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## Protocol Section
### Identification Module
**NCT ID:** NCT06444568
**Brief Title:** Modified Ketogenic Diet in Amnestic Mild Cognitive Impairments
**Official Title:** Efficacy of Modified Ketogenic Diet in Amnestic Mild Cognitive Impairments
#### Organization Study ID Info
**ID:** MKD001
#### Organization
**Class:** OTHER
**Full Name:** Saglik Bilimleri Universitesi
### Status Module
#### Completion Date
**Date:** 2025-02-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Ankara University
#### Lead Sponsor
**Class:** OTHER
**Name:** Saglik Bilimleri Universitesi
#### Responsible Party
**Investigator Affiliation:** Saglik Bilimleri Universitesi
**Investigator Full Name:** Mehmet Ilkin Naharci
**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:** This clinical study aims to examine the effectiveness of a 12-week modified ketogenic diet (MKD) intervention, especially on cognitive functions, in individuals diagnosed with amnestic-mild cognitive impairment (aMCI) and to compare the effects of control groups (passive or active).
Accordingly, a sample of 36 older adults aged 65-80 years diagnosed with aMCI will be randomized into 3 different groups: passive control (without any intervention), active control (MIND: Mediterranean-DASH Intervention for Neurodegenerative Delay diet) or intervention (MKD). They will be monitored according to targeted criteria throughout the 12-week study protocol.
The main questions this study aims to answer are:
* Does a 12-week MKD intervention improve cognitive functions in aMCI?
* Does the effectiveness of the 12-week MKD intervention in aMCI (i.e., in terms of cognitive function, physical and functional measures, or metabolic/inflammatory biomarkers) differ from control groups?
Expected from participants during the study protocol:
* Participants assigned to the passive control arm are expected to come to the research center at the beginning (week 0) and end (week 12) of the protocol and participate in evaluations.
* Participants assigned to the active control (MIND diet) or intervention (MKD) arm are expected to adhere to assigned dietary therapy, keep a weekly food diary, and have weekly phone calls or online meetings with the dietitian to follow up on the diet. These participants assigned to the diet groups are expected to come to the research center at weeks 0, 4, 8, and 12 to participate in the evaluations.
**Detailed Description:** This study is an open-label, parallel-group randomized controlled clinical trial. The researchers hypothesized that a 12-week modified ketogenic diet (MKD) intervention in participants diagnosed with amnestic-mild cognitive impairments (aMCI) would improve cognitive functions and progression criteria compared to control groups.
The research sample will consist of individuals diagnosed with aMCI, and 36 volunteers, 12 individuals, were randomly assigned to three different research arms according to the block randomization method. To evaluate this sample size in the "repeated measures ANOVA" test of three independent groups with a medium effect size (f:0.30), 5% significance level (α), and 90% power (1-β) in the power analysis, the sample size should be at least 27 individuals has been calculated.
According to the dropout rate (25%) reported in similar ketogenic diet intervention studies in the literature, 36 was targeted as the sample size of the study.
For confidentiality purposes, the coding method will be used in the processing of data according to the study arms and the order of inclusion in the protocol (i.e., PC-1, AC-1, or KD-1, passive/active control, and the ketogenic diet, respectively). It is planned to evaluate cognitive functions with ADAS-Cog (Alzheimer's Disease Assessment Scale: Cognitive Subscale), physical performance with motor-cognitive dual-task and hand grip strength, and functional capacity with Lawton instrumental activities of daily living scale. Yesavage Geriatric Depression Scale-short form (GDS-15), which will also be used as an eligibility criterion, will be used to evaluate mood.
Intervention: After examining the food consumption diaries (7 days), diet planning will be made for the appropriate study arm (MIND or MKD). The daily energy of the diets is eucaloric in two diet groups, and daily energy will be determined according to the daily average energy intake determined by the nutritional status assessment of the individual and the ESPEN (European Society for Clinical Nutrition and Metabolism) consensus recommendation.
Ketogenic diet calculations will be made through the KetoDietCalculator program. The two basic principles of the planned modified ketogenic diet are 1) protein intake of 1 g/kg per day, and 2) a ketogenic diet ratio 1:1. According to the determined daily energy intake, the contribution of macronutrients to daily energy will be determined by the ketogenic diet ratio. Controlling protein intake per body weight is not a routine practice in ketogenic diet applications, and in this study - to preserve lean body mass as much as possible in elderly individuals - the ESPEN consensus recommendation will be taken into account in the calculations.
The MIND diet, which is the control group diet, will be planned following the 14 dietary guidelines defined elsewhere, and the above criteria will be applied in the same way in determining daily energy. MIND is a diet whose neuroprotective properties are currently accepted, with its ability to delay cognitive function loss and dementia supported by many population-based prospective studies.
Following the dietary training, both groups will be given brochures containing the basic principles and instructions of the diet and educational materials containing recipes developed specifically for the diet group. Compliance with the ketogenic diet is evaluated according to the individuals' serum ketone level (compliance criterion: β-hydroxybutyrate/BHB: 0.5-2.5 mmol/L) and food consumption diaries evaluated at 4, 8, and 12 weeks. Compliance with the MIND diet, which is the active control diet, will be evaluated with the MIND diet score calculated from weekly food consumption diaries (compliance criterion: MIND score \>10/14).
In evaluating all outcome variables, the per-protocol analysis method will be applied to examine only participants who completed the research protocol. The intention-to-treat method will be used to evaluate some secondary outcome variables (i.e., biomarkers and anthropometry). Changes in primary and secondary outcome variables between the intervention and control groups during the study will be evaluated by repeated measures ANOVA test. All statistical tests will be evaluated in the SPSS (Statistical Package for Social Science) program at 90% power and 5% significance level.
### Conditions Module
**Conditions:**
- Amnestic Mild Cognitive Disorder
- Amnestic Mild Cognitive Impairment
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 36
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The passive control arm will not receive any intervention and will only be evaluated for primary outcome variables at the beginning (week: 0) and at the end (week: 12) of the protocol.
**Label:** Passive control group
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** MIND diet will be applied to participants assigned to the active control arm for 12 weeks. This group will be evaluated at visits (week: 0-4-8-12) in terms of primary and secondary outcome variables, in parallel with the intervention group (KD).
**Intervention Names:**
- Other: Dietary Intervention
**Label:** Active control group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** The modified ketogenic diet (MKD) will be applied to participants assigned to the intervention arm for 12 weeks. This group will be evaluated for primary and secondary outcome variables at visits (weeks 0-4-8-12).
**Intervention Names:**
- Other: Dietary Intervention
**Label:** Intervention group (Modified ketogenic diet)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Active control group
- Intervention group (Modified ketogenic diet)
**Description:** The intervention includes the application and follow-up of different diet therapies to individuals (Ketogenic diet and MIND).
**Name:** Dietary Intervention
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** GDS-15 scores will be evaluated to assess mood at the baseline and end of the protocol visits. This scale evaluates mood between 0 (minimum) and 15 (maximum) scores; scores of 0-4 are considered normal, 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
**Measure:** Geriatric Depression Scale-short form (GDS-15) score
**Time Frame:** Baseline (week:0) - end of the protocol (week:12)
**Description:** The body weight (kg) will be measured with a Tanita SC330 body composition analyzer (Tanita Health Co., Ltd., Tokyo, Japan) at planned visits throughout the protocol (baseline and end of the protocol for passive control, all visits for active control or intervention groups).
**Measure:** Body weight (kg)
**Time Frame:** Baseline (week:0) - week:4 - week:8 - end of the protocol (week:12)
**Description:** The height assessment will be performed using a SECA 220 stadiometer (Seca Ltd., United Kingdom) fixed to the wall and recorded in cm.
**Measure:** Body height (cm)
**Time Frame:** Baseline (week:0)
**Description:** The body mass index (BMI) will be calculated by dividing the measured body weight (kg) by the square of the height (m). The BMI will be calculated and recorded throughout the protocol (baseline and end of the protocol for passive control, all visits for active control or intervention groups).
**Measure:** Body Mass Index (BMI, kg/m^2)
**Time Frame:** Baseline (week:0) - week:4 - week:8 - end of the protocol (week:12)
**Description:** Body composition will be analyzed via bioelectrical impedance analysis (BIA) using a Tanita SC330 body composition analyzer (Tanita Health Co., Ltd., Tokyo, Japan). The fat-free mass (kg) obtained as a result of this analysis will be recorded to examine the effects of the intervention at visits planned throughout the protocol. (baseline and end of protocol for passive control, all visits for active control or intervention groups).
**Measure:** Fat-free mass (kg, via body composition analysis)
**Time Frame:** Baseline (week:0) - week:4 - week:8 - end of the protocol (week:12)
**Description:** Body composition will be analyzed via bioelectrical impedance analysis (BIA) using a Tanita SC330 body composition analyzer (Tanita Health Co., Ltd., Tokyo, Japan). The fat mass (kg) obtained as a result of this analysis will be recorded to examine the effects of the intervention at visits planned throughout the protocol. (baseline and end of protocol for passive control, all visits for active control or intervention groups).
**Measure:** Fat mass (kg, via body composition analysis)
**Time Frame:** Baseline (week:0) - week:4 - week:8 - end of the protocol (week:12)
**Description:** Reported side effects will be recorded weekly only in the MKD arm to monitor compliance and tolerance to the ketogenic diet.
**Measure:** Weekly reported side effects relevant ketogenic diet
**Time Frame:** week 0-12
#### Primary Outcomes
**Description:** Cognitive functions will be evaluated with the ADAS-Cog (Alzheimer's Disease Assessment Scale: Cognitive Subscale) test. This widely used test to assess global cognition, evaluates memory, language, praxis, and orientation with scores ranging from 0 (minimum) to 70 (maximum); increasing scores indicate poorer cognitive performance.
**Measure:** ADAS-Cog score
**Time Frame:** Baseline (week:0) - end of the protocol (week:12)
#### Secondary Outcomes
**Description:** Motor-cognitive dual-task testing will be administered to evaluate physical performance. The determined motor and cognitive tasks are 4 meters walking speed and counting backward from 20, respectively, and time (seconds) will be recorded during these tasks. (baseline and end of the protocol for passive control, all visits for active control or intervention groups).
**Measure:** Dual-task (Physical performance)
**Time Frame:** Baseline (week:0) - week:4 - week:8 - end of the protocol (week:12)
**Description:** Hand grip strength will be recorded to evaluate physical performance. The measurement will be performed using the Takei T.K.K.5401 Grip-D digital hand dynamometer (Takei Scientific Instruments Co., Ltd, Japan) and will be repeated twice with both hands and the average score (kg) will be recorded. (baseline and end of the protocol for passive control, all visits for active control or intervention groups).
**Measure:** Handgrip strength (kg)
**Time Frame:** Baseline (week:0) - week:4 - week:8 - end of the protocol (week:12)
**Description:** Within the scope of the research, the measurement of total cholesterol (TC, mg/dL) was planned to evaluate the effect of dietary intervention on the lipid profile.
**Measure:** Total cholesterol (TC, mg/dL)
**Time Frame:** Baseline (week:0) - end of the protocol (week:12)
**Description:** Within the scope of the research, the measurement of low-density lipoprotein cholesterol (LDL-C, mg/dL) was planned to evaluate the effect of dietary intervention on the lipid profile.
**Measure:** Low-density lipoprotein cholesterol (LDL-C, mg/dL)
**Time Frame:** Baseline (week:0) - end of the protocol (week:12)
**Description:** Within the scope of the research, the measurement of high-density lipoprotein cholesterol (HDL-C, mg/dL) was planned to evaluate the effect of dietary intervention on the lipid profile.
**Measure:** High-density lipoprotein cholesterol (HDL-C, mg/dL)
**Time Frame:** Baseline (week:0) - end of the protocol (week:12)
**Description:** Within the scope of the research, the measurement of Tumor Necrosis Factor-α (TNF-α) was planned to evaluate the effect of dietary intervention on the inflammatory response.
**Measure:** Tumor Necrosis Factor-alpha (TNF-α, pg/mL)
**Time Frame:** Baseline (week:0) - end of the protocol (week:12)
**Description:** Within the scope of the research, serum β-HB was planned at all the visits to monitor compliance with the ketogenic diet. (compliance criteria: β-HB: 0,5-2,5 mmol/L).
**Measure:** β-hydroxybutyrate (β-HB, mmol/L)
**Time Frame:** Baseline (week:0) - week:4 - week:8 - end of the protocol (week:12)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Having been diagnosed with "amnestic mild cognitive impairment/disorder (aMCI)" by the clinician after the evaluation of cognitive functions according to the neuropsychological evaluation method (0.5 according to the Clinical Dementia Rating Scale (CDR).)
* Having at least 6 years of education.
Exclusion Criteria:
* Under the age of 65 or over the age of 80.
* Diagnosis of neurological (other than MCI) or psychological diseases.
* GDS-15 score \> 5 (baseline)
* Kidney/pancreas/liver diseases or dysfunctions, Type 1 diabetes (and Type II diabetic patients receiving insulin replacement therapy), cancer, metabolic diseases (fatty acid oxidation defect, etc.), thyroid dysfunction, pulmonary or autoimmune diseases, head trauma, history of any cardiovascular event (i.e., stroke, myocardial infarction) in the last year.
* Hypercholesterolemia (fasting T-C \>300 mg/dL or LDL-C \>200 mg/dL), non-reference B12 or folate levels according to biochemical tests performed in the last year.
* Nutritional risks (chewing/swallowing difficulties, history of involuntary weight loss in the last 6 months, body mass index \< 22 kg/m2).
* Use of internal device/implant (pacemaker or hearing aid, etc.).
* Medication use (individuals using anticholinergic, antidementia, and opioid class drugs will be excluded; individuals using antidepressant class drugs will be included in the study on the condition that it has been continued for at least 3 months and there is no change in drug type and dose during the study protocol.)
**Maximum Age:** 80 Years
**Minimum Age:** 65 Years
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mehmet I Naharcı, Prof.
**Phone:** (+90)5435418899
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Hilal Şimşek
**Phone:** (+90)5435418899
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Ankara
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mehmet I Naharci, Prof.
- **Phone:** (+90)5435418899
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Gulhane Faculty of Medicine & Gulhane Training and Research Hospital
**Status:** RECRUITING
**Zip:** 06010
#### Overall Officials
**Official 1:**
**Affiliation:** Saglik Bilimleri University
**Name:** Mehmet I Naharcı, Prof.
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Neth BJ, Mintz A, Whitlow C, Jung Y, Solingapuram Sai K, Register TC, Kellar D, Lockhart SN, Hoscheidt S, Maldjian J, Heslegrave AJ, Blennow K, Cunnane SC, Castellano CA, Zetterberg H, Craft S. Modified ketogenic diet is associated with improved cerebrospinal fluid biomarker profile, cerebral perfusion, and cerebral ketone body uptake in older adults at risk for Alzheimer's disease: a pilot study. Neurobiol Aging. 2020 Feb;86:54-63. doi: 10.1016/j.neurobiolaging.2019.09.015. Epub 2019 Sep 26.
**PMID:** 31757576
**Citation:** Phillips MCL, Deprez LM, Mortimer GMN, Murtagh DKJ, McCoy S, Mylchreest R, Gilbertson LJ, Clark KM, Simpson PV, McManus EJ, Oh JE, Yadavaraj S, King VM, Pillai A, Romero-Ferrando B, Brinkhuis M, Copeland BM, Samad S, Liao S, Schepel JAC. Randomized crossover trial of a modified ketogenic diet in Alzheimer's disease. Alzheimers Res Ther. 2021 Feb 23;13(1):51. doi: 10.1186/s13195-021-00783-x.
**PMID:** 33622392
**Citation:** Liu X, Morris MC, Dhana K, Ventrelle J, Johnson K, Bishop L, Hollings CS, Boulin A, Laranjo N, Stubbs BJ, Reilly X, Carey VJ, Wang Y, Furtado JD, Marcovina SM, Tangney C, Aggarwal NT, Arfanakis K, Sacks FM, Barnes LL. Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) study: Rationale, design and baseline characteristics of a randomized control trial of the MIND diet on cognitive decline. Contemp Clin Trials. 2021 Mar;102:106270. doi: 10.1016/j.cct.2021.106270. Epub 2021 Jan 9.
**PMID:** 33434704
**Citation:** de Crom TOE, Mooldijk SS, Ikram MK, Ikram MA, Voortman T. MIND diet and the risk of dementia: a population-based study. Alzheimers Res Ther. 2022 Jan 12;14(1):8. doi: 10.1186/s13195-022-00957-1.
**PMID:** 35022067
**Citation:** Kheirouri S, Alizadeh M. MIND diet and cognitive performance in older adults: a systematic review. Crit Rev Food Sci Nutr. 2022;62(29):8059-8077. doi: 10.1080/10408398.2021.1925220. Epub 2021 May 14.
**PMID:** 33989093
## 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: M29705
- Name: Cognitive Dysfunction
- Relevance: HIGH
- As Found: Mild Cognitive Impairment
- ID: M6301
- Name: Cognition Disorders
- 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:** NCT06444555
**Acronym:** Adonut
**Brief Title:** Adolescent Nutrition in Girls in Burkina Faso and Ethiopia
**Official Title:** Nutritional Needs and Food Supplement Intake of Adolescent Girls in Burkina Faso and Ethiopia
#### Organization Study ID Info
**ID:** ONZ-2024-0038
#### Organization
**Class:** OTHER
**Full Name:** University Ghent
### Status Module
#### Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-28
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Addis Continental Institute of Public Health
**Class:** OTHER_GOV
**Name:** Institut de Recherche en Sciences de la Sante, Burkina Faso
**Class:** OTHER
**Name:** Bill and Melinda Gates Foundation
**Class:** UNKNOWN
**Name:** AfricSanté, Burkina Faso
#### Lead Sponsor
**Class:** OTHER
**Name:** University Ghent
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Adolescents' diets are key to breaking the intergenerational cycle of malnutrition. This study will guide policies and programs on the adequacy, acceptability, and feasibility of implementing balanced energy protein and multiple micronutrient supplementations to fill nutrient gaps in adolescent girls. Using a trial, the study will assess dietary intake and nutrient gaps, acceptability of balanced energy protein and multiple micronutrient supplementations. In addition to the trial, the study will the assess willingness to pay for the supplements and the most effective delivery platform and model to reach vulnerable adolescent girls. The most effective delivery platform and model to reach vulnerable adolescent girls cost-effectively will also be assessed through interviews with (inter)national experts, producers, and the donor community.
**Detailed Description:** In low- and middle-income countries, it is estimated that each year, 21 million adolescent girls become mothers. Infants of adolescent mothers are at increased risk of delivering babies preterm, with low birth weight or length. Targeting nutrition interventions to improve adolescent girls' diet and nutrition is crucial to breaking the intergenerational cycle of poor growth and development. There is a specific need to assess how a balanced energy protein (BEP) and multiple micronutrient (MMN) supplement interventions can be tailored to adolescent girls and women of reproductive age.
This study aims to assess the adequacy, acceptability, and feasibility of implementing nutritional supplementations to fill nutrient gaps in adolescent girls in resource-limited settings. A trial will specifically:
1. assess the short-term acceptability of BEP and MMN supplements
2. assess how nutrition supplements increase nutrient adequacy of diets adolescent girls in resources-limited settings;
Using a qualitative component, the study explores the food agency of adolescents and the most effective delivery platform to reach vulnerable adolescent girls cost-effectively. The overall aim is to guide policies and programs on new formulations of nutritional supplements for adolescent girls in resource-limited settings.
### Conditions Module
**Conditions:**
- Nutrition Deficiency Due to Insufficient Food
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** 200 adolescent girls will be enrolled in Ethiopia and 200 adolescent girls will be enrolled in Burkina Faso.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 400
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Fortified lipid-based nutrient supplement
**Intervention Names:**
- Dietary Supplement: BEP supplement
**Label:** Balanced Energy Protein Supplement
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP).
**Intervention Names:**
- Dietary Supplement: Multiple Micronutrient supplement
**Label:** Multiple Micronutrient Supplement
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Balanced Energy Protein Supplement
**Description:** The BEP supplement used in Burkina Faso is a fortified medium-quantity lipid-based nutrient supplement called Plumpy'Doz. The product is a peanut and milk-based ready-to-use nutritional formulation produced by Nutriset. A peanut-based BEP formulation with a trademark Plumpy'Sup produced by Hilina Enriched Foods PLC will be used in Ethiopia.
**Name:** BEP supplement
**Other Names:**
- Balanced energy protein supplement
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Multiple Micronutrient Supplement
**Description:** The MMS formulation is based on the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP). The formulation contains 15 minerals and vitamins and is administered as a tablet.
**Name:** Multiple Micronutrient supplement
**Other Names:**
- UNIMAPP
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** Acceptability to the nutritional supplements, as measured using a 9-item scale (1 "Dislike extremely" up to 9 "Like extremely")
**Measure:** Acceptability of the supplement
**Time Frame:** Day 8 (after 7 days of consumption)
**Description:** Mean nutrient adequacy ratio of adolescent diets, using 24 h recall
**Measure:** Nutritional adequacy
**Time Frame:** Day 8 (after 7 days of consumption)
#### Secondary Outcomes
**Description:** Mean household head's willingness to pay values elicited through their bids
**Measure:** Willingness to pay for the supplement
**Time Frame:** Day 8 (after 7 days of consumption)
**Description:** Percent of the recommended nutritional supplement consumed during the intervention period, self-reported
**Measure:** Reported consumption of the supplement
**Time Frame:** Day 8 (average of 7-day intervention)
**Description:** Substitution of food and nutrition intake at group level, using 24 h recall
**Measure:** Substitution of food and nutrient intake
**Time Frame:** Day 8 (after 7 days of consumption)
**Description:** Mean energy, macronutrient and micronutrient intake between the BEP and MMS group at endline, using 24 h recall
**Measure:** Nutrient intake
**Time Frame:** Day 8 (after 7 days of consumption)
### Eligibility Module
**Eligibility Criteria:** Eligibility criteria are all based on self-reported information
Inclusion criteria:
* Non-pregnant and non-lactating women
* Without any known chronic illness or acute illness affecting appetite
* Permanent residents of the study area
Exclusion criteria:
* Being allergic to peanuts
* Eating disorders or dietary restrictions
**Gender Based:** True
**Gender Description:** Only females are recruited.
**Healthy Volunteers:** True
**Maximum Age:** 19 Years
**Minimum Age:** 15 Years
**Sex:** FEMALE
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Carl Lachat, Prof
**Phone:** 003292649377
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Laeticia Céline Toé, MD
**Phone:** 003292649377
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Bobo-Dioulasso
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Moctar Ouédraogo, M.S.
- **Phone:** +22670238198
- **Role:** CONTACT
***Contact 2:***
- **Name:** Laeticia C Toé, M.D., M.S.
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Moctar Ouédraogo, M.S.
- **Role:** SUB_INVESTIGATOR
**Country:** Burkina Faso
**Facility:** Agence de Formation, de Recherche et d'Expertise en Santé pour l'Afrique (AFRICSanté)
**Status:** RECRUITING
**Location 2:**
**City:** Addis Ababa
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yemane Berhane, Prof
- **Phone:** +251114168207
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Firehiwot Workneh, Dr.
- **Role:** CONTACT
**Country:** Ethiopia
**Facility:** Addis Continental Institute of Public Health
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Addis Continental Institute of Public Health
**Name:** Yemane Berhane, Prof
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Addis Continental Institute of Public Health
**Name:** Firehiwot Workneh, dr.
**Role:** STUDY_DIRECTOR
**Official 3:**
**Affiliation:** University Ghent
**Name:** Moustapha Drabo, Dr
**Role:** STUDY_DIRECTOR
**Official 4:**
**Affiliation:** University Ghent
**Name:** Carl Lachat, Prof
**Role:** STUDY_CHAIR
**Official 5:**
**Affiliation:** Institute de Recherche en Sciences de la Santé, Bobo Dioulasso
**Name:** Laeticia Céline Toé, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 6:**
**Affiliation:** University Ghent
**Name:** Hans De Steur, Prof
**Role:** PRINCIPAL_INVESTIGATOR
**Official 7:**
**Affiliation:** University Ghent
**Name:** Alemayehu Alemayehu, Dr
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Personal data will only be shared under a data sharing agreement, subject to approval by the relevant authorities. The transfer will only be performed in the public interest, which means that it will increase knowledge and insight to society's direct or indirect benefit.
**Description:** The data will be transferred to the donor in a pseudo-anonymised way. After preparing a data-sharing agreement, the investigators will also share food intake data with the FAO/WHO Global Individual Food Consumption Data Tool. All research output generated by the project is open access as part of the Grant Agreement with the funder. Given the personal nature of the data, individual data will only be shared after a data transfer agreement with third parties. The ICF mentions that data can be shared outside the study team.
**IPD Sharing:** YES
**Time Frame:** IPD data will be shared after data cleaning and quality checks are completed. All study other study materials will be shared after the finalisation of the data collection.
## Derived Section
### Intervention Browse Module - Ancestors
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M17558
- Name: Vitamins
- Relevance: LOW
- As Found: Unknown
- ID: M21009
- Name: Micronutrients
- Relevance: HIGH
- As Found: Operating room
- ID: M16885
- Name: Trace Elements
- Relevance: HIGH
- As Found: Operating room
### Intervention Browse Module - Meshes
- ID: D000018977
- Term: Micronutrients
- ID: D000014131
- Term: Trace Elements
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444542
**Acronym:** U-Screen
**Brief Title:** Understanding Patient Preference on Colorectal Cancer Screening Options-PSU
**Official Title:** Understanding Patient Preference on Colorectal Cancer Screening Options
#### Organization Study ID Info
**ID:** STUDY00023853
#### Organization
**Class:** OTHER
**Full Name:** Milton S. Hershey Medical Center
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-25
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Guardant Health, Inc.
**Class:** UNKNOWN
**Name:** HealthLinc, Inc
**Class:** UNKNOWN
**Name:** PCC Community Wellness Center
#### Lead Sponsor
**Class:** OTHER
**Name:** Milton S. Hershey Medical Center
#### Responsible Party
**Investigator Affiliation:** Milton S. Hershey Medical Center
**Investigator Full Name:** Karen Kim
**Investigator Title:** Dean at Penn State College 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:** There are significant barriers to colorectal cancer screening within underserved populations due to the cost, accessibility, and acceptability of screening methods. Patient-friendly approaches that minimize stress and discomfort for the patient are needed to enhance screening compliance and achieve an early diagnosis. The primary aim of this study is to examine whether the availability of a blood-based screening option, which can be done at the point of service and is familiar to patients, will improve patient compliance to recommended CRC screening
**Detailed Description:** Scientific Background and Gaps Colorectal cancer (CRC) is the third most common cancer type and the second leading cause of cancer death in the United States. The lethal nature of CRC is attributable to its being largely asymptomatic during the early stages and the lack of curative treatment options for patients with progressive disease. Early detection by screening significantly reduces mortality from CRC; however, many people are not up to date with screening, with overall screening rates under 70%. Furthermore, about a quarter of age-eligible adults (27.1 million) have never been screened for CRC. A recent study found that not being up to date with screening was associated with an approximate 3-fold risk for CRC-related mortality. Despite many years of effort and funding support, CRC screening rates have plateaued, with a considerable segment of the population remaining unscreened. The percentage of age-eligible adults who were up to date with CRC screening only increased by 1.4% (4.2 million) from 67.4% in 2016 to 68.8% in 2018. Compliance with CRC screening is particularly poor among medically underserved populations, including those with low income and racial/ethnic minority populations. There are significant barriers to screening within underserved populations due to the cost, accessibility, and acceptability of screening methods. To date, there are many well-established CRC screening modalities and can include invasive and non-invasive options that detect both polyps and cancer or cancer alone. Colonoscopy is considered the gold standard for CRC screening and remains the dominant screening modality in the U.S. However, due to the invasiveness, perception of discomfort and embarrassment, logistical challenges (e.g., lack of transportation, time off of work), cost, and potential risks, the uptake of colonoscopy is low. For patients unwilling to screen with colonoscopy, non-invasive stool-based testing can shift CRC detection to earlier and more curable stages. However, the compliance of stool-based testing is suboptimal due to the cultural stigma surrounding sample collection techniques and the inconvenience of returning the kit for testing. Increasing patient compliance and adherence to screening is critical to improving CRC outcomes. Patient-friendly approaches that minimize stress and discomfort for the patient are needed to enhance screening compliance and achieve an early diagnosis. A blood-based screening option can improve CRC screening uptake and adherence at FQHCs, and, ultimately, eliminate unnecessary cancer disparities.
Previous Data Patient compliance is a major barrier to achieving universal screening. Blood-based testing can offer an alternative for patients who fail to comply with other screening modalities. Blood tests are non-invasive compared to colonoscopy, and individuals are more willing to have a blood test than take a stool sample at home. In a cross-sectional survey of 100 individuals, 91% ranked a blood-based test as their first or second choice of screening (58% for the first choice, 10% tied, and 23% for the second choice) compared with colonoscopy, sigmoidoscopy, or stool-based tests. Furthermore, over two-thirds of minority respondents (n=62) chose a blood-based screening test as their first choice for future screening. Blood-based screening test also presents an opportunity to overcome challenging barriers, such as transportation and time off from work, limiting screening participation.
Study Rationale A key to improving screening participation is patient acceptance of the testing method. Indeed, all the screening modalities have benefits over time, and compliance to testing is essential for successful screening. A blood-based screening test can easily be part of a routine clinic visit and the patient can complete the test while is still at the clinic. Patients are accustomed to providing blood samples for other screening tests, such as cholesterol screening and the use of blood-based CRC screening test is likely more in line with a patient's expectations of medical care. On January 19, 2021, the Centers for Medicare and Medicaid Services announced that the blood-based biomarker test is an appropriate CRC screening once every 3 years for Medicare patients when performed in a CLIA-certified laboratory, ordered by a treating physician, and the blood-based biomarker screening test has a sensitivity greater than or equal to 74% and a specificity greater than or equal to 90% in the detection of CRC.
The last decades have seen many discovery studies identifying promising biomarkers of CRC. Improving testing methods for blood-based CRC testing have been developed and implemented in clinical settings as well. The first blood-based CRC screening test, SEPT9 DNA (Epi proColon), was approved by the FDA in 2016 for persons at average risk for CRC who have chosen not to undergo screening by existing guideline-recommended methods. This study will offer a lab-developed Guardant SHIELD blood-based CRC screening test to patients who failed to complete a stool-based screening test or a colonoscopy six months after receiving an order from their providers. The Guardant SHIELD blood-based screening test will be free to the patients with an order from their providers. The Guardant SHIELD test is a multimodal blood-based colorectal neoplasia detection assay incorporating ctDNA (circulating tumor DNA) assessment of somatic mutations and tumor-derived methylation and fragmentomic patterns to maximize early-stage CRC detection sensitivity. Overall, the Guardant SHIELD blood-based test has a CRC sensitivity of 91% and a specificity of 94%, meeting the Centers for Medicare and Medicaid Services requirement (74% for sensitivity and 90% for specificity). All the blood samples collected in this study will be processed at the CLIA-certified Guardant Health Laboratory.
Compliance by age-eligible patients is essential to the success of any screening program. However, the acceptance by health care providers and the health care system is also critical, and especially colonoscopy remains the dominant modality for CRC in the U.S. Applying the current state of research evidence to health care involves fostering the adoption, implementation, spread, and sustainability of new evidence-based interventions to care. Furthermore, transferring effective interventions into real-world settings and maintaining them is a complicated, long-term process that requires complex phases of intervention diffusion. In this study, we will examine the inclusion of a blood-based screening option to increase patient compliance with CRC screening while developing implementation strategies to facilitate the adoption of a new blood-based screening test at primary care clinics.
### Conditions Module
**Conditions:**
- Colo-rectal Cancer
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 900
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Blood-based colorectal cancer screening
**Name:** Guardant Shield
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** We will ask participants the following survey question: "Will you prefer to use the blood-based screening test for future colorectal cancer screening?" Response options range from 0 to 10 where 0 is "not at all" and 10 is "very much". We will split the response options at the median and categorize the measure into a "yes/no" response.
**Measure:** Patient preference for a blood-based screening option
**Time Frame:** 2023-2025
#### Secondary Outcomes
**Description:** This study will monitor the adoption rates for Guardant SHIELD blood-based screening over time and how long it takes to achieve 2.5%, 16%, and 50% adoption rates (adoption rate = the number of new users / total number of potential users). We will monitor the adoption rate quarterly. In addition, we will also monitor the intensity of use.
This study will monitor the adoption rates for Guardant SHIELD blood-based screening over time and how long it takes to achieve 2.5%, 16%, and 50% adoption rates (adoption rate = the number of new users / total number of potential users). We will monitor the adoption rate quarterly. In addition, we will also monitor the intensity of use
**Measure:** Adoption rate
**Time Frame:** 2023-2025
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
To be enrolled in this study, participants must meet all the following criteria:
1. Between 45-75 years of age
2. Language Proficiency: participants must be fluent in English or Spanish
3. Have an average risk for colorectal cancer
4. Be a patient at one of our partner FQHCs
5. Received a screening order (either using a stool-based test or colonoscopy) six months ago and failed or refused to complete the screening test
6. Able and willing to provide a blood sample per protocol
Exclusion Criteria:
Participants will be excluded from enrolling in the study if they meet any of the following:
1. Family history
* One first-degree relative diagnosed with CRC or advanced adenoma at age \<60 years
* Two first-degree relatives diagnosed with CRC or advanced adenoma at any age
* Known hereditary gastrointestinal cancer syndromes, such as Lynch Syndrome or Familial Adenomatous and Polyposis (FAP)
2. Personal History
* Participants who do not speak either Spanish or English
* History of CRC or adenoma
* History of cancers
* History of inflammatory bowel disease, including chronic ulcerative colitis and Crohn's disease
* Have a recorded up to date CRC screening
* Blood product transfusion in the past 120 days
* A medical condition which, in the opinion of the patient's health provider, should preclude enrollment in the study
**Maximum Age:** 75 Years
**Minimum Age:** 45 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients who failed to complete a stool-based screening test or a colonoscopy six months after receiving an order from their providers
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Paula Lozano, PhD
**Phone:** 312-535-3750
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hershey
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Karen E. Kim, MD
- **Phone:** 717-531-8521
- **Role:** CONTACT
**Country:** United States
**Facility:** Penn State College of Medicine
**State:** Pennsylvania
**Zip:** 17033
#### Overall Officials
**Official 1:**
**Affiliation:** Penn State College of Medicine
**Name:** Karen E. Kim, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**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
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: HIGH
- As Found: Colorectal Cancer
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: 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
### Condition Browse Module - Meshes
- ID: D000015179
- Term: Colorectal Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444529
**Brief Title:** A Double-Masked Comparison of FID 123320 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness
**Official Title:** A Double-Masked Comparison of Apraclonidine Hydrochloride Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness
#### Organization Study ID Info
**ID:** DEW422-C001
#### Organization
**Class:** INDUSTRY
**Full Name:** Alcon Research
### Status Module
#### Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Alcon Research
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to assess the safety and efficacy of Apraclonidine Hydrochloride Ophthalmic Solution 0.125% when compared to Vehicle, in relieving redness of the eye due to minor eye irritations. This study will be conducted in the United States.
**Detailed Description:** The study will consist of six (6) scheduled visits: Screening and/or Baseline Visit (Day -7 to -1), Eligibility Confirmation/Randomization/1st Treatment Visit (Day 1), Week 2 Follow-Up Visit (Day 14), Week 4 Follow-Up Visit (Day 28), Week 8 Follow-Up/Treatment Discontinuation Visit (Day 56) and Exit Visit (Day 63). The expected individual duration of participation in the study is approximately 10 weeks with approximately 56 days of exposure to the investigational product.
### Conditions Module
**Conditions:**
- Ocular Redness
**Keywords:**
- Eye redness
- Irritated eyes
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 240
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** One drop in each eye on Day 1, followed by 2 drops in each eye on Day 2 onward for approximately 8 weeks
**Intervention Names:**
- Drug: Apraclonidine Hydrochloride Ophthalmic Solution
**Label:** Apraclonidine Hydrochloride Ophthalmic Solution
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** One drop in each eye on Day 1, followed by 2 drops in each eye on Day 2 onward for approximately 8 weeks
**Intervention Names:**
- Drug: Vehicle
**Label:** Vehicle
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Apraclonidine Hydrochloride Ophthalmic Solution
**Description:** Investigational ophthalmic solution applied topically to the eye with a dropper bottle
**Name:** Apraclonidine Hydrochloride Ophthalmic Solution
**Other Names:**
- FID 123320
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Vehicle
**Description:** Vehicle (inactive ingredients) applied topically to the eye with a dropper bottle
**Name:** Vehicle
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). This endpoint is co-primary with the 10 hours post-instillation endpoint.
**Measure:** Mean change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1
**Time Frame:** Day 1: Pretreatment; 15 minutes post-treatment
**Description:** Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). This endpoint is co-primary with the 15 minutes post-instillation endpoint.
**Measure:** Mean change from baseline in investigator-assessed ocular redness at 10 hours (600 minutes) post-instillation on Day 1
**Time Frame:** Day 1: Pretreatment; 10 hours (600 minutes) post-treatment
#### Secondary Outcomes
**Description:** Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe).
**Measure:** Mean change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1
**Time Frame:** Day 1: Pretreatment; 1 minute post-treatment
**Description:** Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe).
**Measure:** Mean change from baseline in investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1
**Time Frame:** Day 1: Pretreatment; 8 hours (480 minutes) post-treatment
**Description:** Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe).
**Measure:** Mean change from baseline in investigator-assessed ocular redness at 12 hours (720 minutes) post-instillation on Day 1
**Time Frame:** Day 1: Pretreatment; 12 hours (720 minutes) post-treatment
### Eligibility Module
**Eligibility Criteria:** Key Inclusion Criteria:
* Capable of giving signed informed consent;
* Willing and able to follow all instructions and attend all study visits;
* Able to self-administer eye drops- in the opinion of the investigator;
* History of redness relief drop use within the last 6 months, or a desire to use over-the-counter (OTC) eye drops for redness relief;
* Females capable of becoming pregnant: Agree to urine pregnancy tests and the use of medically acceptable forms of birth control throughout the study;
* Ocular health within normal limits, including best-corrected visual acuity (BCVA) of 20/40 or better in each eye as measured using a Snellen chart;
* Ocular redness at baseline as specified in the protocol;
* Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
* Known contraindications or sensitivities to the use of any of the investigational drug(s) or their components, or any other medication required by the protocol;
* Ocular surgical interventions within 6 months prior to Visit 1 or during the study;
* Ocular conditions that, in the opinion of the investigator, could affect the subject's safety or study parameters (i.e., could affect ocular redness, intraocular pressure, or eyelid position);
* Disallowed medications or devices as specified in the protocol;
* Planned surgery (ocular or systemic) during the study period or within 30 days after the study period;
* Other protocol-defined exclusion criteria may apply.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Alcon Call Center
**Phone:** 1-888-451-3937
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Fort Worth
**Country:** United States
**Facility:** Contact Alcon Call Center for Trial Locations
**State:** Texas
**Zip:** 76134
#### Overall Officials
**Official 1:**
**Affiliation:** Alcon Research, LLC
**Name:** Principal Clinical Trial Lead, Pharma
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012871
- Term: Skin Diseases
- ID: D000012877
- Term: Skin Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M8044
- Name: Erythema
- Relevance: HIGH
- As Found: Redness
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15680
- Name: Skin Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004890
- Term: Erythema
### Intervention Browse Module - Ancestors
- ID: D000019999
- Term: Pharmaceutical Solutions
- ID: D000058647
- Term: Adrenergic alpha-2 Receptor Agonists
- ID: D000000316
- Term: Adrenergic alpha-Agonists
- ID: D000000322
- Term: Adrenergic Agonists
- ID: D000018663
- Term: Adrenergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M12814
- Name: Ophthalmic Solutions
- Relevance: HIGH
- As Found: 14 days
- ID: M230201
- Name: Apraclonidine
- Relevance: HIGH
- As Found: Wedge pressure
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M20746
- Name: Adrenergic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M3668
- Name: Adrenergic alpha-Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M3673
- Name: Adrenergic Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000009883
- Term: Ophthalmic Solutions
- ID: C000016986
- Term: Apraclonidine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444516
**Brief Title:** Study of Safety and Performance of a Novel Ocular Lubricant in Subjects With Dry Eye Disease
**Official Title:** A Single-Arm Study to Evaluate and Demonstrate Safety and Performance of a Novel Ocular Lubricant in Adult Subjects With Dry Eye Disease
#### Organization Study ID Info
**ID:** DEP918-C001
#### Organization
**Class:** INDUSTRY
**Full Name:** Alcon Research
### Status Module
#### Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Alcon Research
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to evaluate and demonstrate the efficacy and safety of an investigational ocular lubricant formulation in patients with mild to moderate dry eye disease (DED).
**Detailed Description:** The study will consist of a Screening visit, a Baseline visit on Day 1, a remote Compliance Check on Day 14, and an Exit visit on Day 30. The expected study duration of participation for each subject is 37 days, with 30 ± 5 days of exposure to the investigational product.
### Conditions Module
**Conditions:**
- Dry Eye Disease
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 185
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** One drop of FID123300 ocular lubricant in each eye on Day 1 in the morning, followed by at least one drop in each eye 4 times a day on Days 2-30.
**Intervention Names:**
- Other: FID123300 ocular lubricant
**Label:** FID123300
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- FID123300
**Description:** Investigational ocular lubricant
**Name:** FID123300 ocular lubricant
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The IDEEL-SB module consists of 20 questions that assess general dry eye symptoms a subject may experience. For each question, the subject will be instructed to select a single response that best represents their answer. The Symptom Bother score is calculated as the mean value of the non-missing item scores 1-20 multiplied by 25. A paired (one-sample) t-test will be used on the change from baseline value at Day 30 for hypothesis testing.
**Measure:** Change from Baseline in Impact of Dry Eye on Everyday Life - Symptom Bother (IDEEL-SB) Questionnaire Score at Day 30
**Time Frame:** Baseline (Day 1); Day 30
### Eligibility Module
**Eligibility Criteria:** Key Inclusion Criteria:
* Willing and able to understand and sign an approved informed consent form.
* Exhibit symptoms of dry eye at the Screening visit.
* Best Corrected Visual Acuity equal to or better than 20/80 Snellen in each eye at the Screening visit.
* Willing to discontinue use of all artificial tear supplements and use only the study product as directed starting at Visit 2/Day 1.
* Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
* Pregnant, breastfeeding, or planning to become pregnant during the study.
* Ocular abnormalities that could adversely affect the safety or efficacy outcome.
* Uncontrolled active systemic diseases.
* Use of systemic medications known to cause dry eye.
* Other protocol-defined exclusion criteria may apply.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Alcon Call Center
**Phone:** 1-888-451-3937
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Largo
**Country:** United States
**Facility:** Lee Shettle Eye
**State:** Florida
**Zip:** 33773
**Location 2:**
**City:** Maitland
**Country:** United States
**Facility:** Kindred Optics at Maitland Vision Center
**State:** Florida
**Zip:** 32751
**Location 3:**
**City:** Orlando
**Country:** United States
**Facility:** Vision Health Institute
**State:** Florida
**Zip:** 32803
**Location 4:**
**City:** Franklin Park
**Country:** United States
**Facility:** Franklin Park Eye Center, PC
**State:** Illinois
**Zip:** 60131
**Location 5:**
**City:** Pittsburg
**Country:** United States
**Facility:** Kannarr Eye Care, LLC
**State:** Kansas
**Zip:** 66762
**Location 6:**
**City:** New York
**Country:** United States
**Facility:** SUNY College of Optometry Clinical Vision Research Center
**State:** New York
**Zip:** 10036
**Location 7:**
**City:** Granville
**Country:** United States
**Facility:** ProCare Vision Center
**State:** Ohio
**Zip:** 43023
**Location 8:**
**City:** Wyomissing
**Country:** United States
**Facility:** Wyomissing Optometric Center
**State:** Pennsylvania
**Zip:** 19610
**Location 9:**
**City:** Memphis
**Country:** United States
**Facility:** Optometry Group, PLLC
**State:** Tennessee
**Zip:** 38111
**Location 10:**
**City:** Wichita Falls
**Country:** United States
**Facility:** Clarke Eyecare Center
**State:** Texas
**Zip:** 76308
#### Overall Officials
**Official 1:**
**Affiliation:** Alcon Research, LLC
**Name:** Sr. Clinical Trial Lead, Vision Care
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007766
- Term: Lacrimal Apparatus Diseases
- ID: D000007637
- Term: Keratoconjunctivitis
- ID: D000003231
- Term: Conjunctivitis
- ID: D000003229
- Term: Conjunctival Diseases
- ID: D000007634
- Term: Keratitis
- ID: D000003316
- Term: Corneal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M18040
- Name: Dry Eye Syndromes
- Relevance: HIGH
- As Found: Dry Eye Disease
- ID: M10664
- Name: Keratoconjunctivitis Sicca
- Relevance: HIGH
- As Found: Dry Eye Disease
- ID: M8271
- Name: Eye Diseases
- Relevance: HIGH
- As Found: Eye Disease
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M10663
- Name: Keratoconjunctivitis
- Relevance: LOW
- As Found: Unknown
- ID: M10786
- Name: Lacrimal Apparatus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6455
- Name: Conjunctivitis
- Relevance: LOW
- As Found: Unknown
- ID: M6453
- Name: Conjunctival Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10660
- Name: Keratitis
- Relevance: LOW
- As Found: Unknown
- ID: M6539
- Name: Corneal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015352
- Term: Dry Eye Syndromes
- ID: D000007638
- Term: Keratoconjunctivitis Sicca
- ID: D000005128
- Term: Eye Diseases
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444503
**Acronym:** OSCAR
**Brief Title:** Clinico-biological Collection of Bone, Calcium and Growth Plate Pathologies.
**Official Title:** Creation of a Biological Collection to Study the Pathophysiology and Identify Predictive Factors for the Evolution of Bone, Calcium and Growth Plate Pathologies.
#### Organization Study ID Info
**ID:** RC31/24/0214
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Toulouse
### Status Module
#### Completion Date
**Date:** 2034-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2034-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Toulouse
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this project is to set up a biological and clinical collection of patients with progressive bone, calcium and growth plate pathologies.
This collection will provide a better understanding of the mechanisms involved in growth plate and bone damage in these diseases and identify factors predictive of progression and new therapeutic targets.
### Conditions Module
**Conditions:**
- Bone Disorder
### Design Module
#### Bio Spec
**Description:** Blood, urine, other body fluids and tissues biopsies
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 350
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** As part of their pathology, patients benefit from clinical monitoring and regular blood and urine tests.
**Intervention Names:**
- Other: Biological
**Label:** Patients suffering from growth plate or bone pathology
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patients suffering from growth plate or bone pathology
**Description:** Blood and urine will be taken in larger quantity
**Name:** Biological
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Patients suffering from growth plate or bone pathology
**Description:** Surgical residues may be preserved in the event of surgery carried out as part of the treatment.
**Name:** Biological
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Blood and urine sampling
**Measure:** Building a collection of biological samples and clinical-biological data from patients presenting bone, calcium and growth plate pathologies
**Time Frame:** Day 0 and through study completion, an average of 5 years
#### Secondary Outcomes
**Measure:** Identification of potential markers of disease progression based on new knowledge.
**Time Frame:** Day 0 and through study completion, an average of 5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Children (from birth) with growth plate or bone pathology
* Patients affiliated to or benefiting from a social security scheme
* Patients able to receive information about the study and to understand the information form in order to participate in the study. This implies :
* mastery of the French language
* Not being subject to a restriction of rights by the judicial authorities
* Patients or legal representatives having given their consent to participate in the study (expression of non-opposition).
Exclusion Criteria:
* Patients under legal protection (guardianship, curatorship or safeguard of justice)
* Pregnant or breast-feeding women
**Maximum Age:** 99 Years
**Minimum Age:** 0 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Patients with with growth plate or bone pathology.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Thomas EDOUARD, MD
**Phone:** 05 61 77 61 10
**Phone Ext:** +33
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Sanaa EDDIRY
**Phone:** 05 61 77 61 10
**Phone Ext:** +33
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** CHU Toulouse
**Name:** Thomas EDOUARD, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009140
- Term: Musculoskeletal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5126
- Name: Bone Diseases
- Relevance: HIGH
- As Found: Bone Disorder
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001847
- Term: Bone Diseases
### 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:** NCT06444490
**Brief Title:** Oral Hygiene Among Portuguese Older Adults
**Official Title:** Comparison of Oral Hygiene Instruction Methods on Oral Hygiene Behaviour Among Older Adults
#### Organization Study ID Info
**ID:** PHDICS
#### Organization
**Class:** OTHER
**Full Name:** Egas Moniz - Cooperativa de Ensino Superior, CRL
### Status Module
#### Completion Date
**Date:** 2023-05-29
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-04
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-05-29
**Type:** ACTUAL
#### Start Date
**Date:** 2023-01-30
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Egas Moniz - Cooperativa de Ensino Superior, CRL
#### 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 clinical trial was to compare two different oral hygiene instruction methods on oral hygiene behavior in older adults. We also wanted to evaluate the self-perception of oral health changes with each instruction method. The main questions we aim to answer were:
* Which method has better results in changing oral hygiene habits?
* Which method has better results in reducing bacterial plaque?
Participants:
* Completed a questionnaire about socioeconomic aspects and oral hygiene habits;
* Were examined to assess their oral hygiene status;
* Completed a questionnaire about self-perception of oral health;
* Received oral hygiene instruction (depending on the group: Generalised Approach or Personalised Technique).
Two months later, they were assessed again on oral hygiene habits, oral hygiene status, and self-perception of oral health.
**Detailed Description:** This study aimed to evaluate the effectiveness of two different oral hygiene instruction methods on oral hygiene behavior in older adults. Secondly, we intended to assess the self-perception of oral health changes with each instruction method.
This study was a clinical trial that included a convenience sample of 60 participants attending a university dental hospital (Egas Moniz Dental Clinic, Almada, Portugal).
Data were collected in two phases: The first phase (baseline) consisted of three parts: a questionnaire focusing on the participant's socioeconomic data and oral hygiene behaviors, clinical records obtained through an intraoral examination, using the Oral Hygiene Index-Simplified (OHI-S), and oral hygiene instruction.
For the oral hygiene instruction, the sample was divided into two groups of 30 participants (n=30) each group, exposed to different methods of professional education. The first one, identified as "General Approach" (GA), focuses more broadly on the different topics of oral diseases and oral hygiene care. The second group, identified as "Personalised Technique" (PT), was based on the specific needs of each participant.
After two months, to establish a follow-up session, the self-reported questionnaire on oral hygiene behavior and self-perceived oral health was administered again and the same clinical records on OHI-S were collected.
### Conditions Module
**Conditions:**
- Oral Hygiene
- Oral Health
- Older
**Keywords:**
- oral hygiene
- oral health
- health motivation
- toothbrushing
- dental devices
- self-perception
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 60
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This approach consisted of a 15-minute session in which the dentist attempted to impart knowledge about oral hygiene in general, highlighting some of the most common situations in this age group, namely the difficulty in achieving correct brushing and flossing, demonstrating the correct technique on a typodont (model), and alerting them to the importance of oral health to general health. Periodontal disease, tooth decay and denture care were also covered in general terms. Participants were given a written explanatory guide to reinforce good oral hygiene habits and an explanation of these diseases or conditions. Appropriate oral hygiene tools were also provided to encourage the expected improvement in oral health. Finally, there was a question-and-answer session to clarify any doubts the participant might have.
**Intervention Names:**
- Behavioral: General Approach Instruction
**Label:** General Approach (GA)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** This approach began with a self-examination in an extra-oral mirror by the participant to allow the professional to understand participant's perception of oral health, and the use of a plaque-disclosing solution to allow the participant to be more sensitive to the areas where brushing and flossing were not effective. Conditions such as caries lesions, major gingival recessions, areas of greater inflammation, areas where plaque accumulation or even tartar was more visible and further denture care were highlighted. The typodont (model) was then used to demonstrate the correct brushing and flossing technique. The session ended with the participant receiving an explanatory guide, a personalized plan, and more appropriate tools to promote the expected improvement in oral health. A question-and-answer session was used to clarify any doubts. This method took about approximately 20 minutes.
**Intervention Names:**
- Behavioral: Personalised Technique Instruction
**Label:** Personalised Technique (PT)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- General Approach (GA)
**Description:** Oral health instruction focused more broadly on the different topics of oral diseases and oral hygiene care.
**Name:** General Approach Instruction
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Personalised Technique (PT)
**Description:** Oral health instruction based on the specific needs of each participant.
**Name:** Personalised Technique Instruction
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Assessment of toothbrushing frequency (\<2x/day or ≥ 2x/day)
**Measure:** Brushing frequency
**Time Frame:** 2 months
**Description:** Assessment of dental floss or interdental brushes usage (yes/no)
**Measure:** Interdental devices usage
**Time Frame:** 2 months
**Description:** Assessment of daily denture cleaning (yes/no)
**Measure:** Denture hygiene
**Time Frame:** 2 months
**Description:** Assess whether participants sleep with their dentures in (yes/no)
**Measure:** Denture care
**Time Frame:** 2 months
**Description:** Assessment of Oral Hygiene Index - Simplified (OHI-S) (Greene \& Vermillion, 1964). The six surfaces examined for the OHI-S are selected from four posterior and two anterior teeth. For posterior teeth, the buccal surfaces of the selected upper molars (usually 16 and 26) and the lingual surfaces of the selected lower molars (usually 36 or 46) are examined. For the incisors, the labial surfaces of the upper right central incisor (11) and the lower left central incisor (31) are evaluated.
A score from 0 to 3 was then recorded for each surface, according to the classification for each index (debris or calculus). For each participant, the debris or calculus index was obtained by summing the scores and dividing by the number of surfaces scored.
The Simplified Oral Hygiene Index is the sum of the Debris Index and the Calculus Index and can range from 0 to 6, with higher scores indicating poorer oral hygiene.
**Measure:** Oral Hygiene Clinical Indicator
**Time Frame:** 2 months
**Description:** Assessment of participants' treatment needs (yes/no)
**Measure:** Treatment needs (oral clinical observation)
**Time Frame:** 2 months
#### Secondary Outcomes
**Description:** Assess the participants' perception of oral health (poor/good)
**Measure:** Self-perception of oral health
**Time Frame:** 2 months
**Description:** Assessment of dry mouth perception (yes/no)
**Measure:** Xerostomia
**Time Frame:** 2 months
**Description:** Assessment of participants' perception of need for treatment (yes/no)
**Measure:** Perceived treatment needs
**Time Frame:** 2 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Being able to speak and understand Portuguese;
* Being able to understand and sign an informed consent form;
* Being literate and able to comply with the study protocol.
Exclusion Criteria:
* Being edentulous;
* Being institutionalized;
* Having disabilities such as blindness, deafness, or dementia.
**Healthy Volunteers:** True
**Minimum Age:** 65 Years
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Almada
**Country:** Portugal
**Facility:** Egas Moniz Dental Clinic
**State:** Caparica
**Zip:** 2825-083
#### Overall Officials
**Official 1:**
**Affiliation:** Egas Moniz School of Health & Science
**Name:** Inês C Santos, MSc
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Data will be available upon reasonable request. The Principal Investigator will review requests.
**Description:** All IPD that underlie will result in a publication.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
**IPD Sharing:** YES
**Time Frame:** IPD will become available immediately after publication.
### References Module
#### References
**Citation:** GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.
**PMID:** 14076341
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: CNSSti
- Name: Central Nervous System Stimulants
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M5373
- Name: Caffeine
- Relevance: LOW
- As Found: Unknown
- ID: T370
- Name: Caffeine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444477
**Acronym:** MATAC
**Brief Title:** Molecular Analysis of Thrombocytopenia and Cancer (MATAC): Investigating Antigenic Mimicry Between Platelets and Tumor Cells in Patients With Immune Thrombocytopenia (ITP) Associated With Cancer
**Official Title:** Molecular Analysis of Thrombocytopenia and Cancer (MATAC): Investigating Antigenic Mimicry Between Platelets and Tumor Cells in Patients With Immune Thrombocytopenia (ITP) Associated With Cancer
#### Organization Study ID Info
**ID:** CHUBX 2024/16
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Bordeaux
### Status Module
#### Completion Date
**Date:** 2024-12
**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:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Bordeaux
#### 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 association between hematologic malignancies and ITP is well described, but this link is much less clear with solid cancers. In cases of ITP associated with cancers, specific cancer treatment can lead to remission or even cure of ITP. Thus, our hypothesis was that chronic expression of GPIIB by tumor cells could have initiated an autoimmune loop against GPIIB, leading to the onset and perpetuation of ITP.
**Detailed Description:** Autoimmune thrombocytopenia, also known as immune thrombocytopenic purpura (ITP), is a rare autoimmune disease characterized by platelet destruction and impaired production, posing a life-threatening risk due to bleeding complications. The pathophysiology of ITP involves complex mechanisms, including both defective platelet production and auto-reactivity of B and T lymphocytes leading to the production of autoantibodies against platelets, found in 35 to 55% of cases. Additionally, in the context of neoplasia, some patients may develop varying degrees of thrombocytopenia, exacerbating morbidity and mortality. A multicenter, retrospective study will collect data from routine care, including birth date, gender, biological parameters related to ITP, dates of treatment initiation and diagnosis of ITP and cancer, types of treatments, and outcomes such as survival or death, without additional medical interventions or appointments.
### Conditions Module
**Conditions:**
- Immune Thrombocytopenia
- Immune Thrombocytopenic Purpura
- Neoplasms
- Cancer
**Keywords:**
- Proteomics
- Mortality
- Side Effects
- Multicenter
- Retrospective
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 70
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: ITP and cancer
**Label:** Patients with a definite diagnosis of both ITP and cancer
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patients with a definite diagnosis of both ITP and cancer
**Description:** ITP and cancer
**Name:** ITP and cancer
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** Remission rate of ITP at 6 months after specific cancer treatment
**Time Frame:** At baseline (Day 0)
#### Secondary Outcomes
**Measure:** All-cause mortality
**Time Frame:** At baseline (Day 0)
**Measure:** Side effects related to ITP and its treatment
**Time Frame:** At baseline (Day 0)
**Measure:** Side effects related to its treatment
**Time Frame:** At baseline (Day 0)
**Measure:** Clinical description of the characteristics of ITP associated with a diagnosis of solid cancer
**Time Frame:** At baseline (Day 0)
**Measure:** Biological description of the characteristics of ITP associated with a diagnosis of solid cancer
**Time Frame:** At baseline (Day 0)
**Measure:** Demographic description of the characteristics of ITP associated with a diagnosis of solid cance
**Time Frame:** At baseline (Day 0)
**Measure:** Therapeutic description of the characteristics of ITP associated with a diagnosis of solid cance
**Time Frame:** At baseline (Day 0)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult patients with a definite diagnosis of both ITP and cancer;
* Synchronous diagnosis of ITP and cancer;
* Onset of ITP occurring 6 months before or after the diagnosis of cancer.
Exclusion Criteria:
* None
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients with a definite diagnosis of both ITP and cancer
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Etienne RIVIERE, MD
**Phone:** (0)557656483
**Phone Ext:** +33
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Dieynaba N'DIAYE
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Bondy
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Laurent GILARDIN, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Laurent GILARDIN, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** AP-HP Hôpital Jean Verdier service de médecine interne
**Location 2:**
**City:** Clermont-Ferrand
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Marc RUIVARD, Prof
- **Role:** CONTACT
***Contact 2:***
- **Name:** Marc RUIVARD, Prof
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** CHU de Clermont-Ferrand - service de médecine interne
**Location 3:**
**City:** Créteil
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Etienne CRICKX, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Etienne CRICKX, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** AP-HP Hôpital Mondor service de médecine interne
**Location 4:**
**City:** Le Kremlin-Bicêtre
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Olivier LAMBOTTE, Prof
- **Role:** CONTACT
***Contact 2:***
- **Name:** Olivier LAMBOTTE, Prof
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** AP-HP Hôpital Bicêtre service de médecine interne
**Location 5:**
**City:** Lille
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Louis TERRIOU, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Louis TERRIOU, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** CHU de Lille - service d'Hématologie
**Location 6:**
**City:** Lyon
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jean-Christophe LEGA, Prof
- **Role:** CONTACT
***Contact 2:***
- **Name:** Jean-Christophe LEGA, Prof
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** HCL - service d'Hématologie
**Location 7:**
**City:** Marseille
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mickael EBBO, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Mickael EBBO, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** AP-HM Hôpital la Timone - service de médecine interne
**Location 8:**
**City:** Montpellier
**Country:** France
**Facility:** CHU de Montpellier - service d'Hématologie
**Location 9:**
**City:** Nancy
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Thomas MOULINET, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Thomas MOULINET, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** CHRU de Nancy - service de Médecine Interne et Immunologie Clinique
**Location 10:**
**City:** Nantes
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Christian AGARD, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Christian AGARD, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Mohamed HAMIDOU, Prof
- **Role:** SUB_INVESTIGATOR
**Country:** France
**Facility:** CHU de Nantes - service de médecine interne
**Location 11:**
**City:** Orléans
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Anne-Laure PITON, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Anne-Laure PITON, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** CHRU d'Orléans - service de Médecine interne
**Location 12:**
**City:** Orléans
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Maxime DESGROUAS, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Maxime DESGROUAS, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** CHRU d'Orléans - service de réanimation
**Location 13:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Thomas PAPO, Prof
- **Role:** CONTACT
***Contact 2:***
- **Name:** Thomas PAPO, Prof
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** AP-HP Hôpital Bichat service de médecine interne
**Location 14:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Olivier FAIN, Prof
- **Role:** CONTACT
***Contact 2:***
- **Name:** Olivier FAIN, Prof
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** AP-HP Hôpital Saint-Antoine service de médecine interne
**Location 15:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lionel GALICIER, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Lionel GALICIER, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** AP-HP Hôpital Saint-Louis service immuno-hématologie
**Location 16:**
**City:** Pessac
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Etienne RIVIERE, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Dieynaba N'DIAYE
- **Role:** CONTACT
***Contact 3:***
- **Name:** Etienne RIVIERE, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** CHU de Bordeaux Service de Médecine Interne et Maladies Infectieuses
**Location 17:**
**City:** Poitiers
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Pascal ROBLOT, Prof
- **Role:** CONTACT
***Contact 2:***
- **Name:** Pascal ROBLOT, Prof
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** CHU de Poitiers - service de médecine interne
**Location 18:**
**City:** Strasbourg
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Emmanuel ANDRES, Prof
- **Role:** CONTACT
***Contact 2:***
- **Name:** Emmanuel ANDRES, Prof
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** CHRU de Strasbourg - service de médecine interne
**Location 19:**
**City:** Toulouse
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Guillaume MOULIS, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Guillaume MOULIS, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** CHU de Toulouse - service de médecine interne
**Location 20:**
**City:** Tours
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** François MAILLOT, Prof
- **Role:** CONTACT
***Contact 2:***
- **Name:** François MAILLOT, Prof
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** CHU de Tours - service de médecine interne
#### Overall Officials
**Official 1:**
**Affiliation:** University Hospital, Bordeaux
**Name:** Etienne RIVIERE, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001791
- Term: Blood Platelet Disorders
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000095542
- Term: Cytopenia
- ID: D000001778
- Term: Blood Coagulation Disorders
- ID: D000006470
- Term: Hemorrhage
- ID: D000010335
- Term: Pathologic Processes
- ID: D000012877
- Term: Skin Manifestations
- ID: D000057049
- Term: Thrombotic Microangiopathies
- ID: D000006474
- Term: Hemorrhagic Disorders
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16680
- Name: Thrombocytopenia
- Relevance: HIGH
- As Found: Thrombocytopenia
- ID: M14547
- Name: Purpura
- Relevance: HIGH
- As Found: Purpura
- ID: M18945
- Name: Purpura, Thrombocytopenic, Idiopathic
- Relevance: HIGH
- As Found: Immune Thrombocytopenia
- ID: M14550
- Name: Purpura, Thrombocytopenic
- Relevance: HIGH
- As Found: Thrombocytopenic Purpura
- ID: M5072
- Name: Blood Platelet Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M3170
- Name: Cytopenia
- Relevance: LOW
- As Found: Unknown
- ID: M21977
- Name: Hemostatic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5059
- Name: Blood Coagulation Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M9556
- Name: Hemorrhage
- Relevance: LOW
- As Found: Unknown
- ID: M15680
- Name: Skin Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M28682
- Name: Thrombotic Microangiopathies
- Relevance: LOW
- As Found: Unknown
- ID: M9560
- Name: Hemorrhagic Disorders
- 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: T3021
- Name: Immune Thrombocytopenia
- Relevance: HIGH
- As Found: Immune Thrombocytopenia
- ID: T3007
- Name: Idiopathic Thrombocytopenic Purpura
- Relevance: HIGH
- As Found: Immune Thrombocytopenia
### Condition Browse Module - Meshes
- ID: D000013921
- Term: Thrombocytopenia
- ID: D000011693
- Term: Purpura
- ID: D000016553
- Term: Purpura, Thrombocytopenic, Idiopathic
- ID: D000011696
- Term: Purpura, Thrombocytopenic
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444464
**Brief Title:** The BEE-Power Study (Boosting Exercise for Excellent Pediatric Blood Pressure)
**Official Title:** The BEE-Power Study (Boosting Exercise for Excellent Pediatric Blood Pressure)
#### Organization Study ID Info
**ID:** 276902
#### Organization
**Class:** OTHER
**Full Name:** Arkansas Children's Hospital Research Institute
### Status Module
#### Completion Date
**Date:** 2026-06-30
**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:** 2026-05-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Arkansas Children's Hospital Research Institute
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this study is to compare two types of exercises, isometric exercise (like squats and planks) and aerobic exercise (such as running), to see which one is more effective at improving blood pressure in teenagers aged 13 to 17.5 years.
The main question the study aims to answer is:
- Do the effects of one session of isometric exercise on the blood pressure of adolescents compare to the effects of one session of aerobic exercise?
Adolescents diagnosed with high blood pressure may qualify for this study. Participants will be randomly assigned to either a single session of isometric exercise or a single session of aerobic exercise.
* Participants will attend 3 study visits in total.
* Study visits should be completed within 4 weeks of enrollment.
* At the initial visit, samples (example: blood) will be collected and body measurements will be taken.
* Participants will be asked to answer questionnaires (diet, growth, and others)
* At visit 2, participants will have their blood pressure measured using a 24 hour blood pressure monitor.
* At visit 3, participants will participate in a single session of either aerobic or isometric exercise. They will wear a 24-hour blood pressure monitor immediately after the exercise session.
**Detailed Description:** Our approach to testing our working hypotheses will be to enroll children ages 13 to 17.5 years with confirmed diagnosis of HBP. Children will be divided equally into two groups (aerobic exercise and isometric exercise groups), with 18 children in each group. Children who meet inclusion criteria will be asked to attend three study visits at the Arkansas Children's Nutrition Center (ACNC). Resting and 24-hour ambulatory blood pressure measurements will be conducted twice during the study: baseline measurement at visit 2 and after a single 50-minute session of exercise at visit 3. To accommodate for any potential dropouts post-assignment and to maintain an even distribution of participants between groups (n =18 each), the study will enroll up to n = 45 children (Refer to the Data Analysis and Randomization section for more details).
The study will follow a randomized parallel group design and will be conducted by the Physical Activity Core - Arkansas Children's Nutrition Center (ACNC) / Arkansas Children's Research Institute in collaboration with the Hypertension Clinic - Nephrology Division at the Arkansas Children Hospital (ACH). Measurements will be completed within four weeks of enrollment. Research staff involved in study procedures are or will be properly trained. All assessments may be repeated if/when needed, and if the participant is willing. Study visits may last up to 3 hours.
Baseline characteristics such as socioeconomic status, pubertal stage, dietary quality, physical fitness (aerobic capacity, body composition) and metabolic phenotyping (glucose, insulin, lipids, etc.) will be used to control for baseline covariates as described in the Data analysis Section.
### Conditions Module
**Conditions:**
- High Blood Pressure
- Overweight and Obesity
- Adolescent Obesity
- Exercise
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 45
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** After baseline 24-hour blood pressure measurements are taken at visit 2, participants will attend a final study visit where they will engage in a single session of aerobic exercise. The exercise routines will include 5 to 10-minute warm-up and cool-down periods, along with a 30-minute workout. Twenty-four hour blood pressure measurements will be taken after the exercise bout.
**Intervention Names:**
- Other: Aerobic exercise
**Label:** Aerobic Exercise
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** After baseline 24-hour blood pressure measurements are taken at visit 2, participants will attend a final study visit where they will engage in a single session of isometric exercise. The exercise routines will include 5 to 10-minute warm-up and cool-down periods, along with a 30-minute workout. Twenty-four hour blood pressure measurements will be taken after the exercise bout.
**Intervention Names:**
- Other: Isometric exercise
**Label:** Isometric Exercise
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Aerobic Exercise
**Description:** After baseline 24-hour blood pressure measurements are taken at visit 2, participants will attend a final study visit where they will engage in a single session of aerobic exercise. The exercise routines will include 5 to 10-minute warm-up and cool-down periods, along with a 30-minute workout. Twenty-four hour blood pressure measurements will be taken after the exercise bout.
**Name:** Aerobic exercise
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Isometric Exercise
**Description:** After baseline 24-hour blood pressure measurements are taken at visit 2, participants will attend a final study visit where they will engage in a single session of isometric exercise. The exercise routines will include 5 to 10-minute warm-up and cool-down periods, along with a 30-minute workout. Twenty-four hour blood pressure measurements will be taken after the exercise bout.
**Name:** Isometric exercise
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Resting measurements will be recorded in the research facility for 2 consecutive hours at visit 2 and before the exercise bout at visit 3
**Measure:** Systolic and diastolic blood pressure in the resting state
**Time Frame:** Within 4 weeks after enrollment: at visits 2 and 3
**Description:** The 24-hour average of systolic and diastolic blood pressure will be calculated from data collected using ambulatory blood pressure monitoring.
**Measure:** Mean (24-hour) systolic and diastolic blood pressure
**Time Frame:** Within 4 weeks after enrollment: at visits 2 and 3
**Description:** The mean systolic and diastolic blood pressure during sleep will be calculated from data collected using ambulatory blood pressure monitoring.
**Measure:** Mean systolic and diastolic blood pressure during sleep
**Time Frame:** Within 4 weeks after enrollment: at visits 2 and 3
**Description:** The mean systolic and diastolic blood pressure during the awake period will be calculated from data collected using ambulatory blood pressure monitoring.
**Measure:** Mean systolic and diastolic blood pressure during the awake period
**Time Frame:** Within 4 weeks after enrollment: at visits 2 and 3
**Description:** Nocturnal dipping pattern will be calculated as follows: Percent day- night BP difference
**Measure:** Nocturnal dipping pattern
**Time Frame:** Within 4 weeks after enrollment: at visits 2 and 3
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria
* Age 13 to 17.5 years old
* Excessive weight: BMI percentile ≥ 85th and \<140% of the 95th percentile or BMI
* 35 to \<40 kg/m2
* Diagnosis of HBP
* HBP treated with lifestyle modifications only
Exclusion Criteria
* Children with class 3 obesity (i.e., BMI ≥ 140% of the 95th percentile or BMI ≥ 40.0 kg/m2)
* Asthma that requires daily use of inhalers to keep symptoms under control
* Asthma that requires use of rescue inhalers (e.g., albuterol) \>2 days per week
* Exercise induced asthma
* Autism spectrum disorder (e.g., Autistic disorder, Rett disorder, Asperger disorder, childhood disintegrative disorder, pervasive developmental disorder not otherwise specified (PDD-NOS)
* Attention deficit hyperactivity disorder (ADHD)
* Oppositional defiant disorder (ODD)
* Epilepsy
* Cancer
* Chronic kidney disease
* Hormonal disease (e.g., hypothyroidism and growth hormone deficiency)
* Autoimmune diseases (e.g., lupus, thyroiditis, juvenile idiopathic arthritis)
* Bleeding disorders (e.g., hemophilia)
* Chronic infections (e.g., HIV, hepatitis B, hepatitis C)
* Type 2 and type 1 diabetes mellitus.
* Other pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest
* Parent/participant refusal to have blood drawn
* Unwillingness to wear a 24-hour ambulatory blood pressure monitor
**Maximum Age:** 17 Years
**Minimum Age:** 13 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Eva C Diaz, M.D.
**Phone:** 5013643056
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Charles M Sinner
**Phone:** (501) 6867580
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Little Rock
**Country:** United States
**Facility:** Arkansas Children's Nutrition Center
**State:** Arkansas
**Zip:** 72202
#### Overall Officials
**Official 1:**
**Affiliation:** Arkansas Children's Nutrition Center
**Name:** Eva C Diaz
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044343
- Term: Overnutrition
- ID: D000009748
- Term: Nutrition Disorders
- ID: D000001835
- Term: Body Weight
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M10024
- Name: Hypertension
- Relevance: HIGH
- As Found: High Blood Pressure
- ID: M26186
- Name: Overweight
- Relevance: HIGH
- As Found: Overweight
- ID: M12701
- Name: Obesity
- Relevance: HIGH
- As Found: Obesity
- ID: M30155
- Name: Pediatric Obesity
- Relevance: HIGH
- As Found: Adolescent Obesity
- ID: M25307
- Name: Overnutrition
- Relevance: LOW
- As Found: Unknown
- ID: M12684
- Name: Nutrition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5114
- Name: Body Weight
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006973
- Term: Hypertension
- ID: D000009765
- Term: Obesity
- ID: D000050177
- Term: Overweight
- ID: D000063766
- Term: Pediatric Obesity
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444451
**Brief Title:** A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata
**Official Title:** A Phase 2, Randomized, Double-blind, Placebo--controlled, Parallel Group, 3-arm, Multinational, Multicenter, Proof-of-concept Study to Evaluate the Efficacy and Safety of Amlitelimab Monotherapy by Subcutaneous Injection in Adult Participants With Severe Alopecia Areata
#### Organization Study ID Info
**ID:** DRI18180
#### Organization
**Class:** INDUSTRY
**Full Name:** Sanofi
#### Secondary ID Infos
**Domain:** CTIS
**ID:** 2024-511225-64
**Type:** REGISTRY
**Domain:** ICTRP
**ID:** U1111-1295-6359
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2026-02-19
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-02-19
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-24
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Sanofi
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is a parallel, Phase 2 multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study to investigate the efficacy and safety of subcutaneous (SC) injections of amlitelimab treatment as monotherapy in participants aged 18 years and older with severe alopecia areata (AA). At the end of the treatment period, all participants will have the option to enter a separate study, the open-label extension (OLE) study, once eligibility is confirmed.
The study duration will be up to 56 weeks for participants not entering the OLE including a 2-to-4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the OLE, the DRI18180 study duration will be up to 40 weeks, including a 2-to-4-week screening, a 36-week randomized double-blind period The total number of visits will be up to 12 visits (or 11 visits for those entering the OLE study).
### Conditions Module
**Conditions:**
- Alopecia Areata
### 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:** 150
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Subcutaneous injection as per protocol
**Intervention Names:**
- Drug: Amlitelimab
**Label:** Amlitelimab dose group 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Subcutaneous injection as per protocol
**Intervention Names:**
- Drug: Amlitelimab
**Label:** Amlitelimab dose group 2
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Subcutaneous injection as per protocol
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Amlitelimab dose group 1
- Amlitelimab dose group 2
**Description:** Pharmaceutical form: Injection solution Route of administration: SC injection
**Name:** Amlitelimab
**Other Names:**
- SAR445229
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Pharmaceutical form: Injection solution Route of administration: SC injection
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss).
**Measure:** Change from baseline in Severity of Alopecia Tool (SALT) score at Week 24
**Time Frame:** Baseline to Week 24
#### Secondary Outcomes
**Description:** SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss).
**Measure:** Change from the baseline in SALT score at Week 36 (key secondary)
**Time Frame:** Baseline to Week 36
**Description:** SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss).
**Measure:** Proportion of participants achieving a SALT score ≤20 at Weeks 24 and 36
**Time Frame:** Week 24 and 36
**Description:** SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss).
**Measure:** Time to SALT score ≤20
**Time Frame:** Up to Week 36
**Description:** SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss).
**Measure:** Proportion of participants achieving a SALT score ≤10 at Weeks 24 and 36
**Time Frame:** Week 24 and 36
**Description:** SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss).
**Measure:** Time to SALT score ≤10
**Time Frame:** Up to Week 36
**Description:** SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). SALT50 is 50% reduction from baseline in SALT score.
**Measure:** Proportion of participants achieving a SALT50 at Weeks 24 and 36
**Time Frame:** Week 24 and 36
**Description:** SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). SALT75 is 75% reduction from baseline in SALT score.
**Measure:** Proportion of participants achieving a SALT75 at Weeks 24 and 36
**Time Frame:** Week 24 and36
**Description:** SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). SALT90 is 90% reduction from baseline in SALT score.
**Measure:** Proportion of participants achieving a SALT90 at Weeks 24 and 36
**Time Frame:** Week 24 and 36
**Description:** ClinRO Measure for EB Hair Loss is a single item, clinician-reported numeric rating scale (NRS) measuring eyebrow hair loss. Scores range from 0 = normal appearance/no eyebrow hair loss to 3 = severe appearance/severe eyebrow hair loss
**Measure:** Proportion of participants achieving ClinRO Measure for eyebrow (EB) Hair Loss 0 or 1 with ≥2-point improvement from baseline at Weeks 24 and 36 (among participants with ClinRO Measure for EB Hair Loss ≥2 at Baseline)
**Time Frame:** Week 24 and 36
**Description:** ClinRO Measure for EL Hair Loss is a single item, clinician-reported numeric rating scale (NRS) measuring eyelash hair loss. Scores range from 0 = normal appearance/no eyelash hair loss to 3 = severe appearance/severe eyelash hair loss.
**Measure:** Proportion of participants achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 with ≥2-point improvement from baseline (among participants with ClinRO Measure for EL Hair Loss ≥2 at Baseline)
**Time Frame:** Week 24 and 36
**Description:** The Patient Global Impression of Change (PGI-C) is a questionnaire that asks participants to provide the overall self-assessment of change in their AA overall on a 5-point scale. The PGI-C will be scored from 1 = Much better to 5 = Much worse.
**Measure:** Proportion of participants achieving a PGI-C response defined as a score of "moderately improved" or "greatly improved" at Weeks 24 and 36
**Time Frame:** Week 24 and 36
**Description:** The Patient Global Impression of Severity (PGI-S) is a single item 5-point scale (1 = no symptoms to 5 = very severe symptoms) which asks a participant to assess current severity of AA symptoms.
**Measure:** Proportion of participants achieving a PGI-S response defined as a score of "mild" or "none" at Weeks 24 and 36
**Time Frame:** Week 24 and 36
**Description:** Skindex-16 for alopecia areata (SKINDEX-16AA) is a tool used to assess the health-related quality of life in participants with skin disorders. The score ranges from 0 to 100, with higher scores indicating a greater burden of AA on the patient.
**Measure:** Mean changes from baseline in SKINDEX-16AA at Weeks 24 and 36
**Time Frame:** Baseline to Week 24 and 36
**Description:** Scalp Hair Assessment patient reported outcome (PRO) is a single item, patient-reported NRS using a 5-point response scale and ranging from 0 to 4, with 0 = no missing hair (0% scalp hair missing) and 4 = nearly all or all missing hair (95- 100% scalp hair missing).
**Measure:** Proportion of participants with PRO Scalp Hair Assessment score of 0 to 1 with ≥2-point improvement from baseline (among participants with PRO Scalp Hair Assessment score ≥3 at Baseline)
**Time Frame:** Week 24 and 36
**Description:** PRO Measure for Eyebrow Hair Loss™ is a single item, patient-reported NRS measuring eyebrow hair loss, ranging from 0 to 3, with 0 = full coverage/no eyebrow hair loss and 3 = barely any/no notable eyebrow hair.
**Measure:** Proportion of participants achieving grade 0 or 1 with ≥2-point improvement from baseline PRO Measure for EB Hair Loss (among participants with PRO Measure for EB Hair Loss ≥2 at Baseline)
**Time Frame:** Week 24 and 36
**Description:** PRO Measure foe Eyelash Hair Loss™ is a single item, patient-reported NRS measuring eyelash hair loss, ranging from 0 to 3, with 0 = full coverage/no eyelash hair loss and 3 = barely any/no notable eyelash hair.
**Measure:** Proportion of participants achieving grade 0 or 1 with ≥2-point improvement from baseline PRO Measure for EL Hair Loss at Weeks 24 and 36 (among participants with PRO Measure for EL Hair Loss ≥2 at Baseline)
**Time Frame:** Week 24 and 36
**Measure:** Proportion of participants who experienced treatment-emergent adverse events (TEAEs), experienced treatment-emergent serious adverse event (TESAEs) and/or Treatment-Emergent adverse event of special interest (AESIs)
**Time Frame:** Up to week 52
**Measure:** Serum amlitelimab concentrations measured at prespecified timepoints
**Time Frame:** Up to Week 52
**Measure:** Incidence of ADAs) of amlitelimab at prespecified timepoints
**Time Frame:** Up to Week 52
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Definitive diagnosis of AA of more than 6 months.
* Diagnosis of severe AA, as determined by all of the following:
1. Hair loss affecting ≥50% of the scalp, as measured by Severity of Alopecia Tool (SALT) at both screening and baseline visits.
2. Current episode of hair loss of less than 8 years.
3. No evidence of terminal hair regrowth within 6 months (ie, equivalent to less than 10 points spontaneous reduction in SALT over the past 6 months).
Note: participants with severe AA for ≥8 years may be enrolled if episodes of regrowth are observed in the affected areas over the past 8 years, spontaneously and/or under treatment.
* Willingness in maintaining a consistent hair style and hair care, including hair products, and to refrain from weaves, extensions, adhesive wigs, other than banded perimeter devices, refrain from shaving of scalp hair for 2 weeks prior to each study visit from baseline to the end of study.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* Participants that are currently experiencing other forms of alopecia, including but not limited to: androgenetic alopecia, trichotillomania, telogen effluvium, traction alopecia, scarring alopecia.
* Participants currently with any local or systemic active medical conditions, including but not limited to seborrheic dermatitis requiring topical treatment to the scalp, lupus erythematosus, lichen planus, psoriasis, secondary syphilis, tinea capitis, thyroiditis, systemic sclerosis, hair transplants, micropigmentation/tattoo of the scalp that in opinion of the Investigator would interfere with evaluations of the investigational medicinal product (IMP) effect on AA due to scalp inflammation.
* Received the specified treatment regimens within the timeframe outlined in the protocol.
* Prior use of any oral JAKi or the topical JAKi ruxolitinib for more than 12 months, regardless if washout period is respected.
* Participants with shaved heads must not enter the study until hair has grown back and SALT score can be reliably administered.
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Trial Transparency email recommended (Toll free for US & Canada)
**Phone:** 800-633-1610
**Phone Ext:** option 6
**Role:** CONTACT
### IPD Sharing Statement Module
**Description:** Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
**IPD Sharing:** YES
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007039
- Term: Hypotrichosis
- ID: D000006201
- Term: Hair Diseases
- ID: D000012871
- Term: Skin Diseases
- ID: D000020763
- Term: Pathological Conditions, Anatomical
### Condition Browse Module - Browse Branches
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M3846
- Name: Alopecia
- Relevance: HIGH
- As Found: Alopecia
- ID: M3847
- Name: Alopecia Areata
- Relevance: HIGH
- As Found: Alopecia Areata
- ID: M10089
- Name: Hypotrichosis
- Relevance: LOW
- As Found: Unknown
- ID: M9293
- Name: Hair Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000505
- Term: Alopecia
- ID: D000000506
- Term: Alopecia Areata
### 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:** NCT06444438
**Brief Title:** Radiological Changes of Glymphatic-meningeal Lymphatic Drainage System After Subarachnoid Hemorrhage
**Official Title:** Radiological Changes of Glymphatic-meningeal Lymphatic Drainage System After Spontaneous Subarachnoid Hemorrhage
#### Organization Study ID Info
**ID:** 2024-0224
#### Organization
**Class:** OTHER
**Full Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University
### Status Module
#### Completion Date
**Date:** 2025-05-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-05-20
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### 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:** Subarachnoid hemorrhage (SAH) is a common and extremely critical disease in neurosurgery. The mortality rate within 30 days of the onset of SAH is as high as 50%, and about 15% of SAH patients die without reaching the hospital. Nearly half of the survivors have severe neurological dysfunction, causing a huge burden to the families and society of the patients.
Recently, the introduction of the "glymphatic-meningeal lymphatic vessels" drainage system has updated the current concept of intracranial cerebrospinal fluid circulation. After subarachnoid hemorrhage, a large number of blood components flooded into the subarachnoid space and entered the cerebrospinal fluid circulation, which directly affected the function of the lymphatic-meningeal lymphatic drainage system. Many preclinical animal studies have pointed out that the damage of the lymphatic-meningeal lymphatic drainage system is involved in the aggravation of cerebral edema, neuroinflammation and hydrocephalus after SAH, which ultimately leads to poor prognosis of patients.
However, at present, the changes of the glymphatic-meningeal lymphatic drainage system after SAH have only been confirmed in animal models, and clinical evidence is lacking. With the development of imaging technology, many research teams have confirmed the functional changes of the lymphatic-meningeal lymphatic drainage system in Alzheimer's disease and Parkinson's disease by using different sequences of non-invasive MRI, such as 3D T2-FLAIR, DTI-ALPS and other sequences.
**Detailed Description:** Subarachnoid hemorrhage (SAH) is a common and extremely critical disease in neurosurgery. The mortality rate within 30 days of the onset of SAH is as high as 50% and about 15% of SAH patients die without reaching the hospital. Nearly half of the survivors have severe neurological dysfunction, causing a huge burden to the families and society of the patients.
Recently, the introduction of the "glymphatic-meningeal lymphatic vessels" drainage system has updated the current concept of intracranial cerebrospinal fluid circulation. After subarachnoid hemorrhage, a large number of blood components flooded into the subarachnoid space and entered the cerebrospinal fluid circulation, which directly affected the function of the lymphatic-meningeal lymphatic drainage system. Many preclinical animal studies have pointed out that the damage of the lymphatic-meningeal lymphatic drainage system is involved in the aggravation of cerebral edema, neuroinflammation, and hydrocephalus after SAH, which ultimately leads to poor prognosis of patients.
However, at present, the changes in the glymphatic-meningeal lymphatic drainage system after SAH have only been confirmed in animal models, and clinical evidence is lacking. With the development of imaging technology, many research teams have confirmed the functional changes of the lymphatic-meningeal lymphatic drainage system in Alzheimer's disease and Parkinson's disease by using different sequences of non-invasive MRI, such as 3D T2-FLAIR, DTI-ALPS, and other sequences.
### Conditions Module
**Conditions:**
- Subarachnoid Hemorrhage
- Lymphatic System Disorder
- Meningeal Lymphatic Vessels
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with aneurysmal subarachnoid hemorrhage
**Intervention Names:**
- Diagnostic Test: subarachnoid hemorrhage
**Label:** Ruptured aneurysm
#### Arm Group 2
**Description:** Patients with unruptured aneurysm
**Label:** Unruptured aneurysm
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Ruptured aneurysm
**Description:** CT presented subarachnoid hemorrhage
**Name:** subarachnoid hemorrhage
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** The drainage function of the lgymphatic system - meningeal lymphatic vessels was observed by magnetic resonance
**Measure:** The drainage function of the glymphatic system - meningeal lymphatic vessels
**Time Frame:** Within 7 days after admission
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* ①18-80 years old; ② Voluntary patients with spontaneous subarachnoid hemorrhage undergoing aneurysm interventional therapy.
Exclusion Criteria:
* ①A history of trauma or prior brain injury (stroke, cerebral hemorrhage, etc., leaving associated chronic changes on CT); ②Patients with imaging data loss and severe comorbidities prior to the onset of SAH
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The patient had no prior brain disease and had a subarachnoid hemorrhage due to a ruptured aneurysm.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Hangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yuanjian Fang, MD
- **Phone:** 87784815
- **Role:** CONTACT
**Country:** China
**Facility:** the Second Affiliated Hospital of Zhejiang University
**State:** Zhejiang
**Status:** RECRUITING
**Zip:** 310000
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020300
- Term: Intracranial Hemorrhages
- 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: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC15
- Name: Blood and Lymph Conditions
### Condition Browse Module - Browse Leaves
- ID: M16135
- Name: Subarachnoid Hemorrhage
- Relevance: HIGH
- As Found: Subarachnoid Hemorrhage
- ID: M11203
- Name: Lymphatic Diseases
- Relevance: HIGH
- As Found: Lymphatic System Disorders
- ID: M9556
- Name: Hemorrhage
- Relevance: HIGH
- As Found: Hemorrhage
- ID: M22113
- Name: Intracranial Hemorrhages
- Relevance: LOW
- As Found: Unknown
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013345
- Term: Subarachnoid Hemorrhage
- ID: D000008206
- Term: Lymphatic Diseases
- ID: D000006470
- Term: Hemorrhage
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444425
**Brief Title:** Artificial Intelligence in Detecting Cardiac Function
**Official Title:** Korotkoff Sounds Dynamically Reflect Changes in Cardiac Function Based on Deep Learning Methods: A Prospective, Multicenter Study
#### Organization Study ID Info
**ID:** KY-2024-108
#### Organization
**Class:** OTHER
**Full Name:** The Fourth Affiliated Hospital of Zhejiang University School of Medicine
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Zhejiang Taizhou hospital
**Class:** OTHER
**Name:** The People's Hospital of Quzhou
**Class:** OTHER
**Name:** Zhejiang Quhua Hospital
#### Lead Sponsor
**Class:** OTHER
**Name:** The Fourth Affiliated Hospital of Zhejiang University School of Medicine
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The Korotkoff Sounds（KS）, which have been in use for over a century, are widely regarded as the gold standard for measuring blood pressure. Furthermore, their potential extends beyond diagnosis and treatment of cardiovascular disease; however, research on the KS remains limited. Given the increasing incidence of heart failure (HF), there is a pressing need for a rapid and convenient prehospital screening method. In this study, we propose employing deep learning (DL) techniques to explore the feasibility of utilizing KS methodology in predicting functional changes in cardiac ejection fraction (LVEF) as an indicator of cardiac dysfunction.
**Detailed Description:** Blood Pressure Measurement：Around 72 hours before and after the completion of the patient\&#39;s echocardiogram, considering the variability in the patient\&#39;s blood pressure and ejection fraction at different times, blood pressure should be measured in each participant at least twice a day, up to a maximum of six times. Each patient should be instructed to remain in a quiet state for 10 minutes before blood pressure measurement. Blood pressure measurement should be conducted according to the following criteria: the cuff used to measure blood pressure should be wrapped around the patient\&#39;s arm above the elbow joint, positioned 2-3 cm above the level of the heart, with a snugness that allows one finger to fit underneath. Place the stethoscope head at the brachial artery pulse point on the left elbow joint, then begin inflation. Inflate continuously until the sound of the pulse beat disappears; then inflate an additional 20 mmHg before stopping inflation. Slowly deflate while listening-the first audible pulse beat is the systolic pressure, and the disappearance of the pulse sound is the diastolic pressure. Use the Hanhong POPULAR-3 electronic stethoscope to record the aforementioned process, with each audio recording lasting 25 seconds uniformly.
Data Analysis Overview:
In terms of data analysis, deep learning models are developed based on Torch version 1.5.0, utilizing Transformer network architecture to analyze the collected audio data.
Network One: Identifying the presence of cardiac functional abnormalities through Korotkoff sounds.
Evaluation Metrics: Receiver Operating Characteristic (AUROC), sensitivity, specificity, and F1 score (harmonic mean of sensitivity and specificity) to assess model performance on the test dataset.
Network Two: NYHA classification of Korotkoff sounds. Evaluation Metrics: Confusion matrix, weighted accuracy, multi-class ROC curve, F1 score.
Network Three: Heart failure classification of Korotkoff sounds in heart failure patients.
Evaluation Metrics: Confusion matrix, weighted accuracy, multi-class ROC curve, F1 score.
Network Four: Left Ventricular Ejection Fraction (LVEF) prediction from Korotkoff sounds.
Evaluation Metrics: Root Mean Squared Error (RMSE), Mean Absolute Error (MAE), Mean Squared Error (MSE), R2 Score.
### Conditions Module
**Conditions:**
- Heart Failure
- Deep Learning
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 922
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with stable heart failure were defined as those with structural heart disease and a history of heart failure episodes but no current symptoms or signs of heart failure after receiving anti-heart failure treatment during hospitalization, such as decreased exercise tolerance (dyspnea, fatigue), fluid retention, etc. Additionally, according to the 2024 Chinese guidelines for the diagnosis and treatment of heart failure consensus, patients eligible for this study will be classified based on ejection fraction into the following categories:
* Reduced ejection fraction heart failure (HFrEF): HFrEF is defined by LVEF \< 40%
* Preserved ejection fraction heart failure (HFpEF): HFpEF is defined by LVEF ≥ 50%
* Heart failure with mid-range ejection fraction (HFmrEF): HFmrEF refers to heart failure characterized by LVEF between 40% and 49%.
**Label:** Heart Failure
#### Arm Group 2
**Description:** There were no structural or functional abnormalities in the cardiac system, and no symptoms or signs of heart failure were observed. Alternatively, the patient has developed organic heart disease without exhibiting any symptoms or signs of heart failure.
**Label:** Normal
### Outcomes Module
#### Primary Outcomes
**Description:** Clinicians employ a combination of criteria to diagnose patients with Cardiac Dysfunction, including clinical symptoms, Left Ventricular Ejection Function, BNP and so on.
**Measure:** Cardiac Dysfunction
**Time Frame:** Echocardiography was performed 72 hours prior to and following anti-Heart Failure treatment.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients who were admitted to the Cardiology Department of the aforementioned four Groups (The Fourth Affiliated Hospital of School of Medicine of Zhejiang University, Zhejiang Taizhou Hospital, Quzhou People\&#39;s Hospital, Zhejiang Quhua Hospital)between June 2024 and December 2024, and successfully underwent echocardiographic examinations.
2. Individuals aged between 18 and 90 years with a resting heart rate ranging from 60 to 100 beats per minute.
3. Demonstrating good compliance, capable of cooperating in completing multiple blood pressure measurements within 72 hours following the completion of echocardiography.
4. Willingness to voluntarily participate in the study.
Exclusion Criteria:
1. Patients with acute decompensated heart failure, acute myocardial infarction, atrioventricular block;
2. Cerebral hemorrhage, severe infection, active digestive tract ulcer, severe hematological diseases, severe liver and kidney dysfunction or other serious medical or surgical conditions;
3. Pregnant or lactating women;
4. Patients with mental illness;
5. Individuals who have participated in other clinical trials within the past 3 months.
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients who were admitted to the Cardiology Department of the aforementioned four Groups (The Fourth Affiliated Hospital of School of Medicine of Zhejiang University, Zhejiang Taizhou Hospital, Quzhou People\&#39;s Hospital, Zhejiang Quhua Hospital) between June 2024 and December 2024, and successfully underwent echocardiographic examinations.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Shudong Xia, MD
**Phone:** +86-13989897610
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M9421
- Name: Heart Failure
- Relevance: HIGH
- As Found: Heart Failure
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006333
- Term: Heart Failure
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444412
**Brief Title:** An Investigational Scan (Ga-68 PSMA-11 PET/CT) for Detection of Disease Recurrence or Progression in Patients With Glioma
**Official Title:** GA-68 PSMA-11 PET To Evaluate Malignant Glioma Recurrence - A Pilot Study
#### Organization Study ID Info
**ID:** 23-007985
#### Organization
**Class:** OTHER
**Full Name:** Mayo Clinic
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2024-03913
**Type:** REGISTRY
**Domain:** Mayo Clinic Institutional Review Board
**ID:** 23-007985
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-04-30
**Type:** ESTIMATED
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-04-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Mayo Clinic
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This clinical trial evaluates whether gallium-68 (Ga-68) prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) imaging is useful in differentiating between disease that has come back after a period of improvement (recurrence) or that is growing, spreading, or getting worse (progression) and treatment effect in patients with glioma. Patients with glioma undergo frequent imaging for assessment of disease status. After first-line treatment however, the correlation between imaging findings and tumor activity can be confused, and surgery is often required for definitive diagnosis. The PET/CT scanner is an imaging machine that combines 2 types of imaging in a single scan. The PET scanner detects and takes pictures of where the radioactive imaging agent (68Ga PSMA-11) has gone in the body and the CT scanner uses x-rays to take structural pictures inside the body. PSMA PET also binds to neoplastic blood vessels, including those in gliomas. This study may help researchers learn whether GA-68 PSMA-11 PET/CT is useful for improving detection of tumor recurrence or progression, as opposed to treatment effects, in patients with gliomas.
**Detailed Description:** PRIMARY OBJECTIVE:
I. To assess uptake of Ga-68 labeled PSMA-11 in regions of high tumor cell density (tumor recurrence) and low tumor cell density/treatment effect to determine whether PSMA-11 uptake differs significantly between true tumor progression versus (vs.) in radiation treatment effects.
SECONDARY OBJECTIVE:
I. To evaluate the immediate safety and tolerability of PSMA PET in patients with glioma.
EXPLORATORY OBJECTIVES:
I. To identify optimal maximum standardized uptake value (SUVmax) thresholds for differentiating viable tumor from treatment effect.
II. To perform a radiology-pathology correlation of PSMA uptake at PET with tumor PSMA immunohistochemistry (IHC) immunostaining, tumor pathology features, and signal and enhancement characteristics at magnetic resonance imaging (MRI) (no research MRI will be obtained, based on MRI images obtained for clinical use).
III. To evaluate the added diagnostic value of gallium Ga 68 (Ga-68 PSMA-11) PET beyond MRI (using information from a clinical MRI\[s\] obtained prior to enrollment in the study) for detecting viable enhancing tumor from treatment effects.
OUTLINE:
Patients receive Ga-68 PSMA-11 intravenously (IV) and then undergo PET/CT over 1 hour, 50-100 minutes after injection.
### Conditions Module
**Conditions:**
- WHO Grade 2 Glioma
- WHO Grade 3 Glioma
- WHO Grade 4 Glioma
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 25
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients receive Ga-68 PSMA-11 IV and then undergo PET/CT over 1 hour, 50-100 minutes after injection.
**Intervention Names:**
- Procedure: Computed Tomography
- Other: Electronic Health Record Review
- Drug: Ga 68 PSMA-11
- Procedure: Positron Emission Tomography
**Label:** Diagnostic (Ga-68 PSMA-11, PET/CT)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Diagnostic (Ga-68 PSMA-11, PET/CT)
**Description:** Undergo PET/CT
**Name:** Computed Tomography
**Other Names:**
- CAT
- CAT Scan
- Computed Axial Tomography
- Computerized Axial Tomography
- Computerized axial tomography (procedure)
- Computerized Tomography
- Computerized Tomography (CT) scan
- CT
- CT Scan
- tomography
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Diagnostic (Ga-68 PSMA-11, PET/CT)
**Description:** Ancillary studies
**Name:** Electronic Health Record Review
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Diagnostic (Ga-68 PSMA-11, PET/CT)
**Description:** Contrast dye given IV
**Name:** Ga 68 PSMA-11
**Other Names:**
- (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
- (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC
- (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
- (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
- (68Ga)Glu-urea-Lys(Ahx)-HBED-CC
- 68Ga-DKFZ-PSMA-11
- 68Ga-HBED-CC-PSMA
- 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
- 68Ga-PSMA
- 68Ga-PSMA-11
- 68Ga-PSMA-HBED-CC
- [68Ga] Prostate-specific Membrane Antigen 11
- [68Ga]GaPSMA-11
- AAA 517
- AAA-517
- AAA517
- Ga PSMA
- Ga-68 labeled DKFZ-PSMA-11
- Ga-68 labeled PSMA-11
- Ga 68 PSMA-11, Intravenous Solution
- Gallium Ga 68 PSMA-11
- Gallium Ga 68-labeled PSMA-11
- Gallium-68 PSMA
- Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
- GaPSMA
- PSMA-HBED-CC GA-68
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Diagnostic (Ga-68 PSMA-11, PET/CT)
**Description:** Undergo PET/CT
**Name:** Positron Emission Tomography
**Other Names:**
- Medical Imaging, Positron Emission Tomography
- PET
- PET Scan
- Positron emission tomography (procedure)
- Positron Emission Tomography Scan
- Positron-Emission Tomography
- proton magnetic resonance spectroscopic imaging
- PT
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Will be summarized based on biopsy-derived classification of the tissue samples. Will graphically evaluate PSMA uptake levels between tissue types using side-by-side boxplots. Will use recursive partitioning analyses to identify optimal cutpoints that best differentiate those samples classified as tumor versus (vs.) radiation treatment effects. Will also evaluate if the observed differences support a priori assumptions on thresholds to differentiate high vs. low PSMA (defined as radiation necrosis or pseudoprogression).
**Measure:** Prostate specific membrane antigen (PSMA) uptake levels
**Time Frame:** Up to 2 weeks
**Description:** Will assess the level of concordance in the classification of tumor vs. not (i.e. treatment effect) in contrast enhancing regions with the gold standard classification based on pathology review using repeated measures of concordance assessments such as an extended Kappa statistic or a repeated measures intraclass correlation coefficient for binary repeated measurements (such as, can have multiple biopsies from the same patient).
**Measure:** Concordance of the PSMA uptake levels (high vs. low)
**Time Frame:** Up to 2 weeks
#### Secondary Outcomes
**Description:** Safety and tolerability will be assessed by summarizing the adverse events reported based on the Common Terminology Criteria for Adverse Events version 5. Will summarize based on type of adverse event along with the grade and perceived attribution to the PSMA positron emission tomography scan.
**Measure:** Incidence of adverse events
**Time Frame:** Up to 2 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 18 years.
* History of World Health Organization (WHO) grade II, III, or IV infiltrating glioma previously treated with first-line chemoradiotherapy.
* MRI findings compatible with contrast-enhancing recurrent infiltrating glioma.
* Planned craniotomy for resection of suspected disease recurrence.
* Willing to sign release of information for any radiation and/or follow-up records.
* Ability to provide informed written consent.
* Ability to provide tissue for mandatory correlative research component.
Exclusion Criteria:
* Previous treatment with antiangiogenic therapy (e.g. bevacizumab).
* Unable to undergo a PSMA PET/CT scan (e.g. body habitus, claustrophobia).
* Any of the following:
* Pregnant women
* Nursing women
* Men or women of childbearing potential unwilling to employ adequate contraception
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Rochester
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Clinical Trials Referral Office
- **Phone:** 855-776-0015
- **Role:** CONTACT
***Contact 2:***
- **Name:** Brian J. Burkett, M.D., M.P.H.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Mayo Clinic in Rochester
**State:** Minnesota
**Zip:** 55905
#### Overall Officials
**Official 1:**
**Affiliation:** Mayo Clinic in Rochester
**Name:** Brian J. Burkett, M.D., M.P.H.
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### See Also Links
**Label:** Mayo Clinic Clinical Trials
**URL:** https://www.mayo.edu/research/clinical-trials
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000018302
- Term: Neoplasms, Neuroepithelial
- ID: D000017599
- Term: Neuroectodermal Tumors
- ID: D000009373
- Term: Neoplasms, Germ Cell and Embryonal
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009380
- Term: Neoplasms, Nerve Tissue
- ID: 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: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14850
- Name: Recurrence
- Relevance: HIGH
- As Found: Recurrence
- ID: M20559
- Name: Disease Progression
- Relevance: LOW
- As Found: Unknown
- ID: M9020
- Name: Glioma
- Relevance: HIGH
- As Found: Glioma
- ID: M20446
- Name: Neoplasms, Neuroepithelial
- Relevance: LOW
- As Found: Unknown
- ID: M19845
- Name: Neuroectodermal Tumors
- Relevance: LOW
- As Found: Unknown
- ID: M20388
- Name: Neuroectodermal Tumors, Primitive
- Relevance: LOW
- As Found: Unknown
- ID: M12318
- Name: Neoplasms, Germ Cell and Embryonal
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12325
- Name: Neoplasms, Nerve Tissue
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T2519
- Name: Glioma
- Relevance: HIGH
- As Found: Glioma
- ID: T4092
- Name: Neuroepithelioma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005910
- Term: Glioma
- ID: D000012008
- Term: Recurrence
### Intervention Browse Module - Ancestors
- ID: D000002614
- Term: Chelating Agents
- ID: D000064449
- Term: Sequestering Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000925
- Term: Anticoagulants
- ID: D000065096
- Term: Calcium Chelating Agents
- ID: D000019275
- Term: Radiopharmaceuticals
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: AnCoag
- Name: Anticoagulants
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
- Abbrev: AA
- Name: Amino Acids
### Intervention Browse Module - Browse Leaves
- ID: M352637
- Name: Gallium 68 PSMA-11
- Relevance: HIGH
- As Found: 6000
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M1804
- Name: Carbamide Peroxide
- Relevance: LOW
- As Found: Unknown
- ID: M7662
- Name: Edetic Acid
- Relevance: HIGH
- As Found: Intensive Care Unit
- ID: M7543
- Name: Pentetic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M5860
- Name: Chelating Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4244
- Name: Anticoagulants
- Relevance: LOW
- As Found: Unknown
- ID: M5381
- Name: Calcium
- Relevance: LOW
- As Found: Unknown
- ID: M5398
- Name: Calcium, Dietary
- Relevance: LOW
- As Found: Unknown
- ID: M21258
- Name: Radiopharmaceuticals
- Relevance: LOW
- As Found: Unknown
- ID: T11
- Name: Lysine
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000004492
- Term: Edetic Acid
- ID: C000718244
- Term: Gallium 68 PSMA-11
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444399
**Brief Title:** Deucravacitinib (BMS-986165) for Pityriasis Rubra Pilaris
**Official Title:** Deucravacitinib (BMS-986165) in the Treatment of Pityriasis Rubra Pilaris
#### Organization Study ID Info
**ID:** 23-012923
#### Organization
**Class:** OTHER
**Full Name:** Mayo Clinic
### 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:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Mayo Clinic
#### Responsible Party
**Investigator Affiliation:** Mayo Clinic
**Investigator Full Name:** Aaron R. Mangold
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The purpose of this study is to evaluate the safety and effectiveness of Deucravacitinib (BMS-986165) in Pityriasis Rubra Pilaris as assessed by the change in Investigator Global Assessment (IGA), PASI- 50, 75, 90, DLQI, NRS itch, and Skindex-16 at week 24. To predict responses through the identification of unique biomarkers of PRP utilizing single-cell RNA sequencing.
### Conditions Module
**Conditions:**
- Pityriasis Rubra Pilaris
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 12
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Subjects will receive Deucravacitinib, twice daily for 24 weeks
**Intervention Names:**
- Drug: Deucravacitinib
**Label:** Pityriasis Rubra Pilaris
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Pityriasis Rubra Pilaris
**Description:** 6 mg administered orally twice daily for 24 weeks.
**Name:** Deucravacitinib
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The Psoriasis Area and Severity Index (PASI) is used to assess the severity of psoriasis. The PASI score evaluates the discoloration, thickness, scaling, and coverage of psoriatic plaques on the skin. It ranges from 0 to 72, with higher scores indicating greater severity.
**Measure:** Change in PASI scores
**Time Frame:** Baseline, 24 weeks
#### Secondary Outcomes
**Description:** The Itch Numeric Rating Scale is a self-administered patient-reported outcome instrument used to assess the severity of itching in patients with atopic dermatitis. It asks patients to rate their worst level of itching in the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst itch imaginable)
**Measure:** Change in patient´s assessment of itch as measured by numeric rating scale
**Time Frame:** Baseline, 24 weeks
**Description:** The DLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
**Measure:** Change in the Dermatology life quality index (DLQI)
**Time Frame:** Baseline, 24 weeks
**Description:** Skindex-16 consists of domain scores that assess how symptoms, emotions, and functioning from the skin issue affect the QOL of patients with skin conditions. The overall score averages the 3 domain scores, all of which are normalized to a 0 to 100 scale, where 0 indicates that their skin condition has no impact on QOL and 100 represents maximal impact on QOL for the worse.
**Measure:** Change in the Skindex-16
**Time Frame:** Baseline, 24 weeks
**Description:** The Investigator Global Assessment (IGA) is a standardized method used by healthcare professionals to evaluate the severity of atopic dermatitis (AD). It provides a comprehensive assessment of the extent and severity of eczema lesions on the skin. The IGA scale includes five points, each with specific morphological descriptions. (0 - Not affected, 1 - Little affected, 2 - Mild, 3 - Moderate, 4 - Severe)
**Measure:** Change in Investigator Global Assessment (IGA)
**Time Frame:** Baseline, 24 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Written informed consent must be obtained before any assessment is performed.
* Female and male patients ≥ 18 years of age.
* Subjects must have a diagnosis of PRP type 1, 2.
* Biopsy result consistent with PRP and not diagnostic for another disease.
* Moderate to severe disease defined as Psoriasis Area and Severity Index (PASI) ≥ 10.
* Candidates for systemic therapy.
* Inadequate response to or not suitable for topical therapy in the opinion of the investigator.
* If using any of the allowed topical treatments on the affected areas, the dose and application frequency should remain stable for 2 weeks prior to randomization and until Week 24.
Exclusion Criteria:
* On excluded therapies, not on a stable dose of a therapy, or incompletely washed out for a therapy (Table-1.).
* Previous use of a TYK2 inhibitor/enrollment in TYK2 inhibitor trials.
* Known hypersensitivity or other adverse reaction to Deucravacitinib (BMS-986165).
* HIV related PRP (PRP type 6).
* atypical forms of PRP, e.g. presenting with ichtyosiform dermatitis, coarse palmoplantar keratosis.
* Currently enrolled in any other clinical trial involving any investigational agent or device.
* Presence of any other skin condition that may affect the evaluations of the study disease.
* Current, severe, progressive or uncontrolled diseases that render the patient unsuitable for the trial, including any medical or psychiatric condition that, in the Investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
* Ongoing use of ANY treatment prohibited by the protocol (Tables 1 \& 2).
* Pregnant or nursing (lactating) women (pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test).
* Women of childbearing potential unless they are using basic methods of contraception which includes:
* Total abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception;
* Female sterilization (have had surgical bilateral oophorectomy \[with or without hysterectomy\], total hysterectomy or tubal ligation at least six weeks before taking study; treatment). In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment;
* Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that patient;
* Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps);
* Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \< 1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS). In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
* In case local regulations deviate from the contraception methods listed above, local regulations apply and will be described in the informed consent form (ICF).
* Note: Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks prior to enrollment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of childbearing potential.
* Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions) which, in the opinion of the investigator, significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
* Moderate-to-severe renal impairment including patients with estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m\^2.
* Active systemic infections during the 2 weeks prior to randomization (common cold viruses excluded) or any infection that reoccurs on a regular basis.
* Current severe progressive or uncontrolled disease which the investigator renders the subject unsuitable for the trial or puts the subject at increased risk.
* Have had any major surgery within 8 weeks prior to screening or will require major surgery during the study that, in the opinion of the investigator would pose an unacceptable risk to the patient.
* Have experienced any of the following within 12 weeks of screening: VTE (DVT/pulmonary embolism \[PE\]), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
* Have a history of recurrent (≥ 2) VTE (DVT/PE).
* Have a history of lymphoproliferative disease; have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for \< 5 years prior to randomization.
* Have had symptomatic herpes zoster infection within 12 weeks prior to randomization.
* Have a history of disseminated/complicated herpes zoster (for example, ophthalmic zoster or CNS involvement).
* ALT or AST \> 2 x upper limits of normal (ULN); alkaline phosphatase (ALP) ≥ 2 x ULN; total bilirubin ≥ 1.5 x ULN; hemoglobin \< 10 g/dL (100.0 g/L); total white blood cell count \< 3000 cells/μL (\< 3.00 x 10\^3/μL or \< 3.00 billion/L); neutropenia (absolute neutrophil count \[ANC\] \< 1500 cells/μL) (\< 1.50 x 10\^3/μL or \< 1.50 billion/L); lymphopenia (lymphocyte count \< 1000 cells/μL) (\< 1.00 x 10\^3/μL or \< 1.00 bilion/L); thrombocytopenia (platelets \< 100,000 cells/μL) (\< 100 x 10\^3/μL or \< 100 billion/L).
* Have a positive test for hepatitis B virus (HBV) defined as:
* Positive for hepatitis B surface antigen (HBsAg); or
* Positive for hepatitis B core antibody (HBcAb) and positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) Note: Patients who are HBcAb-positive and HBV DNA-negative may be enrolled in the study but will require additional HBV DNA monitoring during the study.
* Have hepatitis C virus (HCV) infection (hepatitis C antibody-positive and HCV ribonucleic acid \[RNA\]-positive). Note: Patients who have documented anti-HCV treatment for a past HCV infection AND are HCV RNA-negative may be enrolled in the study.
* Have evidence of HIV infection and/or positive HIV antibodies.
* Have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB.
* Have evidence of active TB or latent TB.
* Have evidence of active TB, defined in this study as the following:
* Positive purified protein derivative (PPD) test (≥ 5 mm induration between approximately 2 and 3 days after application, regardless of vaccination history), medical history, clinical features, and abnormal chest x-ray at screening;
* QuantiFERON®-TB Gold test or T-SPOT®.TB test (as available and if compliant with local TB guidelines) may be used instead of the PPD test. Patients are excluded from the study if the test is not negative and there is clinical evidence of active TB. Exception: patients with a history of active TB who have documented evidence of appropriate treatment, have no history of re-exposure since their treatment was completed, have no clinical features of active TB, and have a screening chest x-ray with no evidence of active TB may be enrolled if other entry criteria met. Such patients would not be required to undergo the protocol-specific TB testing for PPD, QuantiFERON®-TB Gold test, or T-SPOT®.TB test but must have a chest x-ray at screening (i.e., chest imaging performed within the past 6 months will not be accepted).
* Have evidence of untreated/inadequately or inappropriately treated latent TB, defined in this study as the following:
* Positive PPD test, no clinical features consistent with active TB, and a chest x-ray with no evidence of active TB at screening; or
* If the PPD test is positive and the patient has no medical history or chest x-ray findings consistent with active TB, the patient may have a QuantiFERON®-TB Gold test or T-SPOT®.TB test (as available and if compliant with local TB guidelines). If the test results are not negative, the patient will be considered to have latent TB (for purposes of this study); or
* QuantiFERON®-TB Gold test or T- SPOT®.TB test (as available and if compliant with local TB guidelines) may be used instead of the PPD test. If the test results are positive, the patient will be considered to have latent TB. If the test is not negative, the test may be repeated once within approximately 2 weeks of the initial value. If the repeat test results are again not negative, the patient will be considered to have latent TB (for purposes of this study).
* Have been exposed to a live vaccine within 12 weeks of randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination).
* Have donated more than a single unit of blood within 4 weeks prior to screening or intend to donate blood during the course of the study.
* Have a history of intravenous drug abuse, other illicit drug abuse, or chronic alcohol abuse within the 2 years prior to screening or are concurrently using, or expected to use during the study, illicit drugs (including marijuana).
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Aaron Mangold, MD
**Phone:** (480) 301-8000
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Keegan Stewart
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Scottsdale
**Country:** United States
**Facility:** Mayo Clinic in Arizona
**State:** Arizona
**Zip:** 85259
#### Overall Officials
**Official 1:**
**Affiliation:** Mayo Clinic
**Name:** Aaron Mangold, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000017444
- Term: Skin Diseases, Papulosquamous
- ID: D000012871
- Term: Skin Diseases
- ID: D000003872
- Term: Dermatitis
- ID: D000017443
- Term: Skin Diseases, Eczematous
### Condition Browse Module - Browse Branches
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M13805
- Name: Pityriasis
- Relevance: HIGH
- As Found: Pityriasis
- ID: M7068
- Name: Dermatitis, Exfoliative
- Relevance: HIGH
- As Found: Pityriasis Rubra
- ID: M13806
- Name: Pityriasis Rubra Pilaris
- Relevance: HIGH
- As Found: Pityriasis Rubra Pilaris
- ID: M7067
- Name: Dermatitis
- 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: M19712
- Name: Skin Diseases, Eczematous
- Relevance: LOW
- As Found: Unknown
- ID: T2153
- Name: Exfoliative Dermatitis
- Relevance: HIGH
- As Found: Pityriasis Rubra
- ID: T4581
- Name: Pityriasis Rubra Pilaris
- Relevance: HIGH
- As Found: Pityriasis Rubra Pilaris
### Condition Browse Module - Meshes
- ID: D000010915
- Term: Pityriasis
- ID: D000003873
- Term: Dermatitis, Exfoliative
- ID: D000010916
- Term: Pityriasis Rubra Pilaris
### Intervention Browse Module - Ancestors
- ID: D000003879
- Term: Dermatologic Agents
- ID: D000047428
- Term: Protein Kinase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M346703
- Name: Deucravacitinib
- Relevance: HIGH
- As Found: S2
- ID: M7074
- Name: Dermatologic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M25820
- Name: Protein Kinase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000628674
- Term: Deucravacitinib
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444386
**Brief Title:** ECGi of SyncAV With MultiPoint Pacing
**Official Title:** Electrocardiographic Imaging of MultiPoint Pacing and SyncAV: Understanding Optimized Programming for Cardiac Resynchronization Therapy
#### Organization Study ID Info
**ID:** ABT-CIP-10292
#### Organization
**Class:** INDUSTRY
**Full Name:** Abbott Medical Devices
### Status Module
#### Completion Date
**Date:** 2024-04-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-04
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-07-12
**Type:** ACTUAL
#### Start Date
**Date:** 2021-09-29
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Abbott Medical Devices
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The objective of this clinical study was to evaluate the impact of Multipoint Pacing (MPP) and SyncAV programming on ventricular electrical activation time and activation sequence using noninvasive electrocardiographic imaging (ECGi) in patients receiving cardiac resynchronization therapy (CRT).
### Conditions Module
**Conditions:**
- Cardiac Resynchronization Therapy
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 30
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Cardiac resynchronization therapy (CRT) features of MultiPoint Pacing (MPP) and SyncAV (dynamic atrioventricular delay programming) enabled.
**Name:** MPP + SyncAV
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluate acute changes in left ventricular (LV) electrical activation time measured with ECGi resulting from various CRT pacing configurations with MPP and SyncAV
**Measure:** Left ventricular activation time
**Time Frame:** 1 day
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients previously implanted with a SyncAV and MPP-enabled Abbott Quadripolar CRT pacing system
* Patient must be \> 18 years of age, able to provide informed consent and willing to comply with study requirements
* Sinus (or atrial paced) rhythm with intact AV conduction with PR interval ≤ 250 ms
* Patient has documented Left Bundle Branch Block (LBBB)
Exclusion Criteria:
* Resting heart rate \> 100 bpm
* AV Block (1st degree with PR\> 250 ms, 2nd or 3rd degree)
* Documented persistent atrial tachycardia or atrial fibrillation at the moment of enrollment or patients not likely to remain in sinus (or atrial paced) rhythm for the duration of the study
* Recent (\< 3 months) myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for CRT programming changes in the opinion of the investigator
* Women who are pregnant or plan to become pregnant during the study course
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The intended population for this clinical investigation consisted of patients over the age of 18 years who have been previously implanted with an Abbott CRT device capable of SyncAV and MultiPoint Pacing. This clinical investigation enrolled male and female subjects from the general heart failure population. Subjects must have met all eligibility criteria and provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Sylmar
**Country:** United States
**Facility:** Abbott
**State:** California
**Zip:** 91342
### 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:** NCT06444373
**Acronym:** INAIL BRIC
**Brief Title:** Artificial Intelligence in Lung Cancer Screening
**Official Title:** Development of an Artificial Intelligence Model in Lung Cancer Screening for the Diagnosis of Lung Nodules and Risk Stratification in Subjects With Occupational and/or Smoking Exposure
#### Organization Study ID Info
**ID:** 116/INT/2022
#### Organization
**Class:** OTHER
**Full Name:** Scientific Institute San Raffaele
### Status Module
#### Completion Date
**Date:** 2024-05-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-05-22
**Type:** ACTUAL
#### Start Date
**Date:** 2022-12-02
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Scientific Institute San Raffaele
#### Responsible Party
**Investigator Affiliation:** Scientific Institute San Raffaele
**Investigator Full Name:** Giulia Veronesi
**Investigator Title:** Medical Doctor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Single-center, non-profit, observational, retrospective study of collection of clinical and amnestic data and images to create, implement and develop a pilot model of an integrated virtual platform.
**Detailed Description:** The project we propose is a study whose objective was to develop an artificial intelligence program integrated into a web-based platform for the optimization of the performance of lung cancer screening for the diagnosis of lung nodules and risk stratification in subjects exposed to environmental carcinogens and/or cigarette smoke.
Inclusion criteria:
Age \> 50; smokers for at least 20 pack-years (20 cigarillos a day for 20 years) or former heavy smokers if they quit less than 15 years ago; and/or previous professional exposure to asbestos; absence of lung cancer symptoms; who performed lung cancer screening after the year 2000 upon approval of the study by the relevant EC.
### Conditions Module
**Conditions:**
- Lung Cancer Screening
- Asbestos
**Keywords:**
- Artificial Intelligence
- Asbestos
- Lung Cancer Screening
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 728
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Actual Smokers or formers smoker; Age \> 50 years.
**Label:** subjects enrolled in lung cancer screening
### Outcomes Module
#### Primary Outcomes
**Description:** Development and fine-tuning of a pilot deep learning model for automatic detection and diagnosis of screen-detected nodules for risk stratification in subjects with asbestos exposure as part of a lung cancer screening program in high-risk subjects for exposure to asbestos and smoking on retrospective data.
**Measure:** AIM 1 Pilot deep learning model
**Time Frame:** from enrollment to the end of treatment at 2 years
#### Secondary Outcomes
**Description:** Development of an integrated system between the clinical database and several existing imaging volumetric software and risk models for the creation of a pilot platform in order to optimize the organizational management of lung cancer screening.
**Measure:** AIM 2 Clinical database
**Time Frame:** from enrollment to the end of treatment at 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age \> 50 years;
* smokers for at least 20 pack-years (20 cigarettes a day for 20 years) or former heavy smokers if they quit less than 15 years ago;
* and/or previous professional exposure to asbestos;
* absence of lung cancer symptoms;
* who performed lung cancer screening after the year 2000 upon approval of the study by the relevant Etical Committee
Exclusion Criteria:
* Age \< 50 years
* never smokers
* lung cancer symptoms
**Healthy Volunteers:** True
**Minimum Age:** 50 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Age \> 50 years; smokers for at least 20 pack-years (20 cigarettes a day for 20 years) or former heavy smokers if they quit less than 15 years ago; and/or previous professional exposure to asbestos.
All subjects were enrolled in lung cancer screening program.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Milan
**Country:** Italy
**Facility:** IRCCS San Raffaele Scientific Institute
**Zip:** 20132
## 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
### 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: 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: D000008175
- Term: Lung Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444360
**Acronym:** IMPACT
**Brief Title:** Behavioral Activation and Risk Reduction for Stimulant Use Among Sexually Active Young Gay/Bisexual Minority Men (IMPACT)
**Official Title:** Hybrid Type 2 Effectiveness-Implementation Trial of Status Neutral, Integrated Behavioral Activation and Risk Reduction Intervention for Stimulant Use Among Sexually Active Young Gay/Bisexual Sexual Minority Men (Project IMPACT)
#### Organization Study ID Info
**ID:** ATN170
#### Organization
**Class:** OTHER
**Full Name:** Westat
### Status Module
#### Completion Date
**Date:** 2028-12-31
**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:** 2028-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-22
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
**Class:** NIH
**Name:** National Institute on Drug Abuse (NIDA)
**Class:** NIH
**Name:** National Institute of Mental Health (NIMH)
#### Lead Sponsor
**Class:** OTHER
**Name:** Westat
#### 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 use of behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk
**Detailed Description:** IMPACT is a Human Immunodeficiency Virus (HIV) status-neutral, behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk. This study will evaluate the effectiveness of IMPACT and determine feasibility of implementing IMPACT across various settings for translation into real-world practice using a hybrid effectiveness-implementation design.
The IMPACT intervention includes 10 sessions: 2 intervention sessions of HIV risk reduction (RR), 1 session focused on orienting and rationale of behavioral activation (BA), 6 sessions integrating BA and RR-including pre-exposure prophylaxis (PrEP) or antiretroviral therapy (ART) and HIV care-and 1 final session on relapse prevention.
The enhanced Standard of Care (eSOC) group includes two HIV RR intervention sessions.
### Conditions Module
**Conditions:**
- HIV
**Keywords:**
- HIV Sexual Transmission Risk
- Behavioral Activation
- Risk Reduction Intervention
- Stimulant Use
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The study is a two-arm, multisite, and multiformat randomized controlled trial (RCT). IMPACT is a status-neutral intervention that uses behavioral activation (BA)-an evidence-based, cognitive behavior therapy-as a treatment for stimulant use and sexual risk reduction (RR) counseling for young gay/bisexual sexual minority men.
The IMPACT intervention includes 10 sessions: 2 intervention sessions of HIV RR, 1 session focused on orienting and rationale of BA, 6 sessions integrating BA and RR-including pre-exposure prophylaxis (PrEP) or antiretroviral therapy (ART) and HIV care-and 1 final session on relapse prevention.
The enhanced Standard of Care (eSOC) group includes two HIV risk reduction intervention sessions.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 360
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** A multifaceted training and implementation strategy across sites and formats will be used. Participants who report stimulant use in the context of condomless anal sex (CAS), will be randomized using a 2:1 allocation ratio with two-thirds being allocated to the IMPACT intervention. The participants in this arm participate in 10 sessions (approximately 50 minutes each) delivered over the course of approximately 10 weeks.
**Intervention Names:**
- Behavioral: IMPACT
**Label:** IMPACT Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The comparison arm will receive the same 2 HIV sexual risk reduction (RR) intervention sessions and referrals to substance use and mental health treatment, per SOC.
**Intervention Names:**
- Behavioral: eSOC
**Label:** Enhanced Standard of Care (eSOC) Control Group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- IMPACT Group
**Description:** The IMPACT intervention consists of 10 sessions: 2 sessions focused on HIV acquisition/transmission risk reduction (RR), 1 session focused on orienting and rationale to behavioral activation (BA), 6 sessions integrating BA and HIV RR counseling (including PrEP or ART and HIV care), and 1 final session on strategies for slip-ups and recurrence management.
**Name:** IMPACT
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Enhanced Standard of Care (eSOC) Control Group
**Description:** The eSOC group consists of 2 sessions focused on HIV acquisition/transmission risk reduction (RR).
**Name:** eSOC
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The number of times participants report engaging in a CAS act without the protection of prevention-effective PrEP (for those not living with HIV) or viral suppression (for those living with HIV).
**Measure:** Distinct acts of condomless anal sex (CAS) without the protection of PrEP or viral suppression.
**Time Frame:** Participants will recall and report acts of CAS and medication adherence for the 30 days prior to each of 4 visits: Baseline, Month 4, Month 8 and Month 12 after enrollment
#### Secondary Outcomes
**Description:** The number of days participants report having used stimulants
**Measure:** Days of stimulant use
**Time Frame:** Participants will recall and report the number of days they used stimulants out of the 30 days prior to each of 4 visits: Baseline, Month 4, Month 8 and Month 12 after enrollment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 16-24 years, inclusive, at enrollment
* Assigned male at birth
* Identifies as a cisgender boy or man
* Self-reports condomless anal sex (CAS) with another boy/man-receptive or insertive-while using stimulants (1 hour prior to, or during sex) within the last 4 months; stimulants is defined as crystal methamphetamine, cocaine, and MDMA (e.g., ecstasy, molly)
* Willing and able to provide written informed consent for study participation
In addition, virtual participants must meet all the below criteria:
* Access to a computer/smartphone/tablet that can use video chat (e.g., Zoom or Google Meet)
* Provide a mailing address where they can receive a package
* Access to stable internet that they can use for more than 2 hours at a time
* Have a private place (where no one else can see or hear) where they can complete visits online
* Reside within the continental U.S.
Exclusion Criteria:
* Unable to provide informed consent due to severe mental or physical illness
* Concurrent enrollment in another HIV prevention or treatment study (enrollment in a substance treatment program is acceptable
* Non-English-speaking
* Is currently incarcerated or pending incarceration
* Any other medical condition, medical/behavioral intervention, or other condition that, in the opinion of the Site Consortium Project Lead or designee, could interfere with the safety of participants or staff, adherence to study procedures, or compromise interpretation of study results
**Gender Based:** True
**Gender Description:** Assigned male at birth
**Healthy Volunteers:** True
**Maximum Age:** 24 Years
**Minimum Age:** 16 Years
**Sex:** MALE
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Erin Ricketts
**Phone:** 240-453-2786
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Los Angeles
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Eun Kwak
- **Phone:** 310-825-3094
- **Role:** CONTACT
***Contact 2:***
- **Name:** Matthew Mimiaga, ScD, MPH
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of California, Los Angeles
**State:** California
**Zip:** 90025
**Location 2:**
**City:** Los Angeles
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Julie McAvoy-Banerjea
- **Phone:** 323-361-5023
- **Role:** CONTACT
***Contact 2:***
- **Name:** Marvin Belzer, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Children's Hospital Los Angeles
**State:** California
**Zip:** 90027
**Location 3:**
**City:** Atlanta
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sierra Jordan-Thompson
- **Phone:** 404-616-9839
- **Role:** CONTACT
***Contact 2:***
- **Name:** Andres Camacho-Gonzalez, MD, MsC
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Emory Atlanta Adolescent Consortium
**State:** Georgia
**Zip:** 30322
**Location 4:**
**City:** Chicago
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Raymond McPherson
- **Phone:** 312-572-4531
- **Role:** CONTACT
***Contact 2:***
- **Name:** Kelly Bojan, DNP, APRN
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University Illinois Chicago
**State:** Illinois
**Zip:** 60612
**Location 5:**
**City:** New Orleans
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sean Sylve
- **Phone:** 504-988-5348
- **Role:** CONTACT
***Contact 2:***
- **Name:** Tina Simpson, MD, MPH
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Tulane University
**State:** Louisiana
**Zip:** 70112
**Location 6:**
**City:** Boston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Be the Change
- **Phone:** 617-927-6309
- **Role:** CONTACT
***Contact 2:***
- **Name:** Ken Mayer, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** The Fenway Institute
**State:** Massachusetts
**Zip:** 02215
**Location 7:**
**City:** Providence
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** IMPACT 170
- **Phone:** 401-863-3292
- **Role:** CONTACT
***Contact 2:***
- **Name:** Katie Biello, PhD, MPH
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Brown University
**State:** Rhode Island
**Zip:** 02912
#### Overall Officials
**Official 1:**
**Affiliation:** Brown University
**Name:** Katie Biello, PhD, MPH
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** University of California, Los Angeles
**Name:** Matthew Mimiaga, ScD, MPH
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M18250
- Name: HIV Infections
- Relevance: LOW
- As Found: Unknown
- ID: M3522
- Name: Acquired Immunodeficiency Syndrome
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: CNSSti
- Name: Central Nervous System Stimulants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4029
- Name: Central Nervous System Stimulants
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444347
**Brief Title:** Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair
**Official Title:** The Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair in Robotic Anti-Reflux Surgery: A Multi-Institutional Randomized Trial
#### Organization Study ID Info
**ID:** 23-11026766
#### Organization
**Class:** OTHER
**Full Name:** Weill Medical College of Cornell University
### Status Module
#### Completion Date
**Date:** 2030-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Intuitive Surgical
#### Lead Sponsor
**Class:** OTHER
**Name:** Weill Medical College of Cornell University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The aim of this study is to find out if using a certain kind of mesh can reduce the chances of hiatal hernias coming back after anti-reflux surgery. Participants undergoing antireflux surgery will be assigned to one of two groups, a group that has surgery with mesh, or a group that has surgery without mesh.
### Conditions Module
**Conditions:**
- Hiatal Hernia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The biosynthetic mesh group will undergo hiatal hernia repair with Phasix Mesh (Becton Dickinson, Franklin Lakes, NJ) reinforcement, secured with permanent suture. This is a biosynthetic mesh that completely reabsorbs in 12-18 months after surgery. The mesh is designed to provide strength during the initial healing phase after hernia repair, allowing for rapid tissue ingrowth and vascularization, gradually transferring the load to native tissue as it resorbs1. This mesh has been FDA approved for procedures involving soft tissue repair, such as hernia defects.
**Intervention Names:**
- Device: Biosynthetic Mesh
- Procedure: Hiatal Hernia Repair
**Label:** Biosynthetic Mesh
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The non-mesh group will undergo repair with permanent suture only.
**Intervention Names:**
- Procedure: Hiatal Hernia Repair
**Label:** No Mesh
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Biosynthetic Mesh
**Description:** The biosynthetic mesh group will undergo hiatal hernia repair with Phasix Mesh (Becton Dickinson, Franklin Lakes, NJ) reinforcement, secured with permanent suture.
**Name:** Biosynthetic Mesh
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Biosynthetic Mesh
- No Mesh
**Description:** The non-mesh group will undergo hiatal hernia repair with permanent suture only.
**Name:** Hiatal Hernia Repair
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Measure:** Anatomic hiatal hernia recurrence rate
**Time Frame:** 1 year
#### Secondary Outcomes
**Measure:** Anatomic Hiatal Hernia Recurrence rate
**Time Frame:** 3 years
**Measure:** Anatomic Hiatal Hernia Recurrence rate
**Time Frame:** 5 years
**Description:** Reflux symptoms will be assessed using the gastroesophageal reflux disease health related quality of life survey (GERD-HRQL). The highest possible score on this survey is 75, indicating daily incapacitating symptoms in all areas assessed. The lowest possible score is 0, indicating no symptoms.
**Measure:** Reflux Symptoms
**Time Frame:** 2 weeks postoperatively
**Description:** Reflux symptoms will be assessed using the gastroesophageal reflux disease health related quality of life survey (GERD-HRQL). The highest possible score on this survey is 75, indicating daily incapacitating symptoms in all areas assessed. The lowest possible score is 0, indicating no symptoms.
**Measure:** Reflux Symptoms
**Time Frame:** 6 months postoperatively
**Description:** Reflux symptoms will be assessed using the gastroesophageal reflux disease health related quality of life survey (GERD-HRQL). The highest possible score on this survey is 75, indicating daily incapacitating symptoms in all areas assessed. The lowest possible score is 0, indicating no symptoms.
**Measure:** Reflux Symptoms
**Time Frame:** 1 year postoperatively
**Description:** Reflux symptoms will be assessed using the gastroesophageal reflux disease health related quality of life survey (GERD-HRQL). The highest possible score on this survey is 75, indicating daily incapacitating symptoms in all areas assessed. The lowest possible score is 0, indicating no symptoms.
**Measure:** Reflux Symptoms
**Time Frame:** 2 years postoperatively
**Description:** Reflux symptoms will be assessed using the gastroesophageal reflux disease health related quality of life survey (GERD-HRQL). The highest possible score on this survey is 75, indicating daily incapacitating symptoms in all areas assessed. The lowest possible score is 0, indicating no symptoms.
**Measure:** Reflux Symptoms
**Time Frame:** 3 years postoperatively
**Description:** Reflux symptoms will be assessed using the gastroesophageal reflux disease health related quality of life survey (GERD-HRQL). The highest possible score on this survey is 75, indicating daily incapacitating symptoms in all areas assessed. The lowest possible score is 0, indicating no symptoms.
**Measure:** Reflux Symptoms
**Time Frame:** 4 years postoperatively
**Description:** Reflux symptoms will be assessed using the gastroesophageal reflux disease health related quality of life survey (GERD-HRQL). The highest possible score on this survey is 75, indicating daily incapacitating symptoms in all areas assessed. The lowest possible score is 0, indicating no symptoms.
**Measure:** Reflux Symptoms
**Time Frame:** 5 years postoperatively
**Description:** Dysphagia symptoms will be assessed using the Bazaz dysphagia score. The lowest dysphagia severity score being "none", indicating no difficulty swallowing. The highest dysphagia severity score being "severe", indicating frequent difficulty swallowing with the majority of foods.
**Measure:** Dysphagia Symptoms
**Time Frame:** 2 weeks postoperatively
**Description:** Dysphagia symptoms will be assessed using the Bazaz dysphagia score. The lowest dysphagia severity score being "none", indicating no difficulty swallowing. The highest dysphagia severity score being "severe", indicating frequent difficulty swallowing with the majority of foods.
**Measure:** Dysphagia Symptoms
**Time Frame:** 6 months postoperatively
**Description:** Dysphagia symptoms will be assessed using the Bazaz dysphagia score. The lowest dysphagia severity score being "none", indicating no difficulty swallowing. The highest dysphagia severity score being "severe", indicating frequent difficulty swallowing with the majority of foods.
**Measure:** Dysphagia Symptoms
**Time Frame:** 1 year postoperatively
**Description:** Dysphagia symptoms will be assessed using the Bazaz dysphagia score. The lowest dysphagia severity score being "none", indicating no difficulty swallowing. The highest dysphagia severity score being "severe", indicating frequent difficulty swallowing with the majority of foods.
**Measure:** Dysphagia Symptoms
**Time Frame:** 2 years postoperatively
**Description:** Dysphagia symptoms will be assessed using the Bazaz dysphagia score. The lowest dysphagia severity score being "none", indicating no difficulty swallowing. The highest dysphagia severity score being "severe", indicating frequent difficulty swallowing with the majority of foods.
**Measure:** Dysphagia Symptoms
**Time Frame:** 3 years postoperatively
**Description:** Dysphagia symptoms will be assessed using the Bazaz dysphagia score. The lowest dysphagia severity score being "none", indicating no difficulty swallowing. The highest dysphagia severity score being "severe", indicating frequent difficulty swallowing with the majority of foods.
**Measure:** Dysphagia Symptoms
**Time Frame:** 4 years postoperatively
**Description:** Dysphagia symptoms will be assessed using the Bazaz dysphagia score. The lowest dysphagia severity score being "none", indicating no difficulty swallowing. The highest dysphagia severity score being "severe", indicating frequent difficulty swallowing with the majority of foods.
**Measure:** Dysphagia Symptoms
**Time Frame:** 5 years postoperatively
**Measure:** Number of subjects requiring 30 day readmission
**Time Frame:** 30 days following surgery
**Measure:** Number of subjects requiring reoperation
**Time Frame:** 30 days following surgery
**Measure:** Number of subjects developing postoperative Infection
**Time Frame:** 30 days following surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Documented diagnosis of gastroesophageal reflux disease
* Adults aged 18 years or older
* English speaking
* Subject is planned to undergo surgery for reflux disease
Exclusion Criteria:
* Physician deems the subject is unable to complete the study due to documented dementia.
* Subject is undergoing emergent surgery.
* Pregnancy
* Patient has known allergy to tetracycline hydrochloride or kanamycin sulfate
**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:** Niloufar Salehi, MD
**Phone:** 212-746-5187
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Los Angeles
**Contacts:**
***Contact 1:***
- **Name:** Caitlin Houghton, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Caitlin Houghton, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Southern California Keck School of Medicine
**State:** California
**Zip:** 90033
**Location 2:**
**City:** New Orleans
**Contacts:**
***Contact 1:***
- **Name:** Carlos Galvani, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Carlos Galvani, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Louisiana State University School of Medicine
**State:** Louisiana
**Zip:** 70112
**Location 3:**
**City:** Burlington
**Contacts:**
***Contact 1:***
- **Name:** Cameron Stock, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Elliot Servais, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Lahey Hospital and Medical Center
**State:** Massachusetts
**Zip:** 01805
**Location 4:**
**City:** Saint Louis
**Contacts:**
***Contact 1:***
- **Name:** William Gerull, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Michael Awad, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Washington University School of Medicine
**State:** Missouri
**Zip:** 63110
**Location 5:**
**City:** New York
**Contacts:**
***Contact 1:***
- **Name:** Louis Espinosa, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Tanuja Damani, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** New York University Grossman School of Medicine
**State:** New York
**Zip:** 10016
**Location 6:**
**City:** New York
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Niloufar Salehi, MD
- **Phone:** 212-746-5187
- **Role:** CONTACT
***Contact 2:***
- **Name:** Rasa Zarnegar, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Weill Cornell Medicine
**State:** New York
**Zip:** 10065
#### Overall Officials
**Official 1:**
**Affiliation:** Weill Medical College of Cornell University
**Name:** Rasa Zarnegar, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Yamasaki T, Hemond C, Eisa M, Ganocy S, Fass R. The Changing Epidemiology of Gastroesophageal Reflux Disease: Are Patients Getting Younger? J Neurogastroenterol Motil. 2018 Oct 1;24(4):559-569. doi: 10.5056/jnm18140.
**PMID:** 30347935
**Citation:** Li Q, Blume SW, Huang JC, Hammer M, Ganz ML. Prevalence and healthcare costs of obesity-related comorbidities: evidence from an electronic medical records system in the United States. J Med Econ. 2015;18(12):1020-8. doi: 10.3111/13696998.2015.1067623. Epub 2015 Sep 4.
**PMID:** 26134917
**Citation:** Oelschlager BK, Pellegrini CA, Hunter JG, Brunt ML, Soper NJ, Sheppard BC, Polissar NL, Neradilek MB, Mitsumori LM, Rohrmann CA, Swanstrom LL. Biologic prosthesis to prevent recurrence after laparoscopic paraesophageal hernia repair: long-term follow-up from a multicenter, prospective, randomized trial. J Am Coll Surg. 2011 Oct;213(4):461-8. doi: 10.1016/j.jamcollsurg.2011.05.017. Epub 2011 Jun 29. Erratum In: J Am Coll Surg. 2011 Dec;213(6):815.
**PMID:** 21715189
**Citation:** Spiro C, Quarmby N, Gananadha S. Mesh-related complications in paraoesophageal repair: a systematic review. Surg Endosc. 2020 Oct;34(10):4257-4280. doi: 10.1007/s00464-020-07723-0. Epub 2020 Jun 18.
**PMID:** 32556700
**Citation:** Deeken CR, Matthews BD. Characterization of the Mechanical Strength, Resorption Properties, and Histologic Characteristics of a Fully Absorbable Material (Poly-4-hydroxybutyrate-PHASIX Mesh) in a Porcine Model of Hernia Repair. ISRN Surg. 2013 May 28;2013:238067. doi: 10.1155/2013/238067. Print 2013.
**PMID:** 23781348
**Citation:** Alicuben ET, Worrell SG, DeMeester SR. Resorbable biosynthetic mesh for crural reinforcement during hiatal hernia repair. Am Surg. 2014 Oct;80(10):1030-3.
**PMID:** 25264654
**Citation:** Aiolfi A, Cavalli M, Sozzi A, Lombardo F, Lanzaro A, Panizzo V, Bonitta G, Mendogni P, Bruni PG, Campanelli G, Bona D. Medium-term safety and efficacy profile of paraesophageal hernia repair with Phasix-ST(R) mesh: a single-institution experience. Hernia. 2022 Feb;26(1):279-286. doi: 10.1007/s10029-021-02528-z. Epub 2021 Oct 30.
**PMID:** 34716832
**Citation:** Tartaglia E, Cuccurullo D, Guerriero L, Reggio S, Sagnelli C, Mugione P, Corcione F. The use of biosynthetic mesh in giant hiatal hernia repair: is there a rationale? A 3-year single-center experience. Hernia. 2021 Oct;25(5):1355-1361. doi: 10.1007/s10029-020-02273-9. Epub 2020 Jul 25.
**PMID:** 32712835
**Citation:** Panici Tonucci T, Asti E, Sironi A, Ferrari D, Bonavina L. Safety and Efficacy of Crura Augmentation with Phasix ST Mesh for Large Hiatal Hernia: 3-Year Single-Center Experience. J Laparoendosc Adv Surg Tech A. 2020 Apr;30(4):369-372. doi: 10.1089/lap.2019.0726. Epub 2020 Jan 7.
**PMID:** 31910348
**Citation:** Quake, S. Y. L., Peter, B., Munipalle, P. C., & Viswanath, Y. (2023). OGBN O08 The Safety and Efficacy of Laparoscopic Hiatus Hernia Repair with Biosynthetic Mesh (Phasix-ST®): A Single Centre Experience. British Journal of Surgery, 110(Supplement_8), znad348-030.
**Citation:** Konstantinidis H, Charisis C. Surgical treatment of large and complicated hiatal hernias with the new resorbable mesh with hydrogel barrier (Phasix ST): a preliminary study. J Robot Surg. 2023 Feb;17(1):141-146. doi: 10.1007/s11701-022-01406-9. Epub 2022 Apr 9.
**PMID:** 35397107
**Citation:** Abdelmoaty WF, Dunst CM, Filicori F, Zihni AM, Davila-Bradley D, Reavis KM, Swanstrom LL, DeMeester SR. Combination of Surgical Technique and Bioresorbable Mesh Reinforcement of the Crural Repair Leads to Low Early Hernia Recurrence Rates with Laparoscopic Paraesophageal Hernia Repair. J Gastrointest Surg. 2020 Jul;24(7):1477-1481. doi: 10.1007/s11605-019-04358-y. Epub 2019 Aug 29.
**PMID:** 31468330
#### See Also Links
**Label:** "PhasixTM Mesh."
**URL:** https://www.bd.com/en-us/products-and-solutions/products/product-families/phasix-mesh.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020763
- Term: Pathological Conditions, Anatomical
- ID: D000006548
- Term: Hernia, Diaphragmatic
- ID: D000082122
- Term: Internal Hernia
### 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: M9625
- Name: Hernia
- Relevance: HIGH
- As Found: Hernia
- ID: M9629
- Name: Hernia, Hiatal
- Relevance: HIGH
- As Found: Paraesophageal Hernia
- ID: M8880
- Name: Gastroesophageal Reflux
- Relevance: LOW
- As Found: Unknown
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
- ID: M9626
- Name: Hernia, Diaphragmatic
- Relevance: LOW
- As Found: Unknown
- ID: M2344
- Name: Internal Hernia
- Relevance: LOW
- As Found: Unknown
- ID: M25675
- Name: Hernia, Abdominal
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006547
- Term: Hernia
- ID: D000006551
- Term: Hernia, Hiatal
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444334
**Brief Title:** Laser Biostimulation on Implant Covered With PRF in Controlled Diabetics
**Official Title:** Evaluation of the Effect of Laser Biostimulation on Implant Covered With PRF in Controlled Diabetic Patients: A Randomized Clinical Trial.
#### Organization Study ID Info
**ID:** implant PRF and laser
#### Organization
**Class:** OTHER
**Full Name:** National Research Centre, Egypt
### Status Module
#### Completion Date
**Date:** 2024-03-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-03-30
**Type:** ACTUAL
#### Start Date
**Date:** 2023-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** National Research Centre, Egypt
#### Responsible Party
**Investigator Affiliation:** National Research Centre, Egypt
**Investigator Full Name:** Said Abd Allah Kamel Taha
**Investigator Title:** dr
**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 laser biostimulation effect on osseointegration of implant covered by PRF(platelet rich fibrin) in controlled diabetic patients with compromised healing potential.
METHODS: The study was conducted on type 2 controlled diabetic patients receiving 22 implants covered with PRF inserted in posterior maxilla or mandible. Implants were divided randomly into 2 groups. Group1: control group (received no laser irradiation), group2: received diode laser. Peri-implant new bone density and secondary stability were assessed using cone-beam computed tomography and Anycheck device respectively. Density was evaluated immediately post implant insertion and after 5 months, while implant stability was performed 5 months post implant insertion. Statistical analysis was executed significance level P ≤ 0.05.
**Detailed Description:** Study type:
randomized controlled clinical trial.
Study design:
Controlled type II diabetic patients with edentulous posterior areas were randomly selected from dental clinic of Medical and Scientific Centre of Excellence (MSCE), National Research Centre (NRC), Cairo, Egypt, according to inclusion and exclusion criteria to receive a total number of twenty-two dental implants. Implants were randomly distributed with 1:1 allocation ratio into two groups according to exposure to laser irradiation. Group 1 was not exposed to laser irradiation (control group), while group 2 was exposed to laser irradiation. Peri-implant new bone density was evaluated immediately post implant insertion and after 5 months, while secondary implant stability was performed 5 months post implant insertion.
This study was prosecuted with the Code of Ethics of the World Medical Association, they were stated in the Declaration of Helsinki in 1975. Medical Research Ethical Committee of the National Research Centre, Cairo, Egypt permitted this study with approval number (03430423). All patients were familiar with the study's treatment phases and signed a consent form. The study was conducted from January 2023 to March 2024
Radiographic procedures:
Every patient had undergone radiographic analysis pre-operatively using cone beam computed tomography (CBCT) . The intended size and location of the implants were determined and planned virtually by digital software (Planmeca Romexis Viewer 6.2.1.19). Bone density around the implants will be evaluated using CBCT software at (immediately postoperative as baseline and 5 months postoperative. Both groups were radiographed by cone beam CT for evaluation and assessment of bone density around implants by professional blinded investigators. Planmeca Romaxies machine was used with the following specifications: Field of View (FOV) = 8.0x5.0 cm, resolution = 0.300, orientation = portrait, 90 kV, 80mA, and exposure time = 15.019 sec.
Surgical procedures:
Implants (K1 line conical connection double thread, OXY, Italy) were inserted under profound local anesthesia using free hand open flap technique; where mucoperiosteal gingival envelop full thickness flap was performed by crestal incision \& mucoperiosteal reflection exposing bone (Fig 1 a). The preplanned location was confirmed by the aid of CBCT, then sequential drilling was exerted using graduated drills with stoppers under copious amount of saline coolant with the aid of paralleling pins if multiple implants were inserted to be splinted in the same patient.
Implants were screwed with torque between 35-45N to ensure primary stability. Various implants' sizes were utilized ranging from 4 mm to 5.5mm in diameter and from 8mm to 11mm in length in accordance with the virtual pre-plan based on bone geometrical availability. The procedure was executed by a single well-experienced operator who was blinded to the groups.
PRF preparation protocol:
The preparation method of PRF was performed in accordance with the protocol developed by Choukroun et al 2001. PRF was withdrawn and processed from the same operated-on patient's blood; 6ml IV blood withdrawn from the antecubital vein in to two sterile 3ml red vacutainer tubes without anticoagulant, followed by a 12 minute centrifuge with 3000 RPM producing a platelet rich fibrin clot, which is then incised \& separated with 2mm basal layer of RBCs rich in growth factors (Fig 1 b,c). Following the cover screw placement, PRF was extended bucco-lingually and mesio-distally over the alveolar ridge (Fig1 d). Finally, approximation of the flap was achieved using non-resorbable 3/0 suture which was removed after 7-10 days postoperative. Nonsteroidal anti-inflammatory drugs and antibiotics were administered for seven days. Delayed loading was initiated after 5 months of osseointegration process.
Laser irradiation protocol:
Group 2 was exposed to laser irradiation following implant insertion for 3 sessions: Immediately after implant insertion, 2 days after implant insertion and 1 week after insertion (Fig 2 a), using a red Diode(gallium-aluminum-arsenide) LLLT using calibrated diode laser device (Smart M, Lasotronix, Poland) at 635nm wavelength delivered by biomodulating handpiece with the following set parameters: 100mw power output, 8mm handpiece diameter, continuous mode, and time 40 second per point and contact mode \[12\](Fig 2 b). The laser probe was directed towards the implant site, gently touching the tissues mesially, distally, buccally, and lingually to assure the full exposure of the target surface to laser beam (Fig 2c).
### Conditions Module
**Conditions:**
- Diabetes
- Implant Site Reaction
- Platelet Rich Fibrin
**Keywords:**
- laser biostimulation
- PRF
- implants
- osseointegration
- diabetic patient
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** 22 implants were divided randomly into 2 groups. Group1: control group (no laser irradiation), group2: diode laser irradiation group
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** Both the participants as in group 1 or control laser device is off (not active)while in group 2 laser device is active. Outcome Assessor is blinded as the cases is coded and unknown for the Assessor
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 22
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** controlled diabetic patients with 11 implants covered with PRF inserted in posterior maxilla or mandible, not laser irradiated
**Intervention Names:**
- Procedure: PRF platelet rich fibrin
**Label:** control PRF group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** controlled diabetic patients with 11 implants covered with PRF inserted in posterior maxilla or mandible, expoed to Diode laser irradiation
**Intervention Names:**
- Radiation: low level Diode Laser
- Procedure: PRF platelet rich fibrin
**Label:** laser and PRF test group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- laser and PRF test group
**Description:** Group 2 was exposed to laser irradiation following implant insertion for 3 sessions: Immediately after implant insertion, 2 days after implant insertion and 1 week after insertion , using a red Diode(gallium-aluminun-arsenide) LLLT using calibrated diode laser device
**Name:** low level Diode Laser
**Type:** RADIATION
#### Intervention 2
**Arm Group Labels:**
- control PRF group
- laser and PRF test group
**Description:** The preparation method of PRF was performed in accordance with the protocol developed by Choukroun et al 2001. PRF was withdrawn and processed from the same operated-on patient's blood; 6ml IV blood withdrawn from the antecubital vein in to two sterile 3ml red vacutainer tubes without anticoagulant, followed by a 12 minute centrifuge with 3000 RPM producing a platelet rich fibrin clot, which is then incised \& separated with 2mm basal layer of RBCs rich in growth factors
**Name:** PRF platelet rich fibrin
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Digital software program was used for quantitative mean bone density measurements of all the captured radiographs produced by CBCT for both groups. Multiplanar resolution screen (MPR) was selected showing radiographic images of the mandible and maxilla in sagittal and coronal views to quantify bone radiodensity in mesiodistal and buccolingual surfaces respectively , a constant exact area was selected for each view with area =1 5.2mm2, width = 2.00mm, and height = 7.60mm. Five readings of radiodensity in Hounsfield units (HU statistics) were collected by blind investigator for each peri-implant surface (mesial, distal, buccal, and lingual) with slice thickness of 0.5mm. Finally, the mean density values were calculated and tabulated concerning sagittal and coronal views in each implant
**Measure:** Per-implant bone density measurements
**Time Frame:** at immediate day of surgery(baseline) and after 5 months for the same patients
#### Secondary Outcomes
**Description:** AnyCheck device (AnyCheck, Neobiotech Co., Ltd. E-space #1001, 36, Digital-ro 27-gil, Guro-gu, Seoul, Korea, 08381) was utilized 5 months (2nd stability) post implant insertion. AnyCheck is an implant stability meter that measures the stiffness of the alveolar bone-implant interface through a tapping-motion. The degree of osseointegration is calculated in terms of IST (Initial Stability Test) value between 30 to 85. AnyCheck was turned on, then, the tip of the tap¬ping rod maintained contact angle between 0 to 30 degrees with healing abutment. The START button was gently pressed while holding the device stable, the measured value displayed on the LCD screen was recorded (Fig.4). The smaller the measured value, the weaker the degree of osseointegration. Mesiodistal and buccolingual sides of the implant were measured, five IST readings for each side were repetitively recorded by blind examiner and the mean reading was calculated and tabulated
**Measure:** Implant stability measurements
**Time Frame:** only after 5 months from implant insertion
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. nonsmoker patients,
2. age range 30 -60 years,
3. Glycosylated hemoglobin (Hb1C) ranges between 7-8,
4. no other systemic disease,
5. vital signs are normal (blood pressure, temperature, pulse rate, respiratory rate),
6. missing 1st or 2nd mandibular or maxillary premolars or molars,
7. lab investigations are within normal (CBC. liver function AST \&ALT, kidney function urea \&creatinine, Ca level, 25OH Vit D),
8. no need for alveolar bone grafting, and
9. no soft or hard tissue pathology.
Exclusion Criteria:
1. smoker patient,
2. Glycosylated hemoglobin (Hb1C) more than 8 or less than 7,
3. age less than 30 or more than 60,
4. presence of other systemic diseases,
5. vital signs are not normal,
6. lab investigations are not normal (CBC, liver function, kidney function),
7. need for alveolar bone grafting and
8. present soft or hard tissue pathology.
**Maximum Age:** 60 Years
**Minimum Age:** 30 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Guiza
**Country:** Egypt
**Facility:** Oral Surgery Clinic at National Research Centre
#### Overall Officials
**Official 1:**
**Affiliation:** National Research Centre, Egypt
**Name:** Noha M Ismael, PhD
**Role:** STUDY_DIRECTOR
### References Module
#### References
**Citation:** ELsyad MA, Abdraboh AE, Aboelnagga MM, Ghali RM, Lebshtien IT. Effect of Low-Level Laser Irradiation on Stability and Marginal Bone of Narrow Implants Retaining Overdentures in Moderately Controlled Diabetic Patients. J Oral Implantol. 2019 Oct;45(5):391-397. doi: 10.1563/aaid-joi-D-18-00263. Epub 2019 Aug 7.
**PMID:** 31389750
**Citation:** Naujokat H, Kunzendorf B, Wiltfang J. Dental implants and diabetes mellitus-a systematic review. Int J Implant Dent. 2016 Dec;2(1):5. doi: 10.1186/s40729-016-0038-2. Epub 2016 Feb 11.
**PMID:** 27747697
**Citation:** Taha SK, El Fattah SA, Said E, Abdel-Hamid MA, Nemat AH, El Shenawy H. Effect of Laser Bio-Stimulation on Mandibular Distraction Osteogenesis: An Experimental Study. J Oral Maxillofac Surg. 2018 Nov;76(11):2411-2421. doi: 10.1016/j.joms.2018.04.030. Epub 2018 May 7.
**PMID:** 29856939
**Citation:** 4. El-banna R, Shafik M, Shoreibah E: Effect of Platelet Rich Fibrin on the Healing of Intra-bony Defects: A Clinical Study. ADJ-for Girls, Vol. 5, No. 1, January (2018) - PP. 29:35 doi10.21608/adjg.2018.7990
**Citation:** 5.Ghazal, Asmaa M.; Hassan, Susan H.; Mohamed, Fatma I.; Namat, Amany H.; and Taha, Said K. (2023)
**Citation:** 6.Allam AF, Zaky AA, Elshenawy HM, Safwat EM, Hassan ML, Nassar MA, Taha, S.K: Evaluating The Biostimulation Effect Of Diode Laser 650 Nm Combined With TEMPO Oxidized Nano-Cellulose Mixed With Biphasic Tricalcium Phosphate On Bone Healing: Experimental Animal Study. Journal of pharmaceutical Negative Results ¦ Volume 14 ¦ Special Issue 2 ¦ 2023
**Citation:** Khorshidi H, Raoofi S, Bagheri R, Banihashemi H. Comparison of the Mechanical Properties of Early Leukocyte- and Platelet-Rich Fibrin versus PRGF/Endoret Membranes. Int J Dent. 2016;2016:1849207. doi: 10.1155/2016/1849207. Epub 2016 Jan 6.
**PMID:** 26880919
**Citation:** 8-Mowla AE, Sherif H, Bashir D. Evaluation of the effect of platelet rich fibrin (PRF) on bone regeneration in the tibia of diabetic rats (histological and immunohistochemical studies). Egypt J Histol.2020; 43(3): 777-790.
**Citation:** Mayer L, Gomes FV, de Oliveira MG, de Moraes JF, Carlsson L. Peri-implant osseointegration after low-level laser therapy: micro-computed tomography and resonance frequency analysis in an animal model. Lasers Med Sci. 2016 Dec;31(9):1789-1795. doi: 10.1007/s10103-016-2051-3. Epub 2016 Aug 17.
**PMID:** 27534769
**Citation:** Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
**PMID:** 17695343
**Citation:** 11- Choukroun J AF,Schoeffler C, Vervelle A. Une opportunite en paro-implantologie:Le PRF.Implantodontie2001;42:55-62
**Citation:** Matys J, Swider K, Grzech-Lesniak K, Dominiak M, Romeo U. Photobiomodulation by a 635nm Diode Laser on Peri-Implant Bone: Primary and Secondary Stability and Bone Density Analysis-A Randomized Clinical Trial. Biomed Res Int. 2019 Apr 22;2019:2785302. doi: 10.1155/2019/2785302. eCollection 2019.
**PMID:** 31143771
**Citation:** Dos Santos RG, Santos GS, Alkass N, Chiesa TL, Azzini GO, da Fonseca LF, Dos Santos AF, Rodrigues BL, Mosaner T, Lana JF. The regenerative mechanisms of platelet-rich plasma: A review. Cytokine. 2021 Aug;144:155560. doi: 10.1016/j.cyto.2021.155560. Epub 2021 May 15.
**PMID:** 34004552
**Citation:** Habash G, Jayash SN. Diode laser assisted horizontal bone defect regeneration in the treatment of peri-implantitis. Clin Case Rep. 2021 Jan 3;9(3):1247-1252. doi: 10.1002/ccr3.3741. eCollection 2021 Mar.
**PMID:** 33768820
**Citation:** 15- El-banna R, Shafik M, Shoreibah E, Zouair M,Adel Hamid M: Effect of Platelet Rich Fibrin on the Healing of Intra-bony Defects: A Clinical and Experimental Study. Dissertation, faculty of dental Medicine -Al Azhar University 2017
**Citation:** Karaca IR, Ergun G, Ozturk DN. Is Low-level laser therapy and gaseous ozone application effective on osseointegration of immediately loaded implants? Niger J Clin Pract. 2018 Jun;21(6):703-710. doi: 10.4103/njcp.njcp_82_17.
**PMID:** 29888715
**Citation:** Arakeeb MAA, Zaky AA, Harhash TA, Salem WS, El-Mofty M. Effect of Combined Application of Growth Factors and Diode Laser Bio-Stimulation on the Osseo Integration of Dental Implants. Open Access Maced J Med Sci. 2019 Aug 12;7(15):2520-2527. doi: 10.3889/oamjms.2019.672. eCollection 2019 Aug 15.
**PMID:** 31666858
**Citation:** Sleem SSMEB, Zayet MK, El-Ghareeb TI, Saleh HAK. Evaluation of The Bio-Stimulatory Effect of Platelet Rich Fibrin Augmented by Diode LASER Compared to Platelet Rich Fibrin Alone on Dental Implant Replacing Posterior Mandibular Teeth. Randomised Clinical Trial: Split Mouth Study. Open Access Maced J Med Sci. 2019 Mar 14;7(5):869-875. doi: 10.3889/oamjms.2019.183. eCollection 2019 Mar 15.
**PMID:** 30962853
**Citation:** Soares LG, Magalhaes EB, Magalhaes CA, Ferreira CF, Marques AM, Pinheiro AL. New bone formation around implants inserted on autologous and xenografts irradiated or not with IR laser light: a histomorphometric study in rabbits. Braz Dent J. 2013;24(3):218-23. doi: 10.1590/0103-6440201302186.
**PMID:** 23969909
**Citation:** Batista JD, Sargenti-Neto S, Dechichi P, Rocha FS, Pagnoncelli RM. Low-level laser therapy on bone repair: is there any effect outside the irradiated field? Lasers Med Sci. 2015 Jul;30(5):1569-74. doi: 10.1007/s10103-015-1752-3. Epub 2015 May 15.
**PMID:** 25975746
**Citation:** Mandic B, Lazic Z, Markovic A, Mandic B, Mandic M, Djinic A, Milicic B. Influence of postoperative low-level laser therapy on the osseointegration of self-tapping implants in the posterior maxilla: a 6-week split-mouth clinical study. Vojnosanit Pregl. 2015 Mar;72(3):233-40. doi: 10.2298/vsp131202075m.
**PMID:** 25958474
**Citation:** Kusek ER. Immediate implant placement into infected sites: bacterial studies of the Hydroacoustic effects of the YSGG laser. J Oral Implantol. 2011 Mar;37 Spec No:205-11. doi: 10.1563/AAID-JOI-D-10-00014. Epub 2010 Aug 16.
**PMID:** 20712437
**Citation:** Buser D, Weber HP, Lang NP. Tissue integration of non-submerged implants. 1-year results of a prospective study with 100 ITI hollow-cylinder and hollow-screw implants. Clin Oral Implants Res. 1990 Dec;1(1):33-40. doi: 10.1034/j.1600-0501.1990.010105.x.
**PMID:** 2099210
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: AnCoag
- Name: Anticoagulants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4244
- Name: Anticoagulants
- Relevance: LOW
- As Found: Unknown
- ID: M11900
- Name: Mitogens
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444321
**Acronym:** INTERCARE-HF
**Brief Title:** INTEgRated Health CARE for Patients With Frailty and Heart Failure
**Official Title:** INTEgRated Health CARE for Patients With Frailty and Heart Failure (INTERCARE-HF): Evaluation of an Innovation Project
#### Organization Study ID Info
**ID:** 678261
#### Organization
**Class:** OTHER
**Full Name:** Vestre Viken Hospital Trust
### Status Module
#### Completion Date
**Date:** 2028-12-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Drammen municipality
**Class:** OTHER
**Name:** University of Oslo
**Class:** OTHER
**Name:** Oslo University Hospital
#### Lead Sponsor
**Class:** OTHER
**Name:** Vestre Viken Hospital Trust
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Frailty, an aging-related syndrome of physiological decline characterized by marked vulnerability to adverse health outcomes, has attracted increasing attention in cardiology due to the growing elderly population with heart failure. Frail patients are mainly excluded from large cardiovascular intervention studies, and clinical trials addressing frailty and showing an impact on treatment on symptom burden, quality of life and /or outcome has been requested in recent guidelines and consensus documents. The INTEgrRated health CARE for patients with severe frailty and Heart Failure (INTERCARE-HF) is a proof-of-concept study that aims to evaluate the effect of integrated healthcare services for heart failure patients with a severe level of frailty by establishing interdisciplinary and coordinated follow-up teams across the healthcare boundaries. These teams will assess the patient's needs, goals, and risk areas, conduct advance care planning, and develop individualized treatment and follow-up plans. An open-label, non-randomized intervention study aims to recruit 20 patients and heart failure and a clinical Frailty Score (CSF) \>=5. A control-group (N=40) matched on age an clinical frailty scale score will be included. The overall hypothesis is that the intervention is feasible in routine clinical practice with favorable effects on quality of life, symptoms, caregiver distress, and healthcare service utilization.
### Conditions Module
**Conditions:**
- Heart Failure
- Frailty
- Frail Elderly Syndrome
- Symptom, Behavioral
- Utilization, Health Care
- Quality of Life
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Open intervention study with a matched control-group
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** A structured, person-centred and coordinated treatment and follow-up plan tailored to co-morbidities, risk areas, cognitive function and functional level, and the patients' symptoms and needs will be developed by an interdisciplinary team from the hospital and the primary care service. The closest relatives were encouraged to participate. The plan will be followed-up and evetually adjusted after one week and then at least monthly by nurses in the municipality through phone calls and /or home visits. A detailed description will be manualized in a handbook.
**Intervention Names:**
- Behavioral: INTERCARE-HF
**Label:** Intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** A matched control-group will be recruited from the ongoing IT-HEART RCT
**Intervention Names:**
- Behavioral: INTERCARE-HF
**Label:** Matche control group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention
- Matche control group
**Description:** Develpent of an individualized treatment and follow-up plan tailored to co-morbidities, risk areas, cognitive function and functional level as well as the patients' symptoms and needs.
**Name:** INTERCARE-HF
**Other Names:**
- Matched control group
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Between-group differences in The Edmonton Symptom Assessment System revised (ESAS-r) scores
**Measure:** Changes in symptom control and patient satisfaction
**Time Frame:** From baseline to weeks 6, 12, and 52
**Description:** Between-group differences in Kansas City Cardiomyopathy Questionnaire 12 scores
**Measure:** Changes in health-related quality of life
**Time Frame:** From baseline to weeks 6, 12, and 52
#### Secondary Outcomes
**Description:** Changes in Relatives Stress Scale (RSS) scores
**Measure:** Changes in caregiver distress
**Time Frame:** From baseline to weeks 6, 12, and 52
**Description:** Differences in the percentage of days out of the total number of days lost due to unplanned hospital admissions
**Measure:** Total number of days lost due to unplanned hospital re-admissions during the follow-up
**Time Frame:** From baseline to weeks 6, 12, and 52
**Description:** Differences in the percentage of days out of the number of days lost due to unplanned hospital admissions for i. heart failure, ii. kidney failure, dehydration or hyper/hypokalemia, iii. Falls and fractures
**Measure:** The number of days lost due to unplanned hospital re-admissions for specific diagnosis during the follow-up
**Time Frame:** From baseline to weeks 6, 12, and 52
**Description:** Differences in the total number of hospitalizations during follow-up
**Measure:** Total number of hospitalizations
**Time Frame:** From baseline to weeks 6, 12, and 52
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age \>18 years old
* Admitted to hospital with heart failure with symptoms of decompensation including dyspnoea in NYHA class ≥ II, pulmonary congestion on chest x-ray and/or other signs like oedema or positive rales on auscultation and elevated NT-proBNP concentrations at screening
* Clinical Frailty Score ≥5
* Signed informed consent by patient and closest relatives\* and expected cooperation according to the protocol, ICH/GCP and national/local regulations
* Although we preferably will recruit both patients and their relatives, participation from the next-of-kin will not be an exclusion criterium.
Exclusion Criteria:
* Inability to comply with all study requirements, due to major co-morbidities or psychosocial issues, or a history of noncompliance, that might compromise the patient's ability to understand and/or comply with the protocol instructions or follow-up procedures.
* Not being able to understand Norwegian.
* Permanent nursing home and estimated to stay alive for less than 6 months
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Øystein Fossdal, MD
**Phone:** +4791367769
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** John Munkhaugen, MD,MhD
**Phone:** +4797524194
**Role:** CONTACT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart 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: BC14
- Name: Heart and Blood Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M9421
- Name: Heart Failure
- Relevance: HIGH
- As Found: Heart Failure
- ID: M1175
- Name: Frailty
- Relevance: HIGH
- As Found: Frailty
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: HIGH
- As Found: Symptom, Behavioral
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
### Condition Browse Module - Meshes
- ID: D000006333
- Term: Heart Failure
- ID: D000073496
- Term: Frailty
- ID: D000001526
- Term: Behavioral Symptoms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444308
**Brief Title:** Community Health Worker-led Hypertension Management
**Official Title:** Assessing the Efficacy and Safety of Community Health Worker-led Hypertension Management Enabled by a Mobile Clinical Decision Support Application Compared to Physician Care: a Randomized, Controlled, Noninferiority Trial
#### Organization Study ID Info
**ID:** 2024-0566
#### Organization
**Class:** OTHER
**Full Name:** University of Wisconsin, Madison
#### Secondary ID Infos
**Domain:** UW Madison
**ID:** A532050
**Type:** OTHER
**Domain:** UW Madison
**ID:** Protocol Version 3/29/24
**Type:** OTHER
**ID:** 4R33TW011891-03
**Link:** https://reporter.nih.gov/quickSearch/4R33TW011891-03
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2026-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** Fogarty International Center of the National Institute of Health
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Wisconsin, Madison
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study is to determine if hypertension management by community health workers (CHW) supported by a mobile health application and remote physician supervision is non-inferior to management by a physician for the primary outcome of improvement in systolic blood pressure. The target population is patients with hypertension in rural Guatemala. Study duration will be 12-24 months.
**Detailed Description:** The investigators have developed an innovative system of care utilizing CHWs equipped with a mobile application and supported and supervised remotely by physicians. This model of care is adapted from a CHW-led diabetes program enabled by a similar CDS application which the investigators implemented in the same communities in rural Guatemala where we will carry out this proposed study. This program safely led to significant improvements in glycemic control. The mobile application is built on the widely-used CommCare platform and provides clinical decision support (CDS) to CHWs based on protocols from the WHO and the International Society of Hypertension for antihypertensive medication initiation and titration, lifestyle counseling, and identification of patients requiring a higher level of care.
The Primary Objective is to determine if hypertension management by CHWs is non-inferior to care provided directly by a physician.
The Secondary Objective is to evaluate the safety, acceptability to patients, and cost of CHW-led care compared to care provided directly by a physician.
### Conditions Module
**Conditions:**
- Hypertension
**Keywords:**
- community health worker
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** cluster randomized, controlled, non-inferiority trial, each of 15 clusters of geographically grouped communities in the San Lucas Toliman municipality of Guatemala will be randomized to either CHW or physician care
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 400
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Multimodal health systems intervention: hypertension management by trained CHWs equipped with a mobile clinical decision support (CDS) application and remote supervision and support by physicians. CHWs will meet with patients each month and, with the assistance of the CDS application, follow physician-approved and evidence-based protocols to initiate and titrate antihypertensives and medications to reduce cardiovascular risk; identify potential complications of hypertension or problems with medications; and provide lifestyle counseling. For patients with comorbid hypertension and diabetes, CHWs will also manage glycemic therapy and assess for diabetes complications with the assistance of the application.
**Intervention Names:**
- Other: CommCare with Mobile Clinical Decision Support (CDS) Application
- Other: Remote Supervision by Physicians
**Label:** Community Health Worker Care
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Other: CommCare Application without CDS
**Label:** Physician Care
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Community Health Worker Care
**Description:** For those assigned to the CHW arm, management will be assisted by CDS from the CommCare application.
**Name:** CommCare with Mobile Clinical Decision Support (CDS) Application
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Community Health Worker Care
**Description:** teleconsultation with a supervising physician
**Name:** Remote Supervision by Physicians
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Physician Care
**Description:** The physician will have received training and orientation on the same clinical protocols followed by the CHWs, as well as access to reference materials for these protocols, but the version of the CommCare application used will not provide CDS, but will serve to record and review patient data only.
**Name:** CommCare Application without CDS
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Measure:** Participant retention at 6 and 12 months
**Time Frame:** 6 months, 12 months
**Measure:** Proportion of possible study visits completed at 6 and 12 months
**Time Frame:** 6 months, 12 months
**Measure:** Mean duration of study visits
**Time Frame:** up to 24 months
**Measure:** Mean duration of physician review and care coordination time per patient encounter
**Time Frame:** up to 24 months
**Measure:** Comparison of antihypertensive medications prescribed and dosages
**Time Frame:** up to 24 months
**Measure:** Proportion of patients with an indication taking aspirin
**Time Frame:** up to 24 months
**Measure:** Proportion of patients taking two or more antihypertensives
**Time Frame:** up to 24 months
**Measure:** Estimated cost of care
**Time Frame:** up to 24 months
#### Primary Outcomes
**Measure:** Change in Systolic Blood Pressure (SBP)
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
#### Secondary Outcomes
**Measure:** Proportion of Participants with SBP less than 140mmHg
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
**Measure:** Proportion of Participants with SBP less than their personalized goal
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
**Measure:** Change in Diastolic Blood Pressure (DBP)
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
**Measure:** Change in Hemoglobin A1c (HbA1c)
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
**Measure:** Change in Weight
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
**Measure:** Change in Total Cholesterol
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
**Measure:** Change in LDL Cholesterol
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
**Measure:** Change in HDL Cholesterol
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
**Measure:** Change in Triglycerides
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
**Measure:** Change in Creatinine
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
**Measure:** Change in Estimated Glomerular Filtration Rate (eGFR)
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
**Measure:** Change in 10 year CVD risk (per WHO risk prediction charts)
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
**Description:** The H-SCALE: Medication Adherence subscale is scored from 0-21 where higher scores indicate a more positive attitude toward adherence.
**Measure:** Change in Hypertension Self-Care Activity Level Effects (H-SCALE): Medication Adherence Subscale Score
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
**Description:** The H-SCALE: Weight Management subscale is scored from 9-45 where higher scores indicate a more positive attitude toward weight management.
**Measure:** Change in H-SCALE: Weight Management Score
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
**Description:** The H-SCALE: Physical Exercise subscale is scored from 0-14 where higher scores indicate a more positive behavior toward physical exercise.
**Measure:** Change in H-SCALE: Physical Exercise Score
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
**Description:** The H-SCALE: Smoking Exposure subscale is scored from 0-14 where a score of 0 indicates a more positive attitude toward smoking exposure.
**Measure:** Change in H-SCALE: Smoking Exposure Score
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
**Description:** The H-SCALE: Alcohol Intake subscale contains three questions and is scored as abstainer (does not drink) or non-adherent (reported drinking alcohol).
**Measure:** Change in H-SCALE: Alcohol Intake Score
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
**Description:** The H-SCALE: Healthy Eating Plan subscale is scored from 0-70 where higher scores indicate a more positive attitude toward healthy eating.
**Measure:** Change in H-SCALE: Healthy Eating Plan Score
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
**Description:** PACIC will be scored from X-XX where higher scores indicate better assessment of chronic illness care.
**Measure:** Change in selected items from the Patient Assessment of Chronic Illness Care (PACIC) survey
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
**Description:** \[How is this scored?\]
**Measure:** Change in global hypertension care satisfaction score
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
**Description:** \[How is this defined?\]
**Measure:** Change in pill count adherence ratio (PCAR)
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
**Description:** \[How is this scored?\]
**Measure:** Change in self-reported adherence
**Time Frame:** Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults age 18 or greater with diagnosis of hypertension AND blood pressure (BP) greater than or equal to 140/90 OR currently taking antihypertensive medication.
* Ability to provide informed consent
Exclusion Criteria:
* Pregnancy
* Severe comorbid condition(s) with life expectancy less than 1 year
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M10024
- Name: Hypertension
- Relevance: HIGH
- As Found: Hypertension
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006973
- Term: Hypertension
### Intervention Browse Module - Browse Branches
- Abbrev: AnAg
- Name: Antihypertensive Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4277
- Name: Antihypertensive Agents
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444295
**Brief Title:** Testing the Impact of Thrive App Versions on Alcohol Use and Posttraumatic Stress After Recent Sexual Assault
**Official Title:** Project THRIVE: Testing an App-based Early Intervention to Reduce Alcohol Use and PTSD After Sexual Assault
#### Organization Study ID Info
**ID:** STUDY00016193
#### Organization
**Class:** OTHER
**Full Name:** University of Washington
#### Secondary ID Infos
**ID:** R01AA030541
**Link:** https://reporter.nih.gov/quickSearch/R01AA030541
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2028-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-26
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institute on Alcohol Abuse and Alcoholism (NIAAA)
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Washington
#### Responsible Party
**Investigator Affiliation:** University of Washington
**Investigator Full Name:** Emily Dworkin
**Investigator Title:** Assistant Professor: School of Medicine: Psychiatry and Behavioral Sciences
**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 study is to find the most effective and efficient version of the THRIVE app. The THRIVE app is the first app-based preventative intervention that has been found to reduce alcohol misuse and posttraumatic stress in people who have recently experienced sexual assault. In this trial, participants are randomly assigned to receive different versions of the THRIVE app to compare their impact. The THRIVE app is currently only available to participants in this study.
### Conditions Module
**Conditions:**
- Posttraumatic Stress Symptom
- Alcohol Drinking
- Alcohol Problem
**Keywords:**
- Sexual assault
- Mobile health intervention
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** FACTORIAL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 464
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants are invited to use a version of the app for 21 days. Participants receive only the non-core intervention components and do not attend coaching calls.
**Intervention Names:**
- Behavioral: Non-core intervention components
**Label:** No experimental components
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Participants are invited to use a version of the app for 21 days. Participants receive the Activities and Thoughts app modules, but do not attend coaching calls.
**Intervention Names:**
- Behavioral: Activity scheduling
- Behavioral: Cognitive restructuring
- Behavioral: Non-core intervention components
**Label:** Activities + Thoughts
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Participants are invited to use a version of the app for 21 days. Participants receive the Activities app module, but do not attend coaching calls.
**Intervention Names:**
- Behavioral: Activity scheduling
- Behavioral: Non-core intervention components
**Label:** Activities only
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Participants are invited to use a version of the app for 21 days. Participants receive the Thoughts app module, but do not attend coaching calls.
**Intervention Names:**
- Behavioral: Cognitive restructuring
- Behavioral: Non-core intervention components
**Label:** Thoughts only
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** Participants are invited to use a version of the app for 21 days. Participants receive the Activities and Thoughts app modules and attend coaching calls.
**Intervention Names:**
- Behavioral: Activity scheduling
- Behavioral: Cognitive restructuring
- Behavioral: Coaching calls
- Behavioral: Non-core intervention components
**Label:** Activities, Thoughts, & Coaching
**Type:** EXPERIMENTAL
#### Arm Group 6
**Description:** Participants are invited to use a version of the app for 21 days. Participants receive the Activities app module and attend coaching calls.
**Intervention Names:**
- Behavioral: Activity scheduling
- Behavioral: Coaching calls
- Behavioral: Non-core intervention components
**Label:** Activities + Coaching
**Type:** EXPERIMENTAL
#### Arm Group 7
**Description:** Participants are invited to use a version of the app for 21 days. Participants receive the Thoughts app module and attend coaching calls.
**Intervention Names:**
- Behavioral: Cognitive restructuring
- Behavioral: Coaching calls
- Behavioral: Non-core intervention components
**Label:** Thoughts + Coaching
**Type:** EXPERIMENTAL
#### Arm Group 8
**Description:** Participants are invited to use a version of the app for 21 days. Participants receive the non-core intervention components in the app and attend coaching calls.
**Intervention Names:**
- Behavioral: Coaching calls
- Behavioral: Non-core intervention components
**Label:** Coaching only
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Activities + Coaching
- Activities + Thoughts
- Activities only
- Activities, Thoughts, & Coaching
**Description:** Participants will engage in activity scheduling in the app (i.e., "Activities" module). On the first day of using the app, users will create a list of valued/important and avoided activities (e.g., spending time with friends, going to the gym), and then have the option to add alcohol protective behavioral strategies (e.g., adding ice to drinks, alternating alcoholic and nonalcoholic beverages) to activities that the user identifies as being likely to involve drinking. On subsequent days, users will be encouraged to complete at least one activity from their list.
**Name:** Activity scheduling
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Activities + Thoughts
- Activities, Thoughts, & Coaching
- Thoughts + Coaching
- Thoughts only
**Description:** Participants will engage in cognitive restructuring in the app (i.e., "Thoughts" activities). Users first go through an activity involving the identification of maladaptive cognitions and create a list of their maladaptive cognitions. On subsequent days, they engage in a guided in-app activity involving cognitive restructuring of maladaptive cognitions from their list.
**Name:** Cognitive restructuring
**Type:** BEHAVIORAL
#### Intervention 3
**Arm Group Labels:**
- Activities + Coaching
- Activities, Thoughts, & Coaching
- Coaching only
- Thoughts + Coaching
**Description:** Participants will receive 10-20 minute weekly coaching calls during the app use period (4 total, including coaching provided in the enrollment call). All coaching calls will, at minimum, include a check-in, troubleshooting of technical issues, check-in about experience with symptom self-monitoring, and offers of referrals. Coaching calls in conditions involving activity scheduling will involve assistance with the Activities module. Coaching calls in conditions involving cognitive restructuring will involve assistance with the Thoughts module.
**Name:** Coaching calls
**Type:** BEHAVIORAL
#### Intervention 4
**Arm Group Labels:**
- Activities + Coaching
- Activities + Thoughts
- Activities only
- Activities, Thoughts, & Coaching
- Coaching only
- No experimental components
- Thoughts + Coaching
- Thoughts only
**Description:** All participants, regardless of condition, will receive the following non-core THRIVE components.
* 21 days of brief self-report surveys in the app assessing their PTSD symptoms and alcohol use in the prior 24 hours.
* A banner in their app displaying rotating non-personalized encouraging messages from other users. All app users will have the option of submitting encouraging statements to be displayed to all other users. Statements will be vetted by study staff before posting.
* Lists of referral options specific to each recruitment site via the "Resources" section of the app.
* Answers to frequently asked questions about the study, the study consent form, and contact information for the study team via the "Information" section of the app.
* One call with a study "point person" within the first week following randomization to ensure they were able to access the app and troubleshoot access issues
**Name:** Non-core intervention components
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Assessed using the Flourishing Scale. Minimum score = 8, maximum score = 56, higher scores indicate people with many psychological resources and strengths.
**Measure:** Positive mental health
**Time Frame:** Baseline, 3 months, 6 months, 9 months, 1 year
**Description:** Assessed using the Flourishing Index. Minimum score = 0, maximum score = 120, higher scores indicate greater levels of flourishing/human well-being in individuals.
**Measure:** Flourishing
**Time Frame:** Baseline, 3 months, 6 months, 9 months, 1 year
**Description:** Assessed using the Multidimensional Scale of Perceived Social Support. Minimum score = 12, maximum score = 84, higher scores indicate greater level of perceived social support.
**Measure:** Social support
**Time Frame:** Baseline, 3 months, 6 months, 9 months, 1 year
**Description:** Assessed using the University of California Los Angeles 3-Item Loneliness Scale. Minimum score = 3, maximum score = 9, higher scores indicate greater levels of loneliness.
**Measure:** Loneliness
**Time Frame:** Baseline, 3 months, 6 months, 9 months, 1 year
#### Primary Outcomes
**Description:** Assessed using the 16-item Short Form Rutgers Alcohol Problem Index (S-RAPI). Minimum score = 0, maximum score = 64, higher scores mean greater severity of problems.
**Measure:** Past-month alcohol problems
**Time Frame:** Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
**Description:** Assessed via the online Timeline Followback (TLFB)
**Measure:** Past-month number of drinks
**Time Frame:** Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
**Description:** Assessed via the online Timeline Followback (TLFB)
**Measure:** Past-month number of drinking days
**Time Frame:** Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
**Description:** Assessed via the online Timeline Followback (TLFB)
**Measure:** Past-month peak drinks
**Time Frame:** Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
**Description:** Assessed via the online Timeline Followback (TLFB)
**Measure:** Past-month frequency of heavy episodic drinking
**Time Frame:** Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
**Description:** Assessed using the PTSD Checklist (PCL-5) in relation to the index assault. Minimum score = 0, maximum score = 80, higher scores mean greater severity of posttraumatic stress.
**Measure:** Past-month posttraumatic stress symptom severity
**Time Frame:** Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
**Description:** Assessed using the PTSD Checklist (PCL-5) in relation to the index assault. Provisional posttraumatic stress disorder diagnosis is defined as a score greater than or equal to 31.
**Measure:** Past-month provisional diagnosis of posttraumatic stress disorder
**Time Frame:** Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
#### Secondary Outcomes
**Description:** Assessed using the The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Tool Part 2 (not including alcohol questions)
**Measure:** Drug use & problems
**Time Frame:** Baseline, 3 months, 6 months, 9 months, 1 year
**Description:** Assessed using the Cannabis Use Disorder Identification Test - Revised (CUDIT-R). Minimum score = 0, maximum score = 32, higher scores indicate hazardous cannabis use/possible cannabis use disorder.
**Measure:** Cannabis use & problems
**Time Frame:** Baseline, 3 months, 6 months, 9 months, 1 year
**Description:** Assessed using the Center for Epidemiologic Studies Depression Scale - 10 item version. Minimum score = 0, maximum score = 30, higher scores mean greater depressive mood symptoms
**Measure:** Depression
**Time Frame:** Baseline, 3 months, 6 months, 9 months, 1 year
**Description:** Assessed using the Generalized Anxiety Disorder-7 scale. Minimum score = 0, maximum score = 21, higher scores indicate greater severity of generalized anxiety symptoms.
**Measure:** Anxiety
**Time Frame:** Baseline, 3 months, 6 months, 9 months, 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Have reached the legal age of majority in their current state of residence
* Be able to read and speak English fluently
* Own a smartphone that cannot be accessed by others while the study app is installed, or agree to take steps to reduce the risk of access
* Be an enrolled undergraduate or graduate student at a recruitment site at the time of screening
* Reside in the same state as the recruitment site for most of the year
* Have experienced a sexual assault (i.e., unwanted and non-consensual attempted/completed sexual contact) within the past 12 weeks at the time of screening
* Report ≥1 past-month heavy drinking episode (i.e., 5+ drinks on a given day or 15+ drinks in a given week for participants assigned male at birth and 4+ drinks on a given day or 8+ drinks in a given week for participants assigned female or intersex at birth) at the time of screening
* Endorse elevated posttraumatic stress symptoms at screening (defined as a score above a pre-established cut point on a screening measure of PTSD).
Exclusion Criteria:
* Active psychosis
* Location outside of the US at the time of screening
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Emily Dworkin, PhD
**Phone:** 206-503-3287
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Washington
**Name:** Emily Dworkin, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004327
- Term: Drinking Behavior
- ID: D000019966
- Term: Substance-Related Disorders
- ID: D000064419
- Term: Chemically-Induced Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC25
- Name: Substance Related Disorders
### Condition Browse Module - Browse Leaves
- ID: M3774
- Name: Alcohol Drinking
- Relevance: HIGH
- As Found: Alcohol Drinking
- ID: M21842
- Name: Alcohol-Related Disorders
- Relevance: HIGH
- As Found: Alcohol Problems
- ID: M7502
- Name: Drinking Behavior
- Relevance: LOW
- As Found: Unknown
- ID: M21837
- Name: Substance-Related Disorders
- Relevance: LOW
- As Found: Unknown
- 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: D000019973
- Term: Alcohol-Related Disorders
- ID: D000000428
- Term: Alcohol Drinking
### 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: M12478
- Name: Nicotine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444282
**Brief Title:** Emergency Care Action Plans for Infants With Medical Complexity
**Official Title:** Optimization and Implementation Trial of a User-Centered Emergency Care Action Plan for Infants With Medical Complexity
#### Organization Study ID Info
**ID:** 1K23HD109469-01
**Link:** https://reporter.nih.gov/quickSearch/1K23HD109469-01
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** University of Vermont
#### Secondary ID Infos
**ID:** K23HD109469-01
**Link:** https://reporter.nih.gov/quickSearch/K23HD109469-01
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2028-08-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-08-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Vermont
#### Responsible Party
**Investigator Affiliation:** University of Vermont
**Investigator Full Name:** Christian Pulcini
**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:** An Emergency Care Action Plan (ECAP) is a tool intended to be helpful to providers when treating a child with complex medical needs during an emergency. Once created, ECAPs are added to the Electronic Health Record (EHR), shared with the child's caregiver(s), and kept up by all of those involved in a child's care.
The goal of this study is to measure important health outcomes (ex. inpatient days, emergency department visits) in terms of the use of the ECAP for infants discharged from the Neonatal Intensive Care Unit (NICU). This study will also measure other real-time potential challenges related to the use of the ECAP including, but not limited to, if it is being used, if providers and caregivers want to use it, and if they keep using it over a long period of time.
**Detailed Description:** National expert recommendations and human-centered design principles were used to optimize an Emergency Care Action Plan (ECAP) for infants with medical complexity. This study will implement and monitor the effectiveness and feasibility of the optimized Emergency Care Action Plan for infants with medical complexity. The primary objective is to determine the effectiveness of a user-centered Emergency Care Action Plan for infants with medical complexity on emergency health care utilization and cost metrics. The secondary objective is to monitor and evaluate barriers and facilitators to the current and widespread implementation of a user-centered Emergency Care Action Plan for infants with medical complexity.
Research participants will be assigned by chance to receive an ECAP or standard care. Caregivers (parent/legal guardian) of infant participants will be asked to complete periodic surveys during a one-year feasibility trial period. If assigned, caregivers will be asked to help with the process of creating an ECAP for their child.
### Conditions Module
**Conditions:**
- Children With Medical Complexity
- Child, Only
- Infant Morbidity
- Infant Conditions
- Utilization, Health Care
- Emergencies
- Chronic Condition
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** An Emergency Care Action Plan (ECAP) is a brief, pre-populated summary of suggested emergency management for children with medical complexity, embedded in the electronic health record.
**Intervention Names:**
- Other: Emergency Care Action Plan
**Label:** Emergency Care Action Plan
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The current standard of care does not include emergency care planning.
**Label:** Standard Care
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Emergency Care Action Plan
**Description:** An Emergency Care Action Plan (ECAP) is a brief, pre-populated summary of suggested emergency management for children with medical complexity, embedded in a patient's electronic health record for access by providers in an emergency. Patients/families will have digital access to the ECAP and be given a paper copy. The patient's care team and caregiver(s) (parent/legal guardian) will collaborate to create an individualized ECAP containing the following content: caregiver contact information, patient summary, anticipated emergency presentations with suggested management, problem list (emergency relevant only), medication list, technology dependence, baseline important physical exam findings, baseline vital signs, allergies, advance directive information, contact information for established care providers, and other important information.
**Name:** Emergency Care Action Plan
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** Costs for healthcare services received
**Measure:** Cost
**Time Frame:** Day 0 (NICU discharge)-Month 12
**Description:** Caregiver and provider perspectives on observability, usability, acceptability, feasibility and sustainability of Emergency Care Action Plans as well as barriers/facilitators to implementation and suggestions for improvement. Provider perspectives on workflow, technical infrastructure and available resources to support implementation of Emergency Care Action Plans.
**Measure:** Implementation outcomes
**Time Frame:** Day 0 (NICU discharge) to Month 12, assessed at quarterly intervals (Month 3, 6, 9, 12)
#### Primary Outcomes
**Description:** Number of inpatient hospital days
**Measure:** Inpatient hospitalization
**Time Frame:** Day 0 (NICU discharge) to Month 12
#### Secondary Outcomes
**Description:** Caregiver's perceived avoidance of emergency department (ED) visits for their child
**Measure:** Avoidance of ED visits
**Time Frame:** Day 0 (NICU discharge) to Month 12
**Description:** Number of emergency department (ED) visits
**Measure:** Number of ED visits
**Time Frame:** Day 0 (NICU discharge) to Month 12
**Description:** Emergency department (ED) length of stay
**Measure:** ED length of stay
**Time Frame:** Day 0 (NICU discharge) to Month 12
**Description:** Number of interfacility transfers
**Measure:** Interfacility transfers
**Time Frame:** Day 0 (NICU discharge) to Month 12
**Description:** Caregiver perceived stress measured using the University of Washington Caregiver Stress Scale 3 item short form for caregivers of children with serious health conditions.
**Measure:** Caregiver stress
**Time Frame:** Day 0 (NICU discharge) to Month 12, assessed at quarterly intervals (Month 3, 6, 9, 12)
**Description:** Caregiver self-efficacy in health care information or decision making and symptoms identification or management measured using the Parent Measure of Self-Efficacy Managing a Child's Medication and Treatments, adapted from the Patient-Reported Outcomes Measurement Information Systems (PROMIS).
**Measure:** Caregiver self-efficacy
**Time Frame:** Day 0 (NICU discharge) to Month 12, assessed at quarterly intervals (Month 3, 6, 9, 12)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 0 to 6 months
* Admitted to the University of Vermont Medical Center Neonatal Intensive Care Unit (NICU)
* Meets or is expected to meet Children with Medical Complexity status as determined by the treating NICU clinician and defined as "children with multiple significant chronic health problems including multiple organ systems, which result in functional limitations, high health care needs or utilization, and often require need for, or use of, medical technology."
Exclusion Criteria:
* Does not have a caregiver participant who agrees to their participation in the study to complete follow-up surveys
* Does not intend to use University of Vermont Health Network and affiliated sites for care during the one-year trial period
**Maximum Age:** 6 Months
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Christian D Pulcini, MD, MEd, MPH
**Phone:** 585-615-0381
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Roz King, BSN, RN
**Phone:** 802-324-8368
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Burlington
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Christian Pulcini, MD, MEd, MPH
- **Phone:** 585-615-0381
- **Role:** CONTACT
***Contact 2:***
- **Name:** Christian D Pulcini, MD, MEd, MPH
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Vermont Medical Center
**State:** Vermont
**Zip:** 05401
#### Overall Officials
**Official 1:**
**Affiliation:** University of Vermont Larner College of Medicine, University of Vermont Medical Center
**Name:** Christian D Pulcini, MD, MEd, MPH
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Access to trial IPD can be requested by qualified researchers engaging in independent scientific research for individual participant data meta analysis. Proposals may be submitted up to 36 months following article publication. Proposals must be reviewed and approved by an independent review committee identified for this purpose. Proposals should be directed to [email protected].
**Description:** Individual participant data that underlie the results reported in this article after de-identification will be shared (text, tables, figures and appendices).
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
**Time Frame:** Beginning 9 months and ending 26 months following article publication.
### References Module
#### References
**Citation:** Pulcini CD, Dubuque A, Lamberson M, Macy ML, Mistry RD, Pruitt CM, Schnadower D, Zorc JJ, Stevens MW. Pediatric Emergency Medicine Physicians' Perspectives on Emergency Care of Children With Medical Complexity: A Multi-institution Mixed-Methods Assessment. Pediatr Emerg Care. 2022 Aug 1;38(8):e1423-e1427. doi: 10.1097/PEC.0000000000002712. Epub 2022 Apr 18.
**PMID:** 35436769
**Citation:** Pulcini CD, Belardo Z, Ketterer T, Zorc JJ, Mollen CJ. Improving Emergency Care for Children With Medical Complexity: Parent and Physicians' Perspectives. Acad Pediatr. 2021 Apr;21(3):513-520. doi: 10.1016/j.acap.2020.09.006. Epub 2020 Sep 15.
**PMID:** 32947009
**Citation:** Pulcini CD, Coller RJ, Houtrow AJ, Belardo Z, Zorc JJ. Preventing Emergency Department Visits for Children With Medical Complexity Through Ambulatory Care: A Systematic Review. Acad Pediatr. 2021 May-Jun;21(4):605-616. doi: 10.1016/j.acap.2021.01.006. Epub 2021 Jan 21.
**PMID:** 33486099
**Citation:** Pulcini CD, Coller RJ, Macy ML, Alpern E, Harris D, Rodean J, Hall M, Chung PJ, Berry JG. Low-Resource Emergency Department Visits for Children With Complex Chronic Conditions. Pediatr Emerg Care. 2022 Feb 1;38(2):e856-e862. doi: 10.1097/PEC.0000000000002437.
**PMID:** 34009894
**Citation:** Pulcini CD, Rubin DM. Flipping the Script on Emergency Care for Children With Medical Complexity. Pediatrics. 2019 Sep;144(3):e20183905. doi: 10.1542/peds.2018-3905. No abstract available.
**PMID:** 31439622
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M7796
- Name: Emergencies
- Relevance: HIGH
- As Found: Emergency
- ID: M6147
- Name: Chronic Disease
- Relevance: HIGH
- As Found: Chronic Conditions
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004630
- Term: Emergencies
- ID: D000004194
- Term: Disease
- ID: D000002908
- Term: Chronic Disease
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444269
**Brief Title:** Precision Medicine in Action: Phase II Trial of Response Adaptive Ablative Pre-operative SPBI (RAPS) and Non-operative Sentinel Lymph Node Biopsy in Patients With Early-stage ER+ Breast Cancer: RAPS Trial
**Official Title:** Precision Medicine in Action: Phase II Trial of Response Adaptive Ablative Pre-operative SPBI (RAPS) and Non-operative Sentinel Lymph Node Biopsy in Patients With Early-stage ER+ Breast Cancer: RAPS Trial
#### Organization Study ID Info
**ID:** STU-2024-0561
#### Organization
**Class:** OTHER
**Full Name:** University of Texas Southwestern Medical Center
### Status Module
#### Completion Date
**Date:** 2028-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Texas Southwestern Medical Center
#### Responsible Party
**Investigator Affiliation:** University of Texas Southwestern Medical Center
**Investigator Full Name:** Asal Rahimi
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** 1. Efficacy of PULSAR preoperative radiation 2. Evaluate potential of microbubble CEUS as an alternative to operative SLNBx 3. Evaluate potential of OA to evaluate treatment response of pre-operative radiation on the tumor
### Conditions Module
**Conditions:**
- Breast Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 53
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Through extracting and analyzing a large number of features from medical imaging, radiomics has shown promising results in treatment outcome prediction for many diseases including breast cancer (45-50). UTSW physics group has developed several new radiomic approaches and radiomic features, such as a multi-objective radiomics model(51) and a new radiomic "Shell" feature(52). As an exploratory end point for this trial, the investigators will explore the application radiomics using pre-treatment MRI, treatment parameters and clinical characteristics as input to predict pathological response of radiation therapy (XRT) based on pathology report of surgical tissues and local recurrence.
**Name:** Radiomics on MRI
**Type:** RADIATION
#### Intervention 2
**Description:** Microbubble Contrast non-FDA approved for route of administration
**Name:** microbubble CEUS Contrast Enhanced Ultrasound (CEUS)
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** To determine efficacy of single fraction pre-operative radiation in early-stage ER+ breast cancer patients and determine pathologic complete response rate at 10-15 months after radiation. Patients that have not had a complete imaging response on MRI, OA, or on needle biopsy at 9 months will move onto a second fraction of PULSAR radiation of 8 Gy at 9-10 months. Surgery will be at 10-12 months for those with complete imaging response and negative needle biopsy. For those with residual disease surgery will be postponed to 12-15 months.
**Measure:** Single fraction pre-operative radiation
**Time Frame:** 4 years
#### Secondary Outcomes
**Description:** To evaluate the potential of microbubble contrast enhanced ultrasound (CEUS) as a non-operative alternative to sentinel lymph node mapping and biopsy in early-stage ER+ Breast Cancer patients undergoing pre -operative single fraction radiation. Assess concordance of preoperative and pre-radiation microbubble CEUS with SLN mapping and biopsy at time of partial mastectomy.
**Measure:** Microbubble contrast
**Time Frame:** 4 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 1. Invasive epithelial (ductal, medullary, lobular, papillary, mucinous (colloid), or tubular) histologies of the breast 3 cm or less(T1-T2cN0) in women who have not undergone surgery or neoadjuvant endocrine or chemotherapy for current breast cancer diagnosis. For cohort 1, it is highly recommended those tumors are at least 1 cm.
2. Tumor must not involve the overlying skin based on imaging evaluation and/or clinical exam 3. Age \>/= 18 years old and female 4. Greatest Tumor dimension is 3cm or less based on US. MRI measurements can be included only if performed BEFORE the biopsy 5. Tumor must be unifocal 6. The tumor must be visible on CT scan and/or preferably marked with clip(s) in tumor if not visible. At least one clip should be placed in or around tumor prior to enrollment 7. Patients must undergo an MRI for work up to aid in tumor delineation and to rule out additional foci of disease. If additional foci of disease are present, they need to have a negative biopsy to proceed with treatment.
8. Clinically and radiographically node negative on ultrasound of the axilla or MRI on on initial workup prior to microbubble contrast assessment 9. Estrogen receptor positive or Progesterone receptor positive and Her2neu negative 10. Ability to understand and the willingness to sign a written informed consent.
11. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to the start of study and for the duration of radiation therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months
12. If patient has had a prior biopsy clip placed in the lymph node deemed the sentinel lymph node at time of microbubble CEUS, it is up to investigator if additional biopsy and clip placement will be obtained.
Exclusion Criteria:
- 1. Multi-centric disease 2. Prior Radiation to the involved breast 3. Tumor Size \>3cm 4. Patients who are pregnant or lactating due to the potential exposure to the fetus to radiation therapy and unknown effects of radiation therapy to lactating females 5. Prior ipsilateral breast cancer 6. Patients with active lupus or scleroderma 7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Gadolinium or other agents used in study.
8. If patient has a positive lymph node at time of microbubble contrast enhanced ultrasound, they will be removed from the study. Only N0 patients to be treated on this study.
**Gender Based:** True
**Gender Description:** Female only study
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sarah Neufeld, MS
**Phone:** 214-645-8525
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Dallas
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sarah Neufeld, MS
- **Role:** CONTACT
**Country:** United States
**Facility:** UT Southwestern Medical Center-Dallas
**State:** Texas
**Zip:** 75390
#### Overall Officials
**Official 1:**
**Affiliation:** UT Southwestern Medical Center
**Name:** Asal Rahimi, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444256
**Brief Title:** Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder
**Official Title:** Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder: A Pilot Study
#### Organization Study ID Info
**ID:** HSC-MS-24-0330
#### Organization
**Class:** OTHER
**Full Name:** The University of Texas Health Science Center, Houston
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The University of Texas Health Science Center, Houston
#### Responsible Party
**Investigator Affiliation:** The University of Texas Health Science Center, Houston
**Investigator Full Name:** Heather E. Webber, PhD
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to determine the effects of suvorexant (SUVO), on sleep, stress, and drug craving during early abstinence from stimulants and to determine the effects of treatment (SUVO vs. treatment as usual (TAU)) on post-treatment (Days 13-30) residential program length of stay (LOS) and completion rate.
### Conditions Module
**Conditions:**
- Stimulant Use Disorder
**Keywords:**
- Psychostimulants
- substance use
- methamphetamine
- cocaine
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: SUVO
- Drug: TAU
**Label:** SUVO
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: TAU
**Label:** TAU
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- SUVO
**Description:** Participants will receive 20mg of SUVO for 7 days in the evening before bed on Day 5 through Day 11
**Name:** SUVO
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- SUVO
- TAU
**Description:** Participants will receive supportive care and symptomatic medication per protocol at the inpatient facility.
**Name:** TAU
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Change in total sleep duration as assessed by the actigraphy watch
**Time Frame:** Baseline (Day 4), Day 5, day 6, day 7, day 8, day 9, day 10, day 11
**Measure:** Change in wake after sleep onset measured via actigraphy watch
**Time Frame:** Baseline (Day 4), Day 5, day 6, day 7, day 8, day 9, day 10, day 11
**Description:** This is a 7 item questionnaire and is rated on a five-point Likert scale ('0' representing none or not at all and '4' representing very much). Total scores range from 0 to 28, with higher combined scores indicating worse insomnia severity.
**Measure:** Change in self reported sleep quality as assessed by the Insomnia Severity Index (ISI)
**Time Frame:** Day 5 and Day 12
**Description:** This is a 4 item questionnaire and each is scored from 1-5 for a score range of 4-20, higher number indicating worse outcome
**Measure:** Changes in self reported sleep disturbance as assessed by the Patient Reported Outcomes Measurement Information System Short Form (PROMIS-SF)
**Time Frame:** Day 5 and Day 12
**Description:** This is an 8 item questionnaire and each is scored from 1-5 for a total score range of 8-40, higher number indicating worse outcome
**Measure:** Changes in self reported Sleep-Related Impairment as assessed by the Patient Reported Outcomes Measurement Information System Short Form (PROMIS-SF)
**Time Frame:** Day 5 and Day 12
**Description:** This is measured from 0=no stress, 10=extreme stress
**Measure:** Change in self-reported stress as assessed by the Visual Analog Scale (VAS)
**Time Frame:** Day 5 and Day 12
**Description:** The DASS 21 is a 21 item self report questionnaire. Each item is scored from 0 (did not apply to me at all over the last week) to 3 (applied to me very much or most of the time over the past week), higher score indicating a worse outcome
**Measure:** Change in stress and anxiety as assessed by the Depression, Anxiety and Stress Scale (DASS)
**Time Frame:** Day 5 and Day 12
**Description:** This is a 10 item questionnaire, each is scored from 0 (strongly disagree) to 6 (strongly agree) for a total score range of 0-60, higher score indicating worse outcome
**Measure:** Change in craving as assessed by the self reported Stimulant Craving Questionnaire (STCQ)
**Time Frame:** Day 5 and Day 12
#### Secondary Outcomes
**Measure:** Change in resting state alpha power as assessed by EEG
**Time Frame:** Day 5 and Day 12
**Description:** Participants will submerge their hands in a bucket of ice water for up to 2 minutes and a saliva sample will be taken
**Measure:** Change in stress as indicated by the amount of cortisol present in saliva during the cold-pressor task
**Time Frame:** Day 5 and Day 12
**Description:** Participants will submerge their hands in a bucket of ice water for upto 2 minutes and heart rate will be measured
**Measure:** Change in stress as indicated by the change in heart rate during the cold-pressor task
**Time Frame:** Day 5 and Day 12
**Description:** Participants will submerge their hands in a bucket of ice water for upto 2 minutes and blood pressure will be measured
**Measure:** Change in stress as indicated by the change in systolic blood pressure during the cold-pressor task for upto 2 minutes
**Time Frame:** Day 5 and Day 12
**Description:** Participants will submerge their hands in a bucket of ice water for upto 2 minutes and blood pressure will be measured
**Measure:** Change in stress as indicated by the change in diastolic blood pressure during the cold-pressor task for upto 2 minutes
**Time Frame:** Day 5 and Day 12
**Description:** The Doors Task will be used to elicit the RewP component, representing reward sensitivity. The task is a guessing game, where participants guess which door contains a reward behind it. After selecting a door, the participants are notified if they found the prize by a green arrow pointing up or if they did not find the prize by a red arrow pointing down.
**Measure:** Change in the amplitude of the Reward Positivity (RewP) component in microvolts in response to feedback on the Doors Task
**Time Frame:** Day 5 and Day 12
**Description:** Demand is the maximum quantity of Methamphetamine or Cocaine consumed if the drug was free measured in grams or dollar amount
**Measure:** Change in intensity of demand as assessed by the Drug Purchasing Task
**Time Frame:** Day 5 and Day 12
**Measure:** Length of stay (LOS)
**Time Frame:** at time of discharge (up to 30 days form baseline)
**Measure:** Percentage of participants who complete the 30 day treatment
**Time Frame:** at time of discharge (up to 30 days form baseline)
**Description:** This 31-item questionnaire will be administered to assess side effects and adverse events in the SUVO group only
**Measure:** Change in side effects as assessed by the side effects questionnaire
**Time Frame:** Day 5 , Day 12
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Meet Diagnostic and Statistical Manual of Mental Disorders(DSM-5)criteria for primary stimulant use disorder (either cocaine or methamphetamine)
* Be fluent in English and able to understand the consent form
Exclusion Criteria:
* Have an opioid use disorder of any severity
* Have a greater than moderate substance use disorder on any other substance
* Undergoing medication-assisted treatment for withdrawal of any substance
* Have any medical conditions contraindicating SUVO (e.g., severe pulmonary disease, severe cardiovascular disease or clinically abnormal ECG, severe liver or kidney disease, seizure disorder, or sleep disorder -particularly narcolepsy)
* Are currently taking medications with known drug interactions with SUVO (e.g., Monoamine oxidase (MAO) inhibitors, anticonvulsants, haloperidol, phenothiazines, anesthetics, and any sedative)
* Are pregnant or breast feeding
* BMI \> 30 (women only)
* Have a current DSM-5 psychiatric disorder or neurological disease requiring on-going treatment that would make participation unsafe
* Have history of seizure disorder
* Have a head injury with loss of consciousness in the last 5 years
**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:** Heather Webber, PhD
**Phone:** 713-486-2723
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Jessica Vincent
**Phone:** 713-486-2645
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Heather Webber, PhD
- **Phone:** 713-486-2723
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Jessica Vincent
- **Phone:** 713-486-2645
- **Role:** CONTACT
**Country:** United States
**Facility:** The University of Texas Health Science Center at Houston
**State:** Texas
**Zip:** 77030
#### Overall Officials
**Official 1:**
**Affiliation:** The University of Texas Health Science Center, Houston
**Name:** Heather Webber, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: CNSSti
- Name: Central Nervous System Stimulants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: VaCoAg
- Name: Vasoconstrictor Agents
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
### Intervention Browse Module - Browse Leaves
- ID: M4029
- Name: Central Nervous System Stimulants
- Relevance: LOW
- As Found: Unknown
- ID: M11674
- Name: Methamphetamine
- Relevance: LOW
- As Found: Unknown
- ID: M6271
- Name: Cocaine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444243
**Brief Title:** A Multi-centre, Double-blinded, Placebo-controlled, Randomised, Phase II Clinical Trial for Psilocybin-assisted Therapy for Alcohol Use Disorder
**Official Title:** A Multi-centre, Double-blinded, Placebo-controlled, Randomised, Phase II Clinical Trial for Psilocybin-assisted Therapy for Alcohol Use Disorder
#### Organization Study ID Info
**ID:** X23-0055
#### Organization
**Class:** OTHER
**Full Name:** University of Sydney
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Woke Pharmaceuticals
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Sydney
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** To explore the effectiveness of psilocybin-assisted therapy on reducing alcohol consumption in a double-blind, randomised, phase II clinical trial.
**Detailed Description:** New strategies for treating Alcohol Use Disorder (AUD) are urgently needed. Recent evidence has shown promising results for psychedelic-assisted therapies, particularly psilocybin, which has demonstrated efficacy in reducing alcohol consumption and improving psychological well-being. This study aims to evaluate the clinical efficacy and tolerability of psilocybin-assisted therapy compared to a control (niacin) in reducing heavy drinking days (HDD) per week among individuals with AUD.
Primary Objective
To conduct a double-blind, randomised controlled trial with 90 participants diagnosed with Alcohol Use Disorder (AUD). The primary aim is to compare the efficacy of psilocybin-assisted therapy (two sessions of psilocybin, 25 mg per dosing session) versus control (niacin 250mg) and therapy in reducing alcohol consumption, specifically measuring the number of heavy drinking days (HDD) per week.
Secondary Objectives
To compare the efficacy of psilocybin-assisted therapy versus control in improving the characteristics of AUD and addressing common comorbidities associated with AUD, including depression and anxiety.
Study Design
The trial will employ a double-blind, randomised, controlled design. A sample of 90 individuals with AUD will undergo 14 weeks of treatment, which includes 12 therapy sessions and 2 dosing sessions with either psilocybin (25 mg) or control (niacin 250mg). Participants will be assessed for changes in alcohol consumption patterns and improvements in symptoms of depression and anxiety.
### Conditions Module
**Conditions:**
- Alcohol Use Disorder
- Alcohol Dependence
- Depression
- Anxiety
**Keywords:**
- Psilocybin-assisted therapy
- Randomised-Controlled Trial
- Psilocybin
- Psychedelic-Assisted Therapy
- Alcohol Use Disorder Therapy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Multi-centre, Double-blinded, Randomised, Phase II Clinical Trial for Psilocybin-assisted Therapy for Alcohol Use Disorder
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** Double blinded with an additional optional dosing session for open label dosing
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** * 12 weekly sessions of psychotherapy for AUD
* 2 dosing sessions - psilocybin 25mg
* Additional open-label dosing session for participants in control arm post-follow up
* 2 integration sessions following each dosing session (additional dosing session for open label dosing)
* 3 post-treatment follow-up sessions
* Total of 13 clinic sessions
**Intervention Names:**
- Drug: Psilocybin
**Label:** Psilocybin + Therapy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** * 12 weekly sessions of psychotherapy for AUD
* 2 dosing sessions - niacin 250mg
* 2 integration sessions following each dosing session
* 3 post-treatment follow-up sessions
* Total of 13 clinic sessions
**Intervention Names:**
- Drug: Niacin
**Label:** Niacin + Therapy
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Psilocybin + Therapy
**Description:** Psilocybin is a naturally occurring psychedelic prodrug compound produced by more than 200 species of fungi.
**Name:** Psilocybin
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Niacin + Therapy
**Description:** A nutrient in the vitamin B complex that the body needs in small amounts to function and stay healthy. Niacin helps some enzymes work properly and helps skin, nerves, and the digestive tract stay healthy. Niacin is found in many plant and animal products.
Niacin will be used at a concentration of 250mg as an active control.
**Name:** Niacin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Frequency of HDD as measured by the Timeline Follow Back (TLFB) and validated by Phosphatidylethanol (PEth). HDD are defined as ≥4 drinks/day for women and ≥5 drinks/day for men.
**Measure:** Frequency of Heavy Drinking Days (HDD)
**Time Frame:** 52 Weeks
#### Secondary Outcomes
**Description:** The mean alcohol consumption per drinking day will be gathered reported as the number of standard drinks consumed each day.
**Measure:** Mean alcohol consumption per drinking day
**Time Frame:** 52 Weeks
**Description:** Measured by Timeline Follow Back and corroborated with Phosphatidylethanol (PEth) levels
**Measure:** Absence of any HDD
**Time Frame:** 52 Weeks
**Description:** The WHO categorizes alcohol consumption into different risk levels based on average daily intake and associated health risks: Abstainer: Rarely or never drinks alcohol. Low-risk drinking: (Men: Up to 2 standard drinks per day, Women: Up to 1 standard drink per day). Moderate-risk drinking: (Men: 3-4 standard drinks per day, Women: 2-3 standard drinks per day). High-risk drinking: (Men: More than 4 standard drinks per day, Women: More than 3 standard drinks per day). Heavy episodic (binge) drinking: 60 grams (5-6 drinks) or more on a single occasion.
**Measure:** WHO drinking risk level
**Time Frame:** 52 Weeks
**Description:** Alcohol Dependence Scale (ADS) is a measure of the severity of the participant's dependence on alcohol. The measure contains 29 items regarding symptoms and occurrences associated with dependence on alcohol. A total score for the measure is yielded by adding across items. Higher scores indicate more severe dependence.
**Measure:** Dependence Severity
**Time Frame:** 52 Weeks
**Description:** Alcohol craving will be investigated using the Penn Alcohol Craving Scale (PACS). The PACs is a 5-item questionnaire that measures an individual's craving to drink alcohol in the past week.
**Measure:** Alcohol Craving
**Time Frame:** 52 Weeks
**Description:** PEth measures the level of phosphatidylethanol, a direct alcohol biomarker which is found in human blood following alcohol consumption. Phosphatidylethanols are abnormal phospholipids formed in the presence of ethanol
**Measure:** PEth Levels
**Time Frame:** 52 Weeks
**Description:** Measured by cumulative scores on the DASS-21 Anxiety Scale. This scale has a minimum score of 0 and maximum score of 21. A higher score indicates more anxiety.
**Measure:** Changes in Anxiety
**Time Frame:** 52 Weeks
**Description:** Measured by cumulative scores on the DASS-21 Depression Scale. This scale has a minimum score of 0 and maximum score of 21. A higher score indicates greater depression.
**Measure:** Changes in Depression
**Time Frame:** 52 Weeks
**Description:** Changes in suicidal ideation \& behaviours across the treatment period. This will be measured on the C-SRSS (Columbia Suicide Severity Rating Scale). At baseline this will be measured by the baseline version. At each visit following this, this will be recorded on the since last visit version. Higher scores indicate more severe suicidality.
**Measure:** Changes in Suicidal Ideation
**Time Frame:** 52 Weeks
**Description:** To assess whether treatment can change quality of life as measured by the short form Health Survey (SF-36). This survey has 36 items that measure 8 domains of health, including: physical functioning, physical role limitations, bodily pain, general health perceptions, energy/vitality, social functioning, emotional role limitations and mental health. The scores are transformed to range from 0 (worst possible health) to 100 (best possible health).
**Measure:** Changes in Quality of Life
**Time Frame:** 52 Weeks
**Description:** An assortment of liver enzymes will be monitored throughout the trial to investigate any changes that occur in liver function.
**Measure:** Markers of Liver Injury
**Time Frame:** 52 Weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Moderate to severe AUD according to the DSM-5 criteria
2. A desire to reduce or stop drinking
3. Consumed at least 21 standard drinks per week or ≥2 HDD (≥5 standard drinks/day for men; ≥4 for women) in the past week prior to screening
4. Aged ≥18 years old
5. Adequate cognition and English language skills to give valid consent and complete research interviews and assessments (MoCA ≥26)
6. Received prior treatment for AUD (not including study interventions)
7. Stable housing within reasonable distance to a clinical site for the duration of the study
8. Able to identify a significant other (such as a family/friend/partner) who could accompany them from clinic/provide transport and/or be contacted by the study team if required
9. Willing to give written informed consent
Exclusion Criteria:
* a. History of or currently meeting DSM-5 criteria for:
* Any psychotic disorder
* Bipolar disorder type 1 or 2
* Major depression with psychotic features
* Any personality disorders
* Post-traumatic stress disorder
* Hallucinogen persisting perception disorder b. A family history of:
* Schizophrenia or schizoaffective disorder (first- or second-degree relatives), or
* Bipolar disorder type 1 (first degree relatives) c. Suicide risk according to clinician judgement (e.g. previous suicide attempt or self-harm in the past 6 months) and responses to Columbia Suicide Severity Rating Scale (C-SSRS) and SCID-5-RV.
d. Abnormal and/or serious clinical finding or medical condition that may preclude participation e. Concurrent use of psychotropic medication e.g., antidepressants, antipsychotics, psychostimulants, treatments for addictions, other dopaminergic or serotonergic agents (e.g. St John's Wort/tryptophan), lithium, anticonvulsants).
* Use of antidepressants and alcohol pharmacotherapy use considered if assessed by investigator and titrated down with 5 half-lives + 1-week washout f. Use of any medications likely to interact with study medication during the trial (subject to investigator's discretion).
* Low dose opiates permitted for pain management, however, not the night before or after dosing sessions g. Significant alcohol withdrawal (current CIWA-Ar score ≥10, including history of delirium tremens or alcohol withdrawal seizures).
h. Any current substance use disorder (SUD) other than tobacco (e.g. opiates, benzodiazepines, cannabis, psychostimulants, hallucinogens) as per clinician judgement and/or defined by DSM-5 criteria (measured by SCID-RV).
i. Substantial lifetime use (\>25 total) or recent use (past 12 months) of ketamine or classic hallucinogens, such as psilocybin-containing mushrooms or LSD j. Any alcohol pharmacotherapy (e.g. naltrexone, acamprosate) within the past month.
k. Participation in other clinical trials in the previous two months l. Pregnant or lactating (contraception must be used and a sensitive pregnancy test will be performed at baseline and prior to dosing) m. Allergy or hypersensitivity to psilocybin n. Any condition or factor deemed by the study clinician to place the individual at higher risk of an adverse emotional reaction, severe active stressors such as significant legal problems, marital distress or lack of social support.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Kirsten C Morley, PhD
**Phone:** 95153636
**Phone Ext:** 612
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Paul Haber, PhD
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Sydney
**Name:** Paul Haber, PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** University of Sydney
**Name:** Kirsten C Morley, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Individual Participant Data (IPD) might not be shared due to privacy concerns, potential misuse of data, intellectual property rights, and ethical considerations. Additionally, legal restrictions and the need to protect sensitive information can also limit the sharing of IPD.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004327
- Term: Drinking Behavior
- ID: D000019973
- Term: Alcohol-Related Disorders
- ID: D000019966
- Term: Substance-Related Disorders
- ID: D000064419
- Term: Chemically-Induced Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC25
- Name: Substance Related Disorders
### 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: M3774
- Name: Alcohol Drinking
- Relevance: HIGH
- As Found: Alcohol Use
- ID: M3783
- Name: Alcoholism
- Relevance: HIGH
- As Found: Alcohol Use Disorder
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7502
- Name: Drinking Behavior
- Relevance: LOW
- As Found: Unknown
- ID: M21842
- Name: Alcohol-Related Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21837
- Name: Substance-Related Disorders
- Relevance: LOW
- As Found: Unknown
- 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: D000000437
- Term: Alcoholism
- ID: D000000428
- Term: Alcohol Drinking
### Intervention Browse Module - Ancestors
- ID: D000006213
- Term: Hallucinogens
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000011619
- Term: Psychotropic Drugs
- ID: D000000960
- Term: Hypolipidemic Agents
- ID: D000000963
- Term: Antimetabolites
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000057847
- Term: Lipid Regulating Agents
- ID: D000014665
- Term: Vasodilator Agents
- ID: D000014803
- Term: Vitamin B Complex
- ID: D000014815
- Term: Vitamins
- ID: D000018977
- Term: Micronutrients
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: VaDiAg
- Name: Vasodilator Agents
- Abbrev: Lipd
- Name: Lipid Regulating Agents
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M17558
- Name: Vitamins
- Relevance: LOW
- As Found: Unknown
- ID: M17546
- Name: Vitamin B Complex
- Relevance: LOW
- As Found: Unknown
- ID: M12465
- Name: Niacin
- Relevance: HIGH
- As Found: Keep
- ID: M14419
- Name: Psilocybin
- Relevance: HIGH
- As Found: Frozen
- ID: M3777
- Name: Ethanol
- Relevance: LOW
- As Found: Unknown
- ID: M12476
- Name: Niacinamide
- Relevance: LOW
- As Found: Unknown
- ID: M12479
- Name: Nicotinic Acids
- Relevance: LOW
- As Found: Unknown
- ID: M8618
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M9305
- Name: Hallucinogens
- Relevance: LOW
- As Found: Unknown
- ID: M14474
- Name: Psychotropic Drugs
- 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
- ID: M17412
- Name: Vasodilator Agents
- Relevance: LOW
- As Found: Unknown
- ID: M21009
- Name: Micronutrients
- Relevance: LOW
- As Found: Unknown
- ID: M16885
- Name: Trace Elements
- Relevance: LOW
- As Found: Unknown
- ID: T453
- Name: Niacin
- Relevance: HIGH
- As Found: Keep
- ID: T455
- Name: Nicotinamide
- Relevance: LOW
- As Found: Unknown
- ID: T454
- Name: Niacinamide
- Relevance: LOW
- As Found: Unknown
- ID: T456
- Name: Nicotinic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T471
- Name: Vitamin B3
- Relevance: LOW
- As Found: Unknown
- ID: T446
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T448
- Name: Folate
- Relevance: LOW
- As Found: Unknown
- ID: T475
- Name: Vitamin B9
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000009525
- Term: Niacin
- ID: D000011562
- Term: Psilocybin
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444230
**Brief Title:** Effects of Routine Physical Therapy With and Without Neurodevelopmental Technique on GMF, Spasticity and HRQOL in Diplegic CP
**Official Title:** Effects Of Routine Physical Therapy With And Without Neuro-Developmental Technique On Gross Motor Function, Spasticity And Health Related Quality Of Life In Diplegic Cerebral Palsy- A Randomized Controlled Trail
#### Organization Study ID Info
**ID:** REC-UOL-536-09-2023
#### Organization
**Class:** OTHER
**Full Name:** University of Lahore
### Status Module
#### Completion Date
**Date:** 2024-04-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-04-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-07-27
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Lahore
#### Responsible Party
**Investigator Affiliation:** University of Lahore
**Investigator Full Name:** Shehzeena Ashraf
**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:** The aim of this study is to investigate the effects of routine physical therapy with and without neurodevelopmental technique on gross motor function, spasticity and health related quality of life in diplegic cerebral palsy.
**Detailed Description:** The neurological illness known as cerebral palsy is caused by damage to the growing brain and therefore is indicated by anomalies of muscle strength, mobility, and motor functions. Cerebral palsy affects posture, muscle tone, and movement development. Neurodevelopmental technique and routine physical therapy are considered to be effective in treatment of cerebral palsy. This study will investigate the combined effects of neurodevelopmental technique and routine physical therapy versus routine physical therapy on gross motor function, spasticity, and health related quality of life in diplegic cerebral palsy.
### Conditions Module
**Conditions:**
- Cerebral Palsy
**Keywords:**
- cerebral palsy
- gross motor function
- neurodevelopmental technique
- health realted quality of life
- routine physical therapy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 72
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** * Protocol of 40 minutes focusing on gross motor functional movements including upright sitting at the table, walking, kneeling, running and stair climbing.
* Used a Neuro-developmental method to inhibit undesirable movement patterns and facilitate favorable movement patterns.
* Weight-bearing exercises that involved proprioceptive training while in various positions (such as quadruped, kneeling, half kneeling, and standing).
* Facilitating weight transfer forward, backward, and sideways during balancing reactions from various balance board postures
**Intervention Names:**
- Other: Routine Physical therapy with Neurodevelopmental technique
- Other: Routine Physical therapy
**Label:** Neuro-developmental Physical Therapy+ Routine Physical Therapy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** All children in this group received physical therapy of 40 minutes, 3 times per week for 12weeks, which included passive stretching with focus on diplegic limb 8 minutes, neck and trunk postural control for 8 minutes, strength training 8 minutes, ambulation and gait training for 8 minutes with 2 minutes rest interval between each set of exercise.
**Intervention Names:**
- Other: Routine Physical therapy with Neurodevelopmental technique
- Other: Routine Physical therapy
**Label:** Routine Physical therapy:
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Neuro-developmental Physical Therapy+ Routine Physical Therapy
- Routine Physical therapy:
**Description:** participants will recieve a session of 40 minutes including routine physical therapy along with the neurodevelopmental technique for 3 times a week for 12 weeks
**Name:** Routine Physical therapy with Neurodevelopmental technique
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Neuro-developmental Physical Therapy+ Routine Physical Therapy
- Routine Physical therapy:
**Description:** participants will recieve a session of 40 minutes including, stretching, neck and trunk stabilization and strengthening exercise followed by a warm up and cool down for 3 times a week for 12 weeks follo
**Name:** Routine Physical therapy
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** UMN syndrome's component of spasticity is an increase in muscular stretch out reflexes that is velocity-dependent and accompanied by an increase in muscle tone. Bryan Ashworth developed the Ashworth Scale in 1964 while treating patients with MS as a way to grade spasticity. The original Ashworth scale, which rated spasticity on a scale of 0 to 4, classified it as either having no resistance or having limbs that were stiff in flexion or extension. They added 1+ to the scale to boost sensitivity(Bohannon \& Smith, 1987). Muscle spasticity is rated using the modified Ashworth scale score ranging from 0 to 4, having total 6 grades
**Measure:** Modified Ashworth Scale
**Time Frame:** 9 months
**Description:** Each item is rated on a four-point ordinal system of assessment. A score of 0 means the task cannot be performed, a score of 1 means the task is able to be started (10% completion), a score of 2 means the task may be completed partially (10% to 100% completion), and a score of 3 means the task is capable of being finished.Every unobserved item on the GMFM-88 receives a score of 0. On the contrast, GMFM-66, however, items that were not seen received a "not tested" or "missing" score.Both versions of GMFM has an excellent reliability
**Measure:** Gross Motor Function Measure
**Time Frame:** 9 months
**Description:** The Cerebral Palsy Quality of Life for Children (CP QOL-Child) is the very first quality of life survey founded on the International Classification of Function (ICF) created particularly for kids with CP.The CP QOL-Child is available in two versions: the main caregiver-proxy report version (proxy version) for kids ages 4 to 12 and a self-report version for kids ages 9 to 12. The CP QOL-Child's internal consistency, test-retest reliability, and construct validity have all been proven to be reliable and valid.
**Measure:** Cerebral Palsy Quality of Life Questionnaire for Children and Adolescent
**Time Frame:** 9 months
#### Secondary Outcomes
**Description:** The most popular technique for identifying muscle strength deficits is MMT. According to the dimensions of the muscle and the power of the examiner, scores range from zero contractions to a contraction which can be done against gravity and can withstand the examiner's "maximal" resistance. The examiner rates the muscular groups under study as either "weak" or "strong" on a scale of zero to five while applying force against the participant's resistance
**Measure:** Manual Muscle Testing
**Time Frame:** 9 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with an age of 8 to 18 years of both genderswith confirm diagnosis of diplegic cerebral palsy
* Patients could ambulate functionally
* Patients having limited or no prior exposure to NDT
* Individuals with mild to moderate diplegic cerebral palsy, based on established classification scales (GMFM grade I-III)
Exclusion Criteria:
* Patients with other motor or sensory dysfunctions and unable to understand and obey commands
* Patient undergone any orthopedic surgery that was ought to treatspasticity
* Patients with spasticity level 4-5 according to Modified Ashworth Scale
* Patients with Botulinum toxins type A injection within last 6 months
**Maximum Age:** 18 Years
**Minimum Age:** 8 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Lahore
**Country:** Pakistan
**Facility:** University of Lahore
**State:** Punjab
#### Overall Officials
**Official 1:**
**Affiliation:** University of Lahore
**Name:** Shehzeena Ashraf
**Role:** STUDY_CHAIR
### 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: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- 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: M12085
- Name: Muscle Spasticity
- 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: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
- ID: T5292
- Name: Spastic Diplegia Cerebral Palsy
- 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:** NCT06444217
**Acronym:** FibroTG-HD
**Brief Title:** Gene Therapy Development and Validation for Huntington's Disease Fibro TG-HD
**Official Title:** Gene Therapy Development and Validation for Huntington's Disease Fibro TG-HD
#### Organization Study ID Info
**ID:** 2024-A00877-40
#### Organization
**Class:** OTHER_GOV
**Full Name:** University Hospital, Angers
### Status Module
#### Completion Date
**Date:** 2028-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** University Hospital, Angers
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Huntington's disease is a rare and fatal monogenic neurodegenerative disorder whose molecular origin is an expansion of CAG triplets within the first exon of the Huntingtin gene. Although a growing number of emerging therapies are in clinical trials, there are no proven neuroprotective or curative treatments approved by the health authorities, as they have not yet demonstrated any real therapeutic benefit or absence of toxicity. Trans-splicing gene therapy is defined as the correction of a mutated endogenous pre-messenger RNA by a therapeutic exogenous pre-messenger RNA. Trans-splicing is a suitable alternative approach, since it is capable of allelic selectivity and replacement of mutated sequences by the wild-type one, criteria that no therapy tested to date meets. This project involves the therapeutic validation of trans-splicing of Huntingtin gene transcripts, and will evaluate its therapeutic effects in vitro, into primary fibroblast cell lines derived from skin biopsies of Huntington's disease patients.
### Conditions Module
**Conditions:**
- Huntington Disease
**Keywords:**
- Huntington
- gene therapy
- trans-splicing
- fibroblasts
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** skin biopsy
**Intervention Names:**
- Procedure: skin biopsy
**Label:** Huntington's patient
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Huntington's patient
**Description:** skin biopsy
**Name:** skin biopsy
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Correction of mutated endogenous transcripts.
**Measure:** In vitro validation of a RNA trans-splicing gene therapy for the correction of supernumerary CAG repeats into fibroblasts derived from skin biopsies of patients with Huntington's disease.
**Time Frame:** At the inclusion
#### Secondary Outcomes
**Description:** At the inclusion
**Measure:** Quantify the expression of Huntingtin protein (HTT) and its (in)usual protein partners.
**Time Frame:** At the inclusion
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18 ≤ age ≤ 70 years.
* Signed written, free and informed consent to participate in the study.
* Patients with a CAG≥36 allele (with reduced or full penetrance). penetrance)
* People affiliated to or benefiting from a social security scheme.
Exclusion Criteria:
* Individuals who have participated in a gene therapy trial using AAV, ASO, mi/si/shRNA administration, likely to disrupt expression, splicing of pre-mRNAs, mRNA splicing, mRNA expression/regulation/translation, energy or protein metabolism directly or indirectly linked to the Huntingtin gene (HTT), its transcripts and proteins.
* Clinical or paraclinical elements that may suggest a differential diagnosis.
* People unable to express their consent.
* Pregnant, breast-feeding or parturient women
* People deprived of liberty by administrative or judicial decision
* People under legal protection (curatorship, guardianship).
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Charlotte ABRIAL, PhD
**Phone:** 02.41.35.56.15
**Phone Ext:** 33
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Anne-Catherine AUBE-NATHIER, PhD
**Phone:** 02 41 34 54 96
**Phone Ext:** 33
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Angers
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** ABRIAL Charlotte, PhD
- **Phone:** 02.41.35.56.15
- **Phone Ext:** 33
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Anne-Catherine AUBE-NATHIER, PhD
- **Phone:** 02 41 35 54 96
- **Phone Ext:** 33
- **Role:** CONTACT
**Country:** France
**Facility:** ABRIAL
**State:** Maine Et Loire
**Zip:** 49933
#### Overall Officials
**Official 1:**
**Affiliation:** University Hospital, Angers
**Name:** VERNY Christophe, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001480
- Term: Basal Ganglia Diseases
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000003704
- Term: Dementia
- ID: D000002819
- Term: Chorea
- ID: D000020820
- Term: Dyskinesias
- ID: D000009069
- Term: Movement Disorders
- ID: D000020271
- Term: Heredodegenerative Disorders, Nervous System
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000030342
- Term: Genetic Diseases, Inborn
- ID: D000003072
- Term: Cognition Disorders
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M9875
- Name: Huntington Disease
- Relevance: HIGH
- As Found: Huntington's Disease
- ID: M25603
- Name: Ganglion Cysts
- Relevance: LOW
- As Found: Unknown
- ID: M16358
- Name: Synovial Cyst
- Relevance: LOW
- As Found: Unknown
- ID: M4774
- Name: Basal Ganglia Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6904
- Name: Dementia
- Relevance: LOW
- As Found: Unknown
- ID: M6059
- Name: Chorea
- Relevance: LOW
- As Found: Unknown
- ID: M22574
- Name: Dyskinesias
- Relevance: LOW
- As Found: Unknown
- ID: M12029
- Name: Movement Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M22092
- Name: Heredodegenerative Disorders, Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: M6301
- Name: Cognition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T2852
- Name: Huntington Disease
- Relevance: HIGH
- As Found: Huntington's Disease
### Condition Browse Module - Meshes
- ID: D000006816
- Term: Huntington Disease
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444204
**Brief Title:** A Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)
**Official Title:** An Open-Label, Phase 1 Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)
#### Organization Study ID Info
**ID:** POP17091
#### Organization
**Class:** INDUSTRY
**Full Name:** Sanofi
#### Secondary ID Infos
**Domain:** ICTRP
**ID:** U1111-1260-4098
**Type:** REGISTRY
**Domain:** Sanofi Identifier
**ID:** PRN1008-020
**Type:** OTHER
**Domain:** Sanofi Identifier
**ID:** POP17091
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2021-03-23
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2021-03-23
**Type:** ACTUAL
#### Start Date
**Date:** 2020-11-02
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**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:** Principia Biopharma, a Sanofi Company
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
### Description Module
**Brief Summary:** This is a single-dose study to assess the effect of mild or moderate Hepatic Impairment (HI) on the Pharmacokinetics (PK) of rilzabrutinib as well as to evaluate the safety and tolerability of rilzabrutinib in subjects with HI.
### Conditions Module
**Conditions:**
- Hepatic Function Abnormal
- Healthy Volunteers
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 29
**Type:** ACTUAL
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Subjects with mild Hepatic Impairment (HI)
**Intervention Names:**
- Drug: Rilzabrutinib
**Label:** Rilzabrutinib: Mild Hepatic Impairment
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Subjects with moderate Hepatic Impairment (HI)
**Intervention Names:**
- Drug: Rilzabrutinib
**Label:** Rilzabrutinib: Moderate Hepatic Impairment
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Subjects with normal hepatic function
**Intervention Names:**
- Drug: Rilzabrutinib
**Label:** Rilzabrutinib: Healthy-Matched Control
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Rilzabrutinib: Healthy-Matched Control
- Rilzabrutinib: Mild Hepatic Impairment
- Rilzabrutinib: Moderate Hepatic Impairment
**Description:** Rilzabrutinib tablet administered orally
**Name:** Rilzabrutinib
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Area under the concentration-time curve of total rilzabrutinib in plasma from 0 to t (AUC0-t)
**Time Frame:** Up to 30 hours after rilzabrutinib dosing
**Measure:** Area under the concentration-time curve of total rilzabrutinib in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
**Time Frame:** Up to 30 hours after rilzabrutinib dosing
**Measure:** Percent of AUC0-inf extrapolated total rilzabrutinib in plasma (%AUCextrap )
**Time Frame:** Up to 30 hours after rilzabrutinib dosing
**Measure:** Maximum measured concentration of total rilzabrutinib in plasma (Cmax)
**Time Frame:** Up to 30 hours after rilzabrutinib dosing
**Measure:** Time from dosing to maximum measured concentration of total rilzabrutinib in plasma (tmax)
**Time Frame:** Up to 30 hours after rilzabrutinib dosing
**Measure:** Terminal Half-Life of total rilzabrutinib in Plasma (t1/2)
**Time Frame:** Up to 30 hours after rilzabrutinib dosing
**Measure:** Elimination Rate Constant of total rilzabrutinib (Kel)
**Time Frame:** Up to 30 hours after rilzabrutinib dosing
**Measure:** Apparent Total Clearance of rilzabrutinib in the plasma after extra-vascular administration (CL/F)
**Time Frame:** Up to 30 hours after rilzabrutinib dosing
**Measure:** Apparent Volume of Distribution during the Terminal elimination phase after extravascular administration (Vz/F)
**Time Frame:** Up to 30 hours after rilzabrutinib dosing
**Measure:** Fraction of unbound drug ( rilzabrutinib) expressed as percent (%fu)
**Time Frame:** Up to 24 hours after rilzabrutinib dosing
**Measure:** Number of Adverse Events (AE) / Serious Adverse Events (SAE)
**Time Frame:** From date of signed ICF, up to 9 days after rilzabrutinib dosing
**Measure:** Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities
**Time Frame:** Up to 30 hours after rilzabrutinib dosing
#### Secondary Outcomes
**Measure:** Area under the concentration-time curve of rilzabrutinib metabolites in plasma from 0 to t (AUC0-t)
**Time Frame:** Up to 24 hours after rilzabrutinib dosing
**Measure:** Area under the concentration-time curve of rilzabrutinib metabolites in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
**Time Frame:** Up to 24 hours after rilzabrutinib dosing
**Measure:** Percent of AUC0-inf extrapolated rilzabrutinib metabolites in plasma (%AUCextrap)
**Time Frame:** Up to 24 hours after rilzabrutinib dosing
**Measure:** Maximum measured concentration of rilzabrutinib metabolites in plasma (Cmax)
**Time Frame:** Up to 24 hours after rilzabrutinib dosing
**Measure:** Time from dosing to maximum measured concentration of rilzabrutinib metabolites in plasma (tmax)
**Time Frame:** Up to 24 hours after rilzabrutinib dosing
**Measure:** Terminal Half-Life of rilzabrutinib metabolites in Plasma (t1/2)
**Time Frame:** Up to 24 hours after rilzabrutinib dosing
**Measure:** Elimination Rate Constant of rilzabrutinib metabolites (Kel)
**Time Frame:** Up to 24 hours after rilzabrutinib dosing
**Description:** MRAUC is Based on AUC0-t, corrected for Molecular weights (MW). MRAUC = (AUC0-t,M/AUC0-t,P) x (MW,P/MW,M) where M was metabolite and P was parent.
**Measure:** Metabolite-to-parent ratio (MRAUC)
**Time Frame:** Up to 24 hours after rilzabrutinib dosing
**Description:** MRCmax is based on Cmax, corrected for MW. MRCmax = (Cmax,M/ Cmax,P) x (MW,P/MW,M) where M was metabolite and P was parent.
**Measure:** Metabolite-to-parent ratio (MRCmax)
**Time Frame:** Up to 24 hours after rilzabrutinib dosing
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Hepatic Impaired Subjects:
* Non-smoking or light smoker (not exceeding 5 cigarettes per day), adult male or non-pregnant, non-lactating female, 18-75 years of age, inclusive, at screening.
* Weight ≥ 50 kg, at screening.
* Healthy Subjects:
* Non-smoking or light smoker (not exceeding 5 cigarettes per day), healthy, adult males and non-pregnant, non-lactating females, 18-75 years of age, inclusive, at screening.
Subject must be matched for age (within ± 10 years), and sex of the matched subject with hepatic impairment.
--Weight ≥ 50 kg at screening.
Additional inclusion criteria might apply.
Exclusion Criteria:
* Hepatic Impaired Subjects:
* Pregnant or lactating female.
* Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 millimeters of mercury \[mmHg\] and/or diastolic blood pressure ≥ 105 mmHg), or resting pulse rate \< 45 or \> 100 beats per minute (bpm). Measurements may be repeated once in order to determine eligibility.
* Healthy Subjects
* Pregnant or lactating female.
* Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg), or resting pulse rate \< 45 or \> 100 bpm. Measurements may be repeated once in order to determine eligibility.
Additional exclusion criteria might apply.
**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:** Miami
**Country:** United States
**Facility:** Investigational Site Number: 0002
**State:** Florida
**Zip:** 33014
**Location 2:**
**City:** Orlando
**Country:** United States
**Facility:** Investigational Site Number: 0001
**State:** Florida
**Zip:** 32809
#### Overall Officials
**Official 1:**
**Affiliation:** Sanofi
**Name:** Clinical Sciences & Operations
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
**IPD Sharing:** YES
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444191
**Brief Title:** Pharmacokinetics (PK) of Rilzabrutinib (PRN1008) in Healthy Japanese and Caucasian Subjects
**Official Title:** A Phase 1, Single-Center, Open-Label Study to Evaluate the Pharmacokinetics and Tolerability of Rilzabrutinib (PRN1008) in Japanese and Caucasian Healthy Male and Female Subjects
#### Organization Study ID Info
**ID:** PKM17089
#### Organization
**Class:** INDUSTRY
**Full Name:** Sanofi
#### Secondary ID Infos
**Domain:** ICTRP
**ID:** U1111-1260-4452
**Type:** REGISTRY
**Domain:** Sanofi Identifier
**ID:** PRN1008-023
**Type:** OTHER
**Domain:** Sanofi Identifier
**ID:** PKM17089
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2021-04-12
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2021-04-12
**Type:** ACTUAL
#### Start Date
**Date:** 2021-01-04
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**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:** Principia Biopharma, a Sanofi Company
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
### Description Module
**Brief Summary:** This is a single-dose and multiple doses study to assess the Pharmacokinetics (PK) of rilzabrutinib as well as to evaluate the tolerability of rilzabrutinib in Japanese and Caucasian Healthy Male and Female subjects.
### Conditions Module
**Conditions:**
- Healthy Volunteers
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 23
**Type:** ACTUAL
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Rilzabrutinib
**Label:** Cohort 1: Rilzabrutinib
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: Rilzabrutinib
**Label:** Cohort 2: Rilzabrutinib
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cohort 1: Rilzabrutinib
- Cohort 2: Rilzabrutinib
**Description:** Rilzabrutinib tablet(s) administered orally
**Name:** Rilzabrutinib
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Maximum measured concentration of total rilzabrutinib in plasma (Cmax)
**Time Frame:** Up to 48 hours after the last rilzabrutinib dose
**Measure:** Time from dosing to maximum measured concentration of total rilzabrutinib in plasma (tmax)
**Time Frame:** Up to 48 hours after the last rilzabrutinib dose
**Measure:** Area under the concentration-time curve of total rilzabrutinib in plasma from 0 to the last measurable concentration (AUC0-last)
**Time Frame:** Up to 48 hours after the last rilzabrutinib dose
**Measure:** Area under the concentration-time curve of total rilzabrutinib in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
**Time Frame:** Up to 48 hours after the last rilzabrutinib dose
**Measure:** Area under the plasma concentration-time curve of total rilzabrutinib from zero during the dosage interval (AUC0-tau)
**Time Frame:** Up to 48 hours after the last rilzabrutinib dose
**Measure:** Terminal Half-Life of total rilzabrutinib in Plasma (t1/2)
**Time Frame:** Up to 48 hours after the last rilzabrutinib dose
**Measure:** Apparent Total Clearance of rilzabrutinib in the plasma after oral administration (CL/F)
**Time Frame:** Up to 48 hours after the last rilzabrutinib dose
**Measure:** Apparent volume of distribution after oral administration (Vd/F)
**Time Frame:** Up to 48 hours after the last rilzabrutinib dose
**Measure:** Dose proportionality of rilzabrutinib
**Time Frame:** Up to 48 hours after the last rilzabrutinib dose
**Measure:** Accumulation ratio (Rac)
**Time Frame:** Up to 48 hours after the last rilzabrutinib dose
#### Secondary Outcomes
**Measure:** Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities
**Time Frame:** Up to 14 days after rilzabrutinib dosing
**Measure:** Number of Adverse Events (AE) / Serious Adverse Events (SAE)
**Time Frame:** From date of signed ICF, up to 47 days
**Measure:** Bruton's Tyrosine Kinase (BTK) Occupancy characterization
**Time Frame:** Up to 48 hours after the last rilzabrutinib dose
**Measure:** Maximum measured concentration of rilzabrutinib metabolites in plasma (Cmax)
**Time Frame:** Up to 48 hours after the last rilzabrutinib dose
**Measure:** Time from dosing to maximum measured concentration of rilzabrutinib metabolites in plasma (tmax)
**Time Frame:** Up to 48 hours after the last rilzabrutinib dose
**Measure:** Area under the concentration-time curve of rilzabrutinib metabolites in plasma from 0 to the last measurable concentration (AUC0-last)
**Time Frame:** Up to 48 hours after the last rilzabrutinib dose
**Measure:** Area under the concentration-time curve of rilzabrutinib metabolites in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
**Time Frame:** Up to 48 hours after the last rilzabrutinib dose
**Measure:** Area under the plasma concentration-time curve of rilzabrutinib metabolites from zero during the dosage interval (AUC0-tau)
**Time Frame:** Up to 48 hours after the last rilzabrutinib dose
**Measure:** Terminal Half-Life of rilzabrutinib metabolites in Plasma (t1/2)
**Time Frame:** Up to 48 hours after the last rilzabrutinib dose
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Japanese subjects must have both biological parents and all four grandparents of Japanese ancestry and born in a Japanese country of origin.
* Caucasian subjects must have four Caucasian grandparents (Hispanics of white race can be considered Caucasian).
* Healthy adult male or non-pregnant non-lactating females, 18 to 75 years of age (inclusive) at the time of screening.
* Body mass index (BMI) ≥18 and ≤35 (kg/m2), inclusive, and a minimum body weight of 45 kg.
Additional inclusion criteria might apply.
Exclusion Criteria:
* Symptoms consistent with COVID-19 such as fever, cough, and shortness of breath within 14 days before Day 1.
* Positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening or check-in (Day -1).
* Known previous COVID-19 infection.
* Use of any prescription or over-the-counter (OTC) medication, herbal products, or dietary supplements within the 7 days or 5 half-lives, whichever is longer, prior to the first study drug administration. Use of hormonal contraception is allowed prior to and during the study.
Additional exclusion criteria might apply.
**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:** Glendale
**Country:** United States
**Facility:** Investigational Site Number: 0001
**State:** California
**Zip:** 91206
#### Overall Officials
**Official 1:**
**Affiliation:** Sanofi
**Name:** Clinical Sciences & Operations
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
**IPD Sharing:** YES
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444178
**Brief Title:** Assessment of Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban, or Aspirin Plus REGN9933, or Aspirin Plus REGN7508 in Healthy Adult Participants
**Official Title:** A Parallel Group Study in Healthy Participants to Quantitate Increases in Subclinical Gastrointestinal Blood Loss Following Administration of Aspirin Alone or in Combination With Rivaroxaban or Factor XI Inhibitors (REGN9933 or REGN7508)
#### Organization Study ID Info
**ID:** R9933-HV-2424
#### Organization
**Class:** INDUSTRY
**Full Name:** Regeneron Pharmaceuticals
### Status Module
#### Completion Date
**Date:** 2025-07-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-04-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-10-04
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**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:** Regeneron Pharmaceuticals
#### 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 study is researching experimental drugs called REGN9933 and REGN7508 (called "study drugs") and comparing their effects to approved treatments of rivaroxaban and aspirin (called "standard treatments"). Aspirin will be given alone or in combination with the study drugs or the other standard treatments to look at their effects on blood loss in the intestines.
The aim of the study is to see if aspirin alone or the study drugs REGN9933 and REGN7508, when taken with aspirin, cause less minor intestinal bleeding than standard treatments rivaroxaban with aspirin.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
### Conditions Module
**Conditions:**
- Healthy Volunteers
**Keywords:**
- Gastrointestinal (GI) bleeding
- Fecal occult blood testing (FOBT)
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 224
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Randomized 1:1:1:1
**Intervention Names:**
- Drug: Aspirin
**Label:** Arm 1: Aspirin
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Randomized 1:1:1:1
**Intervention Names:**
- Drug: Aspirin
- Drug: REGN9933
**Label:** Arm 2: Aspirin + REGN9933
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Randomized 1:1:1:1
**Intervention Names:**
- Drug: Aspirin
- Drug: REGN7508
**Label:** Arm 3: Aspirin + REGN7508
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Randomized 1:1:1:1
**Intervention Names:**
- Drug: Aspirin
- Drug: Rivaroxaban
**Label:** Arm 4: Aspirin + Rivaroxaban
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Arm 1: Aspirin
- Arm 2: Aspirin + REGN9933
- Arm 3: Aspirin + REGN7508
- Arm 4: Aspirin + Rivaroxaban
**Description:** Oral administration
**Name:** Aspirin
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Arm 2: Aspirin + REGN9933
**Description:** Administered intravenous (IV)
**Name:** REGN9933
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Arm 3: Aspirin + REGN7508
**Description:** Administered IV
**Name:** REGN7508
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Arm 4: Aspirin + Rivaroxaban
**Description:** Oral administration
**Name:** Rivaroxaban
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Change in fecal hemoglobin content (FHC)
**Time Frame:** Baseline and up to day 22
#### Secondary Outcomes
**Measure:** Incidence of treatment-emergent adverse events (TEAE)
**Time Frame:** Up to day 100
**Measure:** Severity of TEAE
**Time Frame:** Up to day 100
**Measure:** Incidence of major bleeding
**Time Frame:** Up to day 100
**Measure:** Incidence of clinically relevant non-major (CRNM) bleeding
**Time Frame:** Up to day 100
**Measure:** Concentrations of REGN9933
**Time Frame:** Up to day 29
**Measure:** Concentrations of REGN7508
**Time Frame:** Up to day 29
**Measure:** Change in activated partial thromboplastin time (aPTT)
**Time Frame:** Baseline and up day 29
**Measure:** Change in prothrombin time (PT)
**Time Frame:** Baseline and up day 29
**Measure:** Incidence of Anti-drug antibody (ADA) to REGN9933
**Time Frame:** Up to day 29
**Measure:** Titer of ADA to REGN9933
**Time Frame:** Up to day 29
**Measure:** Incidence of ADA to REGN7508
**Time Frame:** Up to day 29
**Measure:** Titer of ADA to REGN7508
**Time Frame:** Up to day 29
### Eligibility Module
**Eligibility Criteria:** Key Inclusion Criteria:
1. Body mass index between 18.0 and 32.5 kg/m2 (inclusive) at the screening visit
2. Judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed at screening and/or prior to administration of initial dose of study treatment
3. Normal aPTT, normal PT, and normal platelet counts at screening period and at the day 1 visit as defined by the local laboratory
4. Hemoglobin value ≥11.0 g/dL for females and ≥12.9 g/dL for males at the screening and day 1 visits
5. Negative FOBT at Baseline (visit 2) and visit 3 as defined in the protocol
Key Exclusion Criteria:
1. History of any major surgical procedure or clinically significant physical trauma in the last 6 months, in the opinion of the investigator, that may pose a risk to the participant by study participation
2. Whole blood donation within the previous 56 days or plasma donation within the previous 7 days prior to the screening visit
3. Hospitalized for any reason within 30 days of the screening visit
4. Estimated glomerular filtrate rate (eGFR) of \<60 mL/min/1.73m2 at screening as described in the protocol.
5. Current smoker or former smoker, including e-cigarettes, who stopped smoking within 12 months prior to the screening visit
6. History of illicit drug or alcohol abuse within the last 2 years prior to the day 1 visit
7. Use of any prescription and nonprescription medications or nutritional supplements from approximately 2 weeks or 5 half-lives, as described in protocol
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
**Healthy Volunteers:** True
**Maximum Age:** 55 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Clinical Trials Administrator
**Phone:** 844-734-6643
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Regeneron Pharmaceuticals
**Name:** Clinical Trial Management
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
**Description:** All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
**URL:** https://vivli.org/
## 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: M9556
- Name: Hemorrhage
- Relevance: HIGH
- As Found: Blood Loss
### Condition Browse Module - Meshes
- ID: D000006470
- Term: Hemorrhage
### Intervention Browse Module - Ancestors
- ID: D000000894
- Term: Anti-Inflammatory Agents, Non-Steroidal
- ID: D000018712
- Term: Analgesics, Non-Narcotic
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000893
- Term: Anti-Inflammatory Agents
- ID: D000018501
- Term: Antirheumatic Agents
- ID: D000005343
- Term: Fibrinolytic Agents
- ID: D000050299
- Term: Fibrin Modulating Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000010975
- Term: Platelet Aggregation Inhibitors
- ID: D000016861
- Term: Cyclooxygenase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000058633
- Term: Antipyretics
- ID: D000065427
- Term: Factor Xa Inhibitors
- ID: D000000991
- Term: Antithrombins
- ID: D000015842
- Term: Serine Proteinase Inhibitors
- ID: D000011480
- Term: Protease Inhibitors
- ID: D000000925
- Term: Anticoagulants
### Intervention Browse Module - Browse Branches
- Abbrev: Antipy
- Name: Antipyretics
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: FiAg
- Name: Fibrinolytic Agents
- Abbrev: Analg
- Name: Analgesics
- Abbrev: PlAggInh
- Name: Platelet Aggregation Inhibitors
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AnCoag
- Name: Anticoagulants
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: AA
- Name: Amino Acids
### Intervention Browse Module - Browse Leaves
- ID: M4548
- Name: Aspirin
- Relevance: HIGH
- As Found: Baseline
- ID: M463
- Name: Rivaroxaban
- Relevance: HIGH
- As Found: Compare
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4218
- Name: Anti-Inflammatory Agents, Non-Steroidal
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M20786
- Name: Analgesics, Non-Narcotic
- Relevance: LOW
- As Found: Unknown
- ID: M20604
- Name: Antirheumatic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M8473
- Name: Fibrinolytic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M13865
- Name: Platelet Aggregation Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M19209
- Name: Cyclooxygenase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M29176
- Name: Antipyretics
- Relevance: LOW
- As Found: Unknown
- ID: M30513
- Name: Factor Xa Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M4307
- Name: Antithrombins
- Relevance: LOW
- As Found: Unknown
- ID: M4306
- Name: Antithrombin III
- Relevance: LOW
- As Found: Unknown
- ID: M14343
- Name: Protease Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M18391
- Name: Serine Proteinase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M19609
- Name: HIV Protease Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M4244
- Name: Anticoagulants
- Relevance: LOW
- As Found: Unknown
- ID: T18
- Name: Serine
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000001241
- Term: Aspirin
- ID: D000069552
- Term: Rivaroxaban
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444165
**Brief Title:** Lebrikizumab Pen Ease of Use in Participants With Atopic Dermatitis
**Official Title:** Study to Assess Lebrikizumab Pen Ease of Use in Patients With Atopic Dermatitis
#### Organization Study ID Info
**ID:** 18826
#### Organization
**Class:** INDUSTRY
**Full Name:** Eli Lilly and Company
#### Secondary ID Infos
**Domain:** Eli Lilly and Company
**ID:** J2T-MC-KGBY
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Eli Lilly and Company
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to assess the ease of use of the lebrikizumab pen. Participants will use a practice pad to simulate administration of a dose. Participants will complete the modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ) following the simulated injection.
This study involves one study visit.
### Conditions Module
**Conditions:**
- Atopic Dermatitis
**Keywords:**
- Eczema
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 56
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Injection of lebrikizumab pen into a practice pad.
**Intervention Names:**
- Drug: Lebrikizumab Pen
**Label:** Lebrikizumab Pen
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Lebrikizumab Pen
**Description:** Injected into a practice pad.
**Name:** Lebrikizumab Pen
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** mSQAAQ: This modified, short questionnaire, is an instrument that includes 10 questions about the ease of use and confidence in using the lebrikizumab pen. Responses are scored on a 7-point Likert scale ranging from 'strongly disagree' to 'strongly agree:' (1) Strongly disagree; (2) Disagree; (3) Slightly Disagree; (4) Neither agree nor disagree; (5) Slightly agree; (6) Agree; (7) Strongly agree. Each question will be analyzed and presented individually.
**Measure:** Number of Participants Who Responded Agree or Strongly Agree to the Ease of Use Question Using the Modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ)
**Time Frame:** Day 1
**Description:** mSQAAQ: This modified, short questionnaire, is an instrument that includes 10 questions about the ease of use and confidence in using the lebrikizumab pen. Responses are scored on a 7-point Likert scale ranging from 'strongly disagree' to 'strongly agree:' (1) Strongly disagree; (2) Disagree; (3) Slightly Disagree; (4) Neither agree nor disagree; (5) Slightly agree; (6) Agree; (7) Strongly agree. Each question will be analyzed and presented individually.
**Measure:** Number of Participants Who Responded Agree or Strongly Agree to the Confidence of Use Question Using the mSQAAQ
**Time Frame:** Day 1
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Self-report being diagnosed with atopic dermatitis (AD) by a physician and able to provide approximate diagnosis date.
* Autoinjector or Pen naïve \[have not used an autoinjector or pen previously; permissible to have used a pre-filled syringe (PFS) or vial and syringe\].
* Willing and able to attend an in-person interview session.
* Able to complete the protocol requirements.
Exclusion Criteria:
* Cognitive or physical difficulties that could interfere with ability to understand the training, perform the injection tasks, or complete the study questionnaires as judged by the investigator.
* Are currently enrolled or have participated in the last 3 months, in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Is a health care practitioner who is trained in giving injections.
* Currently pregnant.
* Known hypersensitivity to any component of lebrikizumab or its excipients.
* Treatment with a live (or live attenuated) vaccine within the past 12 weeks.
* Current or chronic infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) per participant self-report.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** This is a single site clinical trial 1-877-CTLILLY (1-877-285-4559)
**Phone:** 1-317-615-4559
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Indianapolis
**Contacts:**
***Contact 1:***
- **Name:** Bill Miller
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Concentrics Research
**State:** Indiana
**Zip:** 46240
#### Overall Officials
**Official 1:**
**Affiliation:** Eli Lilly and Company
**Name:** Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 : Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
**Description:** Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- CSR
**IPD Sharing:** YES
**Time Frame:** Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
**URL:** http://vivli.org/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012871
- Term: Skin Diseases
- ID: D000012873
- Term: Skin Diseases, Genetic
- ID: D000030342
- Term: Genetic Diseases, Inborn
- ID: D000017443
- Term: Skin Diseases, Eczematous
- ID: D000006969
- Term: Hypersensitivity, Immediate
- ID: D000006967
- Term: Hypersensitivity
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7071
- Name: Dermatitis, Atopic
- Relevance: HIGH
- As Found: Atopic Dermatitis
- ID: M7067
- Name: Dermatitis
- Relevance: HIGH
- As Found: Dermatitis
- ID: M7655
- Name: Eczema
- Relevance: HIGH
- As Found: Atopic Dermatitis
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15676
- Name: Skin Diseases, Genetic
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: M19712
- Name: Skin Diseases, Eczematous
- Relevance: LOW
- As Found: Unknown
- ID: M10018
- Name: Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M10020
- Name: Hypersensitivity, Immediate
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003876
- Term: Dermatitis, Atopic
- ID: D000003872
- Term: Dermatitis
- ID: D000004485
- Term: Eczema
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444152
**Brief Title:** Prevalence of Epstein-Barr Virus Infection
**Official Title:** Prevalence of Epstein-Barr Virus Infection in HIV Infected and HIV Uninfected Patients Presenting With Lymphomas in Botswana
#### Organization Study ID Info
**ID:** 831640
#### Organization
**Class:** OTHER
**Full Name:** University of Pennsylvania
### Status Module
#### Completion Date
**Date:** 2024-12-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-04
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-20
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-08-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Botswana
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Pennsylvania
#### 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 will be a cross sectional, pilot study to determine the burden of EBV related lymphomas in this population. Patient information including demographics and HIV status, history of HIV infection, HIV viral load and CD4 counts and ART history will be retrieved from the integrated patient management system (IPMS) Lymph node excision biopsy samples, collected at NHL between 2012 and 2017, from the patient with a diagnosis of lymphoma will be retrieved using IPMS from National Health Laboratory and analyzed by immunohistochemistry.
**Detailed Description:** Lymph node excision biopsy samples,which have been formalin fixed and paraffin embedded, of 50 HIV-infected and 50 HIV-uninfected patients from the patient with a diagnosis of lymphoma, will be retrieved using IPMS from National Health Laboratory. Archived diagnostic biopsy material will be collected from NHL between 2012 and 2017 (5 years). They will be analyzed by immunohistochemistry using LMP-1/EBNA1/ENNA2 staining, either alone or combined which indicates a diagnosis of EBV infection.
We will compute rates of EBV associated lymphomas among HIV infected and HIV uninfected individuals using descriptive statistics. The students t-test will be used for continuous variables while the Pearson's chi squared test (or Fisher's exact test where appropriate) will be used to compare categorical variables. Significance will be assigned for P values of 0.05 or less
### Conditions Module
**Conditions:**
- Lymph Node Excision Biopsy
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 100
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** This study is analyzing stored samples
**Name:** Sample analysis
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The prevalence of EBV associated lymphomas among HIV-infected and HIV-uninfected patients in excision biopsy specimens of lymph nodes. This will be a cross sectional, pilot study to determine the burden of EBV related lymphomas in this population.
**Measure:** Burden of EBV
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* All available lymph node biopsy samples with a diagnosis of lymphoma and complete data of HIV status, HIV viral load and CD4 counts and ART history will be retrieved from IPMS.
Exclusion Criteria:
* Samples with incomplete data
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Formalin fixed paraffin embedded tissue (FFPE) of lymph node excision biopsy samples from the patient with a diagnosis of lymphoma
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Gaborone
**Country:** Botswana
**Facility:** University of Botswana
**Zip:** 267
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007239
- Term: Infections
- ID: D000006566
- Term: Herpesviridae Infections
- ID: D000004266
- Term: DNA Virus Infections
- ID: D000014412
- Term: Tumor Virus Infections
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11220
- Name: Lymphoma
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: HIGH
- As Found: Virus Infection
- ID: M21881
- Name: Epstein-Barr Virus Infections
- Relevance: HIGH
- As Found: Epstein-Barr Virus Infections
- ID: M18250
- Name: HIV Infections
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M3522
- Name: Acquired Immunodeficiency Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M9643
- Name: Herpesviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M7442
- Name: DNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17162
- Name: Tumor Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: T3543
- Name: Lymphosarcoma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000014777
- Term: Virus Diseases
- ID: D000020031
- Term: Epstein-Barr Virus Infections
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444139
**Brief Title:** Probiotic Intervention for Occasional Constipation
**Official Title:** A Randomized, Double-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Efficacy of Probiotics on Gastrointestinal Function in Adults With Occasional Constipation
#### Organization Study ID Info
**ID:** 23PICPP01
#### Organization
**Class:** INDUSTRY
**Full Name:** Probi AB
### Status Module
#### Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**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:** Probi AB
#### 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 clinical trial is to study the effect of probiotics on gut function in subjects with occasional constipation. The main question it aim to answer is if intake of probiotics will decrease the transit time. Participants will randomized to either consume probiotics or a placebo product.
### Conditions Module
**Conditions:**
- Gut Function
**Keywords:**
- Bowel movements, gut function, probiotics
### 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:** 100
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Dietary Supplement: Probiotics
**Label:** Probiotics
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Dietary Supplement: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Probiotics
**Description:** Probiotics
**Name:** Probiotics
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Placebo
**Name:** Placebo
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** Difference in change in gut transit time as assessed by blue-dye method
**Measure:** Transit time
**Time Frame:** Baseline to day 56
#### Secondary Outcomes
**Description:** Frequency of complete and spontaneous bowel movements (CSBM)
**Measure:** Bowel movements
**Time Frame:** Baseline to day 28 and day 56
**Description:** Evaluated by Bristol stool form scale
**Measure:** Stool consistency
**Time Frame:** Baseline to day 28 and day 56
**Description:** Frequency
**Measure:** Bloating and flatulence
**Time Frame:** Baseline to day 28 and day 56
**Description:** Evaluated by a questionnaire
**Measure:** Quality of life
**Time Frame:** Baseline to day 28 and day 56
**Description:** Evaluated by a questionnaire
**Measure:** Digestive symptoms
**Time Frame:** Baseline to day 28 and 56
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Males and females aged 18 - 65 years
* With occasional constipation
* Agrees to maintain current lifestyle habits
* Healthy
* Provided voluntary, written, informed consent to participate in the study
Exclusion Criteria:
* Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
* Allergy, sensitivity, or intolerance to study products or clinical assessment materials
* Chronic constipation
* Current or history of significant diseases or abnormalities of the gastrointestinal tract (examples (include but are not limited to atrophic gastritis, celiac disease, gluten intolerance/sensitivity, inflammatory bowel disease)
* Unstable metabolic disease or chronic diseases
* Unstable hypertension.
* Type I or Type II diabetes, cancer
* Significant cardiovascular event in the past 6 months. History of or current diagnosis with kidney and/or liver diseases
* Self-reported confirmation of current or pre-existing thyroid condition.
* Individuals with an autoimmune disease or are immune compromised
* Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis, blood/bleeding disorders
* Any other condition or lifestyle factor, that may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
**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:** Nisrine Zakaria
**Phone:** 12262424559
**Phone Ext:** 240
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** London
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Nisrine Zakaria
- **Phone:** 12262424559
- **Phone Ext:** 240
- **Role:** CONTACT
***Contact 2:***
- **Name:** David Crowley, Dr
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Canada
**Facility:** KGK Science Clinic
**State:** Ontario
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012817
- Term: Signs and Symptoms, Digestive
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M6472
- Name: Constipation
- Relevance: HIGH
- As Found: Constipation
- ID: M15622
- Name: Signs and Symptoms, Digestive
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003248
- Term: Constipation
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444126
**Brief Title:** The Incidence And Risk Factors Of Recurrent Febrile Seizures And Epilepsy Following Febrile Seizures
**Official Title:** A Prospective Cohort Study Of The Incidence And Risk Factors Of Recurrent Febrile Seizures And Epilepsy Following Febrile Seizures
#### Organization Study ID Info
**ID:** 16/23-BVNĐ2
#### Organization
**Class:** OTHER
**Full Name:** Pham Ngoc Thach University of Medicine
### Status Module
#### Completion Date
**Date:** 2025-09-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-09-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-03-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Pham Ngoc Thach University of Medicine
#### Responsible Party
**Investigator Affiliation:** Pham Ngoc Thach University of Medicine
**Investigator Full Name:** Bui Hieu Anh
**Investigator Title:** Lecturer - Researcher
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The goal of this observational study is to learn about the recurrence and developing epilepsy in children hospitalized with their first febrile sezures. The main questions it aims to answer are:
* What is the risk of recurrence after the first febrile seizure and what are the risk factors for recurrent febrile seizures in Vietnamese children?
* What is the risk of developing epilepsy later in life and what are the risk factors for developing epilepsy in Vietnamese children who have had febrile seizures?
**Detailed Description:** This was a single-center, longitudinal cohort study, in which Vietnamese children were prospectively identified for the first febrile seizures (FS) through the General Pediatric Department and Neurology Department of Children's Hospital 2 in Ho Chi Minh City between March and December 2023. This hospital is one of the largest tertiary pediatric hospitals in southern Vietnam with 1,400 beds, and receives about 90,000 admissions every year, with 800-1,000 cases of initial FS. After recruitment, the participants have been monitored for an average of two years to determine whether they experience recurring FS or develop epilepsy.
Sample size and sampling:
To estimate the incidence of FS recurrence in the cohort study, the sample size was calculated using a specific formula. With the desired level of confidence of 95%, an estimated error of 0.1, and an expected incidence of 31.8% which is based on a similar study conducted by Berg, the minimum sample size required was determined to be 385 participants. The sample size was also estimated based on the number of events per predictor in regression models, with at least 10 events per predictor recommended by Peduzzi et al. For the recurrent FS outcome, we have 12 potential predictor variables including age of onset, male gender, prematurity, low birth weight, neurodevelopmental abnormality, family history of FS or epilepsy, temperature, duration of fever at the time of the seizure, and characteristic of the first FS such as semiology, duration and number of seizures during the illness yielding approximately 120 cases to achieve the required sample size for estimating recurrence of FS. Besides that, we also have 16 potential predictor variables for the subsequent epilepsy outcome, including the above factors adding to the number of FS, and characteristics of all FS (first and recurrences). As such, we aimed to obtain at least 160 children. Finally, the overall sample size required at least 385 patients.
The convenience sampling was applied to recruit the participants. In detail, every weekday, the list of inpatient reports of the General Pediatric Department and Neurology Department on the electronic medical record database of Children's Hospital 2 was used to identify all children who had been diagnosed with FS and admitted to these departments. The investigator met with these children's parents or caregivers and asked a series of screening questions to confirm that they had not previously experienced febrile or unprovoked seizures. If the child had such a history, they were excluded from the study. The patients were then followed up until they recovered and were discharged from the hospital. At this point, the investigator made the final diagnosis of the first FS and assessed whether any exclusion criteria applied. If the patients were eligible for the study, the investigator obtained informed consent from their parents and proceeded to gather study data.
Data collection
The standardized questionnaire solicited child-related data including the age of onset, gender, perinatal history (i.e. age of gestation, birth weight, asphyxia, hospitalization at the neonatal intensive care unit), medical history (previous neurological diseases), family history of FS and epilepsy (including first relative and any relative); seizure-related data including semiology, duration, and number of seizures during the illness; and illness-related data including temperature, duration of fever at the time of the seizure, and the cause of fever. The interviewer obtained a comprehensive description of the seizure from either the parent or, if unavailable, from an eyewitness. Descriptions were compiled from both medical records and interviews, and additional clarification was sought, if necessary, by contacting the parent or witness again. Particular note was taken of the presence of asymmetrical features involving a unilateral arm, leg, or face (or some combination) or an eye deviation to one side, even if the fit later became bilateral tonic-clonic. Those seizures were classified as focal-onset seizures according to the ILAE classification in 2017. The presence of Todd's paresis (paralysis of one limb or one side of the body or a gaze palsy in the immediate postictal period) was considered indicative of a focal seizure. The study used medical records to gather information on seizures, associated symptoms, diagnosis, and temperature.
At the time of the first FS, a detailed neurologic examination and Denver II developmental screening test were conducted by a pediatrician. Test Denver II is a scale to assess the psychomotor development of children under 6 years old, which is validated and used in clinical practice in Vietnam. Test Denver II is a fairly comprehensive assessment of child development and focuses on 4 areas: personal-social, fine motor-adaptive, language, and gross motor. The interpretation of the test results indicates an obvious developmental delay if there are delayed items in at least two areas, with each area having a minimum of two items. A child is considered to have a suspected developmental delay if there are delayed items in one area with at least two items. If there are no signs of suspected or delayed development as described above, the child is considered normal. Developmental Quotient (DQ) is a calculation that reflects the rate of development in any given area and represents the percentage of normal development present at the time of testing.
Developmental Quotient (DQ)= (Developmental age (DA))/(Chronological age (CA)) x 100%
Lumbar puncture was performed only in cases that were indicative of meningitis or encephalitis, whereas neuroimaging (computerized tomography \[CT\] or magnetic resonance imaging \[MRI\]) was performed on children with focal seizures, febrile status epilepticus, or abnormal neurologic examination. Children who experience their first FS in our setting usually do not undergo an electroencephalography (EEG).
Following the initial interview, parents were contacted every three months to determine whether their child had experienced any further seizures and the circumstances under which they occurred. If a febrile seizure recurs or an afebrile seizure occurs, parents can report it immediately and directly to the investigator. Descriptions of the recurrent seizures were obtained in the same manner as for the initial FS. Whenever possible, we also obtained documentation of the recurrence from the medical record. Our goal was to follow children for an average of two years from the initial FS. We considered a seizure unprovoked if there were no acute precipitating circumstances to which the seizure could reasonably be attributed. According to the ILAE practical clinical definition from 2014, epilepsy is characterized by having two unprovoked seizures that are more than 24 hours apart. Children were censored from further analysis if they experienced an unprovoked seizure or were lost to follow-up.
Ethical considerations
The study protocol was approved by the Ethical Committee of Children's Hospital 2 (124/ GCN-BVNĐ2). and written consent was obtained from all participants. Informed consent was obtained from all study participants and their parents/caregivers.
### Conditions Module
**Conditions:**
- Febrile Seizures
- Epilepsy in Children
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 650
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The initial cohort including children hospitalized with their first febrile seizure
**Label:** Initial Febrile Seizures
### Outcomes Module
#### Primary Outcomes
**Description:** Following the initial interview, parents were contacted every three months to determine whether their child had experienced any further seizures and the circumstances under which they occurred. If a febrile seizure recurs or an afebrile seizure occurs, parents can report it immediately and directly to the investigator.
**Measure:** The incidence and risk factors of the recurrence of febrile seizures
**Time Frame:** 2 years
**Description:** We considered a seizure unprovoked if there were no acute precipitating circumstances to which the seizure could reasonably be attributed. According to the ILAE practical clinical definition from 2014, epilepsy is characterized by having two unprovoked seizures that are more than 24 hours apart
**Measure:** The incidence and risk factors of the epilepsy following febrile seizures
**Time Frame:** 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Children had a diagnosis of first febrile seizure based on the definition of the International League Against Epilepsy (ILAE) in 1993. That was a seizure occurring in childhood after one month of age associated with a febrile illness not caused by an infection of the central nervous system, without previous neonatal seizures or a previous unprovoked seizure, and not meeting the criteria for other acute symptomatic seizures. Fever is clinically a temperature of at least 38°C by any method as recorded either in the emergency department, outpatient clinics, or as noted in the medical history, as well as measured upon admission to the inpatient departments.
* Patients were between 1 months and 8 years of age
* Agreement from parents with writen informed consent
Exclusion Criteria:
* febrile paroxysmal events were atypical for seizures
* underlying neurological conditions that increase the likelihood of epilepsy
* unwillingness to return for follow-up
**Maximum Age:** 8 Years
**Minimum Age:** 1 Month
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** All children, who had a diagnosis of first febrile seizure at discharge from the General Pediatric Department and Neurology Department of Children's Hospital 2
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Anh Hieu Bui, M.D.
**Phone:** +84772962612
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Ho Chi Minh City
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Hieu Trung Nguyen, M.D, Ph.D
- **Phone:** +84908393616
- **Role:** CONTACT
***Contact 2:***
- **Name:** Anh Hieu Bui, M.D
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Van Khanh Le, M.D, Ph.D
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Vietnam
**Facility:** Children's Hospital 2
**Status:** RECRUITING
**Zip:** 70000
#### Overall Officials
**Official 1:**
**Affiliation:** Pham Ngoc Thach University of Medicine
**Name:** Hong Kim Tang, M.D, Ph.D
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000001832
- Term: Body Temperature Changes
- ID: D000018882
- Term: Heat Stress Disorders
- ID: D000014947
- Term: Wounds and Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M14850
- Name: Recurrence
- Relevance: LOW
- As Found: Unknown
- ID: M7983
- Name: Epilepsy
- Relevance: HIGH
- As Found: Epilepsy
- ID: M15452
- Name: Seizures
- Relevance: HIGH
- As Found: Seizures
- ID: M6517
- Name: Seizures, Febrile
- Relevance: HIGH
- As Found: Febrile Seizures
- ID: M2454
- Name: Hyperthermia
- Relevance: HIGH
- As Found: Febrile
- ID: M8464
- Name: Fever
- Relevance: HIGH
- As Found: Febrile
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M5111
- Name: Body Temperature Changes
- Relevance: LOW
- As Found: Unknown
- ID: M20924
- Name: Heat Stress Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M24916
- Name: Stress Disorders, Traumatic
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004827
- Term: Epilepsy
- ID: D000012640
- Term: Seizures
- ID: D000003294
- Term: Seizures, Febrile
- ID: D000084462
- Term: Hyperthermia
- ID: D000005334
- Term: Fever
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444113
**Acronym:** KATHAROS
**Brief Title:** Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis
**Official Title:** A Phase IV, Prospective, Multicenter, Open-label, Mother-milk Study to Evaluate Ofatumumab Concentration in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis Receiving Ofatumumab
#### Organization Study ID Info
**ID:** COMB157G2410
#### Organization
**Class:** INDUSTRY
**Full Name:** Novartis
#### Secondary ID Infos
**ID:** 2023-505283-11-00
### Status Module
#### Completion Date
**Date:** 2026-06-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-16
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-31
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**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:** Novartis Pharmaceuticals
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS). The study will include lactating mothers who plan to breastfeed and initiate/re-initiate ofatumumab 2-24 weeks post-partum.
**Detailed Description:** This is a Phase IV study in which breastfeeding mothers treated with ofatumumab and their babies are taking part for up to 1 year. The study consists of a Core Part and a Safety Follow-up Part. The Core Part includes a Screening period and a Sampling period. During the Screening period (up to 4 weeks), the study doctor will assess if mothers can join the study. The Sampling period, during which milk samples and a blood sample will be collected, will last for up to 12 weeks. The Safety Follow-up Part will last for about 9 months, to follow up on health and safety of mothers and their babies.
### Conditions Module
**Conditions:**
- Multiple Sclerosis
**Keywords:**
- Lactating women,
- multiple sclerosis (MS)
- ofatumumab
- milk concentration
- breastfed infant
### 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:** Recommended dose as per ofatumumab label. Injection at weeks 0,1,2 and monthly starting at week 4.
**Intervention Names:**
- Drug: Ofatunumab
**Label:** Ofatunumab
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Ofatunumab
**Description:** No study-treatment is provided for this study. Study participants will be treated with commercially available ofatumumab according to the local label.
**Name:** Ofatunumab
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Quantification of ofatumumab concentration in breast milk of lactating women with RMS who have initiated or re-initiated ofatumumab treatment post-partum.
**Measure:** Concentration of ofatumumab in breast milk.
**Time Frame:** (pre-dose) on the day of second (or subsequent) maintenance dose, then 7, 14, 21, 28 days after the second (or subsequent) maintenance dose"
#### Secondary Outcomes
**Description:** proportion of at least one sample with quantifiable concentration; Maximum concentration; exposure (Area under curve); milk/plasma ratio
**Measure:** Evaluate other PK parameters of ofatumumab in breast milk and plasma of lactating women with RMS who have initiated or re-initiated ofatumumab treatment post-partum
**Time Frame:** 28 days after second(or subsequent) maintenance dose.
**Description:** Estimated relative infant dose (RID, %) over 28 days after the lactating mother receives second or subsequent maintenance dose
**Measure:** Estimation of relative infant dose of ofatumumab
**Time Frame:** 28 days after second (or subsequent) maintenance dose.
**Description:** Rate and nature of adverse events in the mothers treated with ofatumumab to up to 12 months after ofatumumab treatment initiation/re-initiation Rate and nature of serious adverse events and any infection adverse events in the breastfed infants of mothers up to 12 months after ofatumumab treatment initiation/re-initiation
**Measure:** Safety data collected in lactating women receiving ofatumumab and their breastfed infants
**Time Frame:** Upto 12 months
**Description:** Maximum concentration (Cmax) of ofatumumab in breast milk over 28 days after the second (or any subsequent) maintenance dose.
**Measure:** Plasma Pharmacokinetics of OMB157(Cmax)
**Time Frame:** over 28 days after the second (or any subsequent) maintenance dose.
**Description:** The exposure (area under the curve (AUC) of ofatumumab in milk over 28 days (from the second or any subsequent maintenance dose to the next maintenance dose after initiation or re-initiation of ofatumumab post-partum)
**Measure:** Plasma Pharmacokinetics of OMB157(AUC)
**Time Frame:** over 28 days
**Description:** Milk/Plasma (M/P) ratio of ofatumumab at 28 days after the second or any subsequent maintenance dose.
**Measure:** Plasma Pharmacokinetics of OMB157 (M/P Ratio)
**Time Frame:** at 28 days after the second or any subsequent maintenance dose.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Written informed consent must be obtained before any study assessment is performed.
2. Participant is female with a relapsing form of MS and at least 18 years of age at the time of providing consent.
3. Participant must be postpartum at the time of enrollment, plan to be exclusively breastfeeding and willing to provide breast milk samples.
4. Participant has delivered term infant (at least 37 weeks gestation).
5. Participant must plan to initiate or re-initiate or have initiated or re-initiated treatment with ofatumumab between 2 to 24 weeks postpartum. The decision to be treated with ofatumumab and to breastfeed is made in accordance with the treating physician and must be completely independent of the decision to participate in this study.
Exclusion Criteria:
1. Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
2. Participant taking medications prohibited by the study protocol at screening.
3. Pregnant woman, confirmed by positive serum pregnancy test during screening.
4. Female of childbearing potential should use effective contraception as per local label.
5. Participant has history of chronic alcohol abuse or drug abuse in the last year.
6. Participant has any medical, obstetrical, psychiatric or other medical condition that, in the opinion of the Investigator, can jeopardize or would compromise the subject's ability to participate in this study or confound the study assessment.
7. Participant has history of breast implants, breast augmentation, or breast reduction surgery.
8. Participant has received anti-CD20 agents during the second and third trimesters of pregnancy.
9. Active infections, including mastitis (participant may be included once the infection is resolved).
10. Prior or current history of primary or secondary immunodeficiency, or participant in an otherwise severely immunocompromised state.
11. Participant with active hepatitis B disease prior to the initiation or re-initiation of ofatumumab. (Participant with positive hepatitis B serology should consult a liver disease medical standards to prevent hepatitis B reactivation.)
12. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
13. Any contraindication as per local label.
14. Participant who has an infant with any abnormality that may interfere with breastfeeding or confound the study assessment in the opinion of the Investigator.
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Novartis Pharmaceuticals
**Phone:** 1-888-669-6682
**Role:** CONTACT
**Contact 2:**
**Name:** Novartis Pharmaceuticals
**Phone:** +41613241111
**Role:** CONTACT
### IPD Sharing Statement Module
**Description:** Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
**IPD Sharing:** YES
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020278
- Term: Demyelinating Autoimmune Diseases, CNS
- ID: D000020274
- Term: Autoimmune Diseases of the Nervous System
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000003711
- Term: Demyelinating Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M12060
- Name: Multiple Sclerosis
- Relevance: HIGH
- As Found: Multiple Sclerosis
- ID: M15415
- Name: Sclerosis
- Relevance: HIGH
- As Found: Sclerosis
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22098
- Name: Demyelinating Autoimmune Diseases, CNS
- Relevance: LOW
- As Found: Unknown
- ID: M22094
- Name: Autoimmune Diseases of the Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M6909
- Name: Demyelinating Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009103
- Term: Multiple Sclerosis
- ID: D000012598
- Term: Sclerosis
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M347498
- Name: Ofatumumab
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444100
**Brief Title:** Predictors of Child Abuse Among School Going Children and the Impact of Structural Training on Child Abuse Among School Teachers
**Official Title:** Predictors of Child Abuse Among School Going Children and Impact of Structural Training on Child Abuse Among School Teachers of Dhulikhel Municipality
#### Organization Study ID Info
**ID:** 35_2024
#### Organization
**Class:** OTHER
**Full Name:** Kathmandu University School of Medical Sciences
### Status Module
#### Completion Date
**Date:** 2027-01-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-01-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Kathmandu University School of Medical Sciences
#### Responsible Party
**Investigator Affiliation:** Kathmandu University School of Medical Sciences
**Investigator Full Name:** Sita Karki
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Child abuse stands as a global public health crisis, impeding the natural growth and development of children. The repercussions of abuse extend beyond immediate trauma, resulting in heightened medical costs and enduring health consequences that may persist into adulthood. These consequences encompass a spectrum of issues, including attachment disorders, behavioral abnormalities, depression, post-traumatic stress disorder, altered neurobiological structures, suicidal ideation, risky sexual practices, and susceptibility to sexually transmitted infections. The detrimental impact of any form of child abuse lingers into the adult lives of affected individuals.
This study aims to determine the Predictors of Child Abuse among School Going Children and the Impact of Structural Training on Child Abuse Among School Teachers of Dhulikhel Municipality in selected schools of Dhulikhel Municipality. Employing descriptive-analytical, true-experimental, and qualitative research designs, the study involves children aged ≥ 11 and teachers across diverse schools. A purposeful sample technique will be used to select teachers to explore school teachers' strategies in supporting students experiencing childhood violence. A simple stratified sampling technique will be used to select schools and a simple random sampling technique will be used to select the required number of students. Subsequently, one group of teachers undergoes comprehensive training on child protection recognition and response, while another does not. Following a two-week intervention, Investigators will conduct a posttest to evaluate teachers' knowledge and attitudes. To ensure clarity, both standard and self-constructed research tools will be translated into Nepali. Subsequently, these tools will be employed for data collection. The gathered information will be entered into an Excel datasheet and later transferred to Stata version 13 for a comprehensive analysis involving both descriptive and inferential statistics.
**Detailed Description:** This study aims to determine Predictors of Child Abuse among School Going Children and Impact of Structural Training on Child Abuse Among School Teachers of Dhulikhel Municipality in selected schools of Dhulikhel Municipality. Employing descriptive-analytical, true-experimental, and qualitative research designs, the study involves children aged ≥ 11 and teachers across diverse schools Study Population The participants-I Investigator purposefully selected teachers who are teaching in private and public schools of Dhulikhel municipality. The participants-II All children aged 11-18 years of age studying in different schools (public and private) of Dhulikhel Municipality. The participants-III Teachers are teaching in different schools in Dhulikhel Municipality which are selected by using a stratified random sampling technique.
Number of participants and Justification :
The first type of participants is 20-30 for focus group discussion. (3-5 group) The second type of participant is 421 students which is based on sample size calculation.
The Third type of participant is 206 teachers which is based on sample size calculation by taking 40% of the mean different knowledge score /SD to maintain optimum sample size.
Sampling Technique Sample-I Among the 26 schools, there are 8 private schools and 18 government schools. A stratified random sampling technique will be used to select 50% of the schools. From these selected schools, a list of teachers was obtained and categorized based on age, education level, gender, experience, and ethnic group. The required sample numbers will be purposefully selected from these groups, considering their characteristics such as interest and expressiveness. Sample-II In Dhulikhel Municipality, there are a total of 26 schools, encompassing both public and private institutions. To ensure a representative sample, 50% of these schools will be chosen utilizing the stratified random sampling technique. This method involves categorizing the schools based on certain criteria and then randomly selecting schools from each category. Subsequently, a proportionate stratified sampling technique will be employed to determine the necessary number of students from the selected schools. From these chosen schools, classes spanning grades 6 to 12 will be selected using a simple random sampling technique. To ensure a representative group, a proportionnâtes stratified sampling technique will be applied to determine the required number of participants. Sample-III Selected schools will be divided into two groups: an intervention group, where teachers of selected schools will receive training on child abuse, and a control group without training. A comparative analysis will then evaluate the effectiveness of the intervention by assessing teachers' knowledge and attitudes towards child abuse.
Criteria for sample selection Inclusion criteria: The teachers who are teaching in different schools of Dhulikhel Municipality. Exclusion criteria: The teachers who are not available during data collection are not interested and do not give consent to be involved as a participants. Inclusion criteria: The students who are aged 11-18 years old and willing to participate in the study. Exclusion criteria: The students who are sick, unable to understand the Nepali language, and do not give assent for participation in the study. Inclusion criteria: Teachers are teaching in different schools of Dhulikhel Municipality. Exclusion criteria: Teachers are unable to speak the Nepali language and unavailable during data collection.
Data Collection Technique Informed written consent will be obtained from participants after providing comprehensive study information. The study will utilize a focus group discussion to delve into teachers' perceptions of child abuse. The discussion will continue until data saturation is achieved. Randomly selected samples will be invited, with the researcher explaining the study procedures and obtaining both verbal and written consent from teachers, along with assent from children. A dedicated room will be arranged for data collection, and participants will be instructed on how to respond to questions on tablets. Any instances of child abuse identified during data collection will be promptly referred to the OCMC of Dhulikhel Hospital for further management as needed. Participants will receive a diary and pen after being informed about child abuse, as per the Protocol's instructions40. A pretest will be conducted to assess the existing knowledge level and attitude of the teachers toward child abuse. A 5-hour training session, led by an expert team, will follow the pretest questionnaire administration to all participants. The training will cover the introduction, definition, risk factors, signs, symptoms, and management of child abuse. Teachers will also be educated on how to report instances of child abuse. The training will incorporate interactive lectures, group discussions, and role-playing to effectively convey the management of child abuse. A post-test will be administered using the same questionnaires two weeks after the training.
Data collection tools The first part of the study is to assess school teachers' perceptions of child abuse. The focus group discussion will be done by using a self-constructed topic guide. The International Society for the Prevention of Abuse and Neglect (ISPCAN) and United Nations Children's Fund (UNICEF) have developed three questionnaires (one for parents, the ICAST-P; one for young adults, the ICAST-R; and one for children, the ICAST-C) to examine types of victimizations of childhood around the world. The researcher is going to use the ICAST-C tool to assess the prevalence of child abuse in Nepal.The prevalence of child abuse will be assessed using validated outcome measures like ICAST-C (ver3.0 children version) 41. Part-III Self constructed research tool tool will be used to assess knowledge and attitude of teachers toward child abuse.
Pretesting Moc test will be done before the finalization of the topic guide. Pre-testing the data collection tool: Pre-test will be performed on 10% of the total sample size in Banepa Municipality which will not be included in the main study. - Response and feedback will be taken and consulted with the research advisors.
Validity and reliability of tool The validated research tool will be translated into the Nepali language for its simplicity and comprehensibility. The pretest will be done in a 10% sample which will be excluded from the main study. Validity of the tool Content validity of the tool will be maintained by: -consulting with the research advisor, - subject expertise and concern authority, -review of the literature, and pretesting. Pre-testing the data collection tool: Pre-test will be performed on 10% of the total sample size in Banepa Municipality which will not be included in the main study. - Response and feedback will be taken and consulted with the research advisors.
Plan for supervision and monitoring In order to ensure the success and reliability of our research, a robust plan for supervision and monitoring during data collection is imperative. Investigators will begin by clearly defining the research objectives and establishing the guiding principles for our study. A detailed protocol will be crafted, covering every step from participant recruitment to data analysis. Thorough training sessions will be conducted to equip our team with the necessary skills, emphasizing the importance of consistency and accuracy. A well-defined supervision structure, led by a designated supervisor, will oversee the entire process. Regular check-ins, both scheduled and random, will be implemented to monitor progress, address challenges, and maintain alignment with research goals. Continuous data quality checks, a feedback mechanism, and comprehensive documentation will ensure the integrity of our data. Prior to full-scale data collection, a pilot test will be conducted to identify and address potential issues. Adherence to ethical standards, random spot checks, continuous training, and an emergency response plan will further fortify the robustness of our approach. This holistic plan aims to create a proactive and adaptive environment, ensuring the smooth execution of our research endeavors.
### Conditions Module
**Conditions:**
- Child Abuse
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Selected schools will be divided into two groups: an intervention group, where teachers of selected schools will receive training on child abuse, and a control group without training. A comparative analysis will then evaluate the effectiveness of the intervention by assessing teachers' knowledge and attitudes towards child abuse. A pretest will be conducted to assess the existing knowledge level and attitude of the teachers toward child abuse. A 5-hour training session, led by an expert team, will follow the pretest questionnaire administration to all participants. The training will cover the introduction, definition, risk factors, signs, symptoms, and management of child abuse. Teachers will also be educated on how to report instances of child abuse.
The training will incorporate interactive lectures, group discussions, and role-playing to effectively convey the management of child abuse. A post-test will be administered using the same questionnaires two weeks after the training
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 206
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The intervention arm will undergo training on child abuse led by an expert group, while the control arm will not receive this training. Both groups will undergo pre-testing before the intervention, followed by post-testing two weeks after the training period.
**Intervention Names:**
- Procedure: Impact of structural training on child abuse
**Label:** Intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The control arm will not get any training.
**Label:** Control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention
**Description:** A focus group discussion to delve into teachers' perceptions of child abuse. Based on the findings, the training module will be modified as need-based.
Phase II: Randomly selected samples will be invited, with the researcher explaining the study procedures and obtaining verbal and written consent from teachers and assent from children. A dedicated room will be arranged for data collection, and participants will be instructed on how to respond to child abuse questions on tablets.
Phase-III A pretest will be conducted to assess the existing knowledge level and attitude of the teachers toward child abuse. A 5-hour training session, led by an expert team, will follow the pretest questionnaire administration to all participants. Teachers will also be educated on how to report instances of child abuse. A post-test will be administered using the same questionnaires two weeks after the training.
**Name:** Impact of structural training on child abuse
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Schools will be chosen through simple stratified sampling, and students via simple random sampling.The prevalence of child abuse will be assessed using the Child Abuse Screening Tool for Children (ICAST-C) through anonymous and ethically sound surveys.
**Measure:** Predictors of Child Abuse among School Going Children
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** Schools will be chosen through simple stratified sampling, and students via simple random sampling. One group of teachers will receive comprehensive training on child protection, while another will not. A pretest will assess teachers' existing knowledge and attitudes. Subsequently, all participants will undergo a 5-hour training session covering various aspects of recognizing and responding to child abuse followed by a post-test after a two-week training intervention to assess teachers' knowledge and attitudes towards child abuse.
**Measure:** Impact of Structural Training on Child Abuse Among School Teachers in selected schools of Dhulikhel Municipality
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Teachers from various selected secondary schools, both public and private, in Dhulikhel Municipality, Nepal.
Exclusion Criteria:
* Teachers from primary-level schools and refuse to take part in the study.
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sita Karki, MN
**Phone:** +9779841239708
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Kunta Devi PUn, PHD
**Phone:** +9779841239846
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Kandel P, Kunwar R, Karki S, Kandel D, Lamichhane P. Child maltreatment in Nepal: prevalence and associated factors. Public Health. 2017 Oct;151:106-113. doi: 10.1016/j.puhe.2017.06.020. Epub 2017 Jul 29.
**PMID:** 28763786
**Citation:** Kumar MT, Kumar S, Singh SP, Kar N. Prevalence of child abuse in school environment in Kerala, India: An ICAST-CI based survey. Child Abuse Negl. 2017 Aug;70:356-363. doi: 10.1016/j.chiabu.2017.06.025. Epub 2017 Jul 7.
**PMID:** 28692832
**Citation:** Kvist T, Dahllof G, Svedin CG, Annerback EM. Child physical abuse, declining trend in prevalence over 10 years in Sweden. Acta Paediatr. 2020 Jul;109(7):1400-1408. doi: 10.1111/apa.15215. Epub 2020 Mar 6.
**PMID:** 32031703
**Citation:** Miragoli S, Balzarotti S, Camisasca E, Di Blasio P. Parents' perception of child behavior, parenting stress, and child abuse potential: Individual and partner influences. Child Abuse Negl. 2018 Oct;84:146-156. doi: 10.1016/j.chiabu.2018.07.034. Epub 2018 Aug 9.
**PMID:** 30099228
**Citation:** Neupane D, Bhandari PM, Thapa K, Bhochhibhoya S, Rijal S, Pathak RP. Self-reported child abuse in the home: a cross-sectional survey of prevalence, perpetrator characteristics and correlates among public secondary school students in Kathmandu, Nepal. BMJ Open. 2018 Jun 19;8(6):e018922. doi: 10.1136/bmjopen-2017-018922.
**PMID:** 29921678
**Citation:** Shrestha S, Baskota S, Karki U, Poudel L, Bhandari N, Gurung M, Rajbhandari B, Shrestha P. Child Sexual Abuse among School Children of a Municipality: A Descriptive Cross-sectional Study. JNMA J Nepal Med Assoc. 2021 Jul 30;59(239):672-677. doi: 10.31729/jnma.6865.
**PMID:** 34508495
**Citation:** Song Y, Ji CY, Agardh A. Sexual coercion and health-risk behaviors among urban Chinese high school students. Glob Health Action. 2014 May 14;7:24418. doi: 10.3402/gha.v7.24418. eCollection 2014.
**PMID:** 24836445
**Citation:** Tang CS. Childhood experience of sexual abuse among Hong Kong Chinese college students. Child Abuse Negl. 2002 Jan;26(1):23-37. doi: 10.1016/s0145-2134(01)00306-4.
**PMID:** 11860160
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444087
**Acronym:** SPECTRA
**Brief Title:** Patient's Perspective on the Evolution of Hidradenitis Suppurativa Burden After Secukinumab Initiation
**Official Title:** Patient's Perspective on the Evolution of Hidradenitis Suppurativa Burden After Secukinumab Initiation: a French Multicentric Prospective Observational Study
#### Organization Study ID Info
**ID:** CAIN457MFR01
#### Organization
**Class:** INDUSTRY
**Full Name:** Novartis
### Status Module
#### Completion Date
**Date:** 2027-03-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-03-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**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:** Novartis Pharmaceuticals
#### 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 primary objective of this non-interventional study is to describe the evolution of Hidradenitis suppurativa (HS) symptoms 12 months after secukinumab initiation based on the patients' assessment of pain, oozing, and bad smell.
**Detailed Description:** This study is a prospective (primary data), national, descriptive, non-interventional, multicentre study conducted by medical practice and hospital-based dermatologists across different geographical regions in France.
This real-world study does not change the physician-patient relationship or patient management or follow-up. Physicians remain free with their prescriptions and patient follow-up procedures. In fact, secukinumab initiation and all treatment decisions will be made according to routine medical care and independently of study participation.
Recruited patients will be longitudinally followed-up for the duration of the study, up to 24 months (± 3 months) after secukinumab initiation or secukinumab treatment discontinuation before the end of the 24 months of follow-up (early discontinuation).
### Conditions Module
**Conditions:**
- Hidradenitis Suppurativa
**Keywords:**
- secukinumab
- Hidradenitis Suppurativa
- HS
- NIS
- France
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 177
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients prescribed with secukinumab
**Intervention Names:**
- Other: secukinumab
**Label:** secukinumab
### Interventions
#### Intervention 1
**Arm Group Labels:**
- secukinumab
**Description:** This is an observational study. There is no treatment allocation. The decision to initiate secukinumab will be based solely on clinical judgement.
**Name:** secukinumab
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Patients will provide an assessment of pain, oozing and bad smell based on three numeric rating scales (NRS). The most common form of the scale is a horizontal line with a numeric scale ranging from 0 to 10, 0 corresponding to "no symptoms" and 10 being the worst possible symptom. At each visit, these three assessments will cover the last seven days.
**Measure:** Proportion of patients achieving at least 30% reduction of the NRS score for at least one the assessed symptoms
**Time Frame:** Baseline, month 12
#### Secondary Outcomes
**Description:** Proportion of patients achieving at least a 30% reduction of NRS for at least one of the evaluated symptoms (pain, oozing and bad smell) and the proportion of patients achieving at least a 30% reduction of NRS for each symptom evaluated separately (pain, oozing and bad smell)
**Measure:** Proportion of patients achieving at least a 30% reduction of NRS
**Time Frame:** Baseline, month 3, month 6, month 18 and month 24
**Description:** The DLQI consists of ten questions regarding patients' perception of the impact of their disease on different aspects of their health-related quality of life (symptoms and feelings, impact on daily activities, leisure, work, school, personal relationships, and problems with treatment) over the last seven days. The highest possible total score for the DLQI is 30 and higher scores indicate a more severe impact on quality of life.
**Measure:** Proportion of patients achieving at least a 5-point reduction of the Dermatology Life Quality Index (DLQI)
**Time Frame:** Baseline, month 3, month 6, month 18 and month 24
**Description:** The impact of Hidradenitis Suppurativa (HS) on daily life will be studied using seven additional questions on the symptoms experienced by the patient and the impact of HS on daily life over the past three months: physical and psychological fatigue, anxiety, sleep quality, discomfort with dressing, discomfort with washing, and sex and love life. Responses will be collected at each visit by a four-point Likert scale. The improvement will be defined by the decrease of at least one point on the Likert scale between the enrolment visit and the follow-up visits.
**Measure:** Proportion of patients maintaining the improvement up to 24 months of the response of the Impact of Hidradenitis Suppurativa on daily life compared to baseline
**Time Frame:** Baseline, up to 24 months
**Description:** The proportion of patients having stopped at least one of these substances during follow-up will be calculated, and as well as the proportion of patients having stopped one of these substances without using them again until the end of follow-up.
**Measure:** Proportion of patients having stopped at tobacco, alcohol and cannabis use
**Time Frame:** Baseline, month 3, month 6, month 18 and month 24
**Description:** Absenteeism due to HS will be measured by the number of days off taken and the number of days on sick leave over the last three months (enrolment visit and visit at 3 months) or since the last visit (visits at 6, 12, 18 and 24 months). The number of days and its evolution since enrolment will be presented at each visit.
**Measure:** Absenteeism due to Hidradenitis Suppurativa
**Time Frame:** Baseline, month 3, month 6, month 18 and month 24
**Description:** The family member's quality of life will be measured using the FDLQI. The FDLQI is a 10-item-questionnaire with a total score resulting in a maximum of 30 and a minimum of 0 (the higher the score, the more quality of life is impaired). The questionnaire will be proposed to one of the family members (one per patient, the same person throughout the study) going with the patient to the baseline visit and 3, 6, 12, 18 and 24 months after secukinumab initiation. The assessment will refer to the last seven days.
**Measure:** Proportion of patients achieving at least a 5-point reduction of FDLQI compared to the baseline
**Time Frame:** Baseline, month 3, month 6, month 18 and month 24
**Description:** Secukinumab dose regimen prescribed at baseline to describe the use of secukinumab.
**Measure:** Secukinumab dose regimen prescribed at baseline
**Time Frame:** Baseline
**Description:** Proportion of patients receiving up-titration (q4w-to-q2w) or down-titration (q2w-to-q4w) and proportion of patients receiving more than one up-and/or down-titration
**Measure:** Proportion of patients receiving up-titration or down-titration
**Time Frame:** Month 3, month 6, month 12, month 18 and month 24
**Description:** Time spent under each treatment regimen (q4w and q2w) and reason for change
**Measure:** Time spent under each treatment regimen
**Time Frame:** Up to 24 months
**Description:** Total duration of secukinumab treatment (i.e. time elapsed until treatment is discontinued), reason for discontinuation
**Measure:** Total duration of secukinumab treatment
**Time Frame:** Up to 24 months
**Description:** Proportion of patients with at least one temporary discontinuation and its reason
**Measure:** Proportion of patients with at least one temporary discontinuation
**Time Frame:** Up to 24 months
**Description:** Proportion of patients taking all prescribed doses to measure the treatment compliance
**Measure:** Proportion of patients taking all prescribed doses
**Time Frame:** Up to 24 months
**Description:** Proportion of patients achieving at least 55%, 75% and 100% reduction in International Hidradenitis Suppurativa Severity Score System (IHS4) (IHS4-55, 75, 100).
The IHS4 score corresponds to: (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + \[number of drainage tunnels (fistulas/sinuses) multiplied by 4\]. A score of 3 or less corresponds to mild HS, a score of 4 to 10 to moderate HS and a score of 11 or more to severe HS
**Measure:** Proportion of patients achieving a reduction in IHS4
**Time Frame:** Baseline, month 3, month 6, month 12, month 18 and month 24
**Description:** Evolution of AN count (total abscesses and inflammatory nodules)
**Measure:** Evolution of AN count
**Time Frame:** Baseline, month 3, month 6, month 12, month 18 and month 24
**Description:** Percentages of patients with onset or worsening of flares will be described from the data concerning flares collected by the physician at each visit.
**Measure:** Percentages of patients with onset or worsening of flares
**Time Frame:** Baseline, month 3, month 6, month 18 and month 24
**Description:** Itching due to pruritus will be evaluated using an 11-point NRS scale with 0 being "no itch" and 10 being the worst itch imaginable.
**Measure:** Proportion of patients who achieved at least a 30% reduction in the NRS score (pruritus)
**Time Frame:** Baseline, month 3, month 6, month 18 and month 24
**Description:** Treatments of interest will include systemic antibiotics, pain medications and psychotropic drugs.
**Measure:** Proportion of patients receiving at least one medication for HS
**Time Frame:** Month 3, month 6, month 18 and month 24
**Description:** Proportion of patients who had a surgical procedure will be provided
**Measure:** Proportion of patients who had a surgical procedure
**Time Frame:** Up to 24 months
**Description:** Use of dressings and protections for wound care after secukinumab initiation, evaluated by the use of dressings and protections in the seven days prior to visits (data collected by the patient)
**Measure:** Proportion of patients with stable/increased/decreased dressing used since the baseline visit
**Time Frame:** Baseline, month 3, month 6, month 18 and month 24
**Description:** Description of the reasons for secukinumab initiation (e.g.: patient complaints, clinical symptoms, safety events) declared by the participating physician.
**Measure:** Number of patients by reasons for secukinumab initiation
**Time Frame:** Baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Male and female patients ≥ 18 years old,
2. Patients who do not object to participation in the study,
3. Diagnosis of HS clinically confirmed,
4. Initiation of secukinumab treatment for HS in compliance with the summary of product characteristics,
5. The physician's decision to initiate secukinumab has been taken according to his/her own practice and regardless of study participation.
Exclusion Criteria:
1. Patients with any medical or psychological condition which, in the physician's opinion, may prevent participation in the study,
2. Patients participating in a clinical trial.
**Maximum Age:** 99 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study population will include male and female patients (aged ≥ 18 years) with a diagnosis of HS and for whom the decision to initiate treatment with secukinumab was made independently of the study.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Novartis Pharmaceuticals
**Phone:** +41613241111
**Role:** CONTACT
**Contact 2:**
**Name:** Novartis Pharmaceuticals
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Novartis Pharmaceuticals
**Name:** Novartis Pharmaceuticals
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000013543
- Term: Sweat Gland Diseases
- ID: D000012871
- Term: Skin Diseases
- ID: D000017192
- Term: Skin Diseases, Bacterial
- ID: D000001424
- Term: Bacterial Infections
- ID: D000001423
- Term: Bacterial Infections and Mycoses
- ID: D000007239
- Term: Infections
- ID: D000012874
- Term: Skin Diseases, Infectious
- ID: D000013492
- Term: Suppuration
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- 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: M19762
- Name: Hidradenitis Suppurativa
- Relevance: HIGH
- As Found: Hidradenitis Suppurativa
- ID: M18964
- Name: Hidradenitis
- Relevance: HIGH
- As Found: Hidradenitis
- ID: M16323
- Name: Sweat Gland Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19500
- Name: Skin Diseases, Bacterial
- Relevance: LOW
- As Found: Unknown
- ID: M4722
- Name: Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12136
- Name: Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M4721
- Name: Bacterial Infections and Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M15677
- Name: Skin Diseases, Infectious
- Relevance: LOW
- As Found: Unknown
- ID: M16273
- Name: Suppuration
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000017497
- Term: Hidradenitis Suppurativa
- ID: D000016575
- Term: Hidradenitis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444074
**Acronym:** PACT
**Brief Title:** The PACT (Patient Activation Through Conversations) Study
**Official Title:** The PACT (Patient Activation Through Conversations) Study - A Cluster Randomised Trial of a Health Coach-led Patient Activation Program in Type 2 Diabetes.
#### Organization Study ID Info
**ID:** 2023/00667
#### Organization
**Class:** OTHER_GOV
**Full Name:** National Healthcare Group Polyclinics
### Status Module
#### Completion Date
**Date:** 2028-04-22
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-03-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-22
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** National Healthcare Group, Singapore
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** National Healthcare Group Polyclinics
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The PACT Study is a cluster randomised trial of a health coach-led patient activation program in type 2 diabetes. The goal of this clinical trial is to evaluate the effectiveness of a health coaching intervention (PACT program) led by Care Coaches (trained lay persons), in adult participants with sub-optimally controlled Diabetes Mellitus, as compared to participants undergoing routine care for diabetes (Usual Care).
The primary outcome of interest is change in Glycated Haemoglobin (HbA1c) levels over 3 months, 6 months and 12 months. Secondary outcomes include changes in blood pressure, low-density lipoprotein-cholesterol (LDL-C) levels, body mass index (BMI), self-reported diabetes self-care behaviours, self-efficacy, health-related quality of life, and diabetes-related distress, over 3, 6 and 12 months.
Participants in the Intervention arm will undergo the PACT Program, which is a 3-month long health coaching program led by a care coach. Participants review their motivators, health parameters, self-care behaviours, and set goals for improving their diabetes using a PACT report. Subsequently, they will receive fortnightly motivational and problem solving support via telephone or WhatsApp messaging over a 3-month duration, and will return to routine care after 3 months. Participants in the Usual Care arm will have routine care of their diabetes treatment.
**Detailed Description:** Study Methodology
This is a cluster randomised controlled trial comparing the PACT program to Usual Care. Each cluster consists of a Teamlet in a NHG Polyclinic, consisting of a regular group of Family Physicians, a Care Manager, and a Care Coordinator, that provide chronic care for a regular group of about 5000 patients.
Study Population
The study population will include patients with suboptimal control of diabetes (HbA1c \>8%) between the ages of 21 to 64. Patients with a suboptimal control of diabetes frequently require a combination of both pharmacological and lifestyle measures for improvement of their glycaemic levels.
The inclusion criteria include the following:
* Individuals with a diagnosis of Type 2 Diabetes Mellitus who are enrolled in Teamlets in NHGP
* Age between 21 to 64 years old
* HbA1c level of more than 8% in the last 6 months
The exclusion criteria includes the following:
* History of acute coronary syndrome in the past 3 months
* History of stroke or transient ischaemic attacks in the past 3 months
* History of end stage organ failure (liver cirrhosis, cardiac failure, latest eGFR \<30 mL/min/1.73m2 in the last 6 months)
* Cancer requiring treatment in the past 5 years.
* Active psychiatrist follow up
* Social issues that are significant enough for follow-up or referral with a medical social worker within the last 12 months
* Women who are pregnant or breastfeeding
* Patients who are enrolled in other current diabetes-related interventional studies
* Inability to provide written consent for the study protocol and able to commit to the study duration.
These patients are excluded as they may have conditions that could be of a higher priority for management as compared to Diabetes Mellitus, and may not be able to provide informed consent or participate actively in shared decision making.
Summary of Study Design
The unit of randomisation will be each cluster, as represented by a single Teamlet. Randomisation will be carried out on all Teamlets that are involved in this research study from NHG Polyclinics. The study team aims to involve two to three polyclinics that includes six Teamlets in each polyclinic. A total of 12 to 18 Teamlets will hence be involved, subject to resource and recruitment considerations.
Teamlets in each polyclinic will be randomised to either the PACT Program condition or Usual Care condition. Patients who belong to Teamlets that are randomised to the PACT Program condition will be recruited for participation in the PACT Program, and patients who belong to Teamlets that are randomised to the Usual Care condition will be recruited and provided with routine care. Due to the nature of the PACT intervention, blinding of the Teamlet members (Doctor, Care Manager, Care Coach) and patients will not be feasible. The data analyst will be blinded to the group allocation.
The PACT Program intervention will last 3 months. Four participant assessments will be conducted, and this will take place at baseline and at the 3-month, 6-month, and the 12-month mark.
Recruitment of participants will take place over 12 months and follow-up of participants will be carried out over 24 months. Further analysis will be undertaken for 12 months, so the total length of the study will be 4 years and 0 months.
PACT program procedures The PACT program lasts 3 months and is a health coaching program for people with type 2 diabetes.
Patients have an in-person visit with a Care Coach at the baseline visit, where review of their metabolic parameters, self-care behaviors and health motivators is carried out, supported by use of a PACT form. This is followed by goal setting.
The PACT form consists of:
1. Results of patients' latest clinical readings are shared with the patient
2. Patient fills in their key motivators for managing their diabetes well
3. Patient fills in a survey that assesses their own self-care behaviors (diet, exercise, medication adherence), diabetes distress
4. Goal setting with the care coach to set SMART (specific, measurable, achievable, relevant and time-sensitive) goals
The Care Coach has been trained to apply a bio-psychosocial approach, motivational interviewing skills and provide diabetes care support. The discussion will take approximately 15 to 30 minutes.
Supportive follow-up is provided over the following 3 months. The Care Coach will support patients in reviewing their goals, assist in problem solving, and provide motivational support. Follow-up will be conducted 2 weekly via telephone calls and/or WhatsApp messages, according to the patient's preference. Care coaches will minimally send patients a whatsapp message or conduct a phone call, however, we acknowledge that some patients may not reply or pick up the phone. This will take approximately 10 to 20 minutes each time. After 3 months, the patients will be reverted back to routine clinical care.
Outcome Assessments
Patient outcomes will be assessed at baseline (12 months before study period), and at regular intervals over 24 months for clinical data. Patient reported outcomes will be assessed at 3, 6, and 12 months.
1. Clinical Outcomes
* Clinical outcomes will be extracted from the NHGP Business Intelligence database, from routinely collected data.
* The outcomes that will be assessed include:
* Clinical outcomes at baseline and follow-up: HbA1c, systolic and diastolic blood pressure, body mass index, Total cholesterol, HDL-cholesterol, LDL-cholesterol, and Triglyceride levels, serum creatinine level, estimated glomerular filtration rate, urine albumin-creatinine ratio, and the urine protein-creatinine ratio
* At baseline: Presence of co-morbidities, which include hypertension, hyperlipidaemia, ischaemic heart disease, stroke, peripheral vascular disease, previous lower limb amputations, chronic kidney disease, diabetic neuropathy, and diabetic retinopathy
* Patients usually make clinic visits every 3 to 6 months. Clinical outcomes data will be obtained for baseline and over a period of 24 months.
2. Patient reported outcomes
* Patient reported outcomes will be assessed using a questionnaire at baseline, at the 3-month mark, 6-month mark, and at the 12-month mark.
* The questionnaire will be self-administered with interviewer assistance on patient request.
* The baseline and follow-up questionnaires include the following measures:
* Sociodemographic information - Only in baseline questionnaire
* Self-care behaviours, measured with the Summary of Diabetes Self-Care Activities scale (SDSCA)
* Diabetes-related distress, measured with the 2-item Diabetes Distress Scale (DDS-2)
* Diabetes empowerment, measured with the short form of the Diabetes Empowerment Scale (DES-SF)
* Health-related quality of life, measured with the EQ-5D-5L
* Patient satisfaction, as measured by 5 questions from the Patient Satisfaction Questionnaire-III- Only in the PACT 3-month questionnaire.
3. Referral to community exercise programs. As part of comprehensive lifestyle management, the patients may be directed to community exercise programs, such as those run by SportSG. Attendance to such programs will be recorded via patient-reported information in the 3-month, 6-month, and 12-month questionnaires.
4. Adverse events Improvements in self-care behaviors (diet and physical activity) may be associated with hypoglycaemic symptoms. Monitoring for serious hypoglycaemic episodes requiring emergency department visit and/or admissions to hospital will be recorded via patient-reported information the 3-month, 6-month, and 12-month questionnaires.
5. Drugs Prescribed Drugs could affect clinical outcomes such as HbA1c. Information such as drug prescribed, dosage, and cost of medications will be extracted from NHGP Business Intelligence database.
6. Resources and Cost
Costs and resource utilisation will be analysed, including:
* Health-service utilisation costs including Medical (Doctor), Nursing (Care Manager), Allied Health (Dietician, Psychologist, Medical Social Worker) consultation sessions
* Training and utilisation costs for the Care Coaches, including the number of Telephone/WhatsApp follow-up calls by the Care Coaches
* Laboratory tests
* Medication costs
Sample Size and Statistical Methods
Estimation of Sample Size A minimal clinically important difference of 0.4% in HbA1c is expected between participants of the PACT program compared with Usual Care. In estimating the sample size, a standard deviation of 1.2% was used, as estimated from a local study. We aim to recruit between 12 to 18 Teamlets in the study. If 12 Teamlets are recruited (6 Teamlets are randomised to PACT and 6 to the control group), 34 subjects are required for each Teamlet (total 204 participants in the PACT program and 204 participants in Usual Care), at 80% power with one-sided alpha at 5%, and setting the intracluster correlation coefficient at 0.01 with an assumed drop-out rate of 20%. If 18 Teamlets are recruited (9 randomised to PACT and 9 to the control group), 24 subjects are required for each Teamlet (216 participants in the PACT program and 216 participants in Usual Care), at 80% power with one-sided alpha at 5%, and setting the intracluster correlation coefficient at 0.01 with an assumed drop-out rate of 20%. Sample size calculations were conducted using SampSizeV2.
Statistical and Analytical Plans
1. Clinical Outcomes evaluation Categorical data will be summarized as counts (percentage), while continuous data will be summarized as mean (standard deviation) if they are normally distributed or median (interquartile range) if they are skewed. Baseline characteristics will be compared between participants in the PACT program and Usual care. Differences in the outcomes of interest (clinical and patient-reported) at different data points will be compared between participants in the PACT program and Usual Care. As this is a cluster-randomised trial, a mixed model will be used to evaluate the longitudinal difference-in-difference outcomes between the PACT program and Usual Care, incorporating Teamlets as the random effect. Relevant baseline covariates will be included in the model to account for potential confounding factors.
2. Resource and cost evaluation This study will analyse the cost-effectiveness and resource utilisation of the PACT program. The potential economic impact of new program implementation will be studied by estimating the incremental cost effectiveness ratio (ICER) between PACT and Usual Care (incremental direct medical cost per unit improvement in clinical outcome).
Effectiveness outcomes may include differences between PACT and controls in terms of HbA1c, DM-related complications, DM-related deaths, or quality-adjusted life years (QALYs).
### Conditions Module
**Conditions:**
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
**Keywords:**
- Diabetes Mellitus
- Health Coaching
- Endocrinology
- Lifestyle Intervention
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The study design is a pragmatic cluster randomised controlled trial. Each cluster consists of a Teamlet in a National Health Group Polyclinic (NHGP), consisting of a regular group of Family Physicians, a Care Manager, and a Care Coordinator, that provide chronic care for a regular group of about 5000 patients.
Teamlets in each polyclinic will be randomised to either the PACT Program condition or Usual Care condition. Patients who belong to Teamlets that are randomised to the PACT Program condition will be recruited for participation in the PACT Program, and patients who belong to Teamlets that are randomised to the Usual Care condition will be recruited and provided with routine care.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 432
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in the intervention arm will undergo the PACT Program, which is a 3-month long health coaching program.
**Intervention Names:**
- Behavioral: Patient Activation through Conversations (PACT) Program
**Label:** PACT Arm
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients in the Usual Care Arm will undergo routine follow-up for their Diabetes Mellitus. In NHGP, this involves Teamlet care, where patients are taken care of by a team comprising of Family Physicians, a Care Manager (a nurse trained in chronic disease management), and a Care Coordinator, and are seen typically every three to six months for monitoring of their diabetic control.
**Intervention Names:**
- Behavioral: Usual Care
**Label:** Usual Care
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- PACT Arm
**Description:** Participants in the intervention arm will undergo a 3-month long health coaching program where a care coach will review a participant's health parameters and current self-care behaviours, identify health motivators and set goals for improving their diabetes, as well as fortnightly support through text or phone call.
**Name:** Patient Activation through Conversations (PACT) Program
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Usual Care
**Description:** Routine Chronic Disease care
**Name:** Usual Care
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Glycated Hemoglobin
**Measure:** HbA1c
**Time Frame:** 24 Months
#### Secondary Outcomes
**Description:** Systolic and Diastolic Blood Pressure
**Measure:** Blood Pressure
**Time Frame:** 24 months
**Description:** Body Mass Index
**Measure:** BMI
**Time Frame:** 24 months
**Description:** Low density Lipoprotein cholesterol
**Measure:** LDL-C
**Time Frame:** 24 months
**Description:** Estimated glomerular filtration rate
**Measure:** eGFR
**Time Frame:** 24 months
**Description:** Urine Albumin:Creatinine Ratio
**Measure:** uACR
**Time Frame:** 24 months
**Description:** Urine Protein:Creatinine Ratio
**Measure:** uPCR
**Time Frame:** 24 months
**Description:** Summary of Diabetes Self-Care Activities scale (SDSCA)
**Measure:** Self Care Behaviors
**Time Frame:** 12 months
**Description:** 2-item Diabetes Distress Scale (DDS-2)
**Measure:** Diabetes-related distress
**Time Frame:** 12 months
**Description:** Diabetes Empowerment Scale (DES-SF)
**Measure:** Diabetes empowerment
**Time Frame:** 12 months
**Description:** EQ-5D-5L
**Measure:** Health-related quality of life
**Time Frame:** 12 months
**Description:** 5 questions from the Patient Satisfaction Questionnaire-III, only in the PACT Arm
**Measure:** Patient satisfaction
**Time Frame:** 3 months
**Description:** CollaboRATE scale
**Measure:** Shared Decision Making
**Time Frame:** 3 months
**Description:** Patient-reported information for referral to community exercise programs
**Measure:** Referral to community exercise programs
**Time Frame:** 12 months
**Description:** Patient-reported hypoglycaemic episodes requiring emergency department visit and/or admissions to hospital
**Measure:** Adverse events
**Time Frame:** 12 months
**Description:** Drug prescribed, dosage, and cost
**Measure:** Drugs Prescribed
**Time Frame:** 24 months
**Description:** Health-service utilisation costs, training costs, laboratory tests costs, medication costs
**Measure:** Costs and resource utilisation
**Time Frame:** 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Individuals with a diagnosis of Type 2 Diabetes Mellitus who are enrolled in Teamlets in NHGP
* Age between 21 to 64 years old
* HbA1c level of more than 8% in the last 6 months
Exclusion Criteria:
* History of acute coronary syndrome in the past 3 months
* History of stroke or transient ischaemic attacks in the past 3 months
* History of end stage organ failure (liver cirrhosis, cardiac failure, latest eGFR \<30 mL/min/1.73m2 in the last 6 months)
* Cancer requiring treatment in the past 5 years.
* Active psychiatrist follow up
* Social issues that are significant enough for follow-up or referral with a medical social worker within the last 12 months
* Women who are pregnant or breastfeeding
* Patients who are enrolled in other current diabetes-related interventional studies
* Inability to provide written consent for the study protocol and able to commit to the study duration.
**Maximum Age:** 64 Years
**Minimum Age:** 21 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jun Hwee Benjamin Lee, MBBS
**Phone:** +6563553000
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Sabrina Kay Wye Wong, MBBS
**Phone:** +6563553000
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Singapore
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jun Hwee Benjamin Lee
- **Phone:** +6563553000
- **Role:** CONTACT
**Country:** Singapore
**Facility:** NHGP Geylang Polyclinic
**Status:** NOT_YET_RECRUITING
**Zip:** 389707
**Location 2:**
**City:** Singapore
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jun Hwee Benjamin Lee
- **Phone:** +6563553000
- **Role:** CONTACT
**Country:** Singapore
**Facility:** NHGP Ang Mo Kio Polyclinic
**Status:** NOT_YET_RECRUITING
**Zip:** 569666
**Location 3:**
**City:** Singapore
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jun Hwee Benjamin Lee
- **Phone:** +65 63553000
- **Role:** CONTACT
**Country:** Singapore
**Facility:** NHGP Woodlands Polyclinic
**Status:** RECRUITING
**Zip:** 738579
#### Overall Officials
**Official 1:**
**Affiliation:** National Healthcare Group Polyclinics
**Name:** Sabrina Kay Wye Wong, MBBS
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Ministry of Health S. The White Paper on Healthier SG [Internet]. [cited 2023 Jul 7]. Available from: https://www.healthiersg.gov.sg/resources/white-paper/
**Citation:** Ow Yong LM, Koe LWP. War on Diabetes in Singapore: a policy analysis. Health Res Policy Syst. 2021 Feb 8;19(1):15. doi: 10.1186/s12961-021-00678-1.
**PMID:** 33557840
**Citation:** Ministry of Health S. MOH | National Population Health Survey 2019/20 [Internet]. [cited 2023 Jul 7]. Available from: https://www.moh.gov.sg/resources-statistics/reports/national-survey-2019-20
**Citation:** Ministry of Health S. MOH | Singapore Burden of Disease Report 2017 [Internet]. [cited 2023 Jul 7]. Available from: https://www.moh.gov.sg/resources-statistics/singapore-burden-of-disease-report-2017
**Citation:** Png ME, Yoong J, Phan TP, Wee HL. Current and future economic burden of diabetes among working-age adults in Asia: conservative estimates for Singapore from 2010-2050. BMC Public Health. 2016 Feb 16;16:153. doi: 10.1186/s12889-016-2827-1. Erratum In: BMC Public Health. 2016;16(1):589.
**PMID:** 26880337
**Citation:** Ang YG, Yap CW, You AX. Lifetime cost for type 2 diabetes mellitus in Singapore. J Diabetes. 2018 Apr;10(4):296-301. doi: 10.1111/1753-0407.12604. Epub 2017 Sep 29.
**PMID:** 28834603
**Citation:** Ministry of Health S. MOH | Top 4 Conditions of Polyclinic Attendances [Internet]. [cited 2023 Jul 7]. Available from: https://www.moh.gov.sg/resources-statistics/singapore-health-facts/top-4-conditions-of-polyclinic-attendances
**Citation:** Ministry of Health S. MOH CLINICAL PRACTICE GUIDELINES ON DIABETES MELLITUS [Internet]. [cited 2023 Jul 7]. Available from: https://www.moh.gov.sg/hpp/doctors/guidelines/GuidelineDetails/cpgmed_diabetes_mellitus
**Citation:** Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, Hadden D, Turner RC, Holman RR. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000 Aug 12;321(7258):405-12. doi: 10.1136/bmj.321.7258.405.
**PMID:** 10938048
**Citation:** Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53. Erratum In: Lancet 1999 Aug 14;354(9178):602.
**PMID:** 9742976
**Citation:** American Diabetes Association. 4. Lifestyle Management: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S38-S50. doi: 10.2337/dc18-S004.
**PMID:** 29222375
**Citation:** Choi TS, Davidson ZE, Walker KZ, Lee JH, Palermo C. Diabetes education for Chinese adults with type 2 diabetes: A systematic review and meta-analysis of the effect on glycemic control. Diabetes Res Clin Pract. 2016 Jun;116:218-29. doi: 10.1016/j.diabres.2016.04.001. Epub 2016 Apr 26.
**PMID:** 27321339
**Citation:** Association of Diabetes Care and Education Specialists; Kolb L. An Effective Model of Diabetes Care and Education: The ADCES7 Self-Care Behaviors. Sci Diabetes Self Manag Care. 2021 Feb;47(1):30-53. doi: 10.1177/0145721720978154.
**PMID:** 34078208
**Citation:** Skovlund SE, Peyrot M, on behalf of the DAWN International Advisory Panel. The Diabetes Attitudes, Wishes, and Needs (DAWN) Program: A New Approach to Improving Outcomes of Diabetes Care. Diabetes Spectr. 2005 Jul 1;18(3):136-42.
**Citation:** Wong SKW. Providing care for young adults with type 2 diabetes in primary care settings in Singapore: a multi-faceted study. 2022 [cited 2023 Jul 7]; Available from: https://dr.ntu.edu.sg/handle/10356/163576
**Citation:** Ryan RM, Deci EL. Intrinsic and Extrinsic Motivations: Classic Definitions and New Directions. Contemp Educ Psychol. 2000 Jan;25(1):54-67. doi: 10.1006/ceps.1999.1020.
**PMID:** 10620381
**Citation:** Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000 Jan;55(1):68-78. doi: 10.1037//0003-066x.55.1.68.
**PMID:** 11392867
**Citation:** Williams GC, Freedman ZR, Deci EL. Supporting autonomy to motivate patients with diabetes for glucose control. Diabetes Care. 1998 Oct;21(10):1644-51. doi: 10.2337/diacare.21.10.1644.
**PMID:** 9773724
**Citation:** Silva MN, Vieira PN, Coutinho SR, Minderico CS, Matos MG, Sardinha LB, Teixeira PJ. Using self-determination theory to promote physical activity and weight control: a randomized controlled trial in women. J Behav Med. 2010 Apr;33(2):110-22. doi: 10.1007/s10865-009-9239-y. Epub 2009 Dec 11.
**PMID:** 20012179
**Citation:** Pillay J, Armstrong MJ, Butalia S, Donovan LE, Sigal RJ, Vandermeer B, Chordiya P, Dhakal S, Hartling L, Nuspl M, Featherstone R, Dryden DM. Behavioral Programs for Type 2 Diabetes Mellitus: A Systematic Review and Network Meta-analysis. Ann Intern Med. 2015 Dec 1;163(11):848-60. doi: 10.7326/M15-1400. Epub 2015 Sep 29.
**PMID:** 26414227
**Citation:** Huffman MH. Advancing the Practice of Health Coaching: Differentiation From Wellness Coaching. Workplace Health Saf. 2016 Sep;64(9):400-3. doi: 10.1177/2165079916645351. Epub 2016 May 12.
**PMID:** 27174131
**Citation:** Pirbaglou M, Katz J, Motamed M, Pludwinski S, Walker K, Ritvo P. Personal Health Coaching as a Type 2 Diabetes Mellitus Self-Management Strategy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Am J Health Promot. 2018 Sep;32(7):1613-1626. doi: 10.1177/0890117118758234. Epub 2018 Apr 15.
**PMID:** 29658286
**Citation:** Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA. RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health. 2019 Mar 29;7:64. doi: 10.3389/fpubh.2019.00064. eCollection 2019.
**PMID:** 30984733
**Citation:** Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. doi: 10.2337/diacare.23.7.943.
**PMID:** 10895844
**Citation:** Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med. 2008 May-Jun;6(3):246-52. doi: 10.1370/afm.842.
**PMID:** 18474888
**Citation:** Anderson RM, Fitzgerald JT, Gruppen LD, Funnell MM, Oh MS. The Diabetes Empowerment Scale-Short Form (DES-SF). Diabetes Care. 2003 May;26(5):1641-2. doi: 10.2337/diacare.26.5.1641-a. No abstract available.
**PMID:** 12716841
**Citation:** EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
**PMID:** 10109801
**Citation:** Monica 1776 Main Street Santa, California 90401-3208. Patient Satisfaction Questionnaires (PSQ-III and PSQ-18) [Internet]. [cited 2023 Jul 19]. Available from: https://www.rand.org/health-care/surveys_tools/psq.html
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes Mellitus
- ID: M7119
- Name: Diabetes Mellitus, Type 2
- Relevance: HIGH
- As Found: Diabetes Mellitus, Type 2
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000003924
- Term: Diabetes Mellitus, Type 2
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444061
**Brief Title:** The Balance Recovery Confidence (Brc) Scale
**Official Title:** The Turkısh Versıon Of The Balance Recovery Confidence (Brc) Scale: Its Cultural Adaptatıon, Valıdatıon And Relıabılıty In Community-Dwelling Older Adults
#### Organization Study ID Info
**ID:** ADagbasi003
#### Organization
**Class:** OTHER
**Full Name:** Necmettin Erbakan University
### Status Module
#### Completion Date
**Date:** 2025-02-10
**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:** 2024-06-21
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Necmettin Erbakan University
#### Responsible Party
**Investigator Affiliation:** Necmettin Erbakan University
**Investigator Full Name:** Abdulkadir dağbaşı
**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:** Falls in older adults lead to serious consequences, including injury, associated comorbidities, and death. It also causes long-term immobilization and related complications. Therefore, studies on fall issues such as screening for fall risk factors in older adults, measures to be taken to prevent falls, and limiting the effects of falls can contribute to public health by reducing falls in older adults and limiting their effects. In this context, research on the evaluation and development of balance has an extremely important place. So far, physical performance tests and scales have been developed that evaluate different aspects of balance. One of these scales is the Balance Restoration Self-Confidence Scale (BRC). However, the Turkish adaptation of BRC has not been made yet. For these reasons, the aim of the study is to investigate the validity and reliability of the Turkish version of the BRC in community-dwelling older adults.
**Detailed Description:** Old age is a period when individuals lose their independence, the risk of accidents increases and their physical abilities decrease. With aging, changes occur in a person's anatomy and physiology; histological differentiation occurs in tissues and cells, while organ functions decrease. With aging, cardiac output decreases, blood pressure increases, and atherosclerosis develops; Gas exchange of the lungs is impaired, vital capacity decreases; There are losses in the functioning of the gastrointestinal tract, atrophic gastritis and impaired drug metabolism in the liver are common in the elderly; blood sugar rises and osteoporosis occurs with a decrease in bone mass; Muscles atrophy and lean muscle mass decreases. All these morphological and physiological changes bring about immobilization, incontinence, depression, delirium, dementia, pressure sores, osteoporosis, fragility and falls.
Falls threaten the lives of older adults, increase their dependency, and impair their quality of life. According to the World Health Organization, falls are the second leading cause of unintentional injury deaths in the elderly. At the same time, one in five falls results in serious injuries such as bone fractures and head trauma. Environmental risk factors for falls in older adults include slippery surfaces, poor weather, inadequate lighting, unfamiliar stairs and flooring, cables in the ground, etc. the availability of items to hang on, and the lack of handles in bathrooms and toilets. Biological risk factors are advanced age, being female, chronic or acute disease, muscle weakness, osteoporosis, immobility, visual impairment, decreased postural control, gait disorder, decreased reaction time, loss of balance, coordination disorder and cognitive disorders. Whatever the cause, loss of balance control is the primary cause of falls in older adults. For this reason, evaluation and improvement of balance control in the elderly has become one of the main areas of study in the literature on this subject.
The complex structure of balance control also makes its evaluation difficult. Balance control; It requires postural control and control of the center of mass. Postural control is the alignment of the head and body within the support surface against gravity. Interpretation of the environment through visual feedback forms the basis of maintaining postural control. There are many clinical tests to evaluate postural control, such as the functional reaching test, which is based on evaluating static and dynamic balance. Control of the center of mass is the restoration of the center of mass to its previous position after internal or external forces change the center of mass. Control of the center of mass requires the coordination of some movement strategies. Adaptation to the change of the center of mass can also be evaluated with tests such as the Reactive Balance test and Retropulsion test. However, it is thought to be effective in balance control, balance self-efficacy and psychological concerns. For this reason, patient-reported scales measuring self-efficacy and psychological concerns have been developed to evaluate self-efficacy and psychological concerns regarding balance control.
Patient-reported scales measuring self-efficacy and psychological concerns regarding balance control mainly focus on fear of falling, impact of falling, and balance confidence (self-confidence in maintaining balance). Fear of falling can be defined as the fear of walking or standing as a result of previous falls. Scales such as the Activity and Fear of Falling Questionnaire in the Elderly and the Falls Efficacy Scale International (FES-I) are scales developed to evaluate the fear of falling. Fall impact refers to self-confidence in performing daily living activities without falling. Some scales, such as the Fall Effectiveness Scale and the Fall Risk Management and Prevention Ability Perception Scale, were developed to measure the impact of falls. Balance confidence is an individual's self-efficacy to maintain balance while performing a goal-directed task or participating in a specific activity. Scales such as the activities-specific balance confidence (ABC) scale and CONFbal scale are scales structured to measure balance confidence. However, apart from these three important areas of self-efficacy and anxiety (fear of falling, impact of falling and balance confidence), another area that is thought to be important in preventing falls and mitigating their consequences is self-confidence in correcting balance. Confidence in restoring balance; It is the self-sufficiency in restoring the balance that is disrupted as a result of the change of the center of mass by internal or external forces. In other words, self-confidence in restoring balance is the perception of success in stopping a fall at any stage after the fall begins. Self-confidence in restoring balance has been measured in the literature with scales that measure fall efficiency, such as the FES-I or the ABC Scale. However, none of the mentioned scales were developed to measure this area and will not fully reflect the perception of self-confidence in restoring balance. For this reason, BRC was developed by Soh et al. in 2022 to specifically measure the perception of self-confidence in restoring balance. Although the use of the scale has become increasingly widespread in the world by adapting it to different languages, the scale has not yet been adapted to the Turkish language. Therefore, the aim of the current study is to adapt BRC to Turkish in community-dwelling older adults.
### Conditions Module
**Conditions:**
- Old Age
**Keywords:**
- balance
- fall
- old
- confidence
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 76
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** The scale consists of 19 items. The scale measures the self-confidence ability to correct balance in different situations that may cause loss of balance, such as stumbling or slipping. Items are scored between 0 and 10, and the maximum score is 190. A high score indicates a high perception of self-confidence in correcting balance (16).
**Measure:** The balance recovery confidence (BRC) scale
**Time Frame:** first measurement, repeat measurement (7 days)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Being 65 years or older
* Being literate in Turkish
* Having at least one near fall or a history of falling in the last 12 months
* Living independently in the community, with or without the use of a walking aid
* Not having enough cognitive dysfunction to score 24 or less on the SMM test
* Being able to walk 6 meters in 12 seconds in the ZKYT test
* Having the hand reaction to grasp a 30 cm ruler with both hands
Exclusion Criteria:
* Walking around the house with the physical assistance of another person.
* Known active malignant conditions
* Cardiovascular conditions such as neural syncope, cardiac syncope, structural heart diseases such as aortic stenosis, or hospitalization due to myocardial infarction or heart surgery within the last three months
* Lung disorders such as chronic severe obstructive pulmonary disease or oxygen dependence,
* Musculoskeletal disorders such as moderate to severe osteoarthritis, which can affect balance control and muscle function; for example, self-reported trunk and extremity pain or dysfunction, fractures or injuries to the extremities in the past six months
* Neurological conditions such as Parkinson's Disease, sequelae of stroke, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, severe Dementia or epilepsy
* Legal blindness, severe visual impairment, severe hearing impairment or legal deafness
**Healthy Volunteers:** True
**Minimum Age:** 65 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
**Study Population:** Healthy individuals over the age of 65 living independently in society
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** abdulkadir dağbaşı
**Phone:** 5414933347
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Necmettin Erbakan University
**Name:** abdulkadir dağbaşı
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Soh SL, Tan CW, Xu T, Yeh TT, Bte Abdul Rahman F, Soon B, Gleeson N, Lane J. The Balance Recovery Confidence (BRC) Scale. Physiother Theory Pract. 2024 Mar 3;40(3):658-669. doi: 10.1080/09593985.2022.2135420. Epub 2022 Oct 19.
**PMID:** 36259660
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444048
**Brief Title:** Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of an Enterovirus D68-specific Monoclonal Antibody in Healthy Adults
**Official Title:** Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of an Enterovirus D68-specific Monoclonal Antibody (EVD68-228N) in Healthy Adults
#### Organization Study ID Info
**ID:** 23-0005
#### Organization
**Class:** NIH
**Full Name:** National Institute of Allergy and Infectious Diseases (NIAID)
#### Secondary ID Infos
**ID:** 5UM1AI148684-05
**Link:** https://reporter.nih.gov/quickSearch/5UM1AI148684-05
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-04-28
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** KBio Inc
#### Lead Sponsor
**Class:** NIH
**Name:** National Institute of Allergy and Infectious Diseases (NIAID)
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** False
### Description Module
**Brief Summary:** This is a Phase 1, randomized, placebo-controlled, double-blinded study to assess the safety and pharmacokinetics of single IV administrations of EV68-228-N in healthy adult volunteers. Three doses (3, 10 and 30 mg/kg) of EV68-228-N will be evaluated in three separate, sequential cohorts in this single dose escalation study. The cohorts will be randomized in a 5:1 randomization scheme. The first two participants in each cohort will serve as sentinels. Sentinel participants may be located at different sites. Sentinel safety data will be collected through Day 3 before submitting to the Safety Review Committee (SRC) for review. The SRC is comprised of the Principal Investigator (PI), the DMID Medical Monitor, and the DMID Medical Officer. Data to be reviewed will include clinical data collected from Visits 1, 2 and 3, the results of laboratory testing conducted at these visits, solicited adverse events (AEs) and the passive reporting of adverse events through Day 3. From the time of infusion of the sentinels to at least 48 hours after infusion, no new participants will be given study product or placebo, but screening may continue. If no safety signal is detected in the sentinel group, and after approval from the DMID Medical Monitor, the remaining 10 participants in the cohort will be dosed following the overall 5:1 randomization scheme. All participants will be actively monitored for AEs and safety laboratory data following dosing through Day 8. Data will be reviewed by the SRC and discussed with the Safety Monitoring Committee (SMC) for their concurrence before advancing to the next cohort. Electronic review of the safety data by the SMC is required prior to the cohort dose escalation when halting rules are met or there are any safety concerns. The primary objective is to evaluate the safety of a single IV infusion of either 3, 10, or 30 mg/kg of EV68-228-N when administered to healthy adults. The secondary objective is to: 1) characterize the PK of single ascending doses of EV68-228-N for approximately four months following the infusion and 2) measure the occurrence of anti-drug antibodies (ADAs) elicited following a single IV infusion of EV68-228-N in healthy adults.
**Detailed Description:** This is a Phase 1, randomized, placebo-controlled, double-blinded study to assess the safety and pharmacokinetics of single IV administrations of EV68-228-N in healthy adult volunteers. Three doses (3, 10 and 30 mg/kg) of EV68-228-N will be evaluated in three separate, sequential cohorts in this single dose escalation study. The cohorts will be randomized in a 5:1 randomization scheme. The first two participants in each cohort will serve as sentinels. Sentinel participants may be located at different sites. Sentinel safety data will be collected through Day 3 before submitting to the Safety Review Committee (SRC) for review. The SRC is comprised of the Principal Investigator (PI), the DMID Medical Monitor, and the DMID Medical Officer. Data to be reviewed will include clinical data collected from Visits 1, 2 and 3, the results of laboratory testing conducted at these visits, solicited adverse events (AEs) and the passive reporting of adverse events through Day 3. From the time of infusion of the sentinels to at least 48 hours after infusion, no new participants will be given study product or placebo, but screening may continue. If no safety signal is detected in the sentinel group, and after approval from the DMID Medical Monitor, the remaining 10 participants in the cohort will be dosed following the overall 5:1 randomization scheme. All participants will be actively monitored for adverse events (AEs) and safety laboratory data following dosing through Day 8. Data will be reviewed by the SRC and discussed with the Safety Monitoring Committee (SMC) for their concurrence before advancing to the next cohort. Electronic review of the safety data by the SMC is required prior to the cohort dose escalation when halting rules are met or there are any safety concerns. Assuming no safety concerns are identified after review of the first cohort safety data through Day 8, enrollment of Cohort 2 will begin. The dose of EV68-228-N will be increased to 10 mg/kg for the second cohort. The same sentinel design and safety plan will be used to evaluate sentinel participants in Cohort 2 and determine whether to enroll the remaining participants in Cohort 2. In addition, the same sentinel design and safety plan will be used for Cohort 3, which will evaluate the 30 mg/kg dose. Following informed consent, participants will be screened for eligibility, including medical history, physical examination, weight and height measurements, vital signs, screening laboratory tests, and a 12-lead electrocardiogram (ECG). Within 28 days of screening, eligible participants will be seen at the clinical research unit (Day 1) and be randomized to receive either a single intravenous dose of EV68-228-N or placebo (formulation buffer alone). Participants will remain in the unit for at least 5 hours following infusion and return for daily assessments through Day 3. Participants will have follow-up clinic visits on Days 8, 15, 29, 61, 91, and 121. Participants will be monitored and assessed for safety and the incidence of adverse events (AEs) at all visits beginning with the dosing visit. An electronic memory aid will be utilized beginning Day 1 through Day 3 to assist with collecting solicited adverse events (AEs). Safety laboratory studies will be collected at screening and on Days 1, 2, 3, 8, and 29. Concomitant medications taken 28 days before and after dosing will be recorded. Pharmacokinetic (PK) samples will be collected prior to infusion, end of infusion, 1, 3, 5, 24 and 48 hours after end of infusion; and on Days 8, 15, 29, 61, 91, and 121. The single dose pharmacokinetic (PK) parameters to be estimated include maximum observed serum concentration (Cmax), time to Cmax (Tmax), area under the serum concentration-time curve (AUC) from time zero to time t (AUC0-t), from time zero to 48 hours post infusion \[AUC(0-48)\], from time zero to the last measurable concentration \[AUC(0-tlast)\] and extrapolated to infinity \[AUC(0-oo)\], apparent serum terminal elimination phase half-life (t\^1/2), total serum clearance (CL), and volume of distribution during the terminal phase (Vz). PK parameters will be calculated from serum EV68-228-N levels measured using an electrochemiluminescence (ECL) enzyme-linked immunosorbent assay (ELISA). Samples will be collected prior to infusion on Day 1 and on Days 8, 15, 29, 61, 91 and 121 for serum levels of anti-EV68-228-N antibodies. A sample will be collected pre-infusion on Day 1 for hypersensitivity testing in the event that the participant experiences an infusion reaction. These baseline samples will only be analyzed in the event of a hypersensitivity reaction related to the infusion. If a participant experiences anaphylaxis or an anaphylactoid event related to the infusion, three additional samples will be collected: 1) during onset, 2) 2 or more hours after onset, and 3) after resolution of symptoms. The primary objective is to evaluate the safety of a single IV infusion of either 3, 10, or 30 mg/kg of EV68-228-N when administered to healthy adults. The secondary objective is to: 1) characterize the PK of single ascending doses of EV68-228-N for approximately four months following the infusion and 2) measure the occurrence of anti-drug antibodies (ADAs) elicited following a single IV infusion of EV68-228-N in healthy adults.
### Conditions Module
**Conditions:**
- Enterovirus Infection
**Keywords:**
- Antibody
- Double Blind
- Enterovirus
- Healthy Adults
- Monoclonal
- Placebo Controlled
- Randomized
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** TRIPLE
**Masking Description:** Participants, investigators, study personnel performing any study-related assessments following study product administration, and laboratory personnel will be blinded to treatment assignments.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 36
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Healthy adult participants will be randomized at a 5:1 ratio. 10 participants to receive a 3 mg/kg single intravenous infusion of EV68-228-N and 2 Participants matching Placebo (20mM Citrate + 10 mM Glycine, 8% Sucrose, and 0.01% Polysorbate 80)
**Intervention Names:**
- Biological: EV68-228-N
**Label:** Cohort 1A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Healthy adult participants will be randomized at a 5:1 ratio. 10 participants to receive a 3 mg/kg single intravenous infusion of EV68-228-N and 2 Participants matching Placebo (20mM Citrate + 10 mM Glycine, 8% Sucrose, and 0.01% Polysorbate 80)
**Intervention Names:**
- Other: Placebo for EV68-228-N
**Label:** Cohort 1B
**Type:** PLACEBO_COMPARATOR
#### Arm Group 3
**Description:** Healthy adult participants will be randomized at a 5:1 ratio to receive a single intravenous infusion of EV68-228-N and Placebo (20mM Citrate + 10 mM Glycine, 8% Sucrose, and 0.01% Polysorbate 80) 10 mg/kg. N=2
**Intervention Names:**
- Biological: EV68-228-N
**Label:** Cohort 2A
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Healthy adult participants will be randomized at a 5:1 ratio to receive a single intravenous infusion of EV68-228-N and Placebo (20mM Citrate + 10 mM Glycine, 8% Sucrose, and 0.01% Polysorbate 80) 10 mg/kg. N=2
**Intervention Names:**
- Other: Placebo for EV68-228-N
**Label:** Cohort 2B
**Type:** PLACEBO_COMPARATOR
#### Arm Group 5
**Description:** Healthy adult participants will be randomized at a 5:1 ratio to receive a single intravenous infusion of EV68-228-N N=10 and Placebo (20mM Citrate + 10 mM Glycine, 8% Sucrose, and 0.01% Polysorbate 80) 30 mg/kg. N=2
**Intervention Names:**
- Biological: EV68-228-N
**Label:** Cohort 3A
**Type:** EXPERIMENTAL
#### Arm Group 6
**Description:** Healthy adult participants will be randomized at a 5:1 ratio to receive a single intravenous infusion of EV68-228-N N=10 and Placebo (20mM Citrate + 10 mM Glycine, 8% Sucrose, and 0.01% Polysorbate 80) 30 mg/kg. N=2
**Intervention Names:**
- Other: Placebo for EV68-228-N
**Label:** Cohort 3B
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cohort 1A
- Cohort 2A
- Cohort 3A
**Description:** EV68-228-N is a recombinant human monoclonal IgG1 antibody which is produced by genetically engineered plasmids in Nicotiana benthamiana. This intervention is directed against enterovirus EV-D68 capsid protein potentially providing treatments for EV-D68 infection and AMF.
**Name:** EV68-228-N
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- Cohort 1B
- Cohort 2B
- Cohort 3B
**Description:** The placebo is a sterile buffer solution formulated to match the EV68-228-N Drug Product. The formulation is 20mM Citrate + 10 mM Glycine, 8% Sucrose, and 0.01% Polysorbate 80, with a target pH of 5.5. The placebo will be filled into glass vials at 10 mL per vial. The formulation buffer is a clear colorless liquid.
**Name:** Placebo for EV68-228-N
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** through 48 hours post-infusion.
**Measure:** Proportion of participants experiencing solicited adverse events (AEs)
**Time Frame:** Through Day 2
**Measure:** Proportion of participants experiencing serious adverse events (SAEs), medically attended adverse events (MAAEs), and new onset chronic medical conditions (NOCMCs)
**Time Frame:** Through Day 121
**Description:** including clinical and laboratory adverse events (AEs)
**Measure:** Proportion of participants experiencing unsolicited adverse events (AEs)
**Time Frame:** Through Day 29
#### Secondary Outcomes
**Measure:** Apparent serum terminal elimination half-life (t1/2)
**Time Frame:** Through Day 121
**Measure:** Area under the curve from time 0 to 48 hours postdose (AUC0-48) after a single IV infusion of EV68-228-N
**Time Frame:** Through Day 121
**Measure:** Area under the curve from time 0 to time t (AUC0-t) after a single IV infusion of EV68-228-N
**Time Frame:** Through Day 121
**Measure:** Area under the serum concentration-time curve (AUC) from time 0 to infinity (AUC0-8) after a single IV infusion of EV68-228-N
**Time Frame:** Through Day 121
**Measure:** AUC from time 0 to the time of the last quantifiable concentration (AUC0-tlast) after a single IV infusion of EV68-228-N
**Time Frame:** Through Day 121
**Measure:** Incidence of anti-EV68-228-N antibodies as measured by the proportion of participants with detectable anti- EV68-228-N antibodies in serum.
**Time Frame:** Through Day 121
**Measure:** Maximum observed serum concentration (Cmax) after a single IV infusion of EV68-228-N
**Time Frame:** Through Day 121
**Measure:** Time of the Cmax (Tmax)
**Time Frame:** Through Day 121
**Measure:** Total serum clearance (CL)
**Time Frame:** Through Day 121
**Measure:** Volume of distribution during the terminal phase (Vz) calculated from serum EV68-228-N levels
**Time Frame:** Through Day 121'
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Provides written informed consent prior to initiation of any study procedures.
2. Is able to understand and agrees to adhere to planned study procedures and is available for all study visits.
3. Adult volunteers 18 to 49 years of age, inclusive.
4. Females who are of childbearing potential1 must agree not to become pregnant. 1 Not of childbearing potential includes post-menopausal females (defined as no menses for at least 12 months without an alternative medical cause for amenorrhea) or surgically sterile females with documented history of hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy, or Essure® placement.
5. Females who have sexual intercourse with male partners must agree to use at least one acceptable form of contraception for the duration of the study2,3.
2 Acceptable methods of birth control include long-acting reversible contraception (LARC), combined pill, progestin-only pill, hormone-releasing transdermal patch or vaginal ring, and depot medroxyprogesterone acetate (DMPA) injection. Participants who choose to use a licensed hormonal product should use them for a minimum of 28 days prior to study infusion. True sexual abstinence or a monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to the participant's first infusion are also acceptable contraceptive methods.
3 Participants who report practicing true abstinence, defined as no heterosexual vaginal-penile intercourse, need to practice true abstinence at all times during the study. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and the withdrawal method are not acceptable methods of contraception.
6. Females of childbearing potential must agree to not donate ova or oocytes during the study.
7. Participant is in good health5 as determined by medical history, medication use, physical examination, vital signs, and 12-lead ECG at screening and reaffirmed per protocol-defined procedures on Day 1 prior to infusion.
5 Good health is defined by the absence of a medical condition described in the exclusion criteria. If the participant has another current, ongoing medical condition, the condition cannot meet any of the following criteria: (1) was first diagnosed within 3 months of enrollment with a clinically significant condition, in the opinion of investigator that has worsened within 3 months of enrollment; (2) had non-elective surgery, clinically significant medical procedure, or hospitalization within 3 months of enrollment; (3) received new prescription for systemic medication within 30 days of enrollment, unless the new prescription is in the same class of agent or a transition from generic to/from brand name equivalent; or (4) takes medication that may pose a risk to participant's safety or impede assessment of adverse events or study endpoints if they participate in the study.
8. Must agree to refrain from donating blood or blood products6 during the study.
6 This includes whole blood cells, red blood cells, platelets, plasma, and plasma derivatives collected and donated outside of the study blood draws.
9. Body mass index (BMI) 18 kg/m2 to 32 kg/m2, inclusive, and a weight of 125 kg or less at time of screening.
10. Must have adequate venous access for intravenous (IV) infusion and blood sampling.
Exclusion Criteria:
All participants meeting any of the exclusion criteria at baseline will be excluded from study participation.
1. Positive pregnancy test at screening or prior to infusion.
2. Female participant who is lactating.
3. Presence of significant psychiatric condition, that in the opinion of the site PI or appropriate sub-investigator, precludes study participation.
4. History of drug abuse or alcohol abuse within 6 months of enrollment that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation.
5. Has a significant acute illness (with or without fever), as determined by the site PI or appropriate sub-investigator, within 72 hours prior to infusion1.
1 If the participant meets all other eligibility criteria, they may be enrolled and dosed once they meet this eligibility criterion. If the illness resolves within the 28-day screening window, they do not need to be rescreened, otherwise they will need to be rescreened.
6. Currently enrolled in or plans to participate in another clinical trial with an investigational agent that will be received during the study-reporting period.
7. Has a history of significant hypersensitivity, intolerance, or allergy to any drug compound, vaccine, food, or other substance, unless approved by the Investigator (or designee)2.
2 Sensitivity to glycine, citric acid, trisodium citrate, sorbitol, or polysorbate 80 (components of the study product) is exclusionary.
8. Any history of an infusion reaction to any biologic product. 9. Receipt of a monoclonal antibody in the 180 days prior to infusion. 10. Receipt of a blood product within 120 days prior to infusion. 11. Received any live-attenuated vaccine in the 28 days prior or any other vaccine in the 14 days prior to infusion.
12. Has used any prohibited medication within 30 days prior to Day 1 or plans to use prohibited medication3 during the study.
3 Prohibited medications include systemic immunosuppressive drugs, immune modulators (except acetaminophen or non-steroidal anti-inflammatory drugs), oral corticosteroids, and systemic anti-neoplastic agents. Topical, inhaled, and intranasal steroids, as well as topical anti-neoplastic agents are acceptable.
13. Has clinically significant findings4 on 12-lead electrocardiogram. 4 Clinical significance will be determined by a cardiologist. Examples of findings that will lead to exclusion are significant left ventricular hypertrophy, right or left bundle branch block, advanced A-V heart block, non-sinus rhythm (excluding isolated premature atrial contractions), pathologic Q wave abnormalities, significant ST-T wave changes, and prolonged QTc interval. Long QT interval is defined in males as a median QTcB greater than 450 msec or in females as a median QTcB greater than 460 msec (Bazett's correction) at screening.
14. Abnormal vital signs (Grade 1 or higher)5 at screening or on Day 1. 5 Grade 1 or higher is equivalent to: Systolic blood pressure (SBP) \> 140 mmHg or \< 85 mmHg Diastolic blood pressure (DBP) \> 90 mmHg Oral temperature \>/= 38.0°C (100.4°F) 15. Abnormal laboratory results6 that are Grade 1 or worse at screening based on the Toxicity Tables in Appendix B7.
6Creatinine, alanine transaminase (ALT), hemoglobin (Hgb), platelets (PLT), white blood cell count (WBC), and total bilirubin (T bili).
7 Laboratory studies can be repeated once if an alternative, transient etiology for abnormal laboratory values is identified.
16. Known, current human immunodeficiency virus (HIV), hepatitis B Virus (HBV), or hepatitis C virus (HCV) infection 17. Has any medical disease or condition8 that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation9.
8 Medical conditions include, but are not limited to, kidney disease with creatinine clearance \< 90 mL/min/1.73 cm2 (CKD-EPI method); known active liver disease including steatosis; ischemic heart disease, clinically significant cardiac conduction disorder, arrhythmia requiring treatment, congenital long QT syndrome, uncompensated heart failure; diabetes requiring insulin; neuropathy or myopathy; and malignancy (not including squamous cell skin cancer, basal cell skin cancer, or cervical low-grade squamous intraepithelial lesions).
9Participation may be precluded due to safety concerns or inability to adequately evaluate clinical trial endpoints.
**Healthy Volunteers:** True
**Maximum Age:** 49 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** C. Buddy Creech
**Phone:** 16153430332
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Baltimore
**Country:** United States
**Facility:** University of Maryland, School of Medicine, Center for Vaccine Development and Global Health
**State:** Maryland
**Zip:** 21201-1509
**Location 2:**
**City:** Baltimore
**Country:** United States
**Facility:** University of Maryland - Children's Hospital - Pediatrics at the Harbor
**State:** Maryland
**Zip:** 21201-4606
**Location 3:**
**City:** Nashville
**Country:** United States
**Facility:** Monroe Carell Jr. Children's Hospital at Vanderbilt
**State:** Tennessee
**Zip:** 37232-0005
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010850
- Term: Picornaviridae Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000007239
- Term: Infections
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M7930
- Name: Enterovirus Infections
- Relevance: HIGH
- As Found: Enterovirus
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13745
- Name: Picornaviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004769
- Term: Enterovirus Infections
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: AnCoag
- Name: Anticoagulants
- Abbrev: Ot
- Name: Other Dietary Supplements
- Abbrev: AA
- Name: Amino Acids
### Intervention Browse Module - Browse Leaves
- ID: M4230
- Name: Antibodies, Monoclonal
- Relevance: LOW
- As Found: Unknown
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M21320
- Name: Citric Acid
- Relevance: LOW
- As Found: Unknown
- ID: M1837
- Name: Sodium Citrate
- Relevance: LOW
- As Found: Unknown
- ID: M9104
- Name: Glycine
- Relevance: LOW
- As Found: Unknown
- ID: T382
- Name: Citrate
- Relevance: LOW
- As Found: Unknown
- ID: T7
- Name: Glycine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444035
**Brief Title:** Extended Therapeutic Effect of 35kDa Hyaluronan Fragment Injection in Patients With Chronic Pain Caused by Myofascial Pain Syndrome
**Official Title:** 35kDa Hyaluronan Fragment Injection Treatment Myofascial Pain Syndrome
#### Organization Study ID Info
**ID:** HSHN005
#### Organization
**Class:** INDUSTRY
**Full Name:** Nakhia Impex LLC
### Status Module
#### Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2024-10-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**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:** Nakhia Impex LLC
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** To verify the efficacy and safety of HA35 in chronic pain management and to further supplement effective treatments for chronic pain, we designed a proof-of-concept clinical study. This study aims to evaluate the 15-day treatment of HA35 on patients with myofascial pain syndrome and to observe the effects for up to 3 months.
### Conditions Module
**Conditions:**
- Chronic Wound
- Myofascial Pain Syndrome
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### 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:** Subjects received subcutaneous injection of HA35 injection 100mg / 5mL / day near the back pain point for 15 days.
**Intervention Names:**
- Drug: HA35 injection
**Label:** Treatment of myofascial pain syndrome by local injection of pain points
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment of myofascial pain syndrome by local injection of pain points
**Description:** HA35/B-HA injection (Registration number L20200708MP07707; Ministry of Health). The subjects can continue to take oral analgesics during the treatment period, and the comparison of the dose and interval days of the analgesics before and after the treatment can also be used as the effect judgment of the injection.
**Name:** HA35 injection
**Other Names:**
- B-HA injection
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Subjective measurements of pain were submitted using the Numerical Pain Rating Scale (NPRS). Scored at 0-10, the higher the score, the more obvious the pain.
**Measure:** Chronic myofascial pain score
**Time Frame:** after treatment 1 day, 3 days, 5 days, 15 days, 30 days, 60 days, 90 days
#### Secondary Outcomes
**Description:** The global pain scale (GPS) was used to assess the global pain. The total consists of 20 items, each rated on a scale from 0 to 10. The sum of the scores for all items is divided by 2 to obtain the total score. The higher the score, the more significant the pain and its impact.
**Measure:** Overall pain assessment during injection therapy and follow-up
**Time Frame:** after treatment 15 days, 30 days, 60 days, 90 days
**Description:** A questionnaire survey was conducted on patients using the Satisfaction with Medication Questionnaire ( TSQM 1.4 ). There are 4 subscales and 14 questions: the Effectiveness Scale (questions 1-3), the Side Effects Scale (questions 4-8), the Convenience Scale (questions 9-11), and the Overall Satisfaction Scale (questions 12-14). Each subscale is scored from 0 to 100, with higher scores indicating greater satisfaction.
**Measure:** Satisfaction survey of injection treatment
**Time Frame:** after treatment 90 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male and female, aged 18-65 years old ;
* suffering from muscle strain, sprain, fall, wind and other diagnosed as myofascitis in patients with chronic back pain;
* the pain reported by the subject should reach level 3 or higher on the digital rating scale of 0-10 ( 0 means no pain, 10 represents the strongest pain imaginable );
* the mental state is good, and the pain level can be evaluated independently;
* be able to cooperate with the treatment independently and sign a written consent.
Exclusion Criteria:
* Previous severe trauma with permanent musculoskeletal dysfunction;
* symptomatic lumbar disc herniation with neurological deficits;
* specific spinal diseases, including rheumatoid arthritis, ankylosing spondylitis, and osteoporosis;
* diagnosed with mental illness;
* agree not to sign the written consent;
* pregnant, lactating or fertile women;
* currently participating ( or participating in the past 30 days ) in research-based treatment or equipment trials.
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ulaanbaatar
**Country:** Mongolia
**Facility:** Nahia Impex Llc
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000001523
- Term: Mental Disorders
- ID: D000009135
- Term: Muscular Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000012216
- Term: Rheumatic Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M12161
- Name: Myofascial Pain Syndromes
- Relevance: HIGH
- As Found: Myofascial Pain Syndrome
- ID: M8486
- Name: Fibromyalgia
- Relevance: HIGH
- As Found: Myofascial Pain Syndrome
- ID: M29442
- Name: Chronic Pain
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M15803
- Name: Somatoform Disorders
- Relevance: HIGH
- As Found: Pain Syndrome
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- 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: M15045
- Name: Rheumatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6323
- Name: Collagen Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009209
- Term: Myofascial Pain Syndromes
- ID: D000005356
- Term: Fibromyalgia
- ID: D000013577
- Term: Syndrome
- ID: D000013001
- Term: Somatoform Disorders
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M9878
- Name: Hyaluronic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444022
**Brief Title:** hAESCs Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation
**Official Title:** Clinical Study of hAESCs on Prevention of Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation
#### Organization Study ID Info
**ID:** NFEC-2019-128
#### Organization
**Class:** OTHER
**Full Name:** Nanfang Hospital, Southern Medical University
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-31
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2022-07-08
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
#### Lead Sponsor
**Class:** OTHER
**Name:** Nanfang Hospital, Southern Medical 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:** This is a parallel controlled clinical study evaluating the safety and efficacy of hAECs in preventing aGVHD after HSCT.
**Detailed Description:** This study is a controlled trial, with 18 subjects enrolled in the experimental group or the control group. The study will consist of four phases, including screening phase, preparation phase, hAESCs treatment phase and observational follow-up period. The cell dose of the experimental group was 1x10\^6 cells/kg and the control group is infused placebo (the composition was the same as hAESCs injection excipients, but did not contain hAESCs). The infusion of hAESCs/placebo at the day before HSCT and 7th days after HSCT.
### Conditions Module
**Conditions:**
- Acute Graft Versus Host Disease
**Keywords:**
- hAESCs
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The study plans to recruit 18 participants who meet the criteria and is divided into two groups with 9 subjects individually. Infusion of hAESCs/placebo at the day before HSCT and 7th days after HSCT.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 18
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Intravenous infusion of hAESCs to 9 subjects at the day before HSCT and 7th days after HSCT. The dose is 1×10\^6 cell/kg.
**Intervention Names:**
- Biological: Human amniotic epithelial stem cells（hAESCs）
**Label:** hAESCs
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Intravenous infusion of placebo (cell preservation solution with no hAESCs) to other 9 subjects at the day before HSCT and 7th days after HSCT.
**Intervention Names:**
- Biological: placebo (cell preservation solution)
**Label:** placebo (cell preservation solution)
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- hAESCs
**Description:** Human Amniotic Epithelial Cells Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation (hAECs-GVHD)
**Name:** Human amniotic epithelial stem cells（hAESCs）
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- placebo (cell preservation solution)
**Description:** Same dose placebo (cell preservation solution) injections as control group
**Name:** placebo (cell preservation solution)
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** AE occurring throughout the study period will be evaluated using the CTCAE V5.0 standard. AE/SAE and AESI were evaluated after first hAESCs infusion by laboratory examination, measurement of vital signs, physical examination, and subjects' symptoms to detect new abnormalities and/or deterioration of previous conditions and evaluate the safety of the study.
hAESCs intravenous infusion is followed up and monitored closely, mainly including vital signs, physical examination, ECOG, electrocardiogram, blood biochemistry, blood RT, urine RT, coagulation laboratory test, imaging examination, type, frequency and severity of AE.
**Measure:** Follow up closely after intravenous hAESCs therapy to monitor Adverse Event/Serious Adverse Event(AE/SAE)
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** Occurrence and severity (grade) of Graft-versus-host disease after hAECs infusion
**Measure:** Rate of acute graft-versus-host disease in patients
**Time Frame:** 1 year
**Description:** 10 days(d) before hematopoietic stem cell transplantation and 1d, 7d±2, 14d±2, 21d±2, 28d±2, 3 month(m) ± 2 days , 6 m ± 2 days, testing expression of immune cells
**Measure:** Immune reconstitution 6 months before and after hematopoietic stem cell transplantation
**Time Frame:** 6 months
**Description:** The amount of cytokines in plasma was measured: TGF-b
**Measure:** Hematopoietic stem cell transplantation was performed 10 days before and 1 d, 7 d ±2, 14 d ±2, 21 d±2, 28 d ±2 after transplantation The amount of cytokines in plasma was measured
**Time Frame:** 1 month
**Description:** Hematopoietic stem cell transplantation after 7 days ±2, 14 days ±2, 21 days±2, 28d±2, 2M±2 days, 3M±2 days, 6M±2 days, 12M±2 days;
**Measure:** Incidence of CMV and EBV infection
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Standard risk GVHD patients with hematological malignancies older than 18 years;
* High risk GVHD patients with hematological malignancies: haplotype hematopoietic stem cell transplantation patients, donor is female or more than 30 years old;
* Well informed about this study and signed a consent form before the trial;
* Left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion;
* No evidence of lung infection by X-rays examination;
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1, Hematopoietic cell transplantation - specific comorbidity index (HCT-CI) of 0, 1, 2;
* Normal liver and kidney function: Serum bilirubin≤35µmol/L, AST/ALT was less than 2 times the upper limit of normal value, and serum creatinine ≤130µmol/L
Exclusion Criteria:
* Reduce pretreatment dose or secondary transplantation;
* Participate other clinical trials within 2 months before this study;
* Female, 1) pregnant/nursing period, or 2) have a pregnancy plan during the study period, or 3) have fertility and cannot take effective contraception;
* History of severe allergic disease or is allergic to one or more drugs;
* Patients who are considered unsuitable for the study by the investigator.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Xiaojun Huang, MD
**Phone:** 13701389625
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Nanfang Hospital, Southern Medical University
**Name:** Xiaojun Huang
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M9189
- Name: Graft vs Host Disease
- Relevance: HIGH
- As Found: Graft Versus Host Disease
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T2832
- Name: Homologous Wasting Disease
- Relevance: HIGH
- As Found: Graft Versus Host Disease
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: HIGH
- As Found: Acute Graft Versus Host Disease
### Condition Browse Module - Meshes
- ID: D000006086
- Term: Graft vs Host Disease
### 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:** NCT06444009
**Brief Title:** A Phase II Study of Neoadjuvant Immunotherapy in Combination With Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
**Official Title:** Neoadjuvant Immunotherapy in Combination With Chemotherapy in Resectable Head and Neck Cancer：A Randomized, Phase II Study
#### Organization Study ID Info
**ID:** AK112-IIT-C-W-0001
#### Organization
**Class:** OTHER
**Full Name:** West China Hospital
### Status Module
#### Completion Date
**Date:** 2027-12-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Lei Liu
#### Responsible Party
**Investigator Affiliation:** West China Hospital
**Investigator Full Name:** Lei Liu
**Investigator Title:** professor
**Type:** SPONSOR_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:** A Randomized, Phase II Study of ivonescimab or cadonilimab or penpulimab in Combination With Cisplatin and Nab-paclitaxel in Patients With III-IVB (according to the 8th edition of UICC/AJCC staging) locally advanced head and neck squamous cell carcinoma (HNSCC) eligible for resection. This proposed study will evaluate the efficacy and safety of preoperative administration of ivonescimab or cadonilimab or penpulimab combined with chemotherapy in HNSCC who are eligible for resection.
**Detailed Description:** In this study, eligible patients will be randomized in a 1:1:1 ratio to either the ivonescimab combined with chemotherapy treatment group (Cohort 1), or the cadonilimab combined with chemotherapy treatment group (Cohort 2), or the penpulimab combined with chemotherapy treatment group (Cohort 3). Pathological response rate will be the primary outcome measures. Adverse events will also be recorded.
### Conditions Module
**Conditions:**
- Head and Neck Squamous Cell Carcinoma
**Keywords:**
- Locally advanced head and neck squamous cell carcinoma
- Neoadjuvant therapy
- Immunotherapy
- AK112
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** A Randomized, Controlled, Phase II Study
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Neoadjuvant:
Patients receive ivonescimab in combination with nab-paclitaxel + cisplatin for 3 cycles before surgery.
Surgery:
Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection.
Adjuvant:
pCR: Patients receive adjuvant ivonescimab for 16 cycles.
no pCR:
Low/ Medium Risk:
Patients will be treated with intensity modulation radiation therapy (IMRT) alone. Once radiotherapy is complete these patients will receive adjuvant ivonescimab for 16 cycles
High Risk:
All patients will be treated with IMRT concurrent with cisplatin or other standard of care chemoradiotherapy regimen. Once chemoradiotherapy is complete these patients will receive adjuvant ivonescimab for 16 cycles.
**Intervention Names:**
- Drug: Ivonescimab combined with TP
**Label:** Ivonescimab in combination with Nab-paclitaxel + Cisplatin
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Neoadjuvant:
Patients receive cadonilimab in combination with nab-paclitaxel + cisplatin for 3 cycles before surgery.
Surgery:
Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection.
Adjuvant:
pCR: Patients receive adjuvant cadonilimab for 16 cycles.
no pCR:
Low/ Medium Risk:
Patients will be treated with intensity modulation radiation therapy (IMRT) alone. Once radiotherapy is complete these patients will receive adjuvant cadonilimab for 16 cycles
High Risk:
All patients will be treated with IMRT concurrent with cisplatin or other standard of care chemoradiotherapy regimen. Once chemoradiotherapy is complete these patients will receive adjuvant cadonilimab for 16 cycles.
**Intervention Names:**
- Drug: Cadonilimab combined with TP
**Label:** Cadonilimab in combination with Nab-paclitaxel + Cisplatin
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Neoadjuvant:
Patients receive penpulimab in combination with nab-paclitaxel + cisplatin for 3 cycles before surgery.
Surgery:
Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection.
Adjuvant:
pCR: Patients receive adjuvant penpulimab for 16 cycles.
no pCR:
Low/ Medium Risk:
Patients will be treated with intensity modulation radiation therapy (IMRT) alone. Once radiotherapy is complete these patients will receive adjuvant penpulimab for 16 cycles
High Risk:
All patients will be treated with IMRT concurrent with cisplatin or other standard of care chemoradiotherapy regimen. Once chemoradiotherapy is complete these patients will receive adjuvant penpulimab for 16 cycles.
**Intervention Names:**
- Drug: Penpulimab combined with TP
**Label:** Penpulimab in combination with Nab-paclitaxel + Cisplatin
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Ivonescimab in combination with Nab-paclitaxel + Cisplatin
**Description:** Both interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles.
**Name:** Ivonescimab combined with TP
**Other Names:**
- ITP
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Cadonilimab in combination with Nab-paclitaxel + Cisplatin
**Description:** Both interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles.
**Name:** Cadonilimab combined with TP
**Other Names:**
- CTP
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Penpulimab in combination with Nab-paclitaxel + Cisplatin
**Description:** Both interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles.
**Name:** Penpulimab combined with TP
**Other Names:**
- PTP
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** objective response rate
**Measure:** ORR
**Time Frame:** 9-10 weeks
**Description:** event free survival
**Measure:** EFS
**Time Frame:** 1 years
**Description:** overall survival
**Measure:** OS
**Time Frame:** 2 years
#### Primary Outcomes
**Description:** Pathological complete response rate
**Measure:** pCR
**Time Frame:** After surgery (approximately 9-10 weeks after start of study treatment)
#### Secondary Outcomes
**Description:** major pathological remission
**Measure:** MPR
**Time Frame:** After surgery (approximately 9-10 weeks after start of study treatment)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Males and females； Age：18 to 75 years.
2. Histologically or cytologically confirmed head and neck squamous cell carcinoma (HNSCC).
3. Patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC), classified as stage III-IVB according to the 8th edition of UICC/AJCC staging.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. No prior treatment for the cancer.
6. Intention to undergo curative treatment.
7. Patients with normal organ function and suitable for immunotherapy combined with chemotherapy and surgery:
Adequate hematologic function (total white blood cell count ≥ 3.0×10\^9/L, absolute lymphocyte count ≥ 0.8×10\^9/L, absolute neutrophil count ≥ 1.5×10\^9/L, platelets ≥ 100×10\^9/L, hemoglobin ≥ 90g/L); Adequate hepatic function (bilirubin level ≤ 2 times the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN); Adequate renal function (serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula), urine protein \<2+ on dipstick or \<1g in a 24-hour urine collection); Good cardiac function, i.e., normal or clinically insignificant abnormalities on electrocardiogram (ECG), echocardiogram showing a left ventricular ejection fraction (LVEF) ≥50%; Adequate coagulation function: International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times ULN; participants on anticoagulation treatment are eligible if the PT is within the therapeutic range of the anticoagulant;
8. Blood pressure well controlled (defined as systolic blood pressure ≤ 150 mmHg and diastolic blood pressure ≤ 90 mmHg) with or without antihypertensive medication, and no change in antihypertensive treatment within 1 week before the first dose of study medication.
9. Patients with HBV infection capable of having detectable HBV DNA levels (≥10IU/mL or above the limit of quantitation) (manifested as positive for hepatitis B surface antigen (HbsAg) and/or hepatitis B core antibody (anti-HBc)) must receive antiviral therapy according to clinical practice at the site before randomization to ensure adequate viral suppression. Patients must maintain antiviral therapy during the study and for 6 months after the last dose of study treatment. Patients who are anti-HBc positive but do not have detectable HBV DNA (\<10IU/mL or below the limit of quantitation) are not required to receive antiviral therapy unless their HBV DNA levels exceed 10IU/mL or the limit of quantitation during treatment.
10. Women of childbearing potential (15-49 years old) must have a negative pregnancy test within 7 days before starting treatment; patients of childbearing potential must agree to use effective contraception to ensure they do not become pregnant during the study period and for 3 months after stopping treatment.
11. Participants voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Exclusion Criteria:
1. Patients who have received any form of anti-tumor treatment previously.
2. Patients with allergic constitution and congenital immune deficiencies.
3. Patients who have undergone organ transplantation.
4. Patients with a history of severe bleeding tendencies or coagulation dysfunction; those who have had clinically significant bleeding symptoms within 1 month prior to the study treatment, including but not limited to gastrointestinal bleeding, hemoptysis; those who have received prolonged anticoagulation treatment within 10 days prior to the study treatment.
5. Patients who have experienced arteriovenous thrombotic events within 6 months before the study treatment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.
6. Patients with active autoimmune diseases or inflammatory diseases, or a history thereof, including inflammatory bowel disease (e.g., colitis or Crohn's disease), diverticulitis (excluding diverticulosis), systemic lupus erythematosus, sarcoidosis or Wegener's granulomatosis (e.g., granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, and uveitis). Exceptions to this criterion include patients with vitiligo or alopecia; patients with stable hypothyroidism after hormone replacement therapy (e.g., following Hashimoto's thyroiditis); patients with any chronic skin disease not requiring systemic treatment; inclusion of patients without active disease in the last 5 years is allowed only after consultation with the study physician.
7. Patients with active infections, including tuberculosis or human immunodeficiency virus (HIV 1/2 antibody positive).
8. Patients with uncontrollable complications, including but not limited to: persistent or active infections receiving study treatment (except HBV or HCV), symptomatic congestive heart failure, uncontrolled diabetes, uncontrolled hypertension, unstable angina, uncontrolled arrhythmias, active interstitial lung disease, severe chronic gastrointestinal disease with diarrhea, or any psychiatric/social situations that might limit compliance with study requirements, significantly increase the risk of adverse events (AE), or impair the ability of the patient to give written informed consent.
9. Pregnant or breastfeeding women.
10. Patients who do not agree to use effective contraception during the treatment period and for 3 months thereafter.
11. Patients participating in other clinical studies simultaneously.
12. Patients who are critically ill and unable to complete the investigation.
13. Patients with a history of other primary malignant tumors, except for the following: Malignant tumors treated with curative intent and no known active disease for ≥5 years prior to study treatment and with a low risk of relapse; adequately treated non-melanoma skin cancer or in-situ melanoma without evidence of disease; adequately treated carcinoma in situ without evidence of disease.
14. Patients with a history of psychiatric illness (e.g., schizophrenia, mania, anxiety disorder, depression, phobia) or diagnosed with a psychiatric disease at the time of enrollment or their spouses.
15. Patients or their spouses with communication barriers due to confusion, aphasia, intellectual disability, or other reasons that prevent normal responses.
16. Patients with other malignant neoplastic diseases.
17. Patients whom the researcher considers unsuitable for inclusion or whose participation might affect their ability to participate or complete the study for other reasons.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
## 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
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M5550
- Name: Carcinoma, Squamous Cell
- Relevance: HIGH
- As Found: Squamous Cell Carcinoma
- ID: M9348
- Name: Head and Neck Neoplasms
- Relevance: LOW
- As Found: Unknown
- 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
### 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 - 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: M2853
- Name: Immunomodulating Agents
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443996
**Brief Title:** Association of Sleep Quality and Mental Status With Early Recurrence and Prognosis of Colorectal Cancer
**Official Title:** Effects of Sleep Quality and Mental Status on Early Postoperative Recurrence and Prognosis in Patients With Colorectal Cancer: a Prospective Observational Cohort Study
#### Organization Study ID Info
**ID:** FDCRC97-MYL
#### Organization
**Class:** OTHER
**Full Name:** Fudan University
### Status Module
#### Completion Date
**Date:** 2027-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-08-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ma Yanlei
#### Responsible Party
**Investigator Affiliation:** Fudan University
**Investigator Full Name:** Ma Yanlei
**Investigator Title:** Chief physician
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This is a prospective observational cohort study to explore the effects of sleep quality and mental status on early postoperative recurrence and prognosis in patients with colorectal cancer.
**Detailed Description:** Evidence of evidence-based medicine shows that patients with malignant tumors have heavy psychological pressure after disease, and are prone to different degrees of sleep disorders and mental health problems, which often affect the progression and prognosis of the primary tumor. Previous studies have reported that baseline sleep quality was independently associated with risk of progression, risk of death, and response to treatment in patients with metastatic colorectal cancer before and during chemotherapy. Surgery, as a stressor, often causes obvious psychological stress reactions in patients, resulting in varying degrees of sleep disorders and poor mental performance, which may also become a factor affecting the recurrence and prognosis of patients. Therefore, the Department of Colorectal Surgery, Affiliated Cancer Hospital of Fudan University intends to conduct a prospective observational cohort study on the effects of sleep quality and mental state on early postoperative recurrence and prognosis of patients with colorectal cancer, in order to explore the effects of sleep quality and mental state on early postoperative recurrence and prognosis of patients with colorectal cancer.
### Conditions Module
**Conditions:**
- Colorectal Cancer
- Sleep Quality
- Mental Status Change
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 500
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** The duration between the date after surgery to the date of any recurrence or death firstly
**Measure:** Disease-free survival (DFS)
**Time Frame:** through study completion, an average of 1 year
**Description:** Time from the start of surgical randomization to death (from any cause)
**Measure:** Overall Survival
**Time Frame:** through study completion, an average of 1 year
**Description:** The correlation of GAD-7 scale score, PHQ-9 scale score and ESAS scale score with Disease-free survival (DFS), Overall Survival and tumor-free survival rate of patients was analyzed
**Measure:** Effect of sleep quality and mental state on early recurrence and prognosis of patients with colorectal cancer after surgery
**Time Frame:** through study completion, an average of 1 year
#### Secondary Outcomes
**Description:** Tumor markers CEA, CA19-9 was used to determine recurrence in patients with colorectal cancer enrolled in the study. 1, 3, 6, 12, 18, 24 months after the operation until the observation endpoint appeared.
**Measure:** Tumor markers CEA, CA19-9 was used to determine recurrence in patients with colorectal cancer enrolled in the study.
**Time Frame:** From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
**Description:** Enteroscope was used to determine recurrence in patients with colorectal cancer enrolled in the study. 1, 3, 6, 12, 18, 24 months after the operation until the observation endpoint appeared.
**Measure:** Enteroscope was used to determine recurrence in patients with colorectal cancer enrolled in the study.
**Time Frame:** From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
**Description:** Physical examination was used to determine recurrence in patients with colorectal cancer.1, 3, 6, 12, 18, 24 months after the operation until the observation endpoint appeared.
**Measure:** Physical examination was used to determine recurrence in patients with colorectal cancer
**Time Frame:** From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Preoperative fibrocolonoscopy and pathological examination confirmed colorectal cancer;
2. Age 18 \~ 80 years old;
3. Baseline clinical stage TNM Ⅰ to Ⅲ : cT1-4N0-2M0 (AJCC-8 version);
4. The United States Eastern Oncology Consortium (ECOG) physical status score was 0 to 2 points;
5. Laboratory examination results before admission met the following surgical conditions: neutrophil (ANC) ≥1.5×109/L, platelets (PLT) ≥ 100×109/L, total bilirubin (TBI) ≤1.5× upper limit of normal (2mg/dl), alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤2× upper limit of normal; Coagulation parameters in the normal range;
6. Able to complete the required research questionnaire independently or with the assistance of the researcher;
7. Patients were willing to undergo regular follow-up after surgery and had no psychological, family, social, or geographic constraints that affected protocol compliance and follow-up time;
8. Patients and their families can understand and are willing to participate in this clinical study, and sign informed consent.
Exclusion Criteria:
1. Under 18 years of age or over 80 years of age;
2. Have a family history of severe mental illness;
3. People with mental illness or intellectual disability who cannot correctly describe their feelings;
4. The patient has severe systemic infection;
5. No radical operation was performed during the operation due to various reasons;
6. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, peritonitis, etc. requiring emergency surgery;
7. Merge other parts of the transfer;
8. Have serious heart, lung, liver and kidney diseases, can not tolerate surgery;
9. Active stage of liver disease or abnormal liver function, ALT, AST, TBIL is more than 2 times the upper limit of normal value;
10. Renal function damage, Cr ≥ 2 times the upper limit of normal value or BUN ≥ 2 times the upper limit of normal value;
11. The subject's blood white blood cells are lower than the lower limit of normal, or platelets are lower than the lower limit of normal, or there are other blood system diseases;
12. Severe coagulation mechanism disorder and bleeding tendency;
13. Serious uncontrolled medical disease, recent history of myocardial infarction (within 3 months); Acute infection;
14. Patients with uncontrolled severe hypertension and severe diabetes after intervention;
15. The researchers considered that other candidates were not suitable for inclusion in 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 were diagnosed with colorectal cancer by histopathology at the Affiliated Cancer Hospital of Fudan University and underwent surgery for colorectal cancer at the Affiliated Cancer Hospital of Fudan University
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Shanghai
**Country:** China
**Facility:** Fudan University Shanghai Cancer Center
#### Overall Officials
**Official 1:**
**Affiliation:** Fudan University
**Name:** Yanlei Ma, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## 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: M14850
- Name: Recurrence
- Relevance: HIGH
- As Found: Recurrence
- 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: D000012008
- Term: Recurrence
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443983
**Brief Title:** Artificial Intelligence Supported Case Analysis on Nursing Education
**Official Title:** The Effect of Artificial Intelligence Supported Case Analysis on Nursing Students' Case Management Performance and Satisfaction: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** ErciyesUniversity
#### Organization
**Class:** OTHER
**Full Name:** TC Erciyes University
### Status Module
#### Completion Date
**Date:** 2024-03-27
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-03-27
**Type:** ACTUAL
#### Start Date
**Date:** 2024-02-27
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**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:** TC Erciyes University
#### Responsible Party
**Investigator Affiliation:** TC Erciyes University
**Investigator Full Name:** Seda Akutay
**Investigator Title:** Research Assistant
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Background: Rapid developments in the field of artificial intelligence have begun to necessitate changes and transformations in nursing education.
Objective: This study aimed to evaluate the impact of an artificial intelligence-supported case created in the in-class case analysis lecture for nursing students on students' case management performance and satisfaction.
Design: This study was a randomized controlled trial. Method: The study involved 188 third-year nursing students who were randomly assigned to either the AI group (n=94) and control group (n=94). An information form, case evaluation form, knowledge test, and Mentimeter application were used to assess the students' case management performance and nursing diagnoses. The level of satisfaction with the case analysis lecture was evaluated using the VAS scale.
### Conditions Module
**Conditions:**
- Artificial Intelligence
- Nursing Education
- Nursing Students
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** In this study, students will be divided into two groups: those who take an AI-supported case lesson and those who take a standard case lesson.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 188
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Students in this group will take an artificial intelligence-supported in-class case analysis lesson.
**Intervention Names:**
- Other: AI-supported case
**Label:** AI-supported case lesson group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Students in this group will receive a standard in-class case lesson narrated by the instructor.
**Label:** Standard case lesson group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- AI-supported case lesson group
**Description:** In the artificial intelligence-supported case lesson, students will listen to audio and visual content prepared by artificial intelligence.
**Name:** AI-supported case
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The performances of all students included in this study regarding the case lesson were evaluated by means of a knowledge test consisting of 10 questions and a Mentimeter application in which they could indicate their nursing diagnoses. The students will solve the tests after the case lessons are completed. The scores that can be obtained from the tests are between 0-100. As the score of the students increases, it can be interpreted that the level of knowledge increases. In the Mentimeter application, students will be asked to write 5 nursing diagnoses. There is no scoring here, but the application creates a word cloud with the most given answer in a larger font size.
**Measure:** Case management performance
**Time Frame:** 3 hours
**Description:** The level of satisfaction with the case analysis lecture was evaluated using the VAS scale. The VAS scale is scored between 1-10. Students indicate their satisfaction with the processing of the case lesson. High scores on the VAS indicate a high level of satisfaction.
**Measure:** Case Satisfaction
**Time Frame:** 3 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* having taken nursing process lecture before
* having planned care for at least one surgical patient in clinical practice before
* having a mobile phone with internet connection
Exclusion Criteria:
* not attending the case analysis lecture
* not being an active student
* incomplete completion of the data collection forms
* not accepting to participate in the study
**Healthy Volunteers:** True
**Maximum Age:** 25 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Kayseri
**Country:** Turkey
**Facility:** Erciyes University
#### Overall Officials
**Official 1:**
**Affiliation:** TC Erciyes University
**Name:** Seda Akutay, Ress. Asst.
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443970
**Brief Title:** Low and High Flow Suctioning in Intubated Infants
**Official Title:** Physiological Consequences of Low and High Flow Endotracheal Suctioning Devices in Intubated Preterm and Term Infants
#### Organization Study ID Info
**ID:** AAAU9006
#### Organization
**Class:** OTHER
**Full Name:** Columbia University
### Status Module
#### Completion Date
**Date:** 2025-10-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-04-28
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Columbia University
#### Responsible Party
**Investigator Affiliation:** Columbia University
**Investigator Full Name:** Rakesh Sahni
**Investigator Title:** Professor of Pediatrics
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Preterm and term intubuted infants in the NICU will undergo two sequential suctioning procedures: a new, FDA-approved suction device called EXSALTA (ED) and the standard conventional wall (SCW). The physiological consequences, i.e. changes in heart rate (HR), oxygen saturation (SpO2), cerebral oxygenation (C-rSO2), and cerebral fractional oxygen extraction (C-FOE) between ED and SCW ETT tracheal suctioning system in both open and closed catheter system settings will be evaluated using a randomized cross over design in preterm and term infants receiving mechanical ventilation via an ETT. This study will evaluate the hypothesis that there will be significantly lower variations in HR, SpO2, C-rSO2, and C-FOE during ETT suctioning with ED compared to SCW suctioning systems under both open and close ETT suction settings.
**Detailed Description:** Respiratory failure in neonates frequently requires mechanical ventilation through an endotracheal tube (ETT). The presence of an ETT inhibits the infant's intrinsic ability to clear endogenous lung secretions effectively with compromised glottic closure and impaired muccociliary function, and thus regular supportive suctioning of the ETT is essential. The benefits of patent airway are evident, but adverse effects may also result from suctioning which are especially deleterious in extremely preterm infants with immature pulmonary and systemic hemodynamic function. These adverse effects include transient hypoxemia and oxygen desaturation, vasovagal reactions, altered central and cerebral hemodynamics, atelectasis, pneumothorax, and mucosal damage. The cardiorespiratory instability during ETT suctioning is partially attributed to alveolar decruitment and loss of lung volume from disconnecting the ETT from the ventilator circuit and negative suction pressure. Maintenance of lung volume is essential to optimize gas exchange and prevent ventilator induced lung injury. The magnitude of lung volume loss is related to catheter size and applied suctioning pressure and flow, highlighting the complexity of interaction between suction technique, lung mechanics and disease state. In accordance with industry standard codes, a high flow rate is essential to ensure the rapid removal of fluid and secretions from the desired site and the standard conventional wall (SCW) suction outlets provide a minimum flow of approximately 85 liters per minute. Such high flows can lead to endotracheal suctioning-induced alveolar decruitment that may of significant clinical relevance. Recently, a low flow technology suction device EXSALTA (ED) for clearing ETT secretions in patients on ventilators has been approved by FDA. The device uses peristaltic action to move fluids from the patient to a collection canister at a fixed flow rate of 1.4 L/min and eliminates the uncontrolled flow of air from the patient's lungs. The user selects a desired pressure level that is independent of the flow rate, a feature unavailable with SCW wall suction equipment used at patient's bedside. This exceptional microprocessor-controlled tabletop suction device, available at any suction setting, reduces risk of negative pressures in the lungs to help prevent alveolar collapse and hypoxia associated with standard suctioning techniques. This study will examine the hypothesis that there will be significantly lower variations in heart rate (HR), oxygen saturation (SpO2), cerebral oxygenation (C-rSO2), and cerebral fractional oxygen extraction (c-FOE) with ED compared to SCW suction system during open or closed ETT suctioning. To test this hypothesis, the physiological consequences of two ETT suctioning systems in preterm and term infants will be evaluated using the following aims:
AIM 1. To compare the variations in HR (bpm), SpO2 (%), C-rSO2 (%), C-FOE (%) between ED and SCW suctioning systems during routine standard care open and closed ETT suctioning.
AIM II. To compare the incidence (episodes) of cardiorespiratory disturbances, i.e. bradycardia (HR\<80 bpm) and/or hemoglobin oxygen desaturation (SpO2) \< 80% for more than 10s during suctioning with ED and SCW suctioning system during routine standard care open and closed ETT suctioning.
### Conditions Module
**Conditions:**
- Respiratory Failure
**Keywords:**
- cardiorespiratory disturbances
- neonates
- EXSALTA
- Endotracheal Suctioning
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** In each group of study infants (open and closed ETT suctioning), the enrolled subjects will experience ETT suctioning with both methods, i.e. with ED and SCW suctioning systems. Each study infant will undergo two sequential suctioning procedures each day during the two-day study period. On day-1, the infant will be randomly assigned the ED or SCW suctioning device during the first maneuver and the devices will be alternated during the second maneuver. The suctioning device order will be reversed on study day-2 as shown in the study protocol below. In all each infant will have four suctioning maneuvers over two days, two each with ED and SCW suctioning devices.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Device: Exsalta Suction Device
**Label:** Exsalta Device suctioning
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Device: Exsalta Suction Device
**Label:** Coventional wall suctioning
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Coventional wall suctioning
- Exsalta Device suctioning
**Description:** Low flow endotracheal suction device
**Name:** Exsalta Suction Device
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Measured as beats per minute
**Measure:** Change in heart rate (HR)
**Time Frame:** Before suctioning (baseline) and up to 1-hour after suctioning
**Description:** Measured as percent (%) change
**Measure:** Change in oxygen saturation (SpO2)
**Time Frame:** Before suctioning (baseline) and up to 1-hour after suctioning
**Description:** Measured as percent (%) change
**Measure:** Change in cerebral oxygenation (C-rSO2)
**Time Frame:** Before suctioning (baseline) and up to 1-hour after suctioning
**Description:** Measured as difference in SpO2 and C-rSO2 (%)
**Measure:** Change in cerebral fractional oxygen extraction (c-FOE)
**Time Frame:** Before suctioning (baseline) and up to 1-hour after suctioning
#### Secondary Outcomes
**Description:** Count (episodes) of HR\<80% for more than 10 sec
**Measure:** Incidence of bradycardia
**Time Frame:** Before suctioning (baseline) and up to 1-hour after suctioning
**Description:** Count (episodes) of SpO2\<80% for more than 10 sec
**Measure:** Incidence of hemoglobin oxygen desaturation
**Time Frame:** Before suctioning (baseline) and up to 1-hour after suctioning
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Preterm and term infants with birth weight more than 1000g receiving ETT suctioning
Exclusion Criteria:
* Infants with cyanotic congenital heart disease and cardiac rhythm disorders (arrythmias) will be excluded from the study.
**Maximum Age:** 28 Days
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Rakesh Sahni, MD
**Phone:** 212-305-9743
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** New York
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Rakesh Sahni
- **Phone:** 212-305-9743
- **Role:** CONTACT
**Country:** United States
**Facility:** Columbia University
**State:** New York
**Zip:** 10032-3720
#### Overall Officials
**Official 1:**
**Affiliation:** Columbia University
**Name:** Rakesh Sahni, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
### Condition Browse Module - Browse Leaves
- ID: M14968
- Name: Respiratory Insufficiency
- Relevance: HIGH
- As Found: Respiratory Failure
- ID: M25869
- Name: Premature Birth
- 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
### Condition Browse Module - Meshes
- ID: D000012131
- Term: Respiratory Insufficiency
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443957
**Brief Title:** The Preventive Effect of Different Doses of Intranasal Insulin on Postoperative Delirium
**Official Title:** The Preventive Effect and Safety of Different Doses of Insulin Nasal Administration on Postoperative Delirium in Elderly Hip Fracture Patients - a Randomized, Single Blind, Parallel Controlled, Single Center Clinical Trial
#### Organization Study ID Info
**ID:** 23K214-001
#### Organization
**Class:** OTHER
**Full Name:** The First Hospital of Jilin University
### Status Module
#### Completion Date
**Date:** 2024-04-13
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-04-13
**Type:** ACTUAL
#### Start Date
**Date:** 2023-07-29
**Type:** ACTUAL
**Status Verified Date:** 2023-08
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The First Hospital of Jilin 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:** Postoperative delirium is one of the common complications in the older aldults after surgery, which can lead to longer hospita stay，memory loss and reduced quality of life. There is currently no specific treatment. Therefore, it is important to prevent the occurrence of postoperative delirium. This study investigated the effect of intranasal insulin administration on the prevention of postoperative delirium and compared different doses of insulin to find a safe and acceptable method for preventing delirium.
**Detailed Description:** Hip fractures are a common trauma in older adults and occur mainly in older people with osteoporosis. Surgery is the preferred choice for the vast majority of patients with severe pain and limited mobility in older aldults with hip fractures, resulting in higher mortality and disability rates with conservative treatment. But postoperative delirium becomes a challenge. At present, the treatment of delirium includes pharmacological and non-pharmacological methods, but the effect is limited, and now the focus is on preventing delirium, so this study investigated the effect of intranasal insulin administration on the prevention of postoperative delirium.
### Conditions Module
**Conditions:**
- Postoperative Delirium
**Keywords:**
- Postoperative delirium
- Insulin
- Intranasal administration
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 129
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The patient was given 1ml of normal saline intranasally at 19:00 on the first day of surgery, 50 minutes before anesthesia on the day of surgery, and 19:00 on the day of surgery.
**Intervention Names:**
- Drug: Intranasal normal saline
**Label:** Intranasal normal saline
**Type:** PLACEBO_COMPARATOR
#### Arm Group 2
**Description:** The patient was given 1ml of 20U insulin intranasally at 19:00 on the first day of surgery, 50 minutes before anesthesia on the day of surgery, and 19:00 on the day of surgery.
**Intervention Names:**
- Drug: Intranasal insulin-20U
**Label:** Intranasal insulin-20U
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** The patient was given 1ml of 40U insulin intranasally at 19:00 on the first day of surgery, 50 minutes before anesthesia on the day of surgery, and 19:00 on the day of surgery.
**Intervention Names:**
- Drug: Intranasal insulin-40U
**Label:** Intranasal insulin-40U
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intranasal normal saline
**Description:** The patient was given 1ml of normal saline intranasally at 19:00 on the first day of surgery, 50 minutes before anesthesia on the day of surgery, and 19:00 on the day of surgery.
**Name:** Intranasal normal saline
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Intranasal insulin-20U
**Description:** The patient was given 1ml of 20U insulin intranasally at 19:00 on the first day of surgery, 50 minutes before anesthesia on the day of surgery, and 19:00 on the day of surgery.
**Name:** Intranasal insulin-20U
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Intranasal insulin-40U
**Description:** The patient was given 1ml of 40U insulin intranasally at 19:00 on the first day of surgery, 50 minutes before anesthesia on the day of surgery, and 19:00 on the day of surgery.
**Name:** Intranasal insulin-40U
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The CAM-ICU scale is used to evaluate whether postoperative delirium occurs in three groups of patients. The scale is divided into four parts: acute changes and fluctuations in consciousness state, attention disorders, changes in consciousness level, and cognitive confusion. If acute changes in consciousness and attention deficit occur simultaneously, combined with changes in consciousness level and cognitive confusion, either can be diagnosed as postoperative delirium.
**Measure:** postoperative delirium
**Time Frame:** From 18:00 to 19:00 on the 1st postoperative day, the 2nd postoperative day, and the 3rd postoperative day,
#### Secondary Outcomes
**Description:** Assess postoperative pain，0 represents painless, 10 represents severe pain, and the higher the score, the more severe the pain will be.
**Measure:** visual analogue scale
**Time Frame:** On the 1st postoperative day, the 2nd postoperative day, and the 3rd postoperative day,
**Description:** The patient underwent neuraxial anesthesia to obtain 0.5ml of cerebrospinal fluid and measure the lactate content in the cerebrospinal fluid
**Measure:** Lactate content in cerebrospinal fluid
**Time Frame:** During the anesthesia
**Description:** A blood glucose meter is used to measure the patient's fingerstick blood glucose
**Measure:** Blood glucose values
**Time Frame:** 1 day before the operation, 40 minutes after nasal administration of insulin or normal saline, before surgery and immediately after surgery
**Description:** The patient underwent neuraxial anesthesia to obtain 0.5ml of cerebrospinal fluid and measure the glucose content in the cerebrospinal fluid
**Measure:** Glucose content in cerebrospinal fluid
**Time Frame:** During the anesthesia
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Patients with hip fracture scheduled for unilateral hip arthroplasty or intramedullary nailing under subarachnoid block.
Both genders. Age ≥65 years old. Body mass index (BMI) ≤24kg/m2. American Society of Anesthesiologists (ASA) grade I-III.
Exclusion Criteria:
Contraindications to nasal administration (nasal defects or lesions). History of insulin allergy. Inability to communicate preoperatively (coma, severe visual or hearing impairment).
History of severe heart,Liver and kidney disease. History of psychiatric disorders. Preoperative delirium. Multiple traumas or fractures. Contraindications to subarachnoid block.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Changchun
**Country:** China
**Facility:** The first hospital of Jilin University
### References Module
#### References
**Citation:** Marcantonio ER. Delirium in Hospitalized Older Adults. N Engl J Med. 2017 Oct 12;377(15):1456-1466. doi: 10.1056/NEJMcp1605501.
**PMID:** 29020579
**Citation:** Oh ES, Fong TG, Hshieh TT, Inouye SK. Delirium in Older Persons: Advances in Diagnosis and Treatment. JAMA. 2017 Sep 26;318(12):1161-1174. doi: 10.1001/jama.2017.12067.
**PMID:** 28973626
**Citation:** Craft S, Raman R, Chow TW, Rafii MS, Sun CK, Rissman RA, Donohue MC, Brewer JB, Jenkins C, Harless K, Gessert D, Aisen PS. Safety, Efficacy, and Feasibility of Intranasal Insulin for the Treatment of Mild Cognitive Impairment and Alzheimer Disease Dementia: A Randomized Clinical Trial. JAMA Neurol. 2020 Sep 1;77(9):1099-1109. doi: 10.1001/jamaneurol.2020.1840.
**PMID:** 32568367
**Citation:** Huang Q, Li Q, Qin F, Yuan L, Lu Z, Nie H, Gong G. Repeated Preoperative Intranasal Administration of Insulin Decreases the Incidence of Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Radical Gastrointestinal Surgery: A Randomized, Placebo-Controlled, Double-Blinded Clinical Study. Am J Geriatr Psychiatry. 2021 Dec;29(12):1202-1211. doi: 10.1016/j.jagp.2021.02.043. Epub 2021 Feb 23.
**PMID:** 33757723
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003221
- Term: Confusion
- ID: D000019954
- Term: Neurobehavioral Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M6894
- Name: Delirium
- Relevance: HIGH
- As Found: Delirium
- ID: M26370
- Name: Fractures, Bone
- Relevance: LOW
- As Found: Unknown
- ID: M9696
- Name: Hip Fractures
- Relevance: LOW
- As Found: Unknown
- ID: M772
- Name: Emergence Delirium
- Relevance: HIGH
- As Found: Postoperative Delirium
- ID: M6446
- Name: Confusion
- Relevance: LOW
- As Found: Unknown
- ID: M21826
- Name: Neurobehavioral Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- 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: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003693
- Term: Delirium
- ID: D000071257
- Term: Emergence Delirium
### Intervention Browse Module - Ancestors
- ID: D000007004
- Term: Hypoglycemic Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: Micro
- Name: Micronutrients
### Intervention Browse Module - Browse Leaves
- ID: M10365
- Name: Insulin
- Relevance: HIGH
- As Found: Day 1
- ID: M173166
- Name: Insulin, Globin Zinc
- Relevance: HIGH
- As Found: Day 1
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M17768
- Name: Zinc
- Relevance: LOW
- As Found: Unknown
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000007328
- Term: Insulin
- ID: C000557859
- Term: Insulin, Globin Zinc
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443944
**Brief Title:** An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG
**Official Title:** An Expanded Access Program of Cretostimogene Grenadenorepvec in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)
#### Organization Study ID Info
**ID:** CRETO-EAP
#### Organization
**Class:** INDUSTRY
**Full Name:** CG Oncology, Inc.
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** AVAILABLE
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**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:** CG Oncology, Inc.
#### Responsible Party
**Type:** SPONSOR
### Description Module
**Brief Summary:** This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC unresponsive to BCG.
**Detailed Description:** All participants will be assigned the same treatment schedule. Participants will receive an induction course and, if there is no disease recurrence at Week 13, participants will receive a cycle of 3 weekly treatments up to Week 15.
If there is persistent HG Ta and/or CIS at Week 13, participants may receive a second induction course.
If there is no disease present thereafter, participants will receive 3 weekly treatment cycles every 12 weeks through Month 12.
After Month 12, participants will receive 3 weekly treatment cycles every 6 months through the last treatment cycle at Month 24, or until discontinuation from the study treatment.
Disease status will be assessed using urine cytology, cystoscopy, and directed TURBT/biopsy (if indicated) every 12 weeks and CTU/MRU every 24 weeks, for up to 2 years.
### Conditions Module
**Conditions:**
- Non-Muscle Invasive Bladder Cancer
- Urothelial Carcinoma
- Urologic Cancer
- Bladder Cancer
**Keywords:**
- Urology
- Bladder Cancer
- Non Muscle Invasive Bladder Cancer
- Cretostimogene Grenadenorepvec
### Design Module
#### Expanded Access Types
**Treatment:** True
**Study Type:** EXPANDED_ACCESS
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Engineered Oncolytic Adenovirus
**Name:** Cretostimogene Grenadenorepvec
**Other Names:**
- CG0070
**Type:** DRUG
#### Intervention 2
**Description:** Transduction-enhancing agent
**Name:** n-dodecyl-B-D-maltoside
**Other Names:**
- DDM
**Type:** OTHER
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Have pathologically confirmed BCG unresponsive CIS. There is no maximum limit to the amount of prior BCG treatment, but maintenance BCG should be administered on a schedule consistent with standard induction-maintenance protocols. Specifically, the definition of BCG unresponsive CIS will also require the following:
1. Pathologically confirmed relapsed or persistent CIS (with or without HG Ta or HG T1 disease) within 12 months of last dose of adequate BCG treatment for HGUC.
2. Completion of qualifying BCG treatment (e.g., "5+2" minimum exposure) within 12 months of the initial qualifying dose of BCG.
3. Pathological confirmation of BCG unresponsive CIS within 16 weeks of study enrollment.
4. CIS specimen must be predominantly urothelial (transitional cell) and have less than 50% variant histology.
5. No maximum limit to the amount of BCG administered; however, there should be no more than 12 months between cycles of BCG.
* Have all Ta and/or T1 disease and all CIS resected or fulgurated, as feasible, prior to study treatment NOTE: T1 disease resection site must have biopsy evaluation of the prior resection site 2-12 weeks prior to initial study treatment.
* Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy according to Investigator assessment.
* Acceptable baseline organ function
Exclusion Criteria:
* Muscle invasive bladder cancer, locally advanced or metastatic bladder cancer.
* Has had active autoimmune or inflammatory disease requiring systemic treatment within 4 weeks of Day 1. Replacement therapy is not considered an excluded form of systemic treatment and is allowed.
* Has received systemic anti-cancer therapy, including investigational agents, within 4 weeks of Day 1
* Is pregnant, currently breastfeeding or intending to breastfeed, beginning at Screening through 6 weeks after the last study treatment.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Andy Darilek, MD
**Phone:** 949-419-6149
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Vijay Kasturi, MD
**Phone:** 949-419-6149
**Role:** CONTACT
### References Module
#### References
**Citation:** Chang SS, Boorjian SA, Chou R, Clark PE, Daneshmand S, Konety BR, Pruthi R, Quale DZ, Ritch CR, Seigne JD, Skinner EC, Smith ND, McKiernan JM. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline. J Urol. 2016 Oct;196(4):1021-9. doi: 10.1016/j.juro.2016.06.049. Epub 2016 Jun 16.
**PMID:** 27317986
**Citation:** Holzbeierlein JM, Bixler BR, Buckley DI, Chang SS, Holmes R, James AC, Kirkby E, McKiernan JM, Schuckman AK. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline: 2024 Amendment. J Urol. 2024 Apr;211(4):533-538. doi: 10.1097/JU.0000000000003846. Epub 2024 Jan 24.
**PMID:** 38265030
#### See Also Links
**Label:** NCCN Guidelines Bladder Cancer 3.2023
**URL:** https://www.nccn.org/guidelines/recently-published-guidelines
**Label:** NCCN Guidelines Bladder Cancer 4.2024
**URL:** http://www.nccn.org/guidelines/guidelines-detail?category=1&id=1417
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000001745
- Term: Urinary Bladder Diseases
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- 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: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M5030
- Name: Urinary Bladder Neoplasms
- Relevance: HIGH
- As Found: Bladder Cancer
- ID: M5551
- Name: Carcinoma, Transitional Cell
- Relevance: LOW
- As Found: Unknown
- ID: M2976
- Name: Non-Muscle Invasive Bladder Neoplasms
- Relevance: HIGH
- As Found: Non-muscle Invasive Bladder Cancer
- ID: M17320
- Name: Urologic Neoplasms
- Relevance: HIGH
- As Found: Urologic Cancer
- ID: M17315
- Name: Urogenital Neoplasms
- 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: M5026
- Name: Urinary Bladder Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital 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: T5693
- Name: Transitional Cell Carcinoma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001749
- Term: Urinary Bladder Neoplasms
- ID: D000093284
- Term: Non-Muscle Invasive Bladder Neoplasms
- ID: D000014571
- Term: Urologic Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4793
- Name: BCG Vaccine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443931
**Acronym:** BLOCK
**Brief Title:** Cryoablation of Intercostal Nerves for Pain Management in Early Postoperative Period in Patients With Minimally Invasive Mitral Valve Surgery
**Official Title:** Cryoablation of Intercostal Nerves for Pain Management in Early Postoperative Period in Patients With Minimally Invasive Mitral Valve Surgery: a Pilot Prospective Randomized Study
#### Organization Study ID Info
**ID:** 01-4
#### Organization
**Class:** NETWORK
**Full Name:** Meshalkin Research Institute of Pathology of Circulation
### Status Module
#### Completion Date
**Date:** 2025-02-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-02-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-10
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** NETWORK
**Name:** Meshalkin Research Institute of Pathology of Circulation
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A single-center, pilot, prospective, randomized clinical trial with a 1:1 allocation ratio. The aim of our trial is to determine whether cryoablation of intercostal nerves provides a clinically significant analgesic effect, which is reflected in a decrease in opioid analgesics consumption and in a decrease in pain according to VAS in patients undergoing minimally invasive mitral valve surgery. To obtain preliminary data for planning a subsequent larger prospective randomized trial.
**Detailed Description:** Cardiovascular diseases are one of the main causes of death worldwide. According to pathological studies, heart defects occur in 4-7% of cases, and the most common defect among the defects is damage to the mitral valve \[1\]. Significant advances in surgical practice, instrumentation, tissue manipulation, and perfusion technology have made it possible to perform mitral valve surgery using mini-approaches. Minimally invasive mitral valve surgery has become the standard of care in some specialized cardiac centers around the world due to its excellent results, even despite longer cardiopulmonary bypass times and aortic occlusion. In 2008, P. Modi and co-authors, a meta-analysis has been published in which the authors come to the conclusion that a minimally invasive approach for correcting mitral valve pathology actually has significant advantages: early activation of patients, shorter duration of stay in the recovery room, shorter wound healing times, advantages in case of repeated interventions, less the number of bleedings and purulent-septic complications compared to classical sternotomy \[2\]. But despite all the advantages of this approach, severe pain after minimally invasive cardiac surgery continues to remain a serious problem \[3\]. Acute pain occurs after dissection of the chest, pleura and pericardium, compression of the intercostal nerve with a retractor, as well as dissection of the intercostal and pectoral muscles during surgical access. It limits breathing and cough in the postoperative period, which can subsequently lead to hypoxemia, sputum stagnation, atelectasis, pneumonia, myocardial ischemia, slow recovery, and also an increase in the length of hospitalization \[4\]. Therefore, additional emphasis and attention is paid to protocols for early functional restoration and pain reduction for this group of patients. There are protocols for "accelerated recovery after surgery" (ERAS - Enhanced Recovery After Surgery), their use makes it possible to achieve shorter stays in the intensive care unit, reduce hospitalization, improve treatment outcomes and reduce financial costs. One of the components of ERAS is the use of additional pain management modalities \[5\]. However, in cardiac surgery, traditional methods of regional anesthesia, such as thoracic epidural anesthesia or paravertebral block, are not usually used due to intraoperative heparinization and the associated higher risk of spinal or epidural hematoma. Finding an optimal and effective pain management strategy for this category of patients remains an unsolved problem today.
Intercostal nerve cryoablation is considered a relatively new treatment for postoperative pain in patients undergoing minimally invasive mitral valve surgery. One of the first studies of cryoneurolysis was conducted back in 1974 in thoracic surgery \[9\]. In 76 patients, the use of intercostal cryoablation resulted in a significant reduction in postoperative opioid analgesic consumption. These results were subsequently confirmed in several other studies and the data were retrospective. In 2000, a prospective randomized controlled trial was published involving 30 patients who underwent minimally invasive mitral valve surgery or minimally invasive coronary artery bypass grafting and underwent intercostal cryoablation. According to the results, a decrease in postoperative pain syndrome was observed, and less painkillers were required \[10\].
In the study O'Connor LA et al. In patients undergoing surgical stabilization of the ribs, cryoablation of the intercostal nerves resulted in a 25% reduction in opioid analgesics consumption compared with patients who received an extrapleural catheter, and pain scores were reduced by 22% in the cryoablation group \[7\]. Similar results (cryoablation made it possible to significantly reduce morphine consumption compared to the control group and reduce pain)were also described inrecent retrospective studies through 2023 in other patient groups: patients who have undergone pulmonary resectionusing single-port thoracic video-assisted access, where cryoablation was used as a method of postoperative pain relief \[8\] and patients undergoing lung transplantation \[12\].
In the FROST study for 2021 the use of this method in patients with lateral thoracotomy showed significant improvement in spirography parameters (FEV1, FVC) after 48 hours, as well as 30 and 60 days after surgery \[6\]. Studying the influence of pain was not the main objective of this work; pain was assessed using VAS and did not show a difference. However, improvement in breathing parameters in the early postoperative period may indirectly be associated with a lower level of pain and a more comfortable state of the patient; the consumption of opioid analgesics was not properly assessed in this study.
In 2021Peter I Cha and others published a systematic review of 23 studies on the effectiveness of intercostal cryoneurolysis in patients with pectus excavatum, lateral thoracotomy, post-thoracotomy pain syndrome, traumatic rib fracture and chest wall malignancy. Most studies have demonstrated a reduction in inpatient opioid analgesic use with intercostal nerve cryoablation compared with traditional pain management techniques. In patients requiring lateral thoracotomy, intercostal cryoablation results in decreased opioid analgesic dosage (grade 2A) and improved pain scores (grade 2C) postoperatively (PICO guidelines) \[11\].
Finding an effective and at the same time simple strategy for pain relief in the early postoperative period in patients undergoing minimally invasive mitral valve surgery is an urgent task; it is advisable to conduct a prospective clinical study with a well-thought-out design in this direction.
### Conditions Module
**Conditions:**
- Pain, Postoperative
- Opioid Analgesic Consumption
**Keywords:**
- cryoablation
- pain
- minimally invasive mitral valve surgery
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Patients undergoing minimally invasive mitral valve surgery while on cardiopulmonary bypass will be randomized into two groups:
1. Patients receiving cryoablation of intercostal nerves (CryoINB) as a method of pain relief.
2. Patients who will undergo a standard pain management protocol.
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients in the CryoINB group will undergo cryoablation of the intercostal nerves, at the end of surgery before weaning from CPB, using the "ArtiCue" device for 120 seconds at a temperature of -50°C to -70°C, in the intercostal spaces where the surgical approach is located, one intercostal space above and one below it.
**Intervention Names:**
- Procedure: cryoablation of intercostal nerves
**Label:** Cryoablation of intercostal nerves group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients in the group with the standard anesthesia protocol will receive an intercostal block in the area of surgical access - a single injection of 0.75% ropivacaine solution 20 ml.
**Label:** Standard pain management protocol group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cryoablation of intercostal nerves group
**Description:** Patients in the CryoINB group will undergo cryoablation of the intercostal nerves, at the end of surgery before weaning from CPB, using the "ArtiCue" device for 120 seconds at a temperature of -50°C to -70°C, in the intercostal spaces where the surgical approach is located, one intercostal space above and one below it. Cold leads to axonotmesis, in which the axon and myelin sheath are damaged, preventing the pain signal from traveling along the sensory nerve. However, the structural elements of the nerve are preserved, which promotes complete regeneration at a rate of 1-2 mm per day, thereby restoring normal function within several months.
**Name:** cryoablation of intercostal nerves
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Opioid analgesics consumption after surgery, calculated in MME
**Measure:** Opioid analgesic consumption
**Time Frame:** 48 hours after surgery
#### Secondary Outcomes
**Description:** We will use a visual analogue scale (VAS) to determine the intensity of pain
**Measure:** The intensity of pain
**Time Frame:** After extubation, 6, 12, 24, 36, 48 hours after surgery
**Measure:** Dynamics of spirography (FEV1, FVC)
**Time Frame:** before surgery, 48 hours after surgery, before the patient's discharge
**Measure:** Frequency of side effects (nausea, vomiting, etc.)
**Time Frame:** 48 hours after surgery
**Description:** yes/no
**Measure:** Need for inotropic/vasopressor support
**Time Frame:** during surgery and in the ICU
**Description:** number of hours
**Measure:** Duration of mechanical ventilation
**Time Frame:** 12 hours
**Description:** number of days
**Measure:** Duration of ICU stay
**Time Frame:** 10 days
**Description:** number of days
**Measure:** Duration of hospital stay
**Time Frame:** 60 days
**Description:** follow-up
**Measure:** CPPS, numbness in the right arm and in the area of surgical access
**Time Frame:** 2 and 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria:
* Written informed consent;
* Minimally invasive mitral valve surgery.
Non-inclusion criteria:
* patient refusal;
* pregnancy;
* treatment with antidepressants or epileptic drugs;
* depression, which can significantly affect the perception of pain;
* chronic use of analgesics;
* participation in competing randomized clinical trials.
Exclusion criteria:
- Extended mechanical ventilation, more than 12 hours.
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Gleb Moroz, PHD
**Phone:** 347 60 54
**Phone Ext:** 383
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Novosibirsk
**Contacts:**
***Contact 1:***
- **Name:** Gleb Moroz, PHD
- **Phone Ext:** 383
- **Role:** CONTACT
**Country:** Russian Federation
**Facility:** Meshalkin Research Institute of Pathology of Circulation
**Status:** RECRUITING
**Zip:** 630055
### References Module
#### References
**Citation:** Navia JL, Cosgrove DM 3rd. Minimally invasive mitral valve operations. Ann Thorac Surg. 1996 Nov;62(5):1542-4. doi: 10.1016/0003-4975(96)00779-5.
**PMID:** 8893611
**Citation:** Sherazee EA, Chen SA, Li D, Li D, Frank P, Kiaii B. Pain Management Strategies for Minimally Invasive Cardiothoracic Surgery. Innovations (Phila). 2022 May-Jun;17(3):167-176. doi: 10.1177/15569845221091779. Epub 2022 May 6. No abstract available.
**PMID:** 35521910
**Citation:** Lau WC, Shannon FL, Bolling SF, Romano MA, Sakwa MP, Trescot A, Shi L, Johnson RL, Starnes VA, Grehan JF. Intercostal Cryo Nerve Block in Minimally Invasive Cardiac Surgery: The Prospective Randomized FROST Trial. Pain Ther. 2021 Dec;10(2):1579-1592. doi: 10.1007/s40122-021-00318-0. Epub 2021 Sep 20.
**PMID:** 34545530
**Citation:** O'Connor LA, Houseman B, Cook T, Quinn CC. Intercostal cryonerve block versus elastomeric infusion pump for postoperative analgesia following surgical stabilization of traumatic rib fractures. Injury. 2023 Nov;54(11):111053. doi: 10.1016/j.injury.2023.111053. Epub 2023 Sep 18.
**PMID:** 37741705
**Citation:** Maxwell CM, Weksler B, Houda J, Fernando HC. Intercostal Cryoablation During Video-Assisted Lung Resection Can Decrease Postoperative Opioid Use. Innovations (Phila). 2023 Jul-Aug;18(4):352-356. doi: 10.1177/15569845231185583. Epub 2023 Jul 17.
**PMID:** 37461202
**Citation:** Nelson KM, Vincent RG, Bourke RS, Smith DE, Blakeley WR, Kaplan RJ, Pollay M. Intraoperative intercostal nerve freezing to prevent postthoracotomy pain. Ann Thorac Surg. 1974 Sep;18(3):280-5. doi: 10.1016/s0003-4975(10)64357-3. No abstract available.
**PMID:** 4413968
**Citation:** Bucerius J, Metz S, Walther T, Doll N, Falk V, Diegeler A, Autschbach R, Mohr FW. Pain is significantly reduced by cryoablation therapy in patients with lateral minithoracotomy. Ann Thorac Surg. 2000 Sep;70(3):1100-4. doi: 10.1016/s0003-4975(00)01766-5.
**PMID:** 11016387
**Citation:** Koons B, Suzuki Y, Cevasco M, Bermudez CA, Harmon MT, Dallara L, Ramon CV, Nottingham A, Ganjoo N, Diamond JM, Christie JD, Localio AR, Cantu E. Cryoablation in lung transplantation: Its impact on pain, opioid use, and outcomes. JTCVS Open. 2022 Nov 25;13:444-456. doi: 10.1016/j.xjon.2022.11.005. eCollection 2023 Mar.
**PMID:** 37063121
**Citation:** Bolotin G, Lazarovici H, Uretzky G, Zlotnick AY, Tamir A, Saute M. The efficacy of intraoperative internal intercostal nerve block during video-assisted thoracic surgery on postoperative pain. Ann Thorac Surg. 2000 Dec;70(6):1872-5. doi: 10.1016/s0003-4975(00)01757-4.
**PMID:** 11156086
**Citation:** Mamoun NF, Lin P, Zimmerman NM, Mascha EJ, Mick SL, Insler SR, Sessler DI, Duncan AE. Intravenous acetaminophen analgesia after cardiac surgery: A randomized, blinded, controlled superiority trial. J Thorac Cardiovasc Surg. 2016 Sep;152(3):881-889.e1. doi: 10.1016/j.jtcvs.2016.04.078. Epub 2016 May 5.
**PMID:** 27236864
#### See Also Links
**Label:** Bogachev-Prokofiev A. V. et al. Pathology of the mitral valve in connective tissue dysplasia
**URL:** https://doi.org/10.15829/1560-4071-2016-11-81-86
**Label:** Hoan D. T. et al. Continuous Unilateral Erector Spinae Plane Block versus Intravenous Analgesia in Minimally Invasive Cardiac Surgery: A Randomized Controlled Trial
**URL:** https://doi.org/10.3889/oamjms.2022.9071
**Label:** Borys M. et al. Erector spinae-plane block as an analgesic alternative in patients undergoing mitral and/or tricuspid valve repair through a right mini-thoracotomy-an observational cohort study
**URL:** https://doi.org/10.5114/wiitm.2019.85396
**Label:** Cha P. I. et al. Efficacy of intercostal cryoneurolysis as an analgesic adjunct for chest wall pain after surgery or trauma: systematic review
**URL:** https://doi.org/10.1136/tsaco-2021-000690
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-04-05
- Filename: Prot_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: False
- Label: Study Protocol
- Size: 414858
- Type Abbrev: Prot
- Upload Date: 2024-05-21T09:57
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010335
- Term: Pathologic Processes
- 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: M13069
- Name: Pain, Postoperative
- Relevance: HIGH
- As Found: Pain, Postoperative
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010149
- Term: Pain, Postoperative
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M1700
- Name: Ropivacaine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443918
**Brief Title:** A Just-in-Time Adaptive Intervention for Child and Family Mental Health
**Official Title:** A Just-in-Time Adaptive Intervention for Child and Family Mental Health
#### Organization Study ID Info
**ID:** R44MH123368
**Link:** https://reporter.nih.gov/quickSearch/R44MH123368
**Type:** NIH
#### Organization
**Class:** INDUSTRY
**Full Name:** Colliga Apps Corp.
#### Secondary ID Infos
**ID:** R44MH123368
**Link:** https://reporter.nih.gov/quickSearch/R44MH123368
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-23
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institute of Mental Health (NIMH)
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Colliga Apps Corp.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this clinical trial is to test an app-based just-in-time-adaptive intervention (JITAI). The intervention aims to improve child and family mental health. A JITAI provides in-the-moment feedback to coach families. The questions it tests are if the app will improve mental health and family functioning. Participants will download an app on their phone and complete JITAI sessions. Researchers will compare intervention and control groups to see if the app improves mental health.
**Detailed Description:** The following study tests the efficacy of an app-based program designed to improve child and family mental health and well-being. The intervention will include family-based activities for improving child and family mental health and functioning delivered as psychoeducation and activities through the smartphone app, as well as a just-in-time adaptive intervention (JITAI) component where AI analysis for family interactions will be used to provide real-time, dynamic feedback to families. Participants will be informed during consent that they will have a 50-50 chance of receiving the intervention. The study will assess caregiver and child functioning in a variety of domains, such as mental health symptoms, attachment style, and family conflict through a series of baseline and follow-up questionnaires. Caregivers may use their own smartphones, or they will be lent smartphones for the study. Caregivers and children will also be lent Fitbits/Apple Watches. The intervention will last 8 weeks. Data will include daily surveys, daily audio recordings, 15-minute surveys every 2 weeks about their experiences using the app, bi-weekly check-ins, psychoeducational modules, homework activities, JITAI sessions, and passively sensed data. The intervention will be administered through the smartphone app and will include daily 5-15-minute psychoeducation modules and practice sessions and daily JITAI sessions.
### Conditions Module
**Conditions:**
- Mental Health and Well-being
- Family Functioning
**Keywords:**
- Mental health and well-being
- Child development
- Digital mental health
- Digital intervention
- Family functioning
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Half of families will be randomly assigned to the intervention group. The intervention will include family-based activities for improving child and family mental health and functioning delivered as psychoeducation and activities through the smartphone app. The intervention also includes real-time feedback and coaching of family interactions through a just-in-time adaptive intervention (JITAI).
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** Participants will be informed during consent that they will have a 50-50 chance of receiving the intervention.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 357
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The intervention aims to improve child and family mental health and functioning through psychoeducation and family-based activities delivered via a smartphone app. This intervention also includes a just-in-time adaptive intervention (JITAI) for coaching family interactions in real-time. Caregivers will wear smartwatches and carry smartphones for 8 weeks. Children will wear smartwatches. A variety of types of data will be collected from the phones and watches, such as heart rate, activity levels, and sleep. We will also collect daily surveys, daily audio recordings, a 15-minute survey every 2 weeks about their experiences using the app, and check-in calls every 2 weeks.
**Intervention Names:**
- Behavioral: A Just-in-Time Adaptive Intervention for Child and Family Mental Health
**Label:** Intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Caregivers will wear smartwatches and carry smartphones for 8 weeks. Children will wear smartwatches. Participants will complete placebo psychoeducational modules matched in length and reading level to the intervention content. A variety of types of data will be collected from the phones and watches, such as heart rate, activity levels, and sleep. We will also collect daily surveys, daily audio recordings, a 15-minute survey every 2 weeks about their experiences using the app, and check-in calls every 2 weeks.
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention
**Description:** Families in the intervention group will download an app on their smartphones. The app will deliver psychoeducational modules and family-based homework activities. It will include a component where AI is used to assess the quality of family-based interactions and provide in-the-moment feedback and coaching to guide the family interaction.
**Name:** A Just-in-Time Adaptive Intervention for Child and Family Mental Health
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Children in the intervention group will evidence decreased physical health symptoms compared to children in the control group.
**Measure:** Child physical health measured via the Child Health Questionnaire
**Time Frame:** 8 weeks
**Description:** Caregivers in the intervention group will evidence decreased physical health symptoms compared to parents in the control group.
**Measure:** Caregiver physical health measured via the Patient Health Questionnaire
**Time Frame:** 8 weeks
#### Primary Outcomes
**Description:** Children in the intervention group will evidence decreased mental health symptoms compared to children in the control group.
**Measure:** Child mental health symptoms measured by the Child Behavior Checklist
**Time Frame:** 8 weeks
**Description:** Children in the intervention group will evidence increased secure attachment compared to children in the control group.
**Measure:** Child attachment measured via the Attachment Style Classification Questionnaire for Latency Age Children
**Time Frame:** 8 weeks
**Description:** Children in the intervention group will evidence decreased parent-child conflict compared to children in the control group.
**Measure:** Parent-child conflict measured via the Parent-Child Conflict Tactics Scale
**Time Frame:** 8 weeks
#### Secondary Outcomes
**Description:** Caregivers in the intervention group will evidence decreased mental health symptoms compared to caregivers in the control group.
**Measure:** Caregiver mental health measured via the Symptoms Checklist 27-Plus
**Time Frame:** 8 weeks
**Description:** Caregivers in the intervention group will evidence increased secure attachment compared to caregivers in the control group.
**Measure:** Caregiver attachment measured via the Experiences in Close Relationships Scale
**Time Frame:** 8 weeks
**Description:** Caregivers in the intervention group will evidence decreased inter-parental conflict compared to caregivers in the control group.
**Measure:** Inter-parental conflict measured via the Conflict Tactics Scale
**Time Frame:** 8 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria:
* A family income less than or equal to the 33rd percentile for their county of residence OR
* At least one participating family member identifies as belonging to an ethnic/racial minoritized group AND
* Child mental health symptoms at or above the 70th percentile based on any subscale of the Strengths and Difficulties Questionnaire AND
* Participants speak English and/or Spanish AND
* Have a child 6-9 years old at the time of enrollment AND
* Families must be located in Texas or Florida
Exclusion Criteria:
* Active suicidal ideation OR
* Active homicidal ideation OR
* Current child abuse OR
* Current violence in the home
Families meeting these exclusion criteria will undergo a clinical risk assessment and be referred for alternative treatment services.
**Minimum Age:** 6 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Matthew Ahle, B.S.
**Phone:** 512-514-6037
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Adela Timmons, Ph.D.
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Miami
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jonathan Comer, Ph.D.
- **Role:** CONTACT
**Country:** United States
**Facility:** Florida International University
**State:** Florida
**Status:** NOT_YET_RECRUITING
**Zip:** 33199
**Location 2:**
**City:** Austin
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Adela Timmons, Ph.D.
- **Role:** CONTACT
**Country:** United States
**Facility:** The University of Texas at Austin
**State:** Texas
**Status:** RECRUITING
**Zip:** 78712
#### Overall Officials
**Official 1:**
**Affiliation:** Colliga Apps
**Name:** Matthew Ahle, B.S.
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** The University of Texas at Austin
**Name:** Adela Timmons, Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** Florida International University
**Name:** Jonthan Comer, Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Requests can be submitted by providing the researcher's name, contact information, desired date of dataset access, and explanation for the use of data. Colliga Apps administrators will process requests and give access to approved and verified researchers after the completion of a data use agreement.
**Description:** Researchers can request access to data through Colliga's website by filling out a request form at: https://colliga.io/data-repository/.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** Data will become available within 1 year after the completion of the clinical trial. Individual requests for data access will be processed within 3 months. Data will be available for individual researchers' use for 1 year with an opportunity to renew yearly. The repository will be maintained for at least 3 years.
**URL:** https://colliga.io/data-repository/
### References Module
#### See Also Links
**Label:** Colliga Apps website
**URL:** http://colliga.io
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443905
**Brief Title:** Xueshuantong Injection (Lyophilized) in the Prevention of Venous Thromboembolism (VTE) in Hospitalized Patients
**Official Title:** Efficacy, Safety and Cost-effectiveness of Xueshuantong Injection (Lyophilized) in the Prevention of Venous Thromboembolism (VTE) in Hospitalized Patients at Risk of Bleeding: a Real-world Cohort Study
#### Organization Study ID Info
**ID:** JVMID-2023101
#### Organization
**Class:** OTHER
**Full Name:** China-Japan Friendship Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-08-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-26
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Guangxi Wuzhou Pharmaceutical (GROUP) Co., Ltd.
#### Lead Sponsor
**Class:** OTHER
**Name:** China-Japan Friendship Hospital
#### Responsible Party
**Investigator Affiliation:** China-Japan Friendship Hospital
**Investigator Full Name:** Wanmu Xie
**Investigator Title:** chief physician
**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 explore the efficacy, safety and cost-effectiveness of Xueshuantong (lyophilized) for the prevention of venous thromboembolism (VTE) in patients at risk of bleeding.
**Detailed Description:** This is a non-randomized, observational study.
This study primarily aims to investigate the efficacy, safety, and cost-effectiveness of using Xueshuantong injection (lyophilized) for preventing venous thromboembolism (VTE) in patients susceptible to bleeding. The subjects of the study comprise patients during the perioperative period (undergoing procedures lasting 45 minutes or longer), patients with a confirmed spontaneous cerebral hemorrhage (ICH), and patients with a confirmed acute ischemic stroke (AIS).
Additional objectives of this study including:
1. to evaluate the possible dose-dependency of Xueshuantong injection (lyophilized);
2. to evaluate the impact in coagulation function after administration of Xueshuantong injection (lyophilized)
### Conditions Module
**Conditions:**
- Venous Thromboembolism (VTE)
- Thromboembolism
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 21600
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Only Xueshuantong injection(lyophilized) is used after surgery
**Label:** PNS_ONLY
#### Arm Group 2
**Description:** No thrombus prophylaxis after surgery
**Label:** NON_INT
#### Arm Group 3
**Description:** Only low molecular weight heparin(LMWH) is used after surgery
**Label:** LMWH_ONLY
#### Arm Group 4
**Description:** Xueshuantong injection (lyophilized) and low molecular weight heparin are used simultaneously after surgery
**Label:** PNS+LMWH
#### Arm Group 5
**Description:** Conventional treatment
**Label:** ICH_CTL
#### Arm Group 6
**Description:** Conventional treatment + Xueshuantong injection (lyophilized)
**Label:** ICH_PNS
#### Arm Group 7
**Description:** Conventional treatment
**Label:** AIS_CTL
#### Arm Group 8
**Description:** Conventional treatment + Xueshuantong injection(lyophilized)
**Label:** AIS_PNS
### Outcomes Module
#### Primary Outcomes
**Description:** Incidence of venous thromboembolism (VTE)
**Measure:** Incidence of VTE
**Time Frame:** Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
#### Secondary Outcomes
**Description:** Proximal deep venous thrombosis (DVT).
**Measure:** Incidence of proximal DVT
**Time Frame:** Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
**Description:** Distal deep venous thrombosis (DVT).
**Measure:** Incidence of distal DVT
**Time Frame:** Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
**Description:** Pulmonary thromboembolism (PTE).
**Measure:** Incidence of PTE
**Time Frame:** Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
**Description:** Symptomatic venous thromboembolism (VTE).
**Measure:** Incidence of symptomatic VTE
**Time Frame:** Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
**Description:** Non-symptomatic venous thromboembolism (VTE)
**Measure:** Incidence of non-symptomatic VTE
**Time Frame:** Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
**Description:** Deaths of all causes.
**Measure:** Mortality
**Time Frame:** Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
**Description:** Healing time after surgery
**Measure:** Wound healing time
**Time Frame:** Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
**Description:** Time from admission to discharge
**Measure:** Length of stay
**Time Frame:** Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Men or women of ≥18 year old;
* Hospitalized between Jan 1, 2016 and Aug. 1, 2023;
* Received intravenous (IV) Xueshuantong (lyophilized) for ≥3 days;
* Who also meet one of the following criteria:
1. Perioperative patients:
Performed any of the following surgical procedures (≥ 45 minutes in duration) during hospitalization- general surgery, orthopedic surgery, obstetrics and gynecology surgery, neurosurgery, urology surgery, cardiothoracic surgery, obesity surgery or cancer surgery;
2. Hospitalization due to acute spontaneous cerebral hemorrhage:
Diagnosed as cerebral hemorrhage (acute/subacute), or subarachnoid hemorrhage, with clinical manifestations such as conscious disturbance, dyskinesia, or sensory dysfunction. Presence of cerebral hemorrhage was confirmed by imaging;
3. Hospitalization due to acute ischemic stroke:
Diagnosed as ischemic stroke, ischemic stroke (acute/subacute), cerebral infarction, or cerebral infarction (acute/subacute), acute stage or subacute stage of ischemic stroke, with clinical manifestations such as disturbance of consciousness, motor dysfunction, or sensory dysfunction. Presence of cerebral hemorrhage was confirmed by imaging.
Exclusion Criteria:
* Received any traditional Chinese medicine (TCM) that contains total saponins of panax notoginseseng (PNS) other than Xueshuantong (lyophilized);
* Females who are pregnant or breast-feeding;
* Diagnosed venous thromboembolism occurred before enrollment;
* Received intravenous thrombolytic therapy for other reasons during hospitalization;
* Received prophylactic or therapeutic doses of anticoagulants after major surgery;
* Placed vena cava filters for VTE prophylaxis before surgery;
* Received therapeutic dose of anticoagulants during the patient's hospital stay (AIS patients);
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Perioperative patients, spontaneous cerebral hemorrhage, acute ischemic cerebral infarction
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Beijing
**Country:** China
**Facility:** China-Japan Friendship Hospital
**State:** Beijing
**Zip:** 100000
**Location 2:**
**City:** Dongguan
**Country:** China
**Facility:** Dongguan Chinese Medicine Hospital
**State:** Guangdong
**Zip:** 523000
**Location 3:**
**City:** Foshan
**Country:** China
**Facility:** Foshan Hospital of Traditional Chinese Medicine
**State:** Guangdong
**Zip:** 528000
**Location 4:**
**City:** Guangzhou
**Country:** China
**Facility:** Guangzhou Red Cross Hospital
**State:** Guangdong
**Zip:** 510000
**Location 5:**
**City:** Liuzhou
**Country:** China
**Facility:** The First Affiliated Hospital of Guangxi Medical University
**State:** Guangxi
**Zip:** 545000
**Location 6:**
**City:** Nanning
**Country:** China
**Facility:** The First People's Hospital of Nanning
**State:** Guangxi
**Zip:** 530000
**Location 7:**
**City:** Wuzhou
**Country:** China
**Facility:** The People's Hospital of Wuzhou
**State:** Guangxi
**Zip:** 543000
**Location 8:**
**City:** Wuzhou
**Country:** China
**Facility:** Wuzhou Red Cross Hospital
**State:** Guangxi
**Zip:** 543000
**Location 9:**
**City:** Yulin
**Country:** China
**Facility:** Yulin Second People's Hospital
**State:** Guangxi
**Zip:** 537000
**Location 10:**
**City:** Shijiazhuang
**Country:** China
**Facility:** Hebei General Hospital
**State:** Hebei
**Zip:** 050000
**Location 11:**
**City:** Changsha
**Country:** China
**Facility:** The Third Hospital of Changsha
**State:** Hunan
**Zip:** 410000
**Location 12:**
**City:** Jingjiang
**Country:** China
**Facility:** Jingjiang Chinese Medicine Hospital
**State:** Jiangsu
**Zip:** 214500
**Location 13:**
**City:** Dezhou
**Country:** China
**Facility:** Qilu Hospital of Shandong University Dezhou Hospital
**State:** Shandong
**Zip:** 253000
**Location 14:**
**City:** Liaocheng
**Country:** China
**Facility:** Liaocheng People's Hospital
**State:** Shandong
**Zip:** 0635 252000
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000016769
- Term: Embolism and Thrombosis
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular 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: M16682
- Name: Thromboembolism
- Relevance: HIGH
- As Found: Thromboembolism
- ID: M27780
- Name: Venous Thromboembolism
- Relevance: HIGH
- As Found: Venous Thromboembolism
- ID: M9556
- Name: Hemorrhage
- Relevance: LOW
- As Found: Unknown
- ID: M16686
- Name: Thrombosis
- Relevance: LOW
- As Found: Unknown
- ID: M7784
- Name: Embolism
- Relevance: LOW
- As Found: Unknown
- ID: M19128
- Name: Embolism and Thrombosis
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013923
- Term: Thromboembolism
- ID: D000054556
- Term: Venous Thromboembolism
### Intervention Browse Module - Browse Branches
- Abbrev: FiAg
- Name: Fibrinolytic Agents
- Abbrev: AnCoag
- Name: Anticoagulants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M9579
- Name: Heparin
- Relevance: LOW
- As Found: Unknown
- ID: M46053
- Name: Calcium heparin
- Relevance: LOW
- As Found: Unknown
- ID: M9581
- Name: Heparin, Low-Molecular-Weight
- Relevance: LOW
- As Found: Unknown
- ID: M1943
- Name: Tinzaparin
- Relevance: LOW
- As Found: Unknown
- ID: M20153
- Name: Dalteparin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443892
**Brief Title:** Comparison of Pain Relief After Hip Fracture Surgery: Hip and Groin Nerve Block
**Official Title:** Comparison of Postoperative Analgesic Efficacy of Pericapsular Nerve Block (PENG) and Suprainguinal Fascia Iliaca Compartment Block(SFICB) in Intertrochanteric Femur Fractures
#### Organization Study ID Info
**ID:** BSH-ANES-MA-01
#### Organization
**Class:** OTHER_GOV
**Full Name:** Başakşehir Çam & Sakura City Hospital
### Status Module
#### Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-05-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Başakşehir Çam & Sakura City Hospital
#### Responsible Party
**Investigator Affiliation:** Başakşehir Çam & Sakura City Hospital
**Investigator Full Name:** Muzaffer GENCER
**Investigator Title:** Associate Professor Doctor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This observational prospective double-blind study aims to compare the analgesic effectiveness of the pericapsular nerve group block (PENG) group and the suprainguinal fascia iliaca compartment block(SFICB) group to be applied to relieve postoperative pain in participants over the age of 18 who will be treated under spinal anesthesia with intertrochanteric femur fracture. The main question it aims to answer is:
\* Demonstration of whether PENG block or SFICB is more effective for postoperative analgesia in patients who have undergone intertrochanteric femur fracture surgery, based on pain scores, opioid consumption and patient satisfaction.
ıntertrochanteric femur fractures cause severe pain with movement. Postoperatively, participants' movements are severely restricted, increasing the likelihood of complications.
In this study, participants' pain status, VAS score, opioid consumption through patient-controlled analgesia, and satisfaction will be measured with a survey at the end of the 24th hour.
**Detailed Description:** Intertrochanteric femoral fracture accounts for approximately 45% to 50% of all hip fractures. Intertrochanteric femur fractures cause severe pain with movement. Postoperatively, the movements of the participants are severely restricted, which increases the risk of deep vein thrombosis in the lower extremities, pulmonary infection and mortality in the participants.
Peripheral nerve blocks have been shown to have less impact on hemodynamics, respiratory function, and consciousness than systemic pain relief options. It is recommended as a first-line analgesia program, especially for hip surgeries, with its features of shortening postoperative recovery time, reducing the risk of pneumonia, and not hindering postoperative movement. Fascia Iliaca compartment block used in this area is safe and widely used in postoperative hip fractures. However, to provide effective analgesia for hip surgery, it is necessary to simultaneously block the femoral nerve, lateral femoral cutaneous nerve, and obturator nerve. It has been reported that suprainguinal fascia iliaca compartment block does not provide adequate analgesia and does not reduce opioid consumption because the obturatory nerve cannot be blocked. Therefore, blocking the femoral nerve, obturatory nerve and accessory obturatory nerves with PENG block has led to the idea that postoperative pain scores and opioid consumption will decrease significantly. In this study, we aim to compare the effectiveness of suprainguinal fascia iliaca compartment block and PENG block for postoperative analgesia based on pain scores and opioid consumption in intertrochanteric femur fractures.
Pain is a symptom known to be subjective, and in order to minimize differences between participants, it will be questioned with the Numeric Rating Scale (NRS), which is a standardized scale.
The total narcotic analgesic needs of the block-treated participants will be recorded with the PCA device inserted intravenously postoperatively, and their total Tramadol consumption will be recorded.
Mobilization start times and pain during the mobilization process will be questioned with the Turkish-American Pain Society Revised Patient Outcomes Survey.
The Turkish version of the revised American Pain Society patient outcomes survey for surgical patients will be used to evaluate participants' satisfaction with pain management. According to the confirmatory factor analysis fit indices of the Turkish-Revised American Pain Society Patient Outcomes Questionnaire, whose Cronbach's Alpha value was calculated as 0.88, its three-factor structure was found to be appropriate. The Turkish-Revised American Pain Society Patient Outcomes Questionnaire is a tool to improve the quality of pain management for adult patients. With this questionnaire (1) pain intensity and relief; (2) the impact of pain on activity, sleep, and negative emotions; (3) medication side effects; (4) usefulness of pain management information;(5) ability to participate in pain management decisions; and (6) the use of non-pharmacological techniques will be questioned.
Demographic characteristics of the participants, comorbidities, operation times and complications will be recorded and analyzed statistically.
### Conditions Module
**Conditions:**
- Opioid Use
- Pain, Postoperative
- Hip Fractures
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 66
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants with intertrochanteric femur fractures undergoing surgery under spinal anesthesia and receiving postoperative pericapsular nerve block (PENG).
**Intervention Names:**
- Procedure: Pericapsular Nerve Block (PENG)
**Label:** PENG Group
#### Arm Group 2
**Description:** Participants with intertrochanteric femur fractures undergoing surgery under spinal anesthesia and receiving postoperative suprainguinal fascia iliaca compartment block (SFICB).
**Intervention Names:**
- Procedure: Suprainguinal Fascia Iliaca Compartment Block (SFICB)
**Label:** SFICB Group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- PENG Group
**Description:** Evaluation of postoperative analgesic efficacy of PENG block in participants with intertrochanteric femur fractures undergoing surgery under spinal anesthesia.
**Name:** Pericapsular Nerve Block (PENG)
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- SFICB Group
**Description:** Evaluation of postoperative analgesic efficacy of SFICB block in participants with intertrochanteric femur fractures undergoing surgery under spinal anesthesia.
**Name:** Suprainguinal Fascia Iliaca Compartment Block (SFICB)
**Type:** PROCEDURE
### Outcomes Module
#### Other Outcomes
**Description:** The Turkish version of the revised American Pain Society patient outcomes survey for surgical patients will be used to evaluate patients' satisfaction with pain management. According to the confirmatory factor analysis fit indices of the Turkish-Revised American Pain Society Patient Outcomes Questionnaire, whose Cronbach's Alpha value was calculated as 0.88, its three-factor structure was found to be appropriate. The Turkish-Revised American Pain Society Patient Outcomes Questionnaire is a tool to improve the quality of pain management for adult patients. With this questionnaire (1) pain intensity and relief; (2) the impact of pain on activity, sleep, and negative emotions; (3) medication side effects; (4) usefulness of pain management information;(5) ability to participate in pain management decisions; and (6) the use of non-pharmacological techniques will be questioned.
**Measure:** Patient satisfaction
**Time Frame:** At the end of the patient-controlled analgesia procedure
#### Primary Outcomes
**Description:** Postoperative pain assessment is performed using the Numerical Rating Scale (NRS). Participants are asked about their rest pain at 0, 1, 6, 12 and 24 hours after applying a postoperative peripheral nerve block. With this method, participants rate their pain with a precise numerical value from 0 to 10. While zero(0) represents "no pain"; Ten (10) represents the opposite end of the pain continuum (e.g., "The most intense pain imaginable," "As intense pain as possible," "Maximum pain").
**Measure:** Effectiveness on pain scores
**Time Frame:** At 0, 1, 6, 12 and 24 hours after postoperative peripheral nerve block application
#### Secondary Outcomes
**Description:** After the surgery, participants will receive a peripheral nerve block procedure in the postoperative anesthetic care area, and then simultaneously receive intravenous patient-controlled analgesia (PCA) and start an infusion. "Tramadol" was preferred as the treatment method to be used for the PCA method. In preparation for PCA, 400 mg of tramadol is added to 100 cc of physiological saline. As PCA protocol, 1 cc/hour (4 mg/hour) basal infusion dose, 5 cc (20 mg) bolus dose, 30 minutes lockout period (maximum 2 bolus doses in 1 hour) are set. The total number of bolus doses administered by the participants on the PCA device at the end of 24 hours will be recorded and evaluated as the amount of additional opioid needed.
**Measure:** Effect on total narcotic analgesic consumption
**Time Frame:** Total number of bolus doses administered at the end of 24 hours of the intravenous PCA device inserted simultaneously after postoperative peripheral nerve block application
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Those with Interthorachanteric Femur Fracture
* Patients over 18 years of age
* ASA I-II-III
* Fully oriented and able to cooperate
* Patients who underwent PENG or Suprainguinal Fascia iliaca compartment block for postoperative analgesia after elective surgery.
Exclusion Criteria:
* ASA IV-V
* Patients under 18 years of age
* Presence of active infection in the area to be treated
* Chronic analgesic use
* Patients who cannot cooperate with postoperative pain follow-ups
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Participants who underwent surgery under spinal anesthesia with interthorachanteric femur fracture over the age of 18
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** MUZAFFER GENCER
**Phone:** 00905059436459
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** MEVLÜT AYDIN
**Phone:** 00905064284946
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Istanbul
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** MUZAFFER GENCER
- **Phone:** 00905059436459
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Basaksehir Çam Ve Sakura City Hospital
**Status:** RECRUITING
### References Module
#### References
**Citation:** Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
**PMID:** 30063657
**Citation:** Mosaffa F, Taheri M, Manafi Rasi A, Samadpour H, Memary E, Mirkheshti A. Comparison of pericapsular nerve group (PENG) block with fascia iliaca compartment block (FICB) for pain control in hip fractures: A double-blind prospective randomized controlled clinical trial. Orthop Traumatol Surg Res. 2022 Feb;108(1):103135. doi: 10.1016/j.otsr.2021.103135. Epub 2021 Oct 29.
**PMID:** 34715388
**Citation:** Kong M, Tang Y, Tong F, Guo H, Zhang XL, Zhou L, Ni H, Wang B, Liu Y, Liu J. The analgesic efficacy of pericapsular nerve group block in patients with intertrochanteric femur fracture: A randomized controlled trial. PLoS One. 2022 Oct 13;17(10):e0275793. doi: 10.1371/journal.pone.0275793. eCollection 2022.
**PMID:** 36227845
**Citation:** Allard C, Pardo E, de la Jonquiere C, Wyniecki A, Soulier A, Faddoul A, Tsai ES, Bonnet F, Verdonk F. Comparison between femoral block and PENG block in femoral neck fractures: A cohort study. PLoS One. 2021 Jun 4;16(6):e0252716. doi: 10.1371/journal.pone.0252716. eCollection 2021.
**PMID:** 34086782
**Citation:** Choi YS, Park KK, Lee B, Nam WS, Kim DH. Pericapsular Nerve Group (PENG) Block versus Supra-Inguinal Fascia Iliaca Compartment Block for Total Hip Arthroplasty: A Randomized Clinical Trial. J Pers Med. 2022 Mar 6;12(3):408. doi: 10.3390/jpm12030408.
**PMID:** 35330408
**Citation:** Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24.
**PMID:** 21401544
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000005264
- Term: Femoral Fractures
- ID: D000025981
- Term: Hip Injuries
- ID: D000007869
- Term: Leg Injuries
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010335
- Term: Pathologic Processes
- 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: BC26
- Name: Wounds and Injuries
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M13069
- Name: Pain, Postoperative
- Relevance: HIGH
- As Found: Pain, Postoperative
- ID: M26370
- Name: Fractures, Bone
- Relevance: HIGH
- As Found: Fracture
- ID: M9696
- Name: Hip Fractures
- Relevance: HIGH
- As Found: Hip Fracture
- ID: M8402
- Name: Femoral Fractures
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M23105
- Name: Hip Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M10881
- Name: Leg Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010149
- Term: Pain, Postoperative
- ID: D000050723
- Term: Fractures, Bone
- ID: D000006620
- Term: Hip Fractures
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443879
**Acronym:** LRNB
**Brief Title:** Loss and Return of Sensation After Axillary Brachial Plexus Nerve Block - Distally or Proximally
**Official Title:** Loss and Return of Sensation After Axillary Brachial Plexus Nerve Block - Distally or Proximally
#### Organization Study ID Info
**ID:** W1049
#### Organization
**Class:** OTHER
**Full Name:** Balgrist University Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-11-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-23
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Balgrist University Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Peripheral regional anesthesia is the current gold standard of opioid-sparing perioperative analgesia, especially in shoulder, upper limb, and leg surgery. Axillary brachial plexus nerve block is one possible block for upper limb surgery. Loss and return of sensation require time and loss of sensation is supposed to spread from the proximal part to the distal part of the upper limb. Interestingly, until now there is no study about the return of sensation related to the anatomic region.
The investigators hypothesize that the loss and return of sensation after axillary brachial plexus nerve block will first occur in the proximal part of the upper limb and last in the distal part.
**Detailed Description:** Peripheral regional anesthesia is the current gold standard of opioid-sparing perioperative analgesia, especially in shoulder, upper limb, and leg surgery.(1-8) Axillary brachial plexus nerve block is one possible block for upper limb surgery.(4, 5, 9) Loss and return of sensation require time. It is known from clinical practice that loss of sensation occurs from the proximal part of the arm to the distal part of the upper limb.
Interestingly, until now there is no study about the return of sensation related to the anatomic region. The investigators hypothesize that return of sensation after axillary brachial plexus nerve block will develop in the same direction like loss of sensation, what means from proximal to the distal part of the upper limb.
### Conditions Module
**Conditions:**
- Anesthesia
**Keywords:**
- Peripheral regional anesthesia
- Loss and return of sensation
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Evaluating loss and return of sensation after axillary brachial plexus nerve block
**Name:** Axillary brachial plexus nerve block: loss and return of sensation
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** A questionnaire will be used to record the loss of sensation in the upper limb. Sensation loss is recorded separately for the finger, hand, forearm, elbow, and arm. It will distinguish between initial and complete loss of sensation.
**Measure:** Loss of sensation after axillary brachial plexus nerve block
**Time Frame:** Pre-surgery
**Description:** A questionnaire will be used to record the return of sensation in the upper limb. Sensation return is recorded separately for the finger, hand, forearm, elbow, and arm. It will distinguish between initial and complete return of sensation.
**Measure:** Return of sensation after axillary brachial plexus nerve block
**Time Frame:** Immediately after the surgery
#### Secondary Outcomes
**Description:** Pain score (Numeric Rating Scale: 0 to 10) before loss of sensation after the axillary brachial plexus nerve block on a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.
**Measure:** Pain before
**Time Frame:** Pre-surgery
**Description:** Pain score (Numeric Rating Scale: 0 to 10) after loss of sensation after the axillary brachial plexus nerve block on a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.
**Measure:** Pain after
**Time Frame:** Immediately after the surgery
**Description:** Block failure yes or no
**Measure:** Block failure
**Time Frame:** Pre-surgery
**Description:** Amount of pain medication after surgery, measured in mg
**Measure:** Amount of pain medication
**Time Frame:** Immediately after the surgery up to 2 days
**Description:** The patient is expected to be an outpatient. If this does not occur, the days of hospitalization will be recorded.
**Measure:** Prolongation of hospitalization
**Time Frame:** Immediately after the surgery
**Description:** The patient will be asked to rate their satisfaction with the pain therapy on a scale from 0 to 10, with 0 indicating very dissatisfied and 10 indicating very satisfied.
**Measure:** Patients satisfaction with pain therapy
**Time Frame:** Immediately after the surgery
**Description:** The medical staff will be asked to rate their satisfaction with the execution of the axillary brachial plexus nerve block on a scale from 0 to 10, with 0 indicating very dissatisfied and 10 indicating very satisfied.
**Measure:** Satisfaction of medical staff with the execution of the axillary brachial plexus nerve block
**Time Frame:** Immediately after the surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Outpatients with planed surgery with axillary brachial plexus nerve block
* Informed consent as documented by signature
* Age ≥ 18 years
Exclusion Criteria:
* Patients with a known allergy towards the local anaesthetic
**Maximum Age:** 99 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** All outpatients undergoing upper limb surgery with axillary brachial plexus nerve block at Balgrist University Hospital will be eligible to take part in the project.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Stefani Dossi
**Phone:** +41 44 510 73 75
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Zürich
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Hagen Bomberg, Dr.med.
- **Phone:** +41 44 386 11 11
- **Role:** CONTACT
***Contact 2:***
- **Name:** Urs Eichenberger, Prof.Dr.med
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Hagen Bomberg, Dr.med
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** David Lorenzana, Dr.med
- **Role:** SUB_INVESTIGATOR
***Contact 5:***
- **Name:** Neeti Sharma, Med.pract
- **Role:** SUB_INVESTIGATOR
**Country:** Switzerland
**Facility:** Balgrist University Hospital
**State:** Zurich
**Status:** RECRUITING
**Zip:** 8008
#### Overall Officials
**Official 1:**
**Affiliation:** Balgrist University Hospital
**Name:** Hagen Bomberg, Dr.med.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Bomberg H, Bayer I, Wagenpfeil S, Kessler P, Wulf H, Standl T, Gottschalk A, Doffert J, Hering W, Birnbaum J, Spies C, Kutter B, Winckelmann J, Liebl-Biereige S, Meissner W, Vicent O, Koch T, Sessler DI, Volk T, Raddatz A. Prolonged Catheter Use and Infection in Regional Anesthesia: A Retrospective Registry Analysis. Anesthesiology. 2018 Apr;128(4):764-773. doi: 10.1097/ALN.0000000000002105.
**PMID:** 29420315
**Citation:** Bomberg H, Huth A, Wagenpfeil S, Kessler P, Wulf H, Standl T, Gottschalk A, Doffert J, Hering W, Birnbaum J, Spies C, Kutter B, Winckelmann J, Burgard G, Vicent O, Koch T, Sessler DI, Volk T, Raddatz A. Psoas Versus Femoral Blocks: A Registry Analysis of Risks and Benefits. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):719-724. doi: 10.1097/AAP.0000000000000643.
**PMID:** 28806216
**Citation:** Bomberg H, Kubulus C, List F, Albert N, Schmitt K, Graber S, Kessler P, Steinfeldt T, Standl T, Gottschalk A, Wirtz SP, Burgard G, Geiger P, Spies CD, Volk T; German Network for Regional Anaesthesia Investigators. Diabetes: a risk factor for catheter-associated infections. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):16-21. doi: 10.1097/AAP.0000000000000196.
**PMID:** 25474624
**Citation:** Bomberg H, Lorenzana D, Aguirre J, Eichenberger U. [Peripheral Regional Anaesthesia for Perioperative Analgesia]. Praxis (Bern 1994). 2021 Aug;110(10):579-589. doi: 10.1024/1661-8157/a003682. German.
**PMID:** 34344186
**Citation:** Bomberg H, Wetjen L, Wagenpfeil S, Schope J, Kessler P, Wulf H, Wiesmann T, Standl T, Gottschalk A, Doffert J, Hering W, Birnbaum J, Kutter B, Winckelmann J, Liebl-Biereige S, Meissner W, Vicent O, Koch T, Burkle H, Sessler DI, Volk T. Risks and Benefits of Ultrasound, Nerve Stimulation, and Their Combination for Guiding Peripheral Nerve Blocks: A Retrospective Registry Analysis. Anesth Analg. 2018 Oct;127(4):1035-1043. doi: 10.1213/ANE.0000000000003480.
**PMID:** 29863605
**Citation:** Donauer K, Bomberg H, Wagenpfeil S, Volk T, Meissner W, Wolf A. Regional vs. General Anesthesia for Total Knee and Hip Replacement: An Analysis of Postoperative Pain Perception from the International PAIN OUT Registry. Pain Pract. 2018 Nov;18(8):1036-1047. doi: 10.1111/papr.12708. Epub 2018 Jun 25.
**PMID:** 29758587
**Citation:** Gabriel RA, Swisher MW, Sztain JF, Furnish TJ, Ilfeld BM, Said ET. State of the art opioid-sparing strategies for post-operative pain in adult surgical patients. Expert Opin Pharmacother. 2019 Jun;20(8):949-961. doi: 10.1080/14656566.2019.1583743. Epub 2019 Feb 27.
**PMID:** 30810425
**Citation:** Luedi MM, Upadek V, Vogt AP, Steinfeldt T, Eichenberger U, Sauter AR. A Swiss nationwide survey shows that dual guidance is the preferred approach for peripheral nerve blocks. Sci Rep. 2019 Jun 24;9(1):9178. doi: 10.1038/s41598-019-45700-3.
**PMID:** 31235760
**Citation:** Marhofer P, Eichenberger U, Stockli S, Huber G, Kapral S, Curatolo M, Kettner S. Ultrasonographic guided axillary plexus blocks with low volumes of local anaesthetics: a crossover volunteer study. Anaesthesia. 2010 Mar;65(3):266-71. doi: 10.1111/j.1365-2044.2010.06247.x. Epub 2010 Jan 29.
**PMID:** 20121770
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443866
**Brief Title:** I-124 PET/CT Imaging and Dosimetry for RAI-Naïve or Refractory Thyroid Cancer
**Official Title:** CLINICAL UTILITY AND FEASIBILITY OF I-124 PET/CT IMAGING AND DOSIMETRY IN PATIENTS WITH THYROID CANCER
#### Organization Study ID Info
**ID:** MTOCP03
#### Organization
**Class:** OTHER
**Full Name:** Miami Cancer Research Center, Inc.
#### Secondary ID Infos
**Domain:** MiamiCancerRC
**ID:** MBK funding
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2029-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2029-01-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-02-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Miami Cancer Research Center, Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** True
**Is Unapproved Device:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The objective of this study is to demonstrate the clinical utility of I-124 PET/CT imaging and dosimetry in patients with thyroid cancer including 1) Evaluation of extent (volume and pattern) of remnant tissue in post total thyroidectomy setting and distinction of nodal metastases vs remnant tissue for determination of indication for RAI ablation, 2) Evaluation of response to RAI remnant ablation, 3) Evaluation for suspected occult recurrent/metastatic disease, 4) Evaluation of extent of disease in patients with known metastatic disease and 5) Evaluation of RAI avidity of recurrent/metastatic thyroid cancer and response to treatment with thyroid kinase inhibitors (TKI).
Patients who underwent total thyroidectomy for thyroid cancers are studied. Patients who are newly diagnosed, as well as those who have known or suspected to have recurrent or metastatic disease are eligible. Patients receiving TKI treatment are eligible for evaluation prior to and after the treatment. The patients who are considered for TKI/MAPK treatments undergo pre and post treatment with clinically determined oncoprotein/TKR therapeutic agent(s), including multi-TKI, selective BRAF, MEK, PI3K or ERK inhibitors or combination treatments.
### Conditions Module
**Conditions:**
- Thyroid Cancer
- RAI-Refractory Thyroid Cancer
**Keywords:**
- Thyroid Cancer
- RAI-Refractory Thyroid Cancer
- Redifferentiation Therapy
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Diagnostic Test: Disease status detection
- Diagnostic Test: Theranostic dosimetry
- Drug: I-124 PET/CT imaging
**Label:** Thyroid Cancer patients, RAI-naive or refractory
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Thyroid Cancer patients, RAI-naive or refractory
**Description:** RAI dose determination
**Name:** Disease status detection
**Type:** DIAGNOSTIC_TEST
#### Intervention 2
**Arm Group Labels:**
- Thyroid Cancer patients, RAI-naive or refractory
**Description:** Theranostic dosimetric evaluation for optimization of RAI therapy of thyroid cancer
**Name:** Theranostic dosimetry
**Type:** DIAGNOSTIC_TEST
#### Intervention 3
**Arm Group Labels:**
- Thyroid Cancer patients, RAI-naive or refractory
**Description:** Theranostic dosimetry for optimization of RAI therapy for Thyroid Cancer
**Name:** I-124 PET/CT imaging
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Measurements:
1. Administered activity
2. Cumulated activity
3. Standard uptake value
Calculations:
1. Radiation absorbed dose to the target
Correlations to be reported:
1. Administered activity vs absorbed dose
2. Absorbed dose vs response
3. SUV at 48h vs response
**Measure:** Identification and characterization of RAI uptake pattern and kinetics
**Time Frame:** 5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria
* Post-total thyroidectomy patients with diagnosis of thyroid cancer, any histology, subtype, any ATA risk category, for evaluation for residual disease, cervical or remote metastatic disease
* Patients with known or suspected recurrent/metastatic thyroid cancer, identified by ultrasound (US), CT/MR/FDG-PET\|CT or elevated thyroglobulin (Tg).
* Pretreatment and post-treatment evaluation of patients with thyroid cancer deemed RAI-indifferent/refractory who are considered for TKI
* Age ≥ 18
* Ability and willingness to give a written consent
* Life expectancy \> 3 months
* ECOG performance status ≤ 2
Exclusion Criteria
* Cancers metastatic to thyroid
* Age \< 18
* Inability or unwillingness to give a written consent
* Life expectancy \< 3 months
* ECOG performance status ≥ 3
* Pregnant and nursing women.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Adult patients (18 and older) with thyroid cancer
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Seza Gulec, MD
**Phone:** 786-693-0821
**Role:** CONTACT
**Contact 2:**
**Name:** Keila Rios
**Phone:** 786-487-3230
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** North Miami
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Seza Gulec, MD
- **Phone:** 786-693-0821
- **Role:** CONTACT
**Country:** United States
**Facility:** Miami Cancer Research Center
**State:** Florida
**Status:** RECRUITING
**Zip:** 33181
#### Overall Officials
**Official 1:**
**Affiliation:** CEO, MCRC
**Name:** Seza Gulec, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000006258
- Term: Head and Neck Neoplasms
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M16723
- Name: Thyroid Neoplasms
- Relevance: HIGH
- As Found: Thyroid Cancer
- ID: M16718
- Name: Thyroid Diseases
- Relevance: HIGH
- As Found: Thyroid
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7863
- Name: Endocrine Gland Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M9348
- Name: Head and Neck Neoplasms
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013964
- Term: Thyroid Neoplasms
- ID: D000013959
- Term: Thyroid Diseases
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443853
**Brief Title:** Creating Digital Dental Plaque Scoring
**Official Title:** A Novel Approach to Digital Dental Plaque Scoring
#### Organization Study ID Info
**ID:** Digital Scoring
#### Organization
**Class:** OTHER
**Full Name:** Marmara University
### Status Module
#### Completion Date
**Date:** 2024-04-05
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-03-29
**Type:** ACTUAL
#### Start Date
**Date:** 2024-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Marmara 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:** It is aimed to compare dental plaque area measured on images obtained in the clinic by using dental photography and intraoral scanner and to evaluate the correlation of this area with clinical plaque scores.
Clinical dental plaque scoring was measured according to the "Turesky Modified Quigley Hein Plaque Index" after applying a plaque staining agent (Tri Plaque ID Gel, GC Corp., Tokyo, Japan) to evaluate the oral hygiene of 20 patients who applied to the university clinic. Following clinical scoring, intraoral photographs of the patients were taken using dental photography equipment of the same standards (EOS700D, Canon; 100mm lens, Canon; twin flash, Yong Nuo) and scan images were taken with an intraoral scanner (iTero Element Flex, Align Tech., USA). In the data obtained, dental plaque area on the buccal surface of 66 lower and upper jaw anterior teeth were measured with Image J (National Institute for Health, Bethesda, USA) software, and the ratio of dental plaque area to the visible surface area of the tooth was measured.
**Detailed Description:** The (h1) hypothesis of this study was that dental plaque scores measured through digital camera and intraoral scanner images can replace clinical visual scoring. This study aimed to compare dental plaque areas measured on images taken by digital camera and intraoral scanner and to evaluate these areas with clinical plaque scores with the help of a software program and provide a novel plaque index to score dental plaque on the taken intraoral images.
Study Design The tooth arches of the volunteers were stained with a plaque-disclosing solution (Tri Plaque ID Gel, GC Corporation, Tokyo, Japan). The Turesky Modified Quigley Hein Plaque Index (TMQHPI) of anterior teeth of the volunteers' was recorded using clinical visual examination.
Intraoral photographs of the volunteers were taken by using a digital camera (Canon EOS 700D; 100 mm macrolens, Canon Inc., Tokyo, Japan), and 3D images were recorded by an intraoral scanner (iTero Element Flex, Align Technologies, San Jose, California, USA). Photograph and intraoral scanner images were overlapped and pixel-synchronized using the Keynote program.
After synchronization, all taken images were transferred to the Image J V1.53 (National Institute for Health, Bethesda, USA) program. The plaque-covered area and the total surface area of the teeth were marked in the manual mode of the program and the areas were measured in square pixels. Measurements were made on a total of 66 teeth, which can be easily seen on the images. Intraoral scanner plaque area/ tooth surface area ratio and intraoral photograph plaque area/ tooth surface area ratio were calculated and recorded for each tooth.
### Conditions Module
**Conditions:**
- Dental Plaque
**Keywords:**
- dental plaque
- dental plaque scoring
- dental plaque imaging
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 66
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The Turesky Modified Quigley Hein Plaque Index of anterior teeth of the volunteers' was recorded using clinical visual examination after dental plaque staining.
**Intervention Names:**
- Diagnostic Test: Dental plaque scoring and dental plaque coated tooth surface measuring
**Label:** Clinical scoring
#### Arm Group 2
**Description:** Intraoral photographs of the volunteers were taken by using a digital camera (Canon EOS 700D; 100 mm macrolens, Canon Inc., Tokyo, Japan).
All taken photographs were transferred to the Image J V1.53 (National Institute for Health, Bethesda, USA) program. The plaque-covered area and the total surface area of the teeth were marked in the manual mode of the program.
**Intervention Names:**
- Diagnostic Test: Dental plaque scoring and dental plaque coated tooth surface measuring
**Label:** Digital Camera
#### Arm Group 3
**Description:** 3D images of the volunteers were recorded by an intraoral scanner (iTero Element Flex, Align Technologies, San Jose, California, USA).
All taken images were transferred to the Image J V1.53 (National Institute for Health, Bethesda, USA) program. The plaque-covered area and the total surface area of the teeth were marked in the manual mode of the program.
**Intervention Names:**
- Diagnostic Test: Dental plaque scoring and dental plaque coated tooth surface measuring
**Label:** Intraoral Scanner
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Clinical scoring
- Digital Camera
- Intraoral Scanner
**Description:** The Turesky Modified Quigley Hein Plaque Index of anterior teeth of the volunteers' was recorded using clinical visual examination.
Intraoral photographs of the volunteers were taken by using a digital camera and 3D images were recorded by an intraoral scanner. The plaque-covered area and the total surface area of the teeth were marked in the manual mode of the Image J program and the areas were measured in square pixels. The correlation between clinical visual scoring, dental plaque areas on images were compared.
**Name:** Dental plaque scoring and dental plaque coated tooth surface measuring
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** The Turesky Modified Quigley Hein Plaque Index (TMQHPI) of anterior teeth of the volunteers' was recorded using clinical visual examination.Intraoral photographs of the volunteers were taken by using a digital camera and 3D images were recorded by an intraoral scanner.The plaque-covered area and the total surface area of the teeth were marked in the manual mode of the Image J program and the areas were measured.
**Measure:** Correlation between Turesky Modified Quigley Hein Plaque Scores and dental plaque coated surface areas on the images taken by digital camera and intraoral scanner
**Time Frame:** 1 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients without orthodontic brackets, fixed or implant restorations and without severe tooth crowding were included in the study.
Exclusion Criteria:
* Among the patients with orthodontic brackets, severe tooth crowding that could not be visually verified on images, fixed or implant restorations were excluded in the study.
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
**Study Population:** The study included 20 patients between the age of 18 to 45. Among the patients with orthodontic brackets, severe tooth crowding that could not be visually verified on images, fixed or implant restorations were excluded in the study. Measurements were made on a total of 66 teeth, which can be easily seen on the images.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** Marmara University, Department of Restorative Dentistry
**State:** Maltepe
**Zip:** 34854
#### Overall Officials
**Official 1:**
**Affiliation:** Marmara University
**Name:** Dilek Tagtekin, Professor
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003741
- Term: Dental Deposits
- 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: M6970
- Name: Dental Plaque
- Relevance: HIGH
- As Found: Dental Plaque
- ID: M6938
- Name: Dental Deposits
- 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: D000003773
- Term: Dental Plaque
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443840
**Acronym:** AUTONHOME
**Brief Title:** Impact of a Self-rehabilitation and Tele-rehabilitation Program on the Post-stroke Care Pathway
**Official Title:** AUTONHOME: Impact of a Self-rehabilitation and Tele-rehabilitation Program on the Post-stroke Care Pathway : Preliminary Study
#### Organization Study ID Info
**ID:** 2023-A01298-37
#### Organization
**Class:** OTHER
**Full Name:** Association APPROCHE
### Status Module
#### Completion Date
**Date:** 2026-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-06
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Société Neuradom
**Class:** UNKNOWN
**Name:** IMT Atlantique Brest
#### Lead Sponsor
**Class:** OTHER
**Name:** Association APPROCHE
#### 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 AutonHome® clinical investigation, proposed by Dr Charles FATTAL (coordinator of this study), and carried out by the Association Approche (delegated promoter), aims to use the AutonHome® selfeducation device for the rehabilitation of patients who have suffered a Cerebrovascular Accident (CVA), and thus respond to the problems of therapeutic discontinuity highlighted today. Neuradom's AutonHome® device combines self-education and telecare. This device makes it possible to carry out personalised self-education programmes supervised by the therapist, enabling the therapeutic link with the patient to be maintained without the need for the patient to travel. This tool has already proved its usability and perceived usefulness in a previous clinical study, which demonstrated the feasibility of a self-education programme for hemiplegic patients, based on feedback. AutonHome® was considered by users to be a relevant, useful and safe complement to conventional rehabilitation.
On the basis of this feasibility study, the investigators wished to develop a second study around this AutonHome® device. In this second clinical investigation, in addition to perceived usefulness, the main objective is to demonstrate, in a population of stroke victims, that an experimental care pathway combining supervised self-education via AutonHome® with conventional re-education optimises the care pathway in terms of sensory-motor recovery, but also in terms of reduced length of stay and functional and medico-economic added value.
This clinical trial involves two parallel arms. Participants will be randomised into a control group, undergoing conventional in-centre rehabilitation, or into an experimental group, with self-rehabilitation and tele-rehabilitation in addition to conventional rehabilitation. The AutonHome study is a pilot study, with the aim of including 40 participants. Each centre will recruit 10 participants on a 1:1 randomisation basis, with 5 in the experimental group and 5 in the control group. Participants will be monitored for 15 weeks. This clinical investigation is multicentre, with 4 centres involved: the Centre Bouffard Vercelli (66962, Perpignan), the CMRRF de Kerpape (56275 Ploemeur), the association Saint-Hélier (35043, Rennes), and the Fondation ILDYS (29684 Roscoff).
### Conditions Module
**Conditions:**
- Hemorrhagic Unilateral Cortico-subcortical Hemispheric Stroke
- Ischemic Stroke
**Keywords:**
- post-stroke
- tele-rehabilitation
- self-rehabilitation
- AutonHome
- medical device
- Physical Medicine and Rehabilitation
- Rehabilitation Medicine
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This protocol is carried out in accordance with the European Regulation 2017/745 on Medical Devices (MDR) and concerns a Class I medical device (MD) of category 4.2 (Article 82 MDR), corresponding to the CE marked MD used for its intended purpose without the objective of establishing conformity, and with an additional non-invasive and non-burdensome procedure.
This is a comparative, prospective, multicenter study (4 centers), controlled, randomized, open-label, with 2 parallel arms.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will be randomised into a control group, undergoing conventional in-centre rehabilitation.
**Label:** Control group
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** The experimental group will have to carry out the programme of self-rehabilitation and tele-rehabilitation with the AutonHome® device in addition to conventional rehabilitation.
**Intervention Names:**
- Device: AutonHome® device
**Label:** Experimental group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental group
**Description:** The experimental group will have to carry out the programme of self-rehabilitation and tele-rehabilitation with the AutonHome® device in addition to conventional rehabilitation.
**Name:** AutonHome® device
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Change in Fugl-Meyer score between inclusion on Day 0 and the visit on Day 45 (Week 6) Minimum = 0 Maximum = 100
However, as an exploratory secondary endpoint (objective 1a), the sub-scores for the upper limb (UL) and lower limb (LL) will be studied separately, as well as changes at 12 weeks (D80) and 15 weeks (D105).
* Upper limb / 66
* Lower limb / 34 Total / 100
The higher the Fugl Meyer score, the better the sensory-motor recovery. The Fugl Meyer scores will then be compared between the experimental course (on the technical platform and at home) and the control course.
**Measure:** Evaluate the non-inferiority of the experimental course of care, on the technical platform and at home, on the evolution of sensory-motor recovery, compared to the control course.
**Time Frame:** At 0 and 6 weeks
#### Secondary Outcomes
**Description:** Functional independence measure - MIF
Independence :
7: Complete independence (appropriate to circumstances and safe) 6: Modified independence (device, adaptation)
Modified dependence :
5: Supervision 4: Minimal assistance (autonomy = 75% +) 3 : Average assistance (autonomy = 50% +)
Complete dependence 2 : Maximum assistance (autonomy = 25% +)
If an item cannot be checked, tick level 1.
At the end of the test, we obtain a score ranging from 18 to 126. The lower the score, the greater the disability.
**Measure:** Evaluate the recovery of overall functional independence.
**Time Frame:** At 0, 6, 12 and 15 weeks
**Description:** Berg balance scale :
The Berg balance assessment scale was developed to measure static and dynamic balance in adults.
This scale comprises 14 tasks rated from 0 to 4, assessing both static and dynamic balance. The total score ranges from 0 to 56 points. The higher the score, the better the assessment of balance.
**Measure:** The recovery of a seated and standing postural balance, walking and mobility on the plane.
**Time Frame:** At 0, 6, 12 and 15 weeks
**Description:** 6min walk test (6MWT) : The six-minute walk test (6MWT) is an objective assessment of functional physical ability. It measures the distance covered by the patient when walking briskly for 6 minutes.
The 6MWT provides a global assessment of various organ functions, in particular the cardiopulmonary, vascular and neuromuscular systems.
Distance covered: The distance covered during the test is the main parameter measured. In general, a longer distance indicates better functional capacity. Here are some approximate reference values:
Normal: Approximately 400 to 700 metres. Poor: Less than 300 metres. Very good: Over 800 metres.
**Measure:** The recovery of a seated and standing postural balance, walking and mobility on the plane.
**Time Frame:** At 0, 6, 12 and 15 weeks
**Description:** 10-metre walk test (10MWT) : The 10-metre walk test is an assessment tool that measures a patient's walking speed.
It aims to calculate the speed at which a patient can walk a distance of 10 metres.
The walking speed obtained can be used to classify the patient into different categories:
Less than 0.4 m/s: Walking at home. Between 0.4 and 0.8 m/s: Limited walking in the community. More than 0.8 m/s: Unlimited walking in the community.
**Measure:** The recovery of a seated and standing postural balance, walking and mobility on the plane.
**Time Frame:** At 0, 6, 12 and 15 weeks
**Description:** GAS (Goal Attainment Scaling) :
The GAS is a tool for defining specific, individualised objectives for each patient. These objectives are then evaluated in a standardised way, allowing statistical analysis of the results.
At least 3 objectives are set and scored between -3 (regression), -2 (much less), -1 (a little less), 0 (expected result), +1 (a little more), +2 (much more).
**Measure:** Achievement of objectives
**Time Frame:** At 0, 6, 12 and 15 weeks
**Description:** IPA Scale (Impact on Participation and Autonomy Questionnaire) :
* Level of participation perceived by the participant through 32 items spread over 5 domains related to autonomy in activities inside the home (7 items), family roles (7 items), activities outside (5 items), social life and relationships (7 items), work and education (6 items). The last 6 are excluded. Score from 0 (very low level of participation) to 4 (very high level).
* Level of perception of participation restriction: Score of 0 (major problem), 1 (minor problem), 2 (no problem).
**Measure:** Autonomy and social participation
**Time Frame:** At 0, 6, 12 and 15 weeks
**Description:** Number of falls
**Measure:** The risk of adverse effects
**Time Frame:** Every day during 15 weeks
**Description:** Number of moderate or serious adverse events during the session
**Measure:** The risk of adverse effects
**Time Frame:** Every day during 15 weeks
**Description:** Visual Analog Pain Scale: Intensity and sites of pain before or during and after the session
**Measure:** The risk of adverse effects
**Time Frame:** Every day during 15 weeks
**Description:** Borg scale :
The Borg scale is generally rated from 6 to 20. The higher the number, the more intense the perceived effort.
**Measure:** The perception of the effort at each session
**Time Frame:** Every day during 15 weeks
**Description:** Perceived experience of the rehabilitation session in response to the following 4 questions with a scoring that comes in 5 different levels depending on the question :
What is the patient's perception of the rehabilitation session offered? Very poor - Poor - No effect - Positive - Very positive
What is the patient's perception of the quality of the exercises proposed? Very poor - Poor - No effect - Positive - Very positive
What is the patient's perception of the intensity of the exercises proposed? Very poor - Poor - No effect - Positive - Very positive
What is the patient's perception of the motivating nature of the exercises proposed? Very poor - Poor - No effect - Positive - Very positive
**Measure:** The perceived experience of the session.
**Time Frame:** Every day during 15 weeks
**Description:** SIMS MOTIVATION Scale ("Situation Motivation Scale") :
The aim is to determine which type of motivation regulates an individual's behaviour during an activity.
16 items are evaluated: Items 1, 5, 9 and 13 relate to intrinsic motivation (best type of regulation, strong feeling of autonomy).
Items 2, 6, 10 and 14 relate to identified regulation (good type of regulation, high sense of autonomy).
Items 3, 7, 11 and 15 refer to external regulation (poor type of regulation, low sense of autonomy).
Items 4, 8, 12 and 16 relate to motivation (no regulation).
**Measure:** The perceived experience of the session.
**Time Frame:** Every day during 15 weeks
**Description:** Compliance (present at the session) : Yes/No
**Measure:** Compliance with and duration of sessions and stays.
**Time Frame:** Every day during 15 weeks
**Description:** Duration of each session (in minutes)
**Measure:** Compliance with and duration of sessions and stays.
**Time Frame:** Every day during 15 weeks
**Description:** Duration of stay in complete hospitalisation (in days)
**Measure:** Compliance with and duration of sessions and stays.
**Time Frame:** Every day during 15 weeks
**Description:** Duration of stay in partiel hospitalisation (in days)
**Measure:** Compliance with and duration of sessions and stays.
**Time Frame:** Every day during 15 weeks
**Description:** Duration of use at home (in days)
**Measure:** Compliance with and duration of sessions and stays.
**Time Frame:** Every day during 15 weeks
**Description:** SUS (System Usability Scale) : only for the experimental groups. The SUS consists of 10 questions in the form of statements. Each question uses a Likert scale, where the user chooses between 5 possible answers, ranging from 'Strongly disagree' to 'Strongly agree'. The answers to the 10 questions are used to construct a satisfaction score, ranging from 1 to 100. In general, a score of 75 or more is considered 'good', while between 50 and 75 it is considered 'fair' or 'correct'. A score of less than 50 indicates major problems in terms of customer satisfaction.
**Measure:** Study the medium-term appropriation of the selfrehabilitation system by the participants.
**Time Frame:** At 0, 6, 12 and 15 weeks
**Description:** Study of direct and indirect costs
**Measure:** Compare the costs of the experimental care pathway to the costs of a conventional care pathway
**Time Frame:** Every day during 15 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participants who signed the written consent form to participate in the study after free and informed information
* Participants affiliated to a social security scheme (beneficiary or beneficiary) outside the AME.
* 18 years ≤ age ≤ 85 years,
* 1st recent ischemic or hemorrhagic unilateral cortico-subcortical hemispheric stroke
* Minimum post-stroke delay: 7 days
* Maximum post-stroke delay : 30 days
* SOFMER category 2: moderate strokes called category 2 according to SOFMER with an NIHSS (initial score of the National Institute of Health Stroke Scale) between 5 and 14 (Several deficiencies or motor deficit of the lower limb prohibiting walking, with recovery potential, a probable autonomy project (unilateral stroke).
* MoCA \> 23
Exclusion Criteria:
* Participant deprived of liberty (by judicial or administrative decision)
* Adult participant subject to a legal protection measure or unable to express their consent
* Participation in another ongoing clinical trial
* Pregnant or breastfeeding women or women of childbearing age without effective contraception
* Lack of command of the oral and written French language
* Pre-existing neurological pathology
* Severe expression disorders (expression aphasia) affecting intelligibility
* Severe comprehension disorders (comprehension aphasia)
* Major cognitive disorders of the dementia or post-dementia type
* Unstable psychiatric disorders
* Unstabilized medical pathology
* Unbalanced epilepsy
* Color blindness
**Maximum Age:** 85 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Marie-Caroline Delebecque, CRA
**Phone:** 0297826174
**Phone Ext:** +33
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Pauline Coignard, Doctor
**Phone:** 0297826060
**Phone Ext:** +33
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Brest
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Patricia Bourgogne, Doctor
- **Phone:** 0298293939
- **Phone Ext:** +33
- **Role:** CONTACT
**Country:** France
**Facility:** Fondation Ildys
**State:** Bretagne
**Status:** NOT_YET_RECRUITING
**Zip:** 29684
**Location 2:**
**City:** Ploemeur
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Thibaud Honore, Doctor
- **Phone:** 0297826060
- **Phone Ext:** +33
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Juliette Sainson, CRA
- **Phone:** 0297826293
- **Phone Ext:** +33
- **Role:** CONTACT
**Country:** France
**Facility:** CMRRF de Kerpape
**State:** Bretagne
**Status:** NOT_YET_RECRUITING
**Zip:** 56275
**Location 3:**
**City:** Rennes
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Emilie Leblong, Doctor
- **Phone:** 0299295099
- **Phone Ext:** +33
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Linda Bodet, CRA
- **Phone:** 0299295043
- **Phone Ext:** +33
- **Role:** CONTACT
**Country:** France
**Facility:** Association Saint-Hélier
**State:** Bretagne
**Status:** NOT_YET_RECRUITING
**Zip:** 35043
**Location 4:**
**City:** Perpignan
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Charles Fattal, Doctor
- **Phone:** 0430441100
- **Phone Ext:** +33
- **Role:** CONTACT
**Country:** France
**Facility:** Centre Bouffard Vercelli - USSAP
**State:** Pyrénées-Orientales
**Status:** RECRUITING
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** RAOULT, Bérengère, PONTIER, Joanna, FICHEUX, Gilles and FATTAL, Charles, 2020. Étude de faisabilité d'un parcours d'auto-rééducation de patients hémiplégiques. Kinésithérapie Scientifique. Décembre 2020. No. 626, p. 5-13.
## 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: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- 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
### Condition Browse Module - Meshes
- ID: D000020521
- Term: Stroke
- ID: D000083242
- Term: Ischemic Stroke
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443827
**Acronym:** DOC-AMSUL
**Brief Title:** Effect of Intravenous Amantadine Sulphate on Disorders of Consciousness
**Official Title:** Effects of Intravenous Amantadine Sulphate on Brain Dynamics and Neurobehavioral Status in Patients With Disorders of Consciousness
#### Organization Study ID Info
**ID:** 39049
#### Organization
**Class:** OTHER
**Full Name:** Azienda Sanitaria dell'Alto Adige
### Status Module
#### Completion Date
**Date:** 2024-05-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-01-10
**Type:** ACTUAL
#### Start Date
**Date:** 2018-09-15
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Azienda Sanitaria dell'Alto Adige
#### Responsible Party
**Investigator Affiliation:** Azienda Sanitaria dell'Alto Adige
**Investigator Full Name:** Viviana Versace
**Investigator Title:** MD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Double-blind, placebo-controlled, crossover ("within subjects") study with an A-B-A-B treatment scheme to investigate the neuromodulatory effects of intravenous amantadine sulphate at a single daily dose of 200 mg in patients with disorders of consciousness (unresponsive wakefulness syndrome and minimally conscious state) by integrating traditional neurobehavioral assessment with spectral analysis of electrocortical activity derived from 64-channel electroencephalography (EEG) recordings.
**Detailed Description:** Research hypothesis Intravenous amantadine sulphate treatment (200 mg) over five days improves consciousness, defined as an increase in CRS-r score of at least 3 points, and changes the band powers of the EEG in patients with disorder of consciousness admitted in a Neurorehabilitation Department.
### Conditions Module
**Conditions:**
- Amantadine
- Consciousness Disorders
- Electroencephalography
**Keywords:**
- DoC = Disorders of Consciousness
- PSD = Power Spectral Density
- Amantadine sulphate
- EEG
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Double-blind, placebo-controlled, crossover ("within subjects") study with an A-B-A-B treatment scheme, in which "placebo" (A) and "amantadine sulphate" (B) intervention sessions alternated weekly in the same patient for a total of four weeks (A1-B1-A2-B2).
##### Masking Info
**Masking:** NONE
**Masking Description:** Blindness about treatment
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 18
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** To obtain solid evidence of amantadine sulphate effects and their temporal dynamics, we conducted a double-blind, placebo-controlled, crossover ("within subjects") study with an A-B-A-B treatment scheme, in which "placebo" (A) and "amantadine sulphate" (B) intervention sessions alternated weekly in the same patient for a total of four weeks (A1-B1-A2-B2).
**Intervention Names:**
- Drug: Amantadine Sulfate
**Label:** amantadine sulphate and placebo with schema A-B-A-B
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- amantadine sulphate and placebo with schema A-B-A-B
**Description:** intravenous amantadine sulphate at a single daily dose of 200 mg or physiological saline (0.9% NaCl solution)
**Name:** Amantadine Sulfate
**Other Names:**
- physiological saline (0.9% NaCl solution)
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Increase in the Coma Recovery Scale-Revised (CRS-R) score of at least 1 point. The CRS-R consists of 23 items divided into six subscales designed to assess: Auditory (AU), Visual (V), Motor (M), Oromotor/Verbal (O), Communication (C), and Arousal functions (AR).
The total score ranges between 0 (worst) and 23 (best). The subscales are composed of hierarchically ordered items; the lowest items (0) represent reflexive activity, while the highest items (4,5,6,3,2,3 points for AU, V, M, O, C respectively) represent cognitively mediated behaviours. We adopted a cut-off score of 8 for distinguish UWS/VS (\<8) from MCS (≥8) in patients induced by amantadine sulphate vs. placebo
**Measure:** Coma Recovery Scale-Revised (CRS-R)
**Time Frame:** days 14 and 28
**Description:** Change in each canonical band power of EEG induced by amantadine sulphate
**Measure:** EEG band power alpha, beta, theta, delta
**Time Frame:** days 14 and 28
#### Secondary Outcomes
**Description:** Change in "periodic" and "aperiodic" exponents of the average power spectral density vs. placebo and vs healthy controls
**Measure:** "periodic" and "aperiodic" exponents of the average power spectral density
**Time Frame:** days 14 and 28
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Adults with disorders of consciousness due to acquired brain injury classified according to international guidelines based on CRS-R evaluation as unresponsive wakefulness syndrome/vegetative state (UWS/VS) or minimally conscious state (MCS) either in the subacute or chronic stage
Exclusion Criteria:
* Age \< 18 years
* History of epileptic seizures/status epilepticus
* Scalp defects
* pregnancy
* Severe uncompensated heart failure (NYHA IV)
* Atrioventricular block (AV block) second-degree and third-degree
* Known bradycardia (below 55 beats/minute)
* Known long QT interval (QTc according to Bazett \> 420 ms
* History of serious ventricular arrhythmias
* Hypokalemia or hypomagnesemia
* Impaired renal function
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Vipiteno
**Country:** Italy
**Facility:** Hospital of Vipiteno
**State:** Bolzano
**Zip:** 39049
#### Overall Officials
**Official 1:**
**Affiliation:** hospital of Vipiteno
**Name:** Viviana Versace, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000019954
- Term: Neurobehavioral Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- 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: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M6468
- Name: Consciousness Disorders
- Relevance: HIGH
- As Found: Consciousness Disorders
- ID: M21826
- Name: Neurobehavioral Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- 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: D000003244
- Term: Consciousness Disorders
### Intervention Browse Module - Ancestors
- ID: D000000978
- Term: Antiparkinson Agents
- ID: D000018726
- Term: Anti-Dyskinesia Agents
- ID: D000000998
- Term: Antiviral Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000015259
- Term: Dopamine Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018712
- Term: Analgesics, Non-Narcotic
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: Analg
- Name: Analgesics
- Abbrev: AnDyAg
- Name: Anti-Dyskinesia Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: CaAg
- Name: Cardiotonic Agents
### Intervention Browse Module - Browse Leaves
- ID: M3888
- Name: Amantadine
- Relevance: HIGH
- As Found: Photon
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M4295
- Name: Antiparkinson Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4314
- Name: Antiviral Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7473
- Name: Dopamine
- Relevance: LOW
- As Found: Unknown
- ID: M17962
- Name: Dopamine Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M20786
- Name: Analgesics, Non-Narcotic
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000000547
- Term: Amantadine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443814
**Brief Title:** Trial of Meditation for Cardiometabolic Disease in Older Black Women
**Official Title:** A Clinical Trial on the Prevention of Coronary Artery Disease, Insulin Resistance and Hyperlipidemia in Black Women With Meditation and Health Education
#### Organization Study ID Info
**ID:** 1P50AT000082-03
**Link:** https://reporter.nih.gov/quickSearch/1P50AT000082-03
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** Maharishi International University
### Status Module
#### Completion Date
**Date:** 2004-11
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2004-11
**Type:** ACTUAL
#### Start Date
**Date:** 2001-07
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2023-11-13
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Morehouse School of Medicine
**Class:** OTHER
**Name:** Howard University
#### Lead Sponsor
**Class:** OTHER
**Name:** Robert Schneider, MD
#### Responsible Party
**Investigator Affiliation:** Maharishi International University
**Investigator Full Name:** Robert Schneider, MD
**Investigator Title:** Director, Institute for Natural Medicine and Prevention
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This randomized controlled trial compared the efficacy of stress reduction with meditation to a health education (HE) group in 201 older African American women over a one-year study period. They were randomly allocated to either of two behavioral treatment groups-1) the Transcendental Meditation (TM( program or 2) a health education (HE) program. Women participants were recruited, tested, and instructed at two clinical sites: Washington, DC and Atlanta, GA. Outcome measures were carotid intima medial thickness, lipid profile, glucose and insulin resistance, and behavioral factors.
**Detailed Description:** This was a randomized controlled trial that compared the effects of stress reduction using the Transcendental Meditation technique (TM) to a health education (HE) group in 201 African American women \>55 years with high CVD risk over a one-year intervention and follow-up period.
All participants were randomly allocated to either of two behavioral treatment groups-1) the Transcendental Meditation (TM) program or 2) a health education (HE) program of healthy diet, exercise and substance use control. Women participants were recruited, tested, and instructed at two sites:139 were recruited and randomized in Washington, DC and 61 in Atlanta, GA. Outcome measures were carotid intima medial thickness (IMT), lipid profile, glucose and insulin response, blood pressure and lifestyle (diet, exercise, substance use).
### Conditions Module
**Conditions:**
- Atherosclerotic Cardiovascular Disease
- Metabolic Syndrome
- Dyslipidemias
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** Investigators, data collectors and care providers were blinded to participant treatment status. Participants in both intervention groups were given similar expectations of positive outcomes.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 201
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The TM technique is practiced for 20 minutes twice a day. Participants are instructed by a certified teacher in 7-step course to learn how to meditate according to previously standardized and validated procedures.
**Intervention Names:**
- Behavioral: Transcendental Meditation
**Label:** Transcendental Meditation
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The health education group was matched for instructor time and attention to the TM group. The classroom-based health education group receives AHA-based guidelines for healthy diet, exercise and control of substance use. No stress management techniques are taught in this group.
**Intervention Names:**
- Behavioral: Health Education
**Label:** Health Education
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Health Education
**Description:** This is a didactic classroom-based control which educates the patient on adapting a healthier lifestyle through proper diet, exercise, and moderating substance usage according to current AHA guidelines. This intervention does not include a stress management component.
**Name:** Health Education
**Other Names:**
- Health Ed control
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Transcendental Meditation
**Description:** TM is a natural, effortless mental technique practiced for 20 minutes twice a day (morning and evening) which settles down the mind and body. TM can only be taught through a certified instructor and a 7-step process taking place over 4 consecutive days after which the meditator can practice correctly at home twice a day.
**Name:** Transcendental Meditation
**Other Names:**
- TM technique, TM
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** B mode ultrasound measure of carotid artery wall thickness
**Measure:** carotid intima medial thickness
**Time Frame:** 0 and 12 months
#### Secondary Outcomes
**Description:** using the HOMA index
**Measure:** insulin resistance and glucose
**Time Frame:** 0 and 12 months
**Description:** LDL, HDL, total cholesterol (TC), triglycerides (TG) (for LDL, TC and TG), a higher score indicates a worst outcome, for HDL a higher score indicates a better outcome
**Measure:** lipid profile
**Time Frame:** 0 and 12 months
**Description:** measured three times with a mercury sphygmomanometer 5 minutes apart and last two reading averaged
**Measure:** blood pressure
**Time Frame:** 0, 4 and 12 months
**Description:** SF-36 (numerical likert scale and YES/NO response categories are variable in terms of indicating a better or worse outcome)
**Measure:** general perceived health
**Time Frame:** 0, 4 and 12 months
**Description:** block diet questionaire (food choice with pictures) not scaled to indicate a better or worse outcome)
**Measure:** Dietary habits
**Time Frame:** 0, 4 and 12 months
**Description:** Exercise --using the Folsom Physical Activity Questionaire--not scaled to indicate a better or worse outcome
**Measure:** Physical Activity
**Time Frame:** 0, 4 and 12 months
**Description:** substance usage questionnaire for alcohol and illicit drug usage
**Measure:** Substance use
**Time Frame:** 0, 4 and 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* African American women,
* age 55 or older with at least one of the five cardiovascular conditions (below):
* coronary heart disease or
* positive coronary angiography or
* previous MI or
* coronary revascularization or
* percutaneous transluminal coronary angioplasty (PTCA). These conditions were medically documented for the study eligibility and subsequent randomization.
In the absence of these CAD markers: a high risk factor assessment score of at least two points based on the Framingham study/ATP III report was also accepted for eligibility. Risk factors included diabetes, high systolic or diastolic BP, high cholesterol, high LDL-low HDL or smoking.
Exclusion Criteria:
* Myocardial infarction
* unstable angina
* coronary artery by-pass grafting (CABG)
* percutaneous transluminal coronary angioplasty (PTCA)
* stroke within the preceding three months
* carotid artery endarterectomy
* atrial fibrillation
* second or third degree AV block
* heart failure
* clinically significant valvular heart disease
* major psychiatric disorders,
* current alcohol/dependency disorder
* other drug abuse dependency disorder
* non-cardiac life-threatening illness
* participating in a formal stress management program
* plans to move out of the study area or travel extensively
* unwillingness to accept randomization into any study group.
**Gender Based:** True
**Gender Description:** self identified women
**Minimum Age:** 55 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Overall Officials
**Official 1:**
**Affiliation:** Institute for Natural Medicine and Prevention, Maharishi International University
**Name:** Linda Heaton
## 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
- ID: D000052439
- Term: Lipid Metabolism Disorders
- ID: D000001161
- Term: Arteriosclerosis
- ID: D000001157
- Term: Arterial Occlusive Diseases
- ID: D000014652
- Term: Vascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M6546
- Name: Coronary Artery Disease
- Relevance: LOW
- As Found: Unknown
- ID: M26188
- Name: Atherosclerosis
- Relevance: HIGH
- As Found: Atherosclerotic Cardiovascular Disease
- ID: M23005
- Name: Metabolic Syndrome
- Relevance: HIGH
- As Found: Metabolic Syndrome
- ID: M26181
- Name: Dyslipidemias
- Relevance: HIGH
- As Found: Dyslipidemia
- ID: M19506
- Name: Myocardial Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M6549
- Name: Coronary Disease
- Relevance: LOW
- As Found: Unknown
- ID: M10002
- Name: Hyperlipoproteinemias
- Relevance: LOW
- As Found: Unknown
- ID: M10000
- Name: Hyperlipidemias
- Relevance: LOW
- As Found: Unknown
- 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
- ID: M27029
- Name: Lipid Metabolism Disorders
- 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: D000002318
- Term: Cardiovascular Diseases
- ID: D000050197
- Term: Atherosclerosis
- ID: D000024821
- Term: Metabolic Syndrome
- ID: D000050171
- Term: Dyslipidemias
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M10365
- Name: Insulin
- Relevance: LOW
- As Found: Unknown
- ID: M173166
- Name: Insulin, Globin Zinc
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443801
**Brief Title:** Efficacy Of Web-based Breastfeeding Education
**Official Title:** The Efficiency Of Web-Based Breastfeeding Education In Pregnancy According To The Theory Of Breastfeeding Self-Efficacy
#### Organization Study ID Info
**ID:** Marmara U- elıfvlgl-001
#### Organization
**Class:** OTHER
**Full Name:** Marmara University
### Status Module
#### Completion Date
**Date:** 2024-09-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2024-08-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2023-10-02
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Nurdan Demirci
#### Responsible Party
**Investigator Affiliation:** Marmara University
**Investigator Full Name:** Nurdan Demirci
**Investigator Title:** Prof
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Breastfeeding is the safest and healthiest method of feeding an infant and positively affects the health of both the mother and the baby in the short and long term.
Breastfeeding self-efficacy refers to the mother's perceived ability and self-confidence to breastfeed her baby.
Studies have reported that web-based support programs increase the quality of life in individuals, are useful in symptom management, and are effective in raising awareness on the subjects intended to provide support and in gaining positive attitudes and behaviors.
Today, web-based support programs are created thanks to advances in science and technology; It has advantages such as being cheap, easily accessible, not causing any harm when done under control, providing flexibility in the participant's use of time, and accessing the training content whenever needed. Due to the pandemic process, the investigators are in and with the effect of developing technology, training is provided for the needs of individuals by using many alternative education methods such as web-based education and distance education in the field of health, as in many areas. Studies have reported that web-based support programs increase the quality of life in individuals, are useful in symptom management, and are effective in raising awareness on the subjects intended to provide support and in gaining positive attitudes and behaviors.
The study is planned to be carried out between 01.01.2023 and 31.07.2024 in the Family Health Centers affiliated with the Taşköprü District Health Directorate of Kastamonu. The study universe consists of 24-36 weeks pregnant women who come to the Family Health Centers of the Taşköprü District Health Directorate. The sample of the study consisted of 90 primiparous pregnant women, 45 of whom were in the control and 45 in the experimental group, who met the inclusion criteria.
Data collection tools will be applied to women at pregnancy, postpartum 7th day, PP in the 3rd month, and PP in the 6th month.
Appropriate methods will be used in the evaluation of the data. The significance level will be determined as α=0.05.
**Detailed Description:** Breastfeeding is the safest and healthiest method of feeding an infant and positively affects the health of both the mother and the baby in the short and long term. Breast milk not only meets the nutritional needs of the newborn, but also protects it from many diseases, makes a great contribution to its mental and physical development, and most importantly, it provides a unique bond between mother and baby.
According to TDHS 2018 data, the rate of exclusive breastfeeding for the first six months is 41%, and this rate decreases with age. The rate of breastfeeding for 0-1-month-old children is 59%, 2-3-month-olds 45%, and 4-5-month-olds 14%.
One of the most important factors affecting breastfeeding is the mother's perception of self-efficacy. Breastfeeding self-efficacy refers to the mother's perceived ability and self-confidence to breastfeed her baby. Perception of breastfeeding self-efficacy; It determines whether the mother will breastfeed or not, how much effort she will put into it, her thoughts on breastfeeding, and her ability to cope with the difficulties she will face during the breastfeeding process emotionally.
Considering the existence of real or potential problems with breastfeeding, breastfeeding counseling is required for every expectant mother. This counseling will ensure that expectant mothers will be prepared for all kinds of breastfeeding problems that they may experience in the postpartum period. Studies have reported that web-based support programs increase the quality of life in individuals, are useful in symptom management, and are effective in raising awareness on the subjects intended to provide support and in gaining positive attitudes and behaviors.
For successful initiation, maintenance and termination of breastfeeding, mothers should be provided with a balanced diet during pregnancy, necessary breast care, physical and mental health, and training on breastfeeding.
Today, web-based support programs created thanks to advances in science and technology; It has advantages such as being cheap, easily accessible, not causing any harm when done under control, providing flexibility in the participant's use of time, and accessing the training content whenever needed. Due to the pandemic process the investigators are in and with the effect of developing technology, trainings are provided for the needs of individuals by using many alternative education methods such as web-based education and distance education in the field of health, as in many areas. Studies have reported that web-based support programs increase the quality of life in individuals, are useful in symptom management, and are effective in raising awareness on the subjects intended to provide support and in gaining positive attitudes and behaviors.
Studies on this subject are generally studies that briefly mention breastfeeding under the title of baby care and are not long enough. For this reason, the investigators aim to provide maximum benefit by giving this training to expectant mothers who have never given birth before, that is, who will breastfeed their baby for the first time, by addressing the issue of breastfeeding only.
The study is planned to be carried out between 01.01.2023 and 31.07.2024 in the Family Health Centers affiliated to the Taşköprü District Health Directorate of Kastamonu. The universe of the study consists of 24-36 weeks pregnant women who come to the Family Health Centers of the Taşköprü District Health Directorate. The sample of the study consisted of 90 primiparous pregnant women, 45 of whom were in the control and 45 in the experimental group, who met the inclusion criteria.
The data of the study will be applied to both groups at the same time. No training will be given to the control group, and web-based breastfeeding training consisting of 4 modules will be given to the experimental group during their pregnancy. As data collection tools; Pregnant data collection form, Postpartum information form, IOWA infant feeding attitude scale, IMDAT scale, Edinburgh depression scale, Breastfeeding motivation scale, Insufficient milk perception scale, Breastfeeding self-efficacy scale and System usability scale will be used. Data collection tools will be applied to women at pregnancy, postpartum 7th day, PP 3rd month and PP 6th month.
Appropriate methods will be used in the evaluation of the data. The significance level will be determined as α=0.05.
### Conditions Module
**Conditions:**
- Volunteering to Participate in the Study
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This group will not take web-based education.
**Label:** THE GROUP THAT WILL NOT TAKE WEB-BASED BREASTFEEDING EDUCATION IN PREGNANCY
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** this group will take web-based education.
**Intervention Names:**
- Other: THE GROUP THAT WILL TAKE WEB-BASED BREASTFEEDING EDUCATION IN PREGNANCY
**Label:** THE GROUP THAT WİLL TAKE WEB-BASED BREASTFEEDİNG EDUCATION İN PREGNANT
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- THE GROUP THAT WİLL TAKE WEB-BASED BREASTFEEDİNG EDUCATION İN PREGNANT
**Description:** The data of the study will be applied to both groups at the same time. No training will be given to the control group, and web-based breastfeeding training consisting of 4 modules will be given to the experimental group during their pregnancy. As data collection tools; Pregnant data collection form, Postpartum information form, IOWA infant feeding attitude scale, IMDAT scale, Edinburgh depression scale, Breastfeeding motivation scale, Insufficient milk perception scale, Breastfeeding self-efficacy scale and System usability scale will be used. Data collection tools will be applied to women at pregnancy, postpartum 7th day, PP 3rd month and PP 6th month.
Appropriate methods will be used in the evaluation of the data. The significance level will be determined as α=0.05.
The sample of the study consisted of 90 primiparous pregnant women, 45 of whom were in the control and 45 in the experimental group, who met the inclusion criteria.
**Name:** THE GROUP THAT WILL TAKE WEB-BASED BREASTFEEDING EDUCATION IN PREGNANCY
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** In the study, R v3.6.1 program was used for Power analysis, alpha error was 5%, beta error was 20%, it was predicted that between the variables as a result of the study process, and a minimum of 90 (45 case groups, 50 control group)
**Measure:** Number of postpartum women
**Time Frame:** 6 month
#### Secondary Outcomes
**Description:** The Infant Feeding Attitude Scale is used. It includes 17 items with a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Eight statements indicate positive attitude toward breastfeeding and nine statements indicate positive attitude toward formula feeding. The statements indicating positive attitude to breastfeeding were reverse-scored before calculating the total scores of all items. An example for attitude is: "Formula-feeding is more convenient than breastfeeding", and "Breastfeeding increases mother-infant bonding". The total IIFAS score can range from 17 to 85 with higher scores reflecting more positive attitude towards breastfeeding. The total IIFAS is further classified as positive to breastfeeding (a score of 70-85), neutral (a score of 49-69) and positive to formula feeding
**Measure:** Evaluation of Infant Feeding Attitude
**Time Frame:** Antenatal and postpartum 6th month
**Description:** Edinburgh Postnatal/Postpartum Depression Scale is a self-assessment scale developed to determine the risk of depression in the postpartum period and to measure the level and severity of depression. The scale consists of 10 questions in total. Each question provides a four-point Likert-type measurement. Items in questions 3, 5, 6, 7, 8, 9 and 10 of the scale are scored as 3, 2, 1, 0 and indicate gradually decreasing severity. The items in questions 1, 2 and 4 are scored as 0, 1, 2, 3, indicating increasing severity. The total score of the scale is obtained by summing these items. The minimum total score is 0 and the maximum score is 30. The cut-off score of the scale has been reported as 12/13.
**Measure:** Evaluation of Depression Level
**Time Frame:** Postpartum 7th day, 3rd month, and 6th month
**Description:** Perception of Insufficient Milk questionnaire is used. The questionnaire consisted of five sections: urine amount, breast condition, stool amount, weight and satisfaction. The characteristics of each section were evaluated on a scale of 0,1,2 points, and a full score of 10 was considered as the best breast milk intake and 7 and below as inadequate breast milk intake.
**Measure:** Evaluation of Perception of Insufficient Milk
**Time Frame:** Postpartum 7th day, 3rd month, and 6th month
**Description:** The Breastfeeding Self-Efficacy Short Form is a 5-point Likert-type scale (1= "I am never sure" and 5 = "I am always sure"). The minimum score is 14 and the maximum score is 70. A higher score indicates higher breastfeeding self-efficacy.
**Measure:** Evaluation of Breastfeeding Self-Efficacy
**Time Frame:** Postpartum 7th day, 3rd month, and 6th month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Volunteering to participate in the study.
2. Being primiparous at 24-36 weeks of pregnancy.
3. To be able to speak and speak Turkish.
4. To be at least a primary school graduate.
5. Having a computer or smartphone at home and being able to use it.
6. No risk in pregnancy.
7. The woman does not have any chronic disease.
Exclusion Criteria:
1. The emergence of a risky situation during pregnancy.
2. Premature birth of the woman participating in the study.
3. Carrying out a risky birth and hospitalization of the mother or baby due to it.
4. Termination of pregnancy prematurely for any reason (such as infant death)
5. The fact that the pregnant women in the experimental group did not complete the training modules before birth.
6. The fact that the women participating in the study did not respond to the directed scales and questionnaires.
7. The woman's desire to quit working without giving any reason.
**Gender Based:** True
**Gender Description:** Female. Because this research is for pregnant.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** Marmara University
**Zip:** 34854
#### Overall Officials
**Official 1:**
**Affiliation:** Marmara University
**Name:** Elif velioğlu, PhDc
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Marmara University
**Name:** Nurdan Demirci, Prof
**Role:** STUDY_DIRECTOR
### References Module
#### References
**Citation:** Kleinpell R, Ely EW, Williams G, Liolios A, Ward N, Tisherman SA. Web-based resources for critical care education. Crit Care Med. 2011 Mar;39(3):541-53. doi: 10.1097/CCM.0b013e318206b5b5.
**PMID:** 21169819
**Citation:** Maloney S, Haas R, Keating JL, Molloy E, Jolly B, Sims J, Morgan P, Haines T. Breakeven, cost benefit, cost effectiveness, and willingness to pay for web-based versus face-to-face education delivery for health professionals. J Med Internet Res. 2012 Apr 2;14(2):e47. doi: 10.2196/jmir.2040.
**PMID:** 22469659
**Citation:** Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.
**PMID:** 26869575
**Citation:** Dennis CL, Faux S. Development and psychometric testing of the Breastfeeding Self-Efficacy Scale. Res Nurs Health. 1999 Oct;22(5):399-409. doi: 10.1002/(sici)1098-240x(199910)22:53.0.co;2-4.
**PMID:** 10520192
**Citation:** Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.
**PMID:** 14649593
#### See Also Links
**Label:** 2018 Turkey Demographic and Health Survey,Hacettepe University Institute of Population Studies Ankara, Turkey
**URL:** https://fs.hacettepe.edu.tr/hips/dosyalar/Ara%C5%9Ft%C4%B1rmalar%20-%20raporlar/2018%20TNSA/TDHS2018_mainReport_compressed.pdf
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443788
**Brief Title:** Trans-perineal Ultrasound in Assessment of PPROMs
**Official Title:** Trans-perineal Ultrasound in Assessment of Preterm Pre-labor Rupture of Membranes Compared to Speculum Examination: Accuracy Study
#### Organization Study ID Info
**ID:** MS 715/2023
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-04
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-15
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ain Shams University
#### Responsible Party
**Investigator Affiliation:** Ain Shams University
**Investigator Full Name:** Maya Abdelrazek
**Investigator Title:** Lecturer in Obstetrics and Gynecology
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Accurate and timely diagnosis of preterm pre-labor rupture of membranes (PPROM) is important to prevent adverse maternal and fetal outcomes. Following a history of PPROM, physical examination should be performed in a way that minimizes the risk of infection using a speculum. This is important to confirm the diagnosis by visualizing the amniotic fluid passing from the cervical canal or pooling in the vagina. In addition to examining the cervix to assess its dilatation and effacement and look for umbilical cord prolapse or fetal prolapse. However, Pelvic exam is one of the most common anxiety provoking medical procedures that's why this study aims at using the transperineal ultrasound as a non-invasive, accurate, cost effective, applicable and readily available tool in assessment of PPROM with less patient anxiety and fear.
**Detailed Description:** Preterm pre-labor rupture of membranes (PPROM) refers to the disruption of fetal membranes before the beginning of labor, resulting in spontaneous leakage of amniotic fluid. PROM, which occurs prior to 37 weeks of gestation, defined as preterm PROM. The definition is similarly defined by ACOG, NICE, RANZCOG and World Health Organization (WHO).
PROM occurs in approximately 5%-10% of all pregnancies, of which approximately 80% occur at term.
There are numerous risk factors for PPROM, such as intrauterine infection at early gestational age, lower socioeconomic status of pregnant women, inadequate prenatal care and inadequate nutrition during pregnancy, sexually transmitted infections, vaginal bleeding, and smoking during pregnancy.
PPROM is linked to significant maternal and fetal morbidity and mortality. It has been shown to be the cause of 18%-20% and 21.4% of prenatal mortalities and morbidity respectively.
Complications of PPROM for the fetus and newborn consist of prematurity, fetal distress, cord compression, deformation and altered pulmonary development leading to pulmonary hypoplasia and pulmonary hypertension, necrotizing enterocolitis (NEC) and neurologic disorder.
Infectious morbidities in mother, fetus and newborn have been related to both PROM and prolonged rupture of membranes. Maternal complications include intra-amniotic infection, which occurs in 13%-60% of women with PROM, placental abruption, and postpartum endometritis.
Diagnosis of ROM is usually made by observing leakage of the amniotic fluid or by observing the amniotic fluid pooling in the vaginal vault.A golden standard method has not yet been defined in PROM. Diagnostic tests should be used when the diagnosis is not certain following history, examination with sterile speculum and ultrasonography evaluation. Among biochemical tests, PAMG-1 and IGFBP-1 have the features of being easily applicable tests. PAMG-1 comes into prominence with its high sensitivity and specificity. Results of tests used in PROM diagnosis must be supported by clinical findings But in Low resource settings may not have access to some tests due to their cost.
In practice, most complaints of fluid leakage are not due to membrane rupture. However, a complaint of fluid leakage warrants at least a speculum examination to check for amniotic fluid pooling. Speculum examinations are invasive and performing a speculum examination on a patient with the complaint of fluid leakage may be of no consequence when PPROM is ruled out. However, speculum examinations association with the latency periods in PPROM cases is not known and sterile vaginal examinations have been proven to shorten latency periods.
Speculum examination and digital vaginal examination are both similarly invasive in nature, and it may be possible speculum examinations can shorten latency periods as well. Women commonly experience anxiety and fear before and during a pelvic examination. Anxiety or fear has been reported in 21%- 64% of women. Additional studies have reported women experiencing embarrassment of up to 52%, anxiety in 21%-49% and pain in 22%-68%.
The hypothesis of this study is that transperineal ultrasound can be an accurate exam for diagnosis of PPROM and assess of cervical length, effacement and presenting parts in addition to umbilical cord prolapse with less patients anxiety.
### Conditions Module
**Conditions:**
- PPROM
- Preterm Premature Rupture of Membrane
**Keywords:**
- transperineal ultrasound
- speculum exmaination
- PPROM
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Evaluation of amniotic fluid pooling via transperineal ultrasonography will be performed. Images will be captured in sagittal and transverse planes. Sagittal plane images will be captured with ultrasound probe placed in between labia major, parallel to their long axis. Transverse plane images will be captured with ultrasound probe placed on posterior fourchette, parallel to the plane of posterior.
Images will be evaluated for appearance of accumulated hypoechogenic fluid around cervix. Whenever collection is spotted, three largest dimensions of fluid will be measured (length, width, depth).
Fluid accumulations around the cervix that are clearly demarcated from surrounding tissues were considered positive.
Cervical length detected . Presenting part and cord prolapse
**Intervention Names:**
- Diagnostic Test: transperineal ultrasound
**Label:** Pregnant women with history suggestive of PPROMs between 24 to 37 weeks' gestation
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Pregnant women with history suggestive of PPROMs between 24 to 37 weeks' gestation
**Description:** The following measurement will be recorded:
1. Amniotic fluid pooling assessment will be performed in sagittal and transverse planes. ,
* Images will be evaluated for appearance of accumulated hypoechogenic fluid around cervix. Whenever collection is spotted, three largest dimensions of fluid will be measured (length, width, depth).
* Fluid accumulations around the cervix that are clearly demarcated from surrounding tissues will be considered positive.
2. Cervical length: it will be measured between the internal os point to the external os point below. Cervical dilatation will be measured in a transverse plane from inner to inner.
3. Presence of fetal part prolapse and/or cord prolapse
**Name:** transperineal ultrasound
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Images by ultrasound will be evaluated for appearance of accumulated hypoechogenic fluid around cervix. Whenever collection is spotted, three largest dimensions of fluid will be measured (length, width, depth) comparing it to speculum examination by observing amniotic fluid leaking through the cervix or pooling of amniotic fluid in posterior vaginal vault
**Measure:** Accuracy in diagnosis of PPROM by trans-perineal ultrasound
**Time Frame:** at time of diagnosis (24 to 37 weeks' gestation)
#### Secondary Outcomes
**Description:** comapred to speculum examination (subjective)
**Measure:** assessment of cervical length and dilatation by ultrasound (objective) in mm.
**Time Frame:** at time of diagnosis (24 to 37 weeks' gestation)
**Description:** compared to visualization by speculum (visualizing any fetal part or cord prolapsiing from the cervix)
**Measure:** assessment of fetal parts or cord prolapse by ultrasound
**Time Frame:** at time of diagnosis (24 to 37 weeks' gestation)
**Description:** using State-Trait Anxiety Inventory (STAI). 1 = not at all / almost never, 2 = somewhat/sometimes, 3 = moderately so / often, and 4 = very much so / almost always
**Measure:** assessment of patients' anxiety (Tolerability to the examination)
**Time Frame:** at time of diagnosis (24 to 37 weeks' gestation)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Pregnant women with history suggestive of preterm prelabor rupture of membranes (PPROM):
* Sudden gush of fluid per vagina or.
* Continuous leakage of fluid per vagina or.
* Feeling wet or.
* Feeling inability to stop urinating.
* 24 to 37 weeks' gestation.
Exclusion Criteria:
* • Women in active labor (uterine contraction with cervical dilatation more than or equal to 5 cm).
* Women with vaginal bleeding.
* Vulvovaginitis (vaginal discharge).
* Cervical cerclage in place.
* Intrauterine fetal demise (IUFD).
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Maya M. Abdelrazek
**Phone:** 01222393983
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** Faculty of Medicine, Ain Shams University
**Status:** RECRUITING
**Zip:** 11591
#### Overall Officials
**Official 1:**
**Affiliation:** Ain Shams University
**Name:** Maya M. Abdelrazek, MD
**Role:** PRINCIPAL_INVESTIGATOR
## 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
- ID: D000014947
- Term: Wounds and Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M25869
- Name: Premature Birth
- Relevance: HIGH
- As Found: Preterm
- ID: M8452
- Name: Fetal Membranes, Premature Rupture
- Relevance: HIGH
- As Found: Premature Rupture of Membranes
- ID: M15241
- Name: Rupture
- Relevance: HIGH
- As Found: Rupture
- 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
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000047928
- Term: Premature Birth
- ID: D000005322
- Term: Fetal Membranes, Premature Rupture
- ID: D000012421
- Term: Rupture
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443775
**Brief Title:** An Observational Study to Assess Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) on Dry Eye Symptoms and Quality of Life of Adult Participants With Mild to Moderate Dry Eye Disease (DED)
**Official Title:** Patient Experience Study Evaluating The Effect of Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) on Dry Eye Symptoms and QOL in Patients With Mild to Moderate DED and High Digital Device Use
#### Organization Study ID Info
**ID:** P25-007
#### Organization
**Class:** INDUSTRY
**Full Name:** AbbVie
### Status Module
#### Completion Date
**Date:** 2024-07-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** AbbVie
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Dry Eye Disease (DED) is a condition where the tear film of the eye becomes unstable and along with ocular surface inflammation and damage leads to inadequate tear production and eye lubrication. This study will evaluate Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) in adult participants with dry eye symptoms and who are high digital device users.
NGE-UD is an over-the-counter (OTC) monograph drug indicated for the temporary relief of symptoms of eye dryness. Participants will administer 1 drop of NGE-UD on Day 1 for the acute phase of the study, after Day 1 participants will administer 1-2 eye drops in each eye at least twice a day but as much as needed through Day 15. Around 50 adult participants will be enrolled at one site in the United States.
There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site as per standard of care.
### Conditions Module
**Conditions:**
- Dry Eye
**Keywords:**
- Dry Eye
- Next Generation Emulsion Preservative Free Eye Drops (NGE-UD)
- AGN-OPTIVEPLUS
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive one drop of Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) on Day 1, after Day 1 participants will administer 1-2 eye drops in each eye at least twice a day but as much as needed through Day 15.
**Intervention Names:**
- Drug: Next Generation Emulsion Preservative Free Eye Drops (NGE-UD)
**Label:** NGE-UD
### Interventions
#### Intervention 1
**Arm Group Labels:**
- NGE-UD
**Description:** Eye Drops
**Name:** Next Generation Emulsion Preservative Free Eye Drops (NGE-UD)
**Other Names:**
- Refresh Digital
- Refresh Optive Advanced
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time to 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability to 100=complete disability). A negative number change from baseline represents an improvement.
**Measure:** Change from Baseline in Ocular Surface Disease Index (OSDI) Score
**Time Frame:** Baseline to Day 15
**Description:** The Current Symptom Survey is a 5-item questionnaire where the participants rate their ocular symptoms at the current moment using a scale ranging from '0 = strongly disagree' to '100 = strongly agree.'
**Measure:** Change from Baseline in Current Symptom Score
**Time Frame:** Baseline to Day 15
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* During a routine visit, investigator will decide whether artificial tears are the appropriate treatment for potential participants with dry eyes and will then consider enrollment into this study.
* Participant with at least one sign of dry eye:
* Three consecutive tear break-up time (TBUT) tests \<= 10 seconds in at least one eye at Screening Visit OR;
* Grade 1 to 4 (modified National Eye Institute \[NEI\] Grid, score range = 0 to 5) staining in at least 1 area of the cornea (5 areas examined) or conjunctiva (6 areas examined) that is related to dry eye in at least 1 eye at both at Screening Visit.
* Use of digital devices of 8 hours or more per day.
* Adult participants who answer yes to the following questions:
* Do you use digital devices at least 8 hours per day? Yes or No
* Are your eyes dry, irritated while using a digital screen like a computer or smartphone? Yes or No
Exclusion Criteria:
* Use of artificial tears in the last 24 hours.
* Current use of more than 4 drops of artificial tears per day in each eye.
* Use of dry eye treatment other than artificial tears.
* Are currently on ocular medications.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Adult participants with dry eye disease and who are high digital device users.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** ABBVIE CALL CENTER
**Phone:** 844-663-3742
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Town And Country
**Country:** United States
**Facility:** Saint Louis Eye Institute /ID# 263275
**State:** Missouri
**Status:** RECRUITING
**Zip:** 60025
#### Overall Officials
**Official 1:**
**Affiliation:** AbbVie
**Name:** ABBVIE INC.
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### See Also Links
**Label:** Related Info
**URL:** https://www.abbvieclinicaltrials.com/study/?id=P25-007
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007766
- Term: Lacrimal Apparatus Diseases
- ID: D000005128
- Term: Eye Diseases
- ID: D000007637
- Term: Keratoconjunctivitis
- ID: D000003231
- Term: Conjunctivitis
- ID: D000003229
- Term: Conjunctival Diseases
- ID: D000007634
- Term: Keratitis
- ID: D000003316
- Term: Corneal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M18040
- Name: Dry Eye Syndromes
- Relevance: HIGH
- As Found: Dry Eye
- ID: M10664
- Name: Keratoconjunctivitis Sicca
- Relevance: HIGH
- As Found: Dry Eye
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M10663
- Name: Keratoconjunctivitis
- Relevance: LOW
- As Found: Unknown
- ID: M10786
- Name: Lacrimal Apparatus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6455
- Name: Conjunctivitis
- Relevance: LOW
- As Found: Unknown
- ID: M6453
- Name: Conjunctival Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10660
- Name: Keratitis
- Relevance: LOW
- As Found: Unknown
- ID: M6539
- Name: Corneal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015352
- Term: Dry Eye Syndromes
- ID: D000007638
- Term: Keratoconjunctivitis Sicca
### Intervention Browse Module - Ancestors
- ID: D000019999
- Term: Pharmaceutical Solutions
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M12814
- Name: Ophthalmic Solutions
- Relevance: HIGH
- As Found: Design
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000009883
- Term: Ophthalmic Solutions
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443762
**Brief Title:** First Human Trial of Targeting MDM2/MDMX PET Imaging
**Official Title:** First in Human Study on PET Imaging of Solid Tumors Using an MDM2/MDMX-Specific Probe
#### Organization Study ID Info
**ID:** 2023YJZ73
#### Organization
**Class:** OTHER
**Full Name:** Peking University Cancer Hospital & Institute
### Status Module
#### Completion Date
**Date:** 2025-05-30
**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:** 2024-11-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-10
**Type:** ESTIMATED
**Status Verified Date:** 2023-09
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Peking University Cancer Hospital & Institute
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Investigation of the Radiotracer Uptake of \[68Ga\] MDM2/MDMX Peptide at Lesion Sites in Patients with Malignant Tumors, and Evaluation of the Capability of \[68Ga\] MDM2/MDMX Peptide to Detect Overexpression of MDM2/MDMX in Tumor Patients, Particularly Those with Recurrent or Advanced Disease.
### Conditions Module
**Conditions:**
- MDM2/MDMX Gene Mutation
- Nuclear Medicine
- Positron Emission Tomography Imaing
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** \[68Ga\] MDM2/MDMX Peptide PET/CT Imaging: Patients are intravenously injected with prepared and quality-assured \[68Ga\] MDM2/MDMX Peptide (0.05-0.1 mCi/kg). Imaging is performed 40 minutes to 1 hour post-injection using either the United Imaging uEXPLORER 2m PET/CT or Siemens Biograph m-CT flow PET/CT for whole-body scans, extending from the top of the head to the feet. In cases where conventional imaging reveals indeterminate lesions, delayed imaging is conducted for further differentiation. The patient is positioned supine with calm respiration. The imaging conditions for the head and torso remain as described above. Data are reconstructed using the OSEM method to produce coronal, sagittal, and axial PET and PET/CT fusion images.
**Intervention Names:**
- Drug: [68Ga] MDM2/MDMX Peptide
**Label:** Experimental group patients who underwent PET scanning with injection probes
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental group patients who underwent PET scanning with injection probes
**Description:** Utilizing a peptide with high affinity to MDM2/MDMX as the targeting moiety for radiopharmaceuticals, this study explores the diagnostic efficacy of \[68Ga\] MDM2/MDMX Peptide in patients with malignant tumors exhibiting high MDM2/MDMX expression. This approach not only provides a basis for the early diagnosis of malignant tumors but also facilitates the formulation of effective precision therapy strategies tailored to the tumor's MDM2/MDMX expression profile, particularly for patients with recurrent and metastatic disease.
\[68Ga\] MDM2/MDMX Peptide, a novel MDM2/MDMX-targeted molecular probe labeled with 68Ga, utilizes DOTA as a bifunctional chelator for complexing with 68Ga3+. The labeling process is straightforward, allowing for direct use without purification, and demonstrates high in vivo stability.
**Name:** [68Ga] MDM2/MDMX Peptide
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Standardized Uptake Values (SUV) of \[68Ga\] MDM2/MDMX Peptide at various time points within the imaging window for target lesions or suspected tumor lesions in subjects with solid tumors or suspected solid tumors.
**Measure:** SUV
**Time Frame:** 1 hour and 2 hours after drug injection
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Ages 18 to 75 years, both males and females are eligible;
2. Participants must meet the following criteria for blood routine and liver/kidney function tests: Complete blood count: WBC ≥ 4.0 × 10\^9/L or neutrophils ≥ 1.5 × 10\^9/L, platelets ≥ 100 × 10\^9/L, hemoglobin ≥ 90 g/L; prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal (ULN); liver and kidney function: Total bilirubin ≤ 1.5 times the upper threshold limit (ULT), ALT/AST ≤ 2.5 ULN or ≤ 5 ULT for participants with liver metastasis, alkaline phosphatase (ALP) ≤ 2.5 ULN (if bone or liver metastases are present, ALP ≤ 4.5 ULN); Blood urea nitrogen (BUN) ≤ 1.5 × ULT, serum creatinine (SCr) ≤ 1.5 × ULT;
3. Normal cardiac function;
4. An expected survival of ≥ 12 weeks;
5. Good follow-up compliance;
6. According to RECIST 1.1 criteria, there must be at least one measurable target lesion;
7. Women of childbearing age (15-49 years) must have a negative pregnancy test conducted within 7 days prior to enrollment; patients of childbearing potential must agree to use effective contraceptive methods to ensure they do not conceive during the study and for three months after examinations;
8. Patients recommended for PET/CT evaluation for tumor diagnosis and staging by a clinician;
9. Participants must fully understand the study and voluntarily participate, and must sign an informed consent form.
Exclusion Criteria:
1. Severe abnormalities in liver and kidney function as well as hematological parameters;
2. Patients who are planning a pregnancy;
3. Pregnant or lactating women;
4. Individuals unable to lie flat for thirty minutes;
5. Individuals who refuse to participate in this clinical study;
6. Individuals suffering from claustrophobia or other psychiatric disorders;
7. Other conditions deemed by the researchers as unsuitable for participation in the trial.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M5860
- Name: Chelating Agents
- Relevance: LOW
- As Found: Unknown
- ID: M21258
- Name: Radiopharmaceuticals
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443749
**Brief Title:** Closure of the Appendiceal Stump
**Official Title:** Closure of the Appendiceal Stump With a Polymer Clip Versus Intracorporeal Ligation With a Single Instrument in Laparoscopic Appendectomy; Prospective Randomized Trial
#### Organization Study ID Info
**ID:** KAHRAMANMARASKSUGCSTOPUZ1.....
#### Organization
**Class:** OTHER
**Full Name:** Kahramanmaras Sutcu Imam University
### Status Module
#### Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2023-12-11
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sezgin Topuz
#### Responsible Party
**Investigator Affiliation:** Kahramanmaras Sutcu Imam University
**Investigator Full Name:** Sezgin Topuz
**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:** Laparoscopic appendectomy is a well-defined surgical technique. However, concerns remain about whether closure of the appendiceal stump should be done with clips, endoloops, staples, or other techniques. If tying is to be used in the closure of the appendiceal stump, there is no consensus on which technique (intracorporoyal, extracorporoyal, etc.) should be used for ligation. For this reason, there is a need for studies on different binding techniques and instruments currently used. The aim of this study was to compare the use of unilateral intracorporeal knot and polymer endoclip closure during laparoscopic appendectomy.
**Detailed Description:** Patients who are scheduled to undergo laparoscopic appendectomy after the ethics committee approval will be included consecutively. Patients will be randomized into 2 groups: those who will be closed with a polymer endoclip (Group 1) and those who will be closed with an intracorporeal node with a single instrument (Group 2). Data such as age, gender, body mass index, comorbidities, previous abdominal surgeries, medications used by the patients, as well as the presence of ileus, perforation, and diffuse peritonitis will be recorded. After laparoscopic dissection, the appendiceal stump will be closed with a polyper homologous clip in Group 1 and the stump will be closed with an intracorporial node with a single instrument in Group 2. The operation times of the patients, the time elapsed after the end of the dissection until the pathology specimen comes out of the skin (to be determined as the closure time), complications such as ileus, intra-abdominal abscess, bleeding and fistula related to stump closure problems encountered in the postoperative period will be recorded and compared. Patients will be followed by the corresponding author In both surgical methods, it is routinely used to close the appendiceal stump and in the polymer clip application, a clip with a locking mechanism is used when the stump is tightened with an applicator. In the intracorporial node with one hand, the surgical node is made by circulating the tip of the suture material around the appendix with a single instrument (the other end is kept fixed outside the abdomen)
### Conditions Module
**Conditions:**
- Appendectomy
**Keywords:**
- Appendectomy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 48
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** the appendiceal stump will be closed with a polyper homologous clip
**Intervention Names:**
- Procedure: appendectomy
**Label:** group1
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** the stump will be closed with an intracorporial node with a single instrument in
**Intervention Names:**
- Procedure: appendectomy
**Label:** group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- group
- group1
**Description:** the appendiceal stump will be closed with a polyper homologous clip or with an intracorporial node
**Name:** appendectomy
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** operation time
**Measure:** operation time
**Time Frame:** 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria
* Patients who are diagnosed with acute appendicitis
Exclusion Criteria:
* bleeding diathesis
* cirrhotic acid,
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sezgin Topuz
**Phone:** +905370252264
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Muhammed Alkan
**Role:** CONTACT
### 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:** NCT06443736
**Brief Title:** TRESPASS Clinical Study
**Official Title:** Antenatal ThREe Steps Perineal mASSage in Reducing Perineal Trauma and Post-partum Morbidities: TRESPASS Clinical Study
#### Organization Study ID Info
**ID:** 17506
#### Organization
**Class:** OTHER
**Full Name:** Azienda Sanitaria-Universitaria Integrata di Udine
### Status Module
#### Completion Date
**Date:** 2026-04-19
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-04-19
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-19
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-27
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Azienda Sanitaria-Universitaria Integrata di Udine
#### Responsible Party
**Investigator Affiliation:** Azienda Sanitaria-Universitaria Integrata di Udine
**Investigator Full Name:** Martina Arcieri
**Investigator Title:** Principal Investigator, Medical Doctor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The purpose of this study is to assess the superiority of a standardized perineal massage in the decrease in vagino-perineal lacerations.
**Detailed Description:** Perineal trauma from delivery correlates with an increased incidence of perineal pain and discomfort, dyspareunia and sexual dysfunction, as well as urinary and anal incontinence and therefore have a significant impact on women's physical and mental health. Prepartum perineal massage has been shown to reduce the incidence of spontaneous vagino-perineal tears and promote better anatomo-functional recovery of the perineum in the postpartum period. To date, there are no guidelines on the best modes of perineal massage, and there is a lack of true standardization of the process in the literature. The authors developed, on the basis of the evidence available at the present time, a peculiar type of perineal massage, embedded in a standardized clinical process including training and follow-up of the patient. All pregnant patients who meet the inclusion criteria will be selected and offered participation in the study by delivering the information brochure at the 2nd trimester obstetrical visit. If at the 3rd trimester obstetrical visit the patient expresses willingness to participate in the study, consent will be signed and enrollment and randomization to the study will be performed. The patient will then be notified of the date of the training meeting held by the investigator and/or co-authors; at this meeting, a brief lecture on aspects of primary pelvic floor prevention will be offered to patients in group A, who will also be educated on the perineal massage proposed by the Authors. Group B patients will equally be offered a short lecture on aspects of primary prevention, leaving the patient free choice in pelvic floor education in pregnancy. Group A patients will perform the learned perineal massage at home, reporting their adherence to the study in a diary. After delivery, at the time of discharge, a data collection form regarding postpartum perineal pain will be given to the patient and the date of the 45-day follow-up visit will be communicated. Thus, the primary endpoint of the present study is to assess the difference in incidence in the two study groups of the absence of vagino-perineal tears (intact perineum). Secondary endpoints to be assessed are the superiority of perineal massage on the duration of the second stage of labor, on incidence of operative delivery and episiotomies, and on perineal pain and dyspareunia in postpartum. Investigating the relationship between prepartum perineal massage and perineal tears (and related short- and long-term morbidity) could lead to improvement in obstetric clinical practice by giving the right guidance to the pregnant woman in pelvic floor education.
### Conditions Module
**Conditions:**
- Perineal Laceration, Tear, or Rupture During Delivery
**Keywords:**
- Perineal Laceration
- Perineal Trauma
- Vaginal delivery
- Perineal massage
- Operative vaginal birth
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 154
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Procedure: Standardized perineal massage
**Label:** Standardized perineal massage
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Behavioral: Primary prevention
**Label:** Standard prevention
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Standardized perineal massage
**Description:** Patients in this arm will be educated in the perineal massage proposed by the authors; the training will be performed during a group session, (organized bimonthly) conducted by obstetrical staff specialists, in the presence of the principal investigator and/or co-authors. In these sessions, a brief lecture on aspects of primary prevention related to pelvic floor structures (healthy diet, body weight control, moderate physical activity avoiding excessive exertion, posture control, therapy minctional education) and then screened an explanatory video regarding the three-step perineal massage proposed by the authors. The adequately prepared patient should then apply such perineal massage at home from the 34th gestational week until delivery according to the procedural methods provided.
**Name:** Standardized perineal massage
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Standard prevention
**Description:** Patients in this arm will be offered a group meeting in which aspects of primary prevention related to the structures of the pelvic floor (healthy diet, body weight control, moderate physical activity avoiding exertion excessive exertion, posture control, micturition educational therapy); participation in this meeting will be on a voluntary basis, and patients randomized to that group will have free choice in educating the pelvic floor pelvic floor in pregnancy.
**Name:** Primary prevention
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The degree of perineal tears will be assessed at the delivery by using the classification system for perineal tears recommended by the Royal College of Obstetricians and Gynaecologists (RCOG classification).
**Measure:** Rate of intact perineum and perineal tears (classified on the basis of RCOG classification) in the two groups
**Time Frame:** At the delivery
#### Secondary Outcomes
**Description:** Second stage describes the period of time from complete cervical dilation to 10 centimeters to the delivery of the neonate. It will be assessed in minutes.
**Measure:** Duration of the second stage of labor in the two groups
**Time Frame:** At the delivery
**Description:** It will be assessed considering the number of participants in each group receiving operative delivery or episiotomy
**Measure:** Rate of operative delivery and episiotomies in the two groups
**Time Frame:** During labor and delivery
**Description:** After delivery, at the time of discharge, the patient will be given a data collection form regarding postpartum perineal pain using NRS scale to be completed at 7-14-21 days after delivery and will be told the date of the follow-up visit at 45 days.
**Measure:** Change from the baseline in perineal pain in postpartum using the Numeric Pain Rating Scale (0-10).
**Time Frame:** At 7-14-21 days postpartum
**Description:** During the follow-up visit at 45 days, a general evaluation of the external and internal genitalia and pelvic floor (PC test) and swab test for perineal pain assessment will be performed on that occasion; the on-site completion of the Pelvic Pain Impact Questionnaire to assess the impact of perineal pain on quality of life will also be requested.
**Measure:** Change from the baseline in perineal pain in postpartum using the Pelvic Pain Impact Questionnaire
**Time Frame:** at 45 +/-5 days postpartum.
**Description:** During the follow-up visit 45 days after delivery, the Marinoff Dyspareunia Scale questionnaire for the assessment of dyspareunia in postpartum women who have resumed sexual intercourse will be requested to be completed on site.
**Measure:** Change from the baseline in dyspareunia in postpartum using the Marinoff Dyspareunia Scale
**Time Frame:** At 45 +/-5 days postpartum.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Single pregnancy
* Part presented cephalic
* Age between 18 and 40 years
* Pregravid body mass index (BMI) between 18 and 29.9
* Understanding of the Italian language
* Estimated Fetal Weight in range (3rdcentile to 97thcentile according to Intergrowth)
Exclusion Criteria:
* Multipara
* Age \< 18 years and age \> 40 years
* Presence of pre-pregnancy bladder-sphincter-perineal disorders
* Medical contraindications to vaginal delivery
* Birth occurred by cesarean section
* Pregravid BMI \> 30
* Estimated Fetal Weight \< 3rdcentile (Small for Gestational Age/Intrauterine Growth Restriction fetus) or \> 97thcentile (\> 4500 g) according to Intergrowth
* Fetal weight at birth \> 4500 g
* Twin pregnancy
* Preterm delivery (\< 37 weeks gestation)
* Personal history of connective tissue disease
* Lack of informed consent
**Healthy Volunteers:** True
**Maximum Age:** 40 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Martina Arcieri
**Phone:** +00393478114704
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Udine
**Contacts:**
***Contact 1:***
- **Name:** Lorenza Driul
- **Role:** CONTACT
***Contact 2:***
- **Name:** Martina Arcieri
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Italy
**Facility:** Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ostetrica e Ginecologica Udine
**Status:** RECRUITING
**Zip:** 33100
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-02-20
- Filename: Prot_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: False
- Label: Study Protocol
- Size: 101763
- Type Abbrev: Prot
- Upload Date: 2024-05-14T05:50
## 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: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M15241
- Name: Rupture
- Relevance: HIGH
- As Found: Rupture
- ID: M22785
- Name: Lacerations
- Relevance: HIGH
- As Found: Laceration
### Condition Browse Module - Meshes
- ID: D000012421
- Term: Rupture
- ID: D000022125
- Term: Lacerations
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443723
**Brief Title:** Metabolic Dysfunction Associated Fatty Liver Disease in Long-Term Cholecystectomy Patients
**Official Title:** Metabolic Dysfunction Associated Fatty Liver Disease in Long-Term Cholecystectomy: A Cross-sectional Case-control Study
#### Organization Study ID Info
**ID:** CholecystectomyMAFLD
#### Organization
**Class:** OTHER
**Full Name:** Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-04-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-04-30
**Type:** ACTUAL
#### Start Date
**Date:** 2023-11-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
#### Responsible Party
**Investigator Affiliation:** Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
**Investigator Full Name:** Semih Sezer
**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:** The aim of this study was to examine the association between metabolic associated fatty liver disease (MAFLD) in participants who had undergone cholecystectomy and those who had not undergone cholecystectomy. MAFLD is defined as hepatic steatosis(with ultrasonography) entity in addition to the presence of overweight or obesity, diabetes mellitus, or evidence of metabolic dysfunction.
In this way, the long-term effects of cholecystectomy surgeries, which are commonly performed in the society and thought to be harmless, will be evaluated.
**Detailed Description:** Cholecystectomy is known to be a harmless operation with low perioperative mortality and morbidity. However, the unexplained increase in metabolic disorders in cholecystectomy patients has led to the need for further investigation of cholecystectomy patients. Non-alcoholic fatty liver disease is an important health problem with an average prevalence of 25% worldwide and serious hepatic and systemic complications. The aim of this study was to examine the association of cholecystectomy with metabolic dysfunction associated fatty liver disease (MAFLD), which is an important public health problem in the long-term.
This case-controlled cross-sectional study was planned to evaluate the relationship between patients who had undergone cholecystectomy with MAFLD. MAFLD is defined as hepatic steatosis entity in addition to the presence of overweight or obesity, diabetes mellitus, or evidence of metabolic dysfunction.
The study included 86 participants with cholecystectomy and 63 participants without cholecystectomy. It was planned to compare the participants according to the diagnostic criteria for MAFLD (with or without MAFLD).
### Conditions Module
**Conditions:**
- Liver Steatoses
**Keywords:**
- Ultrasaund
- obesity
- cholecystectomy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 149
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Evaluation of hepatosteatosis by hepatobiliary ultrasonography in cholecystectomy patients. Height, hip, waist circumference, blood pressure measurement and hemogram, lipid parameters.
**Intervention Names:**
- Diagnostic Test: USG, blood tests, waist, hip, height and blood pressure measurements
**Label:** cholecystectomy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Evaluation of hepatosteatosis by hepatobiliary ultrasonography in participants without cholecystectomy. Height, hip, waist circumference, blood pressure measurement and hemogram, lipid parameters.
**Intervention Names:**
- Diagnostic Test: USG, blood tests, waist, hip, height and blood pressure measurements
**Label:** Control
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control
- cholecystectomy
**Description:** MAFLD is defined as hepatic steatosis entity in addition to the presence of overweight or obesity, DM, or evidence of metabolic dysfunction.
Metabolic dysfunction (two or more of the following)
1. waist circumference ≥ 90 cm in men and 88 cm in women,
2. blood pressure ≥ 130/85 mmHg or on specific drug treatment,
3. plasma triglycerides (TG) ≥ 150 mg/dl or on specific drug treatment,
4. plasma high-density lipoprotein cholesterol (HDL-C) \< 40 mg/dl for men and 50 mg/dl for women or on specific drug treatment,
5. prediabetes (FBS 100 to 125 mg/dl or HbA1c 5.7 to 6.4%),
6. homeostasis model assessment of insulin resistance (HOMA-IR) score ≥ 2.5.
**Name:** USG, blood tests, waist, hip, height and blood pressure measurements
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** fasting plasma glucose \>126mg/dL
**Measure:** diabetes mellitus
**Time Frame:** through study completion, an average of 4 months
**Description:** BMI \>25 kg/m2
**Measure:** definition of overweight
**Time Frame:** through study completion, an average of 4 months
**Description:** ≥102 cm in men and 88 cm in women
**Measure:** Upper limits of waist circumference
**Time Frame:** through study completion, an average of 4 months
**Description:** fasting plasma glucose of 100-125 mg/dL
**Measure:** Definition of pre-diabetes
**Time Frame:** through study completion, an average of 4 months
**Description:** ≥130/85 mmHg
**Measure:** Blood pressure upper limit
**Time Frame:** through study completion, an average of 4 months
**Description:** \<40 mg/dL for males and \<50 mg/dL for females.
**Measure:** HDL-cholesterol levels
**Time Frame:** through study completion, an average of 4 months
**Description:** ≥1.70 mmol/L
**Measure:** Triglyceride levels
**Time Frame:** through study completion, an average of 4 months
**Description:** hepatic steatosis + (diabetes mellitus and/or overweight and/or metabolic dysfunction) metabolic dysfunction is defined as the presence of at least two criteria(Pre-diabetes, TG, HDL, blood pressure, waist circumference)
**Measure:** Diagnosis of MAFLD
**Time Frame:** through study completion, an average of 4 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* who were found to have undergone cholecystectomy at least five years ago,
* who could feed orally and perform activities of daily living
* participants who had not undergone cholecystectomy with similar characteristics were included in the study
Exclusion Criteria:
* those with chronic liver disease
* malignancy or history of malignancy
* in a chemotherapy program
* with active infection
* any organ failure
* pregnancy
* use of drugs that cause steatosis in the liver
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ankara
**Country:** Turkey
**Facility:** Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11107
- Name: Liver Diseases
- Relevance: HIGH
- As Found: Liver Disease
- ID: M8375
- Name: Fatty Liver
- Relevance: HIGH
- As Found: Fatty Liver
- ID: M12701
- Name: Obesity
- 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: T5868
- Name: Visceral Steatosis
- Relevance: HIGH
- As Found: Liver Steatosis
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008107
- Term: Liver Diseases
- ID: D000005234
- Term: Fatty Liver
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Hemat
- Name: Hematinics
### Intervention Browse Module - Browse Leaves
- ID: M10365
- Name: Insulin
- Relevance: LOW
- As Found: Unknown
- ID: M173166
- Name: Insulin, Globin Zinc
- Relevance: LOW
- As Found: Unknown
- ID: 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:** NCT06443710
**Brief Title:** Technetium [99mTc]-H7ND in Patients With Gastrointestinal Malignancies and Healthy Volunteers
**Official Title:** A Phase I Clinical Study of the Pharmacokinetics and Safety of Technetium [99mTc]-H7ND Injection in Patients With Gastrointestinal Malignancies and Healthy Volunteers
#### Organization Study ID Info
**ID:** 2023LP02630
#### Organization
**Class:** OTHER
**Full Name:** Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd.
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The primary objective of this study is: to evaluate the safety of technetium \[99mTc\]-H7ND injection in patients with gastrointestinal malignancies and in healthy subjects. The secondary objectives of this study are: (1) to examine the pharmacokinetics of technetium \[99mTc\]-H7ND Injection in healthy subjects. (2) Detect the metabolic stability of technetium \[99mTc\]-H7ND injection in healthy humans. (3) Detect the biodistribution and estimate the absorbed dose of radiation from internal irradiation of technetium \[99mTc\]-H7ND injection in patients with malignant tumors of the gastrointestinal tract and in healthy humans.
### Conditions Module
**Conditions:**
- Solid Tumor
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 24
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Each patient will receive 10 or 20 mCi ± 20% technetium \[99mTc\]-H7ND injection intravenously
**Intervention Names:**
- Drug: Technetium [99mTc]-H7ND injection
**Label:** Patients with malignant tumors of the gastrointestinal tract or healthy subjects
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patients with malignant tumors of the gastrointestinal tract or healthy subjects
**Description:** Technetium \[99mTc\]-H7ND injection is a radiolabeled fibroblast activation protein inhibitor
**Name:** Technetium [99mTc]-H7ND injection
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluation of adverse events and serious adverse events according to the Common Terminology Criteria for the Evaluation of Adverse Events (NCI-CTCAE) version 5.0
**Measure:** Security Indicators
**Time Frame:** 1-7 days from time of injection
#### Secondary Outcomes
**Description:** Measure the count ratio of technetium \[99mTc\]-H7ND tumor area to blood pool, surrounding normal tissue, liver, and muscle in the integrated region of interest.
**Measure:** uptake value ratio
**Time Frame:** 3 days after injection
**Description:** SPECT/CT whole-body scans were performed at different time points after drug injection to obtain radioactivity counts (%ID) in each major irradiated organ at each time phase to reflect the biodistribution of the drug in the body
**Measure:** biodiversity distribution
**Time Frame:** 3 days after injection
**Description:** Plot the "time-activity count" curve for each major organ and calculate the area under the curve. Calculate the retention time of each major exposed organ and apply the software to estimate the absorbed dose of internal radiation for each major exposed organ.
**Measure:** internal radiation dose
**Time Frame:** 3 days after injection
**Description:** Blood samples were collected at different time points after drug injection, and urine samples were collected at different time intervals for detection of technetium \[99mTc\] H7ND prototype and its radioactive metabolites using either a radioactive HPLC detector or a radioactive TLC detector.
**Measure:** Concentration of technetium [99mTc] H7ND prototype and its radioactive metabolites
**Time Frame:** Predose and up to 72 hours postdose
**Description:** Cmax
**Measure:** Pharmacokinetic parameters
**Time Frame:** Predose and up to 72 hours postdose
**Description:** AUC(0-t)
**Measure:** Pharmacokinetic parameters
**Time Frame:** Predose and up to 72 hours postdose
**Description:** AUC(0-∞)
**Measure:** Pharmacokinetic parameters
**Time Frame:** Predose and up to 72 hours postdose
**Description:** Tmax
**Measure:** Pharmacokinetic parameters
**Time Frame:** Predose and up to 72 hours postdose
**Description:** T1/2
**Measure:** Pharmacokinetic parameters
**Time Frame:** Predose and up to 72 hours postdose
**Description:** AUC_%Extrap
**Measure:** Pharmacokinetic parameters
**Time Frame:** Predose and up to 72 hours postdose
**Description:** CL
**Measure:** Pharmacokinetic parameters
**Time Frame:** Predose and up to 72 hours postdose
**Description:** Vd
**Measure:** Pharmacokinetic parameters
**Time Frame:** Predose and up to 72 hours postdose
**Description:** MRT
**Measure:** Pharmacokinetic parameters
**Time Frame:** Predose and up to 72 hours postdose
**Description:** λz
**Measure:** Pharmacokinetic parameters
**Time Frame:** Predose and up to 72 hours postdose
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. All subjects should be adult males or females aged 18-75 years (including borderline values, based on the time of signing the informed consent form) at screening, and not less than 1/3 of the total number of cases of each gender
2. All subjects who are males or females of childbearing potential must be using effective contraception during the study period (effective contraception means sterilization, intrauterine hormonal devices, condoms, contraceptive pills/agents, abstinence, or vasectomy)
3. All subjects are fully aware of the purpose, nature, methods, and possible adverse effects of the trial, voluntarily participate and sign a written informed consent form, and are able to follow the protocol requirements to complete the study
4. Healthy subjects with a body mass index within the range of 18.0 to 26.0 kg/m2 (including the borderline value), male subjects weighing ≥ 50 kg, female subjects weighing ≥ 45 kg
5. Healthy subjects are in good health or do not have a history of major diseases
6. Vital signs, physical examination, laboratory tests, and 12-lead electrocardiogram (ECG) results of healthy subjects during the screening period are not abnormal or the abnormalities are not clinically significant.
7. Gastrointestinal malignant tumor subjects with histologically/cytologically confirmed diagnosis of gastrointestinal malignant tumors (including stomach, small intestine and colorectum)
8. Subjects with gastrointestinal malignant tumors with an ECOG score of 0 - 1
9. Subjects with gastrointestinal malignant tumors Blood routine: WBC ≥ 3 × 109 / L, ANC ≥ 1.5 × 109 / L, Hb ≥ 90 g / L, PLT ≥ 75 × 109 / L; Liver function: TBIL ≤ 1.5 × ULN, ALT, AST ≤ 3 × ULN (≤ 5 × ULN for liver metastases); Kidney function: Cr ≤ 1.5 × ULN; Coagulation function: Prothrombin time (PT) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN, international normalized ratio (INR) ≤1.5×ULN; Electrolytes: corrected magnesium ≥LLN, allowed to correct electrolytes during the screening period Cardiac function: left ventricular ejection fraction ≥ 50%
10. Subjects who have recovered to Grade 1 (CTCAE Version 5.0) from damage caused by other therapies, except: alopecia, hyperpigmentation; and if nutritionally stable, the presence of irrecoverable long-term toxicity as determined by the Investigator is permitted.
11. Subjects with gastrointestinal malignancies expected to survive ≥ 12 weeks
Exclusion Criteria:
1. Pregnant (positive screening pregnancy test) or breastfeeding female
2. History of alcohol or drug abuse/dependence
3. Known allergy to radioactive rays, or history of other severe allergies
4. Human immunodeficiency virus (HIV) positive or not definitively negative, hepatitis C virus (HCV) or syphilis spirochete antibody test positive, hepatitis B virus (HBV) surface antigen positive and quantitative HBV DNA test ≥ 1.0×103 IU/mL
5. Significant occupational exposure to ionizing radiation in the past 10 years
6. Unable to repeat venipuncture
7. Participation in a clinical study of another drug within 30 days prior to screening and use of another test drug
8. Other conditions that, in the opinion of the investigator, make participation in this clinical trial inappropriate
9. Subjects with gastrointestinal malignancies requiring treatment of symptomatic brain metastases
10. Subjects with gastrointestinal malignancies who have a history of other malignancies, except for malignant lesions that have been treated with therapeutic measures 5 or more years prior to the initiation of investigational drug use and are not known to be active, and who, in the judgment of the Investigator, are at low risk of recurrence. Adequately treated non-melanoma skin cancer or malignant freckle-like nevus without evidence of disease progression. Adequately treated in situ cervical cancer with no evidence of progression. Intraepithelial tumor of the prostate gland without evidence of prostate adenocarcinoma
11. Subjects with gastrointestinal malignancies who have developed clinically significant cardiovascular disease (including, but not limited to, myocardial infarction, unstable angina pectoris, symptomatic congestive heart failure, and uncontrolled severe arrhythmia) within 6 months prior to initiation of study drug use
12. Subjects with gastrointestinal malignancies who have hypertension that is uncontrollable with a single agent
13. Subjects with malignant tumors of the gastrointestinal tract who have a history of hepatic disease or other conditions that interfere with the absorption, distribution, excretion, or metabolism of the drug, as determined by the investigator
14. Subjects with gastrointestinal malignancies have a history of coagulopathy or coagulation disorders.
15. History of arterial or venous embolism in subjects with gastrointestinal malignancies
16. Subjects with gastrointestinal malignancies who, in the judgment of the investigator, have received any medications and treatments prior to enrollment that may interfere with the trial data or that may have resulted in serious side effects that have not been fully cleared
17. Subjects with gastrointestinal malignancies who have an active or uncontrolled infection requiring systemic therapy within 14 days prior to initiation of study drug use
18. Subjects with malignant tumors of the gastrointestinal tract who have undergone major surgical procedures within 28 days prior to the start of investigational drug use-
**Healthy Volunteers:** True
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
## Derived Section
### Condition Browse Module - Meshes
- ID: D000009369
- Term: Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443697
**Brief Title:** A Machine Learning Prediction Model for Delayed CIPONV
**Official Title:** A Machine Learning-based Prediction Model for Delayed Clinically Important Postoperative Nausea and Vomiting in High-risk Patients Undergoing Laparoscopic Gastrointestinal Surgery
#### Organization Study ID Info
**ID:** 2024ZSLYEC-202
#### Organization
**Class:** OTHER
**Full Name:** Sixth Affiliated Hospital, Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2024-05-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-05-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-23
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sixth Affiliated Hospital, Sun Yat-sen University
#### Responsible Party
**Investigator Affiliation:** Sixth Affiliated Hospital, Sun Yat-sen University
**Investigator Full Name:** Zhi-Nan Zheng
**Investigator Title:** Attending doctor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Postoperative nausea and vomiting (PONV) can lead to serious postoperative complications, but most symptoms are mild. Clinically important PONV (CIPONV) refers to PONV symptoms that have a significant impact on the patient's well-being and recovery. Present predictive systems for PONV are mainly concentrated on early PONV. However, there is currently no suitable prediction model for delayed PONV, particularly delayed CI-PONV. This study aims to develop and validate a prediction model for delayed CI-PONV using machine learning algorithms utilizing perioperative data from patients undergoing laparoscopic gastrointestinal surgery.
All 1154 patients in the FDP-PONV trial will be enrolled in this study. Delayed CIPONV is defined as experiencing CIPONV between 25-120 hours after surgery. After selecting the modeling variables from 81 perioperative clinical features, six machine learning models are established to generate the risk prediction models for delayed CIPONV. The area under the receiver operating characteristic curve, accuracy, sensitivity, specificity, positive predictive value, negative predictive value, F1 score and Brier score are used to evaluate the model performance. Shape Additive explanation analysis was conducted to evaluate feature importance.
**Detailed Description:** The website https://mvansmeden.shinyapps.io/BeyondEPV/ was used for sample size calculation, considering 6 candidate predictors, an event fraction of 0.14, and a criterion value for reduced mean predictive squared error of 0.03. The calculated sample size is 1080, with a minimally required expected event per variable of 25.1. Therefore, a sample size of 1154 patients is deemed sufficient to support the inclusion of 6 predictors in the development of the predictive model.
A total of 81 variables, including demographics, comorbidities, laboratory findings, as well as information related to anesthesia and surgery, are prospectively collected in the FDP-PONV trial and considered as potential predictive factors in this study. The least absolute shrinkage and selection operator method is used to identify clinically significant variables. Further selection of the final predictors is performed using stepwise regression based on the Akaike Information Criterion.
The entire dataset is randomly divided into a training set and a validation set in a ratio of 7:3. Six machine learning models, namely logistic regression, random, extreme gradient boosting, k-nearest neighbor, gradient boosting decision, and multi-layer perceptron, were developed to create risk prediction models for delayed CIPONV. The performance of the models is assessed by comparing the area under the receiver operating characteristic curve, accuracy, sensitivity, specificity, positive predictive value, negative predictive value, F1 score, Brier score and calibration curve. Bootstrap resamples is conducted 1000 times on the training cohort to evaluate the predictive model's performance. Decision curve analysis is conducted to assess the clinical applicability of the model. The SHapley Additive Explanations library (SHAP) is used to interpret the prediction model.
### Conditions Module
**Conditions:**
- Postoperative Nausea and Vomiting
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 1154
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The FDP-PONV trial was a randomized, controlled, double-blind trial that aimed to evaluate the effectiveness and safety of fosaprepitant in managing postoperative nausea and vomiting in patients undergoing laparoscopic gastrointestinal surgery. The FDP-PONV trial was approved by the Ethics Committee of the Sixth Affiliated Hospital of Sun Yat-sen University (2021ZSLYEC-78) and registered at Clinicaltrials.gov (NCT04853147).
**Intervention Names:**
- Other: No intervention
**Label:** All 1154 participants enrolled in the FDP-PONV trial
### Interventions
#### Intervention 1
**Arm Group Labels:**
- All 1154 participants enrolled in the FDP-PONV trial
**Description:** This is a secondary analysis nested in a cohort of high-risk postoperative nausea and vomiting patients, and no intervention is implemented.
**Name:** No intervention
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** A postoperative nausea and vomiting severity score of ≥ 5 based on the simplified postoperative nausea and vomiting impact scoring system, assessed between 25 and 120 hours after surgery.
**Measure:** Delayed clinically important postoperative nausea and vomiting
**Time Frame:** Every 24 hours after surgery (at 2-day, 3-day, 4-day and 5-day)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
a) age between 18 and 75 years, b) having 3 or 4 Apfel risk factors, and c) scheduled to undergo laparoscopic gastrointestinal surgical procedures under general anesthesia.
Exclusion Criteria:
a) American Society of Anesthesiologists (ASA) physical status greater than 3, b) severe hepatic dysfunction, c) contraindications to fosaprepitant, 5-HT3 receptor antagonist, or dexamethasone, d) preoperative use of medications known to have antiemetic properties, e) presence of mental disorders or inability to communicate, and f) pregnant or nursing women.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** All 1154 patients in the FDP-PONV trial will be enrolled in this study. The FDP-PONV trial was a randomized, controlled, double-blind trial that aimed to evaluate the effectiveness and safety of fosaprepitant in managing PONV in patients undergoing laparoscopic gastrointestinal surgery. The FDP-PONV trial was approved by the Ethics Committee of the Sixth Affiliated Hospital of Sun Yat-sen University (2021ZSLYEC-78), and registered at Clinicaltrials.gov (NCT04853147).
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Zhinan Zheng, MD
**Phone:** 0086-15915734893
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Guangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Zhinan Zheng, MD
- **Phone:** 0086-15915734893
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Yang Zhao, MD
- **Phone:** 0086-13802435520
- **Role:** CONTACT
**Country:** China
**Facility:** Department of Anesthesia, The Sixth Affiliated Hospital, Sun Yat-sen University
**State:** Guangdong
**Status:** RECRUITING
**Zip:** 510655
#### Overall Officials
**Official 1:**
**Affiliation:** The Sixth Affiliated Hospital, Sun Yat-sen University
**Name:** Zhinan Zheng, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
**PMID:** 10485781
**Citation:** Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29.
**PMID:** 22290456
**Citation:** Nino MC, Calle S, Ruiz D, Baron MA, Cohen D, Martinez JE, Benitez DS, Mejia JA, Guerra JD, Kattah L. Rethinking postoperative nausea and vomiting prevention beyond perioperative medications. J Clin Anesth. 2024 Aug;95:111457. doi: 10.1016/j.jclinane.2024.111457. Epub 2024 Mar 29. No abstract available.
**PMID:** 38554569
**Citation:** Chow R, Navari RM, Terry B, DeAngelis C, Prsic EH. Olanzapine 5 mg vs 10 mg for the prophylaxis of chemotherapy-induced nausea and vomiting: a network meta-analysis. Support Care Cancer. 2022 Feb;30(2):1015-1018. doi: 10.1007/s00520-021-06606-x. No abstract available.
**PMID:** 34613472
**Citation:** White PF, Sacan O, Nuangchamnong N, Sun T, Eng MR. The relationship between patient risk factors and early versus late postoperative emetic symptoms. Anesth Analg. 2008 Aug;107(2):459-63. doi: 10.1213/ane.0b013e31817aa6e4.
**PMID:** 18633024
**Citation:** Wu CL, Berenholtz SM, Pronovost PJ, Fleisher LA. Systematic review and analysis of postdischarge symptoms after outpatient surgery. Anesthesiology. 2002 Apr;96(4):994-1003. doi: 10.1097/00000542-200204000-00030. No abstract available.
**PMID:** 11964610
**Citation:** Mraovic B, Simurina T. Effects of an intravenous lidocaine bolus before tracheal extubation on recovery after breast surgery - Lidocaine at the End (LATE) study: a randomized controlled clinical trial. Croat Med J. 2023 Aug 31;64(4):222-230. doi: 10.3325/cmj.2023.64.222.
**PMID:** 37654034
**Citation:** Hermans V, De Pooter F, De Groote F, De Hert S, Van der Linden P. Effect of dexamethasone on nausea, vomiting, and pain in paediatric tonsillectomy. Br J Anaesth. 2012 Sep;109(3):427-31. doi: 10.1093/bja/aes249.
**PMID:** 22879656
**Citation:** Gan TJ, Gu J, Singla N, Chung F, Pearman MH, Bergese SD, Habib AS, Candiotti KA, Mo Y, Huyck S, Creed MR, Cantillon M; Rolapitant Investigation Group. Rolapitant for the prevention of postoperative nausea and vomiting: a prospective, double-blinded, placebo-controlled randomized trial. Anesth Analg. 2011 Apr;112(4):804-12. doi: 10.1213/ANE.0b013e31820886c3. Epub 2011 Mar 8.
**PMID:** 21385988
**Citation:** Mc Loughlin S, Terrasa SA, Ljungqvist O, Sanchez G, Garcia Fornari G, Alvarez AO. Nausea and vomiting in a colorectal ERAS program: Impact on nutritional recovery and the length of hospital stay. Clin Nutr ESPEN. 2019 Dec;34:73-80. doi: 10.1016/j.clnesp.2019.08.010. Epub 2019 Sep 11.
**PMID:** 31677715
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012817
- Term: Signs and Symptoms, Digestive
- ID: D000011183
- Term: Postoperative Complications
- 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: M17582
- Name: Vomiting
- Relevance: HIGH
- As Found: Vomiting
- ID: M22074
- Name: Postoperative Nausea and Vomiting
- Relevance: HIGH
- As Found: Postoperative Nausea and Vomiting
- ID: M12273
- Name: Nausea
- Relevance: HIGH
- As Found: Nausea
- ID: M15622
- Name: Signs and Symptoms, Digestive
- Relevance: LOW
- As Found: Unknown
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009325
- Term: Nausea
- ID: D000014839
- Term: Vomiting
- ID: D000020250
- Term: Postoperative Nausea and Vomiting
### Intervention Browse Module - Browse Branches
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M44622
- Name: Fosaprepitant
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443684
**Brief Title:** A Study of Molecular Residual, Dynamic Monitoring and Recurrence of Stage III Driver Mutated NSCLC
**Official Title:** Prospective, Observational Study of Molecular Residual, Dynamic Monitoring and Recurrence of Stage III Driver Mutated NSCLC
#### Organization Study ID Info
**ID:** ADX-MRD-LC
#### Organization
**Class:** OTHER
**Full Name:** Shanghai Chest Hospital
### Status Module
#### Completion Date
**Date:** 2026-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-03-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-05-08
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Shanghai Chest Hospital
#### Responsible Party
**Investigator Affiliation:** Shanghai Chest Hospital
**Investigator Full Name:** Lu Shun
**Investigator Title:** Professor Chief of Shanghai Lung Cancer Center
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The goal of this prospective, observational study is to explore the value of dynamic monitoring of minimal residual lesions in driver mutated stage III NSCLC for disease recurrence and prognosis assessment. The main question it aims to answer is:
1) Whether MRD(Minimal residual disease) status can predict recurrence events in stage III driven-mutant NSCLC in advance
**Detailed Description:** Non-small cell lung cancer in stage III (IIIa, IIIIb, IIIc) has a low survival rate, and the 5-year survival rate of stage III patients is less than 30%. In clinical studies of non-small cell lung cancer operable stage III driver gene mutations, postoperative targeted adjuvant therapy improves patient survival relative to postoperative chemotherapy.
The tumor patients still have residual malignant tumor cells in vivo during or after treatment, and minimal residual foci are released during cell necrosis or apoptosis. Early the domestic large lung cancer MRD((Minimal residual disease)) prospective research results, for the first time through the dynamic monitoring of MRD high negative predictive value defined the potential cure population, found that postoperative MRD negative population could not benefit from adjuvant therapy, clarify the existence of preoperative Non-shedding tumor does not affect postoperative MRD monitoring, and exploring the stage II / III MRD turn high risk of postoperative lung cancer. Therefore, for nearly 70% of patients with driver gene-positive non-small-cell lung cancer, detecting clear driver gene mutations in the peripheral blood is expected to stratify the risk of recurrence/progression.
### Conditions Module
**Conditions:**
- Non Small Cell Lung Cancer
### Design Module
#### Bio Spec
**Description:** Full blood samples processed into plasma, buffy coat,and serum Formalin-fixed paraffin-embedded tumor tissue
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 305
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Stage III NSCLC eligible for direct surgery
Interventions:
Diagnostic Test: MRD（LC-10）include 10 lung cancer-related driver gene mutation site
**Intervention Names:**
- Diagnostic Test: MRD
**Label:** Direct surgery
#### Arm Group 2
**Description:** Stage III NSCLC eligible for neoadjuvant therapy followed by surgery
Interventions:
Diagnostic Test: MRD（LC-10）include 10 lung cancer-related driver gene mutation site
**Intervention Names:**
- Diagnostic Test: MRD
**Label:** Neoadjuvant and surgery
#### Arm Group 3
**Description:** Unresectable Stage III NSCLC eligible for Chemoradiotherapy.
Interventions:
Diagnostic Test: MRD（LC-10）include 10 lung cancer-related driver gene mutation site
**Intervention Names:**
- Diagnostic Test: MRD
**Label:** Chemoradiotherapy
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Chemoradiotherapy
- Direct surgery
- Neoadjuvant and surgery
**Description:** MRD（LC-10）include 10 lung cancer-related driver gene mutation site
**Name:** MRD
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Patients are defined as MRD positive if lung cancer driver genes are detected in peripheral blood post-surgery using NGS methods, and radiological recurrence is based on RECIST 1.1 criteria.
**Measure:** Correlation of MRD status in driver gene-positive NSCLC patients with 12-month relapse events
**Time Frame:** 2022.12--2025.03
#### Secondary Outcomes
**Description:** Patients are defined as MRD positive if lung cancer driver genes are detected in peripheral blood post-surgery using NGS methods, and radiological recurrence is based on RECIST 1.1 criteria.
**Measure:** Correlation of MRD status in driver gene-positive NSCLC patients with RFS
**Time Frame:** 2022.12--2025.03
**Description:** Patients are defined as MRD positive if the NGS method detects lung cancer driver gene positivity in the peripheral blood post-surgery.
**Measure:** Correlation of MRD status in driver gene-positive NSCLC patients with OS
**Time Frame:** 2022.12--2025.03
**Description:** Patients are defined as MRD positive if lung cancer driver genes are detected in peripheral blood post-surgery using NGS methods, and radiological recurrence is based on RECIST 1.1 criteria.
**Measure:** Correlation of MRD status in driver gene-positive NSCLC patients with 24-month relapse events
**Time Frame:** 2022.12--2025.03
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients with stage III non-small cell lung cancer were confirmed by imaging and histological biopsy
2. Age≥ 18
3. ECOG PS:0-1
4. Tumor molecular testing by EBUS or biopsy confirmed positive for one or more of the following driver genes:EGFR\\ALK\\ROS1\\RET\\KRAS\\PIK3CA\\BRAF\\HER2\\MET
5. Patients who met and agreed to surgery or radical chemoradiotherapy, and the remaining samples after cutting tissue sections did not affect the possible further clinical treatment of the subject
6. Provide 20 mL peripheral blood samples periodically
7. The subjects volunteered to join the study, and signed the informed consent form, with good compliance, and actively cooperated with the hospital for routine clinical diagnosis and treatment follow-up
Exclusion Criteria:
1. Patients with other malignancies within 5 years
2. According to the investigator, the patient also had other diseases that may affect the follow-up and short-term survival
3. The subject had other factors that may lead to the termination of the study, such as other serious diseases (including mental illness), serious laboratory abnormalities, and family or social factors that affected the safety of the subject, or the collection of data and samples
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** 305 The main research purpose of this project is to associate the MRD status of driver gene positive patients with 12 months of recurrent events. The follow-up is 2 years, so according to the number of patients with stage IIIA NSCLC in each center, and the patient enrollment is planned within 1 year. A total of 305 stage III NSCLC patients were collected
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ziming Li, M.D.
**Phone:** 8613764590226
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Xiamen
**Contacts:**
***Contact 1:***
- **Name:** Guojun Geng, M.D.
- **Role:** CONTACT
***Contact 2:***
- **Name:** Guojun Geng, M.D.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** First Affiliated Hospital of Xiamen University
**State:** Fujian
**Status:** RECRUITING
**Location 2:**
**City:** Guangzhou
**Contacts:**
***Contact 1:***
- **Name:** Yuan Qiu, M.D.
- **Role:** CONTACT
***Contact 2:***
- **Name:** Yuan Qiu, M.D.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** The First Affiliated Hospital of Guangzhou Medical University
**State:** Guangdong
**Status:** RECRUITING
**Location 3:**
**City:** Harbin
**Contacts:**
***Contact 1:***
- **Name:** Yan Yu, M.D.
- **Role:** CONTACT
***Contact 2:***
- **Name:** Yan Yu, M.D.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Affiliated Cancer Hospital of Harbin Medical University
**State:** Heilongjiang
**Status:** RECRUITING
**Location 4:**
**City:** Changsha
**Contacts:**
***Contact 1:***
- **Name:** Wenxiang Wang, M.D.
- **Role:** CONTACT
***Contact 2:***
- **Name:** Wenxiang Wang, M.D.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Hunan Cancer Hospital
**State:** Hunan
**Status:** RECRUITING
**Location 5:**
**City:** Jinan
**Contacts:**
***Contact 1:***
- **Name:** Zhongmin Peng, M.D.
- **Role:** CONTACT
***Contact 2:***
- **Name:** Zhongmin Peng, M.D.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Shandong Provincial Hospital
**State:** Shandong
**Status:** RECRUITING
**Location 6:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** ziming Li
- **Phone:** 8613764590226
- **Role:** CONTACT
**Country:** China
**Facility:** Shanghai Chest hospital
**State:** Shanghai
**Status:** RECRUITING
**Location 7:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Name:** Di Ge, M.D.
- **Role:** CONTACT
***Contact 2:***
- **Name:** Di Ge, M.D.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Zhongshan Hospital Affiliated to Fudan University
**State:** Shanghai
**Status:** RECRUITING
**Location 8:**
**City:** Taiyuan
**Contacts:**
***Contact 1:***
- **Name:** Weihua Yang, M.D.
- **Role:** CONTACT
***Contact 2:***
- **Name:** Weihua Yang, M.D.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Shanxi Cancer Hospital
**State:** Shanxi
**Status:** RECRUITING
**Location 9:**
**City:** Xi'an
**Contacts:**
***Contact 1:***
- **Name:** Junke Fu, M.D.
- **Role:** CONTACT
***Contact 2:***
- **Name:** Junke Fu, M.D.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** The First Affiliated Hospital of Xi 'an Jiaotong University
**State:** Shanxi
**Status:** RECRUITING
**Location 10:**
**City:** Hangzhou
**Contacts:**
***Contact 1:***
- **Name:** Jian Hu, M.D.
- **Role:** CONTACT
***Contact 2:***
- **Name:** Jian Hu, M.D.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** The First Affiliated Hospital of Zhejiang University
**State:** Zhejiang
**Status:** RECRUITING
**Location 11:**
**City:** Hangzhou
**Contacts:**
***Contact 1:***
- **Name:** Qixun Chen, M.D.
- **Role:** CONTACT
***Contact 2:***
- **Name:** Qixun Chen, M.D.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Zhejiang Cancer Hospital
**State:** Zhejiang
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Shanghai Chest Hospital
**Name:** Shun Lu, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
## 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: BC04
- Name: Neoplasms
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
### Condition Browse Module - Browse Leaves
- ID: M14850
- Name: Recurrence
- Relevance: HIGH
- As Found: Recurrence
- ID: M11172
- Name: Lung Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M5546
- Name: Carcinoma, Non-Small-Cell Lung
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012008
- Term: Recurrence
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443671
**Acronym:** PKUCH-R09
**Brief Title:** Neoadjuvant Fruquintinib Plus Tislelizumab Combined With mCapeOX Versus CapeOX for Mid-high pMMR/MSS Locally Advanced Rectal Cancer
**Official Title:** Neoadjuvant Fruquintinib Plus Tislelizumab Combined With mCapeOX Versus CapeOX for Mid-high pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Open-label, Multicenter, Randomized Controlled Trial
#### Organization Study ID Info
**ID:** PKUCH-R09
#### Organization
**Class:** OTHER
**Full Name:** Peking University Cancer Hospital & Institute
### Status Module
#### Completion Date
**Date:** 2028-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Peking University Cancer Hospital & Institute
#### 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 neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX works to treat mid-high pMMR/MSS locally advanced rectal cancer patients compared with CapeOX. It will also learn about the safety of neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX. The main questions it aims to answer are:
* Does neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX improve the pCR rate of mid-high pMMR/MSS locally advanced rectal cancer patients?
* What medical problems do participants have when receiving neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX? Researchers will compare Fruquintinib and Tislelizumab combined with mCapeOX to CapeOX to see if neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX works to treat mid-high pMMR/MSS locally advanced rectal cancer patients.
Participants will:
* Receive Fruquintinib and Tislelizumab combined with mCapeOX or CapeOX before surgery up to 4 cycles
* Receive radical operations and three years follow-up
* Keep a diary of their postoperative pathology results and survival
### Conditions Module
**Conditions:**
- Rectal Cancer
**Keywords:**
- local advanced rectal cancer
- neoadjuvant chemotherapy
- pMMR/MSS
- Furoquinib and Tislelizumab
- CapeOX
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 132
**Type:** ESTIMATED
**Phases:**
- PHASE2
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Receiving CapeOX treatment for up to four cycles before surgery:
Capecitabine: 1000mg/m2, BID, PO, D1-14, Q3W; Oxaliplatin: 130 mg/m2, intravenous drip for 0-2 hours, D1, Q3W.
**Intervention Names:**
- Drug: CapeOX
**Label:** CapeOX group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Receiving Fruquintinib plus Tislelizumab combined with mCapeOX treatment for up to four cycles before surgery:
Fruquintinib: 3mg/d, QD, PO, Use for 2 weeks, stop for 1 week, Q3W; Tislelizumab: 200mg, D1, Intravenous infusion, Q3W; Capecitabine: 825mg/m2, BID, PO, D1-14, Q3W; Oxaliplatin: 100 mg/m2, intravenous drip for 0-2 hours, D1, Q3W.
**Intervention Names:**
- Drug: Fruquintinib and Tislelizumab combined with mCapeOX
**Label:** Fruquintinib and Tislelizumab combined with mCapeOX
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- CapeOX group
**Description:** Receiving CapeOX treatment for up to four cycles before surgery:
Capecitabine: 1000mg/m2, BID, PO, D1-14, Q3W; Oxaliplatin: 130 mg/m2, intravenous drip for 0-2 hours, D1, Q3W.
**Name:** CapeOX
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Fruquintinib and Tislelizumab combined with mCapeOX
**Description:** Receiving Fruquintinib plus Tislelizumab combined with mCapeOX treatment for up to four cycles before surgery:
Fruquintinib: 3mg/d, QD, PO, Use for 2 weeks, stop for 1 week, Q3W; Tislelizumab: 200mg, D1, Intravenous infusion, Q3W; Capecitabine: 825mg/m2, BID, PO, D1-14, Q3W; Oxaliplatin: 100 mg/m2, intravenous drip for 0-2 hours, D1, Q3W.
**Name:** Fruquintinib and Tislelizumab combined with mCapeOX
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Pathological complete response(pCR) rates are defined as no viable tumor cells remaining in the primary tumor and lymph nodes (ypT0N0), that is, subjects with level 0 of the AJCC 8th edition Tumor Regression Grading (TRG) scoring system proportion.
**Measure:** Pathological complete response(pCR) rates
**Time Frame:** 10 days after surgery
#### Secondary Outcomes
**Description:** Adverse events (AEs) refer to adverse medical events that occur after clinical trial subjects receive a drug, but are not necessarily causally related to the treatment. AE can be any adverse and unexpected symptoms, signs, laboratory test abnormalities or diseases, etc., including at least the following situations: 1) Pre-existing medical conditions/diseases (before entering clinical trials) will be recorded as adverse events only if they worsen after starting to use the trial drug (including worsening of symptoms, signs, and laboratory test abnormalities); 2) Any new AE: any new adverse medical condition (including symptoms, signs, newly diagnosed diseases); 3) Abnormal clinically significant laboratory test results. Diagnostic or therapeutic invasive (such as surgery) and non-invasive procedures should not be reported as AEs, but when the disease condition that causes the procedures meets the definition of AE, they should be reported.
**Measure:** Adverse events (AEs)
**Time Frame:** From the beginning to the 21st day after the end of neoadjuvant treatment
**Description:** MPR: The proportion of residual viable tumor cells in the postoperative specimen in the tumor bed is less than or equal to 10%.
**Measure:** Major Pathologic Response(MPR)
**Time Frame:** 10 days after surgery
**Description:** EFS is defined as the time from randomization to the occurrence of any of the following events, whichever occurs first: tumor disease progression on imaging as assessed by RECIST 1.1; tumor recurrence, including local recurrence or distant recurrence, as assessed on imaging or tissue biopsy transfer; death from any cause.
**Measure:** 3-year event-free survival (EFS) rate
**Time Frame:** 36 months after randomization
**Description:** OS is defined as the time between the date of randomization and death from any cause.
**Measure:** 3-year overall survival (OS) rate
**Time Frame:** 36 months after randomization
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* The subjects voluntarily joined this study and signed an informed consent form;
* Age: 18-75 years old (including 18 and 75 years old), regardless of gender;
* Histologically confirmed rectal adenocarcinoma; Immunohistochemistry suggests pMMR, or PCR suggests MSS type patients;
* The tumor location meets the following criteria:
1. Colonoscopy or digital examination shows that the distance from the lower edge of the tumor to the anus is 6-15cm or more than 4cm from the ARJ;
2. MRI/CT determines that the lower edge of the tumor or the lower edge of the invading part is not higher than the sacral promontory pubic line;
* Preoperative staging meets the following conditions:
1. Preoperative staging of tumor infiltration breaking through the intestinal muscle layer (T3) or above or accompanied by periintestinal lymph node metastasis;
2. Non invasion of the intrinsic fascia of the rectum (MRF -);
3. No swelling observed in lateral lymph nodes (short diameter not exceeding 7mm)
4. There is no clear evidence of distant metastasis, and R0 resection is expected to be feasible after treatment; \*Baseline partial phase method: Rectal T2/DWI MR or Abdominal Pelvic CT or PET/CT or PET/MRI;
* Have not received any anti-tumor treatment for rectal cancer in the past, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc;
* ECOG score: 0-1 points;
* Able to swallow tablets and capsules normally;
* The plan is to complete the entire process of neoadjuvant therapy and undergo surgical resection;
* The main organs and bone marrow function are basically normal (no blood components or cell growth factors were used within 14 days before enrollment):
1. Blood routine: Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, hemoglobin ≥ 90g/L;
2. International standardized ratio (INR) ≤ 1.5 x Upper limit of normal value (ULN), and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN;
3. Liver function: Total bilirubin ≤ 1.5 x ULN, ALT/AST ≤ 2.5 x ULN；
4. Renal function: serum creatinine ≤ 1.5 x ULN, and creatinine clearance rate (CCr) ≥ 50mL/min;
* Women of childbearing age must undergo a serum pregnancy test within 14 days before treatment, and the result is negative; Qualified patients with fertility (male and female) must agree to use reliable contraceptive methods (hormone or barrier methods or abstinence, etc.) with their partners during the trial period and at least 6 months after the last medication.
Exclusion Criteria:
* Have a history of allergies to any anti-angiogenic targeted drugs, any components of monoclonal antibodies, capecitabine, oxaliplatin, or other platinum-based drugs in the past;
* Preoperative evidence suggests distant metastasis (including lymph node metastasis in the iliac foramen area) Metastasis of aortic lymph nodes and retroperitoneal lymph nodes above the root level of IMA; In addition to clear liver lung metastasis, liver lung nodules with unknown properties should also be excluded;
* Symptoms of incomplete or complete intestinal obstruction; Or preoperative colonoscopy may indicate narrowing of the intestinal lumen circumference; Or if the tumor is too large, colonoscopy cannot pass through the tumor;
* Those who are currently using immunosuppressive agents, systemic or absorbable local hormone therapy to achieve immunosuppressive effects (dosage\&gt;10mg/day prednisone or other therapeutic hormones), and continue to use them within 2 weeks prior to enrollment;
* Receive attenuated live vaccines within 4 weeks prior to the first use of the study drug;
* Any active autoimmune disease or history of autoimmune disease (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or complete remission of childhood asthma in adulthood without any intervention can be included; subjects with asthma requiring medical intervention with bronchodilators cannot be included);
* Other malignant tumors in the past 5 years (excluding skin basal cell or squamous cell carcinoma, cervical carcinoma in situ, breast cancer, thyroid papillary carcinoma and small kidney carcinoma that are clinically cured after proper treatment (OS\&gt;5 years));
* Congenital or acquired immune deficiency (such as HIV infected persons), or active hepatitis (hepatitis B: HBsAg positive and HBV DNA ≥ 104 copies/ml; hepatitis C: HCV antibody positive and HCV RNA\&gt;1 × 103 copies/ml);
* Have uncontrolled clinical symptoms or diseases of the heart, such as: (1) NYHA grade 2 or above heart failure; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within one year; (4) Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention;
* Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
* Active or uncontrolled severe infections (≥ CTCAE level 2 infection);
* Urinary routine indicates that urine protein is ≥ 2+, and the 24-hour urine protein content is\&gt;1.0g;
* Known genetic or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, splenic hyperfunction, etc.) or undergoing thrombolytic or anticoagulant therapy;
* The patient currently has digestive tract diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresectable tumors, or other conditions determined by the researcher that may cause gastrointestinal bleeding or perforation;
* Patients with significant evidence of bleeding tendency or medical history within the 3 months prior to enrollment (bleeding\&gt;30 mL within 3 months, vomiting blood, black stool, and rectal bleeding), hemoptysis (fresh blood\&gt;5 mL within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months;
* Pregnant (positive pregnancy test before medication) or breastfeeding women;
* According to the judgment of the researchers, the subjects may have other situations that may affect the results of the study or cause the study to be forced to stop midway, such as drug abuse, serious illnesses (including mental illnesses such as seizures), and other medical, psychological, or social conditions that may endanger patient safety and compliance.
**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:** Ai Wen Wu, M.D.
**Phone:** +8613911577190
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Xiao Kang Lei, M.D.
**Phone:** +8618811181993
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xiao Kang Lei, M.D.
- **Phone:** 108-819-6086
- **Role:** CONTACT
**Country:** China
**Facility:** Peking University Cancer Hospital & Institute
**State:** Haidian District
**Zip:** 100142
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000015179
- Term: Colorectal Neoplasms
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14846
- Name: Rectal Neoplasms
- Relevance: HIGH
- As Found: Rectal Cancer
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012004
- Term: Rectal Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000000970
- Term: Antineoplastic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M137899
- Name: Tislelizumab
- Relevance: HIGH
- As Found: Intensive Care
- ID: M377
- Name: Capecitabine
- Relevance: LOW
- As Found: Unknown
- ID: M1674
- Name: Oxaliplatin
- Relevance: LOW
- As Found: Unknown
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000707970
- Term: Tislelizumab
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443658
**Brief Title:** Benefits of Inhalation of Hypertonic Saline Solution Prior to Physiotherapy ELTGOL Technique in Bronchiectasis
**Official Title:** Benefits of Inhalation of Hypertonic Saline Solution Prior to ELTGOL Physiotherapy in Bronchiectasis
#### Organization Study ID Info
**ID:** FISHT2021
#### Organization
**Class:** OTHER
**Full Name:** Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
### Status Module
#### Completion Date
**Date:** 2027-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-23
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** NETWORK
**Name:** University Hospital of Girona Dr.Josep Trueta
**Class:** OTHER
**Name:** Germans Trias i Pujol Hospital
#### Lead Sponsor
**Class:** OTHER
**Name:** Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
#### 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:** Bronchiectasis is a chronic bronchial disease in which the usual capacity to remove secretions does not function correctly, causing mucus retention that leads to chronic infection. As with all infections, the use of antibiotics and puss removal are essential treatment elements. Physiotherapeutic techniques are used to assist in the removal of secretions, although these are time-consuming practices that need to be much better studied and which patients often do not continue practicing diligently. A physiotherapeutic technique called (Slow prolonged expiration in lateral decubitus) ELTGOL has been shown to be somewhat effective but as the mucus is viscous in this disorder, it can be difficult to get it to move. It is thought that saline solution inhalations may reduce mucus viscosity and could help to ease expectoration, facilitating the removal of the mucus by the physiotherapeutic technique. This project aims to test this hypothesis, which if true could represent an advance in the treatment of this severely debilitating disease.
**Detailed Description:** Bronchiectasis is a prevalent chronic infectious disease with impaired mucociliary clearance. The persistence of high bacterial loads in the bronchi is associated with airway and systemic inflammation. Management is based on treatment of bronchial infection and on removal of secretions by airway clearance techniques (ACTs) although no therapy has been approved due to low quality of evidence. Inhalation of hypertonic saline (HS) could be useful in facilitate mucus removal especially if it is administer prior an effective ACT.Our hypothesis is that the long-term combination of HS and the ELTGOL technique will facilitate secretion removal in bronchiectasis and this will be associated with changes in mucus composition and better control of the disease.
Study design: A 12-month parallel-group, multicentre, double-blind randomised-controlled trial. Patients will be randomly assigned to receiving HS, isotonic saline (IS) or no inhalation before practicing ELTGOL technique.
The main objective is to evaluate the effect of the combination of once-daily inhaled HS and twice daily ELTGOL technique in mucus clearance in bronchiectasis. Secondary aims: to determine its effect on mucus properties, the impact of cough,exacerbations, quality of life, microbiology and pulmonary function; to evaluate adverse effects and adherence.
Study population: adult patients with non-cystic fibrosis bronchiectasis in stable state with chronic mucopurulent or purulent sputum.
### Conditions Module
**Conditions:**
- Bronchiectasis Adult
**Keywords:**
- airway clearance
- hypertonic saline
- respiratory physiotherapy
### 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:** 57
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Control group. Patients will do twice-daily ELTGOL technique
**Intervention Names:**
- Other: ELTGOL
**Label:** ELTGOL group
**Type:** OTHER
#### Arm Group 2
**Description:** Placebo group. Patients will do twice-daily ELTGOL technique and will receive 5ml of 0.9% saline before performing the ELTGOL technique in the morning
**Intervention Names:**
- Drug: Isotonic saline
- Other: ELTGOL
**Label:** ELTGOL + isotonic saline solution (0,9%)
**Type:** PLACEBO_COMPARATOR
#### Arm Group 3
**Description:** Experimental group. Patients will do twice-daily ELTGOL technique and will receive 5ml of 7% saline before performing the ELTGOL technique in the morning
**Intervention Names:**
- Other: Hypertonic saline
- Other: ELTGOL
**Label:** ELTGOL + hypertonic saline solution (7%)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ELTGOL + hypertonic saline solution (7%)
**Description:** Patients from intervention group will inhale hypertonic saline solution 5 minutes before performing the morning ELTGOL technique
**Name:** Hypertonic saline
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- ELTGOL + isotonic saline solution (0,9%)
**Description:** Patients from placebo group will inhale isotonic saline solution 5 minutes before performing the morning ELTGOL technique
**Name:** Isotonic saline
**Other Names:**
- Physiologic saline
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- ELTGOL + hypertonic saline solution (7%)
- ELTGOL + isotonic saline solution (0,9%)
- ELTGOL group
**Description:** Patients from control group will perform the ELTGOL technique twice-daily
**Name:** ELTGOL
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Sputum weight will be measured with a precision balance after the intervention
**Measure:** The change in the sputum weight in grams during intervention
**Time Frame:** Baseline and 12 months later
#### Secondary Outcomes
**Description:** Sputum properties will be evaluated analyzing viscosity (mPa/s) and elasticity (Pa)
**Measure:** Change in sputum properties 1
**Time Frame:** Changes between Month 1 and Month 12
**Description:** Sputum properties will be evaluated analyzing solids in sputum
**Measure:** Change in sputum properties 2
**Time Frame:** Changes between Month 1 and Month 12
**Description:** Sputum volume will be measured with a calibrated container
**Measure:** Change from baseline in the 24hours sputum volume in milliliters
**Time Frame:** Over the 12-month treatment period.
**Description:** Sputum weight will be measured with a precision balance
**Measure:** Change from baseline in the 24hours sputum weight
**Time Frame:** Over the 12-month treatment period.
**Description:** Assessed with the Leicester Cough Questionnaire (LCQ). Score form 3 to 21 (3 better and 21 worse cough)
**Measure:** Change in cough
**Time Frame:** Over the 12-month treatment period.
**Description:** Based on clinical history
**Measure:** Number of exacerbations
**Time Frame:** Over the 12-month treatment period.
**Description:** Based on clinical history
**Measure:** Time to the first exacerbation
**Time Frame:** Over the 12-month treatment period.
**Description:** Assessed with Bronchiectasis health questionnaire (BHQ). BHQ score from 0-100 (0 best and 100 worse quality of life)
**Measure:** Change in quality of life
**Time Frame:** Over the 12-month treatment period
**Description:** Assessed with a forced spirometry
**Measure:** Change in post-bronchodilator ( forced expiratory volume at one second) FEV1
**Time Frame:** Over the 12-month treatment period in ml
**Description:** Assessed through vial counting.
**Measure:** Treatment adherence 1
**Time Frame:** Over the 12-month treatment period
**Description:** Assessed through the diary card.
**Measure:** Treatment adherence 2
**Time Frame:** Over the 12-month treatment period
**Description:** Assessed through Morisky-Green test. Score from 0 to 4 (0 best and 4 worse adherence)
**Measure:** Treatment adherence 3
**Time Frame:** Over the 12-month treatment period
**Description:** Assessed by Borg scale at the end of interventions. Score 0-10 (0 best and 10 worse breathlessness)
**Measure:** Adverse events 1
**Time Frame:** Over the 12-month treatment period
**Description:** Assessed by oxygen desaturation
**Measure:** Adverse events 2
**Time Frame:** Over the 12-month treatment period
**Description:** Assessed by Visual Analogue Scale (VAS) scale (pain assessment)
**Measure:** Adverse events 3
**Time Frame:** Over the 12-month treatment period
**Description:** Sputum weight will be measured with a precision balance after the intervention
**Measure:** Change in sputum weight during intervention
**Time Frame:** Between Month 12 and Month 13
**Description:** Sputum volume will be measured with a calibrated container
**Measure:** Change in sputum volume in 24h sputum volume
**Time Frame:** Between Month 12 and Month 13
**Description:** Assessed with the Leicester Cough Questionnaire (LCQ). Score form 3 to 21 (3 better and 21 worse cough)
**Measure:** Change in cough
**Time Frame:** Between Month 12 and Month 13
**Description:** Assessed with a forced spirometry
**Measure:** Change in post-bronchodilator FEV1
**Time Frame:** Between Month 12 and Month 13
**Description:** Assessed with Bronchiectasis health questionnaire (BHQ). BHQ score from 0-100 (0 best and 100 worse quality of life)
**Measure:** Change in quality of life
**Time Frame:** Between Month 12 and Month 13
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult patients with bronchiectasis confirmed by high resolution computed tomography
* No exacerbations in the previous month
* Chronic mucopurulent and purulent sputum
* ≥10ml daily expectoration
* At least one exacerbation in the previous year
* (Forced expiratory volume the 1st second) FEV1 ≥30% after bronchodilation
* Sign the informed consent
Exclusion Criteria:
* Current smokers or a smoking history of ≥20 p-y
* Asthma, allergic bronchopulmonary aspergillosis or Cystic Fibrosis
* Pregnant or lactating women
* Following mucoactive treatment in the previous month
* Inability to perform ELTGOL, spirometry or to attend visits
* Practicing pulmonary rehabilitation in the previous 6 months
* Change of treatment the previous month
* Uncontrolled hypertension
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Gerard Muñoz, PhD PT
**Phone:** 0034-972940294
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Neus Puigdevall, PT
**Phone:** 0034-972940294
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Girona
**Contacts:**
***Contact 1:***
- **Name:** Montse Vendrell, PhD MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Gerard Muñoz, PhD PT
- **Role:** CONTACT
**Country:** Spain
**Facility:** University Hospital of Girona Dr. Josep Trueta
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** University Hospital of Girona Dr.Josep Trueta
**Name:** Montserrat Vendrell, PhD MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Study data access will be provided for collaborative purposes
**Description:** All IPD collected data can be shared as long as it is for research collaboration
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
**IPD Sharing:** YES
**Time Frame:** Once the manuscript is accepted for publication
### References Module
#### References
**Citation:** Munoz G, de Gracia J, Buxo M, Alvarez A, Vendrell M. Long-term benefits of airway clearance in bronchiectasis: a randomised placebo-controlled trial. Eur Respir J. 2018 Jan 11;51(1):1701926. doi: 10.1183/13993003.01926-2017. Print 2018 Jan.
**PMID:** 29326318
**Citation:** Munoz G, Buxo M, de Gracia J, Olveira C, Martinez-Garcia MA, Giron R, Polverino E, Alvarez A, Birring SS, Vendrell M. Validation of a Spanish version of the Leicester Cough Questionnaire in non-cystic fibrosis bronchiectasis. Chron Respir Dis. 2016 May;13(2):128-36. doi: 10.1177/1479972316632005. Epub 2016 Feb 22.
**PMID:** 26902541
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000001982
- Term: Bronchial Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M5263
- Name: Bronchiectasis
- Relevance: HIGH
- As Found: Bronchiectasis
- ID: M27137
- Name: Respiratory Aspiration
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5258
- Name: Bronchial Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001987
- Term: Bronchiectasis
### 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:** NCT06443645
**Acronym:** SCARA-B
**Brief Title:** Role of Sodium-glucose Linked Transporter 2 (SGLT2) and Its Inhibitor Over CARdiotoxicity Induced by Anthracyclines and Breast Cancer Tumorigenesis SCARA-B
**Official Title:** Role of Sodium-glucose Linked Transporter 2 (SGLT2) and Its Inhibitor Over CARdiotoxicity Induced by Anthracyclines and Breast Cancer Tumorigenesis - SCARA-B
#### Organization Study ID Info
**ID:** 2023-024
#### Organization
**Class:** OTHER
**Full Name:** Institut de cancérologie Strasbourg Europe
### Status Module
#### Completion Date
**Date:** 2026-04-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Institut de cancérologie Strasbourg Europe
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** In the context of breast cancer, in case of an indication for chemotherapy, anthracycline-based protocols make it possible to improve the overall survival of patients most at risk. The frequency of anthracycline-related cardiac toxicities (ARCT) increases with the cumulative dose of anthracyclines administered and explains, at least in part, the increased risk of cardiovascular (CV) mortality in patient populations treated for breast cancer. The numerous indications for anthracycline-based protocols have made it possible to describe ARCT, among which heart failure with reduced left ventricular ejection fraction (LVEF) remains one of the most comorbid. In addition to left ventricular dysfunction, anthracyclines have been associated with endothelial dysfunction, microvascular damage and myocardial ischemia responsible for dilated cardiomyopathy.
Different approaches have attempted to better understand and prevent these ARCT. However, apart from the notion of limit cumulative doses of anthracyclines, few of them have made it possible to screen patients at risk and prevent the onset of cardiac dysfunction. The search for biological markers (Troponin I, BNP) or ultrasound markers (Longitudinal Strain) warning of subclinical cardiac damage is still struggling to assert its interest due in particular to significant inter- and intra-observer variability. Therapeutically, ACE inhibitors and beta-blockers have shown a significant improvement in the incidence rate of LVEF reduction during adjuvant treatment of breast cancer. However, despite equivalent signals in other cancers, the studies conducted to date are insufficiently powered and the role of these treatments is limited to secondary prevention or the treatment of objective heart failure. It remains necessary to determine new biological markers that can identify patients most at risk of ARCT and thus adapt our therapeutic prevention strategies. To do this, it is first necessary to better understand the pathophysiology underlying these ARCT.
The objective of this study is to determine whether expression of the receptor among endothelium and circulating cells, SGLT2, is associated with an additional risk of presenting cardiovascular toxicity following treatment with anthracycline. If this association is demonstrated, it will then be possible to better screen and prevent these cardiovascular complications.
### Conditions Module
**Conditions:**
- Breast Neoplasms
**Keywords:**
- Breast cancer
- Cardiotoxicities
- SGLT2
- Anthracyclines
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Indication for anthracycline-based chemotherapy after first-line surgery
**Intervention Names:**
- Drug: Anthracycline
**Label:** Adjuvant scheme
#### Arm Group 2
**Description:** Indication for anthracycline-based chemotherapy
**Intervention Names:**
- Drug: Anthracycline
**Label:** Neoadjuvant scheme
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Adjuvant scheme
- Neoadjuvant scheme
**Description:** as standard of care
**Name:** Anthracycline
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Measurement of protein expression (Western Blot) and mRNA (RT-qPCR) of SGLT2 within the different models studied and according to the cumulative quantity of anthracyclines received and the patient's cardiovascular history before and after epirubine infusion.
**Measure:** Evaluate the expression of SGLT2
**Time Frame:** At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
**Description:** Measurement of the polarization of peripheral blood mononuclear cells (PBMCs) into pro-inflammatory M1 and anti-inflammatory M2 before and after epirubine infusion.
**Measure:** Evaluate the expression of SGLT2
**Time Frame:** At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
**Description:** Fluorescence measurement of the level of reactive oxygen species (ROS) formation and senescence of cardiovascular cells before and after epirubine infusion.
**Measure:** Evaluate the expression of SGLT2
**Time Frame:** At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
**Description:** Measurement of inflammatory mediators secreted by circulating cells.Comparison with positive and negative controls that induce inflammation and ROS before and after epirubine infusion.
**Measure:** Evaluate the expression of SGLT2
**Time Frame:** At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
#### Secondary Outcomes
**Description:** Measurement of the antiplatelet activity of endothelial celles (ECs) mediated by nitric oxide (NO), the procoagulant activity and the adhesion of platelets and monocytes to ECs before and after epirubine infusion.
**Measure:** Evaluate the ex vivo functional impact at the endothelial and cardiac level of exposure to patient plasma during treatment
**Time Frame:** At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
**Description:** Quantification of inflammatory mediators in plasma and produced by treated cardiovascular cells before and after epirubine infusion.
**Measure:** Evaluate the ex vivo functional impact at the endothelial and cardiac level of exposure to patient plasma during treatment
**Time Frame:** At cycles 1, 2, 3, 4 and 2-3 weeks after end of treatement.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patient \> 18 years old
* Diagnosed with localized breast cancer
* Indication for first-line surgery or anthracycline-based chemotherapy.
Exclusion Criteria:
* History of chemotherapy or targeted therapy or immunotherapy administered before inclusion
* Patient currently being treated with anti-SGLT2, conversion enzyme inhibitor or ARA2
* Patient with known heart disease (ischemic, rhythmic, valvular, etc.)
* Patient with a Glomerular filtration rate \< 45 mL/min/1.73m² according to the pre-therapeutic assessment
* Patient with impaired liver function
* Patient who is pregnant or breastfeeding
* Patient with a second cancer undergoing treatment
* Patient under guardianship or curatorship, protection of justice or deprived of liberty
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The recruited population concerns adult patients followed for localized breast cancer and for whom treatment with anthracycline is indicated in the adjuvant or neoadjuvant situation.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Simon NANNINI
**Phone:** +33368767360
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Manon VOEGELIN
**Phone:** +33368767360
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Strasbourg
**Contacts:**
***Contact 1:***
- **Name:** Simon NANNINI
- **Role:** CONTACT
***Contact 2:***
- **Name:** Jean-Emmanuel KURTZ
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Simon NANNINI
- **Role:** SUB_INVESTIGATOR
**Country:** France
**Facility:** Institut de cancérologie Strasbourg Europe
#### Overall Officials
**Official 1:**
**Affiliation:** Institut de cancérologie Strasbourg Europe
**Name:** Jean-Emmanuel KURTZ
**Role:** PRINCIPAL_INVESTIGATOR
## 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
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000010335
- Term: Pathologic Processes
- ID: D000064420
- Term: Drug-Related Side Effects and Adverse Reactions
- ID: D000064419
- Term: Chemically-Induced Disorders
- ID: D000011832
- Term: Radiation Injuries
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000009385
- Term: Neoplastic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC25
- Name: Substance Related Disorders
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Neoplasms
- ID: M30145
- Name: Carcinogenesis
- Relevance: HIGH
- As Found: Tumorigenesis
- ID: M5720
- Name: Cell Transformation, Neoplastic
- Relevance: HIGH
- As Found: Tumorigenesis
- ID: M30670
- Name: Cardiotoxicity
- Relevance: HIGH
- As Found: Cardiotoxicity
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M30303
- Name: Drug-Related Side Effects and Adverse Reactions
- Relevance: LOW
- As Found: Unknown
- ID: M30302
- Name: Chemically-Induced Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14679
- Name: Radiation Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M12330
- Name: Neoplastic Processes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
- ID: D000063646
- Term: Carcinogenesis
- ID: D000002471
- Term: Cell Transformation, Neoplastic
- ID: D000066126
- Term: Cardiotoxicity
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443632
**Brief Title:** WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy
**Official Title:** WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy: A Prospective Randomized Controlled Phase II Clinical Trial
#### Organization Study ID Info
**ID:** SDZLEC2024-077-01
#### Organization
**Class:** OTHER
**Full Name:** Shandong Cancer Hospital and Institute
### Status Module
#### Completion Date
**Date:** 2025-10-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-10-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Shandong Cancer Hospital and Institute
#### Responsible Party
**Investigator Affiliation:** Shandong Cancer Hospital and Institute
**Investigator Full Name:** Jinbo Yue
**Investigator Title:** Director of Radiation Oncology Department
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** In China, pediatric tumors are the second leading cause of death in children. Radiotherapy is critical to the treatment of pediatric cancer, with about one-third of patients requiring it and nearly 50% for certain cancers, but young age and immature cognitive abilities pose challenges for precise positioning, leading to reliance on sedatives such as propofol or chloral hydrate, which pose health risks. Radiotherapy technicians are exploring new methods such as psychological interventions, but these methods are challenging for children aged 0-4, who account for a high proportion of pediatric cancer cases in China. Therefore, new methods for children aged 0-4 are urgently needed.
**Detailed Description:** Approximately 400,000 children and adolescents globally and 22,000 children in China are diagnosed with malignancies each year, with pediatric tumors being the second leading cause of death in children. Radiotherapy is crucial for pediatric cancer treatment, with about one-third of patients requiring it and nearly 50% for certain cancers, but young age and immature cognitive abilities pose challenges for precise positioning and irradiation, leading to reliance on sedatives like propofol or chloral hydrate, which carry health risks. A retrospective study found a 5.8% incidence of cardiopulmonary complications with propofol-only anesthesia during pediatric radiotherapy, and guidelines and studies indicate that anesthetics pose rare but serious risks and may impact neurological development and learning abilities, highlighting the need to reduce sedative use to minimize side effects and improve long-term quality of life for pediatric cancer patients.
Radiotherapy technicians are exploring new methods like psychological interventions, as shown by Sonja et al.'s study where psychological intervention significantly reduced the need for sedation anesthesia in children undergoing radiotherapy, with better outcomes observed in girls. A 2023 multicenter study found that audiovisual-assisted radiotherapy (AVATAR) effectively reduced sedative use and improved quality of life and anxiety in 3-10-year-old children, with significant QoL improvements for children aged 5-7 and their parents. However, the application of these methods is challenging for children aged 0-4, who account for the highest proportion (30.59%) of newly diagnosed pediatric cancer cases in China. Therefore, new methods for children aged 0-4 years are urgently needed. Our center's prospective study (Oct 2021 - Oct 2022) with 28 children aged 0-4 found that the WASPE method combined with optical surface monitoring systems (OSMS) effectively guided young children to complete radiotherapy with reduced sedative use, with 69% of parents preferring the sleep adjustment method.
Based on promising findings, our study will randomize 0-4-year-old radiotherapy patients into sleep adjustment or conventional sedation groups to compare radiotherapy completion rates, improve quality of life (assessed via PedsQL™), and reduce parental anxiety (evaluated using SAS), all monitored by optical surface monitoring systems (OSMS).
### Conditions Module
**Conditions:**
- Pediatric Cancer
**Keywords:**
- Pediatric cancer
- Radiotherapy
- Sleep adjustment
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 46
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** For eligible children aged 0-4, inform parents about the condition and sign an informed consent form. Explain the specific sleep adjustment plan to help parents prepare the child for positioning and radiotherapy appointments.
**Intervention Names:**
- Other: Sleep Adjustment
**Label:** Sleep Adjustment
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** For eligible children aged 0-4, administer chloral hydrate rectally or orally before positioning and radiotherapy implementation, allowing the child to enter a sedated state for accurate positioning and completion of the radiotherapy session.
**Label:** Sedation
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Sleep Adjustment
**Description:** (1) Establishing a sleep schedule with early bedtime and wake-up times; (2) Establishing a consistent bedtime routine based on the child's preferences, such as wearing a sleep sack, providing soothing touch before sleep, offering a pacifier, using white noise, or playing sleep-inducing music; (3) Setting a fixed afternoon radiotherapy time each day and familiarizing the child with the radiotherapy environment beforehand; (4) Engaging the child in stimulating activities like watching videos, playing with toys, snacking, or outdoor activities to keep them awake from morning until 2 PM before radiotherapy; (5) Ensuring the child reaches deep sleep; (6) Completing the radiotherapy plan.
**Name:** Sleep Adjustment
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Number of Successful Radiotherapy Completions / Total Number of Radiotherapy Sessions
**Measure:** Completion Rate of Radiotherapy
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** Using the Pediatric Quality of Life Inventory (PedsQL), which ranges from 0 to 100, where higher scores indicate better quality of life
**Measure:** Quality of Life Score for the Child
**Time Frame:** 6 months
**Description:** Using the Self-Rating Anxiety Scale (SAS), which ranges from 20 to 80, where higher scores indicate greater anxiety.
**Measure:** Anxiety Score for the Parent
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patient of any gender, aged 0-4 years
* Pathologically confirmed diagnosis of pediatric malignant solid tumors (including Wilms tumor, neuroblastoma, rhabdomyosarcoma, hepatoblastoma, germ cell tumors, etc.).
* The child's parents can cooperate with the implementation of the sleep training plan.
* Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
* Expected survival of the patient ≥3 months.
* Normal major organ function (within 14 days before enrollment)
* The patient's parents must provide informed consent for the study before participation and voluntarily sign the informed consent form.
Exclusion Criteria:
* Primary or metastatic lesions that cannot undergo radiotherapy (as determined by the investigator).
* Children who can independently maintain position fixation.
* Children with clinical signs of central nervous system dysfunction.
* Children with sleep disorders.
* Other significant medical conditions that may impact the study (e.g., severe cardiopulmonary diseases). The decision is at the discretion of the investigator.
* Severe or uncontrolled infections.
* Allergy to sedatives.
* The investigator deems the patient unsuitable for participation in this clinical study for other reasons.
**Maximum Age:** 4 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jinbo Yue, Dorcter
**Phone:** 0531-67626442
**Phone Ext:** 0531-67626442
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Jinan
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jinbo Yue, doctor
- **Phone:** 0531-67626442
- **Role:** CONTACT
**Country:** China
**Facility:** Department of Radiation Oncology, Shandong Cancer Hospital and Institute
**State:** Shandong
**Status:** RECRUITING
**Zip:** 0531
#### Overall Officials
**Official 1:**
**Affiliation:** Shandong Cancer Hospital and Institute
**Name:** Jinbo Yue, Dorcter
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Bhakta N, Force LM, Allemani C, Atun R, Bray F, Coleman MP, Steliarova-Foucher E, Frazier AL, Robison LL, Rodriguez-Galindo C, Fitzmaurice C. Childhood cancer burden: a review of global estimates. Lancet Oncol. 2019 Jan;20(1):e42-e53. doi: 10.1016/S1470-2045(18)30761-7.
**PMID:** 30614477
**Citation:** Ni X, Li Z, Li X, Zhang X, Bai G, Liu Y, Zheng R, Zhang Y, Xu X, Liu Y, Jia C, Wang H, Ma X, Zheng H, Su Y, Ge M, Zeng Q, Wang S, Zhao J, Zeng Y, Feng G, Xi Y, Deng Z, Guo Y, Yang Z, Zhang J. Socioeconomic inequalities in cancer incidence and access to health services among children and adolescents in China: a cross-sectional study. Lancet. 2022 Sep 24;400(10357):1020-1032. doi: 10.1016/S0140-6736(22)01541-0.
**PMID:** 36154677
**Citation:** Jairam V, Roberts KB, Yu JB. Historical trends in the use of radiation therapy for pediatric cancers: 1973-2008. Int J Radiat Oncol Biol Phys. 2013 Mar 1;85(3):e151-5. doi: 10.1016/j.ijrobp.2012.10.007. Epub 2012 Dec 27.
**PMID:** 23273995
**Citation:** McMullen KP, Hanson T, Bratton J, Johnstone PA. Parameters of anesthesia/sedation in children receiving radiotherapy. Radiat Oncol. 2015 Mar 11;10:65. doi: 10.1186/s13014-015-0363-2.
**PMID:** 25889312
**Citation:** Yildirim I, I Celik A, B Bay S, Pasin O, Tutuncu AC. Propofol-based balanced anesthesia is safer in pediatric radiotherapy. J Oncol Pharm Pract. 2019 Dec;25(8):1891-1896. doi: 10.1177/1078155218825296. Epub 2019 Jan 30.
**PMID:** 30700212
**Citation:** Cote CJ, Wilson S. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures. Pediatr Dent. 2019 Jul 15;41(4):259-260.
**PMID:** 31439084
**Citation:** Stratmann G, Sall JW, May LD, Bell JS, Magnusson KR, Rau V, Visrodia KH, Alvi RS, Ku B, Lee MT, Dai R. Isoflurane differentially affects neurogenesis and long-term neurocognitive function in 60-day-old and 7-day-old rats. Anesthesiology. 2009 Apr;110(4):834-48. doi: 10.1097/ALN.0b013e31819c463d.
**PMID:** 19293705
**Citation:** Briner A, De Roo M, Dayer A, Muller D, Habre W, Vutskits L. Volatile anesthetics rapidly increase dendritic spine density in the rat medial prefrontal cortex during synaptogenesis. Anesthesiology. 2010 Mar;112(3):546-56. doi: 10.1097/ALN.0b013e3181cd7942.
**PMID:** 20124985
**Citation:** Haeberli S, Grotzer MA, Niggli FK, Landolt MA, Linsenmeier C, Ammann RA, Bodmer N. A psychoeducational intervention reduces the need for anesthesia during radiotherapy for young childhood cancer patients. Radiat Oncol. 2008 Jun 4;3:17. doi: 10.1186/1748-717X-3-17.
**PMID:** 18522761
**Citation:** Gutkin PM, Skinner L, Jiang A, Donaldson SS, Loo BW Jr, Oh J, Wang YP, von Eyben R, Snyder J, Bredfeldt JS, Breneman JC, Constine LS, Faught AM, Haas-Kogan D, Holmes JA, Krasin M, Larkin C, Marcus KJ, Maxim PG, McClelland S 3rd, Murphy B, Palmer JD, Perkins SM, Shen CJ, Terezakis S, Bush K, Hiniker SM. Feasibility of the Audio-Visual Assisted Therapeutic Ambience in Radiotherapy (AVATAR) System for Anesthesia Avoidance in Pediatric Patients: A Multicenter Trial. Int J Radiat Oncol Biol Phys. 2023 Sep 1;117(1):96-104. doi: 10.1016/j.ijrobp.2023.03.063. Epub 2023 Mar 30.
**PMID:** 37001762
**Citation:** Liu P, Huang Q, Zhang T, Zhang X, Shi P, Qi L, Yue J. WASPE Sleep Deprivation, Paired with an Optical Surface Monitoring System, Can Provide Accurate Radiation Therapy to Pediatric Patients Without the Need for Sedation. Pract Radiat Oncol. 2023 May-Jun;13(3):e292-e300. doi: 10.1016/j.prro.2022.11.007. Epub 2022 Dec 6.
**PMID:** 36494032
**Citation:** Lawler G. A review of surface guidance in extracranial stereotactic body radiotherapy (SBRT/SABR) for set-up and intra-fraction motion management. Tech Innov Patient Support Radiat Oncol. 2022 Jan 19;21:23-26. doi: 10.1016/j.tipsro.2022.01.001. eCollection 2022 Mar.
**PMID:** 35079644
**Citation:** Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.
**PMID:** 11932914
**Citation:** Dunstan DA, Scott N. Norms for Zung's Self-rating Anxiety Scale. BMC Psychiatry. 2020 Feb 28;20(1):90. doi: 10.1186/s12888-019-2427-6.
**PMID:** 32111187
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M5941
- Name: Chloral Hydrate
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443619
**Brief Title:** Efficacy of Glucose in Serratus Anterior Plane Block to Reduce the Occurrence of Chronic Post-mastectomy Pain
**Official Title:** Efficacy of Glucose Addition to Bupivacaine in Serratus Anterior Plane Block to Reduce the Occurrence of Chronic Post-mastectomy Pain: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** R.24.04.2582.
#### Organization
**Class:** OTHER
**Full Name:** Mansoura University
### Status Module
#### Completion Date
**Date:** 2025-07-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-04
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Mansoura University
#### Responsible Party
**Investigator Affiliation:** Mansoura University
**Investigator Full Name:** Mahmoud Mohammed Alseoudy
**Investigator Title:** Associate professor of Anesthesia, Intensive care and pain management
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Nearly 50% of patients suffer from chronic pain following breast cancer surgery. Several regional anesthesia techniques, including paravertebral block, erector spinae plane block, pectoral nerves block, and serratus anterior plane block, have been applied for acute pain control and prevention of chronic pain after breast cancer surgery. Exploiting the beneficial effect of glucose in regulating neuroinflammation and neuropathic pain, we hypothesize that the addition of glucose to bupivacaine could be superior to bupivacaine in ultrasound-guided SAPB in improving the quality of postoperative analgesia and preventing chronic pain after mastectomy. Patients will be randomly allocated into one of two equal groups (30 patients each ); the study group; Group I( B-D) (n=30): will receive unilateral USG-deep SAPB 0.4 ml/kg Of 0.25 % isobaric bupivacaine with addition of 15ml glucose 5% to (30 ml total volume); Group (B-N) (n=30): will receive unilateral USG-deep SAPB 0.4 ml/kg Of 0.25% isobaric bupivacaine to be diluted with 15ml isotonic saline (30 ml total volume). The occurence of postmastectomy pain, 3 months after surgery, will be the primary outcome.
**Detailed Description:** Breast cancer is the most commonly diagnosed malignancy and the leading cause of cancer-related death in women. Although early detection and treatment have increased survival rates, chronic postsurgical pain (CPSP) is one of the most common complications of breast cancer surgery.
Nearly 50% of patients suffer from chronic pain following breast cancer surgery which is known as Post Mastectomy Pain Syndrome (PMPS). There are several risk factors for PMPS, including younger age, invasive surgical interventions, adjuvant radiation therapy following surgery, and high pain score in the early postoperative period. Several regional anesthesia (RA) techniques, including paravertebral block (PVB), pectoral nerves (PECS) block, and the erector spinae plane block (ESPB), have been applied for acute pain control and prevention of chronic pain after breast cancer surgery (BCS).
Recently, the serratus anterior plane block (SAPB) has become a newer interfacial plane block that appears to be safe and easily performed under ultrasound (de la Torre et al., 2014). A study concluded that preoperative SAPB with ropivacaine reduced the prevalence of CPSP at 3 months postoperativelyfrom 51.7% to 25.6%. Various adjuvants like fentanyl, clonidine, magnesium sulphate, nalbuphine, and dexamethasone have been used with bupivacaine in different blocks for prolonging the duration of analgesia and prevention of chronic pain. Using glucose 5% has been progressively applied to treat many peripheral entrapment neuropathies and has been proven to have outstanding effects in a few high-quality studies. Glucose 5% could decrease neurogenic inflammation by impeding the discharge of substance P and calcitonin gene-related peptides, which are pro-nociceptive substances that contribute to neurogenic inflammation and neuropathic pain. Exploiting the beneficial effect of glucose in regulating neuroinflammation and neuropathic pain, we hypothesize that the addition of glucose, as an adjuvant, to bupivacaine in the regional anesthesia technique for breast surgery could improve the quality of postoperative analgesia and prevent chronic pain after mastectomy. We hypothesize that the addition of glucose to bupivacaine could be superior to bupivacaine in ultrasound-guided SAPB in improving the quality of postoperative analgesia and preventing chronic pain after mastectomy. This randomized, double-blind study was designed to compare the efficacy and safety of co-administration of glucose and bupivacaine (study group), and bupivacaine alone (control group) in ultrasound-guided SAPB in patients undergoing modified radical mastectomy using the occurence of postmastectomy pain, 3 months after surgery, as the primary outcome.
### Conditions Module
**Conditions:**
- Post-mastectomy Pain Syndrome
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 190
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** will receive unilateral USG-deep SAPB ; 15 ml 0.5 % isobaric bupivacaine with addition of 15ml glucose 10% to (30 ml total volume).
**Intervention Names:**
- Procedure: unilateral USG-deep SAPB with glucose
**Label:** Group I
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** will receive unilateral USG-deep SAPB; 15ml 0.5% isobaric bupivacaine to be diluted with 15ml isotonic saline0.9% (30 ml total volume).
**Intervention Names:**
- Procedure: unilateral USG-deep SAPB without glucose
**Label:** Group Π
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group I
**Description:** patients will receive unilateral USG-deep SAPB ; 15 ml 0.5 % isobaric bupivacaine with addition of 15ml glucose 10% to (30 ml total volume).
**Name:** unilateral USG-deep SAPB with glucose
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Group Π
**Description:** will receive unilateral USG-deep SAPB; 15ml 0.5% isobaric bupivacaine to be diluted with 15ml isotonic saline0.9% (30 ml total volume).
**Name:** unilateral USG-deep SAPB without glucose
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** The prevalence of chronic pain (post mastectomy pain syndrome) of any severity: Numerical pain scale (NRS) \>0 on a 0 - 10 scale
**Measure:** The prevalence of chronic pain (post mastectomy pain syndrome)
**Time Frame:** 3 months after surgery
#### Secondary Outcomes
**Description:** Numerical pain scale (NRS) on a 0 - 10 scale, o no pain, 10 worst pain
**Measure:** Numerical pain scale (NRS)
**Time Frame:** over 24 hours
**Description:** total consumption of morphine in the first 24 hours
**Measure:** Postoperative opioid consumption.
**Time Frame:** over 24 hours
**Description:** Patient satisfaction with pain management assessed 24 h after surgery using an 11-point Likert scale (range, 0-10: 0, entirely unsatisfied; 10,fully satisfied).
**Measure:** Patient satisfaction with pain management
**Time Frame:** 24 hours
**Description:** The severity of CPSP and its impact on daily function assessed 3 and 6 months after surgery using the revised brief pain inventory (BPI) Chinese-Simplified version
**Measure:** The severity of CPSP and its impact on daily function
**Time Frame:** 3 and 6 months after surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* American Society of Anesthesiologists physical status I-II
* age ranging from 20 to 60 years
* scheduled for unilateral modified radical mastectomy
Exclusion Criteria:
* patient refusal to participate in the study
* infection at site of needle insertion
* hypersensitivity to the studied drugs
* psychotic disorders,
* bilateral MRM ,
* bleeding disorder
* chronic renal or hepatic diseases
**Maximum Age:** 60 Years
**Minimum Age:** 20 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M5315
- Name: Bupivacaine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443606
**Acronym:** BEZURSO 2
**Brief Title:** Efficacy and Safety of Bezafibrate 400 mg and Bezafibrate 200 mg as Adjunctive Treatments in Patients With Primary Biliary Cholangitis and Non-optimal Biochemical Response to Ursodeoxycholic Acid Therapy
**Official Title:** Efficacy and Safety of Bezafibrate 400 mg and Bezafibrate 200 mg as Adjunctive Treatments in Patients With Primary Biliary Cholangitis and Non-optimal Biochemical Response to Ursodeoxycholic Acid Therapy: a 12-month, Double-blind, Randomized, Placebo-controlled Trial With a 12-month, Double-blind, Placebo-free Extension Phase.
#### Organization Study ID Info
**ID:** APHP220822
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique - Hôpitaux de Paris
### Status Module
#### Completion Date
**Date:** 2028-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**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:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-21
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assistance Publique - Hôpitaux de Paris
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Primary biliary cholangitis (PBC) is a rare chronic, progressive, cholestatic liver disease that leads to cirrhosis and its life-threatening complications if undertreated. Ursodeoxycholic acid (UDCA) is the standard-of-care therapy for PBC. However, patients with an inadequate biochemical response to UDCA according to the Paris-2 criteria are still at high-risk of poor clinical outcome. In this situation of biochemical resistance to UDCA, bezafibrate 400 mg/d given in association with UDCA has been shown to improve the symptoms, biochemical response (BEZURSO study), histologic features, and possibly long-term clinical outcome. However, it has been shown that even patients with an adequate response to UDCA but persistent elevation in biochemical markers of cholestasis or liver inflammation, including alkaline phosphatases (ALP), gamma-glutamyl transpeptidase (GGT), transaminases, or total bilirubin (i.e., non-optimal biochemical response) have still an increased risk of death or liver transplantation in the long term, thus defining the complete normalization of these markers as the new clinically-relevant target for PBC treatment. In parallel to these findings, bezafibrate 400 mg/d as a second-line therapy for PBC could be associated with potentially dose-related, muscle, kidney, or liver toxic effects, and whether bezafibrate 200 mg/d could have a better benefit/risk ratio in this disease-setting remains to be determined. Therefore, our aim is to evaluate the efficacy and safety of bezafibrate 400 mg and bezafibrate 200 mg as adjunctive treatments in PBC patients with non-optimal biochemical response to UDCA.
**Detailed Description:** The study is a phase-3 multicenter, randomized, parallel-group (1:1:1), placebo-controlled trial with a 12-month, double-blind, placebo-free extension phase.
It evaluates the efficacy and safety of bezafibrate 400 mg and bezafibrate 200 mg as adjunctive treatments in patients with PBC with an non-optimal biochemical response to UDCA.
Treatments groups :
Arm 1: Bezafibrate 400 mg and Placebo of Bezafibrate 200 mg until 96 weeks in double blind.
Arm 2: Bezafibrate 200 mg and Placebo of Bezafibrate 400 mg until 96 weeks in double blind.
Arm 3: Placebo of Bezafibrate 400 mg and Placebo of Bezafibrate 200 mg until 48 weeks in double blind. Then follow-up extension phase of bezafibrate 400 mg or bezafibrate 200 mg (second randomization) until 48 weeks in double blind.
Assessement: Study visits at Inclusion, Randomisation (M0) and then every 3 months until W48 and extension until W96. In accordance with routine care, an additional follow-up is added between 108 and 120 weeks
32 sites within the French network of reference and competence centres for rare liver diseases FILFOIE will participate.
No interim analysis planned. Analysis will be performed at the end of the study after data reviewed and data base locked according to the intent to treat principle.
### Conditions Module
**Conditions:**
- BPC
- Non Optimal Response to UDCA
**Keywords:**
- Bezafibrate
- PBC
- Digestive System Diseases
- Ursodeoxycholic Acid
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 108
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Bezafibrate 400 mg and Placebo of Bezafibrate 200 mg until 48 weeks in double blind
**Intervention Names:**
- Drug: Bezafibrate 400 mg in addition to UDCA therapy
**Label:** Bezafibrate 400 mg group in addition to UDCA therapy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Bezafibrate 200 mg and Placebo of Bezafibrate 400 mg until 96 weeks in double blind.
**Intervention Names:**
- Drug: Bezafibrate 200 mg in addition to UDCA therapy
**Label:** Bezafibrate 200 mg group in addition to UDCA therapy
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Placebo of Bezafibrate 400 mg Placebo of Bezafibrate 200 mg until 48 weeks in double blind. And follow-up extension phase of bezafibrate 400 mg and bezafibrate 200 mg until 48 weeks in double blind.
**Intervention Names:**
- Drug: Placebo in addition to UDCA therapy
**Label:** Placebo group in addition to UDCA therapy
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Bezafibrate 400 mg group in addition to UDCA therapy
**Description:** * Bezafibrate 400 mg and Placebo of Bezafibrate 200 mg in addition to continued UDCA at minimum dose of 12 mg/kg/d.
* Duration 96 weeks bezfibrate/ UDCA = daily oral dose.
**Name:** Bezafibrate 400 mg in addition to UDCA therapy
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Bezafibrate 200 mg group in addition to UDCA therapy
**Description:** * Bezafibrate 200 mg and Placebo of Bezafibrate 400 mg in addition to continued UDCA at minimum dose of 12 mg/kg/d.
* Duration 96 weeks bezfibrate/ UDCA = daily oral dose.
**Name:** Bezafibrate 200 mg in addition to UDCA therapy
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Placebo group in addition to UDCA therapy
**Description:** * Placebo of Bezafibrate 400 mg and Placebo of Bezafibrate 200 mg in addition to continued UDCA at minimum dose of 12 mg/kg/d.
* Duration 96 weeks placebo /UDCA = daily oral dose.
**Name:** Placebo in addition to UDCA therapy
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Proportion of patients with a complete biochemical response defined by normal serum levels of alkaline phosphatase (ALP), gamma-glutamyl transpeptidase (GGT), aminotransferases (AST, ALT), and total bilirubin at 48 weeks of treatment.
**Measure:** To assess the effect of bezafibrate 200 mg and bezafibrate 400 mg versus placebo as adjunctive treatments in patients with PBC and a non-optimal response to UDCA.
**Time Frame:** Week 48
#### Secondary Outcomes
**Description:** Proportion of patients with serious adverse events (SAE) and/or adverse events (AE) at W48 and W96 (extension phase), including creatinine \> 150 μmol/L, CPK \> 10 xULN, or ALT \> 5 xULN.
**Measure:** To compare adverse effects between groups, in particular on muscle, kidney, and liver.
**Time Frame:** Week 48 and Week 96 ( extension phase)
**Description:** Proportion of patients with significant pruritus based on worst itch numerical rating scale (WI-NRS).
**Measure:** To compare symptoms (Pruritus) between groups
**Time Frame:** Week 48 and Week 96 (extension phase)
**Description:** Proportion of patients with significant fatigue at W48 and W96 based on PBC-40 questionnaire.
**Measure:** To compare symptoms (fatigue) between groups.
**Time Frame:** Week 48 and Week 96 (extension phase)
**Description:** Changes from baseline to W48 and W96 in quality of life assessed by PBC-40.
**Measure:** To compare quality of life (QoL) between groups.
**Time Frame:** Week 48 and Week 96 (extension phase)
**Description:** Proportion of patients with a deep biochemical response defined by normal levels of ALP, GGT, ALT, AST, and a total bilirubin ≤ 0.6 mg/dL.
**Measure:** Level of liver biochemical parameters between groups
**Time Frame:** Week 48 and Week 96 (extension phase)
**Description:** To compare changes in non-invasive markers of liver fibrosis between groups.
**Measure:** Changes in liver stiffness by Fibroscan
**Time Frame:** Week 48 and Week 96 (extension phase)
**Description:** To compare changes in non-invasive markers of liver fibrosis between groups.
**Measure:** Changes in liver stiffness (Fibroscan) by ELF test.
**Time Frame:** Week 48 and Week 96 (extension phase)
**Description:** To compare changes in non-invasive markers of liver fibrosis between groups.
**Measure:** Changes in liver stiffness (Fibroscan) by FIB-4 score.
**Time Frame:** Week 48 and Week 96 (extension phase)
**Description:** To compare changes in non-invasive markers of liver fibrosis between groups.
**Measure:** Proportion of patients with advanced fibrosis or cirrhosis as diagnosed by Fibroscan
**Time Frame:** Week 48 and Week 96 (extension phase)
**Description:** To compare changes in non-invasive markers of liver fibrosis between groups.
**Measure:** Proportion of patients with moderately advanced or advanced disease as diagnosed by the Rotterdam criteria
**Time Frame:** Week 48 and Week 96 (extension phase)
**Description:** Occurrence of all-cause and liver-related deaths, LT, referral for LT, ascites, spontaneous bacterial peritonitis, variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, hepatocellular carcinoma, unscheduled hospitalization, development of any new comorbidities or significant worsening of preexisting ones at W48 and W96.
**Measure:** To compare occurrence of clinical events including death, LT, or liver complications between groups.
**Time Frame:** Week 48 and Week 96 (extension phase)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 18 and \< 80 years
* Diagnosis of PBC based on at least 2 of the following criteria (EASL clinical practice guidelines 2017):
* Elevated ALP level
* Presence of antimitochondrial antibody (immunofluorescence titer ≥ 1:40 or positive antigen-specific test), specific antinuclear immunofluorescence (nuclear dots or perinuclear rims) or positive antigen-specific test for anti-gp210 or anti-Sp100 antibodies
* Records of histologic features suggestive of, or compatible with PBC
* UDCA therapy for the past 12 months (stable dose ≥ 12 mg/kg/d for ≥ 3 months prior to inclusion).
* Non-optimal response to UDCA defined by at least one of the following criteria (ratios of absolute values to ULN rounded to the first decimal digit) observed at least 2 times at ≥ 4 weeks interval in the past 3 months, including at the inclusion visit assessment:
* ALP \> 1.0 xULN
* GGT \> 3.0 xULN
* ALT or AST \> 1.0 xULN
* Total and conjugated bilirubin \> 1.0 xULN
* Women of childbearing potential must use at least one barrier contraceptive during the study and for at least 90 days after the last dose.
* Affiliation to a social security system (AME excepted).
* Signed informed consent.
Exclusion Criteria:
* Any of the following signs of advanced chronic liver disease:
* Total bilirubin \> 2.0 xULN
* Serum albumin \< 32 g/l
* Platelet count \< 100,000/mm3
* INR \> 1.3 or prothrombin index \< 60%
* Child-Pugh score B or C
* MELD score ≥ 14
* History ≤ 24 months or presence of cirrhotic decompensation
* Patients on the waiting list for LT
* GFR estimated by CKI-EPI equation \< 60 mL/min
* CPK \> 5.0 xULN
* AST or ALT \> 3.0 xULN
* History of LT
* Autoimmune hepatitis (AIH) overlap syndrome defined by at least 2 of the following 3 criteria including the histologic one:
* ALT \> 5.0 xULN
* IgG \> 20 g/l or presence of anti-smooth muscle or anti-SLA antibodies
* Histologic features characteristic of, or compatible with AIH
* Any other chronic hepatic comorbidities (HCV, HBV, NASH, alcoholic liver disease, hemochromatosis, Wilson's disease, α1-antitrypsin deficiency, celiac disease)
* Untreated hypo or hyperthyroidism (Hashimoto or Graves autoimmune thyroiditis)
* Conditions that may cause non-hepatic increases in ALP (Paget's disease, osteodystrophy, hyperparathyroidism, dysglobulinemia)
* Gilbert's syndrome or chronic hemolysis (hyperbilirubinemia with an unconjugated to total bilirubin ratio ≥ 75%)
* History of or established or suspected hepatocellular carcinoma
* History of malignancy diagnosed or treated within 2 years (recent localized treatment of squamous or non-invasive basal skin cancers is permitted)
* Any severe comorbidity that may reduce life expectancy ≤ 2 years
* Pregnancy or lactating
* Known intolerance to bezafibrate
* Known hypersensitivity to bezafibrate, any of the components of Befizal© or other fibrates
* Known photosensitivity reactions or photoallergy reactions to fibrates
* Patient with congenital galactosemia, glucose malabsorption, or lactase deficiency because of presence of lactose in LP tablets of bezafibrate
* Participation in any other interventional study in the past 6 months
* Any of the following medications used in the past 3 months before inclusion: bezafibrate, fenofibrate, ciprofibrate, gemfibrozil, obeticholic acid, budesonide, any other systemic corticosteroids, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, everolimus, methotrexate.
* Use of statins in the month before inclusion
**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:** Christophe Corpechot, MD
**Phone:** + 33 (0) 1 49 28 28 36
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Christophe Corpechot, Doctor
- **Phone:** + 33 (0) 1 49 28 28 36
- **Role:** CONTACT
**Country:** France
**Facility:** Hepatology department - Hospital Saint Antoine
**Zip:** 75012
#### Overall Officials
**Official 1:**
**Affiliation:** Assistance Publique - Hôpitaux de Paris
**Name:** Christophe Corpechot, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001649
- Term: Bile Duct Diseases
- ID: D000001660
- Term: Biliary Tract Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000002780
- Term: Cholestasis, Intrahepatic
- ID: D000002779
- Term: Cholestasis
- ID: D000008107
- Term: Liver Diseases
- ID: D000008103
- Term: Liver Cirrhosis
- ID: D000005355
- Term: Fibrosis
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M6002
- Name: Cholangitis
- Relevance: HIGH
- As Found: Cholangitis
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11105
- Name: Liver Cirrhosis, Biliary
- Relevance: HIGH
- As Found: Primary Biliary Cholangitis
- ID: M11103
- Name: Liver Cirrhosis
- Relevance: LOW
- As Found: Unknown
- ID: M4935
- Name: Bile Duct Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4946
- Name: Biliary Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6019
- Name: Cholestasis
- Relevance: LOW
- As Found: Unknown
- ID: M6020
- Name: Cholestasis, Intrahepatic
- Relevance: LOW
- As Found: Unknown
- ID: M11107
- Name: Liver Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8485
- Name: Fibrosis
- Relevance: LOW
- As Found: Unknown
- ID: T4683
- Name: Primary Biliary Cholangitis
- Relevance: HIGH
- As Found: Primary Biliary Cholangitis
### Condition Browse Module - Meshes
- ID: D000002761
- Term: Cholangitis
- ID: D000008105
- Term: Liver Cirrhosis, Biliary
### Intervention Browse Module - Ancestors
- ID: D000002756
- Term: Cholagogues and Choleretics
- ID: D000005765
- Term: Gastrointestinal 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: Gast
- Name: Gastrointestinal Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Lipd
- Name: Lipid Regulating Agents
### Intervention Browse Module - Browse Leaves
- ID: M17329
- Name: Ursodeoxycholic Acid
- Relevance: HIGH
- As Found: Branch of
- ID: M4915
- Name: Bezafibrate
- Relevance: HIGH
- As Found: Mucus
- ID: M8881
- Name: Gastrointestinal 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: D000014580
- Term: Ursodeoxycholic Acid
- ID: D000001629
- Term: Bezafibrate
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443593
**Acronym:** NCVRCT
**Brief Title:** Effect of Micronutrient Supplementation on Nerve Conduction Velocity in T1D- RCT
**Official Title:** Vitamin B12, Vitamin D and Iron Supplementation for Improvement of Nerve Conduction Velocities in Children and Youth With Type 1 Diabetes
#### Organization Study ID Info
**ID:** JCDC/BHR/24/014
#### Organization
**Class:** OTHER
**Full Name:** Hirabai Cowasji Jehangir Medical Research Institute
### Status Module
#### Completion Date
**Date:** 2025-02-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-02-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-08
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hirabai Cowasji Jehangir Medical Research Institute
#### Responsible Party
**Investigator Affiliation:** Hirabai Cowasji Jehangir Medical Research Institute
**Investigator Full Name:** Dr. Anuradha Khadilkar
**Investigator Title:** Consultant Pediatrician and Deputy Director
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Type 1 diabetes can complicate to peripheral neuropathy due to preferential involvement of small unmyelinated nerve fibers (pain and temperature sensation) followed by myelinated nerve fibers (vibration and proprioception). The SEARCH for diabetes in youth study found diabetic neuropathy in 7% of T1D youth. The clinical form of peripheral neuropathy is rare in childhood and pathophysiological changes begin during childhood and accelerate in puberty. Adolescents with these changes can be picked up more reliably by electrophysiological studies than by clinical examination. Nerve conduction studies are the gold standard diagnostic tests for detection of peripheral neuropathy. Role of vitamin B12 in nerve regeneration is well known while causal association of vitamin D deficiency in type 1 diabetes and its role in axonal degeneration is also reported. The previous ongoing studies from authors' group have shown relationship between poor oral iron intake and subclinical neuropathy in children with type 1 diabetes (manuscript in submission). The present randomised clinical trial is aimed at assessing vitamin B12, vitamin D and iron supplementation for improvement of nerve conduction velocities in children and youth with type 1 diabetes.
### Conditions Module
**Conditions:**
- Type 1 Diabetes
**Keywords:**
- Diabetic neuropathy
- children and youth with type 1 diabetes
- vitamin B12
- vitamin D
- oral iron
- Nerve conduction velocity
### 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:** 120
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Only vitamin B12 supplements 2.2 mcg OD for 24 weeks
**Intervention Names:**
- Dietary Supplement: Tablet VitaBliss vitamin B12 (2.2 mcg)
**Label:** Arm 1: Only vitamin B12 supplements
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Vitamin B12 2.2 mcg OD daily and oral iron 25 mg OD daily for 24 weeks
**Intervention Names:**
- Dietary Supplement: Tablet VitaBliss vitamin B12 (2.2 mcg) and Syrup Orofer (5 ml = 50 mg)
**Label:** Arm 2: Vitamin B12 and oral iron supplements
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Vitamin B12 2.2 mcg OD daily and vit D3 60,000 IU once in three months for 24 weeks
**Intervention Names:**
- Dietary Supplement: Tablet VitaBliss vitamin B12 (2.2 mcg) and Tablet Tayo (60000 IU)
**Label:** Arm 3: Vitamin B12 and vitamin D3
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Arm 1: Only vitamin B12 supplements
**Description:** Oral vitamin B12 supplement 2.2 mcg from BLISS WELNESS, Bliss Lifesciences, LLP to be administered once daily for 24 weeks
**Name:** Tablet VitaBliss vitamin B12 (2.2 mcg)
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Arm 2: Vitamin B12 and oral iron supplements
**Description:** Oral vitamin B12 supplement 2.2 mcg from BLISS WELNESS, Bliss Lifesciences, LLP to be administered once daily for 24 weeks and oral iron 25 mg from Emcure Pharmaceuticals Ltd. to be administered once daily for 24 weeks
**Name:** Tablet VitaBliss vitamin B12 (2.2 mcg) and Syrup Orofer (5 ml = 50 mg)
**Type:** DIETARY_SUPPLEMENT
#### Intervention 3
**Arm Group Labels:**
- Arm 3: Vitamin B12 and vitamin D3
**Description:** Oral vitamin B12 supplement 2.2 mcg from BLISS WELNESS, Bliss Lifesciences, LLP to be administered once daily for 24 weeks and oral vitamin D3 (60000 IU) from Eris Lifesciences Ltd to be administered once in 3 months for 24 weeks
**Name:** Tablet VitaBliss vitamin B12 (2.2 mcg) and Tablet Tayo (60000 IU)
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** Change in nerve conduction velocity of children and adolescents with type 1 diabetes after supplementation with vitamin B12, oral iron and vitamin D
**Measure:** Nerve conduction velocity
**Time Frame:** 6 months
**Description:** Change in serum vitamin B12, serum ferritin, serum vitamin D3 levels using standardized assays in children and adolescents with type 1 diabetes after supplementation with vitamin B12, oral iron and vitamin D
**Measure:** Serum vitamin B12, serum ferritin, serum vitamin D3
**Time Frame:** 6 months
#### Secondary Outcomes
**Description:** Maximum relative power (watt/kg) will be assessed using jumping mechanography
**Measure:** Dynamic muscle function
**Time Frame:** 6 months
**Description:** Maximum relative force (Newton/kg) will be assessed using jumping mechanography
**Measure:** Dynamic muscle function
**Time Frame:** 6 months
**Description:** Glycemic control will be assessed using glycated hemoglobin (HbA1c) by standardized assays
**Measure:** Glycemic control (HbA1c)
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Children/ parents/ youth willing to participate in the study with an informed consent/ assent.
2. Children/ youth Age \> 10 years
3. Diabetes duration \> 2 years
4. Diagnosed with type 1 diabetes
Exclusion Criteria:
1. Age \< 10 years
2. Diabetes duration \< 2 years
3. Children/ youth receiving vitamin B12, vitamin D and/or oral iron supplements
4. Children/ youth with any other disease condition involving nerve or muscle function
5. Children/ parents/ youth not willing to consent to participate in the study.
**Maximum Age:** 22 Years
**Minimum Age:** 10 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Anuradha Khadilkar, MBBS MD DCH
**Phone:** +910206057004
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Pune
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Anuradha V. Khadilkar, MBBS,MD,DCH
- **Phone:** +910206057004
- **Role:** CONTACT
**Country:** India
**Facility:** Hirabai Cowasji Jehangir Medical Research Institute
**State:** Maharashtra
**Status:** RECRUITING
**Zip:** 411001
### 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: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M7117
- Name: Diabetes Mellitus, Type 1
- Relevance: HIGH
- As Found: Type 1 Diabetes
- ID: M7124
- Name: Diabetic Neuropathies
- 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: 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: D000003922
- Term: Diabetes Mellitus, Type 1
### Intervention Browse Module - Ancestors
- ID: D000018977
- Term: Micronutrients
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000006397
- Term: Hematinics
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
- Abbrev: Vi
- Name: Vitamins
- Abbrev: Mi
- Name: Mineral
### Intervention Browse Module - Browse Leaves
- ID: M17558
- Name: Vitamins
- Relevance: HIGH
- As Found: Period
- ID: M17546
- Name: Vitamin B Complex
- Relevance: HIGH
- As Found: Every 4 weeks
- ID: M21009
- Name: Micronutrients
- Relevance: LOW
- As Found: Unknown
- ID: M16885
- Name: Trace Elements
- Relevance: LOW
- As Found: Unknown
- ID: M9934
- Name: Hydroxocobalamin
- Relevance: HIGH
- As Found: Variant
- ID: M17548
- Name: Vitamin B 12
- Relevance: HIGH
- As Found: Variant
- ID: M10533
- Name: Iron
- Relevance: LOW
- As Found: Unknown
- ID: M17550
- Name: Vitamin D
- Relevance: LOW
- As Found: Unknown
- ID: M6003
- Name: Cholecalciferol
- Relevance: LOW
- As Found: Unknown
- ID: M8618
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M9485
- Name: Hematinics
- Relevance: LOW
- As Found: Unknown
- ID: T441
- Name: Cobalamin
- Relevance: HIGH
- As Found: Variant
- ID: T444
- Name: Cyanocobalamin
- Relevance: HIGH
- As Found: Variant
- ID: T476
- Name: Vitamin B12
- Relevance: HIGH
- As Found: Variant
- ID: T451
- Name: Methylcobalamin
- Relevance: HIGH
- As Found: Variant
- ID: T442
- Name: Cholecalciferol
- Relevance: LOW
- As Found: Unknown
- ID: T479
- Name: Vitamin D3
- Relevance: LOW
- As Found: Unknown
- ID: T440
- Name: Calciferol
- Relevance: LOW
- As Found: Unknown
- ID: T341
- Name: Iron Supplement
- Relevance: LOW
- As Found: Unknown
- ID: T446
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T448
- Name: Folate
- Relevance: LOW
- As Found: Unknown
- ID: T475
- Name: Vitamin B9
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000014815
- Term: Vitamins
- ID: D000006879
- Term: Hydroxocobalamin
- ID: D000014805
- Term: Vitamin B 12
- ID: D000014803
- Term: Vitamin B Complex
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443580
**Brief Title:** Interoceptive Intervention for Pulmonary Hypertension
**Official Title:** The Relationship Between Interoception and Psychological Outcomes: A Mind-Body Intervention in Patients With Pulmonary Hypertension
#### Organization Study ID Info
**ID:** 24/MISC/01
#### Organization
**Class:** OTHER_GOV
**Full Name:** Golden Jubilee National Hospital
### Status Module
#### Completion Date
**Date:** 2024-10-18
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10-18
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-17
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Golden Jubilee National Hospital
#### Responsible Party
**Investigator Affiliation:** Golden Jubilee National Hospital
**Investigator Full Name:** Derick Moore
**Investigator Title:** Trainee Clinical Psychologist
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Background Pulmonary hypertension is a rare and incurable condition characterised by fatigue and breathlessness. The effects of pulmonary hypertension has a significant impact on an individual's emotional wellbeing and there are currently no established psychological interventions to improve this. Interoception is defined as the ability to perceive the internal state of the body and emerging research suggests that interventions to improve interoception can improve well-being.
Aims The project aims to develop an interoceptive based intervention for those with pulmonary hypertension and examine the feasibility and acceptability of this. Additional aims are to explore the preliminary results of the intervention.
Methods A randomised control feasibility trial will be used. Thirty-two participants will be included. Participants will be patients within the Scottish Pulmonary Vascular Unit diagnosed with pulmonary hypertension and randomly assigned to either the intervention or control (waitlist) group. The intervention will be an eight-session online group and participants will complete measures for interoception, anxiety, depression, health related quality of life, as well as a feasibility and acceptability questionnaire. Quantitative analysis will include descriptive statistics and T-tests (including non-parametric versions) to analyse the feasibility and gain a preliminary understanding of the intervention.
Practical Applications It is hoped that the findings will identify a sample size for a larger trial whilst also informing future clinical practice. This project will be written up for a suitable journal and will be presented at an appropriate conference.
### Conditions Module
**Conditions:**
- Interoception
- Pulmonary Hypertension
**Keywords:**
- interoception
- pulmonary hypertension
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 32
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** an 8 week online group intervention where participants will learn skills to improve interoception and connect with their body.
**Intervention Names:**
- Other: interoceptive group based intervention
**Label:** group based interoceptive intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** participants will wait until first group have completed intervention before commencing themselves
**Label:** waitlist
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- group based interoceptive intervention
**Description:** 8 week online group intervention aiming to improve interoception.
**Name:** interoceptive group based intervention
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** This self-report measure includes 32-items split into eight subscales of interoception. Participants rate each item on a six-point Likert scale, with higher scores indicating higher interoception. This measure has been shown to be reliable, including for those with a long-term health condition
**Measure:** Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
**Time Frame:** baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
#### Secondary Outcomes
**Description:** A questionnaire will be developed by the lead researcher to collect information regarding feasibility and acceptability. This will be completed at the end of the intervention. Participants will be asked about different aspects of the intervention, their engagement in the study and their perceptions of change regarding managing their PH. Questionnaires will be structured statements and participants will be asked to rate their response on a five-point Likert scale. There will also be a comment section at the end of the questionnaire for participants to discuss any additional thoughts they may have.
**Measure:** Feasibility and Acceptability Questionnaire
**Time Frame:** at 8 weeks (during last intervention session)
**Description:** is a self-report measure that has been widely used to assess generalised anxiety within primary care settings and has shown good reliability and construct validity (Johnson et al., 2019). It consists of seven items measuring generalised anxiety and is scored on a four-point Likert scale. Scores range from 0-21 with higher scores indicating greater anxiety severity.
**Measure:** The Generalised Anxiety Disorders Scale (GAD-7)
**Time Frame:** baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
**Description:** a self-report measure consisting of nine items measuring depressive symptoms within primary care settings and has shown to have good psychometric properties (Johnson et al., 2019). Items are scored on a four-point Likert scale with scores ranging from 0-27, with higher scores indicating greater depression severity.
**Measure:** Patient Health Questionnaire 9 (PHQ-9)
**Time Frame:** baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
**Description:** a 10 item self-report questionnaire measuring HRQoL that has been specifically designed for those with PH and has been used in previous PH research (Rawling et al., 2022; Odevoglu et al., 2018). Items are scored on a six-point Likert scale with scores ranging from 0-50 with higher scores indicating lower levels of HRQoL.
**Measure:** emPHasis-10
**Time Frame:** baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participants will be patients under the care of the Scottish Pulmonary Vascular Unit (SPVU) at the Golden Jubilee University National Hospital (GJUNH).
* Diagnosed with any type of PH.
* Adults over 18 years.
* Fluent in English.
* Able to commit to the duration of the research (expected to be three months from initial recruitment to the end of treatment).
Exclusion Criteria:
* Individuals with current thoughts of self-harm or suicide.
* Presenting with comorbid alcohol or substance misuse.
* Currently engaging in any additional psychological interventions at the time of the study.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Derick Moore
**Phone:** +44 07805511803
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Lynne Johnston, Doctorate Clinical Psychology
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Glasgow
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Joanne McGarry
- **Role:** CONTACT
**Country:** United Kingdom
**Facility:** Golden Jubilee National Hospital
**State:** Clydebank
**Zip:** g81 4dy
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-04-30
- Filename: Prot_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: False
- Label: Study Protocol
- Size: 241351
- Type Abbrev: Prot
- Upload Date: 2024-05-29T15:59
- Date: 2024-04-30
- Filename: ICF_001.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 138878
- Type Abbrev: ICF
- Upload Date: 2024-05-29T16:03
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
### Condition Browse Module - Browse Leaves
- ID: M10024
- Name: Hypertension
- Relevance: HIGH
- As Found: Hypertension
- ID: M10027
- Name: Hypertension, Pulmonary
- Relevance: HIGH
- As Found: Pulmonary Hypertension
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006976
- Term: Hypertension, Pulmonary
- ID: D000006973
- Term: Hypertension
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443567
**Acronym:** ABaCAS
**Brief Title:** Arterial Blood Pressure and Cardiac Arrest
**Official Title:** Arterial Blood Pressure and Cardiac Arrest
#### Organization Study ID Info
**ID:** B01830
#### Organization
**Class:** OTHER_GOV
**Full Name:** Manchester University NHS Foundation Trust
### Status Module
#### Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**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:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** North West Ambulance Service nhs foundation trust
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Manchester University NHS Foundation Trust
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** To describe and measure diastolic and systolic femoral arterial pressure during medical cardiac arrest.
To define baseline measures. To describe and measure arterial blood pressure after placement of an ITD device.
To observe the diastolic pressure immediately prior to return of spontaneous circulation.
To quantify and describe the effects of intravenous adrenaline on arterial blood pressure in cardiac arrest.
**Detailed Description:** Cardiac arrest is a complex disorder whose outcome is reliant on a huge number of factors. Moreover, many interventions are time critical, therefore an intervention that may be lifesaving if given early, may have no benefit if instigated further in the disease course. For these reasons' studies involving cardiac arrest are incredibly difficult to carry out and interpret. Many of the interventions carried out during cardiac arrest are aimed at improving blood pressure and thereby increasing the amount of blood and oxygen delivered to the myocardium in the hopes of achieving a return of spontaneous circulation (ROSC). However current data on what a 'normal' blood pressure, based largely upon non-invasive measurement, during cardiac arrest is severely limited, making comparison and evaluation of interventions extremely difficult. This provides the basis for this study in order to prospectively collate and describe data from invasive blood pressure monitoring during adult, medical cardiac arrest in the pre-hospital environment.
3. Research Question/Aim(s) To measure and describe femoral arterial pressure during cardiac arrest with mechanical CPR by a LUCAS device. 3.1 Objectives Primary objective To quantify and describe baseline arterial systolic blood pressure as measured by an invasive femoral line in adult patients suffering medical cardiac arrest in the pre-hospital setting. This will be defined as a line of best fit for systolic blood pressure superimposed on the arterial trace during a 3 minute period.
Secondary Objectives
* To quantify and describe baseline arterial diastolic blood pressure as measured by an invasive femoral line in adult patients suffering medical cardiac arrest in the pre-hospital setting. This will be defined as a line of best fit for diastolic blood pressure superimposed on the arterial trace during a 3 minute period.
* To quantify and describe arterial blood pressure after the placement of an ITD device over a 3 minute period.
* To quantify and describe the effect of intravenous adrenaline on blood pressure as administered in line with ALS guidelines (every 3-5 mins) in adult patients in cardiac arrest.
* To document the diastolic blood pressure of those patients that achieve return of spontaneous circulation (ROSC) following out of hospital cardiac arrest.
### Conditions Module
**Conditions:**
- Cardiac Arrest
**Keywords:**
- impedance threshold device
- blood pressure
- cardiac arrest
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** blood pressure measurement pre and post impedance threshold device placement
**Intervention Names:**
- Device: impedance threshold device
**Label:** adult cardiac arrest
### Interventions
#### Intervention 1
**Arm Group Labels:**
- adult cardiac arrest
**Description:** impedance threshold device (ResQPOD, Zoll) applied to airway
**Name:** impedance threshold device
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Measure:** systolic femoral invasive blood pressure
**Time Frame:** 3 mins average with CPR by LUCAS device
#### Secondary Outcomes
**Measure:** femoral diastolic pressure
**Time Frame:** 3 mins average with CPR by LUCAS device
**Measure:** femoral arterial pressure, both systolic and diastolic
**Time Frame:** 3 mins average post placement of ICD device
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult patients (≥18years) in medical cardiac arrest
* Deemed suitable to attempt resuscitation.
Exclusion Criteria:
* Prisoners
* \<18years
* Pregnancy
* Traumatic cardiac arrest
* Arrest caused by hypovolaemia, tension or tamponade as determined by the clinical team on scene
* Inability to secure a patent airway.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Adult patients (18+) suffering an out of hospital cardiac arrest (OHCA) by a presumed medical cause that have been deemed suitable to attempt resuscitation of.
All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage, and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation except where the study inclusion and exclusion criteria EXPLICITLY state otherwise.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** ian tyrrell-marsh, MBChB
**Phone:** 01612761234
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M9411
- Name: Heart Arrest
- Relevance: HIGH
- As Found: Cardiac Arrest
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006323
- Term: Heart Arrest
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443554
**Brief Title:** Evaluation of the Effectiveness of a Community Health Management Program for Dry Eye Disease in Middle-Aged and Elderly Individuals
**Official Title:** Evaluation of the Effectiveness of a Community Health Management Program for Dry Eye Disease in Middle-Aged and Elderly Individuals
#### Organization Study ID Info
**ID:** 2023ks-61-1
#### Organization
**Class:** OTHER
**Full Name:** Fujian University of Traditional Chinese Medicine
### Status Module
#### Completion Date
**Date:** 2025-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Fujian University of Traditional Chinese Medicine
#### Responsible Party
**Investigator Affiliation:** Fujian University of Traditional Chinese Medicine
**Investigator Full Name:** Zhang Shiyan
**Investigator Title:** Director
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study evaluates the effectiveness of a community health management program for middle-aged and elderly patients with dry eye disease (DED). By comparing the community-based health management plan with conventional treatment, the study aims to determine the impact on eye health and quality of life.
### Conditions Module
**Conditions:**
- Dry Eye Disease
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 182
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Procedure: Health Management Intervention Program
**Label:** Intervention group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Procedure: Standard Treatment
**Label:** Control group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention group
**Description:** This study implemented a 12-week eye health management intervention program based on the Protection Motivation Theory (PMT). The intervention included eye health interventions conducted twice weekly at community health service locations.During the health management process, specialist doctors from higher-level comprehensive hospitals provided professional guidance, while community general practitioners took on a leading role. They provided personalized eye health management for patients under the guidance of the PMT theory. The intervention content included group education, individual guidance, experience sharing meetings, and traditional Chinese medicine appropriate technology, among other aspects.
**Name:** Health Management Intervention Program
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Control group
**Description:** Each week, patients were subjected to standard treatment and follow-up procedures, including basic interventions, medication, and routine follow-up via phone or WeChat, during which general conditions were assessed.
**Name:** Standard Treatment
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** GAS is an individualized assessment method encompassing multiple personal goals, with a standardized formula for calculating total scores to facilitate comparisons. A score of 50 represents the expected level of achievement, with higher scores indicating greater goal attainment. GAS demonstrates good reliability, validity, and sensitivity. Based on the GAS goal list, researchers and participants collaboratively select goals and assign weights. Expected goals (assigned 0 points) and other goal levels (significantly above expected +2, slightly above expected +1, slightly below expected -1, significantly below expected -2) are established. Goal attainment is evaluated during follow-up, and GAS scores are calculated.
**Measure:** Goal Attainment Scaling (GAS)
**Time Frame:** 12 weeks
**Description:** The OSDI questionnaire assesses common dry eye symptoms and their frequency, aiding in the grading of dry eye severity. It focuses on symptoms such as dryness, foreign body sensation, stinging, photophobia, blurred vision, and the impact on daily life and environmental factors. Symptoms are rated on a scale of frequency: always (4 points), most of the time (3 points), half of the time (2 points), occasionally (1 point), and never (0 points). The OSDI total score is calculated as (sum of item scores × 25)/12, ranging from 0 to 100, with higher scores indicating more severe symptoms.
**Measure:** Ocular Surface Disease Index (OSDI)
**Time Frame:** 12 weeks
**Description:** The Schirmer I test measures tear secretion by placing a Schirmer strip under the lower eyelid conjunctiva with the patient's eyes closed, measuring tear absorption over 5 minutes. This test is widely used to evaluate dry eye syndrome. Tear secretion measured by Schirmer I test (without anesthesia) \>5 mm/5 min and ≤10 mm/5 min indicates mild dry eye; \>3 mm/5 min and ≤5 mm/5 min indicates moderate dry eye; and ≤3 mm/5 min indicates severe dry eye.
**Measure:** Schirmer I Test
**Time Frame:** 12 weeks
**Description:** NEI-VFQ-25：This is one of the most commonly used ophthalmic quality of life questionnaires, assessing vision-related issues and patients' quality of life. It consists of 25 questions divided into three parts: general health and vision, limitations in activities, and responses to vision problems. The items are categorized into dimensions such as overall health, overall vision, eye pain, near activities, distance activities, peripheral vision, color vision, driving, social functioning, role limitations, dependency, and mental health. Respondents rate their subjective experience on a 5 or 6-point scale, with scores weighted according to the question type, using values such as 100, 75, 50, 25, 0, or not scored. The highest possible score is 100, and the lowest is 0. Scores for each dimension are averaged, and overall scores for each section are averaged from the dimension scores. Higher scores indicate better quality of life.
8.Diagnostic Criteria for Dry eye disease (DED).
**Measure:** Quality of Life for Dry Eye Patients
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients meeting the diagnostic criteria for dry eye disease.
2. Middle-aged and elderly individuals aged 45 years and above.
3. Normal cognitive and expressive abilities.
4. Informed consent and ability to complete the survey.
5. Voluntary participation in the study.
Exclusion Criteria:
1. Patients with other ocular surface diseases, including stye, trachoma, allergic conjunctivitis, etc.
2. Patients with severe cataracts, glaucoma, uveitis, retinal detachment, optic nerve diseases, high myopia, or other conditions.
3. Patients who have undergone eye surgery or have a history of eye trauma in the past three months.
4. Patients who did not sign the informed consent form.
**Minimum Age:** 45 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Zhang Shiyan
**Phone:** 15159718855
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Fuzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Zhang Shiyan
- **Phone:** 15159718855
- **Role:** CONTACT
**Country:** China
**Facility:** The Third People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine
**State:** Fujian
**Status:** RECRUITING
**Zip:** 350000
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007766
- Term: Lacrimal Apparatus Diseases
- ID: D000007637
- Term: Keratoconjunctivitis
- ID: D000003231
- Term: Conjunctivitis
- ID: D000003229
- Term: Conjunctival Diseases
- ID: D000007634
- Term: Keratitis
- ID: D000003316
- Term: Corneal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M18040
- Name: Dry Eye Syndromes
- Relevance: HIGH
- As Found: Dry Eye Disease
- ID: M10664
- Name: Keratoconjunctivitis Sicca
- Relevance: HIGH
- As Found: Dry Eye Disease
- ID: M8271
- Name: Eye Diseases
- Relevance: HIGH
- As Found: Eye Disease
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M10663
- Name: Keratoconjunctivitis
- Relevance: LOW
- As Found: Unknown
- ID: M10786
- Name: Lacrimal Apparatus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6455
- Name: Conjunctivitis
- Relevance: LOW
- As Found: Unknown
- ID: M6453
- Name: Conjunctival Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10660
- Name: Keratitis
- Relevance: LOW
- As Found: Unknown
- ID: M6539
- Name: Corneal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015352
- Term: Dry Eye Syndromes
- ID: D000007638
- Term: Keratoconjunctivitis Sicca
- ID: D000005128
- Term: Eye Diseases
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443541
**Acronym:** SCALE
**Brief Title:** Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men
**Official Title:** SCALE: Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men
#### Organization Study ID Info
**ID:** STUDY00006481
#### Organization
**Class:** OTHER
**Full Name:** Emory University
#### Secondary ID Infos
**ID:** 1R01MH133259
**Link:** https://reporter.nih.gov/quickSearch/1R01MH133259
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2028-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2028-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-27
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institute of Mental Health (NIMH)
**Class:** UNKNOWN
**Name:** Center for Creative Initiatives in Health and Population (CCIHP)
**Class:** OTHER
**Name:** Georgia State University
#### Lead Sponsor
**Class:** OTHER
**Name:** Emory University
#### Responsible Party
**Investigator Affiliation:** Emory University
**Investigator Full Name:** Kathryn Yount
**Investigator Title:** Professor of Global Health
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This project, SCALE, will be the first to compare lower-intensity (standard) and higher-intensity implementation strategies to deliver GlobalConsent-an efficacious web-based sexual violence prevention program-to men attending six universities across Vietnam. Following a rigorous, mixed-methods, comparative interrupted-time-series design, researchers will collect novel data to compare implementation fidelity, drivers and outcomes, effectiveness, and cost-effectiveness across implementation strategy groups. This partnership includes universities also engaged in a violence-prevention training grant (D43TW012188), offering an unparalleled opportunity for capacity strengthening and evidence generation to guide national leaders on best strategies for launching GlobalConsent at scale, to address a gendered risk factor in adolescence, and thereby, improve an array of health outcomes into adulthood.
**Detailed Description:** Sexual violence is prevalent in adolescence and heightens the risk of harmful long-term health effects. Sexual violence includes any sexual act committed against a person without freely given consent. All genders may experience sexual violence, but sexual violence more often burdens women than men globally, and men most often perpetrate such violence. Adolescence is a period of vulnerability to sexual violence, with about one in five college women in the US experiencing a campus sexual assault and 91% of victims being women. Less is known about rates of sexual violence on college campuses. Still, estimates from large, multi-country surveys confirm that young men's reported sexually violent behavior and young women's reported sexual violence victimization are high, including in Asia/Pacific. In Vietnam, from 2010 to 2019, women's reports of lifetime sexual violence by a partner increased (10% to 13%), especially in women 18-24 years (5% to 14%). Such trends may reflect changing exposure and more openness to discuss sex and sexual violence. Also, nearly one in ten women (9%) report non-partner sexual violence since age 15, mostly perpetrated by non-family male acquaintances, co-workers, or strangers. Young women who are victims of sexual violence are at heightened risk of acute and chronic mental and physical health conditions.
The researchers will use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Proctor et al. frameworks and a mixed-methods, comparative interrupted time series (CITS) design to compare implementation; implementation drivers and outcomes; implementation effectiveness; and cost-effectiveness of lower-intensity vs higher-intensity (LIS; HIS) implementation strategies to deliver GlobalConsent.
### Conditions Module
**Conditions:**
- Violence, Sexual
**Keywords:**
- Behavioral Intervention
- GlobalConsent
- Sexual Violence
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This cluster-randomized design assigns six universities to High-intensity implementation strategies (HIS) or Lower-intensity (LIS) implementation strategies to deliver GlobalConsent education.
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 3439
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Students in either randomization group will become active consumers of GlobalConsent with an email introduction to the program, process, delivery schedule, data collection procedures, and consent.
**Intervention Names:**
- Behavioral: High-intensity implementation strategies (HIS)-Students
- Behavioral: Low-intensity implementation strategies (LIS) for Students
**Label:** Students
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Faculty will receive access to educational material based on the university randomization implementation strategies group.
**Intervention Names:**
- Other: High-intensity implementation strategies (HIS) for Faculty
- Other: Low-intensity implementation strategies (LIS) for Faculty
**Label:** Faculty
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Leaders will receive site-specific (University) invitations and material based on the implementation strategies group.
**Intervention Names:**
- Other: High-intensity implementation strategies (HIS) for Leaders
- Other: Low-intensity implementation strategies (LIS) for Leaders
**Label:** Leaders
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Implementation team members will receive passive access to web-based materials and training according to the university-specific implementation strategies group.
**Intervention Names:**
- Other: High-intensity implementation strategies (HIS) for Implementation Team Members
- Other: Low-intensity implementation strategies (LIS) Implementation Team Members
**Label:** Implementation Team Members
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Students
**Description:** Students in the HIS group will receive educational outreach in a pre-implementation in-person orientation to GlobalConsent, covering similar topics and three monthly one-hour learning sessions during implementation in which technical questions about program access or progression can be addressed; more intensive intervention to enhance adherence with more frequent email/Short Message Service (SMS), completion reminders; and demand generation encouraging program completion.
**Name:** High-intensity implementation strategies (HIS)-Students
**Other Names:**
- HIS-Students
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Students
**Description:** Students in the LIS group will receive basic implementation strategies of the GlobalConsent often used to deliver online programs at US universities with email/SMS completion reminders with a predetermined frequency for 12 weeks.
**Name:** Low-intensity implementation strategies (LIS) for Students
**Other Names:**
- LIS-Students
**Type:** BEHAVIORAL
#### Intervention 3
**Arm Group Labels:**
- Faculty
**Description:** * Passive access to web-based educational materials
* Town halls (3) with general faculty to define sexual violence; rates in young people; acute/chronic effects over the life course; primary-prevention evidence-based interventions (EBIs)
**Name:** High-intensity implementation strategies (HIS) for Faculty
**Other Names:**
- HIS-Faculty
**Type:** OTHER
#### Intervention 4
**Arm Group Labels:**
- Faculty
**Description:** Passive access to web-based educational materials
**Name:** Low-intensity implementation strategies (LIS) for Faculty
**Other Names:**
- LIS-Faculty
**Type:** OTHER
#### Intervention 5
**Arm Group Labels:**
- Leaders
**Description:** * Site-specific invitation to participate
* Passive access to web-based educational materials
* One pre-implementation webinar to define sexual violence; rates among young people in Vietnam; acute/chronic effects over life course; primary-prevention EBIs; recap of project description and collaboration; share GlobalConsent website for passive access to educational materials
* Monthly emails from trained internal facilitators to university leaders with updates on implementation progress
* One post-implementation webinar to share anonymized findings (by IS group); discuss plan for sustainment (including guidance on how to handle reporting of sexual violence in existing university counseling centers)
**Name:** High-intensity implementation strategies (HIS) for Leaders
**Other Names:**
- HIS-Leaders
**Type:** OTHER
#### Intervention 6
**Arm Group Labels:**
- Leaders
**Description:** * Site-specific invitation to participate
* Passive access to web-based educational materials
* One pre-implementation webinar to define sexual violence; rates among young people in Vietnam; acute/chronic effects over life course; primary-prevention EBIs; recap of project description and collaboration; share GlobalConsent website for passive access to educational materials
**Name:** Low-intensity implementation strategies (LIS) for Leaders
**Other Names:**
- LIS-Leaders
**Type:** OTHER
#### Intervention 7
**Arm Group Labels:**
- Implementation Team Members
**Description:** * Passive access to web-based educational materials
* In-person technical training on campus-wide implementation of GlobalConsent; discussion and demonstration of GlobalConsent program; standardized implementation manual
* In-person leadership training to champion GlobalConsent with internal stakeholders (leaders, implementation teams, faculty, students); leadership styles; managing teams; influence without authority; managing conflict; emotional intelligence; negotiation; leading change
* Biweekly (six) 1-hr recorded quality-improvement team webinars to provide refresher training; assess implementation progress; assess modifications; build peer-network; provide anonymized data on implementation progress for discussion
**Name:** High-intensity implementation strategies (HIS) for Implementation Team Members
**Other Names:**
- HIS-Implementation Team Members
**Type:** OTHER
#### Intervention 8
**Arm Group Labels:**
- Implementation Team Members
**Description:** * Passive access to web-based educational materials
* In-person technical training on campus-wide implementation of GlobalConsent; discussion and demonstration of GlobalConsent program; standardized implementation manual
**Name:** Low-intensity implementation strategies (LIS) Implementation Team Members
**Other Names:**
- LIS Implementation Team Members
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Students will be asked if they had engaged in any of seven prosocial bystander behaviors in the past 3 months (or since the last time completing the questionnaire). Items are scored as 0 = never performed, 1 = performed once, 2 = performed more than once. The numbers of participants who report engaging in at least one of seven prosocial bystander behaviors at least once are presented here.
**Measure:** Students' Reported Prosocial Bystander Behavior
**Time Frame:** Baseline, quarterly up to 28 months
**Description:** The Sexual Experiences Survey (SES) is an assessment tool used to measure the prevalence of sexual aggression. It is designed to measure the frequency and severity of sexual aggression acts committed by an individual. The SES is a self-report questionnaire developed by researchers at the University of Michigan. The Sexual Experiences Survey - Short Form Victimization is a multi-item measure to assess unwanted sexual victimization. Surveys will be provided quarterly for up to 28 months.
**Measure:** Students' reported Sexually Violent Behavior
**Time Frame:** Baseline, quarterly up to 28 months
#### Secondary Outcomes
**Description:** Perceptions of sexual violence will be assessed by respondents rating their level of agreement with 3 statements regarding the frequency and impact of sexual violence at their university using a 5-point Likert ranging from "Totally disagree" to "Totally agree."
Surveys will be provided to all groups at different time points as below:
* Students: quarterly for up to 28 months.
* Faculty: Baseline, 24 months, and 49 months
* Leaders: Baseline and 36 months
* Implementation Team: Baseline, month 15, month 18, and month 42
**Measure:** Perceptions of Sexual Violence form at their respective university
**Time Frame:** Baseline and up to 49 months
**Description:** Leadership in implementation teams is assessed using two scales, one for implementation team supervisors, and one for implementation team staff. Each scale has 13 items and uses a 5-point Likert ranging from "Totally disagree" to "Totally agree" to assess respondent's agreement on statements about their team supervisor (for staff) or themselves (for supervisors).
**Measure:** Implementation Team Scale for staff and supervisors
**Time Frame:** Baseline, month 15, month 18, and month 42
**Description:** For implementation team members only: The cultural exchange inventory assesses the teamwork environment of GlobalConsent implementation teams using 7 items. Respondents give their level of agreement, using a 5-point Likert ranging from "Totally disagree" to "Totally agree," on statements such as "The implementation team is working well together to implement GlobalConsent" and "My colleagues are devoting a lot of time and energy to maintain the collaboration of the implementation team.
**Measure:** Cultural Exchange Inventory
**Time Frame:** Baseline, month 15, month 18, and month 42
**Description:** For implementation team members only: The College Date Rape Attitude Survey (CDRAS), a measure intended to assess attitudes related to the risk of committing rape in adolescents and young adults, the CDRAS measures four rape-related attitudes: Entitlement, Blame Shifting, Traditional Roles, and Overwhelming Sexual Arousal. The CDRAS contains 20 items measuring attitudes toward date rape. All items require responses on a 5-point Likert scale. The responses for the attitude scale are strongly agree, agree, neutral, disagree, and strongly disagree. Scoring is reversed for appropriate items; so that high scores (5) always correspond to the most desirable (rape-related) responses.
**Measure:** College Date Rape Attitudes & Behaviors Scale
**Time Frame:** Baseline, month 15, month 18, and month 42
**Description:** This scale assesses respondents' attitudes towards sexual violence prevention programming by asking them to rate their level of agreement with 10 statements, such as "Implementing sexual violence prevention programming with students at our university is something I support," "...addresses a relevant problem among our students," "...would be easy for students to participate in." These statements will be rated using a 5-point Likert ranging from "Totally disagree" to "Totally agree."
Surveys will be provided to all groups at different time points as below:
* Students: quarterly for up to 28 months.
* Faculty: Baseline, 24 months, and 49 months
* Leaders: Baseline and 36 months
* Implementation Team: Baseline, month 15, month 18, and month 42
**Measure:** Acceptability, Feasibility, and Appropriateness of Programming to Prevent Sexually Violent Behavior among Students
**Time Frame:** Baseline and up to 49 months
**Description:** This scale assesses respondents' attitudes towards the GlobalConsent program specifically by asking them to rate their level of agreement or disagreement with 10 statements, such as "Implementing GlobalConsent with students at our university is something I support," "...addresses a relevant problem among our students," "...would be easy for students to participate in." these statements will be rated using a 5-point Likert ranging from "Totally disagree" to "Totally agree."
Surveys will be provided to all groups at different time points as below:
* Students: quarterly for up to 28 months.
* Faculty: Baseline, 24 months, and 49 months
* Leaders: Baseline and 36 months
* Implementation Team: Baseline, month 15, month 18, and month 42
**Measure:** Acceptability, Feasibility, and Appropriateness of GlobalConsent
**Time Frame:** Baseline and up to 49 months
**Description:** Knowledge of the law is assessed with 12 items where respondents indicate if they think the situations described are illegal (scored as 1), legal, but harmful (2), or legal and not harmful (3), with example items including "Forcing a person to have oral sex" and "Pressuring someone to have sex." Items will be re-coded such that responses indicating an accurate estimate or overestimate of the illegality and harms of sexual violence were coded as "1" and items indicating an underestimation of the illegality and harms of sexual violence were coded as "0".
Surveys will be provided to all groups at different time points as below:
* Students: quarterly for up to 28 months.
* Faculty: Baseline, 24 months, and 49 months
* Leaders: Baseline and 36 months
* Implementation Team: Baseline, month 15, month 18, and month 42
**Measure:** Sexual Violence Legality and Harm (Information about Sexual Activity)
**Time Frame:** Baseline and up to 49 months
**Description:** This form adapted the Sexual Consent Scale to ask respondents to rate their level of agreement with 12 statements about sexual consent using a 5-point Likert ranging from "totally disagree" to "totally agree". It includes statements such as "If a person consents for sex, one can continue sexual contact even if the person changes their mind," and "Obtaining consent for sex is just as necessary in a long-term relationship as in a new relationship."
Surveys will be provided to all groups at different time points as below:
* Students: quarterly for up to 28 months.
* Faculty: Baseline, 24 months, and 49 months
* Leaders: Baseline and 36 months
* Implementation Team: Baseline, month 15, month 18, and month 42
**Measure:** Active Consent (Information about Sexual Consent)
**Time Frame:** Baseline and up to 49 months
**Description:** This form is a combination of the Illinois Rape Myth Acceptance Scale and the College Date Rape Attitudes \& Behaviors Scale. This assesses attitudes towards sexual assault and rape by asking respondents to rate their level of agreement or disagreement with 15 statements using a 5-point Likert ranging from "totally disagree" to "totally agree". Statements include "If a woman dresses in a sexy dress, she is asking for sex," and "When guys rape, it is usually because of their strong desire for sex."
Surveys will be provided to all groups at different time points as below:
* Students: quarterly for up to 28 months.
* Faculty: Baseline, 24 months, and 49 months
* Leaders: Baseline and 36 months
* Implementation Team: Baseline, month 15, month 18, and month 42
**Measure:** Rejection of Rape Myths (Attitudes about Sexual Situations)
**Time Frame:** Baseline and up to 49 months
**Description:** This form assesses the perceptions of respondents in their university's faculty and leaders' potential response to sexual violence on their university campus. Questions ask about behaviors of abuse, sexual assault, and stalking, and their level of agreement or disagreement with whether faculty and leaders would believe a student reporting experiencing these behaviors, respect a student who reported experiencing these behaviors or admire a student intervening in these behaviors. Agreement is assessed using a 5-point Likert ranging from "totally disagree" to "totally agree"
Surveys will be provided to all groups at different time points as below:
* Students: quarterly for up to 28 months.
* Faculty: Baseline, 24 months, and 49 months
* Leaders: Baseline and 36 months
* Implementation Team: Baseline, month 15, month 18, and month 42
**Measure:** Perceptions of Campus Climate
**Time Frame:** Baseline and up to 49 months
**Description:** Students only: This form asks respondents' agreement or disagreement on 5 alcohol-related questions focusing on decision-making, behavior, and sexual violence. It assesses agreement or disagreement using a 5-point Likert ranging from "totally disagree" to "totally agree".
**Measure:** Alcohol Impairment Knowledge/Effects of Alcohol on Cognition
**Time Frame:** Baseline, quarterly up to 28 months
**Description:** Students only: Empathy for rape victims will be assessed with a modified version of the Rape Empathy Scale (RES). This assessment includes 10 items where participants were asked to choose between two statements, one of which reflected greater empathy towards rapists ("I understand the helplessness a rapist might feel during a rape since he cannot control his actions") and one of which reflected greater empathy towards victims ("I understand the helplessness a victim might feel during a rape"). Responses are scored as 1 (more empathy for victim) or 0 (more empathy for perpetrator) and total scores range from 0 to 10 where higher scores indicate more empathy towards rape victims.
**Measure:** Empathy for Rape Victims
**Time Frame:** Baseline, quarterly up to 28 months
**Description:** Students only: This is a 7-item scale measuring agreement or disagreement with statements focusing on sexual communication. Agreement and disagreement is assessed using a 5-point Likert ranging from "totally disagree" to "totally agree."
**Measure:** Sexual Communication Attitudes
**Time Frame:** Baseline, quarterly up to 28 months
**Description:** Students only: Bystander Self-Efficacy will be measured using the Bystander Efficacy Scale, which was developed for a project that evaluated the effectiveness of a sexual violence prevention program based on preventing antecedents to sexual violence by increasing prosocial bystander behavior. On this measure, participants are asked to indicate their confidence, on a 3-point scale, in performing each of 10 bystander behaviors (e.g., "Speak up to a guy who is making excuses for using physical force in a sexual relationship."). Scores are created by subtracting the mean of the 10 items from 100 to create a scale of perceived ineffectiveness; thus, higher scores indicate lesser effectiveness.
**Measure:** Bystander Self-Efficacy
**Time Frame:** Baseline, quarterly up to 28 months
**Description:** Students only: Readiness to Intervene will be measured using three intent-to-help subscales.
* Intent to Help Friend Scale: Sexual Abuse
* Intent to Help Friend Scale: Intimate Partner Violence Intent to help is an attitude that is related to bystander action. Participants will be asked how likely they are to take different bystander actions.
The second Intent to Help subscale focuses on participants' intent to help strangers in both sexual abuse and intimate partner abuse situations.
Responses range from 1 (not at all likely) to 5 (extremely likely). The average is calculated from the answers across the items to score this measure.
**Measure:** Bystander Intention to Intervene (Readiness to Intervene)
**Time Frame:** Baseline, quarterly up to 28 months
**Description:** Students only: Depression will be measured using the Patient Health Questionnaire 9 (PHQ-9): The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. The PHQ-9 is completed by the participant in minutes and is rapidly scored by a clinician. The PHQ-9 can also be administered repeatedly, which can reflect the improvement or the worsening of depression in response to treatment. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression.
**Measure:** Severity Measure for Depression
**Time Frame:** Baseline
**Description:** Students will complete the Generalized Anxiety Disorder 7-item (GAD-7), which is a quick and easy tool to help identify patients with anxiety and monitor treatment response. The GAD-7 has been validated as a diagnostic tool and a severity assessment scale. The scale consists of 7 items. The total score can range from 0 to 21, and it indicates the severity of anxiety as follows:
0 to 4: Minimal anxiety 5 to 9: Mild anxiety 10 to 14: Moderate anxiety 15 to 21: Severe anxiety
**Measure:** Generalized Anxiety Disorder
**Time Frame:** Baseline
**Description:** Students only: The Disability Assessment will be assessed by using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), which is a generic assessment instrument for health and disability used across all diseases, including mental, neurological and addictive disorders, applicable in both clinical and general population settings. It is a tool to measure the level of disability and functioning in six domains. The answers rate each question on a scale from 0 (none) to 4 (extreme or cannot do).
There are three scoring methods: simple score, complex score, or average score. The simple score is the sum of the ratings for each question. The complex score is the sum of the ratings multiplied by a weight factor. The average score is the mean of the ratings for each domain.
**Measure:** Disability Assessment and Schedule
**Time Frame:** Baseline
**Description:** Students only: The DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure-Adult is a tool designed to assess mental health domains that are important across various psychiatric diagnoses. It consists of 23 questions that evaluate 13 psychiatric domains, such as depression, anxiety, somatic symptoms, and more. Each item on the measure is rated on a 5-point scale (0=none or not at all; 1=slight or rare, less than a day or two; 2=mild or several days; 3=moderate or more than half the days; and 4=severe or nearly every day). A mild (i.e., 2) or greater rating on any item within a domain may guide additional inquiry and follow-up to determine if a more detailed assessment for that domain is necessary. Consistently high scores on a particular domain may indicate significant and problematic symptoms for the individual that might warrant further assessment, treatment, and follow-up
**Measure:** Diagnostic and Statistical Manual (DSM)-5 Cross Cutting Symptom Measure
**Time Frame:** Baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria for Students:
* 18-24 years old,
* Men who self-identify as heterosexual or bisexual (who are attracted to women),
* Enrolled as first-year students in any of the six participating study universities in North, Central, and South Vietnam.
Exclusion Criteria for Students:
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
Inclusion Criteria for Faculty:
* All registered lecturers at each of the six participating study universities will be eligible to participate in the climate surveys in years 1, 3, and 5.
Exclusion Criteria for Faculty:
* None
Inclusion Criteria for Leaders:
* Recommendation of study staff at each participating study university
* Knowledge about the implementation environment and implementation of GlobalConsent.
Exclusion Criteria for Leaders:
* None
Inclusion Criteria for Implementation Teams:
* Identified by relevant study staff.
Exclusion Criteria for Implementation Teams:
* None
**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:** Kathryn Yount, PhD
**Phone:** 404-727-8511
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Cần Thơ
**Country:** Vietnam
**Facility:** Can Tho University of Medicine and Pharmacy (CTUMP)
**Status:** RECRUITING
**Location 2:**
**City:** Da Nang
**Country:** Vietnam
**Facility:** Da Nang University of Medical Technology & Pharmacy (DUMTP)
**Status:** RECRUITING
**Location 3:**
**City:** Hanoi
**Contacts:**
***Contact 1:***
- **Name:** Tran Hung Minh, MD, MSc
- **Phone:** 0243 5770261
- **Role:** CONTACT
**Country:** Vietnam
**Facility:** Hanoi Medical University
**Status:** RECRUITING
**Zip:** 116001
**Location 4:**
**City:** Ho Chi Minh City
**Country:** Vietnam
**Facility:** Ho Chi Minh City Medicine and Pharmacy University
**Status:** NOT_YET_RECRUITING
**Location 5:**
**City:** Huế
**Country:** Vietnam
**Facility:** Hue University of Medicine and Pharmacy
**Status:** RECRUITING
**Zip:** 470000
**Location 6:**
**City:** Hải Phòng
**Country:** Vietnam
**Facility:** Hai Phong University of Medicine and Pharmacy
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Emory University
**Name:** Kathryn Yount, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Emory Dataverse for publicly available data and by reasonable request to the PI for any restricted data.
**Description:** The research team will share three waves of fully deidentified panel data with faculty; and 10 waves of fully deidentified panel data with students.
**Info Types:**
- STUDY_PROTOCOL
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** Data will be made available for sharing beginning 12 months after the publication of the primary aims papers or 12 months after the end of the performance period, whichever comes first.
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443528
**Brief Title:** Comparison of Lung Ultrasound Scores With Clinical Models for Predicting Bronchopulmonary Dysplasia：A Multi-center Prospective Cohort Study
**Official Title:** Comparison of Lung Ultrasound Scores With Clinical Models for Predicting Bronchopulmonary Dysplasia：A Multi-center Prospective Cohort Study
#### Organization Study ID Info
**ID:** jddyyy
#### Organization
**Class:** OTHER
**Full Name:** The First Hospital of Jilin University
### Status Module
#### Completion Date
**Date:** 2029-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The First Hospital of Jilin University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study aimed to fill this knowledge gap and designed a multicentre cohort study to verify the hypothesis that LUS has good reliability to predict BPD in China and to compare the predictive value of LUS and clinical models for the development of BPD at different time points in infants born before and after 28 weeks.
### Conditions Module
**Conditions:**
- Lung Ultrasound
- Bronchopulmonary Dysplasia
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 1620
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Diagnostic Test: lung ultrasound
**Label:** Preterm infants with GA <32 weeks
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Preterm infants with GA <32 weeks
**Description:** All enrolled infants underwent LUS examination performed by two ultrasound physicians. Monitoring included a complete lung scan in the first 24 hours of life (T0) and at day 3 (T1). All neonates underwent weekly ultrasound examinations until 36 weeks postmenstrual age (T2, T3...), so that the T2 scan was carried out at the end of the first week of life. LUS was performed according to a standardized protocol \[13\] when the neonate was in a quiet state, during routine clinical care to minimise discomfort. All ultrasound images and videos were digitally recorded, anonymised, and reviewed by a senior independent ultrasonographer blinded to patients' clinical information. Each lung was divided into three regions according to the anterior and posterior axillary lines and the mammary line. The regions were the upper-anterior, lower-anterior, and latera regions.
**Name:** lung ultrasound
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** The outcome was bronchopulmonary dysplasia, as defined by the NIH in 2001 and Jensen in 2019：（1）no BPD as not receiving supplemental oxygen (O2) for 28 days or at 36 weeks;mild BPD as receiving O2 for greater than or equal to 28 days but not at 36 weeks; moderate BPD as receiving O2 for greater than or equal to28 days plus treatment with less than 30% O2 at 36 weeks; and severe BPD as receiving O2 for greater than or equal to 28 days plus greater than or equal to 30% O2 or positive pressure at 36 weeks；（2）No BPD was defined as breathing in room air at 36 weeks' PMA; grade 1 BPD as receipt of nasal cannula ≤2L/min (or hood O2); grade 2 BPD as nasal cannula \>2L/min, nasal continuous positive airway pressure (CPAP), or nasal intermittent positive pressure ventilation;and grade 3 BPD as invasive mechanical ventilation
**Measure:** bronchopulmonary dysplasia
**Time Frame:** 2024.06.01-2027.06.30
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Preterm infants with GA \<32 weeks.
2. Infants with enrollment within 24 hours from birth
3. Parental written consent is obtained.
Exclusion Criteria:
1. Complex congenital malformations or chromosomal abnormalities
2. Congenital lung diseases or congenital heart defects
3. Infants with enrollment after 24 hours from birth
**Maximum Age:** 32 Weeks
**Minimum Age:** 0 Weeks
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** Infants who meet all of the inclusion and exclusion criteria will be included
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000055397
- Term: Ventilator-Induced Lung Injury
- ID: D000055370
- Term: Lung Injury
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000007235
- Term: Infant, Premature, Diseases
- ID: D000007232
- Term: Infant, Newborn, Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: All
- Name: All Conditions
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5273
- Name: Bronchopulmonary Dysplasia
- Relevance: HIGH
- As Found: Bronchopulmonary Dysplasia
- ID: M28143
- Name: Lung Injury
- Relevance: LOW
- As Found: Unknown
- ID: M28152
- Name: Ventilator-Induced Lung Injury
- 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: M25869
- Name: Premature Birth
- Relevance: LOW
- As Found: Unknown
- ID: M10279
- Name: Infant, Premature, Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10276
- Name: Infant, Newborn, Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T874
- Name: Bronchopulmonary Dysplasia
- Relevance: HIGH
- As Found: Bronchopulmonary Dysplasia
### Condition Browse Module - Meshes
- ID: D000001997
- Term: Bronchopulmonary Dysplasia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443515
**Acronym:** ARTE
**Brief Title:** Respiratory Trends During Blood Transfusions in Newborns.
**Official Title:** Evaluation of Respiratory Trends During Blood Transfusions in Newborns.
#### Organization Study ID Info
**ID:** 6438
#### Organization
**Class:** OTHER
**Full Name:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS
### Status Module
#### Completion Date
**Date:** 2026-01-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**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:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The prevalence of transfusion reactions is between 1 and 11% of transfusions. Most reactions are mild and do not pose a life-threatening risk to the patient. More serious problems may be the only manifestations that lead to suspicion of a transfusion reaction.
Most noninfectious transfusion reactions are immune-mediated. Two main types of reactions can be distinguished: TACO (transfusion associated cardiac overload, which is a cardiogenic pulmonary edema) and TRALI (transfusion related acute lung injury, non-cardiogenic pulmonary edema).
Although TRALI are diagnoses of exclusion, the presence of noncardiogenic pulmonary edema and respiratory problems in the vicinity of blood product transfusions should raise suspicion. Other signs of TRALI are hypotension and tachycardia, while in TACO arterial hypertension with positive water balance can be observed.
According to previous reports, the prevalence of transfusion reactions in the neonatal population is approximately 8%. Factors associated with these reactions are low birth weight and low gestational age. However, diagnostic criteria of respiratory transfusion reactions are not uniform across studies, and often the generic terms "acute lung injury" have been used.
Therefore, the primary objective of this study is to evaluate the respiratory trend during blood transfusions; secondary objectives are the study of risk factors for the development of respiratory worsening and the possible association with complications.
### Conditions Module
**Conditions:**
- Blood Transfusion Complication
- Blood Transfusion Associated Adverse Reactions
- Respiratory Complication
- Respiratory Morbidity
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 71
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All infants undergoing blood transfusions will be enrolled in the study
**Intervention Names:**
- Diagnostic Test: lung ultrasound
**Label:** study group
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- study group
**Description:** Lung ultrasound examinations will be performed within 6 hours before and after blood transfusion to assess interstitial-alveolar fluid retention and calculate a LUS score
**Name:** lung ultrasound
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** LUS score according to previous publications (Brat et al., 2015) will be calculated
**Measure:** Changes in lung ultrasound score (LUS score) before and after transfusions
**Time Frame:** within 6 hours before and after the transfusion
**Description:** non-invasive peripheral oxygen saturation/fraction of inspired oxygen (SFR) will be calculated from clinical charts: data validated by caregivers (primary nurses) will be extracted from the electronic charts to calculate this ratio
**Measure:** Changes in non-invasive peripheral oxygen saturation/fraction of inspired oxygen (SFR) before and after transfusions
**Time Frame:** within 6 hours before and after the transfusion
#### Secondary Outcomes
**Description:** MAP as displayed by ventilators will be recorded as median values
**Measure:** Changes in ventilatory parameters (mean airway pressure) for patients on nasal continuous positive airway pressure (nCPAP) or mechanical ventilation
**Time Frame:** within 6 hours before and after the transfusion
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* admitted newborns requiring blood transfusions as per local practice and/or international guidelines
Exclusion Criteria:
* newborns with major malformations
* need for palliative care
* lack of informed consent
**Maximum Age:** 1 Month
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Stefano Nobile, MD, PhD, MSc
**Phone:** +39 06 30151
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Stefano Nobile
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Roma
**Country:** Italy
**Facility:** Fondazione Policlinico Gemelli IRCCS
**Zip:** 00168
#### Overall Officials
**Official 1:**
**Affiliation:** Fondazione Policlinico Universitario A. Gemelli, IRCCS
**Name:** Stefano Nobile, MD, PhD, MSc
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M30490
- Name: Transfusion Reaction
- Relevance: HIGH
- As Found: Blood Transfusion Associated Adverse Reactions
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000065227
- Term: Transfusion Reaction
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443502
**Brief Title:** A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis
**Official Title:** An Open-label Single-Arm Phase 3 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Vedolizumab Intravenous in the Treatment of Pediatric Subjects With Active Chronic Pouchitis
#### Organization Study ID Info
**ID:** Vedolizumab-3041
#### Organization
**Class:** INDUSTRY
**Full Name:** Takeda
#### Secondary ID Infos
**Domain:** EU CT Number
**ID:** 2023-504773-20
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2029-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2029-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-25
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**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:** Takeda
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** When some people have their large bowel removed, a surgeon can make a "pouch" from part of the small bowel to connect it to the back passage (anus). Pouchitis is when the pouch becomes inflamed (swollen) or infected. The main aim of this study is to find out if vedolizumab improves pouchitis symptoms and pouch inflammation. Other aims include to find out if vedolizumab is well tolerated and if it causes any medical problems (adverse events or side effects) and to look for any changes in the well-being of participants during their treatment with vedolizumab.
Participants will receive up to 6 infusions of vedolizumab. First 3 infusions are in first 6 weeks (Day 1, Week 2 and Week 6). Participants who are getting benefit may continue with the treatment for up to 7.5 months (30 weeks) in total. After completing treatment with vedolizumab, participants will visit their clinic for a health check at Week 34. One final health check will be scheduled 4.5 months (18 weeks) after the last vedolizumab infusion.
Participants who continue to benefit from their treatment at the end of this study will be invited to continue treatment with vedolizumab in another clinical study (Vedolizumab-3042).
**Detailed Description:** The drug being tested in this study is called vedolizumab. This study will look at the efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity of vedolizumab in pediatric participants with active chronic pouchitis.
The study will enroll approximately 30 participants. All the participants will be enrolled in a single treatment group to receive treatment with vedolizumab along with ciprofloxacin, metronidazole, or other antibiotics based on participant's weight mentioned as follows:
* Participants with body weight greater than or equal to (\>=) 30 kilogram (kg) will receive vedolizumab, high dose
* Participants with body weight greater than (\>) 15 to less than (\<) 30 kg will receive vedolizumab, medium dose
* Participants with body weight 10 to 15 kg will receive vedolizumab, low dose
All participants will receive vedolizumab intravenous infusion at Day 1, Weeks 2, 6, 14, 22, and 30 along with concomitant antibiotic treatment from Day 1 through Week 2.
This multi-center trial will be conducted globally. The overall duration of the study is up to 57 weeks. Participants will be followed up for 18 weeks after the last dose of the study drug for safety.
### Conditions Module
**Conditions:**
- Pouchitis
**Keywords:**
- Drug Therapy
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Vedolizumab, high dose in participants with body weight \>=30 kg, medium dose in participants with body weight \>15 to \<30 kg and low dose in participants with body weight 10 to 15 kg, infusion, intravenously at Day 1, Weeks 2 and 6 during induction period and every 8 weeks (Q8W) at Weeks 14, 22 and 30 during maintenance period along with ciprofloxacin, metronidazole, vancomycin, amoxicillin clavulanate or rifaximin concomitant antibiotics, orally from Day 1 to Week 2 during induction period (unless intolerant or contraindicated).
**Intervention Names:**
- Drug: Vedolizumab
- Drug: Concomitant Antibiotic Therapy
**Label:** Vedolizumab
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Vedolizumab
**Description:** Vedolizumab intravenous infusion.
**Name:** Vedolizumab
**Other Names:**
- Entyvio
- MLN0002
- Kynteles
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Vedolizumab
**Description:** Ciprofloxacin, metronidazole, vancomycin, amoxicillin clavulanate or rifaximin.
**Name:** Concomitant Antibiotic Therapy
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Clinical (mPDAI) remission is defined as mPDAI score \<5 and a reduction of mPDAI score by \>=2 points from Baseline. The mPDAI score is calculated as a sum of two subscales based on clinical symptoms (0 to 6) and endoscopic findings (0 to 6): 1) Clinical Symptoms: Stool Frequency (0=usual postoperative stool frequency to 2=three or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare to 1=Present daily); Fecal urgency or abdominal cramps (0=None to 2=Usual), Fever (temperature \>37.8 degrees celsius \[C\]) (0=Absent and 1=Present); 2) Endoscopic Inflammation Findings: Edema (0=not present to 1=present); Granularity (0=not present to 1=present); Friability (0=not present to 1=present); Loss of vascular pattern (0=not present to 1=present); Mucous exudates (0=not present to 1=present); Ulcerations (0=not present to 1=present). The total mPDAI score can range from 0 to 12. A higher mPDAI score is indicative of worse disease.
**Measure:** Percentage of Participants Achieving Clinical Modified Pouchitis Disease Activity Index (mPDAI) Remission at Week 14
**Time Frame:** At Week 14
#### Secondary Outcomes
**Description:** Clinical (mPDAI) remission is defined as mPDAI score \<5 and a reduction of mPDAI score by \>=2 points from Baseline. The mPDAI score is calculated as a sum of two subscales based on clinical symptoms (0 to 6) and endoscopic findings (0 to 6): 1) Clinical Symptoms: Stool Frequency (0=usual postoperative stool frequency to 2=three or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare to 1=Present daily); Fecal urgency or abdominal cramps (0=None to 2=Usual), Fever (temperature \>37.8 degrees C) (0=Absent and 1=Present); 2) Endoscopic Inflammation Findings: Edema (0=not present to 1=present); Granularity (0=not present to 1=present); Friability (0=not present to 1=present); Loss of vascular pattern (0=not present to 1=present); Mucous exudates (0=not present to 1=present); Ulcerations (0=not present to 1=present). The total mPDAI score can range from 0 to 12. A higher mPDAI score is indicative of worse disease.
**Measure:** Percentage of Participants Achieving Clinical (mPDAI) Remission at Week 34
**Time Frame:** At Week 34
**Description:** PDAI remission is PDAI score \<7 and reduction of score by \>=3 points from Baseline. PDAI score calculated as sum of 3 subscales based on clinical symptoms (0-6), endoscopic findings (EF) (0-6), and histologic changes (0-6): 1)Clinical Symptoms: Stool Frequency (0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare,1=Present daily); Fecal urgency or abdominal cramps (0=None, 2=Usual),Fever (temperature\>37.8 degree C) (0=Absent,1=Present);2) EF Findings: Edema (0=not present, 1=present);Granularity (0=not present, 1=present); Friability (0=not present,1=present);Loss of vascular pattern (0=not present, 1=present); Mucous exudates (0=not present, 1=present);Ulcerations (0=not present,1=present);3) Acute Histologic Inflammation: Polymorphic nuclear leukocyte infiltration (0=None, 3=Severe+crypt abscess); Ulceration per low power field (mean) (0=0% to 3=\>50%). Total PDAI score ranges 0-18. Higher score means worse disease.
**Measure:** Percentage of Participants Achieving Pouchitis Disease Activity Index (PDAI) Remission at Weeks 14 and 34
**Time Frame:** At Weeks 14 and 34
**Description:** Clinical (mPDAI) response is defined as a reduction in mPDAI score by \>=2 points from baseline. The mPDAI score is calculated as a sum of two subscales based on clinical symptoms (0 to 6) and endoscopic findings (0 to 6): 1) Clinical Symptoms: Stool Frequency (0=usual postoperative stool frequency to 2=three or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare to 1=Present daily); Fecal urgency or abdominal cramps (0=None to 2=Usual), Fever (temperature \>37.8 degrees C) (0=Absent and 1=Present); 2) Endoscopic Inflammation Findings: Edema (0=not present to 1=present); Granularity (0=not present to 1=present); Friability (0=not present to 1=present); Loss of vascular pattern (0=not present to 1=present); Mucous exudates (0=not present to 1=present); Ulcerations (0=not present to 1=present). The total mPDAI score can range from 0 to 12. A higher mPDAI score is indicative of worse disease.
**Measure:** Percentage of Participants Achieving Clinical (mPDAI) Response at Weeks 14 and 34
**Time Frame:** At Weeks 14 and 34
**Description:** The mPDAI score is calculated as a sum of two subscales based on clinical symptoms (0 to 6) and endoscopic findings (0 to 6): 1) Clinical Symptoms: Stool Frequency (0=usual postoperative stool frequency to 2=three or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare to 1=Present daily); Fecal urgency or abdominal cramps (0=None to 2=Usual), Fever (temperature \>37.8 degrees C) (0=Absent and 1=Present); 2) Endoscopic Inflammation Findings: Edema (0=not present to 1=present); Granularity (0=not present to 1=present); Friability (0=not present to 1=present); Loss of vascular pattern (0=not present to 1=present); Mucous exudates (0=not present to 1=present); Ulcerations (0=not present to 1=present). The total mPDAI score can range from 0 to 12. A higher mPDAI score is indicative of worse disease.
**Measure:** Change From Baseline in Total (mPDAI) Score at Weeks 14 and 34
**Time Frame:** Baseline, Weeks 14 and 34
**Description:** The PDAI score calculated as sum of 3 subscales based on clinical symptoms (0-6), endoscopic findings (0-6), and histologic changes (0-6): 1)Clinical Symptoms: Stool Frequency (0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare,1=Present daily); Fecal urgency or abdominal cramps (0=None, 2=Usual),Fever (temperature\>37.8 degree C) (0=Absent,1=Present); 2) Endoscopic Findings: Edema (0=not present, 1=present);Granularity (0=not present, 1=present); Friability (0=not present,1=present);Loss of vascular pattern (0=not present, 1=present); Mucous exudates (0=not present, 1=present);Ulcerations (0=not present,1=present);3) Acute Histologic Inflammation: Polymorphic nuclear leukocyte infiltration (0=None, 3=Severe + crypt abscess); Ulceration per low power field (mean) (0=0 percentage \[%\] to 3=\>50%). Total PDAI score ranges 0-18. Higher score means worse disease.
**Measure:** Change From Baseline in Total PDAI Score at Weeks 14 and 34
**Time Frame:** Baseline, Weeks 14 and 34
**Description:** The PDAI Clinical Symptoms subscore is a sum of scores (0 to 6) from findings for stool frequency (0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare to 1=Present daily); Fecal urgency or abdominal cramps (0=None to 2=Usual), Fever (temperature\>37.8 degree C) (0=Absent to 1=Present). Higher scores are indicative of worse disease.
**Measure:** Change From Baseline in PDAI Clinical Symptoms Subscore at Weeks 14 and 34
**Time Frame:** Baseline, Weeks 14 and 34
**Description:** The PDAI Endoscopic Inflammation subscore is a sum of scores (0 to 6) from findings for Edema (0=not present to 1=present); Granularity (0=not present to 1=present); Friability (0=not present to 1=present); Loss of vascular pattern (0=not present to 1=present); Mucous exudates (0=not present to 1=present); Ulcerations (0=not present to 1=present). Higher scores are indicative of worse disease.
**Measure:** Change From Baseline in PDAI Endoscopic Subscore at Weeks 14 and 34
**Time Frame:** Baseline, Weeks 14 and 34
**Description:** The PDAI Acute Histologic Inflammation subscore is a sum score (0 to 6) from findings for Polymorphic nuclear leukocyte infiltration (0=None to 3=Severe + crypt abscess); Ulceration per low power field (mean) (0=0% to 3=\>50%). Higher scores are indicative of worse disease.
**Measure:** Change From Baseline in PDAI Acute Histologic Inflammation Subscore at Weeks 14 and 34
**Time Frame:** Baseline, Weeks 14 and 34
**Description:** The EQ-5D-Y (Proxy Version 1.1) is composed of two sections. The first section contains one question for each of the five dimensions: mobility, looking after myself, doing usual activities, having pain or discomfort, and feeling worried, sad, or unhappy. Participants select from three response levels (no problems, some problems, a lot of problems) for each dimension. A health state profile score can be calculated from the responses on these five dimensions. The index score ranges from 0 (0 indicating a health state equivalent to death) to 1 (indicating full health). Higher scores demonstrate higher health utility. The second section includes a visual analogue scale (EuroQol \[EQ\] visual analogue scale). The scale is scored from 0 (the worst) to 100 (the best imaginable health). The reference to a high score indicates a better outcome of quality of life.
**Measure:** EuroQol- 5 Dimension for Youth (EQ-5D-Y) Total Scores at Weeks 14 and 34
**Time Frame:** At Weeks 14 and 34
**Description:** The EQ-5D-Y (Proxy Version 1.1) is composed of two sections. The first section contains one question for each of the five dimensions: mobility, looking after myself, doing usual activities, having pain or discomfort, and feeling worried, sad, or unhappy. Participants select from three response levels (no problems, some problems, a lot of problems) for each dimension. A health state profile score can be calculated from the responses on these five dimensions. The index score ranges from 0 (0 indicating a health state equivalent to death) to 1 (indicating full health). Higher scores demonstrate higher health utility. The second section includes a visual analogue scale (EQ visual analogue scale). The scale is scored from 0 (the worst) to 100 (the best imaginable health). The reference to a high score indicates a better outcome of quality of life.
**Measure:** Change From Baseline in the EQ-5D-Y Scores at Weeks 14 and 34
**Time Frame:** Baseline, Weeks 14 and 34
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. The participant weighs \>=10 kg at the time of screening and first dose.
2. Has active chronic pouchitis, defined by a mPDAI score \>=5 assessed using the 3-day average of participant-reported clinical symptoms prior to the screening endoscopy (that is \[ie\] video pouchoscopy with biopsy) or bowel preparation for the endoscopy and a minimum mPDAI endoscopic subscore of 2 (outside the staple or suture line) and either:
* Has had \>=1 previous episodes of pouchitis within 1 year before the screening visit, with symptoms lasting at least 4 weeks treated with \>=2 weeks of antibiotic or other prescription therapy (ie, other antibiotics, probiotics, immunomodulators, or anti-tumor necrosis factor \[TNFs\] within 1 year before screening). Or
* Has had an inadequate response with, or lost response to, or are intolerant to antibiotic therapy (ie, requiring maintenance antibiotic therapy taken for \>=4 weeks immediately before the baseline endoscopy visit or not able to receive or continue antibiotic treatment due to intolerance or other contraindication).
Exclusion Criteria:
The exclusion criteria are divided into 3 categories: active chronic pouchitis exclusion criteria, infectious disease exclusion criteria, and general exclusion criteria.
Active Pouchitis Exclusion Criteria:
1. Has symptoms believed to be predominantly due to irritable pouch syndrome.
2. Has isolated cuffitis.
3. Is found to have dysplasia at the screening endoscopy.
4. Has mechanical complications of the pouch (for example \[e.g.\] pouch stricture or pouch fistula).
5. Currently requires or has a planned surgical intervention during the study.
6. Has a diverting stoma.
Infectious Disease Exclusion Criteria:
7. Has evidence of an active infection (e.g. sepsis, cytomegalovirus \[CMV\], or listeriosis) during screening.
8. Had a clinically significant infection (e.g. pneumonia, pyelonephritis, coronavirus disease 2019 \[COVID-19\]) within 35 days before first dose of study drug.
9. Has active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performed within 3 months of screening or during the screening period that is positive, as defined by:
* A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, or
* A TB skin test reaction \>=5 millimeter (mm). NOTE: If participant have received Bacillus Calmette-Guérin vaccine, then a QuantiFERON TB Gold test should be performed instead of the TB skin test.
NOTE: Participants with documented previously treated TB with a negative QuantiFERON test can be included in the study.
10. Has evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants (e.g. HBsAg negative and hepatitis B antibody positive) may, however, be included.
NOTE: If a participant tests negative for HBsAg, but positive for HBcAb, the participant would be considered eligible if the absence of HBV DNA is confirmed by HBV DNA polymerase chain reaction reflex testing performed in the central laboratory.
11. Has chronic hepatitis C virus (HCV) (ie, positive HCV antibody \[HCVAb\] and HCV Ribonucleic Acid \[RNA\]).
NOTE: Participants who are HCVAb-positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured \[defined as no evidence of HCV RNA at least 12 weeks before baseline\]).
12. Has any identified congenital or acquired immunodeficiency (e.g. common variable immunodeficiency, HIV infection, organ transplantation).
13. Has positive stool studies for ova and/or parasites or stool culture at screening visit.
14. Has positive Clostridium difficile stool test at screening visit.
General Exclusion Criteria:
15. Is taking, has taken, or is required to take any excluded medications.
16. Has active cerebral/meningeal disease, signs/symptoms, or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.
17. Has evidence of dysplasia or history of malignancy other than a successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
18. Has any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, GI, genitourinary, hematologic, coagulation, immunological, endocrine/metabolic, neurologic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise participant safety.
**Maximum Age:** 17 Years
**Minimum Age:** 2 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Takeda Contact
**Phone:** +1-877-825-3327
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Leuven
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Site Contact
- **Phone:** 3216343843
- **Role:** CONTACT
***Contact 2:***
- **Name:** Ilse Hoffman
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Belgium
**Facility:** UZ Leuven
**State:** Vlaams Brabant
**Zip:** 3000
**Location 2:**
**City:** Zagreb
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Site Contact
- **Phone:** 38514600291
- **Role:** CONTACT
***Contact 2:***
- **Name:** Iva Hojsak
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Croatia
**Facility:** Klinika Za Djecje Bolesti Zagreb
**State:** Grad Zagreb
**Zip:** 10000
**Location 3:**
**City:** Praha
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Site Contact
- **Phone:** 420234770260
- **Role:** CONTACT
***Contact 2:***
- **Name:** Katarina Mitrova
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Czechia
**Facility:** Fakultni nemocnice v Motole
**Zip:** 150 06
**Location 4:**
**City:** Athens
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Site Contact
- **Phone:** 306976062713
- **Role:** CONTACT
***Contact 2:***
- **Name:** Georgios Bamias
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Greece
**Facility:** General Hospital of Diseases Thoracos of Athens "Sotiria"
**State:** Attiki
**Zip:** 115 27
**Location 5:**
**City:** Jerusalem
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Site Contact
- **Phone:** 97226666482
- **Role:** CONTACT
***Contact 2:***
- **Name:** Dan Turner
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Israel
**Facility:** Shaare Zedek Medical Center
**State:** Yerushalayim
**Zip:** 9103102
**Location 6:**
**City:** Petach Tikvah
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Site Contact
- **Phone:** 97235305006
- **Role:** CONTACT
***Contact 2:***
- **Name:** Dror Shouval
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Israel
**Facility:** Schneider Childrens Medical Center of Israel Petah Tikvah PIN
**Zip:** 4920235
**Location 7:**
**City:** Napoli
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Site Contact
- **Phone:** 393333511152
- **Role:** CONTACT
***Contact 2:***
- **Name:** Caterina Strisciuglio
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Italy
**Facility:** AOU dell'Universita degli Studi della Campania Luigi Vanvitelli - Piazza Luigi Miraglia, 2
**State:** Campania
**Zip:** 80138
**Location 8:**
**City:** Trieste
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Site Contact
- **Phone:** 390403785380
- **Role:** CONTACT
***Contact 2:***
- **Name:** Matteo Bramuzzo
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Italy
**Facility:** IRCCS Materno Infantile Burlo Garofolo - INCIPIT - PIN
**State:** Friuli-Venezia Giulia
**Zip:** 34137
**Location 9:**
**City:** Roma
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Site Contact
- **Phone:** 390649979387
- **Role:** CONTACT
***Contact 2:***
- **Name:** Marina Aloi
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Italy
**Facility:** AOU Policlinico Umberto I-Viale Regina Elena, 324
**State:** Lazio
**Zip:** 00161
**Location 10:**
**City:** Roma
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Site Contact
- **Phone:** 390668591
- **Role:** CONTACT
***Contact 2:***
- **Name:** Simona Faraci
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Italy
**Facility:** IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN
**State:** Lazio
**Zip:** 00165
**Location 11:**
**City:** Genova
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Site Contact
- **Phone:** 390105636350
- **Role:** CONTACT
***Contact 2:***
- **Name:** Serena Arrigo
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Italy
**Facility:** Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
**State:** Liguria
**Zip:** 16147
**Location 12:**
**City:** Messina
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Site Contact
- **Phone:** 390902212918
- **Role:** CONTACT
***Contact 2:***
- **Name:** Claudio Romano
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Italy
**Facility:** Az Ospedaliera Universitaria Policlinico G Martino
**State:** Sicilia
**Zip:** 98124
**Location 13:**
**City:** Warszawa
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Site Contact
- **Phone:** 48500111648
- **Role:** CONTACT
***Contact 2:***
- **Name:** Jaroslaw Kierkus
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Poland
**Facility:** Instytut Pomnik Centrum Zdrowia Dziecka
**State:** Mazowieckie
**Zip:** 04-736
**Location 14:**
**City:** Krakow
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Site Contact
- **Phone:** 48126582011
- **Role:** CONTACT
***Contact 2:***
- **Name:** Malgorzata Sladek
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Poland
**Facility:** Collegium Medicum Uniwersytetu Jagiellonskiego
**Zip:** 30-663
**Location 15:**
**City:** Esplugues de Llobregat
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Site Contact
- **Phone:** 34932532100
- **Role:** CONTACT
***Contact 2:***
- **Name:** Francisco Javier Martin de Carpi
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Sant Joan de Deu - PIN
**State:** Barcelona
**Zip:** 08950
**Location 16:**
**City:** Valencia
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Site Contact
- **Phone:** 34669840927
- **Role:** CONTACT
***Contact 2:***
- **Name:** Ester Donat Aliaga
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Universitari i Politecnic La Fe de Valencia
**Zip:** 46026
#### Overall Officials
**Official 1:**
**Affiliation:** Takeda
**Name:** Study Director
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
**Description:** Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
**IPD Sharing:** YES
**URL:** https://vivli.org/ourmember/takeda/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007079
- Term: Ileitis
- ID: D000004751
- Term: Enteritis
- ID: D000005759
- Term: Gastroenteritis
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000007077
- Term: Ileal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M21404
- Name: Pouchitis
- Relevance: HIGH
- As Found: Pouchitis
- ID: M10127
- Name: Ileitis
- Relevance: LOW
- As Found: Unknown
- ID: M7913
- Name: Enteritis
- Relevance: LOW
- As Found: Unknown
- ID: M8875
- Name: Gastroenteritis
- 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: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10125
- Name: Ileal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000019449
- Term: Pouchitis
### Intervention Browse Module - Ancestors
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000005765
- Term: Gastrointestinal Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
### Intervention Browse Module - Browse Leaves
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: HIGH
- As Found: Ambient
- ID: M288641
- Name: Vedolizumab
- Relevance: HIGH
- As Found: Combines
- ID: M17388
- Name: Vancomycin
- Relevance: LOW
- As Found: Unknown
- ID: M11767
- Name: Metronidazole
- Relevance: LOW
- As Found: Unknown
- ID: M3995
- Name: Amoxicillin
- Relevance: LOW
- As Found: Unknown
- ID: M6176
- Name: Ciprofloxacin
- Relevance: LOW
- As Found: Unknown
- ID: M21710
- Name: Clavulanic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M21845
- Name: Amoxicillin-Potassium Clavulanate Combination
- Relevance: LOW
- As Found: Unknown
- ID: M4224
- Name: Antibiotics, Antitubercular
- Relevance: LOW
- As Found: Unknown
- ID: M1946
- Name: Rifaximin
- Relevance: LOW
- As Found: Unknown
- ID: M6204
- Name: Clavulanic Acids
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M8881
- Name: Gastrointestinal Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000000900
- Term: Anti-Bacterial Agents
- ID: C000543529
- Term: Vedolizumab
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443489
**Brief Title:** A Trial of SHR-4849 in Advanced Solid Tumors
**Official Title:** A Phase I ,Open-label, Multicenter Clinical Study to Evaluate the Safety, Tolerability , Pharmacokinetics and Efficacy of SHR-4849 in Patients With Advanced Solid Tumors
#### Organization Study ID Info
**ID:** SHR-4849-101
#### Organization
**Class:** INDUSTRY
**Full Name:** Suzhou Suncadia Biopharmaceuticals Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**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:** Suzhou Suncadia Biopharmaceuticals Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-4849 injection in Advanced Solid Tumors. To explore the reasonable dosage of SHR-4849 for Advanced Solid Tumors.
### Conditions Module
**Conditions:**
- Advanced Solid Tumors
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: SHR-4849
**Label:** SHR-4849
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- SHR-4849
**Description:** SHR-4849
**Name:** SHR-4849
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** DLT：the incidence of events associated with the investigational drug determined by the investigator during the observation period
**Time Frame:** up to 21 days
**Measure:** Incidence and severity of AE/SAE：According to NCI-CTCAE v5.0 evaluation criteria, from the signing of informed consent to the end of safety follow-up；
**Time Frame:** up to 24 months
**Measure:** MTD or MAD：after all subjects of dose escalation phase be enrolled，and all subjects complete at least one cycle of dosing observation.
**Time Frame:** up to 24 months
**Measure:** RP2D：after all subjects of dose escalation and dose expansion phase be enrolled，and all subjects complete at least one cycle of dosing observation.
**Time Frame:** up to 24 months
#### Secondary Outcomes
**Measure:** ORR： Objective Response Rate (ORR) as Assessed by investigators. The proportion of subjects whose best response was PR or CR according to RECIST1.1
**Time Frame:** up to 24 months
**Measure:** DCR：Disease Control Rate(DCR) as Assessed by investigators. the proportion of subjects whose best response was PR or CR or SD according to RECIST1.1
**Time Frame:** up to 24 months
**Measure:** DoR: Duration of Response (DOR) as Assessed by investigators according to RECIST1.1, Defined as the period of time from the first documented tumor response to the first documented objective progression or death of any cause.
**Time Frame:** up to 24 months
**Measure:** PFS: Progression-free Survival (PFS) as Assessed by investigators according to RECIST1.1. Defined as the time from the initiation of the first medication to tumor progression or death from any cause (whichever comes first)；
**Time Frame:** up to 24 months
**Measure:** OS: Overall Survival . Defined as the time from the initiation of the first medication to death from any cause.
**Time Frame:** up to 30 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Subject has provided informed consent prior to initiation of any study-procedures
2. Age from 18 to 75 years old at the time of signing the informed consent
3. Histologically or cytologically confirmed advanced solid tumors
4. At least one measurable lesion was identified per RECIST 1.1
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
6. Has a life expectancy of at least 3 months.
7. Adequate organ function
8. Subjects of both genders of child-bearing potential were required to use highly effective contraception from the time they provided written informed consent until 6 months after the last dose of the trial drug
Exclusion Criteria:
1. Subjects with active central nervous system (CNS) metastasis.
2. Subjects with a history of malignant tumors within 5 years prior to the first dose
3. Subjects with uncontrolled cancer pain.
4. Subjects with severe cardiovascular disease.
5. Subjects with clinically significant hemorrhage
6. Subjects with uncontrolled pleural effusion, peritoneal effusion and pericardial effusion
7. Subjects highly suspected of interstitial lung disease
8. Subjects with serious infection within 4 weeks prior to the first dose
9. Known history of human immunodeficiency virus (HIV)，active hepatitis B virus or hepatitis C virus infection.
10. The adverse events of previous antineoplastic therapy did not recover to NCI-CTCAE≤ grade 1
11. Subjects who received anti-cancer treatment within 4 weeks prior to the first dose
12. Subjects who received major surgery within 4 weeks prior to the first dose
13. Subjects who plan to receive or have received live vaccines within 28 days prior to the first dose.
14. Female subjects who were pregnant, lactating, or planned to become pregnant during the study period
15. Known allergic to any component of SHR-4849 products
16. Alcohol abuse, drug abuse, other serious medical conditions (including mental illness) requiring combined treatment, and other conditions that may affect subject safety or data collection.
17. Based on the investigator's judgment, subjects with other conditions that may affect study results, interfere with study procedures,
**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:** wei Hou
**Phone:** +86 18036618327
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Meshes
- ID: D000009369
- Term: Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443476
**Brief Title:** Tenting Abutment Technique Versus Screw"Tent-Pole" Technique for Augmentation of Posterior Atrophic Mandible
**Official Title:** A Comparative Study Between Tenting Abutment Technique Versus Screw"Tent-Pole" Technique for Augmentation of Posterior Atrophic Mandible Randomized Clinical Trial
#### Organization Study ID Info
**ID:** OMFS (3-3-5)
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2024-10-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-10-01
**Type:** ACTUAL
**Status Verified Date:** 2023-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**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:** Alaa Mohmmed Salem Hafedh
**Investigator Title:** PRINCIPLE INVESTIGATOR
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** To evaluate a novel method using a designed tenting abutment to reduce number of surgeries and the edentulous healing period is shortened. In addition, to prevent vertical and horizontal collapse of the bone graft and minimizes resorption of the bone graft during the healing the atrophic posterior mandible.
The tent pole provides excellent mechanical properties; stability \& fixation, yet very poor features to preserve the integrity of the soft tissue.
Using the tenting abutment technique will help preserve the soft tissue and decrease the amount of dehiscence that might accompany the use of the tent pole.
**Detailed Description:** Augmentation of insufficient bone volume can be brought about by different methods, including, particulate and block grafting materials, guided Bone Regeneration with or without growth and differentiation factors, ridge splitting, expansion and distraction osteogenesis, either alone or in combination. These techniques may be used for horizontal/vertical ridge augmentation.
Xenograft bone has been utilized for the reconstruction of large 3-dimensional defects because it has no donor site morbidity and is of an unlimited volume in quantity.
Guided bone regeneration (GBR) describes the use of membranes to regenerate bony defects. A membrane for GBR needs to be biocompatible, cell occlusive, non-toxic, moldable and possess space-maintaining properties including stability.
* e. Explanation for choice of comparators (conventional titanium mesh): Tent pole offers superb mechanical properties for guided bone regeneration treatment in larger areas and it is regarded one of the most available covers for guided bone regeneration yet one of the cheapest.
B. Objectives:
* a. Aim of the study:
* To evaluate the quantity of gained bone under tenting abutment compared to a tent pole.
* To evaluate amount of wound dehiscence postoperatively using tenting abutment technique compared to a tent pole.
* ·To optimize the anatomical situation in order to facilitate implant installation.
7b. Hypothesis:
* Bone is a dynamic and living tissue with the capacity to repair and regenerate in response to injury. It is further possible to guide bone cells into an area that previously consisted of bony tissue to regenerate bone and increase the bone volume.
* Tenting abutment is suitable as a biomaterial for creating a space between the bone cortex and the periosteum to enhance new bone regeneration.
* Tenting abutment material will enhance the quantity and quality of newly formed bone.
* Tenting abutment will cause less soft tissue dehiscence and will dramatically decrease the percentage of the collapse of the space produced by the bone graft and minimizes resorption of the grafting material compared to the titanium mesh.
7c. Primary and secondary objectives:
1. Primary objective:
Evaluate bone gained (height and width) and the period of time of healing in the atrophic posterior mandible when using tenting abutment technique compared to tent pole.
2. Secondary objectives:
Evaluation of soft tissue dehiscence and resorption of the grafting material that might occur using tent pole compared to the tenting abutment.
### Conditions Module
**Conditions:**
- Posterior Atrophic Mandible
**Keywords:**
- SANTA
- tent abutment
- Tent pole
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Evaluate bone gained (height and width) and the period of time of healing in the atrophic posterior mandible when using the tenting abutment technique compared to the tent pole
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 16
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Using a tent pole to gain bone in the atrophic posterior mandible.
**Intervention Names:**
- Procedure: Tent pole technique
**Label:** conventional group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Using a Tenting abutment to gain bone in the atrophic posterior mandible
**Intervention Names:**
- Procedure: Tenting abutment technique
**Label:** study group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- study group
**Description:** To evaluate a novel method using a designed tenting abutment to reduce number of surgeries and the edentulous healing period is shortened. In addition, to prevent vertical and horizontal collapse of the bone graft and minimizes resorption of the bone graft during the healing the atrophic posterior mandible.
**Name:** Tenting abutment technique
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- conventional group
**Description:** using the Tent pole technique to gain bone vertical and horizontal loss
**Name:** Tent pole technique
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** height gained and width gained Measure unit milimerter (mm) Measure device :CBCT
**Measure:** height gained and width gained
**Time Frame:** before and post operative four months
#### Secondary Outcomes
**Description:** measure clinically (yes-no)
**Measure:** Soft tissue dehiscence
**Time Frame:** after one month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with atrophic posterior mandible.
* Both sexes.
* No intraoral soft and hard tissue pathology.
* No systemic condition that contraindicates implant placement
Exclusion Criteria:
* Local criteria:
* Untreated gingivitis, periodontitis.
* Insufficient oral hygiene.
* Previous radiation therapy for the head and neck neoplasia, or bone augmentation to implant site..
Systemic criteria:
* Systemic disorders.
* Heavy smoking of more than 20 cigarettes per day.
* Bone pathology.
* ·Psychiatric problems. Emotional instability. Unrealistic aesthetic demands.
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** alaa Mohammed Hafedh, master
**Phone:** +201008164907
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Cairo
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Alaa Mohammed Hafedh, Master
- **Phone:** 01008164907
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Alaa Mohammed Hafedh
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** supervisor
**Name:** Mohamed ahmed Farid shehab, professor
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020763
- Term: Pathological Conditions, Anatomical
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4589
- Name: Atrophy
- Relevance: HIGH
- As Found: Atrophic
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001284
- Term: Atrophy
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443463
**Brief Title:** Long-term Safety and Tolerability of BHV-7000
**Official Title:** A Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy
#### Organization Study ID Info
**ID:** BHV7000-201
#### Organization
**Class:** INDUSTRY
**Full Name:** Biohaven Pharmaceuticals, Inc.
#### Secondary ID Infos
**ID:** 2023-508813-18-00
**Type:** CTIS
### Status Module
#### Completion Date
**Date:** 2027-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**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:** Biohaven Therapeutics Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy
### Conditions Module
**Conditions:**
- Focal Epilepsy
**Keywords:**
- Focal Epilepsy
- Epilepsy
- Seizure
- Refractory Epilepsy
- Partial Epilepsy
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 660
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: BHV-7000
**Label:** BHV-7000 50 mg
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: BHV-7000
**Label:** BHV-7000 75 mg
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- BHV-7000 50 mg
**Description:** BHV-7000 50 mg. Participants will take open-label investigational product (IP) once daily
**Name:** BHV-7000
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- BHV-7000 75 mg
**Description:** BHV-7000 75 mg. Participants will take open-label investigational product (IP) once daily
**Name:** BHV-7000
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Safety is assessed by the number of unique subjects with deaths, serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, moderate and severe AEs, and grade 3 and 4 laboratory abnormalities
**Measure:** To evaluate the safety and tolerability of BHV-7000
**Time Frame:** Up to 52 weeks
### Eligibility Module
**Eligibility Criteria:** Key Inclusion Criteria:
* Subjects who completed the double-blind phase (DBP) of prior parent study, BHV7000-302 or BHV7000-303.
* (FOCBP) Females of Child Bearing Potential must have a negative urine pregnancy test at the Baseline/Day 0 visit
Key Exclusion Criteria:
* Any condition, such as an ongoing AE with/without sequelae, or is poorly tolerating IP in the double-blind phase of the parent study, that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator.
* Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures
**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:** Chief Medical Officer
**Phone:** 203-404-0410
**Role:** CONTACT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M7983
- Name: Epilepsy
- Relevance: HIGH
- As Found: Epilepsy
- ID: M15452
- Name: Seizures
- Relevance: LOW
- As Found: Unknown
- ID: M7984
- Name: Epilepsies, Partial
- Relevance: HIGH
- As Found: Focal Epilepsy
- ID: M369
- Name: Drug Resistant Epilepsy
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004827
- Term: Epilepsy
- ID: D000004828
- Term: Epilepsies, Partial
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443450
**Brief Title:** [Trial of device that is not approved or cleared by the U.S. FDA]
**Official Title:** [Trial of device that is not approved or cleared by the U.S. FDA]
#### Organization Study ID Info
**ID:** SOF-005-P
#### Organization
**Full Name:** [Redacted]
### Status Module
**Delayed Posting:** True
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** WITHHELD
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Name:** [Redacted]
#### Responsible Party
**Old Name Title:** [Redacted]
**Old Organization:** [Redacted]
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443437
**Brief Title:** Effect of Bee-buzzy Vibrating Cold Application and Marionette Doll on Pain and Fear During Phlebotomy
**Official Title:** Effect of Bee-buzzy Vibrating Cold Application and Marionette Doll on Pain and Fear During Phlebotomy Among Preschool Children: A Randomized Controlled Study
#### Organization Study ID Info
**ID:** bee-buzzy&marionette doll
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**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:** Shimaa Hassan Khalf allah
**Investigator Title:** lecturer
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Non-pharmacological methods are often used as a creative strategy to reduce pain and fear in children during a painful procedure such as phlebotomy. In this context, external vibratory cold application and a marionette doll are a commonly used as non-pharmacological distraction method to reduce pain and fear. In the literature, there are studies with cold application, vibrating devices and a marionette doll in bee appearance therefor this study is aimed to evaluate the effect of bee-buzzy vibrating cold application and marionette doll on pain and fear during phlebotomy among preschool children.
**Detailed Description:** Pain is one of the negative experiences faced in pediatric patients due to various medical interventions and often causes fear and anxiety. Pain perception is affected by the child's age, cognitive development, communication skills, previous pain experiences, and pain beliefs. Severe and long-term pain resulting from interventions can cause behavioral and physiological problems. In this period, if the pain is not alleviated or eliminated with appropriate interventions, it may cause neurological and behavioral disorders in the future. Nurses are responsible for minimizing the pain felt by children exposed to painful interventions and helping them cope with it .
### Conditions Module
**Conditions:**
- Fear of Pain
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** FACTORIAL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** children who will receive bee-buzzy vibrating cold application
**Intervention Names:**
- Other: bee-buzzy vibrating cold application marionette doll
**Label:** study group 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** children who will receive marionette doll
**Intervention Names:**
- Other: bee-buzzy vibrating cold application marionette doll
**Label:** study group 2
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** children who will receive routine care
**Intervention Names:**
- Other: Rotuine care
**Label:** control group
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- study group 1
- study group 2
**Description:** * Bee-buzzy will be attached to the arm of the preschool child (who is included in the bee-buzzy group) by the researchers, where the phlebotomy will be performed on the child. It reduces pain through its cold wings and vibration. It helps to distract attention during phlebotomy and reduces the feeling of pain and fear. Bee-buzzy will be tied 5 cm above the area from which blood will be drawn, and after waiting for 15 seconds, the nurse will perform a phlebotomy.
* A marionette doll group; while the nurse is going to perform the phlebotomy operation on the preschool child, one of the researchers will try to distract the child by paly with marionette doll. The researchers will receive training in play therapy
**Name:** bee-buzzy vibrating cold application marionette doll
**Other Names:**
- marionette doll
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- control group
**Description:** children in control group will receive routine hospital are
**Name:** Rotuine care
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Facial expression rating scale (Wong-Baker Faces Pain Rating Scale). The Facial Expression Rating Scale includes 6 facial expressions and is a scale that provides a rating between 0 and 10 (Conlon, 2009; Huguet et al., 2010). Facial expressions range from"0" a smiling "brutal" face, 1-2 "It hurts a little", 3-4 "It hurts a little more", 5-6 "It hurts even more", 7-8 "It hurts a lot", and 9-10 "It hurts worst". This scale does not require words or numerical values and is a reliable and valid measurement tool in the assessment of acute pain. With this scale, the child's pain will be evaluated and recorded by both the nurse who will perform the phlebotomy and the parent.
**Measure:** child pain
**Time Frame:** during phlebotomy
#### Secondary Outcomes
**Description:** The "Children's Fear Scale" by McMurtry et al. (2011). This scale includes 5 different facial expressions. This scale is scored between 0 and 4 and it is stated to be a reliable and valid measurement tool in the evaluation of fear (McMurtry et al., 2011). The permission to use the scale was obtained by Binay and Bal Yılmaz (2019), and Turkish validity and reliability studies were conducted (Binay \& Bal Yılmaz, 2019; Binay \& Bal Yilmaz, 2022).
**Measure:** child fear
**Time Frame:** during phlebotomy
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. children and parents who agreed to participate in the study
2. children had successful phlebotomy in the first attempt.
Exclusion Criteria:
1. Children who are having a chronic disease
2. Mental disability or mental retardation
3. Taking analgesics in the last 24 hours
4. Undergone a surgical procedure,
5. Not having a successful phlebotomy on the first attempt,
6. The child and his/her family not being willing to participate in the study.
**Healthy Volunteers:** True
**Maximum Age:** 6 Years
**Minimum Age:** 3 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Shimaa H Khalf allah, post doctor
**Phone:** 01097248758
**Phone Ext:** 01124969115
**Role:** CONTACT
**Contact 2:**
**Name:** Atyat M Hassan, post doctor
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Assiut
**Contacts:**
***Contact 1:***
- **Name:** shimaa h khalf allah
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Assiut university children hospital
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Assiut university faculty of nursing
**Name:** Safaa R Osman, post doctor
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** Assiut university faculty of nursing
**Name:** . Nahed T Mohamed, post doctor
**Role:** STUDY_CHAIR
**Official 3:**
**Affiliation:** Assiut university faculty of nursing
**Name:** Amira H Abdelfatah, post doctor
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Yildirim BG, Gerceker GO. The Effect of Virtual Reality and Buzzy on First Insertion Success, Procedure-Related Fear, Anxiety, and Pain in Children during Intravenous Insertion in the Pediatric Emergency Unit: A Randomized Controlled Trial. J Emerg Nurs. 2023 Jan;49(1):62-74. doi: 10.1016/j.jen.2022.09.018. Epub 2022 Nov 12.
**PMID:** 36376127
**Citation:** Wang Y, Guo L, Xiong X. Effects of Virtual Reality-Based Distraction of Pain, Fear, and Anxiety During Needle-Related Procedures in Children and Adolescents. Front Psychol. 2022 Apr 19;13:842847. doi: 10.3389/fpsyg.2022.842847. eCollection 2022.
**PMID:** 35519646
**Citation:** Ugucu G, Akdeniz Uysal D, Guzel Polat O, Artuvan Z, Polat Kulcu D, Aksu D, Gulgun Altintas M, Cetin H, Orekici Temel G. Effects of cartoon watching and bubble-blowing during venipuncture on pain, fear, and anxiety in children aged 6-8 years: A randomized experimental study. J Pediatr Nurs. 2022 Jul-Aug;65:e107-e114. doi: 10.1016/j.pedn.2022.03.016. Epub 2022 Apr 8.
**PMID:** 35410736
**Citation:** Turgut MA, Turkmen AS. The effect of lighted toy on reducing pain and fear during blood collection in children between 3 and 6 years: A randomized control trial. J Pediatr Nurs. 2023 May-Jun;70:111-116. doi: 10.1016/j.pedn.2023.02.009. Epub 2023 Mar 9.
**PMID:** 36905910
**Citation:** McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
**PMID:** 21806301
**Citation:** Kuo HC, Pan HH, Creedy DK, Tsao Y. Distraction-Based Interventions for Children Undergoing Venipuncture Procedures: A Randomized Controlled Study. Clin Nurs Res. 2018 May;27(4):467-482. doi: 10.1177/1054773816686262. Epub 2016 Dec 30.
**PMID:** 28038497
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
### Condition Browse Module - Browse Leaves
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443424
**Brief Title:** Assessment of Pediatric Challenging Airway
**Official Title:** Preoperative Assessment of Pediatric Challenging Airway and Endotracheal Tube Sizing Using Point-of-Care Ultrasound Versus Traditional Methods in Elective Surgeries
#### Organization Study ID Info
**ID:** pocus in pediatric airway
#### Organization
**Class:** OTHER_GOV
**Full Name:** Zagazig University
### Status Module
#### Completion Date
**Date:** 2026-03-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Zagazig University
#### Responsible Party
**Investigator Affiliation:** Zagazig University
**Investigator Full Name:** Heba Helmy Elshair
**Investigator Title:** assistant lecturer of Anesthesia, Intensive care and PaiN Managment
**Type:** PRINCIPAL_INVESTIGATOR
### Description Module
**Brief Summary:** The goal of these Observational study is to learn about pediatric airway the main question to answer is:
1-Is using point-of-care ultrasound provide an easy, early, and accurate preoperative assessment of the challenging pediatric airway and sizing of the endotracheal tube using more than traditional methods.
### Conditions Module
**Conditions:**
- Airway Complication of Anesthesia
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 101
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 1 Day
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** usage of ultrasound device in pediatric airway asessment
**Name:** ultrasound device
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** estimate tubal size by ultasound parameters;distance from the skin to the anterior part of the trachea at the hyoid level (ANS-hyoid), The Anterior Neck Soft Tissue Thickness at the level of the vocal Cords. (ANS-VC), The pre - epiglottic space (Pre-E ), the distance from the epiglottis to the mid - point of the distance between the vocal cords (E-VC) , The subglottic transverse diameter and compare with age formula in pediatric
**Measure:** Estimation of tube size using point of care ultrasound compared to age formula in pediatric population
**Time Frame:** pre induction
#### Secondary Outcomes
**Description:** determine the accuracy of point of care ultrasound in assessing challenging pediatric airway in correlation to Cormack Lehane grading in pediatric patients
**Measure:** Determine the accuracy of point of care ultrasound in assessing challenging pediatric airway
**Time Frame:** pre induction
**Description:** ● To record any obstacles that may interfere with the ultrasound assessment such as: acoustic, anatomic , optical illusion artifact.
**Measure:** Record any obstacles that may interfere with the ultrasound
**Time Frame:** during opeartion
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 1) Patient's parents' consent. 2) Age:from one to 4 years old. 3) Both sexes (male and female). 4) BMI with in (5-85%) of body mass index of the child birth of same age and sex.
5) Physical status: American Society of Anesthesiologists (ASA) physical status I and II.
6) Type of operation: elective surgery under general anesthesia with endotracheal intubation
Exclusion Criteria:
* 1) Pre-existing airway malformations or pathology like facial or cervical fracture 2) Deformity of the airway anatomy \[by masses or tumors\]. 3) Pathology of the airway \[edema, burn and arthritis\]. 4) Anticipated difficult airway
**Healthy Volunteers:** True
**Maximum Age:** 4 Years
**Minimum Age:** 1 Year
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** pediatric population
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** heba elshair, M.B, B.Ch
**Phone:** +201064157744
**Phone Ext:** 002
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** alshaimaa kamel, MD
**Phone:** +201005593169
**Phone Ext:** 002
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Zagazig
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** heba elshair, M.B, B.Ch
- **Phone:** +201064157744
- **Phone Ext:** 002
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Faculty of Medicine
**State:** Sharkia
**Zip:** 44511
#### Overall Officials
**Official 1:**
**Affiliation:** Anesthesia, Intensive care and Pain Managment Department, Faculty of medicine, Zagazig university
**Name:** heba elshair, M.B, B.Ch
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
### References Module
#### References
**Citation:** Santillanes G, Gausche-Hill M. Pediatric airway management. Emerg Med Clin North Am. 2008 Nov;26(4):961-75, ix. doi: 10.1016/j.emc.2008.08.004.
**PMID:** 19059095
**Citation:** Brambrink AM, Braun U. Airway management in infants and children. Best Pract Res Clin Anaesthesiol. 2005 Dec;19(4):675-97. doi: 10.1016/j.bpa.2005.07.002.
**PMID:** 16408541
**Citation:** Litman RS, McDonough JM, Marcus CL, Schwartz AR, Ward DS. Upper airway collapsibility in anesthetized children. Anesth Analg. 2006 Mar;102(3):750-4. doi: 10.1213/01.ane.0000197695.24281.df.
**PMID:** 16492823
**Citation:** Krishna SG, Bryant JF, Tobias JD. Management of the Difficult Airway in the Pediatric Patient. J Pediatr Intensive Care. 2018 Sep;7(3):115-125. doi: 10.1055/s-0038-1624576. Epub 2018 Jan 28.
**PMID:** 31073483
**Citation:** Mirghassemi A, Soltani AE, Abtahi M. Evaluation of laryngoscopic views and related influencing factors in a pediatric population. Paediatr Anaesth. 2011 Jun;21(6):663-7. doi: 10.1111/j.1460-9592.2011.03555.x. Epub 2011 Mar 14.
**PMID:** 21401798
**Citation:** Lee SU, Jung JY, Kim DK, Kwak YH, Kwon H, Cho JH, Park JW, Choi YJ. New decision formulas for predicting endotracheal tube depth in children: analysis of neck CT images. Emerg Med J. 2018 May;35(5):303-308. doi: 10.1136/emermed-2017-206795. Epub 2018 Feb 6.
**PMID:** 29437848
**Citation:** Lin J, Bellinger R, Shedd A, Wolfshohl J, Walker J, Healy J, Taylor J, Chao K, Yen YH, Tzeng CT, Chou EH. Point-of-Care Ultrasound in Airway Evaluation and Management: A Comprehensive Review. Diagnostics (Basel). 2023 Apr 25;13(9):1541. doi: 10.3390/diagnostics13091541.
**PMID:** 37174933
**Citation:** Pan S, Lin C, Tsui BCH. Neonatal and paediatric point-of-care ultrasound review. Australas J Ultrasound Med. 2022 Oct 13;26(1):46-58. doi: 10.1002/ajum.12322. eCollection 2023 Feb.
**PMID:** 36960139
**Citation:** Sotoodehnia M, Khodayar M, Jalali A, Momeni M, Safaie A, Abdollahi A. Prediction of difficult laryngoscopy / difficult intubation cases using upper airway ultrasound measurements in emergency department: a prospective observational study. BMC Emerg Med. 2023 Jul 25;23(1):78. doi: 10.1186/s12873-023-00852-4.
**PMID:** 37491186
**Citation:** Sutagatti JG, Raja R, Kurdi MS. Ultrasonographic Estimation of Endotracheal Tube Size in Paediatric Patients and its Comparison with Physical Indices Based Formulae: A Prospective Study. J Clin Diagn Res. 2017 May;11(5):UC05-UC08. doi: 10.7860/JCDR/2017/25905.9838. Epub 2017 May 1.
**PMID:** 28658880
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443411
**Brief Title:** R&D of Non-invasive Innovative Intracranial Waves Monitoring System for Diagnostics and Treatment Monitoring of Patients With Normal Tension Glaucoma
**Official Title:** R&D of Non-invasive Innovative Intracranial Waves Monitoring System for Diagnostics and Treatment Monitoring of Patients With Normal Tension Glaucoma
#### Organization Study ID Info
**ID:** 2024-BE10-0001
#### Organization
**Class:** OTHER
**Full Name:** Lithuanian University of Health Sciences
### Status Module
#### Completion Date
**Date:** 2025-02-22
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2024-12-22
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-22
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Kaunas University of Technology
#### Lead Sponsor
**Class:** OTHER
**Name:** Lithuanian University of Health Sciences
#### Responsible Party
**Investigator Affiliation:** Lithuanian University of Health Sciences
**Investigator Full Name:** Ugne Kevalaite
**Investigator Title:** MD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Assessment and monitoring of intracranial pressure (ICP) changes are important in the management of cerebral pathologies. In the eye, ICP increase and decrease both correlate with optic neuropathies, the former because of papilledema and the latter related to glaucoma. While the relationship between ICP elevation and papilledema is well established, the relationship between low ICP and glaucoma is still poorly understood. So far, ICP monitoring is performed invasively, but this entails risks including infection, spurring the study of non-invasive alternatives. While none of currently methods in use can fully replace invasive techniques, certain measures show great potential for specific applications. In this context, monitoring the intracranial pressure changes of normal tension glaucoma may lead to a better understanding of how intracranial pressure waves vary in normal tension glaucoma. Treatment of normal tension glaucoma as a two-pressure disease needs periodic intracranial dynamic monitoring sessions for evaluation of treatment effectiveness and for needed corrections of treatment methodology.
Project aim is to be able to monitor the "missing link" of intracranial dynamics of patients with normal tension glaucoma according to circadian rhythm: in the morning, during lunch and in the evening. The opportunity to monitor ICP waves non-invasively for patients with normal tension glaucoma will be implemented for the first time by using novel non-invasive intracranial pressure waves real-time monitoring system invented by KTU team in 2022 (patent applications are in the process of registration in the EU and USA).
### Conditions Module
**Conditions:**
- Normal Tension Glaucoma
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 156
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The prospective clinical study will include at least 56 patients with NTG using non-invasive ICP waves monitoring system through a human eye orbit without applying external pressure to the eye with approximately 10 millisecond temporal resolution. It is a prospective longitudinal study of patients with normal tension glaucoma by the inclusion age from 25 to 65 years. The standard monitoring session will last 1-3 minutes. Sex: male and female. Exclusion criterion is documented neurodegenerative disorders.
**Intervention Names:**
- Other: Monitoring of cerebral hemodynamics
**Label:** Glaucoma group
#### Arm Group 2
**Description:** 100 healthy subjects using non-invasive ICP waves monitoring system through a human eye orbit without applying external pressure to the eye with approximately 10 millisecond temporal resolution.
**Intervention Names:**
- Other: Monitoring of cerebral hemodynamics
**Label:** Control group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control group
- Glaucoma group
**Description:** A specially designed pair of goggles will be put on the patient's head. The closed eyelids, along with the surrounding tissues, will be in contact with a thin, elastic, non-allergic film used to seal water filled inside the goggles. Pulse waves, including those originating from cerebrospinal fluid pulsation, will be transmitted from the eyelids to the water, where they will be detected by a pressure sensor and recorded with a laptop.
**Name:** Monitoring of cerebral hemodynamics
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Validation of non-invasive ICP waves real-time monitoring through a human eye orbit without applying external pressure to diagnose NTG with the required sensitivity and specificity to make treatment decisions.
**Measure:** A validated non-invasive ICP waves real-time monitoring technology
**Time Frame:** From 2024-04-22 till 2025-02-22
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 25-65 years of age.
* The patient, after reading the personal information form, confirms in writing his / her consent to participate in the study.
* The study group includes patients with a primary open-angle normal intraocular pressure glaucoma diagnosis confirmed by an ophthalmologist (typical glaucomatous changes in the optic nerve disc and eye area, open angle of the anterior chamber, intraocular pressure in the diurnal curve with/without anti-glaucoma medication ≤ 21 mmHg) and IOP ≤ 21mmHg on study day with/without anti-glaucoma medication.
* The control group includes healthy volunteers who do not suffer from glaucoma, acute or chronic uncompensated disease that may affect the results of the research, and according to age and anthropometric data correspond to the individuals of other research groups.
Exclusion Criteria:
* Patient's refusal to participate in biomedical research.
* Persons younger than 25 years or older than 65 years.
* A woman who may become pregnant, be pregnant or breastfeeding.
* The patient is allergic or sensitive to local anesthetics.
* Suffering from an eye disease that may distort the results of the study, if so decided by the examining physician.
* Patients who have had orbital or eye trauma.
* Patients who have undergone any eye surgery.
* Patients with acute or chronic, but currently aggravated, respiratory system disease.
* Patients with uncompensated cardiovascular diseases (II-III AV block or cardiogenic shock).
* Patients with uncompensated diabetes.
* Neurological diseases, mental illnesses identified in the anamnesis.
**Maximum Age:** 65 Years
**Minimum Age:** 25 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study will include patients treated at the Clinic of Eye Diseases, Hospital of Lithuanian UHS.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Kaunas
**Country:** Lithuania
**Facility:** Lithuanian University of Health Sciences
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009798
- Term: Ocular Hypertension
- ID: D000005128
- Term: Eye Diseases
- ID: D000009901
- Term: Optic Nerve Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M9013
- Name: Glaucoma
- Relevance: HIGH
- As Found: Glaucoma
- ID: M28692
- Name: Low Tension Glaucoma
- Relevance: HIGH
- As Found: Normal Tension Glaucoma
- ID: M10024
- Name: Hypertension
- Relevance: LOW
- As Found: Unknown
- ID: M12731
- Name: Ocular Hypertension
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12832
- Name: Optic Nerve Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005901
- Term: Glaucoma
- ID: D000057066
- Term: Low Tension Glaucoma
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443398
**Brief Title:** Spine of Caregivers of Children With Cerebral Palsy
**Official Title:** Evaluation of the Spine of Primary Caregivers of Children With Cerebral Palsy
#### Organization Study ID Info
**ID:** KAEU-T.ATAHAN-005
#### Organization
**Class:** OTHER
**Full Name:** Kirsehir Ahi Evran Universitesi
### Status Module
#### Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-31
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### 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
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study was to assess pain (rest, activity, and night pain using the Visual Analog Scale), disability (neck using the Neck Disability Index; lumbar using the Oswestry Disability Index), and curvature (cervical, thoracic, and lumbar using the Spinal Mouse) in primary caregivers of children with cerebral palsy.
### Conditions Module
**Conditions:**
- Cerebral Palsy
- Spine Deformity
**Keywords:**
- Primary Caregivers
- Pain
- Disability
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 127
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Primary caregivers with healthy children between the ages of 0-18 were included.
**Label:** Control Group
#### Arm Group 2
**Description:** Primary caregivers who had a child diagnosed with Cerebral Palsy between the ages of 0-18 and met the inclusion criteria were included.
**Label:** Study Group
### Outcomes Module
#### Primary Outcomes
**Description:** Parents' quality of life was measured using the Nottingham Health Profile. The scale has two parts. 0 represents the best health status, 100 the worst. Score on the scale and health status have an inverse relationship. As the score increases, the health status deteriorates.
**Measure:** Life Quality
**Time Frame:** 16 week
**Description:** Functional problems related to the neck were assessed using the Neck Disability Index. The scale has 10 items. There are 6 options in each item and each option is scored between 0 and 5 depending on the severity of the limitation. Although the total score of the survey varies between 0 and 50, a higher score indicates an increase in limitation.
**Measure:** Disability
**Time Frame:** 16 week
**Description:** Oswestry Disability Index was used to determine the degree of disability. The scale consists of a total of 10 items measuring the severity of pain, personal care, lifting, walking, sitting, standing, social life, sleeping, travel and pain degree. Each item is rated between 0-5. As the total score increases, the disability level increases. The maximum score is 50 points; Between 31 and 50 points is considered severe, between 11 and 30 points is considered moderate, and between 1 and 10 points is considered mild.
**Measure:** Disability
**Time Frame:** 16 week
**Description:** Spine evaluation was performed with a spinal mouse device. The device is a computer-aided electromagnetic device that can be held by hand and used to measure spinal mobility in various postures.
**Measure:** Spine
**Time Frame:** 16 week
#### Secondary Outcomes
**Description:** Sociodemographic information of the caregivers, such as name, surname, age, gender, height, weight, BMI, and educational status, were recorded.
**Measure:** Socio-demographic Form
**Time Frame:** 16 week
**Description:** The pain intensity of the patients was measured using the Visual Analogue Scale. The pain intensity score ranges from 0 to 10. An increase in the score indicates an increase in pain; a decrease in the score indicates a decrease in pain.
**Measure:** Pain Intensity
**Time Frame:** 16 week
**Description:** Gross Motor Function Classification System (Children with Cerebral Palsy are classified in 5 levels (1-5) according to their motor skills, functional abilities, assistive technology and wheelchair requirements)
**Measure:** Gross Motor Function Classification
**Time Frame:** 16 week
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Primary caregiver between the ages of 25-54
* Has a child diagnosed with Cerebral Palsy between the ages of 0-18
* Does not have inflammatory pain
* Without pain originating from abdominal-pelvic organs
* Volunteer caregivers were included
Exclusion Criteria:
* Having acute fracture and malignancy
* Had a surgical operation (related to spine disorders)
* Having a care burden for more than one disabled individual
* Caregivers with chronic illnesses (such as neurological, psychological disorders) were excluded
**Maximum Age:** 54 Years
**Minimum Age:** 25 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
**Study Population:** It was conducted with caregivers of children with Cerebral Palsy who were receiving physiotherapy at Kırşehir Training and Research Hospital Physical Therapy and Rehabilitation Center and who met the exclusion-inclusion criteria.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Atahan Turhan, PhD
**Phone:** +90 554 571 72 91
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Kırşehir
**Country:** Turkey
**Facility:** Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center
**Status:** RECRUITING
### 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: BC16
- Name: Diseases and Abnormalities at or Before Birth
- 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: M12
- Name: Congenital Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M13157
- Name: Paralysis
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- 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:** NCT06443385
**Brief Title:** E-mail Nudges for Prescribing Risky Drugs
**Official Title:** E-mails to Nudge Safer and Better-Informed Prescribing of Risky Drugs
#### Organization Study ID Info
**ID:** AAAV1928
#### Organization
**Class:** OTHER
**Full Name:** Columbia University
#### Secondary ID Infos
**Domain:** AEA RCT Registry (socialscienceregistry.org)
**ID:** AEARCTR-0013549
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2025-12-31
**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:** 2024-08-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Southern California
**Class:** OTHER
**Name:** Bowdoin College
**Class:** OTHER
**Name:** Abdul Latif Jameel Poverty Action Lab
**Class:** UNKNOWN
**Name:** Minnesota Management and Budget
**Class:** UNKNOWN
**Name:** Minnesota Board of Pharmacy
#### Lead Sponsor
**Class:** OTHER
**Name:** Columbia University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study will test e-mails to encourage engagement with the Minnesota prescription monitoring program (PMP/PDMP) and will evaluate the effect of these e-mails on PMP/PDMP use and controlled substance prescribing.
**Detailed Description:** Drug overdose deaths have skyrocketed in recent years, and many overdoses continue to involve prescribed medications like opioids and stimulants. At the same time, state prescription drug monitoring programs (PDMPs), which help clinicians prescribe these medications safely, remain underused. In Minnesota, 32% of opioid prescriptions are written by clinicians who do not use the PDMP. In many states, including Minnesota, policymakers have limited tools to raise PDMP use even though it is often required under state law. To address this policy dilemma, this study will test e-mails designed to facilitate PDMP use and evaluate their effects on PDMP use and controlled substance prescribing. This study will include a projected 7,126 physician and physician assistant prescribers of opioids and other controlled substances who lack active PDMP accounts, never query the PDMP, or query the PDMP infrequently relative to their prescribing volume. To generate evidence on clinician motivation for responding to encouragement, the study will randomly vary messaging to focus on legal requirements to use the PDMP vs. clinical benefits of the PDMP.
### Conditions Module
**Conditions:**
- Opioid Prescribing
- Prescription Drug Misuse
**Keywords:**
- opioids
- prescribing
- overprescribing
- prescription drug monitoring programs
- controlled substances
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Clinicians will be assigned at random to one of three arms: PDMP legal mandate e-mails, PDMP clinical benefit emails, or a control group.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 7126
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Behavioral: PDMP Legal Mandate E-mail
**Label:** Legal Mandate Messaging
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Behavioral: PDMP Clinical Benefit E-mail
**Label:** Clinical Benefit Messaging
**Type:** EXPERIMENTAL
#### Arm Group 3
**Label:** Control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Legal Mandate Messaging
**Description:** E-mails highlighting the state's legal requirements to use the PDMP. There will be one initial email and one follow-up email one month later.
**Name:** PDMP Legal Mandate E-mail
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Clinical Benefit Messaging
**Description:** E-mails highlighting the clinical benefits of having access to the PDMP and checking the PDMP before prescribing opioids. There will be one initial email and one follow-up email one month later.
**Name:** PDMP Clinical Benefit E-mail
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** An indicator for increased PDMP engagement during the 2-month period after the first e-mails were sent. It will indicate whether the level of engagement rose from the baseline level that resulted in the clinician's enrollment into the study. For clinicians who lacked an account, the outcome will indicate whether they created one; for clinicians with an inactive account, the outcome will indicate whether they reactivated it. For those who never searched, it will indicate any search, and for those who rarely searched, it will indicate whether their search rate rose.
**Measure:** Rate of PDMP Engagement
**Time Frame:** 2 months
**Description:** A composite of several measures of potentially guideline-discordant opioid prescribing. These will include:
1. Opioid co-prescriptions with other opioids
2. Opioid co-prescriptions with benzodiazepines, gabapentinoids, and stimulants
3. High daily opioid doses
4. Long-duration opioid prescriptions to opioid-naïve individuals
**Measure:** Volume of Potentially Guideline-discordant Opioid Prescribing
**Time Frame:** 2 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Minnesota physician or physician assistant
* Controlled substance prescriber not following state requirements to maintain an active PDMP account, or opioid prescriber not searching the PDMP or infrequently searching the PDMP
Exclusion Criteria:
* No e-mail address available
**Healthy Volunteers:** True
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Adam Sacarny, PhD
**Phone:** 914-715-0217
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Minneapolis
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Brock Reed, PharmD
- **Role:** CONTACT
**Country:** United States
**Facility:** Minnesota Board of Pharmacy
**State:** Minnesota
**Zip:** 55414
**Location 2:**
**City:** Saint Paul
**Country:** United States
**Facility:** Minnesota Management and Budget
**State:** Minnesota
**Zip:** 55155
**Location 3:**
**City:** New York
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Adam Sacarny, PhD
- **Phone:** 914-715-0217
- **Role:** CONTACT
**Country:** United States
**Facility:** Columbia University Irving Medical Center
**State:** New York
**Zip:** 10032
#### Overall Officials
**Official 1:**
**Affiliation:** Columbia University
**Name:** Adam Sacarny, PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** University of Southern California
**Name:** Mireille Jacobson, PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** Bowdoin College
**Name:** Tatyana Avilova, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000019966
- Term: Substance-Related Disorders
- 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: M1557
- Name: Drug Misuse
- Relevance: HIGH
- As Found: Drug Misuse
- ID: M30133
- Name: Prescription Drug Misuse
- Relevance: HIGH
- As Found: Prescription Drug Misuse
- ID: M21837
- Name: Substance-Related Disorders
- Relevance: LOW
- As Found: Unknown
- 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: D000076064
- Term: Drug Misuse
- ID: D000063487
- Term: Prescription Drug Misuse
### Intervention Browse Module - Ancestors
- ID: D000000962
- Term: Antimalarials
- ID: D000000981
- Term: Antiprotozoal Agents
- ID: D000000977
- Term: Antiparasitic Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: Analg
- Name: Analgesics
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
### Intervention Browse Module - Browse Leaves
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
- ID: M216702
- Name: RV 538
- Relevance: HIGH
- As Found: Eucalyptol
- ID: M4280
- Name: Antimalarials
- Relevance: LOW
- As Found: Unknown
- ID: M4298
- Name: Antiprotozoal Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4294
- Name: Antiparasitic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000033110
- Term: RV 538
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443372
**Brief Title:** GCF Bax and Bcl-xl Levels in Periodontitis
**Official Title:** Gingival Crevicular Fluid Levels of Apoptotic Regulatory Proteins Bax and Bcl-xl in Stage III Periodontitis
#### Organization Study ID Info
**ID:** Apoptosis
#### Organization
**Class:** OTHER
**Full Name:** Aydin Adnan Menderes University
### Status Module
#### Completion Date
**Date:** 2024-04-12
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2020-01-27
**Type:** ACTUAL
#### Start Date
**Date:** 2019-03-22
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Aydin Adnan Menderes University
#### Responsible Party
**Investigator Affiliation:** Aydin Adnan Menderes University
**Investigator Full Name:** Beral Afacan
**Investigator Title:** Assoc. Prof.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Intrinsic apoptosis pathway plays a critical role in the host immune defense and inflammation and its dysregulation is involved in various chronic diseases. Bcl-2 protein family primarly mediates this mitochondrial pathway. This study aimed to investigate the pro-apoptotic Bax and anti-apoptotic Bcl-xl levels and their association with interleukin-22 (IL-22) and transforming growth factor-beta 1 (TGF-β1) in gingival crevicular fluid (GCF) of patients with periodontitis. In total 75 systemically healthy and non-smoker individuals consisting of stage III periodontitis (n=23), gingivitis (n=26), periodontally healthy (n=26) were enrolled. Whole-mouth clinical periodontal measurements were recorded. Bax, Bcl-xl, IL-22 and TGF-β1 levels in GCF were determined by ELISA. Data were analyzed using non-parametric statistical tests.
**Detailed Description:** According to the 2017 World Workshop on the Classification of Periodontal and Peri-implant Diseases and Conditions, participants were categorized into three groups:
I. Periodontitis group (n=23), II. Gingivitis group (n=26) III. Periodontally healthy group (n=26)
Clinical periodontal measurements included probing depth (PD), clinical attachment loss (CAL), the dichotomous scoring of bleeding on probing (BOP +/-), gingival index (GI), and plaque index (PI). All clinical parameters were recorded at six points (mesiobuccal, buccal, distobuccal, mesiopalatal/mesiolingual, palatal/lingual, and distopalatal/distolingual) per tooth, except the 3rd molars, by a single investigator (C.Ö.) using a manual periodontal probe.
The percentage of radiographic bone loss (RBL) at the interproximal sites were calculated on the digital panoramic radiographs as the ratio of the distance between bone level and the cemento-enamel junction to the length of the root.
GCF samples were obtained 1 day following the clinical periodontal measurements. GCF was collected from the buccal aspects of non-contiguous interproximal sites in two single-rooted teeth via steril paper strips. Fluid samples were obtained from two deepest pockets in periodontitis group and the most inflamed sites with clinical signs of redness or edema in gingivitis group. In the periodontally healthy groups, samples were taken from the sites without visible inflammation. All samples were stored at -80 °C until further analysis.
Measurements of Bax, Bcl-xl, IL-22, and TGF-β1 levels in GCF samples were performed by the commercially available enzyme-linked immunosorbent assay (ELISA) kits. GCF molecule levels were expressed as total amounts at two samples per 30 s.
A statistical software package was used for all data analyses. The distribution of clinical and biochemical data was checked by Shapiro-Wilk's normality test. Since the data were not normally distributed, the differences between study groups in clinical measurements and GCF levels of Bax, Bcl-xl, IL-22, and TGF-β1 were compared by the Kruskal-Wallis non-parametric test with the Dunn-Bonferroni post hoc method. Spearman rank correlation analysis was performed to evaluate the correlations of four protein levels in GCF with clinical parameters. p\<0.05 was considered as statistically significant.
### Conditions Module
**Conditions:**
- Periodontitis
- Gingivitis
- Periodontal Health
### Design Module
#### Bio Spec
**Description:** Gingival crevicular fluid
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 75
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Periodontitis group (n = 23, generalized stage III) had interproximal CAL≥5 mm, along with PD≥6 mm and RBL extending to the mid-third of the root or beyond at 30% of the teeth or more. CAL was not originated from endodontic lesions draining through the marginal periodontium, dental caries extending into the cervical areas of the teeth, trauma-related gingival recession or distal bone loss in 2nd molars owing to extractions of 3rd molars. They had ≤4 teeth lost due to periodontitis.
**Intervention Names:**
- Other: Clinical periodontal measurements, GCF sampling
**Label:** Periodontitis
#### Arm Group 2
**Description:** Gingivitis group (n = 26) exhibited PD was ≤3 mm and BOP was ≥30% in the entire mouth as well as no detectable interproximal CAL or RBL.
**Intervention Names:**
- Other: Clinical periodontal measurements, GCF sampling
**Label:** Gingivitis
#### Arm Group 3
**Description:** Periodontally healthy controls (n = 26) had clinically healthy gingiva on intact periodontium with PD ≤3 mm and BOP \<10% and without detectable interproximal CAL and RBL.
**Intervention Names:**
- Other: Clinical periodontal measurements, GCF sampling
**Label:** Periodontal Health
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Gingivitis
- Periodontal Health
- Periodontitis
**Description:** Clinical periodontal measuements included PD, CAL, BOP (+/-), GI, and PI. Clinical recordings were performed at six points (mesiobuccal, buccal, distobuccal, mesiopalatal, palatal, and distopalatal) of all teeth, except the 3rd molars.
GCF samples were obtained 1 day following the clinical measurements. GCF was sampled with paper strips from two deepest pockets in periodontitis group; the most inflamed sites with clinical signs of redness or edema in gingivitis group; and the sites without visible inflammation in periodontally healthy group. GCF and saliva samples were stored at -80 °C until further analysis.
**Name:** Clinical periodontal measurements, GCF sampling
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Total amounts (ng)
**Measure:** GCF Bax levels
**Time Frame:** 24 hours after clinical periodontal measurements
**Description:** Total amounts (ng)
**Measure:** GCF Bcl-xl levles
**Time Frame:** 24 hours after clinical periodontal measurements
#### Secondary Outcomes
**Description:** Total amounts (ng)
**Measure:** GCF IL-22 levels
**Time Frame:** 24 hours after clinical periodontal measurements
**Description:** Total amounts (ng)
**Measure:** GCF TGF-β1 levels
**Time Frame:** 24 hours after clinical periodontal measurements
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* No history of smoking
* At least 18 natural teeth (excluding 3rd molars)
Exclusion Criteria:
* Being diagnosed with diabetes mellitus, rheumatoid arthritis, cardiovascular system diseases, endocrine, immunologic, and mucocutaneous disorders
* Use of antibiotics, antihypertensives immunosuppressive and anti-inflammatory drugs within the past 6 months and topical antiseptic solutions in the last 3 months
* Having periodontal treatment in the previous year
* Wearing removable partial dentures or orthodontic appliances
* Restorative and endodontic therapy requirements
* Pregnant or nursing women
**Healthy Volunteers:** True
**Maximum Age:** 48 Years
**Minimum Age:** 27 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
**Study Population:** This prospective case-control study consecutively enrolled 75 individuals (36 males and 39 females; aged 27 to 48 years; mean age, 37.30 ± 5.10 years) from the Department of Periodontology, School of Dentistry, Aydın Adnan Menderes University, Aydın, Turkey, in the period from March 2019 to January 2020.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Aydın
**Country:** Turkey
**Facility:** Adnan Menderes University, Faculty of Dentistry, Department of Periodontology
**Zip:** 09100
#### Overall Officials
**Official 1:**
**Affiliation:** Aydin Adnan Menderes University
**Name:** Beral Afacan
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000007239
- Term: Infections
- ID: D000005882
- Term: Gingival Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M13427
- Name: Periodontitis
- Relevance: HIGH
- As Found: Periodontitis
- ID: M9003
- Name: Gingivitis
- Relevance: HIGH
- As Found: Gingivitis
- 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
- 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
### Condition Browse Module - Meshes
- ID: D000005891
- Term: Gingivitis
- ID: D000010518
- Term: Periodontitis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443359
**Brief Title:** HYPOFRACTIONATED REGIONAL NODAL IRRADIATION IN BREAST CANCER
**Official Title:** HYPOFRACTIONATED REGIONAL NODAL IRRADIATION IN BREAST CANCER
#### Organization Study ID Info
**ID:** 2018-226
#### Organization
**Class:** OTHER
**Full Name:** William Beaumont Hospitals
### Status Module
#### Completion Date
**Date:** 2025-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2018-11-13
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** William Beaumont Hospitals
#### Responsible Party
**Investigator Affiliation:** William Beaumont Hospitals
**Investigator Full Name:** Joshua Dilworth
**Investigator Title:** MD, Radiation Oncology
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is a prospective clinical trial designed to evaluate the efficacy and safety of hypofractionated regional nodal irradiation in breast cancer patients. After enrollment, participants will be stratified into 2 Groups based on the extent of axillary surgery. Participants will complete activities and assessments at baseline, and after completion of treatment at 1-2 weeks, 3 months, 6 months, 1 year, 2 year, and 3 years following completion of treatment.
**Detailed Description:** This is a prospective clinical trial designed to evaluate the efficacy and safety of hypofractionated regional nodal irradiation in breast cancer patients. Participants are stratified into 2 Groups based on the extent of axillary surgery after enrollment.
Group 1: sentinel lymph node procedure with or without select removal of clipped (clinically involved) lymph nodes.
Group 2: axillary lymph node dissection (with or without sentinel lymph node procedure) or patients who have more than 5 sentinel lymph nodes removed will be stratified into group 2.
Participants will complete activities and assessments at baseline, and after completion of treatment at 1-2 weeks, 3 months, 6 months, 1 year, 2 year, and 3 years following completion of treatment. At baseline consultations, history and physical, lymphedema assessment, toxicity assessment, photographs (optional), patient-reported outcome questionnaire and radiation simulation will be completed. Hypofractionated radiation therapy will be completed weekly through the end of treatment with toxicity assessments. At the 1-2 week follow up, toxicity assessment, photographs (optional) and the patient-reported outcome questionnaire will be completed. At the 3 month, 6 month, 1 year, 2 year and 3 year follow-ups a lymphedema assessment, toxicity assessment, photographs (optional), patient-reported outcome questionnaire and follow up examination will be completed.
All patients will receive a dose of 42.56 Gy in 16 daily fractions to the whole breast or chest wall and regional lymph nodes. A boost dose of 10 or 12.5 Gy in 4 or 5 daily fractions of 2.5 Gy, respectively, will be administered to either the lumpectomy cavity or mastectomy scar, as appropriate. Critical organs will be contoured into the treatment planning such as the heart, left anterior descending artery, ipsilateral lung.
Patients may receive neoadjuvant or adjuvant systemic treatment on this trial. In general, the patient should receive systemic treatment according to the current standard of care at the time of enrollment, taking into account the discretion of the treating medical oncologist.
Expected radiation-related acute adverse events (i.e., those experienced within the first 6 months following treatment) are similar to those with conventionally fractionated radiotherapy and include fatigue and tenderness, pruritus, hyperpigmentation, hypopigmentation, dry desquamation, and moist desquamation of the skin. Potential late effects of radiation include arm lymphedema, shoulder stiffness, fibrosis of normal tissue, telangiectasia, hyperpigmentation, or hypopigmentation of the skin, brachial plexopathy, myositis, rib fracture, pneumonitis, second malignancy, or cardiomyopathy. The participants will be monitored for adverse events during radiotherapy and following radiotherapy.
### Conditions Module
**Conditions:**
- Breast Cancer
**Keywords:**
- lymphedema
- hypofractionated
- radiation therapy
### Design Module
#### Design Info
**Allocation:** NON_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:** Group 1: sentinel lymph node procedure with or without select removal of clipped (clinically involved) lymph nodes. Patients who have more than 5 sentinel lymph nodes removed will be stratified into group 2.
**Intervention Names:**
- Radiation: hypofractionated radiation
**Label:** Group 1: sentinel lymph node procedure with or without select removal of clipped lymph nodes
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Group 2: axillary lymph node dissection (with or without sentinel lymph node procedure). Patients who have more than 5 sentinel lymph nodes removed will be stratified into group 2.
**Intervention Names:**
- Radiation: hypofractionated radiation
**Label:** Group 2: axillary lymph node dissection
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group 1: sentinel lymph node procedure with or without select removal of clipped lymph nodes
- Group 2: axillary lymph node dissection
**Description:** All patients will receive a dose of 42.56 Gy in 16 daily fractions to the whole breast or chest wall and regional lymph nodes. A boost dose of 10 or 12.5 Gy in 4 or 5 daily fractions of 2.5 Gy, respectively, will be administered to either the lumpectomy cavity or mastectomy scar, as appropriate.
**Name:** hypofractionated radiation
**Type:** RADIATION
### Outcomes Module
#### Primary Outcomes
**Description:** Chronic arm lymphedema will be assessed at the 3 year follow up. Determination of chronic lymphedema will be based on measurements of arm circumference prior to radiation simulation and through the 3 year follow up visit. Clinically significant lymphedema is defined as a 10% or greater difference in ipsilateral arm, forearm, or both, compared to the contralateral side.
**Measure:** Number of participants with chronic arm lymphedema
**Time Frame:** 3 years post radiation therapy
#### Secondary Outcomes
**Description:** Recurrence will be determined based on the physical exam, imaging and routine follow up visits. This includes local recurrence (ipsilateral breast or chest wall tumor recurrence), regional recurrence (regional lymph nodes, including the ipsilateral axilla (levels 1-3), supraclavicular fossa, or internal mammary chain), locoregional recurrence (local or regional recurrence), and distant metastasis ( outside the ipsilateral breast or ipsilateral regional lymph nodes).
**Measure:** Number of participants with recurrence of cancer
**Time Frame:** 3 years post radiation therapy
**Description:** This is defined as the number of months participants experienced no locoregional recurrence or distant metastasis from completion date of radiation therapy until the date of progression. The date of progression will be defined as the date of initial suspicion for progression by physical exam or imaging studies.
**Measure:** Progress-free survival (months)
**Time Frame:** 3 years
**Description:** This is defined as the number of months participants survived from completion date of radiation therapy until the date of death. If a participant is alive, the participant censored at the date of last documentation of the patient being alive.
**Measure:** Overall survival (months)
**Time Frame:** 3 years
**Description:** Number of acute toxicities associated with radiation experienced by participants based on the follow-up assessments at 1-2 weeks, 3 months, 6 months following radiation therapy completion
**Measure:** Number acute toxicities
**Time Frame:** 6 months
**Description:** Number of chronic toxicities associated with radiation experienced by participants based on the follow-up assessments completed at 2 weeks, 3 months, 6 months and 12 months following radiation therapy
**Measure:** Number of chronic toxicities
**Time Frame:** 1 year
**Description:** This will be assessment for participants with an intact breast at baseline and at each follow up visit using the Harvard Breast Cosmesis scale. This is a 4-point Likert scale (poor - treated breast seriously distorted, Fair - treated breast clearly difference from untreated breast but not seriously distorted, Good - treated breast slightly different from untreated breast, Excellent - treated breast nearly identical to untreated breast). Cosmetic outcome will be assessed at 1-2 weeks, 3 months, 6 months, 1 year, 2 years, 3 years.
**Measure:** Cosmetic Outcome
**Time Frame:** 3 years
**Description:** The number of participants who experience lymphedema requiring intervention such as use of a compression sleeve. This will be determined based on completed follow up assessments.
**Measure:** Lymphedema requiring intervention
**Time Frame:** 3 years
**Description:** Quality of Life will be assessment using the Cancer Therapy - Breast Cancer (FACT-B) questionnaire. Participants will rate 37 statements on a scale of 0-4 (0 - not at all, 1 - a little bit, 2 - somewhat, 3 - quite a bit, 4 - very much). Negatively worded items are recoded so that a higher score indicates a better quality of life for all items. The FACT-B total score is the sum of scores of all five subscales, ranging from 0 (worst quality of life) to 148 (best quality of life).
**Measure:** Participant Perception of Quality of Life
**Time Frame:** 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Female
* Age ≥ 18 years old
* Life expectancy of \>5 years
* ECOG (Zubrod) performance status 0-1
* Histologically confirmed invasive carcinoma of the breast, including ductal, lobular, mammary, medullary, and tubular histologies
* Clinical T stage of cT0, cT1, cT2, or cT3
* Clinical N stage of cN0, cN1, or cN2a
* Clinical M stage of cM0Definitive surgery must be performed (either partial mastectomy or mastectomy without immediate reconstruction) with negative surgical margins (defined as no invasive tumor or DCIS on ink).
* Must have pathologic T stage of pT1, pT2, or pT3, or if receiving neoadjuvant chemotherapy, ypT0, ypTis, ypT1, ypT2, or ypT3
* Pathologic N stage of pN0, pN1, pN2a, or pN3a, or if receiving neoadjuvant chemotherapy, ypN0,ypN1, ypN2, or ypN3a) NOTE: any patient with clinically involved but undissected lymph nodes that would require a radiation boost will not be eligible.
* The radiation oncologist is planning to treat the breast/chest wall and ipsilateral regional lymphatics (including the axillary, supraclavicular, and internal mammary chains)
* Patient is able to understand and willing to sign an IRB approved written informed consent document
* All dosimetric constraints outlined in protocol section 3.5 can be met
Exclusion Criteria:
* Clinical or pathologic T4 disease, including inflammatory breast cancer
* Clinical N stage of cN2b, cN3 disease, pathologic N stage of pN2b, pN3b, or pN3c disease, or if receiving neoadjuvant chemotherapy, ypN2b, ypN3b, or ypN3c disease
* Radiologic evidence of gross residual disease
* History of prior ipsilateral breast cancer (invasive disease or DCIS)
* Active or history of another malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
* Prior history of radiation therapy to the neck, breast, or thorax. Prior radioactive oral iodine is permitted.
* History of active collagen vascular disease including systemic lupus erythematosis, scleroderoma, or dermatomyositis with an elevated CK level
* Pregnancy, active breast feeding, or refusal or inability to use highly effective means of contraception in participants of child-bearing potential.
* The patient is a prisoner.
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mary Martin, RN
**Phone:** 248-551-0439
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Dearborn
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mary Martin, RN
- **Phone:** 248-551-0439
- **Role:** CONTACT
**Country:** United States
**Facility:** Corewell Health William Beaumont University Hospital
**State:** Michigan
**Status:** RECRUITING
**Zip:** 48124
**Location 2:**
**City:** Royal Oak
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mary Martin
- **Phone:** 248-551-0439
- **Role:** CONTACT
**Country:** United States
**Facility:** Corewell Health William Beaumont University Hospital
**State:** Michigan
**Status:** RECRUITING
**Zip:** 48073
**Location 3:**
**City:** Troy
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mary Martin, RN
- **Phone:** 248-551-0439
- **Role:** CONTACT
**Country:** United States
**Facility:** Corewell Health William Beaumont University Hospital
**State:** Michigan
**Status:** RECRUITING
**Zip:** 48085
#### Overall Officials
**Official 1:**
**Affiliation:** William Beaumont Hospitals
**Name:** Joshua Dilworth, MD
**Role:** PRINCIPAL_INVESTIGATOR
## 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: BC15
- Name: Blood and Lymph Conditions
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M11206
- Name: Lymphedema
- 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:** NCT06443346
**Acronym:** PRESO
**Brief Title:** Prospective Registry of EoSinophilic esOphagitis
**Official Title:** Prospective Registry of EoSinophilic esOphagitis (PRESO)
#### Organization Study ID Info
**ID:** PRESO
#### Organization
**Class:** OTHER
**Full Name:** IRCCS San Raffaele
### Status Module
#### Completion Date
**Date:** 2044-12-31
**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:** 2034-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** IRCCS San Raffaele
#### Responsible Party
**Investigator Affiliation:** IRCCS San Raffaele
**Investigator Full Name:** Alberto Barchi
**Investigator Title:** Medical Doctor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This is a prospective registry of all the Eosinophilic Esophagitis (EoE) patients referred to the third level referral centre of San Raffaele Scientific Institute
**Detailed Description:** Primary objective of the study is to create a registry of all EoE patients with \> 18 years of age referring to the Motility and EoE Unit of San Raffaele Hospital, in order to register clinical, endoscopic and histologic data on the disease, to further design and propose future prospective or retrospective studies to increase disease knowledge and foster collaborations with other centers nationally and internationally
### Conditions Module
**Conditions:**
- Eosinophilic Esophagitis
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 1000
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 10 Years
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Eosinophilic Esophagitis patients with a proper diagnosis
**Name:** Eosinophilic Esophagitis
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** The prospective collection of histologic, endoscopic and clinical data on EoE patients
**Time Frame:** 10 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Participant is willing and able to give informed consent for participation in the study.
2. The medical product is the standard of care for the patient or the participant is taking the medicinal product according to clinical practice
3. Being diagnosed with EoE as per guidelines of the disease
Exclusion Criteria:
1. No clear diagnosis of EoE
2. Not willing to provide informed consent to the inclusion in the registry
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** EoE patients with a definite diagnosis according to the recent guidelines: \>15 eos HPF as peak eosinophils count in at least 1 esophageal location in presence of symptoms of esophageal disfunction, undergoing various treatment and subsequent follow-up visits and endoscopies
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Alberto Barchi, MD
**Phone:** +393348630784
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Furuta GT, Katzka DA. Eosinophilic Esophagitis. N Engl J Med. 2015 Oct 22;373(17):1640-8. doi: 10.1056/NEJMra1502863.
**PMID:** 26488694
**Citation:** Arias A, Perez-Martinez I, Tenias JM, Lucendo AJ. Systematic review with meta-analysis: the incidence and prevalence of eosinophilic oesophagitis in children and adults in population-based studies. Aliment Pharmacol Ther. 2016 Jan;43(1):3-15. doi: 10.1111/apt.13441. Epub 2015 Oct 28.
**PMID:** 26510832
**Citation:** Mansoor E, Cooper GS. The 2010-2015 Prevalence of Eosinophilic Esophagitis in the USA: A Population-Based Study. Dig Dis Sci. 2016 Oct;61(10):2928-2934. doi: 10.1007/s10620-016-4204-4. Epub 2016 Jun 1.
**PMID:** 27250980
**Citation:** Dellon ES, Peery AF, Shaheen NJ, Morgan DR, Hurrell JM, Lash RH, Genta RM. Inverse association of esophageal eosinophilia with Helicobacter pylori based on analysis of a US pathology database. Gastroenterology. 2011 Nov;141(5):1586-92. doi: 10.1053/j.gastro.2011.06.081. Epub 2011 Jul 14.
**PMID:** 21762663
**Citation:** Kottyan LC, Davis BP, Sherrill JD, Liu K, Rochman M, Kaufman K, Weirauch MT, Vaughn S, Lazaro S, Rupert AM, Kohram M, Stucke EM, Kemme KA, Magnusen A, He H, Dexheimer P, Chehade M, Wood RA, Pesek RD, Vickery BP, Fleischer DM, Lindbad R, Sampson HA, Mukkada VA, Putnam PE, Abonia JP, Martin LJ, Harley JB, Rothenberg ME. Genome-wide association analysis of eosinophilic esophagitis provides insight into the tissue specificity of this allergic disease. Nat Genet. 2014 Aug;46(8):895-900. doi: 10.1038/ng.3033. Epub 2014 Jul 13.
**PMID:** 25017104
**Citation:** Ma C, Schoepfer AM, Safroneeva E; COREOS Collaborators; COREOS Collaborators. Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS): An International Multidisciplinary Consensus. Gastroenterology. 2021 Sep;161(3):748-755. doi: 10.1053/j.gastro.2021.04.080. Epub 2021 May 20. No abstract available.
**PMID:** 34022180
**Citation:** Hahn JW, Lee K, Shin JI, Cho SH, Turner S, Shin JU, Yeniova AO, Koyanagi A, Jacob L, Smith L, Fond G, Boyer L, Lee SW, Kwon R, Kim S, Shin YH, Rhee SY, Moon JS, Ko JS, Yon DK, Papadopoulos NG. Global Incidence and Prevalence of Eosinophilic Esophagitis, 1976-2022: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3270-3284.e77. doi: 10.1016/j.cgh.2023.06.005. Epub 2023 Jun 17.
**PMID:** 37331411
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004935
- Term: Esophageal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005759
- Term: Gastroenteritis
- ID: D000004802
- Term: Eosinophilia
- ID: D000007960
- Term: Leukocyte Disorders
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000006969
- Term: Hypersensitivity, Immediate
- ID: D000006967
- Term: Hypersensitivity
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M8091
- Name: Esophagitis
- Relevance: HIGH
- As Found: Esophagitis
- ID: M28851
- Name: Eosinophilic Esophagitis
- Relevance: HIGH
- As Found: Eosinophilic Esophagitis
- 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
- ID: M8875
- Name: Gastroenteritis
- Relevance: LOW
- As Found: Unknown
- ID: M7961
- Name: Eosinophilia
- Relevance: LOW
- As Found: Unknown
- ID: M10963
- Name: Leukocyte Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10018
- Name: Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M10020
- Name: Hypersensitivity, Immediate
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T2089
- Name: Eosinophilic Gastroenteritis
- Relevance: HIGH
- As Found: Eosinophilic Esophagitis
### Condition Browse Module - Meshes
- ID: D000004941
- Term: Esophagitis
- ID: D000057765
- Term: Eosinophilic Esophagitis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443333
**Acronym:** NIDBase
**Brief Title:** National, Multicentric Registry Study on Neuroimmunological Diseases in China
**Official Title:** National, Multicentric Registry Study on Neuroimmunological Diseases in China
#### Organization Study ID Info
**ID:** XWZC20210115
#### Organization
**Class:** OTHER
**Full Name:** Xuanwu Hospital, Beijing
### Status Module
#### Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2020-12-01
**Type:** ACTUAL
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Xuanwu Hospital, Beijing
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this study is to establish a real-world clinical neuroimmune disease research cohort, to follow up and observe the prognosis of patients with different subtypes and subgroups, and to provide support for the treatment, early warning, and outcome prediction research of neuroimmune diseases.
**Detailed Description:** The purposes of this study are:(1)Establishing a clinical neuroimmune disease research cohort.(2)Collecting the blood, cerebrospinal fluid and other biological samples of the enrolled patients to discover and detect the new neural antibodies, so as to facilitate the diagnosis of related diseases.(3) Conducting in-depth exploration of the Genetic material of patients with neuroimmune diseases and healthy volunteers with second-generation sequencing technology, discovering the pathogenic genes and the mechanism of disease progression.The enrolled patients will be collected Clinical and therapeutic information. Blood and cerebrospinal fluid from the patients will be collected for sequencing analysis and antibody detection. They will also receive the 2-year follow-up with collection of basic clinical information, cognitive function, EDSS score, etc. Healthy volunteers will have their blood collected for sequencing analysis.
Finish the gene sequencing analysis of blood samples from enrolled patients and healthy volunteers to establish the disease gene database and the reference gene database of the healthy population and find the unique expression quantitative trait loci (eQTL) in China, so as to clarify the pathogenic genes and the key mechanism of neuroimmune disease occurrence and development.
### Conditions Module
**Conditions:**
- Multiple Sclerosis
- NMO Spectrum Disorder
- Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
- Myasthenia Gravis
- Autoimmune Encephalitis
- Acute Disseminated Encephalomyelitis
### Design Module
#### Bio Spec
**Description:** The biological samples of enrolled patients and healthy volunteers, such as blood and cerebrospinal fluid.
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** OTHER
#### Enrollment Info
**Count:** 7000
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 2 Years
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients diagnosed with neuroimmune diseases by a neurologist.
**Intervention Names:**
- Other: Data collection and follow-up observation
**Label:** neuroimmune diseases patient
#### Arm Group 2
**Description:** Healthy adults undergoing medical examinations at the Xuanwu Hospital Physical Examination Center.
**Intervention Names:**
- Other: Data collection
**Label:** Health Volunteers
### Interventions
#### Intervention 1
**Arm Group Labels:**
- neuroimmune diseases patient
**Description:** At the time of enrollment, the patient's biological samples are collected to obtain genetic information. Following enrollment, trained investigators carry out a 2-year follow-up observation through face-to-face, telephone call or online visits. During the follow-up, basic clinical information, laboratory tests, imaging examinations, neurophysiology, clinical classification, medication use, and scale assessments are collected.
**Name:** Data collection and follow-up observation
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Health Volunteers
**Description:** Collect demographic and genetic information from healthy volunteers upon enrollment.
**Name:** Data collection
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Whether there is recurrence in patients followed up at 12 and 24 months after enrollment
**Measure:** Annual recurrence rate
**Time Frame:** At 12 and 24 months after enrollment
#### Secondary Outcomes
**Description:** Change from baseline in Expanded Disability Status Scale scores (EDSS，range from 0 to 10 points, with a higher score indicating a more severe degree of neurological impairment).
**Measure:** Change in Expanded Disability Status Scale scores (EDSS)
**Time Frame:** At 6,12,18,24 months after enrollment
**Description:** whether there are New or enlarged lesions in T1WI, T2WI, T2 FLAIR, Sag bravo, DTI, and BOLD MRI of head, optic nerve and spinal cord in neuroimmune disease patients.
**Measure:** Change in MRI of head, optic nerve and spinal cord
**Time Frame:** At 6,12,18,24 months after enrollment
**Description:** Collect the patient's serum and cerebrospinal fluid to measure the types and concentrations of autoantibodies. Note any changes compared to the baseline.
**Measure:** Change in serum and CSF autoimmune antibody status
**Time Frame:** At 6,12,18,24 months after enrollment
**Description:** Change from baseline in Activity of Daily Living Scale (ADL, range from 14 to 56 points, with higher scores indicating poorer daily life abilities).
**Measure:** Change in Activity of Daily Living Scale (ADL)
**Time Frame:** At 6,12,18,24 months after enrollment
**Description:** Change from baseline in the relative power spectral density of the delta and theta bands in patients.
**Measure:** Change in the relative power spectral density
**Time Frame:** At 6,12,18,24 months after enrollment
**Description:** Change from baseline in Symbol Digit Modalities Test (SDMT, scores range from 0 to 110, with lower scores indicating more severe cognitive impairment).
**Measure:** Changes in Symbol Digit Modalities Test (SDMT)
**Time Frame:** At 6,12,18,24 months after enrollment
**Description:** Change from baseline in Montreal Cognitive Assessment Test (MoCA, scores range from 0 to 30, with lower scores indicating more severe cognitive impairment).
**Measure:** Changes in Montreal Cognitive Assessment Test (MoCA)
**Time Frame:** At 6,12,18,24 months after enrollment
**Description:** Change from baseline in Mini-Mental Status Exam (MMSE, scores range from 0 to 30, with lower scores indicating more severe cognitive impairment.)
**Measure:** changes in Mini-Mental Status Exam (MMSE)
**Time Frame:** At 6,12,18,24 months after enrollment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients who diagnosed at Xuanwu Hospital, Capital Medical University with any of the following conditions:
* Multiple Sclerosis (the criteria followed the Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria)
* NMO Spectrum Disorder (the criteria followed the Diagnosis and Treatment Guidelines for Optic Neuromyelitis Spectrum Disorders in China 2016)
* Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (the criteria followed the Consensus of Chinese Experts on Diagnosis and Treatment of Anti-Myelin Oligodendrocyte Glycoprotein Immunoglobulin G Antibody-Associated Diseases)
* Myasthenia Gravis (the criteria followed the Guidelines for the Diagnosis and Treatment of Myasthenia Gravis in China 2020)
* Autoimmune Encephalitis (the criteria followed the China Expert Consensus on Diagnosis and Treatment of Autoimmune Encephalitis 2017)
* Acute Disseminated Encephalomyelitis (the criteria are based on the article titled "Acute disseminated encephalomyelitis" 2007).
* Healthy adults who underwent a physical examination at the Physical Examination Center of Xuanwu Hospital, Capital Medical University
Exclusion Criteria:
* Women during pregnancy or lactation.
* Patients with other neurological diseases or serious mental diseases.
* Patients with serious liver and kidney function or other important organ dysfunction.
* Unable to cooperate with follow-up work and venous blood collection due to poor compliance of patients or healthy volunteers, or incomplete clinical and imaging data.
**Healthy Volunteers:** True
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Patients and healthy volunteers from China
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Junwei Hao, MD
**Phone:** 01083198277
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Junwei Hao, MD
- **Phone:** 01083198277
- **Role:** CONTACT
**Country:** China
**Facility:** Xuanwu Hospital ,Capital Medical University
**State:** Beijing
**Status:** RECRUITING
**Zip:** 100053
#### Overall Officials
**Official 1:**
**Affiliation:** Xuanwu Hospital, Beijing
**Name:** Junwei Hao, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020278
- Term: Demyelinating Autoimmune Diseases, CNS
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000003711
- Term: Demyelinating Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000090862
- Term: Neuroinflammatory Diseases
- ID: D000020361
- Term: Paraneoplastic Syndromes, Nervous System
- ID: D000009423
- Term: Nervous System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000010257
- Term: Paraneoplastic Syndromes
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000020511
- Term: Neuromuscular Junction Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000002494
- Term: Central Nervous System Infections
- ID: D000007239
- Term: Infections
- ID: D000009188
- Term: Myelitis, Transverse
- ID: D000009902
- Term: Optic Neuritis
- ID: D000009901
- Term: Optic Nerve Diseases
- ID: D000003389
- Term: Cranial Nerve Diseases
- ID: D000005128
- Term: Eye Diseases
- ID: D000056784
- Term: Leukoencephalopathies
- ID: D000094025
- Term: Post-Infectious Disorders
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC01
- Name: Infections
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12060
- Name: Multiple Sclerosis
- Relevance: HIGH
- As Found: Multiple Sclerosis
- ID: M15415
- Name: Sclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M7842
- Name: Encephalomyelitis
- Relevance: HIGH
- As Found: Encephalomyelitis
- ID: M12112
- Name: Myasthenia Gravis
- Relevance: HIGH
- As Found: Myasthenia Gravis
- ID: M7825
- Name: Encephalitis
- Relevance: HIGH
- As Found: Encephalitis
- ID: M12414
- Name: Neuromyelitis Optica
- Relevance: HIGH
- As Found: NMO Spectrum Disorder
- ID: M7836
- Name: Encephalomyelitis, Acute Disseminated
- Relevance: HIGH
- As Found: Acute Disseminated Encephalomyelitis
- ID: M22094
- Name: Autoimmune Diseases of the Nervous System
- Relevance: HIGH
- As Found: Autoimmune Encephalitis
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22098
- Name: Demyelinating Autoimmune Diseases, CNS
- Relevance: LOW
- As Found: Unknown
- ID: M6909
- Name: Demyelinating Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2803
- Name: Neuroinflammatory Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M13170
- Name: Paraneoplastic Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M22160
- Name: Paraneoplastic Syndromes, Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M12367
- Name: Nervous System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22297
- Name: Neuromuscular Junction Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5743
- Name: Central Nervous System Infections
- Relevance: LOW
- As Found: Unknown
- ID: M12142
- Name: Myelitis
- Relevance: LOW
- As Found: Unknown
- ID: M12143
- Name: Myelitis, Transverse
- Relevance: LOW
- As Found: Unknown
- ID: M12387
- Name: Neuritis
- Relevance: LOW
- As Found: Unknown
- ID: M12833
- Name: Optic Neuritis
- Relevance: LOW
- As Found: Unknown
- ID: M12832
- Name: Optic Nerve Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6605
- Name: Cranial Nerve Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M28591
- Name: Leukoencephalopathies
- 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: T3973
- Name: Myasthenia Gravis
- Relevance: HIGH
- As Found: Myasthenia Gravis
- ID: T554
- Name: Autoimmune Encephalitis
- Relevance: HIGH
- As Found: Autoimmune Encephalitis
- ID: T2673
- Name: Hashimoto Encephalopathy
- Relevance: HIGH
- As Found: Autoimmune Encephalitis
- ID: T4103
- Name: Neuromyelitis Optica Spectrum Disorder
- Relevance: HIGH
- As Found: NMO Spectrum Disorder
- ID: T165
- Name: Acute Disseminated Encephalomyelitis
- Relevance: HIGH
- As Found: Acute Disseminated Encephalomyelitis
- ID: T3988
- Name: Myelitis
- Relevance: LOW
- As Found: Unknown
- ID: T4263
- Name: Optic Neuritis
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004679
- Term: Encephalomyelitis
- ID: D000009157
- Term: Myasthenia Gravis
- ID: D000009103
- Term: Multiple Sclerosis
- ID: D000004660
- Term: Encephalitis
- ID: D000020274
- Term: Autoimmune Diseases of the Nervous System
- ID: D000009471
- Term: Neuromyelitis Optica
- ID: D000004673
- Term: Encephalomyelitis, Acute Disseminated
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443320
**Acronym:** VIDEOTSA
**Brief Title:** Evaluation of the Videodrama Therapeutic Device for Children With Autism Spectrum Disorders
**Official Title:** Evaluation of the Videodrama Therapeutic Device for Children With Autism Spectrum Disorders
#### Organization Study ID Info
**ID:** GHT_CHIRB 20220420
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Intercommunal Robert Ballanger
### Status Module
#### Completion Date
**Date:** 2027-03-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-03-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-12-04
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Centre Hospitalier Intercommunal Robert Ballanger
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Autism spectrum disorder (ASD) is a neurodevelopmental disorder (Valerie, Sperenza, 2009) that begins early in development, characterized by persistent deficits in communication and social interactions across various contexts and restricted, repetitive patterns of behavior, interests, or activities. These symptoms significantly impact social, school/professional functioning, or other important areas and are not better explained by intellectual disability or global developmental delay (American Psychiatric Association, 2013).
**Detailed Description:** Currently, managing children with ASD emphasizes compensating for communication and social interaction disabilities. Communication tools like PECS or Makaton and social skills groups have shown effectiveness but have limitations, particularly not addressing sensory atypicalities seen in children with ASD. These sensory atypicalities are evident when children watch videos on screens. The idea is to use video to understand the sensory experiences of children with ASD and help them move away from an isolated relationship with screens. New technologies can further isolate children with ASD in their autistic sphere. The hypothesis is that observing these children with screens will provide better understanding of their sensory experiences and improve therapeutic support towards play and interaction with others
### Conditions Module
**Conditions:**
- Autism Spectrum Disorder (ASD)
**Keywords:**
- autism
- videodrama
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Children participating in videodrama sessions, one per week for 9 sessions.
**Intervention Names:**
- Device: videodrama sessions
**Label:** Group of young ASD patients receiving videodrama sessions and interviews
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients included in the cohort will be managed as part of their routine care
**Label:** Cohort of ASD patients not receiving videodrama but receiving care in participating units
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group of young ASD patients receiving videodrama sessions and interviews
**Description:** Patients will benefit from videodrama sessions, one per week for 9 sessions
**Name:** videodrama sessions
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Sensory atypicality frequency will be assessed using the Dunn Sensory Profile questionnaire, describing child behavior in various sensory experiences
**Measure:** Dunn Sensory Profile questionnaire
**Time Frame:** 9 months
#### Secondary Outcomes
**Description:** Observe improvements in social skills (interaction and communication) in children with ASD, assessed by the Cars-T questionnaire,
**Measure:** Cars-T questionnaire
**Time Frame:** 9 months
**Description:** Observation of the emergence of a symbolic game. This emergence will be evaluated by the passation of the scenotest, a test which reveals the different modalities of integration of the game.
**Measure:** Sceno Test
**Time Frame:** 9 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Children aged 3 to 12 years.
* Clinically confirmed ASD by a psychiatrist.
* Parental or legal guardian consent for participation.
* Child showing a strong interest in screens and/or video content.
* Ability to tolerate the presence of other children.
* Minimum of 9 video drama sessions.
* Not having benefited from disease care in the past.
* Affiliation to a social security system
Exclusion Criteria:
* No ASD diagnosis.
* Younger than 3 or older than 12 at the study start.
* No interest in screens or video content.
* Parental or legal guardian refusal for participation.
* Dropping out before completing 9 sessions.
* Patient having benefited a disease care in the past
**Maximum Age:** 12 Years
**Minimum Age:** 3 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mathilde ZERR
**Phone:** 0182372332
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Constance LEMARCHAND
**Phone:** 0149367250
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Aulnays-sous-bois
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mathilde ZERR
- **Phone:** 0182372332
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Constance LEMARCHAND
- **Phone:** 01 49 36 72 50
- **Role:** CONTACT
***Contact 3:***
- **Name:** Virginie CRUVEILLER
- **Role:** SUB_INVESTIGATOR
**Country:** France
**Facility:** CHI Robert Ballanger
**Status:** RECRUITING
**Zip:** 93600
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000065886
- Term: Neurodevelopmental 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: M4623
- Name: Autistic Disorder
- Relevance: HIGH
- As Found: Autism
- ID: M206
- Name: Autism Spectrum Disorder
- Relevance: HIGH
- As Found: Autism Spectrum Disorder
- ID: M5903
- Name: Child Development Disorders, Pervasive
- Relevance: HIGH
- As Found: Autism Spectrum Disorder
- ID: M5902
- Name: Developmental Disabilities
- Relevance: LOW
- As Found: Unknown
- ID: M30644
- Name: Neurodevelopmental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001321
- Term: Autistic Disorder
- ID: D000067877
- Term: Autism Spectrum Disorder
- ID: D000002659
- Term: Child Development Disorders, Pervasive
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443307
**Brief Title:** Real-world Study to Evaluate the Efficacy and Safety of Liposome Irinotecan
**Official Title:** A Prospective, Multi-cohort, National Multicenter Real-world Study to Evaluate the Efficacy and Safety of Liposome Irinotecan
#### Organization Study ID Info
**ID:** CSPC-DEY-CRC-K02
#### Organization
**Class:** OTHER
**Full Name:** Peking University
### Status Module
#### Completion Date
**Date:** 2026-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-04
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Peking University
#### 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, multicenter, real-world study. There are four cohorts. Cohorts 1-3 include second-line, posterior-line, and neoadjuvant colorectal cancer patients, respectively. Cohort 4 include patients with the exception of those with pancreatic and colorectal cancer. As this study is a real-world investigation, treatment procedures, visit schedules, and examinations will be based on the routine clinical practice of physicians. Through the above cohort, the efficacy and safety of irinotecan liposome are comprehensively observed.
### Conditions Module
**Conditions:**
- Colorectal Cancer
- Solid Tumor
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 933
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Cohort 1 is a concurrent control design, including patients treated with irinotecan liposome (Nal-IRI) or irinotecan (IRI) plus fluorouracils as second-line treatment for metastatic colorectal cancer.
**Intervention Names:**
- Drug: Irinotecan Liposome
**Label:** Second-line treatment for colorectal cancer
#### Arm Group 2
**Description:** Cohort 2 is a Simon two-stage design, is planned to include patients who are treated with a NAL-IRI based combination regimen and have used IRI as a late-line treatment for metastatic colorectal cancer.
**Intervention Names:**
- Drug: Irinotecan Liposome
**Label:** Posterior line treatment of colorectal cancer
#### Arm Group 3
**Description:** Cohort 3 is a single-arm design and planned to enroll patients who received Nal-IRI+ oxaliplatin + fluorouracils as neoadjuvant chemotherapy for colorectal cancer.
**Intervention Names:**
- Drug: Irinotecan Liposome
**Label:** Neoadjuvant therapy for colorectal cancer
#### Arm Group 4
**Description:** Cohort 4 is a single-arm design and is planned to enroll patients who are treated with the NAL-IRI containing regimen as second-line or beyond treatment for nonpancreatic, noncolorectal cancers.
**Intervention Names:**
- Drug: Irinotecan Liposome
**Label:** Patients with non-pancreatic and non-colorectal cancer received second-line or above treatment
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Neoadjuvant therapy for colorectal cancer
- Patients with non-pancreatic and non-colorectal cancer received second-line or above treatment
- Posterior line treatment of colorectal cancer
- Second-line treatment for colorectal cancer
**Description:** The experimental group will collect data from patients treated with Nal-IRI as the chemotherapy regimen. It is recommended to use according to the label, clinical practice shall prevail.
**Name:** Irinotecan Liposome
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** To investigate the safety with Nal-IRI and IRI.
**Measure:** Incidence of grade ≥3 adverse events assessed by CTCAE 5.0 (Cohort 1)
**Time Frame:** Assessed except to 10 months.
**Description:** To investigate antitumor efficacy of Nal-IRI, proportion of patients with complete (CR) or partial response (PR) assessed by RECIST v1.1.
**Measure:** Objective response rate (Cohort 2 and 4)
**Time Frame:** From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months.
**Description:** To assess surgical conversion rates in patients who could be surgically resected.
**Measure:** R0 resection rate (Cohort 3)
**Time Frame:** From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months.
#### Secondary Outcomes
**Description:** To investigate antitumor efficacy of Nal-IRI, proportion of patients with complete (CR) or partial response (PR) assessed by RECIST v1.1.
**Measure:** Objective response rate (Cohort 1)
**Time Frame:** From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months.
**Description:** To investigate antitumor efficacy of Nal-IRI, proportion of patients with complete , partial or stable response (SD) assessed by RECIST v1.1.
**Measure:** Disease control rate (Cohort 1,2,4)
**Time Frame:** From initial medication to the date of first documented progression or end of medication.Assessed up to 6 months.
**Description:** To investigate antitumor efficacy of study. From initial medication to the date of first documented progression or end of medication, whichever came first.
**Measure:** Progression free survival (Cohort 1,2,4)
**Time Frame:** From initial medication to the date of first documented progression or date of death from any cause, whichever came first. Assessed up to 24 months.
**Description:** To investigate antitumor efficacy of Nal-IRI. From initial medication to the date of death from any cause.
**Measure:** Overall survival (Cohort 1,2,4)
**Time Frame:** From initial medication to the date of death from any cause. Assessed up to 42 months.
**Description:** To assess the incidence and severity of adverse events in combination regimens.
**Measure:** Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0 (Cohort 1,2,3,4)
**Time Frame:** Assessed except to 24 months.
**Description:** To investigate the effect of Nal-IRI.
**Measure:** Pathological complete response rate (Cohort 3)
**Time Frame:** After treatment and surgery, assessed up to 6 months.
**Description:** To investigate the effect of Nal-IRI.
**Measure:** Event-free survival (Cohort 3)
**Time Frame:** The time from enrollment to any event, including death, disease progression, or switch to a treatment, occurred first. Assessed up to 12 months.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Cohort 1:
* Patients with histologically or cytopathologically confirmed colorectal adenocarcinoma who were diagnosed with unresectable metastatic disease.
* Known to be pMMR/MSS or MMR/MS status unknown.
* Prior first-line systemic oxaliplatin - and fluorouracils-based therapy for metastatic disease progressed.
* Patients had not received IRI or Nal-IRI during the treatment phase of metastatic disease.
* Patients were scheduled to receive Nal-IRI plus fluorouracils or IRI plus fluorouracils chemotherapy regimens as second-line systemic therapy.
2. Cohort 2:
* Patients with histologically or cytopathologically confirmed colorectal adenocarcinoma who were diagnosed with unresectable metastatic disease;
* Known to be pMMR/MSS or MMR/MS status unknown.
* Patients had received ≤ 3 lines of previous treatment for metastatic disease.
* Progression of metastatic disease after treatment with an IRI-containing regimen (no limit on the number of IRI treatment lines).
* The patient had not previously received Nal-IRI and was scheduled to receive a systemic Nal-IRI containing chemotherapy regimen as palliative treatment.
* Have at least one measurable lesion according to RECIST v1.1.
3. Cohort 3:
* High-risk (CRS score 3-5) synchronous liver metastatic colorectal adenocarcinoma with ≤5 liver metastases, confirmed by histopathology or cytopathology, and planned resection.
* Known to be pMMR/MSS or MMR/MS status unknown.
* The patient was scheduled to receive Nal-IRI+ oxaliplatin + fluorouracils chemotherapy regimen as neoadjuvant therapy.
4. Cohort 4:
* Non pancreatic cancer and non colorectal cancer patients confirmed by histopathology and/or cytology.
* Have received at least one systemic treatment for unresectable diseases;
* Plan to receive a systemic treatment regimen containing Nal IRI;
* At least one measurable lesion (according to RECIST v1.1);
Exclusion Criteria:
Cohort 1-4:
* Treatment with an immune checkpoint inhibitor (e.g., pembrolizumab, nivolumab) was planned during chemotherapy.
* Allergy to irinotecan or liposomal irinotecan and its excipients is known.
* Female patients known to be pregnant or lactating.
* Other patients who were deemed by the investigator to be ineligible for enrollment.
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** This study was a prospective, multicenter real-world study with four cohorts. Cohort 1 include patients as second-line treatment for metastatic colorectal cancer. Cohort 2 include patients as a late-line treatment for metastatic colorectal cancer. Cohort 3 include patients as neoadjuvant chemotherapy for colorectal cancer.
Cohort 4 include patients as second-line or beyond treatment for nonpancreatic, noncolorectal cancers. Through the above cohort, the efficacy and safety of irinotecan liposome are comprehensively observed.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Lin Shen
**Phone:** 01088196561
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lin Shen, MD
- **Phone:** (86)10-88196561
- **Role:** CONTACT
***Contact 2:***
- **Name:** Lin Shen, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Jian Li, MD
- **Role:** SUB_INVESTIGATOR
**Country:** China
**Facility:** Beijing Cancer Hospital
**State:** Beijing
**Status:** RECRUITING
**Zip:** 100142
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: HIGH
- As Found: Colorectal Cancer
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: 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
### Condition Browse Module - Meshes
- ID: D000015179
- Term: Colorectal 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: M1674
- Name: Oxaliplatin
- Relevance: LOW
- As Found: Unknown
- ID: M1671
- Name: Irinotecan
- Relevance: HIGH
- As Found: Infection
- ID: M8600
- Name: Fluorouracil
- Relevance: LOW
- As Found: Unknown
- ID: M29349
- Name: Topoisomerase I Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### 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:** NCT06443294
**Brief Title:** Development of a Smoking Cessation Video Series
**Official Title:** Development of a Smoking Cessation Video Series
#### Organization Study ID Info
**ID:** IRB-23-10-6207
#### Organization
**Class:** OTHER
**Full Name:** Wayne State University
### Status Module
#### Completion Date
**Date:** 2024-10-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-10-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-25
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-25
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Wayne State University
#### Responsible Party
**Investigator Affiliation:** Wayne State University
**Investigator Full Name:** Michael Schmidt
**Investigator Title:** Graduate Student Researcher
**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 seeks to develop and test an internet video series aimed at helping individuals reduce cigarette smoking. Participants (daily smokers) will be asked to watch a series of six videos (approximately 6.5 minutes each) which cover various empirically-supported smoking cessation strategies and tools. Examples of strategies included in the videos include noticing smoking cues and consequences and relaxation training. Participants' demographic information, motivation to change, reactions to the video series alliance with video therapist, and confidence in avoiding smoking will all be measured. Additionally, participants will be asked to report their smoking behavior at study baseline and follow-up.
### Conditions Module
**Conditions:**
- Tobacco Use Cessation
- Tobacco Smoking
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants randomly assigned to this group will be provided access to the video intervention series.
**Intervention Names:**
- Behavioral: Smoking cessation video series.
**Label:** Video Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Label:** No-Video Group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Video Group
**Description:** The intervention in this study is a series of six videos totally approximately 40 minutes. These videos are led by a doctoral psychology student with experience in working with tobacco smokers. Videos utilize empirically-supported strategies for smoking cessation.
**Name:** Smoking cessation video series.
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Cigarettes smoked in past 30 days.
**Measure:** Smoking Quantity/Frequency
**Time Frame:** Measured at baseline and 30 days following completion of video series.
**Description:** Scale based on measure previously developed and used by PI of this study (Schmidt et al., 2023). Outcome explores participants' experience with and opinions of video intervention (e.g., video helpfulness, clarity, etc.).
**Measure:** Subjective Reactions to Video Series
**Time Frame:** Measured upon completion of video series, within 2 weeks of beginning study.
**Description:** Participants' belief in their ability to avoid smoking. SEQ-12: Etter et al., 2000)
**Measure:** Self-Efficacy Questionnaire
**Time Frame:** Measured upon completion of video series (within 2 weeks of beginning study) and at 30-day follow-up.
#### Secondary Outcomes
**Description:** Participants' sense of alliance with therapist leading video intervention. (WAI-I: Penedo et al., 2020).
**Measure:** The Working Alliance Inventory for Guided Internet Interventions
**Time Frame:** Measured upon completion of video series, within 2 weeks of beginning study.
**Description:** Participants' level of motivation to change smoking behavior measured using a stages of change ladder based in Motivational Interviewing principles.
**Measure:** Motivation to Quit Smoking (Change Ladder)
**Time Frame:** Measured upon completion of video series (within 2 weeks of beginning study) and one-month follow-up.
**Description:** Whether participants made a quit attempt during the course of the study. Measured using a single, "yes or no" item asking whether participants attempted to quit smoking in the past month.
**Measure:** Smoking Quit Attempt
**Time Frame:** Measured at 30-day follow-up.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Daily smoker
* Interested in reducing smoking
* Not currently enrolled in any smoking cessation program.
Exclusion Criteria:
* Not interested in reducing smoking
* Currently enrolled in a smoking cessation program.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Detroit
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Michael BR Schmidt, MA
- **Phone:** 734-780-4110
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Emily Grekin, PhD
- **Phone:** 313-577-2820
- **Role:** CONTACT
**Country:** United States
**Facility:** Wayne State University
**State:** Michigan
**Status:** RECRUITING
**Zip:** 48202
### IPD Sharing Statement Module
**Description:** Individual participant data is not planned to be shared with other researchers.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Abroms LC, Lee Westmaas J, Bontemps-Jones J, Ramani R, Mellerson J. A content analysis of popular smartphone apps for smoking cessation. Am J Prev Med. 2013 Dec;45(6):732-6. doi: 10.1016/j.amepre.2013.07.008.
**PMID:** 24237915
**Citation:** Burman A, Haeder SF, Xu WY. Provider directory inaccuracy and timely access for mental health care. Am J Manag Care. 2023 Feb;29(2):96-102. doi: 10.37765/ajmc.2023.89318.
**PMID:** 36811984
**Citation:** Grant S, Colaiaco B, Motala A, Shanman R, Booth M, Sorbero M, Hempel S. Mindfulness-based Relapse Prevention for Substance Use Disorders: A Systematic Review and Meta-analysis. J Addict Med. 2017 Sep/Oct;11(5):386-396. doi: 10.1097/ADM.0000000000000338.
**PMID:** 28727663
**Citation:** Guo YQ, Chen Y, Dabbs AD, Wu Y. The Effectiveness of Smartphone App-Based Interventions for Assisting Smoking Cessation: Systematic Review and Meta-analysis. J Med Internet Res. 2023 Apr 20;25:e43242. doi: 10.2196/43242.
**PMID:** 37079352
**Citation:** Lee EB, An W, Levin ME, Twohig MP. An initial meta-analysis of Acceptance and Commitment Therapy for treating substance use disorders. Drug Alcohol Depend. 2015 Oct 1;155:1-7. doi: 10.1016/j.drugalcdep.2015.08.004. Epub 2015 Aug 13.
**PMID:** 26298552
**Citation:** Magill M, Ray L, Kiluk B, Hoadley A, Bernstein M, Tonigan JS, Carroll K. A meta-analysis of cognitive-behavioral therapy for alcohol or other drug use disorders: Treatment efficacy by contrast condition. J Consult Clin Psychol. 2019 Dec;87(12):1093-1105. doi: 10.1037/ccp0000447. Epub 2019 Oct 10.
**PMID:** 31599606
**Citation:** Richardson CG, Vettese L, Sussman S, Small SP, Selby P. An investigation of smoking cessation video content on YouTube. Subst Use Misuse. 2011;46(7):893-7. doi: 10.3109/10826084.2011.570628.
**PMID:** 21599505
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443281
**Brief Title:** Pain Phenotyping in Patients With Neuropathic Pain After Spinal Cord Injury
**Official Title:** Pain Phenotyping in Patients With Neuropathic Pain After Spinal Cord Injury
#### Organization Study ID Info
**ID:** 2024-00134
#### Organization
**Class:** OTHER
**Full Name:** University of Zurich
### Status Module
#### Completion Date
**Date:** 2030-04-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2030-04-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-17
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-25
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Swiss National Science Foundation
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Zurich
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The development of neuropathic pain is one of the most debilitating sequels after a spinal cord injury (SCI). The overall aim of this study is to investigate potential underlying pathophysiological mechanisms of neuropathic pain after SCI. The functionality of the nociceptive pathway in humans as well as its plastic changes following SCI will be inferred with sophisticated sensory and pain phenotyping using quantitative sensory testing (i.e., psychophysical measures), objective neurophysiological measures of pain processing and the recording of pain-related autonomic responses (i.e., galvanic skin response, cardiovascular measures and pupil dilation). In addition, the interplay between the somatosensory and autonomic nervous system and its association with the development and maintenance of neuropathic pain after SCI will be investigated.
### Conditions Module
**Conditions:**
- Spinal Cord Injuries
- Pain, Neuropathic
- Nociceptive Pain
- Neuropathy
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Diagnostic Test: Neurophysiology
- Diagnostic Test: Cardiovascular test
- Diagnostic Test: Experimental pain paradigms
- Diagnostic Test: Quantitative sensory testing
- Diagnostic Test: Clinical pain phenotype
**Label:** Patients with spinal cord injury with neuropathic pain
#### Arm Group 2
**Intervention Names:**
- Diagnostic Test: Neurophysiology
- Diagnostic Test: Cardiovascular test
- Diagnostic Test: Experimental pain paradigms
- Diagnostic Test: Quantitative sensory testing
**Label:** Patients with spinal cord injury but without neuropathic pain
#### Arm Group 3
**Intervention Names:**
- Diagnostic Test: Neurophysiology
- Diagnostic Test: Cardiovascular test
- Diagnostic Test: Experimental pain paradigms
- Diagnostic Test: Quantitative sensory testing
- Diagnostic Test: Clinical pain phenotype
**Label:** Patients with peripheral neuropathy
#### Arm Group 4
**Intervention Names:**
- Diagnostic Test: Neurophysiology
- Diagnostic Test: Cardiovascular test
- Diagnostic Test: Experimental pain paradigms
- Diagnostic Test: Quantitative sensory testing
**Label:** Healthy subjects
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Healthy subjects
- Patients with peripheral neuropathy
- Patients with spinal cord injury but without neuropathic pain
- Patients with spinal cord injury with neuropathic pain
**Description:** Pain-related evoked potentials and nerve conduction studies
**Name:** Neurophysiology
**Type:** DIAGNOSTIC_TEST
#### Intervention 2
**Arm Group Labels:**
- Healthy subjects
- Patients with peripheral neuropathy
- Patients with spinal cord injury but without neuropathic pain
- Patients with spinal cord injury with neuropathic pain
**Description:** Blood pressure control, orthostatic intolerance test, baro-reflex sensitivity, heart-rate variability
**Name:** Cardiovascular test
**Type:** DIAGNOSTIC_TEST
#### Intervention 3
**Arm Group Labels:**
- Healthy subjects
- Patients with peripheral neuropathy
- Patients with spinal cord injury but without neuropathic pain
- Patients with spinal cord injury with neuropathic pain
**Description:** Temporal summation of pain, conditioned pain modulation
**Name:** Experimental pain paradigms
**Type:** DIAGNOSTIC_TEST
#### Intervention 4
**Arm Group Labels:**
- Healthy subjects
- Patients with peripheral neuropathy
- Patients with spinal cord injury but without neuropathic pain
- Patients with spinal cord injury with neuropathic pain
**Description:** Thermal and mechanical sensory testing
**Name:** Quantitative sensory testing
**Type:** DIAGNOSTIC_TEST
#### Intervention 5
**Arm Group Labels:**
- Patients with peripheral neuropathy
- Patients with spinal cord injury with neuropathic pain
**Description:** Pain drawings, plus and minus signs of pain
**Name:** Clinical pain phenotype
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Pain drawings, plus and minus signs of pain
**Measure:** Spinal cord injury patients: clinical pain phenotype including the spatial pain extent and pain intensity
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Pain drawings, plus and minus signs of pain
**Measure:** Spinal cord injury patients: clinical pain phenotype including the spatial pain extent and pain intensity
**Time Frame:** Cross-sectional: once in a chronic stage (1 year post-injury)
**Description:** Pain drawings, plus and minus signs of pain
**Measure:** Patients with peripheral neuropathy: clinical pain phenotype including the spatial pain extent and pain intensity
**Time Frame:** Cross-sectional: once in a chronic stage (1 year post-injury)
#### Secondary Outcomes
**Description:** Amplitude in uV
**Measure:** Spinal cord injury patients / healthy controls: somato-sensory evoked potentials
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Latency in ms
**Measure:** Spinal cord injury patients / healthy controls: somato-sensory evoked potentials
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Amplitude in uV
**Measure:** Spinal cord injury patients / healthy controls: contact-heat evoked potentials
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Latency in ms
**Measure:** Spinal cord injury patients / healthy controls: contact-heat evoked potentials
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Amplitude in uV
**Measure:** Spinal cord injury patients / healthy controls: N13 spinal potential
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Latency in ms
**Measure:** Spinal cord injury patients / healthy controls: N13 spinal potential
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Amplitude in mV
**Measure:** Spinal cord injury patients / healthy controls: motor neurographies
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Latency in ms
**Measure:** Spinal cord injury patients / healthy controls: motor neurographies
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Nerve conduction velocity in m/s
**Measure:** Spinal cord injury patients / healthy controls: motor neurographies
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Amplitude in mV
**Measure:** Spinal cord injury patients / healthy controls: sensory neurography
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Latency in ms
**Measure:** Spinal cord injury patients / healthy controls: sensory neurography
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Nerve conduction velocity in m/s
**Measure:** Spinal cord injury patients / healthy controls: sensory neurography
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Systolic, diastolic and mean arterial pressure all in mmHg variability
**Measure:** Spinal cord injury patients / healthy controls: resting blood pressure
**Time Frame:** Cross-sectional: once in a chronic stage (1 year post-injury)
**Description:** Delta mmHg
**Measure:** Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a cold pressure test
**Time Frame:** Cross-sectional: once in a chronic stage (1 year post-injury)
**Description:** Delta mmHg
**Measure:** Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a Valsalva maneuvre
**Time Frame:** Cross-sectional: once in a chronic stage (1 year post-injury)
**Description:** Delta mmHg
**Measure:** Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a sit-up test
**Time Frame:** Cross-sectional: once in a chronic stage (1 year post-injury)
**Description:** ms/mmHg
**Measure:** Patients with peripheral neuropathy / healthy controls: baro-reflex sensitivity
**Time Frame:** Cross-sectional: once in a chronic stage (1 year post-injury)
**Description:** RMSSD (root mean square of successive differences), high frequency/low frequency ratio
**Measure:** Patients with peripheral neuropathy / healthy controls: heart rate variability
**Time Frame:** Cross-sectional: once in a chronic stage (1 year post-injury)
**Description:** Change in numeric rating scale of pain from the first three to the last three pinprick stimuli
**Measure:** Spinal cord injury patients / healthy controls: temporal summation of pain after repetitive application of 12 pinprick stimuli
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Changes in pressure pain threshold (measured by an algometer in delta kg) before and during a cold water bath
**Measure:** Spinal cord injury patients / healthy controls: conditioned pain modulation
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Change in numeric rating scale of pain from the first three to the last three pinprick stimuli
**Measure:** Patients with peripheral neuropathy / healthy controls: temporal summation of pain after repetitive application of 12 pinprick stimuli
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Changes in pressure pain threshold (measured by an algometer in delta kg) before and during a cold water bath
**Measure:** Patients with peripheral neuropathy / healthy controls: conditioned pain modulation
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Warm detection threshold (°C), cold detection threshold (°C), heat pain threshold (°C), cold pain threshold (°C)
**Measure:** Spinal cord injury patients / healthy controls: thermal sensory testing tested with a thermode
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Mechanical detection threshold (mN)
**Measure:** Spinal cord injury patients / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Mechanical pain threshold (mN)
**Measure:** Spinal cord injury patients / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Mechanical pain sensitivity (numeric rating scale of pain 0-10)
**Measure:** Spinal cord injury patients / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Vibration detection threshold (a.u.) tested with Rydel Seiffer tuning fork
**Measure:** Spinal cord injury patients / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Warm detection threshold (°C), cold detection threshold (°C), heat pain threshold (°C), cold pain threshold (°C)
**Measure:** Patients with peripheral neuropathy / healthy controls: thermal sensory testing tested with a thermode
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Mechanical detection threshold (mN)
**Measure:** Patients with peripheral neuropathy / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Mechanical pain threshold (mN)
**Measure:** Patients with peripheral neuropathy / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Mechanical pain sensitivity (numeric rating scale of pain 0-10)
**Measure:** Patients with peripheral neuropathy / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
**Time Frame:** Longitudinal: change from 1 month up to 12 months
**Description:** Vibration detection threshold (a.u.) tested with Rydel Seiffer tuning fork
**Measure:** Patients with peripheral neuropathy / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
**Time Frame:** Longitudinal: change from 1 month up to 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Spinal injury cohort - general inclusion criteria:
* Aged between 18-80 years
* Traumatic and non-traumatic etiology
* Para- and tetraplegic SCI
* Complete and incomplete SCI
* SCI with and without neuropathic pain
* Additional inclusion criteria for longitudinal study:
* SCI since less than one month
* Additional inclusion criteria for cross-sectional study:
* SCI since more than one year
* Control cohorts with peripheral neuropathy:
* General inclusion criteria:
* Aged between 18-80 years
* Neurological disorder affecting the peripheral nervous system (i.e., peripheral neuropathy)
* Peripheral neuropathy with or without neuropathic pain
* Additional inclusion criteria for longitudinal study:
* Peripheral neuropathy since less than one month
* Additional inclusion criteria for cross-sectional study:
* Peripheral neuropathy since more than one year
* Control cohorts without neuropathy / healthy volunteers
* General inclusion criteria:
* Aged between 18-80 years
* No medical condition affecting the peripheral and/or central nervous system (e.g., pain, systemic disease, psychological disorder)
Exclusion Criteria:
* Inability to follow study instructions
* Pregnancy
* Medically manifested psychological disorder
* Medical condition affecting the peripheral and/or central nervous system other than the desired experimental condition (e.g., additional peripheral neuropathy in the SCI cohort)
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** In- and outpatients of Balgrist University Hospital Zurich
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Michèle Hubli, PD Dr.
**Phone:** +41 44 510 72 03
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Zurich
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Michèle Hubli, PD Dr.
- **Phone:** +41 44 510 72 03
- **Role:** CONTACT
**Country:** Switzerland
**Facility:** Balgrist University Hospital
**Status:** RECRUITING
**Zip:** 8008
#### Overall Officials
**Official 1:**
**Affiliation:** University of Zurich
**Name:** Armin Curt, Prof. Dr.
**Role:** PRINCIPAL_INVESTIGATOR
## 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: D000010523
- Term: Peripheral Nervous System Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000010146
- Term: Pain
- 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: M12381
- Name: Neuralgia
- Relevance: HIGH
- As Found: Pain, Neuropathic
- ID: M29404
- Name: Nociceptive Pain
- Relevance: HIGH
- As Found: Nociceptive Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: HIGH
- As Found: Injury
- ID: M15915
- Name: Spinal Cord Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22023
- Name: Trauma, Nervous System
- 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: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013119
- Term: Spinal Cord Injuries
- ID: D000009437
- Term: Neuralgia
- ID: D000059226
- Term: Nociceptive Pain
- ID: D000014947
- Term: Wounds and Injuries
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |