes related to cirrhosis, such as survival, disease progression and the development of hepatocellular carcinoma (HCC). It contains different molecules (ascorbic acid, zinc and glycyrrhizic acid) with recognized antioxidant and immunomodulatory properties. Glycyrrhizin (0.033g), the most important active ingredient of the supplement, is known to have an immunomodulatory, antiviral and biological effect, and has also demonstrated various anti-inflammatory properties (such as increased production of IL-10: a potent anti-inflammatory cytokine that inhibits the synthesis of many proinflammatory proteins), as well as an anti-apoptotic effect, hepatocyte proliferation and stabilization of cell membranes in the liver. Recent data suggest that Viusid ameliorates oxidative stress through the reduction of 105 lipid peroxidation products and that it has an immunomodulatory effect on cytokine secretion through increased cytokine secretion by the liver. cytokines through increased production of IFN-y and IL-l0, decreased production of IL-ly, stabilized tumor necrosis factor and secretion in HCV patients who have failed previous antiviral treatments.
Taking into account the benefits of Viusid, such as the reduction of inflammation and the immunomodulatory effect, a randomized double-blind study is proposed to evaluate the treatment with this food supplement in 200 patients with post-COVID syndrome diagnosed, assessing the improvement of their symptoms before and after treatment for 1 month, through clinical and paraclfnical examinations.
### Conditions Module
**Conditions:**
- Post-COVID-19 Syndrome
- COVID-19
- Dyspnea
- Fatigue
- Cough
- Inflammation
**Keywords:**
- COVID-19
- Antioxidants
- Post-COVID-19 Syndrome
- Fatigue
- Immunomodulator
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 200
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Oral administration of viusid oral solution 30 mL 3 times a day with the main meals (breakfast, lunch and dinner) for 30 days.
**Intervention Names:**
- Dietary Supplement: Viusid Oral Solution
**Label:** Viusid Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Oral administration of placebo 30 mL 3 times a day with the main meals (breakfast, lunch and dinner) for 30 days.
**Intervention Names:**
- Dietary Supplement: Placebo
**Label:** Placebo Group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Viusid Group
**Description:** Patients in the experimental intervention group will be administered Viusid Oral Solution (CATALYSIS S.L., Madrid, Spain) 30 mL orally 3 times a day with the main meals (breakfast, lunch and dinner) for 30 days.
**Name:** Viusid Oral Solution
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Placebo Group
**Description:** Patients in the experimental intervention group will be administered Placebo (CATALYSIS S.L., Madrid, Spain) 30 mL orally 3 times a day with the main meals (breakfast, lunch and dinner) for 30 days.
**Name:** Placebo
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** Symptom assessment will be performed using the Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F).
The scale consists of 18 items relating to the subjective experience of fatigue. Each item asks respondents to place an "X," representing how they currently feel, along a visual analogue line that extends between two extremes. In contrast to discrete, Likert-type scales, the VAS-F places fewer restrictions on the range of responses available to individuals. However, the benefi ts of a visual analogue scale may be offset by the frequent reluctance of individuals to use the highest and lowest extremes.
Scoring Each line is 100 mm in length - thus, scores fall between 0 and 100. The instrument also possesses two subscales: fatigue (items 1-5 and 11-18) and energy (items 6-10). Though individuals do not require training in order to score the scale, developers are quick to point out that high levels of inter-rater reliability are vital if results are to be correctly interpreted.
**Measure:** Evaluation of the symptoms associated with post-COVID-19 syndrome.
**Time Frame:** 30 days
**Description:** Evaluation of inflammation associated with Post-COVID-19 syndrome by analysis of IL-6 in venous blood samples before and after treatment, compared to the placebo group. The values for IL-6 concentration in the blood of healthy donors varied between 0 and 43.5 pg/ml. IL-6 concentrations above 43.5 pg/ml will be taken as inflammation values.
**Measure:** Evaluation of inflammation associated with Post-COVID-19 syndrome.
**Time Frame:** 30 days
**Description:** Evaluation of oxidative stress associated with Post-COVID-19 syndrome by analysis of glutathione peroxidase concentration in venous blood samples before and after treatment, compared to the placebo group. Reference normal intervals range from 196 to 477 U/L in plasma, from 49 to 93 U/gHb in erythrocytes and from 52 to 96 U/gHb in whole blood.
**Measure:** Evaluation of oxidative stress associated with Post-COVID-19 syndrome
**Time Frame:** 30 days
**Description:** To evaluate the effect of Viusid on the recovery of respiratory symptoms associated with Post-COVID-19 syndrome by thoracic CT imaging analysis before and after treatment and in comparison with the placebo group.
For the CT assessment, image analysis will be performed through digital processing, where different grayscale image data will be extracted in order to obtain numerical information about the evident pulmonary fibrosis, taking into account the intensity of the targets in the region of interest (i.e. lung tissue), comparing it with control images of healthy lungs. In addition, radiomic analysis and segmentation of the affected areas will be applied to obtain quantitative data on the severity of fibrosis. In addition, the images of interest will be visually analyzed by the project's medical staff, so that fibrosis can be directly diagnosed.
**Measure:** Evaluation of pulmonar fibrosis associated with Post-COVID-19 syndrome
**Time Frame:** 30 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Patients with one or more of the following symptoms, persistent after suffering COVID-19:
* Extreme tiredness (Fatigue).
* Shortness of breath
* Chest pain
* Problems with memory or concentration ("Brain fog")
* Insomnia
* Palpitations
* Dizziness
* Tingling
* Joint pain
* Depression and anxiety
* Tinnitus or ear pain
* Malaise, diarrhea, stomach pain, loss of appetite
* Fever, cough, headache, dry throat, changes in sense of smell or taste
* Rash
Exclusion Criteria:
* Patients with a positive diagnosis of COVID-19 in the last 14 days.
* Patients who have presented symptoms similar to Post-COVID syndrome prior to the onset of COVID-19 due to a concomitant disease.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Bogotá
**Country:** Colombia
**Facility:** Fundación CR INVESTIGATION INSTITUTE
**State:** Bogotá DC
**Zip:** 110131
### IPD Sharing Statement Module
**Info Types:**
- STUDY_PROTOCOL
- SAP
- CSR
**IPD Sharing:** YES
### References Module
#### References
**Citation:** Montani D, Savale L, Noel N, Meyrignac O, Colle R, Gasnier M, Corruble E, Beurnier A, Jutant EM, Pham T, Lecoq AL, Papon JF, Figueiredo S, Harrois A, Humbert M, Monnet X; COMEBAC Study Group. Post-acute COVID-19 syndrome. Eur Respir Rev. 2022 Mar 9;31(163):210185. doi: 10.1183/16000617.0185-2021. Print 2022 Mar 31.
**PMID:** 35264409
**Citation:** Silvagno F, Vernone A, Pescarmona GP. The Role of Glutathione in Protecting against the Severe Inflammatory Response Triggered by COVID-19. Antioxidants (Basel). 2020 Jul 16;9(7):624. doi: 10.3390/antiox9070624.
**PMID:** 32708578
**Citation:** Sudre CH, Murray B, Varsavsky T, Graham MS, Penfold RS, Bowyer RC, Pujol JC, Klaser K, Antonelli M, Canas LS, Molteni E, Modat M, Jorge Cardoso M, May A, Ganesh S, Davies R, Nguyen LH, Drew DA, Astley CM, Joshi AD, Merino J, Tsereteli N, Fall T, Gomez MF, Duncan EL, Menni C, Williams FMK, Franks PW, Chan AT, Wolf J, Ourselin S, Spector T, Steves CJ. Attributes and predictors of long COVID. Nat Med. 2021 Apr;27(4):626-631. doi: 10.1038/s41591-021-01292-y. Epub 2021 Mar 10. Erratum In: Nat Med. 2021 Jun;27(6):1116.
**PMID:** 33692530
**Citation:** Vilar Gomez E, Gra Oramas B, Soler E, Llanio Navarro R, Ruenes Domech C. Viusid, a nutritional supplement, in combination with interferon alpha-2b and ribavirin in patients with chronic hepatitis C. Liver Int. 2007 Mar;27(2):247-59. doi: 10.1111/j.1478-3231.2006.01411.x.
**PMID:** 17311621
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- 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: D000012120
- Term: Respiration Disorders
- ID: D000012818
- Term: Signs and Symptoms, Respiratory
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC01
- Name: Infections
### Condition Browse Module - Browse Leaves
- ID: M10293
- Name: Inflammation
- Relevance: HIGH
- As Found: Inflammation
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M7591
- Name: Dyspnea
- Relevance: HIGH
- As Found: Dyspnea
- ID: M2561
- Name: COVID-19
- Relevance: HIGH
- As Found: COVID-19
- ID: M8364
- Name: Fatigue
- Relevance: HIGH
- As Found: Fatigue
- ID: M6590
- Name: Cough
- Relevance: LOW
- As Found: Unknown
- 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: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M15623
- Name: Signs and Symptoms, Respiratory
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000086382
- Term: COVID-19
- ID: D000004417
- Term: Dyspnea
- ID: D000013577
- Term: Syndrome
- ID: D000007249
- Term: Inflammation
- ID: D000005221
- Term: Fatigue
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
### Intervention Browse Module - Browse Leaves
- ID: M4292
- Name: Antioxidants
- Relevance: LOW
- As Found: Unknown
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M2853
- Name: Immunomodulating Agents
- Relevance: LOW
- As Found: Unknown
- ID: M3628
- Name: Adjuvants, Immunologic
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437197
**Brief Title:** Evaluation of Using Platelet-Rich Fibrin in Adult Pulpotomy
**Official Title:** Clinical and Radiographic Evaluation of Platelets Rich Fibrin in Adult Pulpotomy: Randomized Clinical Trial
#### Organization Study ID Info
**ID:** 867/2992
#### Organization
**Class:** OTHER
**Full Name:** Al-Azhar University
### Status Module
#### Completion Date
**Date:** 2024-03-23
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-03-18
**Type:** ACTUAL
#### Start Date
**Date:** 2023-03-12
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2023-02-09
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Al-Azhar University
#### Responsible Party
**Investigator Affiliation:** Al-Azhar University
**Investigator Full Name:** Ahmed Ibrahim Ahmed Qandeel
**Investigator Title:** Demonstrator of Endodontics, Faculty of Dental Medicine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this interventional randomized clinical trial is to evaluate the use of platelet rich fibrin in full pulpotomy in mature adult teeth.
The main questions it aims to answer are:
1. Does the use of platelet rich fibrin in complete pulpotomy in mature permanent teeth will raise the success rate of full pulpotomy of adult teeth?
2. Does the use of cone beam computed tomography scans will be more effective in early detection of apical periodontitis than periapical radiographs?
Participants will be asked to do the following:
* Receive the pulpotomy treatment of their target tooth.
* Record the pain score in the pain assessment chart.
* Attend the follow-up visits. They'll receive a full pulpotomy treatment of their target tooth. Researchers will evaluate the usage of platelet rich fibrin in performing the pulpotomy procedure of adult teeth and if cone beam computed tomography scans will be more effective in early detection of apical periodontitis than periapical radiographs.
### Conditions Module
**Conditions:**
- Irreversible Pulpitis
**Keywords:**
- Pulpotomy
- Platelet Rich Fibrin
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Pulpotomy of adult teeth using Hydraulic Calcium Silicate Cement.
**Intervention Names:**
- Procedure: Pulpotomy
**Label:** Hydraulic Calcium Silicate Cement
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Pulpotomy of adult teeth using platelet Rich fibrin.
**Intervention Names:**
- Procedure: Pulpotomy
**Label:** platelet rich fibrin (PRF)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Hydraulic Calcium Silicate Cement
- platelet rich fibrin (PRF)
**Description:** Removal of the coronal pulp chamber in an adult teeth
**Name:** Pulpotomy
**Other Names:**
- Pulp amputation
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** The radiographic changes was evaluated using periapical radiographs. the outcome was measured using the periapical index scoring 1,2,3,4 or 5 with 1 indicating normal and 5 indicates severe periodontitis with exacerbating features.
**Measure:** Radiographic changes in periapical area using periapical radiographs.
**Time Frame:** 6 and 12 months.
#### Secondary Outcomes
**Description:** The postoperative pain was measured by modified modified Visual analog scale VAS which is is segmented into ten levels according to severity of pain, no pain (0), mild pain (1-3), moderate pain (4-6), or severe pain (7-10).
**Measure:** Postoperative pain
**Time Frame:** Immediately, 24, 48, 72 hours and 7 days.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patient age: 25-35 years
2. Mature permanent premolar teeth with two separate roots.
3. Clinical diagnosis of irreversible pulpitis.
4. Patients without existing medical condition.
Exclusion criteria:
1. Immature teeth.
2. Non-restorable teeth.
3. Non-vital Teeth.
4. Uncontrolled pulpal bleeding.
5. Periodontally affected teeth.
**Healthy Volunteers:** True
**Maximum Age:** 35 Years
**Minimum Age:** 25 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** Faculty of Dental Medicine, Al-Azhar university
**Zip:** 11651
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Iaculli F, Rodriguez-Lozano FJ, Briseno-Marroquin B, Wolf TG, Spagnuolo G, Rengo S. Vital Pulp Therapy of Permanent Teeth with Reversible or Irreversible Pulpitis: An Overview of the Literature. J Clin Med. 2022 Jul 11;11(14):4016. doi: 10.3390/jcm11144016.
**PMID:** 35887779
**Citation:** Hanna SN, Perez Alfayate R, Prichard J. Vital Pulp Therapy an Insight Over the Available Literature and Future Expectations. Eur Endod J. 2020 Mar 1;5(1):46-53. doi: 10.14744/eej.2019.44154. eCollection 2020.
**PMID:** 32342038
**Citation:** Guideline on Pulp Therapy for Primary and Immature Permanent Teeth. Pediatr Dent. 2016 Oct;38(6):280-288. No abstract available.
**PMID:** 27931467
**Citation:** AAE Position Statement on Vital Pulp Therapy. J Endod. 2021 Sep;47(9):1340-1344. doi: 10.1016/j.joen.2021.07.015. Epub 2021 Aug 3. No abstract available.
**PMID:** 34352305
**Citation:** Cervino G, Laino L, D'Amico C, Russo D, Nucci L, Amoroso G, Gorassini F, Tepedino M, Terranova A, Gambino D, Mastroieni R, Tozum MD, Fiorillo L. Mineral Trioxide Aggregate Applications in Endodontics: A Review. Eur J Dent. 2020 Oct;14(4):683-691. doi: 10.1055/s-0040-1713073. Epub 2020 Jul 29.
**PMID:** 32726858
**Citation:** Cushley S, Duncan HF, Lappin MJ, Tomson PL, Lundy FT, Cooper P, Clarke M, El Karim IA. Pulpotomy for mature carious teeth with symptoms of irreversible pulpitis: A systematic review. J Dent. 2019 Sep;88:103158. doi: 10.1016/j.jdent.2019.06.005. Epub 2019 Jun 20.
**PMID:** 31229496
**Citation:** Linsuwanont P, Wimonsutthikul K, Pothimoke U, Santiwong B. Treatment Outcomes of Mineral Trioxide Aggregate Pulpotomy in Vital Permanent Teeth with Carious Pulp Exposure: The Retrospective Study. J Endod. 2017 Feb;43(2):225-230. doi: 10.1016/j.joen.2016.10.027. Epub 2016 Dec 29.
**PMID:** 28041685
**Citation:** Qudeimat MA, Alyahya A, Hasan AA. Mineral trioxide aggregate pulpotomy for permanent molars with clinical signs indicative of irreversible pulpitis: a preliminary study. Int Endod J. 2017 Feb;50(2):126-134. doi: 10.1111/iej.12614. Epub 2016 Feb 22.
**PMID:** 26841969
**Citation:** Taha NA, Khazali MA. Partial Pulpotomy in Mature Permanent Teeth with Clinical Signs Indicative of Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2017 Sep;43(9):1417-1421. doi: 10.1016/j.joen.2017.03.033. Epub 2017 Jun 30.
**PMID:** 28673494
**Citation:** Awawdeh L, Al-Qudah A, Hamouri H, Chakra RJ. Outcomes of Vital Pulp Therapy Using Mineral Trioxide Aggregate or Biodentine: A Prospective Randomized Clinical Trial. J Endod. 2018 Nov;44(11):1603-1609. doi: 10.1016/j.joen.2018.08.004. Epub 2018 Oct 3.
**PMID:** 30292451
**Citation:** Asgary S, Eghbal MJ, Shahravan A, Saberi E, Baghban AA, Parhizkar A. Outcomes of root canal therapy or full pulpotomy using two endodontic biomaterials in mature permanent teeth: a randomized controlled trial. Clin Oral Investig. 2022 Mar;26(3):3287-3297. doi: 10.1007/s00784-021-04310-y. Epub 2021 Dec 2.
**PMID:** 34854987
**Citation:** Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e56-60. doi: 10.1016/j.tripleo.2005.07.011.
**PMID:** 16504852
**Citation:** Borie E, Olivi DG, Orsi IA, Garlet K, Weber B, Beltran V, Fuentes R. Platelet-rich fibrin application in dentistry: a literature review. Int J Clin Exp Med. 2015 May 15;8(5):7922-9. eCollection 2015.
**PMID:** 26221349
**Citation:** Patidar S, Kalra N, Khatri A, Tyagi R. Clinical and radiographic comparison of platelet-rich fibrin and mineral trioxide aggregate as pulpotomy agents in primary molars. J Indian Soc Pedod Prev Dent. 2017 Oct-Dec;35(4):367-373. doi: 10.4103/JISPPD.JISPPD_178_17.
**PMID:** 28914251
**Citation:** Eid A, Mancino D, Rekab MS, Haikel Y, Kharouf N. Effectiveness of Three Agents in Pulpotomy Treatment of Permanent Molars with Incomplete Root Development: A Randomized Controlled Trial. Healthcare (Basel). 2022 Feb 25;10(3):431. doi: 10.3390/healthcare10030431.
**PMID:** 35326909
**Citation:** Keswani D, Pandey RK, Ansari A, Gupta S. Comparative evaluation of platelet-rich fibrin and mineral trioxide aggregate as pulpotomy agents in permanent teeth with incomplete root development: a randomized controlled trial. J Endod. 2014 May;40(5):599-605. doi: 10.1016/j.joen.2014.01.009. Epub 2014 Mar 6.
**PMID:** 24767550
**Citation:** Noor Mohamed R, Basha S, Al-Thomali Y. Efficacy of platelet concentrates in pulpotomy - a systematic review. Platelets. 2018 Jul;29(5):440-445. doi: 10.1080/09537104.2018.1445844. Epub 2018 Mar 14.
**PMID:** 29537945
**Citation:** Kumar V, Juneja R, Duhan J, Sangwan P, Tewari S. Comparative evaluation of platelet-rich fibrin, mineral trioxide aggregate, and calcium hydroxide as pulpotomy agents in permanent molars with irreversible pulpitis: A randomized controlled trial. Contemp Clin Dent. 2016 Oct-Dec;7(4):512-518. doi: 10.4103/0976-237X.194107.
**PMID:** 27994420
**Citation:** Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.
**PMID:** 24049221
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003788
- Term: Dental Pulp Diseases
- ID: D000014076
- Term: Tooth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14525
- Name: Pulpitis
- Relevance: HIGH
- As Found: Pulpitis
- ID: M6984
- Name: Dental Pulp Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16831
- Name: Tooth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011671
- Term: Pulpitis
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
### Intervention Browse Module - Browse Leaves
- ID: M5381
- Name: Calcium
- Relevance: LOW
- As Found: Unknown
- ID: M5398
- Name: Calcium, Dietary
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437184
**Acronym:** DiOpTB
**Brief Title:** Increased Tuberculosis Case Detection - a Cluster-randomized Trial Combining Available Resources and Novel Strategies for High Endemic Areas
**Official Title:** Increased Tuberculosis Case Detection - a Cluster-randomized Trial Combining Available Resources and Novel Strategies for High Endemic Areas
#### Organization Study ID Info
**ID:** DiOpTB - Version 17 230424
#### Organization
**Class:** OTHER
**Full Name:** Aarhus University Hospital
### Status Module
#### Completion Date
**Date:** 2026-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-03
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** Linkoeping University
**Class:** OTHER
**Name:** University of Gondar
#### Lead Sponsor
**Class:** OTHER
**Name:** Aarhus University Hospital
#### Responsible Party
**Investigator Affiliation:** Aarhus University Hospital
**Investigator Full Name:** Frauke Rudolf
**Investigator Title:** MD, PhD, Clinical Associated Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** As estimated by the WHO 10.6 million new Tuberculosis (TB) cases were identified in 2022- while more than three million went undetected and untreated. The low detection rate illustrates the failure to recognise and diagnose TB in the current cascade of healthcare and is a major obstacle to effective TB control programs. This multi-centre cluster-randomised clinical trial will evaluate the effect (i.e., diagnostic yield) of improving the point-of-care diagnostics already in place in most primary health-care centres in low-resource settings. The present study will be conducted in two different geographical settings in the Western and Eastern African countries of Guinea Bissau and Ethiopia. This improved clinical diagnostic pathway may improve case detection rates at primary healthcare level, ensuring prompt commencement of treatment, thereby diminishing transmission risk in the community and improving treatment outcomes. The Optimized Diagnostic Procedure (ODP) will utilize instructed sputum sampling and pooling as well as computer-aided detection (CAD) chest X-ray (CXR) and additional pooled sputum sample as well as non-sputum sampling (faecal and a buccal/tongue swab and saliva) for GeneXpert Ultra PCR (Xpert) as state-of-the-art add-ons to the routine diagnostic pathway for TB. This adds to the key components of the WHO "End TB" strategy - early diagnosis - and if successful, may be rapidly approved by the WHO and implemented by governments globally with potentially major public health benefits.
The study will be conducted in close liaison with the national Ministries of Health and TB programs in Guinea-Bissau and Ethiopia. This will facilitate any relevant findings to be taken forward for implementation into policy and practice. Capacity development, training and educational activities will be closely aligned to this study.
**Detailed Description:** 2 Objectives 2.1 Primary objective
1. Diagnostic yield of active TB within ten days, comparing Enhanced Usual Diagnostic Procedure (EUDP) to Optimized Diagnostic Procedure (ODP).
2.2 Secondary objectives
1. Number of patients treated for TB within two weeks comparing EUDP to ODP.
2. The additional diagnostic yield of CAD CXR compared to Xpert and culture.
3. Improved follow-up (FU) rates in the cascade of care (i.e., one week and six months FU for all included and treatment start and outcome for all TB diagnosed).
4. Differences in diagnostic yield of active TB between routine sputum samples, instructed sputum samples and non-sputum samples (faecal and saliva combined with buccal/tongue swabs).
5. Feasibility of including Oxford Nanopore sequencing for detection and molecular resistance patterns measured as rate of analysed samples within two weeks.
3 Background In 2022, the WHO estimated that of a total 10.6 million new TB cases, more than three million went undiagnosed and of the remaining seven million only 57% were bacteriologically confirmed (1). In sub-Saharan African settings such as Ethiopia and Guinea Bissau, smear microscopy remains the major diagnostic tool in most areas despite the rollout of rapid diagnostic tests such as Xpert. In a multi-centre trial by Theron et al, the implementation of Xpert in African settings did indeed reduce diagnostic delay but unfortunately without any effect on the numbers who were initiated on TB treatment nor on mortality (2). The trial showed that Xpert rollout was not superior to enhanced, well-equipped, microscopy-based diagnostic facilities. In an editorial to the Lancet written by our group, it was concluded that TB elimination could be better advanced by improving currently available tools than by expanding Xpert testing to peripheral health facilities (2, 3). Nevertheless, when TB is diagnosed with a point of care test, there is a need to ensure that correct treatment is provided. However, culture-based drug susceptibility testing is very scarce in high endemic areas and often takes several weeks or months to perform (4). Recently, the Cryptic study (5) has shown that genotypic drug susceptibility testing (gDST) may guide treatment with a sensitivity and specificity well above 90% for key drugs. New techniques such as MinION (Oxford Nanopore Technologies) have also made it possible to perform sequencing and gDST directly from sputum samples. Such point-of-care-based sequencing technology is comparable in size to a USB flash drive (6) and may be attached to a laptop computer at a health centre in a high endemic area.
A cluster-randomised trial implementing the TBscore recently showed a fourfold increase in case detection rate in Ethiopia but not in Guinea-Bissau (7). It identified that factors such as laboratory capacity and routines in collecting and examining sputum smear samples may have a high impact on case detection rate and could be optimized based on the available resources. Surprisingly, the sensitivity of sputum smear microscopy ranges from 20-80% with an average of about 50% (8), which may partly be due to patient selection but also depend on considerable variability in sputum collection strategies and/or laboratory procedures. In a comparison of sputum collection methods by Datta et al (9), pooling of sputum and structured instructions before sampling on average led to a twofold higher diagnostic yield whereas a spot versus morning sample showed no difference. A multi-centre study including Ethiopia, comparing fluorescence microscopy to conventional light microscopy showed a small but significant increase in sensitivity (72.8 vs 65.8%)(10). Further, recent research has shown that buccal and tongue swabs, that are easily obtained, can hold valuable diagnostic potential. (11) In smear-negative patients with presumed TB, the available diagnostic tools in high endemic countries include CXR but standardized procedures for evaluation of CXR have been scarce. Recently, CAD software based on artificial intelligence algorithms such as qXR (Qure.ai, India) have improved detection of microbiologically confirmed TB from 50-60% by experienced radiologists to 70-84% with a specificity of 80% by CAD (12). However, a recent systematic review concluded as did the WHO that there are too few high-quality studies to fully assess its diagnostic accuracy (13). We now propose to conduct a multi-centre cluster-randomised clinical trial to evaluate whether improvements on available diagnostic resources can increase the diagnostic yield of active TB and decrease mortality for patients diagnosed with TB.
4 Methods 4.1 Location and nature of sites The present study will be conducted in two African countries: Guinea-Bissau and Ethiopia. In Bissau, the capital of Guinea-Bissau, The Bandim Health Project has been a Health and Demographic Surveillance Site (HDSS) for 45 years and has a well-defined study population of approximately 100,000 under continued surveillance. Within the study area there are two health centres (HCs) from where patients with presumed TB will be enrolled (Bandim HC, Belem HC).
In Ethiopia the study will be conducted in collaboration with the University of Gondar in the region of North-Gondar, which has a population of more than two million. Two health centres located in North Gondar Zone, namely Azezo HC and Gondar HC will participate. The Gondar University Hospital is a teaching and referral hospital and will be used for further management of severe TB cases during this study.
4.2 Epidemiology and study population 4.2.1 Guinea-Bissau The epidemiology of TB in the Bissau study population has been extensively described (14-18). The overall incidence of TB has declined only slightly since 2004 and was estimated at 273/100,000 population in 2020, while TB/HIV co-infection declined from 108 per 100.000 to 14 per 100,000 over the period (19). Smear negative cases and case fatality rate likewise declined over the period. The incidence of smear positive TB remained stable at 188 per 100,000 between 2004 and 2011 (20). All HCs have basic laboratory facilities to carry out sputum smear microscopy and all provide TB treatment. The national referral hospital for TB, Hospital Raoul Follereau, is located adjacent to the study area and is a close collaborating partner. The incidence rate of TB in Guinea-Bissau as a whole is 361 per 100,000 with a case detection rate estimated at 35% (21, 22).
4.2.2 Ethiopia TB continues to be a major public health concern in Ethiopia fuelled by the expansion of the HIV epidemic since the 1990s. According to the 2022 WHO TB report (1), Ethiopia is among high-burden countries for both TB and TB/HIV and has an estimated incidence rate of 119 per 100,000, and a TB mortality of 17.7 per 100,000 (21). HIV-positive TB incidence is 6.2 per 100,000 and case detection rate is currently estimated at 73% (21, 22). These figures are high considering that Ethiopia is the second most populous country in Africa with an estimated total population size of more than 100 million. HIV screening is carried out as a routine.
4.3 Design The present study is designed as an open-label, stepped-wedge cluster-randomised controlled trial (23) to investigate an optimized diagnostic procedure for active TB in healthcare centres in Guinea-Bissau and Ethiopia. Applying the stepped-wedge design ensures that all participating HCs will implement the intervention during the study period. This design is particularly useful for evaluating the population-level impact of an intervention, which is of interest in this study. All clusters (i.e., HCs) start with Enhanced Usual Diagnostic Procedure (EUDP) and are then randomized to switch to the intervention phase at predefined time points (see table 1).
See below for detailed description of sample size calculations.
4.4 Bandim TBscore The Bandim TBscore (TBscore) (Table 2) consists of five symptoms (cough, haemoptysis, dyspnoea, chest pain, and night sweats) and six signs (pale inferior conjunctivae, pulse \>100 per minute, positive finding at lung auscultation, temperature \>37°C (axillary), body mass index (BMI) \<18/\<16, and mid-upper-arm circumference (MUAC) \<220 mm/\<200 mm) (24). Each variable contributes one point while BMI and MUAC contribute an additional point if BMI\<16/MUAC\<200 mm; hence, the maximum score is 13. The score divides patients into three severity classes (SC): SC-I, TBscore 0-5; SC-II, TBscore 6-7, and SC-III, TBscore≥8. A simplified version of the score - TBscoreII - with a maximum score of 8 points has also been developed (25). The advantage of the latter score is that it can be performed without a physician present. The TBscore has been assessed in both Gondar and Bissau and found to be a useful add on in the diagnostic cascade of care.(7)
4.5 Buccal, tongue swap and saliva sample Buccal and tongue samples will be collected using the Omniswab (Whatman, catalogue #WB100035) and added to a container where patients leave a saliva sample. Samples will be collected by trained laboratory staff, who gently brush the inside of each cheek and then the tongue of the participant for 10 seconds with the OmniSwab. The OmniSwab has a breakpoint and the head will be ejected into 500 µl buffer containing 50 mM Tris pH 8.0, 50 mM EDTA, 50 mM sucrose, 100 mM NaCl, and 1% SDS, and transported to the laboratory at 4˚C. (11) There, the OmniSwab-collected samples will be vortexed in the saliva, and the swabs heads removed. One part of the sample will be analyzed using Xpert Ultrawhile the other part will be stored at - 80 °C until further processing.
4.6 Computer-aided detection chest X-ray (CAD CXR) applying artificial intelligence (AI) A preliminary study using an AI based CAD CXR software (qXR, Qure) compared to two Ethiopian radiologists included 498 CXRs from a previously performed randomized controlled trial on the TBscore. Of those, the less experienced radiologist found 50, the more experienced radiologist found 100 and CAD CXR found 83 to be indicative of TB. Using Xpert PCR as the gold standard for TB diagnosis, the overall AUC for the CAD CXR was 0.84 while the less experienced radiologist performed at a sensitivity of 41.4% and a specificity of 94.1% and the experienced radiologist's assessments were 55.2% sensitive and 85.0% specific. The agreement between the radiologists was moderate (kappa=0.45), as was the agreement between each radiologist and the software (kappa=0.36, kappa=0.59).
In the present study we will include a mobile phone app to guide photographing analog X-ray films. These photographs will then be uploaded to a locally placed box (qbox) and analyzed on site.
4.7 Enrolment At all sites adult patients will be screened during consultations carried out at primary healthcare centres. All patients presenting with cough of any duration, sputum production, or weight loss will have their TBscore assessed. All participating health centres have previous experience collecting the symptoms and signs necessary for the TBscore and completing a score chart from which the TBscore can be calculated. All patients with a TBscore≥4 will be referred for TB diagnostics. Patients with 4≤TBscore\<6 will be referred to fluorescence microscopy while patients with TBscore≥6 will be referred to Xpert PCR. The staff at the sites will receive general training in TB diagnosis and then the healthcare facilities will, following a random sequence, switch from Enhanced Usual Diagnostic Procedure (EUDP), consisting of standard TB program diagnostics but ensuring availability of all reagents, to intervention (i.e., OPD).
4.7.1 Enhanced Usual Diagnostic Procedure (EUDP) The standard TB diagnostics in both settings consist of performing the sputum smear analysis by the clinical routine. Smear-negative cases will be followed as per standard routine (Figure 1A).
4.7.2 The Optimized Diagnostic Procedure (ODP) intervention
A three-step package which involves (Figure 1B):
1. Oral and mobile phone-guided instructions by study staff Patients will be instructed to take several deep breaths, hold their breath for a moment, and repeat this several times until coughing is induced including instructions to cough deeply and vigorously whilst breathing out (26). Instructions will be presented to the participating patients on a mobile phone to ensure consistent instructions to all participants.
2. Pooling of two spot sputum samples (9) Two instructed pooled spot samples will be split into two parts (27) and investigated by fluorescence microscopy (28). The other part of the pooled sputum sample will be frozen for later confirmation with batch-wise BACTEC 960 MGIT as a gold standard for microbiological diagnosis.
As an add on, we will analyze a subgroup of samples with the MinION to assess applicability in a low resource setting.
3. Smear-negative cases at the first visit will be assessed for persisting symptoms and referred to a CXR unit Those with a CXR CAD result suggestive of active TB will be treated for TB. The smear negative cases will also leave an additional instructed spot sputum sample which will be pooled and one part analyzed by Xpert Ultra and the other part by BACTEC 960 MGIT culture. Additionally, non-sputum sampling will be performed and analyzed by Xpert Ultra including saliva combined with buccal and tongue sample using the same swab as well as a faecal sample Xpert Ultra using the WHO-recommended direct procedure. (29) In a feasibility study, on the basis of intention to treat (either by smear microscopy or CXR/clinical grounds) the participants will be asked for an additional instructed sputum sample which will extracted using EZ1 and sequenced using nanopore sequencing and the EPI2ME bioinformatic platform as previously described. (6) 4.7.3 Implementation of the ODP and EUDP Upon commencement of the intervention arm, the staff will be trained in applying optimized diagnostic procedures.
For all included patients (both in the EUDP and the ODP) a follow-up visit one week from first encounter will take place, to ensure initiation of treatment (for smear positive cases) or to screen for persisting symptoms and carry out a second clinical evaluation (smear negative cases). Diagnosis will be according to local standards and based on smear microscopy, CXR, and WHO clinical criteria including for extrapulmonary cases (30, 31). During the intervention, the physician can overrule the TBscore if needed. At all clinics, both in the EUDP and ODP (i.e. intervention) phase, all included patients will be referred to HIV testing at adjacent HIV-treatment clinics, where pre- and post-testing counselling will be carried out.
4.7.4 Inclusion criteria At the participating healthcare facilities, all patients ≥15 years old with presumed TB with cough, sputum production, and/or weight loss of any duration are eligible to participate. Healthcare facilities (n=4, two in each of the countries) will switch from Enhanced Usual Diagnostic Procedure (EUDP) to Optimized Diagnostic Procedure (ODP) following a random sequence.
4.7.5 Exclusion criteria
1. TB treatment within the past year.
2. Cerebral disturbances impairing the ability to give informed consent or follow the treatment regime.
5 Outcomes 5.1 Primary outcomes
1. Number of smear positive, Xpert PCR positive, or CXR positive patients comparing EUDP to ODP.
5.2 Secondary outcomes
1. Number of patients on active TB treatment comparing EUDP clinics to ODP clinics.
2. Diagnostic yield of CAD CXR compared to smear microscopy, Xpert PCR, and culture.
3. Follow-up rates in the cascade of care (i.e. one-week and six-months follow-up for all included and treatment start and outcome for all diagnosed with TB)
4. Differences in diagnostic yield between instructed sampling, buccal samples, fecal samples and routine sputum sample.
6 Sample size and statistical analyses Based on a previous study in the same setting, we found that among patients with a TBscore≥3 there were a total of 5% smear positive cases both in Guinea-Bissau and Ethiopia. Using a higher cut-off value at TBscore≥4 increases specificity and is estimated to increase the case detection yield to 6% (based on previous data) using routine sputum collection and sputum smear analysis. Increasing the TBscore cut-off value thus leads to a lower referral rate of 54% of all screened (instead of 73%) while increasing the number of smear positive cases in the sample (from 5% to 6%). As both settings now use Xpert MTB/RIF Ultra as the primary diagnostic method, initial case rate is estimated at 8% (32). Based on systematic reviews, it is estimated that the diagnostic yield of an instructed sputum where two spot-samples are pooled and processed using LED microscopy will lead to an at least twofold increase in sensitivity (9, 10, 27, 33). Adding CAD CXR onto those that are smear negative by the optimized sputum smear strategy is estimated to increase the number of patients diagnosed with TB 2.5-fold. To show an increase in diagnostic yield using ODP from a conservative estimate of 7% to 14% with a power of 80% and a significance level of 0.05, two clusters in each country are needed, including 132 patients per time interval (of 22 weeks). The estimated inclusion rate per cluster per week is 6 patients, which means that it should take 66 weeks to reach a target of 1584 inclusions.
Sample size was calculated using the "steppedwedge" function in Stata (34). The diagnostic yield, time to diagnosis, and treatment outcomes will be calculated.
Detection rates will be compared between control (EUDP) and intervention (ODP) in a generalized linear mixed effects model taking into account time and center effect and allowing for intra-cluster correlation, i.e., a mixed effect logistic regression for longitudinal data. A similar repeated measurements model will be used to analyze and compare groups on patient characteristics.
7 Timeframe Study preparations will start August 2023 with establishment of enrolment procedures and training of staff. Enrolment will take place for 68 weeks (from June 2024 to September 2025). End of follow-up will be April 2026. For details, please see Table 3. Overall responsible body for activities planned is the PI in collaboration with local VIP and TAP personnel.
8 Public health importance 8.1 Major advances TB case-finding remains a challenge, particularly in overburdened healthcare facilities with limited access to diagnostics (35-37). A simple disease management strategy combined with improved utilization of available diagnostics may ensure that more patients with TB are treated and earlier and that those at high risk of dying are targeted appropriately with a rational use of limited resources. The major advance of adding a standardized approach to patients with presumed TB will be to decrease the substantial burden of undiagnosed TB with simple means, which makes it a sustainable, affordable, and practicable tool.
8.2. New approach The strength of the Bandim TBscore strategy is that it guides the health care professional through a structured interview and uses the existing laboratory set-up, which is of great benefit compared to other more advanced diagnostic tools. The diagnostic algorithm simply utilizes what is already part of the primary healthcare setup, thereby increasing the chance of being applicable in similar settings worldwide. Similarly, the novel technologies employed in the ODP can easily be integrated into clinical settings worldwide.
8.3. Generalizability of trial results This trial will test implementation of a cheap, readily available, practical point-of-care package which requires only minor additional training of staff. If shown to be effective in identifying additional TB cases, use of the Bandim TBscore and improved diagnostics may be expected to be endorsed with little delay by the WHO and national governments as a standard part of TB diagnosis and management.
8.4. Contribution to improved disease management and public health In under-funded over-burdened healthcare facilities with a large patient load presenting with co-morbidities, many patients with TB remain undiagnosed and untreated (35-37). Simple clinical tools at points of care which can identify up patients with active TB may have great potential for diagnosing patients with TB early and thereby preventing TB-associated morbidity and mortality. Targeting delayed TB diagnosis and TB-related mortality will add to the agenda of reducing poverty-related diseases. The resources used to combat TB and the productive years lost to TB inflict a punishing toll on the economies of TB-endemic countries and helps perpetuate the cycle of poverty. The majority of TB is now concentrated in the World's poorest countries, thus effective and practicable programs to detect and cure TB early is the most feasible method of controlling the disease.
8.5 Improvements in patient care A major strength of the Bandim TBscore is its ability to continually assess disease severity during treatment as has previously been shown by our group (25, 38, 39). Thus, the score may be used both to enhance the number of confirmed TB cases among patients with presumed TB and serve as an easily adaptable monitoring tool during the treatment or re-evaluation of these.
9 Ethical considerations Consultative approval is expected to be granted from the Regional Ethics Committee in the Central Denmark Region, Denmark and permission to carry out the study will likewise be sought from the national ethics committees in Guinea-Bissau and Ethiopia. Written information will be provided in the official language Portuguese/Amharic and oral information will be provided to all eligible patients in the widely spoken language Portuguese Creole/Amharic. Informed written consent or a fingerprint if illiterate will be kept together with case report forms.
10 Capacity Building and future implications The present study will serve as a platform for relevant capacity building for good clinical practice and good clinical laboratory practice in the two African sites as well as promote a stronger linkage within Africa, building on the existing links with Institutions in the EU. In addition, the capacity building and networking activities planned for this project aim to integrate African partners into the rapidly developing global network of TB trial sites; in particular it will build a resource of patients with presumed TB with detailed clinical data which is rare among TB studies in Africa(1). We have built a well-functioning infrastructure to carry out trials at the primary healthcare level, which is seldom done in TB research. We now aim to utilize this solid basis and our experience to improve TB case detection further.
11 The Nordic collaboration and study group The Nordic collaborators in this trial have been working together since 2016. The main aim of the collaboration is to improve case finding of TB using applicable interventions in high endemic settings. Capacity building is an essential part of the collaboration and all trials make efforts to involve existing structures and political elements in the settings in which they are carried out. Workshops will be held throughout the trial period.
Christian Morberg Wejse (CW), MD, PhD is a consultant at the Department of Infectious Diseases, Aarhus University Hospital and Professor of Cross-Cultural Medicine and Global Health at the Department of Public Health, Aarhus University. He has supervised more than 20 research projects in Guinea-Bissau.
Thomas Schön (TS), MD, PhD is a consultant of clinical microbiology and infectious diseases and a professor at the Department of Biomedical and Clinical Sciences Linköping University. He has undertaken multiple research projects in Ethiopia and Sweden. Both CW and TS have been involved in the development of the present research project and act as supervisors during the trial.
Frauke Rudolf (FR), MD, PhD is senior registrar at the Department of Infectious Diseases, Aarhus University Hospital where she is responsible for TB patients, and clinical associate professor at Aarhus University. She has completed her PhD in Guinea-Bissau, evaluating a clinical score for TB. In recent years her research has focused on improving TB case detection and assessing gender differences in TB.
Anita Zalisz, will be working on the project in the capacity of PhD-student. Anita will be responsible for supervising procedures in Bissau including data collection, data entry, as well as disseminating results.
Mulugeta Aemero (MA), professor, Head, Tropical \& Infectious Diseases Research Centre, CMHSCSH, University of Gondar, Ethiopia, will be working on the project in the capacity of project collaborator in Gondar, Ethiopia.
Temesgen Tadesse (TT), MD, is a physician, who will be working on the project in the capacity of radiologist in Gondar, Ethiopia. Segenet Bizuneh (SB), MD, is a physician, who will be working on the project in the capacity of internist in Gondar, Ethiopia. Dessie Abebaw Angaw, Assistant Professor of Epidemiology and Biostatistics, will be working on the project in the capacity of project collaborator and supervisor in Gondar, Ethiopia.
Masresha Seyoum, BSc, MSc, Diagnostic Coordinator at UoGCSH, will be working on the project in the capacity of microbiologist in Gondar, Ethiopia.
Lilica Sanca (LS), BSc, and Ebba Abate (EA), PhD, are key personnel in Guinea-Bissau and Ethiopia respectively. LS is responsible for the national refence laboratory for TB in Guinea-Bissau while EA has completed his PhD in Gondar, has formerly worked as Director General, Ethiopian Public Health Institute (EPHI), Ethiopia and is now Project Director for the North Africa Saving Lives and Livelihood Initiative, Project Hope Namibia, Namibia.
Armando Sifna (AS), MD, is a physician with extensive experience in TB and is part of the TB program under the ministry of health in Guinea-Bissau.
12 Exploiting and disseminating the project results The standardised approach to TB management resulting from implementing the Bandim TBscore and improving available diagnostics is simple to communicate and translate into policy and WHO guidelines. The national partners in this project work within the national TB programs and may disseminate project results rapidly into policy changes at the national level. There are no intellectual property rights issues preventing a global dissemination of the Bandim TBscore which will be attempted through peer-reviewed publications and conference
### Conditions Module
**Conditions:**
- Tuberculosis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 1584
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The standard TB diagnostics in both settings consist of performing the sputum smear analysis by the clinical routine. Smear-negative cases will be followed as per standard routine (Figure 1A).
**Label:** Enhanced Usual Diagnostic Procedure (EUDP)
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** 1. Oral and mobile phone-guided instructions by study staff
2. Pooling of two spot sputum samples (9)
3. Smear-negative cases at the first visit will be assessed for persisting symptoms and referred to a CXR unit.
**Intervention Names:**
- Diagnostic Test: ODP
**Label:** The Optimized Diagnostic Procedure (ODP) intervention
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- The Optimized Diagnostic Procedure (ODP) intervention
**Description:** se previously
**Name:** ODP
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** 1. Number of smear positive, Xpert PCR positive, or CXR positive patients comparing EUDP to ODP.
**Measure:** 1. Number of smear positive, Xpert PCR positive, or CXR positive patients comparing EUDP to ODP.
**Time Frame:** 1.5 years
#### Secondary Outcomes
**Measure:** 1. Number of patients on active TB treatment comparing EUDP clinics to ODP clinics.
**Time Frame:** 1.5 years
**Measure:** 2. Diagnostic yield of CAD CXR compared to smear microscopy, Xpert PCR, and culture.
**Time Frame:** 1.5 years
**Measure:** 3. Follow-up rates in the cascade of care (i.e. one-week and six-months follow-up for all included and treatment start and outcome for all diagnosed with TB)
**Time Frame:** 1.5 years
**Measure:** 4. Differences in diagnostic yield between instructed sampling, buccal samples, fecal samples and routine sputum sample.
**Time Frame:** 1.5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* patients ≥15 years old with presumed TB with cough, sputum production, and/or weight loss of any duration are eligible to participate
Exclusion Criteria:
* 1. TB treatment within the past year. 2. Cerebral disturbances impairing the ability to give informed consent or follow the treatment regime.
**Maximum Age:** 120 Years
**Minimum Age:** 15 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Frauke Rudolf
**Phone:** 51372359
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009164
- Term: Mycobacterium Infections
- ID: D000000193
- Term: Actinomycetales Infections
- ID: D000016908
- Term: Gram-Positive Bacterial Infections
- ID: D000001424
- Term: Bacterial Infections
- 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
### Condition Browse Module - Browse Leaves
- ID: M17127
- Name: Tuberculosis
- Relevance: HIGH
- As Found: Tuberculosis
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12119
- Name: Mycobacterium Infections
- Relevance: LOW
- As Found: Unknown
- ID: M4722
- Name: Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M19252
- Name: Gram-Positive 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
### Condition Browse Module - Meshes
- ID: D000014376
- Term: Tuberculosis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437171
**Brief Title:** FeNO as a Marker of Allergic Reactions to OFC and Response of OMA Treatment in Multiple FA
**Official Title:** The Use of Exhaled Nitric Oxide as a Predictive Marker of Allergic Reactions to Oral Food Challenge and Clinical Response of Omalizumab Treatment in Subjects With Multiple Food Allergies
#### Organization Study ID Info
**ID:** ML45389
#### Organization
**Class:** OTHER
**Full Name:** AAADRS Clinical Research Center
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** AAADRS Clinical Research Center
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
### Description Module
**Brief Summary:** This is a Phase IV, open-label, single-center study to evaluate the change in FeNO as a marker of clinical response to OMA in participants with multiple FA.
**Detailed Description:** This is a Phase IV, open-label, single-center study to evaluate the change in FeNO as a marker of clinical response to OMA in participants with multiple FA. Twenty (20) participants will be enrolled over a 9-month enrollment period from an allergy and asthma medical specialty clinic. Should the participant meet all eligibility criteria, then following the Screening Period, the participant will be dosed with OMA and asked to continue to follow their food avoidance regimen.
Participants will return to the clinic every two weeks for 16-weeks, and then every 2 or 4-weeks (depending on dosing) for the remaining 36-weeks, for a total of 52-weeks. Primary endpoint analyses will occur at Week 16 and Week 52.
Description of XOLAIR treatment schedule:
Omalizumab will be dosed according to the OUtMATCH Study dosing. Patients will be monitored for acute hypersensitivity reactions for at least 61 minutes after the end of the injection. Epinephrine and parenteral diphenhydramine must be readily available for immediate use if required to treat a hypersensitivity reaction; site personnel must be able to detect and treat such reactions. Patients with severe hypersensitivity reactions (e.g., stridor, angioedema, life-threatening change in vital signs) must be withdrawn from study treatment.
All adverse events of systemic hypersensitivity reactions or anaphylactoid or anaphylaxis reactions must be reported within 24 hours to the Sponsor.
### Conditions Module
**Conditions:**
- Food Allergy
**Keywords:**
- Food Allergy
- Multiple Food Allergies
- Biomarker
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Omalizumab dose and frequency based on baseline patient weight and total IgE
**Intervention Names:**
- Biological: Omalizumab
**Label:** Open Label Injection of Omalizumab
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Open Label Injection of Omalizumab
**Description:** Omalizumab dose and frequency based on baseline subject weight and total IgE
**Name:** Omalizumab
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** biomarker
**Measure:** FeNO change from baseline to week 52
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** biomarker
**Measure:** Time to change from baseline FeNO during OFC
**Time Frame:** at baseline and at week 16
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients must meet the following criteria for study entry:
* Able and willing to provide written informed consent from patient and parent or guardian and to comply with the study protocol.
* Age 6 years of age or older at Visit 1
* Documented history of food allergy to one or more of the following foods based on SPT performed at baseline visit:
* peanut
* milk
* egg
* tree nuts (Walnut/Pecan, Cashew/Pistachio, Almond, Hazelnut, Brazil nut)
Exclusion Criteria:
* Patients who meet any of the following criteria will be excluded from study entry:
* Diagnosis of asthma requiring maintenance medication, including inhaled steroids, leukotriene modifiers, LABA/ICS, biologics medications (Intermittent asthma \[Step 1\] is allowed and defined according to the 2020 NAEPP guidelines (as 'asthma requiring only prn SABA use) and FEV1 \< 80% of predicted normal.
* Diagnosis of nasal polyps, cystic fibrosis or any respiratory condition that will skew normally occurring FeNO levels
* FeNO (measured in ppb) is lower than a value expected for the age, height, and gender of the participant or inability to perform respiratory collection maneuver
* Systemic steroids, leukotriene modifiers, or nasal steroids for any cause/diagnosis within 4 weeks of baseline
* Biologic use, for any diagnosis, within five half-lives of Screening
* Antibiotic use, systemic/oral/intramuscular, for any cause/diagnosis within 2 weeks of baseline
* Active smoker, cigarette, cigar, vape, recreational, and/or prior 10 pack year history
* Participant weight or IgE levels outside of the dosing table for OMA
* Known history of anaphylaxis/hypersensitivity to OMA
* Any medical condition that is serious or unstable that in the opinion of the PI could confound the study results and/or interfere with subject participation or adherence
* Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of OMA
* Women of childbearing potential must have a negative serum pregnancy test result during the screening period
**Minimum Age:** 6 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Miguel Lanz, MD
**Phone:** 3054440441
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Claudia Eisenlohr, MIB
**Phone:** 3054440441
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Coral Gables
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Miguel J Lanz, MD
- **Phone:** 305-444-0441
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Claudia P Eisenlohr, MIB
- **Phone:** 305 444-0441
- **Role:** CONTACT
***Contact 3:***
- **Name:** Miguel J Lanz, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** AAADRS Clinical Research Center
**State:** Florida
**Status:** RECRUITING
**Zip:** 33134
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007154
- Term: Immune System Diseases
- ID: D000006969
- Term: Hypersensitivity, Immediate
### Condition Browse Module - Browse Branches
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M10018
- Name: Hypersensitivity
- Relevance: HIGH
- As Found: Allergy
- ID: M8636
- Name: Food Hypersensitivity
- Relevance: HIGH
- As Found: Food Allergy
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10020
- Name: Hypersensitivity, Immediate
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006967
- Term: Hypersensitivity
- ID: D000005512
- Term: Food Hypersensitivity
### Intervention Browse Module - Ancestors
- ID: D000018926
- Term: Anti-Allergic Agents
- ID: D000018927
- Term: Anti-Asthmatic Agents
- ID: D000019141
- Term: Respiratory System Agents
### Intervention Browse Module - Browse Branches
- Abbrev: AAll
- Name: Anti-Allergic Agents
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: VaDiAg
- Name: Vasodilator Agents
### Intervention Browse Module - Browse Leaves
- ID: M413
- Name: Omalizumab
- Relevance: HIGH
- As Found: Tea
- ID: M12507
- Name: Nitric Oxide
- Relevance: LOW
- As Found: Unknown
- ID: M20962
- Name: Anti-Allergic 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
### Intervention Browse Module - Meshes
- ID: D000069444
- Term: Omalizumab
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437158
**Brief Title:** Use of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients
**Official Title:** Efficacy and Safety of Different Concentrations of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients
#### Organization Study ID Info
**ID:** 2023-12-19
#### Organization
**Class:** OTHER
**Full Name:** West China Hospital
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-03-08
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2023-12-19
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** West China Hospital
#### Responsible Party
**Investigator Affiliation:** West China Hospital
**Investigator Full Name:** Yi Ji
**Investigator Title:** Clinical 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:** Bleomycin has nowadays been more and more widely used in the sclerotherapy of LMs, which has been proven to be primarily dose dependent. The investigators aim to compare the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of LMs for pediatric patients.
**Detailed Description:** Lymphatic malformations (LMs) are vascular anomalies that arise from abnormal embryonic development of the lymphatic system and might present as dilated lymphatic channels or cysts lined by lymphatic endothelial cells. With an estimated incidence of approximately 1/4000-1/2000, LMs can occur at any site in the lymphatic system, in which head, neck and axilla were mostly detected and have been reported to account for over 75%. Based on the location and size of the lesion and the extent of involvement, LMs may be asymptomatic with incidental detection, or chronic abdominal pain and distension due to their compression of surrounding structures, or critical and even fatal secondary to their volvulus, hemorrhage, infection and rupture. Surgical excision is a definitive treatment for LMs, while it may be difficult at times because of the infiltrative nature of the lesions, leading to a high incidence of complications like vital organ injuries, nerve injuries, bleeding, infection scar formation, and recurrences. Sclerotherapy is a simpler alternative to tedious surgical excision treatment for LMs and avoids the complications related to surgery. As an anticancer drug extracted from Streptomyces verticillus, Bleomycin has been more and more widely used in the sclerotherapy of LMs for pediatric patients, which has been proven to be primarily dose dependent. However, the optimum concentration of Bleomycin in the sclerotherapy of LMs for pediatric patients has not been strictly validated, due to the lack of high-quality RCT studies. The investigators aim to compare the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of LMs for pediatric patients.
### Conditions Module
**Conditions:**
- Lymphatic Malformation
**Keywords:**
- Lymphatic Malformation
- Bleomycin
- Sclerotherapy
- Intracystic injection
- High-dose concentrations
- Low-dose concentrations
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The investigators aim to compare the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of lymphatic malformations for pediatric patients.
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** In this arm, patients with lymphatic malformations were treated by intracapsular injection with low-dose concentrations (1mg/ml) of Bleomycin.
**Intervention Names:**
- Drug: Bleomycin
**Label:** Low-dose Concentrations (1mg/ml) of Bleomycin
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** In this arm, patients with lymphatic malformations were treated by intracapsular injection with high-dose concentrations (2mg/ml) of Bleomycin.
**Intervention Names:**
- Drug: Bleomycin
**Label:** High-dose Concentrations (2mg/ml) of Bleomycin
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- High-dose Concentrations (2mg/ml) of Bleomycin
- Low-dose Concentrations (1mg/ml) of Bleomycin
**Description:** To validated the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of lymphatic malformations for pediatric patients
**Name:** Bleomycin
**Other Names:**
- Zeocin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Changes of Volume is defined as follows: a complete (90%-100% reduction in LMs volume), substantial (60%-89% reduction in LMs volume), intermediate (20%-59% reduction in LMs volume), or no (\< 20% reduction in LMs volume) response 3 to 6 months post-therapy as assessed by imaging.
**Measure:** Changes of Volume
**Time Frame:** 3 to 6 months post-therapy
#### Secondary Outcomes
**Description:** Score of Pain is selfassessed at each visit on a 0 to 10 visual analog scale (where 0 indicates no pain and 10 indicates the worst pain imaginable), reported along with period duration.
**Measure:** Score of Pain
**Time Frame:** 3 to 6 months post-therapy
**Description:** Global efficacy is assessed at each visit beginning at MS by the physician and self-assessed by the participant and proxy (parents) on a 0 to 10 visual analog scale (where 0 indicates no efficacy and 10 indicates complete resolution).
**Measure:** Global Efficacy
**Time Frame:** 3 to 6 months post-therapy
**Description:** Score of Quality of Life is assessed by the validated Children-Dermatological Life Quality Index (C-DLQI).
**Measure:** Score of Quality of Life
**Time Frame:** 3 to 6 months post-therapy
**Description:** Number of Participants with Efficacy was assessed by 2 independent experts.
**Measure:** Number of Participants with Efficacy
**Time Frame:** 3 to 6 months post-therapy
**Description:** Number of Participants with Safety was assessed based on physical signs and monitoring of imaging examinations or laboratory test.
**Measure:** Number of Participants with Safety
**Time Frame:** 3 to 6 months post-therapy
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male or female participants less than 14 years of age at the time of informed consent/assent form was signed.
* Participants whose parents have voluntarily given written consent and participants who provided assent (if applicable) after the study has been explained to them.
* Participants with LMs of all sites measured and confirmed via imaging at screening, with rapid progression, resluting in obvious symptoms or dysfunction, which could not be radically resected and could be treated by sclerotherapy.
Exclusion Criteria:
* Penicillin allergy.
* Vascular tumors or combined vascular malformations.
* Participants who may have had surgical or sclerotherapy treatment by other hardeners.
* LMs growing slowly, without obvious symptoms or dysfunction, which does not need to be treated prematurely.
**Maximum Age:** 14 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yi Ji, Ph.D.
**Phone:** +8618980606865
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Min Yang, M.D.
**Phone:** +8615928411140
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Chengdu
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yi Ji, Ph.D.
- **Phone:** +8618980606865
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Min Yang, M.D.
- **Phone:** +8615928411140
- **Role:** CONTACT
**Country:** China
**Facility:** West China Hospital of Sichuan University
**State:** Sichuan
**Status:** RECRUITING
**Zip:** 610041
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Sun J, Wang C, Li J, Song D, Guo L. The efficacy of bleomycin sclerotherapy in the treatment of lymphatic malformations: a review and meta-analysis. Braz J Otorhinolaryngol. 2023 Jul-Aug;89(4):101285. doi: 10.1016/j.bjorl.2023.101285. Epub 2023 Jun 29.
**PMID:** 37423005
**Citation:** De Maria L, De Sanctis P, Balakrishnan K, Tollefson M, Brinjikji W. Sclerotherapy for lymphatic malformations of head and neck: Systematic review and meta-analysis. J Vasc Surg Venous Lymphat Disord. 2020 Jan;8(1):154-164. doi: 10.1016/j.jvsv.2019.09.007. Epub 2019 Nov 14.
**PMID:** 31734224
**Citation:** Wu Z, Zou Y, Fu R, Jin P, Yuan H. A nomogram for predicting sclerotherapy response for treatment of lymphatic malformations in children. Eur J Med Res. 2022 Oct 21;27(1):209. doi: 10.1186/s40001-022-00844-3.
**PMID:** 36271467
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000018190
- Term: Lymphatic Vessel Tumors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000008206
- Term: Lymphatic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12
- Name: Congenital Abnormalities
- Relevance: HIGH
- As Found: Malformations
- ID: M11199
- Name: Lymphangioma
- Relevance: HIGH
- As Found: Lymphatic Malformations
- ID: M25277
- Name: Lymphatic Abnormalities
- Relevance: HIGH
- As Found: Lymphatic Malformations
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M11203
- Name: Lymphatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T3529
- Name: Lymphatic Malformations
- Relevance: HIGH
- As Found: Lymphatic Malformations
### Condition Browse Module - Meshes
- ID: D000008202
- Term: Lymphangioma
- ID: D000044148
- Term: Lymphatic Abnormalities
- ID: D000000013
- Term: Congenital Abnormalities
### Intervention Browse Module - Ancestors
- ID: D000000903
- Term: Antibiotics, Antineoplastic
- ID: D000000970
- Term: Antineoplastic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infe
- Name: Anti-Infective Agents
### Intervention Browse Module - Browse Leaves
- ID: M5042
- Name: Bleomycin
- Relevance: HIGH
- As Found: Toothpaste
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4224
- Name: Antibiotics, Antitubercular
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000001761
- Term: Bleomycin
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437145
**Acronym:** MW2acute
**Brief Title:** Acute Effects of HIIT vs. MICT on HRV
**Official Title:** Acute Effects of High Intensity Interval Training (HIIT) vs. Moderate Intensity Continuous Training (MICT) on Heart Rate Variability Parameters in Patients After Myocardial Infarction
#### Organization Study ID Info
**ID:** UKCLRehab2024/1
#### Organization
**Class:** OTHER
**Full Name:** University Medical Centre Ljubljana
### Status Module
#### Completion Date
**Date:** 2024-06-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-16
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Medical Centre Ljubljana
#### Responsible Party
**Investigator Affiliation:** University Medical Centre Ljubljana
**Investigator Full Name:** Borut Jug
**Investigator Title:** Prof.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Heart rate variability (HRV) is impaired in patients after myocardial infarction. Most studies so far have proved chronic beneficial effects of different types of exercise on HRV parameters. Data on acute effects of different types of exercise training (e.g. high intensity interval training \[HIIT\] and moderate intensity continuous training \[MICT\]) is scarce.
Patients in the study will perform both HIIT and MICT in a random order and in-between break of at least 48 hours. A 5-minute high resolution ECG recording will be performed before and immediately after both HIIT and MICT.
### Conditions Module
**Conditions:**
- Myocardial Infarction
**Keywords:**
- exercise training
- high intensity interval training
- moderate intensity continuous training
- heart rate variability
- myocardial infarction
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** Each patient will have a bout of HIIT during one session and a bout of MICT during another session performed in a random order.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** HRV parameters analysis will be blinded regarding the exercise training modality.
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The high-intensity interval training session consists of 5-min warm-up and 5-min cool-down periods. The main part has 7 cycles. Each cycle consists of 1.5 min of 80-90% of HRpeak and 3 min of 65-70% of HRpeak.
**Intervention Names:**
- Other: Type of Exercise
**Label:** High intensity interval training (HIIT)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** The moderate-intensity continuous training session consists of 5 min warm-up and 3-min cool down period. The main part consists of 32 min of 75% of HRpeak.
**Intervention Names:**
- Other: Type of Exercise
**Label:** Moderate intensity continuous training (MICT)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- High intensity interval training (HIIT)
- Moderate intensity continuous training (MICT)
**Description:** The high-intensity interval training session consists of 5-min warm-up and 5-min cool-down periods. The main part has 7 cycles. Each cycle consists of 1.5 min of 80-90% of HRpeak and 3 min of 65-70% of HRpeak. The moderate-intensity continuous training session consists of 5 min warm-up and 3-min cool down period. The main part consists of 32 min of 75% of HRpeak.
**Name:** Type of Exercise
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** SD1, SD2
**Measure:** Non-linear methods
**Time Frame:** 5-minutes high resolution ECG recording before and after an exercise session
#### Primary Outcomes
**Description:** High frequency domain of the HRV
**Measure:** HF parameter
**Time Frame:** 5-minutes high resolution ECG recording before and after an exercise session
#### Secondary Outcomes
**Description:** Low frequency domain of the HRV
**Measure:** LF parameter
**Time Frame:** 5-minutes high resolution ECG recording before and after an exercise session
**Description:** Standard deviation of NN intervals
**Measure:** SDNN
**Time Frame:** 5-minutes high resolution ECG recording before and after an exercise session
**Description:** Root mean square of successive RR interval differences
**Measure:** RMSSD
**Time Frame:** 5-minutes high resolution ECG recording before and after an exercise session
**Description:** Percentage of successive RR intervals that differ by more than 50 ms
**Measure:** pNN50
**Time Frame:** 5-minutes high resolution ECG recording before and after an exercise session
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* myocardial infarction in last 120 days
* sinus rhythm
Exclusion Criteria:
* contraindications for exercise training
* uncontrolled dysrhythmias
* Heart Failure NYHA IV stage
* cognitive impairment
* pregnancy
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Marko Novaković, MD, PhD
**Phone:** 0038615228032
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Ljubljana
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Marko Novaković, MD, PhD
- **Phone:** 0038615228032
- **Role:** CONTACT
**Country:** Slovenia
**Facility:** University Medical Centre Ljubljana
**Status:** RECRUITING
**Zip:** 1000
#### Overall Officials
**Official 1:**
**Affiliation:** University Medical Centre Ljubljana
**Name:** Marko Novaković, MD, PhD
**Role:** STUDY_CHAIR
### References Module
#### References
**Citation:** Routledge FS, Campbell TS, McFetridge-Durdle JA, Bacon SL. Improvements in heart rate variability with exercise therapy. Can J Cardiol. 2010 Jun-Jul;26(6):303-12. doi: 10.1016/s0828-282x(10)70395-0.
**PMID:** 20548976
**Citation:** El-Malahi O, Mohajeri D, Mincu R, Bauerle A, Rothenaicher K, Knuschke R, Rammos C, Rassaf T, Lortz J. Beneficial impacts of physical activity on heart rate variability: A systematic review and meta-analysis. PLoS One. 2024 Apr 5;19(4):e0299793. doi: 10.1371/journal.pone.0299793. eCollection 2024.
**PMID:** 38578755
**Citation:** Grassler B, Thielmann B, Bockelmann I, Hokelmann A. Effects of different exercise interventions on heart rate variability and cardiovascular health factors in older adults: a systematic review. Eur Rev Aging Phys Act. 2021 Nov 17;18(1):24. doi: 10.1186/s11556-021-00278-6.
**PMID:** 34789148
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007511
- Term: Ischemia
- ID: D000010335
- Term: Pathologic Processes
- ID: D000009336
- Term: Necrosis
- ID: D000017202
- Term: Myocardial Ischemia
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000014652
- Term: Vascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12155
- Name: Myocardial Infarction
- Relevance: HIGH
- As Found: Myocardial Infarction
- ID: M10282
- Name: Infarction
- Relevance: HIGH
- As Found: Infarction
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M12284
- Name: Necrosis
- Relevance: LOW
- As Found: Unknown
- ID: M6546
- Name: Coronary Artery Disease
- Relevance: LOW
- As Found: Unknown
- ID: M19506
- Name: Myocardial Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009203
- Term: Myocardial Infarction
- ID: D000007238
- Term: Infarction
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437132
**Acronym:** 5-D
**Brief Title:** Decoding Death and Dying in People With Dementia by Digital Thanotyping
**Official Title:** Decoding Death and Dying in People With Dementia by Digital Thanotyping
#### Organization Study ID Info
**ID:** 101088414 5-D ERC-2022-CoG
#### Organization
**Class:** OTHER
**Full Name:** University of Bergen
### Status Module
#### Completion Date
**Date:** 2028-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2028-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Leiden University
**Class:** OTHER
**Name:** Harvard University
**Class:** OTHER
**Name:** Yale University
**Class:** OTHER
**Name:** Tohoku University
**Class:** UNKNOWN
**Name:** Bergen kommune
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Bergen
#### Responsible Party
**Investigator Affiliation:** University of Bergen
**Investigator Full Name:** Bettina Husebo
**Investigator Title:** Prof, MD, PhD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** How can healthcare professionals recognize that a person with dementia is at the end of life? When people are dying, their physical, mental, and social abilities are gradually declining. No reliable method of predicting perceived dying currently exists although the technology is available (sensors, algorithms).
The aim of Decoding Death and Dying in Dementia by Digital thanotyping (5-D) is to provide methods and tools to diagnose and describe dying to an unprecedented level of accuracy and robustness, within a timespan larger than is possible now, focusing on the case of dying people with dementia as one of the most vulnerable and difficult to study groups. 5-D combines clinical assessment tools with wearable sensing technology to monitor a) pain and distressing symptoms, b) behavioral and psychological symptoms in dementia (BPSD), c) oral changes, and to decode "the point of no return" as the beginning of perceived dying.
To obtain this outcome in nursing home patients with dementia, the investigator will test the main hypothesis: from monitoring the evolution of thanotype components over time and their interdependencies, the prediction of the "point of no return" is possible. The objectives of 5-D are:
O1. Collect data using sensors and validated assessment scales. O2. Develop estimation methods for BPSD from sensor measurements. O3. Develop digital tools to capture the expression of pain. O4. Determine the relationship between breathing and oral symptoms. O5. Develop models for symptom interdependencies at the end of life and the "point of no return".
O6. Perform human-in-the-loop validation of developed tools, models, and algorithms.
The ground-breaking interdisciplinary novelty of 5-D endeavors to enhance the understanding of end-of-life underlying pain and symptoms in people with dementia. Advancing our theoretical knowledge to uncover how, when, and why perceived dying can be identified opens the doors for transferable research across several scientific fields
**Detailed Description:** Decoding death and dying in people with dementia by digital thanotyping (5-D) aims to pioneer the methodology of defining perceived dying by a data- and knowledge-driven digital representation of the end-of-life trajectory and its associated processes inferred from different measurements. The investigator proposes a novel digital thanotyping approach (Greek for thánatos) defined as the moment-by-moment in-situ quantification of the individual state of the human body. In 5-D, the investigator defines the "point of no return" as the declining state from which the person with dementia does not recover and marks the beginning of the perceived dying. In this trial the investigator describes methods and tools to define dying to an unprecedented level of accuracy and robustness, within a timespan larger than is possible now in one of the most difficult to access and vulnerable groups. Results will be transferable to other life-threatening diseases, relevant for hospitals and homecare services alike. The investigator hypothesizes that, from monitoring the evolution of clinical manifestations over time and their interdependencies, the prediction of the point of no return is possible.
5-D is a 5-year, multicenter, observation-analytic, longitudinal study aimed toward method development combining clinical data and information with systems modelling and systems identification. The investigator will recruit people with dementia (N=480) from the 10-12 Norwegian nursing homes (NH) from the Bergen Municipality, which have a cumulative capacity of \>800 patients/year (out of a total of 2500 patients/year across the municipality). The recruitment pool will be extended, if necessary, to other NHs within the municipality. The investigator chooses NHs as the location for this research (instead of patient homes) because 57% of the dying population and 97% of all people with dementia in Norway die in NHs.(12) Most people in NHs present multimorbidity; among them, 52% have severe dementia (Mini-Mental-State Examination, MMSE score 0-11), 25% moderate dementia (MMSE 12-17), 16% mild dementia (18-23), and 6% no dementia (24-30).(13) Inclusion criteria: NH inhabitants \>64 years, with significant cognitive impairment.(14) Exclusion criteria: people without informed/presumed consent, people already participating in other studies, people who might be distressed by sensors.
### Conditions Module
**Conditions:**
- Dementia
**Keywords:**
- end of life
- dementia
- nursing home
- pain assessment and treatment
- symptom assessment and treatment
- mouth care
### Design Module
#### Bio Spec
**Description:** Saliva and plaque collection from the mouth
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 480
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Persons with dementia
**Intervention Names:**
- Other: No intervention
**Label:** Participants
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Participants
**Description:** The study is observational and will not include any specific interventions other than the regular care practice that the participants receive from their care providers. The study will use a wrist-mounted smartwatch for monitoring (Garmin VivoActive5). Previous studies show acceptability toward wearable devices among persons with dementia. Moreover, the investigator will use Somnofy, VitalThings, a radar installation mounted behind the patients bed. At the very end of life, the investigator will also apply Shimmer3 Ebio sensor measuring the patients breathing activities. Before starting the data collection, care staff will recognize any discomfort or distress potentially caused by the devices, in which case the relevant device will be immediately removed.
**Name:** No intervention
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** Mortality risk measure for general wellbeing, medical comorbidity, degree of somatic illness; top 2 scores are good, bottom 2 indicate serious illness with comorbidities. Bedside measure validated in NH with people with dementia.
**Measure:** General Medical Health Rating Scale (GMHR)
**Time Frame:** Baseline
**Description:** A medication list will be compiled according to the Anatomical Therapeutic Chemical classification (ATC codes); including and of life, palliative treatment
**Measure:** Chart review
**Time Frame:** Baseline
**Description:** Classification of cognitive impairment, 0 no cognitive impairment, 0.5 questionable impairment, 1 mild cognitive impairment, 2 moderate cognitive impairment, 3 severe cognitive impairment.
**Measure:** Clinical Dementia Rating (CDR)
**Time Frame:** Baseline
**Description:** Distinction between dementia and delirium for inclusion to study, \>4 indicates delirium; will be used as an exclusion criteria (participants must score \<4)
**Measure:** 4 A's Test for Delirium (4AT)
**Time Frame:** Baseline
**Description:** Mortality risk measure for general wellbeing, higher scores indicate greater disability (1-9)
**Measure:** Clinical Frailty Scale (CFS)
**Time Frame:** Baseline
#### Primary Outcomes
**Description:** Symptom assessment for palliative care period and the end of life period, with added items: death rattle, dyspnea, sleep disturbances, emesis specific to end of life. Likert scale 0-10; 0 indicating no symptoms and 10 is worst symptom.
**Measure:** Edmonton Symptom Assessment System (ESAS++)
**Time Frame:** Baseline and every 6.months (up to three years); When the patient is suggested to be at the end of life and is dying; ESAS will be assessed once the day.
**Description:** Digital biomarker estimations for behavioural and psychological disturbances (BPSD) e.g., apathy, agitation, pain, and sleep disturbances. Moreover, different types of breathing patterns (e.g., dyspnea, death rattle, lunge edema) Estimation of activity changes and selected BPSD resulting from the combined digital phenotype modeling; these estimations are experimental and "scores" will be based on analysis of found data after data collection period.
**Measure:** Digital biomarker estimations
**Time Frame:** Baseline and every 6.months (up to three years), continuous up to 12 weeks if a serious health event occurs]
#### Secondary Outcomes
**Description:** Personal functional daily activities such as toileting, eating, self-care, movement/ambulation, transfers, bathing. 6 sections - scoring 1-5 on each, higher score indicates greater disability.
**Measure:** Activities of Daily Living (ADL) - Physical Self Maintenance Scale (PSMS), Lawton and Brody, 1969.
**Time Frame:** Baseline and every 6.months (up to three years)
**Description:** Validated in Norwegian nursing homes, measuring symptoms of behavioral and psychological symptoms of dementia (BPSD) such as: apathy, agitation, depression, anxiety, sleep disturbance, and appetite/eating. Gives scores 1-4 (higher numbers being daily occurance) for amount, 1-3 for intensity and burden of care related to symptom for caregiver (1-5) for each symptom.
**Measure:** Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)
**Time Frame:** Baseline and every 6.months (up to three years)
**Description:** Measurement of pain specific to a dementia population; visual analog scale alongside likert scale 0-10, 0 being no pain and 10 being the worst pain, validated with persons with dementia
**Measure:** Mobilization - Observation - Behavioral - Intensity - Dementia Pain Scale (MOBID-2)
**Time Frame:** Baseline and every 6.months (up to three years)
**Description:** Oral health section only/specific of the InterRai-PC, assessment of symptoms
**Measure:** InterRai-Palliative Care (InterRai-PC)
**Time Frame:** Baseline and every 6.months (up to three years)
**Description:** Biological material will be collected:
1. for gum and mucosal tissue status, unstimulated saliva will be collected
2. for carious lesions, collection of plaque samples will be collected from 2 teeth
3. oral dryness will be measured using an oral moisture-checking device
4. mucosal lesions diagnosis will be obtained from clinical pictures to determine deviation from normal healthy tissues.
**Measure:** Oral inspection
**Time Frame:** Baseline and every 4.months (up to three years)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Nursing home resident
* \>64 years old
* People with dementia or who have a likely diagnosis of dementia
* Score of \<4 on the 4 A's Test for Delirium (4AT) will be required for inclusion (no delirium)
Exclusion Criteria:
* People without dementia or cognitive impairment
* People that are considered already in a health status emergency (\< 6 weeks to live)
* People that are not living in the nursing home
* People without informed/presumed consent
**Minimum Age:** 65 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
**Study Population:** nursing home patients with dementia
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Bettina S. Husebø, PhD
**Phone:** 48094660
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Monica Patrascu, PhD
**Phone:** 91198669
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Bergen
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Morten Amundsen
- **Phone:** +4755397700
- **Role:** CONTACT
**Country:** Norway
**Facility:** Bergen Røde Kors Sykehjem AS
**State:** Vestland
**Status:** RECRUITING
**Zip:** 5043
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M6904
- Name: Dementia
- Relevance: HIGH
- As Found: Dementia
- ID: M6845
- Name: Death
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- 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: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003704
- Term: Dementia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437119
**Brief Title:** The Antagonistic Effect of Plant Nutrients on Health Damage Caused by Environmental Pollutants
**Official Title:** A Randomized Double-blind Controlled Trial Study on the Antagonistic Effect of Plant Nutrients on Health Damage Caused by Environmental Pollutants
#### Organization Study ID Info
**ID:** IRB#2024-03-1102
#### Organization
**Class:** OTHER
**Full Name:** Fudan University
### Status Module
#### Completion Date
**Date:** 2024-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Amway (China) Daily-Use Commodity Co.,Ltd
#### Lead Sponsor
**Class:** OTHER
**Name:** Fudan University
#### Responsible Party
**Investigator Affiliation:** Fudan University
**Investigator Full Name:** Ruihua Dong
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The study attempts to conduct randomized controlled trials to understand whether daily exposure to environmental pollutants can cause harm to human health, explore whether the intake of plant nutritional supplements can alleviate potential health hazards caused by environmental pollutants, and provide scientific basis for the prevention and treatment of health hazards caused by environmental pollutant exposure.
### Conditions Module
**Conditions:**
- Intestinal Functional Disorder
- Inflammation
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Subjects were stratified by gender using SAS 9.3 (SAS Institute Inc. NC, US). Eligible subjects were randomly assigned equally to one of the two survey groups based on a computer-generated randomization list. The generated random list is verified by statisticians and kept confidential during the study period. The random list is kept in a separate envelope.
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** The on-site implementation personnel and those responsible for coordinating the study only received the study number of the subjects, and were unaware of the intervention group allocation of the subjects. The subjects were also unaware of their intervention allocation. A copy of the sealed envelope of the non blinded study number for each subject is provided only to the study supervisor. Before the completion of data collection, the investigators and researchers kept the blind method for treatment allocation. All subjects were monitored in a double-blind way throughout the study period, and the subjects could not distinguish their own grouping by asking questions or from appearance and texture.
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 103
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The compound plant nutrients include extracts of licorice, sophora, wild cherry berry, dendrobium officinale, and pomegranate. They should be taken three times a day, one pack at a time, brewed and dissolved in warm water, and taken with meals or after meals.
**Intervention Names:**
- Dietary Supplement: Compound plant nutrients
**Label:** Nutrition supplement group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** A placebo with an indistinguishable appearance and color. 3 times a day, 1 pack at a time, dissolve in warm water and take with meals or after meals.
**Intervention Names:**
- Dietary Supplement: placebo
**Label:** placebo group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Nutrition supplement group
**Description:** The compound plant nutrients include extracts of licorice, sophora, wild cherry berry, dendrobium officinale, and pomegranate.
**Name:** Compound plant nutrients
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- placebo group
**Description:** A placebo with an indistinguishable appearance and color.
**Name:** placebo
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** Py GC/MS method for detecting microplastic (MPs) levels in feces of research subjects.
**Measure:** Fecal microplastics (MPs) levels
**Time Frame:** up to 2 months
**Measure:** Fecal metagenomic sequencing
**Time Frame:** up to 2 months
**Description:** ELISA detection of MCP-1 abundance in the blood of research subjects
**Measure:** MCP-1
**Time Frame:** up to 2 months
**Description:** ELISA detection of IL-1β abundance in the blood of research subjects
**Measure:** IL-1β
**Time Frame:** up to 2 months
**Description:** ELISA detection of IL-6 abundance in the blood of research subjects
**Measure:** IL-6
**Time Frame:** up to 2 months
**Description:** ELISA detection of TNF-α abundance in the blood of research subjects
**Measure:** TNF-α
**Time Frame:** up to 2 months
**Measure:** PBMC single-cell sequencing analysis
**Time Frame:** up to 2 months
#### Secondary Outcomes
**Description:** Determine Red blood cell count (RBC) through blood routine examination
**Measure:** Red blood cell count (RBC)
**Time Frame:** up to 1 months
**Description:** Determine White blood cell count (WBC) through blood routine examination
**Measure:** White blood cell count (WBC)
**Time Frame:** up to 1 months
**Description:** Determine Lymphocyte count through blood routine examination
**Measure:** Lymphocyte count
**Time Frame:** up to 1 months
**Description:** Determine urinary protein through Urinalysis
**Measure:** urinary protein
**Time Frame:** up to 2 months
**Description:** Determine urine cast through Urinalysis
**Measure:** urine cast
**Time Frame:** up to 2 months
**Description:** Measure blood creatinine and urine creatinine, and calculate creatinine clearance rate based on this
**Measure:** creatinine clearance rate
**Time Frame:** up to 2 months
**Description:** Measuring plasma albumin content to evaluate liver function
**Measure:** albumin
**Time Frame:** up to 2 months
**Description:** Measuring aspartate aminotransferase content to evaluate liver function
**Measure:** aspartate aminotransferase
**Time Frame:** up to 2 months
**Description:** Measuring aspartate aminotransferase content to evaluate liver function
**Measure:** alanine aminotransferase
**Time Frame:** up to 2 months
**Description:** Measuring total bilirubin to evaluate liver function
**Measure:** total bilirubin
**Time Frame:** up to 2 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Volunteers aged 18-65,
* BMI\<35 kg/m2,
* agreed and signed an informed consent form.
Exclusion Criteria:
* Suffering from known congenital or acquired immunodeficiency diseases, allergic diseases, gastrointestinal diseases, and other acute and chronic diseases that require treatment;
* Within one month before the experiment, use immunosuppressive drugs, antibiotics, probiotics, prebiotics, synthetic bacteria, or other drugs that are active in gastrointestinal motility;
* Consume nutritional supplements within one month before the experiment;
* Basic medical history (hypertension, diabetes); Having bad habits (smoking, drinking);
* Receive influenza vaccine within 12 months before the experiment;
* During pregnancy or lactation;
* Weight changes exceeding 5% within the three months prior to the experiment;
* Has been enrolled or planned to be enrolled in other studies.
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ruihua Dong
**Phone:** +86 158 0065 0952
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** School of Public Health，Fudan University
**Name:** Ruihua Dong
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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: HB
- Name: Herbal and Botanical
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T257
- Name: Pomegranate
- Relevance: LOW
- As Found: Unknown
- ID: T208
- Name: Licorice
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437106
**Brief Title:** The Effect of Maternally Scent-digested Blanket on Stress, Crying and Physiological Parameters of Premature Newborns
**Official Title:** The Effect of Maternally Scent-digested Blanket on the Stress Level, Crying Duration and Physiological Parameters of Premature Newborns
#### Organization Study ID Info
**ID:** SSL&APM
#### Organization
**Class:** OTHER
**Full Name:** Istanbul University - Cerrahpasa (IUC)
### Status Module
#### Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-09
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Istanbul University - Cerrahpasa (IUC)
#### Responsible Party
**Investigator Affiliation:** Istanbul University - Cerrahpasa (IUC)
**Investigator Full Name:** Shahla Shafaati Laleh
**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:** Olfaction is a highly developed and crucial sensory modality that connects the infant and the mother, facilitating the infant's ability to locate and reach the mother's breast. the olfactory important sensory ability develops during intrauterine life . By the 11th week of pregnancy, human embryos have completely developed olfactory cells, indicating the complete formation and functionality of the olfactory sensory system during the first trimester . Hence, the olfactory sense undergoes development between the 26th and 28th weeks of pregnancy and, like other senses, plays a role in producing both motor and emotional responses .The mature olfactory system of newborn infants also effectively reduces pain and distress. The results of some studies have shown that the mother's voice and the smell of breast milk can reduce discomfort scores and analgesic effects during painful procedures . Odors can trigger the release of neurotransmitters, such as endorphins, in infants. Neurotransmitters are released in infants to alleviate painful stimuli, leading to a drop in stress levels . Researchers clinical experience shows that covering the baby calms and reduces crying. But no evidence-based studies have been conducted.
The present study is planned in the form of a randomized controlled trial design and will investigate the effect of a blanket impregnated with the mother's scent on the amount of stress, duration of crying and physiological parameters of premature infants admitted to the NICU.
Hypotheses:
In premature newborns;
H1: Covering with a blanket with maternal scent digested reduces the stress level of newborns.
H2: Covering with a blanket with maternal scent digested reduces the crying time of newborns.
H3: Covering with a blanket with maternal scent digested positively affects the physiological parameters of newborns.
H4: Covering with a blanket with maternal scent digested is more effective in reducing the stress level of newborns than covering with a blanket without maternal scent and the control group (babies not covered).
H5: Covering with a blanket with maternal scent digested is more effective in reducing the crying time of newborns than covering with a blanket without maternal scent and the control group (babies not covered).
H6: Covering with a blanket with maternal scent digested affects the physiological parameters of newborns more positively than the cover with maternal scent undigested and the control group (babies not covered).
**Detailed Description:** When preterm babies are admitted to the NICU, preterm babies are deprived of mother's hugs, sounds, and smells. Maternal involvement has recently been recognized as an important aspect of the care of hospitalized preterm infants that has a positive impact on clinical outcomes. Standard care in babies can cause stress, and following may cause pain in the baby over time. Both pharmacological and non-pharmacological approaches are used together to alleviate pain and reduce stress in infants. One of the non-medicinal methods is maternal odor. Researches has indicated that maternal odors, including breast milk, body odor, and amniotic fluid, particularly the odor of breast milk, can decrease stress reactions in newborn infants, such as crying and motor activity . The present study will be conducted with the aim of determining the effect of a blanket impregnated with the mother's smell on the amount of stress, crying duration and physiological parameters of premature babies
Method:
Place of the Research :
The data of current study will be collected on premature babies hospitalized in the neonatal intensive care unit of Al-Zahra Teaching and Research Hospital and Taleghani Teaching and Research Hospital, which are mother and baby friendly hospitals in Tabriz city.
Sample research:
TG\*Power software (latest ver. 3.1.9.7; Heinrich-Heine Universität Düsseldorf, Düsseldorf, Germany) was used to determine the sample size in the study. In the study, Rad (2021)\*\* investigated the effect of the smell of breast milk and the smell of another mother's breast milk on the behavioral responses to pain caused by hepatitis B (HB) vaccine injection in preterm babies. In the study, a significant difference was observed for peak heart rate values, and intra-group and inter-group differences were calculated. In the smell of breast milk group, the pretest mean heart rate was 139 ± 16.1 points and the posttest mean was 146 ± 14.3 points. In the another mother's breast milk group, the pretest mean heart rate was 141 ± 15.6 points and the posttest mean was 153 ± 15.5 points. In the control group, the pre-test average heart rate was 139 ± 17.8 points and the post-test average was 155 ± 17.7 points. Power was calculated using the "ANOVA: Repeated measures, within-between interaction" method for two repeated measurements of heart rate averages in three groups. As a result, was determined that should be 54 observations in the sample with a statistical power level of 80% and a significance level of 5% for the calculated (f=0.220)\* effect size. Considering sample loss (10%) such as dropping out of the study, will be sufficient to work with at least 60 participants. Participants will be grouped with 20 participant in each group.
Data collection tools: Mother and baby information form, baby monitor which is used to evaluate the baby's heart rate and oxygen saturation level and the baby's temperature, , stopwatches designed to count the baby's breathing and crying time, baby stress scale and evaluation form Babies will be used.
Application of the research:
Before the start of data collection, the family of an infant who meets the selection criteria planned for the research is informed about the purpose and content of the research, and they are asked if they want to participate in the study and their written consent is obtained. Through the "informed consent form". Before conducting, the research will be explained to midwives, doctors and other personnel working in the research unit. Necessary tools will be available before conducting (stopwatch, blanket,...). In this research, random allocation will be done through random blocks with the size of blocks of 6 and 9 and with the allocation ratio of 1:1:1. In order to hide the allocation of the type of intervention, it will be written on a sheet of paper and placed inside the opaque envelopes and numbered consecutively. The envelopes will be determined according to the order of the participants entering the open study and the type of intervention received. Random allocation and allocation concealment will be done by a person not involved in sampling and data collection. A square shaped blanket (made of cotton fabric) is given to the mother for one night, as in Jessen's (2020) study, placed in contact with and between the breasts of the showered mother, so that the blanket is impregnated with the mother's scent. to be The mother is asked to keep the blanket in the sealed plastic bag given to her during the day and to use her regular shampoo, regular soap. and avoid using new products. All blankets are washed with the same detergent before giving to the mother. Babies covered with a blanket impregnated with their mother's scent formed group 1 (20 participant), babies covered with a blanket not covered with their mother's scent, group 2 (n = 20) and babies in the control group, which was not covered with any blanket. , forms group 3 (20 participant). All babies' diapers are changed and cleaned at least half an hour before the operation. Babies will be fed. In order to prevent heat loss and create equal conditions, this method is performed with a naked baby (with diapers) in the incubator. No painful procedures will be performed on the day of the request, at least half an hour before and half an hour after. Before the intervention, i.e. 5 minutes before the measurement (blanket impregnated with mother's smell and plain blanket without mother's smell), the premature baby is evaluated and the stress level and physiological parameters are observed and recorded. This process starts for one hour in the morning. Observation by the researcher from before the intervention to after the intervention to evaluate the stress level, duration of crying and physiological parameters of the babies is taken 5 minutes before the intervention, immediately after the intervention, every 15 minutes during the intervention and 5 minutes after the intervention. . . The stress level is evaluated by observation by the researcher who does not know which group the babies are in. In addition, the infant's physiological parameters are evaluated 5 minutes before the intervention, immediately after the intervention, every 15 minutes during the intervention and 5 minutes after the intervention by the same researcher. During the intervention, the baby will be left alone to avoid affecting stress symptoms, crying duration and physiological parameters, and 30 minutes after the procedures performed on the baby, the intervention will take place and no other actions will be performed during the intervention.
intervention group; Blanket group impregnated with mother's smell: (intervention group 1)
1. Parents of babies in intervention group 1 first fill out the "Mother and Baby Information Form".
2. A blanket impregnated with the smell of the mother is covered over the baby for one hour in the morning for three days.
3. The stress level of babies is evaluated by the researcher through observation before, during and after the intervention.
4. Physiological parameters of babies and duration of crying are evaluated by the same observer.
5. Heart rate and oxygen saturation of the baby are checked and recorded before, during and after the intervention.
6. When the treatment and care is not done on the baby, the research procedure will be done.
Simple blanket group without mother's smell: (intervention group 2)
1. Parents of babies in intervention group 2 first fill in the "Mother and Baby Information Form".
2. A blanket that does not smell of the mother and is simple is covered over the baby for three days in the morning for one hour.
3. The stress level of babies is evaluated by the researcher through observation before, during and after the intervention.
4. Physiological parameters of babies and duration of crying are evaluated by the same observer.
5. Heart rate and oxygen saturation of the baby are checked and recorded before, during and after the intervention.
6. When the treatment and care is not done on the baby, the research procedure will be done.
control group:
1. Babies in the control group first fill out the "Mother and Baby Information Form".
2. The usual care method of the unit will be applied to the baby without any intervention.
3. The amount of stress of the babies is evaluated by the researcher through observation in the morning at the same time as the babies of the intervention group.
4. Physiological parameters of babies and duration of crying are evaluated by the same observer.
5. The baby's heart rate and oxygen saturation are checked and recorded.
6. When the treatment and care is not done on the baby, the research procedure will be done
Research data analysis:
The data obtained in the research will be analyzed using SPSS software for Windows 24.0. In data evaluation, number, percentage, average and standard deviation will be used as descriptive statistical methods. Before conducting the hypothesis tests, data distribution characteristics are checked with the Kolmogorov Smirnov test, skewness and homogeneity of variance are checked with Levene's test, and if conditions exist, the independent sample t test is checked. T test is used to compare continuous data between two independent groups. Otherwise, the Mann Whitney U test is used to compare continuous data between more than two independent groups. One-way Anova test will be used for comparison, if not available, Kruskal Wallis tests will be used. After one-way ANOVA test, Benforrini and Tukey tests will be used as additional post-hoc analysis to determine differences. And two-by-two Mann Whitney U tests are used for the Kruskal Wallis test. Among the continuous variables of the research, the correlation analysis will be evaluated and the classified data will be evaluated with the chi-square test. In all analyses, values of p\<0.05 (two-sided) will be considered statistically significant.
### Conditions Module
**Conditions:**
- Family-centered Care
**Keywords:**
- The smell of mother
- baby
- stress
- physiological parameters
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Intervention group one includes premature babies who receive a blanket impregnated with the mother's smell.
The second intervention group includes premature babies who receive a blanket without the smell of the mother.
The control group includes premature babies who do not receive any intervention and receive routine care.
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Intervention group 1 consists of premature babies who receive a blanket impregnated with the mother's odor.
**Intervention Names:**
- Behavioral: A blanket impregnated with the mother's odor
**Label:** A blanket impregnated with the mother's odor
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Intervention group 2 includes premature babies who receive a blanket without the smell of the mother.
**Intervention Names:**
- Behavioral: blanket without mother's smell
**Label:** blanket without mother's smell
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** The control group includes premature babies who receive no intervention and receive routine care.
**Intervention Names:**
- Behavioral: control group
**Label:** control group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- A blanket impregnated with the mother's odor
**Description:** Intervention group 1 consists of premature babies who receive a blanket impregnated with the mother's odor.
**Name:** A blanket impregnated with the mother's odor
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- blanket without mother's smell
**Description:** Intervention group two consists of preterm infants who receive blanket without mother's odor.
**Name:** blanket without mother's smell
**Type:** BEHAVIORAL
#### Intervention 3
**Arm Group Labels:**
- control group
**Description:** The control group includes premature babies who are not subjected to any intervention and receive the usual care.
**Name:** control group
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The stess levels of the infants will be evaluated via Infant stress scale. Infant stress scale was developed by Ceylan and Bolışık for assessing stress in premature infants contains 24 items: "facial expression", "body color", "breathing", "activity level", "relaxation", "muscle tone". ", "end limbs" and "body posture" consists of 8 subgroups: it is enough for the baby to show only one of the behaviors in each of the items for scoring. If the baby shows both signs (behavior) in Each of the items in the table (for example, both scores 1 and 2 will be the highest score for the action. This scale is designed on a 3-point Likert scale between 0 and 2 points). The maximum is 16 points and the minimum is 0 points. The higher the stress score, the higher the stress level of the baby is evaluated by the researcher.
**Measure:** Infant stress level:
**Time Frame:** The stress level of the baby will be evaluated 5 minutes before the intervention, immediately after the intervention, every 15 minutes during the intervention and 5 minutes after the intervention for a total of one hour for 3 consecutive days.
**Description:** The oxygen saturation levels of the baby will be measured by a monitor that is connected to the baby and shows the level of oxygen saturation. The observation is done by the researcher.
**Measure:** Oxygen saturation measurement:
**Time Frame:** Oxygen saturation of the baby will be measured 5 minutes before the intervention, immediately after the intervention, every 15 minutes during the intervention and 5 minutes after the intervention, for a total of one hour for 3 consecutive days.
**Description:** A stopwatch will be use to determine the respiratory rate in a minute of babies. The evaluation is done by the researcher.
**Measure:** Respiratory rate/minute:
**Time Frame:** The infant's breathing is measured 5 minutes before the intervention, immediately after the intervention, every 15 minutes during the intervention and 5 minutes after the intervention, for a total of one hour for 3 consecutive days.
**Description:** Through a monitor that shows the baby's skin temperature. The temperature is recorded in Celsius in the newborn assessment form. The evaluation is done by the researcher.
**Measure:** Body temperature:
**Time Frame:** The baby's temperature is measured 5 minutes before the intervention, immediately after the intervention, every 15 minutes during the intervention and 5 minutes after the intervention, for a total of one hour for 3 consecutive days.
**Description:** To determine the baby's heart rate, a monitor that is connected to the baby and measures the heart rate/minute will be used. The evaluation is done by the researcher.
**Measure:** Heart rate/minute:
**Time Frame:** The baby's heart rate will be measured 5 minutes before the intervention, immediately after the intervention, every 15 minutes during the intervention and 5 minutes after the intervention, for a total of one hour for 3 consecutive days.
**Description:** A stopwatch will be used to determine the duration of the baby's crying. The evaluation will be done by the researcher. The duration of the baby's crying in seconds will be recorded in the baby's evaluation form
**Measure:** The duration of the baby's crying:
**Time Frame:** The duration of the baby's crying is measured for one hour during the evaluation process. This will be done for 3 consecutive days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* The baby is in the neonatal period (babies between 0 and 28 days),
* Admission to the neonatal intensive care unit has been completed.
* Between 28 and 36 weeks of pregnancy,
* The general situation is stable.
* Not having conditions that prevent pain assessment (intracranial bleeding, neuromotor development delay, etc.),
* The child has not been sedated or sedated in the last 6 hours.
* Baby's breastfeeding should be finished 30 minutes before the intervention. Its weight is more than 1000 grams.
* Apgar score is high,
* Consent of the families to participate in the research
Exclusion Criteria:
Hospitalized for a second time during the data collection process. Lack of literacy in parents
**Healthy Volunteers:** True
**Maximum Age:** 36 Weeks
**Minimum Age:** 28 Weeks
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** shahla shafaati laleh, Master
**Phone:** 00989364357181
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Istanbul
**Contacts:**
***Contact 1:***
- **Name:** Shahla shafaati laleh
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Shahla shafaati laleh
- **Phone:** 00989364357181
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Istanbul - cerrahpasha University
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Turkey , Istanbul University- cerrahpasha
**Name:** shahla shafaati laleh, Master
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007752
- Term: Obstetric Labor, Premature
- 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
### 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: M25869
- Name: Premature Birth
- Relevance: HIGH
- As Found: Premature Newborns
- ID: M10772
- Name: Obstetric Labor, Premature
- Relevance: LOW
- As Found: Unknown
- 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
### Condition Browse Module - Meshes
- ID: D000047928
- Term: Premature Birth
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437093
**Brief Title:** The Effect of Relactation Support Program on Milk Release
**Official Title:** The Effect of Relactation Support Program on Milk Release, Mother-Infant Attachment and Maternity Role
#### Organization Study ID Info
**ID:** emelabdullahyusuf46
#### Organization
**Class:** OTHER
**Full Name:** Inonu University
### Status Module
#### Completion Date
**Date:** 2022-10-22
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-10-20
**Type:** ACTUAL
#### Start Date
**Date:** 2021-10-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-09
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Inonu University
#### Responsible Party
**Investigator Affiliation:** Inonu University
**Investigator Full Name:** Emel GÜÇLÜ CİHAN
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Aim: This study aimed to determine the effect of relactation support program on milk release, mother-infant attachment and maternity role.
Materials and Methods: This single-group pre-test post-test experimental study was conducted with 34 mothers who had 1-4 month old infants, stopped breastfeeding at least 15 days and at most 3 months ago and were registered in the family health centers of a province in the southern Turkey. The relactation support program was completed in 15 days, with eight home visits and seven telephone support sessions. The data were collected using a personal information form, a mother-infant follow-up form, the Maternal Attachment Inventory (MAI) and the Barkin Index of Maternal Functioning (BIMF).
Keywords: Mother-Infant Attachment, Maternity Role, Midwifery, Relactation, Milk Release.
**Detailed Description:** This is a single-group pre-test post-test experimental study. This study was conducted between October 2021 and October 2022 in Family Health Centers (FHCs) in province in southern Turkey. By using the G\*power 3.1 program, the sample size was determined to include 29 mothers/women under 5% margin of error, 95% confidence level, and 95% power of representation.
### Conditions Module
**Conditions:**
- Breast Feeding, Exclusive
- Mother-Child Relations
**Keywords:**
- breast feeding
- connecting
- maternal role
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** This is a single-group pre-test post-test experimental study.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 34
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** In our midwifery intervention, the mother was firstly educated about breastfeeding and relactation, using educational brochures prepared by the researchers. Afterwards, the mother was taught "nipple stimulation", "skin-to-skin contact" and "finger feeding method", and the first feeding of the baby was performed together with the mother. After this first intervention in the FHC, all interventions were performed at home. The follow-ups continued for 15 days with one day of telephone support and one day of home visit. Since the majority of mothers did not accept video calls (privacy, etc.), telephone support was provided only verbally.
**Intervention Names:**
- Other: TEACHING RELACTATION TECHNIQUES
**Label:** single-group pre-test post-test experimental study
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- single-group pre-test post-test experimental study
**Description:** In our midwifery intervention, the mother was firstly educated about breastfeeding and relactation, using educational brochures prepared by the researchers. Afterwards, the mother was taught "nipple stimulation", "skin-to-skin contact" and "finger feeding method", and the first feeding of the baby was performed together with the mother. After this first intervention in the FHC, all interventions were performed at home. The follow-ups continued for 15 days with one day of telephone support and one day of home visit. Since the majority of mothers did not accept video calls (privacy, etc.), telephone support was provided only verbally.
**Name:** TEACHING RELACTATION TECHNIQUES
**Other Names:**
- BREASTFEEDING EDUCATION
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Mother-Infant Follow-Up Form filled out at the first meeting with the participants.This form was prepared by the researchers and includes information about the mothers' breastfeeding issues, breast health problems (cracks, mastitis, etc.), number of daily breastfeeding, number of daily milk release, amount of milk release, baby's weight and presence of sucking problems, which should be followed up during relactation.
**Measure:** Questionnaire
**Time Frame:** First day
**Description:** Maternal Attachment Scale was used for pretest.This 4-point Likert-type scale has a total of 26 items, scoring as "always =4", "often =3", "sometimes =2", and "never =1". The lowest and highest scores on the scale are 26 and 104, respectively. Higher scale scores refer to greater maternal attachment.
**Measure:** Scale 1
**Time Frame:** First day
**Description:** Barkin Index of Maternal Functioning Scale was used for pretest. Index of Maternal Functioning consists of 16 items, scoring as "completely disagree=0", "disagree=1", "partially disagree=2", "undecided=3", "partially agree=4", "agree=5", "completely agree=6". The lowest and highest scores on the scale are 0 and 96, respectively. The scale has five subscales:
* Self-Care (2, 11, 13 items)
* Maternal Psychology (8, 10 items)
* Infant Care (items 12, 14, 15, 16)
* Social Support (items 6, 7, 9)
* Maternal adjustment (items 1, 3, 4, 5).
**Measure:** Scale 2
**Time Frame:** First day
#### Secondary Outcomes
**Description:** Mother-Infant Follow-Up Form was filled out every day for 15 days.Finally, it was filled on the 16th day.
**Measure:** Questionnaire
**Time Frame:** 1-16 days
**Description:** Maternal Attachment Scale was used for posttest.
**Measure:** Scale 1 Scale 1 (Attachment Inventory)
**Time Frame:** 16. day
**Description:** The Barkin Index of Maternal Functioning was used for posttest.
**Measure:** Scale 2
**Time Frame:** 16. day
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
For mothers;
* Having no milk release,
* Using no pharmacological agents that may increase milk release,
* Being not pregnant,
* Having no communication problem,
* Being literate,
* Being between the ages of 18-35 years,
* Having singleton gestation in their last childbirth,
* Using no medication that prevents breastfeeding (chemotherapy, etc.). For babies;
* Being healthy
* Having no congenital sucking problem (cleft palate, cleft lip, etc.)
Exclusion Criteria:
For mothers;
* Using any pharmacologic agent to increase milk release,
* Having a diagnosis of psychiatric illness. For babies;
* Having any metabolic disease that may prevent breastfeeding (galactosemia, phenylketonuria, etc.) or any other chronic disease (advanced heart disease, etc.).
**Gender Based:** True
**Healthy Volunteers:** True
**Maximum Age:** 35 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Malatya
**Country:** Turkey
**Facility:** Inonu Universty
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437080
**Brief Title:** Hypoferritinemia Without Anemia Among Reproductive Age Females
**Official Title:** Hypoferritinemia Without Anemia Among Reproductive Age Females: Frequency, Determinants and Treatment Outcomes
#### Organization Study ID Info
**ID:** 70122031
#### Organization
**Class:** OTHER
**Full Name:** Akram Medical Complex
### Status Module
#### Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-01
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-10-10
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Lahore
**Class:** INDUSTRY
**Name:** Scotmann Pharmaceuticals
**Class:** INDUSTRY
**Name:** The Searle Company Limited Pakistan
#### Lead Sponsor
**Class:** OTHER
**Name:** Akram Medical Complex
#### Responsible Party
**Investigator Affiliation:** Akram Medical Complex
**Investigator Full Name:** Shehla Javed Akram
**Investigator Title:** Chief executive officer (CEO)
**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 randomized controlled trial is to compare the treatment outcomes of oral iron supplementation (Group A) versus Intravenous (IV) iron supplementation (Group B) versus normal diet (no treatment) (Group C) on the serum ferritin level and to determine the outcomes in the severity of symptoms of HWA, among reproductive age females (age 18-45) with hypoferritinemia without Anemia (HWA), after four months of the start of the intervention.
The main questions it aims to answer are:
1. What are the main determinants of HWA?
2. There is no difference/ difference in the treatment outcomes after intervention
3. There is no difference/ difference in the severity of symptoms of HWA after intervention.
Participants will:
* Randomly divided into 3 groups (A, B and C) to receive treatment.
* 100 patients will be allocated to each of the three study groups i.e., group A, B and C. The participants of Group A will get oral Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mg (Fersip) daily for three months, participants of group B will get IV Ferric Carboxymaltose (Ferinject) for 03 months (3 doses) and Group C will remain on their normal diet,
* Visit the clinic once every 1 month for 03 months for doses and assessment of symptoms and adverse events will be done.
* All 03 groups will be called after one month of the last dose and the blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and the severity of symptoms to assess the effectiveness of the intervention.
**Detailed Description:** At present the commonly identified presentation is Iron Deficiency Anemia which currently affects more than 1 billion people while Hypoferritenemia without Anemia (HWA) is at least twice as common. HWA is poorly recognized by clinicians despite its high prevalence, probably because of suboptimal screening recommendations.
HWA: Patients having normal Hemoglobin of ≥12 g/dl and having below normal range ferritin level \< 30ng/ml and patients suffering from any of the following symptoms of
* Fatigue/ tiredness
* Poor work productivity
* Poor attention
* Poor memory
* Sore tongue
* Poor condition of skin, nails or hair, including hair loss.
* Delayed skin wound healing
* Palpitation
* Restless Leg Syndrome
As the symptoms and signs of the HWA are nonspecific which may happen in other systemic diseases or psychiatric disorders so patients with HWA are either recommended no tests or later on end up with expensive tests for heart failure and renal failure on the other end which can be the result of chronic iron deficiency. Clinicians usually advise iron studies when there is documented anemia which results in underdiagnoses of HWA.
In United Kingdom, National Diet and Nutrition Survey (2008/2009-2011/2012) were conducted. The study found that around 15·5 % of women of 19 to 64 years of age had serum ferritin levels \< 15ng/ ml (Adams \& White, 2015). Another National survey conducted in US found that around 11% of the women belonging to 18 to 49 years of age had plasma ferritin levels \< 12ng/ ml.
In another study conducted in Iran 2020, serum ferritin levels were observed among 120 females. The sample was selected from the outpatient department of a medicine clinic. The blood samples of the participants were obtained to have a complete account of their CBC and serum ferritin levels. Results revealed that 41.7% of the patients had severe iron deficiency with low level of serum ferritin values (value \<10ng/ml). Among symptoms of iron deficiency, the most common symptom reported among 79.2% patients was fatigue. Other symptoms include hair loss reported by 73.3%, dizziness reported by 70.0%, headache reported by 65.8%, poor concentration reported by (61.7%), palpitation by (60.0%), chest pain by (55.8%) and legs pain by (47.5%) of the participants. Among females of younger age group (less than 25 years), lower levels of serum ferritin were associated with heavy menstrual bleeding. Whereas, among females of older age group (above 25 years of age) poor nutrition reported to be a significant risk factor of low serum ferritin values. In conclusion, the study addressed low serum ferritin without anemia as a concealed disease that should be addressed by considering its treatment and diagnosis because patients with normal hemoglobin levels can develop iron deficiency anemia within days after diagnosis.
To the best of researcher's knowledge, no study related to HWA has been conducted in Pakistan; therefore, the prevalence of Iron Deficiency Anemia (IDA) in Pakistan has been added in the present literature review. Results show that a total of 45% of population is suffering from IDA in Pakistan.
The rationale of this study is to highlight the struggling issue of HWA which is battling to be recognized as one of the factors contributing to the symptoms indicated above, as was previously stated. This study is important to be conducted as it will not only pave ways to recognize the category of HWA but will also help patients to receive targeted treatment and saving them from the risk of drug abuse and over-medication. As per the researcher's knowledge, there is a scarcity of data on Pakistan's population as no study exists on HWA in Pakistan.
Above literature review clearly reflects that there is a wide gap regarding some aspects of HWA. First, it is an underdiagnosed entity as it has nonspecific symptoms which can be found in other diseases. Although there are estimates of disease burden, but exact value is not known especially in developing countries. Secondly, there is a lot of data regarding causes of iron deficiency but paucity exists regarding determinants/causes of HWA. Thirdly, there is contrary data regarding management, few investigators believe that oral iron therapy shall be the first line therapy while other believes that intravenous (IV) therapy shall be given first to reduce symptoms.
OBJECTIVES
1. To determine the frequency and Determinants of HWA among women of reproductive age
2. To compare the treatment outcomes of oral iron supplementation (Group 1) versus Intravenous (IV) iron supplementation (Group 2) versus normal diet (Group 3) on the serum ferritin level after four months of start of intervention
3. To determine the outcomes in the severity of symptoms of HWA after four months of start of intervention
DETERMINANTS OF HWA
* Heavy menstrual bleeding
* Blood donation history
* Blood transfusion history
* Dietary intake
* Number of pregnancies
* Current status of lactation
* Family history of Anemia
* History of blood diseases
* Medication history of vitamins, minerals, or any other supplementation
* History of Drugs intake
* Disturbed Thyroid level and Blood Sugar levels
* Various co-morbidities or clinical conditions including, celiac disease, hemorrhoids, malignancies, hematuria, heart disease, renal failure, chronic gastric symptoms/ gastric ulcers, delayed wound healing and chronic liver disease
* The Symptom Severity Scale is a self-administered questionnaire that has been adapted from Spies-Derglo et al., to assess the severity of symptoms in patients.
DATA COLLECTION TOOL
For data collection, a structured close-ended questionnaire will be used. The developed questionnaire has six sections.
1. The first section consists of 5 qualifying question asking about age, premature menopause, blood transfusion history, supplementation history and history of any symptom of HWA (Defined above).
2. The second section will record the socio-demographic characteristics of the participants including, education, monthly family income, region of residence, religion, working status, marital status and the number of children and the utilization of antenatal care if ever pregnant.
3. The third section will be used to record the determinants leading to low serum ferritin levels including blood donation history, current lactation and pregnancy status, number of pregnancies, family history of Anemia, Menorrhagia; heavy menstrual bleeding, blood diseases, history of intake of medication other than supplements and vitamins, history of co-morbidities, and frequency of meals per day. The dietary score will also be measured using an individual DDS questionnaire. The score of DDS will be then recoded into different categories (≤ 3 as low, 4-5 as moderate, and ≥ 6 as high dietary diversity) according to the "Guidelines for measuring household and Individual Dietary Diversity".
4. The fourth section will record the serum ferritin, CBC, thyroid and blood sugar levels of the participants determined through lab tests. Participants having Vitamin B12 deficiency, Folic Acid deficiency, serum ferritin values \>10ng/mL, disturbed thyroid and blood sugar levels, any chronic conditions will not be included in RCT.
5. Fifth section will inquire about the severity of clinical symptoms of participants at Visit 1 using a symptom severity scale to record baseline data.
6. The last section will be used to record the occurrence of adverse events followed by the administration of supplementation dosage to the participants of group A and B at visits 2, 3, 4, and 5, Serum ferritin value at visit 5 and the incidence and severity of clinical symptoms of HWA among patients at visit 5. Last question in section six will enquire about the subjective knowledge of participants regarding improvement in their symptoms before and after the intervention.
DATA COLLECTION PROCESS Cross-Sectional Study Study participants will be selected from four hospitals of Lahore through simple random sampling technique. Patients will be enrolled after meeting inclusion and exclusion criteria and filling of questionnaire during face to face interviews. At the end of each interview, the blood sample will be taken. Their blood will be tested for CBC and serum ferritin values at the end of the face to face interview. Informed written consent will be taken from each respondent before the start of the interview.
Randomized Control Trial (RCT)
* Females having normal CBC, hemoglobin level above 12mg/dl and serum ferritin level below 30 ng/ml and normal thyroid and blood sugar levels will be selected for the intervention.
* Females will be randomly assigned to three study groups.
* After randomization, 100 patients will be allocated to each of the three study groups i.e., group A, B and C. The participants of Group A will get oral Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mg (Fersip) daily for three months, participants of group B will get IV Ferric Carboxymaltose (Ferinject) for 03 months (3 doses) and Group C will remain on their normal diet,
* Assessment of symptoms and adverse event will be done
* All 03 groups will be called and their blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and severity of symptoms to assess the effectiveness of the intervention.
### Conditions Module
**Conditions:**
- Hypoferritenemia Without Anemia (HWA)
- Iron Deficiency Without Anemia)
**Keywords:**
- Hypoferritenemia without Anemia (HWA)
- Reproductive age females
- Symptoms of HWA
- Determinants of HWA
- Low serum ferritin levels, Iron deficiency
- Cross-sectional study (Phase 1)
- Randomized controlled trial (Phase 2)
- Transferrin saturation (TSAT)
- Intervention
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** After randomization, 100 patients will be allocated to each of the three study groups, (total participants selected 300) i.e., group A, B and C.
The participants of Group A will get oral Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mg (Fersip) daily for three months, participants of group B will get IV Ferric Carboxymaltose (Ferinject) for 03 months (3 doses) and Group C will remain on their normal diet
All 03 groups will be called and their blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and severity of symptoms to assess the effectiveness of the intervention.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 1331
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 100 participants of Group A will get oral iron supplementation (Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron), 100 mg for 03 months. Participants will consume 01 tablet per day for 03 months.
After completion of the treatment period blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and severity of symptoms to assess the effectiveness of the intervention.
**Intervention Names:**
- Drug: Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mg
**Label:** Oral iron supplement
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** 100 participants of Group B will get IV iron supplementation (Ferric Carboxymaltose) for 03 months (01 dose per month for 03 months).
After completion of the treatment period blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and severity of symptoms to assess the effectiveness of the intervention.
**Intervention Names:**
- Drug: Ferric Carboxymaltose
**Label:** Intravenous (IV) iron supplementation
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** 100 participants will remain on their normal diet for 03 months. After 03 months blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and severity of symptoms to assess the effectiveness of the intervention.
**Label:** Normal diet
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Oral iron supplement
**Description:** 01 tablet daily for 03 months, This is assigned to Group A.
**Name:** Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mg
**Other Names:**
- Fersip
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Intravenous (IV) iron supplementation
**Description:** 03 doses (50 mg iron/mL) per month for 03 months. This is assigned to Group B.
**Name:** Ferric Carboxymaltose
**Other Names:**
- Ferinject
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Symptom severity score before intervention: This questionnaire contains eight questions with multiple-choice responses, with a score ranging from 0 point (not at all), 1 point (mild symptoms/ rarely), 2 points (moderate/ sometimes) and 3 points (severe/ frequently). The total symptom severity score will be calculated as the mean of the scores for the eight individual items and will be recorded at week 1
**Measure:** Symptom severity scale
**Time Frame:** Week 1 (Baseline)
**Description:** A questionnaire will be use to access the determinants. The questions included are blood donation history, vitamin supplementation drug, medication history, total preganacies, currently pregnant or lactating, heavy menstural bleeding, number of days of menstural bleeding and pads changed, frequency of stools per day, family history of anemia, frequency of meals per day and meal skipping
**Measure:** Determinants of Serum Ferritin value
**Time Frame:** Week 1 (Baseline)
**Description:** The characteristics that will be surveyed at level of education, region, religion, income, marital status, number of children, antenatal care and working status
**Measure:** Socio demographic characteristics of participants
**Time Frame:** Week 1 (Baseline)
**Description:** For pattern of diet intake: History regarding daily meal frequency and skipping meals and 24 hour recall dietary of an individual will be surveyed: The score of all food groups will then be computed to get the final DDS. DDS of ≤3 will be considered low, 4-5 will be considered as moderate and ≥6 will be considered as a high DDS.
**Measure:** Dietary Diversity questionnaire
**Time Frame:** Week 1 (Baseline)
**Description:** Serum ferritin levels before intervention
**Measure:** Serum ferritin levels
**Time Frame:** Week 1 (Baseline)
**Description:** Complete blood count (CBC)
**Measure:** Hemoglobin levels
**Time Frame:** week 1 (Baseline)
**Description:** Thyroid functions
**Measure:** Thyroid-stimulating hormone (TSH)
**Time Frame:** Week 2
**Description:** blood sugar levels
**Measure:** Random blood sugar
**Time Frame:** Week 2
#### Secondary Outcomes
**Description:** Defined as participants self-reported adverse effects. Items that will be surveyed are nausea, vomiting, diarhhea, fever and others.
**Measure:** Adverse events
**Time Frame:** Week 6, 10, 16
**Description:** Change in symptoms severity score after intervention: This questionnaire contains eight questions with multiple-choice responses, with a score ranging from 0 point (not at all), 1 point (mild symptoms/ rarely), 2 points (moderate/ sometimes) and 3 points (severe/ frequently). The total symptom severity score will be calculated as the mean of the scores for the eight individual items and will be recorded at week 6, 10, 16
**Measure:** Symptom severity scale
**Time Frame:** Week 6, 10, 16
**Description:** Change in serum ferritin levels as the result 90 tablets for 03 months (01 tablet everyday for 03 months)
**Measure:** Change in serum ferritin levels as result of oral intervention: Fersip
**Time Frame:** Week 16
**Description:** Change in serum ferritin levels as the result of 03 doses (500 mg) per month for 03 months. The change will be measured through serum ferritin blood test results.
**Measure:** Change in serum ferritin levels as result of intravenous (IV) iron intervention: Ferinject
**Time Frame:** Week 16
**Description:** Comparison of treatment outcomes of oral and IV iron supplementation and normal diet: The treatment outcomes will be measured through serum ferritin test as a comparison between 03 arms. Adverse events will also be compared. Items that will be surveyed for adverse events are are nausea, vomiting, diarrhea, fever and others
**Measure:** Comparison of treatment outcomes of groups (A, B and C)
**Time Frame:** Week 16
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Reproductive age females: 18 to 45 years
* Clinical symptoms of iron deficiency which are fatigue/ tiredness, poor work productivity, poor attention and memory loss, sore tongue, poor condition of skin, nails or hair, including hair loss, delayed skin wound healing, palpitation and restless leg syndrome
* Normal CBC: hemoglobin level12mg/dl and above
* Serum ferritin levels: below 30 ng/ml
* Normal thyroid levels
* Normal blood sugar levels
* Willing and able to sign informed consent
Exclusion Criteria:
* Males
* Post-menopausal
* Premature menopause
* Anemic Females: hemoglobin levels i.e. less than 12 g/dl
* Serum ferritin level above 30 ng/ml.
* Disturbed thyroid levels
* Disturbed blood sugar levels
* Pregnant
* Lactating
* Blood donors
* Co-morbidities i.e., celiac disease, hemorrhoids, malignancies, hematuria, ulcers, heart failure, renal failure, chronic gastric symptoms/ gastric ulcers, chronic liver disease, disturbed thyroid levels and diabetes
* Any medication or supplement which may impact iron metabolism.
* History of iron or multivitamins supplementation in the last 3 months
**Gender Based:** True
**Gender Description:** Females of reproductive age
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Lahore
**Country:** Pakistan
**Facility:** Fatima Memorial Hospital
**State:** Punjab
**Zip:** 54782
**Location 2:**
**City:** Lahore
**Country:** Pakistan
**Facility:** General Hospital Lahore
**State:** Punjab
**Zip:** 54782
**Location 3:**
**City:** Lahore
**Country:** Pakistan
**Facility:** Gulab Devi Hospital
**State:** Punjab
**Zip:** 54782
**Location 4:**
**City:** Lahore
**Country:** Pakistan
**Facility:** Sir Gangaram Hospital
**State:** Punjab
**Zip:** 54782
#### Overall Officials
**Official 1:**
**Affiliation:** The univeristy of Lahore
**Name:** Dr. Abdul Majeed Akhtar, MBBS, PhD
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** University of Punjab
**Name:** Dr. Rubeena Zakir, MBBS, PhD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Abuaisha M, Itani H, El Masri R, Antoun J. Prevalence of Iron Deficiency (ID) without anemia in the general population presenting to primary care clinics: a cross-sectional study. Postgrad Med. 2020 Apr;132(3):282-287. doi: 10.1080/00325481.2020.1715701. Epub 2020 Jan 22.
**PMID:** 31933400
**Citation:** Adams J, White M. Characterisation of UK diets according to degree of food processing and associations with socio-demographics and obesity: cross-sectional analysis of UK National Diet and Nutrition Survey (2008-12). Int J Behav Nutr Phys Act. 2015 Dec 18;12:160. doi: 10.1186/s12966-015-0317-y.
**PMID:** 26684833
**Citation:** Al-Jafar HA. HWA: Hypoferritinemia without anemia a hidden hematology disorder. J Family Med Prim Care. 2017 Jan-Mar;6(1):69-72. doi: 10.4103/2249-4863.214986.
**PMID:** 29026752
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000019189
- Term: Iron Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000000747
- Term: Anemia, Hypochromic
### Condition Browse Module - Browse Branches
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M20857
- Name: Anemia, Iron-Deficiency
- Relevance: HIGH
- As Found: Iron Deficiency
- ID: M2781
- Name: Iron Deficiencies
- Relevance: HIGH
- As Found: Iron Deficiency
- ID: M4070
- Name: Anemia
- Relevance: HIGH
- As Found: Anemia
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21177
- Name: Iron Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4077
- Name: Anemia, Hypochromic
- Relevance: LOW
- As Found: Unknown
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000740
- Term: Anemia
- ID: D000018798
- Term: Anemia, Iron-Deficiency
- ID: D000090463
- Term: Iron Deficiencies
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Mi
- Name: Mineral
### Intervention Browse Module - Browse Leaves
- ID: M10533
- Name: Iron
- Relevance: LOW
- As Found: Unknown
- ID: T341
- Name: Iron Supplement
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437067
**Brief Title:** Study on Prognosis of Acute-on-chronic Liver Failure Complicated by Bacterial or Fungal Infection
**Official Title:** A Real-world Study on the Long-term Prognosis of Acute-on-chronic Liver Failure
#### Organization Study ID Info
**ID:** ACLF-I
#### Organization
**Class:** OTHER
**Full Name:** Tongji Hospital
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Qin Ning
#### Responsible Party
**Investigator Affiliation:** Tongji Hospital
**Investigator Full Name:** Qin Ning
**Investigator Title:** Professor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The subjects of this study were inpatients with ACLF who were admitted to Tongji Hospital in Wuhan from March 2023 to June 2025. After patients were enrolled, The patient's general information (gender, age, past medical history, etc.), complications (ascites, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding, etc.), laboratory tests (CRP, PCT, INR, WBC, fungal/bacterial diagnostic tests, etc.), symptoms and signs at the time of infection, and at admission (D1), D4, D7, D14, D21, etc.) were recorded Save the blood separately. The patients were divided into fungal infection group, bacterial infection group and non-infection group according to the infection status after admission.
### Conditions Module
**Conditions:**
- Acute-On-Chronic Liver Failure
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 400
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** patients without bacterial or fungal infection
**Label:** non-infection group
#### Arm Group 2
**Description:** patients with bacterial infection
**Label:** bacterial infection group
#### Arm Group 3
**Description:** patients with fungal infection
**Label:** fungal infection group
### Outcomes Module
#### Primary Outcomes
**Description:** incidence rate of bacterial or fungal infection
**Measure:** incidence rate of bacterial or fungal infection
**Time Frame:** 28 days and 90 days
**Description:** mortality rate of bacterial or fungal infection
**Measure:** mortality rate of bacterial or fungal infection
**Time Frame:** 28 days and 90 days
#### Secondary Outcomes
**Description:** incidence rate of complications
**Measure:** incidence rate of complications
**Time Frame:** 28 days and 90 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. TBIL ≥ 12 mg/mL and INR ≥ 1.5
2. Chronic hepatitis B
Exclusion Criteria:
(1) \<18 or \>80 years old; (2) primary hepatic or extrahepatic carcinoma; (3) with severe diseases of other organs or systems; (4) pregnancy; (5) imcomplete information
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Inpatients with ACLF admitted to Tongji Hospital in Wuhan from March 2023 to June 2025.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Tao Chen, Professor
**Phone:** +8618971419301
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Wuhan
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Qin Ning, PHD,MD
- **Phone:** +8602783662391
- **Role:** CONTACT
***Contact 2:***
- **Name:** Qin Ning, PHD,MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Tao Chen, PHD,MD
- **Role:** SUB_INVESTIGATOR
**Country:** China
**Facility:** Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
**State:** Hubei
**Status:** RECRUITING
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000008107
- Term: Liver Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000017114
- Term: Liver Failure, Acute
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19415
- Name: Liver Failure
- Relevance: HIGH
- As Found: Liver Failure
- ID: M25970
- Name: Hepatic Insufficiency
- Relevance: HIGH
- As Found: Liver Failure
- ID: M29168
- Name: End Stage Liver Disease
- Relevance: HIGH
- As Found: Chronic Liver Failure
- ID: M30498
- Name: Acute-On-Chronic Liver Failure
- Relevance: HIGH
- As Found: Acute on Chronic Liver Failure
- ID: M12136
- Name: Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M11107
- Name: Liver Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19431
- Name: Liver Failure, Acute
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000017093
- Term: Liver Failure
- ID: D000048550
- Term: Hepatic Insufficiency
- ID: D000058625
- Term: End Stage Liver Disease
- ID: D000065290
- Term: Acute-On-Chronic Liver Failure
### 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: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437054
**Brief Title:** Verification of the Efficacy/Safety of the Mixed Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss
**Official Title:** Verification of the Efficacy/Safety of the Mixed Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss (Pilot Study)
#### Organization Study ID Info
**ID:** ITV-2309-098-1469
#### Organization
**Class:** OTHER
**Full Name:** Seoul National University Hospital
### Status Module
#### Completion Date
**Date:** 2028-09-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-02-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2025-02-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Seoul National University Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study is a prospective, randomized pilot study. To verify an efficacy/safety of the mixed drug injectable delivery vehicle for treating intractable hearing loss. Hearing test, endoscopy of tympanic membrane and CT scans will be conducted after intratympanic treatment for evaluation.
**Detailed Description:** The goal of this clinical trial (pilot study) is to evaluate the Efficacy and Safety of Combined Hyaluronic Acid and Dexamethasone Treatment in Patients with Hearing Loss. The main questions it aims to answer are: • Q1. Verification of safety, • Q2. Therapeutic effect of drug injection on sensorineural hearing loss. Participants will undergo several assessment tests (Verification of adverse effects in the external and middle ear through endoscopy, Confirmation of adverse effects through imaging, Hearing test to check for additional hearing loss, Check if subjective ear fullness persists for more than a week aside from the drug effect). If there is a comparison group: Researchers will compare dexamethasone and hyaluronic acid to verify hearing improvement and safety.
### Conditions Module
**Conditions:**
- Hearing Loss, Sensorineural
- Hearing Loss, Sudden
- Intratympanic Injection
**Keywords:**
- drug delivery
- Dexamethasone
- Hyaluronic acid
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 26
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The experimental group received a single injection of Dexamethasone (5mg/ml) and Saline (D+Saline) mixed in a 1:1 ratio (with a possibility of a second injection if necessary). Additionally, two drops of Indocyanine Green (ICG: 25mg) were added, approximately 100μl (2.5mg/ml).
**Intervention Names:**
- Drug: Dexamethasone
- Other: Indocyanine green(ICG)
**Label:** Dexamethasone+Saline+ICG
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** The experimental group received a single injection of Dexamethasone (5mg/ml) and Hyaluronic acid (D+HA) mixed in a 1:1 ratio (with a possibility of a second injection if necessary). Additionally, two drops of Indocyanine Green (ICG: 25mg) were added, approximately 100μl (2.5mg/ml).
**Intervention Names:**
- Drug: Dexamethasone
- Drug: Hyaluronic acid
- Other: Indocyanine green(ICG)
**Label:** Dexamethasone+Hyaluronic Acid+ICG
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dexamethasone+Hyaluronic Acid+ICG
- Dexamethasone+Saline+ICG
**Description:** Dexamethasone 5mg/ml
**Name:** Dexamethasone
**Other Names:**
- Dexamethasone Inj (Dexamethasone disodium phosphate 5㎎) [Daewon Pharm]
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Dexamethasone+Hyaluronic Acid+ICG
**Description:** Hyaluronic Acid 20mg/2ml
**Name:** Hyaluronic acid
**Other Names:**
- Hyruan Plus Inj (Sodium Hyaluronate 10.0mg) [LG Chem]
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Dexamethasone+Hyaluronic Acid+ICG
- Dexamethasone+Saline+ICG
**Description:** ICG 25mg
**Name:** Indocyanine green(ICG)
**Other Names:**
- Cellbiongreen Inj (IndocyanineGreen 25mg) [Cellbion]
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Confirming healing time of perforation and inflammation (Safety)
**Measure:** Analysis of Side Effect Rate through tympanic membrane endoscopy Imaging in 26 participants
**Time Frame:** 0, 1day and 1 week after intratympanic injection
**Description:** Checking a time duration of drug in middle and inner ear (Durability)
**Measure:** Analysis of Drug Duration through CT Imaging in 26 participants
**Time Frame:** 0, 1day and 1 week after intratympanic injection
**Description:** Verifying therapeutic effect of intratympanic drug delivery vehicle (Efficacy)
**Measure:** Comparison of Auditory Threshold Values Between Two Groups to Confirm Treatment Efficacy in 26 participants
**Time Frame:** 0, 1day, 1 week and/or 1 month after intratympanic injection
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with sudden hearing loss, Meniere's disease, ototoxic hearing loss, and noise-induced hearing loss of 25dB HL at the frequency at which hearing loss occurs as a result of pure tone hearing test
* Patients whose original hearing ability has not been restored with existing standard treatment (oral, intravenous steroids)
* Those who have not participated in clinical trials within 3 months are selected as subjects
Exclusion Criteria:
* Pregnant or lactating women
* When accompanied by lesion, infection, or anatomical deformity of the outer ear, middle ear, or inner ear
* Those with liver disease or metabolic disease or a history thereof
* History of hypersensitivity to indocyanine green or iodine hypersensitivity
* History of ear surgery
* Cases with posterior labyrinth lesions
* Patients with a history of hypersensitivity to the ingredients of this drug
* In addition, serious diseases such as end-stage renal disease, end-stage liver disease, cardiovascular surgery, progressive brain tumor, progressive hemorrhage, and progressive cerebral hemorrhage are included Cases with brain disease and cancer are excluded from the study
**Minimum Age:** 19 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006311
- Term: Hearing Disorders
- ID: D000004427
- Term: Ear Diseases
- ID: D000010038
- Term: Otorhinolaryngologic Diseases
- ID: D000012678
- Term: Sensation Disorders
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M24420
- Name: Hearing Loss
- Relevance: HIGH
- As Found: Hearing Loss
- ID: M6840
- Name: Deafness
- Relevance: HIGH
- As Found: Hearing Loss
- ID: M9407
- Name: Hearing Loss, Sensorineural
- Relevance: HIGH
- As Found: Hearing Loss, Sensorineural
- ID: M6841
- Name: Hearing Loss, Sudden
- Relevance: HIGH
- As Found: Hearing Loss, Sudden
- ID: M9400
- Name: Hearing Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7601
- Name: Ear Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12961
- Name: Otorhinolaryngologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15490
- Name: Sensation Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000034381
- Term: Hearing Loss
- ID: D000003638
- Term: Deafness
- ID: D000006319
- Term: Hearing Loss, Sensorineural
- ID: D000003639
- Term: Hearing Loss, Sudden
### Intervention Browse Module - Ancestors
- ID: D000000893
- Term: Anti-Inflammatory Agents
- ID: D000000932
- Term: Antiemetics
- ID: D000001337
- Term: Autonomic Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- 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: D000011480
- Term: Protease Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000276
- Term: Adjuvants, Immunologic
- ID: D000007155
- Term: Immunologic Factors
- ID: D000055675
- Term: Viscosupplements
- ID: D000020011
- Term: Protective Agents
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: Infe
- Name: Anti-Infective Agents
### Intervention Browse Module - Browse Leaves
- ID: M9878
- Name: Hyaluronic Acid
- Relevance: HIGH
- As Found: Users
- ID: M7102
- Name: Dexamethasone
- Relevance: HIGH
- As Found: Children
- ID: M235549
- Name: Dexamethasone acetate
- Relevance: HIGH
- As Found: Children
- ID: M199152
- Name: BB 1101
- Relevance: HIGH
- As Found: Children
- 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: M19609
- Name: HIV Protease Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M14343
- Name: Protease Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M3628
- Name: Adjuvants, Immunologic
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
- ID: M28295
- Name: Viscosupplements
- Relevance: LOW
- As Found: Unknown
- ID: M21869
- Name: Protective Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000003907
- Term: Dexamethasone
- ID: C000018038
- Term: Dexamethasone acetate
- ID: C000101468
- Term: BB 1101
- ID: D000006820
- Term: Hyaluronic Acid
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437041
**Brief Title:** Effect of Antibiotic Pretreatment on the Efficacy of WMT in the Treatment of Irritable Bowel Syndrome
**Official Title:** Effect of Antibiotic Pretreatment on the Efficacy of WMT in the Treatment of Irritable Bowel Syndrome in Adults: a Multi-center, Randomized, Placebo-controlledClinical Study
#### Organization Study ID Info
**ID:** WMT-ABx-IBS-202405
#### Organization
**Class:** OTHER
**Full Name:** The Second Hospital of Nanjing Medical University
### Status Module
#### Completion Date
**Date:** 2030-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2029-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Faming Zhang
#### Responsible Party
**Investigator Affiliation:** The Second Hospital of Nanjing Medical University
**Investigator Full Name:** Faming Zhang
**Investigator Title:** Professor, Gastroenterology
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This is a randomized controlled trial to explore the efficacy of antibiotic pretreatment on the efficacy of WMT in the treatment of Irritable bowel syndrome in adults: a multi-center, randomized, placebo-controlled clinical study
**Detailed Description:** All included in the standard but do not accord with standard of any rule out subjects will be included in this study. Demographic characteristics, Gastrointestinal Symptoms Rating Scales（GSRS），IBS Symptom Severity Scaleand(IBS-SSS) 、Pittsburgh Sleep Quality Index（PSQI）、Self-rating Anxiety Scale（SAS）、Self-rating Depression Scale（SDS）and clinical outcomes will be collected. After the treatment, the efficacy and safety will be evaluated during the follow-up period.
### Conditions Module
**Conditions:**
- Irritable Bowel Syndrome
**Keywords:**
- Irritable bowel syndrome
- washed microbiota transplantation
- antibiotic pretreatment
- randomized controlled trial
- transendoscopic enteral tube
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 96
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients will receive three enemas of ornidazole 0.5g+50ml saline through the TET tube, followed by WMT once daily for a duration of 3 days.
**Intervention Names:**
- Drug: Ornidazole
**Label:** Treatment
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients will receive three enemas of a placebo of equal volume through the TET tube, followed by WMT once daily for a duration of 3 days.
**Intervention Names:**
- Drug: Placebo
**Label:** Control
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment
**Description:** Patients will receive three consecutive enemas of ornidazole 0.5g+50ml saline through the TET tube, followed by WMT treatment once daily for a duration of 3 days.
**Name:** Ornidazole
**Other Names:**
- washed microbiota transplantation
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Control
**Description:** Patients will receive three consecutive enemas of placebo of equal volume through the TET tube, followed by WMT treatment once daily for a duration of 3 days
**Name:** Placebo
**Other Names:**
- washed microbiota transplantation
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Gastrointestinal Symptom Rating Scale (GSRS) included 5 items: abdominal pain (3 items), reflux (2 items), dyspepsia (4 items), diarrhea (3 items) and constipation (3 items). The severity of each symptom was assessed using a 4-point Likert scale, with a score of 0 indicating no symptoms and a score of 3 indicating very severe symptoms.
**Measure:** Gastrointestinal Symptoms Rating Scales（GSRS）
**Time Frame:** One-week, Four-week and Eight-week post-WMT
**Description:** IBS symptom severity scale (IBS-SSS) consists of five items, which assess the severity of abdominal pain, the frequency of abdominal pain, the degree of abdominal distention and discomfort, the satisfaction of bowel habit and behavior, and the impact of intestinal symptoms on life. Each item was divided into 5 levels, increasing by 20 points, and the total score was 500 points. A score of 75 to 175 is mild, 176 to 300 is moderate, and more than 300 is severe.
**Measure:** IBS Symptom Severity Scaleand(IBS-SSS)
**Time Frame:** One-week, Four-week and Eight-week post-WMT
#### Secondary Outcomes
**Description:** PSQI was used to assess the sleep quality of the subjects in the last month. It consisted of 19 self-rated items and 5 patient-rated items.
**Measure:** Pittsburgh Sleep Quality Index（PSQI）
**Time Frame:** One-week, Four-week and Eight-week post-WMT
**Description:** Self-rating anxiety Scale (SAS) is a self-rating scale used to evaluate the subjective feelings of patients with anxiety. It contains 20 items and is divided into 4 grades.
**Measure:** Self-rating Anxiety Scale（SAS）
**Time Frame:** One-week, Four-week and Eight-week post-WMT
**Description:** Self-rating Depression Scale,SDS is a self-rating scale that measures subjective feelings of depression. It contains 20 items and is scored on a 4-point scale.
**Measure:** Self-rating Depression Scale（SDS）
**Time Frame:** One-week, Four-week and Eight-week post-WMT
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Voluntarily signed the informed consent, age 18 years old or more, men and women all can;
2. According to the Roman IV standard diagnosis of IBS: recurrent abdominal pain or discomfort, weekly attacks within the past 3 months at least 3 d, accompanied by the following two and two or more:
(1) associated with defecation; (2) changes in defecation frequency; (3) changes in stool characteristics (appearance).
The following symptoms were not included in the diagnostic criteria but supported the diagnosis: (1) abnormal bowel frequency: bowel movements less than 3 times per week or more than 3 times per day; (2) the excrement characters and abnormal: dry bulb dung or hard dung, or paste dung/dilute waste water; (3) bowel effort; (4) Defecation urgency, endless defecation, mucus excretion and abdominal distension.
Diagnostic considerations: (1) Diagnosis should be based on the exclusion of organic diseases; (2) the intestinal symptoms of irritable bowel syndrome has certain characteristics, such as abdominal pain or discomfort with bowel movements, this group of symptoms is different from the other functional bowel disease, such as functional constipation, functional diarrhea, functional abdominal pain). (3) Irritable bowel syndrome often coexists with other functional gastrointestinal disorders.
3. The subjects or their legal representatives gave informed consent, fully understood the purpose of the study, were able to communicate well with the researchers, and understood and complied with the requirements of the study.
Exclusion Criteria:
* Subjects meeting any of the following exclusion criteria must be excluded from the study:
1. The patient was accompanied by other mental disorders besides anxiety and depression.
2. Combined with the results of colonoscopy within the past 24 months, the patient has an organic lesion of the digestive tract (e.g., tumor, inflammation, anal fissure, Crohn's disease, ulcerative colitis, intestinal adhesion, intestinal tuberculosis, etc.).
3. Has a history of major surgery within 3 months or a history of severetrauma, and recovery is not completely;
6. There are contraindications to colonic transendoscopic intestinal tubeimplantation, such as severe intestinal stenosis, obstruction, deep ulcer,and high risk of operation perforation; Severe ulcers or a large numberof pseudopolyps exist in the fixed area of titanium clips, which are notsuitable for fixation. The subjects' behavior was seriously uncontrolled.
7. Any of the following abnormalities in cardiac function and performance:a. According to the New York Heart Association (NYHA) cardiacfunction classification, cardiac function grade # or above;b. new onset myocardial infarction or unstable angina pectoriswithin 6 months;c. ECG showed QTc prolongation (QTc≥ 450ms in men and≥470ms in women);d. Drug-refractory atrial arrhythmias and drug-refractory ventriculararrhythmias (including grade 2 or higher atrioventricular block).
8. Patients with poor lung function that is considered by the investigatorto have an impact on the study treatment, such as patients with acuteexacerbation of COPD or patients requiring long-term use of oral orintravenous steroids for control (except inhalers/sprays); 9. No control autoimmune disease and/or need long-term use of hormone(except local external use sex); 10. Patients with metabolic diseases and poorly controlled by drugs(such as thyroid dysfunction), or patients with metabolic diseases accompanied by gastrointestinal function complications (such as gastrointestinal autonomic nerve dysfunction, diabetic gastroparesis,etc.) 11. Suffering from reproductive system diseases (including but not limited toovarian cysts, endometriosis, primary dysmenorrhea, etc.) that may lead to abdominal pain; 12. Significant laboratory abnormalities that, in the judgment of theinvestigator, may affect the safety of the subjects or the completion ofthe clinical study, including:A) the hemoglobin \< 100 g/L; B) Serum creatinine ≥1.5 times theupper limit of normal (ULN) C) abnormal liver function, defined asAST\>1.5×ULN and/or ALT\>1.5×ULN and/or total bilirubin \>1.5×ULN;D) blood clotting function: PLT acuities were 80 x 109 / L, APTT \> 1.5 xULN, PT \> 1.5 x ULN, INR \> 1.5 x ULN; E) abnormal results or defecateoccult blood stool and has prompted the clinical significance of thegastrointestinal tract.
13. Have active hepatitis (requiring or taking long-term treatment), HIV, oractive tuberculosis; 14. A history of drug or alcohol abuse (i.e., drinking more than 14 servings per week of beer, 45 mL of 40% spirits, or 150 mL of wine) or substance abuse; 15. The known allergic to research similar drugs, drugs or accessories; 16. Use of anti-infective drugs (antibiotics, antifungal, antiviral) within 14days before enrollment, or need anti-infective treatment at enrollmentevaluation; 17. Drugs and supplements that affect gastrointestinal motility and functioncannot be stopped during the study, including but not limited to:antibiotics such as erythromycin; Drugs that modulate the intestinal microecology, such as probiotics such as Bifidobacterium; Theparasympathetic nerve inhibitors, some scopolamine and atropine,belladonna, etc; Muscle relaxants, such as succinylcholine; Opioid preparations; Drugs thatinhibit gastric acid secretion; 18. Pregnant or lactating women, or refusing to use an effectivecontraceptive method within 3 months after the last dose of treatment; 19. 3 months prior to dosing involved in drug interventional clinical trials; 20. Suffering from malignant tumors;21. There were other circumstances that the investigator consideredinappropriate for participatin
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Faming Zhang, PhD
**Phone:** 086-025-58509883
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Bota Cui
**Phone:** 086-025-58509884
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Nanjing
**Country:** China
**Facility:** Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
**State:** Jiangsu
**Zip:** 210011
#### Overall Officials
**Official 1:**
**Affiliation:** The Second Hospital of Nanjing Medical University
**Name:** Faming Zhang, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Singh P, Alm EJ, Kelley JM, Cheng V, Smith M, Kassam Z, Nee J, Iturrino J, Lembo A. Effect of antibiotic pretreatment on bacterial engraftment after Fecal Microbiota Transplant (FMT) in IBS-D. Gut Microbes. 2022 Jan-Dec;14(1):2020067. doi: 10.1080/19490976.2021.2020067.
**PMID:** 35014601
**Citation:** Xu J, Xu H, Guo X, Zhao H, Wang J, Li J, He J, Huang H, Huang C, Zhao C, Li Y, Zhou Y, Peng Y, Nie Y. Pretreatment with an antibiotics cocktail enhances the protective effect of probiotics by regulating SCFA metabolism and Th1/Th2/Th17 cell immune responses. BMC Microbiol. 2024 Mar 18;24(1):91. doi: 10.1186/s12866-024-03251-2.
**PMID:** 38500062
**Citation:** Keshteli AH, Millan B, Madsen KL. Pretreatment with antibiotics may enhance the efficacy of fecal microbiota transplantation in ulcerative colitis: a meta-analysis. Mucosal Immunol. 2017 Mar;10(2):565-566. doi: 10.1038/mi.2016.123. Epub 2016 Dec 21. No abstract available.
**PMID:** 28000680
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000003109
- Term: Colonic Diseases, Functional
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M25118
- Name: Irritable Bowel Syndrome
- Relevance: HIGH
- As Found: Irritable Bowel Syndrome
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6337
- Name: Colonic Diseases, Functional
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000043183
- Term: Irritable Bowel Syndrome
- ID: D000013577
- Term: Syndrome
### Intervention Browse Module - Ancestors
- ID: D000000563
- Term: Amebicides
- ID: D000000981
- Term: Antiprotozoal Agents
- ID: D000000977
- Term: Antiparasitic Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000000994
- Term: Antitrichomonal 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: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M12876
- Name: Ornidazole
- Relevance: HIGH
- As Found: Vacuum aspiration
- ID: M4224
- Name: Antibiotics, Antitubercular
- Relevance: LOW
- As Found: Unknown
- ID: M3904
- Name: Amebicides
- 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: D000009950
- Term: Ornidazole
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437028
**Brief Title:** Evaluating the Efficacy of Perinatal Membrane Allografts for the Treatment of Diabetic Foot Ulcers.
**Official Title:** A Multicenter, Prospective, Randomized, Controlled, Evaluation of the Efficacy of Perinatal Membrane Allografts as Adjuncts to Standard of Care Versus Standard of Care Alone for the Treatment of Diabetic Foot Ulcers.
#### Organization Study ID Info
**ID:** SB-24-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Samaritan Biologics
### Status Module
#### Completion Date
**Date:** 2026-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Emergent Clinical Consulting, LLC
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Samaritan Biologics
#### 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:** The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients.
The main question that this study aims to answer is:
Does the use of perinatal tissue allografts in conjunction with standard of care wound management techniques result in a higher percentage of patients achieving complete wound closure (i.e. healing) as compared to patients being treated with standard of care alone after 6 and 12 weeks of treatment.
One ulcer on each participant's foot will receive weekly 1) applications of perinatal tissue allografts and standard of care wound management or 2) standard of care wound management alone. Pictures of the ulcer and measurements of its size will be measured every week to track its healing progress over a total treatment period of 12 weeks. Additionally, the participants will be asked to fill out a questionnaire about the wound impacts their life.
**Detailed Description:** Patients with diabetes often develop ulcers on their lower extremities. While some ulcers can be managed using standard of care wound management techniques including debridement, moist dressings, infection control and off-loading, many develop into chronic, non-healing wounds. Chronic non-healing wounds can lead to higher risk of infection, amputation and decreased quality of life.
Advanced wound therapies aim to promote rapid and complete healing of chronic wounds. An example of an advanced wound therapy are perinatal tissue allografts. These include human amniotic / chorionic membranes, which have been confirmed by the United States Food \& Drug Administration's Tissue Reference Group to meet the criteria for regulation solely under Section 361 of the Public Health Service Act as defined in Title 21 of the Code of Federal Regulations - Part 1271 for the management of diabetic foot ulcers.
The focus of this clinical trial is to determine the clinical utility of treating diabetic foot ulcers with weekly applications of perinatal tissue allografts in addition to standard of care wound management techniques compared to applying standard of care wound management only.
It is hypothesized that the addition of perinatal tissue allografts will result in a higher percentage of patients achieving complete wound closure (i.e. healing) compared to patients being treated with standard of care alone after 6 and 12 weeks of treatment.
To test this hypothesis the study will consist of patients who will undergo a 2-week screening phase, a 12-week treatment phase and a follow-up phase of up to 3 months. Briefly, during the 2-week screening phase, patients meeting inclusion criteria will have an identified index wound managed with standard of care. Index wounds that are not reduced by more than 20% in the screening phase will be randomized into the treatment groups. During the 12-week treatment phase, index wounds will be treated weekly with either allograft and standard of care or standard of care alone. During the follow-up phase, the site of the index wound will be evaluated to determine recurrence of the wound.
Evaluation of data (outcome measures) associated with the trial will include intent to treat and per protocol analyses which will be performed by at least one blinded statistician and investigator.
### Conditions Module
**Conditions:**
- Diabetic Foot Ulcer
**Keywords:**
- Diabetes
- Diabetic Foot
- Allograft
- Amnion
- Chorion
- Wound healing
- Advanced wound care
- Comparative effectiveness
- Lower extremity ulcer
- Time to heal
- Treatment
- Diabetes complication
- Skin ulcer
- Neuropathy
- Peripheral artery disease
- Ischemia
- Wagner Grade
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 180
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients will receive weekly applications of multilayer perinatal tissue allograft in addition to standard of care wound management.
**Intervention Names:**
- Other: Multilayer perinatal tissue allograft
- Other: Standard of care
**Label:** Multilayer perinatal tissue allograft
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients will receive weekly applications of a full thickness perinatal tissue allograft in addition to standard of care wound management.
**Intervention Names:**
- Other: Full thickness perinatal tissue allograft
- Other: Standard of care
**Label:** Full thickness perinatal tissue allograft
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Standard of care (SOC) will include cleansing of the index wound with sterile normal saline solution, followed by sharp debridement to remove necrotic tissue, application of appropriate dressings and wound off-loading.
**Intervention Names:**
- Other: Standard of care
**Label:** Standard of care (SOC) wound management
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Multilayer perinatal tissue allograft
**Description:** The multilayer perinatal tissue allograft is an amnion - amnion allograft
**Name:** Multilayer perinatal tissue allograft
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Full thickness perinatal tissue allograft
**Description:** The full thickness perinatal tissue allograft is an amnion - intermediate layer - amnion allograft
**Name:** Full thickness perinatal tissue allograft
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Full thickness perinatal tissue allograft
- Multilayer perinatal tissue allograft
- Standard of care (SOC) wound management
**Description:** Standard of care (SOC) will include cleansing of the index wound with sterile normal saline solution, followed by sharp debridement to remove necrotic tissue, application of appropriate dressings and wound off-loading.
**Name:** Standard of care
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The percentage of wounds completely healed. Complete healing will be defined as 100% epithelialization without drainage and need for dressing or wound size ≤ 0.1cm\^2 as determined by the site investigator and validated by a blinded review board.
**Measure:** Incidence of Complete Wound Closure
**Time Frame:** 6- and 12-weeks following study screening phase
#### Secondary Outcomes
**Description:** Time to complete healing within 12 weeks will be determined via a Kaplan-Meier analysis
**Measure:** Time to complete healing
**Time Frame:** 12-weeks following study screening phase
**Description:** Percent reduction of wound area \[(Ai-Axw\]) / Ai\] x100, where Ai is the area of the index wound at randomization, Axw is the wound area at 4 and 12 weeks.
**Measure:** Percent reduction in wound area
**Time Frame:** 4- and 12-weeks following study screening phase
**Description:** Will determine if and when an ulcer occurs again at the same location of the index ulcer via monitoring of the ulcer site
**Measure:** Incidence of ulcer recurrence
**Time Frame:** Up to 3-months following complete healing or from the conclusion of the 12-week treatment phase (which ever occurs first)
**Description:** The average number of allografts used to achieve complete healing will be calculated
**Measure:** Average number of allografts used
**Time Frame:** 12-weeks following study screening phase
**Description:** Wound-QoL questionnaire on quality of life with chronic wounds
**Measure:** Wound Quality of life questionnaire
**Time Frame:** 12-weeks following study screening phase
**Description:** Unfavorable outcome during the study directly related to the index wound and graft (cellulitis, osteomyelitis, infection of the treated extremity, etc...)
**Measure:** Serious adverse events
**Time Frame:** 12-weeks following study screening phase
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male or female age 18 or older
* Type 1 or type 2 diabetes mellitus
* Signed informed consent
* Wound is diabetic in origin
* Ulcer duration of ≥ 4 weeks \[i.e. recalcitrant/unresponsive to SOC (\<50% decrease in size when treated with standard of care), but wound duration not longer than 1 year\] with documented failure of prior treatment to heal the wound
* Wound size: 1 cm2 - 25 cm2
* Wound present anatomically on the foot as defined by beginning below the malleoli of the ankle and located on the plantar surface
* No clinical signs of infection
* Wound does not extend into tendon or bone and no evidence of osteomyelitis (Wagner Score: Grade 1)
* Additional wounds may be present but should not be within 3 cm of the index / study wound so that coalescence cannot occur
* Serum creatinine \< 3.0 mg/dL
* HbA1c \< 12% at randomization
* Patient should exhibit adequate vascular perfusion to affected extremity determined within 1 month of screening via one or a combination of the following:
* Ankle-brachial index (ABI) with results of ≥ 0.70 and ≤ 1.2 mm Hg.
* If medial calcinosis is suspected, a toe-brachial index ≥ 0.70 should be evaluated in the patient in lieu of ABI
* Toe systolic blood pressure of \> 30mm HG
* Doppler arterial waveforms which are triphasic or biphasic at the ankle of the infected leg
* Toe pressure transcutaneous oximetry: ≥ 60mm Hg
* Patient is of legal consenting age
* Patient is willing to provide informed consent and is willing to participate in all procedures and follow-up evaluations necessary to complete study.
Exclusion Criteria:
* Wound extending to tendon or bone
* Index wound greater than 25 cm2
* HbA1c \> 12% within previous 90 days
* Serum creatinine level 3.0 mg/dL or greater (indicative or renal impairment)
* Patients with a known history of poor compliance with medical treatments
* Patients previously randomized into this study, or presently participating in another clinical trial
* Patients currently receiving radiation therapy or chemotherapy
* Patient with known or suspected local skin malignancy to the index wound
* Patients with uncontrolled autoimmune connective tissue diseases
* Non-revascularizable surgical sites
* Active infection at wound site
* Presence of a Charcot abnormality
* Any pathology that would limit the blood supply and compromise healing
* Patients who have received a biomedical or topical growth factor for their wound within the previous 30 days
* Patients who are pregnant or breast feeding
* Patients who are taking medications that are considered immune system modulators that could affect graft incorporation
* Patients taking a Cox-2 inhibitor
* Patients with wound healing \>20% during the screening period
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jeremy J Mercuri, PhD
**Phone:** 484-883-2033
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Jerry Chang, BS
**Phone:** 352-256-2707
**Role:** CONTACT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000003925
- Term: Diabetic Angiopathies
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000007871
- Term: Leg Ulcer
- ID: D000012883
- Term: Skin Ulcer
- ID: D000012871
- Term: Skin Diseases
- ID: D000048909
- Term: Diabetes Complications
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000003929
- Term: Diabetic Neuropathies
- ID: D000005534
- Term: Foot Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC05
- Name: Musculoskeletal Diseases
### Condition Browse Module - Browse Leaves
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M19933
- Name: Diabetic Foot
- Relevance: HIGH
- As Found: Diabetic Foot
- ID: M18919
- Name: Foot Ulcer
- Relevance: HIGH
- As Found: Foot Ulcer
- ID: M17206
- Name: Ulcer
- Relevance: HIGH
- As Found: Ulcer
- ID: M29213
- Name: Peripheral Arterial Disease
- Relevance: LOW
- As Found: Unknown
- ID: M10883
- Name: Leg Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M26004
- Name: Diabetes Complications
- Relevance: LOW
- As Found: Unknown
- ID: M15686
- Name: Skin Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M7120
- Name: Diabetic Angiopathies
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7124
- Name: Diabetic Neuropathies
- Relevance: LOW
- As Found: Unknown
- ID: M8658
- Name: Foot Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000017719
- Term: Diabetic Foot
- ID: D000016523
- Term: Foot Ulcer
- ID: D000014456
- Term: Ulcer
### 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: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437015
**Brief Title:** Comparison of CIMT vs Mirror Therapy Effect in Infarcted CVA Patients for Improving Hand Functions
**Official Title:** Comparison of CIMT vs Mirror Therapy Effect in Infarcted CVA Patients for Improving Hand Functions
#### Organization Study ID Info
**ID:** MSRSW/Batch-Fall22/720
#### Organization
**Class:** OTHER
**Full Name:** Superior University
### Status Module
#### Completion Date
**Date:** 2024-10-29
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-05-20
**Type:** ACTUAL
#### Start Date
**Date:** 2023-11-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Superior University
#### Responsible Party
**Investigator Affiliation:** Superior University
**Investigator Full Name:** Muhammad Naveed Babur
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** CIMT vs Mirror therapy for improving hand function in infarcted CVA patients. Randomized clinical trial study design will be followed. Data will be collected from following centers: Minhaj Physiotherapy Centre, Home visits, Sughra sidiq trust hospital, Ibad hospital Samundri. Probability Random Sampling is used.
### Conditions Module
**Conditions:**
- Infected Joint
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 26
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Diagnostic Test: Constraint-Induced Movement Therapy
**Label:** Constraint-Induced Movement Therapy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Other: Mirror Therapy
**Label:** Mirror Therapy
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Constraint-Induced Movement Therapy
**Description:** patient's unaffected hand is tied with a triangular bandage or splint and the patient asks to perform the exercise through the affected hand. for up to 6 hours a day for 5days week /4 weeks and the patient nonparetic arm restrained from the use by having the patient placing a mitt on the hand or a sling on the unaffected hand, forcing the use of the affected limb to promote purposeful movements when performing functional tasks.
**Name:** Constraint-Induced Movement Therapy
**Type:** DIAGNOSTIC_TEST
#### Intervention 2
**Arm Group Labels:**
- Mirror Therapy
**Description:** In this group training was given for 45min a day for 5 days a week for 4 weeks. Mirror box which was of 18×24inch \[was placed on the learning table and exercises were carried out by the patient looking into the mirror where an unaffected limb is placed in front of the mirror, through looking into the mirror patient assumes the reflection of the unaffected limb as the paretic limb. Exercises performed were hand opening and closing, wrist extension and flexion, squeezing, opposition, the calculation
**Name:** Mirror Therapy
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** it is a stroke-specific, performance-based impairment index.Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully
**Measure:** The Fugl-Meyer Assessment (FMA)
**Time Frame:** 12 Months
**Description:** It is used to assess functional ability of the paretic arm and hand. This test consists of 13 functional tasks: open a jar of coffee, draw a line with a ruler, put toothpaste on a toothbrush, cut medium consistency putty,pour a glass of water wring out a washcloth,clean a pair of eyeglasses,zip up a zipper,botton up 5 buttons,dry back with a towel,place a container on a table and carry a bag up the stairs.
**Measure:** The Chedoke Arm and Hand Activity Inventory (CAHAI)
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Infarcted CVA patients
* Patients with hand improvement needed
* Patients in recovery stage of stroke from 2 months to 1 year
* Patients who can participate in 45 mins of session
Exclusion Criteria:
* Patients with hand function disturbed due to any other reason except infarcted CVA, - - - Patients with shoulder subluxation and upper limb contractures
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Lahore
**Country:** Pakistan
**Facility:** Minhaj Physiotherapy, opp Shalimar Hospital , Shalimar
**State:** Punjab
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06437002
**Acronym:** FULLBR_ANBN
**Brief Title:** Exploring the Full Body Representation in Anorexia Nervosa and Bulimia Nervosa
**Official Title:** Exploring the Full Body Representation in Anorexia Nervosa and Bulimia Nervosa
#### Organization Study ID Info
**ID:** 49C403
#### Organization
**Class:** OTHER
**Full Name:** Istituto Auxologico Italiano
### Status Module
#### Completion Date
**Date:** 2026-05-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Turin, Italy
**Class:** OTHER
**Name:** Open University
**Class:** OTHER
**Name:** Heriot-Watt University
**Class:** OTHER
**Name:** Catholic University of the Sacred Heart
#### Lead Sponsor
**Class:** OTHER
**Name:** Istituto Auxologico Italiano
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The ability to mentally recall a motor act without any overt movement is called motor imagery (MI). The movement simulation that occurs on a cognitive level can be seen as a way in which we express the mental representation of the body in action. MI tasks can be used as a proxy for the exploration of the mental representations of the body. Interestingly, MI tasks differ in the degree of action monitoring required to resolve the task. More in detail, we can allocate MI tasks along a continuum that goes from more implicit MI tasks (less action monitoring required for the resolution of the task) to more explicit MI tasks (more action monitoring required for the resolution of the task).
Eating disorders such as anorexia nervosa (AN) and bulimia nervosa (BN) are both characterized by body image distortion and impairments (i.e. overestimation of the perceived body), however, on a different state of the physical body: on one hand we have a highly malnourished body, on the other hand, we might have a healthy-looking body or an overweight body. As above mentioned, MI tasks can be used as a proxy for the exploration of the mental representations of the body and people affected by AN and BN show impairment on their imagined body. This means that people affected by AN and BN might respond differently when assessed for their MI abilities.
We hypothesize that people affected by AN might show greater impairment in their motor imagery abilities because of the greater discrepancy between the physical body (malnourished) and the mental body representation in comparison to people affected by BN, who usually have a health weight, even an altered body representation. Nevertheless, we might expect the alteration of body representation not strictly linked to the physical body dimensions, in the case of no difference between AN and BN. This would be of relevance for the creation of rehabilitative programs.
**Detailed Description:** The ability to mentally recall a motor act without any overt movement is called motor imagery (MI). The movement simulation that occurs on a cognitive level can be seen as a way in which we express the mental representation of the body in action. MI tasks can be used as a proxy for the exploration of the mental representations of the body. Interestingly, MI tasks differ in the degree of action monitoring required to resolve the task. More in detail, we can allocate MI tasks along a continuum that goes from more implicit MI tasks (less action monitoring required for the resolution of the task) to more explicit MI tasks (more action monitoring required for the resolution of the task).
Eating disorders such as anorexia nervosa (AN) and bulimia nervosa (BN) are both characterized by body image distortion and impairments (i.e. overestimation of the perceived body, however, on a different state of the physical body: on one hand we have a highly malnourished body, on the other hand, we might have a healthy-looking body or an overweight body. As above mentioned, MI tasks can be used as a proxy for the exploration of the mental representations of the body and people affected by AN and BN show impairment on their imagined body. This means that people affected by AN and BN might respond differently when assessed for their MI abilities.
Recent studies explored MI, through more explicit and more implicit MI tasks in people affected by eating disorders, such as AN and BN. For example, when it comes to more implicit MI tasks, Campione et al observed that people affected by AN and BN do not show a temporal advantage when mentally rotating pictured hands based on their own hands compared to other hand stimuli, as opposed to controls. Authors point out how people affected by eating disorders show an alteration of the MI process highlighting an alteration of body schema. Authors grouped AN and BN patients in their analysis without considering the responses about the psychiatric condition. Recently, in a work by Scarpina et al, authors observed how people affected by AN present altered MI processes independently from the level of awareness required since alterations emerged in the more implicit (i.e. laterality judgment tasks) and more explicit (i.e. Mental Motor Chronometry (MMC) tasks) tasks. Such evidence points out an alteration of the imagery process in AN and confirms what was observed also by Campione et al for people suffering from AN. Both studies focused their attention on hands only. In the study of Urgesi et al, when using the own-body transformation task (requiring left-right judgments on a schematic human figure that may be facing toward (front-facing) or away from the observers (back-facing)), authors observed a partial impairment (t-score calculated as patients' reaction times on accuracy ratios) of people affected by BN in resolving such a more implicit MI task: people with BN were impaired in providing laterality judgments on the front-facing human figure, wherein participants had to perform a mental transformation of their own body to assume the perspective of the body stimulus. Interestingly, this study focused its attention on the full body mental representation, but for a more implicit type of task only. Purcell et al, again, grouped AN and BN participants and compared their performance to controls at a more implicit MI task, which involves several body parts (i.e. sensitive body parts: abdomen, buttocks, thigh; controls body parts: shin, forearm, head). Participants were asked to execute a movement or to imagine executing the same movement (i.e. sizing a body part) involving the body parts above-mentioned. People affected by AN and BN required significantly more time to imagine tracing sensitive body parts compared to control body parts than healthy controls (HCs). Despite Purcell et al consider their task as more implicit, in our opinion, in this experiment a more explicit process of MI was assessed. That is because "participants were asked to execute a movement or to imagine executing the same movement", this means that the degree of action monitoring, grounding the task resolution, highly increased because participants were made aware of using their MI skills to solve the task (i.e. participants are openly asked to execute and imagine movements). When it comes to the full body, Guardia et al observe that people affected by AN overestimate their body size when asked to judge whether or not a door aperture is wide enough for them to pass through (i.e. first-person perspective). This does not happen for a third person present in the room with them. This shows an overestimation of the mentally represented body in AN. Lastly, in the work of Meregalli et al, authors compared acute AN (not differentiated by the type, restrictive or binge purging) and control in a series of MI-based tasks: results evidence that patients with AN displayed greater difficulty than control in explicitly imagining movements, in mentally rotating human figures, and in adopting a different egocentric visuospatial perspective. No significant differences were observed in an MMC-based task and the mental rotation of 3D objects. Overall, these previous pieces of evidence may suggest altered MI processes in individuals affected by eating disorders, such as AN and BN. Interestingly, literature reports stronger results for people affected by AN and BN when the resolution of more implicit MI-based tasks is considered, while for more explicit ones (i.e. MMC tasks) results do not seem clear-cut.
In previous studies patients were often grouped within a more generic "eating disorder sample", rather than considered by the diagnosis, such as AN (restrictive vs binge purging) and BN, and no comparison between the three was made (AN restrictive vs AN binge purging vs BN). However, the psychopathology behind these disorders is very different. More in detail, AN is characterized by i) restriction of energy intake relative to requirements, leading to a significant low body weight in the context of the age, sex, developmental trajectory, and physical health (less than minimally normal/expected, ii) intense fear of gaining weight or becoming fat or persistent behavior that interferes with weight gain, and iii) disturbed by one's body weight or shape, self-worth influenced by body weight or shape, or persistent lack of recognition of seriousness of low body weight. Moreover, we can distinguish between the restricting type (i.e. During the last 3 months has not regularly engaged in binge-eating or purging) and the binge-purging type (i.e. During the last 3 months has regularly engaged in binge-eating or purging). Differently, when it comes to BN, the condition is characterized by i) recurrent episodes of binge eating, as characterized by both eating, within any 2-hour period, an amount of food that is definitively larger than what most individuals would eat in a similar period of time under similar circumstances, and a feeling that one cannot stop eating or control what or how much one is eating, ii) recurrent inappropriate compensatory behaviors in order to prevent weight gain such as self-induced vomiting; misuse of laxatives, diuretics, or other medications; fasting or excessive exercise, iii) the binge eating and inappropriate compensatory behaviors occur, on average, at least once a week for 3 months, iv) self-evaluation is unjustifiability influenced by body shape and weight, v) the disturbance does not occur exclusively during episodes of AN. Moreover, despite both AN and BN are characterized by body image distortion and impairments (i.e. overestimation of the perceived body), this occurs in response to a different state of the physical body (i.e. highly malnourished body vs healthy-looking body/overweight body). In regards to such clinical differences, studies evaluating MI processes, especially when different body parts are involved (e.g. hands and the whole body as for previous studies), should consider each condition per se, AN restrictive, AN binge-purging, and BN.
We hypothesize that people affected by AN might show greater impairment in their motor imagery abilities because of the greater discrepancy between the physical body (malnourished) and the mental body representation in comparison to people affected by BN, who usually have a health weight, even an altered body representation. Nevertheless, we might expect the alteration of body representation not strictly linked to the physical body dimensions, in the case of no difference between AN and BN. This would be of relevance for the creation of rehabilitative programs.
### Conditions Module
**Conditions:**
- Anorexia Nervosa/Bulimia
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Behavioral: Mental Motor Chronometry (MMC) Task Hands and Feet and Whole Body
**Label:** anorexia nervosa restrictive/ANr
#### Arm Group 2
**Intervention Names:**
- Behavioral: Mental Motor Chronometry (MMC) Task Hands and Feet and Whole Body
**Label:** anorexia nervosa binge-purging/ANbp
#### Arm Group 3
**Intervention Names:**
- Behavioral: Mental Motor Chronometry (MMC) Task Hands and Feet and Whole Body
**Label:** bulimia nervosa/bn
#### Arm Group 4
**Intervention Names:**
- Behavioral: Mental Motor Chronometry (MMC) Task Hands and Feet and Whole Body
**Label:** Health control/Hc
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Health control/Hc
- anorexia nervosa binge-purging/ANbp
- anorexia nervosa restrictive/ANr
- bulimia nervosa/bn
**Description:** The MMC will be used as a measure of MI and it is adapted for use in hands, feet, and the whole body as well as for online experimentation. The task is comprised of two conditions, MI, and motor execution, in which respectively participants will be asked to imagine and execute a movement sequence with both hands and feet and the whole body.
Hand movements: index and thumb opposition; thumb extension from the fist; middle finger crossed on the index finger; and extension of the index and the little fingers.
Foot movements: foot internal rotation, foot external rotation, foot dorsiflexion, and foot plantarflexion.
Whole-body movements: take a small bow, lift arms over the head and stand on the tips of the toes (stretch), extend hands forward and lower the backside (squats) and a small jump.
The types of movements required to be executed by participants are simple and do not require much energy. Therefore, people affected by AN and BN should be able to perform them without problems.
**Name:** Mental Motor Chronometry (MMC) Task Hands and Feet and Whole Body
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Participants will watch a video of each movement and then will be asked to practice the movements. This will be followed by the MI condition for each body district. During the MI trials, participants will be asked to imagine performing the sequence of movements for each hand and each foot, five times, as quickly and as accurately as possible with their eyes closed. The whole-body movement trials will be imagined five times, but the block of trials will be repeated twice to ensure each body district is imagined the same number of times (e.g. imagery for the left limb was repeated for the right limb). After the MI condition participants will complete the motor execution task for each body district.
The order of the body district will be randomized between participants. For each participant and each body district, we will compute the average duration of the four movements for the right and the left side separately, both in the imagery and in the motor execution conditions.
**Measure:** Mental Motor Chronometry (MMC)
**Time Frame:** Immediately after the intervention/procedure
### Eligibility Module
**Eligibility Criteria:** People affected by AN
Inclusion Criteria:
* Female;
* age between 18 and 55 years old;
* diagnosis of AN (restrictive and binge-purging type\*), as per DSM V criteria (APA, 2013);
* BMI ≤ 17,5 Kg/m2;
* right-handed (i.e. Edinburgh Handedness Inventory (EHI) (Veale, 2014)).
* Restricting type: During the last 3 months, the individual has not engaged in recurrent episodes of binge eating or purging behaviour (i.e. self-induced vomiting or the misuse of laxatives, diuretics, or enemas). This subtype describes presentations in which weight loss is accomplished primarily through dieting, fasting, and/or excessive exercise.
* Binge-eating/purging type: During the last 3 months, the individual has engaged in recurrent episodes of binge eating or purging behaviour (i.e. self-induced vomiting or the misuse of laxatives, diuretics, or enemas).
Exclusion criteria:
* presence of motor impairments, such as: motor disorders, broken limbs, inability to move, amputation of limbs, etc... because of the nature of the tasks - see the section Mental Motor Chronometry (MMC) Task Hands and Feet and Whole Body;
* presence of neurological deficits, motor disorders, or somatosensory perception disorders (e.g. peripheral neuropathy); previous head injury;
* schizophrenia spectrum disorders and other psychotic disorders on an acute phase;
* pregnancy;
* heavy use of medication because of acute symptoms.
People affected by BN
Inclusion Criteria:
* female;
* age between 18 and 55 years old;
* diagnosis of BN, as per DSM V criteria (APA, 2013);
* BMI ≤ 17,5 Kg/m2 or BMI ≥ 30 Kg/m2;
* right-handed (i.e. EHI (Veale, 2014)).
Exclusion criteria:
* presence of motor impairments, such as: motor disorders, broken limbs, inability to move, amputation of limbs, etc... because of the nature of the tasks - see the section Mental Motor Chronometry (MMC) Task Hands and Feet and Whole Body;
* presence of neurological deficits, motor disorders, or somatosensory perception disorders (e.g. peripheral neuropathy); previous head injury;
* schizophrenia spectrum disorders and other psychotic disorders on an acute phase;
* pregnancy;
* heavy use of medication because of acute symptoms.
HCs - enrolled voluntarily
Inclusion Criteria:
* female;
* age between 18 and 55 years old;
* right-handed (i.e. EHI (Veale, 2014)).
Exclusion criteria:
* history of eating disorders or obesity in the past 5 years and currently;
* BMI ≤ 17,5 Kg/m2 or BMI ≥ 30 Kg/m2;
* presence of motor impairments, such as: motor disorders, broken limbs, inability to move, amputation of limbs, etc... because of the nature of the tasks - see the section Mental Motor Chronometry (MMC) Task Hands and Feet and Whole Body;
* presence of neurological deficits, motor disorders, or somatosensory perception disorders (e.g. peripheral neuropathy); previous head injury;
* schizophrenia spectrum disorders and other psychotic disorders on an acute phase;
* pregnancy;
* heavy use of medication because of acute symptoms.
Comparability between the four groups (AN restrictive vs AN binge-purging vs BN vs HCs) in terms of age and education will be guaranteed.
**Maximum Age:** 55 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
**Study Population:** Female subjects affected by AN (restrictive and binge-purging type) and BN who will be hospitalized at the U.O. dei Disturbi del Comportamento Alimentare, San Giuseppe Hospital, Piancavallo (VCO), Italy will be selected and will be considered eligible for participation in the study.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Federico Brusa, Ph.D
**Phone:** +393517797622
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Milano
**Contacts:**
***Contact 1:***
- **Name:** Istituto Auxologico Italiano
- **Role:** CONTACT
**Country:** Italy
**Facility:** istituto Auxologico italiano IRCSS
**State:** MI
**Zip:** 20145
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012817
- Term: Signs and Symptoms, Digestive
- ID: D000001068
- Term: Feeding and Eating Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000006963
- Term: Hyperphagia
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M4181
- Name: Anorexia
- Relevance: HIGH
- As Found: Anorexia
- ID: M4182
- Name: Anorexia Nervosa
- Relevance: HIGH
- As Found: Anorexia Nervosa
- ID: M5304
- Name: Bulimia
- Relevance: HIGH
- As Found: Bulimia
- ID: M26956
- Name: Bulimia Nervosa
- Relevance: HIGH
- As Found: Bulimia Nervosa
- ID: M15622
- Name: Signs and Symptoms, Digestive
- Relevance: LOW
- As Found: Unknown
- ID: M4380
- Name: Feeding and Eating Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10014
- Name: Hyperphagia
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000855
- Term: Anorexia
- ID: D000002032
- Term: Bulimia
- ID: D000000856
- Term: Anorexia Nervosa
- ID: D000052018
- Term: Bulimia Nervosa
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436989
**Brief Title:** Effect of Temperature Leaching Solution of Disposable Plastic Tableware on Intestinal Health of Adults
**Official Title:** Effect of Temperature Leaching Solution of Disposable Plastic Tableware on Intestinal Health of Adults
#### Organization Study ID Info
**ID:** 20240306-1
#### Organization
**Class:** OTHER_GOV
**Full Name:** Zhejiang Chinese Medical University
### Status Module
#### Completion Date
**Date:** 2024-12-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2024-06-13
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-24
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Xiang Zeng
#### Responsible Party
**Investigator Affiliation:** Zhejiang Chinese Medical University
**Investigator Full Name:** Xiang Zeng
**Investigator Title:** Associate professor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Studies have shown that disposable plastic tableware will cause harm to human health after heat exposure, which is closely related to the rapid development of modern society and economy and the accelerated pace of life. Most of the existing studies focused on the characterization of micro-nano plastic particles and organic pollutants such as bisphenol A and polycyclic aromatic hydrocarbons produced after thermal exposure of disposable plastic tableware, but did not pay sufficient attention to the potential relationship with individual health effects. In addition; Sporadic animal tests and molecular tests have verified the health hazards of disposable plastic tableware leaching solution. Based on the previous research results, we believe that the leaching solution of disposable plastic tableware at high temperature environment will disturb the intestinal flora structure, affect the intestinal metabolic profile, and produce adverse health outcomes for human intestinal health. This study intends to recruit healthy school students as research objects, and collect urine and stool samples of test subjects, in order to explore the effects of high-temperature leaching solution of disposable plastic tableware on intestinal health of adults.
**Detailed Description:** The method of single blind randomized controlled cross trial was adopted. A total of 80 healthy adults were recruited and divided into test group and control group according to the principle of randomization. During the trial period, the experimental group used a disposable plastic cup to drink a cup of hot water boiled in a hot kettle in the morning and in the evening (reduced to room temperature, about 300mL), while the control group also used a disposable plastic cup to drink room temperature water without heat exposure. The first phase lasted for 5 working weeks, and after a one-month washout period in the middle, the experimental group and the control group crossed. The second phase of the cross-over trial also lasted 5 workweeks. A total of four medical examinations were performed throughout the trial period, before and after the first and second trials. A check-up lasts half a day.
Health outcome indicators: height, weight, body composition analysis, saliva, blood pressure, blood, urine sample, stool sample indicators.
Urine, feces and blood samples were collected to detect the relevant indicators in order to explore the potential mechanism of the harm of heavy metals in the hot exposure leaching solution of disposable plastic tableware to human intestinal health.
### Conditions Module
**Conditions:**
- Intestinal Dysfunction
- Inflammation
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 300ml pure water cooled to room temperature in a kettle.
**Intervention Names:**
- Other: hot purified water
**Label:** hot water
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** 300 ml pure water without any treatment
**Intervention Names:**
- Other: hot purified water
**Label:** normal temperature water
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- hot water
- normal temperature water
**Description:** Hot purified water,drink once a workday,almost 360mL.Buy from regular channels.
**Name:** hot purified water
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** We plan to measure serum concentrations of C-reactive protein(CRP)
**Measure:** C-reactive protein(CRP)
**Time Frame:** Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4weeks plants exposure in second stage.
#### Primary Outcomes
**Description:** We plan to measure forced vital capacity (FVC) of lung function.
**Measure:** Forced Vital Capacity(FVC)
**Time Frame:** Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4weeks plants exposure in second stage
**Description:** We plan to measure systolic blood pressure (SBP) and diastolic blood pressure (DBP)
**Measure:** Blood Pressure(BP)
**Time Frame:** Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4weeks plants exposure in second stage.
#### Secondary Outcomes
**Description:** We plan to measure Heart Rate Variability (HRV).
**Measure:** Heart Rate Variability(HRV)
**Time Frame:** Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4weeks plants exposure in second stage.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* .Healthy college students aged 18 to 35;
* .Subjects can receive the intervention in this study.
Exclusion Criteria:
* 1.Have been diagnosed with diabetes, ulcerative colitis, Crohn's disease, or an infectious disease;
* Chemotherapy, radiation or surgery 3-6 months prior to sampling;
* Abnormal bowel movements one week before sampling;
* I was menstruating at the time of sampling;
* In the past three months, the sample has taken probiotics and other related health products and dietary supplements.
**Healthy Volunteers:** True
**Maximum Age:** 35 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Hangzhou
**Country:** China
**Facility:** Zhejiang Chinese Medicine University
**State:** Zhejiang
**Zip:** 310000
### 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: 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: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436976
**Brief Title:** The Effect of Probiotics ATG-F4 in Cancer Patients
**Official Title:** The Effect of Probiotics ATG-F4 in Cancer Patients
#### Organization Study ID Info
**ID:** CNUH 2023-08-012
#### Organization
**Class:** OTHER
**Full Name:** Chungnam National University Hospital
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-18
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** AtoGen Co. Ltd
#### Lead Sponsor
**Class:** OTHER
**Name:** Chungnam National University Hospital
#### Responsible Party
**Investigator Affiliation:** Chungnam National University Hospital
**Investigator Full Name:** Hyewon-Ryu
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Patients with advanced colorectal cancer or pancreatic cancer who are receiving oxaliplatin-based chemotherapy will be included. The research participants in this study will consume probiotics along with safety and anti-cancer agent side effect-related questionnaires, blood, and fecal sample collection for up to 12 weeks from the date of registration. The total duration of participation for research subjects is 12 weeks.
**Detailed Description:** Chemotherapy is one of the cancer treatment methods, but some anticancer agents appear to influence the occurrence and progression of cachexia. Chemotherapy-Induced Cachexia refers to symptoms such as appetite loss, weight loss, muscle mass reduction, and fatigue caused by chemotherapy. While anticancer agents are used to eliminate or suppress tumor cells, most are administered intravenously, potentially causing damage not only to tumor cells but also to healthy cells and tissues. Cyclophosphamide, 5-fluorouracil (5-FU), and cisplatin induce negative nitrogen balance leading to weight loss, while cisplatin, irinotecan, adriamycin, and etoposide can cause muscle wasting through NF-κB activation. Additionally, muscle loss due to combination chemotherapy like FOLFIRI (5-fluorouracil, irinotecan, cisplatin) is associated with extracellular signal-regulated kinase 1/2 (ERK1/2) and p38 mitogen-activated protein kinase activation. Furthermore, research approached from a metabolic perspective has shown clear differences between cancer-induced cachexia and chemotherapy-induced cachexia, highlighting the need to differentiate and study cachexia induced by anticancer agents separately from cancer cachexia. In conclusion, while anticancer agents are essential for the demise of cancer cells and the inhibition of tumor growth, the occurrence of cachexia due to chemotherapy-induced damage to normal cells through prolonged administration poses a challenge that needs to be addressed to maintain the overall health of patients.
On the other hand, the microbiome refers to the total sum of all microorganisms present in a specific environment, and the human microbiome specifically refers to the collection of commensal, symbiotic, and pathogenic microorganisms coexisting with the human body. Approximately 95% of all microbes reside in the gastrointestinal tract, including the colon, and they are also widely distributed in the respiratory, reproductive, oral, and skin systems. The gut microbiome is known to play a crucial role in nutrient absorption, immune system regulation, and prevention of infectious diseases within the body.
Several studies suggest that changes in the composition and function of the gut microbiome may contribute to the development and progression of cachexia in cancer patients undergoing chemotherapy. In experiments where gut microbiota from mice treated with chemotherapy were transplanted into germ-free mice, an increase in inflammation-related C-X-C motif chemokine ligand 1 (CXCL1) was observed in the germ-free mice, accompanied by a significant decrease in their movement and physical activity. This result indicates that chemotherapy induces changes in the gut microbiota, which in turn can impact the entire body.
Chemotherapy can induce dysbiosis, an imbalance in the microbial community structure, leading to a reduction in beneficial bacteria and overgrowth of harmful bacteria, which can trigger inflammation and impair intestinal barrier function. Ultimately, this can promote inflammatory responses, exacerbating muscle loss and weight loss in cancer patients. Moreover, it can also affect nutrient absorption and metabolism, leading to malnutrition and energy imbalance.
Additionally, gut microbial communities produce various metabolites, such as short-chain fatty acids (SCFAs), which play important roles in host metabolism and immune function regulation. Dysbiosis may affect intestinal protein synthesis and energy metabolism. Overall, the profound involvement of the gut microbiome and metabolites in chemotherapy-induced cachexia symptoms suggests that microbiome-based therapies could be an interesting development target for alleviating or treating chemotherapy-induced cachexia.
Probiotics are generally known to improve gastrointestinal conditions such as constipation and diarrhea, inhibit harmful bacteria in the gut, and prevent diseases through their regulatory effects on intestinal function. They are also known to have effects such as immune enhancement, improvement of vaginal health, and alleviation of allergies. In particular, there is ongoing global research aimed at developing probiotics as therapeutic agents for the microbiome, which constitutes the total microorganisms in the gut. Recently, with the FDA approval of microbiome therapy for clostridiosis difficile infection, research in this area has been increasing.
The test strain of Lactobacillus reuteri ATG-F4 used in this study has been confirmed to be safe based on preclinical research results. When administered to mice transplanted with tumors and then treated with anticancer agents, it was observed to improve weight loss, muscle mass reduction, and muscle strength decline. Additionally, it helped alleviate diarrhea symptoms and normalize gut microbiota. These effects were found to be associated with the suppression of inflammatory responses induced by anticancer agents. Based on previous studies, this trial was planned to analyze the impact of the investigational product LT-002 (Lactobacillus reuteri ATG-F4) on the safety and improvement of anticancer agent side effects in cancer patients.
### Conditions Module
**Conditions:**
- Pancreatic Cancer
- Colon Cancer
**Keywords:**
- probiotics
- pancreatic cancer
- colon cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The group that will be consuming probiotics (LT-002 (Lactobacillus reuteri ATG-F4)) for 12 weeks. The subjects will take a daily intake of 4 x 10\^10 colony forming unit (CFU) of LT-002.
**Intervention Names:**
- Drug: LT-002 (Lactobacillus reuteri ATG-F4
**Label:** LT-002 (Lactobacillus reuteri ATG-F4) arm
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- LT-002 (Lactobacillus reuteri ATG-F4) arm
**Description:** The group that will be consuming probiotics for 12 weeks.
**Name:** LT-002 (Lactobacillus reuteri ATG-F4
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Body weight measured by Bio-electrical Impedance Analysis
**Measure:** Changes of Body weight (Kg)
**Time Frame:** baseline, 4 weeks, 8 weeks
#### Secondary Outcomes
**Description:** Lean body mass measured by Bio-electrical Impedance Analysis
**Measure:** Lean body mass
**Time Frame:** baseline, 4 weeks, 8 weeks
**Description:** kg/m\^2
**Measure:** Body mass index
**Time Frame:** baseline, 4 weeks, 8 weeks
**Description:** C-reactive protein (mg/dL) measured by laboratory analysis
**Measure:** C-reactive protein
**Time Frame:** baseline, 4 weeks, 8 weeks
**Description:** Interleukin-6 (pg/mL) measured by laboratory analysis
**Measure:** Interleukin-6
**Time Frame:** baseline, 4 weeks, 8 weeks
**Description:** Absolute neutrophil count and lymphocyte count will be combined to report Neutrophil to lymphocyte ratio
**Measure:** Neutrophil to lymphocyte ratio
**Time Frame:** baseline, 4 weeks, 8 weeks
**Description:** Platelet and lymphocyte count will be combined to report Neutrophil to lymphocyte ratio
**Measure:** Platelet to lymphocyte ratio
**Time Frame:** baseline, 4 weeks, 8 weeks
**Description:** Progression free survival (from initiation of chemotherapy to disease-progression or death, whenever occured first)
**Measure:** Progression-free survival
**Time Frame:** Up to 24 weeks, by 3 months
**Description:** Overall survival (from diagnosis to death)
**Measure:** Overall survival
**Time Frame:** Up to 24 seeks, by 3 months
**Description:** The EORTC Quality of life questionnaire - C30 score consists of 30 items divided into three subdomains: overall quality of life, functional areas, and symptom areas. Higher scores in the overall quality of life and functional areas indicate a better quality of life, while lower scores in the symptom areas also indicate a better quality of life.
**Measure:** effects of probiotics to Quality of life
**Time Frame:** baseline, 4 weeks, 8 weeks
**Description:** Chemotherapy toxicity Survey
**Measure:** Chemotherapy toxicity
**Time Frame:** baseline, 4 weeks, 8 weeks
**Description:** Changes in gut microbiome profiles, using 16s RNA analysis.
**Measure:** Changes in gut microbiome profiles
**Time Frame:** baseline, 4 weeks, 8 weeks
**Description:** Hand grip strength measurement using Digital grip strength dynamometer, T.K.K 5401, Japan). Hand grip strength will be measured to estimate the physical performances of participants.
**Measure:** Hand grip strength
**Time Frame:** baseline, 4 weeks, 8 weeks
**Description:** Mid calf circumference will be measured to estimate the lean body mass of participants.
**Measure:** Mid calf circumference
**Time Frame:** baseline, 4 weeks, 8 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients diagnosed with advanced colorectal cancer or pancreatic cancer who are undergoing treatment with Oxaliplatin-based chemotherapy at Chungnam National University Hospital, including both newly diagnosed and recurrent cases.
* Aged 19 years or older.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 points.
* Expected life expectancy of at least 3 months.
* Ability to understand the requirements of the clinical trial and willingness to sign the informed consent form.
Exclusion Criteria:
* Presence of known brain metastases.
* Malignant bowel obstruction requiring surgical intervention.
* Uncontrolled, active infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmias, or any psychiatric/social conditions that may limit compliance with the study requirements.
* Partial or complete intestinal obstruction.
* Pregnant or lactating women.
* Use of antibiotics, antifungals, or antiviral agents on more than one occasion within the past month.
* Consumption of probiotics products or fermented milk more than twice within the past month.
* Patients with neurological or psychiatric disorders.
**Minimum Age:** 19 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Hyewon Ryu, Professor
**Phone:** 82 + 42 280 6834
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Sora Kang, clinical professor
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Daejeon
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sora Kang, Clinical professor
- **Phone:** +82 42-280-6834
- **Role:** CONTACT
***Contact 2:***
- **Name:** Hyewon Ryu
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Korea, Republic of
**Facility:** Chungnam National University Hospital
**Status:** RECRUITING
**Zip:** 35015
#### Overall Officials
**Official 1:**
**Affiliation:** Department of Hematology Oncology
**Name:** Hyewon Ryu, Professor
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Due to the organization's policy, personal information of participants cannot be shared.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000010182
- Term: Pancreatic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000015179
- Term: Colorectal Neoplasms
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M13110
- Name: Pancreatic Neoplasms
- Relevance: HIGH
- As Found: Pancreatic Cancer
- ID: M6338
- Name: Colonic Neoplasms
- Relevance: HIGH
- As Found: Colon Cancer
- 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: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System 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: M17890
- Name: Colorectal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M10448
- Name: Intestinal Neoplasms
- 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: T4387
- Name: Pancreatic Cancer
- Relevance: HIGH
- As Found: Pancreatic Cancer
### Condition Browse Module - Meshes
- ID: D000010190
- Term: Pancreatic Neoplasms
- ID: D000003110
- Term: Colonic Neoplasms
### 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: T355
- Name: Acidophilus
- Relevance: HIGH
- As Found: Next
- ID: T120
- Name: Cola
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436963
**Brief Title:** Exploring the Application of Narrative Medicine Combined With Case-Based Learning in the Standardized Training of General Practice Residents
**Official Title:** Narrative Medicine Combined With Case-Based Learning
#### Organization Study ID Info
**ID:** 2022KY815
#### Organization
**Class:** OTHER
**Full Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University
### Status Module
#### Completion Date
**Date:** 2023-12-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-31
**Type:** ACTUAL
#### Start Date
**Date:** 2022-07-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This was a prospective, longitudinal, single-center nonrandomized controlled study. A total of 36 first- and second-year general practice residents of Zhejiang University School of Medicine were voluntarily enrolled in the experimental group. The remaining 9 residents served as a control group. The experimental group received narrative medicine training combined with CBL training. The control group received normal CBL training. None of the participants had previously had any training in narrative medicine. Teaching evaluation scores were measured for all subjects at baseline and 1 year after the training.
### Conditions Module
**Conditions:**
- Narrative Medicine
- Case-based Learning
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 45
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The experimental group received narrative medicine training combined with CBL training
**Intervention Names:**
- Behavioral: narrative medicine training combined with CBL training
**Label:** narrative medicine training combined with CBL training
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The control group received normal CBL training
**Intervention Names:**
- Behavioral: CBL training
**Label:** CBL training
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- narrative medicine training combined with CBL training
**Description:** The experimental group received narrative medicine training combined with CBL training.
**Name:** narrative medicine training combined with CBL training
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- CBL training
**Description:** The control group received normal CBL training.
**Name:** CBL training
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The satisfaction survey was divided into five levels, ranging from "strongly agree" to "strongly disagree". The higher percent of agree means better result.
**Measure:** Satisfaction Survey of Residents in the Experimental Group
**Time Frame:** 12 months
**Description:** The SEGUE scale scores were generated by assigning a value of "1" for "yes", "0" for "no" and "0.5" for "cannot answer". High scores indicate stronger clinical communication skills.
**Measure:** Comparison of the SEGUE scale scores Between the Experimental Group and the Control Group
**Time Frame:** 12 months
**Description:** The JSE-S scale scores adopts a 7-point Likert scale ranging from "strongly disagree" to "strongly agree". The higher total score indicating a greater level of empathy.
**Measure:** Comparison of the JSE-S scale scores Between the Experimental Group and the Control Group
**Time Frame:** 12 months
**Description:** The SEGUE scale scores were generated by assigning a value of "1" for "yes", "0" for "no" and "0.5" for "cannot answer". High scores indicate stronger clinical communication skills.
**Measure:** Comparison of the SEGUE scale in Different Grades Before and After Training in the Experimental Group
**Time Frame:** 12 months
**Description:** The JSE-S scale scores adopts a 7-point Likert scale ranging from "strongly disagree" to "strongly agree". The higher total score indicating a greater level of empathy.
**Measure:** Comparison of the JSE-S scale in Different Grades Before and After Training in the Experimental Group
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* first- and second-year general practice residents of Zhejiang University School of Medicine
Exclusion Criteria:
* third-year general practice residents of Zhejiang University School of Medicine
**Maximum Age:** 28 Years
**Minimum Age:** 24 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Hangzhou
**Country:** China
**Facility:** Second Affiliated Hospital, School of Medicine, Zhejiang University
**State:** Zhejiang
**Zip:** 310009
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436950
**Brief Title:** Electrical Phrenic Nerve Stimulation in Patients With VIDD
**Official Title:** Electrical Phrenic Nerve Stimulation in Patients With Ventilator-induced Diaphragm Dysfunction: a Randomized Controlled Study
#### Organization Study ID Info
**ID:** TEPNS_01
#### Organization
**Class:** OTHER
**Full Name:** Peking University Third Hospital
### Status Module
#### Completion Date
**Date:** 2025-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Peking University Third Hospital
#### Responsible Party
**Investigator Affiliation:** Peking University Third Hospital
**Investigator Full Name:** Wang Zongyu
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** This study aims to examine efficacy of transcutaneous electrical phrenic nerve stimulation (TEPNS) in ventilator-induced diaphragmatic dysfunction (VIDD). The investigators recruit VIDD patients, and randomly assign the patients into TEPNS group and control group. TEPNS group receives TEPNS twice a day for consecutive 5 days. Control group only receives usual care. The investigators collect diaphragm function indicators and outcomes to evaluate the efficacy.
**Detailed Description:** Ventilator-induced diaphragmatic dysfunction (VIDD) is common in intensive care unit (ICU). There is a need of measurements to improve VIDD. The investigators hypothesize that transcutaneous electrical phrenic nerve stimulation (TEPNS) will increase diaphragmatic function. This study is a single centre, randomized controlled trial with control or treatment group in a 1:1 ratio. Eligible patients include aged ≥ 18 years, ventilated for at least 48 h with an expected stay of more than 7 days in the ICU, and diaphragm thickening fraction (DTF)\< 25%. The patients are randomly allocated to either receiveTEPNS and usual care (TEPNS group) or usual care only (control group). Blind is not used. TEPNS is conducted twice a day for consecutive 5 days. Electrodes are applied to bilateral neck skin which phrenic nerve runs underneath. Clinical data are collected, including baseline characteristics, airway pressure, esophageal pressure, gastric pressure, ventilation days, ICU length of stay, 28-day mortality, etc.
### Conditions Module
**Conditions:**
- Diaphragms
- Phrenic Nerves
**Keywords:**
- Ventilator-induced diaphragmatic dysfunction
- transcutaneous electrical phrenic nerve stimulation
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Transcutaneous electrical phrenic nerve stimulation (TEPNS) group: TEPNS+usual care Control group: usual care
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The patients in TEPNS group receive TEPNS and usual care.
**Intervention Names:**
- Device: transcutaneous electrical phrenic nerve stimulation (TEPNS)
**Label:** transcutaneous electrical phrenic nerve stimulation (TEPNS) group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The patients in control group receive usual care only.
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- transcutaneous electrical phrenic nerve stimulation (TEPNS) group
**Description:** TEPNS is conducted twice a day for consecutive 5 days. Electrodes are applied to bilateral neck skin which phrenic nerve runs underneath.
**Name:** transcutaneous electrical phrenic nerve stimulation (TEPNS)
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Pdi=gastric pressure - esophageal pressure
**Measure:** Transdiaphragmatic pressure (Pdi)
**Time Frame:** Collected once a day after transcutaneous electrical phrenic nerve stimulation (TEPNS) for consecutive 5 days
#### Secondary Outcomes
**Description:** Determined from respiratory mechanics indicators provided by ventilator or calculated from them
**Measure:** Airway pressure, esophageal pressure, gastric pressure, airway occlusion pressure, driving pressure, transpulmonary pressure
**Time Frame:** Collected once a day after TEPNS for consecutive 5 days
**Description:** Determined from respiratory mechanics indicators provided by ventilator
**Measure:** Esophageal pressure-time product
**Time Frame:** Collected once a day after TEPNS for consecutive 5 days
**Description:** Mechanical ventilation days in 28 days after enrollment
**Measure:** Ventilation days
**Time Frame:** Collected at 28 days after enrollment
**Description:** Days of ICU stay in 28 days after enrollment
**Measure:** Length of ICU stay
**Time Frame:** Collected at 28 days after enrollment
**Description:** Survival outcomes
**Measure:** 28-day mortality
**Time Frame:** Collected at 28 days after enrollment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* aged ≥ 18 years
* ventilated for at least 48 h with an expected stay of more than 7 days in the ICU
* diaphragm thickening fraction (DTF)\< 25%
Exclusion Criteria:
* having a pacemaker
* cutaneous lesion that could interfere with probes
* previous diaphragmatic nerve paralysis
* body mass index \> 35 kg/m2
* severe chronic obstructive pulmonary disease (FEV1/FVC\<30%)
* pregnancy or lactation
* decision to withhold life-sustaining treatment
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Zongyu Wang, Dr.
**Phone:** 008601082267028
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Name:** Zongyu Wang, Doctor
- **Phone:** 86-010-82267028
- **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:** Zongyu Wang, Dr.
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Bao Q, Chen L, Chen X, Li T, Xie C, Zou Z, Huang C, Zhi Y, He Z. The effects of external diaphragmatic pacing on diaphragm function and weaning outcomes of critically ill patients with mechanical ventilation: a prospective randomized study. Ann Transl Med. 2022 Oct;10(20):1100. doi: 10.21037/atm-22-4145.
**PMID:** 36388825
**Citation:** Medrinal C, Machefert M, Lamia B, Bonnevie T, Gravier FE, Hilfiker R, Prieur G, Combret Y. Transcutaneous electrical diaphragmatic stimulation in mechanically ventilated patients: a randomised study. Crit Care. 2023 Aug 30;27(1):338. doi: 10.1186/s13054-023-04597-1.
**PMID:** 37649092
**Citation:** O'Rourke J, Sotak M, Curley GF, Doolan A, Henlin T, Mullins G, Tyll T, Omlie W, Ranieri MV. Initial Assessment of the Percutaneous Electrical Phrenic Nerve Stimulation System in Patients on Mechanical Ventilation. Crit Care Med. 2020 May;48(5):e362-e370. doi: 10.1097/CCM.0000000000004256.
**PMID:** 32191413
**Citation:** Sotak M, Roubik K, Henlin T, Tyll T. Phrenic nerve stimulation prevents diaphragm atrophy in patients with respiratory failure on mechanical ventilation. BMC Pulm Med. 2021 Oct 8;21(1):314. doi: 10.1186/s12890-021-01677-2.
**PMID:** 34625059
**Citation:** Poulard T, Bachasson D, Fosse Q, Nierat MC, Hogrel JY, Demoule A, Gennisson JL, Dres M. Poor Correlation between Diaphragm Thickening Fraction and Transdiaphragmatic Pressure in Mechanically Ventilated Patients and Healthy Subjects. Anesthesiology. 2022 Jan 1;136(1):162-175. doi: 10.1097/ALN.0000000000004042.
**PMID:** 34788380
**Citation:** Goligher EC, Dres M, Patel BK, Sahetya SK, Beitler JR, Telias I, Yoshida T, Vaporidi K, Grieco DL, Schepens T, Grasselli G, Spadaro S, Dianti J, Amato M, Bellani G, Demoule A, Fan E, Ferguson ND, Georgopoulos D, Guerin C, Khemani RG, Laghi F, Mercat A, Mojoli F, Ottenheijm CAC, Jaber S, Heunks L, Mancebo J, Mauri T, Pesenti A, Brochard L. Lung- and Diaphragm-Protective Ventilation. Am J Respir Crit Care Med. 2020 Oct 1;202(7):950-961. doi: 10.1164/rccm.202003-0655CP.
**PMID:** 32516052
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436937
**Acronym:** Giant Leaps
**Brief Title:** Protein Quality of Fava Bean and Honey Chlorella in Humans
**Official Title:** Protein Quality of Fava Bean Meat Analogue and Honey Chlorella Ingested as Mixed Meals in Healthy Volunteers
#### Organization Study ID Info
**ID:** GIANT LEAPS
#### Organization
**Class:** OTHER
**Full Name:** Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
### Status Module
#### Completion Date
**Date:** 2026-09-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-05-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-10
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** European Commission
#### Lead Sponsor
**Class:** OTHER
**Name:** Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
#### Responsible Party
**Investigator Affiliation:** Assistance Publique - Hôpitaux de Paris
**Investigator Full Name:** Robert Benamouzig
**Investigator Title:** Professor in Gastroenterology
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The goal of the project is to determine the protein quality of alternative protein sources, honey chlorella and Faba bean, ingested as mixed meals in healthy subjects equipped with naso-ileal tube. For this purpose, Chlorella and Faba bean are intrinsically labelled with 15N. Faba bean is processed to produce a meat analogue. Chlorella is introduced in a drink. The protein quality is determined by following the digestive and metabolic fate of 15N during a 8h postprandial investigation.
**Detailed Description:** The objective is to determine the nutritional quality of protein from honey chlorella and faba bean meat analogue in healthy humans, especially in terms of protein and amino acid digestibility as well as nitrogen retention. Ileal digestibility is determined in ileal digesta collected postprandially with a naso-ileal tube. The protein sources are intrinsically labelled in 15N in order to track dietary nitrogen and amino acids in the samples.
Ethical and regulatory aspects:
The protocol has been approved to the Ethical Committee and authorized the French Agency of Drugs and Health. The personal data management will be in accordance with the regulation on personal data protection ( " regulation n° 2018-493 du 20 juin 2018").
Meal:
The meal will consist in either a drink containing 40 g of honey chlorella or a mixed meal containiong 80 g of meat analogue, to provide 20 g protein. Sensory tests will be realized to optimize the organoleptic properties of the meal.
Volunteers:
Sixteen subjects will be included in the study. The investigators plan to recruit around 40 volunteers to accommodate for the usual 60% dropouts.
Four days before the experiment, the volunteers will follow a standard diet adapted to their body weight to control their protein intake (1.3 g protein/kg body weight).
The volunteers will arrive at the Human Nutrition Research Centre of Avicenne Hospital on the morning before the day of the experiment. They will be equipped with a double lumen intestinal tube that will be allowed to progress through the intestinal tract for 24h. One of the lumen is radio opaque and serves to perfuse a non-absorbable maker in the intestine (slow marker method). The other lumen is dedicated to the continuous aspiration of the effluents, 15 cm below the perfusion site. The measurement of the non-absorbable marker in the effluents allows the determination of the effluent flow rate.
On the evening before the experimental day, they will ingest 3 oral doses of deuterated water 99 % to reach 5g/kg total body water, to label the intestinal endogenous proteins.
On the day of the experiment, the position of the tube will be checked by radiography to verify its location at the terminal ileum. A catheter will be inserted in the forearm vein for blood sampling. The perfusion of the non-absorbable marker, PEG-4000 (20g/l), will start at a flow rate of 1ml/min. The intestinal flow and the basal ileal sample will be collected during 30 min. Basal plasma sample will be sampled.
Then, at t=0, the volunteers will drink the test-meal. Until t=8h, intestinal content will be continuously collected by aspiration and pooled every 30 minutes. Blood will be sampled every 30 minutes during 4h and hourly thereafter. The urine will be collected every 2 h for 8 h.
Measurements:
In the ilel digesta:
PEG-4000 by turbidimetric method, total N and 15N enrichment by EA-IRMS, amino acid concentrations by UPLC (after acid hydrolysis HCl 6N at 110°C for 24h), 15N amino acid enrichment by GC-c-IRMS (after purification on cation exchange resin and derivatization), 2H amino acid enrichment by GC-c-IRMS, microbiome analysis (DNA sequencing), peptide analysis (LC-MS).
In the plasma:
Glucose, urea (colorimetric methods), insulin (ELISA), amino acid concentrations (UPLC), 15N enrichment in plasma protein, urea and free amino acids (EA-IRMS, after purification on cation exchange resin and derivatization).
In the urine:
Urea (colorimetric method) and 15N urea (EA-IRMS, after purification on cation exchange resin and derivatization).
Main outcomes are:
Real ileal digestibility of protein and amino acids (digestive losses), Postprandial deamination (metabolic losses), Net Postprandial Protein Utilization
### Conditions Module
**Conditions:**
- Protein Quality of Chlorella and Fababean Meat Analogue
**Keywords:**
- Digestibility
- healthy humans
- nasoileal tubes
- stable isotopes
- nitrogen retention
- postprandial
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 16
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The subjects ingest a single meal: a drink including 40 g of honey chlorella intrinsically labelled with 15N, to provide 20g protein from chlorella
**Intervention Names:**
- Dietary Supplement: Single meal containing 20 g of 15N intrinsically labelled protein from honey chlorella
**Label:** Honey Chlorella
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The subjects ingest a single meal: a mixed meal including 80 g of faba bean meat analogue intrinsically labelled with 15N, to provide 20g protein from faba bean
**Intervention Names:**
- Dietary Supplement: Single meal containing 20 g of 15N intrinsically labelled protein from faba bean meat analogue
**Label:** Faba bean meat analogue
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Honey Chlorella
**Description:** Ingestion of a 15N labeled test meal. Subjects are equipped with a nasoileal tube. 15N is followed in biological fluids (plasma, effluents, urines).
**Name:** Single meal containing 20 g of 15N intrinsically labelled protein from honey chlorella
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Faba bean meat analogue
**Description:** Ingestion of a 15N labeled test meal. Subjects are equipped with a nasoileal tube. 15N is followed in biological fluids (plasma, effluents, urines).
**Name:** Single meal containing 20 g of 15N intrinsically labelled protein from faba bean meat analogue
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** The measurement of nitrogen (mmol) and 15N enrichment (atom %) in ileal samples allow to determine the amount of dietary nitrogen in the lumen. Dietary nitrogen that is recovered in the ileal samples are then considered as non absorbed.
**Measure:** Ileal digestibility of protein and amino acids
**Time Frame:** -30 minutes to 8 hours after the test meal
**Description:** The measurement of urea (mmol) and 15N enrichment of urea (atom %) allow to determine the amount of dietary N that was transferred to urea, thus accounting for metabolic losses. Metabolic losses of dietary N, together with digestive losses of dietary N, are not retained in the body.
**Measure:** Net Postprandial Protein Utilization (NPPU)
**Time Frame:** 0 to 8 hours after the test meal
**Description:** The measurement of amino acid concentration (mmol) and their individual 15N enrichment (atom %) allow the determination of dietary amino acids remaining in the lumen. Dietary amino acids that are recovered in the ileal samples are then considered as non absorbed.
**Measure:** Ileal digestibility of amino acids
**Time Frame:** -30 minutes to 8 hours after the test meal
#### Secondary Outcomes
**Description:** urea and amino acids (mmol/l)
**Measure:** Nitrogen metabolites in blood in response to the ingestion of 15N fava bean
**Time Frame:** 0 to 8 hours after the test meal
**Description:** plasma glucose (mmol/l)
**Measure:** Plasma glucose in blood in response to the ingestion of 15N fava bean
**Time Frame:** 0 to 8 hours after the test meal
**Description:** plasma insulin (pmol/l)
**Measure:** Plasma insulin in blood in response to the ingestion of 15N fava bean
**Time Frame:** 0 to 8 hours after the test meal
**Description:** Microbial DNA sequencing
**Measure:** Ileal microbiota
**Time Frame:** -0.5 h before the meal
**Description:** Peptidomic anlaysis by LC-MS
**Measure:** Peptide composition of ileal digesta
**Time Frame:** 0-8 h after the test meal
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18\<BMI\<30
* Good health (WHO=0)
* For woman: use of birth control
Exclusion Criteria:
* food allergy
* allergy against latex
* pregnant women
* Positive serology for AgHBS, AcHbc, HCV, HIV
* Anemia
* Excessive alcohool consumption
* Hypertension, diabetes, digestive, hepatic or renal diseases, cardiac disease
* Exercice\>7h/week
* Blood donation within 3 months before the study
* Participation to another clinical study within 3 months before the study
**Healthy Volunteers:** True
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Claire Gaudichon, PhD, Prof
**Phone:** 33189100852
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Gheorghe Airinei, MD
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** INRAE
**Name:** Claire Gaudichon, PhD, Prof
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** Assistance Publique - Hôpitaux de Paris
**Name:** Robert Benamouzig, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436924
**Brief Title:** Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day
**Official Title:** Safety and Efficacy of Workflows of High Volume Single Operators in a Left Atrial Appendage Occlusion Device Implant Procedural Day: SAFE HV
#### Organization Study ID Info
**ID:** SAFE HV
#### Organization
**Class:** OTHER
**Full Name:** Heart Rhythm Clinical and Research Solutions, LLC
### Status Module
#### Completion Date
**Date:** 2025-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Boston Scientific Corporation
#### Lead Sponsor
**Class:** OTHER
**Name:** Heart Rhythm Clinical and Research Solutions, LLC
#### 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:** SAFE HV is an observational, prospective, multi-center, non-randomized study evaluating real-world clinical experience of centers where a single procedural physician schedules eight or more left atrial appendage occlusion (LAAO) device implant procedures in a single calendar day.
**Detailed Description:** Since 2009, Watchman FLX™ and its predecessor, Watchman™ have provided a safe and effective alternative to oral anticoagulation for over 200,000 patients in the United States and Europe. Advancements in the design of the Watchman FLX™ have made the device available to a wider range of patients. As more patients qualify for the device, more implant procedures are necessary to provide them with this life-changing treatment option.
Some Watchman FLX™ implanters perform high volumes of implant procedures on certain days. While performing a high-volume of implant procedures is desirable for many reasons, it must be determined that cases performed under such circumstances are comparable in safety and efficacy to implant procedures performed at lower volumes. While there has been no differentiation between high and low volume cases in previous studies, data obtained in this study will be compared to overall safety and efficacy data available from the PINNACLE FLX clinical trial and the SURPASS analysis to ensure that safety and efficacy outcomes are comparable.
Additionally, this study will collect data on the workflows of these high-volume implanters that will help determine which factors contribute to the successful performance of high volumes of Watchman FLX™ implants in a single day. In the future this information may be used to help other implanters optimize workflows to increase their volume of daily implants and hence, provide more opportunities for patients to access this transformative device.
### Conditions Module
**Conditions:**
- Atrial Fibrillation
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 678
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Watchman LAAO device implant
**Intervention Names:**
- Device: Left Atrial Appendage Device Implant
**Label:** Subjects undergoing LAAO device implant
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Subjects undergoing LAAO device implant
**Description:** The Watchman Device is implanted into the left atrial appendage and is designed to close it off and keep blood clots from escaping that area.
**Name:** Left Atrial Appendage Device Implant
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Incidence of peri-procedural complications summarized descriptively and compared to historical data
**Measure:** Peri-procedural complications
**Time Frame:** Procedure through discharge, an average of 1-3 days
**Description:** Assessed by successful closure of the left atrial appendage defined by peri-device leakage of \<5mm. This will be identified at the post implant imaging.
**Measure:** Peri-device leakage
**Time Frame:** Date of implant up to 90 days
**Description:** Incidence of post procedure complications summarized descriptively and compared to historical data.
**Measure:** Late onset complications
**Time Frame:** Discharge to 30 days.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. 18 years of age or older
2. Able and willing to participate in baseline and follow up evaluations for the full length of the study
3. Clinically qualified, in the opinion of the Investigator, to receive a LAAO device
4. Receiving a Watchman FLX™ or Watchman FLX Pro™ LAAO device as part of their plan of care
5. Having their LAAO device implant procedure scheduled on a qualifying high-volume\* procedure day as assessed within 2 days (≤ 2 calendar days) prior to the planned procedure date
\*high-volume - a calendar day in which the single implanting physician schedules ≥ 8 LAAO device implant procedures, regardless of the device manufacturer
6. Willing and able to provide informed consent
Exclusion Criteria:
1. Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
2. In the opinion of the Investigator, any known contraindication to a LAAO device or implant procedure
3. Having their LAAO device implant procedure scheduled on a day in which the single implanting physician scheduled \< 8 LAAO device implant procedures as assessed within 2 days (≤ 2 calendar days) prior to the planned procedure date
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study population will include subjects who are clinically qualified for a Watchman FLX™ or Watchman FLX Pro™ LAAO device implant and would receive one regardless of participation in the study, who meet all eligibility criteria for the study, and present at participating institutions for a LAAO device implant procedure on a day in which a single implanting physician scheduled at least eight LAAO device implant procedures, regardless of the device manufacturer (i.e., high-volume).
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Lynn Landborg
**Phone:** 763-381-9135
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Carolyn Mills
**Phone:** 205-807-0864
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Savannah
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lindsey Lamb, MHSA
- **Phone:** 912-350-9032
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Ritzie A Trinidad, MBA
- **Phone:** 912-350-3110
- **Role:** CONTACT
***Contact 3:***
- **Name:** Todd Senn, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** David Newton, MD
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** Memorial Health University Medical Center
**State:** Georgia
**Status:** RECRUITING
**Zip:** 31404
#### Overall Officials
**Official 1:**
**Affiliation:** St. Vincent's
**Name:** Saumil Oza, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001145
- Term: Arrhythmias, Cardiac
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4586
- Name: Atrial Fibrillation
- Relevance: HIGH
- As Found: Atrial Fibrillation
- ID: M4453
- Name: Arrhythmias, Cardiac
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001281
- Term: Atrial Fibrillation
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436911
**Acronym:** VAX-002-01
**Brief Title:** To Evaluate Safety and Immunogenicity of a Prophylactic Plasmid DNA
**Official Title:** Phase 1/2 Study to Evaluate Safety and Immunogenicity of a Prophylactic Plasmid DNA Booster Vaccine Against SARS-CoV-2 [Covigenix VAX-002] in Generally Healthy Adults 18 Years and Older
#### Organization Study ID Info
**ID:** ENTVAX-002-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Entos Pharmaceuticals Inc.
### Status Module
#### Completion Date
**Date:** 2026-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Calian CRO
**Class:** INDUSTRY
**Name:** Q2 Solutions
**Class:** UNKNOWN
**Name:** PCI Pharma Services
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Entos Pharmaceuticals Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Currently, several vaccines are available to combat the COVID-19 pandemic. The persistence of SARS-CoV-2 globally requires the development of additional vaccines to aid in preventing further SARS-CoV-2 infections. Covigenix VAX-002 is a vaccine based off its predecessors VAX-001 and VAX-001-1b. All three are plasmid DNA vaccines that express key antigenic determinants from SARS-CoV-2 and use the Entos Pharmaceuticals' Fusogenix proteo-lipid vehicle (PLV) platform. Currently, the safety and tolerability of VAX-001 and VAX-001-1b for primary vaccination following 1 or 2 doses are being investigated in a Phase 1/2 study (ENTVAX01-101). In Phase 1, VAX-001 was administered to healthy adults on Day 0 and Day 14, as either 2 low doses (100 μg/dose) or 2 high doses (250 μg/dose). Overall, data suggest that VAX-001 is safe at both the low and high dose levels. The Phase 2 part evaluates VAX-001-1b in adults at a 100 μg dose level on a 1-dose and a 2-dose schedule (Days 0 and 28). An interim analysis conducted on data from 18 participants in the sentinel group who had received their first dose of 100 μg showed that VAX-001-1b was overall safe with minor adverse events (AEs) registered. No serious adverse events (SAEs) were reported. After a review of the data, the Data Safety Monitoring Committee (DSMC) provided their recommendations for the participants in the 100 μg dose sentinel group to receive a second dose.
The present study investigates the safety and immunogenicity of VAX-002 when given as a booster dose to generally healthy adults aged 18 years or older who have received a primary vaccination course or a booster dose of an authorized COVID-19 vaccine at least 3 months prior to Day 0.
VAX-002 was specifically designed to address the new circulating omicron variants of SARS-CoV-2.
The study consists of 2 parts: a dose-finding/safety evaluation part (Phase 1) to determine the dose of VAX-002 for booster vaccination (100 μg or 250 μg) followed by an adaptive Phase
**Detailed Description:** Phase 1 is the randomized, observer-blinded, multi-center, dose-finding part of the study, followed by an adaptive Phase 2 in which the optimal dose, determined from Phase 1, will be evaluated for safety and efficacy. In Phase 1 up to 50 participants are planned to be randomized 1:1 into one of two groups: either 100 μg intramuscular (IM) injection or 250 μg IM injection. Participants are to receive a single 0.5 mL IM injection of VAX-002 100 μg or 250 μg on Day 0. Follow-up visits will occur on Days 7, 14, 17 (phone call visit), 21, 28, 42, and 180. An interim analysis is planned once all participants in Phase 1 have completed their Day 28 visit to evaluate dose-response and safety to support optimal dose selection for Phase 2.
In Phase 2 approximately 250 participants will be enrolled and will receive a single 0.5 mL IM
injection of the optimal VAX-002 dose (determined in the Phase 1 interim analysis) on Day 0. Follow- up visits will occur on Days 7, 14, 17 (phone call visit), 21, 28, 42, and 180.
### Conditions Module
**Conditions:**
- COVID-19
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** In Phase 1 up to 50 participants are planned to be randomized 1:1 into one of two groups: either 100 μg intramuscular (IM) injection or 250 μg IM injection. Participants are to receive a single 0.5 mL IM injection of VAX-002 100 μg or 250 μg on Day 0. Follow-up visits will occur on Days 7, 14, 17 (phone call visit), 21, 28, 42, and 180. An interim analysis is planned once all participants in Phase 1 have completed their Day 28 visit to evaluate dose-response and safety to support optimal dose selection for Phase 2.
In Phase 2 approximately 250 participants will be enrolled and will receive a single 0.5 mL IM
injection of the optimal VAX-002 dose (determined in the Phase 1 interim analysis) on Day 0. Follow- up visits will occur on Days 7, 14, 17 (phone call visit), 21, 28, 42, and 180.
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** In Phase 1 up to 50 participants are planned to be randomized 1:1 into one of two groups: either 100 μg intramuscular (IM) injection or 250 μg IM injection. Participants are to receive a single 0.5 mL IM injection of VAX-002 100 μg or 250 μg on Day 0. Follow-up visits will occur on Days 7, 14, 17 (phone call visit), 21, 28, 42, and 180. An interim analysis is planned once all participants in Phase 1 have completed their
**Intervention Names:**
- Drug: COVIGENIX VAX- 002
**Label:** Phase 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** In Phase 2 approximately 250 participants will be enrolled and will receive a single 0.5 mL IM
injection of the optimal VAX-002 dose (determined in the Phase 1 interim analysis) on Day 0. Follow- up visits will occur on Days 7, 14, 17 (phone call visit), 21, 28, 42, and 180.
**Intervention Names:**
- Drug: COVIGENIX VAX- 002
**Label:** Phase 2
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Phase 1
- Phase 2
**Description:** ENTVAX-001-01
**Name:** COVIGENIX VAX- 002
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** * To assess the humoral immune response Phase 1/2: Spot forming cells per million peripheral blood mononuclear cells (PBMC) and the differential expression of T cellular markers measured at specified timepoints from baseline (Day 0) through EOS Phase 1/2: Immunophenotyping flow cytometry performed at specified timepoints from baseline (Day 0) through EOS response of Covigenix VAX-002 booster to the SARS-CoV-2 S protein
* To evaluate dose-response immunity
* To evaluate antigen specific B and Tcell response by interferon-gamma enzyme-linked immunosorbent spot (ELISpot) assay with overlapping peptide pools (15mers overlapping by 11 residues) of vaccine antigens and by immunophenotyping T cells by flow cytometry (samples will be bio-banked for future analysis depending on the immune response)
* To evaluate anti-fusion-associated small transmembrane (FAST) protein antibodies
* To evaluate anti-dsDNA antibodies
**Measure:** Exploratory Outcome
**Time Frame:** 13 months
#### Primary Outcomes
**Description:** To evaluate the safety of VAX-002; Frequency and grade of each solicited local (injection site) and systemic reactogenicity AE from Day 0 through Day 28 Phase 2: Frequency and grade of each solicited local (injection site) and systemic reactogenicity AE at Day 0 through Day 28 Phase 1 only: Frequency and grade of unsolicited AEs, SAEs, and medically- attended AEs (MAAEs) from administration of investigational product (IP) through Day 28 Phase 2: Frequency and grade of unsolicited AEs, SAEs, and MAAEs from IP administration through Day 28 Phase 1/2: Frequency, type, and grade of SAEs related to IP administration, MAAEs related to IP administration, adverse events of special interest (AESI), or COVID-19 illness from IP administration through end-of-study (EOS)
**Measure:** Primary Outcome
**Time Frame:** 13 months
#### Secondary Outcomes
**Description:** To assess SARS-CoV-2 neutralizing antibody response:
Phase 1 only : Antibody responses at specified timepoints from baseline (Day 0) through Day 28 - Geometric mean neutralizing antibody titers, as measured by SARS-CoV-2 neutralization assay
Phase 1/2: Antibody responses at specified timepoints from baseline (Day 0) through EOS
- Geometric mean neutralizing antibody titers, as measured by SARSCoV2 neutralization assay
Phase 1 only: Seroconversion rate (% of participants who seroconvert), defined as a 4-fold or greater increase in neutralizing antibody titers, as measured by SARSCoV-2 neutralization assay from baseline (Day 0) through Day 28 Phase 1/2: Seroconversion rate (% of participants who seroconvert), defined as a 4-fold or greater increase in neutralizing antibody titers, as measured by SARS-CoV-2 neutralization assay at specified timepoints from baseline (Day 0) through EOS
**Measure:** Secondary Outcome
**Time Frame:** 13 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
- 1. Generally healthy adults aged 18 years or older at the time of enrollment and with a body mass index (BMI) of ≤30 kg/m2
* Completion of a prior COVID-19 primary vaccination course or booster (any commercially available within the study country) at least 3 months prior to enrollment OR recent clinically documented SARS-CoV-2 infection (by polymerase chain reaction \[PCR\] or antibody test) in the past three months but not within one month from enrollment.
* Willing to refrain from receiving an authorized COVID-19 booster dose until at least 90 days post IP administration.
* Female participants of child-bearing potential must have practiced adequate contraception for 30 days before IP injection, have a negative pregnancy test on the day of IP injection, and agree to continue adequate contraception until 180 days after IP injection. (Please refer to Section 10.44 for the definition of childbearing potential and adequate contraception).
* Male participants must agree to continue adequate contraception until 180 days after IP injection.
* Able to consent to participate in the study and signed an Informed Consent Form (ICF).
* Able and willing to complete all the scheduled study procedures during the whole study period (approximately 6.5 months).
* Generally, in good health, as determined by a review of medical history and a physical examination within 14 days prior to IP injection.
Exclusion Criteria:
* 1. History of anaphylaxis to key ingredients within the vaccine. 2. History of seizure disorder, encephalopathy, or psychosis. 3. Female participant is pregnant (positive urine pregnancy test), lactating, or plans to become pregnant during the 180 days of enrollment. 4. Positive test result for human immunodeficiency virus (HIV) or hepatitis B and C at Screening (test to be performed at the discretion of the investigator based on medical history or physical examination). 5. Positive result of lateral flow test for SARS-COV-2 on Day 0. 6. Laboratory (hematological and biochemistry) examination that is out of normal range or greater than a Grade 2 abnormality. Grade 1 abnormalities will not be exclusionary if considered not clinically significant by the investigator. Laboratory tests include: complete blood count (CBC), prothrombin time (PT), partial thromboplastin time (PTT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin (T Bil), creatinine (CR), lipase, and blood glucose at screening. 7. Transient mild laboratory abnormalities may be rescreened once, and the participant will be excluded if the laboratory repeat test is abnormal as per local laboratory normal values and the investigator's assessment. 8. Presents with any acute febrile disease (oral temperature ≥37.5°C \[99.5oF\]) or active infectious disease within 48 hours prior to IP injection. 9. Unstable concomitant underlying conditions. Note: Stable condition defined as: the participant is appropriately managed on consistent disease management; for example, participants with well-controlled hypertension, adult-onset diabetes, benign prostate hypertrophy, or hypothyroid disease will be eligible for enrollment. The treatment regimen should be stable for at least 3 months prior to entering the study. Once IP treatment has started, the patient must be willing to maintain all aspects of the treatment regimen and forgo any elective changes in medication or management. Emergency changes in medication or management would be captured as an AE. 10. History of Guillain-Barre Syndrome or degenerative neurological disorders; a history of autoimmune, inflammatory disease or potential immune-mediated diseases (pIMD), or any condition that may put the participant at increased risk of safety events. 11. History of serious cardiovascular diseases, such as arrhythmia, conduction block, history of myocardial infarction, and severe hypertension not controlled with medication. 12. History of immunodeficiency, asplenia, or functional asplenia. 13. History of platelet disorder or other bleeding disorder that may cause contraindication for IM injection. 14. Heavy smoker (\>10 cigarettes per day), vaper (\>1 mL of e-liquid per day), or cannabis user (\[near\] daily use). Smokers have to agree to use the same cigarette brand throughout the study.
15. History or diagnosis of coagulopathies. 16. Prior receipt of immunosuppressive medication, cytotoxic therapy, or systemic corticosteroids within 6 months before Day 0. 17. Recent receipt of blood products within 4 months before Day 0. 18. Administration of other investigational drugs within 3 months before Day 0 or planned use during the study period. 19. Currently has or a history of any condition that, in the opinion of the investigator, may interfere with the participant's compliance, evaluation of study objectives, or informed consent process (i.e., medical, psychological, social, or other conditions).
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yvonne Bessem, PhD
**Phone:** 4164606574
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Catalina Vasquez
**Phone:** 7804995396
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Edmonton
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dr. Frank Hoentjen, MD
- **Phone:** (780) 492- 8691
- **Role:** CONTACT
***Contact 2:***
- **Name:** Frank Hoentjen, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Canada
**Facility:** University of Alberta
**State:** Alberta
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** Related Info
**URL:** https://www.entospharma.com/
## 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
### 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: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436898
**Acronym:** PoCH-Rehab
**Brief Title:** Proof of Concept of Hybrid Robotics for Gait Rehabilitation of Persons Post-stroke
**Official Title:** Proof of Concept of Hybrid Robotics for Gait Rehabilitation of Persons Post-stroke (PoCH-Rehab)
#### Organization Study ID Info
**ID:** PoCH-Rehab
#### Organization
**Class:** OTHER
**Full Name:** Fondazione Don Carlo Gnocchi Onlus
### Status Module
#### Completion Date
**Date:** 2025-11-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-16
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Istituto Italiano di Tecnologia
**Class:** OTHER
**Name:** Istituto Nazionale di Ricovero e Cura per Anziani
#### Lead Sponsor
**Class:** OTHER
**Name:** Fondazione Don Carlo Gnocchi Onlus
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Persons post-stroke suffer from hemiparesis affecting the functional abilities of the controlesional lower limb. Improving walking is therefore a primary rehabilitation goal for such patients. Robotic-Assisted Rehabilitation (RAR, e.g. exoskeletons) and Functional Electrical Stimulation (FES) are promising techniques to facilitate the functional recovery after stroke. allowing benefits to be maintained over long term.
**Detailed Description:** Exoskeletons were originally developed for subjects with spinal cord injury where they demonstrated a positive impact on rehabilitation and relative costs. The investigators expect the same trend also for stroke. Based on prior exploratory activities using an overgorund exoskeleton (TWIN_Acta) in gait rehabilitation post stroke, in this project the aim is to merge the potential of an overground exoskeleton and FES to treat the lower limb motor deficits in persons post-stroke, strengthening their residual abilities. Synchronized pairing of the two devices might boost the functional recovery of gait post-stroke by promoting neural reorganization The persons post stroke will undergo 20 gait rehabiliation sessions with the exoskeleton and with FES applied to the lower limb muscles during execution of gait with the aim of improving various gait and quality of life parameters. This experimental intervention will be compared to a control intervention using an exoskeleton alone for gait rehabiltation post stroke.
### Conditions Module
**Conditions:**
- Stroke Sequelae
- Gait, Hemiplegic
**Keywords:**
- Gait rehabilitation
- Exoskeleton
- Functional Electrical Stimulation
- Hemiplegia
- Overground
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Assessor blind to treatment arm
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 70
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will train gait with an overground exoskeleton and a combined myoelectrically controlled Functional Electrostimulation System (FES) applied to lower limb muscles during execution of gait.
**Intervention Names:**
- Device: Combined overground gait exoskeleton and FES applied to lower limb
**Label:** Exoskeleton plus FES
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will train gait with an overground exoskeleton.
**Intervention Names:**
- Device: Overground gait exoskeleton
**Label:** Exoskeleton
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Exoskeleton plus FES
**Description:** Gait rehabilitation for persons with stroke, with an overground exoskeleton combined with an electromyographically controlled FES applied to lower limb muscles during gait.
**Name:** Combined overground gait exoskeleton and FES applied to lower limb
**Other Names:**
- TWIN_Acta and FITFES
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Exoskeleton
**Description:** Gait rehabilitation for persons with stroke, with an overground exoskeleton.
**Name:** Overground gait exoskeleton
**Other Names:**
- TWIN_Acta
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The SUS assesses Usability and Acceptability of a device. The SUS consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. The scores will be normalized to produce a percentile ranking. The higher the percentage the better the tested device is considiered.
**Measure:** System Usability scale (SUS)
**Time Frame:** At baseline and at post after 4 weeks of intervention
**Description:** Gait velocity during 3D gait analysis measured while walking overground over 10 meters. Velocity is measured in meters/second
**Measure:** Velocity of gait
**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
#### Secondary Outcomes
**Description:** The motricity index is an ordinal method fo measuring limb strength. Maximum total lower limb score is 99. Scoring goes from 0 no movement to 33 normal power.
**Measure:** Motricity Index Lower limb (MI LL)
**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
**Description:** The scale evaluates and measures neuromotor recovery in post stroke patients. Items are scored on a 3-point ordinal scale, from 0 cannot perform to score 2 performs fully. Maximum score for lower limb is 34.
**Measure:** Fugl Meyer Assessment of motor recovery after stroke. Lower limb (FMA LL)
**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
**Description:** The FAC assesses functional ambulation in patients undergoing physical therapy. The clinician ticks a box of 5 broad categories of walking ability from not being able to walk or needing help from to or more persons to score of 5 if they can walk independently anywhere.
**Measure:** Functional Ambulation Category (FAC)
**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
**Description:** The 7-item SRMS was devised from the 28-item SRMS and inquires upon intrinsic and extrinsic motivation domains for rehabilitation. Scores range from 1 to 7 so the total score can range from 7-35 with higher scores indicating higher motivation.
**Measure:** Stroke Rehabilitation Motivation Scale (7-item SRMS)
**Time Frame:** At baseline and at post after 4 weeks of intervention
**Description:** The impact of fatigue on day-to-day function is measured using the Fatigue Severity Scale (FSS). This measure is a self-report scale with nine questions answered on a 7-point Likert scale. The FSS score is reported as one total score which is the mean of the nine items. Scores range from 1 to 7 and higher scores indicate greater impact of fatigue on daily life.
**Measure:** Fatigue Severity Scale (FSS)
**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
**Description:** The Modified Ashworth Scale (MAS) is a revised version of the original Ashworth Scale that measures spasticity in patients with lesions to the central nervous system. MAS is an assessment that is used to measure the increase in muscle tone. MAS assigns a grade of spasticity from a 0-4 ordinal scale with higher score indicating more spasticity. The grade is assigned by moving a joint/muscle through a high velocity quick stretch.Spasticity of calf and knee muscles will be tested
**Measure:** Ashworth scale
**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
**Description:** MMT is a standardized set of assessments that measure muscle strength and function. Score range 0-5, minimum 0, maximum 5/5 meaning normal strength. Strength of calf and knee muscles will be tested.
**Measure:** Manual muscle test (MMT)
**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
**Description:** The Five Times Sit to Stand Test measures one aspect of transfer skill. The test provides a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements. Patient is timed while standing up and sitting down 5 times in row.
**Measure:** Five times sit to stand test (5TStS)
**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
**Description:** The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk. Patient are timed while standing up from a chair walking 3 meters, turning around, walking 3 meters and sitting down again.
The patient sits in the chair with his/her back against the chair back. On the command "go," the patient rises from the chair, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down.
Timing begins at the instruction "go" and stops when the patient is seated.
**Measure:** Timed up and go test (TUG)
**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
**Description:** Walking capcaity is measured with the Participant timed while walking a 30 meter track constantly for 2 minutes. Participants are permitted to use their walking aids if necessary. The distance walked in 2 minutes is recorded and reported in metres
**Measure:** Two minutes walking test (2MWT)
**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
**Description:** Walking speed is measured by the timed 10 m Walk Test (10MWT). Participants walk a distance of 10 m at their usual speed with their usual walking aids. Participants are timed while walking 10 meters from a starting point to an end point. Time taken from meter 2 to meter 8. Two repetitions are completed and the average time is used to calcualte walking speed in metres/second.
**Measure:** 10 meter walking test (10MVT)
**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
**Description:** The walking handicap scale is a questionnaire asking subjective gait skills. The scale goes from 1 to 6, with score 1 being a physiological gait only with a physiotherapist, to score 6 being unrestricted community ambulation gait.
**Measure:** The walking handicap scale (WHS)
**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
**Description:** the BDI-II is a patient reported outcome that quantifies severity of depression. BDI-II identifies overt behavioral characteristics of depression. Items are on a four-point scale that ranges from 0 to 3. Ratings are summed to provide a total score ranging from 0 - 63. Scores \>10 generally meet the threshold for a diagnosis of depression.
**Measure:** Beck Depression Inventory-II (BDI-II)
**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
**Description:** A questionnaire asking how acceptable and easy to use the technological device is. The theoretical model of UTAUT suggests that the actual use of technology is determined by behavioural intention. The perceived likelihood of adopting the technology is dependent on the direct effect of four key constructs, namely performance expectancy, effort expectancy, social influence, and facilitating conditions. The UTAUT examines the acceptance of technology, determined by the effects of performance expectancy, effort expectancy, social influence and facilitating conditions.
**Measure:** Unified Theory of Acceptance and Use of Technology (UTAUT)
**Time Frame:** At baseline and at post after 4 weeks of intervention
**Description:** Organized reporting of adverse events occurring during the use of the device
**Measure:** Report of adverse events
**Time Frame:** at baseline and at post after 4 weeks of intervention
**Description:** EQ-5D-FL is a standardized instrument for use as a measure of health for clinical and economic appraisal.Applicable to a wide range of health conditions and treatments, the EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.
Measures the 5 dimensions of:
1. mobility
2. self-care
3. usual activities
4. pain/discomfort
5. anxiety/depression Each dimension is scored on a Likert scale of 5 levels, with higher scores indicating more severe problems.
**Measure:** Euro Quality of Life-5 -dimension Questionnaire (EQ-5D-5L)
**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
**Description:** Lower limb data will be captured utilizing two wearable Inertia Measurement Units (IMUs) operating at 280 Hz. These IMUs will be placed on both feet to analyze spatio-temporal gait characteristics. Through data processing, deviations from typical movement patterns will be quantified.
**Measure:** Motion parameters derived from the kinematics of the body
**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
**Description:** Postural data of the lower limb will be acquired using an optoelectronic system combined with two force plates, sampling at 2000 Hz. Utilizing data processing techniques, deviations from normal postural dynamics will be determined.
**Measure:** Postural capabilities will be evaluated based on body kinetics
**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
**Description:** Muscle synergies will be extracted from the Electromyography (EMG) envelope of each participant detected during overground gait employing the Non-Negative Matrix Factorization algorithm. Treatment-induced changes in the resemblance of muscle synergies to physiological patterns will be assessed. Module similarity will be gauged through the maximum scalar product of muscle weightings between each participant and the normative reference. Additionally, the activation profile similarity will be measured using the Pearson's correlation coefficient of each module's activation profile.
**Measure:** Muscular synergies
**Time Frame:** at baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
**Description:** Changes in the I2MWT will be evaluated through IMU sampling at 280 Hz positioned on the lower back. Deviations from the typical performance observed in healthy subjects will be evaluated.
**Measure:** Instrumented 2 Minute Walk test (I2MWT)
**Time Frame:** at baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
**Description:** Changes in the instrumented Timed Up and Go (ITUG) test will be examined. The TUG test will be administered with an IMU sampling at 280 Hz positioned on the lower back. Deviations from the typical performance observed in healthy subjects will be evaluated.
**Measure:** Instrumented Timed Up and Go (ITUG)
**Time Frame:** at baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
18 years or older
* Diagnosis of first unilateral ischemic or hemorrhagic ictus, at least two weeks from the event, ischemic or hemorrhagic
* diagnosis confermed with Computer Tomography or Magnetic Resonance Imaging
* 1 ≤ FAC (Functional ambulation category) ≤ 3
* 50 kg ≤ weight ≤ 90 kg
* 150 cm ≤ height ≤ 192 cm
* Femor length: 355-475 mm
* Tibia length: 405-485 mm
* Pelvic width 690-990 mm
* shoe size 36-45
* Capable of standing unsupported for at least one minute
Exclusion Criteria:
* Mini Mental State Examination score (corrected for age and education) \< 24
* Clinical evidence in the medical records of visuospatial and ideomotor apraxia, behavioral disorders, neglect, severe visual and auditory sensory disorders or those which prevent use of the device
* patients at risk of fractures or with strategic fractures (unstabilized fractures or spinal instability)
* Major head trauma
* Subarachnoid hemorrhage, cerebral thrombosis
* Cardio-respiratory or internal clinical instability
* Pregnant or breastfeeding status;
* Recent malignant neoplasm
* Chronic inflammatory diseases with joint involvement of the lower limbs;
* Severe spasticity (Ashworth\>3)
* Significant limitations in passive ROM of the hips and knees
* Problems with the integrity of the skin at the interface surfaces with the device or which would prevent sitting.
* Implanted electronic devices
* Epilepsy
* Severe peripheral neuropathies
**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:** Tiziana Lencioni, PhD
**Phone:** 024030
**Phone Ext:** 8547
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Johanna Jonsdottir, PhD
**Phone:** 024030
**Phone Ext:** 8840
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Milan
**Country:** Italy
**Facility:** Fondazione Don Carlo Gnocchi IRCCS
**Zip:** 20148
#### Overall Officials
**Official 1:**
**Affiliation:** Research Head of Biomedical Technology Department
**Name:** Maurizio Ferrarin, PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Research Head of the Neurological Unit
**Name:** Andrea Corsonello, PhD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** at request to the Principal investigator
**Description:** Data will be available upon request
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
**IPD Sharing:** YES
**Time Frame:** Preliminary data will be available at the end of the study February 2025
## 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
- ID: D000009461
- Term: Neurologic Manifestations
### 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: M9515
- Name: Hemiplegia
- Relevance: LOW
- As Found: Unknown
- ID: M22058
- Name: Gait Disorders, Neurologic
- Relevance: HIGH
- As Found: Gait, Hemiplegic
- 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
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020521
- Term: Stroke
- ID: D000020233
- Term: Gait Disorders, Neurologic
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436885
**Brief Title:** An Exploratory Study of Efficacy and Safety of Iruplinalkib Tablets in Patients With ROS1 Positive Non-small Cell Lung Cancer
**Official Title:** An Exploratory Study of Efficacy and Safety of Iruplinalkib Tablets in Patients With ROS1 Positive Non-small Cell Lung Cancer
#### Organization Study ID Info
**ID:** QLMA-NSCLC-IIT-001
#### Organization
**Class:** OTHER_GOV
**Full Name:** Henan Cancer Hospital
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-28
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Henan Cancer Hospital
#### Responsible Party
**Investigator Affiliation:** Henan Cancer Hospital
**Investigator Full Name:** Yanqiu Zhao
**Investigator Title:** professor of medicine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This is a single-arm, open, multicenter exploratory clinical trial to observe and evaluate the efficacy and safety of Iruplinalkib Tablets in patients with ROS1 positive non-small cell lung cancer.
**Detailed Description:** Iruplinalkib Tablets should be administered orally at a roughly fixed time each day. Once daily, on an empty stomach or with food, 60mg per dose for days 1 to 7, 180 mg per dose from day 8 if tolerated. Swallow the tablet whole, do not crush, divide or chew the tablet.
The primary end point was objective response rate
### Conditions Module
**Conditions:**
- Non-Small Cell Lung Cancer
**Keywords:**
- non-small cell lung cancer
- ROS1
- Iruplinalkib Tablets
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 39
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Iruplinaakib tablets should be administered orally at a roughly fixed time each day. Once daily, on an empty stomach or with food, 60mg per dose for days 1 to 7, 180 mg per dose from day 8 if tolerated. Swallow the tablet whole, do not crush, divide or chew the tablet
**Intervention Names:**
- Drug: Iruplinalkib tablets
**Label:** Treatment group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment group
**Description:** Iruplinalkib tablets should be administered orally at a roughly fixed time each day. Once daily, on an empty stomach or with food, 60mg per dose for days 1 to 7, 180 mg per dose from day 8 if tolerated. Swallow the tablet whole, do not crush, divide or chew the tablet
**Name:** Iruplinalkib tablets
**Other Names:**
- Qi Xin Ke
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Objective Response Rate
**Time Frame:** up to 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Volunteer to join the study and sign the informed consent
2. ≥18 years old
3. Histologically or cytologically confirmed stage III unresectable or stage IV ROS1 positive non-small cell lung cancer
4. The ECOG performance status is 0-2
5. At least one measurable lesion according to RECIST 1.1
6. Can swallow pills normally
7. No brain metastases, or asymptomatic brain metastases, or symptomatic brain metastases that are stable for \>4 weeks after treatment
8. The function of vital organs meets the following requirements (no blood component, cell growth factor drugs are allowed within 14 days before the first medication):
Absolute neutrophil count ≥1.5×109/L Platelet ≥100×109/L Hemoglobin ≥90 g/L Serum albumin ≥30 g/L Serum total bilirubin ≤1.5×ULN ALT and AST≤ 2.5 x ULN; if liver metastasis exists, ALT and AST≤5ULN AKP≤ 2.5×ULN Serum creatinine ≤1.5×ULN International Standardized Ratio (INR) ≤1.5×ULN (not receiving anticoagulation therapy)
9. Non-surgical sterilization or female patients of reproductive age who are required to use a medically approved contraceptive method (such as an IUD, contraceptive pill or condom) during the study treatment period and for 3 months after the end of the study treatment period; Serum or urine HCG tests must be negative for women of childbearing age who have been sterilized without surgery within 7 days prior to the first dose. And must be non-lactation period; For male patients whose partner is a woman of reproductive age, effective contraception should be used during the trial and within 3 months after the last dose of the trial drug
Exclusion Criteria:
1. Patients who are participating in another clinical study or are receiving another investigational drug, or who received the investigational device within 4 weeks prior to the first treatment of our investigational drug. Patients may be included in this study if they are participating in a non-interventional clinical trial
2. Mixed small cell and NSCLC histology
3. Known history or evidence of interstitial lung disease or active non-infectious pneumonia
4. Have had other malignancies within the past 5 years or at the same time (except cured basal cell carcinoma of the skin and cervical carcinoma in situ)
5. Prior surgery or immunotherapy must be completed at least 4 weeks, and radiotherapy must be completed at least 2 weeks before the investigational drug begins
6. Have high blood pressure that is not well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); Allow the above parameters to be achieved through the use of antihypertensive therapy; A history of hypertensive crisis or hypertensive encephalopathy
7. Have clinical symptoms or diseases of heart that are not well controlled, such as: (1) NYHA2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention, (5) QTc\>450ms (male); QTc\>470ms (Female)
8. Patients with pleural effusion, ascites, or pericardial effusion requiring drainage can be enrolled if their symptoms are assessed to be stable after drainage
9. Congenital or acquired immune deficiency (such as HIV infection); Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥2000 IU/ml, or hepatitis C virus antibody positive
10. Live vaccine was administered within 4 weeks prior to or possibly during the study period
11. The presence of active gastrointestinal (GI) disease or other conditions that significantly interfere with the absorption, distribution, metabolism, or excretion of the investigational drug
12. Known allergy to the investigational drug or its excipients
13. According to the investigator's judgment, the patient has other factors that may affect the study results or lead to the forced termination of the study, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment, serious laboratory abnormalities, and family or social factors, which will affect the safety of the patient.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yanqiu Zhao
**Phone:** 13938252350
**Role:** CONTACT
**Contact 2:**
**Name:** Jie Liu
**Phone:** 13838586825
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Zhengzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yanqiu Zhao
- **Phone:** 13938252350
- **Role:** CONTACT
**Country:** China
**Facility:** Henan cancer hospital
**State:** Henan
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Henan Cancer Hospital
**Name:** Yanqiu Zhao
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012142
- Term: Respiratory Tract Neoplasms
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000002283
- Term: Carcinoma, Bronchogenic
- ID: D000001984
- Term: Bronchial Neoplasms
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M11172
- Name: Lung Neoplasms
- Relevance: HIGH
- As Found: Lung Cancer
- ID: M5546
- Name: Carcinoma, Non-Small-Cell Lung
- Relevance: HIGH
- As Found: Non-Small Cell Lung Cancer
- ID: M5534
- Name: Carcinoma
- 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
- ID: M5540
- Name: Carcinoma, Bronchogenic
- Relevance: LOW
- As Found: Unknown
- ID: M5260
- Name: Bronchial Neoplasms
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008175
- Term: Lung Neoplasms
- ID: D000002289
- Term: Carcinoma, Non-Small-Cell Lung
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436872
**Brief Title:** The Effect of Informing the Relatives of Patients Undergoing Open Heart Surgery
**Official Title:** The Effect of Informatıon Provıded to the Relatıves of Patıents Undergoıng Open Heart Surgery on the Qualıty of Lıfe and Caregıver Burden.
#### Organization Study ID Info
**ID:** GOBAEK-2022/206
#### Organization
**Class:** OTHER
**Full Name:** Trakya University
### Status Module
#### Completion Date
**Date:** 2023-10-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-09-30
**Type:** ACTUAL
#### Start Date
**Date:** 2022-05-27
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-19
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Trakya University
#### Responsible Party
**Investigator Affiliation:** Trakya University
**Investigator Full Name:** Esra Akdeniz
**Investigator Title:** BSN Nurse
**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 type of study clinical trial is to determine the effect of informing the relatives of patients undergoing open heart surgery on the patients; quality of life and caregiver burden.The main question it aims to answer are:
H1: Informing caregivers of patients undergoing open heart surgery improves the quality of life of patients.
H2: Informing caregivers of patients undergoing open heart surgery reduces caregiver burden.Relatives of patients who have undergone open heart surgery will be informed about home care before discharge. The researcher will compare the study group with the control group to see if the information given to the caregiver makes a difference on the patient\'s quality of life.
**Detailed Description:** In the study, patients were assigned to the study and control groups via the randomizer.org website.
The Caregiver Information Form was administered by the nurse researcher in a face-to-face meeting with the caregiver. The Patient Introduction Form was filled out by the researcher from the patients'; files. The Multidimensional Quality of Life Scale was administered by the researcher through a face-to-face interview with the patient. The Caregiving Burden Scale was introduced to the caregiver by the researcher and filled in by the caregiver himself. The Caregiver Tracking Form, prepared to track the patient and the caregiver, was applied to the caregiver by the researcher in order to determine the caregivers zero point. The first data collection was carried out 48 hours after the patient was admitted to the service and before information was given. Caregivers in the study group were given 45 minutes of training and a booklet in line with the training booklet prepared according to daily life activities aimed at improving the patients quality of life and reducing the caregiver's care burden. The caregivers in the study group were given the researcher's contact number and were able to reach the researcher whenever they needed.
Patients in the control group underwent standard procedure; No information, training booklet or contact number was provided. The Caregiver Information Form was administered by the researcher in a face-to-face meeting with the caregiver. The Patient Introduction Form was filled out by the researcher from the patients'; files. Multidimensional Quality of Life Scale was administered by the researcher. The Caregiving Burden Scale was introduced to the caregiver by the researcher and filled in by the caregiver himself. The Caregiver Tracking Form, prepared to track the patient and the caregiver, was applied to the caregiver by the researcher in order to determine the caregiver's zero point. Initial data were collected between 48 hours after the patient was admitted to the ward and before discharge.
Caregiving burden scale and multidimensional quality of life form were applied to both groups at the 4th week, 8th week and 12th week. Patients in the intervention group were informed again according to their needs.
### Conditions Module
**Conditions:**
- Open Heart Surgery
- Life Quality
- Caregiver Burden
**Keywords:**
- open heart surgery
- life quality
- caregiver burden
- nursing information
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Masking Description:** The data analysed by a independent researcher
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 94
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Caregivers in the study group were given 45 minutes of training and a booklet in line with the training booklet prepared according to daily life activities aimed at improving the patient's quality of life and reducing the caregiver's care burden. The caregivers in the study group were given the researcher's contact number and were able to reach the researcher whenever they needed.
**Intervention Names:**
- Other: informing patients with using a booklet
**Label:** intervention group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients in the control group underwent standard procedure; No information, training booklet or contact number was provided. The Caregiver Information Form was administered by the researcher in a face-to-face meeting with the caregiver. The Patient Introduction Form was filled out by the researcher from the patients' files. Multidimensional Quality of Life Scale was administered by the researcher. The Caregiving Burden Scale was introduced to the caregiver by the researcher and filled in by the caregiver himself. The Caregiver Tracking Form, prepared to track the patient and the caregiver, was applied to the caregiver by the researcher in order to determine the caregiver's zero point.
**Label:** Control Group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- intervention group
**Description:** The intervention group was informed before discharge and was given an information booklet. A phone number was given so that the researcher could contact the nurse. In the 4th week, 8th week and 12th week, information was given according to the information needs of the patient and caregiver.
**Name:** informing patients with using a booklet
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The multidimensional quality of life scale, which is psychometrically strong, short, easy to apply and suitable for patients diagnosed with Cardiovascular Disease, is a tool developed by Avis et al. for the purpose of multidimensional measurement of HRQoL and whose Turkish validity and reliability was obtained by Demir. The total score of the scale varies between 35-245.
**Measure:** Multidimensional quality of life scale
**Time Frame:** 12 weeks
**Description:** It was developed by Zarit, Reever and Bach-Peterson in 1980 to evaluate the stress experienced by caregivers of individuals in need of care. The evaluation of the scale is made based on the total score, and a minimum of 0 and a maximum of 88 points can be obtained from the scale. . 0-20 points obtained from the scale are classified as "little/no burden", 21-40 points as "moderate burden", 41-60 points as "severe burden" and 61-88 points as "extreme burden". A high scale score indicates that the distress experienced is high.
**Measure:** Caregiver burden scale
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria for patients:
* Over 65 years of age,
* Does not have any psychological problems and can communicate in Turkish
* Literate,
* Having undergone open heart surgery for the first time
* After being taken to the Cardiovascular Surgery Service, they are stable after completing the 48-hour critical period,
* Elderly individuals who agreed to participate in the research constituted the patient sample of the study.
Inclusion Criteria for caregivers
* The person who is primarily responsible for the patient care and will accompany the patient for 12 weeks, Caregivers,
* Between the ages of 18-65,
* Does not have any psychological problems and can communicate in Turkish,
* The caregiver sample was created by caregiver individuals who agreed to participate in the research.
Exclusion Criteria for patients:
* Those with neurological or metabolic diseases that may cause functional disability
* Previously had open heart surgery
* Patients with mental and cognitive dysfunction
* Patients who did not attend at least one of the post-surgical evaluations for any reason were excluded from the sample.
Exclusion Criteria for caregivers
* Those with neurological or metabolic diseases that may cause functional disability
* Transferring the patient care to someone else during the 12-week working period,
* Caregivers who did not attend at least one of the post-surgical evaluations for any reason were excluded from the sample.
**Minimum Age:** 65 Years
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Edirne
**Country:** Turkey
**Facility:** Trakya University
**Zip:** 22030
#### Overall Officials
**Official 1:**
**Affiliation:** Trakya Üniversite
**Name:** Esra Akdeniz, BSN
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000013315
- Term: Stress, Psychological
- 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: M2480
- Name: Caregiver Burden
- Relevance: HIGH
- As Found: Caregiver Burden
- ID: M16105
- Name: Stress, Psychological
- Relevance: LOW
- As Found: Unknown
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Life Quality
### Condition Browse Module - Meshes
- ID: D000084802
- Term: Caregiver Burden
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436859
**Brief Title:** The Effect of Stress Ball on Labor Pain, Anxiety and Satisfaction in Labor
**Official Title:** Phd Student Msc Midwifery Öznur HAYAT ÖKTEM
#### Organization Study ID Info
**ID:** Hayatoktem03
#### Organization
**Class:** OTHER
**Full Name:** Gulhane School of Medicine
### Status Module
#### Completion Date
**Date:** 2025-05-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-05-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Öznur Hayat Öktem
#### Responsible Party
**Investigator Affiliation:** Gulhane School of Medicine
**Investigator Full Name:** Öznur Hayat Öktem
**Investigator Title:** PhD student
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this study was to determine the effect of stress ball use during labor on labor pain, anxiety and satisfaction levels in women admitted to Karabük Training and Research Hospital for delivery.
H1 Using the Stress Ball in Labor reduces labor pain. H2 Using the Stress Ball in Labor Reduces Anxiety H3 Use of Stress Ball in Labor increases labor satisfaction.
**Detailed Description:** Birth is accepted as one of the physiological behaviors that have existed since the beginning of mankind and whose formation cycle has not changed. Birth is a health condition that many women desire at some point in their lives. While birth is a normal physiological process and should be an important tool for happiness, it also carries risks such as pain, suffering and discomfort. For this reason, one of the first thoughts a pregnant woman has about childbirth is labor pain. Birth pain is a central and universal part of a woman birth experience.Causes of labor pain include psychological factors such as fear and anxiety, previous experiences, birth environment, lack of information and inadequate support, as well as physical causes such as uterine contractions, cervical dilatation and effacement. Anxiety and tension experienced by pregnant women during the labor process can slow down the progress of labor. Anxiety also reduces women self-confidence, and pregnant women perceive themselves as inadequate and incompetent. Anxiety experienced during labor leads women to cesarean section at their own request.
Utilizing non-pharmacologic and supportive methods to reduce labor pain is an important part of nursing/midwifery practices. Providing alternatives that allow women to make active decision-making to reduce pain management and anxiety during labor may affect pain, anxiety and hormonal oscillations. Currently, alternative strategies to reduce the use of medication during labor are being considered.
In line with the results of this study, it is thought that the stress ball may be effective in labor, where anxiety and pain are frequently experienced.
After obtaining all official permissions, it is planned to collect the data face-to-face. In the data collection phase, the researcher will first explain the purpose of the study to the women who meet the inclusion criteria and inform them about the study through written consent of the women will be obtained. When the women in the control and experimental groups are admitted to the delivery room, the Introductory Information ; will be collected by the researcher by face-to-face interview method. In addition,;State Anxiety Scale; will be administered during the first admission, VAS before cervical dilatation 0-3 cm, 3-8 cm and 8-10 cm and before placenta emergence, and ;State Anxiety Scale; will be administered when dilatation is 0-3 and 3-8 cm (at the beginning and end of the active phase of labor).;Birth Satisfaction Scale; will be administered in the first 24 hours after delivery before the patient is discharged. Data collection will be done similarly in both groups.
According to randomization, pregnant women in the intervention group will receive ;stress ball therapy; during labor.
### Conditions Module
**Conditions:**
- Pregnancy
- Labor
**Keywords:**
- Stress ball
- labor pain
- anxiety
- satisfaction
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 48
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Stress ball group
**Intervention Names:**
- Behavioral: stress ball group
**Label:** Experiment
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Routine care
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experiment
**Description:** According to randomization, pregnant women in the intervention group will receive "stress ball therapy" during labor.
**Name:** stress ball group
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The pregnant woman's pain will be evaluated with VAS.
**Measure:** Labor pain
**Time Frame:** Vaginal examination is 0-3 cm in the latent phase, 3-8 cm in the active phase, 8-10 cm in the transitional phase and will be measured with VAS at the end of the second phase and before placenta separation.
**Description:** The state anxiety scale will be filled for anxiety .
**Measure:** Anxiety
**Time Frame:** State anxiety scale will be administered in the latent phase before the stress ball is applied and at 8 cm after the stress ball is applied.
**Description:** A minimum of 30 and a maximum of 150 points can be obtained from the scale. The higher the score, the higher the level of satisfaction.
**Measure:** Birth satisfaction status
**Time Frame:** This form will be administered in the first 24 hours after delivery before discharge.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Being at 38 weeks or more of pregnancy,
* Having a single, healthy fetus in head position,
* Applying during the latent phase of labor (cervical dilatation between 0-3 cm), .To give birth vaginally.
Exclusion Criteria:
* Having become pregnant through assisted reproductive techniques,
* Having a gestational or chronic disease,
* Having an obstacle to giving birth vaginally,
* Suspicion of fetal anomaly,
* Not volunteering to work,
* Women under the age of 18,
* Women who are illiterate in Turkish,
* Decision to perform caesarean section during labor,
* The participant wishes to withdraw from the research,
* Development of fetal distress,
* Using vacuum or forceps during birth, .Women with vision, hearing or mental problems.
**Gender Based:** True
**Healthy Volunteers:** True
**Maximum Age:** 35 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Meltem UĞURLU, associate professor
**Phone:** 05555807841
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Karabük
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** PhD student Öznur HAYAT ÖKTEM, Phd Student Msc Midwife
- **Phone:** +905053202563
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Karabuk Training and Research Hospital, obstetrics clinic
**Status:** RECRUITING
**Zip:** 78100
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M26008
- Name: Labor Pain
- Relevance: HIGH
- As Found: Labor Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000048949
- Term: Labor Pain
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436846
**Brief Title:** Genomic Risk in Retroperitoneal Sarcoma
**Official Title:** Characterization of the Genomic Risk Underlying Retroperitoneal Liposarcoma
#### Organization Study ID Info
**ID:** 21-8008
#### Organization
**Class:** OTHER
**Full Name:** Fox Chase Cancer Center
### Status Module
#### Completion Date
**Date:** 2027-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-03-07
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Fox Chase Cancer 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 protocol intends to explore the biology which may underlie recurrences of retroperitoneal liposarcoma. Surgery remains the only curative intent intervention for this disease. Often, tumors recur in locations within the retroperitoneum remote from the original primary tumor. This study hypothesizes that normal appearing retroperitoneal fat actually harbors underlying genetic changes which predispose to development of future liposarcoma. To accomplish this goal, retroperitoneal fat is sampled from quadrants within and remote from the primary tumor and is subsequently subjected to genetic analyses looking for such predisposing factors.
### Conditions Module
**Conditions:**
- Retroperitoneal Liposarcoma
- Soft Tissue Sarcoma
### Design Module
#### Bio Spec
**Description:** Samples of retroperitoneal fat (x4), subcutaneous fat (x1), primary tumor samples (x3) - all collected during surgery for tumor.
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The entire study is a singular cohort of patients with retroperitoneal liposarcoma (index or recurrent) who undergo surgical resection of their tumor.
**Intervention Names:**
- Other: Biospecimen sample collection during standard-of-care surgery
**Label:** Cohort 1
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cohort 1
**Description:** Patients in this observational study are undergoing planned surgical resection of their retroperitoneal sarcoma as prescribed by their primary surgeon and treatment team. In addition to removal of the primary tumor, surgeons remove 4 samples of retroperitoneal fat and a sample of subcutaneous fat for further study at the time of the operation.
**Name:** Biospecimen sample collection during standard-of-care surgery
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** MDM2 amplification of primary tumors and fat samples will be tested by immunohistochemistry and/or fluorescence in situ hybridization.
**Measure:** Presence of MDM2 amplification in "normal" retroperitoneal fat
**Time Frame:** Through study completion, an average of 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult patients (age ≥18 years).
* Histologically confirmed retroperitoneal liposarcoma via preoperative biopsy, or cross-sectional imaging suspicious for liposarcoma with planned surgical resection
* Will be undergoing surgical resection for treatment of primary or recurrent disease
* Have provided informed consent to participate in this study
Exclusion Criteria:
• Prior surgical anatomy which makes sampling of remote areas of the retroperitoneum technically impossible or clinically undesirable for safety reasons
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Adult patients (age 18 years or older) with retroperitoneal tumors suspicious for liposarcoma.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Anthony Villano, MD
**Phone:** 215-728-3686
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Philadelphia
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Anthony Villano, MD
- **Phone:** 215-728-3686
- **Role:** CONTACT
***Contact 2:***
- **Name:** Margaret vonMehren, MD
- **Role:** SUB_INVESTIGATOR
***Contact 3:***
- **Name:** Andres Correa, MD
- **Role:** SUB_INVESTIGATOR
***Contact 4:***
- **Name:** Jeffrey Farma, MD, FACS
- **Role:** SUB_INVESTIGATOR
***Contact 5:***
- **Name:** Stephanie Greco, MD, FACS
- **Role:** SUB_INVESTIGATOR
***Contact 6:***
- **Name:** Alexander Kutikov, MD, FACS
- **Role:** SUB_INVESTIGATOR
***Contact 7:***
- **Name:** Sanjay Reddy, MD, FACS
- **Role:** SUB_INVESTIGATOR
***Contact 8:***
- **Name:** Lori Rink, PhD
- **Role:** SUB_INVESTIGATOR
***Contact 9:***
- **Name:** Marc Smaldone, MD, MSHP, FACS
- **Role:** SUB_INVESTIGATOR
***Contact 10:***
- **Name:** Robert Uzzo, MD, MBA, FACS
- **Role:** SUB_INVESTIGATOR
***Contact 11:***
- **Name:** Rosalia Viterbo, MD, FACS
- **Role:** SUB_INVESTIGATOR
***Contact 12:***
- **Name:** Shuanzeng Wei, MD, PhD
- **Role:** SUB_INVESTIGATOR
***Contact 13:***
- **Name:** Johnathan Whetstine, PhD
- **Role:** SUB_INVESTIGATOR
***Contact 14:***
- **Name:** Margaret von Mehren, MD
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** Fox Chase Cancer Center
**State:** Pennsylvania
**Status:** RECRUITING
**Zip:** 19111
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000018204
- Term: Neoplasms, Connective and Soft Tissue
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000018205
- Term: Neoplasms, Adipose Tissue
- ID: D000000008
- Term: Abdominal Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
### 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: M15327
- Name: Sarcoma
- Relevance: HIGH
- As Found: Sarcoma
- ID: M11080
- Name: Liposarcoma
- Relevance: HIGH
- As Found: Liposarcoma
- ID: M15020
- Name: Retroperitoneal Neoplasms
- Relevance: HIGH
- As Found: Retroperitoneal Liposarcoma
- 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: M20351
- Name: Neoplasms, Adipose Tissue
- Relevance: LOW
- As Found: Unknown
- ID: M7
- Name: Abdominal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: T5284
- Name: Soft Tissue Sarcoma
- Relevance: HIGH
- As Found: Soft Tissue Sarcoma
- ID: T3479
- Name: Liposarcoma
- Relevance: HIGH
- As Found: Liposarcoma
- ID: T4986
- Name: Retroperitoneal Liposarcoma
- Relevance: HIGH
- As Found: Retroperitoneal Liposarcoma
### Condition Browse Module - Meshes
- ID: D000012509
- Term: Sarcoma
- ID: D000008080
- Term: Liposarcoma
- ID: D000012186
- Term: Retroperitoneal Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436833
**Brief Title:** Comparison of Bowel Preparation Using 2 Liter Polyethylene Glycol Regimen Plus Elobixibat Versus 4-Liter Polyethylene Glycol Regimen
**Official Title:** Comparison of Bowel Preparation Using 2 Liter Polyethylene Glycol Regimen Plus Elobixibat Versus 4-Liter Polyethylene Glycol Regimen: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 67017
#### Organization
**Class:** OTHER_GOV
**Full Name:** Rajavithi Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-11-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-24
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Rajavithi Hospital
#### 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:** Comparison of bowel preparation using 2 liter polyethylene glycol regimen plus elobixibat Versus 4-Liter polyethylene glycol regimen. This study based on hypothesis that show Boston bowel preparation scale which 2L PEG regimen plus Elobixibat have result no significant difference from 4L PEG regimen
**Detailed Description:** The trial study in participant who visit to Rajavithi hospital for indication of colonoscopy such as Colorectal cancer screening, Iron deficiency anemia, Chronic diarrhea, chronic constipation, abdominal pain, unintentional weight loss, History of stool occult blood test , abnormal finding from imaging
Randomized participant as above in to two group as bowel preparation regimen Group 1 the participant recieved Polyethylene glycol 2 liter split dose plus Elobixibat 10 milligram.
Group 2 the participant recieved Polyethylene 4 liter split dose
Result of the study show the difference of 2 regimen of bowel preparation which regimen better than another by measuring cleanliness of bowel preparation. The cleanliness of bowel preparation measured by Boston bowel preparation scale
### Conditions Module
**Conditions:**
- Bowel Preparation Solution
- Colonoscopy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 360
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Take Elobixibat 10 mg, one day before colonoscopy at 8 a.m. Take Polyethylene glycol 1 Liter, one day before colonoscopy at 8 p.m. Take polyethylene glycol 1 Liter, at day of colonoscopy at 5 a.m.
**Intervention Names:**
- Drug: 2-Liter polyethylene glycol plus elobixibat
**Label:** 2-Liter polyethylene glycol plus elobixibat
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Take Polyethylene glycol 2 Liter, one day before colonoscopy at 8 p.m. Take polyethylene glycol 2 Liter, at day of colonoscopy at 5 a.m.
**Intervention Names:**
- Drug: 4-Liter polyethylene glycol
**Label:** 4-Liter polyethylene glycol
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 2-Liter polyethylene glycol plus elobixibat
**Description:** Take Elobixibat 10 mg, one day before colonoscopy at 8 a.m. Take Polyethylene glycol 1 Liter, one day before colonoscopy at 8 p.m. Take polyethylene glycol 1 Liter, at day of colonoscopy at 5 a.m.
**Name:** 2-Liter polyethylene glycol plus elobixibat
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- 4-Liter polyethylene glycol
**Description:** Take Polyethylene glycol 2 Liter, one day before colonoscopy at 8 p.m. Take polyethylene glycol 2 Liter, at day of colonoscopy at 5 a.m.
**Name:** 4-Liter polyethylene glycol
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Bowel preaparation measure by Boston bowel preparation scale
**Measure:** Comparison efficacy of bowel preparation before colonoscopy between 2 group
**Time Frame:** During colonoscopy procedure
#### Secondary Outcomes
**Description:** Duration since start colonoscopy insertion until withdrawal endoscope
**Measure:** Overall procedural time of colonoscopy
**Time Frame:** During colonoscopy procedure
**Description:** Perform successful endoscopy to cecum
**Measure:** Cecal intubation rate
**Time Frame:** During colonoscopy procedure
**Description:** Duration since endoscopy withdrawal from cecum to anal canal
**Measure:** Withdrawal time of colonoscopy
**Time Frame:** During colonoscopy procedure
**Description:** At least one adenoma presented in this colonoscopy
**Measure:** Adenoma detection rate
**Time Frame:** During colonoscopy procedure
**Description:** Satisfaction score evaluate by Linkert scale
**Measure:** Patient satisfaction in their bowel preparation regimen
**Time Frame:** 1 day before colonoscopy
**Description:** Nausea, vomiting, abdominal pain, bloating, sleep disturbance, chest pain, dizziness, dyspnea, leg edema
**Measure:** Adverse event in each group
**Time Frame:** During 24 hour after taking bowel preparation
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adute aged 18-80 year old
* Indication for colonoscopy(one selected)
1. Colorectal cancer screening
2. Stool occult blood test positive
3. History of colonic polyp
4. abdominal pain
5. Iron deficiency anemia
6. Chronic diarrhea
7. chronic constipation
8. Unintentional weight loss
9. Gastrointestinal bleeding
10. Abnormal imagind study
* Participant acceptconsent information
Exclusion Criteria:
* Pregnancy or lactation
* Gastroparesis, gastric outlet obstuction
* Bowel obstruction
* Gastrointestinal tract surgery
* Inflammatory bowel disease
* ASA(American society of anesthesiologist physical status) status \> or = 4
* Allergic to Elobixibat or PEG
* Chronic kidney disease stage 4-5(GFR \<30 ml/min)
* Biliary tract obstruction
* Previous history of inadequate bowel preparation
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Apichet Sirinawasatien, M.D.
**Phone:** 023548108
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Somchai Uthiwamek, M.D.
**Phone:** 0851267424
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Rajavithi Hospital
**Name:** Apichet Sirinawasatien, M.D.
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**Description:** No plan for IPD sharing
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Yamaguchi D, Hidaka H, Matsunaga T, Akutagawa T, Tanaka Y, Jubashi A, Takeuchi Y, Tsuruoka N, Sakata Y, Miyahara K, Tominaga N, Kawakubo H, Takamori A, Shimoda R, Noda T, Ogata S, Tsunada S, Esaki M. Efficacy of elobixibat as bowel preparation agent for colonoscopy: Prospective, randomized, multi-center study. Dig Endosc. 2022 Jan;34(1):171-179. doi: 10.1111/den.14010. Epub 2021 May 24.
**PMID:** 33971037
**Citation:** Nakajima A, Seki M, Taniguchi S. Determining an optimal clinical dose of elobixibat, a novel inhibitor of the ileal bile acid transporter, in Japanese patients with chronic constipation: a phase II, multicenter, double-blind, placebo-controlled randomized clinical trial. J Gastroenterol. 2018 Apr;53(4):525-534. doi: 10.1007/s00535-017-1383-5. Epub 2017 Aug 24.
**PMID:** 28840422
**Citation:** Mohamed R, Hilsden RJ, Dube C, Rostom A. Split-Dose Polyethylene Glycol Is Superior to Single Dose for Colonoscopy Preparation: Results of a Randomized Controlled Trial. Can J Gastroenterol Hepatol. 2016;2016:3181459. doi: 10.1155/2016/3181459. Epub 2016 Apr 13.
**PMID:** 27446836
**Citation:** Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010 Oct;72(4):686-92. doi: 10.1016/j.gie.2010.06.068.
**PMID:** 20883845
**Citation:** Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.
**PMID:** 19136102
**Citation:** Parente F, Vailati C, Bargiggia S, Manes G, Fontana P, Masci E, Arena M, Spinzi G, Baccarin A, Mazzoleni G, Testoni PA. 2-Litre polyethylene glycol-citrate-simethicone plus bisacodyl versus 4-litre polyethylene glycol as preparation for colonoscopy in chronic constipation. Dig Liver Dis. 2015 Oct;47(10):857-63. doi: 10.1016/j.dld.2015.06.008. Epub 2015 Jul 6.
**PMID:** 26232311
**Citation:** Acosta A, Camilleri M. Elobixibat and its potential role in chronic idiopathic constipation. Therap Adv Gastroenterol. 2014 Jul;7(4):167-75. doi: 10.1177/1756283X14528269.
**PMID:** 25057297
**Citation:** Nakajima A, Taniguchi S, Kurosu S, Gillberg PG, Mattsson JP, Camilleri M. Efficacy, long-term safety, and impact on quality of life of elobixibat in more severe constipation: Post hoc analyses of two phase 3 trials in Japan. Neurogastroenterol Motil. 2019 May;31(5):e13571. doi: 10.1111/nmo.13571. Epub 2019 Feb 21.
**PMID:** 30793431
**Citation:** Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. doi: 10.1111/j.1572-0241.2002.05827.x.
**PMID:** 12135020
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436820
**Brief Title:** ICP & Outflow Study
**Official Title:** The Relationship Between Intracranial Pressure and Aqueous Outflow in Idiopathic Intracranial Hypertension
#### Organization Study ID Info
**ID:** 310393.
#### Organization
**Class:** OTHER
**Full Name:** Guy's and St Thomas' NHS Foundation Trust
### Status Module
#### Completion Date
**Date:** 2025-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Guy's and St Thomas' NHS Foundation Trust
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study aims to investigate the relationship between intracranial pressure (ICP) and aqueous outflow (the flow of the eye's internal fluid out of the eye), in patients with increased intracranial pressure (idiopathic intracranial hypertension (IIH)).
Through observing changes in aqueous outflow facility in patients scheduled for lumbar Puncture (LP) as part of their routine care the objectives we aim to answer include:
* Investigating the effect of lumbar puncture induced reduction in ICP on patients with known or suspected IIH, compared to control patients, who will be receiving LP for reasons not pertaining to high pressure.
* Comparing pre lumbar puncture aqueous outflow facility between patients with idiopathic intracranial hypertension and control patients.
Outside of the standard care provided for these patients as part of their scheduled lumbar puncture, they will have measurements of their eye taken before and after their lumbar puncture.
**Detailed Description:** This study aims to investigate the relationship between intracranial pressure (ICP) and aqueous outflow (the flow of the eye's internal fluid out of the eye), in patients with increased intracranial pressure (idiopathic intracranial hypertension (IIH)).
The effect of lowering intracranial pressure on aqueous outflow will be examined by taking additional measurements before and after a procedure called a lumbar puncture (LP). These measurements include a scan to measure the dimensions of the eye, intraocular pressure reading, and a non-invasive technique to measure aqueous outflow (electronic Schiotz tonography) which is used regularly in the eye research unit at St Thomas' Hospital.
Study participants will already be scheduled for a lumbar puncture as they have known or suspected IIH, and LP is routinely used to investigate this. Additionally, control participants having LP for reasons not pertaining to a condition that may elevate intracranial pressure will also be included. Study participants will finish their involvement following the second aqueous outflow reading, after their LP.
A lumbar puncture procedure directly measures the intracranial pressure, but also reduces the pressure in the process. If aqueous outflow is measured before and after lumbar puncture, it will provide more information about whether the change in intracranial pressure affects the intraocular pressure due to a change in the rate of fluid flowing out of the eye. If a relationship between intracranial pressure and aqueous outflow is found to be present, it may offer an alternative non-invasive measurement for intracranial pressure. Additionally, this study would highlight an avenue of investigation into dysregulation of intraocular pressure in conditions such as glaucoma. Similarly, negative findings would help inform ongoing discussions and controversies in the literature regarding relationships between intraocular pressure and intracranial pressure.
### Conditions Module
**Conditions:**
- Eye Change
- Idiopathic Intracranial Hypertension
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 66
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with suspected Idiopathic intracranial hypertension, who require a lumbar puncture as part of their standard care.
**Intervention Names:**
- Procedure: Lumbar puncture
**Label:** Suspected IIH patient group
#### Arm Group 2
**Description:** Patients who require lumbar puncture for reasons not pertaining to raised intracranial pressure as part of their standard care.
**Intervention Names:**
- Procedure: Lumbar puncture
**Label:** Control group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control group
- Suspected IIH patient group
**Description:** Lumbar puncture procedure performed within a clinical setting
**Name:** Lumbar puncture
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** To investigate the effect of lumbar puncture induced reduction in intracranial pressure on aqueous outflow facility in patients with known or suspected idiopathic intracranial hypertension, compared to control patients.
**Measure:** Primary Outcome Meassure
**Time Frame:** 18 Months
#### Secondary Outcomes
**Description:** To compare pre lumbar puncture aqueous outflow facility between patients with idiopathic intracranial hypertension and control patients.
**Measure:** Secondary Outcome Measure
**Time Frame:** 18 Months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Males or female between the ages of 18 and 80 (inclusive).
* Able to understand the study and give informed consent.
* Willing, able and available to participate in all aspects of the study.
* Able to undergo accurate tonography.
* Diagnosis of IIH or suspected diagnosis of IIH as determined by a consultant subspecialist neurologist or neuro-ophthalmologist.
Control group will only include:
* Individuals requiring lumbar puncture as part of their standard care for reasons other than suspected raised intracranial pressure e.g. for CSF sampling to analyse oligoclonal bands or other conditions necessitating lumbar puncture for diagnostic/prognostic purposes.
* Individuals suspected of having a raised intracranial pressure but, upon measurement of the opening pressure, are found to have an intracranial pressure within normal limits.\*
* In this study, where there are considered to be signs of raised intracranial pressure as judged by a consultant neuro ophthalmologist or neurologist, in combination with an opening CSF pressure 20cmH2O or greater, this will be taken as a raised intracranial pressure. Normal CSF pressure is taken as 19cmH2O or lower. In asymptomatic patients, pressures of up to 25cmH2O will be considered normal.
Exclusion Criteria
* Under 18 or over 80 years of age.
* Diagnosis of ocular hypertension (ocular hypertension is defined as any individual with an intraocular pressure above 24mmHg measured on Goldman tonometry, irrespective of corneal thickness. This applies to intraocular pressure measured historically as well on the day of assessment).
* Diagnosis of glaucoma of any subtype (glaucoma is defined on the basis of any glaucomatous optic nerve head appearance \[including that defined on the basis of optic nerve head optical coherence tomography\] or visual field defect, irrespective of intraocular pressure).
* Diagnosis of any significant retinal, corneal or other ocular abnormality aside from optic nerve head oedema secondary to raised ICP.
* Previous intraocular surgery or any surgery in which the conjunctiva has been breached e.g. optic nerve sheath fenestration or squint surgery.
* Diagnosis of raised intracranial pressure secondary to space occupying lesions.
* Any central nervous system or other systematic disorder that is likely to make lumbar puncture high risk or likely to render accurate recording of opening pressures unreliable.
* Mental impairment conflicting with informed consent.
* Patients who might not adequately understand written information given in English or verbal explanations in English will not be included as participants in the study must be able to understand English to complete some of the tests.
* Participants will not be included if they are involved in research deemed by the investigators to impact the outcomes of this study.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients will be recruited from neuro-ophthalmology clinics and neurology clinics in St Thomas hospital London UK
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Kin Sheng Lim
**Phone:** 02071884885
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10024
- Name: Hypertension
- Relevance: HIGH
- As Found: Hypertension
- ID: M21521
- Name: Intracranial Hypertension
- Relevance: HIGH
- As Found: Intracranial Hypertension
- ID: M14416
- Name: Pseudotumor Cerebri
- Relevance: HIGH
- As Found: Idiopathic Intracranial Hypertension
- ID: M17400
- Name: Vascular 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: T3002
- Name: Idiopathic Intracranial Hypertension
- Relevance: HIGH
- As Found: Idiopathic Intracranial Hypertension
### Condition Browse Module - Meshes
- ID: D000019586
- Term: Intracranial Hypertension
- ID: D000011559
- Term: Pseudotumor Cerebri
- ID: D000006973
- Term: Hypertension
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436807
**Brief Title:** PMCF Study of the CE-marked Drainova® ArgentiC Catheter
**Official Title:** Post-Market Clinical Follow-up Study to Assess the Safety, Performance, and Clinical Benefit of the CE-marked Drainova® ArgentiC Catheter
#### Organization Study ID Info
**ID:** 23-079
#### Organization
**Class:** INDUSTRY
**Full Name:** ewimed GmbH
### Status Module
#### Completion Date
**Date:** 2026-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** LS medcap GmbH
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** ewimed GmbH
#### Responsible Party
**Type:** SPONSOR
### Description Module
**Brief Summary:** The goal of this observational study is to learn about the performance of the drainova® ArgentiC Catheter in clinical routine, which is used to treat fluid accumulations in hollow body structures. The device is already on the market and participants receive the catheter as part of their regular treatment.
The main questions of this study are:
* Does the device function as intended?
* Are there any other safety risks that have not been identified?
* Does it lower the symptoms of the patients as intended?
Doctors and patients will answer questions regarding the improvement of the patients´ symptoms and if there were any problems with the catheter.
**Detailed Description:** The drainova® ArgentiC Catheter initially received the CE mark in 2019 under the Medical Device Directive 93/42/EEC, thus being considered a legacy device under the Medical Device Regulation (EU) 2017/745 (MDR). In order to fulfill the requirements of the MDR, this PMCF study is planned to be conducted to obtain clinical data on the device confirming its safety, performance and clinical benefit in clinical routine according to the instructions for use (IFU).
This PMCF study is performed as a purely observational activity within the current standards of care and without additional invasive or burdensome procedures. The drainova® ArgentiC catheter is a catheter indicated for the treatment of patients with pleural effusions and ascites, both in the malignant and non-malignant manifestations.
### Conditions Module
**Conditions:**
- Pleural Effusion
- Pleural Effusion, Malignant
- Ascites
- Ascites, Malignant
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 162
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** The tunneled catheter is an implant product that enables the drainage of effusion accumulations from serous body cavities so that the symptoms caused by an effusion are relieved by draining off the accumulated fluids.
**Name:** Indwelling catheter
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Measured by assessing the VAS score of the patient´s symptoms (e.g. pain) at baseline and discharge (defined by clinical routine).
**Measure:** Ascites- and pleural effusion-associated symptom relief
**Time Frame:** Discharge (1-7 days post-implantation)
**Description:** Occurrence of catheter blockage, occlusion or displacement
**Measure:** Catheter patency
**Time Frame:** Discharge (1-7 days post-implantation)
**Description:** Must meet the following items:
1. Successful placement at the defined location
2. Feasibility of initial drainage of fluid (volume in ml)
**Measure:** Implantation success
**Time Frame:** Immediately after procedure
**Description:** Frequency of device- and/ or procedure-related major adverse events (MAEs), infections and device deficiencies
**Measure:** Incidence of major adverse events, infections and device deficiencies
**Time Frame:** Up to three months post-implanatation
#### Secondary Outcomes
**Description:** Quality-of-life will be assessed by QoL questionnaire
**Measure:** Improvement of the patients´ quality-of-life vs. baseline
**Time Frame:** discharge (1-7 days post-implantation), 30 days, 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients ≥ 18 years old
* Patients being able to give informed consent
Exclusion Criteria:
Patients with any contraindication according to the IFU:
* presence of septa in the body cavity
* coagulopathy
* infection in the body cavity
* lymphatic effusion
* shift of the mediastinum (by more than 2 cm to the ipsilateral side of the pleural effusion)
* known allergies to any of the materials used in the drainage product
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients with recurrent, refractory, malignant and non-malignant effusions in serous body cavities according to the IFU.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Natasa Mitrovic, MSc
**Phone:** +49 7471 9849 9529
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Heidrun Steinle, Dr
**Phone:** +49 7471 9848 0175
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** LS medcap GmbH
**Name:** Heidrun Steinle, Dr
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010995
- Term: Pleural Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000010335
- Term: Pathologic Processes
- ID: D000010997
- Term: Pleural Neoplasms
- ID: D000012142
- Term: Respiratory Tract Neoplasms
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
### 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
### Condition Browse Module - Browse Leaves
- ID: M18563
- Name: Pleural Effusion, Malignant
- Relevance: HIGH
- As Found: Pleural Effusion, Malignant
- ID: M13886
- Name: Pleural Effusion
- Relevance: HIGH
- As Found: Pleural Effusion
- ID: M4509
- Name: Ascites
- Relevance: HIGH
- As Found: Ascites
- ID: M13885
- Name: Pleural Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13887
- Name: Pleural 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
### Condition Browse Module - Meshes
- ID: D000016066
- Term: Pleural Effusion, Malignant
- ID: D000010996
- Term: Pleural Effusion
- ID: D000001201
- Term: Ascites
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436794
**Brief Title:** "Mantou" Screening for GDM Before 20 Weeks of Gestation
**Official Title:** "Mantou" Screening for Gestational Diabetes Mellitus Before 20 Weeks of Gestation:A Prospective,Multicenter Study.
#### Organization Study ID Info
**ID:** MS-GDM-01
#### Organization
**Class:** OTHER
**Full Name:** The First Affiliated Hospital with Nanjing Medical University
### Status Module
#### Completion Date
**Date:** 2026-05-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-08-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-16
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Jiang Ziyan
#### Responsible Party
**Investigator Affiliation:** The First Affiliated Hospital with Nanjing Medical University
**Investigator Full Name:** Jiang Ziyan
**Investigator Title:** MD
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Gestational diabetes mellitus (GDM) can occur in overweight, hyperinsulinemia, insulin resistance pregnant women, or lean, insulin deficiency pregnant women. At least 5% of all pregnant women will develop GDM, which is even higher among Asians. Poor control of GDM in late pregnancy will increase the following risks: macrosomia, preeclampsia, shoulder dystocia, cesarean section, stillbirth and other risks. At present, the screening method for GDM is 75g of glucose OGTT test. However, when drinking sugared water on an empty stomach, the pregnant women will feel nausea, stomach burning, and hunger when waiting for blood drawing. Some women vomit after drinking sugared water, resulting in inaccurate test results and poor compliance, affecting the accuracy of diagnosis of GDM. "Sugar tolerance Mantou" has been used for screening diabetes since 1982. It is made of 100g flour and contains 75g glucose of the same amount. It is a feasible method to use Mantou instead of sugar powder to screen GDM. Mantou is an acceptable diet for Chinese people, which greatly reduces nausea, vomiting, hunger and other discomfort, and increases GDM screening rate. At present, the cesarean section rate in China remains high, and the weight and nutritional management of pregnant women are not satisfied. Many pregnant women, especially those in country-level areas, have already gained excessive weight when referred from to delivery hospitals, leading to an increase in pregnancy complications such as preeclampsia and macrosomia, increasing the cesarean section rate and delivery risk. Therefore, it is necessary to screen GDM in advance. Moving forward the screening of GDM and strengthening the management of pregnant women's weight can effectively reduce the occurrence of pregnancy complications.
### Conditions Module
**Conditions:**
- GDM
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 5925
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Label:** 12-14 weeks
#### Arm Group 2
**Label:** 15-17 weeks
#### Arm Group 3
**Label:** 18-20 weeks
### Outcomes Module
#### Primary Outcomes
**Measure:** GDM incidence rate
**Time Frame:** up to 28 weeks of gestation
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:Singleton , before 20 weeks of gestation, aged 18-40 years old, able to understand the experimental requirements, willing and able to follow the experimental and follow-up procedures.
Exclusion Criteria: diabetes diagnosed before pregnancy, serious heart disease, blood disease, immune system disease and other unsuitable for pregnancy, twin or multiple pregnancy, age\<18 or\>40, fetal death in utero before 28 weeks, serious mental illness, and inability to communicate.
**Healthy Volunteers:** True
**Maximum Age:** 40 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
**Study Population:** pregnant woman
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** ziyan jiang
**Phone:** 13512534017
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Nanjing
**Country:** China
**Facility:** First Affiliated Hospital of Nanjing Medical University
**State:** Jiangsu
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M19012
- Name: Diabetes, Gestational
- Relevance: LOW
- As Found: Unknown
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436781
**Brief Title:** Effect of Maolactin™ FMR on Exercise Recovery, Inflammation, and Muscle Comfort in an Otherwise Healthy Population
**Official Title:** Effect of Maolactin™ FMR Supplementation on Exercise Recovery, Inflammation, and Muscle Comfort in an Otherwise Healthy Population: A Double-blind Randomized Placebo-controlled Study
#### Organization Study ID Info
**ID:** MAOJOI(A)
#### Organization
**Class:** INDUSTRY
**Full Name:** RDC Clinical Pty Ltd
### Status Module
#### Completion Date
**Date:** 2025-07-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-04-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-31
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** RDC Clinical Pty Ltd
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This is a double blind, randomised, placebo-controlled, parallel-group trial to evaluate the effect of Maolactin FMR supplementation on post exercise inflammation, exercise recovery and muscle fatigue and pain in an otherwise healthy population of adults 18-65 years old over 10 weeks with 8 weeks of supplementation.
This is PART A of the study.
### Conditions Module
**Conditions:**
- Post Exercise Inflammation
- Exercise Recovery
- Muscle Fatigue
- Muscle Pain
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 2 capsules containing a total of 500 mg/day active proteins taken once daily before the morning meal
**Intervention Names:**
- Drug: Maolactin
**Label:** Maolactin
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** 2 capsules containing maltodextrin (0mg/day active proteins) taken once daily before the morning meal
**Intervention Names:**
- Drug: Maltodextrin
**Label:** Maltodextrin
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Maolactin
**Description:** Once daily dose of 2 capsules containing a total of 500mg/day Maolactin
**Name:** Maolactin
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Maltodextrin
**Description:** Once daily dose of 2 capsules of Maltodextrin containing a total of 0mg/day Maolactin
**Name:** Maltodextrin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Change in post exercise muscle breakdown as assessed by creatine kinase (CK) via blood test
**Measure:** Change in post exercise muscle breakdown
**Time Frame:** Baseline (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise) and Week 8 (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise)
#### Secondary Outcomes
**Description:** Change in Weight as measured by digital scales
**Measure:** Change in Weight
**Time Frame:** Baseline and Week 8
**Description:** Change in BMI as assessed by digital scale for weight and stadiometer for height
**Measure:** Change in Body Mass Index (BMI)
**Time Frame:** Baseline and Week 8
**Description:** Change in MSK-HQ as self-reported by participants. Scored on a range of 0-56, with a higher score indicating health status.
**Measure:** Change in Musculoskeletal Health Questionnaire (MSK-HQ)
**Time Frame:** Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))
**Description:** Change in VAS Muscle Pain as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of muscle pain.
**Measure:** Change in Visual Analogue Scale (VAS) Muscle Pain
**Time Frame:** Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))
**Description:** Change in VAS Pain as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of pain
**Measure:** Change in Visual Analogue Scale (VAS) Pain
**Time Frame:** Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))
**Description:** Change in VAS Fatigue as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of fatigue.
**Measure:** Change in Visual Analogue Scale (VAS) Fatigue
**Time Frame:** Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))
**Description:** Change in VAS Mobility as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of mobility.
**Measure:** Change in Visual Analogue Scale (VAS) Mobility
**Time Frame:** Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))
**Description:** Change in VAS Stiffness as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of stiffness.
**Measure:** Change in Visual Analogue Scale (VAS) Stiffness
**Time Frame:** Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))
**Description:** Change in MFI as self-reported by participants. Comprises 20 questions rated on a 5 point scale. with a higher score indicating a higher level of fatigue.
**Measure:** Change in Multidimensional Fatigue Inventory (MFI)
**Time Frame:** Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))
**Description:** Change in PRSS as self-reported by participants. A single-item, 0 to 10 point scale where 0 = very poorly recovered (poor performance) and 10 = fully recovered (optimal performance).
**Measure:** Change in The Perceived Recovery Status Scale (PRSS)
**Time Frame:** Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))
**Description:** Change in BP as assessed by digital blood pressure monitor
**Measure:** Change in Blood Pressure (BP)
**Time Frame:** Baseline and Week 8
**Description:** Change in HR as assessed by digital heart rate monitor
**Measure:** Change in Heart Rate (HR)
**Time Frame:** Baseline (Time 0 and every 5 minutes until return to baseline) and Week 8 (Time 0 and every 5 minutes until return to baseline)
**Description:** Change in Oxygen Saturation as measured by pulse oximeter
**Measure:** Change in Oxygen Saturation
**Time Frame:** Baseline and Week 8
**Description:** Change in Cytokines as measured by blood test
**Measure:** Change in Cytokines
**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
**Description:** Change in NF-kB as measured by blood test
**Measure:** Change in Nuclear Factor KappaB (NF-kB)
**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
**Description:** Change in P-selectin as measured by blood test
**Measure:** Change in P-selectin
**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
**Description:** Change in E-selectin as measured by blood test
**Measure:** Change in E-selectin
**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
**Description:** Change in Lp-PLA2 as measured by blood test
**Measure:** Change in Lipoprotein-associated Phospholipase A2 (Lp-PLA2)
**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
**Description:** Change in ICAM-1 as measured by blood test
**Measure:** Change in Intercellular Cell Adhesion Molecule-1 (ICAM-1)
**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
**Description:** Change in ICAM-2 as measured by blood test
**Measure:** Change in Intercellular Cell Adhesion Molecule-2 (ICAM-2)
**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
**Description:** Change in VCAM-1 as measured by blood test
**Measure:** Change in Vascular Cell Adhesion Molecule-1 (VCAM-1)
**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
**Description:** Change in PECAM-1 as measured by blood test
**Measure:** Change in Platelet Endothelial Cell Adhesion Molecule-1 (PECAM-1)
**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
**Description:** Change in ESR as measured by blood test
**Measure:** Change in Erythrocyte Sedimentation Rate (ESR)
**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
**Description:** Change in LDH as measured by blood test
**Measure:** Change in Lactate Dehydrogenase (LDH)
**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
**Description:** Change in P38 as measured by blood test
**Measure:** Change in P38 Mitogen-activated Protein Kinases (P38)
**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
**Description:** Change in E/LFT as measured by blood test
**Measure:** Change in Electrolytes and Liver Function Tests (E/LFT)
**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
**Description:** Change in Lactic acid as measured by blood test
**Measure:** Change in Lactic acid
**Time Frame:** Baseline (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise) and Week 8 (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise)
**Description:** Change in CRP as measured by blood test
**Measure:** Change in C-reactive protein (CRP)
**Time Frame:** Baseline (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise) and Week 8 (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise)
**Description:** Change in myoglobin as measured by blood test
**Measure:** Change in myoglobin
**Time Frame:** Baseline (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise) and Week 8 (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise)
**Description:** Change in 1 Repetition Max (1-RM) as assessed by exercise testing
**Measure:** Change in 1 Repetition Max (1-RM)
**Time Frame:** Baseline (Session 1 and Session 2 (+24 hours)) and Week 8 (Session 1, Session 2 (+24 hours))
**Description:** Change in Number of Repetitions to Fatigue as assessed by exercise testing
**Measure:** Change in Number of Repetitions to Fatigue
**Time Frame:** Baseline (Session 1 and Session 2 (+24 hours)) and Week 8 (Session 1, Session 2 (+24 hours)
**Description:** Change in Hand Grip Strength as measured by dynamometer
**Measure:** Change in Hand Grip Strength
**Time Frame:** Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))
**Description:** Change in BORG Perception of intensity (RPE) as self-reported by participants. Rates exertion from a scale of 6 (no exertion) to 20 (maximum effort). A rating between 12 to 14 typically reflects a moderate or somewhat hard level of intensity.
**Measure:** Change in BORG Perception of intensity (RPE)
**Time Frame:** Baseline (Session 1 and Session 2 (+24 hours)) and Week 8 (Session 1, Session 2 (+24 hours)
**Description:** Change in Adverse Events self-reported by participants
**Measure:** Change in Adverse Events
**Time Frame:** 8 week period from enrolment to participant conclusion
**Description:** Change in Gastrointestinal Tolerance as measured by Gastrointestinal Tolerance (GIT) Questionnaire
**Measure:** Change in Gastrointestinal Tolerance
**Time Frame:** 1 week after starting product
**Description:** Change in diet as assessed by 3 day Diet Recall
**Measure:** Change in diet
**Time Frame:** Baseline and Week 8
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults 18-65 years old
* Generally healthy
* BMI 19.0 - 29.9 kg/m2
* Able to provide informed consent
* Generally active, low to moderately trained (with a minimum of 1 resistance exercise sessions per week)
* Agree not to change current diet and/or exercise frequency or intensity during study period
* Agree to not participate in another clinical trial while enrolled in this trial
Exclusion Criteria:
* Undertaking high intensity exercise training and or undertaking more than 3 days of resistance training per week.
* Serious illness(1) e.g., mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions
* Unstable illness(2) e.g., diabetes and thyroid gland dysfunction
* Unstable intake of any medication or supplement(3)
* Acute injuries on reporting area
* Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
* Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin
* Receiving medications known to affect inflammation such as steroids
* Active smokers, nicotine use or drug (prescription or illegal substances) abuse
* Chronic past and/or current alcohol use (\>21 alcoholic drinks per week)
* Pregnant or lactating women
* Allergic to any of the ingredients in active or placebo formula
* Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
1. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
2. An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity.
3. An unstable intake is any dose that has changed by more than 10% of the previous dose in the past 4-weeks
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Amanda Rao, PhD
**Phone:** +61 414 488 559
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** David Briskey, PhD
**Phone:** +61 421 784 077
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Brisbane
**Country:** Australia
**Facility:** RDC Clinical Pty Ltd
**State:** Queensland
**Zip:** 4006
#### Overall Officials
**Official 1:**
**Affiliation:** RDC Clinical Pty Ltd
**Name:** David Briskey, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000009135
- Term: Muscular Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000059352
- Term: Musculoskeletal Pain
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M10293
- Name: Inflammation
- Relevance: HIGH
- As Found: Inflammation
- ID: M30156
- Name: Myalgia
- Relevance: HIGH
- As Found: Muscle Pain
- ID: M8364
- Name: Fatigue
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12092
- Name: Muscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M29444
- Name: Musculoskeletal Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000063806
- Term: Myalgia
- ID: D000007249
- Term: Inflammation
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |