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## Protocol Section
### Identification Module
**NCT ID:** NCT06443268
**Acronym:** CODE:QoL
**Brief Title:** Cerebrovascular Disease: Quality of Life (CODE: QoL)
**Official Title:** Cerebrovascular Disease: Quality of Life (CODE: QoL)
#### Organization Study ID Info
**ID:** 2023-00224
#### Organization
**Class:** OTHER
**Full Name:** University of Zurich
### 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:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2028-04-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-05-27
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-04
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Zurich
#### Responsible Party
**Investigator Affiliation:** University of Zurich
**Investigator Full Name:** Susanne Wegener
**Investigator Title:** Prof. Dr. med.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this observational study is to learn about quality of life, stress and caregiver burden in patients with stroke and their caregivers.
The main question is:
• to discover the factors associated with quality of life and stress in patient-caregiver dyads.
Participants will be asked to fill out questionnaires and agree to provide a hair sample (in order to measure stress hormones in hair) and consent to use of their routine clinical and laboratory data.
Researchers will compare a group of participants without stroke to establish a comparable baseline.
**Detailed Description:** Introduction/Background
In Switzerland, approximately 21,000 people suffer a stroke each year. Stroke causes neurological impairments for those affected and brings about a sudden change in their life situation. The relatives of stroke patients receive new social roles and are challenged in a new way by the morbidity of the affected person, leading to a change in their quality of life and aggravation of stress. Unlike chronic diseases, a stroke occurs suddenly, so relatives have no opportunity to gradually adapt to the new living circumstances or to deal with the new psychosocial roles and demands beforehand. To what extent the daily life of patients and their relatives changes and what impact this has on their quality of life and stress has not been systematically investigated in Switzerland thus far.
Aims and significance of the project
The aim of the project is to systematically assess the quality of life and stress, as well as to capture stress biomarkers in stroke patients and their relatives. The investigators plan to conduct sequential measurements of quality of life and stress hormones at multiple time points over 12 months. The goal is in particular to uncover the relationships between the extent of patients' impairments, their quality of life, and stress in affected individuals and their relatives. This is a first-time project with the goal of learning more about stressors and biological relationships. This will create the basis for a multimodal intervention to improve the quality of life of those affected and their relatives, which will be investigated in a follow-up project.
Methods
The Investigators plan a prospective study with a survey of stroke patients and their relatives regarding their quality of life in everyday life. It will also be examined, how multiple stress biomarkers (which will be determined in blood and hair) are related to quality of life and stress and which clinical factors have a positive and negative influence on the well-being of patients and their relatives.
### Conditions Module
**Conditions:**
- Quality of Life
- Stroke, Acute
- Sexual Behavior
- Stress
- Cortisol Excess
- Incontinence, Urinary
- Caregiver Burden
- Transient Ischemic Attack
- Intracerebral Hemorrhage
- Cerebrovascular Disorders
**Keywords:**
- Stroke, QoL, HRQoL, Patient-Caregiver dyads, Stress, Burden
### Design Module
#### Bio Spec
**Description:** Hair samples, routine blood samples
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 680
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage
**Intervention Names:**
- Diagnostic Test: questionnaire, hair samples, blood samples, clinical exam
**Label:** Patients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage
#### Arm Group 2
**Description:** Caregivers of patients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage
**Intervention Names:**
- Diagnostic Test: questionnaire, hair samples, blood samples, clinical exam
**Label:** Caregivers of patients described above
#### Arm Group 3
**Description:** Patients WITHOUT ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage or with an event \> 3 years ago AND no disability
**Intervention Names:**
- Diagnostic Test: questionnaire, hair samples, blood samples, clinical exam
**Label:** Patients WITHOUT ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage
#### Arm Group 4
**Description:** may include close relatives
**Intervention Names:**
- Diagnostic Test: questionnaire, hair samples, blood samples, clinical exam
**Label:** Caregivers of patients above
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Caregivers of patients above
- Caregivers of patients described above
- Patients WITHOUT ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage
- Patients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage
**Description:** The following parameters will be sequentially assessed in caregivers and patients (baseline, at 3 months and at 12 months): 1) quality of life / functioning will be determined through questionnaires (SF-36, EQ-5DL, ECOG (Eastern Cooperative Oncology Group) / Karnofsky, Barthel Index, ICIQ) 2) stress levels \& anxiety levels, caregiver burden will be assessed by the following questionnaires: Distress Thermometer, SBQ-G, GAD-7, PHQ-9, PSS-10, ZBI, PAC. Cortisol will be measured in hair to indicate stress within the past 3 months \[18\]. Fasting glucose, lipid profiles and HbA1c along with blood count, sodium, potassium, creatinine, TSH (thyroid-stimulating hormone) will be measured in routine blood samples from patients at the time of clinical checkups. Blood pressure, pulse and BMI will be determined during clinical visit in patients and additionally in caregivers.
**Name:** questionnaire, hair samples, blood samples, clinical exam
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** will be assessed using Short Form - 36 (SF-36)
Multi-item scale with 8 domains assessing health related quality of life:
* limitations in physical activities
* limitations in social activities
* limitations in usual role activities because
* pain
* limitations in social role activities
* vitality
* overall mental health
* overall health
Domains are scored seperately; Values span from 0 to 100, higher values indicate fewer limitations
**Measure:** Quality of Life as assessed via Short Form - 36 (SF-36)
**Time Frame:** caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
#### Secondary Outcomes
**Description:** as assessed using Perceived Stress Scale - 10 (PSS-10)
Scoring is based on 2 subscales:
Subscale 1: Perceived self-efficacy (PSE), range: (4-20)
Subscale 2: Perceived helplessness (PH), range: (6-30)
Total score PSS-10 is evaluated by adding both sub scale scores.
Values span from 10 to 50, higher values indicate higher levels of stress
**Measure:** Stress
**Time Frame:** caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
**Description:** Measure of caregiver burden
Questionnaire: 11 items / Likert scales (1-5)
Values span from 11 to 55, higher values indicate positive aspects of caregiving
**Measure:** Positive Aspects of Caregiving:
**Time Frame:** caregivers at 0, 3 and 12 months after cerebrovascular event.
**Description:** Measure of caregiver burden
22 items / Likert scales (0-4) Values span from 0 to 88, higher values indicate higher caregiver burden
**Measure:** Zarit Burden Interview:
**Time Frame:** caregivers at 0, 3 and 12 months after cerebrovascular event.
**Description:** will be assessed using Stroke Impact Scale 3.0 (SIS-3.0)
SIS-3.0 includes 60 items and assesses 9 domains using Likert scales:
* Strength - 4 items
* Hand function - 5 items
* Activities of daily living - 10 items
* Mobility - 9 items
* Communication - 7 items
* Emotion - 9 items
* Memory and thinking - 7 items
* Participation/Role function - 8 items
* Perceived recovery since stroke onset - single-item VAS (visual analog scale)
Domains are scored seperately; Values span from 0 to 100, higher values indicate fewer limitations
**Measure:** Stroke Related Quality of Life
**Time Frame:** patients at 0, 3 and 12 months after cerebrovascular event.
**Description:** will be assessed using General Anxiety Disorder- (GAD-7)
7 items / Likert scales (0-3) Values span from 0 to 21, higher values indicate higher level of anxiety and functional impairment
**Measure:** Anxiety
**Time Frame:** caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
**Description:** will be assessed using Patient Health Questionnaire - 9 (PHQ-9)
9 items, evaluated by likert scale (0-3) Values span from 0 to 27, higher values indicate higher probability of depression and decreased functional status
**Measure:** Depression
**Time Frame:** caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
**Description:** will be assessed using Sexual Behavior Questionnaire German (SBQ-G)
Equal base questions (1-6) and gender specific questions m(7-11), f(7-10)
Single item evaluation with two answer categories
(0-1) dysfunctional (2-3) functional
Evaluation of MGISD (Mean Global Index of sexual Dysfunction): Arithmetic mean of 1,4,5,6,8f/11m
**Measure:** Sexual Quality of Life
**Time Frame:** caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
**Description:** will be assessed using International Consultation on Incontinence Questionnaire (ICIQ)
3 Questions regarding urinary incontinence
* Frequency?
* Severity?
* Impact on quality of life?
Score is sum of answer values (1 + 2 + 3); Range: 0-21
Scoring Categories
* slight (1-5)
* moderate (6-12)
* severe (13-18)
* very severe (19-21)
**Measure:** Incontinence
**Time Frame:** caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
**Description:** will be assessed using National Institutes of Health Stroke Scale (NIHSS)
NIHSS
* 13 assessed functional domains
* Range 0-42, higher score indicates severe impairment
**Measure:** neurological functioning of the patients (NIHSS)
**Time Frame:** patients at 0, 3 and 12 months after cerebrovascular event.
**Description:** will be assessed using modified Rankin Scale (mRS)
mRS
• Range: (0-6) 0 = no symptoms, 6 = death, higher score indicates severe impairment
**Measure:** neurological functioning of the patients (mRS)
**Time Frame:** patients at 0, 3 and 12 months after cerebrovascular event.
**Description:** will be assessed using Barthel Index
Barthel Index
* Physical impairment in daily life / self-care
* score ranges from 0-100
* higher score indicates fewer limitations
**Measure:** neurological functioning of the patients (Barthel Index)
**Time Frame:** patients at 0, 3 and 12 months after cerebrovascular event.
**Description:** will be assessed using Distress Thermometer
Assessment with Visual Analog Scale (0-10), higher scale indicates more distress.
Selection of aspects in life causing distress
**Measure:** Distress
**Time Frame:** caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
**Description:** will be assessed using EuroQol-5 (EQ5-DL)
Evaluation of 5 different aspects of health with likert scale (1-5)
* MOBILITY
* SELF-CARE
* USUAL ACTIVITIES
* PAIN / DISCOMFORT
* ANXIETY / DEPRESSION
Each domain is scored individually, higher values indicate higher impairment of quality of life
**Measure:** Quality of Life (short)
**Time Frame:** caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
**Description:** will be assessed using EuroQol-5 (EQ5-DL)
Visual analog scale:
EQ VAS 0-100, higher score indicates better perceived current health
**Measure:** Quality of Life (short)
**Time Frame:** caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
**Description:** Stress biomarkers
**Measure:** cortisol / cortisone in hair (pg/mg)
**Time Frame:** caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
**Description:** Stress biomarkers
**Measure:** fasting glucose (mmol/l)
**Time Frame:** patients at 0, 3 and 12 months after cerebrovascular event.
**Description:** Stress biomarkers
**Measure:** HbA1c (in %)
**Time Frame:** patients at 0, 3 and 12 months after cerebrovascular event.
**Description:** Stress biomarkers
**Measure:** Lipid profiles (LDL, HDL, triglycerides in mmol/l)
**Time Frame:** patients at 0, 3 and 12 months after cerebrovascular event.
**Description:** Stress biomarkers
**Measure:** TSH (mU/l)
**Time Frame:** patients at 0, 3 and 12 months after cerebrovascular event.
**Description:** Stress biomarkers
**Measure:** Blood pressure (systolic & diastolic in mmHg)
**Time Frame:** caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
### Eligibility Module
**Eligibility Criteria:** Control group:
Inclusion criteria:
* over 18 years old
* No previous stroke OR previous stroke \>3 years ago
* No significant disability (maximum mRS 1)
* ambulatory patients at the University Hospital of Zurich (USZ), Dept. of Neurology
* Patients' AND caregiver's ability to give informed consent
* Patients' AND close relative's / caregiver's willingness to participate
Exclusion criteria:
• Medication with steroid hormones (prednisone, prednisolone, dexamethasone, methylprednisolone, hydrocortisone etc.) within last 3 months
Main Group:
Inclusion criteria:
* over 18 years old
* Patients diagnosed with either transient ischemic attack, ischemic stroke or intracerebral hemorrhage and their caregivers
* Caregiver of a patient as described above, age over 18 years
* Hospitalized or ambulatory patients at the University Hospital of Zurich (USZ) included within 28 days from event.
* Patients' AND caregiver's ability to give informed consent
* Patients' AND caregiver's willingness to participate
Exclusion criteria:
• Medication with steroid hormones (prednisone, prednisolone, dexamethasone, methylprednisolone, hydrocortisone etc.) within last 3 months
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Control group:
We will include 40 patients without previous stroke OR patients with a minor stroke \> 3 years ago and no sustained significant disability (mRS 0 or 1) along with their close relative (to simulate informal caregivers) (total 80 participants).
Main group:
We will include 300 patients and informal caregivers with a first cerebrovascular event treated at our clinic \> 18 years. The caregivers will be defined as the closest person to the patient with the most contact. (total 600 participants)
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** anton.schmick@usz.ch
**Name:** Anton Schmick, MD
**Phone:** +41442551111
**Role:** CONTACT
**Contact 2:**
**Email:** susanne.wegener@usz.ch
**Name:** Susanne Wegener, MD
**Phone:** +41442551111
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Zürich
**Contacts:**
***Contact 1:***
- **Email:** anton.schmick@usz.ch
- **Name:** Anton Schmick, MD
- **Role:** CONTACT
***Contact 2:***
- **Email:** susanne.wegener@usz.ch
- **Name:** Susanne Wegener, MD
- **Role:** CONTACT
***Contact 3:***
- **Name:** Schmick Anton, MD
- **Role:** SUB_INVESTIGATOR
**Country:** Switzerland
**Facility:** Department of Neurology, University Hospital Zurich
**State:** Zurich
**Status:** RECRUITING
**Zip:** 8091
#### Overall Officials
**Official 1:**
**Affiliation:** University of Zurich
**Name:** Susanne Wegener, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** not planned at the time of register entry
**IPD Sharing:** NO
### References Module
#### References
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**PMID:** 27783737
**Citation:** Zhang J, Lee DT. Meaning in stroke family caregiving: A literature review. Geriatr Nurs. 2017 Jan-Feb;38(1):48-56. doi: 10.1016/j.gerinurse.2016.07.005. Epub 2016 Sep 23.
**PMID:** 27671537
**Citation:** Jeong YG, Myong JP, Koo JW. The modifying role of caregiver burden on predictors of quality of life of caregivers of hospitalized chronic stroke patients. Disabil Health J. 2015 Oct;8(4):619-25. doi: 10.1016/j.dhjo.2015.05.005. Epub 2015 May 29.
**PMID:** 26123859
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## 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: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020300
- Term: Intracranial Hemorrhages
- ID: D000002545
- Term: Brain Ischemia
- ID: D000013315
- Term: Stress, Psychological
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000014555
- Term: Urination Disorders
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000059411
- Term: Lower Urinary Tract Symptoms
- ID: D000020924
- Term: Urological Manifestations
- ID: D000019960
- Term: Elimination Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M22306
- Name: Stroke
- Relevance: HIGH
- As Found: Stroke, Acute
- ID: M9556
- Name: Hemorrhage
- Relevance: HIGH
- As Found: Hemorrhage
- ID: M5792
- Name: Cerebral Hemorrhage
- Relevance: HIGH
- As Found: Intracerebral Hemorrhage
- ID: M5795
- Name: Ischemic Attack, Transient
- Relevance: HIGH
- As Found: Transient Ischemic Attack
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: HIGH
- As Found: Cerebrovascular Disorders
- ID: M2480
- Name: Caregiver Burden
- Relevance: HIGH
- As Found: Caregiver Burden
- ID: M6689
- Name: Cushing Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M17299
- Name: Urinary Incontinence
- Relevance: HIGH
- As Found: Incontinence, Urinary
- ID: M7936
- Name: Enuresis
- Relevance: HIGH
- As Found: Incontinence, Urinary
- ID: M27171
- Name: Nocturnal Enuresis
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22113
- Name: Intracranial Hemorrhages
- Relevance: LOW
- As Found: Unknown
- ID: M5794
- Name: Brain Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M16105
- Name: Stress, Psychological
- Relevance: LOW
- As Found: Unknown
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M17305
- Name: Urination Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M29464
- Name: Lower Urinary Tract Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M22659
- Name: Urological Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M21832
- Name: Elimination Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T1679
- Name: Cushing's Syndrome
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020521
- Term: Stroke
- ID: D000002543
- Term: Cerebral Hemorrhage
- ID: D000002546
- Term: Ischemic Attack, Transient
- ID: D000002561
- Term: Cerebrovascular Disorders
- ID: D000014549
- Term: Urinary Incontinence
- ID: D000004775
- Term: Enuresis
- ID: D000006470
- Term: Hemorrhage
- ID: D000084802
- Term: Caregiver Burden
### Intervention Browse Module - Browse Branches
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M9912
- Name: Hydrocortisone
- Relevance: LOW
- As Found: Unknown
- ID: M155245
- Name: Hydrocortisone 17-butyrate 21-propionate
- Relevance: LOW
- As Found: Unknown
- ID: M228609
- Name: Hydrocortisone acetate
- Relevance: LOW
- As Found: Unknown
- ID: M263259
- Name: Hydrocortisone hemisuccinate
- Relevance: LOW
- As Found: Unknown
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443255
**Brief Title:** Cocaine, Lidocaine/Xylometazoline and Saline for Nasal Analgesia
**Official Title:** Comparison of Cocaine, Lidocaine/Xylometazoline and Saline for Intranasal Analgesia - A Blinded Triple Crossover Study
#### Organization Study ID Info
**ID:** 2023-506644-17
#### Organization
**Class:** OTHER
**Full Name:** Rigshospitalet, Denmark
### 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:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**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:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Rigshospitalet, Denmark
#### Responsible Party
**Investigator Affiliation:** Rigshospitalet, Denmark
**Investigator Full Name:** Mo Haslund Larsen
**Investigator Title:** Principal investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** When performed by trained personnel nasotracheal intubation is a safe and effective technique for attaining a secure airway in preparation for surgery of the head and neck. The procedure can be deemed necessary due to the nature of the surgical procedure or considerations in regard to the patient's comorbidities. For a certain group of patients with expected difficult airways, the procedure is done whilst they are awake and aided by fiberoptics.
For these awake patients, extra precautions must be taken to ensure the procedure is conducted with minimal pain and discomfort. The pain and discomfort arises from the mechanical manipulation of the nasal mucosa and can be alleviated in part by means of topical analgesia as well as through decongestion, providing more space within the nasal cavity. For these purposes, several drugs in varying combinations and dosages are used, but no single drug choice is universally recommended.
Cocaine is one of these appropriate drugs. It is a magistral formula used especially due to its unique combination of both vasoconstrictive and analgesic properties. Concerns have though been raised regarding cocaine's potential toxicity and alternative medications are continuously sought after.
A combination of lidocaine and xylometazoline can also be used for preparation of the nose prior to awake nasal fiberoptic intubation. Lidocaine contributes with its analgesic effect whilst xylometazoline functions as the vasoconstrictor.
The investigators wish to compare the analgesic effects of cocaine and lidocaine/phenylephrine to each other and saline when subjectively scored on a visual analogue scale of 0-100 mm immediately after simulated awake nasal intubation on healthy volunteers.
### Conditions Module
**Conditions:**
- Analgesia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 12
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 2 mL 4% cocaine hydrochloride
**Intervention Names:**
- Drug: Cociane hydrochloride 4%
**Label:** Cocaine
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** 1.5 mL of 4% lidocaine and 0.5 mL 0.1% xylometazoline
**Intervention Names:**
- Drug: Lidocaine 4%
- Drug: Xylometazoline 0.1%
**Label:** Xylometazoline and lidocaine
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** 2 ml of 0,9% saline solution
**Intervention Names:**
- Drug: Saline 0.9%
**Label:** Saline
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cocaine
**Description:** 2 mL of 4% cocaine
**Name:** Cociane hydrochloride 4%
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Xylometazoline and lidocaine
**Description:** 1.5 mL of 4% lidocaine
**Name:** Lidocaine 4%
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Xylometazoline and lidocaine
**Description:** 0.5 mL of xylometazoline 0.1%
**Name:** Xylometazoline 0.1%
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Saline
**Description:** 2 mL of saline 0.9%
**Name:** Saline 0.9%
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Self reported pain on a visual analogue scale of 0-100 mm
**Measure:** Pain regarding the procedure
**Time Frame:** Immediately following the procedure of 10 cm insertion of a 6.0 nasal endotracheal tube
#### Secondary Outcomes
**Description:** Self reported pain on a visual analogue scale of 0-100 mm
**Measure:** Pain regarding the procedure
**Time Frame:** One minute after the procedure of insertion of a 6.0 nasal endotracheal tube
**Description:** Volume within both nasal cavities measured with acoustic rhinometry
**Measure:** Volume
**Time Frame:** 5 minutes before drug administration and 1, 3, 5, 7 and 9 minutes after drug administration
**Description:** Preferred nasal cavity based on a comparison of the degree of vasoconstriction of the nasal mucosa evaluated by fiberoptic endoscopy assessed by ENT-specialist
**Measure:** Fiberoptic endoscopy
**Time Frame:** Fiberoptic endoscopy performed 10 minutes before drug administraion and 10 minutes after drug administration
**Description:** Concentraion of cocaine and cocaine's main metabolite benzoylecgonine in blood and saliva samples respectively
**Measure:** Drug test detection
**Time Frame:** 15 minutes before drug administration and 1, 2 and 3 hours after drug administration
**Description:** Measurement of heart rate
**Measure:** Heart rate
**Time Frame:** 5 minutes before drug administration and 1, 2, 3, 4 and 5 minutes after drug administration
**Description:** Measurement of mean arterial blood pressure
**Measure:** Blood pressure
**Time Frame:** 5 minutes before drug administration and 1, 2, 3, 4 and 5 minutes after drug administration
**Description:** The degree of discomfort and unpleasentness of taste of the drug administration on a scale of 1-10 and whether they felt exaltation after drug administration.
**Measure:** Patient-centred questions
**Time Frame:** 15 minutes after drug administration
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 18 years
* Proficient in spoken and written Danish
* Healthy volunteers (no active diagnoses)
* Negative hCG (human chorionic gonadotropin) urine stix for women of childbearing potential
Exclusion Criteria:
* Known nasal malformation
* Known coagulopathy
* Current antithrombotic treatment
* Self-reported epistaxis occurring more than once a month
* Symptoms of a common cold within the past week
* Hypersensitivity to local anaesthetics of amide type or any of the excipients
* Hypertension
* Narrow-angle glaucoma
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** mo.haslund.larsen.02@regionh.dk
**Name:** Mo H Larsen, MD
**Phone:** +4535456589
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Rigshospitalet, Denmark
**Name:** Mo H Larsen, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010468
- Term: Perceptual Disorders
- ID: D000019954
- Term: Neurobehavioral Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
### 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: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M3727
- Name: Agnosia
- Relevance: HIGH
- As Found: Analgesia
- ID: M13379
- Name: Perceptual Disorders
- 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: T241
- Name: Agnosia
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000377
- Term: Agnosia
### Intervention Browse Module - Ancestors
- ID: D000000779
- Term: Anesthetics, Local
- ID: D000000777
- Term: Anesthetics
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000000889
- Term: Anti-Arrhythmia Agents
- ID: D000061567
- Term: Voltage-Gated Sodium Channel Blockers
- ID: D000026941
- Term: Sodium Channel Blockers
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000014663
- Term: Nasal Decongestants
- ID: D000014662
- Term: Vasoconstrictor Agents
- ID: D000019141
- Term: Respiratory System Agents
### Intervention Browse Module - Browse Branches
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: ChanBlk
- Name: Channel Blockers
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: VaCoAg
- Name: Vasoconstrictor Agents
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: CNSSti
- Name: Central Nervous System Stimulants
### Intervention Browse Module - Browse Leaves
- ID: M11014
- Name: Lidocaine
- Relevance: HIGH
- As Found: Solution
- ID: M228477
- Name: Xylometazoline
- Relevance: HIGH
- As Found: Ambroxol
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M6271
- Name: Cocaine
- Relevance: LOW
- As Found: Unknown
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M4109
- Name: Anesthetics, Local
- Relevance: LOW
- As Found: Unknown
- ID: M4213
- Name: Anti-Arrhythmia Agents
- Relevance: LOW
- As Found: Unknown
- ID: M23177
- Name: Sodium Channel Blockers
- Relevance: LOW
- As Found: Unknown
- ID: M30025
- Name: Diuretics, Potassium Sparing
- Relevance: LOW
- As Found: Unknown
- ID: M7966
- Name: Ephedrine
- Relevance: LOW
- As Found: Unknown
- ID: M27586
- Name: Pseudoephedrine
- Relevance: LOW
- As Found: Unknown
- ID: M17410
- Name: Nasal Decongestants
- Relevance: LOW
- As Found: Unknown
- ID: M17409
- Name: Vasoconstrictor Agents
- Relevance: LOW
- As Found: Unknown
- ID: M21137
- Name: Respiratory System Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008012
- Term: Lidocaine
- ID: C000009695
- Term: Xylometazoline
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443242
**Brief Title:** Efficacy and Safety of Low-dose Laser Acupuncture on Treating Insomnia Associated With Major Depressive Disorder
**Official Title:** Efficacy and Safety of Low-dose Laser Acupuncture on Treating Insomnia Associated With Major Depressive Disorder: A Randomised Controlled Trial
#### Organization Study ID Info
**ID:** XYEFYLL-(Research)-2024-36
#### Organization
**Class:** OTHER
**Full Name:** Universiti Sains Malaysia
### Status Module
#### Completion Date
**Date:** 2027-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**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:** Mohammad Farris Iman Leong Bin Abdullah
#### Responsible Party
**Investigator Affiliation:** Universiti Sains Malaysia
**Investigator Full Name:** Mohammad Farris Iman Leong Bin Abdullah
**Investigator Title:** Principal investigator
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this randomized controlled trial is to assess the efficacy and safety of low-dose laser acupuncture (LLA) in alleviating insomnia symptoms among patients suffering from major depressive disorder.
The study seeks to answer the following questions:
1. How effective is LLA in alleviating insomnia symptoms as compare with SLA and control subjects among patients with major depressive disorder across pre-treatment, mid-treatment and post-treatment assessment?
2. What role do CORT and 5-HT play in the co-occurrence and progression of insomnia and major depressive disorder, and how does LLA act on these mechanisms to provide relief?
3. Does LLA enhance the effectiveness of pharmacological interventions in treating insomnia and major depressive disorder when used as an adjunctive treatment?
4. How does the safety and acceptability of LLA compare to traditional acupuncture in terms of eliminating discomfort and potential side effects? Researchers will compare the effects of LLA with sham laser acupuncture (SLA) and standard medication treatments to evaluate its efficacy and safety.
Participants involved in this study will:
Undergo 30 treatment sessions with LLA or SLA, five times a week for six weeks. Continue their usual pharmacological treatments for major depressive disorder. Participants will undergo comprehensive assessments at key points: pre-treatment, immediately post-treatment, and 12 weeks post-treatment. These evaluations will measure sleep quality indices, levels of depression and anxiety, and blood levels of CORT and 5-HT to assess the impact of LLA on insomnia symptoms and biochemical markers. Additionally, participant acceptance and the safety of the treatment will be monitored, including recording any adverse events and medication usage, to determine the effectiveness and safety of LLA in treating insomnia associated with major depressive disorder.
By focusing on these elements, the study aims to provide clear, actionable insights into the benefits and risks of LLA as a treatment option for insomnia associated with major depressive disorder, enhancing the current treatment landscape and patient outcomes.
**Detailed Description:** This randomised controlled trial aims to explore the therapeutic potential of low-dose laser acupuncture (LLA) for treating insomnia in patients diagnosed with major depressive disorder. The study will investigate the physiological and psychological impacts of LLA in comparison with sham laser acupuncture (SLA) and standard pharmacological therapies.
Intervention Details:
LLA involves the application of a low-level laser to specific acupoints known to affect sleep and mood regulation. The technique mimics traditional acupuncture but uses laser light to stimulate these points without physical penetration of the skin, offering a non-invasive alternative with potentially fewer adverse effects. The primary acupoints targeted in this study include Baihui (GV20), Yintang (GV29), Anmian (EX-HN22), Shenmen (HT7), Neiguan (PC6), Sanyinjiao (SP6), and Taichong (LR3).
Study Phases:
The study will be structured into three key phases: pre-treatment, immediately post-treatment, and 12 weeks post-treatment. During the pre-treatment phase, baseline evaluations will be conducted to establish initial levels of insomnia and depressive symptoms in participants. The treatment phase will follow, lasting six weeks, with participants receiving five sessions per week. Subsequent assessments will occur immediately post-treatment to evaluate the immediate effects of the interventions, and again at 12 weeks post-treatment to assess the long-term outcomes.
Research Focus:
The study will particularly focus on the effectiveness of LLA in improving sleep quality as measured by validated scales and objective assessments like actigraphy, which monitors sleep-wake patterns. Additionally, the research will assess changes in psychological state and biochemical markers, which are critical in understanding the interaction between sleep disorders and depression. These measures will help ascertain whether LLA can alter the physiological pathways typically disrupted in major depressive disorder, potentially offering a new avenue for treatment that could complement or reduce the need for pharmacological intervention.
Innovation and Potential Impact:
By integrating a novel, non-invasive method such as LLA, the study could significantly impact the treatment strategies for insomnia in the context of major depressive disorder. This approach not only aims to reduce symptoms but also to enhance overall treatment tolerance and patient adherence, addressing key challenges in managing these interlinked conditions.
### Conditions Module
**Conditions:**
- Major Depressive Disorder
- Insomnia
### 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:** 120
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** In the Low-Dose Laser Acupuncture (LLA) group, participants receive treatments using the xS-998D06 semiconductor laser acupoint therapeutic device from Nanjing Xiaosong Medical Instruments. This device operates at a wavelength of 780 nm and an output power of 5 mW. Each 20-minute session involves securing the device's probe to specific acupoints (Baihui, Yintang, Anmian, Shenmen, Neiguan, Sanyinjiao, and Taichong) using medical tape. Treatments occur daily for 5 consecutive days each week, with a two-day break, over a 6-week period. All participants, regardless of group assignment, will maintain their regular antidepressant regimen.
**Intervention Names:**
- Device: Low-Dose Laser Acupuncture (LLA)
- Drug: Standard Medication Management (Control Group)
**Label:** Low-Dose Laser Acupuncture (LLA) Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants in the Sham Laser Acupuncture (SLA) group undergo a sham treatment involving the same procedure and acupoint targeting as the LLA group. The difference lies in the instrument probe being fixed to the acupoint but emitting a dummy laser, simulating the acupuncture experience without actual laser emission. All participants, regardless of group assignment, will maintain their regular antidepressant regimen.
**Intervention Names:**
- Device: Sham Laser Acupuncture (SLA)
- Drug: Standard Medication Management (Control Group)
**Label:** Sham Laser Acupuncture (SLA) Group
**Type:** SHAM_COMPARATOR
#### Arm Group 3
**Description:** The control group, which serves as a non-intervention comparison, will continue their standard treatment regimen using SSRIs (Selective Serotonin Reuptake Inhibitors).
**Intervention Names:**
- Drug: Standard Medication Management (Control Group)
**Label:** Control Group
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Low-Dose Laser Acupuncture (LLA) Group
**Description:** The intervention utilizes the xS-998D06 semiconductor laser acupoint therapeutic device specifically designed for targeted acupoint therapy. This device is critical in delivering precise low-dose laser therapy at a controlled wavelength and power. The laser treatment is directed towards enhancing neurological function and potentially alleviating symptoms of insomnia and depression by stimulating specific acupoints associated with mental health and sleep.
**Name:** Low-Dose Laser Acupuncture (LLA)
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Sham Laser Acupuncture (SLA) Group
**Description:** Sham laser acupuncture serves as a control to assess the placebo effect of the laser treatment. It involves the same procedure as LLA but uses a non-emitting laser probe. This intervention is designed to mimic the LLA setup without delivering actual laser therapy, allowing for an evaluation of the psychological and physiological effects of the placebo compared to the active laser treatment.
**Name:** Sham Laser Acupuncture (SLA)
**Type:** DEVICE
#### Intervention 3
**Arm Group Labels:**
- Control Group
- Low-Dose Laser Acupuncture (LLA) Group
- Sham Laser Acupuncture (SLA) Group
**Description:** This intervention involves the continued use of standard pharmacological treatment with SSRIs for managing symptoms of depression. It serves as a control to evaluate the effects of laser acupuncture against conventional medical treatment without the introduction of additional therapeutic modalities. Participants' adherence to their prescribed medication regimen is monitored and documented, ensuring an accurate comparison of treatment effects across groups.
**Name:** Standard Medication Management (Control Group)
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** This outcome measure evaluates the change in sleep quality in patients with major depressive disorder (MDD) and insomnia treated with Low-Dose Laser Acupuncture (LLA). The Pittsburgh Sleep Quality Index (PSQI) is used, with scores ranging from 0 to 21, where higher scores indicate poorer sleep quality.
**Measure:** Change in Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)
**Time Frame:** Pre-treatment, immediately post-treatment and 12 weeks post-treatment.
**Description:** This outcome measure assesses the change in insomnia severity in patients with MDD and insomnia treated with LLA. The Insomnia Severity Index (ISI) is used, with scores ranging from 0 to 28, where higher scores indicate more severe insomnia.
**Measure:** Change in Insomnia Severity Assessed by Insomnia Severity Index (ISI)
**Time Frame:** Pre-treatment, immediately post-treatment and 12 weeks post-treatment.
**Description:** This outcome measure evaluates the change in objective sleep patterns in patients with MDD and insomnia treated with LLA. Actigraphy provides data on sleep parameters such as total sleep time, sleep efficiency, and number of awakenings.
**Measure:** Objective Sleep Patterns Assessed by Actigraphy
**Time Frame:** Pre-treatment, immediately post-treatment and 12 weeks post-treatment.
#### Secondary Outcomes
**Description:** This outcome measure evaluates the impact of LLA on the severity of depressive symptoms in patients with MDD and insomnia. The Hamilton Depression Rating Scale (HAMD) is used, with scores ranging from 0 to 52, where higher scores indicate more severe depression symptoms.
**Measure:** Severity of Depressive Symptoms Assessed by Hamilton Depression Rating Scale (HAMD)
**Time Frame:** Pre-treatment, immediately post-treatment and 12 weeks post-treatment.
**Description:** This outcome measure evaluates the impact of LLA on the severity of anxiety symptoms in patients with MDD and insomnia. The Self-Rating Anxiety Scale (SAS) is used, with scores ranging from 20 to 80, where higher scores indicate more severe anxiety symptoms.
**Measure:** Severity of Anxiety Symptoms Assessed by Self-Rating Anxiety Scale (SAS)
**Time Frame:** Pre-treatment, immediately post-treatment and 12 weeks post-treatment.
**Description:** This outcome measure examines the change in serum corticosterone levels in patients with MDD and insomnia treated with LLA. Corticosterone levels are measured in ng/mL, with higher levels typically associated with higher stress and worse outcomes.
**Measure:** Serum Corticosterone Levels
**Time Frame:** Pre-treatment, immediately post-treatment and 12 weeks post-treatment.
**Description:** This outcome measure examines the change in serum 5-hydroxytryptamine (5-HT) levels in patients with MDD and insomnia treated with LLA. 5-HT levels are measured in ng/mL, with lower levels typically associated with worse outcomes in depression and insomnia.
**Measure:** Serum 5-Hydroxytryptamine (5-HT) Levels
**Time Frame:** Pre-treatment, immediately post-treatment and 12 weeks post-treatment.
**Description:** This outcome measure assesses the incidence of treatment-emergent adverse events to determine the safety of LLA. It compares the dropout rates due to adverse effects among patients in the LLA, Sham Laser Acupuncture (SLA), and control groups.
**Measure:** Incidence of Treatment-Emergent Adverse Events
**Time Frame:** Throughout the study duration (Pre-treatment through 12 weeks post-intervention)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Inpatients with a diagnosis of major depressive disorder (diagnosed according to the relevant diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders-V).
2. Male or female, 18 to 60 years of age.
3. Participants complaining of insomnia at initial screening.
4. PSQI score over 7.
5. HAMD score between 20 and 35.
6. No use of hypnotic medication or acupuncture treatment within the last month.
7. No cognitive or communication disorders.
8. Willingness to accept random group assignment and sign an informed consent form.
9. Those who have been on stable dose of antidepressant for at least the most recent two weeks and willing to maintain on the same dosage throughout the study.
Exclusion Criteria:
1. Individuals with a marked tendency towards suicide, as assessed by a specialist;
2. Individuals previously diagnosed with schizophrenia, bipolar disorder, or other psychiatric disorders;
3. Individuals with severe alcohol or drug abuse issues;
4. Individuals with liver or kidney dysfunction, or with uncontrollable tumors or significant cerebrovascular diseases;
5. Women who are pregnant or breastfeeding;
6. Individuals likely to have poor compliance or who are fearful of acupuncture treatment.
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### IPD Sharing Statement Module
**Access Criteria:** All researchers and study participants upon request after completion of the study.
**Description:** Anonymized individual data will be made available after publication of the study's findings. The data will be uploaded in Figshare data repository after completion of the study.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
**IPD Sharing:** YES
**Time Frame:** The data will be uploaded in Figshare data repository after completion of the study and it will be available for 2 years after completion of the study.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000019964
- Term: Mood Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000020919
- Term: Sleep Disorders, Intrinsic
- ID: D000020920
- Term: Dyssomnias
- ID: D000012893
- Term: Sleep Wake Disorders
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M7061
- Name: Depressive Disorder
- Relevance: HIGH
- As Found: Depressive Disorder
- ID: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depressive Disorder
- ID: M7060
- Name: Depressive Disorder, Major
- Relevance: HIGH
- As Found: Major Depressive Disorder
- ID: M10356
- Name: Sleep Initiation and Maintenance Disorders
- Relevance: HIGH
- As Found: Insomnia
- ID: M21835
- Name: Mood Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M22242
- Name: Parasomnias
- Relevance: LOW
- As Found: Unknown
- ID: M22654
- Name: Sleep Disorders, Intrinsic
- Relevance: LOW
- As Found: Unknown
- ID: M22655
- Name: Dyssomnias
- Relevance: LOW
- As Found: Unknown
- ID: M15696
- Name: Sleep Wake Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007319
- Term: Sleep Initiation and Maintenance Disorders
- ID: D000003866
- Term: Depressive Disorder
- ID: D000003863
- Term: Depression
- ID: D000003865
- Term: Depressive Disorder, Major
### Intervention Browse Module - Browse Branches
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M4247
- Name: Antidepressive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M19649
- Name: Selective Serotonin Reuptake Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M4854
- Name: Benzocaine
- Relevance: LOW
- As Found: Unknown
- ID: M15512
- Name: Serotonin
- Relevance: LOW
- As Found: Unknown
- ID: T433
- Name: Tannic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443229
**Brief Title:** Effect of Telerehabilitation Use in the Treatment of Non-specific Chronic Low Back Pain in the Brazilian Afrodescendants
**Official Title:** Effect of Telerehabilitation Use in the Treatment of Non-specific Chronic Low Back Pain in the Brazilian Afrodescendants Population: a Randomized Controlled Trial Protocol
#### Organization Study ID Info
**ID:** 5.991.168
#### Organization
**Class:** OTHER
**Full Name:** University of Sao Paulo General Hospital
### Status Module
#### Completion Date
**Date:** 2025-04-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2024-12-22
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-10-01
**Type:** ACTUAL
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Sao Paulo General Hospital
#### 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 study is to measure the effect of telerehabilitation on the treatment of nonspecific chronic LBP in the adults Brazilian Black population. The main questions it aims to answer are:
1. Will the graded activity exercises guided by educational approach or only the educational approach alone improve low back pain intensity, functional capacity, quality of life, anxiety, fear-avoidance beliefs due to nonspecific chronic low back pain before, immediately after the 4-week intervention, and after 3 and 6 months of follow-up?
2. How will participants' behaviors in terms of frequency and adherence, exercise feedback diary, and educational approach for nonspecific chronic low back pain be?
What are the participants' opinions and any difficulties or barriers encountered throughout the study?
3. What are the perceptions of discrimination based on race, gender, age, socioeconomic status, and education when accessing healthcare services for the treatment of low back pain in the past?
Researchers will compare Group Experimental Graded Activity with Educational Program with Telerehabilitation to a placebo (only Educational Approach ) to see improve the pain intensity and functional capacity because of low back pain.
Participants will:
* Take Group Experimental (GAEP) or a placebo (OEA) 3 times per week, for 1 month.
* Keep a feedback diary of their symptoms and the barriers they have.
* Visit the researcher by online teleassessment after one month, 3 months and 6 months follow-up.
**Detailed Description:** Background: Low back pain (LBP) is highly prevalent, ranging from 30 to 70% in developed and industrialized countries, leading to health costs and work absenteeism. However, when it comes to the Black population, studies addressing the treatment of nonspecific chronic LBP while considering the specificities of this population are scarce. The use of telerehabilitation opens up opportunities for the physiotherapy community to address musculoskeletal conditions.
The goal of this study is to measure the effect of telerehabilitation on the treatment of nonspecific chronic LBP in the adult Brazilian Black population.
Methods: A randomized controlled double-blind clinical trial, with a 1:1 allocation of 102 Afro-Brazilian participants divided into two groups, with 51 participants in each, experiencing nonspecific chronic LBP for at least 3 months, of both sexes, aged 18-65 years, residing in Brazil, and divided into the Gradual Activity Group (GAG) and Control Group (CG), with a duration of 12 sessions, three times per week. The intervention will involve the adaptation of an exercise program protocol based on gradual activity with progressive exercise intensity, through the web applications Physitrack® (researcher) and Physiapp® (participant). Sociodemographic and clinical characteristics will be evaluated. The primary outcome will be pain intensity, and secondary outcomes will include functional capacity, quality of life, beliefs, and fears. Also the perceptions of discrimination based on race, gender, age, socioeconomic status, and education will be assessed regarding prior access to healthcare services for the treatment of LBP. The groups will be assessed at baseline (T0), immediately post-treatment (T1), at 3-months (T2) and 6-months (T3) follow-ups. Data will be collected and managed using the REDCap® electronic data capture tools.
Discussion: Evidence suggests that telerehabilitation can be utilized as a potential tool to promote the treatment of non-severe conditions of nonspecific chronic LBP, but few studies have investigated the Black population while considering the specificities of populations that historically suffer from social inequalities in accessing healthcare treatments.
### Conditions Module
**Conditions:**
- Telerehabilitation
- Low Back Pain
**Keywords:**
- Telerehabilitation
- Low Back Pain
- Black People
- Pain
- Disability
- Rehabilitation
- Health of Ethnic Minorities
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** A randomized controlled double-blind clinical trial, with a 1:1 allocation of 102 participants divided into two groups (intervention or control).
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** Participants will be evaluated pre- and post-intervention by a blind evaluator, previously trained to obtain information and confirm eligibility criteria, in addition to primary and secondary outcomes. The evaluator will be asked to guess which group the participants were in (intervention or control) at the end of the study to measure the blindness of the evaluator. Regarding the data analyst, he will be blind to carry out this stage of the study.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 102
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Exercises for warming up, strengthening, and relaxation, along with informational sessions incorporating an educational approach for low back pain using Telerehabilitation platform.
**Intervention Names:**
- Behavioral: Graded Activity based in exercises and educational approach
**Label:** Graded Activity based in exercises and educational approach
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Educational approach for low back pain using Telerehabilitation platform.
**Intervention Names:**
- Other: Educational Approach
**Label:** Educational Approach
**Type:** SHAM_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Graded Activity based in exercises and educational approach
**Description:** Exercises for warming up, strengthening, and relaxation, along with informational sessions incorporating an educational approach for low back pain using Telerehabilitation platform. Participants will be randomized into two groups: the Experimental Group (EG), which will receive graded activity along with the educational approach, three times a week, over 12 sessions, totaling 4 weeks.
The intervention will involve adapting a protocol from an exercise program based on gradual activity with progressively increasing exercise intensity using web applications from Physitrack® Ltd., LDN, United Kingdom (used by the physiotherapist/researcher) and Physiapp® (used by the participant). Participants will be provided with (i) a welcome letter outlining the intervention/group components they are allocated to; (ii) instructions on how to use the Physiapp® web application (web browser, Android or iOS app) at home.
**Name:** Graded Activity based in exercises and educational approach
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Educational Approach
**Description:** Educational approach for low back pain using Telerehabilitation platform. Participants will receive educational materials with an isolated educational approach, with the delivery of the materials occurring three times a week.
**Name:** Educational Approach
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** Sociodemographic characteristics (gender, age, marital status, self-declared race), socioeconomic factors (years of education and individual income), main occupational activity they have performed throughout their lives, and whether they are still engaged in it at the time of the research, according to the Brazilian Classification of Occupations. Clinical characteristics will include anthropometric variables: self-reported weight and height for subsequent calculation of Body Mass Index, stratified according to age groups as recommended by the World Health Organization, alcohol and tobacco consumption, self-reported diseases, and behavioral variables such as level of physical activity assessed by the International Physical Activity Questionnaire. Additionally, participants will be asked about medication consumption, dosages, seeking healthcare professionals for LBP treatment.
**Measure:** Sociodemographic and clinics characteristics
**Time Frame:** The Sociodemographic and clinics characteristics will be evaluated at baseline (T0).
**Description:** For the assessment of Perception of Discrimination, the adaptation of the "Everyday Discrimination to the context of healthcare utilization" scale and adapted for the healthcare context will be used. It consists of 7 qualitative statements about the experience during the search for and treatment of the health condition, in this case, for LBP, and the higher the score, the more present the perception of discrimination.
**Measure:** Perception of discrimination
**Time Frame:** The Perception of Discrimination will be evaluated at 6 months (T3).
#### Primary Outcomes
**Description:** Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS). It is an 11-point scale ranging from 0 to 10, with zero indicating no pain and 10 indicating the most unbearable pain experienced by the participant. The subject will be asked about the presence of pain specifically localized to the lumbar region. Additionally, the frequency (every day, more than 15 days per month, between 8 and 15 days per month, between 1 and 7 days per month, or between 4 and 11 crises per year) and duration of symptoms (less than 2 years, 2 to 5 years, 6 to 10 years, more than 10 years) will be queried. The following definition of LBP will be utilized: "pain in the area between the 12th rib and the gluteal fold with or without leg pain.
**Measure:** Pain intensity
**Time Frame:** The participants' pain intensity will be evaluated at baseline (T0), after 12 sessions (T1), at 3 months (T2), and at 6 months (T3).
#### Secondary Outcomes
**Description:** The Roland-Morris Disability Questionnaire (RMDQ) will be used. This questionnaire assesses the impact of low back pain on work and daily life activities due to symptoms, and it is better recommended for a population with low functional disability. The instrument has been validated for Brazilian Portuguese, is quick and easy to administer, with an average response time of five minutes. Scores are obtained by summing the items, which range from zero (no disability) to 24 (severe disability). Scores higher than 14 indicate physical disability. The minimum clinically important difference is 5 points.
**Measure:** Functional disability
**Time Frame:** The participants' functional disability will be evaluated at baseline (T0), after 12 sessions (T1), at 3 months (T2), and at 6 months (T3).
**Description:** To assess quality of life, the 12-Item Short-Form Health Survey (SF-12) will be used as a quicker alternative to the 36-Item Health Survey. Comprising twelve items derived from the SF-36, the SF-12 assesses eight different dimensions influencing quality of life, considering the individual's perception of their health over the past four weeks. Each item has a set of responses distributed on a Likert-type scale, evaluating the following dimensions: physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Through the instrument's own algorithm, two scores can be measured: the physical component summary (PCS) and the mental component summary (MCS). In both, scores range from 0 to 100 points, with higher scores associated with better quality of life. Psychometric properties of the instrument have also been evaluated.
**Measure:** Quality of life Impact
**Time Frame:** The participants' quality of life will be evaluated at baseline (T0), after 12 sessions (T1), at 3 months (T2), and at 6 months (T3).
**Description:** For anxiety assessment, the State-Trait Anxiety Inventory (STAI) will be used, which has been translated and adapted for use in Brazil. The scale consists of 2 self-report scales that assess state and trait anxiety. The scale comprises 20 items scored from 1 to 4 each, resulting in a total score ranging from 20 to 80 points. For each question, the corresponding score is assigned, but for positively framed questions, the score is reversed. Scores \> 42 tend to indicate anxiety, while scores \< 38 tend to indicate depression. The STAI Manual suggests using the title "Self-Assessment Questionnaire" instead of the term Anxiety.
**Measure:** State-Trait Anxiety
**Time Frame:** The participants' State-Trait Anxiety will be evaluated at baseline (T0), after 12 sessions (T1), at 3 months (T2), and at 6 months (T3).
**Description:** The Fear Avoidance Beliefs Questionnaire (FABQ), translated into Brazilian Portuguese, contains two sub-scales that are evaluated separately: fear-avoidance beliefs related to work (FABQ-work) and physical activity (FABQ-physical). Fear avoidance related to physical activity will be considered present (score ≥15) or absent (\<15), while fear avoidance related to work will be considered present if the FABQ-work score is ≥ 34.
**Measure:** Fear Avoidance Beliefs
**Time Frame:** The participants' fear avoidance beliefs will be evaluated at baseline (T0), after 12 sessions (T1), at 3 months (T2), and at 6 months (T3).
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Self-identify as Black (Black or Brown), according to Brazilian Institute of Geography and Statistics (IBGE) classification;
* Age range from 18 to 65 years old;
* Both biological sexes (female and male);
* Sedentary or physically active participants;
* Present chronic low back pain with a score ≥ 3 on the Numeric Pain Rating Scale for more than 3 months and due to nonspecific causes;
* Able to read, write, and speak Brazilian Portuguese;
* Live in Brazil in urban or rural areas;
* Have access to the internet;
* Possess a device with internet access with a screen, camera, microphone, and speaker (smartphone, tablet, or computer); and
* Have a reasonable self-assessment ability to use the internet (through a 4-item scale from poor, fair, good to excellent).
Exclusion Criteria:
* History of traumatic injury.
* Previous surgery related to the lumbar spine.
* Undergoing cancer treatment.
* Presenting with any inflammatory rheumatological condition.
* Decompensated cardiovascular disorders.
* Presence of comorbidity or condition that may hinder active participation in the prescribed exercises to be performed at home.
* Severe psychological disorders.
* Pregnant individuals.
* Awaiting surgical procedure.
* Having undergone intervention including exercise or physiotherapeutic treatment in the last 3 months.
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Sao Paulo
**Country:** Brazil
**Facility:** Dept. Physical Therapy, Audiology and Speech Therapy at Medical School, University of Sao Paulo
**Zip:** 05360-000
#### Overall Officials
**Official 1:**
**Affiliation:** University of Sao Paulo
**Name:** Ingred Merllin B de Souza, MSc
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Document Section
### Large Document Module
#### Large Docs
- Date: 2023-03-08
- Filename: SAP_000.pdf
- Has ICF: False
- Has Protocol: False
- Has SAP: True
- Label: Statistical Analysis Plan
- Size: 106740
- Type Abbrev: SAP
- Upload Date: 2024-05-28T14:59
- Date: 2023-03-15
- Filename: ICF_001.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 254761
- Type Abbrev: ICF
- Upload Date: 2024-05-28T15:00
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4714
- Name: Back Pain
- Relevance: HIGH
- As Found: Back Pain
- ID: M19433
- Name: Low Back Pain
- Relevance: HIGH
- As Found: Low Back Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001416
- Term: Back Pain
- ID: D000017116
- Term: Low Back Pain
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443216
**Brief Title:** Sleep Modulation to Treat Depression
**Official Title:** Auditory Closed-loop Modulation of Slow Wave Sleep to Treat Major Depressive Disorder
#### Organization Study ID Info
**ID:** 2023-01804
#### Organization
**Class:** OTHER
**Full Name:** University of Geneva, Switzerland
### Status Module
#### Completion Date
**Date:** 2026-07
**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:** 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:** 2024-05-22
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Christoph Nissen
#### Responsible Party
**Investigator Affiliation:** University of Geneva, Switzerland
**Investigator Full Name:** Christoph Nissen
**Investigator Title:** Prof. Dr. med.
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Current first-line treatments for major depression (antidepressants and psychotherapy) show a long latency to response, and less than half of all patients experience full remission with optimized treatment, indicating the need for new developments. The aim of this study is to extend and further develop a longstanding line of research of using sleep neurophysiology as a 'window to the brain' and treatment development in major depression. Particularly, this project is designed to test the feasibility, efficacy and mechanisms of action of a new sleep-based treatment technology.
**Detailed Description:** The planned study is a single-centre, doubled-blind, randomized, sham controlled, repeated measures within-subject (stimulation and sham) study including patients with major depression and healthy controls, across four sleep laboratory nights (adaptation, baseline, stimulation and sham in counterbalanced order). The investigators will test the primary hypothesis that auditory-closed loop suppression of slow wave sleep will improve depressive clinical symptomatology compared to sham stimulation.
### Conditions Module
**Conditions:**
- Major Depressive Disorder
- Healthy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with major depressive disorder according to ICD-10 criteria
**Intervention Names:**
- Device: Auditory closed-loop stimulation
- Device: Sham stimulation
**Label:** Experimental Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Healthy controls
**Intervention Names:**
- Device: Auditory closed-loop stimulation
- Device: Sham stimulation
**Label:** Healthy Group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental Group
- Healthy Group
**Description:** Auditory closed-loop suppression of slow wave sleep
**Name:** Auditory closed-loop stimulation
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Experimental Group
- Healthy Group
**Description:** No auditory stimulation
**Name:** Sham stimulation
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Measure of the severity of depressive symptomatology
The scores range between 0 to 60. The higher the score, the more symptamology of depression the subjects presents.
**Measure:** Montgomery Åsberg Depression Rating Scale
**Time Frame:** Up to three weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Written informed consent
* MDD according to ICD-10 criteria (F32.1/2, F33.1/2; i.e. unipolar depression) for patient group
Exclusion Criteria:
* Relevant psychiatric disorders (other than MDD for the patient group), such as organic psychiatric disorders, lifetime history of substance dependency or current substance abuse (smoking will be allowed for recruitment reasons), schizophrenia or other psychotic disorders, affective disorders including bipolar disorder, borderline personality disorder, autism or other severe psychiatric disorders
* Known pregnancy
* Unstable medical conditions, such as unstable cardiovascular or metabolic disorders, etc.
* Relevant neurological disorders, including epilepsy, stroke, etc.
* Organic sleep disorders including relevant sleep apnea (AHI\>15/h), periodic limb movement disorder (PLMS index\>5/h), Restless-Legs-Syndrome (RLS), narcolepsy, circadian rhythm disorder or shift work/ jet lag
* Intake of medication affecting the central nervous system (other than antidepressants and lithium in patients); patients receiving benzodiazepines or (es)ketamine will not be included
* Current brain stimulation treatment, such as electroconvulsive therapy (ECT), TMS or deep brain stimulation
* Contraindications for tDCS or TMS studies, including but not limited to metal in the head/ brain or epilepsy
* Hearing impairment or tinnitus (auditory stimulation study)
* Inability to follow the procedures of the study (for example due to language problems)
* Left-handedness
**Healthy Volunteers:** True
**Maximum Age:** 60 Years
**Minimum Age:** 30 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** christoph.nissen@hug.ch
**Name:** Christoph Nissen, Prof. Dr. med.
**Phone:** +41.22.305.45.38
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Geneva
**Contacts:**
***Contact 1:***
- **Name:** Christoph Nissen, Prof. Dr. med.
- **Role:** CONTACT
**Country:** Switzerland
**Facility:** University of Geneva
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000019964
- Term: Mood Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000001526
- Term: Behavioral Symptoms
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7061
- Name: Depressive Disorder
- Relevance: HIGH
- As Found: Depressive Disorder
- ID: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depressive Disorder
- ID: M7060
- Name: Depressive Disorder, Major
- Relevance: HIGH
- As Found: Major Depressive Disorder
- ID: M21835
- Name: Mood Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003866
- Term: Depressive Disorder
- ID: D000003863
- Term: Depression
- ID: D000003865
- Term: Depressive Disorder, Major
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443203
**Brief Title:** Multimodal Prehabilitation in Colorectal Cancer Patients
**Official Title:** A Randomized Controlled Clinical Trial on Multimodal Prehabilitation in Colorectal Cancer Patients to Improve Functional Capacity and Lower Postoperative Complications.
#### Organization Study ID Info
**ID:** 849/2019/Sper/AUSLFe
#### Organization
**Class:** OTHER
**Full Name:** University Hospital of Ferrara
#### Secondary ID Infos
**Domain:** Italian Ministry of Health
**ID:** RF-2018- 12367272
**Type:** OTHER_GRANT
### 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:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-06-15
**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:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital of Ferrara
#### Responsible Party
**Investigator Affiliation:** University Hospital of Ferrara
**Investigator Full Name:** Carlo Feo
**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:** Postoperative complications can occur in up to 50% of individuals undergoing colorectal resection and are associated with poor prognosis, increased costs, and lower health-related quality of life. Even in the absence of complications, after major surgery, patients reduce their physiological and functional capacity by 20-40% and show a higher level of fatigue for 6-8 weeks. Many of these negative effects can be decreased by applying specific ERAS (Enhanced Recovery After Surgery) programs which, by attenuating the neuro-endocrine response induced by surgical trauma, accelerate patients\' post-operative convalescence and facilitate their return to functional activities.
In this study, the research group hypothesizes that a prehabilitation program based on physical exercise, nutritional optimization and psychological support (trimodal) carried out by patients in the 4 weeks before elective colorectal resection surgery can determine: 1) better physical performance 8 weeks after surgery (measured by the 6-minute walk test), 2) a possible decrease in postoperative complications, and 3) a reduction in in-hospital (direct) and post-hospital discharge (indirect) costs.
**Detailed Description:** This study aims to determine the effect of prehabilitation on patients\' functional capacity and postoperative complications. It is a randomized trial including 112 patients undergoing colorectal surgery for cancer. Patients will be allocated to intervention group receiving 4 weeks trimodal prehabilitation (N=56) or control group receiving no prehabilitation (N=56). After surgery, both groups will follow 8 weeks rehabilitation based on Enhanced Recovery After Surgery (ERAS) guidelines. The primary endpoint is functional capacity, secondary outcomes include postoperative complications and a cost-effectiveness analysis. Multimodal prehabilitation is expected to increase functional capacity and lower postoperative complications.
### Conditions Module
**Conditions:**
- Colon Cancer
- Prehabilitation
**Keywords:**
- prehabilitation
- colorectal surgery
- functional capacity
- six-minute walking test
- post-operative outcomes
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized controlled clinical trial
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- CARE_PROVIDER
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 112
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** physical exercise, psychological support and nutritional optimization 4-weeks before surgery
**Intervention Names:**
- Other: Trimodal prehabilitation
**Label:** Trimodal prehabilitation
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients no receiveing prehabilitation and undergoing standard rehabilitation alone after surgery
**Label:** control group without preoperative prehabilitation
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Trimodal prehabilitation
**Description:** Trimodal prehabilitation program (4-week physical exercise before surgery, nutritional optimization, and psychological support) in patients undergoing ERAS colorectal resection for cancer
**Name:** Trimodal prehabilitation
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The primary outcome for functional capacity was measured by the 6-Minute Walking Test (6MWT), chosen as a validated, objective measure of colorectal surgery recovery integrating all components of physical activity.
**Measure:** Postoperative functional capacity
**Time Frame:** From enrollment to the end of treatment at 8 weeks after surgery
#### Secondary Outcomes
**Description:** To evaluate post-operative complications, the Clavien-Dindo classification has been used as a combined measure of morbidity and mortality.
**Measure:** Post-operative complications
**Time Frame:** Within 30 days after surgery
**Description:** To evaluate the length of postoperative hospital stay
**Measure:** Hospital length of stay
**Time Frame:** Within 30 days after surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* patients of age \>18 years;
* elective colorectal resection for colonic cancer.
Exclusion Criteria:
* metastatic disease;
* severe walking impairments;
* renal failure stage \>2;
* ASA score \>3;
* preoperative chemo-radiation therapy.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** fcl@unife.it
**Name:** CARLO CF FEO, MD FACS
**Phone:** +39 3282198106
**Role:** CONTACT
**Contact 2:**
**Email:** antonio.pesce@unife.it
**Name:** ANTONIO AP PESCE, MD PhD FACS
**Phone:** +39 3286680943
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Ferrara
**Contacts:**
***Contact 1:***
- **Email:** ilaria.panzini@ausl.fe.it
- **Name:** Ilaria IP Panzini, MD
- **Phone:** +390532235548
- **Role:** CONTACT
***Contact 2:***
- **Name:** Carlo CF Feo, MD FACS
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Antonio AP Pesce, MD PhD FACS
- **Role:** SUB_INVESTIGATOR
**Country:** Italy
**Facility:** Unità Operativa Qualità, Accreditamento, Ricerca organizzativa
**Status:** RECRUITING
**Zip:** 44123
#### Overall Officials
**Official 1:**
**Affiliation:** Università degli Studi di Ferrara
**Name:** Carlo CF Feo, MD FACS
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Bojesen RD, Dalton SO, Skou ST, Jorgensen LB, Walker LR, Eriksen JR, Grube C, Justesen TF, Johansen C, Slooter G, Carli F, Gogenur I. Preoperative multimodal prehabilitation before elective colorectal cancer surgery in patients with WHO performance status I or II: randomized clinical trial. BJS Open. 2023 Nov 1;7(6):zrad134. doi: 10.1093/bjsopen/zrad134.
**PMID:** 38060453
**Citation:** Molenaar CJL, Minnella EM, Coca-Martinez M, Ten Cate DWG, Regis M, Awasthi R, Martinez-Palli G, Lopez-Baamonde M, Sebio-Garcia R, Feo CV, van Rooijen SJ, Schreinemakers JMJ, Bojesen RD, Gogenur I, van den Heuvel ER, Carli F, Slooter GD; PREHAB Study Group. Effect of Multimodal Prehabilitation on Reducing Postoperative Complications and Enhancing Functional Capacity Following Colorectal Cancer Surgery: The PREHAB Randomized Clinical Trial. JAMA Surg. 2023 Jun 1;158(6):572-581. doi: 10.1001/jamasurg.2023.0198. Erratum In: JAMA Surg. 2023 May 3;:
**PMID:** 36988937
**Citation:** Carli F, Charlebois P, Stein B, Feldman L, Zavorsky G, Kim DJ, Scott S, Mayo NE. Randomized clinical trial of prehabilitation in colorectal surgery. Br J Surg. 2010 Aug;97(8):1187-97. doi: 10.1002/bjs.7102.
**PMID:** 20602503
**Citation:** Gillis C, Fenton TR, Sajobi TT, Minnella EM, Awasthi R, Loiselle SE, Liberman AS, Stein B, Charlebois P, Carli F. Trimodal prehabilitation for colorectal surgery attenuates post-surgical losses in lean body mass: A pooled analysis of randomized controlled trials. Clin Nutr. 2019 Jun;38(3):1053-1060. doi: 10.1016/j.clnu.2018.06.982. Epub 2018 Jul 9.
**PMID:** 30025745
## Document Section
### Large Document Module
#### Large Docs
- Date: 2018-05-20
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 273200
- Type Abbrev: Prot_SAP
- Upload Date: 2024-05-21T05:14
## 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: 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: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
- 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:** NCT06443190
**Brief Title:** Indigenous-Led Transition Pathway for Young Adults
**Official Title:** The Impact of a Novel Indigenous-Led Patient Navigator Service for Transition-Age Youth
#### Organization Study ID Info
**ID:** Pro00138085
#### Organization
**Class:** OTHER
**Full Name:** University of Alberta
### 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:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**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:** University of Alberta
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The objective of this pathway is to establish and evaluate a novel Indigenous-led patient navigator (IPN) program for Indigenous adolescents living with chronic health conditions in Maskwacis, Alberta. Over the last three years a community-based participatory research partnership was developed with Elders and community members from Maskwacis, Maskwacis Health Services, and researchers from the University of Alberta. Previous research identified the need for an IPN to support Indigenous young adults and their caregivers in managing their health conditions transitioning into adulthood and transferring from pediatric to adult healthcare. The aim of partnership now is to evaluate whether a community-derived IPN program co-designed with an established group of Maskwacis Elders, Knowledge Keepers, healthcare providers, caregivers and youth with lived experience can aid in improving the experience of transitioning into adult healthcare services for Indigenous youth and their families living in Maskwacis, Alberta.
**Detailed Description:** Purpose: to implement and evaluate a novel Indigenous Patient Navigator (IPN) pathway for Indigenous young adults with complex and chronic medical conditions, and their families, living in Maskwacis, AB learning to manage their health condition transitioning into adulthood.
Hypothesis: the Indigenous-Led Pathway for Young Adults will provide substantial benefits to youth and families, including but not limited to cultural ceremony and Elder-support, emotional support, accessing medical appointments and preventing loss to follow-up, feeling engaged with the adult health care system, developing self-management and self-advocacy skills, and reducing feelings of anxiety and isolation. The investigators expect the pathway will improve the health of Indigenous adolescents and young adults living with chronic health conditions in Maskwacîs, ultimately improving the wellbeing of the entire community.
Justification: The investigators' previous research has identified key barriers to care included finances (e.g., cost and availability of transportation to healthcare appointments), intergenerational trauma making it difficult to prioritize the health condition, racism and discrimination in health care settings, lack of cultural safety, and loss of benefits at age 18 (e.g., Jordan's Principle does not apply to young adults). Facilitating factors identified include family support and culture, peer support networks, health condition education, and having safe spaces in healthcare settings where Indigenous imagery and medicines were visibly displayed.
During a series of in-person meetings with our Community Advisory Committee (CAC) the Investigators discussed study findings and possible strategies to address them. The Elders and Knowledge Keepers concluded that a community-based, Indigenous-led patient navigator service would be a logical approach to helping transition-age youth navigate the healthcare system between pediatric and adult care. It was felt that both the barriers and facilitators summarized above provided evidence for the need for an IPN, and that an IPN could help mitigate some of the social determinants of health that prevent adolescents and young adults from attending medical appointments, filling prescriptions, and managing their health condition(s). IPN programs in Canada exist in acute care settings, children's hospitals, cancer care, and adult outpatient settings. To the Investigators' knowledge, a community based IPN program focusing on transition age youth does not yet exist in Canada.
Objectives
1. To strengthen the existing partnership with the CAC and Maskwacis Health Services, through regular gatherings, engaging in ceremony and traditions, respecting cultural protocol, encouraging feedback, and ensuring our committee members guide the project's activities to benefit the community in a good way.
2. To co-design and implement a novel IPN service for Indigenous adolescents with special health care needs residing in Maskwacis through community engagement sessions and meetings with senior management of Maskwacis Health Services and Alberta Health Services.
3. To evaluate the IPN service, addressing the following questions:
1. How do Indigenous youth transitioning into adult care describe their experiences of transitioning, the role of the IPN in helping them through this transition, and the impact of the IPN program on the Indigenous perspective of health and wellness?
2. How can these findings promote improved outcomes for Indigenous youth in transition?
4. To create sustainability of the IPN role within the Maskwacis community and enable the creation of an IPN program for transition-age youth in other Indigenous communities in Alberta, both on- and off-reserve.
Research Method/Procedures
Study design and setting: Qualitative study to evaluate an IPN program using a community-based participatory action research approach. The study will be conducted with and within the community of Maskwacis, Alberta, Maskwacis Health Services and the Awasisak Indigenous Health Program at the Stollery Children's Hospital. Maskwacis is located approximately 90 km southeast of Edmonton. It has a population of \~18 000 residents divided among Four Nations (Samson, Louis Bull, Ermineskin, Montana) and a small satellite location in Pigeon Lake.
Participant Recruitment: The CAC and community members will assist Investigators to find ways to recruit participants from the community. A community-based research assistant (RA) will approach potentially eligible participants at participating recruitment clinics.
IPN Role: The IPN role will be co-designed and implemented based on thorough community engagement including the CAC, Alberta Health Services and Maskwacis Health Services. Allowing flexibility within the role and developing the IPN role with guidance from the CAC and community will allow the IPN to serve participants, families and the community in the most appropriate and effective way.
Below is a list of supports that may potentially be provided to participants by the IPN:
1. Connect participants with community supports including housing, social assistance, disability payments, education, and employment opportunities.
2. Connect participants with cultural resources: cultural programming and events, ceremony, connection with Elders.
3. Scheduling primary care and/or specialty care appointments as appropriate to address specific medical/mental health needs.
4. Accessing transportation to medical and social service appointments.
5. Providing in person support and advocacy for participants during health care appointments.
6. Work with the participant to create a smart phone-based health passport containing key information about their health condition, names and doses of medications, schedule of upcoming appointments, and contact names, phone number and addresses for their doctors, nurses, and allied health professionals. For participants not having access to a smartphone, this information will be provided on a wallet-sized card.
7. Support adherence to follow-up clinic visits and health maintenance including completing clinically indicated laboratory tests and obtaining prescription refills as needed.
8. Assist with financial and insurance paperwork (e.g., Jordan's Principal, Non-Insured Health Benefits, Alberta Income for the Severely Handicapped).
9. Promote self-management skills by providing tools, educational resources, and coaching.
10. Facilitate in-person group sessions open to all participants at a community hall. Group sessions reduce isolation, empower youth to build connections, advocate for themselves and each other, and incorporate Indigenous cultural ceremonies.
Navigators will use electronic technology (cell phone, email, text message, social media) to maintain contact and provide support for participants. The needs of each participant will vary and hence the program will be participant and family-centered and specific. There will be no a priori limits on the frequency of contact between the navigator and participant; contact may be as frequent as daily, or as infrequently as every 2 months at a minimum, depending on participants' needs.
Health Information Access + Documentation:
Participants will be asked for permission for the research team and IPN to review their health information within their Electronic Medical Record within Alberta Health Services and Maskwacis Health Services databases, so the IPN can understand their health condition and how they use the health care system during this transition. The IPN will record every contact and nature of assistance provided using the AHS EMR Connect Care, in a standardized encounter format.
IPN training: Plan for an Indigenous identifying individual who has a minimum of a Bachelor of Social Work or a Bachelor of Science in Nursing, and experience working with adolescents and/or young adults in a community setting. The IPN will be trained by a) other IPNs in Alberta (e.g., Four Winds Program, led by team member Dr. Oster), b) staff at the Awasisak Indigenous Health Program at the Stollery with AHS onboarding and orientation as appropriately determined by the reporting manager, c) a non-Indigenous patient navigator at the Stollery, affiliated with the Transition Navigator Trial led by team member Dr. Mackie, and d) staff at Maskwacis Health Services. The IPN will receive privacy and confidentiality training as per TCPS-2, as well as AHS Privacy and Confidentiality Training. Most importantly, the IPN will be continually involved with the team's CAC to receive guidance and feedback on the IPN role and implementation and engage in ceremony.
Study Logistics:
1. Navigator Meeting: The IPN will schedule a face-to-face meeting with the participant, or with caregiver(s) if the participant has developmental delay precluding their participation independent of a caregiver, or both. Prior to the meeting the IPN will review the electronic medical record of the youth participant to understand their health condition and access of healthcare. During this meeting the IPN will complete an assessment of the participant's healthcare needs and learn about the participant's journey with their health condition, as well as build trust and rapport with the family. Using the information from both the interview, as well as from review of their electronic medical record, the navigator will create an individual-centered transition plan, in collaboration with the participant, caregiver(s), and if needed with community partners.
2. Navigator support: Participants will then work with the IPN for up to 18 months. Support offered by the IPN is previously described under "IPN Role".
3. Peer Support Sessions + Talking Circles: The IPN will organize peer support sessions for study participants held every 3 months in-person in Maskwacis. Both youth participants and caregiver participants are invited to take part in peer support sessions. The purpose of these sessions will be to build a sense of community for youth living with chronic health conditions and their caregivers, reduce isolation, and empower participants to develop self-management and self-advocacy skills together in an engaging and fun environment. Life skills topics such as budgeting and job interviewing will be included. A community Elder will attend the peer sessions to provide cultural ceremony and share traditional teachings such as smudging and prayer. During the sessions talking circles will be offered for participants to engage in discussion with Elders and each other regarding their experience working with the IPN. Participants may attend as many or as little of the peer support sessions as they wish.
4. Exit Interview: Participants will complete a follow-up semi-structured interview, held either in-person or virtually, conducted by the RA to ask about their experience receiving IPN support. Feedback will be elicited on what aspects of IPN support was helpful and what could be improved upon. Healthcare providers who work at clinic sites where recruitment took place will also be asked to take part in an individual interview about how the IPN service impacted their practice and care provision to Indigenous youth and their families.
### Conditions Module
**Conditions:**
- Chronic Diseases in Adolescence
**Keywords:**
- transition
- Indigenous
- community based participatory action research
- health care navigator
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will work with an Indigenous Patient Navigator (IPN) for up to 18 months. The IPN may have the following roles in supporting the youth +/- their caregiver in managing their healthcare and health condition:
* Spiritual: connect with community Elders, connect with cultural programs, arrange smudging and ceremony
* Physical: find housing, find a family doctor, arrange transportation, fill prescriptions, create a health passport
* Mental: arrange health benefits, schedule appointments, find employment, connect to community services
* Emotional: connect with peers, find mental health supports, support youth at appointments, communicate with youth's healthcare team
**Intervention Names:**
- Other: Indigenous Patient Navigator Support
**Label:** Indigenous Patient Navigator Support
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Indigenous Patient Navigator Support
**Description:** See Arm Description
**Name:** Indigenous Patient Navigator Support
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Participants will complete a follow-up semi-structured interview, held either in-person or virtually, conducted by the RA to ask about their experience receiving IPN support. Feedback will be elicited on what aspects of IPN support was helpful and what could be improved upon. Healthcare providers who work at clinic sites where recruitment took place will also be asked to take part in an individual interview about how the IPN service impacted their practice and care provision to Indigenous youth and their families. All interviews will be recorded and transcribed verbatim, and NVivo software will be used for analysis. Thematic analysis will be used to extrapolate and systematically analyze patterns in the data generated by the qualitative data.
**Measure:** Qualitative Analysis - Semi-structured interviews
**Time Frame:** 18 months
#### Secondary Outcomes
**Description:** Talking circles will be offered during the peer support sessions and facilitated by a community Elder. Participants will be asked about their transition experience moving from pediatric to adult care, how the IPN helped them (or didn't help them) to manage their health care and health condition, and how the IPN impacted their health and wellness. All interviews will be recorded and transcribed verbatim, and NVivo software will be used for analysis. Thematic analysis will be used to extrapolate and systematically analyze patterns in the data generated by the qualitative data.
**Measure:** Qualitative Analysis - Talking circles
**Time Frame:** 18 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* age 16-25 years;
* having a pediatric-onset chronic health condition of at least 3 months' duration that requires adult specialty follow-up care, including physical conditions (e.g., diabetes), mental health conditions (e.g., anxiety, depression), and/or developmental disorders (e.g., autism, fetal alcohol spectrum disorder);
* residing in Maskwacis;
* self-identified as an Indigenous person;
* reading level ≥ grade 6. For participants with developmental or intellectual delay (\< grade 6 reading level), they may take part in the program alongside their caregiver(s).
Exclusion Criteria:
* not identifying as Indigenous
* not residing in Maskwacis
**Maximum Age:** 25 Years
**Minimum Age:** 16 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Edmonton
**Contacts:**
***Contact 1:***
- **Email:** alyssa.chappell@albertahealthservices.ca
- **Name:** Alyssa Chappell, BScN, RN
- **Phone:** 7807774418
- **Role:** CONTACT
***Contact 2:***
- **Name:** Andrew S. Mackie, MD, SM
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Richard Oster, PhD
- **Role:** SUB_INVESTIGATOR
**Country:** Canada
**Facility:** Stollery Children's Hospital
**State:** Alberta
**Zip:** T6G 2R3
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M6147
- Name: Chronic Disease
- Relevance: HIGH
- As Found: Chronic Disease
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002908
- Term: Chronic Disease
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443177
**Brief Title:** The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage
**Official Title:** The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage
#### Organization Study ID Info
**ID:** IRB-300012920
#### Organization
**Class:** OTHER
**Full Name:** University of Alabama at Birmingham
#### Secondary ID Infos
**Domain:** UAB
**ID:** UAB
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-07-31
**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:** 2026-03-31
**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:** 2024-05-06
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Alabama at Birmingham
#### Responsible Party
**Investigator Affiliation:** University of Alabama at Birmingham
**Investigator Full Name:** Jesse G. A. Jones, MD
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The purpose of the study is to see that in addition to existing therapy, how well an additional procedure named spinal cord stimulation might reduce blood vessel spasm from aneurysm rupture.
**Detailed Description:** The Investigators' overarching hypothesis is that sympathetic innervation plays a substantial role in conferring cerebral vasospasm (CVS) risk to aneurysmal subarachnoid hemorrhage (aSAH) patients and is associated with severity of clinical features and outcomes. Specifically, the Investigators surmise that central (hypothalamic) and local (arterial adventitia) sympathetic inputs are upregulated following SAH and integrate at the level of the neuromuscular junction to abnormally increase cerebrovascular tone. The long-term goal of this program is to use orthogonal approaches to undertake a comprehensive electrophysiological, functional genomics, and advanced imaging analysis of CVS. The Investigators hope is these data inform therapeutic pathways to modulate implicated pathogenic mechanisms and reduce CVS incidence and severity, thereby improving overall clinical outcomes in aSAH. In the short-term, the Investigators will focus on elucidating the modulatory role of cervical spinal cord stimulator (SCS) on sympathetic innervation to the cerebral vasculature.
This is a Phase 2 prospective, randomized single center study assessing the safety and efficacy of SCS for reducing vasospasm. aSAH patients who meet inclusion criteria and provide informed consent will be randomly assigned to SCS or a sham procedure. Subjects will be blinded until the end of the study, with no allowance for crossover. Temporary leads will stimulate, utilizing a paradigm established from prior human studies and the effect measured with daily transcranial doppler (TCD). Leveraging prior experience in vascular and functional neurosurgery, the Investigators' group is poised to make a substantial impact. Below the Investigators outline a feasible framework to modulate sympathetic drivers of CVS.
Aim 1: Perform feasibility analysis of SCS placement and operation in the aSAH setting. It is presently unknown how temporary SCS will impact the workflow and care of patients with acutely ruptured cerebral aneurysms. Given the rate of new aSAH cases at the Investigators' center (\~50 per year), initiation of prospective data collection and longitudinal study are required. The Investigators will comprehensively assess operative time for electrode implantation, lead function and data transmission efficiency in the ICU, site infection/pressure injury and untoward systemic effects (hypotension, arrhythmia) for all patients enrolled at the Investigators' center.
Aim 2: Quantify the sympathetic modulating effect of SCS on cerebral blood flow during CVS. Further characterization of the sympathetic contribution to CVS will establish a rationale for functional/neuromodulatory therapies such as SCS. The Investigators will perform cervical epidural stimulation through temporary leads and monitor effects on cerebral blood flow by daily TCD. Experiments will continue throughout the 14-day CVS window to capture longitudinal changes in sympathetic tone and vascular response. Quantitative TCD metrics (velocity, resistance, Lindegaard ratio) will be compared between on- and off-stimulation epochs. The Investigators' study will not only fundamentally advance the Investigators' understanding of vasospasm, but also provide a framework to elucidate mechanisms of other cerebrovascular conditions.
### Conditions Module
**Conditions:**
- Vasospasm, Cerebral
- Aneurysmal Subarachnoid Hemorrhage
**Keywords:**
- aSAH
- CVS
- Sympathetic Modulation
- Ruptured brain aneurysm
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 25
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants randomized to receive temporary electrode inserted through the skin into the epidural space of participants upper back/lower neck.
**Intervention Names:**
- Device: Vectris trial leads and stimulation
**Label:** Spinal Cord Stimulation
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants randomized to not receive temporary electrode.
**Intervention Names:**
- Device: Sham
**Label:** Sham Comparator
**Type:** SHAM_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Spinal Cord Stimulation
**Description:** The electrode is placed into the epidural space using standard epidural placement techniques with paramedian approach. The initial electrode settings have been adopted from prior studies. Should any significant discomfort be elicited from the stimulation, first the amplitude will be decreased to an acceptable level. If an acceptable level of stimulation is unable to be found, the stimulation will be discontinued.
**Name:** Vectris trial leads and stimulation
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Sham Comparator
**Description:** No electrode is placed.
**Name:** Sham
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Pre-SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
**Measure:** Pre-Cerebrovascular response - Velocity
**Time Frame:** Day 1 - Day 14
**Description:** Pre-SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
**Measure:** Pre-Cerebrovascular response - Resistance
**Time Frame:** Day 1 - Day 14
**Description:** Pre-SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
**Measure:** Pre-Cerebrovascular response - Lindegaard ratio
**Time Frame:** Day 1 - Day 14
**Description:** Post SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
**Measure:** Post-Cerebrovascular response - Velocity
**Time Frame:** Day 1 - Day 14
**Description:** Post SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
**Measure:** Post-Cerebrovascular response - Resistance
**Time Frame:** Day 1 - Day 14
**Description:** Post SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
**Measure:** Post-Cerebrovascular response - Lindegaard ratio
**Time Frame:** Day 1 - Day 14
**Description:** Daily transcranial Doppler studies will be performed to obtain quantitative data on cerebrovascular response during the critical 14-day vasospasm window.
**Measure:** Transcranial Doppler (TCD) velocities of cerebral arteries
**Time Frame:** Day 1 - Day 14
#### Secondary Outcomes
**Description:** Overall survival is defined for all patients and measured from time of treatment to death or end of a study. The analyses for overall survival will be like that of the primary endpoint. It will also utilize Kaplan Meier methods and Cox proportional hazards modeling to compare the overall survival to the treatment-dependent prognosis index.
**Measure:** Overall Survival
**Time Frame:** Through study completion, approximately 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Diagnosed with Fisher grade 3 or 4 aneurysmal subarachnoid hemorrhage (1)
4. Ability to undergo endovascular treatment of aneurysmal subarachnoid hemorrhage
5. For females of reproductive potential: Negative pregnancy test at time of treatment
6. Plan to undergo standard of care and follow-up
Exclusion Criteria:
1. Medically unfit to undergo endovascular treatment (e.g., Hunt Hess grade 5)
2. Does not provide consent for the procedure.
3. Posterior circulation aneurysmal subarachnoid hemorrhage.
4. Initial aneurysm treatment after post bleed day 1
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** jessejones@uabmc.edu
**Name:** Jesse Jones, MD
**Phone:** 205-934-7170
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Birmingham
**Country:** United States
**Facility:** University of Alabama at Birmingham
**State:** Alabama
**Zip:** 35233
#### Overall Officials
**Official 1:**
**Affiliation:** University of Alabama at Birmingham
**Name:** Jesse Jones, MD
**Role:** PRINCIPAL_INVESTIGATOR
## 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: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC04
- Name: Neoplasms
### Condition Browse Module - Browse Leaves
- ID: M4113
- Name: Aneurysm
- Relevance: LOW
- As Found: Unknown
- ID: M16135
- Name: Subarachnoid Hemorrhage
- Relevance: HIGH
- As Found: Subarachnoid Hemorrhage
- ID: M9556
- Name: Hemorrhage
- Relevance: HIGH
- As Found: Hemorrhage
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: LOW
- As Found: Unknown
- ID: M22114
- Name: Vasospasm, Intracranial
- Relevance: HIGH
- As Found: Cerebral Vasospasm
- 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: D000020301
- Term: Vasospasm, Intracranial
- ID: D000006470
- Term: Hemorrhage
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443164
**Brief Title:** Efficacy of a Chronic Pain Treatment Prior to Gender-affirming Surgery
**Official Title:** Efficacy of a Single-session Treatment for Reducing Chronic Pain Prior to Gender-affirming Surgery
#### Organization Study ID Info
**ID:** STUDY00026520
#### Organization
**Class:** OTHER
**Full Name:** Oregon Health and Science University
### Status Module
#### Completion Date
**Date:** 2025-01-31
**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:** 2025-01-31
**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:** 2024-03-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Oregon Health and Science University
#### Responsible Party
**Investigator Affiliation:** Oregon Health and Science University
**Investigator Full Name:** Jenna Stapleton
**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 primary objective of this study is to examine a single-session, 2-hour group intervention provided to a population of transgender or gender-diverse patients with chronic pain prior to gender-affirming surgery, to determine if participants who receive the intervention have less pain-related distress compared to participants randomly assigned to the control group.
**Detailed Description:** The primary objective of this study is to examine a single-session, 2-hour group intervention provided to a population of transgender and gender-diverse patients with chronic pain prior to gender-affirming surgery, to determine if participants who receive the intervention have less pain-related distress compared to participants randomly assigned to the control group. This study will help extend the research literature on chronic pain experienced by transgender patients, and specifically will examine if a brief, group intervention is effective for reducing pain catastrophizing and pain distress prior to surgery.
Safety and effectiveness of the Empowered Relief intervention used in this study has been demonstrated in multiple clinical trials, but has not been studied yet with this particular population. The Empowered relief intervention was created by Beth Darnall © Stanford University.
The hypothesis of this research study is that transgender patients with chronic pain who receive the group intervention, prior to having a gender-affirming surgery, will have lower scores on the pain catastrophizing scale after completing the intervention compared to participants in the control group:
Hypothesis: µ1 \<(\<=) µ2. The primary endpoint of this study is to test if the mean change in the score on the Pain Catastrophizing Scale is different between the treatment and the control group. The secondary endpoint, is to examine if pain severity scores decreased. An exploratory endpoint, after data collection and analysis is complete, is to run a focus group with participants who received the intervention to learn more about their experience to inform future treatment and research. Safety endpoints are that participants will receive informed consent, which will include learning they may discontinue participation in the study at any time, as well as procedures for maintaining confidentiality of identifying information. Each person screened will already be referred to the Transgender Health Program by a primary care provider and/or mental health provider. If screening indicates that a person has severe depression or regular thoughts involving suicidal content, then that person will not be included in the study but instead will be offered resources and highly recommended to contact their referring provider for additional support.
### Conditions Module
**Conditions:**
- Transgenderism
- Pain Catastrophizing
- Pain, Chronic
- Gender Identity
**Keywords:**
- Chronic Pain
- Gender Diversity
- Gender Affirming Surgery
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Interventional Group Control Group
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 78
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Pain Management Class Prior to Gender Affirming Surgery
**Intervention Names:**
- Behavioral: Empowered Relief
**Label:** Pain Management Class
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** SOC for Gender Affirming Surgery
**Intervention Names:**
- Other: Standard of Care
**Label:** SOC - No Class
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Pain Management Class
**Description:** Pain Management Course that has been used to treat pain in patients with different pain conditions.
**Name:** Empowered Relief
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- SOC - No Class
**Description:** Gender Affirming surgery without any attention to pain conditions prior to surgery.
**Name:** Standard of Care
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** This measure is a 13-item self-assessment instrument of pain-related negative thoughts, and measures constructs of rumination, magnification and helplessness. It is the primary outcome measure of this research study. Each item is measured on a 5-point Likert scale, with endpoints 0 (not at all) to 4 (all the time) and possible scores ranging from 0-52. In a clinical setting, such as a pain clinic providing treatments for chronic pain, a score on this measure of "10" or higher indicates a person could benefit from treatment; however, the published cut-off scores are higher and as follows: a Total Score of 20 is considered in the average range (50th percentile), and a Total Score of \>= 30 is above average (75th percentile). This measure is shown to have excellent internal consistency (coefficient alphas: total PCS = .87, rumination = .87, magnification = .66, and helplessness = .78.
**Measure:** Pain Catastrophizing
**Time Frame:** Participants will be assessed as part of a cohort for up to 7 months. There will be a total of three cohorts.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. affiliated with the OHSU Transgender Health Program and have completed their initial consultation for gender-affirming surgery,
2. who have chronic pain (defined as \> 3 months of pain),
3. who rate their average level of pain intensity as at least a 4 or higher (on 0-10 pain scale)
4. who have fluency in English. Empowered Relief may only be delivered by a certified instructor, and for this research study the instructor is only able to offer the curriculum in English.
Exclusion Criteria:
1. have had a pain-focused behavioral therapy in the past year, or
2. have severe depression and/or moderate or higher risk of suicidality based on the person's score on the PHQ-9 greater than 20.
**Gender Based:** True
**Gender Description:** Anyone who identifies as gender diverse or transgender and seeking gender affirming surgical care.
**Healthy Volunteers:** True
**Maximum Age:** 100 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** stapletj@ohsu.edu
**Name:** Jenna W. Stapleton, PhD
**Phone:** 503-418-1980
**Role:** CONTACT
**Contact 2:**
**Email:** fellersa@ohsu.edu
**Name:** Sarah L. Feller, BS
**Phone:** 503-494-6233
**Role:** CONTACT
### IPD Sharing Statement Module
**Description:** If information is shared in the future outside OHSU it will be deidentified and shared as a data set.
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M29442
- Name: Chronic Pain
- Relevance: HIGH
- As Found: Chronic Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: HIGH
- As Found: Chronic
### Condition Browse Module - Meshes
- ID: D000059350
- Term: Chronic Pain
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443151
**Brief Title:** Role of Endothelial Function in SCI CVD Risk
**Official Title:** Role of Vascular Endothelial Function After Spinal Cord Injury Related Cardiovascular Disease Risk
#### Organization Study ID Info
**ID:** 2016729-2
#### Organization
**Class:** OTHER
**Full Name:** Craig Hospital
### 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:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-03-30
**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:** 2024-05-07
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Colorado, Boulder
#### Lead Sponsor
**Class:** OTHER
**Name:** Craig 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:** Individuals with spinal cord injury have heart attacks and strokes more frequently, and much earlier in life. People with spinal cord injuries develop plaque in vessels much faster, and the reasons why are unclear. Doctors generally attributed the increased risk with weight gain and developing diabetes, but many studies have shown that even without these common factors, plaque in vessels is developing more often and faster. Endothelial cells are a single layer of cells that line all vessels in the body and plays an important role in vessel health. Damage to endothelial cells is known to lead to heart attacks and strokes. Past studies on endothelial cells of people with spinal cord injury have been unclear. The investigators have new data that these cells are unhealthy after spinal cord injury a measurement. This includes measuring endothelial health by directly altering its function using a catheter in the arm and measuring small particles in blood called endothelial microvesicles. If the project is successful, the investigators will learn important information on the health of endothelial cells after spinal cord injury. The investigators will also be able to use these markers of endothelial cell function to create treatments to improve vessel health and prevent heart attacks and strokes later in life in people with spinal cord injury.
**Detailed Description:** Adults with spinal cord injury (SCI) demonstrate accelerated atherosclerotic cardiovascular disease (ASCVD) occurring \~4 fold more often, and decades earlier in life. Importantly, atherosclerosis has been detected in people with SCI independent of traditional risk factors, much earlier in life, and appear recalcitrant to conventional risk mitigating inventions such as exercise and diet. Also, as disease is silent, many individuals are not screened for this atherosclerotic burden and only aware after the major vascular event of a myocardial infarction or stroke. The mechanisms which drive early ASCVD is unknown. Endothelial cell dysfunction precedes radiographic or angiographic evidence of atherosclerosis, and plays a central role in the development, progression and severity of atherosclerotic vascular disease. While it has been suggested that SCI results in compromised endothelial health, there is little empirical data on the degree or scope of impairment as well as mechanisms underlying any potential impairment. Endothelial dysfunction may be an important factor underlying the increased risk and prevalence of ASCVD and associated events in adults with SCI and a viable target for therapeutic intervention. Preliminary data suggests primary endothelial cell impairment related to its vasodilator function and provide potential mechanisms related to oxidative stress burden. The investigators also present the potential of endothelial cell derived microvesicles as a biomarker and mediator of endothelial cell dysfunction. The aim of this proposal is to determine whether endothelial function is impaired in adults with SCI. Our hypothesis is that endothelium-dependent vasodilation is impaired in adults with SCI and oxidative stress and endothelial cell derived microvesicles contribute to this dysfunction. Results supporting this hypothesis will: 1) provide mechanistic insight into the excess risk of ASCVD in adults with SCI; 2) identify therapeutic targets for reducing cardiovascular risk in this population; and 3) provide scientific rationale for vascular-related treatment clinical trials aimed at improving vascular health and reducing cardiovascular risk in individuals with SCI.
### Conditions Module
**Conditions:**
- Spinal Cord Injuries
- Cardiovascular Diseases
- Endothelial Dysfunction
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Men and women of all races, ethnic backgrounds, over the age of 18 years: adults with chronic (\>12 months), motor complete (AIS A/B) SCI with paraplegia (neurological level of injury \[NLI\] at T2 or below).
**Intervention Names:**
- Procedure: Brachial intra-arterial infusion of vasoactive and antioxidant drugs (acetylcholine, nitroprusside, ascorbic acid)
- Procedure: venous occlusion plethysmography
- Drug: Acetylcholine
- Drug: Sodium Nitroprusside
- Drug: Ascorbic acid
- Procedure: venous phlebotomy
**Label:** Spinal Cord Injury
#### Arm Group 2
**Description:** Non-injured men and women of all races, ethnic backgrounds, over the age of 18 years.
**Intervention Names:**
- Procedure: Brachial intra-arterial infusion of vasoactive and antioxidant drugs (acetylcholine, nitroprusside, ascorbic acid)
- Procedure: venous occlusion plethysmography
- Drug: Acetylcholine
- Drug: Sodium Nitroprusside
- Drug: Ascorbic acid
- Procedure: venous phlebotomy
**Label:** Control (Non-Spinal Cord Injury)
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control (Non-Spinal Cord Injury)
- Spinal Cord Injury
**Description:** The brachial artery in the non-dominant arm will be catheterized to infuse endothelium-dependent vasodilator acetylcholine, endothelium-independent vasodilator nitroprusside, and antioxidant ascorbic acid at concentrations to have isolated effect in the forearm.
**Name:** Brachial intra-arterial infusion of vasoactive and antioxidant drugs (acetylcholine, nitroprusside, ascorbic acid)
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Control (Non-Spinal Cord Injury)
- Spinal Cord Injury
**Description:** Whole forearm blood flow will be measured by mercury-strain gauge while venous occlusion is applied to the forearm and hand by rapid-cuff inflation to sub-arterial pressures. Changes in whole forearm blood flow with be measured at baseline, endothelial agonists, and removal of oxidative stress via acorbic acid.
**Name:** venous occlusion plethysmography
**Type:** PROCEDURE
#### Intervention 3
**Arm Group Labels:**
- Control (Non-Spinal Cord Injury)
- Spinal Cord Injury
**Description:** Endothelium-dependent vasodilation will then be assessed by changes in FBF in response to intra-arterial infusions of the endothelial agonist acetylcholine infused at rates of 4.0, 8.0, 16.0 μg/100 mL of forearm tissue/min to generate a dose-response curve.
**Name:** Acetylcholine
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Control (Non-Spinal Cord Injury)
- Spinal Cord Injury
**Description:** Endothelium-independent vasodilation will be assessed by changes in forearm blood flow in response to intra-arterial infusions of sodium nitroprusside at 1.0, 2.0, 4.0 μg/100 mL forearm tissue/min.
**Name:** Sodium Nitroprusside
**Type:** DRUG
#### Intervention 5
**Arm Group Labels:**
- Control (Non-Spinal Cord Injury)
- Spinal Cord Injury
**Description:** Ascorbic acid will be infused at a constant rate (12 mg/100 mL tissue/min) and maintained at the same rate while the acetylcholine and sodium nitroprusside dose-response curves are repeated.
**Name:** Ascorbic acid
**Type:** DRUG
#### Intervention 6
**Arm Group Labels:**
- Control (Non-Spinal Cord Injury)
- Spinal Cord Injury
**Description:** Venous blood samples will be collected to measure baseline cardiometabolic characteristics and isolate endothelial cell microvesicles for characterizations and in vitro experiments.
**Name:** venous phlebotomy
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Total forearm blood flow with be measured by strain gauge venous plethysmography under baseline conditions and under pharmacological manipulation with acetylcholine at increasing concentrations (8, 16, 32ug/ml).
**Measure:** Endothelium-dependent vasodilation
**Time Frame:** Measured at baseline (without acetylcholine) and immediately after each acetylcholine dose for 3-5 minutes.
**Description:** Total forearm blood flow with be measured by strain gauge venous plethysmography under baseline conditions and under pharmacological manipulation with sodium nitroprusside at increasing concentrations (1, 2, 4ug/ml).
**Measure:** Endothelium-independent vasodilation
**Time Frame:** Measured at baseline (without sodium nitroprusside) and immediately after each sodium nitroprusside dose for 3-5 minutes.
**Description:** Endothelial cell-derived microvesicles will be collected from venous blood samples and counted used flow cytometry to determine a circulating concentration.
**Measure:** Endothelial cell-derived microvesicles concentration
**Time Frame:** Baseline
**Measure:** Association of Endothelial cell-derived microvesicles to Endothelium-dependent vasodilation
**Time Frame:** Baseline
**Description:** Endothelial cell-derived microvesicles will be sorted and collected by fluorescence-activated cell sorting (FACS) flow cytometry. The endothelial cell-derived microvesicles will be co-cultured with human coronary artery endothelial cells. Endothelial Nitric Oxide Synthase and phosphorylation sites of interest will be measured by intracellular protein expression quantification of whole cell lysates by capillary electrophoresis immunoassays. Nitric oxide production will be assessed by total nitric oxide and nitrate/nitrite parameter assays.
**Measure:** Endothelial cell-derived microvesicles effects of human coronary artery endothelial cells nitric oxide bioavailability
**Time Frame:** Baseline
**Description:** Endothelial cell-derived microvesicles will be sorted and collected by fluorescence-activated cell sorting (FACS) flow cytometry. The endothelial cell-derived microvesicles will be co-cultured with human coronary artery endothelial cells. Super oxide dismutase and catalase expression will be measured by intracellular protein expression quantification of whole cell lysates by capillary electrophoresis immunoassays. Intracellular oxidative stress will be assessed by ROS-Glo H2O2 assay.
**Measure:** Endothelial cell-derived microvesicles effects of human coronary artery endothelial cells reactive oxygen species and antioxidant capacity
**Time Frame:** Baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Men and women of all races, ethnic backgrounds\>18 years of age
* Traumatic spinal cord injury (Sports, Assault, Transport, Fall, Other Traumatic Causes)
* Time since injury (\> 12 months)
* Paraplegia Motor Complete Injury (neurological level of injury at T2 or below, ASIA Impairment Scale A or B
Exclusion Criteria:
* History of high blood pressure
* History cardiovascular disease (coronary artery disease, congestive heart failure, myocardial infarction, cerebrovascular accident).
* History high cholesterol
* History of Diabetes Type I or Type II
* History of Obstructive Pulmonary Disease
* History of Chronic Kidney or Liver Disease
* History of Cancer
* History of Autoimmune Disease (Thyroid Disease, Lupus, Rheumatoid Arthritis, etc).
* History of smoking tobacco in the last 12 months
* History of alcohol use
**Healthy Volunteers:** True
**Maximum Age:** 89 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Men and women of all races, ethnic backgrounds, over the age of 18 years with history chronic motor complete paraplegia, but free of overt chronic diseases assessed by clinically documented medical history, physical examination, and blood chemistries and hematological evaluation.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** cmorey@craighospital.org
**Name:** Clare Morey, SLP-CCC
**Phone:** 303-789-8621
**Role:** CONTACT
**Contact 2:**
**Email:** apark@craighospital.org
**Name:** Andrew Park, MD
**Phone:** 303-789-8101
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Englewood
**Contacts:**
***Contact 1:***
- **Email:** cmorey@craighospital.org
- **Name:** Clare Morey, SLP-CCC
- **Phone:** 303-789-8621
- **Role:** CONTACT
***Contact 2:***
- **Email:** gquintero@craighospital.org
- **Name:** Genevieve Quintero, B.S.
- **Role:** CONTACT
***Contact 3:***
- **Name:** Andrew Park, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Christopher DeSouza, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 5:***
- **Name:** Brian Stauffer, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Craig Hospital
**State:** Colorado
**Status:** RECRUITING
**Zip:** 80113
#### Overall Officials
**Official 1:**
**Affiliation:** Craig Hospital
**Name:** Andrew Park, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Data sharing will be facilitated through active participation in Open Data Commons for SCI (ODC-SCI). ODC-SCI is a cloud-based community-governed repository to store, share, and publish research data on Spinal Cord Injury and is compliant with requirements for FAIR and trustworthy repositories established by NIH.
**IPD Sharing:** YES
### References Module
#### See Also Links
**Label:** Related Info
**URL:** https://doi.org/10.58275/AHA.24CDA1268666.pc.gr.193652
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000013118
- Term: Spinal Cord Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000020196
- Term: Trauma, Nervous System
- ID: D000014947
- Term: Wounds and Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M15916
- Name: Spinal Cord Injuries
- Relevance: HIGH
- As Found: Spinal Cord Injury
- ID: M15915
- Name: Spinal Cord Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M22023
- Name: Trauma, Nervous System
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013119
- Term: Spinal Cord Injuries
- ID: D000002318
- Term: Cardiovascular Diseases
### Intervention Browse Module - Ancestors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000020011
- Term: Protective Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000014815
- Term: Vitamins
- ID: D000018977
- Term: Micronutrients
- ID: D000000959
- Term: Antihypertensive Agents
- ID: D000014665
- Term: Vasodilator Agents
- ID: D000020030
- Term: Nitric Oxide Donors
- ID: D000018679
- Term: Cholinergic Agonists
- ID: D000018678
- Term: Cholinergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AnAg
- Name: Antihypertensive Agents
- Abbrev: NiOxD
- Name: Nitric Oxide Donors
- Abbrev: VaDiAg
- Name: Vasodilator Agents
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M4513
- Name: Ascorbic Acid
- Relevance: HIGH
- As Found: Sorafenib
- ID: M12536
- Name: Nitroprusside
- Relevance: HIGH
- As Found: Rosiglitazone
- ID: M3473
- Name: Acetylcholine
- Relevance: HIGH
- As Found: PAC
- ID: M4292
- Name: Antioxidants
- Relevance: HIGH
- As Found: Grade 3
- ID: M17412
- Name: Vasodilator Agents
- Relevance: LOW
- As Found: Unknown
- ID: M25496
- Name: Endothelium-Dependent Relaxing Factors
- Relevance: LOW
- As Found: Unknown
- ID: M21869
- Name: Protective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M17558
- Name: Vitamins
- 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: M4277
- Name: Antihypertensive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M12507
- Name: Nitric Oxide
- Relevance: LOW
- As Found: Unknown
- ID: M20758
- Name: Cholinergic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
- ID: T437
- Name: Ascorbic Acid
- Relevance: HIGH
- As Found: Sorafenib
- ID: T477
- Name: Vitamin C
- Relevance: HIGH
- As Found: Sorafenib
### Intervention Browse Module - Meshes
- ID: D000001205
- Term: Ascorbic Acid
- ID: D000009599
- Term: Nitroprusside
- ID: D000000109
- Term: Acetylcholine
- ID: D000000975
- Term: Antioxidants
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443138
**Acronym:** PRIMECHO
**Brief Title:** Preparation for Medical and Surgical Procedures in Oncogeriatry.
**Official Title:** Preparation for Medical and Surgical Procedures in Oncogeriatry. Pilote Study PRIMECHO
#### Organization Study ID Info
**ID:** 23-AOIP-03
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de Nice
### Status Module
#### Completion Date
**Date:** 2026-09-10
**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:** 2026-09-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-10
**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:** Centre Hospitalier Universitaire de Nice
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Surgical management is one of the most frequently used interventions in the treatment of many cancers, but it can be associated with a high risk of postoperative complications.
The maintenance and optimization of functional abilities before, during and after treatment are major for elderly cancer patients, as it is now well established that there is a link between the level of functional capacity and the occurrence of these complications.
The scientific literature shows that the benefits of pre- and post-operative training programs, but these benefits only apply to a fraction of the patients adhering to the programs. The modalities of intervention (training load, follow-up, etc.) as well as patient involvement in these programs are major issues that need to be addressed to optimize their benefits.
Individualizing pre-habilitation, on the basis of the management of the training load, and therefore objective fatigue, would enable better patient adherence to the program, and optimize its benefits.
In this context, the PRIMECHO project aims to individualize pre-habilitation in order to improve functional of patients in the pre-habilitation or accelerated recovery after surgery phase. The aim is for the patient to be in optimum physical condition at the time of the intervention or treatment.
### Conditions Module
**Conditions:**
- Geriatric Oncology
**Keywords:**
- ederly
- cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Implementation of a personalized pre-habilitation program at home before surgery
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: Personalized pre-habilitation program
**Label:** Personalized pre-habilitation program
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Personalized pre-habilitation program
**Description:** Each patient will undergo 4 weeks of individualized pre-habilitation before surgery.
Each session (1 session per day) will be carried out autonomously by the patient at home, via a dedicated application (Activiti Pro) installed on their tablet or smartphone.
**Name:** Personalized pre-habilitation program
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Metres walked during 6 minutes
**Measure:** Maximal walking distance to 6 -MWT
**Time Frame:** at inclusion
**Description:** Metres walked during the test
**Measure:** Maximal walking distance to 6 -MWT
**Time Frame:** at 4 weeks
**Description:** Metres walked during the test
**Measure:** Maximal walking distance to 6 -MWT
**Time Frame:** at 8 weeks
**Description:** Metres walked during the test
**Measure:** Maximal walking distance to 6 -MWT
**Time Frame:** at 16 weeks
#### Secondary Outcomes
**Description:** QLQC30 is a 30-item instrument designed to measure quality of life in all cancer patients.
It contains 30 questions and assesses the quality of life of oncological patients multidimensionally over 10 subscales. All sub-scales and the 6 individual items have a score range from 0 to 100 points. A higher score represents better function and a higher quality of life. In the symptom subscale, however, a higher score represents a higher level of symptoms or problems. Since there is no total score, all subscales and the individual items must be considered individually and evaluated using normative data.
**Measure:** EORTC-QLQC30
**Time Frame:** at inclusion, 4 weeks, 8 weeks, 16 weeks
**Description:** Multidiensional Fatigue Inventory-20 (MFI-20) questionnaire. 5 scales. Higher scores means worse outcome.
General Fatigue dimension: Minimum value: 4. Maximum Value: 20. Physical fatigue dimension: Minimum value: 4. Maximum Value: 20. Reduced activity dimension: Minimum value: 4. Maximum Value: 20. Reduced motivation dimension: Minimum value: 4. Maximum Value: 20. Mental fatigue dimension: Minimum value: 4. Maximum Value: 20.
**Measure:** Fatigue scale (MFI-20)
**Time Frame:** at inclusion, 4 weeks, 8 weeks, 16 weeks
**Description:** This questionnaire assesses overall physical activity and sedentary time over the last seven days. The questionnaire looks at intense, moderate and walking activity, as well as time spent sitting down (sedentary lifestyle), whether during leisure activities, at work, in daily life or during transport.
The questionnaire composed with 7 questions classifies the subject according to 3 levels of activity: inactive, moderate, high.
**Measure:** Internationnal Physiqual activity questionaire (IPAQ-short)
**Time Frame:** at inclusion, 4 weeks, 8 weeks, 16 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patient aged 70 or over
* Cancer patient with planned surgery,
* Mini Mental State Examination score greater than or equal to 24 (performed in advance by the geriatrician),
* Patient affiliated to or benefiting from a social security insurance
* Signed free and informed consent.
Exclusion Criteria:
* Inability to walk or perform unsupervised exercises.
* Vulnerable people
**Minimum Age:** 70 Years
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** boulahssass.r@chu-nice.fr
**Name:** Rabia Boulahssass, MD
**Phone:** 04 92 03 41 94
**Role:** CONTACT
**Contact 2:**
**Email:** chorin.f@chu-nice.fr
**Name:** Frédéric Chorin
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Centre Hospitalier Universitaire de Nice
**Name:** Rabia Boulahssass, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Meshes
- ID: D000009369
- Term: Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443125
**Brief Title:** Study on Therapeutic Mechanism of Natural Psychotherapy for Neurosis
**Official Title:** Study on Therapeutic Mechanism of Natural Psychotherapy for Neurosis
#### Organization Study ID Info
**ID:** CASPsy6
#### Organization
**Class:** OTHER
**Full Name:** Beijing HuiLongGuan Hospital
### Status Module
#### Completion Date
**Date:** 2025-08-01
**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:** 2025-08-01
**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:** 2023-09-26
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Xiang Yang Zhang
#### Responsible Party
**Investigator Affiliation:** Beijing HuiLongGuan Hospital
**Investigator Full Name:** Xiang Yang Zhang
**Investigator Title:** Professor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** explore objective indicators of the efficacy of natural psychotherapy in the treatment of disorders such as obsessive-compulsive disorder
**Detailed Description:** 1. To evaluate the cognitive function, Cognitive control, emotion and other aspects of neurosis patients, and to understand and master the cognitive behavior indicators of this population.
2. Investigate the pathological mechanism of neurotic patients from the aspects of electroencephalic graph/functional magnetic resonance imaging (EEG/fMRI) and biology.
3. To investigate the therapeutic effect of natural psychotherapy on cognitive impairment and related mood, sleep and symptom intervention in neurotic patients. In order to achieve the symptoms of neurosis patients, cognitive impairment and related mood and sleep intervention and promotion, while providing a scientific basis for neurosis rehabilitation.
### Conditions Module
**Conditions:**
- Obsessive-Compulsive Disorder
**Keywords:**
- obsessive-compulsive disorder
- natural psychotherapy
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Inpatient naturopathic treatment was performed once a day for 45 consecutive days
**Intervention Names:**
- Other: Natural psychotherapy
**Label:** Natural Psychotherapy intervention for obsessive-compulsive disorder
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Natural Psychotherapy intervention for obsessive-compulsive disorder
**Description:** Draw ideas from traditional Chinese culture, learn from the practice of Morita therapy in Japan, and create local practice experience. At the same time, a variety of research methods such as cognitive assessment and brain imaging were used to establish the scientific, professional and objective evaluation indexes of the therapy.
**Name:** Natural psychotherapy
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Obsessive-compulsive symptoms were assessed according to the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), The total score ranges from 0 to 40, with higher scores indicating more severe symptoms.
**Measure:** Obsessive-compulsive symptoms
**Time Frame:** Baseline, 12 weeks
**Description:** Cognitive inhibition was assessed using the emotional color-word Stroop task. The emotional Stroop task is a type of being Widely used cognitive inhibition assessment tools. The longer the reaction time, the worse the cognitive inhibition ability.
**Measure:** Cognitive function
**Time Frame:** Baseline, 12 weeks
**Description:** Mood changes judged using gait and face recognition
**Measure:** Mood and behavior
**Time Frame:** Baseline, 12 weeks
**Description:** To explore the ERP component analysis related to cognitive inhibition and Behavioral inhibition in obsessive-compulsive disorder (OCD) by event related potential (ERP) analysis
**Measure:** ERP components associated with cognitive function
**Time Frame:** Baseline, 12 weeks
**Description:** The changes of resting-state functional connectivity were analyzed in patients with OCD before and after intervention. Resting-state functional connectivity：FC(Functional connectivity). Resting-state functional brain imaging data were collected using a GE 3.0T magnetic resonance scanner (GE Discovery MR750) at the Brain Imaging Center, Institute of Psychology, Chinese Academy of Sciences.
**Measure:** rest fMRI in Obsessive-compulsive patients
**Time Frame:** Baseline, 12 weeks
**Description:** behavioral inhibition was assessed using the emotional stop signal task (SST). The emotional SST task is a type of being Widely used behavioral inhibition assessment tools. Among them, the greater the SSRT, the worse the behavioral inhibition ability.
**Measure:** Behavioral inhibition
**Time Frame:** Baseline, 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Have a diagnosis of obsessive-compulsive disorder or compulsive behavior
* Duration of symptoms for not less than 12 months
* Age 15-60 years old.
* You can participate in the whole experiment and offline assessment in Beijing
Exclusion Criteria:
* Documented disease of physical diseases including, but not limited to stroke, tumor, Parkinson's disease, Huntington's disease, seizure, epilepsy, history of brain trauma
* Subjects who suffered from alcohol or illegal drug abuse/dependence
**Maximum Age:** 60 Years
**Minimum Age:** 15 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** zhangxy@psych.ac.cn
**Name:** Zhang Y Xiang, M.D., Ph.D
**Phone:** +86-10-62710644
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Name:** Zhang X Yang
- **Role:** CONTACT
**Country:** China
**Facility:** Institute of Psychology, Chinese Academy of Sciences
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Institute of Psychology, Chinese Academy of Science
**Name:** Xiang-Yang Zhang, M.D., Ph.D
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Data with be available on request
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010554
- Term: Personality Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000001008
- Term: Anxiety Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M6419
- Name: Compulsive Personality Disorder
- Relevance: HIGH
- As Found: Compulsive Disorder
- ID: M12706
- Name: Obsessive-Compulsive Disorder
- Relevance: HIGH
- As Found: Obsessive-Compulsive Disorder
- ID: M12437
- Name: Neurotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M13462
- Name: Personality 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: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003193
- Term: Compulsive Personality Disorder
- ID: D000009771
- Term: Obsessive-Compulsive Disorder
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443112
**Acronym:** CCERCIAFAO
**Brief Title:** Pregnancy Outcomes According to Cervical Cerclage Indications and Factors Affecting Pregnancy Duration and Outcomes
**Official Title:** Pregnancy Outcomes According To Cervical Cerclage Indications And Factors Affecting Pregnancy Duration And Outcomes: A 2-Year Comparison Of Patients Who Underwent History-Based, Ultrasound-Based, or Rescue Cerclage
#### Organization Study ID Info
**ID:** BasaksehirCamveSakuraH
#### Organization
**Class:** OTHER_GOV
**Full Name:** Başakşehir Çam & Sakura City Hospital
### Status Module
#### Completion Date
**Date:** 2024-05-10
**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:** 2024-05-10
**Type:** ACTUAL
#### Start Date
**Date:** 2024-05-10
**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:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Başakşehir Çam & Sakura City Hospital
#### 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 study aimed to asses predictive factors associated with successful cervical cerclage and poor pregnancy outcomes in all indications.129 pregnant women who underwent cerclage at 12-25 weeks gestation in a perinatal medical center were included. The patients were divided into three subgroups for data analysis. Groups included patients with respectively history-indicated cerclage (group 1), ultrasound-indicated cerclage (group 2), and rescue cerclage (group 3). The investigators defined successful cerclage as postponing birth until after the 28th week of gestation and a 'good outcome' was defined as delivery beyond 34 completed weeks.Factors associated with successful cervical cerclage and perinatal outcomes after the procedure for all three groups were analyzed. The investigators also calculated post-cerclage the cervical length cut-off value required to predict if birth could be postponed until after the 28th week of gestation in women with cervical insufficiency.
**Detailed Description:** This study retrospectively reviewed data from pregnant women who underwent cerclage from July 2021 to July 2023 in Çam and Sakura City Hospital, which is a perinatal medical center in Istanbul, Turkey. The local ethics committee approved the study.
All procedures followed the relevant guidelines and regulations of the institutional ethics review board and the Declaration of Helsinki.
The patients were divided into three subgroups for data analysis. Group 1 included patients with history-indicated cerclage, who had second-trimester pregnancy loss associated with painless cervical dilatation in the absence of labor or placental abruption, or previous cerclage due to painless cervical dilatation in the second trimester. Group 2 comprised patients with ultrasound-indicated cerclage, who had a history of spontaneous preterm birth before the 34th week previously and their cervical length (CL) was \<25 mm before the 24th week of gestation in the current singleton pregnancy, or who had \<10 mm cervical length in the current singleton pregnancy without history. Group 3 consisted of patients undergoing rescue cerclage, who had premature cervical dilatation and exposure of fetal membranes in the vagina, was detected in ultrasound or speculum examination of the cervix. All cervical cerclage procedures were performed by a senior obstetrician using the McDonald technique with Mersilene tape or No:1 proline. The investigators collected the following data from medical records: maternal age at cervical cerclage, gravidity, parity, body mass index, history of a cervical cone biopsy, history of premature birth and cervical cerclage, procalcitonin level, C-reactive protein (CRP) level, gestational age at cerclage, pre-and post-cerclage CL, week of birth, pregnancy complications (preterm premature rupture of the membranes (PPROM), abruptio placenta, chorioamnionitis). The investigators defined successful cerclage as postponing birth until after the 28th week of gestation and a 'good outcome' was defined as delivery beyond 34 completed weeks. The indications and the pregnancy outcomes (miscarriage, gestational age at delivery, birth weight, prolongation of pregnancy, and rate of preterm birth before 34 weeks) of cervical cerclage were reviewed and the factors associated with successful cervical cerclage were analyzed.
Moreover, receiver operating characteristic (ROC) curves were used to calculate the pre-cerclage and post-cerclage CL cut-off value required to predict if birth could be postponed birth until after the 28th week of gestation in women with cervical insufficiency (CI). Thus, the investigators extracted significant factors for a successful cervical cerclage for long-term pregnancy sustenance in women with CI.
### Conditions Module
**Conditions:**
- Cervical Incompetence (Complicating Pregnancy)
**Keywords:**
- cervical cerclage indications
- cervical insufficiency
- post-cerclage cervical length
- Pregnancy outcomes
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 129
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Group 1 included patients with history-indicated cerclage, who had second-trimester pregnancy loss associated with painless cervical dilatation in the absence of labor or placental abruption, or previous cerclage due to painless cervical dilatation in the second trimester.
**Intervention Names:**
- Procedure: transvaginal cervical cerclage by Mc Donald technique
**Label:** history-indicated cerclage group (group1)
#### Arm Group 2
**Description:** Group 2 comprised patients with ultrasound-indicated cerclage, who had a history of spontaneous preterm birth before the 34th week previously and their cervical length was \<25 mm before the 24th week of gestation in the current singleton pregnancy, or who had \<10 mm cervical length in the current singleton pregnancy without history.
**Intervention Names:**
- Procedure: transvaginal cervical cerclage by Mc Donald technique
**Label:** (Group 2) patients with ultrasound-indicated cerclage
#### Arm Group 3
**Description:** Group 3 consisted of patients undergoing rescue cerclage, who had premature cervical dilatation and exposure of fetal membranes in the vagina, was detected in ultrasound or speculum examination of the cervix.
**Intervention Names:**
- Procedure: transvaginal cervical cerclage by Mc Donald technique
**Label:** Group 3 consisted of patients undergoing rescue cerclage
### Interventions
#### Intervention 1
**Arm Group Labels:**
- (Group 2) patients with ultrasound-indicated cerclage
- Group 3 consisted of patients undergoing rescue cerclage
- history-indicated cerclage group (group1)
**Description:** In the McDonald operation, a suture is is inserted around the exo-cervix as high as possible to approximate to the level of the internal os and thereby prevent second-trimester abortion.
**Name:** transvaginal cervical cerclage by Mc Donald technique
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Factors affecting time (time in days) elapsed from cerclage procedure to birth were evaluated
**Measure:** Latency from the time of cerclage procedure to delivery
**Time Frame:** time from cerclage procedure to birth
**Description:** receiver operating characteristic (ROC) curves were used to calculate the pre-cerclage and post-cerclage CL (length in centimeters) cut-off value required to predict if birth could be postponed birth until after the 28th week of gestation in women with CI. Thus, we extracted significant factors for a successful cervical cerclage for long-term pregnancy sustenance in women with CI.
**Measure:** pre-cerclage and post-cerclage cervical length cut-off value required to predict if birth could be postponed birth until after the 28th week of gestation in women with cervical insufficiency.
**Time Frame:** time from diagnosis to birth
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Pregnants that underwent cervical cerclage between July 2021 and July 2023 with singleton pregnancies
Exclusion Criteria:
* Pregnant women without follow-up whose post-procedure data cannot be accessed
* Multiple pregnancies
**Gender Based:** True
**Gender Description:** pregnant women who underwent cerclage
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
**Study Population:** 18-45 aged Pregnant women who underwent cerclage at 12-25 weeks gestation from July 2021 to July 2023 in Çam and Sakura City Hospital, which is a perinatal medical center in Istanbul, Turkey.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** İstanbul Başakşehir Çam ve Sakura City Hospital
**State:** Basaksehir
**Zip:** 34480
#### Overall Officials
**Official 1:**
**Affiliation:** Başakşehir Çam ve Sakura City Hospital
**Name:** Zeynep Kayaoglu yıldırım, MD
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** Başakşehir Çam ve Sakura City Hospital
**Name:** Elif Sagban Gedik, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Song RK, Cha HH, Shin MY, Choi SJ, Oh SY, Kim JH, Roh CR. Post-cerclage ultrasonographic cervical length can predict preterm delivery in elective cervical cerclage patients. Obstet Gynecol Sci. 2016 Jan;59(1):17-23. doi: 10.5468/ogs.2016.59.1.17. Epub 2016 Jan 15.
**PMID:** 26866031
**Citation:** Chan LL, Leung TW, Lo TK, Lau WL, Leung WC. Indications for and pregnancy outcomes of cervical cerclage: 11-year comparison of patients undergoing history-indicated, ultrasound-indicated, or rescue cerclage. Hong Kong Med J. 2015 Aug;21(4):310-7. doi: 10.12809/hkmj144393. Epub 2015 Jul 17.
**PMID:** 26183455
**Citation:** Cook JR, Chatfield S, Chandiramani M, Kindinger L, Cacciatore S, Sykes L, Teoh T, Shennan A, Terzidou V, Bennett PR. Cerclage position, cervical length and preterm delivery in women undergoing ultrasound indicated cervical cerclage: A retrospective cohort study. PLoS One. 2017 Jun 1;12(6):e0178072. doi: 10.1371/journal.pone.0178072. eCollection 2017.
**PMID:** 28570639
## Document Section
### Large Document Module
#### Large Docs
- Date: 2023-11-22
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 280097
- Type Abbrev: Prot_SAP
- Upload Date: 2024-05-29T00:31
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000002577
- Term: Uterine Cervical Diseases
- ID: D000014591
- Term: Uterine Diseases
- ID: D000005831
- Term: Genital Diseases, Female
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000000026
- Term: Abortion, Habitual
- ID: D000000022
- Term: Abortion, Spontaneous
- ID: D000091662
- Term: Genital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14127
- Name: Pregnancy Complications
- Relevance: HIGH
- As Found: Complicating Pregnancy
- ID: M5828
- Name: Uterine Cervical Incompetence
- Relevance: HIGH
- As Found: Cervical Incompetence
- 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: M5825
- Name: Uterine Cervical Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17339
- Name: Uterine Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8943
- Name: Genital Diseases, Female
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25
- Name: Abortion, Habitual
- Relevance: LOW
- As Found: Unknown
- ID: M21
- Name: Abortion, Spontaneous
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011248
- Term: Pregnancy Complications
- ID: D000002581
- Term: Uterine Cervical Incompetence
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443099
**Brief Title:** Needle and Shotblocker on Pain and Satisfaction in Intramuscular Injection Pain
**Official Title:** The Effect of Cold Needle and Shotblocker on Pain and Satisfaction in Intramuscular Injection Pain: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** Shotblocker
#### Organization
**Class:** OTHER
**Full Name:** Necmettin Erbakan University
### Status Module
#### Completion Date
**Date:** 2024-09-24
**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:** 2024-08-24
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-24
**Type:** ESTIMATED
**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:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Necmettin Erbakan University
#### Responsible Party
**Investigator Affiliation:** Necmettin Erbakan University
**Investigator Full Name:** Yadigar Ordu
**Investigator Title:** Doctor of Teaching Member
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** In this study, it is aimed to compare cold needle and shotblocker in intramuscular injection pain. This is a triple-blind randomized clinical trial. June September 2024, the universe of the research will be composed of patients who applied to the emergency department of Necmettin Erbakan University Faculty of Medicine Hospital for cyanocobalamin injection. Considering that losses may occur during the data collection process, the study will be completed with a total of 120 patients. Intramuscular injection of the deltoid November will be applied to the intervention-1 group with a cold needle, intervention-2 group with a shotblocker, and the control group with the standard method. People will be determined by block randomization. After each application, the pain and satisfaction due to the injection will be evaluated. The data will be compared between the groups.
**Detailed Description:** This study aims to compare cold injection and ShotBlocker in intramuscular injection pain. This is a triple-blind randomized clinical trial. The population of the research will consist of patients who applied to the emergency department of Necmettin Erbakan University Faculty of Medicine Hospital to receive cyanocobalamin injection between June and September 2024. Considering that losses may occur during the data collection process, the study will be completed with a total of 120 patients. The data of the study will be collected with the "Patient Diagnosis Form", "Visual Analog Scale (VAS)" and "Injection Satisfaction Scale". Block randomization method will be used to assign participants to groups. All injections will be performed by a single nurse working in the injection unit in accordance with the research procedure. Once the injection procedure is completed, participants will be asked to rate injection pain and satisfaction. Pain assessment will be performed by another emergency nurse who is independent from the study and contributes to the study. Researchers will participate in this process as observers. The people who will perform the application and evaluate the pain and satisfaction will be different. In this way, the person evaluating the pain will not know which application was performed on the participant, and blinding will be ensured. Additionally, the data of the study will be coded as A, B and C and entered into SPSS, thus ensuring statistical blinding. Thus, it is planned to conduct the research with triple blinding. All injections will be made using cyanocobalamin injection (1 ml), 5 cc syringe, 25 Gauge orange syringe tip. Before the injection, it will be checked whether the pain score is "0" with VAS. The participant will be given a Fowler position, the deltoid area will be checked on the arm to be treated, the arm will be flexed and brought closer to the body, and the position will be given. Injections will be given to each group according to the IM injection application protocol. Intramuscular injection will be applied to the deltoid muscle in the intervention-1 group, with a cold needle, in the intervention-2 group, with a shot blocker, and in the control group, with the standard method. Subjects will be determined by block randomization. All participants will be allowed to rest for two minutes after each injection. After two minutes, they will be asked to mark the level of pain caused by the procedure on the VAS. Similarly, they will be asked to mark their satisfaction with the procedure on the injection satisfaction scale. Then, the line marked by the person will be measured with a 10 cm ruler and the numerical equivalent of pain and satisfaction will be determined. Data will be compared between groups.
### Conditions Module
**Conditions:**
- Intramuscular Injection
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** It is a C-shaped plastic tool with small blunt protrusions on one side that contact the skin. It does not have any side effects. The protruding surface of the ShotBlocker is pressed against the skin during injection and the injection is performed through the opening. It is thought to provide pain control as an application of gate control theory. In addition to the IM injection application procedure, after the skin is cleaned in the patient group, the protruding part of the ShotBlocker (Bionix, Press Firmly, USA) will be placed in contact with the skin. The ShotBlocker will be pressed firmly against the skin and the injection will be made through the central opening of the ShotBlocker. Once the injection is complete, the ShotBlocker will be removed from the skin.
**Intervention Names:**
- Other: Different methods used after intramuscular injection
**Label:** shotblocker group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** In addition to the IM injection procedure, a cold needle tip will be used in the needle tip changing procedure step. For this, before the application, the 25 Gauge orange syringe tip will be placed in a cold thermos and kept at 0-2 degrees Celsius with ice batteries. The appropriate temperature range will be checked with a digital thermometer.
**Intervention Names:**
- Other: Different methods used after intramuscular injection
**Label:** Cold needle group
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Applications will be carried out according to the IM injection application protocol. Identifying the deltoid region. Clean the area around the injection site (five cm) with 70% disposable alcohol cotton in circular motions, wait for the alcohol to dry in the area (5 seconds). Injecting the drug every 10 sec/ml. 10 seconds before withdrawing the needle. wait. Retracting the needle straight and steady at the angle at which the tissue was entered.
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cold needle group
- shotblocker group
**Description:** Different methods will be used during intramuscular injection. One of them is shotblocker. There are studies reporting that it reduces pain according to the gate control theory. The other method is cold injection. In this method, the injector tips will be cooled to 0-2 degrees and used in injection application.
**Name:** Different methods used after intramuscular injection
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Visual Pain Scale (Visual Analog Scale-VAS) is a reliable measurement tool developed to measure individuals' pain levels. The scale is simple, interesting, quick to fill out, and easy to score. There are subjective descriptive expressions at both ends of a 10-cm ruler (0: lowest pain level and 10: highest pain level). The patient will be asked to mark the place on the line that expresses his/her pain.
**Measure:** injection pain
**Time Frame:** up to 2 months
#### Secondary Outcomes
**Description:** The injection satisfaction scale is a 0-10 cm ruler that will be used to evaluate patients' satisfaction with the injection application. Patients will mark their satisfaction with the injection application on the ruler.
**Measure:** injection satisfaction
**Time Frame:** up to 2 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Being between the ages of 18-65,
* No problems with speaking and understanding Turkish,
* Body mass index (BMI) between 18.5 and 30,
* Just starting the first dose of cyanocobalamin treatment,
* No history of allergy to the drug,
* No vision, hearing or perception problems,
* Having orientation to place and time,
* No sensorimotor deficit,
* No history of diabetes,
* Not taking oral or parenteral analgesic treatment before the application,
* VAS score before injection is "0",
* No deficiency in limbs,
* No pregnancy,
* Female individuals who are not in their menstrual cycle,
* Volunteering to participate in the research.
Exclusion Criteria:
* Another injection into the deltoid area,
* Development of drug-related allergy or other complications,
* Scar, incision, infection, sensitivity, burn, cut, etc. in the injection area. to be found,
* Wants to leave the research.
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
## 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
### 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
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M3777
- Name: Ethanol
- Relevance: LOW
- As Found: Unknown
- ID: T244
- Name: Orange
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443086
**Brief Title:** Long-term Outcomes of Duodenal Adenocarcinoma From a Large Cohort
**Official Title:** Long-term Survival Outcomes of Duodenal Adenocarcinoma: a Cohort Study With 15-year Single-center Experience
#### Organization Study ID Info
**ID:** NFEC-2024-171
#### Organization
**Class:** OTHER
**Full Name:** Nanfang Hospital, Southern Medical University
### 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:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-28
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### 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:** False
### Description Module
**Brief Summary:** The investigators will conducted a hospital-based cohort study in our 15-year experience with DA aimed at investigating the long-term outcomes of the patients with DA, along with analyzing the impact of the tumor characteristics, operations and adjuvant therapy on survival outcomes.
**Detailed Description:** Numerous meta-analyses and systematic reviews have delved into the treatment of DA, yet the majority of the studies retrospective, single-center, and small sample size series, particularly in China. To bridge this knowledge gap, the investigators will conduct a hospital-based cohort study designed to investigate the long-term survival outcomes of the participants with the non-ampulla duodenal adenocarcinoma, and the effects of tumor characteristics, surgery, and adjuvant therapy on survival outcomes.
### Conditions Module
**Conditions:**
- Gastrointestinal Disease
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 400
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The patients included in this study were drawn from a hospital-based cohort and included cases diagnosed and treated at the facility. Inclusion criteria were histologically confirmed non-ampulla DA, including all stages of disease at diagnosis. Patients were excluded if they had ampulla cancer or other forms of gastrointestinal cancer, had incomplete medical records, or lost follow-up shortly after diagnosis. This rigorous selection process ensured the homogeneity of the study population and the relevance of the findings to non-ampulla DA.
**Intervention Names:**
- Procedure: Radical operation and perioperative therapy
**Label:** Duodenal carcinoma patients
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Duodenal carcinoma patients
**Description:** Surgical intervention, particularly radical excision, was performed for each patient, including the extent of resection and lymph node dissection. Information on adjuvant therapies, such as chemotherapy and radiotherapy, was also recorded, specifying the regimens and durations.
**Name:** Radical operation and perioperative therapy
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Median survival is the time it takes half of the individuals in a given study population to reach or exceed a particular end event, calculated from the time an event occurred. Median survival is a statistical index describing the distribution of survival time.
**Measure:** Median overall survival time
**Time Frame:** 2009.10-2023.06
**Description:** Three-year survival rate, also known as survival rate, refers to the number of patients with a disease who are still alive at the end of three years of follow-up as a percentage of the number of cases observed
**Measure:** 3-year overall survival rate
**Time Frame:** 2009.10-2023.06
**Description:** Five-year survival rate, also known as survival rate, refers to the number of patients with a disease who are still alive at the end of five years of follow-up as a percentage of the number of cases observed
**Measure:** 5-year overall survival rate
**Time Frame:** 2009.10-2023.06
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria:
(1) histologically confirmed non-ampulla DA;
Exclusion criteria:
1. had other gastrointestinal cancer;
2. had incomplete medical records, or lost follow-up shortly after diagnosis;
3. refused clinical data collection.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The patients included in this study were drawn from a hospital-based cohort and included cases diagnosed and treated at the facility. Inclusion criteria were histologically confirmed non-ampulla DA, including all stages of disease at diagnosis. Patients were excluded if they had ampulla cancer or other forms of gastrointestinal cancer, had incomplete medical records, or lost follow-up shortly after diagnosis. This rigorous selection process ensured the homogeneity of the study population and the relevance of the findings to non-ampulla DA.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** hao.liu@alumni.uni-heidelberg.de
**Name:** Hao Liu, MD, PhD
**Phone:** +86-20-62787626
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China
**Name:** Hao Liu, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-04-02
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 4891401
- Type Abbrev: Prot_SAP
- Upload Date: 2024-06-03T00:38
- Date: 2024-04-02
- Filename: ICF_001.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 116704
- Type Abbrev: ICF
- Upload Date: 2024-06-03T00:20
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002277
- Term: Carcinoma
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M3585
- Name: Adenocarcinoma
- Relevance: HIGH
- As Found: Adenocarcinoma
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: HIGH
- As Found: Gastrointestinal Diseases
- ID: M7255
- Name: Digestive System Diseases
- Relevance: HIGH
- As Found: Gastrointestinal Diseases
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000230
- Term: Adenocarcinoma
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443073
**Brief Title:** The Mere-measurement Effect of Patient-reported Outcomes
**Official Title:** The Mere-measurement Effect in Patient-reported Outcomes: A Randomized Control Trial With Speech Pathology Patients
#### Organization Study ID Info
**ID:** ECS 2153/2023
#### Organization
**Class:** OTHER
**Full Name:** Medical University of Vienna
### Status Module
#### Completion Date
**Date:** 2025-05-22
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-03
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-08-22
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-15
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Medical University of Vienna
#### Responsible Party
**Investigator Affiliation:** Medical University of Vienna
**Investigator Full Name:** Preston Long
**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 use of patient-reported outcome (PROs) have become increasingly commonplace across many healthcare settings over the past two decades. The value of PROs is now acknowledged by healthcare providers and patients alike. However, to date, little is known about the best practices for formulating PRO measures (PROMS), but even more specifically, the effect had on the responding patients as a result of item word choice, emotional valence, or frequency of use. That is, 1) does the positive or negative wording of items affect the patient's perspective on the latent variable, 2) is there a degree of subliminal influence or measurement effects on their behaviour resulting from exposure to PROs, and finally, 3) is such an effect amplified with repeated exposure?
**Detailed Description:** There is currently sufficient evidence to suggest that attributes such as the wording of questions, their presentation order, the context where they are asked, and the item's social sensitivity (e.g. I do not abuse my prescriptions), have an effect on participant responses (1,2). This family of variables are most oft referred to as method effects. Method effects largely regard the phenomenon in which the presentation of an item affects the participant's response independent of the content in question. The end goal within this area of study is to correct for any response bias resulting from the items used. This research primarily concerns psychometrics. It is important to note that while method effects relate to the research questions proposed, it is not the key feature of interest. The ensuing inquiry will not simply focus directly on changes to item responses, but instead, on changes to patient perceptions and behaviours as a result of their exposure to the measures themselves. This has been coined the mere-measurement effect (3) Research supports the claim that asking certain questions can influence behaviours on the same topic (4,5). For example, a randomized-control trial was conducted to assess the impact of asking questions pertaining to blood donation habits of the participants. The researchers found that the subjects whom were asked about their habits were significantly more likely to donate blood than their control counter parts at the following blood-drive (6). Other researchers found that when clinicians did not ask patients with Attention Deficit Hyperactivity Disorder (ADHD) to report whether they were currently medicated on a disease-related severity questionnaire, patients were more likely to report un-medicated symptomologies (7). In other words, patients on ADHD medications responded more symptomatically similar to their un-medicated selves when their medication status was not included on the questionnaire. This suggests that the medication status item itself, may have mitigated ADHD symptoms by bringing the patient's treatment into a higher state of awareness/directing attention.
Thus, it may be that asking patients about their intent to have an operation increases the likelihood of them opting for it, or, that asking them about their exercise increases their physical activity level. If so, this may have significant implications for the effect of routinely collecting patient-reported outcomes (PROs), as well as for utilizing measurements as interventions. However, before value can be attached to such an effect, first the presence and strength must be evaluated in the patient-specific context.
To date, no mere-measurement effect factors have been investigated in the context of patient-reported outcomes measures (PROMs) and particularly not in regard to how they may influence patient perceptions and behaviours. Therefore, exploration of this family of effects must be reduced to a few key anticipated features, namely, emotional valence (positive/negative) and frequency. For instance, would wording a cleft-lip question negatively, such as "I do not like my face", actually decrease the patient's preference for their own face, and, does repeated exposure to this question increase the magnitude of the effect.
This randomized controlled trial (RCT) review will be the first to the authors' knowledge to examine if measuring patient- reported outcomes directly effects their corresponding behaviour, and if this effect can be attributed in part to item wording and/or frequency of exposure.
PROMs \& Speech Disorders Three recent reviews regarding patient-reported outcomes in speech pathologies were identified (8,9,10). Francis et al. list a number of PRO measures that were designed for administration with subjects with any kind of voice disorders. The Evaluating Voice Disability-Quality of Life Questionaire (EVD-QOL) aims at assessing the general range of functional problems in voice disorders. The 30-items Voice Handicap Index (VHI) and its 10-items short version VHI-10 aim at providing a psychometrically robust voice diasability/handicap inventory. The Voice-Related Quality of Life (V-RQOL) aims at measuring the impact of voice problems on the quality of life. The Voice Activity and Participation Profile (VAPP) aims at identifying voice activity limitation and participation restriction separately. The Voice Symptom Scale (VoiSS) is an inventory of voice symptoms for assessing baseline pathology and response to change. The Communicative Participation Item Bank (CPIB) aims at assessing communication participation in all kinds of communication disorders. The Voice Self-Efficacy Questionnaire (VSEQ) monitors self-efficacy in individuals with self-declared voice problems before and after interventions. The Vocal Fatigue Handicap Questionnaire (VFHQ) and the Vocal Fatigue Index (VFI) aim at reflecting vocal fatigue.
Additional PROs include the Aging Voice Index, the Evaluation of the Ability to Sing Easily, the Glottal Function Index, the Linear Analog Scale of Assessment of Voice Quality, the Speech Disability Questionnaire, the Trans Woman Voice Questionnaire, the Vocal Cord Dysfunction Questionnaire, and the Vocal Tract Discomfort Scale Slavych, Zraick \& Ruleman, 2021.
The researchers have opted to use the CPIB and the VHI because these are well established and the former covers all kinds of communication disorders, while the VHI is using particularly negative wording in its original form.
1.2 STUDY RATIONALE The purpose of the mere-measurement study is to identify the most advantageous way to measure outcomes for patients. This will be accomplished by collecting measures on the same topic at different time intervals and with different wording of questions. The findings of this study should help researchers and clinicians collect measurements from patients in the least burdensome and most beneficial manner possible.
The primary objective of the mere-measurement study is to assess the effects of different collection methods on the responders wellbeing.
The secondary objectives of this study are to:
* What frequency of collection is best for patients?
* What style of question wording is best for patients?
Research Questions:
* Does the assigned positivity or negativity of an item effect patient perception or behaviour on the topic inquired?
* Does frequency of exposure to an item have an effect on patient perception or behaviour of the topic inquired?
Hypotheses:
H1 = The more a patient reads and responds to questions about their speech condition the more their speech condition will be affected.
H2 = The directionality of impact on a speech condition will be congruent with the emotional valence of the items used.
STUDY DESIGN Once a subject has agreed to participate in this study, they will be asked to complete online questionnaires as well as record their voice reading a collection of random words 2-4 times.
This study follows a 2x2 design. Participants will be randomly assigned to one of four groups. Randomization will be accomplished by using the MUW randomizer. Participants will be stratified by education and speech disorder type. The healthy case control group will undergo case matching to ensure comparability across groups. Each group will receive two brief speech pathology severity questionnaires but at different frequencies, and with slight adjustments to the wording. Depending on the experimental group, a subject will complete the questionnaires either two or four times, separated each time by one week. The questionnaires, in all groups, will take approximately 15 minutes to complete. Lastly, at the very start and once at the very end of the study, every participant will also be asked to record a brief 45 second audio file in the online survey as well as complete two additional psychological questionnaires.
The measures in this study cover the following tools (complete measures are uploaded in the ECS):
* A patient-reported outcome on voice health - Voice Handicap Index (VHI) or Voice Handicap Index Positively adapted (VHI-PA)
* A patient-reported outcome on speech health - Communicative Participation Item Bank (CPIB) or Communicative Participation Item Bank Positively adapted (CPIB-PA)
* A self-esteem stability scale - Self-Esteem Stability Scale (SESS)
* A self-esteem scale - Rosenberg Self-Esteem Scale (RSS)
* Two question measure of disease impact (2DB)
* A single-question measure of disease activity (1DS)
* Audio recording of text read aloud (ARec)
Study population All patients with Muscle tension dysphonia, Inducible laryngeal obstruction, Amyotrophic lateral sclerosis (ALS), suffering from a stroke or other brain injury/damage/trauma, (aphasia, dysarthria), and Parkinson's disease will be targeted for recruitment. There are no geographic location requirements. The participation schedule can be found below. Patients will be informed of the schedule in advance. A subject must complete any respective sampling epoch within 48 hours of the prescribed date in order to qualify as completed. Subjects must also have strong English skills and be technologically savvy to participate. Only adults will be included in the study.
Study Design Flow Group 1: High frequency-negative: 1 week between each collection
1. Demographics, VHI, CPIB, SESS, RSS, 1DS, 1DB, ARec\*
2. VHI, CPIB, SE, SSE, 1DS, 2DB, ARec
3. VHI, CPIB, SE, SSE, 1DS, 2DB, ARec
4. VHI, CPIB, SE, SSE, 1DS, 2DB, ARec Group 2: High frequency-positive: 1 week between each collection
<!-- -->
1. Demographics, VHI-PA, CPIB-PA, SESS, RSS, 1DS, 2DB, ARec\*
2. VHI-PA, CPIB-PA, SE, SSE, 1DS, 2DB, ARec
3. VHI-PA, CPIB-PA, SE, SSE, 1DS, 2DB, ARec
4. VHI-PA, CPIB-PA, SE, SSE, 1DS, 2DB, ARec Group 3: Low frequency-negative: 2 weeks between each collection
1: Demographics, VHI, CPIB, SESS, RSS, 1DS, 2DB, ARec\* 2: VHI, CPIB, SE, SSE, 1DS, 2DB, ARec Group 4: Low frequency-positive: 2 weeks between each collection
1. Demographics, VHI-PA, CPIB-PA, SESS, RSS, 1DS, 2DB, 1ARec\*
2. VHI-PA, CPIB-PA, SE, SSE, 1DS, 2DB, 1ARec Control: (once at start, once at low frequency completion/final outcome collection, once at high frequency completion)
1: Demographics, ARec x 3
Healthy Control: (once at start, once at low frequency completion/ final outcome collection, once at high frequency completion)
1. Demographics, ARec x 3
\*completed prior to assessments
\*English was chosen as the study language as a wider range of validated assessments exist in this language. The AI used for speech analysis is also best suited for and trained (66%) on English. Lastly, English is the most prolific language (native + secondary speakers) in the world which will facilitate the speed of recruitment.
Subjects who meet any of the following criteria will be excluded from study entry:
• Under the age of 18
NUMBER OF SUBJECTS PARTICIPATING IN THE STUDY Subjects will be randomly separated into six groups including control and healthy control, with approximately 33 subjects per group. A formal power analysis was performed using G\*power with parameters sourced from relevant seminal research (Conner et al., 2011; Godin et al., 2011). The following parameters were used for the sample size analysis: two-tailed directionality; effect size of 0.30; a priori computation, anticipated power of 0.95, and an error rate of 0.0023. Means difference tests between independent groups within the t-test family were utilized.
RECRUITMENT PROCEDURE Recruitment into the mere-measurement study will be performed supported by Probando. Probando is a previously approved patient recruitment service that specializes in online advertising. All recruitment materials are uploaded to the ECS. A description of the Probando recruitment service and procedures can be found as an attachment, as well as the recruitment materials for all subjects including healthy controls and a screenshot of the currently inactive landing page. As a part of their service, Probando uses the study inclusion and exclusion criteria to screen potential interested subjects. If they qualify and permit contact, their contact information will be provided to the MUW researchers for direct outreach. Therefore, all study timings, measures, and data will be distributed and collected only by the study researchers. Patients will be able to withdraw from the study at any time without providing a reason. To limit potential bias, an initial self-report of an official diagnosis is required to participate. Additionally, the patients will also confirm their diagnosis with a checkbox, for the purpose of minimizing the risk of malingering patients. If an individual is highly motivated to participate and does not suffer from a qualifying speech disorder they can still apply to participate as a healthy control. Furthermore, this sample would be more representative of a telemedicine community.
DATA SOURCES
Participants' and study data will be recorded in the study database. Study data will be collected at defined time points (see Section 1.5) using a single online format:
• SoSci survey (www.soscisurvey.de) is a routinely used, safe, online questionnaire distribution and data retrieval platform. Within this platform, five links will be created, one for each group. These will connect subjects to the questionnaires and to the instructions for capturing the audio file.
An email address for every participant will be required for communication and dissemination of participation credits. All individuals with access to participants' personal information are obligated to respect their privacy and only use and disclose their information as described in the informed consent document.
Demographic information and mere-measurement study results are secured against unauthorized access. Security measures reduce the risk of unauthorized individuals accessing subject personal information, but such risks cannot be entirely eliminated. All audio recordings will be stored only for the duration of the study. Upon closure, they will be deleted.
The information collected from the mere-measurement study will be kept confidential. Subject personal information will be stored safely at MUW and pseudonymized as discussed in the previous section.
DATA COLLECTION
Online, subjects will complete a battery of questionnaires totalling approximately 15-20 minutes of time following the informed consent. Informed consent will be collected online via the SoSci survey tool. The following parameters will be applied to the virtual informed consent:
• The patient information including the data protection section is displayed above the checkbox. The patients are informed about what happens to their data, their benefits, and risks in sufficient detail but simple detail in this section.
• The checkbox says that patients have read and understood the text and that they agree.
• The patients will confirm their diagnosis with a checkbox, for the purpose of minimizing the risk of malingering patients Depending on the group assigned, a participant will have to complete this battery either 2 or 4 times. The control and healthy group will complete only demographics questions and the audio recordings, no PROMs will be collected. The four intervention groups will be randomized using a digital randomization tool provided by the MUW (https://www.meduniwien.ac.at/randomizer/ ).
All patients, across all intervention groups, will complete the read-aloud activity prior to the first collection of PROMs. This will serve as the baseline for later comparison. Following the first recording, all subsequent recordings will be completed after completing the PROMs. An electronic bank transfer form (MUW standard bank form) will be emailed to participants at the end of the study to complete the 50€ transfer. These electronic records will be immediately destroyed upon successful completion.
DATA MANAGEMENT Patient-reported data will be captured using SoSci survey with an account owned by the Center for Outcomes Research. These data will not be transferred outside of the MUW. Data transfers between the investigators of this study will be managed using procedures described in a jointly developed Data Transfer Plan. All data transferred between the two MUW centers, speech pathology and outcome research, will be identified only by a subject ID code, unless otherwise consented by patients and agreed upon in the Data Transfer Plan.
DATA QUALITY ASSURANCE Patients will consent that pseudonymized patient data will be hosted and analysed at the MUW. MUW will not share the data with any third parties or collaborators. MUW regularly processes medical data and is subject to the GDPR requirements. MUW is responsible for data quality and will perform oversight of the data management of this study. Investigators and study coordinators will receive an initial training session on the protocol, study flow, study database, survey tool, documentation, and expectations, and any applicable study processes. Access to data for secondary use cases will not be enabled.
SOURCE DATA DOCUMENTATION
Source documents (electronic) are those in which participant data are recorded and documented for the first time. The source documentation for this study will be:
* Participant demographic information and eligibility assessment
* Completed Informed Consent Forms
* Audio recordings
* Completed PROMs
### Conditions Module
**Conditions:**
- Measurement, Psychological Stress
- Speech Disorders
- Assessment, Self
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 170
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants with a speech disorder who do not receive the intervention and only complete the outcomes.
**Label:** Control: unhealthy
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** Participants without a speech disorder who do not receive the intervention and only complete the outcomes.
**Label:** Control: healthy
**Type:** NO_INTERVENTION
#### Arm Group 3
**Description:** Four groups receiving different rates of questionnaire exposure and wording at either two or four week intervals.
**Intervention Names:**
- Other: Patient-reported outcomes for speech disorders: positive
**Label:** Experimental groups
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental groups
**Description:** The Communicative Participation Item Bank (CPIB) aims to assess communication participation in all kinds of communication disorders. The Voice Self-Efficacy Questionnaire (VSEQ) monitors self-efficacy in individuals with self-declared voice problems before and after interventions. The Vocal Fatigue Handicap Questionnaire (VFHQ) and the Vocal Fatigue Index (VFI) aim at reflecting vocal fatigue. Both have been adapted to reflect purely positive wording.
**Name:** Patient-reported outcomes for speech disorders: positive
**Other Names:**
- Patient-reported outcomes for speech disorders: negative
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** • An audio recording of a standardized text, with the order of the paragraphs randomized in between every exposure. This text was adapted from the standard "Rainbow Passage" read aloud assessment with the field of speech pathologies (Dietsch et al., 2023). Artificial intelligence - ChatGPT - was used to recreate novel text of the same length and difficulty as the "Rainbow Passage" which is called "In the heart of a lush valley" (the text is uploaded in the ECS). An adapted version was opted for to eliminate the possibility of previous exposure.
**Measure:** audio recording of a standardized text
**Time Frame:** Baseline and at each experimental instance occuring once a week for up to four weeks
#### Secondary Outcomes
**Description:** A three-item self-esteem stability scale - Self-Esteem Stability Scale (SESS). Scores range from 1-6 with higher scores suggesting less stability.
**Measure:** Self-Esteem Stability Scale (SESS)
**Time Frame:** Baseline and at each experimental instance occuring once a week for up to four weeks
**Description:** A single-question measure of disease activity (1DS). Score range of 1-5 with higher scores denoting more activity.
**Measure:** Disease activity (1DS)
**Time Frame:** Baseline and at each experimental instance occuring once a week for up to four weeks
**Description:** A nine-item scale measuring self-esteem. Score range of 1-4 with high scores denoting lower self-esteem.
**Measure:** A self-esteem scale - Rosenberg Self-Esteem Scale (RSS)
**Time Frame:** Baseline and at each experimental instance occuring once a week for up to four weeks
**Description:** Two-question measure of disease impact (2DB). Score range of 1-4 with higher scores denoting more impact.
**Measure:** Disease Impact
**Time Frame:** Baseline and at each experimental instance occuring once a week for up to four weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
All patients will be required to have a qualifying disorder known to effect speech as identified below. Patients who meet the eligibility criteria will be invited to participate in the study by the researchers. Eligibility will be assessed prior to enrolment recruitment screening. AKH patients are not targeted for this study. All patients, regardless of geographic location around the world, can be recruited. The study is entirely online.
Subjects must meet the following inclusion criteria for study entry:
* Strong English skills\*
* Technology savvy - able to complete online questionnaire
* Suffering from one of the following:
* Muscle tension dysphonia
* Inducible laryngeal obstruction
* Amyotrophic lateral sclerosis (ALS)
* Patients after a stroke or other brain injury/damage/trauma, (aphasia, dysarthria)
* Parkinson's disease
Exclusion Criteria:
* Under the age of 18
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** preston.long@meduniwien.ac.at
**Name:** Preston Long, PhD
**Phone:** +43 (0)1 40400-66100
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Vienna
**Contacts:**
***Contact 1:***
- **Email:** preston.long@meduniwien.ac.at
- **Name:** Preston Long, PhD
- **Phone:** +43 (0)1 40400-66100
- **Role:** CONTACT
**Country:** Austria
**Facility:** Preston Long
**Status:** RECRUITING
**Zip:** 1020
### References Module
#### References
**Citation:** Schwarz, N. (1999). Self-reports: How the questions shape the answers. American Psychologist, 54(2), 93-105. https://doi.org/10.1037/0003-066X.54.2.93
**Citation:** Näher, A.-F., & Krumpal, I. (2012). Asking sensitive questions: The impact of forgiving wording and question context on social desirability bias. Quality & Quantity: International Journal of Methodology, 46(5), 1601-1616. https://doi.org/10.1007/s11135-011-9469-2
**Citation:** Morwitz, V. G., Johnson, E., & Schmittlein, D. (1993). Does measuring intent change behavior?. Journal of consumer research, 20(1), 46-61.
**Citation:** Sandberg T, Conner M. A mere measurement effect for anticipated regret: impacts on cervical screening attendance. Br J Soc Psychol. 2009 Jun;48(Pt 2):221-36. doi: 10.1348/014466608X347001. Epub 2008 Sep 12.
**PMID:** 18793492
**Citation:** Godin G, Sheeran P, Conner M, Delage G, Germain M, Belanger-Gravel A, Naccache H. Which survey questions change behavior? Randomized controlled trial of mere measurement interventions. Health Psychol. 2010 Nov;29(6):636-44. doi: 10.1037/a0021131.
**PMID:** 20939639
**Citation:** Godin G, Sheeran P, Conner M, Germain M. Asking questions changes behavior: mere measurement effects on frequency of blood donation. Health Psychol. 2008 Mar;27(2):179-84. doi: 10.1037/0278-6133.27.2.179.
**PMID:** 18377136
**Citation:** Lineweaver TT, Kercood S, Gabor AJ, Cervantes J, Laine A, Baker E. The effect of medication and question wording on self-reported symptoms and their accuracy in young adults with attention-deficit/hyperactivity disorder. Br J Clin Psychol. 2021 Jun;60(2):252-269. doi: 10.1111/bjc.12276. Epub 2021 Jan 4.
**PMID:** 33393098
**Citation:** Cohen ML, Hula WD. Patient-Reported Outcomes and Evidence-Based Practice in Speech-Language Pathology. Am J Speech Lang Pathol. 2020 Feb 7;29(1):357-370. doi: 10.1044/2019_AJSLP-19-00076. Epub 2020 Feb 3.
**PMID:** 32011905
**Citation:** Francis DO, Daniero JJ, Hovis KL, Sathe N, Jacobson B, Penson DF, Feurer ID, McPheeters ML. Voice-Related Patient-Reported Outcome Measures: A Systematic Review of Instrument Development and Validation. J Speech Lang Hear Res. 2017 Jan 1;60(1):62-88. doi: 10.1044/2016_JSLHR-S-16-0022.
**PMID:** 28030869
**Citation:** Slavych BK, Zraick RI, Ruleman A. A Systematic Review of Voice-Related Patient-Reported Outcome Measures for Use with Adults. J Voice. 2024 Mar;38(2):544.e1-544.e14. doi: 10.1016/j.jvoice.2021.09.032. Epub 2021 Nov 12.
**PMID:** 34782227
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-04-08
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 253503
- Type Abbrev: Prot_SAP
- Upload Date: 2024-05-27T04:04
- Date: 2024-04-08
- Filename: ICF_001.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 128526
- Type Abbrev: ICF
- Upload Date: 2024-06-03T04:07
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000007806
- Term: Language Disorders
- ID: D000003147
- Term: Communication Disorders
- ID: D000019954
- Term: Neurobehavioral Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M15864
- Name: Speech Disorders
- Relevance: HIGH
- As Found: Speech Disorders
- ID: M16105
- Name: Stress, Psychological
- Relevance: HIGH
- As Found: Psychological Stress
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M10823
- Name: Language Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M6374
- Name: Communication Disorders
- 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
### Condition Browse Module - Meshes
- ID: D000013064
- Term: Speech Disorders
- ID: D000013315
- Term: Stress, Psychological
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443060
**Brief Title:** The Effect of Virtual Reality and Buzzy Application on Pain, Fear and Anxiety During Prick Test in Children
**Official Title:** The Effect of Virtual Reality and Buzzy Application on Pain, Fear and Anxiety During Prick Test in Children: Randomized Controlled Study
#### Organization Study ID Info
**ID:** FundaTEZ
#### Organization
**Class:** OTHER
**Full Name:** KTO Karatay University
### Status Module
#### Completion Date
**Date:** 2024-10-15
**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:** 2024-09-15
**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:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** KTO Karatay 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:** Allergy is a hypersensitivity reaction to a triggering agent. Tests used in allergy are divided into two: in vivo and in vitro. Among the in vivo tests routinely used, epidermal, intradermal and patch tests are used, and the most commonly used is the skin prick test. In order to prevent the negative effects of pain, it is important to be informed about the appropriate approach to children, newborns and babies, and effective pain management, according to their cognitive development levels. Pain management in children should be done appropriately with accurate assessment tools. This will increase the quality of life, reduce hospitalizations, shorten the length of hospital stay and reduce costs. Pain experiences experienced during childhood will cause later pain experiences to be perceived as more severe and cause anxiety and fear. Anxiety is a psychological, physiological and behavioral state that develops in response to a perceived or existing threat. Anxiety, which can also be expressed as worry or anxiety, is a emotional state that can occur in various ways, such as restlessness, tension, easy fatigue, lack of concentration, muscle tension, and sleep disturbance, in which autonomic and somatic symptoms occur in the body, without any reason.
Virtual reality provides multi-sensory information as children focus on the simulated world. Virtual reality, one of the cognitive methods; It can create an environment where three-dimensional pictures or animations created on the computer can interact in people's minds. It is also defined as a distraction method created by software, which creates the feeling that users are in the environment even though they are not in the real environment, and can interact with people in the environment. When all these studies were examined, no three-group study was found comparing a distracting method with a physical method for the 7-10 age group. Additionally, there is a study that used virtual reality in the prick test, but there is no method that has been proven to be superior to virtual reality. In this study, it will be investigated whether virtual reality and buzzy applications have a reducing effect on pain, fear and anxiety compared to the control group. Virtual reality and buzzy techniques will also be compared with each other. Since no such study has been found in the literature, it is thought to contribute to the field.
**Detailed Description:** Allergy is a hypersensitivity reaction to a triggering agent. Tests used in allergy are divided into two: in vivo and in vitro. Among the in vivo tests routinely used, epidermal, intradermal and patch tests are used, and the most commonly used is the skin prick test. In order to prevent the negative effects of pain, it is important to be informed about the appropriate approach to children, newborns and babies, and effective pain management, according to their cognitive development levels. Pain management in children should be done appropriately with accurate assessment tools. This will increase the quality of life, reduce hospitalizations, shorten the length of hospital stay and reduce costs. Pain experiences experienced during childhood will cause later pain experiences to be perceived as more severe and cause anxiety and fear. Anxiety is a psychological, physiological and behavioral state that develops in response to a perceived or existing threat. Anxiety, which can also be expressed as worry or anxiety, is a emotional state that can occur in various ways, such as restlessness, tension, easy fatigue, lack of concentration, muscle tension, and sleep disturbance, in which autonomic and somatic symptoms occur in the body, without any reason.
Virtual reality provides multi-sensory information as children focus on the simulated world. Virtual reality, one of the cognitive methods; It can create an environment where three-dimensional pictures or animations created on the computer can interact in people's minds. It is also defined as a distraction method created by software, which creates the feeling that users are in the environment even though they are not in the real environment, and can interact with people in the environment.
When all these studies were examined, no three-group study was found comparing a distracting method with a physical method for the 7-10 age group. Additionally, there is a study that used virtual reality in the prick test, but there is no method that has been proven to be superior to virtual reality. In this study, it will be investigated whether virtual reality and buzzy applications have a reducing effect on pain, fear and anxiety compared to the control group. Virtual reality and buzzy techniques will also be compared with each other. Since no such study has been found in the literature, it is thought to contribute to the field.
### Conditions Module
**Conditions:**
- Pain
- Fear
- Anxiety
- Children, Only
- Virtual Reality
**Keywords:**
- BUZZY
- Virtual Reality
- Pain
- Fear
- Anxiety
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 111
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** After the scales are filled in, the child will be shown a cartoon film deemed appropriate by the experts by wearing VR glasses and headphones before the Prick test (average 2 minutes). The appropriate cartoon will be shown to the VR glasses group for an average of 15 minutes. After the child starts watching the cartoon, the child will be asked to extend his/her left arm and the prick test process will begin.
**Intervention Names:**
- Behavioral: Virtual Reality Group
**Label:** Virtual Reality Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The CFS-D scale will be completed only by the child to measure the anxiety level before the procedure. To assess pain and fear, the WB-FACES pain scale and the CFS fear scale will be completed by the child, parent and researcher before the procedure. The buzzy cold and vibration device will be connected to the children in the buzzy experimental group 5-10 seconds before the procedure, at least 8-10 cm above the area to be treated (upper part of the left arm antecubital fossa) and the prick test application will be started.
**Intervention Names:**
- Behavioral: Buzzy Application Group
**Label:** Buzzy Application Group
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Children in this group will be given routine explanations according to the outpatient clinic procedure and prick test will be applied before the procedure.
**Intervention Names:**
- Other: Control Group
**Label:** Control Group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Virtual Reality Group
**Description:** Before starting the Prick procedure, the child in the virtual reality group, which is determined by randomisation, will be given a brief information about how the allergy test will be performed and about virtual reality. Before the Prick test (approximately 2 minutes before the Prick test), the child will start to watch a film deemed appropriate by the experts by wearing virtual reality and headphones. After the child starts watching the film, the child will be asked to extend his/her left arm and solutions will be dripped on the forearm and the puncture will be performed with a lancet. The child will continue to watch the film during the whole procedure.
**Name:** Virtual Reality Group
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Buzzy Application Group
**Description:** Before starting the prick procedure, the child in the buzzy group, which was determined by randomisation, will be given a brief information about how the allergy test will be performed and the buzzy device. The children in the buzzy experimental group will be connected to the buzzy cold and vibration device at least 8-10 cm above the area to be treated (upper part of the left arm antecubital fossa) 5-10 seconds before starting the procedure and the prick test application will be started.
**Name:** Buzzy Application Group
**Type:** BEHAVIORAL
#### Intervention 3
**Arm Group Labels:**
- Control Group
**Description:** Before starting the prick procedure, the children in the control group determined by randomisation will be given routine explanations according to the outpatient clinic procedure before starting the procedure and the prick test will be applied.
**Name:** Control Group
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The Child Anxiety Scale-Stability Scale (CAS-D); is shaped like a thermometer with a light bulb at the bottom and horizontal lines at intervals going upwards. In this scale for children aged four to ten, children are instructed to 'Imagine that all your anxious or nervous feelings are at the bulb or bottom of the thermometer'. A transparent metre is placed over the child's rating on which ½ point increments are marked, then the ½ point increment is rounded up to the nearest number. The score can range from 0-10. Above 5 points indicates high anxiety. The CVI is 0.89, the correlation coefficient is 0.99.
**Measure:** The Child Anxiety Scale-Stability Scale (CAS-D)
**Time Frame:** six month
**Description:** Child Fear Scale; This scale assesses pain-related fear in children. The Child Fear Scale (CFS) developed by McMurty et al. (2011) is a scale suitable for the 5-10 age group and consists of five drawn facial expressions ranging from neutral expression (0=no fear) to frightened face (4=severe fear). It can be easily assessed by researchers and health professionals who provide care/intervention to children (McMurtry et al., 2011). There is no gold standard self-report scale that assesses fear for children. Test-retest method was used in the validity study of the scale. The Turkish version of the scale was adapted by Özalp Gerçeker et al. (2018) and the Content Validity Index (CVI) was found to be 0.89 and the correlation coefficient was 0.96 (Özalp Gerçeker et al., 2018).
**Measure:** Child Fear Scale (CFS)
**Time Frame:** six month
**Description:** Wong-Baker FACES Pain Rating Scale (WB-FACES); It was developed by Wong and Baker in 1981 and revised in 1983. It is used to diagnose pain in children and adolescents aged 3-18 years. This scale, which can be used safely over the age of three, consists of six facial parts scored between 0-10. The face shape representing no pain is evaluated as 0 points and the face shape representing severe pain is evaluated as 10 points. Participants are asked to choose the best facial expression that best describes them. WB_FACES is a scale suitable for use in Turkey (Sahiner \& Bal, 2015) and will be evaluated by the parents and the researcher as well as the child's self-report in this study.
**Measure:** Wong-Baker FACES Pain Rating Scale (WB-FACES)
**Time Frame:** six month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* The child must be between the ages of 7-10
* It will be the first time that a prick test will be applied.
* The child can speak and understand Turkish comfortably
* He and his family agree to participate in the study.
* Not having used analgesic medication at least six hours ago
Exclusion Criteria:
* The child has any diagnosed psychiatric disorder
* Having visual, auditory or speech disorders
* Having a chronic disease other than allergy
**Healthy Volunteers:** True
**Maximum Age:** 10 Years
**Minimum Age:** 7 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** fundakaya033@gmail.com
**Name:** Funda Gürbüz
**Phone:** 05065005321
**Phone Ext:** 7522
**Role:** CONTACT
**Contact 2:**
**Email:** eminegeckil@gmail.com
**Name:** Emine Geçkil
**Phone:** 0506 628 54 60
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Necmettin Erbakan Üniversitesi Hemşirelik Fakültesi
**Name:** Emine Geçkil
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** After the research is over
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M4324
- Name: Anxiety Disorders
- Relevance: HIGH
- As Found: Anxiety
- ID: M13066
- Name: Pain
- 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: D000001008
- Term: Anxiety Disorders
### 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:** NCT06443047
**Acronym:** STITCH
**Brief Title:** Suturing Through-the-scope System Used for Prophylactic Closure of Colonic Post-ESD Defects
**Official Title:** Suturing Through-the-scope System Used for Prophylactic Closure of Colonic Post-ESD Defects: A Randomized Trial vs Conventional Clips That it Highlights the Importance of Suturing in Promoting Healing and Closure of the Colonic ESD Defects
#### Organization Study ID Info
**ID:** 3938 - STITCH
#### Organization
**Class:** OTHER
**Full Name:** Istituto Clinico Humanitas
### 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:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Istituto Clinico Humanitas
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** True
### Description Module
**Brief Summary:** The goal of this study is to perform a randomized trial to compare a new through-the-scope suturing system and conventional clips for closure of defect after ESD for 30-60 mm colonic polyps. More precisely, the hypothesis posits that the new through-the-scope suturing system can achieve higher complete closure rates in a shorter time in comparison to conventional clips.
**Detailed Description:** Large superficial colonic polyps are increasingly detected thanks to colorectal cancer screening programs worldwide. ESD is the technique which provides a high-quality resection of these large polyps.
Nevertheless, several adverse events affect ESD, especially in the colon. They could be life-threatening, call for or prolong the hospitalization, require blood transfusion, additional endoscopic or surgical procedures and increase costs.
Thus, preventing these adverse events is an important clinical and medico-economic objective. Endoscopic closure of post-ESD defects could reduce this risk. However, closing these large defects with conventional clips can be difficult, unsuccessful and prolong the duration of the whole procedure. A new trough-the-scope suturing system could successfully provide a complete endoscopic closure of post-ESD defects in the colon in a reasonable time.
Expected benefits are a decrease of morbidity and costs related to colonic ESD procedure
### Conditions Module
**Conditions:**
- Precancerous Lesion of Colon
**Keywords:**
- precancerous colorectal lesions
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The goal of this study is to perform a randomized trial to compare a new through-the-scope suturing system and conventional clips for closure of defect after ESD for 30-60 mm colonic polyps. More precisely, the hypothesis posits that the new through-the-scope suturing system can achieve higher complete closure rates in a shorter time in comparison to conventional clips.
Considering an α risk set at 5%, a power set at 80%, given an expected complete resection rate of 70% in the control group and of 95% in the experimental group, 33 patients in each group are required. Thus, the investigators will enroll 66 subjects
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 66
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Closure of the defect will be performed at the end of the Endoscopic Submucosal Dissection procedure with clips (Boston scientific®). Pictures or movies of the closing defect will be necessary to independently confirm the complete closure.
**Label:** ESD with clips
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** Closure of the defect will be performed at the end of the ESD procedure with a new TTS suturing system (X-Tack Boston scientific®). Pictures or movies of the closing defect will be necessary to independently confirm the complete closure.
**Intervention Names:**
- Device: TTS suturing system
**Label:** TTS suturing system
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- TTS suturing system
**Description:** The use of TTS suturing system could allow a quick, complete endoscopic closure of colonic post-ESD defects, providing relevant clinical and medico-economic benefits.
**Name:** TTS suturing system
**Type:** DEVICE
### Outcomes Module
#### Other Outcomes
**Description:** To assess, it will compare the proportion between the 2 groups of post-polypectomy syndrome at Day 7
**Measure:** Proportion of post-polypectomy syndrome
**Time Frame:** 1 week
**Description:** Compare and assess the proportion of clinically significant delayed bleeding at 1 month
**Measure:** Proportion of clinically significant delayed bleeding
**Time Frame:** 1 month
**Description:** To assess the cost-effectiveness ratio, estimated by dividing the difference in costs observed between the two strategies by the difference of effectiveness at 1 month. The effectiveness criterion being the closure time at 1 month
**Measure:** Cost-effectiveness ratio
**Time Frame:** 1 month
**Description:** To compare the length of hospitalization defined as the number of procedural nights in the hospitals
**Measure:** Length of hospitalization
**Time Frame:** up to 1 week
#### Primary Outcomes
**Description:** To assess the proportion of complete closure, defined when opposite margins are drawn together without a persistent post-resection defect of more than 1 cm (pictures and/or videos)
**Measure:** Compare the proportion of complete closure between the two groups
**Time Frame:** Intra-procedural
#### Secondary Outcomes
**Description:** To assess the closure procedure time, which is defined by duration between the beginning of assemblage of the suturing system and the end of the closure in the intervention group and between the opening of the bag of the first clip until the end of the closure in the control group.(pictures-videos)
**Measure:** duration of the closure procedure
**Time Frame:** up to 2 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patient suffering from 30-60 mm colonic polyps with indication of ESD
* Male or female patients aged \> 18 years' old
* Patients able to fill in questionnaires written in Italian
Exclusion Criteria:
* Failure of endoscopic resection
* Suspicion of deep submucosal cancer by analysis of pit pattern (KUDO Vn)
* Polyp involving the appendix deeply (type 2 or 3 according to Toyonaga classification)
* Polyp inside the ileo-cecal valvula.
* Rectal lesions
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** alessandro.repici@hunimed.eu
**Name:** Alessandro Repici, Prof.
**Phone:** 028224 7493
**Role:** CONTACT
**Contact 2:**
**Email:** alessandro.daprano@humanitas.it
**Name:** Alessandro D'Aprano, Dr.
**Phone:** 028224 3678
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** IRCCS Humanitas Research Hospital - Rozzano 20089, Milan, Italy
**Name:** Alessandro Repici, Prof.
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Morgan E, Arnold M, Gini A, Lorenzoni V, Cabasag CJ, Laversanne M, Vignat J, Ferlay J, Murphy N, Bray F. Global burden of colorectal cancer in 2020 and 2040: incidence and mortality estimates from GLOBOCAN. Gut. 2023 Feb;72(2):338-344. doi: 10.1136/gutjnl-2022-327736. Epub 2022 Sep 8.
**PMID:** 36604116
**Citation:** Arnold M, Sierra MS, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global patterns and trends in colorectal cancer incidence and mortality. Gut. 2017 Apr;66(4):683-691. doi: 10.1136/gutjnl-2015-310912. Epub 2016 Jan 27.
**PMID:** 26818619
**Citation:** Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.
**PMID:** 29313949
**Citation:** Schoen RE, Pinsky PF, Weissfeld JL, Yokochi LA, Church T, Laiyemo AO, Bresalier R, Andriole GL, Buys SS, Crawford ED, Fouad MN, Isaacs C, Johnson CC, Reding DJ, O'Brien B, Carrick DM, Wright P, Riley TL, Purdue MP, Izmirlian G, Kramer BS, Miller AB, Gohagan JK, Prorok PC, Berg CD; PLCO Project Team. Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy. N Engl J Med. 2012 Jun 21;366(25):2345-57. doi: 10.1056/NEJMoa1114635. Epub 2012 May 21.
**PMID:** 22612596
**Citation:** Nishihara R, Wu K, Lochhead P, Morikawa T, Liao X, Qian ZR, Inamura K, Kim SA, Kuchiba A, Yamauchi M, Imamura Y, Willett WC, Rosner BA, Fuchs CS, Giovannucci E, Ogino S, Chan AT. Long-term colorectal-cancer incidence and mortality after lower endoscopy. N Engl J Med. 2013 Sep 19;369(12):1095-105. doi: 10.1056/NEJMoa1301969.
**PMID:** 24047059
**Citation:** Jacques J, Schaefer M, Wallenhorst T, Rosch T, Lepilliez V, Chaussade S, Rivory J, Legros R, Chevaux JB, Leblanc S, Rostain F, Barret M, Albouys J, Belle A, Labrunie A, Preux PM, Lepetit H, Dahan M, Ponchon T, Crepin S, Marais L, Magne J, Pioche M. Endoscopic En Bloc Versus Piecemeal Resection of Large Nonpedunculated Colonic Adenomas : A Randomized Comparative Trial. Ann Intern Med. 2024 Jan;177(1):29-38. doi: 10.7326/M23-1812. Epub 2023 Dec 12.
**PMID:** 38079634
**Citation:** Arezzo A, Passera R, Marchese N, Galloro G, Manta R, Cirocchi R. Systematic review and meta-analysis of endoscopic submucosal dissection vs endoscopic mucosal resection for colorectal lesions. United European Gastroenterol J. 2016 Feb;4(1):18-29. doi: 10.1177/2050640615585470. Epub 2015 May 5.
**PMID:** 26966519
**Citation:** Liu M, Zhang Y, Wang Y, Zhu H, Xu H. Effect of prophylactic closure on adverse events after colorectal endoscopic submucosal dissection: A meta-analysis. J Gastroenterol Hepatol. 2020 Nov;35(11):1869-1877. doi: 10.1111/jgh.15148. Epub 2020 Jul 5.
**PMID:** 32542857
**Citation:** Dong L, Zhu W, Zhang X, Xie X. Does Prophylactic Closure Improve Outcomes After Colorectal Endoscopic Submucosal Dissection? A Systematic Review and Meta-analysis. Surg Laparosc Endosc Percutan Tech. 2024 Feb 1;34(1):94-100. doi: 10.1097/SLE.0000000000001248.
**PMID:** 38011072
**Citation:** Pohl H, Grimm IS, Moyer MT, Hasan MK, Pleskow D, Elmunzer BJ, Khashab MA, Sanaei O, Al-Kawas FH, Gordon SR, Mathew A, Levenick JM, Aslanian HR, Antaki F, von Renteln D, Crockett SD, Rastogi A, Gill JA, Law RJ, Elias PA, Pellise M, Wallace MB, Mackenzie TA, Rex DK. Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial. Gastroenterology. 2019 Oct;157(4):977-984.e3. doi: 10.1053/j.gastro.2019.03.019. Epub 2019 Mar 15.
**PMID:** 30885778
**Citation:** Kobara H, Tada N, Fujihara S, Nishiyama N, Masaki T. Clinical and technical outcomes of endoscopic closure of postendoscopic submucosal dissection defects: Literature review over one decade. Dig Endosc. 2023 Jan;35(2):216-231. doi: 10.1111/den.14397. Epub 2022 Aug 25.
**PMID:** 35778927
**Citation:** Farha J, Ramberan H, Aihara H, Zhang LY, Mehta A, Hage C, Schlachterman A, Kumar A, Shinn B, Canakis A, Kim RE, D'Souza LS, Buscaglia JM, Storm AC, Samarasena J, Chang K, Friedland S, Draganov PV, Qumseya BJ, Jawaid S, Othman MO, Hasan MK, Yang D, Khashab MA, Ngamruengphong S; ESD-Closure working group. A novel through-the-scope helix tack-and-suture device for mucosal defect closure following colorectal endoscopic submucosal dissection: a multicenter study. Endoscopy. 2023 Jun;55(6):571-577. doi: 10.1055/a-1970-5528. Epub 2022 Nov 2.
**PMID:** 36323330
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: HB
- Name: Herbal and Botanical
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T120
- Name: Cola
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443034
**Acronym:** NEPHROL1
**Brief Title:** Predictive Determinants of Nephrotic Syndrome Remission in Patients With At-risk Polymorphism of APOL1
**Official Title:** Predictive Determinants of Nephrotic Syndrome Remission in Patients With Focal Segmental Glomerulosclerosis or Minimal Change Disease and At-risk Polymorphism of APOL1 Gene
#### Organization Study ID Info
**ID:** APHP240269
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique - Hôpitaux de Paris
### 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:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-28
**Study First Submit QC Date:** 2024-06-03
### 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:** This is a multicentric retrospective observational cohort study.
As primary objective, the study aims to evaluate the factors associated with nephrotic syndrome remission in patient with nephrotic syndrome, biopsy-prove minimal change disease or focal segmental glomerulosclerosis, and an at-risk variant of the APOL1 gene.
As secondary objectives, this study aims:
* To evaluate the benefit of corticosteroids in obtaining the remission of nephrotic syndrome
* To identify the predictors of complete renal remission of nephrotic syndrome
* To evaluate the benefit of corticosteroids in reducing the incidence of end-stage renal disease
* To assess the adverse events of corticosteroids in patients treated with corticosteroids.
**Detailed Description:** The APOL1 gene synthesizes Apolipoprotein L1, a transport protein for hydrophobic molecules. When this gene presents bi-allelic "at risk" polymorphisms, it has been associated with an increased risk of end-stage renal disease. These polymorphisms can be frequent on a population scale, affecting up to 32% of patients in some West African countries. The pathogenic nature of these variants is now well established and has been highlighted on several occasions, notably in HIV-associated nephropathy (HIVAN - HIV Associated Nephropathy) or more recently in COVID-19-associated nephropathy (COVAN - COVID Associated Nephropathy), where almost all patients carry APOL1 risk alleles. Irrespective of the causative agent, nephropathy associated with APOL1 risk variants is regularly revealed by a nephrotic syndrome. This syndrome is characterized by generalized edema, high-range proteinuria and acute kidney injury. The course of the disease is particularly difficult to predict and highly variable, with some patients requiring rapid and definitive dialysis while others recover normal renal function without sequelae of proteinuria. In addition to this inter-individual variability, there is also variability in clinical practice with regard to the use of high-dose corticosteroids to induce disease remission. This is largely due to the rarity of the disease in the West and its possible under-diagnosis in developing countries. However, new drugs specifically targeting APOL1 are currently being developed, but their use is currently restricted to studies that exclude the most severe patients. In patients with at-risk APOL1 variants and nephrotic syndromes, it therefore appears critical to identify the determinants associated with remission of nephropathy, to quantify the efficacy of current therapies and to facilitate access to emerging drugs for the most severely ill subjects.
The main aim of this study is to evaluate the predictors (drug, clinical, histological or biological parameters) associated with nephrotic syndrome remission in patients with nephrotic syndrome, biopsy proven focal segmental glomerulosclerosis or minimal change disease and an at-risk variant of the APOL1 gene.
Population involved: eligible patients will be enrolled if they are more than 18 years old, have nephrotic syndrome (serum albumin \< 30 g/L and urine protein creatinine ratio \> 3 g/g) and biopsy-proven focal segmental glomerulosclerosis or minimal change disease.
Data analysis: the association of each explanatory variable with the variable "remission of nephrotic syndrome" will first be assessed using a semi-parametric univariable Cox model.Then, a multivariable Cox model will be performed with the explanatory variables associated with the variable "remission of nephrotic syndrome" with a p value \< 0.2 at the Wald test in univariable Cox regression analysis. Variables independently associated with remission of nephrotic syndrome will be those with a two-sided p value \< 0.05 after stepwise backward elimination in the multivariate model.
In order to assess the robustness of our results with the statistical approach, the investigators will also conduct association analyses between the predictor variables and the variable of interest using the machine learning analysis known as "Random Forrest analysis".
As secondary outcomes, the association between corticosteroids and nephrotic syndrome remission will be evaluated. The association between corticosteroids and end-stage renal disease will also be evaluated as a secondary outcome. The third secondary outcome evaluated will be the association between the predictor variables and complete remission of nephrotic syndrome. The last secondary outcome will be the assessment of corticosteroids safety evaluated following the common terminology criteria for adverse event version 5.0.
### Conditions Module
**Conditions:**
- Nephrotic Syndrome
- Focal Segmental Glomerulosclerosis
- APOL1 Associated Kidney Disease
**Keywords:**
- Nephrotic syndrome
- Covid-19 associated nephropathy
- human immunodeficiency virus associated nephropathy
- APOL1 associated kidney disease
- Focal segmental glomerulosclerosis
- Minimal change disease
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 124
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Description: remission of nephrotic syndrome is defined as a complete or partial remission of nephrotic syndrome as follows:
* Complete remission:
* Urine protein / creatinine ratio \< 0.3 g/g AND
* Albuminemia \> 35 g/L
* Partial remission:
* Urine protein / creatinine ratio \> 0.3 g/g AND
* Urine protein / creatinine ratio \< 3.5 g/g AND
* \> 50% reduction of urine protein / creatinine ratio from baseline (at the time of biopsy)
**Measure:** nephrotic syndrome remission
**Time Frame:** up to 12 months
#### Secondary Outcomes
**Description:** estimated glomerular filtration rate (eGFR) below 15 ml/min/1.73m2 repeatedly over a period \> 3 months OR dialysis \> 3 months OR kidney transplantation.
**Measure:** end stage renal disease
**Time Frame:** up to 12 months
**Description:** Urine protein / creatinine ratio \< 0.3 g/g AND Albuminemia \> 35 g/L
**Measure:** complete remission of nephrotic syndrome Time Frame : between kidney biopsy and last follow-up
**Time Frame:** up to 12 months
**Description:** The number of serious adverse events will be measured in patients treated with corticosteroids according to the CTCAE toxicity grading system for the following adverse events combined: death (all causes), grade 3 or higher infections, sickle cell disease vaso-occlusive crisis, and new-onset or hospitalization-requiring diabetes mellitus.
**Measure:** adverse effects of corticosteroids
**Time Frame:** up to 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult patients followed in 6 nephrology centers between 01/01/2016 and 01/06/2024.
* With characterization of APOL1 gene risk status
* Proteinuria/creatinuria ratio \> 3 g/g at diagnosis of renal disease (within 48 hours of the diagnostic renal biopsy)
* Hypoalbuminemia \< 30 g/L at diagnosis of renal disease (within 48 h of diagnostic renal biopsy)
* Minimal change disease or segmental and focal hyalinosis lesions on renal biopsy.
Exclusion Criteria:
* Presence of diffuse deposits of immunoglobulins or complement fractions on immunofluorescence study
* Presence of endo- or extracapillary hypercellular lesions on light microscopy
* Opposition to the use of medical data
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients APOL1 gene status will be obtained from the Hôpital Européen Georges Pompidou genetic laboratory (performing all APOL1 gene analysis in Paris greater area).
Patients with a biopsy-proven focal segmental glomerulosclerosis or minimal change disease and nephrotic syndrome will be screened in each center.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** Romain.brousse@aphp.fr
**Name:** Romain Brousse, MD, PhD
**Phone:** +33156017043
**Role:** CONTACT
**Contact 2:**
**Email:** Jean-jacques.boffa@aphp.fr
**Name:** Boffa Jean-Jacques, MD, PhD
**Phone:** +33156016029
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Email:** Romain.brousse@aphp.fr
- **Name:** Romain Brousse, MD, PhD
- **Phone:** +33156017043
- **Role:** CONTACT
***Contact 2:***
- **Email:** Jean-jacques.boffa@aphp.fr
- **Name:** Boffa Jean-Jacques, MD, PhD
- **Phone:** +33156016029
- **Role:** CONTACT
**Country:** France
**Facility:** Néphrologie & Dialyses department, Tenon Hospital
**Zip:** 75020
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000005921
- Term: Glomerulonephritis
- ID: D000009393
- Term: Nephritis
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10698
- Name: Kidney Diseases
- Relevance: HIGH
- As Found: Kidney Disease
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12349
- Name: Nephrotic Syndrome
- Relevance: HIGH
- As Found: Nephrotic Syndrome
- ID: M12346
- Name: Nephrosis
- Relevance: HIGH
- As Found: Nephrotic Syndrome
- ID: M9033
- Name: Glomerulosclerosis, Focal Segmental
- Relevance: HIGH
- As Found: Focal Segmental Glomerulosclerosis
- ID: M2561
- Name: COVID-19
- Relevance: LOW
- As Found: Unknown
- ID: M18250
- Name: HIV Infections
- Relevance: LOW
- As Found: Unknown
- ID: M3522
- Name: Acquired Immunodeficiency Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M10199
- Name: Immunologic Deficiency Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M12347
- Name: Nephrosis, Lipoid
- Relevance: LOW
- As Found: Unknown
- ID: M18713
- Name: AIDS-Associated Nephropathy
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9031
- Name: Glomerulonephritis
- Relevance: LOW
- As Found: Unknown
- ID: M12338
- Name: Nephritis
- Relevance: LOW
- As Found: Unknown
- ID: T2357
- Name: Focal Segmental Glomerulosclerosis
- Relevance: HIGH
- As Found: Focal Segmental Glomerulosclerosis
- ID: T3828
- Name: Minimal Change Disease
- Relevance: HIGH
- As Found: Minimal Change Disease
- ID: T2525
- Name: Glomerulonephritis
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007674
- Term: Kidney Diseases
- ID: D000009404
- Term: Nephrotic Syndrome
- ID: D000009401
- Term: Nephrosis
- ID: D000005923
- Term: Glomerulosclerosis, Focal Segmental
- ID: D000013577
- Term: Syndrome
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443021
**Acronym:** pPD
**Brief Title:** Influence of Variable Inflow Volume, Dwell Duration and Glucose Concentration on Ultrafiltration Volume in APD Patients
**Official Title:** Investigation of the Influence of Variable Fill Volume, Dwell Duration and Dialysis Fluid Glucose Composition on Measured Ultrafiltration Volume (UFV) in Automated Peritoneal Dialysis (APD) Patients
#### Organization Study ID Info
**ID:** PD-pPD-01-ESP
#### Organization
**Class:** INDUSTRY
**Full Name:** Fresenius Medical Care Deutschland GmbH
### 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:** 2024-06-03
**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:** 2024-05-17
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Winicker Norimed GmbH
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Fresenius Medical Care Deutschland GmbH
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of the current investigation is to provide proof of concept for a future approach to improve UF prediction accuracy. While building on the ideas of the past, the concept is augmented by leveraging additional diagnostic technologies and digital data analytics methodologies.
**Detailed Description:** The primary objective of this study is:
- UFV determined per defined dwells with variable dwell duration, dialysis fluid glucose composition and inflow volumes
The secondary objectives of this study are:
* Mean daily UFV
* Defined laboratory parameter like urea, creatinine, glucose, sodium determined in blood and dialysate during the extended PET (in dialysate additionally determination: phosphate, albumin removal)
* Treatment parameter: performed treatment duration and volume
* Fluid status measured by Body Composition Monitor (BCM)
* Manual IPP determination during the extended PET: At the first half of the dwell (during the first hour) for every 20 min and during the second half after 2h, 3h and 4h dwell time
* Residual renal function (RRF): renal urea and creatinine clearance, 24h urine output, Glomerular filtration rate (GFR)
* Extended PET
* 24 h batch collection (including e.g. total peritoneal clearance)
* Analysis of daily dietetic fluid intake, weight and further parameters documented by the patient in a patient diary
### Conditions Module
**Conditions:**
- Renal Failure
- Chronic Kidney Diseases
**Keywords:**
- Renal replacement therapy
- Peritoneal dialysis
- Automated peritoneal dialysis
- PD cycler
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SEQUENTIAL
**Intervention Model Description:** Prospective, multi-centric, interventional
##### 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:** During the clinical phase, patients are treated continuously with the PD cycler sleep•safe harmony.
The total duration of the clinical for the individual patient comprises a maximum of 17 weeks starting from V0
**Intervention Names:**
- Device: PD cycler
**Label:** Peritoneal dialysis (PD)
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Peritoneal dialysis (PD)
**Description:** After a training phase and a run-in period of up to 6 weeks, depending on the PD cycler used prior to the study, the interventional phase will be initiated.
* Study phase A, variation of dwell duration: Duration of short cycles (cycle 1 and 2) 30 min, 60 min, 90 min, 120 min (and 150 min depending on the patient´s constitution and at the discretion of the treating physician)
* Study phase B, variation of dialysis fluid glucose composition: 1st cycle: 1.5% glucose concentration, 2nd cycle: 2.3% glucose concentration, 3rd cycle: 1.5% glucose concentration, 4th cycle: 2.3% glucose concentration; all following cycles to be applied as prescribed by the treating physician.
* Study phase C, variation of fill volume: 60% fill volume, 80% fill volume, 100% fill volume and 120% fill volume. (Volume of 120% will only be applied in case the patient tolerates these volumes according to the IPP.
**Name:** PD cycler
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** UFV determined per defined dwells with variable dwell duration, dialysis fluid glucose composition and inflow volumes.
**Measure:** Ultrafiltration volume (UFV)
**Time Frame:** every day during the 11 weeks treatment
#### Secondary Outcomes
**Description:** Fluid status measured by Body Composition Monitor (BCM)
**Measure:** Fluid status
**Time Frame:** At study start, and then after 3 weeks, 4 weeks and 5 weeks.
**Description:** RRF (24 h urine output)
**Measure:** 24 h batch collection
**Time Frame:** At study start, and then after 3 weeks, 4 weeks and 5 weeks.
**Description:** RRF (GFR)
**Measure:** 24 h batch collection
**Time Frame:** At study start, and then after 3 weeks, 4 weeks and 5 weeks.
**Description:** RRF (renal creatinine clearance)
**Measure:** 24 h batch collection
**Time Frame:** At study start, and then after 3 weeks, 4 weeks and 5 weeks.
**Description:** RRF (renal urea clearance)
**Measure:** 24 h batch collection
**Time Frame:** At study start, and then after 3 weeks, 4 weeks and 5 weeks.
**Description:** Peritoneal urea clearance
**Measure:** 24 h batch collection
**Time Frame:** At study start, and then after 3 weeks, 4 weeks and 5 weeks.
**Description:** Peritoneal creatinine clearance
**Measure:** 24 h batch collection
**Time Frame:** At study start, and then after 3 weeks, 4 weeks and 5 weeks.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Informed consent signed and dated by study patient and investigator/ authorized physician
* Patients between 18-65 of age
* Chronic kidney disease (CKD) patients being treated with nocturnal APD for at least 3 months
* Ability to understand the nature and requirements of the study
* Total Kt/V ≥ 1.7 (counting from recruitment of the patient the measurement should not be older than 3 months)
* APD patients using sleep•safe PD-cycler or sleep•safe harmony PD-cycler with an IPP ≤ 18 cm H2O for the fill volume of 120%
Exclusion Criteria:
* Any condition which could interfere with the patient's ability to comply with the study
* Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg)
* Patients who have been subject to peritonitis/ exit site infection during the last 4 weeks
* Women of childbearing age without effective means of contraception, pregnancy (pregnancy test will be conducted at start and end of study) or lactation period
* Life expectancy \< 3 months
* Patients suffering from uncontrolled/ not well adjustable diabetes
* Recent history of drain related problems, catheter malfunction, or frequent alarms during treatment
* Patients with uncontrolled hypertension and/ or previous history of vascular instability during PD
* Patients treated with intermittent APD
* Participation in an interventional clinical study during the preceding 30 days
* Previous participation in the same study
* APD patients having dwell exchanges throughout the day ("day dwell")
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** Manuela.Stauss-Grabo1@freseniusmedicalcare.com
**Name:** Manuela Stauss-Grabo, Dr.
**Phone:** +49 1525 469 1929
**Role:** CONTACT
**Contact 2:**
**Email:** tatiana.de-los-rios@freseniusmedicalcare.com
**Name:** Tatiana DL Ríos
**Phone:** +49 6172 2688876
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Hospital Son Espases
**Name:** Isabel Garcia Méndez, Dr.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000051437
- Term: Renal Insufficiency
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10698
- Name: Kidney Diseases
- Relevance: HIGH
- As Found: Kidney Disease
- ID: M26718
- Name: Renal Insufficiency
- Relevance: LOW
- As Found: Unknown
- ID: M26717
- Name: Renal Insufficiency, Chronic
- Relevance: HIGH
- As Found: Chronic Kidney Disease
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007674
- Term: Kidney Diseases
- ID: D000051436
- Term: Renal Insufficiency, Chronic
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M18008
- Name: Dialysis Solutions
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06443008
**Brief Title:** Effects of Myoelectric Biofeedback on Upper Limb Function in Post-stroke Patients
**Official Title:** Objective To Investigate the Effect of Myoelectric Biofeedback Therapy Combined With Comprehensive Rehabilitation Training on Upper Extremity Motor Function in Elderly Patients With Hemiplegia With Cerebral Infarction
#### Organization Study ID Info
**ID:** KY-2024-099
#### Organization
**Class:** OTHER
**Full Name:** The Fourth Affiliated Hospital of Zhejiang University School of Medicine
### 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:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-27
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-28
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### 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 purpose of this clinical trial is to investigate the effect of myoelectric biofeedback therapy on upper limb function in elderly patients with cerebral infarction, and to analyze the adjustment of stroke condition and quality of life.The main questions it aims to answer are:
1. Does myoelectric biofeedback therapy promote the restoration of upper limb function in elderly patients with cerebral infarction?
2. What medical problems do participants have with myoelectric biofeedback therapy?
**Detailed Description:** We divided the participants into control group and observation group using simple random method.We will number the numbers according to the order of inclusion: then from any row in the random number table as a starting point, we will get a random number sequentially from its series of numbers, paired with the included case number, and list the random distribution table.The control group was represented by odd numbers of random tables and even numbers by observation groups.The probability of being included in the control group and the observation group were 50% respectively.The control group underwent comprehensive rehabilitation training, and the observation group conducted myoelectric biofeedback treatment on the basis of the control group.
Control group treatment plan
1. After stroke, medical staff should adjust the position of the patient every 2 hours, so that the patient's position is adjusted between the healthy side position and other positions, and provide the patient with soft pillow limit.
2. Passive training, in the initial physical disability of the patient after treatment by the rehabilitation therapist to provide passive training for the patient, specifically by the rehabilitation therapist on the affected side joint.
3. Anti-spasmodic activities, through the patient's activity training to avoid spastic symptoms, help the patient to change the posture to a healthy side position before the training begins.
4. At the beginning of the training, the rehabilitation therapist places both hands under the patient's shoulder blades, so that the patient's shoulders and shoulder blades are stretched forward to help the patient stay seated.In addition, the patient is provided with Bobas handshake training to maintain the trunk forward tilt position during the training process, maintaining the center of gravity below, helping the patient to stay seated for a long time for balance training.
5. Active training, the rehabilitation therapist instructs the patient to put the hand on the prepared cushion in advance, and then let the patient use both upper limbs to stretch the fixed elastic band to implement impedance training.After the above activities can be completed, you can try to implement refined operations, including threading and other activities that require high hand activities.After the patient's upper limb function has been restored, he or she can conduct autonomous life ability training under the guidance of a rehabilitation therapist, including basic activities such as getting up and washing.The pre-active training training time is maintained at about 0.5 h, and the maximum number of training times in one day is 3 times, and the intensity of training can be increased appropriately after the patient's physical condition has recovered.
Observation group treatment plan
The observation group carried out myoelectric biofeedback therapy on the basis of the control group:
After disinfection of the triangular, triceps and extensor muscles of the patient, the feedback electrode was attached to the area. The stimulation frequency was set at 50 Hz and the stimulation pulse width was set at 200 μs.During treatment, the patient is instructed to listen carefully to the device's password, drive the affected limb according to the specific password, and then perform tension and relaxation training.For each muscle group, the training time of each muscle group is about 0.5 h, 1 / d.In the later stage of treatment, the training intensity can be increased appropriately, so that the patient can carry out weight lifting during the feedback treatment, and listen to the password issued by the device to carry out muscle strength exercise.
### Conditions Module
**Conditions:**
- Biofeedback
- Rehabilitation
- Cerebral Infarction
**Keywords:**
- Rehabilitation treatment
- upper extremity motor function
- emg biofeedback
- cerebral infarction
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Comprehensive rehabilitation treatment in control group
**Label:** control group
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** The observation group carried out myoelectric biofeedback therapy on the basis of the control group
**Intervention Names:**
- Device: Observation Group
**Label:** Observation Group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Observation Group
**Description:** On the basis of myoelectric biofeedback treatment in the control group, the control group was trained alternately in each muscle group (triangle muscle, triceps brachii muscle group and forearm extensor muscle group). For example,After disinfection of the triangular, triceps and extensor muscles of the patient, the feedback electrode was attached to the area. The stimulation frequency was set at 50 Hz and the stimulation pulse width was set at 200 μs.During treatment, the patient is instructed to listen carefully to the device's password, drive the affected limb according to the specific password, and then perform tension and relaxation training.For each muscle group, the training time of each muscle group is about 0.5 h, 1 / d.In the later stage of treatment, the training intensity can be increased appropriately, so that the patient can carry out weight lifting during the feedback treatment, and listen to the password issued by the device to carry out muscle strength exercise.
**Name:** Observation Group
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Fugl-Meyer Functional Score (FMA) is evaluated, and the higher the score, the stronger the motor function.
**Measure:** Effect of myoelectric biofeedback therapy on upper limb function in elderly patients with cerebral infarction
**Time Frame:** Within 3 days of hospitalization, on the 1 day of discharge, one month after discharge
#### Secondary Outcomes
**Description:** Assessment of Daily Living Ability Scale (ADL)is evaluated,The higher the score, the greater the independence of life.
**Measure:** Influence on stroke quality of life in elderly patients with cerebral infarction
**Time Frame:** Within 3 days of hospitalization, on the 1 day of discharge, one month after discharge
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Subject volunteered to participate in the experiment and signed informed consent
2. Age ≥ 65 years old, no gender limit;
3. Diagnosis of stroke patients;
4. No other major cardiovascular diseases
Exclusion Criteria:
1. Subject's poor compliance
2. Subjects with skin allergies
3. Those who do not meet the criteria for diagnosis and inclusion;
4. People with severe consciousness disorders, severe dementia, speech disorders, etc. who are unable to communicate and describe the disease;
5. can not cooperate as required, poor compliance;
6. participants in other clinical trials;
**Maximum Age:** 80 Years
**Minimum Age:** 65 Years
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** 505184583@qq.com
**Name:** Yinkai Cheng
**Phone:** +86-15067757337
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Yiwu
**Contacts:**
***Contact 1:***
- **Email:** 505184583@qq.com
- **Name:** Yinkai Cheng
- **Phone:** 15067757337
- **Role:** CONTACT
**Country:** China
**Facility:** Yinkai Cheng
**State:** Zhejiang
**Zip:** 310000
#### Overall Officials
**Official 1:**
**Affiliation:** The Fourth Affiliated Hospital Zhejiang University School of Medicine
**Name:** Yinkai Cheng
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007511
- Term: Ischemia
- ID: D000010335
- Term: Pathologic Processes
- ID: D000009336
- Term: Necrosis
- ID: D000020520
- Term: Brain Infarction
- ID: D000002545
- Term: Brain Ischemia
- ID: D000002561
- Term: Cerebrovascular Disorders
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000020521
- Term: Stroke
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M22306
- Name: Stroke
- Relevance: LOW
- As Found: Unknown
- ID: M5793
- Name: Cerebral Infarction
- Relevance: HIGH
- As Found: Cerebral Infarction
- ID: M10282
- Name: Infarction
- Relevance: HIGH
- As Found: Infarction
- ID: M9515
- Name: Hemiplegia
- Relevance: LOW
- As Found: Unknown
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M12284
- Name: Necrosis
- Relevance: LOW
- As Found: Unknown
- ID: M22305
- Name: Brain Infarction
- Relevance: LOW
- As Found: Unknown
- ID: M5794
- Name: Brain Ischemia
- 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: D000002544
- Term: Cerebral Infarction
- ID: D000007238
- Term: Infarction
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442995
**Acronym:** EPIMAG
**Brief Title:** Evaluation of the Efficacy of the Addition of Magnesium Sulfate to Morphine on the Occurrence of Acute Urinary Retention Following Epidural Anesthesia for Cesarean Section.
**Official Title:** Superiority Randomized Double-blind Controlled Trial of Epidural Magnesium Sulfate Addition Versus Placebo on the Occurrence of Acute Post-caesarean Urinary Retention
#### Organization Study ID Info
**ID:** PO24038*
#### Organization
**Class:** OTHER
**Full Name:** CHU de Reims
### Status Module
#### Completion Date
**Date:** 2025-08
**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:** 2025-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** CHU de Reims
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Peri-medullary anesthesia is the preferred anesthetic technique for Caesarean surgery. Compared with general anesthesia, it reduces maternal and fetal morbidity and mortality, as well as postoperative pain. However, this technique exposes the patient to the adverse effects of peri-medullary morphine, particularly the risk of postoperative urinary retention. Urinary retention during the first 72 hours after Caesarean section affects around 33% of parturients.
This is a particularly debilitating event for parturients, exposing them to the risk of further urinary catheterization, increased theoretical risk of urinary tract infection, traumatic urethral injury, hindered accelerated rehabilitation and altered maternal satisfaction.
Several studies have demonstrated the benefits of adding magnesium sulfate to epidural anesthesia for Caesarean sections, notably by reducing postoperative pain.
Magnesium sulfate may also have a facilitating effect on postoperative micturition, thanks to its sympathicolytic effect.
This hypothesis is supported by a retrospective study carried out in our maternity hospital, which showed a 15% reduction in post-Caesarean urinary retention when women were given magnesium sulfate in addition to the drugs traditionally used for epidurals.
This little-known property needs to be clarified
**Detailed Description:** The main objective of this study is to evaluate the efficacy of the addition of epidural magnesium sulfate in reducing the occurrence of acute post-Caesarean urine retention.
In fact, the incidence of acute urine retention after epidural anaesthesia for Caesarean section is around 33%. Two encouraging studies suggest that adding magnesium sulfate to epidurals could reduce the incidence of acute urine retention by 15%.
This study will be carried out on the obstetric population of the REIMS maternity hospital, starting in summer 2024. It is a randomized, double-blind, placebo-controlled clinical trial. The number of subjects required is calculated at 290 patients, with a power of 80% and an alpha risk of 5%. The statistical hypothesis is that magnesium sulfate reduces the incidence of acute urine retention by 15% compared with placebo (isotonic saline).
Parturients will be informed of the study during a pre-anaesthetic consultation in the 6th month of pregnancy.
Some of these patients will be scheduled for delivery by caesarean section. The remaining patients will be scheduled for a vaginal delivery, which may end up being an emergency caesarean section (10-15% of patients).
After the Caesarean section, patients are taken to the post-procedure monitoring room, where they are monitored for 2 hours.
It is at this point that patients are examined to verify the inclusion and non-inclusion criteria of the protocol. If the inclusion and non-inclusion criteria are met, our teams will provide patients with explanatory documents on our protocol, as well as a consent form for their signature.
When the patient agrees to enter the protocol, the investigators randomize her to one of the following groups:
* Group A: injection of morphine 2 mg into the epidural catheter + magnesium sulfate 500 mg
* Group B: injection of morphine 2 mg into the epidural catheter + isotonic saline.
Group B is the control group. This is the protocol we use in daily practice for parturients who have undergone Caesarean section, in line with the French recommendations of anesthesia societies.
This reduces the parturient's postoperative pain for 20-24 hours. Group A will be the experimental group. Patients will be monitored in the post-natal care unit for 72 hours. The investigators will carry out the same monitoring and care as a parturient outside the protocol. Various data on diuresis, the quantity of urine in the bladder visualized by ultrasound, and the need for urinary catheterization will be recorded.
Statistical analyses will determine whether the incidence of acute urine retention differs between each group.
### Conditions Module
**Conditions:**
- Urinary Retention
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 290
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Injection of 500 mg magnesium sulfate + 2 mg morphine into the epidural space
**Intervention Names:**
- Drug: Injection of 500 mg magnesium sulfate + 2 mg morphine into the epidural space
**Label:** Magnesium Sulfate
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Injection of Isotonic saline + 2 mg morphine into the epidural space
**Intervention Names:**
- Drug: Injection of Isotonic saline + 2 mg morphine into the epidural space
**Label:** Isotonic saline
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Magnesium Sulfate
**Description:** When the patient agrees to enter the protocol, the investigators randomize the patient and proceed to the injection of morphine 2 mg into the epidural catheter + magnesium sulfate 500 mg
**Name:** Injection of 500 mg magnesium sulfate + 2 mg morphine into the epidural space
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Isotonic saline
**Description:** When the patient agrees to enter the protocol, the investigators randomize the patient and proceed to Injection of morphine 2 mg into the epidural catheter + isotonic saline. This is the protocol the investigators use in daily practice for parturients who have undergone Caesarean section, in line with the French recommendations of anesthesia societies
**Name:** Injection of Isotonic saline + 2 mg morphine into the epidural space
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** diuresis
**Time Frame:** 72 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients who have undergone scheduled or emergency Caesarean section surgery under extended epidural anesthesia or combined epidural and spinal anesthesia at the Reims University Hospital.
* Patients who have just undergone caesarean section and have the epidural catheter in place in the post-interventional monitoring room (SSPI).
* Patients who agree to take part in the research and have signed the informed consent form
* Patients of legal age
* Patients affiliated to a social security scheme
Exclusion Criteria:
* Minor patients
* Patients protected by law
* Patients allergic to local anesthetics, morphine or magnesium sulfate
* Patients with severe renal insufficiency (GFR \< 30 ml/min)
* Patients with pre-pregnancy mictional disorders
* Patients with an American Society of Anesthesiologists (ASA) score of 4
* Patients undergoing caesarean section under general anaesthesia, after failure of perimedullary anaesthesia
* Patients with accidental intraoperative injury to the urinary tract
* Patients who have received intravenous magnesium sulfate in the 24 hours preceding cesarean section
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** mriffault@chu-reims.fr
**Name:** Maxime Riffault
**Phone:** 00336 79 63 29 55
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Reims
**Country:** France
**Facility:** Chu Reims
**Zip:** 51092
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014555
- Term: Urination Disorders
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M18552
- Name: Urinary Retention
- Relevance: HIGH
- As Found: Urinary Retention
- ID: M17305
- Name: Urination Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000016055
- Term: Urinary Retention
### Intervention Browse Module - Ancestors
- ID: D000000701
- Term: Analgesics, Opioid
- ID: D000009294
- Term: Narcotics
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000000777
- Term: Anesthetics
- ID: D000000889
- Term: Anti-Arrhythmia Agents
- ID: D000000927
- Term: Anticonvulsants
- ID: D000002121
- Term: Calcium Channel Blockers
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000077264
- Term: Calcium-Regulating Hormones and Agents
- ID: D000015149
- Term: Tocolytic Agents
- ID: D000012102
- Term: Reproductive Control Agents
### Intervention Browse Module - Browse Branches
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: ChanBlk
- Name: Channel Blockers
- Abbrev: Analg
- Name: Analgesics
- Abbrev: AntiConv
- Name: Anticonvulsants
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: Repr
- Name: Reproductive Control Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
### Intervention Browse Module - Browse Leaves
- ID: M11270
- Name: Magnesium Sulfate
- Relevance: HIGH
- As Found: Increasing
- ID: M11982
- Name: Morphine
- Relevance: HIGH
- As Found: Screening
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
- ID: M12245
- Name: Narcotics
- Relevance: LOW
- As Found: Unknown
- ID: M4213
- Name: Anti-Arrhythmia Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4246
- Name: Anticonvulsants
- Relevance: LOW
- As Found: Unknown
- ID: M5381
- Name: Calcium
- Relevance: LOW
- As Found: Unknown
- ID: M5384
- Name: Calcium Channel Blockers
- Relevance: LOW
- As Found: Unknown
- ID: M5398
- Name: Calcium, Dietary
- Relevance: LOW
- As Found: Unknown
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
- ID: M17869
- Name: Tocolytic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008278
- Term: Magnesium Sulfate
- ID: D000009020
- Term: Morphine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442982
**Brief Title:** Analyzing Gait Pattern Using Insole-type Gait Analyzer in Patient With Gait Disturbance
**Official Title:** Usefulness of Insole-type Gait Analyzer in Collecting Gait Data From Patients With Gait Disturbance
#### Organization Study ID Info
**ID:** 9-2021-0055
#### Organization
**Class:** OTHER
**Full Name:** Yonsei University
### Status Module
#### Completion Date
**Date:** 2025-05-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-02
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-06-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-06-02
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Yonsei University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to explore the usefulness of information from insole-type gait analyzer in adults with subjective gait and balance disorders.
The main questions it aims to answer are:
How useful is an insole-type gait analyzer for collecting gait data from patients with gait disturbances?
Researchers will explore the usefulness of collected data and does not establish a control group.
Participants will:
Participants will conduct survey and perform the Timed up and go test wearing an insole-type gait analyzer.
**Detailed Description:** A screening test is conducted after obtaining consent. The screening test assesses whether participants can walk independently on flat ground, following an inquiry into their baseline symptoms and signs.
Participants will conduct A history survey, a sarcopenia questionnaire, and the International Physical Activity Questionnaire (IPAQ).
Participants will wear insole-type gait analyzer and undergo the Timed Up and Go test.
The measurement values of the accelerometer and pressure sensors recorded in the insole-type gait analyzer will be examined to determine the presence of missing or outlier data. Researchers will explore the data collection frequency and analysis methods to extract clinically significant data.
### Conditions Module
**Conditions:**
- Gait Disorders, Neurologic
**Keywords:**
- gait analysis
- smart insole
- neurologic disorder
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** This study aims to explore the usefulness of collected data and does not establish a control group. Patients with subjective gait and balance disorders will wear insole-type gait analyzer and walk, then the collected data will be examined."
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 600
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with subjective gait and balance disorders will wear insole-type gait analyzer and walk, then the collected data will be examined."
**Intervention Names:**
- Device: insole-type gait analyzer
**Label:** Insole wearing group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Insole wearing group
**Description:** Patients with subjective gait and balance disorders will wear insole-type gait analyzer and walk, then the collected data will be examined.
**Name:** insole-type gait analyzer
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The participants will wear insole-type gait analyzer and undergo the Timed Up and Go test.
The above test assesses walking speed along with balance ability during walking, and this is performed as follows.
1. A 46 cm high armrest chair, a color cone is placed at a distance of 3 meters from the chair and the subject is instructed to sit on the chair.
2. In the preparation phase, the subject leans against the chair backrest and places his/her arms on the armrests, then stands up on the instruction "Start", walks 3 meters, turns around the color cone, returns to the starting point and sits down on the chair.
5) Data Verification The measurement values of the accelerometer and pressure sensors recorded in the insole-type gait analyzer will be examined to determine the presence of missing or outlier data. The investigators will explore the data collection frequency and analysis methods to extract clinically significant data.
**Measure:** Timed up and go test (TUG)
**Time Frame:** TUG test session will last approximately 5 minutes. and TUG test will be performed at baseline.
**Description:** Questionnaire that evaluates the decrease in muscle strength and functional performance along with a decrease in muscle mass and it is highly related to aging and chronic diseases. The evaluation method is conducted by having the examiner ask the subject about the following questionnaire, and the scores for the answers are recorded.
It consists of 5 questions, and each question is scored 0-2 points. The higher the score, the higher the risk of sarcopenia. If the score is 4 or higher, sarcopenia may be suspected.
**Measure:** Korean version of Sarcopenia Screening Questionnaire
**Time Frame:** This K-SSQ session will last approximately 1 minutes, it will be performed at baseline.
**Description:** Tests that assess various aspects of an individual's daily physical activity16 and it can provide information about activity level. The examiner questions the subject based on the questionnaire below, records related information, calculates the total activity time and intensity, and classifies it as 'low', 'medium', and 'high'.
**Measure:** Korean version of the International Physical Activity Questionnaire (K-IPAQ)
**Time Frame:** This K-IPAQ session will last approximately 3 minutes, it will be performed at baseline.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. adults aged 19 and over (based on the age on their national ID at the time of consent)
2. adults complaining subjective gait or balance disorders
3. individuals who voluntarily agree to participate in the study and sign a consent form
Exclusion Criteria:
1. individuals unable to walk independently on flat ground for more than 6 minutes
2. individuals who cannot read ordinary print with glasses due to visual reasons
3. individuals who cannot understand conversation even with a hearing aid due to auditory reasons
4. individuals with clinically significant disorders in the cardiovascular, gastrointestinal, respiratory, or endocrine systems
5. individuals considered clinically unsuitable for the trial by the trial manager or person in charge based on significant medical findings.
**Minimum Age:** 19 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** kny8452@yuhs.ac
**Name:** Na Young Kim, MD, PhD
**Phone:** +82 010 9127 4482
**Role:** CONTACT
**Contact 2:**
**Email:** rehab1@yuhs.ac
**Name:** Seung Ick Choi
**Phone:** +82 010 8821 5297
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Yongin-si
**Contacts:**
***Contact 1:***
- **Email:** kny8452@yuhs.ac
- **Name:** Na Young Kim
- **Phone:** +82 010 9127 4482
- **Role:** CONTACT
***Contact 2:***
- **Email:** rehab1@yuhs.ac
- **Name:** Seung Ick Choi
- **Phone:** +82 010 8821 5297
- **Role:** CONTACT
***Contact 3:***
- **Name:** Na Young Kim, MD, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Korea, Republic of
**Facility:** Yongin Severance Hospital
**State:** Gyeonggi-do
**Status:** RECRUITING
**Zip:** 16995
#### Overall Officials
**Official 1:**
**Affiliation:** Severance Hospital
**Name:** Na Young Kim, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Alexander NB. Differential diagnosis of gait disorders in older adults. Clin Geriatr Med. 1996 Nov;12(4):689-703.
**PMID:** 8890111
**Citation:** Tinetti ME. Clinical practice. Preventing falls in elderly persons. N Engl J Med. 2003 Jan 2;348(1):42-9. doi: 10.1056/NEJMcp020719. No abstract available.
**PMID:** 12510042
**Citation:** Bennett DA, Beckett LA, Murray AM, Shannon KM, Goetz CG, Pilgrim DM, Evans DA. Prevalence of parkinsonian signs and associated mortality in a community population of older people. N Engl J Med. 1996 Jan 11;334(2):71-6. doi: 10.1056/NEJM199601113340202.
**PMID:** 8531961
**Citation:** Salzman B. Gait and balance disorders in older adults. Am Fam Physician. 2010 Jul 1;82(1):61-8.
**PMID:** 20590073
**Citation:** Verghese J, LeValley A, Hall CB, Katz MJ, Ambrose AF, Lipton RB. Epidemiology of gait disorders in community-residing older adults. J Am Geriatr Soc. 2006 Feb;54(2):255-61. doi: 10.1111/j.1532-5415.2005.00580.x.
**PMID:** 16460376
**Citation:** Fortin C, Feldman DE, Cheriet F, Labelle H. Clinical methods for quantifying body segment posture: a literature review. Disabil Rehabil. 2011;33(5):367-83. doi: 10.3109/09638288.2010.492066. Epub 2010 Jun 23.
**PMID:** 20568973
**Citation:** Kim H, Lee S, Lee D, Choi S, Ju J, Myung H. Real-time human pose estimation and gesture recognition from depth images using superpixels and SVM classifier. Sensors (Basel). 2015 May 26;15(6):12410-27. doi: 10.3390/s150612410.
**PMID:** 26016921
**Citation:** Chun MY. Validity and reliability of korean version of international physical activity questionnaire short form in the elderly. Korean J Fam Med. 2012 May;33(3):144-51. doi: 10.4082/kjfm.2012.33.3.144. Epub 2012 May 24.
**PMID:** 22787536
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-05-31
- Filename: Prot_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: False
- Label: Study Protocol
- Size: 434006
- Type Abbrev: Prot
- Upload Date: 2024-05-31T04:49
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M22058
- Name: Gait Disorders, Neurologic
- Relevance: HIGH
- As Found: Gait Disorders, Neurologic
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000020233
- Term: Gait Disorders, Neurologic
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442969
**Brief Title:** Implementing an Intervention to Reduce Heat Stress and Chemical Exposures
**Official Title:** Implementing an Intervention to Reduce Heat Stress and Chemical Exposures
#### Organization Study ID Info
**ID:** HS-2024-0081
#### Organization
**Class:** OTHER
**Full Name:** San Diego State University
### Status Module
#### Completion Date
**Date:** 2025-08
**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:** 2024-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** San Diego State University
#### Responsible Party
**Investigator Affiliation:** San Diego State University
**Investigator Full Name:** Nicolas Lopez Galvez
**Investigator Title:** Assistant Professor in Environmental Health at the School of Public Health
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The investigators are studying the dangers that farmworkers face while working in the fields and at home. The investigators goals are:
1. Measure how much heat and chemicals farmworkers in Imperial County are exposed to.
The investigators will ask the participants to wear a special belt under their clothes during work to measure heat. The investigators will also put two small temperature monitors in the participant's home for a day. The investigators will collect a urine sample to check hydration, and also measure the participants height, weight, blood pressure, and some blood markers for diseases using a simple finger-prick test.
To measure chemicals, the investigators will give the participants a wristband to wear for a week and hang another in the participants home. The investigators will also collect dust from each participant's home with a vacuum. Then, the investigators will analyze everything at San Diego State University.
After collecting samples, a trained community health worker will ask the participants a few questions about their work, lifestyle, health symptoms, and any hazards they face. The investigators will meet the participants twice at their homes to distribute the tools which will later be collected. Once the tools are collected, the investigators will have the chance to follow up with the participants if they have any questions.
2. Provide help to lower heat and chemical exposure with the help of community health workers.
3. Measure heat and chemicals again using the same methods to see if the project made a difference.
4. Talk to participants about what they liked and how the investigators can make future projects better.
### Conditions Module
**Conditions:**
- Dehydration
- Heat Stress
**Keywords:**
- Farm worker
- Heat exposure
- Chemical exposure
- Agricultural worker
- Take-home exposure
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All participants will receive the intervention
**Intervention Names:**
- Other: Education and resources provided by community health workers
**Label:** All participants
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- All participants
**Description:** The intervention will consist of implementing existing tools provided by EPA's Design for the Environment program, CalOSHA and NIOSH sector-specific guidance for agricultural workers, the Imperial County Department of Public Health and materials from California Department of Toxics Substances Control. The investigators will utilize and adjust existing educational tools such as the Heat Illness Prevention plan developed by CalOSHA. In addition to the educational materials, the investigators will give each farmworker cooling working gear to be worn during their work-shift with (specialized clothes that has been used in other occupational settings). The investigators will provide all participants with a low-cost fan filter, known as Corsi-Rosenthal box built jointly by the community health/research team to reduce chemicals at home, and a small A/C unit to reduce heat stress.
**Name:** Education and resources provided by community health workers
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Skin temperature in degrees Celsius derived from skin temperature monitor worn against the participant's skin.
**Measure:** Individual heat stress
**Time Frame:** Assessment at baseline (pre-intervention) and again immediately (week) after the intervention
**Description:** Household temperature in degrees Celsius, derived from weather monitor placed in the participant's home.
**Measure:** Participant household temperature
**Time Frame:** Assessment at baseline (pre-intervention) and again immediately (week) after the intervention
**Description:** Specific gravity of participant's urine
**Measure:** Participant hydration level
**Time Frame:** Assessment at baseline (pre-intervention) and again immediately (week) after the intervention
**Description:** Participants will be asked to wear a silicon wristbands twice; once at baseline and again after the intervention. The research team will collect the wristbands and transport them to San Diego State University for analysis of different classes of chemicals, including pesticides, organophosphates, pyrethroids, and legacy pollutants. The chemicals adhered to the wristbands will be extracted in ethyl acetate and then passed through a solid-phase extraction. Extracts will be analyzed using a two-dimensional gas chromatography coupled to time-of-flight mass spectrometry at San Diego State University. The final concentration of each chemical will be expressed as nanograms per gram of wristband.
**Measure:** Concentration of chemicals measured in silicon wristband worn by study participant
**Time Frame:** Assessment at baseline (pre-intervention) and again immediately (week) after the intervention
**Description:** Silicon wristbands will be hung in participants' homes twice; once at baseline and again after the intervention. The research team will collect the wristbands and transport them to San Diego State University for analysis of different classes of chemicals, including pesticides, organophosphates, pyrethroids, and legacy pollutants. The chemicals adhered to the wristbands will be extracted in ethyl acetate and then passed through a solid-phase extraction. Extracts will be analyzed using a two-dimensional gas chromatography coupled to time-of-flight mass spectrometry at San Diego State University. The final concentration of each chemical will be expressed as nanograms per gram of wristband.
**Measure:** Concentration of chemicals measured in silicon wristbands hung in the participant's household.
**Time Frame:** Assessment at baseline (pre-intervention) and again immediately (week) after the intervention
**Description:** The research team will visit the participant's home twice to collect the dust samples of the living area using a vacuum; once at baseline and again after the intervention. After collection, the research team will transport the dust samples to San Diego State University to measure the concentrations of different classes of chemicals, including pesticides, organophosphates, pyrethroids, and legacy pollutants. The chemicals in the dust will be extracted in ethyl acetate and then passed through a solid-phase extraction. Extracts will be analyzed using a two-dimensional gas chromatography coupled to time-of-flight mass spectrometry at San Diego State University. The final concentration of each chemical will be expressed as nanograms per gram of dust.
**Measure:** Concentration of chemicals measured in participant's household dust collected with a vacuum
**Time Frame:** Assessment at baseline (pre-intervention) and again immediately (week) after the intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Currently living in Imperial County, California, USA
* Currently work in agriculture
* Plan on living in Imperial Valley for the next 6 months
Exclusion Criteria:
* Not currently living in Imperial County, California, USA
* Not currently working in agriculture
* Not planning to live in Imperial Valley for the next 6 months
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** nilopez@sdsu.edu
**Name:** Nicolas I Lopez-Galvez, PhD
**Phone:** 858-292-1416
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** El Centro
**Contacts:**
***Contact 1:***
- **Name:** Brandon Toji
- **Role:** CONTACT
***Contact 2:***
- **Name:** Alejandra Early
- **Role:** CONTACT
**Country:** United States
**Facility:** Lideres Campesinas Imperial
**State:** California
**Status:** RECRUITING
**Zip:** 92243
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014883
- Term: Water-Electrolyte Imbalance
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000010335
- Term: Pathologic Processes
- ID: D000014947
- Term: Wounds and Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M6883
- Name: Dehydration
- Relevance: HIGH
- As Found: Dehydration
- ID: M20924
- Name: Heat Stress Disorders
- Relevance: HIGH
- As Found: Heat Stress
- ID: M24916
- Name: Stress Disorders, Traumatic
- Relevance: LOW
- As Found: Unknown
- ID: M17624
- Name: Water-Electrolyte Imbalance
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003681
- Term: Dehydration
- ID: D000018882
- Term: Heat Stress Disorders
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442956
**Brief Title:** Effect of Rapid Heat Stress on Firefighters Musculoskeletal Injury Risk
**Official Title:** The Impact of Rapid Heat Stress on Firefighters' Strength, Dynamic Balance, and Movement Quality
#### Organization Study ID Info
**ID:** STUDY00002549
#### Organization
**Class:** OTHER
**Full Name:** Louisiana State University Health Sciences Center Shreveport
### Status Module
#### Completion Date
**Date:** 2026-05
**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:** 2025-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**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:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Louisiana State University Health Sciences Center Shreveport
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** This study will examine the effect of heat stress on factors that influence musculoskeletal injury risk in firefighters. Participants will attend 4 data collection sessions. 1: informed consent, screening, and familiarization. 2: pre-tests (strength, balance, and movement quality). 3: heat stress (rapid or gradual) followed by post-tests (strength, balance, and movement quality). 4: heat stress (rapid or gradual) followed by post-tests.
**Detailed Description:** This study utilizes a crossover design, with participants acting as their own controls and participating in both the control (gradual uncompensable heat) and experimental (rapid heat stress (RHS)) conditions. The independent variable is the type of heat stress (uncompensable or rapid). The dependent variables are: peak concentric muscle torque (hip abductors, hip adductors, knee flexors, knee extensors), dynamic balance (Y-Balance Test, Firefighter-Specific Functional-Balance Test (FFSFBT)), and frontal plane movement quality (Forward-Step-Down Test (FSDT)). These will be measured three times, once during pre-testing and twice during post-testing as described below.
The study will consist of four visits. Visit one will be the informed consent and familiarization to the outcome measures. Participants will be educated on filling out the 24-hour food/drink diary, and asked to standardize their diet as close as possible to this record the 24 hours before visits 2, 3, and 4. Injury history and demographic data will be collected at visit 1.
Visit two will be the pre-test data collection, which will occur at approximately 22°C. Participants will complete all outcome measures (torque, balance, movement quality measures). Body composition will also be measured in the BodPod at this time.
Before visits 2, 3, and 4, participants will follow the safety guidelines outlined below to ensure proper hydration:
* 48 hours before: no heat stress (will contact participant to determine if they have been called out to a live fire. Data collection will be postponed if so)
* 24 hours before: no alcohol consumption, no energy drink consumption (normal coffee/tea is allowed)
* 24 hours before: no physical activity (exercise or vigorous play)
* 24 hours before: drink 3.7L of total water to make sure to be well-hydrated
* 2 hours before: eat last meal
Visits three and four will consist of a steady-state treadmill protocol inside the environmental chamber (37-38°C, 50% humidity) followed by post-test measures. During either session three or four, the participant will don his/her firefighting gear (jacket, pants, hood, boots, gloves) and perform the treadmill test with the gear on. This is the RHS trial and will be denoted GEAR. In the other session, the participant will wear exercise clothes (shirt and shorts) plus a weighted backpack to replicate the weight of the gear. This is the gradual uncompensable heat stress trial and will be denoted NOGEAR. The order of the GEAR and NOGEAR sessions will be randomized and counterbalanced to prevent crossover effects.
Upon arrival for the pre-testing visit (session two), participants will be measured for height using a stadiometer and weight. Body composition will be measured once with the BodPod (Cosmed, USA). They will warm up for five minutes on an exercise bike or treadmill then proceed with taking the outcome measures.
Upon arrival for visits three and four, participants will be weighed again. A urine sample will be collected to assess hydration status. They will swallow the core temperature (Tc) capsule 40-45 minutes prior to the start of the session using a small amount of 20°C water, with no further water ingestion throughout the protocol to avoid artificially lowering Tc. Participants will be fit with the Equivital EQLife Monitor (Equivital, NY) system to record heartrate (HR) and Tc. They will then perform the treadmill protocol, and post-test measures will be completed immediately following the cessation of the treadmill test with removal of their gear. They will be weighed following exercise to determine changes in body weight due to sweating.
Sessions three and four will be separated by at least seven days to reduce the influence of heat acclimatization and fatigue. Continuous monitoring of Tc and HR will help ensure participant safety.
The treadmill exercise protocol begins with a graded approach to reach aerobic steady state. The treadmill protocol includes an initial five-minute stage at 3 miles per hour and a 0% grade, followed by increases in percent grade of 4% at minute 5 and 8% at minute 10 and continued throughout the test. Following the final planned incremental increase in treadmill incline, the incline will then be adjusted to ensure that the subject remains at steady-state for the duration of the protocol, defined by a respiratory exchange ratio between 0.9-0.99 using the lab's metabolic cart (Parvomedics, USA). HR, rating of perceived exertion (RPE), thermal comfort, and thermal sensation will be recorded at each 0.5°C interval. The treadmill test will be stopped when participants either reach a Tc of 39°C or a volitional maximum (participant is unable to continue exercise). The investigators will also halt the test if signs of excessive heat stress are present (unsteady gait, confusion, dizziness, slurred speech, etc.) Should the participant not meet either termination criteria, there will be a 50 minute time limit for the treadmill protocol for the GEAR condition and 2 hour limit for the NOGEAR condition. Both GEAR and NOGEAR sessions will begin with the same treadmill test.
Following the treadmill test, the participants will complete the post-test outcome measures. These consist of isokinetic torque of the hip abductors and adductors, isokinetic torque of the knee flexors and extensors, the Y-Balance Test, the FFSFBT, and FSDT. Participants will doff their gear immediately following cession of the treadmill test. For unilateral tests, the dominant leg will be recorded and used for these tests; this is the leg used to kick a ball. Outcome measure order will be standardized for each participant with testing order based on primary outcomes and difficulty of each test. The FSDT will be performed first, as this is the primary outcome and previous research showed that recovery after a maximal exertion stimulus happens quickly. The FFSFBT will be performed next, followed by the Y-Balance Test. Isokinetic testing will be last due to the fatiguing nature of this testing. Hip muscles will be tested first, followed by thigh muscles. Three minutes will be allotted for rest and instruction between each outcome measure. Five minutes of rest will be given between isokinetic tests to allow for machine set-up and instructions. One minute of rest will be given between each isokinetic speed, with three speeds tested for the hip (30°, 60°, and 120° per second) and knee (60°, 180°, and 300° per second) muscles.
Participants will be followed for 2 years, with 6-month follow-up calls to track injury status. Details on type of injury, location of injury, and time lost to work will be collected.
### Conditions Module
**Conditions:**
- Occupational Injuries
- Heat Stress
- Leg Injury
- Back Injuries
**Keywords:**
- firefighter
- musculoskeletal
- slip
- trip
- fall
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** randomized crossover
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 28
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in the rapid heat stress arm will perform an exercise protocol on a treadmill in a hot, humid environment while wearing firefighter protective gear. This results in an uncompensable heat environment with a rapid increase in core temperature.
**Intervention Names:**
- Other: Rapid Heat Condition
**Label:** Rapid Heat Stress
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants in the rapid heat stress arm will perform an exercise protocol on a treadmill in a hot, humid environment while wearing light exercise clothing. This results in an uncompensable heat environment but with a gradual increase in core temperature.
**Intervention Names:**
- Other: Gradual Heat Condition
**Label:** Gradual Heat Stress
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Rapid Heat Stress
**Description:** The heat condition is the intervention. Personal protective equipment will be used to create the rapid heat stress condition, resulting in a rapid rise in core temperature. This will be in combination with the physiological heat produced by the treadmill protocol.
**Name:** Rapid Heat Condition
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Gradual Heat Stress
**Description:** The gradual heat condition is the control. Physiological heat will be produced by exercise on a treadmill, and light exercise clothing will help moderate the rise in core temperature.
**Name:** Gradual Heat Condition
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** a step-down task that is performed off a 20 cm box. Five repetitions are performed to give one score (minimum score 0, maximum score 6). A higher score is worse.
**Measure:** Forward-Step-Down Test
**Time Frame:** Familiarization trials (session 1, recruitment); pre-testing (baseline, session 2 (approximately day 7)); post-control and post-experimental sessions (session 3 (approximately day 14) & 4 (approximately day 21)).
**Description:** A dynamic balance test that is performed on the dominant leg, reaching in the anterior, posteromedial, and posterolateral directions. The length of reach is standardized to participants' leg length. A higher score is better, with 0 being the minimum distance and the maximum distance in anterior reach being 126cm, and the maximum posteromedial and posterolateral directions being 149cm.
**Measure:** Y-Balance Test
**Time Frame:** Familiarization trials (session 1, recruitment); pre-testing (baseline, session 2 (approximately day 7)); post-control and post-experimental sessions (session 3 (approximately day 14) & 4 (approximately day 21)).
**Description:** A dynamic balance test performed by stepping down from a 15cm box, walking across a low beam (4cm high), and stepping up onto a 10cm box, turning around, and returning to the original box. 8 Trials are performed. In 4 trials, a bar is placed at 75% of the participant's height for them to negotiate while on the beam. A faster time with fewer errors is better.
**Measure:** Firefighter Specific Functional Balance Test
**Time Frame:** Familiarization trials (session 1, recruitment); pre-testing (baseline, session 2 (approximately day 7)); post-control and post-experimental sessions (session 3 (approximately day 14) & 4 (approximately day 21)).
**Description:** Knee flexor/extensor isokinetic strength will be tested at 60°, 180°, and 300° per second from the seated position with 5, 10, and 10 concentric contractions for each speed. A higher reading of strength is better.
**Measure:** Knee Flexor/Extensor Isokinetic Test
**Time Frame:** Familiarization trials (session 1); pre-testing (baseline, session 2); post-control and post-experimental sessions (session 3&4).
**Description:** Hip abductor/adductor strength will be tested at 30°, 60°, and 120° per second from the standing position. A higher reading of strength is better.
**Measure:** Hip Abductor/Adductor Isokinetic Test
**Time Frame:** Familiarization trials (session 1, recruitment); pre-testing (baseline, session 2 (approximately day 7)); post-control and post-experimental sessions (session 3 (approximately day 14) & 4 (approximately day 21)).
#### Secondary Outcomes
**Description:** Participants will be contacted after sessions 1-4 to follow up on occurrence of musculoskeletal injuries, with 0 representing no injury and numerical values indicating presence of injury.
**Measure:** Injury Occurrence
**Time Frame:** 6 months, 12 months, 18 months, 24 months after session 4.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* professional firefighter
* healthy per the Physical Activity Readiness Questionnaire+ screening
Exclusion Criteria:
* unable to swallow core temperature capsule
* unable to follow pre-testing hydration criteria
* musculoskeletal injury in the past 3 months that limits ability to perform outcome measures
* females with known pregnancy (risk of hyperthermia to fetus)
**Healthy Volunteers:** True
**Maximum Age:** 57 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** erin.mccallister@lsuhs.edu
**Name:** Erin McCallister, DPT
**Phone:** 3188133502
**Role:** CONTACT
**Contact 2:**
**Email:** cory.coehoorn@lsuhs.edu
**Name:** Cory Coehoorn, PhD
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shreveport
**Country:** United States
**Facility:** LSUHSC-Shreveport
**State:** Louisiana
**Zip:** 71103
#### Overall Officials
**Official 1:**
**Affiliation:** LSUHSC-Shreveport
**Name:** Erin McCallister, DPT
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
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**PMID:** 10993420
**Citation:** Brown MN, Char RMML, Henry SO, Tanigawa J, Yasui S. The effect of firefighter personal protective equipment on static and dynamic balance. Ergonomics. 2019 Sep;62(9):1193-1201. doi: 10.1080/00140139.2019.1623422. Epub 2019 Jun 17.
**PMID:** 31204598
**Citation:** Cheung SS, McLellan TM. Influence of hydration status and fluid replacement on heat tolerance while wearing NBC protective clothing. Eur J Appl Physiol Occup Physiol. 1998;77(1-2):139-48. doi: 10.1007/s004210050312.
**PMID:** 9459534
**Citation:** Cheung SS, McLellan TM. Comparison of short-term aerobic training and high aerobic power on tolerance to uncompensable heat stress. Aviat Space Environ Med. 1999 Jul;70(7):637-43.
**PMID:** 10416998
**Citation:** Cheung SS, McLellan TM, Tenaglia S. The thermophysiology of uncompensable heat stress. Physiological manipulations and individual characteristics. Sports Med. 2000 May;29(5):329-59. doi: 10.2165/00007256-200029050-00004.
**PMID:** 10840867
**Citation:** Coehoorn CJ, Neary JP, Krigolson OE, Service TW, Stuart-Hill LA. Firefighter salivary cortisol responses following rapid heat stress. J Therm Biol. 2022 Aug;108:103305. doi: 10.1016/j.jtherbio.2022.103305. Epub 2022 Aug 7.
**PMID:** 36031202
**Citation:** Coehoorn CJ, Patrick Neary J, Krigolson OE, Stuart-Hill LA. Firefighter pre-frontal cortex oxygenation and hemodynamics during rapid heat stress. Brain Res. 2023 Jan 1;1798:148156. doi: 10.1016/j.brainres.2022.148156. Epub 2022 Nov 4.
**PMID:** 36343724
**Citation:** Colburn D, Russo L, Burkard R, Hostler D. Firefighter protective clothing and self contained breathing apparatus does not alter balance testing using a standard sensory organization test or motor control test in healthy, rested individuals. Appl Ergon. 2019 Oct;80:187-192. doi: 10.1016/j.apergo.2019.05.010. Epub 2019 Jun 18.
**PMID:** 31280804
**Citation:** Ftaiti F, Grelot L, Coudreuse JM, Nicol C. Combined effect of heat stress, dehydration and exercise on neuromuscular function in humans. Eur J Appl Physiol. 2001 Jan-Feb;84(1-2):87-94. doi: 10.1007/s004210000339.
**PMID:** 11394259
**Citation:** Gagge AP, Stolwijk JA, Hardy JD. Comfort and thermal sensations and associated physiological responses at various ambient temperatures. Environ Res. 1967 Jun;1(1):1-20. doi: 10.1016/0013-9351(67)90002-3. No abstract available.
**PMID:** 5614624
**Citation:** Games KE, Winkelmann ZK, McGinnis KD, McAdam JS, Pascoe DD, Sefton JM. Functional Performance of Firefighters After Exposure to Environmental Conditions and Exercise. J Athl Train. 2020 Jan;55(1):71-79. doi: 10.4085/1062-6050-75-18. Epub 2019 Dec 26.
**PMID:** 31876454
**Citation:** Hewett TE, Ford KR, Hoogenboom BJ, Myer GD. Understanding and preventing acl injuries: current biomechanical and epidemiologic considerations - update 2010. N Am J Sports Phys Ther. 2010 Dec;5(4):234-51.
**PMID:** 21655382
**Citation:** Lopes TJA, Simic M, Myer GD, Ford KR, Hewett TE, Pappas E. The Effects of Injury Prevention Programs on the Biomechanics of Landing Tasks: A Systematic Review With Meta-analysis. Am J Sports Med. 2018 May;46(6):1492-1499. doi: 10.1177/0363546517716930. Epub 2017 Jul 31.
**PMID:** 28759729
**Citation:** Nascimento LR, Teixeira-Salmela LF, Souza RB, Resende RA. Hip and Knee Strengthening Is More Effective Than Knee Strengthening Alone for Reducing Pain and Improving Activity in Individuals With Patellofemoral Pain: A Systematic Review With Meta-analysis. J Orthop Sports Phys Ther. 2018 Jan;48(1):19-31. doi: 10.2519/jospt.2018.7365. Epub 2017 Oct 15.
**PMID:** 29034800
**Citation:** McCallister E, Flower D. Can the forward-step-down test be used reliably in the clinical setting to assess movement changes resulting from maximal exertion? A pilot study. Internet Journal of Allied Health Sciences and Practice. 2020; 18(4).
**Citation:** Nybo L, Nielsen B. Hyperthermia and central fatigue during prolonged exercise in humans. J Appl Physiol (1985). 2001 Sep;91(3):1055-60. doi: 10.1152/jappl.2001.91.3.1055.
**PMID:** 11509498
**Citation:** Orr R, Simas V, Canetti E, Schram B. A Profile of Injuries Sustained by Firefighters: A Critical Review. Int J Environ Res Public Health. 2019 Oct 16;16(20):3931. doi: 10.3390/ijerph16203931.
**PMID:** 31623104
**Citation:** Park KM, Cynn HS, Choung SD. Musculoskeletal predictors of movement quality for the forward step-down test in asymptomatic women. J Orthop Sports Phys Ther. 2013;43(7):504-10. doi: 10.2519/jospt.2013.4073. Epub 2013 Jun 11.
**PMID:** 23756380
**Citation:** Periard JD, Eijsvogels TMH, Daanen HAM. Exercise under heat stress: thermoregulation, hydration, performance implications, and mitigation strategies. Physiol Rev. 2021 Oct 1;101(4):1873-1979. doi: 10.1152/physrev.00038.2020. Epub 2021 Apr 8.
**PMID:** 33829868
**Citation:** Powers CM. The influence of abnormal hip mechanics on knee injury: a biomechanical perspective. J Orthop Sports Phys Ther. 2010 Feb;40(2):42-51. doi: 10.2519/jospt.2010.3337.
**PMID:** 20118526
**Citation:** van Melick N, Meddeler BM, Hoogeboom TJ, Nijhuis-van der Sanden MWG, van Cingel REH. How to determine leg dominance: The agreement between self-reported and observed performance in healthy adults. PLoS One. 2017 Dec 29;12(12):e0189876. doi: 10.1371/journal.pone.0189876. eCollection 2017.
**PMID:** 29287067
**Citation:** Wohlgemuth K, Sekiguchi Y, Mota J. Overexertion and heat stress in the fire service: a new conceptual framework. Am J Ind Med. 2023 Aug;66(8):705-709. doi: 10.1002/ajim.23482. Epub 2023 Apr 16.
**PMID:** 37062940
**Citation:** Coehoorn, C. J., Stuart-Hill, L. A., Abimbola, W., Neary, J. P., & Krigolson, O. E. Firefighter neural function and decision-making following rapid heat stress. Fire Safety Journal, 2020; 118. https://doi.org/10.1016/j.firesaf.2020.103240
**Citation:** Games, K. E., Winkelmann, Z. K., & Eberman, L. E. Physical Exertion Diminishes Static and Dynamic Balance in Firefighters. International Journal of Athletic Therapy and Training. 2020; 25(6), 318-322. https://doi.org/10.1123/ijatt.2019-0063
**Citation:** Gokeler A, Welling W, Zaffagnini S, Seil R, Padua D. Development of a test battery to enhance safe return to sports after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2017 Jan;25(1):192-199. doi: 10.1007/s00167-016-4246-3. Epub 2016 Jul 16.
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**Citation:** Claiborne TL, Timmons MK, Pincivero DM. Test-retest reliability of cardinal plane isokinetic hip torque and EMG. J Electromyogr Kinesiol. 2009 Oct;19(5):e345-52. doi: 10.1016/j.jelekin.2008.07.005. Epub 2008 Oct 8.
**PMID:** 18845450
**Citation:** Brent JL, Myer GD, Ford KR, Paterno MV, Hewett TE. The effect of sex and age on isokinetic hip-abduction torques. J Sport Rehabil. 2013 Feb;22(1):41-6. doi: 10.1123/jsr.22.1.41. Epub 2012 Jun 18.
**PMID:** 22715125
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M20924
- Name: Heat Stress Disorders
- Relevance: HIGH
- As Found: Heat Stress
- ID: M10881
- Name: Leg Injuries
- Relevance: HIGH
- As Found: Leg Injuries
- ID: M21503
- Name: Back Injuries
- Relevance: HIGH
- As Found: Back Injury
- ID: M29576
- Name: Occupational Injuries
- Relevance: HIGH
- As Found: Occupational Injuries
- ID: M17685
- Name: Wounds and Injuries
- Relevance: HIGH
- As Found: Injury
- ID: M24916
- Name: Stress Disorders, Traumatic
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000018882
- Term: Heat Stress Disorders
- ID: D000007869
- Term: Leg Injuries
- ID: D000019567
- Term: Back Injuries
- ID: D000060051
- Term: Occupational Injuries
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442943
**Brief Title:** Impact of the Digital Multi-domain Cognitive Intervention in High-risk Populations for Dementia
**Official Title:** Impact of the Digital Multi-domain Cognitive Intervention in High-risk Populations for Dementia
#### Organization Study ID Info
**ID:** K2024-04-028
#### Organization
**Class:** OTHER
**Full Name:** Fujian Provincial Hospital
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-04
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-04
**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
#### Lead Sponsor
**Class:** OTHER
**Name:** Fujian Provincial Hospital
#### Responsible Party
**Investigator Affiliation:** Fujian Provincial Hospital
**Investigator Full Name:** Yuanjiao Yan
**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:** Dementia is a chronic, progressive neurodegenerative disease characterized by acquired cognitive impairment as its core manifestation. The most common type of dementia is Alzheimer's Disease (AD), also known as "Senile Dementia," accounting for 60-80% of all dementia cases. Currently, there are approximately 10 million AD patients in China, with the number showing an increasing trend year by year, imposing a heavy economic and caregiving burden on families and society. Studies have shown that AD has a clinically silent period of 15 to 20 years (SCD\\MCI), where the risk of developing dementia is ten times higher than that of healthy elderly individuals. Nearly 50% of MCI patients progress to dementia within 5 years, and about 14.1% of SCD patients develop dementia within the same timeframe. Early detection, diagnosis, and intervention are currently the most effective strategies for preventing and treating AD. Therefore, this study aims to verify the intervention effect of integrated cognitive intervention in high-risk populations for senile dementia (SCD, MCI) based on the cognitive rehabilitation model through randomized controlled trials, and to analyze attrition rates, participation rates, etc., which have good research and application value.
**Detailed Description:** Based on the cognitive rehabilitation model, this study aims to develop a digital multimodal cognitive intervention program, and conduct feasibility studies and randomized controlled trials. The intervention includes health knowledge education, exercise intervention, art intervention, and cognitive training, etc. The feasibility, effectiveness, and safety of this intervention approach will be evaluated.
### Conditions Module
**Conditions:**
- Cognitive Dysfunction
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 172
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in the intervention group received the digtal multi-domain cognitive intervention. The digital multi-domain cognitive intervention system is used to carry out various intervention activities. The activities include learning about health knowledge once a week; home-based exercise three times per week, for 30 minutes each time; art therapy once a week, for 90 minutes at a time; and cognitive training, which includes memory, attention, executive function, and visuospatial training, conducted three times per week, with each session lasting 30 minutes.
**Intervention Names:**
- Behavioral: Multi-domain Cognitive Intervention
**Label:** Intervention group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participant in the control group reveived the health education , once a week, covering the prevention and treatment of chronic diseases in the elderly, as well as healthy lifestyles for the elderly
**Intervention Names:**
- Behavioral: Multi-domain Cognitive Intervention
**Label:** Control group
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control group
- Intervention group
**Description:** * Cognitive rehabilitation includes home-based exercise, three times per week, for 30 minutes each session.
* Cognitive stimulation involves art therapy, once a week, for 90 minutes per session.
* Cognitive training encompasses memory, attention, executive function, and visuospatial training, conducted three times per week, with each session lasting 30 minutes.
* Health education, once a week, covering the prevention and treatment of chronic diseases in the elderly, as well as healthy lifestyles for the elderly.
**Name:** Multi-domain Cognitive Intervention
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The Chinese version of Montreal Cognitive Assessment will be used to assess the global cognitive function.The scale has a total score of 30 points, encompassing eight assessment sections: visual-spatial and executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. It involves multiple cognitive domains. A higher score indicates better cognitive functioning.
**Measure:** Global cognitive function
**Time Frame:** Baseline (pre-intervention), six-month follow-up (post-intervention)
#### Secondary Outcomes
**Description:** The Chinese version of Auditory Verbal Learning Test will be used to assess the memory. This includes immediate memory, short-term memory, long-term memory, and recognition memory. A higher score indicates better memory performance.
**Measure:** Memory
**Time Frame:** Baseline (pre-intervention), six-month follow-up (post-intervention)
**Description:** The Chinese version of Verbal Fluency Test will be used to assess the verbal fluency. A higher score indicates better verbal language performance.
**Measure:** Verbal fluency
**Time Frame:** Baseline (pre-intervention), six-month follow-up (post-intervention)
**Description:** The Chinese version of Boston Naming Test will be used to assess the naming difficulty. The total scores range from 0 to 30, a higher score indicates better language functioning.
**Measure:** Naming difficulty
**Time Frame:** Baseline (pre-intervention), six-month follow-up (post-intervention)
**Description:** The Chinese version of Shape Trail Test will be used to assess the execuite function. The shorter the usage time indicates better executive functioning.
**Measure:** Executive function
**Time Frame:** Baseline (pre-intervention), six-month follow-up (post-intervention)
**Description:** The Chinese version of Rey-Osterrieth Complex Figure Test will be used to assess the visuospatial skills. A higher score indicates better visual-spatial structural abilities.
**Measure:** Visuospatial skills
**Time Frame:** Baseline (pre-intervention), six-month follow-up (post-intervention)
**Description:** The Chinese version of Health-Promoting Lifestyle Profile-II will be used to assess the health lifestyle . The total score range from 40 to 160. A higher score indicates better health lifestyle.
**Measure:** Health-Promoting Lifestyle
**Time Frame:** Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
**Description:** The Chinese version of self-rated abilities for health practices scale will be used to assess the ability of health practice. The total score range from 0 to 112. A higher score indicates higher self-efficacy in healthy behaviors.
**Measure:** Abilities for health practices
**Time Frame:** Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
**Description:** The University of California at Los Angels Loneliness scale will be used to assess the loneliness. A higher score indicates more lonliness.
**Measure:** Lonliness
**Time Frame:** Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
**Description:** The Lubben Social Network Scale will be used to assess the social network. The lower score indicates lower risk of social isolation.
**Measure:** Social network
**Time Frame:** Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
**Description:** The Quality of life-Alzheimer's disease scale will be used the quality of life. A higher score indicates better quality of life. The highest score is 39 points.
**Measure:** Quality of life
**Time Frame:** Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
**Description:** The Self-rating Anxiety Scale will be used. The subjects will fill in the form based on their own situation in the past week.
**Measure:** Anxiety
**Time Frame:** Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
**Description:** The Geriatric Depression Scale will be used to assess the depression. The Cronbach coefficient of this scale is 0.93.
**Measure:** Depression
**Time Frame:** Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
**Description:** The Chinese version of Self-efficacy Scale will be used to assess the self-efficacy. The total score range from 10 to 40.
**Measure:** Self-efficacy
**Time Frame:** Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
**Description:** The Self-esteem Scale will be used to assess the self-esteem. A higher score indicates higher level of Self-esteem.
**Measure:** Self-esteem
**Time Frame:** Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
**Description:** The Athens Insomnia Scale will be used to assess the sleep quality.The Cronbach coefficient of this scale is 0.89, highest score is 24.
**Measure:** Sleep quality
**Time Frame:** Baseline (pre-intervention), six-month follow-up (post-intervention)
**Description:** The Subjective Cognitive Decline Questionnaire 9 will be used to assess the subjective cognitive function. The Cronbach coefficient of this scale is 0.88, highest score is 9.
**Measure:** Subjective cognitive function
**Time Frame:** Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* MCI (refer to Peterson's diagnostic criteria) or SCD (refer to the diagnostic framework proposed by Jak bondi and Jessen et al.);
* Able to communicate normally in Mandarin;
* Certain level of comprehension and judgment abilities, aware of the purpose of the survey and consents to participate.
Exclusion Criteria:
* Patients with dementia exhibiting abnormal mental behavior;
* Individuals with severe hearing or speech impairments;
* Those with serious physical illnesses who are unable to cooperate and complete the survey.
**Minimum Age:** 55 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** fjslkyk@163.com
**Name:** lian fayang, MD
**Phone:** 0591-87557768
**Phone Ext:** 86
**Role:** CONTACT
**Contact 2:**
**Email:** yuanjiao1994@126.com
**Name:** Yuanjiao Yan, PhD
**Phone:** 18120826271
**Phone Ext:** 86
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Fuzhou
**Contacts:**
***Contact 1:***
- **Email:** yuanjiao1994@126.com
- **Name:** yuanjiao yan, PhD
- **Phone:** +8618120826271
- **Role:** CONTACT
**Country:** China
**Facility:** Fujian Provincial Hospital
**State:** Fujian
**Status:** RECRUITING
**Zip:** 350001
#### Overall Officials
**Official 1:**
**Affiliation:** Study Director Fujian Provincial Hospital\Shengli clinical medical college of Fujian Medical university
**Name:** Yuanjiao Yan, PhD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** Researchers whose proposed use of the data has been approved
**Description:** Research data and research-related materials will be available in a repository or online. After completion of the study, relevant data will be provided in the form of a universal resource locator or digital object identifier.
**Info Types:**
- SAP
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** After completion of the study, relevant data will be provided in the form of a universal resource locator or digital object identifier.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000003072
- Term: Cognition Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M6904
- Name: Dementia
- Relevance: HIGH
- As Found: Dementia
- ID: M29705
- Name: Cognitive Dysfunction
- Relevance: HIGH
- As Found: Cognitive Dysfunction
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M6301
- Name: Cognition Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003704
- Term: Dementia
- ID: D000060825
- Term: Cognitive Dysfunction
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442930
**Acronym:** EXTUBE
**Brief Title:** EXtubation Related Complications - the EXTUBE Study (EXTUBE)
**Official Title:** EXtubation Related Complications - an International Observational Study To Understand the Impact and BEst Practices in the Operating Room and Intensive Care Unit - the EXTUBE Study
#### Organization Study ID Info
**ID:** 23-5794
#### Organization
**Class:** OTHER
**Full Name:** University Health Network, Toronto
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-28
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Health Network, Toronto
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** EXTUBE is an international, multicentre, prospective cohort study evaluating the incidence, risk factors, and outcomes of extubation-related complications and describing clinical practices related to extubation after general anesthesia or after critical illness in the operating room (OR), out of OR anesthesia location or intensive care unit (ICU).
**Detailed Description:** Globally, over 200 million people each year require extubation. While routinely performed, extubation is a skilled and potentially high-risk procedure that should be performed only when physiologic, pharmacologic, and contextual conditions are optimal.Complications at this stage of patient care can result in decreased oxygen delivery to the brain and body, sometimes leading to serious adverse events such as cardiac arrest, brain damage, or death. Indeed, one quarter of airway complications that result in death or brain death occur at the time of extubation.
Despite the frequency of extubation and the potential for life-threatening complications, there is a lack of systematic data on the rate and circumstances under which these severe complications occur. The limited data indicate 10-30% of extubations may lead to severe complications, depending on the population and outcome definition. However, the certainty of these estimates is severely limited because they are based on studies that are small, mostly single-center, based on clinician recall, only capture a small portion of extubation complications (e.g., malpractice claims), or do not reflect current clinical practice. In addition, most lack a denominator and exclude successful extubations, making estimates of actual complication rates and risk factors impossible.
There has been no large study of extubation techniques or adherence to guidelines, so procedural factors associated with complications must be elucidated. While adherence to clinical practice guidelines has not been formally evaluated, surveys show non-adherence to some best practices and considerable variation in practice, and data from audits and medicolegal claims show that lack of adherence to best practices is frequently at the root cause of severe adverse extubation outcomes, with half of the complications deemed preventable. Therefore, data on the frequency and nature of extubation complications, patient and procedural risk factors for complications, and guideline adherence rates are needed before these preventable events can be addressed.
EXTUBE (EXtubation related complications - an international observational study To Understand the impact and BEst practices in the operating room and intensive care unit) is an international, multicenter, prospective cohort study
The primary objective of this study is to determine the incidence of severe extubation-related complications within 60 minutes after extubation in adults who have undergone mechanical ventilation for general anesthesia or critical illness. The secondary objectives are to determine: 1) the incidence of mild extubation complications; 2) patient- and procedure-related risk factors for extubation complications; 3) the association between extubation complications and outcomes until hospital discharge; and 4) the rate of adherence to extubation clinical practice guidelines.
### Conditions Module
**Conditions:**
- Extubation
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 3000
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** The primary outcome will be the occurrence of at least one of the following (composite outcome) occurring within 60 minutes after the end of extubation:
i) Severe hypoxemia (oxygen saturation as measured by pulse oximetry falls below SpO2 \< 80%) ii) Cardiac arrest iii) Need for airway management (reintubation, insertion of a supraglottic airway, bag-mask ventilation).
**Measure:** At least one of the following, occurring within 60minutes after extubation (composite outcome): i) Severe hypoxemia ii) Cardiac arrest iii) Need for airway management
**Time Frame:** Within 60 minutes after the end of extubation
#### Secondary Outcomes
**Description:** Difficult airway (i.e., anticipated or experienced difficulty by an experienced airway manager with any or all of laryngoscopy or tracheal intubation, supraglottic airway use, face-mask ventilation, or front-of-neck airway) if reintubation is required
**Measure:** Difficult airway if reintubation is required
**Time Frame:** Within 60 minutes after the end of extubation
**Description:** Complications related to airway management (e.g., oesophageal intubation) if reintubation is required
**Measure:** Complications related to airway management if reintubation is required
**Time Frame:** Within 60 minutes after the end of extubation
**Description:** Unplanned non-invasive respiratory support
**Measure:** Unplanned non-invasive respiratory support
**Time Frame:** Within 60 minutes after the end of extubation
**Description:** Emergency front of neck airway should airway management be required after extubation
**Measure:** Emergency front of neck airway
**Time Frame:** Within 60 minutes after the end of extubation
**Description:** Cardiac arrhythmia requiring chemical or electrical treatment
**Measure:** Cardiac arrhythmia requiring chemical or electrical treatment
**Time Frame:** Within 60 minutes after the end of extubation
**Description:** Hypotension (systolic arterial pressure \< 65 mmHg recorded at any time or \< 90 mmHg for \>30 minutes)
**Measure:** Hypotension
**Time Frame:** Within 60 minutes after the end of extubation
**Description:** Severe hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥120 mmHg)
**Measure:** Hypertension
**Time Frame:** Within 60 minutes after the end of extubation
**Description:** Aspiration of gastric contents (gastric contents inhaled into the larynx and the respiratory tract)
**Measure:** Pulmonary aspiration
**Time Frame:** Within 60 minutes after the end of extubation
**Description:** Pneumothorax/pneumo-mediastinum
**Measure:** Barotrauma
**Time Frame:** Within 60 minutes after the end of extubation
**Description:** Dental injury (notable change to the patient's dentition attributable to extubation or to reintubation, should this be required)
**Measure:** Dental injury
**Time Frame:** Within 60 minutes after the end of extubation
**Description:** In-hospital mortality
**Measure:** Mortality
**Time Frame:** Within 7 days after extubation
**Description:** Re-intubation within 48 hours of extubation
**Measure:** Re-intubation
**Time Frame:** Within 48 hours after extubation
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult patients (\> 18 years old)
* Undergoing extubation of an endotracheal tube (including index extubation and re-extubations) after general anesthesia in the OR, out of OR anesthesia location or ICU
* Undergoing extubation during the specified enrollment window
Exclusion Criteria:
* Patients will be excluded if the extubation is performed in the context of withdrawal of life support measures,
* Patients will be excluded if the extubation is performed for tracheostomy decannulation
* Patients will be excluded if the extubation is accidental.
For each patient who is not included, reasons for exclusion will be reported.
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** All adult patients (\> 18 years old) undergoing extubation of an endotracheal tube (including index extubation and re-extubations) after general anesthesia in the OR, out of OR anesthesia location or ICU during the specified enrollment window
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** matteo.parotto@uhn.ca
**Name:** Matteo Parotto, MD, PhD
**Phone:** +1 416 340 3567
**Role:** CONTACT
**Contact 2:**
**Email:** jo.carroll@uhn.ca
**Name:** Jo Carroll
**Phone:** +1 416 340 3567
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Toronto
**Contacts:**
***Contact 1:***
- **Email:** matteo.parotto@uhn.ca
- **Name:** Matteo Parotto, MD, PhD
- **Phone:** +1 416 340 3567
- **Role:** CONTACT
***Contact 2:***
- **Email:** jo.carroll@uhn.ca
- **Name:** Jo Carroll
- **Phone:** +1 416 340 3567
- **Role:** CONTACT
**Country:** Canada
**Facility:** University Health Network
**State:** Ontario
**Zip:** M5G2C4
#### Overall Officials
**Official 1:**
**Affiliation:** UHN
**Name:** Matteo Parotto, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442917
**Brief Title:** The Effect of Breathing Exercise and Affirmation Method Used in Labor on Women's Birth Self-Efficacy and Satisfaction
**Official Title:** The Effect of Breathing Exercise and Affirmation Method Used in Labor on Women's Birth Self-Efficacy and Satisfaction
#### Organization Study ID Info
**ID:** 20.478.486/1213
#### Organization
**Class:** OTHER
**Full Name:** Çanakkale Onsekiz Mart University
### Status Module
#### Completion Date
**Date:** 2022-11-30
**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:** 2022-10-31
**Type:** ACTUAL
#### Start Date
**Date:** 2022-04-10
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** Mehmet Akif Ersoy Canakkale State Hospital
#### Lead Sponsor
**Class:** OTHER
**Name:** Çanakkale Onsekiz Mart University
#### Responsible Party
**Investigator Affiliation:** Çanakkale Onsekiz Mart University
**Investigator Full Name:** Remziye Gültepe
**Investigator Title:** PhD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Purpose: This research was conducted to determine the effect of breathing exercise and affirmation method used in labor on women's birth self-efficacy and satisfaction.
Materials and Methods: The sample of the study, in which the randomized controlled experimental design type was applied, consisted of 128 nulliparous pregnant women. Data were collected with Pregnant Descriptive Information Form, Innate Period Evaluation Form, Visual Analog Scale, Affirmation Statement Evaluation Form, Short Form of the Childbirth of Self-Efficacy Inventory and Birth Satisfaction Scale. Pregnant women who are in the first stage of labor have been using diaphragmatic breathing exercise to one group, affirmation method to one group, both diaphragmatic exercise and affirmation method to one group since the active phase, while pregnant women in the control group have not been given any intervention, they have received routine care. Descriptive statistical methods, chi-square test, one-way analysis of variance, t-test for dependent and independent groups were used in the analysis of the data.
**Detailed Description:** This study was conducted in four groups. Groups; The group in which the affirmation method was used in labor (Affirmation Group - OG), the group in which breathing exercises were used in labor (Breathing Group - NG), the group in which both breathing exercises and affirmation methods were used in labor (Breathing and Affirmation Group - NOG), and the group in which no intervention was made other than routine hospital practices. It is divided into a non-existent group (Control Group - CG). The numbers given to the groups (1, 2, 3, 4) were determined by the lottery method. The name of each group was written on the papers and numbered in order of drawing. The numbers 3 were assigned to the Breathing group, 1 to the Affirmation group, 2 to the Breathing and Affirmation group, and 4 to the Control group. Considering data loss in the distribution of the study into groups, numbers from 1 to 200 were randomized for 4 groups using a computer-assisted randomization program (https://www.rstudio.com). In order to ensure homogeneity in the randomization of the intervention groups and the control group, five matching criteria were taken into consideration. These match criteria; It was determined as the mother's age, education level (secondary school and below, high school and above), employment status (working/not working), gestational age, and prenatal education. Homogeneity of the groups was tested in the evaluation of the study.
Pregnant women to be included in the study were assigned to groups according to the numbers in the columns according to the eligibility criteria. In order to avoid being influenced by each other, pregnant women were included in the study one by one, and after the birth of one pregnant woman was completed, the other pregnant woman was included in the study.
### Conditions Module
**Conditions:**
- Birth Self-efficacy
- Birth Satisfaction
**Keywords:**
- self-efficacy
- self-satisfaction
- breathing exercise
- affirmation
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 128
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 32 the Pregnant Identifying Characteristics Form, the Short Version of the Self-Efficacy Scale in Childbirth was completed before the pregnancy intervention and the VAS was measured.
**Intervention Names:**
- Behavioral: Breathing Exercise
**Label:** Breathing Exercise Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** 32 pregnant women who were admitted to the hospital for childbirth and were in the latent phase (0-3 cm) filled out the pre-intervention Pregnant Identifying Characteristics Form, the Short Version of the Self-Efficacy Scale in Childbirth, and the VAS was measured.
**Intervention Names:**
- Behavioral: Affirmation Method
**Label:** Affirmation Method Group
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** During the latent phase, affirmation phrases were shown to the pregnant women and the application was explained and the application was made with breathing exercise training.
**Intervention Names:**
- Behavioral: Breathing Exercise and Affirmation Method
**Label:** Breathing Exercise and Affirmation Method Group
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Routine midwifery care was applied during the trauma.
**Label:** control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Breathing Exercise Group
**Description:** 32 the Pregnant Identifying Characteristics Form, the Short Version of the Self-Efficacy Scale in Childbirth was completed before the pregnancy intervention and the VAS was measured. Breathing exercise training and application were carried out during the latent phase process. In this training, the importance of proper breathing was explained and diaphragmatic breathing application was made.
During the active phase process (4-7 cm), the Innatal Period Evaluation Form was filled out and the VAS was measured, and diaphragmatic breathing exercise was performed every 30 minutes from the beginning of contraction until the end of contraction. During the transition phase (8-10 cm), the Innatal Period Evaluation Form, the Short Version of the Self-Efficacy Scale in Childbirth were filled out and the VAS was measured, and diaphragmatic breathing exercise was performed once every 15 minutes from the beginning of contraction to the end of contraction.
**Name:** Breathing Exercise
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Affirmation Method Group
**Description:** 32 pregnant women who were admitted to the hospital for childbirth and were in the latent phase (0-3 cm) filled out the pre-intervention Pregnant Identifying Characteristics Form, the Short Version of the Self-Efficacy Scale in Childbirth, and the VAS was measured. During the latent phase, affirmation phrases were shown to the pregnant women and the application was explained. During the active phase process (4-7 cm), the Innatal Period Evaluation Form was filled out and the VAS was measured, and the affirmation phrases were repeated and used by the researcher every 30 minutes from the beginning of the contraction until the end of the contraction.
During the transition phase (8-10 cm), the Innatal Period Evaluation Form, the Short Version of the Self-Efficacy Scale in Childbirth were filled out and the VAS was measured, and affirmation sentences and support sentences were said every 15 minutes from the beginning of the contraction to the end of the contraction.
**Name:** Affirmation Method
**Type:** BEHAVIORAL
#### Intervention 3
**Arm Group Labels:**
- Breathing Exercise and Affirmation Method Group
**Description:** During the latent phase, affirmation phrases were shown to the pregnant women and the application was explained and the application was made with breathing exercise training. In this training, the importance of proper breathing was explained and diaphragmatic breathing application was made. During the active phase process (4-7 cm), the Congenital Period Evaluation Form was filled out and the VAS was measured, and diaphragmatic breathing exercise was performed once every 30 minutes from the beginning of contraction to the end of contraction, and the affirmation phrases were repeated and used by the researcher
**Name:** Breathing Exercise and Affirmation Method
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** birth self-efficacy of pregnant women.The lowest total score that can be obtained from the scale is 32, and the highest total score is 320. As the scores from the scale increase, the self-efficacy levels of pregnant women in labor increase.
**Measure:** birth self-efficacy scale
**Time Frame:** in the active phase of labor
**Description:** birth satisfaction of pregnant women.As a result of the scale, a score between 0 and 40 is received. It is interpreted that as the score obtained as a result of the scale increases, the woman's birth satisfaction increases, while a low score indicates that the birth satisfaction is not at a sufficient level.
**Measure:** birth satisfaction scale
**Time Frame:** in the active phase of labor
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
The one who is open to communication,
* between the ages of 18-45 Dec,
* At least a primary school graduate,
\* Nulliparous,
* Non-risky pregnancy in terms of mother and baby (multiple pregnancy, preeclampsia, etc.),
\* In the first stage of labor (0-3 cm dilatation), which is,
* Living at term and having a single pregnancy,
* No analgesic or anesthetic substance is applied during the trauma, \* Pregnant women who volunteer to participate in the research
Exclusion Criteria:
* Your mother wants to leave without working, \* Pregnant women who developed cesarean section indication after being included in the study
**Gender Based:** True
**Gender Description:** Woman
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Çanakkale
**Country:** Turkey
**Facility:** Çanakkale Onsekiz Mart Üniversitesi
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M27137
- Name: Respiratory Aspiration
- Relevance: HIGH
- As Found: Breathing
- 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: D000053120
- Term: Respiratory Aspiration
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442904
**Brief Title:** Can a Digital Education Program in Radiographic Imaging Technique for Dental Professionals Improve Image Quality?
**Official Title:** A Digital Education Program in Oral and Maxillofacial Radiology: Effect on Image Quality Evaluated in a Cluster Randomized Controlled Trial
#### Organization Study ID Info
**ID:** Umea University, Sweden
#### Organization
**Class:** OTHER
**Full Name:** Umeå University
### 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:** 2024-06-04
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-04
**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:** Västerbotten County Council, Sweden
#### Lead Sponsor
**Class:** OTHER
**Name:** Umeå University
#### Responsible Party
**Investigator Affiliation:** Umeå University
**Investigator Full Name:** Maria Garoff
**Investigator Title:** Associate professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to learn if a digital education program designed for dental professionals can lead to radiographic examinations of better quality. The main questions it aims to answer are:
Does the digital education program lead to more radiographic examinations of good quality? Does the digital education program lead to better theoretical and practical understanding regarding image quality among dental professionals?
Researchers will compare answers from a theoretical test and image quality in radiographic examinations between participants with respectively without access to the digital education program.
Participants will:
* have access to the digital education program for three months
* after three months all study participants are invited to answer a theoretical test
**Detailed Description:** The present study aims to evaluate a digital education programs effect on image quality in intraoral radiographic examinations performed by dental professionals. The present study is part of an on-going cross sectional descriptive project where dental professionals employed in general dental care in the county of Västerbotten, Sweden constitute the study population. The purpose of the project is to gain a broader understanding of a digital education programs impact on the theoretical and practical competencies among dental professionals regarding intraoral dental radiographic examinations.
Approximately 80 dental professionals have provided written informed consent regarding study participation. In the present study, approximately 40 participants will for three months be offered the intervention and join a digital education program. Approximately 40 participants will during the same period not be offered the intervention and constitute the control group. Effects on practical competencies between groups will be evaluated when analyzing image quality of intraoral radiographic examinations. Effects on theoretical competencies between groups will be analyzed with a theoretical test.
Cluster randomization of dental clinics will be made for study included participants to either intervention group or control group. Recruitment of study participants will end in August 2024.
The investigators hypothesize that the digital education program will improve the theoretical competence and radiographic image quality in intraoral radiographic examinations.
### Conditions Module
**Conditions:**
- Radiography
- Dentistry
**Keywords:**
- digital education
- oral and maxillofacial radiology
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- INVESTIGATOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Access to a digital education program for three months.
**Intervention Names:**
- Other: Digital education program
**Label:** Intervention group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The control group is not offered any intervention.
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention group
**Description:** The approximately six hours long digital education program will be available for three months and implies further education in intraoral radiographic examinations.
**Name:** Digital education program
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Change in image quality of intraoral radiographic examinations measured with a protocol designed for diagnostic image quality assessment. Comparisons between intervention- and control group will be made.
**Measure:** Image quality
**Time Frame:** Baseline and three months post-intervention
#### Secondary Outcomes
**Description:** Change in theoretical competence measured in a theoretical test. Comparisons between intervention- and control group will be made.
**Measure:** Theoretical competence
**Time Frame:** One month post-intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
• Dental professionals performing radiographic examinations employed in general dentistry in the County Council of Västerbotten, Sweden
Exclusion Criteria:
• Dental professionals not performing radiographic examinations
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** maria.garoff@umu.se
**Name:** Maria Garoff, Assoc. Prof.
**Phone:** +46 (0)90-785 60 84
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Umeå
**Country:** Sweden
**Facility:** Folktandvården Region Västerbotten
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Umeå University
**Name:** Maria Garoff, Assoc. Prof.
**Role:** PRINCIPAL_INVESTIGATOR
### 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:** NCT06442891
**Brief Title:** Self-Administered Relaxing Acupressure to Reduce Fatigue in Adolescent and Young Adult Cancer Survivors
**Official Title:** A Pilot Study of Self-Administered Acupressure for Fatigue Among Adolescent and Young Adult (AYA) Cancer Survivors
#### Organization Study ID Info
**ID:** UMCC 2024.016
#### Organization
**Class:** OTHER
**Full Name:** University of Michigan Rogel Cancer Center
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2024-03772
**Type:** REGISTRY
**Domain:** University of Michigan Comprehensive Cancer Center
**ID:** HUM00248915
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**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 Michigan Rogel Cancer Center
#### 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:** This clinical trial tests the feasibility of self-administered relaxing acupressure on fatigue in adolescent and young adult (AYA) cancer survivors. Acupressure, a type of complementary or alternative medicine, is the application of pressure or localized massage to specific sites on the body to control symptoms. Relaxing acupressure has been shown to improve cancer-related fatigue (CRF) in adults, however, less is known about the impact of relaxing acupressure on CRF in AYA cancer survivors."
**Detailed Description:** PRIMARY OBJECTIVE:
I. Determine the feasibility of implementing a randomized controlled trial of a six-week, self-administered relaxing acupressure intervention in AYA cancer survivors with clinically relevant CRF.
SECONDARY OBJECTIVE:
I. Explore participants' perspectives of acceptability and satisfaction with the six-week acupressure interventions using semi-structured interviews.
EXPLORATORY OBJECTIVE:
I. Determine the preliminary efficacy of a six-week, virtual, self-administered relaxing acupressure intervention on clinically significant changes in CRF in post-treatment AYA cancer survivors.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive access to an acupressure mobile application and an AcuWand on study and self-administer relaxing acupressure to 9 acupoints over 27 minutes once daily (QD) for 6 weeks.
ARM II: Patients receive access to an acupressure mobile application and an AcuWand and self-administer sham acupressure to non-acupressure point locations over 27 minutes QD for 6 weeks.
### Conditions Module
**Conditions:**
- Hematopoietic and Lymphatic System Neoplasm
- Malignant Solid Neoplasm
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Patients are blinded to intervention.
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients receive access to acupressure mobile application and an AcuWand on study and self-administer relaxing acupressure to 9 acupoints over 27 minutes QD for 6 weeks.
**Intervention Names:**
- Procedure: Acupressure Therapy
- Other: Internet-Based Intervention
- Other: Interview
- Other: Medical Device Usage and Evaluation
- Other: Questionnaire Administration
**Label:** ARM I (relaxing acupressure)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients receive access to acupressure mobile application and an AcuWand and self-administer sham acupressure to non-acupressure point locations over 27 minutes QD for 6 weeks.
**Intervention Names:**
- Procedure: Acupressure Therapy
- Other: Internet-Based Intervention
- Other: Interview
- Other: Medical Device Usage and Evaluation
- Other: Questionnaire Administration
**Label:** ARM II (sham acupressure)
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ARM I (relaxing acupressure)
**Description:** Self-administer relaxing acupressure
**Name:** Acupressure Therapy
**Other Names:**
- Acupressure
- Ischemic Compression
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- ARM II (sham acupressure)
**Description:** Self-administer sham acupressure
**Name:** Acupressure Therapy
**Other Names:**
- Acupressure
- Ischemic Compression
**Type:** PROCEDURE
#### Intervention 3
**Arm Group Labels:**
- ARM I (relaxing acupressure)
- ARM II (sham acupressure)
**Description:** Receive access to acupressure mobile app
**Name:** Internet-Based Intervention
**Type:** OTHER
#### Intervention 4
**Arm Group Labels:**
- ARM I (relaxing acupressure)
- ARM II (sham acupressure)
**Description:** Ancillary studies
**Name:** Interview
**Type:** OTHER
#### Intervention 5
**Arm Group Labels:**
- ARM I (relaxing acupressure)
- ARM II (sham acupressure)
**Description:** Receive an AcuWand
**Name:** Medical Device Usage and Evaluation
**Type:** OTHER
#### Intervention 6
**Arm Group Labels:**
- ARM I (relaxing acupressure)
- ARM II (sham acupressure)
**Description:** Ancillary studies
**Name:** Questionnaire Administration
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Self-administered acupressure implementation will be feasible if all participants are recruited over 2 years. Descriptive statistics will be used to summarize recruitment rate.
**Measure:** Recruitment rate
**Time Frame:** Up to 2 years
**Description:** Self-administered acupressure implementation will be feasible if 60% of participants complete the baseline and 6-week patient-reported measures and if 60% of acupressure group participants self-report acupressure practice for at least 27 minutes on at least 3 days per week. Descriptive statistics will be used to summarize adherence.
**Measure:** Adherence
**Time Frame:** At 6 weeks
**Description:** Interview data will be analyzed using inductive content analysis. Perspectives of the intervention will be analyzed using inductive content analysis.
**Measure:** Satisfaction
**Time Frame:** Up to week 10
**Description:** Measured using the Patient Reported Outcomes Measurement Information Systems Fatigue 4a questionnaire. Results are continuously scaled and appropriately analyzed by Gaussian-based statistical models. Change in fatigue will be analyzed using a Full Information Maximum Likelihood mixed-effects linear regression model. Specifically, change from baseline will be evaluated by including fixed-effects coefficients for time, treatment, and the important interaction effects that will determine whether changes from baseline are greater in the relaxing acupressure group, relative to controls. Random Y-intercepts in the model will be incorporated to accommodate the nesting of repeated observations within subject. Change in fatigue will be analyzed using a Full Information Maximum Likelihood mixed-effects linear regression model.
**Measure:** Change in fatigue
**Time Frame:** At baseline and up to week 10
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 15 - 39 years old
* At least three months post cancer treatment (e.g., surgery, radiation or chemotherapy). Participants receiving maintenance hormonal or targeted therapies will be allowed to enroll as determined by the study investigator
* Report clinically relevant fatigue in the past seven days (Patient Reported Outcomes Measurement Information Systems \[PROMIS\] Fatigue 4a scores ≥ 55)
* Speak / read English
* CRF started at or after the diagnosis of cancer
* Completed cancer treatment within the past five years
Exclusion Criteria:
* Diagnosis of untreated anemia, mood disorder, or hypothyroidism
* Plan to begin new pharmacological, psychological, or other treatments (i.e., physical therapy or dietary supplements) for CRF during the study. Although, participants may continue usual treatments for CRF if the treatments were initiated at least eight weeks prior to study enrollment, and the dose has not changed
* Plan to become pregnant or lactating during the study period
* Received acupressure or acupuncture in the past year
**Maximum Age:** 39 Years
**Minimum Age:** 15 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ann Arbor
**Contacts:**
***Contact 1:***
- **Email:** rjknoerl@med.umich.edu
- **Name:** Robert Knoerl
- **Phone:** 734-764-8617
- **Role:** CONTACT
***Contact 2:***
- **Name:** Robert Knoerl
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Michigan Comprehensive Cancer Center
**State:** Michigan
**Zip:** 48109
#### Overall Officials
**Official 1:**
**Affiliation:** University of Michigan Rogel Cancer Center
**Name:** Robert Knoerl
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M8364
- Name: Fatigue
- Relevance: LOW
- As Found: Unknown
### 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:** NCT06442878
**Brief Title:** Benefits of a Belly Dance Psychomotor Intervention
**Official Title:** Effects of Psychomotor Intervention Program Mediated by Belly Dance in Adults Women.
#### Organization Study ID Info
**ID:** UÉ
#### Organization
**Class:** OTHER
**Full Name:** University of Évora
### Status Module
#### Completion Date
**Date:** 2024-10-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**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 Évora
#### Responsible Party
**Investigator Affiliation:** University of Évora
**Investigator Full Name:** Simone Leara Barroso Pereira
**Investigator Title:** MS
**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 the present study is to analyze the effects of a psychomotor intervention program mediated by belly dance in adult women. This Quasi-experimental study is a controlled trial with one arm. Participants will be allocated to one group which will be i) control and ii) experimental. That is at first i) will attend a control period without intervention (6 weeks) and at second ii) will attend an intervention period participating on the intervention program mediated by belly dance (12 weeks). Participants will be accessed at a baseline, at post control and at post intervention.
**Detailed Description:** Sedentary lifestyles has been identified as one of the main causes for the development of pathologies as are cardiovascular diseases and of mental health problems such as anxiety and depression. Associated with this, psychomotor factors can also be negatively affected as well as the perception of well-being. Women's daily life associated with tasks accumulation is referred to as a barrier to engaging in physical have progressively made it more difficult for them to perform formal physical activity (Barranco-Ruiz, 2020). Dance can help in this scenario because it is a pleasurable activity that favors social and intrapersonal relationships, working simultaneously on factors such as balance, motor coordination, agility, body awareness, and rhythm, having a positive impact on quality of life and well-being. In this way, dance, through its various components associated with movement, can assume a character of health promotion, also making possible a space of attention for women (Hernandes et al, 2018). Studies have already been carried out focusing on the effects of belly dancing on body image, quality of life and self-esteem in women with cancer, experienced and professional experienced and professional belly dancers/practitioners, elderly women with depression, pregnant women and depression, pregnant women and those with chronic pain (Boing, 2018; Toberna, 2020; Castrillon, 2017). No studies were found that looked at psychomotor factors (balance, agility and body body awareness), or indicators of well-being focused on body image, movement image and and mood states.
The proposed study has a quasi-experimental design with two pre-tests and one post- test, with only one group, the experimental group being its own control. In this way, we will apply Pre-test 1 and after six weeks without intervention, we will apply Pre-test 2 in order to obtain the results referring to the control group. After that, we will start the intervention itself, which will last twelve weeks and will culminate with the Post test 1.
### Conditions Module
**Conditions:**
- Adult Women
**Keywords:**
- woman, body awareness, dance, balance and well-being.
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 21
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The same group, will do the intervention will attend the belly dance program. The control group will maintain the usually daily activities, not attending any exercise program for a month and a half, and than will be a experimental group with 2 sessions / week of 60 minutes on alternated days.
**Intervention Names:**
- Other: Belly Dance Program
**Label:** Control and Experimental Group
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control and Experimental Group
**Description:** All Belly Dance sessions comprised 5 phases: 1) opening ritual (5 min), in which participants will be welcomed and perceived how people were feeling. 2) warm-up (15 min), in which thinking and feeling are integrated during the movements, isolating each part of the body according to Laban's body organization. 3) main phase (30 min), will be proposed individual, pair and group activities, in order to achieve the objectives planned. This phase will end with a choreography composition or a challenge; 4) cool-down (5 min) with stretching and physiological parameters normalization; and 5) ending ritual (5 min), in which the participants will be invented to share their sessions' experience.
**Name:** Belly Dance Program
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Balance and Postural Control outcome measure assessed by Modified Star Excursion Balance Test (MSEBT); stand stork test and standing stork test (blind).
**Measure:** Change from Baseline to post control and to post intervention
**Time Frame:** [ 0, 6 weeks] vs. [0,12 weeks]
**Description:** Agility outcome measure assessed by Hexagonal Obstacle Test.
**Measure:** Change from Baseline to post control and to post intervention
**Time Frame:** [ 0, 6 weeks] vs. [0,12 weeks]
**Description:** Rhythm perception and reproduction assessed by Go No Go Test
**Measure:** Change from Baseline to post control and to post intervention
**Time Frame:** [ 0, 6 weeks] vs. [0,12 weeks]
**Description:** Body Awareness outcome measure assessed by the Multidimensional Assessment of Interoceptive Awareness (MAIA), ranging an 8-scale state-trait questionnaire with 32 items and the Awareness-Body-Chart test (ABC).
**Measure:** Change from Baseline to post control and to post intervention
**Time Frame:** [ 0, 6 weeks] vs. [0,12 weeks]
**Description:** Body Image outcome measure will assessed using the Body Investment Scale (BIS), ranging with a Likert-type scale ranging from 1 (strongly disagree) to 5 (strongly agree).
**Measure:** Change from Baseline to post control and to post intervention
**Time Frame:** [ 0, 6 weeks] vs. [0,12 weeks]
**Description:** Image of movement outcome measure will accessed using the miq-3 test, made up of three subscales to assess the kinesthetic and visual modalities; and two Likert-type subscales with 7 levels of response, ranging from "very difficult" to "very easy".
**Measure:** Change from Baseline to post control and to post intervention
**Time Frame:** [ 0, 6 weeks] vs. [0,12 weeks]
**Description:** Mood States outcome measure will accessed using the Poms Mood Test with a likert scale with a score of 0 "not at all" and 5 "very much".
**Measure:** Change from Baseline to post control and to post intervention
**Time Frame:** [ 0, 6 weeks] vs. [0,12 weeks]
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Woman aged \> 17 years and \<60 years
* Availability to participate in the program
Exclusion Criteria:
* Presence of cognitive impairment (Mini-Mental State Examination);
* Presence of motor impairment, neurological problems or diseases compromising the program participation;
* Unavailability to participate in the program.
**Healthy Volunteers:** True
**Maximum Age:** 59 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Évora
**Country:** Portugal
**Facility:** Simone Leara Barroso Pereira
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Barranco-Ruiz Y, Paz-Viteri S, Villa-Gonzalez E. Dance Fitness Classes Improve the Health-Related Quality of Life in Sedentary Women. Int J Environ Res Public Health. 2020 May 26;17(11):3771. doi: 10.3390/ijerph17113771.
**PMID:** 32466496
**Citation:** Boing L, Baptista F, Pereira GS, Sperandio FF, Moratelli J, Cardoso AA, Borgatto AF, de Azevedo Guimaraes AC. Benefits of belly dance on quality of life, fatigue, and depressive symptoms in women with breast cancer - A pilot study of a non-randomised clinical trial. J Bodyw Mov Ther. 2018 Apr;22(2):460-466. doi: 10.1016/j.jbmt.2017.10.003. Epub 2017 Oct 12.
**PMID:** 29861250
**Citation:** Castrillon T, Hanney WJ, Rothschild CE, Kolber MJ, Liu X, Masaracchio M. The effects of a standardized belly dance program on perceived pain, disability, and function in women with chronic low back pain. J Back Musculoskelet Rehabil. 2017;30(3):477-496. doi: 10.3233/BMR-150504.
**PMID:** 27858690
**Citation:** Hernandes JC, Di Castro VC, Mendonca ME, Porto CC. Quality of life of women who practice dance: a systematic review protocol. Syst Rev. 2018 Jul 10;7(1):92. doi: 10.1186/s13643-018-0750-5.
**PMID:** 29991355
**Citation:** Toberna CP, Horter D, Heslin K, Forgie MM, Malloy E, Kram JJF. Dancing During Labor: Social Media Trend or Future Practice? J Patient Cent Res Rev. 2020 Apr 27;7(2):213-217. doi: 10.17294/2330-0698.1723. eCollection 2020 Spring.
**PMID:** 32377554
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M4854
- Name: Benzocaine
- Relevance: LOW
- As Found: Unknown
- ID: T433
- Name: Tannic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442865
**Acronym:** AMNIODERM+
**Brief Title:** AMNIODERM+ Medical Device Clinical Study
**Official Title:** Freeze-dried Amniotic Membrane in the Treatment of Non-healing Wounds: a Single-arm, Retrospectivelyprospective Clinical Trial
#### Organization Study ID Info
**ID:** AD+29082022ZP
#### Organization
**Class:** INDUSTRY
**Full Name:** BioHealing s.r.o.
### Status Module
#### Completion Date
**Date:** 2023-03-30
**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:** 2023-03-30
**Type:** ACTUAL
#### Start Date
**Date:** 2022-11-16
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** BioHealing s.r.o.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This is retrospectively-prospective clinical trial with medical device AMNIODERM+ intended for the non-healing wounds. Retrospective data will contain information about the subject's history and wound treatment by SoC. Prospective data will contain information about wound treatment by AMNIODERM+®.
### Conditions Module
**Conditions:**
- Non-healing Wound
- Diabetic Foot
**Keywords:**
- medical device
- AMNIODERM+
- non-healing wounds
- DFU
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 20
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Subjects with a diabetic neuropathic or neuroischemic wounds, anywhere on the leg, ranging in size between 2 cm2 and 16 cm2, that has not healed at least 20% after the 6 weeks of the standard of care (SoC) with the known therapeutic history ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion.
Retrospective data will contain information about the subject's history and wound treatment by SoC.
**Intervention Names:**
- Device: AMNIODERM+
**Label:** Retrospective data
#### Arm Group 2
**Description:** Subjects with a diabetic neuropathic or neuroischemic wounds, anywhere on the leg, ranging in size between 2 cm2 and 16 cm2, that has not healed at least 20% after the 6 weeks of the standard of care (SoC) with the known therapeutic history ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion.
Prospective data will contain information about wound treatment by AMNIODERM+®.
**Intervention Names:**
- Device: AMNIODERM+
**Label:** Prospective data
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Prospective data
- Retrospective data
**Description:** A common surgical approach in chronic wound treatment aims at the promotion of epithelization by a combination of debridement manipulations (removal of non-vital tissues) and infection/inflammation management using antibacterial wound dressings (antibiotics or silver covering). The advantages of biomaterials can be attributed to their unique mechanical, immunological, and regenerative properties.
The product will be evaluated in the subjects not responding to SoC.
**Name:** AMNIODERM+
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Analyses of primary and secondary endpoints: The error rate During data collection, a change was made to the CIP regarding complete wound closure (wound heal). Whether a wound was healed was determined by the opinion of the investigator and not by the size of the wound as measured by Imito® application. The error rate of the Imito® measuring application in determining the size of the wound was 10 %, i.e. based on that and clinical experience the threshold of 0.1 cm2 was determined. Wounds smaller than or equal to 0.1 cm2 were considered as complete closure. The investigator confirmed the wound closure in an accompanying comment in the eCRF.
**Measure:** Non-healing wounds measuring
**Time Frame:** 6 + 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Males and females over 18 years of age
2. Type 1 or Type 2 diabetes mellitus
3. Presence of a diabetic neuropathic or neuroischemic wound, anywhere on the leg, that has not healed at least 20% after the 6 weeks of the standard of care (SoC)
4. History of an evaluable defect ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion
5. Size of a wound to be evaluated 2 to 16 cm2
6. Wound treatment can be provided either on an inpatient or outpatient basis, based on the doctor's decision
7. The subject agrees to periodic visits to the clinical trial site during their participation in the clinical trial
8. The subject is able to understand the clinical trial information
9. Signed informed consent form
10. Data on previous wound care are available in the subject medical documentation
Exclusion Criteria:
1. Necrotic wound requiring surgical treatment
2. Pregnancy or breastfeeding
3. Venous etiology of ulceration
4. Burns or chemical burns
5. Clinical manifestations of systemic infection
6. Undermined wound edges
7. The wound involves deeper structures (bone, tendons, joints)
8. Inadequately controlled diabetes mellitus with HbA1c \> 12 % (DCCT) diabetes mellitus
9. Renal insufficiency with eGF \< 30ml/min/1.73m2
10. Infected ulceration either Stage ≥2 according to EWMA Position Document (2006) (Appendix II) or with CRP \>10
11. Topical treatment with any growth factor-based products
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Subjects with a diabetic neuropathic or neuroischemic wounds, anywhere on the leg, ranging in size between 2 cm2 and 16 cm2, that has not healed at least 20% after the 6 weeks of the standard of care (SoC) with the known therapeutic history ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Lubochna
**Country:** Slovakia
**Facility:** Národní Endokrinologický a Diabetologický ústav
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003925
- Term: Diabetic Angiopathies
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000016523
- Term: Foot Ulcer
- ID: D000007871
- Term: Leg Ulcer
- ID: D000012883
- Term: Skin Ulcer
- ID: D000012871
- Term: Skin Diseases
- ID: D000048909
- Term: Diabetes Complications
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000003929
- Term: Diabetic Neuropathies
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M19933
- Name: Diabetic Foot
- Relevance: HIGH
- As Found: Diabetic Foot
- ID: M7120
- Name: Diabetic Angiopathies
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M18919
- Name: Foot Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M17206
- Name: Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M10883
- Name: Leg Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M15686
- Name: Skin Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M26004
- Name: Diabetes Complications
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7124
- Name: Diabetic Neuropathies
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000017719
- Term: Diabetic Foot
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4224
- Name: Antibiotics, Antitubercular
- Relevance: LOW
- As Found: Unknown
- ID: M251802
- Name: Imidacloprid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442852
**Brief Title:** Study on the Relationship Between Peripheral Blood miRNA and Risk and Severity of Alzheimer's Disease
**Official Title:** Study on the Relationship Between Peripheral Blood miRNA and Risk and Severity of Alzheimer's Disease
#### Organization Study ID Info
**ID:** TJ-IRB20210116
#### Organization
**Class:** OTHER
**Full Name:** Tongji Hospital
### Status Module
#### Completion Date
**Date:** 2026-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-04-03
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**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:** Jiajie Chen
#### Responsible Party
**Investigator Affiliation:** Tongji Hospital
**Investigator Full Name:** Jiajie Chen
**Investigator Title:** doctor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Alzheimer's Disease, AD is a type of neurofibrillary tangles formed by the deposition of beta amyloid proteins within the nervous system cells and excessive phosphorylation of extracellular Tau proteins, NFTs are the main pathological features of central nervous system degeneration, also known as senile dementia. In addition, synaptic plasticity damage and neuroinflammation also play important roles in the progression of AD. Neurosynapses are the sites where neurons interact with each other in terms of function, and are also crucial for neuronal information transmission and communication. Synapses are the fundamental units in the brain, and synaptic activity can stimulate the maturation of mushroom like dendritic spines and form new synapses, enabling synaptic strength to adapt to changes in the internal and external environment, thereby playing an important role in learning and memory. Previous studies have shown that synaptic activity interruption and synaptic loss can already be detected in the AD brain, especially in the early stages. Multiple studies have shown a higher correlation between synaptic disorders characterized by synaptic loss and decreased synaptic activity and cognitive impairment in Alzheimer's disease compared to age-related plaques and neurofibrillary tangles. Therefore, understanding the potential mechanisms of synaptic disorders will contribute to the development of early treatment strategies for AD. MicroRNAs (miRNAs) are a type of small non coding RNA with a length of approximately 22 nucleotides. Their main function is to silence target genes at the post transcriptional level and inhibit the translation process of their proteins. MiRNAs are involved in many physiological processes and pathological pathways, including development, tumorigenesis, and heart disease. Recently, people have also studied the abnormal regulatory role of miRNAs in AD synaptic disorders. Some miRNAs enriched in the brain, such as miR-124, MiR-132 is abnormally expressed in the AD brain, mediating synaptic plasticity damage. However, most of the miRNAs mentioned above are not directly related to synaptic activity, and their regulation of AD synaptic damage is likely to be a broad-spectrum effect. At present, there are 12 miRNAs closely related to synaptic plasticity that have been identified. By detecting changes in miRNAs closely related to synaptic plasticity in peripheral blood of AD patients and healthy volunteers, and exploring their relationship with the severity of AD lesions, it may provide new directions for early diagnosis of AD. The purpose of this study is to: (1) detect the expression levels of miRNAs closely related to synaptic plasticity in the peripheral blood of healthy volunteers and AD patients, and identify the miRNAs with the greatest differences; (2) Analyze the relationship between the expression levels of the aforementioned miRNAs in the peripheral blood of AD patients and the severity of the disease; (3) Analyze the relationship between the expression levels of the aforementioned miRNAs in the peripheral blood of AD patients and the commonly used neuropsychiatric scale scores. We plan to clarify the changes in peripheral blood miRNAs and their relationship with the severity of AD through case-control studies, in order to provide new directions for early diagnosis of AD.
### Conditions Module
**Conditions:**
- Alzheimer Disease
- MicroRNAs
### Design Module
#### Bio Spec
**Description:** serum
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 500
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Alzheimer's patients who meet the inclusion criteria and sign an informed consent form
**Intervention Names:**
- Other: exposure
**Label:** Alzheimer's disease patients
#### Arm Group 2
**Description:** Healthy volunteers who meet the inclusion criteria and sign informed consent
**Intervention Names:**
- Other: exposure
**Label:** Healthy control
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Alzheimer's disease patients
- Healthy control
**Description:** The observed exposure factor was the expression level of synaptic associated mirna in the serum of patients with Alzheimer's disease and healthy volunteers
**Name:** exposure
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** synaptic associated miRNA
**Measure:** miR-135a
**Time Frame:** December 2024
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Alzheimer's disease patients:
* Meet the diagnostic criteria of NINCDS-ADRDA for AD
* Clinical Dementia Scale (CDR) score ≥0.5
Healthy volunteers:
* No complaints or symptoms of cognitive impairment
* MMSE score is higher than the threshold value
Exclusion Criteria:
Alzheimer's disease patients:
* Dementia or cognitive impairment due to other diseases
* Combined with delirium
* A history of drug abuse
* Severe deafness, aphasia and other impact scale score
Healthy volunteers:
* had an organic brain lesion
* Suffering from other major physical diseases: such as severe immune diseases
**Healthy Volunteers:** True
**Minimum Age:** 65 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
**Study Population:** Alzheimer's patients or healthy volunteers at Tongji Hospital in Wuhan
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** 1005843466@qq.com
**Name:** Jiajie Chen
**Phone:** 0086-15927561646
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Wuhan
**Contacts:**
***Contact 1:***
- **Email:** 1005843466@qq.com
- **Name:** Jiajie Chen
- **Phone:** 0086-15927561646
- **Role:** CONTACT
**Country:** China
**Facility:** Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
**State:** Hubei
**Status:** RECRUITING
**Zip:** 430000
#### Overall Officials
**Official 1:**
**Affiliation:** Tongji Hospital
**Name:** Kai Zheng
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003704
- Term: Dementia
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000024801
- Term: Tauopathies
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M3885
- Name: Alzheimer Disease
- Relevance: HIGH
- As Found: Alzheimer's Disease
- ID: M6904
- Name: Dementia
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23002
- Name: Tauopathies
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T2192
- Name: Familial Alzheimer Disease
- Relevance: HIGH
- As Found: Alzheimer's Disease
### Condition Browse Module - Meshes
- ID: D000000544
- Term: Alzheimer Disease
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442839
**Brief Title:** AI-Based Imaging Model for Bladder Cancer Prediction
**Official Title:** Development and Validation of an Image-Based Artificial Intelligence Predictive Model for Bladder Cancer
#### Organization Study ID Info
**ID:** SL-II2023-303-02
#### Organization
**Class:** OTHER
**Full Name:** Third Affiliated Hospital, Sun Yat-Sen University
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-10-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**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:** Third Affiliated Hospital, Sun Yat-Sen University
#### Responsible Party
**Investigator Affiliation:** Third Affiliated Hospital, Sun Yat-Sen University
**Investigator Full Name:** Yun Luo
**Investigator Title:** Director of Urology
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Bladder cancer is the ninth most common malignant tumor worldwide, characterized by high malignancy and poor prognosis. We intend to develop a CT-based tumor budding predictive model for bladder cancer using deep learning algorithms. This model will facilitate preoperative assessment of patient conditions, enabling the formulation of more precise and personalized treatment plans.
### Conditions Module
**Conditions:**
- Develop a CT-based Tumor Budding Predictive Model for Bladder Cancer Using Deep Learning Algorithms
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 2000
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** for training the model, from Sun Yat-sen Memorial Hospital of Sun Yat-sen University.
**Intervention Names:**
- Other: No specific interventions.
**Label:** training cohort
#### Arm Group 2
**Description:** used to evaluate the model's performance, is from Sun Yat-sen Memorial Hospital of Sun Yat-sen University.
**Intervention Names:**
- Other: No specific interventions.
**Label:** internal validation cohort
#### Arm Group 3
**Description:** used to evaluate the model's performance, is from the Third Affiliated Hospital of Sun Yat-sen University.
**Intervention Names:**
- Other: No specific interventions.
**Label:** external validation cohort 1
#### Arm Group 4
**Description:** used to evaluate the model's performance, is from the Second Affiliated Hospital of Dalian Medical University.
**Intervention Names:**
- Other: No specific interventions.
**Label:** external validation cohort 2
#### Arm Group 5
**Description:** used to evaluate the model's performance, is from the First Affiliated Hospital of Chongqing Medical University.
**Intervention Names:**
- Other: No specific interventions.
**Label:** external validation cohort 3
#### Arm Group 6
**Description:** used to evaluate the model's performance, is from the Yan'an Hospital Affiliated to Kunming Medical University.
**Intervention Names:**
- Other: No specific interventions.
**Label:** external validation cohort 4
### Interventions
#### Intervention 1
**Arm Group Labels:**
- external validation cohort 1
- external validation cohort 2
- external validation cohort 3
- external validation cohort 4
- internal validation cohort
- training cohort
**Description:** No specific interventions.
**Name:** No specific interventions.
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Tumor budding is a histopathological phenomenon observed in various types of cancer, including bladder cancer. It refers to the presence of single cells or small clusters of cells (less than five) at the invasive front of tumors. These buds are indicative of an epithelial-mesenchymal transition (EMT), a process where epithelial cells acquire mesenchymal, invasive characteristics, which is crucial for cancer invasion and metastasis.
**Measure:** Tumor Budding: An Overview
**Time Frame:** One year after being discharged following surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Bladder cancer patients treated from January 1, 2014, to January 1, 2023;
2. Hospitalized and underwent transurethral resection of bladder tumor (TURBT) or radical cystectomy;
3. Complete clinical, preoperative CT, and pathological data.
Exclusion Criteria:
1. Patients who previously underwent surgical treatment for bladder cancer at other centers, making it difficult to obtain their preoperative data;
2. Patients with other concurrent pelvic or urinary system malignancies;
3. Patients with poor quality, low resolution, or faded CT or pathological images.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** patients with bladder cancer
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** luoyun8@mail.sysu.edu.cn
**Name:** Yun Luo, Dr.
**Phone:** 13560189936
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Guangzhou
**Contacts:**
***Contact 1:***
- **Email:** luoyun8@mail.sysu.edu.cn
- **Name:** Yun Luo, Dr.
- **Phone:** 13560189936
- **Role:** CONTACT
**Country:** China
**Facility:** the Third Affiliated Hospital of Sun Yat-sen University
**State:** Guangdong
**Status:** RECRUITING
**Zip:** 510630
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014571
- Term: Urologic Neoplasms
- 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
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5030
- Name: Urinary Bladder Neoplasms
- Relevance: HIGH
- As Found: Bladder Cancer
- ID: M17320
- Name: Urologic Neoplasms
- Relevance: LOW
- As Found: Unknown
- 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
### Condition Browse Module - Meshes
- ID: D000001749
- Term: Urinary Bladder Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442826
**Acronym:** AURITEST
**Brief Title:** Non-invasive Auricular Simulation for Exam Anxiety and Depression in University Students
**Official Title:** Efficacy of Non-invasive Auricular Simulation for Exam Anxiety and Depression in University Students: A Pilot 3-arm Randomised Controlled Trial
#### Organization Study ID Info
**ID:** 8/2023
#### Organization
**Class:** OTHER
**Full Name:** Fundació Tecnocampus Mataró-Maresme
### Status Module
#### Completion Date
**Date:** 2024-06-21
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-21
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**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:** Fundació Tecnocampus Mataró-Maresme
#### 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 Spain, depression, anxiety, and stress are highly prevalent in the general population as well as in college students. In college students, Ramón Arbués et al. found a moderate prevalence of depression (18.4%), anxiety (23.6%) and stress (34.5%). It is essential to take responsibility for promoting health education, disease prevention, protection and care for our young people.
Academic performance can be altered due to the stressful nature of exam situations, which can lead to increased anxiety and decrease expected performance, mainly due to effects such as decreased attention span, concentration and retention of information.
Modulation of vagal tone is a therapeutical strategy to heightened parasympathetic activity and withdrawal sympathetic activity. Auricular transcutaneous VNS (ATVNS) by which parasympathetic nerve system is modulated by means of the stimulation of the auricular branch of the vagus nerve that provides somatosensory innervation to the external ear.
It has been shown that there are different effective interventions to reduce the symptoms of stress, depression, anxiety and insomnia in university students, but they are based on psychological interventions or face-to-face and cognitive-behavioral therapeutic approach, so this study proposal incorporates noninvasive atrial stimulation as an alternative to traditional treatments, which apart from being cost-effective, is easy to apply, well tolerated and presumably can have beneficial effects in the short term.
In the present pilot study, we propose to investigate the degree of depression, anxiety and stress on crucial dates of final exams of 1st year students of the Double Degree Physiotherapy - Physical Activity and Sport Sciences of the Health Department of the TecnoCampus.
We will also evaluate the feasibility of a study to assess the efficacy of a non-pharmacological intervention, through a neuroreflex stimulation of vagal tone, with a non-invasive atrial stimulation protocol.
### Conditions Module
**Conditions:**
- Anxiety
- Stress
- Insomnia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: Non-invasive auricular stimulation
**Label:** True non-invasive auricular stimulation (TniAS)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Other: Sham auricular stimulation (SAS)
**Label:** Sham auricular stimulation (SAS)
**Type:** PLACEBO_COMPARATOR
#### Arm Group 3
**Description:** Participants in the No-Intervention group (NI) will not receive any active intervention as part of the trial.
**Label:** No-intervention group (NI)
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- True non-invasive auricular stimulation (TniAS)
**Description:** Single session TniAS stimulation will be achieved by applying four stimulation patches. These patches consist of stainless steel spheres with a diameter of 1.2 mm, covered with adhesive circular paper measuring 8 mm in diameter.
Point 1. Located in the Triangular Fossa, upper and central level at the vertex of the Fossa, at junction between the upper root and the lower root of the Antihelix.
Point 2. Located in the inner part of the Cymba (upper) conchae, in the angle formed by the lower root of the antihelix and the ascending branch of the Helix.
Point 3. Located in the middle depression of the Cavum (lower) conchae.
Poinit 4. It is located at the inner superior quadrant of Lobe, below the external curve of the Intertragus notch, in a depression 3-4 mm from the insertion of the lobe to the face.
**Name:** Non-invasive auricular stimulation
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Sham auricular stimulation (SAS)
**Description:** Sham intervention will be conducted following the exact same procedure as the TniAS group, with the only difference being the use of sham stimulation patches. These sham patches will consist of the same patches utilized in the TniAS group, except for the absence of the stainless steel spheres. During the application of these sham patches, the investigator will adhere to the identical process as in the TniAS group, with the exception that no palpation will be performed to locate the exact points, and only minimal pressure required for patch adherence will be applied to minimize any substantial stimulation. Participants in the SAS group will also be explicitly instructed not to stimulate the points until the removal of the patches.
The removal of the sham stimulation patches will follow the precise protocol applied in the TniAS group, ensuring consistency in the study procedures across both groups.
**Name:** Sham auricular stimulation (SAS)
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** o evaluate the effectiveness of our recruitment strategy, we will analyze several key metrics, including the number of eligible participants, the number who expressed interest by completing the initial form, the participants who proceeded to the initial interview, and finally, the number of students who enrolled in the study. Additionally, we will carefully examine the reasons provided by students who declined to participate, allowing us to refine our recruitment approach.
**Measure:** Recruitment strategy effectiveness
**Time Frame:** Week 0
**Description:** Any side effects that may arise during the study will be meticulously monitored, and their frequency and severity will be assessed based on patients' self-reports. These side effects will be categorized as either minor, relevant, or important according to the patients' descriptions and assessments. Additionally, we will maintain a record of the number of participants who chose to remove at least one of the patches due to the side effects they experienced
**Measure:** Safety and Tolerability
**Time Frame:** Week 2
#### Secondary Outcomes
**Description:** The exclusion rate will be analyzed based on the percentage of participants interested in the study who do not fulfill the inclusion criteria. Additionally, reasons for exclusion will be documented.
**Measure:** Exclusion rate
**Time Frame:** Week 0
**Description:** We will meticulously record and analyze the percentage of participants who discontinue or withdraw from the study, which means they do not attend the final assessment session. Detailed information about the reasons for dropout will be collected to gain valuable insights into participant retention and engagement throughout the study
**Measure:** Dropout rate
**Time Frame:** Week 2
**Description:** We will assess the percentage of participants who adhere to the treatment protocol. Participants will be considered adherent if at least two out of the four auricular stimulation patches remain in place at the final assessment visit. Adherence will be evaluated based on self-reported information provided by participants during the last assessment interview.
**Measure:** Compliance to the intervention protocol
**Time Frame:** Week 2
**Description:** We will evaluate the feasibility of our data collection methods by gauging participants' perceptions of the ease of administration, comprehensibility, and time required for data collection. This assessment will employ a 5-point Likert scale and will be complemented by qualitative feedback. Additionally, outcome assessors will record any difficulties encountered during the data collection process.
**Measure:** Data collection feasibility
**Time Frame:** Week 2
**Description:** To determine the success of participant blinding, we will inquire during the final assessment session whether participants believe they received an active treatment. They will be provided with response options including "Yes," "No," or "I don't know.
**Measure:** Participant blinding success:
**Time Frame:** Week 2
**Description:** he success of outcome assessor blinding will be assessed at the end of the final evaluation of each participant. Assessors will have to choose between 3 possible answers; "the participant was in the intervention group", "the participant was in the sham group", or "I don't know".
**Measure:** Outcome assessor blinding success
**Time Frame:** Week 2
**Description:** We will employ the DASS anxiety subscale to measure participants' anxiety levels. This subscale comprises questions that delve into anxiety-related feelings and experiences, providing a quantitative measure of anxiety symptomatology. Higher scores on this subscale indicate greater levels of anxiety.
**Measure:** Anxiety
**Time Frame:** Week 2
**Description:** The DASS instrument includes a stress subscale that helps us assess participants' stress levels. Participants will respond to items that reflect stress-related experiences, allowing us to quantify their perceived stress. Higher scores on this subscale indicate elevated stress levels.
**Measure:** Stress
**Time Frame:** Week 2
**Description:** The DASS also contains a depression subscale that enables us to assess depressive symptoms. Participants will provide responses related to their mood and emotional well-being, allowing us to gauge the extent of their depressive symptomatology. Higher scores on this subscale indicate a greater level of depressive symptoms.
**Measure:** Depression
**Time Frame:** Week 2
**Description:** The ISI consists of seven items that assess the severity of sleep-onset and sleep-maintenance difficulties, satisfaction with current sleep patterns, interference with daily functioning, noticeability of impairments attributed to sleep problems, and the level of distress caused by the sleep difficulties. Higher scores indicates greater insomnia severity.
**Measure:** Insomnia
**Time Frame:** Week 2
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* At least 18 years old
* Tecnocampus undergraduate students from Physical Therapy and Sports Science Double Degree of 1rst course.
* To sign the informed consent
* Understand Catalan or Spanish language
* With the intention to attend to the first call exams of the 2nd trimester.
Exclusion Criteria:
* Receiving pharmacological medication for anxiety or mental disorders
* Receiving psychological treatment
* Pregnancy or breastfeeding
* Participants with part-time enrolment
* With skin lesions in both auricula,
* Participating in another study
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** cfernandezja@tecnocampus.cat
**Name:** Carles Fernández Jané
**Phone:** 931696500
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Mataró
**Contacts:**
***Contact 1:***
- **Email:** cfernandezja@tecnocampus.cat
- **Name:** Carles Fernández Jané
- **Phone:** 931696500
- **Role:** CONTACT
**Country:** Spain
**Facility:** Tecnocampus
**State:** Barcelona
**Status:** RECRUITING
**Zip:** 08302
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7061
- Name: Depressive Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M7058
- Name: Depression
- Relevance: LOW
- As Found: Unknown
- ID: M4324
- Name: Anxiety Disorders
- Relevance: HIGH
- As Found: Anxiety
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001008
- Term: Anxiety Disorders
### Intervention Browse Module - Browse Branches
- Abbrev: HB
- Name: Herbal and Botanical
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T204
- Name: Kava
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442813
**Acronym:** PREGNANCY
**Brief Title:** Effects Of Emotional Freedom Technique and Hypermesis Gravidarum
**Official Title:** Effects Of Emotional Freedom Technique and Hypermesis Gravidarum
#### Organization Study ID Info
**ID:** E-54022451-050.05.04-91178
#### Organization
**Class:** OTHER
**Full Name:** Bezmialem Vakif University
#### Secondary ID Infos
**Domain:** BezmialemVU
**ID:** MMeseduzu
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-08-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-20
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-12
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Bezmialem Vakif University
#### Responsible Party
**Investigator Affiliation:** Bezmialem Vakif University
**Investigator Full Name:** Merve Meşedüzü
**Investigator Title:** LECTURER
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this clinical study is to determine whether EFT (Emotional Freedom Techniques) is effective in alleviating nausea and vomiting in pregnant women with hyperemesis. Additionally, the study aims to gather information on the safety of EFT application. The primary questions it seeks to answer are:
Does EFT reduce nausea and vomiting in pregnant women with hyperemesis? Is EFT applicable for use in pregnant women with hyperemesis? Researchers will compare the effectiveness of EFT to traditional nursing education on non-pharmacological interventions for preventing nausea and vomiting in pregnant women with hyperemesis.
Participants:
Pre-EFT application survey scale questions will be asked to the pregnant women with hyperemesis.
EFT will be applied once by the researcher to the pregnant women with hyperemesis.
For control, the same survey scale questions will be asked to the same pregnant women two days after the EFT application for post-test purposes.
For control, the same survey scale questions will be asked to the same pregnant women seven days after the EFT application for post-test purposes.
The same procedures will be applied in the same manner to the control group that will receive education.
**Detailed Description:** Type of Research: It is planned to be randomized, controlled and experimental. Place and Characteristics of the Research: The research will be carried out in the women health and diseases service and Gynecology polyclinics of Bezmialem Vakif University Faculty of Medicine Central Hospital.
Population and Sample of the Research:The sample size was determined as a minimum of 74 people in total using the G Power 3.1 method. The effect size was determined using the t test values in the reference study in which the scale was used with a similar patient group.
Criteria for Inclusion in the Study:Pregnant women who are between 6 and 14 weeks of gestation, aged between 20 and 40 years old, and have complaints of nausea and vomiting are eligible for the study. These participants should report their discomfort as 5 or above on the VAS scale. Additionally, they must not have been diagnosed with a high-risk pregnancy or any psychological disorders. Lastly, they must voluntarily agree to participate in the study.
Criteria for Exclusion from the Study: Exclusion criteria are the presence of coordination and language problems in the pregnant woman and her desire to leave the study at any time or not to participate.
Survey Scales Descriptive Information Form: The pregnancy information form, prepared in line with the literature review conducted by the researchers, includes socio-demographic (age of the pregnant woman, education and employment status, income level, family type and place of residence), obstetric (current gestational week and pregnancy history), psychosocial information. It consists of questions about social and medical history (pregnancy desire), whether there is a chronic disease) and VAS Scale. VAS is a measurement tool used to measure both pain intensity and pain relief, which is simple, effective and repeatable and requires minimal tools.
2. Pregnancy-Specific Nausea and Vomiting Severity Scale (PUQE-24): its form specific to the pregnancy period that evaluates nausea and vomiting for the last 12 hours. It was later reported that it would be more appropriate to evaluate the last 24 hours for clinical use, as the last 12 hours sometimes include the sleep period in terms of nausea and vomiting in pregnant women. Thereupon, the Pregnancy-Unique Quantification of Emesis (PUQE-24) Scale was developed and evaluate the severity of pregnancy-specific nausea and vomiting in the last 24 hours. Its Turkish validity and reliability were conducted.
Pregnancy-Specific Nausea and Vomiting Severity Scale (PUQE-24) consists of 3 questions:duration of nausea or stomach discomfort, number of vomiting episodes, and number of retching episodes. Answers to the questions are scored between 1 and 5 points. The total score of the scale is obtained by the sum of the scores of the answers given to the questions. The lowest possible score that can be obtained from the scale is 3 and the highest score is 15. If the total score obtained as a result of the PUQE-24 scoring system is 3-6, it is considered mild, 7-12 is considered moderate, and 13-15 is considered severe nausea and vomiting. The scale has no subdimensions. Cronbacha alpha value of the Turkish version of the scale is 0.75.
3.World Health Organization Quality of Life Scale: The WHOQOL-100 scale was developed with the participation of 15 centers from many countries. This scale allows cross-cultural comparisons. WHOQOL-100 was later abbreviated as WHOQOLBREF. WHOQOL-BREF consists of four sub-dimensions: physical domain, spiritual domain, social domain and environmental domain. The validity and reliability of the World Health Organization Quality of Life Scale 31 Short Form-Turkish Version (WHOQOL-BREF-TR) in Turkey was determined. WHOQOL-BREF-TR used in this study consists of 27 questions. For each question, there are options that can be scored between 1 and 5. The scale does not have a total score. The score range that can be obtained from each other sub-dimension is obtained by multiplying the arithmetic mean of that sub-dimension by 4. The score range that can be received for each sub-dimension is between 4-20. Increasing scores from the subscales indicate that the quality of life also increases
### Conditions Module
**Conditions:**
- Hyperemesis Gravidarum
- Pregnancy
**Keywords:**
- hyperemesis gravidarum
- quality life
- pregnancy
- Emotional Freedom Techniques
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** EXPERIMENTAL GROUP First Stage: Determining the groups by randomization method and filling out the data collection forms for the groups (pre-test).
Second Stage: Training pregnant women in the control group on the management of standard hyperemesis gravidarum (training content will be prepared and opinions will be obtained from 3 experts in the field).
For the intervention group, pregnant women were given a session with EFT (Average: 40-60 minutes) and a program was created for the pregnant woman to do affirmations in between depending on her condition (Positiveness with EFT strokes 3 times a day).
Third Stage: After 15 days, it is planned to conduct post-tests for both groups and
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 74
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** First Stage: Determining the groups by randomization method and filling out the data collection forms for the groups (pre-test).
Second Stage: Training pregnant women in the control group on the management of standard hyperemesis gravidarum (training content will be prepared and opinions will be obtained from 3 experts in the field).
For the intervention group, pregnant women were given a session with EFT (Average: 40-60 minutes) and a program was created for the pregnant woman to do affirmations in between depending on her condition (Positiveness with EFT strokes 3 times a day).
Third Stage: After 15 days, it is planned to conduct post-tests for both groups and complete the study. In the final stage, pregnant women\&#39;s questions will be answered, counseling will continue where deemed necessary, and prepared training booklets will be given to pregnant women
**Intervention Names:**
- Behavioral: EFT GROUP
**Label:** EXPERİMENTAL GROUP
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Pregnant women diagnosed with hyperemesis gravidarum (HG) who meet the inclusion criteria for the study will constitute the control group. Providing training to the control group only for HG management (training content will be prepared and opinions will be obtained from 3 experts in the field).
**Label:** CONTROL GROUP
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- EXPERİMENTAL GROUP
**Description:** One times one pregnancy
**Name:** EFT GROUP
**Other Names:**
- emotıonal free technıcal
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The degree of reduction in the severity of nausea and vomiting. The PUQE-24 (Pregnancy-Unique Quantification of Emesis and Nausea) scale is used, where each question is scored between 1 and 5. The total score is the sum of these three questions. Minimum Score: 3 (each question scoring 1) Maximum Score: 15 (each question scoring 5) These scores are used to rate the severity of nausea and vomiting in pregnancy. Lower scores indicate milder symptoms, while higher scores indicate more severe symptoms.
**Measure:** Pregnancy-Unique Quantification of Emesis and Nausea (PUQE-24)
**Time Frame:** 3 months
#### Secondary Outcomes
**Description:** Evaluation of improvements in quality of life or psychological well-being, patient satisfaction with the treatment, and reduction in the need for pharmacological interventions. The WHOQOL-BREF (World Health Organization Quality of Life - BREF) scale is used, which comprises 26 items covering four domains: physical health, psychological health, social relationships, and environment. Each domain is scored between 0 and 100. Minimum Score: 0 (poorer quality of life) Maximum Score: 100 (better quality of life)
**Measure:** WHOQOL-BREF (World Health Organization Quality of Life - BREF)
**Time Frame:** 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Pregnant women between 6-14 weeks of pregnancy
* Pregnant women between the ages of 20-40
* Pregnant women with complaints of nausea and vomiting
* Pregnant women who report their discomfort as 5 or above on the vas scale
* Pregnant women who have not been diagnosed with risky pregnancy
* Pregnant women who do not have any psychological disorders
* Pregnant women who voluntarily agreed to participate in the research
Exclusion Criteria:
* Coordination and language problems in the pregnant woman
* Wants to leave the study at any time
* Not wanting to participate in the study
**Gender Based:** True
**Gender Description:** Pregnancy
**Healthy Volunteers:** True
**Maximum Age:** 40 Years
**Minimum Age:** 20 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** mervemeseduzu@gmail.com
**Name:** Merve MESEDUZU, LECTURER
**Phone:** 800-555-5555
**Role:** CONTACT
**Contact 2:**
**Name:** LECTURER
**Phone:** 800-555-5555
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** İ̇stanbul
**Contacts:**
***Contact 1:***
- **Email:** mervemeseduzu@gmail.com
- **Name:** Merve MESEDUZU
- **Phone:** 800-555-5555
- **Role:** CONTACT
***Contact 2:***
- **Name:** Merve MESEDUZU
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Turkey
**Facility:** Bezmialem Vakif Universty
**State:** Fatih
**Zip:** 34093
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000048968
- Term: Morning Sickness
- ID: D000011248
- Term: Pregnancy Complications
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000014839
- Term: Vomiting
- ID: D000012817
- Term: Signs and Symptoms, Digestive
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M9990
- Name: Hyperemesis Gravidarum
- Relevance: HIGH
- As Found: Hyperemesis Gravidarum
- ID: M26009
- Name: Morning Sickness
- 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: M17582
- Name: Vomiting
- Relevance: LOW
- As Found: Unknown
- ID: M15622
- Name: Signs and Symptoms, Digestive
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006939
- Term: Hyperemesis Gravidarum
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442800
**Brief Title:** Impacts of Alcohol Warning Labels: An Online Experiment
**Official Title:** Online Randomized Experiment Evaluating the Perceived Effectiveness of Alcohol Warning Labels
#### Organization Study ID Info
**ID:** 23-1218
#### Organization
**Class:** OTHER
**Full Name:** University of North Carolina, Chapel Hill
#### Secondary ID Infos
**ID:** 1R01AA030548-01
**Link:** https://reporter.nih.gov/quickSearch/1R01AA030548-01
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2024-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**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 North Carolina, Chapel Hill
#### 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 experiment is to examine responses to alcohol warning messages about 10 different topics among US adult alcohol consumers. The main questions this experiment aims to answer are:
Which warning topics make alcohol consumers in the US want to drink less alcohol? Which warning topics remind alcohol consumers in the US of alcohol's harms? Which warning topics help alcohol consumers in the US learn something new? There will be a total of 20 alcohol messages, 2 messages for each of the 10 topics. For each topic, participants will be randomly assigned to 1 of the 2 messages so that they view a total of 10 alcohol messages. All 10 messages will be shown in random order. Participants will rate each message on how much it makes them want to drink less alcohol, reminds them that drinking can be harmful, and teaches them something new.
**Detailed Description:** This study aims to determine which topics in alcohol warning labels are most effective at making US adults who consume alcohol want to drink less alcohol, which topics best remind consumers of alcohol's harms, and which topics are most likely to teach consumers something new. The survey research company NORC at the University of Chicago will recruit a sample of 1,000 US adults ages 21+ who consumed alcohol at least one time per week during the past 4 weeks.
Participants will complete a within-subjects online randomized experiment in which they view and rate messages shown on alcohol containers. Participants will rate each message on perceived message effectiveness (primary outcome), reminding of alcohol's harms (secondary outcome), and learning something new (secondary outcome). These tasks will be repeated for 10 messages, each with a different topic. There will be 9 warning topics (i.e., topics about alcohol's harms) and 1 control topic (i.e., neutral topic not about alcohol's harms). In this within-subjects experiment, the survey will present the topics in random order and participants will view 1 of 2 messages for each topic.
### Conditions Module
**Conditions:**
- Alcohol Drinking
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 1000
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will view and rate 10 messages shown on alcohol containers.
**Intervention Names:**
- Behavioral: Liver Cancer
- Behavioral: Throat and Mouth Cancer
- Behavioral: Colorectal Cancer
- Behavioral: Multiple Cancers
- Behavioral: Liver Disease
- Behavioral: Hypertension
- Behavioral: Dementia
- Behavioral: Drinking Guidelines
- Behavioral: Current Warning
- Behavioral: Control
**Label:** Alcohol Messages
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Alcohol Messages
**Description:** Participants will view messages about the risk of liver cancer from alcohol consumption.
**Name:** Liver Cancer
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Alcohol Messages
**Description:** Participants will view messages about the risk of throat and mouth cancer from alcohol consumption.
**Name:** Throat and Mouth Cancer
**Type:** BEHAVIORAL
#### Intervention 3
**Arm Group Labels:**
- Alcohol Messages
**Description:** Participants will view messages about the risk of colorectal cancer from alcohol consumption.
**Name:** Colorectal Cancer
**Type:** BEHAVIORAL
#### Intervention 4
**Arm Group Labels:**
- Alcohol Messages
**Description:** Participants will view messages about the risk of multiple cancers from alcohol consumption.
**Name:** Multiple Cancers
**Type:** BEHAVIORAL
#### Intervention 5
**Arm Group Labels:**
- Alcohol Messages
**Description:** Participants will view messages about the risk of liver disease from alcohol consumption.
**Name:** Liver Disease
**Type:** BEHAVIORAL
#### Intervention 6
**Arm Group Labels:**
- Alcohol Messages
**Description:** Participants will view messages about the risk of hypertension from alcohol consumption.
**Name:** Hypertension
**Type:** BEHAVIORAL
#### Intervention 7
**Arm Group Labels:**
- Alcohol Messages
**Description:** Participants will view messages about the risk of dementia from alcohol consumption.
**Name:** Dementia
**Type:** BEHAVIORAL
#### Intervention 8
**Arm Group Labels:**
- Alcohol Messages
**Description:** Participants will view messages about guidelines for alcohol consumption.
**Name:** Drinking Guidelines
**Type:** BEHAVIORAL
#### Intervention 9
**Arm Group Labels:**
- Alcohol Messages
**Description:** Participants will view the current warning that is required on most alcoholic beverage containers sold in the US.
**Name:** Current Warning
**Type:** BEHAVIORAL
#### Intervention 10
**Arm Group Labels:**
- Alcohol Messages
**Description:** Participants will view neutral messages unrelated to the harms of alcohol consumption.
**Name:** Control
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The study will assess perceived message effectiveness using 1 item: "How much does this message make you want to drink less alcohol?" Response options will range from "not at all" (coded as 1) to "a great deal" (coded as 5). Higher scores indicate more perceived message effectiveness.
**Measure:** Perceived message effectiveness
**Time Frame:** Assessed during one-time 15-minute online study survey
#### Secondary Outcomes
**Description:** The study will assess reminding of alcohol's harms using 1 item: "How much does this message remind you that drinking alcohol can be harmful?" Response options will range from not at all (1) to a great deal (5). Higher scores indicate greater reminding of alcohol's harms.
**Measure:** Reminding of alcohol's harms
**Time Frame:** Assessed during one-time 15-minute online study survey
**Description:** The study will assess learning something new with 1 item: "Did you learn something new from this message?" Response options will be yes (1) and no (0).
**Measure:** Learning something new
**Time Frame:** Assessed during one-time 15-minute online study survey
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 21 and older
* Reside in the United States
* Able to complete a survey in English
* Consumed alcohol at least once per week during the past 4 weeks
Exclusion Criteria:
* Under the age of 21
* Reside outside of the United States
* Unable to complete a survey in English
* Consumed alcohol less than once per week during the past 4 weeks
**Healthy Volunteers:** True
**Minimum Age:** 21 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** mghall@unc.edu
**Name:** Marissa Hall, PhD
**Phone:** 919-966-0233
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Chapel Hill
**Contacts:**
***Contact 1:***
- **Email:** mghall@unc.edu
- **Name:** Marissa Hall, PhD
- **Phone:** 919-966-0233
- **Role:** CONTACT
**Country:** United States
**Facility:** University of North Carolina
**State:** North Carolina
**Zip:** 27599
#### Overall Officials
**Official 1:**
**Affiliation:** University of North Carolina, Chapel Hill
**Name:** Marissa Hall, PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Stanford University
**Name:** Anna Grummon, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Data and code will be made publicly available.
**Description:** Investigators will post de-identified individual participant data in a public repository.
**Info Types:**
- SAP
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** Investigators will post individual participant data upon acceptance of any manuscripts associated with the data generated in this study.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004327
- Term: Drinking Behavior
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M3774
- Name: Alcohol Drinking
- Relevance: HIGH
- As Found: Alcohol Drinking
- ID: M7502
- Name: Drinking Behavior
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000428
- Term: Alcohol Drinking
### Intervention Browse Module - Ancestors
- ID: D000006397
- Term: Hematinics
### Intervention Browse Module - Browse Branches
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
### Intervention Browse Module - Browse Leaves
- ID: M11110
- Name: Liver Extracts
- Relevance: HIGH
- As Found: Fractions
- ID: M3777
- Name: Ethanol
- Relevance: LOW
- As Found: Unknown
- ID: M9485
- Name: Hematinics
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008110
- Term: Liver Extracts
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442787
**Brief Title:** Analysis of Mandibular Proximal Segment Position Using Virtual Orthognathic Surgical Planning, Individualized Guides, and Osteosynthesis Plates
**Official Title:** Analysis of Mandibular Proximal Segment Position Using Virtual Orthognathic Surgical Planning, Individualized Guides, and Osteosynthesis Plates
#### Organization Study ID Info
**ID:** E-54022451-050.04-150505
#### Organization
**Class:** OTHER
**Full Name:** Bezmialem Vakif University
### Status Module
#### Completion Date
**Date:** 2025-03-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Bezmialem Vakif 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:** Orthognathic surgery is a surgical procedure performed to correct dentofacial deformities. In recent years, with the use of virtual surgical planning, cutting guides, and patient-specific osteosynthesis plates, highly predictable results can be achieved. While there are many positive reports regarding the use of patient-specific plates in maxillary positioning in orthognathic surgery, there is a lack of sufficient studies comparing the results obtained in mandibular positioning. Additionally, numerous designs of proximal segment positioning devices have been published, but comparative studies on their effectiveness have not been conducted. Therefore, a study comparing these approaches has been planned.
**Detailed Description:** Orthognathic surgery is a frequently used treatment method for correcting dentofacial deformities. Bilateral sagittal split osteotomy (BSSO), developed by Trauner and Obwegeser, is still used today with many design modifications. There is a potential for incorrect positioning of the proximal segment during fixation. Regarding mandibular setback surgery, many authors have reported a tendency for medial and posterior rotation of the proximal segment during the postoperative period. Proximal segment displacement may result from the condyle not seating properly in the fossa or from early contacts between the proximal and distal segments. These early contacts cause rotation of the proximal segment while the mandible is fixed. If the displacement exceeds the adaptive capacity of the condyle, a high rate of condylar resorption or postoperative relapse may occur. Various condylar positioning devices have been developed to overcome this issue.
The introduction of virtual surgical planning (VSP) has helped to overcome some of the errors and difficulties in model surgery and conventional surgical planning. Computer-aided design and manufacturing (CAD/CAM) splints have been shown to be accurate in transferring the surgical plan to real life, but some errors may still occur. Patient-specific 3D-printed osteosynthesis plates have been developed to overcome these errors. Many studies have reported high accuracy of these plates in the maxilla. However, some other studies have reported errors of 5-6 mm. Similar accuracy rates have been reported for the mandible, but there are fewer studies in this area.
VSP not only allows the surgeon to visualize 3D movements but also shows the osteotomy design, screw placement locations, fixation design, and early bone contacts. The amount of trimming of the distal segment is determined by examining whether any openings or narrowings occur after minor movements are made to the proximal segment based on the rotation of the distal segment or the complex "pitch" and "roll" movements of the occlusal plane. After all these movements are given with virtual planning, personalized cutting guides, positioning guides, and patient-specific plates are needed to transfer this plan to real life.
Recent developments in VSP have focused on accurately transferring preoperative planning to surgery. The most significant development in this regard is patient-specific plates and cutting guides. This technology enables surgeons and engineers to produce patient-specific cutting guides to determine the incision lines. These guides also determine the thickness of the bone in the areas where plate screws will be placed and ensure avoidance of tooth roots. Patient-specific plates are designed and manufactured to fit into pre-prepared holes and hold the osteotomized segments together in the desired position. Despite being a new technology, several studies have shown that VSP and patient-specific plates have better final surgical accuracies compared to VSP and splints.
### Conditions Module
**Conditions:**
- CAD-CAM
- Patients Specific Manufacturing
- Osteotomy, Sagittal Split Ramus
**Keywords:**
- virtual surgical planning
- orthognathic surgery
- custom plate
- mandibular condyle position
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Orthognathic surgery is a surgical procedure performed to correct dentofacial deformities. In recent years, with the use of virtual surgical planning, cutting guides, and patient-specific osteosynthesis plates, highly predictable results can be achieved. While there are many positive reports regarding the use of patient-specific plates in maxillary positioning in orthognathic surgery, there is a lack of sufficient studies comparing the results obtained in mandibular positioning. Additionally, numerous designs of proximal segment positioning devices have been published, but comparative studies on their effectiveness have not been conducted. Therefore, a study comparing these approaches has been planned
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Orthognathic surgery will be performed (n=20) (control group)
**Intervention Names:**
- Device: conventional splints
**Label:** control group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Orthognathic surgery will be performed (n=20)
**Intervention Names:**
- Device: cutting guides and positioning guides
**Label:** group 2
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Orthognathic surgery will be performed (n=20)
**Intervention Names:**
- Device: cutting guides and fixation plates
**Label:** group 3
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- control group
**Description:** only intermediate and final splint will be used during the surgery
**Name:** conventional splints
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- group 2
**Description:** patient's specific manufacturing cutting guide and positioning guide related with orthognathic surgery
**Name:** cutting guides and positioning guides
**Type:** DEVICE
#### Intervention 3
**Arm Group Labels:**
- group 3
**Description:** patient's specific manufacturing cutting guide and fixation plates related with orthognathic surgery
**Name:** cutting guides and fixation plates
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Firstly;
The following reference planes and lines will be created on the Mimics (Materialise, Belgium, v21) software:
* Frankfort Horizontal Plane (FHD): Right and left side porion and the plane passing through the right side orbitale
* Midsagittal Reference Plane (MSR): Perpendicular to FHD, nasion and plane determined to pass through basion points Lateral Condylar Pole (LKK) (Right-Left): the outermost part of the condyle head point
* Medial Condylar Pole (MKK) (Right-Left): innermost part of the condyle head point Linear and angular measurements to be made with these planes.
**Measure:** compare the mandibular condyle changes preoperative and postoperative period
**Time Frame:** in the first week after the surgery
#### Secondary Outcomes
**Description:** Postoperative CT data will be transferred to Mimics (Materialise, Belgium, v21) software in DICOM format. Here, a 3D head and jaw model will be obtained from this data. For this purpose, 24 cephalometric points will be selected in both models. In this software, an analysis containing these points will be created and the 2-dimensional linear distances between the preoperative and postoperative positions of these points will be calculated. The accuracy between preoperative and postoperative models will be evaluated in the Mimics software.
**Measure:** Rate of the virtual surgical planning accuracy
**Time Frame:** in the first week after the surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Healthy individuals over 18 years of age
2. Patients with skeletal Class 2 and Class 3 malocclusion requiring bimaxillary orthognathic surgery
3. Patients who have undergone orthodontic treatment prior to surgery
Exclusion Criteria:
1. Patients with cleft lip and palate or craniofacial deformities
2. Oligodontia
3. Patients in whom the study protocol could not be continued due to intraoperative complications such as guide mismatch or bad split, or due to reasons such as inability to obtain postoperative CT scans
4. Patients with pre-existing temporomandibular joint disorders prior to surgery
5. Patients who have undergone previous orthognathic surgery
6. Patients with a history of maxillary or mandibular trauma
7. Patients requiring segmental maxillary surgery
8. Patients with bone metabolism disorders
9. Patients allergic to titanium
10. Pregnant individuals
**Healthy Volunteers:** True
**Maximum Age:** 55 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Istanbul
**Contacts:**
***Contact 1:***
- **Email:** tpergel@bezmialem.edu.tr
- **Name:** taha pergel, DDS
- **Phone:** +902124531850
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Bezmialem Vakıf Universty
**State:** Fatih
**Status:** RECRUITING
**Zip:** 34093
### IPD Sharing Statement Module
**IPD Sharing:** YES
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442774
**Acronym:** DDT
**Brief Title:** MamaConecta: Digital Tool for Maternal Mental Health
**Official Title:** Digital Tool to Improve Maternal Mental Health: Enhancing Well-being, Early Detection, Diagnosis Support, and Monitoring of Mental Health Problems During the Perinatal Period
#### Organization Study ID Info
**ID:** ATC/CT001/2023
#### Organization
**Class:** INDUSTRY
**Full Name:** A Thousand Colibris, S.L
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Hospital Universitari Vall d'Hebron Research Institute
**Class:** OTHER
**Name:** University Rovira i Virgili
**Class:** OTHER
**Name:** Hospital del Mar Research Institute (IMIM)
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** A Thousand Colibris, S.L
#### 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 randomized controlled trial is to validate a digital health tool, Dana app, that enhances well-being and supports mental health monitoring for women during the perinatal period. The primary purpose is to improve maternal well-being, early detection of mental health issues, and aid in the diagnosis and monitoring by healthcare professionals in women transitioning into motherhood. The main questions it aims to answer are:
* Does the app improve overall maternal well-being during the perinatal period?
* Can the app increase the early detection rates of perinatal mental health disorders?
* Can the app be an effective tool to support healthcare professionals to diagnose perinatal mental health problems?
* How effective is the app in improving obstetric outcomes and the psychological and cognitive development of infants?
Researchers will compare the group using the app with a control group not using the digital tool to see if Dana provides significant improvements in maternal and infant health outcomes.
Participants will:
* Use the mobile application from 12-14 weeks of gestation until 24 months postpartum.
* Undergo regular assessments to monitor their emotional state, lifestyle, clinical, and obstetric data.
* Participate in evaluations for their infants' psychological and cognitive development at various stages from birth to two years old.
This trial is conducted at multiple centers, including Hospital Vall d'Hebron, the Sexual and Reproductive Health Care Services (ASSIR) in Tarragona and ASSIR Litoral (Barcelona), Hospital del Mar, following CONSORT standards. The study aligns with the Health and Culture priorities of the Spanish Government's Scientific, Technical, and Innovation Research Plan 2021-2023.
**Detailed Description:** BACKGROUND:
Mental disorders are becoming one of the major health problems in today's society, exacerbated in women who are and will become mothers. Global studies indicate that 80% of women who are going to become mothers experience mood disorders such as stress, fear, loneliness, or guilt during the perinatal period. In 1 out of every 5 cases, these mental disorders worsen and lead to severe mental health issues such as post-traumatic stress disorder, psychosis, suicidal ideation, or postpartum depression. However, 75% of women with perinatal mental disorders are underdiagnosed and do not receive adequate treatment, either due to a lack of detection or support within healthcare systems. This has a consequent impact on the health and well-being of the mother, her family, the child, and ultimately, society. In this context, the company A Thousand Colibris S.L (ATC) has developed digital health software to improve well-being during this period, as well as to detect, assist in the diagnosis, and monitor mental health disorders in mothers from pregnancy up to two years after childbirth.
Consequences of Perinatal Mental Health Disorders:
The consequences of perinatal mental health problems extend beyond the mother, affecting the child, the family, and society as a whole.
1. Maternal health disorders: Perinatal mental health disorders have been identified in women of all cultures, ages, social levels, and races. Although the term postpartum depression is often used to describe disorders that develop after childbirth, a range of disorders can appear during pregnancy and the postpartum period, including anxiety, depression, stress disorders, panic, or postpartum psychosis. If left untreated, these illnesses can have a devastating impact on women and their families, being one of the leading causes of maternal death during pregnancy and the two years following childbirth.
2. Impact on the future health of the child: Without appropriate intervention, these disorders can persist and have negative consequences for both the mother and the baby. The impact of the mother's health on the future health of the baby, on mother-newborn interactions, breastfeeding difficulties, and the mother-child bond is well documented. The failure to detect certain aspects of maternal health can manifest in complications during childbirth or later in the child's development.
3. Impact on family well-being: The mother's mood and symptoms of anxiety and other disorders also have a direct impact on the partner, who may not understand what is happening, feel overwhelmed, and not know how to help.
Digital psychological interventions:
Given the growing ubiquity of the Internet and the widespread use of smartphones, mindfulness-based cognitive-behavioral interventions can also be offered digitally. In this regard, researchers have been successfully adapting decades-old techniques commonly used in cognitive-behavioral therapies to the context of smartphone applications, which have demonstrated efficacy in reducing symptoms of depression, anxiety, stress, insomnia, and even suicidal thoughts. However, the potential of smartphone applications in promoting well-being, and preventing and treating mental health problems in pregnant women, has yet to be fully exploited. Despite the limited number of studies and controlled trials involving health apps for pregnant women, online app stores are flooded with pregnancy apps that have not been tested using rigorous scientific methods. This has sparked an increasing debate among researchers and policymakers regarding the evaluation of quality and certification of health apps that do not meet the needs of patients and doctors, particularly concerning safety and efficacy. Health applications should be evaluated with the same rigor as other types of interventions, such as pharmacotherapy and psychotherapy.
HYPOTHESES:
Hypothesis 1: Dana is a digital tool that improves the well-being of women transitioning into motherhood and increases the early detection of mental health disorders.
Hypothesis 2 (Class IIa Certification): The tool provides monitoring of maternal health and assists in diagnosis for healthcare professionals.
OBJECTIVES:
General:
To validate a digital tool as a solution to (a) improve maternal well-being, mental and physical health during the perinatal period, (b) increase early detection of maternal mental health disorders, and (c) assist in the diagnosis and monitoring of perinatal mental health problems.
Specific:
* Validate the effectiveness of the digital tool in improving well-being at the end of pregnancy (34 weeks gestation), initial postpartum (6 weeks postpartum), and long-term (6, 12, and 24 months postpartum).
* Verify the effectiveness of the digital tool in preventing symptoms of anxiety and depression during the perinatal period (pregnancy and postpartum up to 24 months postpartum).
* In women with symptoms detected in the baseline assessment, analyze the effectiveness of the tool in preventing symptom escalation.
* In women with stabilized mental pathology, analyze the effectiveness of the tool in preventing symptom escalation.
* Verify the effectiveness of the digital tool in improving secondary outcomes related to childbirth: childbirth experience and postpartum-related post-traumatic stress.
* Verify the effectiveness of the digital tool in improving obstetric and neonatal health secondary outcomes.
* Analyze the use of healthcare services and the cost of perinatal mental health.
* Verify the effectiveness of the intervention developed to increase prenatal bonding and postpartum attachment.
* Verify the effectiveness of the intervention developed to improve postpartum secondary outcomes: satisfaction with the maternal role, self-efficacy, stress with the maternal role, and proportion of breastfeeding.
* Analyze the secondary relationship between childbirth experience, post-traumatic stress, and postpartum depression.
* Analyze the data collected by the digital tool and wearables to identify patterns and correlations that may be useful for the prediction and early detection of disorders in mothers and babies.
* Analyze infant neurodevelopment and psychopathology during the first two years of life.
METHODOLOGY:
1. Design: A randomized clinical trial, blinded to the investigator, with two parallel groups (1 experimental group using the digital tool and 1 control group).
The protocol has been designed following the CONsolidated Standards Of Reporting Trials (CONSORT: http://www.consortstatement.org) and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT).
2. Participants: The study will be conducted at Vall d'Hebrón Hospital, the Sexual and Reproductive Health Care Services (ASSIR) in Tarragona, ASSIR del Litoral (Barcelona), and Hospital del Mar.
Participants will be pregnant women between 12-14 weeks of gestation who are following their pregnancy at these centers, and they and their babies will be followed up until 24 months postpartum.
3. Sample Size: To estimate the necessary sample size to detect significant differences between groups, an alpha risk error of 0.05 and a beta risk error of 0.2 for one-tailed tests have been accepted, considering a dropout rate of 40%. According to data from Viskovich et al. (2020) and Rash et al. (2011) related to the Satisfaction With Life Scale, 16 subjects per group are needed to determine minimum differences of 1.86 points, assuming a standard deviation of 2.07 points. According to data from Tovote et al. (2014) related to the World Health Organization-5 Well-Being Index, 11 subjects per group are needed to determine minimum differences of 20.6 points, assuming a standard deviation of 19.0 points. According to data from Ahlqvist-Björkroth et al. (2019) related to the Edinburgh Postnatal Depression Scale, 26 subjects per group are needed to determine minimum differences of 2.13 points, assuming a standard deviation of 2.46 points. Finally, according to data from Moix et al. (2021) related to the State-Trait Anxiety Inventory, 11 subjects per group are needed to determine minimum differences of 5.54 points, assuming a standard deviation of 4.5 points. Thus, 64 subjects per arm are needed, so a total sample of 300 pregnant women per center should be recruited.
4. Procedures:
4.1. Recruitment: Participants will be recruited through midwives from the Primary Care Centers and Sexual and Reproductive Health Care Services (ASSIR) of Tarragona, and ASSIR of Barcelona Litoral - Hospital del Mar. Recruitment will be through obstetricians and midwives from the same center. Women who visit before 15 weeks of gestation and meet the inclusion and exclusion criteria will be eligible to participate in the study. The healthcare professional conducting the visit will be responsible for validating the inclusion and exclusion criteria.
4.2. Randomization: Balanced randomization by center will be carried out through the digital tool itself, so the researchers will be blind to the intervention. Participants will need to download the mobile application, where during the registration process and center selection, they will be randomized into the control or intervention group. Women in the intervention group will be offered access to the full digital tool, while those in the control group will have an app with no content.
4.3. Blinding: Researchers analyzing the primary data and conducting infant evaluations will not know which group the women have been assigned to. Midwives and obstetricians who conduct recruitment will also be unaware, unless the participant discloses it after being randomized. Neither the researchers nor the midwives will have access to group assignments. Researchers conducting primary data analysis or neonatal evaluations will not know the participants' group assignments until the end of the study. Due to the nature of the intervention, participants cannot be blinded to their group assignment.
4.4. Pseudonymization: Data pseudonymization and protection will be ensured using the REDCap system. Each participating health center and hospital (as independent data controllers) will have access only to their own center's data, not to data from other centers. Data from the entire study recorded in REDCap and app data will be accessible only by the co-sponsors and co-controllers of the data mentioned in the protocol.
### Conditions Module
**Conditions:**
- Pregnancy Related
- Mental Health Issue
- Postpartum Depression
- Postpartum Anxiety
- Well-Being, Psychological
**Keywords:**
- mental health
- pregnancy
- mobile application
- wellbeing
- child neurodevelopment
- antenatal depression screening
- early detection
- postpartum
- digital health
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** Participants will download an app that will randomise them on the intervention or control group.
**Who Masked:**
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 1200
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants of this group will have care as usual from healthcare providers. Participants will have the study variables measured (by questionnaires and monitoring via wearable).
**Intervention Names:**
- Other: Monitoring via wearable
**Label:** Control
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Participants of this group will have access to the content of the application and will use it regularly from the start of the study until 4 months postpartum. Participants will have the study variables measured (by questionnaires and monitoring via wearable)
**Intervention Names:**
- Other: Mobile application
- Other: Monitoring via wearable
**Label:** Mobile application
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Mobile application
**Description:** The intervention that has been developed is a digital tool of a biopsychosocial nature based on the main cognitive-behavioral strategies: psychoeducation, reflection, self-observation, guided visualizations, mindfulness and progressive muscle relaxation.
The intervention consists of 3 main areas of work:
* Programs: Biopsychosocial programs in text and audio format.
* Community: Forum with directed questions and space to share experiences between mothers.
* Diary: Space to record mood and emotional record.
The entire tool works transversally in 4 dimensions: self-care, relationship with perinatal changes, relationship with the baby, social relationship.
The tool itself includes 3 mental health and well-being screening questionnaires: Whooley Questionnaire and the Edinburgh Postnatal Depression Scale (EPDS).
**Name:** Mobile application
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Control
- Mobile application
**Description:** Participants that own a wearable will connect it to monitor variables related to sleeping patterns, activity and stress (see variables section).
**Name:** Monitoring via wearable
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Assessed using the World Health Organization-5 Well-Being Index (WHO-5). The WHO-5 is a brief 5-item self-report instrument designed to measure current mental well-being. It has adequate validity for screening depression and measuring clinical trial outcomes, with good properties when used in pregnant women (Mortazavi et al., 2021).
Min value: 0 Max value: 25 Higher scores: Indicate better well-being. Scores below 13 suggest poor well-being, indicative of depression.
**Measure:** Maternal well-being
**Time Frame:** 12-14 weeks, 33-34 weeks of gestation, 6 weeks, 6, 12, 24 months postpartum.
#### Secondary Outcomes
**Description:** Using the Edinburgh Postpartum Depression Scale (EPDS), a 10-item questionnaire for detecting postpartum depression symptoms, validated for pregnancy and in Spanish women (Levis et al., 2020; Vázquez \& Míguez, 2019).
Min value: 0 Max value: 30 Higher scores: Indicate worse symptoms. Scores ≥10 suggest possible depression; scores ≥13 or positive for question 10 indicate a high likelihood.
**Measure:** Depression
**Time Frame:** 12-14 and 29-30 weeks of pregnancy, 6 weeks, 6, 12, 24 months postpartum.
**Description:** Using the State-Trait Anxiety Inventory (STAI), a 40-item tool for assessing state and trait anxiety (Brunton et al., 2015).
Min value: 20 per subscale (STAI-S and STAI-T) Max value: 80 per subscale Higher scores: Indicate worse anxiety outcomes.
**Measure:** Anxiety
**Time Frame:** 12-14 and 33-34 weeks of pregnancy, 6 weeks, 6, 12, 24 months postpartum.
**Description:** Using the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ A-B), a 33-item tool to quantify fear of childbirth.
Min value: 0 Max value: 165 Higher scores: Indicate higher levels of fear; scores \>85 suggest high fear levels.
**Measure:** Birth Fear
**Time Frame:** 12-14 and 33-34 weeks of pregnancy, 6 weeks postpartum.
**Description:** Using the Pittsburgh Sleep Quality Index (PSQI), a 19-item tool to assess sleep quality over the past 30 days.
Min value: 0 Max value: 21 Higher scores: Indicate worse sleep quality; scores \>5 suggest poor sleep.
**Measure:** Sleep
**Time Frame:** 12-14 and 33-34 weeks of pregnancy
**Description:** Using the Maternal Antenatal Attachment Scale (MAAS) to assess the emotional bond with the unborn child.
Min value: 19 Max value: 95 Higher scores: Indicate a stronger emotional bond.
**Measure:** Maternal Antenatal attachment
**Time Frame:** 29-30 weeks of pregnancy.
**Description:** Using the Postpartum Bonding Questionnaire (PBQ) to measure the maternal bond with the baby post-birth.
Min value: 0 Max value: 125 Higher scores: Indicate worse bonding outcomes.
**Measure:** Bonding
**Time Frame:** 6 weeks, 6, 12, 24 months postpartum.
**Description:** Using the Mackey Satisfaction Childbirth Questionnaire to measure childbirth satisfaction.
Min value: 11 Max value: 55 Higher scores: Indicate higher satisfaction.
**Measure:** Birth Experience
**Time Frame:** 33-34 weeks of pregnancy, 6 weeks postpartum.
**Description:** The City Birth Trauma Scale (BiTS): Psychological assessment tool designed to measure traumatic stress responses specifically related to childbirth. It is used to identify symptoms of birth-related post-traumatic stress disorder (PTSD) in women who have recently given birth. The scale helps healthcare providers to assess the severity and impact of traumatic childbirth experiences on mothers.
Minimum value: 0 Maximum value: 80 Higher scores: Indicate more severe symptoms of trauma related to childbirth.
**Measure:** Traumatic stress responses related to childbirth
**Time Frame:** 6 weeks postpartum
**Description:** Parental Stress Index (PSI): This evaluation tool measures parental stress levels in mothers and fathers. The PSI consists of 36 questions that evaluate different factors that may contribute to parental stress, such as the child's health, the relationship with the partner, social support, work demands, and parental expectations regarding the child's development.
Min value: 36 Max value: 180 Higher scores: Indicate higher stress levels.
**Measure:** Parental stress
**Time Frame:** 6, 12, 24 months postpartum.
**Description:** Parenting Sense of Competence (PSOC): This evaluation tool measures the perception of parental competence in mothers and fathers. The PSOC consists of 16 questions that evaluate satisfaction with the parental role, confidence in parenting skills, the ability to adapt to the child's demands, and the perception that the parental role is a rewarding task. The questionnaire is used to identify parents who may need additional support to develop confidence and parenting skills, and improve family health and well-being.
Minimum value: 16 Maximum value: 96 Higher scores: Indicate better perceived parental competence.
**Measure:** Maternal empowerment
**Time Frame:** Postpartum: 6 weeks and 24 months
**Description:** Using the International Physical Activity Questionnaire (IPAQ) to measure physical activity levels.
Min value: 0 Max value: Varies based on intensity and frequency Higher scores: Indicate higher physical activity levels.
**Measure:** Physical Activity
**Time Frame:** 12-14 and 33-34 weeks of pregnancy.
**Description:** Pregnancy complications (measured in presence of gestational diabetes, preeclampsia, preterm birth, growth restriction, diagnosis of perinatal mental health disorder, need for psychotropic drugs, smoking habit).
Higher values: Indicate higher complications during pregnancy.
**Measure:** Pregnancy outcomes
**Time Frame:** 1 week after birth collected retrospectively for pregnancy and childbirth
**Description:** Cost for the healthcare system (measured on number of visits to obstetrician/gynecology, midwife, psychology, physiotherapy, emergency room, hospital admissions)
Higher values: Indicate higher expenses for the healthcare system.
**Measure:** Health costs 1
**Time Frame:** 1 week after birth collected retrospectively for pregnancy and childbirth. 2 years postnatally collected retrospectively for the postnatal period.
**Description:** Duration of hospital admission (measured in days).
Higher values: Indicate higher expenses for the healthcare system.
**Measure:** Health costs 2
**Time Frame:** 1 week after birth collected retrospectively for pregnancy and childbirth. 2 years postnatally collected retrospectively for the postnatal period.
**Description:** Gestational age at delivery (weeks+days) Normal range: 37-42 weeks Lower values: Indicate preterm newborns. Higher values: Indicate postterm newborns.
**Measure:** Neonatal outcomes 1
**Time Frame:** 1 week after birth collected retrospectively
**Description:** Cord arterial pH (potential of hydrogen)
Normal pH:
Range: 7.25 to 7.35 Implication: Indicates that the newborn had adequate oxygenation and no significant acidosis during labor and delivery.
Mild Acidosis:
Range: 7.20 to 7.24 Implication: Suggests a slight decrease in oxygen levels. While it may not immediately be cause for concern, it warrants monitoring for any signs of distress or complications.
Moderate Acidosis:
Range: 7.10 to 7.19 Implication: Indicates moderate hypoxia and the possibility of metabolic acidosis. This condition may require intervention and close monitoring of the newborn for any further complications.
Severe Acidosis:
Range: Below 7.10 Implication: Suggests significant hypoxia and severe metabolic acidosis, which can be associated with perinatal asphyxia. Immediate medical evaluation and intervention are typically required to address any potential adverse outcomes.
**Measure:** Neonatal outcomes 2
**Time Frame:** 1 week after birth collected retrospectively
**Description:** Neonatal complications at birth (descriptive: admission to the ICU, neonatal sepsis)
**Measure:** Neonatal outcomes 3
**Time Frame:** 1 week after birth collected retrospectively
**Description:** Apgar score: The Apgar score is a quick test performed on a newborn at 1 minute and 5 minutes after birth. The purpose of the test is to determine how well the baby tolerated the birthing process and how well the baby is doing outside the mother's womb.
The Apgar score assesses five criteria, each scored on a scale of 0 to 2, with a maximum total score of 10:
Score 7-10: Generally considered normal; indicates that the newborn is in good health.
Score 4-6: Fairly low; may require some medical intervention such as oxygen or physical stimulation.
Score 0-3: Critically low; requires immediate resuscitation and medical attention.
**Measure:** Neonatal outcomes 4
**Time Frame:** 1 week after birth collected retrospectively
**Description:** Weight (in grams)
**Measure:** Neonatal outcomes 5
**Time Frame:** 1 week after birth collected retrospectively
**Description:** Height (centimeters)
**Measure:** Neonatal outcomes 6
**Time Frame:** 1 week after birth collected retrospectively
**Description:** Head circumference (centimeters)
**Measure:** Neonatal outcomes 7
**Time Frame:** 1 week after birth collected retrospectively
**Description:** Type of birth. Measures in normal vaginal birth, instrumental birth and caesarian section.
**Measure:** Birth outcomes 1
**Time Frame:** 1 week after birth collected retrospectively
**Description:** State of the perineum after delivery: Measured in intact perineum, I degree tear, II degree tear, III degree tear, IV degree tear and episiotomy.
**Measure:** Birth outcomes 2
**Time Frame:** 1 week after birth collected retrospectively
**Description:** Type of analgesia during delivery: measured in epidural (yes/no), raquideal (yes/no), local (yes/no), and general (yes/no)
**Measure:** Birth outcomes 3
**Time Frame:** 1 week after birth collected retrospectively
**Description:** Labor induction: Descriptive yes/no
**Measure:** Birth outcomes 4
**Time Frame:** 1 week after birth collected retrospectively
**Description:** Maternal complications at birth (descriptive: admission to the ICU, obstetric emergency)
**Measure:** Birth outcomes 5
**Time Frame:** 1 week after birth collected retrospectively
**Description:** Maternal heart rate variability (HRV)
Heart rate:
Minimum Value: Varies depending on the individual's baseline, but generally, a healthy resting heart rate for adults ranges from 60 to 100 beats per minute (bpm).
Maximum Value: This can vary widely based on activity and stress levels, but for pregnant women, a heart rate consistently above 100 bpm at rest might be concerning
Maternal heart rate variability (HRV) refers to the variation in time intervals between heartbeats, which is a marker of autonomic nervous system function.
Minimum Value: HRV does not have a fixed minimum value, but lower HRV generally indicates reduced autonomic flexibility and poor cardiovascular health.
Maximum Value: Similarly, there is no fixed maximum value, but higher HRV is generally associated with better cardiovascular fitness and autonomic regulation.
**Measure:** Biomarkers 1 (stress)
**Time Frame:** From 12 weeks of pregnancy until 2 years postpartum
**Description:** Sleeping patterns (measured with wearable):
Key Metrics Monitored by Wearable:
Sleeping patterns refer to the habitual sleep behaviors of an individual. Bed time start (date and time), bed time end (date and time) and awake time (in minutes) will be combined to report total sleep (in minutes).
The overall of this metrics will give a score for sleeping patterns. Higher levels mean higher levels of resting.
**Measure:** Biomarkers 2 (sleep)
**Time Frame:** From 12 weeks of pregnancy until 2 years postpartum
**Description:** Level of physical activity (measured with wearable):
The heart rate monitor of the wearable measures the wearer's heart rate to gauge intensity of physical activity.
The amount of time (in minutes) will give us the time a day spent in physical activities of moderate or higher intensity (HR\>100bpm).
Higher levels mean higher levels of physical activity.
**Measure:** Biomarkers 3 (activity)
**Time Frame:** From 12 weeks of pregnancy until 2 years postpartum
**Description:** Ages and Stages Questionnaires (ASQ): This evaluation tool measures child development in areas such as communication, social behavior, motor coordination, language, and learning. The ASQ consists of different questionnaires adapted to different ages, which are completed by parents or caregivers. The results are used to identify children with potential developmental delays and provide early interventions to improve their cognitive and emotional health. The ASQ is widely used in clinical practice and research in the field of child development.
Scores vary across different developmental domains: Communication, Social Behavior, Motor Coordination, Language, Learning.
Higher scores: Indicate better developmental outcomes .
**Measure:** Child neurodevelopment
**Time Frame:** 6 months, 12 months and 24 months postpartum.
**Description:** The Bayley Scales of Infant and Toddler Development, commonly referred to as the Bayley Scales, is a standardized assessment tool used to evaluate the developmental functioning of infants and toddlers, typically from 1 month to 42 months of age.
The Bayley Scales consist of five key domains, each designed to measure different aspects of a child's development: cognitive, language, motor, social-emotional and adaptive behaviour.
The result is presented in percentiles (0-100)
Higher scores: Indicate better developmental outcomes.
**Measure:** Child neurodevelopment
**Time Frame:** 4 months and 24 months postpartum.
**Description:** Vineland III: This evaluation tool is designed to measure adaptive skills in individuals of all ages, from infancy to adulthood.
Scores vary across different subscales: Communication Skills, Social Skills, Daily Living Skills.
Higher scores: Indicate better adaptive functioning.
**Measure:** Adaptative behaviour
**Time Frame:** 4 months and 24 months postpartum.
**Description:** Type of breastfeeding at discharge from hospital. Descriptive outcome reported as exclusive breastfeeding, mixed feeding or artificial feeding.
**Measure:** Breastfeeding outcomes
**Time Frame:** 1 week after birth collected retrospectively
**Description:** Breastfeeding duration (measured in days)
**Measure:** Breastfeeding outcomes
**Time Frame:** Postpartum: 4 months, 1 year after childbirth collected retrospectively
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Gestational age between 12-14 weeks of gestation.
* The first obstetric ultrasound has been performed.
* Women who know how to read and understand Spanish.
* Women who have access to a mobile phone with an internet connection (data or wifi)
* Women who have knowledge of technology tools via app.
* Have signed the informed consent to participate in the study.
Exclusion Criteria:
* Termination of pregnancy, or early miscarriage
* Perinatal loss at any time during pregnancy.
* Severe mental pathology or moderate unstable mental pathology.
* Consumption of toxic substances.
**Gender Based:** True
**Gender Description:** Pregnancy
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** veronica@athousandcolibris.com
**Name:** Veronica Montesinos
**Phone:** +34622353245
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Barcelona
**Contacts:**
***Contact 1:***
- **Email:** maia.brik@vallhebron.cat
- **Name:** Maia Brik
- **Phone:** +34934893000
- **Phone Ext:** Ext 3186
- **Role:** CONTACT
***Contact 2:***
- **Name:** Maia Brik, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Vall d'Hebron
**State:** Catalunya
**Zip:** 08550
**Location 2:**
**City:** Barcelona
**Contacts:**
***Contact 1:***
- **Name:** Esther Insa, PhD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Esther Insa, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital del Mar
**Zip:** 08003
**Location 3:**
**City:** Tarragona
**Contacts:**
***Contact 1:***
- **Email:** carmen.hernandez@urv.cat
- **Name:** Carmen Hernández, PhD
- **Phone:** +34977558175
- **Role:** CONTACT
***Contact 2:***
- **Name:** Carmen Hernandez, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Universitat Rovira i Virgili
**Zip:** 43007
#### Overall Officials
**Official 1:**
**Affiliation:** A Thousand Colibris, S.L
**Name:** Roser Palau-Costafreda
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** The data-sharing plans for the current study are unknown and will be made available at a later date.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** undefined
**Citation:** Uguz F, Yakut E, Aydogan S, Bayman MG, Gezginc K. Prevalence of mood and anxiety disorders during pregnancy: A case-control study with a large sample size. Psychiatry Res. 2019 Feb;272:316-318. doi: 10.1016/j.psychres.2018.12.129. Epub 2018 Dec 25.
**PMID:** 30597383
**Citation:** Glover, V., Ahmed-Salim, Y., &amp;amp;amp;amp;amp;amp;amp; Capron, L. (2016). Maternal anxiety, depression, and stress during pregnancy: Effects on the fetus and the child, and underlying mechanisms. In Fetal Development: Research on Brain and Behavior, Environmental Influences, and Emerging Technologies (pp. 213-227). Springer International Publishing. https://doi.org/10.1007/978-3-319-22023-9_12
**Citation:** Glover V. Effects of Maternal Prenatal Stress on the Fetal Brain and Hope for the Prevention of Psychopathology. Biol Psychiatry. 2020 Mar 15;87(6):487-488. doi: 10.1016/j.biopsych.2019.11.008. No abstract available.
**PMID:** 32081251
**Citation:** Fairbrother N, Young AH, Janssen P, Antony MM, Tucker E. Depression and anxiety during the perinatal period. BMC Psychiatry. 2015 Aug 25;15:206. doi: 10.1186/s12888-015-0526-6.
**PMID:** 26303960
**Citation:** Evans K, Morrell CJ, Spiby H. Systematic review and meta-analysis of non-pharmacological interventions to reduce the symptoms of mild to moderate anxiety in pregnant women. J Adv Nurs. 2018 Feb;74(2):289-309. doi: 10.1111/jan.13456. Epub 2017 Oct 16.
**PMID:** 28921612
**Citation:** Cena L, Gigantesco A, Mirabella F, Palumbo G, Trainini A, Stefana A. Prevalence of Maternal Postnatal Anxiety and Its Association With Demographic and Socioeconomic Factors: A Multicentre Study in Italy. Front Psychiatry. 2021 Sep 30;12:737666. doi: 10.3389/fpsyt.2021.737666. eCollection 2021.
**PMID:** 34658970
**Citation:** Beddoe AE, Lee KA. Mind-body interventions during pregnancy. J Obstet Gynecol Neonatal Nurs. 2008 Mar-Apr;37(2):165-75. doi: 10.1111/j.1552-6909.2008.00218.x.
**PMID:** 18336440
**Citation:** Alder J, Fink N, Bitzer J, Hosli I, Holzgreve W. Depression and anxiety during pregnancy: a risk factor for obstetric, fetal and neonatal outcome? A critical review of the literature. J Matern Fetal Neonatal Med. 2007 Mar;20(3):189-209. doi: 10.1080/14767050701209560.
**PMID:** 17437220
**Citation:** Yuen WS, Lo HC, Wong WN, Ngai FW. The effectiveness of psychoeducation interventions on prenatal attachment: A systematic review. Midwifery. 2022 Jan;104:103184. doi: 10.1016/j.midw.2021.103184. Epub 2021 Oct 28.
**PMID:** 34753018
**Citation:** Woody CA, Ferrari AJ, Siskind DJ, Whiteford HA, Harris MG. A systematic review and meta-regression of the prevalence and incidence of perinatal depression. J Affect Disord. 2017 Sep;219:86-92. doi: 10.1016/j.jad.2017.05.003. Epub 2017 May 8.
**PMID:** 28531848
**Citation:** Veringa IK, de Bruin EI, Bardacke N, Duncan LG, van Steensel FJ, Dirksen CD, Bogels SM. 'I've Changed My Mind', Mindfulness-Based Childbirth and Parenting (MBCP) for pregnant women with a high level of fear of childbirth and their partners: study protocol of the quasi-experimental controlled trial. BMC Psychiatry. 2016 Nov 7;16(1):377. doi: 10.1186/s12888-016-1070-8.
**PMID:** 27821151
**Citation:** Van den Bergh BRH, van den Heuvel MI, Lahti M, Braeken M, de Rooij SR, Entringer S, Hoyer D, Roseboom T, Raikkonen K, King S, Schwab M. Prenatal developmental origins of behavior and mental health: The influence of maternal stress in pregnancy. Neurosci Biobehav Rev. 2020 Oct;117:26-64. doi: 10.1016/j.neubiorev.2017.07.003. Epub 2017 Jul 28.
**PMID:** 28757456
**Citation:** van Agteren J, Iasiello M, Lo L, Bartholomaeus J, Kopsaftis Z, Carey M, Kyrios M. A systematic review and meta-analysis of psychological interventions to improve mental wellbeing. Nat Hum Behav. 2021 May;5(5):631-652. doi: 10.1038/s41562-021-01093-w. Epub 2021 Apr 19.
**PMID:** 33875837
**Citation:** Urech C, Fink NS, Hoesli I, Wilhelm FH, Bitzer J, Alder J. Effects of relaxation on psychobiological wellbeing during pregnancy: a randomized controlled trial. Psychoneuroendocrinology. 2010 Oct;35(9):1348-55. doi: 10.1016/j.psyneuen.2010.03.008. Epub 2010 Apr 22.
**PMID:** 20417038
**Citation:** Steptoe A, Deaton A, Stone AA. Subjective wellbeing, health, and ageing. Lancet. 2015 Feb 14;385(9968):640-648. doi: 10.1016/S0140-6736(13)61489-0. Epub 2014 Nov 6.
**PMID:** 25468152
**Citation:** Stein A, Pearson RM, Goodman SH, Rapa E, Rahman A, McCallum M, Howard LM, Pariante CM. Effects of perinatal mental disorders on the fetus and child. Lancet. 2014 Nov 15;384(9956):1800-19. doi: 10.1016/S0140-6736(14)61277-0. Epub 2014 Nov 14.
**PMID:** 25455250
**Citation:** Smith A, Twynstra J, Seabrook JA. Antenatal depression and offspring health outcomes. Obstet Med. 2020 Jun;13(2):55-61. doi: 10.1177/1753495X19843015. Epub 2019 Apr 24.
**PMID:** 32714436
**Citation:** Sadler LS, Slade A, Close N, Webb DL, Simpson T, Fennie K, Mayes LC. Minding the Baby: Enhancing reflectiveness to improve early health and relationship outcomes in an interdisciplinary home visiting program. Infant Ment Health J. 2013 Sep 1;34(5):391-405. doi: 10.1002/imhj.21406.
**PMID:** 24049219
**Citation:** Pearson RM, Carnegie RE, Cree C, Rollings C, Rena-Jones L, Evans J, Stein A, Tilling K, Lewcock M, Lawlor DA. Prevalence of Prenatal Depression Symptoms Among 2 Generations of Pregnant Mothers: The Avon Longitudinal Study of Parents and Children. JAMA Netw Open. 2018 Jul 6;1(3):e180725. doi: 10.1001/jamanetworkopen.2018.0725.
**PMID:** 30646025
**Citation:** Oyarzabal EA, Seuferling B, Babbar S, Lawton-O'Boyle S, Babbar S. Mind-Body Techniques in Pregnancy and Postpartum. Clin Obstet Gynecol. 2021 Sep 1;64(3):683-703. doi: 10.1097/GRF.0000000000000641.
**PMID:** 34162789
**Citation:** Muller M, Matthies LM, Goetz M, Abele H, Brucker SY, Bauer A, Graf J, Zipfel S, Hasemann L, Wallwiener M, Wallwiener S. Effectiveness and cost-effectiveness of an electronic mindfulness-based intervention (eMBI) on maternal mental health during pregnancy: the mindmom study protocol for a randomized controlled clinical trial. Trials. 2020 Nov 17;21(1):933. doi: 10.1186/s13063-020-04873-3.
**PMID:** 33203471
**Citation:** Morres ID, Tzouma NA, Hatzigeorgiadis A, Krommidas C, Kotronis KV, Dafopoulos K, Theodorakis Y, Comoutos N. Exercise for perinatal depressive symptoms: A systematic review and meta-analysis of randomized controlled trials in perinatal health services. J Affect Disord. 2022 Feb 1;298(Pt A):26-42. doi: 10.1016/j.jad.2021.10.124. Epub 2021 Oct 30.
**PMID:** 34728280
**Citation:** Khoury B, Lecomte T, Fortin G, Masse M, Therien P, Bouchard V, Chapleau MA, Paquin K, Hofmann SG. Mindfulness-based therapy: a comprehensive meta-analysis. Clin Psychol Rev. 2013 Aug;33(6):763-71. doi: 10.1016/j.cpr.2013.05.005. Epub 2013 Jun 7.
**PMID:** 23796855
**Citation:** Huguet A, Rao S, McGrath PJ, Wozney L, Wheaton M, Conrod J, Rozario S. A Systematic Review of Cognitive Behavioral Therapy and Behavioral Activation Apps for Depression. PLoS One. 2016 May 2;11(5):e0154248. doi: 10.1371/journal.pone.0154248. eCollection 2016.
**PMID:** 27135410
**Citation:** Hernandez-Martinez C, Val VA, Murphy M, Busquets PC, Sans JC. Relation between positive and negative maternal emotional states and obstetrical outcomes. Women Health. 2011 Mar;51(2):124-35. doi: 10.1080/03630242.2010.550991.
**PMID:** 21476173
**Citation:** Hernandez-Martinez C, Arija V, Balaguer A, Cavalle P, Canals J. Do the emotional states of pregnant women affect neonatal behaviour? Early Hum Dev. 2008 Nov;84(11):745-50. doi: 10.1016/j.earlhumdev.2008.05.002. Epub 2008 Jun 20.
**PMID:** 18571345
**Citation:** Goodman JH, Guarino A, Chenausky K, Klein L, Prager J, Petersen R, Forget A, Freeman M. CALM Pregnancy: results of a pilot study of mindfulness-based cognitive therapy for perinatal anxiety. Arch Womens Ment Health. 2014 Oct;17(5):373-87. doi: 10.1007/s00737-013-0402-7. Epub 2014 Jan 22.
**PMID:** 24449191
**Citation:** Goodman JH, Chenausky KL, Freeman MP. Anxiety disorders during pregnancy: a systematic review. J Clin Psychiatry. 2014 Oct;75(10):e1153-84. doi: 10.4088/JCP.14r09035.
**PMID:** 25373126
**Citation:** Firth J, Torous J, Nicholas J, Carney R, Pratap A, Rosenbaum S, Sarris J. The efficacy of smartphone-based mental health interventions for depressive symptoms: a meta-analysis of randomized controlled trials. World Psychiatry. 2017 Oct;16(3):287-298. doi: 10.1002/wps.20472.
**PMID:** 28941113
**Citation:** Espie CA, Emsley R, Kyle SD, Gordon C, Drake CL, Siriwardena AN, Cape J, Ong JC, Sheaves B, Foster R, Freeman D, Costa-Font J, Marsden A, Luik AI. Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Jan 1;76(1):21-30. doi: 10.1001/jamapsychiatry.2018.2745.
**PMID:** 30264137
**Citation:** Domhardt M, Gesslein H, von Rezori RE, Baumeister H. Internet- and mobile-based interventions for anxiety disorders: A meta-analytic review of intervention components. Depress Anxiety. 2019 Mar;36(3):213-224. doi: 10.1002/da.22860. Epub 2018 Nov 19.
**PMID:** 30450811
**Citation:** Closa-Monasterolo R, Gispert-Llaurado M, Canals J, Luque V, Zaragoza-Jordana M, Koletzko B, Grote V, Weber M, Gruszfeld D, Szott K, Verduci E, ReDionigi A, Hoyos J, Brasselle G, Escribano Subias J. The Effect of Postpartum Depression and Current Mental Health Problems of the Mother on Child Behaviour at Eight Years. Matern Child Health J. 2017 Jul;21(7):1563-1572. doi: 10.1007/s10995-017-2288-x.
**PMID:** 28188472
**Citation:** Chung KF, Lee CT, Yeung WF, Chan MS, Chung EW, Lin WL. Sleep hygiene education as a treatment of insomnia: a systematic review and meta-analysis. Fam Pract. 2018 Jul 23;35(4):365-375. doi: 10.1093/fampra/cmx122.
**PMID:** 29194467
**Citation:** Battulga B, Benjamin MR, Chen H, Bat-Enkh E. The Impact of Social Support and Pregnancy on Subjective Well-Being: A Systematic Review. Front Psychol. 2021 Sep 9;12:710858. doi: 10.3389/fpsyg.2021.710858. eCollection 2021.
**PMID:** 34566789
**Citation:** Arranz Freijo, E., Olabarrieta, F., Manzano, A., Barreto, F. B., Roncallo, C. P., Sánchez Murciano, M., Rekagorri, J., &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp; Garcia, M. D. (2019). Assessment and preventive education for families, based on the principles of positive parenting. Early Child Development and Care, 189(5), 792-801. https://doi.org/10.1080/03004430.2017.1344234
#### See Also Links
**Label:** Study Website: MamaConecta is the name under which we publicly present the clinical study investigating perinatal mental health and the impact of digital health tools on prevention and treatment. The co-promoters of this study are A THOUSAND COLIBRIS S.L
**URL:** https://mamaconecta.com/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000003866
- Term: Depressive Disorder
- ID: D000019964
- Term: Mood Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000011644
- Term: Puerperal Disorders
- ID: D000011248
- Term: Pregnancy Complications
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
### Condition Browse Module - Browse Leaves
- ID: M7061
- Name: Depressive Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depression
- ID: M21076
- Name: Depression, Postpartum
- Relevance: HIGH
- As Found: Postpartum Depression
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M21835
- Name: Mood Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14499
- Name: Puerperal Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000019052
- Term: Depression, Postpartum
- ID: D000003863
- Term: Depression
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442761
**Brief Title:** SCD Stem Cell Mobilization and Apheresis Using Motiixafortide
**Official Title:** Sickle Cell Disease Stem Cell Mobilization and Apheresis Using Motiixafortide
#### Organization Study ID Info
**ID:** SCDSTEMM
#### Organization
**Class:** OTHER
**Full Name:** St. Jude Children's Research Hospital
### Status Module
#### Completion Date
**Date:** 2026-07
**Type:** ESTIMATED
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** BioLineRx, Ltd.
#### Lead Sponsor
**Class:** OTHER
**Name:** St. Jude Children's Research Hospital
#### 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 is being done to see if the study drug, motixafortide, is safe in participants with sickle cell disease (SCD). Investigators also want to see if the drug will help the body increase the number of stem cells that can be collected for possible future transplant use.
PRIMARY OBJECTIVE
* To characterize the safety and tolerability of motixafortide in participants with SCD as determined by the incidence of adverse events (AEs).
SECONDARY OBJECTIVES
* To characterize the efficacy of a single dose (Part A) or two doses (Part B) of motixafortide for hematopoietic stem cell (HSC) mobilization and apheresis collection in participants with SCD as determined by the yield of CD34+ cells (CD34+ cells/kg).
* To measure the mobilization effects of single-day (Part A) or daily dosing (Part B) dosing with motixafortide in the peripheral blood in participants with SCD as determined by peak peripheral blood CD34+ counts
* To recommend a phase 2 dosing strategy based on safety, efficacy, and mobilization effects
**Detailed Description:** This study is divided into 2 parts. Participants will be assigned to a part based on when they enroll. Early in the study, participants will be assigned to part A. Later in the study, participants will be assigned to part B. In both parts, participants will receive the study drug, motixafortide, by an injection under the skin. About 8 hours after the injection, stem cells will be collected. Participants will follow-up within 7-10 days after the study drug and stem cell collection. Study staff will contact participants about 30 days after the last drug dose administration.
### Conditions Module
**Conditions:**
- Sickle Cell Disease
**Keywords:**
- Stem Cell Mobilization
- Apheresis
- Motixafortide
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 15
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Part A: Participants who enroll early will be assigned to Part A. Part A participants will get one dose of the study drug and one stem cell collection process.
**Intervention Names:**
- Drug: Motixafortide
**Label:** Treatment-Arm A-Single Dose
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Part B: Participants who enroll later in the study will be assigned to Part B. Part B participants will get two doses of the study drug and two stem cell collection processes over two days (one on each day).
**Intervention Names:**
- Drug: Motixafortide
**Label:** Treatment-Arm B-Two Daily Doses
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment-Arm A-Single Dose
- Treatment-Arm B-Two Daily Doses
**Description:** Given Subcutaneously (under the skin).
**Name:** Motixafortide
**Other Names:**
- APHEXDA™
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** To assess the safety and tolerability of motixafortide in participants with sickle cell disease (SCD) as determined by the incidence of adverse events.
**Time Frame:** 0 - 30 days
#### Secondary Outcomes
**Measure:** To determine the yield of CD34+ cells/kg after a single or daily dose of motixafortide in participants with SCD.
**Time Frame:** 1 - 2 days
**Measure:** To determine the mobilization effects as determined by peripheral blood CD34+ counts/uL after a single or daily dose of motixafortide in participants with SCD.
**Time Frame:** 1 - 2 days
**Measure:** To recommend a phase 2 dosing strategy of one or two doses motixafortide in participants with SCD based on the incidence of adverse events
**Time Frame:** through study completion, an average of 1 year
**Measure:** To recommend a phase 2 dosing strategy for timing of apheresis based on peripheral blood CD34+ counts/uL after motixafortide administration in participants with SCD
**Time Frame:** through study completion, an average of 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participants with severe sickle cell disease (SCD) who are ≥18 years of age and willing to donate autologous hematopoietic stem cells (HSCs) for advancing future gene therapy for SCD after collection of back-up product. Severe SCD, for the purpose of this study, will be defined as participants who are receiving chronic transfusion therapy due to SCD related complications or are eligible for or currently enrolled on an allogeneic transplant protocol.
* Participant must have a documented diagnosis of SCD with documentation of SCD genotype by medical history
* Participants should either have a central line in place or be able to undergo apheresis without the necessity of the insertion of a central venous catheter
* ECOG performance status/Karnofsky score/Lansky score \>80
* White blood cell (WBC) count \>3.0 x 10\^9/L, absolute neutrophil count (ANC) \>1.0 x 10\^9/L, and platelet count \>150 x 10\^9/L, and hemoglobin \>7.0 gm/dL
* Adequate renal function defined as serum/plasma creatinine \< 1.5 mg/dL and an estimated glomerular filtration rate (eGFR) of at least 60 mL/min/1.73 m\^2 based on the CKD-Epi equation or the St. Jude equation.
* Adequate liver function defined as direct bilirubin \< 2.5 times the upper limit of normal range; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 times the upper limit of normal range.
* Participant's cardiac function (i.e., ejection fraction \>40%) and pulmonary status (i.e., no evidence of pulmonary hypertension) must be sufficient to undergo apheresis, as assessed by the Principal Investigator and an independent physician evaluating the participant.
* Negative serologic tests for syphilis, hepatitis B and C, HIV, and HTLV-1/II
* Feasible manual or automated exchange transfusion plan to achieve hemoglobin S (HbS) near 30% within one week of mobilization
* Female participants of childbearing age should have a negative serum pregnancy test within one week of beginning motixafortide administration.
* Participants of childbearing potential should agree to use of a highly effective form of contraception during treatment and for at least 1 month after the last dose of motixafortide. Women of childbearing potential must agree to use 2 methods of effective contraception: One barrier method (e.g. diaphragm, or condom or sponge, each of which are to be combined with a spermicide) and one hormonal method, unless she uses a highly effective method. Highly effective methods of contraception include:
* Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal
* Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable
* Intrauterine device (IUD)
* Intrauterine hormone-releasing system (IUS)
* Bilateral tubal occlusion
* Vasectomised partner
* Sexual abstinence.
Exclusion Criteria:
* Emergency room admission or hospitalization in the past 14 days prior to first dose of study drug
* Major surgery in the past 30 days prior to first dose of study drug
* Active and painful splenomegaly or splenomegaly (size greater than upper limit of normal on examination).
* Participant who, by medical history, requires rare donor registry RBC units for transfusion, or is unable to receive routine transfusion. Eligible study participants must have undergone prior work-up for the presence of red cell alloantibodies and confirmation of available compatible blood product support
* Known allergy to or contraindication for motixafortide administration, or medications routinely administered during apheresis
* Participant who has had a prior autologous or allogeneic transplantation, inclusive of gene therapy
* Active viral, bacterial, fungal, or parasitic infection.
* History of cancer, excluding squamous carcinoma of the skin and cervical carcinoma in situ.
* Participant who has received experimental therapy within 4 weeks prior to providing informed consent
* Poorly controlled diabetes mellitus, as assessed by the Investigator
* Concomitant treatment with alternative investigational agent unable to be held for 30 days
* Unwillingness to use a highly effective method of contraception for 1 month after motixafortide
* Pregnancy
* Inability or unwillingness of research participant or legal guardian/ representative to give written informed consent.
* Inability or unwillingness of research participant to hold hydroxyurea for 30 days prior to first dose of study drug
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** referralinfo@stjude.org
**Name:** Alexis Leonard, MD
**Phone:** 866-278-5833
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Memphis
**Contacts:**
***Contact 1:***
- **Email:** referralinfo@stjude.org
- **Name:** Alexis Leonard, MD
- **Phone:** 866-278-5833
- **Role:** CONTACT
***Contact 2:***
- **Name:** Alexis Leonard, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Akshay Sharma, MBBS, MSc
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** St. Jude Children's Research Hospital
**State:** Tennessee
**Zip:** 38105
#### Overall Officials
**Official 1:**
**Affiliation:** St. Jude Children's Research Hospital
**Name:** Alexis Leonard, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** St. Jude Children's Research Hospital
**Name:** Akshay Sharma, MBBS, MSc
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
**Description:** Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
**IPD Sharing:** YES
**Time Frame:** Data will be made available at the time of article publication.
### References Module
#### See Also Links
**Label:** St. Jude Children's Research Hospital
**URL:** http://www.stjude.org
**Label:** Clinical Trials Open at St. Jude
**URL:** http://www.stjude.org/protocols
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000000745
- Term: Anemia, Hemolytic, Congenital
- ID: D000000743
- Term: Anemia, Hemolytic
- ID: D000000740
- Term: Anemia
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000006453
- Term: Hemoglobinopathies
- ID: D000030342
- Term: Genetic Diseases, Inborn
### Condition Browse Module - Browse Branches
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4085
- Name: Anemia, Sickle Cell
- Relevance: HIGH
- As Found: Sickle Cell Disease
- ID: M4070
- Name: Anemia
- Relevance: LOW
- As Found: Unknown
- ID: M9547
- Name: Hemolysis
- Relevance: LOW
- As Found: Unknown
- ID: M4073
- Name: Anemia, Hemolytic
- Relevance: LOW
- As Found: Unknown
- ID: M4075
- Name: Anemia, Hemolytic, Congenital
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9539
- Name: Hemoglobinopathies
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: T5229
- Name: Sickle Cell Anemia
- Relevance: HIGH
- As Found: Sickle Cell Disease
### Condition Browse Module - Meshes
- ID: D000000755
- Term: Anemia, Sickle Cell
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442748
**Acronym:** LIBRA
**Brief Title:** Short Versus Long-term Levetiracetam in Brain Tumors
**Official Title:** Short Versus Long-term Levetiracetam in Brain Tumors: A Phase 3 Randomized Controlled Trial (LIBRA)
#### Organization Study ID Info
**ID:** 4385
#### Organization
**Class:** OTHER
**Full Name:** Tata Memorial Centre
### Status Module
#### Completion Date
**Date:** 2031-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2031-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Tata Memorial Centre
#### Responsible Party
**Investigator Affiliation:** Tata Memorial Centre
**Investigator Full Name:** Dr Archya Dasgupta
**Investigator Title:** Assistant Professor, Radiation Oncology
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Levetiracetam is the commonly preferred anti-seizure medicine in patients with brain tumors. This drug has reduced the risk of seizure events occurring but is associated with a risk of side effects such as increased headache, drowsiness, loss of muscle coordination, and psychological challenges in patients. In patients undergoing appropriate treatment for brain tumors and controlled of seizures in the initial few months of levetiracetam, the chance of further seizures is relatively low. The optimal duration to give levetiracetam is not well defined for these patients, and currently as standard treatment levetiracetam is continued for 2-3 years. This study aims to answer this question by comparing patients on a short course of levetiracetam (experimental arm) versus a longer course of levetiracetam (standard arm), with the anticipation that a shorter duration of treatment will not lead to increased seizure episodes.
**Detailed Description:** Patients with prior history of seizure from primary brain tumor in the supratentorial location with controlled seizure on levetiracetam monotherapy for at least six months will be considered for the study. Patients more than 18 years of age with KPS ≥ 50 will be eligible. Patients will be randomized in one of the two arms (standard arm or experimental arm) in a 1:1 ratio and stratified based on seizure type, location, histology, tumor grade, and adjuvant therapy. Randomization will be done by the statistician via computerized software using a permuted block design. In the standard arm, patients will continue on the same dose and schedule of levetiracetam (typically prescribed in the range of 1000-3000 mg/ day in 2-3 divided doses) for a duration of 2 years. In the experimental arm, levetiracetam will be tapered by 250- 500 mg every week and stopped. Follow-ups will be done every 3-6 months as per standard practice for the given tumor histology. Neuroimaging will be done 6-12 monthly as per routine clinical practice. The quality-of-life assessment will be done every six months. The primary endpoint is 2-year seizure free survival calculated from the time of randomization.
Patients will continue to receive standard treatment, including adjuvant therapy as standard practice. In case in either arm, the patient develops a seizure episode after stopping levetiracetam will be restarted on levetiracetam monotherapy. If a patient develops a seizure episode while on levetiracetam monotherapy, further add-on antiepileptics will be considered as per standard practice by the responsible physician. Any complications arising from previous treatments (e.g., radio necrosis) or recurrent disease during the study period will be managed according to standard institutional practice without any influence of the study.
The study will be conducted at Tata Memorial Centre with a total sample size of 604 patients for a duration of seven years.
### Conditions Module
**Conditions:**
- Seizures
- Brain Tumors
- Antiepileptics
- Levetiracetam
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 604
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** In the standard arm, patients will continue on the same dose and schedule of levetiracetam (prescribed in the range of 1000-3000 mg/ day in 2-3 divided doses) for a duration of 2 years.
**Intervention Names:**
- Drug: Levetiracetam
**Label:** STANDARD
**Type:** OTHER
#### Arm Group 2
**Description:** In the experimental arm, levetiracetam will be tapered by 250- 500 mg every week and then stopped.
**Intervention Names:**
- Drug: Levetiracetam
**Label:** EXPERIMENTAL
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- EXPERIMENTAL
- STANDARD
**Description:** Levetiracetam is usually preferred in brain tumor-related epilepsy. Levetiracetam is a second-generation antiepileptic drug that binds to synaptic vesicle glycoprotein SV2A, which interferes with the release of neurotransmitters from the synaptic vesicle and control seizure by multiple mechanisms.
**Name:** Levetiracetam
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Seizure-free survival measured using Kaplan-Meier product limit method survival calculated from the time of randomization.
**Measure:** 2-year seizure free survival
**Time Frame:** 7 year
#### Secondary Outcomes
**Description:** Overall survival calculated using Kaplan-Meier product-limit method. Death from any cause will be considered as an event.
**Measure:** Overall survival
**Time Frame:** 7 year
**Description:** Progression-free survival calculated using Kaplan-Meier product-limit method. Date of radiological progression will be considered as an event.
**Measure:** Progression-free survival
**Time Frame:** 7 year
**Description:** Cumulative cost of antiepileptic medications and cost of management of seizures between the two groups will be compared using proportions of expenditure.
**Measure:** Cost-benefit analysis Cost-benefit analysis
**Time Frame:** 7 year
**Description:** The European Organization for Research and Treatment of Cancer (EORTC) quality of life (QOL) core questionnaire (C30) will be used. The summary scores will be calculated from the raw scores as per the manual, ranging from 0 to 100, with higher scores representing better outcomes. The global score and scores of subdomains will be calculated during follow-up and compared with baseline.
**Measure:** Quality of life core questionnaire
**Time Frame:** 7 year
**Description:** The European Organization for Research and Treatment of Cancer (EORTC) brain module (BN20) questionnaire will be used. The summary scores will be calculated from the raw scores as per the manual, ranging from 0 to 100, with higher scores representing better outcomes. The global score and scores of subdomains will be calculated during follow-up and compared with baseline.
**Measure:** Quality of life brain cancer module
**Time Frame:** 7 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria: • Age ≥ 18years
* History of seizure
* Histological diagnosis of primary brain tumor
* Supratentorial location of primary tumor
* Controlled on levetiracetam monotherapy for 6 months
* Index surgery within 1 year
* Karnofsky Performance Scale (KPS) ≥ 50
Exclusion Criteria:
* KPS \< 50
* No history of seizure
* Unclear history of seizure episodes in the past
* Use of antiepileptics other than levetiracetam in the previous 6 months
* No histological diagnosis
* Progressive disease
* Brain metastasis
* Altered mental status with deficits in understanding or inability to consent to the study
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** archya1010@gmail.com
**Name:** Archya Dasgupta, MD
**Phone:** 02224177000
**Phone Ext:** 6861
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Tata Memorial Centre Mumbai
**Name:** Archya Dasgupta
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
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**PMID:** 30921011
**Citation:** Olafsson E, Ludvigsson P, Gudmundsson G, Hesdorffer D, Kjartansson O, Hauser WA. Incidence of unprovoked seizures and epilepsy in Iceland and assessment of the epilepsy syndrome classification: a prospective study. Lancet Neurol. 2005 Oct;4(10):627-34. doi: 10.1016/S1474-4422(05)70172-1.
**PMID:** 16168931
**Citation:** Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, Engel J Jr, Forsgren L, French JA, Glynn M, Hesdorffer DC, Lee BI, Mathern GW, Moshe SL, Perucca E, Scheffer IE, Tomson T, Watanabe M, Wiebe S. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014 Apr;55(4):475-82. doi: 10.1111/epi.12550. Epub 2014 Apr 14.
**PMID:** 24730690
**Citation:** Scheffer IE, Berkovic S, Capovilla G, Connolly MB, French J, Guilhoto L, Hirsch E, Jain S, Mathern GW, Moshe SL, Nordli DR, Perucca E, Tomson T, Wiebe S, Zhang YH, Zuberi SM. ILAE classification of the epilepsies: Position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):512-521. doi: 10.1111/epi.13709. Epub 2017 Mar 8.
**PMID:** 28276062
**Citation:** Hildebrand J, Lecaille C, Perennes J, Delattre JY. Epileptic seizures during follow-up of patients treated for primary brain tumors. Neurology. 2005 Jul 26;65(2):212-5. doi: 10.1212/01.wnl.0000168903.09277.8f.
**PMID:** 16043788
**Citation:** Villemure JG, de Tribolet N. Epilepsy in patients with central nervous system tumors. Curr Opin Neurol. 1996 Dec;9(6):424-8. doi: 10.1097/00019052-199612000-00005.
**PMID:** 9007399
**Citation:** Englot DJ, Chang EF, Vecht CJ. Epilepsy and brain tumors. Handb Clin Neurol. 2016;134:267-85. doi: 10.1016/B978-0-12-802997-8.00016-5.
**PMID:** 26948360
**Citation:** Liigant A, Haldre S, Oun A, Linnamagi U, Saar A, Asser T, Kaasik AE. Seizure disorders in patients with brain tumors. Eur Neurol. 2001;45(1):46-51. doi: 10.1159/000052089.
**PMID:** 11150841
**Citation:** Xie M, Wang X, Duan Z, Luan G. Low-grade epilepsy-associated neuroepithelial tumors: Tumor spectrum and diagnosis based on genetic alterations. Front Neurosci. 2023 Jan 9;16:1071314. doi: 10.3389/fnins.2022.1071314. eCollection 2022.
**PMID:** 36699536
**Citation:** Hwang SL, Lin CL, Lee KS, Lieu AS, Kuo TH, Chang CZ, Yen CP, Lin CK, Loh JK, Huang TY, Howng SL. Factors influencing seizures in adult patients with supratentorial astrocytic tumors. Acta Neurochir (Wien). 2004 Jun;146(6):589-94: discussion 594. doi: 10.1007/s00701-004-0266-8. Epub 2004 May 24.
**PMID:** 15168227
**Citation:** Yuen TI, Morokoff AP, Bjorksten A, D'Abaco G, Paradiso L, Finch S, Wong D, Reid CA, Powell KL, Drummond KJ, Rosenthal MA, Kaye AH, O'Brien TJ. Glutamate is associated with a higher risk of seizures in patients with gliomas. Neurology. 2012 Aug 28;79(9):883-9. doi: 10.1212/WNL.0b013e318266fa89. Epub 2012 Jul 25.
**PMID:** 22843268
**Citation:** Andronesi OC, Kim GS, Gerstner E, Batchelor T, Tzika AA, Fantin VR, Vander Heiden MG, Sorensen AG. Detection of 2-hydroxyglutarate in IDH-mutated glioma patients by in vivo spectral-editing and 2D correlation magnetic resonance spectroscopy. Sci Transl Med. 2012 Jan 11;4(116):116ra4. doi: 10.1126/scitranslmed.3002693.
**PMID:** 22238332
**Citation:** Nagashima H, Tanaka K, Sasayama T, Irino Y, Sato N, Takeuchi Y, Kyotani K, Mukasa A, Mizukawa K, Sakata J, Yamamoto Y, Hosoda K, Itoh T, Sasaki R, Kohmura E. Diagnostic value of glutamate with 2-hydroxyglutarate in magnetic resonance spectroscopy for IDH1 mutant glioma. Neuro Oncol. 2016 Nov;18(11):1559-1568. doi: 10.1093/neuonc/now090. Epub 2016 May 5.
**PMID:** 27154922
**Citation:** Englot DJ, Magill ST, Han SJ, Chang EF, Berger MS, McDermott MW. Seizures in supratentorial meningioma: a systematic review and meta-analysis. J Neurosurg. 2016 Jun;124(6):1552-61. doi: 10.3171/2015.4.JNS142742. Epub 2015 Dec 4.
**PMID:** 26636386
**Citation:** Yap KY, Chui WK, Chan A. Drug interactions between chemotherapeutic regimens and antiepileptics. Clin Ther. 2008 Aug;30(8):1385-407. doi: 10.1016/j.clinthera.2008.08.011.
**PMID:** 18803983
**Citation:** van der Meer PB, Dirven L, van den Bent MJ, Preusser M, Taphoorn MJB, Ruda R, Koekkoek JAF. Prescription preferences of antiepileptic drugs in brain tumor patients: An international survey among EANO members. Neurooncol Pract. 2021 Oct 21;9(2):105-113. doi: 10.1093/nop/npab059. eCollection 2022 Apr. Erratum In: Neurooncol Pract. 2022 Oct 19;10(1):106.
**PMID:** 35371521
**Citation:** Maschio M, Dinapoli L, Sperati F, Pace A, Fabi A, Vidiri A, Muti P. Levetiracetam monotherapy in patients with brain tumor-related epilepsy: seizure control, safety, and quality of life. J Neurooncol. 2011 Aug;104(1):205-14. doi: 10.1007/s11060-010-0460-x. Epub 2010 Nov 25.
**PMID:** 21107994
**Citation:** de Bruin ME, van der Meer PB, Dirven L, Taphoorn MJB, Koekkoek JAF. Efficacy of antiepileptic drugs in glioma patients with epilepsy: a systematic review. Neurooncol Pract. 2021 May 28;8(5):501-517. doi: 10.1093/nop/npab030. eCollection 2021 Oct.
**PMID:** 34589231
**Citation:** Kumar A, Maini K, Kadian R. Levetiracetam. 2023 Dec 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK499890/
**PMID:** 29763065
**Citation:** Li ZR, Wang CY, Zhu X, Jiao Z. Population Pharmacokinetics of Levetiracetam: A Systematic Review. Clin Pharmacokinet. 2021 Mar;60(3):305-318. doi: 10.1007/s40262-020-00963-2. Epub 2021 Jan 15.
**PMID:** 33447943
**Citation:** Howard P, Remi J, Remi C, Charlesworth S, Whalley H, Bhatia R, Hitchens M, Mihalyo M, Wilcock A. Levetiracetam. J Pain Symptom Manage. 2018 Oct;56(4):645-649. doi: 10.1016/j.jpainsymman.2018.07.012. Epub 2018 Jul 21.
**PMID:** 30036676
**Citation:** Dewan MC, Thompson RC, Kalkanis SN, Barker FG 2nd, Hadjipanayis CG. Prophylactic antiepileptic drug administration following brain tumor resection: results of a recent AANS/CNS Section on Tumors survey. J Neurosurg. 2017 Jun;126(6):1772-1778. doi: 10.3171/2016.4.JNS16245. Epub 2016 Jun 24.
**PMID:** 27341048
**Citation:** Rosati A, Buttolo L, Stefini R, Todeschini A, Cenzato M, Padovani A. Efficacy and safety of levetiracetam in patients with glioma: a clinical prospective study. Arch Neurol. 2010 Mar;67(3):343-6. doi: 10.1001/archneurol.2009.335.
**PMID:** 20212232
**Citation:** Lim DA, Tarapore P, Chang E, Burt M, Chakalian L, Barbaro N, Chang S, Lamborn KR, McDermott MW. Safety and feasibility of switching from phenytoin to levetiracetam monotherapy for glioma-related seizure control following craniotomy: a randomized phase II pilot study. J Neurooncol. 2009 Jul;93(3):349-54. doi: 10.1007/s11060-008-9781-4. Epub 2009 Jan 24.
**PMID:** 19169651
**Citation:** Chamberlain JM, Kapur J, Shinnar S, Elm J, Holsti M, Babcock L, Rogers A, Barsan W, Cloyd J, Lowenstein D, Bleck TP, Conwit R, Meinzer C, Cock H, Fountain NB, Underwood E, Connor JT, Silbergleit R; Neurological Emergencies Treatment Trials; Pediatric Emergency Care Applied Research Network investigators. Efficacy of levetiracetam, fosphenytoin, and valproate for established status epilepticus by age group (ESETT): a double-blind, responsive-adaptive, randomised controlled trial. Lancet. 2020 Apr 11;395(10231):1217-1224. doi: 10.1016/S0140-6736(20)30611-5. Epub 2020 Mar 20. Erratum In: Lancet. 2023 May 6;401(10387):1498.
**PMID:** 32203691
**Citation:** Roberti R, Rocca M, Iannone LF, Gasparini S, Pascarella A, Neri S, Cianci V, Bilo L, Russo E, Quaresima P, Aguglia U, Di Carlo C, Ferlazzo E. Status epilepticus in pregnancy: a literature review and a protocol proposal. Expert Rev Neurother. 2022 Apr;22(4):301-312. doi: 10.1080/14737175.2022.2057224. Epub 2022 Apr 7.
**PMID:** 35317697
**Citation:** Cucchiara F, Pasqualetti F, Giorgi FS, Danesi R, Bocci G. Epileptogenesis and oncogenesis: An antineoplastic role for antiepileptic drugs in brain tumours? Pharmacol Res. 2020 Jun;156:104786. doi: 10.1016/j.phrs.2020.104786. Epub 2020 Apr 8.
**PMID:** 32278037
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000016543
- Term: Central Nervous System Neoplasms
- ID: D000009423
- Term: Nervous System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
### Condition Browse Module - Browse Leaves
- ID: M15452
- Name: Seizures
- Relevance: HIGH
- As Found: Seizures
- ID: M5209
- Name: Brain Neoplasms
- Relevance: HIGH
- As Found: Brain Tumor
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M18937
- Name: Central Nervous System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12367
- Name: Nervous System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001932
- Term: Brain Neoplasms
- ID: D000012640
- Term: Seizures
### Intervention Browse Module - Ancestors
- ID: D000000927
- Term: Anticonvulsants
- ID: D000018697
- Term: Nootropic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: AntiConv
- Name: Anticonvulsants
- Abbrev: NootAg
- Name: Nootropic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
### Intervention Browse Module - Browse Leaves
- ID: M1741
- Name: Levetiracetam
- Relevance: HIGH
- As Found: Deltoid
- ID: M4246
- Name: Anticonvulsants
- Relevance: LOW
- As Found: Unknown
- ID: M340819
- Name: polysaccharide-K
- Relevance: LOW
- As Found: Unknown
- ID: M20774
- Name: Nootropic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000077287
- Term: Levetiracetam
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442735
**Acronym:** IPUS
**Brief Title:** Clinical Application of Intrapartum Ultrasound
**Official Title:** Vaginal Delivery Facilitated by Intrapartum Ultrasound During Labor
#### Organization Study ID Info
**ID:** A2023-264-01
#### Organization
**Class:** OTHER
**Full Name:** Third Affiliated Hospital, Sun Yat-Sen University
### Status Module
#### Completion Date
**Date:** 2023-12-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-31
**Type:** ACTUAL
#### Start Date
**Date:** 2022-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Third Affiliated Hospital, Sun Yat-Sen University
#### Responsible Party
**Investigator Affiliation:** Third Affiliated Hospital, Sun Yat-Sen University
**Investigator Full Name:** Ping Li
**Investigator Title:** Clinical Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Intrapartum ultrasound monitoring is to be compared with conventional labor monitoring to clarify the accuracy of this technology, and then provide a basis for later related research.
**Detailed Description:** Intrapartum ultrasound monitoring is to be compared with conventional labor monitoring to clarify the accuracy of this technology, and then provide a basis for later related research. All pregnant women intending to have a vaginal delivery were enrolled in the study. After admission, women were randomly assigned to either intrapartum ultrasound (IPUS) or vaginal examination (VE). In IPUS group, the patient was evaluated by ultrasound, including fetal orientation, pelvic and cervical conditions. IPUS and VE were performed every 2 to 4 hours during the first stage of labor and at least hourly during the second stage. The progress of labor, the occurrence of complications and the prediction of the success rate of vaginal delivery were observed. Finally, the investigators compared whether there were any differences in labor and vaginal delivery complications between the two groups.
### Conditions Module
**Conditions:**
- Abnormal Labor
- Complication of Delivery
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 455
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** IPUS group women were performed pelvic examination at admission and every 2 to 4 hours during the first stage of labor and at least hourly during the second stage by intrapartum ultrasound.
**Intervention Names:**
- Other: intrapartum ultrasound
**Label:** Intrapartum ultrasound
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** VE group women were performed pelvic examination at admission and every 2 to 4 hours during the first stage of labor and at least hourly during the second stage by vaginal examination.
**Intervention Names:**
- Other: vaginal examination
**Label:** Vaginal examination
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intrapartum ultrasound
**Description:** In IPUS group, the patient's labor was observed by intrapartum ultrasound.
**Name:** intrapartum ultrasound
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Vaginal examination
**Description:** In VE group, the patient's labor was observed by vaginal examination.
**Name:** vaginal examination
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Medical record about the length of first stage of labor
**Measure:** Duration of the first stage of labor
**Time Frame:** Day 1
**Description:** Medical record about the length of second stage of labor
**Measure:** Duration of the second stage of labor
**Time Frame:** Day 1
**Description:** physiological parameter about the body temperature when the patient has fever
**Measure:** Number of Participants with fever
**Time Frame:** Day 3
**Description:** clinical assessment about the soft birth canal laceration after labor, including I(Perineal skin and vaginal entrance mucosa laceration, little bleeding）, II（The lacerated injury has reached the fascia and muscle layer of the perineum, involved the mucous membrane of the posterior wall of the vagina, extended to the groove on both sides of the posterior wall of the vagina and tore upward, the anatomical structure is not easy to identify, and there is more bleeding）,III（The lacerated wound extends deep into the perineum, the external anal sphincter is broken, and the rectal mucosa is intact）, IV（The anus, rectum and vagina are completely penetrated, the rectointestinal cavity is exposed, the histological tissue is seriously damaged）
**Measure:** Number of Participants with the soft birth canal laceration I, II,III, IV
**Time Frame:** Day 1
**Description:** total postpartum blood loss in 24 hours measured by weighing method
**Measure:** Number of Participants with postpartum hemorrhage
**Time Frame:** Day 1
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* All pregnant women in the delivery room for vaginal trial labor
Exclusion Criteria:
* Those who reject ultrasound
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Guangzhou
**Country:** China
**Facility:** Third Affiliated Hospital of Sun Yat-Sen University
**State:** Guangdong
**Zip:** 510630
### IPD Sharing Statement Module
**Description:** All data generated or analyzed during this study are available from the Central Contact Person on reasonable request.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007744
- Term: Obstetric Labor Complications
- ID: D000011248
- Term: Pregnancy Complications
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7594
- Name: Dystocia
- Relevance: HIGH
- As Found: Abnormal Labor
- ID: M10764
- Name: Obstetric Labor Complications
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004420
- Term: Dystocia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442722
**Brief Title:** Surgical Treatment of DDH With and Without Capsulorrhaphy
**Official Title:** Evaluation of Surgical Treatment Outcomes for Developmental Dysplasia of Hip With and Without Capsulorrhaphy : a Comparative Study
#### Organization Study ID Info
**ID:** Soh-Med-24-04-06MD
#### Organization
**Class:** OTHER
**Full Name:** Sohag University
### Status Module
#### Completion Date
**Date:** 2025-12-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-02
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sohag University
#### Responsible Party
**Investigator Affiliation:** Sohag University
**Investigator Full Name:** Ali Abdelaal Bakheet
**Investigator Title:** assistant lecturer
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The goal of this interventional study is to evaluates the surgical treatment outcomes of Developmental Dysplasia of Hip with and without capsulorrhaphy between 1-6 years of age . it compares the effectiveness of these approaches in improving postoperative stability , range of motion , and long-term success rates for DDH patients undergoing surgery .:
### Conditions Module
**Conditions:**
- Developmental Dysplasia of the Hip
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** one group will undergo capsulorrhaphy, a surgical procedure to tighten the hip capsule
**Intervention Names:**
- Procedure: DDH with capsulorrhaphy
**Label:** DDH with capsulorrhaphy
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** group has no tightness of the hip capsule
**Intervention Names:**
- Procedure: DDH without capsulorrhaphy
**Label:** DDH without capsulorrhaphy
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- DDH with capsulorrhaphy
**Description:** group will undergo capsulorrhaphy, a surgical procedure to tighten the hip capsule ,
**Name:** DDH with capsulorrhaphy
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- DDH without capsulorrhaphy
**Description:** group will not undergo capsulorrhaphy, a surgical procedure without tightness the hip capsule
**Name:** DDH without capsulorrhaphy
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** radiological
**Measure:** Severin's grading
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. age: from 1 year to 6 years
2. sex: males and females
3. Children who received no operative treatment before.
Exclusion Criteria:
1. Children who were treated operatively before presentation.
2. Children who had teratologic, post septic or neuromuscular hip dislocation.
**Healthy Volunteers:** True
**Maximum Age:** 6 Years
**Minimum Age:** 1 Year
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** ali.mohamed@med.sohag.edu.eg
**Name:** Ali Bakheet, ass. lecturer
**Phone:** 020-01010505552
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Sohag
**Contacts:**
***Contact 1:***
- **Email:** ali.mohamed@med.sohag.edu.eg
- **Name:** Ali Bakheet, ass.lecturer
- **Phone:** 020-01010505552
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Sohag Faculty Medicin
**Zip:** 82716
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006617
- Term: Hip Dislocation
- ID: D000004204
- Term: Joint Dislocations
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000009139
- Term: Musculoskeletal Abnormalities
- ID: D000000013
- Term: Congenital Abnormalities
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: All
- Name: All Conditions
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M2363
- Name: Developmental Dysplasia of the Hip
- Relevance: HIGH
- As Found: Developmental Dysplasia of the Hip
- ID: M9694
- Name: Hip Dislocation, Congenital
- Relevance: HIGH
- As Found: Developmental Dysplasia of the Hip
- ID: M7385
- Name: Joint Dislocations
- Relevance: LOW
- As Found: Unknown
- ID: M9693
- Name: Hip Dislocation
- Relevance: LOW
- As Found: Unknown
- ID: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12
- Name: Congenital Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M12096
- Name: Musculoskeletal Abnormalities
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000082602
- Term: Developmental Dysplasia of the Hip
- ID: D000006618
- Term: Hip Dislocation, Congenital
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442709
**Brief Title:** Combined Anti-IL6R and Anticoagulation Therapy in Advanced NPC Patients
**Official Title:** Combined Anti-IL6R and Anticoagulation Therapy Improves Prognosis in Patients With Advanced Nasopharyngeal Carcinoma
#### Organization Study ID Info
**ID:** 2023-K015
#### Organization
**Class:** OTHER
**Full Name:** Affiliated Hospital of Nantong University
### Status Module
#### Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-08-01
**Type:** ACTUAL
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-25
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Affiliated Hospital of Nantong University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The investigators have demonstrated the crucial role of the liver-lung axis in the distant metastasis of NPC. Furthermore, the investigators have identified a potential therapeutic approach to improve outcomes in NPC patients by identifying those most suitable for anticoagulant therapy. Further, the combination of anticoagulant therapy and anti-IL6R therapy has shown promising results in enhancing the prognosis of NPC patients. These findings highlight the significance of targeting the liver-lung axis and utilizing personalized treatment strategies for NPC.
**Detailed Description:** Distant metastasis accounts for nasopharyngeal carcinoma (NPC)-related mortalities. Recently, extracellular vesicles (EVs) have been widely explored as key mediators of bidirectional tumor-host cell interactions by mediating pre-metastatic niche (PMN) formation. However, considering the complexity of the human body, multiple organ studies of tumor metastasis remain poorly understood. Here, the investigators have demonstrated the crucial role of the liver-lung axis in the distant metastasis of NPC. The investigators demonstrated mechanistically that hepatocellular derived EVs can be specifically taken up by the lung to form a hypercoagulable pre-metastatic microenvironment associated with IL6.Furthermore, the investigators have identified a potential therapeutic approach to improve outcomes in NPC patients by identifying those most suitable for anticoagulant therapy. Further, the combination of anticoagulant therapy and anti-IL6R therapy has shown promising results in enhancing the prognosis of NPC patients. These findings highlight the significance of targeting the liver-lung axis and utilizing personalized treatment strategies for NPC.
### Conditions Module
**Conditions:**
- Nasopharyngeal Carcinoma
**Keywords:**
- nasopharyngeal narcinoma
- metastasis
- extracellular vesicles
- organ-organ crosstalk
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Tocilizumab, an IL6R inhibitor, injected once a month at a dose of 4mg/kg in advanced NPC patients.
Asprin，an anticoagulant, taken orally once daily at a dose of 100mg in advanced NPC patients.
**Intervention Names:**
- Drug: Tocilizumab Asprin
**Label:** Combined Anti-IL6R and Anticoagulation Therapy in Advanced NPC Patients
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Placebo replaces tocilizumab and asprin in advanced NPC patients.
**Intervention Names:**
- Other: Placebo
**Label:** Receive placebo in Advanced NPC Patients
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Combined Anti-IL6R and Anticoagulation Therapy in Advanced NPC Patients
**Description:** Tocilizumab alone, Asprin alone, Tocilizumab combined with Asprin. Tocilizumab, an IL6R inhibitor, injected once a month at a dose of 4mg/kg in advanced NPC patients.
Asprin，an anticoagulant, taken orally once daily at a dose of 100mg in advanced NPC patients.
**Name:** Tocilizumab Asprin
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Receive placebo in Advanced NPC Patients
**Description:** Placebo replaces tocilizumab and asprin in advanced NPC patients.
**Name:** Placebo
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** After the patients are diagnosed and treated, CT scans is used semi-annually to determine the progression and metastasis of tumor.
**Measure:** Tumor progression and metastasis
**Time Frame:** Five to Ten years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Clinical diagnosis of NPC with distant metastasis
* Must be able to swallow tablets
Exclusion Criteria:
* Liver disease
* Blood disease
* Long-term use of anticoagulants
**Maximum Age:** 70 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Nantong
**Country:** China
**Facility:** Bo You
**State:** Jiangsu
**Zip:** 226000
#### Overall Officials
**Official 1:**
**Affiliation:** Department of Otorhinolaryngology-Head and Neck Surgery, Affiliated Hospital of Nantong University
**Name:** Bo You, Doctor
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Researchers must clearly state the purpose of their study and ensure it aligns with the scientific objectives of the data sharing initiative. A detailed research plan, including research design, data analysis methods, and expected results, should be provided to ensure the data is used in a reasonable and effective manner. Additionally, researchers must outline data security and privacy protection measures to ensure the safe storage, transmission, and use of the data in compliance with relevant regulations and policies.
**Description:** Study protocol, statistical analysis plan, informed consent form, clinical study report, and analytic code will be shared to other researchers.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** Two years after this clinical trial finished.
## 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: D000009303
- Term: Nasopharyngeal Neoplasms
- ID: D000010610
- Term: Pharyngeal Neoplasms
- ID: D000010039
- Term: Otorhinolaryngologic Neoplasms
- ID: D000006258
- Term: Head and Neck Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009302
- Term: Nasopharyngeal Diseases
- ID: D000010608
- Term: Pharyngeal Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000010038
- Term: Otorhinolaryngologic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M1730
- Name: Nasopharyngeal Carcinoma
- Relevance: HIGH
- As Found: Nasopharyngeal Carcinoma
- ID: M12307
- Name: Neoplasm Metastasis
- 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: M12254
- Name: Nasopharyngeal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M13517
- Name: Pharyngeal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12962
- Name: Otorhinolaryngologic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M9348
- Name: Head and Neck Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12253
- Name: Nasopharyngeal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13515
- Name: Pharyngeal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12961
- Name: Otorhinolaryngologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4047
- Name: Nasopharyngeal Carcinoma
- Relevance: HIGH
- As Found: Nasopharyngeal Carcinoma
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000077274
- Term: Nasopharyngeal Carcinoma
### Intervention Browse Module - Browse Branches
- Abbrev: AnCoag
- Name: Anticoagulants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4244
- Name: Anticoagulants
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442696
**Brief Title:** Effect Of HCP On Nutrition, Physical Activity And Body Mass Index
**Official Title:** Effect Of Healthy Choices Program On Nutrition, Physical Activity And Body Mass Index In Adolescents
#### Organization Study ID Info
**ID:** 123
#### Organization
**Class:** OTHER
**Full Name:** Bahçeşehir University
### Status Module
#### Completion Date
**Date:** 2023-01-15
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-06-15
**Type:** ACTUAL
#### Start Date
**Date:** 2022-05-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-07
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Bahçeşehir University
#### Responsible Party
**Investigator Affiliation:** Bahçeşehir University
**Investigator Full Name:** Tugba Duygu Ozmet
**Investigator Title:** Instructor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to test effectiveness of "The Healthy Choices Program, in adolescents. The main question\[s\] it aims to answer are:
1. Effectiveness of Healthy Choices on Body Mass Index
2. Effectiveness of Healthy Choices on Health Attitude, Nutrition and Physical Activity Knowledge
3. Effectiveness of Healthy Choices on Fruit,vegetable, water consumption
**Detailed Description:** In our study, a quasi-experimental design with a pre-test and post-test control group was used. This study was carried out between May 2022 and January 2023. 150 adolescents in the 5th, 6th and 7th grades of two secondary schools in Istanbul were included in the study. One of the schools was designated as the intervention group (n=75) and the other as the control group (n=75). Six sessions of training were given to the intervention group. Data were collected using the Descriptive Characteristics Form, Healthy Habits Questionnaire, Adolescent Attitude Scale, Adolescent Physical Activity Knowledge Scale, Adolescent Nutrition Knowledge Scale and Physical Activity Questionnaire. Chi-square test, t test, Mann-Whitney U test, Wilcoxon test were used to analyze the data.
### Conditions Module
**Conditions:**
- Obesity
- Adolescent Obesity
**Keywords:**
- School nursing
- Healthy choices
- Nutrition
- Physical Activity
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 150
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 10-14 years old adolescent are given health education Health education was given
**Intervention Names:**
- Other: Health Education: Healthy Choices Program
**Label:** Intervention Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** 10-14 years old adolescent are not given health education
**Label:** Control Group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention Group
**Description:** Six session for students and school personel
**Name:** Health Education: Healthy Choices Program
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** It was measured by using Healthy Habits Questionnaire. (Item 1:How many servings of ruits or vegetables do you eat a day? (One serving is most easily identified by the size of the palm of your hand.) There is no scoring for this questionnaire.
**Measure:** Increasing consumption of fruit and vegetables in the experimental group
**Time Frame:** Up to six months
**Description:** It was measured by using the Healthy Habits Questionnaire. (Item 5:How many hours a day do you watch TV/movies or sit and play video/computer games? There is no scoring for this questionnaire.)
**Measure:** Decreasing screen time of adolescents in the experimental group
**Time Frame:** Up to six months
**Description:** It was measured using the Healthy Habits and Physical Activity Questionnaire. In Healthy Habits Questionnaire Item 8:How much time a day do you spend in active play (faster breathing/heart rate or sweating)? was used. The Physical Activity Questionnaire is a 7-day recall-based measurement tool designed to assess overall physical activity levels throughout the school year.The minimum score for each item of the questionnaire is 1 and the maximum score is 5. The minimum score to be obtained from questionnaire is 9 and the maximum score is 45. Item 10 is not included in scoring.
**Measure:** Increasing physical activity level of adolescents in the experimental group
**Time Frame:** Up to six months
**Description:** It was measured by Healthy Habits Questionnaire (Item 9:How How many 8-ounce servings of the following do you drink a day (soda,fruit juice,sport drinks)
**Measure:** Decreasing consumption sugary drinks of adolescents in the experimental group
**Time Frame:** Up to six months
#### Secondary Outcomes
**Description:** It was measured by using Healthy Habits Questionnaire (Item 9:How many 8-ounce servings of the following do you drink water/milk a day?)There is no scoring for this questionnaire.
**Measure:** Increasing consumption water and milk of adolescents in the experimental group
**Time Frame:** Up to six months
**Description:** It was measured using the healthy lifestyle attitude scale. The scale was composed of 14 items to determine adolescents' attitudes toward nutrition, physical activity, and sleep behavior. The responses are scored on a 5-point Likert-type scale ranging from strongly disagree (1) to agree (5) strongly. The Cronbach's alpha of the original scale is 0.84 and the item-total score correlations are between 0.43 and 0.68 .
**Measure:** Increasing healthy lifestyle attitude scale score of adolescents in the experimental group
**Time Frame:** Up to six months
**Description:** It was measured using the adolescent nutrition knowledge scale. The scale consisted of 20 items and was developed to determine the level of knowledge about nutrition in adolescents, such as the types of nutrients, portion size, and eating habits. The answer categories of each question are structured as "yes", "no" or "do not know". The Cronbach's alpha of the original scale is 0.86, and item-total score correlations are between 0.13 and 0.59.
**Measure:** Increasing adolescent nutrition knowledge of adolescents in the experimental group
**Time Frame:** Up to six months
**Description:** It was measured using the adolescent activity knowledge scale. The Activity Scale consists of 12 items and was developed to determine the knowledge level of physical activity and exercise in adolescents. The answers categories of each question are structured as "yes", "no", and "do not know". The Cronbach's alpha of the original scale is 0.69, and item-total score correlations are between 0.22 and 0.46.
**Measure:** Increasing Adolescent activity knowledge of adolescents in the experimental group
**Time Frame:** Up to six months
**Description:** The weight and height of adolescents were measured by the researcher. Tanita Bc-730 was used as a weighing machine. Mesilife Mst-200 was used as a height meter. They were measured in schools. After, body mass indexes were calculated for each adolescent.
**Measure:** Reducing Body Mass Index of adolescents in the experimental group
**Time Frame:** Up to six months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male and female adolescents in 6th, 7th and 8th grades
* Adolescents without mental disabilities
* Families and adolescents who agree to participate in the study
Exclusion Criteria:
* Families and adolescents who did not agree to participate in the study were not included in the study.
**Gender Based:** True
**Healthy Volunteers:** True
**Maximum Age:** 14 Years
**Minimum Age:** 10 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** Tugba Duygu OZMET
**Zip:** 34100
#### Overall Officials
**Official 1:**
**Affiliation:** Bahçeşehir University
**Name:** Tugba D Ozmet, PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Bahçeşehir University
**Name:** Tugba D Ozmet, PhD
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000050177
- Term: Overweight
- ID: D000044343
- Term: Overnutrition
- ID: D000009748
- Term: Nutrition Disorders
- ID: D000001835
- Term: Body Weight
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12701
- Name: Obesity
- Relevance: HIGH
- As Found: Obesity
- ID: M30155
- Name: Pediatric Obesity
- Relevance: HIGH
- As Found: Adolescent Obesity
- ID: M26186
- Name: Overweight
- Relevance: LOW
- As Found: Unknown
- ID: M25307
- Name: Overnutrition
- Relevance: LOW
- As Found: Unknown
- ID: M12684
- Name: Nutrition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5114
- Name: Body Weight
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009765
- Term: Obesity
- ID: D000063766
- Term: Pediatric Obesity
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442683
**Acronym:** SimuEchoNeo
**Brief Title:** Efficacy of Simulation-based Neonatal Echocardiography Training (SimuEchoNeo)
**Official Title:** Efficacy of Simulation-based Neonatal Echocardiography Training: a Randomized Controlled Trial
#### Organization Study ID Info
**ID:** ID2259
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Caen
### Status Module
#### Completion Date
**Date:** 2023-10-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-03
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-10-31
**Type:** ACTUAL
#### Start Date
**Date:** 2021-05-02
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Caen
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Echocardiographic examination plays a critical role in neonatology, but its bedside training faces challenges due to limited patient access. While simulation training has proven effective in different fields of adult medical care, its application in neonatal echocardiography remains unexplored.
Researchers will compare simulation-based training to usual training (theorical and bedside) for neonatal echocardiography among pediatric residents to see if simulation-trained residents have better skills.
Participants will undergo :
* theorial, simulation-based and bedside training or
* theorical and bedside training only.
**Detailed Description:** All participants were granted full access to the online theorical course throughout the semester of participation, which encompass a presentation of the study and a theorical training. In addition, during their Neonatal Intensive Care Unit (NICU) residency/night shifts, all residents had the possibility to learn bedside transthoracic echocardiography (TTE) and document their experiences using a collection form provided at the time of inclusion.
Beyond access to the e-learning, the simulation group participated in standardized training using the neonatal simulator EchoCom\|Neo during the first month of their 6-month residency in NICU. The training session involved a maximum of four residents at the same time, one teacher and one EchoCom\|Neo simulator.
The session consisted of the modified Peyton 4-steps process (demonstration, deconstruction, comprehension, performance) with the normal heart scenario set on the simulator, presentation of a persistent ductus arteriosus (PDA), a pericardial effusion case and an evaluation of each resident individually, on the simulator set with normal heart scenario, performing a TTE with a description of the visible structures. The minimum passing score for the validation of the training session was set at 12 out of 14 (reference score, table 1). If the minimum passing score was not achieved, a second training session must have been scheduled until the minimum passing score was reached.
The entire simulation session typically lasted between 2.5 to 3 hours. For standardization of training sessions, pre-registered videos were used whenever applicable (presentation of the simulation session, presentation of the simulator, and first and second Peyton's steps), and the training was conducted by the same teacher throughout the study, in the respective hospital of each resident (Caen, Rouen or Tours).
Two evaluation timepoints were defined at the middle (3 to 4 months after initial training, M3-M4), and at the end of the 6-month residency (6 months after the training, M6).
The evaluation session took place using the EchoCom\|Neo simulator (EchoCom GmbH, Nieheim, Germany), set with the normal heart scenario, and placed on an open neonatal warmer, in the respective hospital of each resident. Each resident was evaluated individually with video recording for second evaluation.
Before starting the evaluation, each resident had 5 minutes to familiarize themselves with the handling of the simulator probe. They were asked to perform 7 TTE sections, with the teacher listing each expected TTE section at the beginning of the evaluation.
At each evaluation session, two evaluators conducted independent assessments. One evaluator was a pediatric cardiologist, blinded to the randomization, while the other was a pediatric resident (the simulation TTE training's teacher). One evaluator was physically present during the evaluation, while the other used video recording. Each evaluator assigned two scores for each resident:
* A reference score: 2 points for each section (optimal, suboptimal, not found), total out of 14 points.
* A custom-made score: 1 point for each anatomic structure within each section, emphasizing visualization and recognition of heart structures, total out of 33 points.
The duration of the TTE at 3 and 6 months were also recorded with second precision. Following the second evaluation at M6, the number of bedside TTE performed was documented, and a satisfaction questionnaire based on a Likert scale was requested.
### Conditions Module
**Conditions:**
- Simulation-based Training on Residents
**Keywords:**
- Neonatology
- Simulation-based training
- Echocardiography
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Multicentered randomized controlled trial.
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- CARE_PROVIDER
- OUTCOMES_ASSESSOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 52
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Theorical training, simulation-based training and bedside training
**Intervention Names:**
- Diagnostic Test: TTE simulation-based medical training
**Label:** Simulation group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Theorical and bedside training
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Simulation group
**Description:** half-day simulation-based neonatal echocardiography training.
**Name:** TTE simulation-based medical training
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Difference in TTE score at 3 months between the two groups
**Measure:** Transthoracic echocardiography (TTE) score at 3 months
**Time Frame:** 3 to 4 months after initial training
#### Secondary Outcomes
**Description:** Difference in TTE score at 6 months between the two groups
**Measure:** TTE score at 6 months
**Time Frame:** 6 months after initial training
**Description:** TTE duration at 3 and 6 months
**Measure:** TTE duration
**Time Frame:** 3-4 months and 6 months
**Description:** Satisfaction score over 25 points
**Measure:** Satisfaction score at 6 months
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* residents at all training levels (from first to fifth year) completing a 6-month residency or at least night shifts in neonatology at one of the 3 French NICUs involved (University Hospitals of Caen, Rouen or Tours)
Exclusion Criteria:
* Residents who had already received a TTE training (cardiology or cardiopediatrics 6-month residency or postgraduate training in cardiology or echocardiography)
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Caen
**Country:** France
**Facility:** University Hospital of Caen
**Zip:** 14000
**Location 2:**
**City:** Rouen
**Country:** France
**Facility:** University Hospital of Rouen
**Zip:** 76000
**Location 3:**
**City:** Tours
**Country:** France
**Facility:** University Hospital of Tours
**Zip:** Tours
### IPD Sharing Statement Module
**Description:** Deidentified individual participant data (including data dictionaries) will be made available, in addition to study protocols, the statistical analysis plan, and the informed consent form. The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to amelie.blanchetiere\[at\]unicaen.fr.
**Info Types:**
- STUDY_PROTOCOL
- ICF
- CSR
**IPD Sharing:** YES
**Time Frame:** when asked.
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442670
**Acronym:** ULIS
**Brief Title:** Understanding New Semantic Memory Learnings Across the Lifespan
**Official Title:** Understanding New Semantic Memory Learnings Across the Lifespan
#### Organization Study ID Info
**ID:** 2024-A00167-40
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Caen
### Status Module
#### Completion Date
**Date:** 2026-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-28
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Centre Hospitalier Universitaire de Besancon
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Caen
#### 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 research is to specify the changes in brain connectivity (i.e. EEG phase synchronisation between brain regions) associated with semantic learning between individuals belonging to different age groups.
**Detailed Description:** Semantic memory is a crucial concept in cognitive science. It has long been conceptualised as a static, amodal memory system containing knowledge about the world, concepts and symbols. Although recourse to this concept is inevitable, the mechanisms, both cognitive and neurobiological, that govern it are far from being elucidated. There are many debates and controversies in this fundamental field of cognitive science, and more specifically around the question of the acquisition and formation of knowledge in semantic memory. The literature on the development of semantic memory during ontogeny is full of contradictions.
A review of this literature highlights the many unanswered questions surrounding semantic memory. How quickly is information encoded and then consolidated into a format that justifies the term semantic knowledge? What are the neural bases underlying the formation of knowledge in semantic memory? How does semantic knowledge evolve through new episodes? How do these mechanisms evolve during ontogeny? To what extent can some semantic learning be preserved from cognitive ageing? In the face of these many questions, the literature highlights the lack of tasks enabling semantic memory to be approached in an operational manner and the need to specify the cerebral mechanisms involved at different ages of life.
The general hypotheses that will be tested as part of the ULIS project are as follows:
1. New semantic learning is possible independently of episodic memory processes.
2. This learning differs according to the age of the participants.
### Conditions Module
**Conditions:**
- Neurodevelopmental Changes (Childhood, Ageing)
**Keywords:**
- Semantic memory
- Childhood
- Ageing
- EEG
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Device: Electroencephalography
**Label:** 6-7 years children
#### Arm Group 2
**Intervention Names:**
- Device: Electroencephalography
**Label:** 10-11 years children
#### Arm Group 3
**Intervention Names:**
- Device: Electroencephalography
**Label:** 20-35 years adults
#### Arm Group 4
**Intervention Names:**
- Device: Electroencephalography
**Label:** 60-70 older adults
#### Arm Group 5
**Intervention Names:**
- Device: Electroencephalography
**Label:** 70-80 older adults
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 10-11 years children
- 20-35 years adults
- 6-7 years children
- 60-70 older adults
- 70-80 older adults
**Description:** Phase synchrony during the completion of the semantic memory task
**Name:** Electroencephalography
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Measure:** EEG Phase synchrony differences between age groups
**Time Frame:** Through study completion, an average of 2 years
#### Secondary Outcomes
**Measure:** Behavioral performance differences between age groups (semantic memory task)
**Time Frame:** through study completion, an average of 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Non-opposition by the participant or those exercising parental authority in the case of minors
* French language fluency (assessed by the investigating team)
* Absence of global cognitive deficit attested by a score on the MOCA (Montreal Cognitive Assessment) scale greater than or equal to 26/30 (test carried out at inclusion).
Exclusion Criteria:
* Person subject to a guardianship, curatorship or safeguard of justice measure
* Non affiliation to a social security scheme
**Maximum Age:** 80 Years
**Minimum Age:** 6 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Healthy volunteers
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** thomas.hinault@inserm.fr
**Name:** Thomas Hinault, PhD
**Phone:** +33231568140
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University Hospital, Caen
**Name:** Clémence Tomadesso
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442657
**Acronym:** DERM-H-PROTECT
**Brief Title:** Pressure Sore Prevention Strategy for the Prone Position
**Official Title:** Comparison of Two Care Strategies (5-layer Hydrocellular Dressings Versus Thick Hydrocolloid Dressings) in Preventing the Development of Pressure Sore Lesions Induced by Prone Positioning in Intensive Care Patients. Multicenter Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 2023-A00932-43
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Caen
### Status Module
#### Completion Date
**Date:** 2027-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-18
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Caen
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The aim of this clinical trial is to determine whether 5-layer hydrocellular dressings are effective in preventing the development of pressure sores during prone positioning in the intensive care unit. The main questions it aims to answer are:
- are hydrocellular dressings the best strategy for preventing pressure sores? is this strategy simpler and less costly? The researchers will compare hydrocellular dressings with hydrocolloid dressings to find out whether they are more effective in preventing the development of pressure sores in the prone position.
Participants will be given either hydrocellular or hydrocolloid dressings, and caregivers will assess whether or not pressure sores develop after prone positioning.
**Detailed Description:** Hydrocellular dressings will be compared with hydrocolloid dressings to determine their effectiveness in preventing pressure ulcers during ventral decubitus in intensive care. The dressings will cover the skin in at-risk areas, and caregivers will assess whether or not pressure sores develop in these areas after prone positioning. The stage of these pressure sores will also be assessed.
The time spent on each strategy and the cost per strategy will also be evaluated. Dressings will be applied for the entire period during which participants are placed in the prone position. If they develop pressure sores during this period, they will be followed up until their discharge from intensive care to study the evolution of these pressure sores.
### Conditions Module
**Conditions:**
- Pressure Ulcers Prevention in Prone Positioning in Intensive Care
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 180
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Application of hydrocellular dressings prior to prone positioning and standard pressure sore prevention strategy. Dressings can remain in place for up to 7 days.
**Intervention Names:**
- Other: Hydrocellular dressing
**Label:** Hydrocellular
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Application of hydrocolloids dressings prior to prone positioning and standard pressure sore prevention strategy. Dressings are removed after each prone position.
**Intervention Names:**
- Other: Hydrocolloids dressing
**Label:** Hydrocolloid
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Hydrocellular
**Description:** Application of hydrocellular dressings to at-risk areas prior to prone positioning. Assessment of pressure sores and their stage after prone positioning.
**Name:** Hydrocellular dressing
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Hydrocolloid
**Description:** Application of hydrocolloids dressings to at-risk areas prior to prone positioning.
**Name:** Hydrocolloids dressing
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Time to occurrence of a grade 2 or higher pressure ulcer in the intensive care unit in VD, according to the National Pressure Ulcer Advisory Panel (NPUAP) classification
**Measure:** Compare the time to onset of one or more pressure ulcers during Ventral Decubitus(VD) sessions in the ICU with the type of preventive dressing selected (thick hydrocolloid or 5-layer hydrocellular)
**Time Frame:** 30 minutes after being put back on its back
#### Secondary Outcomes
**Description:** Number of pressure sores (stages 1 to 4) on predetermined risk areas protected by both types of dressing (periorbital, malar, mandible/chin, thorax, shoulders, iliac crests, knees, other).
**Measure:** Compare the location of pressure sores between the two groups
**Time Frame:** 30 minutes after putting the participant back on his back
**Description:** Severity of pressure sore according to NPUAP classification (stages 1 to 4)
**Measure:** Compare the severity of pressure sores between the two groups
**Time Frame:** 30 minutes after putting the participant back on his back
**Description:** Evolution of the pressure sore according to NPUAP classification. During the VD period, assessment is carried out daily after repositioning in Dorsal Decubitus (DD). After the end of the DV, any dressings applied to treat a pressure sore will no longer be the randomized dressings, but the most suitable dressings according to the predefined management protocol . Classification of the pressure sore will be carried out at D7, D14, D28 or on the day of discharge from the intensive care unit
**Measure:** Compare the evolution of pressure sores between the two groups up to discharge from the intensive care unit.
**Time Frame:** 30 minutes after the participant has been put back on his back after each prone session, then at D7, D14 and D28 or at discharge from intensive care if the participant has had a pressure sore
**Description:** Time spent on each of the two care strategies in minutes
**Measure:** Compare the care required to apply, monitor and remove the two types of dressing
**Time Frame:** Three years
**Description:** Overall cost of each care strategy. An assessment of the direct cost of dressings will be made on the basis of the number recorded for each patient
**Measure:** Compare the cost of medical devices, by dressing strategy, until VD sessions are discontinued
**Time Frame:** Three years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Major patient
* Moderate to severe acute respiratory distress syndrom (Arterial oxygen pressure /Inspired Fraction of oxygen ratio \< 200) requiring at least one VD session.
* Affiliated to the French social security system
* Sedated patient on mechanical ventilation
Exclusion Criteria:
* Pregnant or breast-feeding women
* Patient under guardianship or trusteeship
* Minor patients
**Maximum Age:** 110 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** hamelin-a@chu-caen.fr
**Name:** Agathe Hamelin
**Phone:** 02.31.06.47.11
**Role:** CONTACT
**Contact 2:**
**Email:** tomadesso-c@chu-caen.fr
**Name:** Clémence Tomadesso
**Phone:** 02 31 06 53 86
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** CHU Caen
**Name:** Agathe Hamelin
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012883
- Term: Skin Ulcer
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M6870
- Name: Pressure Ulcer
- Relevance: HIGH
- As Found: Pressure Ulcer
- ID: M17206
- Name: Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M15686
- Name: Skin Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003668
- Term: Pressure Ulcer
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442644
**Brief Title:** Live Music in the Intensive Care Unit
**Official Title:** Live Music in the Intensive Care Unit
#### Organization Study ID Info
**ID:** 1-10-72-66-24
#### Organization
**Class:** OTHER
**Full Name:** Aarhus University Hospital
### Status Module
#### Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Region MidtJylland Denmark
**Class:** INDUSTRY
**Name:** Novo Nordisk A/S
**Class:** OTHER
**Name:** The Royal Conservatory of Music
#### Lead Sponsor
**Class:** OTHER
**Name:** Aarhus University Hospital
#### Responsible Party
**Investigator Affiliation:** Aarhus University Hospital
**Investigator Full Name:** Linette Thorn
**Investigator Title:** Specialized intensive care nurse
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this quasi-experimental pre- post test study is to test a patient-tailored live music intervention's effect on stress and pain reduction in adult, critically ill patients admitted to the intensive care unit.
The main question it aims to answer is:
• Does live music reduce stress and pain in adult intensive care patients?
In the pre-post test design, the patients will be their own control. There will be no randomisation. Researchers will compare measurements of heartrate, respiration rate, heartrate variability, blood pressure and pain before and after the live music intervention to see if live music effects these vital parameters.
Participants will listen to live music in their room in the intensive care unit for 5 to 15 minutes.
**Detailed Description:** 1. Introduction The intensive care unit (ICU) has been and is still undergoing paradigmatic changes and technological advancements, meaning that an increased number of patients are conscious during their ICU stay and more survive to remember their ICU admission. Patients are admitted to the ICU because they are in urgent need of life saving treatments. However, an ICU admission can be a traumatic experience for patients and their relatives. The ICU patient room is designed with the purpose of promoting advanced care and treatment performed by the healthcare professionals. However, the room leaves little space for positive sensory inputs for the patients and the relatives; rather the environment is a highly technological, noisy, unfamiliar and often frightening experience for the patients and their relatives - memories of this may follow them for years. In this project, the investigators aim to test patient-tailored live music as an intervention to reduce stress and pain for adult ICU patients.
2. Project aim The aim of this study is to test a patient-tailored live music intervention's effect on stress reduction in adult, critically ill patients admitted to the intensive care unit.
3. Design and analysis method The study is a quasi-experimental pre- post test study, with patients being their own control. The pre-post test measurements will be carried out at predefined time points (5 minutes before and 5 minutes after the intervention). Our primary outcome, the HRV, will be measured continuously 5 minutes before the music intervention, during the whole intervention and 5 minutes after the intervention. There will be no randomisation.
Relevant static calculations will be performed using Stata. Statistical analysis will be supported by a statistician at CONNECT (A data support centre for clinical and genomic data).
4. Music intervention This study will be performed in collaboration with the Royal Academy of Music, Aarhus, Denmark (RAMA) and ICU departments across Central Denmark Region, Aarhus University Hospital being main investigator.
The musicians have participated in a training programme after which they are able to carry out one-on-one patient-tailored music sessions for adult patients at the ICU carried out in the patient's room.
Each music intervention comprises three components: 1) A prior briefing by the nurse on the patients' condition relevant for the musical practice 2) A patient-tailored live music session in the patient room and 3) A debriefing with the nurse.
The musicians plan a programme for each intervention day, and the patients will therefore not have the opportunity to choose specific pieces of music. The musicians prepare a mix of relaxing, soothing, familiar and unknown music with low-pitched instruments, e.g., guitar and piano, in a slow tempo (60-80 beats per minute), with a predictable musical structure, rhythm, and tonality, as it has been shown that low-pitched and low-intensity music may be calming and may regulate arousal levels. The length of the music intervention will range from 5 to 15 minutes depending on how many music pieces the patient wants to listen to or based on the nurse's assessment of the patient's condition.
5. Sample size Aarhus University Hospital is the main research centre, but the study is a multi-centre study with participation of the Regional Hospitals of Gødstrup, Horsens and Viborg; all have agreed to participate. The intervention is fully implemented at all hospitals.
The sample size is calculated based on an estimated population of 1103, corresponding to the patients receiving the intervention at all four sites annually. The investigators have determined that a sample size of 202 is needed to estimate the effect with a confidence level of 95%, margin of error of 5% and population proportion of 80%.
Patients will be included consecutively.
6. Project organisation and feasibility As Aarhus University Hospital is the main study site and also the largest, the investigators will include the majority of patients. This means that the investigators will have a larger percentage of the total sample size than the regional hospitals. A project nurse will collect data at each site.
The project group consists of one project nurse and one nurse manager at each site.
Furthermore, the group consists of Professor in Nursing at Aarhus University Hospital Pia Dreyer, Associate Professor at The Royal Academy of Music (Aarhus/Aalborg) Margrethe Langer Bro, project nurse Linette Thorn and the main applicant. The results from this pretest-posttest study will be published in a peer-reviewed journal (e.g., Nursing in Critical Care). Results will also be presented at national and international conferences.
7. Impact of the project Instead of being exposed to an unpleasant room with little opportunity to rest their minds, patients (together with their relatives) will be given the opportunity to experience positive, musical stimuli that bring pleasant experiences and memories, which may support the patients mental well-being and rehabilitation both in the short and long term. The project has the potential to be implemented in more ICU departments across Denmark and potentially also in a broad range of non-ICU hospital departments.
### Conditions Module
**Conditions:**
- Stress
- Pain
**Keywords:**
- Intensive care unit
- Live music
- Quantitative
- Stress
- Pain
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 202
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Live music interventions
**Intervention Names:**
- Other: Live music in the intensive care unit
**Label:** Adult intensive care patients
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Adult intensive care patients
**Description:** To test a patient-tailored live music intervention's effect on stress reduction in adult, critically ill patients admitted to the intensive care unit.
**Name:** Live music in the intensive care unit
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** measured via the HeartMath Sensor, which is validated for measuring stress levels
**Measure:** Heartrate variability
**Time Frame:** baseline (10 minutes before listening to live music), during (5-15 minutes of listening to live music), after (10 minutes after listening to live music)
#### Secondary Outcomes
**Description:** Heart beat per minut
**Measure:** Heartrate
**Time Frame:** baseline (5 minutes before listening to live music), after (5 minutes after listening to live music)
**Description:** Monitoring pain on a scale of 0-10, where 0 is no pain and 10 is the worst pain imaginable
**Measure:** The patient's subjective pain experience via a numerical ranking scale (NRS)
**Time Frame:** baseline (5 minutes before listening to live music), after (5 minutes after listening to live music)
**Description:** Questionaire
**Measure:** Patient's self-reported stress level measured by STAI (State-Trait Anxiety Inventory) a validated short version to measure the stress level.
**Time Frame:** baseline (5 minutes before listening to live music), after (5 minutes after listening to live music)
**Description:** Mean arteriel blood pressure meassured by artery cannula
**Measure:** Blood pressure
**Time Frame:** baseline (5 minutes before listening to live music), after (5 minutes after listening to live music)
**Description:** Breaths per minut
**Measure:** Respiration rate
**Time Frame:** baseline (5 minutes before listening to live music), after (5 minutes after listening to live music)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults (\>18 years)
* Admitted to one of the four participating ICU departments for a minimum of 24 hours
* Able to read and speak Danish
* For incapable patients, it is necessary to have a close relative (e.g., spouse or adult child), as these will provide proxy consent for study participation
Exclusion Criteria:
* Unstable patients with a need of change/adjustment of the ongoing treatment of e.g. drug infusions or ventilator settings during the music intervention, as this can possibly affect the HRV measurements.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** linlauri@rm.dk
**Name:** Linette Thorn, Master
**Phone:** +0045 28917602
**Role:** CONTACT
**Contact 2:**
**Email:** annasoe6@rm.dk
**Name:** Anna Holm, post. doc
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Aarhus
**Contacts:**
***Contact 1:***
- **Email:** linlauri@rm.dk
- **Name:** Linette Thorn
- **Phone:** +4528917602
- **Role:** CONTACT
**Country:** Denmark
**Facility:** Aarhus University Hospital
**State:** Region Midtjylland
**Zip:** 8200
#### Overall Officials
**Official 1:**
**Affiliation:** Aarhus University Hospital
**Name:** Linette Thorn, Master
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442631
**Brief Title:** MyStroke for Stroke Survivors and Caregivers
**Official Title:** An Individualized Video-based Stroke Education Platform for Stroke Survivors and Caregivers
#### Organization Study ID Info
**ID:** 850498
#### Organization
**Class:** OTHER
**Full Name:** University of Pennsylvania
### Status Module
#### Completion Date
**Date:** 2029-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2029-03-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2025-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### 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:** True
### Description Module
**Brief Summary:** The goal of this multicenter randomized trial is to evaluate the impact of a personalized video-based stroke education platform on patient-centered and health system-centered outcomes. The main questions this study aims to address are:
1. Does a personalized, video-based educational platform improve stroke knowledge?
2. Does a personalized, video-based educational platform reduce post-discharge health system utilization?
3. Do different strategies of nudging improve engagement with educational material after hospital discharge?
In order to determine the effect of this personalized stroke education strategy, researchers will compare subjects who receive standard stroke education with those who receive the personalized stroke education platform in addition to standard standard education. Patient knowledge will be assessed 90-days after discharge. Study participants will include both stroke patients and caregivers, who will:
1. Receive standard education during the stroke hospitalization
2. Complete a survey on the day of hospital discharge to assess their baseline knowledge.
3. Half of the subjects will be randomly assigned to also receive access to the personalized stroke education platform on the day of discharge.
4. All subjects will complete two follow-up study visits (7 and 90 days after discharge) in order to complete surveys.
**Detailed Description:** Stroke education represents a unique opportunity to empower stroke survivors (and caregivers) to promote self-management, augment adherence, and reduce post-stroke healthcare utilization. Despite being a key quality metric for stroke centers, most patient and caregiver education is poorly retained and a common source of dissatisfaction. In fact, most survivors are unaware of the cause of their stroke, their modifiable risk factors, and how to properly respond to future stroke symptoms. Although there is no gold standard, most centers rely on a combination of bedside verbal communication and standardized printed materials. Prior work has clarified that effective and durable educational interventions benefit from engaging content, personalization, accessibility, and low cost/burden. Retention is very poor during the stroke hospitalization, but this can be overcome by promoting ongoing engagement after discharge.
To that end, our group developed a web-based educational platform (MyStroke) that leverages the electronic health record to personalize video-based educational content for each stroke survivor. Simple but engaging videos are curated to address each patient's stroke etiology, individualized risk factors, prescribed stroke prevention medications, and post-stroke lifestyle issues. This approach transforms point-of-care stroke education, and integrated nudges reveal opportunities for re-education and re-engagement after hospital discharge to achieve a durable impact. In a recent single-center pilot trial, MyStroke improved patient and caregiver satisfaction and improved key elements of stroke knowledge. The objective of this proposal is to build upon our encouraging preliminary experience and conduct a multicenter randomized trial to evaluate the impact of MyStroke on both patient-centered (stroke knowledge, self-efficacy, satisfaction, quality of life) and health system-centered outcomes (medication adherence and health system utilization).
Electronic nudges will leverage principles of behavioral economics (i.e. enhanced nudges) to promote ongoing engagement. Our preliminary data indicate that even bland nudges promote engagement, but here we propose to use both bland nudges and enhanced nudges, such that platform analytics will compare the influence of different nudge types. Use of technology in this context stands to bridge geographic distances, connect stakeholders, and increase access to information, but it important to recognize the potential to exacerbate inequities for elderly patients and those with limited access to technology. Issues of digital inclusivity will be evaluated to reveal opportunities for platform improvement. The MyStroke platform offers a scalable solution stroke education which imposes no burden on the clinical team due to its reliance on a limited number of input fields which can be harvested from the electronic health record to individualized content for each patient.
### Conditions Module
**Conditions:**
- Stroke, Acute
- Ischemic Stroke, Acute
**Keywords:**
- stroke education
- ischemic stroke
- stroke knowledge
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Masking Description:** Given the nature of the intervention (an educational platform), masking of participants is not feasible, but other key study members (and clinicians) will be blinded to the study assignment.
**Who Masked:**
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 586
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in this arm of the study will receive institutional standard stroke education during the course of the hospitalization, standardized across the 5 participating sites. Standard education consists of non-standardized verbal bedside education by the care team, a standardized stroke educational booklet, and standardized verbal instructions by the bedside nurse addressing stroke risk factors and medications.
**Label:** Standard stroke education
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** Participants in this arm of the study will receive institutional standard stroke education in addition to access to MyStroke, a personalized video-based education platform. Each participant will receive their personalized page via email or SMS, as per their preference, and they will receive automated nudges to visit educational material after hospital discharge.
**Intervention Names:**
- Behavioral: MyStroke
**Label:** MyStroke + standard stroke education
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MyStroke + standard stroke education
**Description:** MyStroke is a video-based educational platform that curates brief educational videos to inform patients and caregivers about key aspects of their stroke. Upon registering a user, information regarding the patient's stroke etiology, relevant stroke risk factors, and stroke prevention medications are used to populate educational content that is relevant to the individual. Users receive automated nudges to revisit MyStroke after hospital discharge on day 1, 3, 5, 7, and weekly thereafter.
**Name:** MyStroke
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Total score from the 5-question SPER (scale 0-10; higher score reflects better knowledge)
**Measure:** The Stroke Patient Education Retention (SPER) survey (7 days)
**Time Frame:** 7 days
**Description:** 5-point Likert-scale (Q: I am satisfied with the quality of my stroke education; Answers range from strongly disagree to strongly agree)
**Measure:** Patient satisfaction with stroke education (7 days)
**Time Frame:** 7 days
**Description:** The proportion of patients who correctly identify their stroke etiology (multiple choice)
**Measure:** Stroke etiology awareness (7 days)
**Time Frame:** 7 days
**Description:** The proportion of patients who correctly identify at least one of their vascular risk factors (select all that apply)
**Measure:** Stroke risk factor awareness (7 days)
**Time Frame:** 7 days
**Description:** The proportion of patients who correctly identify all prescribed antithrombotic medications (free response)
**Measure:** Antithrombotic medication awareness (7 days)
**Time Frame:** 7 days
**Description:** Total score from the 13 item questionnaire (each item scored 0-10; total score 0-130; higher scores represent higher levels of self-efficacy)
**Measure:** Stroke Self-Efficacy Questionnaire (SSEQ) (7 days)
**Time Frame:** 7 days
**Description:** A standardized measure of health-related quality of life across 5 domains. Each domain is scored using a 5-point ordinal scale (1-5), and the Level Sum Score (LSS) is calculated as the sum of the 5 scores (LSS range is 5-25, lower scores represent higher quality of life).
**Measure:** EuroQoL EQ-5D-5L (7 days)
**Time Frame:** 7 days
#### Primary Outcomes
**Description:** Total score from the 5-question SPER (scale 0-10; higher score reflects better knowledge)
**Measure:** The Stroke Patient Education Retention (SPER) survey
**Time Frame:** 90 days
#### Secondary Outcomes
**Description:** 5-point Likert-scale (Q: I am satisfied with the quality of my stroke education; Answers range from strongly disagree to strongly agree)
**Measure:** Patient satisfaction with stroke education
**Time Frame:** 90 days
**Description:** The proportion of patients who correctly identify their stroke etiology (multiple choice)
**Measure:** Stroke etiology awareness
**Time Frame:** 90 days
**Description:** The proportion of patients who correctly identify at least one of their vascular risk factors (select all that apply)
**Measure:** Stroke risk factor awareness
**Time Frame:** 90 days
**Description:** The proportion of patients who correctly identify all prescribed antithrombotic medications (free response)
**Measure:** Antithrombotic medication awareness
**Time Frame:** 90 days
**Description:** Total score from the 13 item questionnaire (each item scored 0-10; total score 0-130; higher scores represent higher levels of self-efficacy)
**Measure:** Stroke Self-Efficacy Questionnaire (SSEQ)
**Time Frame:** 90 days
**Description:** A standardized measure of health-related quality of life across 5 domains. Each domain is scored using a 5-point ordinal scale (1-5), and the Level Sum Score (LSS) is calculated as the sum of the 5 scores (LSS range is 5-25, lower scores represent higher quality of life).
**Measure:** EuroQoL EQ-5D-5L
**Time Frame:** 90 days
**Description:** This will be assessed based on pharmacy record review to quantify the Proportion of Days Covered (PDC). PDC is calculated by dividing the number of days with medications available by the total number of days in question (scored between 0 - 1; higher numbers represent more favorable adherence)
**Measure:** Medication adherence
**Time Frame:** 90 days
**Description:** The number of Emergency Room visits will be summed in the first 90 days following hospital discharge
**Measure:** Emergency Department utilization
**Time Frame:** 90 days
**Description:** The number of urgent outpatient visits with primary care and neurologist will be summed in the first 90 days following hospital discharge
**Measure:** Urgent outpatient visits
**Time Frame:** 90 days
**Description:** The number of communications with primary care or neurology providers via telephone or provider communication apps will be summed in the first 90 days following hospital discharge
**Measure:** Outpatient provider communication
**Time Frame:** 90 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* At least 18 years old
* Admitted to hospital with clinical diagnosis of acute ischemic stroke (imaging confirmation not required)
* Stroke symptom onset within 30 days of enrollment
* Being discharged to either home or an acute rehabilitation facility
* Access to internet enabled device (smartphone, tablet, computer)
* Fluent in either English or Spanish (does not need to be native or primary language)
* Willingness and ability to sign informed consent
Exclusion Criteria:
* Severe aphasia (score of ≥2 on NIHSS item 9)
* Ischemic stroke that is attributed to a surgical procedure
* Resides in a skilled nursing facility prior to admission
* Being discharged to skilled nursing facility or long-term acute care facility
* Unwillingness or inability to participate in remote/virtual study visits
* A terminal or advanced condition that raises the possibility the subject may not survive 90 days
* Any other illness or condition that the investigator feels would pose a hazard to the subject from participation in the study
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** christopher.favilla@pennmedicine.upenn.edu
**Name:** Christopher G Favilla, MD
**Phone:** 2156153727
**Role:** CONTACT
**Contact 2:**
**Email:** nichole.gallatti@pennmedicine.upenn.edu
**Name:** Nichole Gallatti
**Phone:** 2153498651
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Lancaster
**Contacts:**
***Contact 1:***
- **Email:** Danielle.Cross@pennmedicine.upenn.edu
- **Name:** Danielle Cross, MD
- **Phone:** 717-396-9167
- **Role:** CONTACT
**Country:** United States
**Facility:** Lancaster General Hospital
**State:** Pennsylvania
**Zip:** 17602
**Location 2:**
**City:** Philadelphia
**Contacts:**
***Contact 1:***
- **Email:** Christina.Blum@pennmedicine.upenn.edu
- **Name:** Christina Blum, MD
- **Phone:** 215-662-8581
- **Role:** CONTACT
**Country:** United States
**Facility:** Penn Presbyterian Medical Center
**State:** Pennsylvania
**Zip:** 19104
**Location 3:**
**City:** Philadelphia
**Country:** United States
**Facility:** The Hospital of the University of Pennsylvania
**State:** Pennsylvania
**Zip:** 19104
**Location 4:**
**City:** Philadelphia
**Contacts:**
***Contact 1:***
- **Email:** Daniel.Cristancho@pennmedicine.upenn.edu
- **Name:** Daniel Cristancho, MD
- **Phone:** 215-662-3606
- **Role:** CONTACT
**Country:** United States
**Facility:** Pennsylvania Hospital
**State:** Pennsylvania
**Zip:** 19107
**Location 5:**
**City:** West Chester
**Country:** United States
**Facility:** Chester County Hospital
**State:** Pennsylvania
**Zip:** 19380
#### Overall Officials
**Official 1:**
**Affiliation:** Assistant Professor of Neurology at the University of Pennsylvania
**Name:** Christopher G Favilla, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** The data will be publicly available and searchable on figshare (figshare.com), and the availability of shared derived data will be described in publications and presentation.
**Description:** Once a manuscript describing such data is accepted for publication, the deidentified dataset contributing to the publication will be shared publicly using the figshare repository (figshare.com). The availability of shared derived data will be described in publications and presentation.
**Info Types:**
- STUDY_PROTOCOL
- SAP
**IPD Sharing:** YES
**Time Frame:** We anticipate final sharing of data will take place at the completion of the 5-year project, but if an interim analysis results in a publication, the dataset will be shared at that time-point.
## 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
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M22306
- Name: Stroke
- Relevance: HIGH
- As Found: Stroke, Acute
- ID: M2400
- Name: Ischemic Stroke
- Relevance: HIGH
- As Found: Ischemic Stroke
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020521
- Term: Stroke
- ID: D000083242
- Term: Ischemic Stroke
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442618
**Brief Title:** Effectiveness of Extracorporeal Shockwave Therapy and Nutraceutical Supplementation in the Treatment of Epicondylitis: a Clinical Trial
**Official Title:** Effectiveness of Extracorporeal Shockwave Therapy and Nutraceutical Supplementation in the Treatment of Epicondylitis: a Clinical Trial
#### Organization Study ID Info
**ID:** MFR042024
#### Organization
**Class:** OTHER
**Full Name:** University of Palermo
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Palermo
#### Responsible Party
**Investigator Affiliation:** University of Palermo
**Investigator Full Name:** Prof.ssa Giulia Letizia Mauro
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Lateral epicondylitis is a pathologic condition of the musculotendinous system, characterized by the presence of pain at the lateral epicondyle of the humerus; it is a tendinopathy of the extensor muscles of the forearm, often caused by overuse or repetitive use of the arm, forced extension of the elbow, or direct trauma to the humeral epicondyle. This study evaluated the efficacy of Extracorporeal ShockWave Treatment (ESWT) combined with a supplemental nutraceutical treatment of Hyaluronic Acid, Collagen, Vitamin C, and Manganese, compared with single treatment in patients with lateral epicondylitis in term of improvement in pain, functional capacity, muscle strength, and reduction of inflammation on ultrasound images. A clinical trial was conducted at the U.O.C. of "Recovery and Functional Rehabilitation" of A.O.U.P. "P. Giaccone" of Palermo from Marc 2024 to July 2024. Patients were randomized into 3 groups: in group "A", n° 5 sessions of focal ESWT were given every six days; in group "B", patients took daily for 30 days, supplemental nutraceutical treatment of Hyaluronic Acid, Collagen, Vitamin C, and Manganese; and group "C", patients had combined treatment of ESWT (one session every six days for a total of five sessions) and nutraceutical supplementation (one administration per day for one month). All patients were evaluated at enrollment (T0), after one month, at the end of rehabilitation treatment (T1), and at a follow up 30 days after the end of treatment (T2). Researched will compare patients treated with ESWT or with nutraceutical treatment, and patients who had combined treatment to see if there are real differences in term of pain reduction and improved short- and long-term quality of life.
### Conditions Module
**Conditions:**
- Epicondylitis, Lateral
- Epicondylitis of the Elbow
- Tennis Elbow
**Keywords:**
- Epicondylitis
- Extracorporeal ShockWave Treatment (ESWT)
- Nutraceutical Supplementation
- Rehabilitation
- Musculoskeletal Disease
- Tendinopathy
- Tennis Elbow
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 45
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Group A participants were invited to come to our department's outpatient clinics, wearing comfortable clothing. Meetings were held every six days, for a total of 5 sessions (30 days), lasting about 20 minutes each.
**Intervention Names:**
- Other: Extracorporeal Shockwave Treatment (Group A)
**Label:** Extracorporeal Shokwave Theraphy (Group A)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Participants in Group B performed home therapy with nutraceutical supplementation containing: hyaluronic acid (200 mg), collagen (5,000 mg), manganese (10 mg) and vitamin C (250 mg), daily for 30 days; they were advised to always take it at the same time and independently of meals, so as not to interfere with absorption.
**Intervention Names:**
- Other: Nutraceutical Supplementation (Group B)
**Label:** Nutraceutical Supplementation (Group B)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Participants in group C were invited to come to our department's outpatient clinics to perform treatment with focal ESWT; they had one session every six days for a total of 5 sessions lasting about 20 minutes each. Patients in this group took also additional nutraceutical therapy every day or 30 days.
**Intervention Names:**
- Other: Combined Treatment (Group C)
**Label:** Combined Treatment (Group C)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Extracorporeal Shokwave Theraphy (Group A)
**Description:** Each session involved a 1:1 ratio of patient to physiatrist. The treatment modality was explained to the patient preliminarily, and before each session, the patients were clinically evaluated and the location of pain was identified.; so patients were asked to assume a comfortable position, and treatment with focal ESWTs was started as per the ISMST protocol
**Name:** Extracorporeal Shockwave Treatment (Group A)
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Nutraceutical Supplementation (Group B)
**Description:** Participants in Group B performed home therapy with nutraceutical supplementation containing: hyaluronic acid (200 mg), collagen (5,000 mg), manganese (10 mg) and vitamin C (250 mg), daily for 30 days. Patients were advised to shake the compound, before taking, and to store it at room temperature not exceeding 25 °C, in a cool, dry place, away from light and heat sources. The compound is also free of gluten and lactose, so it can be safely administered.
**Name:** Nutraceutical Supplementation (Group B)
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Combined Treatment (Group C)
**Description:** Participants in group C were invited to come to our department\'s outpatient clinics to perform treatment with focal ESWT; they had one session every six days for a total of 5 sessions lasting about 20 minutes each. Patients in this group took also additional nutraceutical therapy; they took a daily supplemental treatment of hyaluronic acid, collagen, vitamin C and manganese for 30 days.
**Name:** Combined Treatment (Group C)
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The NRS is a subjective scale that rates the extend of pain with a score between 0 and 10. a score of 10 corresponds to maximum pain.
**Measure:** Extent of pain: Numeric Rating Scale (NRS 0-10)
**Time Frame:** At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2)
**Description:** This scale consists of 2 parts, namely pain (5 items) and functional activities (10 items). Each item has a score from 0 (no pain or difficulty in performing a task) to 10 (the worst pain or inability to perform a task). The total score is the combined score of the 2 parts
**Measure:** Intensity of pain and disability: Patient-Rated Tennis Elbow Evaluation Scale (PRTEE)
**Time Frame:** At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2)
#### Secondary Outcomes
**Description:** This questinnaire is an important assessment tool, based on a district questionnaire, self-completed by the patient that aims to assess upper limb function; it consists of 38 questions, divided into 3 modules investigating different aspects of daily life, work activities, and sports/rehabilitation practices. The 38 items are scored from 1 to 5 (best score 1 and worst score 5) and refer to the patient's ability in the last 7 days
**Measure:** Disability: Disability of the Arm, Shoulder and Hand (DASH) Questionnaire
**Time Frame:** At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2)
**Description:** Handgrip strength was measured using a dynamometer; the patients squeezed the dynamometer maximally for 3 s. Three trials were attempted with 60 s of rest between each, and the average of all 3 grips were recorded.
**Measure:** Handgrip strength
**Time Frame:** At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2)
**Description:** The thickness of the common extensor tendon (CET) was assessed by ultrasound images.
**Measure:** Thickness of the common extensor tendon (CET)
**Time Frame:** At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Diagnosis of lateral epicondylitis;
* Ultrasound evidence of inflammatory status of the tendon of the wrist common extensor muscle;
* Numerical Rating Scale (NRS) at T0 ≥ 4;
* Pharmacological wash out starting seven days before treatment;
* Written informed consent.
Exclusion Criteria:
* Pregnancy;
* Already diagnosed or diagnostically defined neoplasms;
* Pacemaker wearers;
* Coagulation disorders and/or anticoagulant therapy;
* Skin lesions and/or local infections;
* Tendon injury and/or previous surgery on the wrist extensor tendons;
* Cervical myelopathy;
* Epilepsy;
* Patients with contraindications and/or allergies to the active ingredients of nutracetical supplementation;
* Obesity with BMI\&gt;30 (kg/m2).
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** giulia.letiziamauro@unipa.it
**Name:** Giulia Letizia Mauro
**Phone:** +39 0916554160
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Palermo
**Contacts:**
***Contact 1:***
- **Email:** giulia.letiziamauro@unipa.it
- **Name:** Giulia Professor Letizia Mauro
- **Phone:** +39 0916554061
- **Role:** CONTACT
**Country:** Italy
**Facility:** A.O.U.P. "P. Giaccone"
**Status:** RECRUITING
**Zip:** 90127
### IPD Sharing Statement Module
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
- ANALYTIC_CODE
**IPD Sharing:** YES
### References Module
#### References
**Citation:** Yang TH, Huang YC, Lau YC, Wang LY. Efficacy of Radial Extracorporeal Shock Wave Therapy on Lateral Epicondylosis, and Changes in the Common Extensor Tendon Stiffness with Pretherapy and Posttherapy in Real-Time Sonoelastography: A Randomized Controlled Study. Am J Phys Med Rehabil. 2017 Feb;96(2):93-100. doi: 10.1097/PHM.0000000000000547.
**PMID:** 27323324
**Citation:** Pellegrino R, Di Iorio A, Filoni S, Mondardini P, Paolucci T, Sparvieri E, Tarantino D, Moretti A, Iolascon G. Radial or Focal Extracorporeal Shock Wave Therapy in Lateral Elbow Tendinopathy: A Real-Life Retrospective Study. Int J Environ Res Public Health. 2023 Feb 28;20(5):4371. doi: 10.3390/ijerph20054371.
**PMID:** 36901381
**Citation:** Kinney WR, Anderson BR. Nonoperative Management of Lateral Epicondyle Tendinopathy: An Umbrella Review. J Chiropr Med. 2023 Sep;22(3):204-211. doi: 10.1016/j.jcm.2023.04.004. Epub 2023 Jul 10.
**PMID:** 37644995
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000070639
- Term: Elbow Tendinopathy
- ID: D000052256
- Term: Tendinopathy
- ID: D000009135
- Term: Muscular Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000092464
- Term: Elbow Injuries
- ID: D000001134
- Term: Arm Injuries
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000013708
- Term: Tendon Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M27013
- Name: Tendinopathy
- Relevance: LOW
- As Found: Unknown
- ID: M16486
- Name: Tennis Elbow
- Relevance: HIGH
- As Found: Tennis Elbow
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M627
- Name: Elbow Tendinopathy
- Relevance: LOW
- As Found: Unknown
- ID: M12092
- Name: Muscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2926
- Name: Elbow Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M4444
- Name: Arm Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M16479
- Name: Tendon Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013716
- Term: Tennis Elbow
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M17558
- Name: Vitamins
- Relevance: LOW
- As Found: Unknown
- ID: M4513
- Name: Ascorbic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M9878
- Name: Hyaluronic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M11335
- Name: Manganese
- Relevance: LOW
- As Found: Unknown
- ID: T437
- Name: Ascorbic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T477
- Name: Vitamin C
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442605
**Brief Title:** Clinical Research on the Application of Single-channel Uterine Fibroid Morcellation System in Laparoscopic Myomectomy
**Official Title:** Clinical Research on the Application of Single-channel Uterine Fibroid Morcellation System in Laparoscopic Myomectomy
#### Organization Study ID Info
**ID:** 2024016
#### Organization
**Class:** OTHER
**Full Name:** First People's Hospital of Hangzhou
### Status Module
#### Completion Date
**Date:** 2027-06-19
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-19
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** First People's Hospital of Hangzhou
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Research Purpose The purpose of this study is to explore whether the application of a single-channel uterine fibroid morcellation system compared to a multi-channel specimen retrieval bag during laparoscopic myomectomy can shorten the operative time and improve the efficiency of fibroid removal.
Research Design This study is a single-center, randomized, single-blind, 1:1 controlled trial.
Intervention Measures Study participants were randomly assigned in a 1:1 ratio into two groups.
Experimental group: Conventional laparoscopic myomectomy with the use of a single-channel uterine fibroid morcellation system for fragmentation and retrieval of the fibroids.
Control group: Conventional laparoscopic myomectomy with the use of a multi-channel specimen retrieval bag and a conventional laparoscopic uterine fibroid morcellator for fragmentation and retrieval of the fibroids.
Observation Indicators Primary observation indicator: Time required for fibroid fragmentation and retrieval (from the placement of the single-channel uterine fibroid morcellation system or the multi-channel specimen retrieval bag to complete removal from the abdominal cavity).
Secondary observation indicators: Success rate of placement, intraoperative damage and leakage rate, gynecological surgeon satisfaction with the surgery, total weight of retrieved uterine fibroid fragments.
### Conditions Module
**Conditions:**
- Leiomyoma, Uterine
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 22
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Conventional laparoscopic myomectomy with the use of a single-channel uterine fibroid morcellation system for fragmentation and retrieval of the fibroids.
**Intervention Names:**
- Device: single-channel uterine fibroid morcellation system
**Label:** Experimental group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Conventional laparoscopic myomectomy with the use of a multi-channel specimen retrieval bag and a conventional laparoscopic uterine fibroid morcellator for fragmentation and retrieval of the fibroids.
**Intervention Names:**
- Device: Multi-channel specimen retrieval bag + conventional laparoscopic uterine fibroid morcellator
**Label:** Control group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental group
**Description:** Conventional laparoscopic myomectomy is performed with the use of a single-channel uterine fibroid morcellation system for fragmentation and retrieval of the fibroids during the procedure.
**Name:** single-channel uterine fibroid morcellation system
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Control group
**Description:** In conventional laparoscopic myomectomy, a multi-channel specimen retrieval bag is used during the procedure, along with a conventional laparoscopic uterine fibroid morcellator for fragmentation and retrieval of the fibroids.
**Name:** Multi-channel specimen retrieval bag + conventional laparoscopic uterine fibroid morcellator
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Using a stopwatch, record the time it takes from the placement of the single-channel uterine fibroid morcellation system or the multi-channel specimen retrieval bag until the complete removal of the single-channel uterine fibroid morcellation system or the multi-channel specimen retrieval bag from the abdominal cavity.
**Measure:** Time required for fibroid fragmentation and retrieval
**Time Frame:** intraoperative
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Patients with uterine fibroids who meet the surgical indications. Patients aged 18 and above but below 45, who strongly request to preserve the uterus.
Patients planning to undergo laparoscopic myomectomy. Those who understand the purpose, procedures, potential risks of this trial, voluntarily participate in this study, and sign the informed consent form.
Exclusion Criteria:
Patients who cannot tolerate laparoscopic surgery due to their overall physical condition.
Patients with multiple fibroids have at least 4 fibroids, with the largest diameter of a single fibroid being equal to or greater than 10cm.
Patients who require surgical procedures other than laparoscopic myomectomy (excluding pelvic adhesion lysis, resection of mesosalpingeal cysts measuring less than 2cm, and superficial intraperitoneal lesions resection/electrocoagulation).
Preoperatively considering the possibility of uterine fibroid malignancy. Patients with preoperative unclear diagnosis, requiring differentiation from ovarian tumors.
Previously undergone lower abdominal or pelvic intraperitoneal surgery, or patients with severe pelvic or abdominal adhesions.
Presence of untreated infectious sexual diseases, including but not limited to vaginitis, cervical inflammatory diseases, and pelvic inflammatory diseases.
Patients who cannot understand the research protocol, cannot cooperate with the research and follow-up, and any other patients that researchers deem unsuitable for participation in this study.
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** 362303714@qq.com
**Name:** Yahui Wang
**Phone:** +8615158150768
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hangzhou
**Country:** China
**Facility:** Hangzhou First People's Hospita
**State:** Zhejiang
**Zip:** 310006
#### Overall Officials
**Official 1:**
**Affiliation:** Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
**Name:** Jinyi Tong
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** If necessary, other researchers can ask us to share the raw data via email after the results are published.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Wei Y, Zhou X, Ren QZ, Ma Q, Tao X, Shao M, Jia S. A self-developed contained bag for laparoscopic myomectomy morcellation. Ginekol Pol. 2022;93(8):605-613. doi: 10.5603/GP.a2022.0002. Epub 2022 Mar 22.
**PMID:** 35315012
**Citation:** Wang W, Liang H, Zhao F, Yu H, Rong C, Feng W, Chen Q, Yang Y, Li Q, Feng D, Dong Y, Xue M, Liang J, Ling B. A Novel Multi-Port Containment System for Laparoscopic Power Morcellation to Prevent Tumoral Spread: A Retrospective Cohort Study. Front Surg. 2022 Feb 3;9:803950. doi: 10.3389/fsurg.2022.803950. eCollection 2022.
**PMID:** 35187057
**Citation:** Venturella R, Rocca ML, Lico D, La Ferrera N, Cirillo R, Gizzo S, Morelli M, Zupi E, Zullo F. In-bag manual versus uncontained power morcellation for laparoscopic myomectomy: randomized controlled trial. Fertil Steril. 2016 May;105(5):1369-1376. doi: 10.1016/j.fertnstert.2015.12.133. Epub 2016 Jan 19.
**PMID:** 26801067
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009379
- Term: Neoplasms, Muscle Tissue
- ID: D000018204
- Term: Neoplasms, Connective and Soft Tissue
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000009372
- Term: Neoplasms, Connective Tissue
- ID: D000003240
- Term: Connective Tissue Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M10901
- Name: Leiomyoma
- Relevance: HIGH
- As Found: Leiomyoma
- ID: M25846
- Name: Myofibroma
- Relevance: HIGH
- As Found: Leiomyoma, Uterine
- ID: M20350
- Name: Neoplasms, Connective and Soft Tissue
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M12317
- Name: Neoplasms, Connective Tissue
- Relevance: LOW
- As Found: Unknown
- ID: M6464
- Name: Connective Tissue Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007889
- Term: Leiomyoma
- ID: D000047708
- Term: Myofibroma
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442592
**Acronym:** CATAMARAN Ped
**Brief Title:** Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
**Official Title:** CATAMARAN - Pediatrics : Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
#### Organization Study ID Info
**ID:** RC23_0548
#### Organization
**Class:** OTHER
**Full Name:** Nantes University Hospital
#### Secondary ID Infos
**Domain:** ANSM (IDRCB)
**ID:** 2024-A00428-39
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2025-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** University of Angers - Pays de la Loire psychology laboratory
#### Lead Sponsor
**Class:** OTHER
**Name:** Nantes 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:** The leading cause of birth defects, Congenital Heart Defects (CHD) affect 12 million people worldwide and 41,000 newborns/year in Europe. It's a major cause of life-long morbidity and mortality, and a crucial public health issue. More than 50% of childs born with critical CHD will develop Neurodevelopmental Disorders (NDs), requiring specific care and impairing quality of life. NDs corresponds to early and lasting disturbances in cognitive, affective and behavioral development, linked to abnormalities in brain development. They are heterogeneous, affecting language, learning, motor skills, intellectual efficiency, social cognition, attention, memory and executive functions, and are associated with psychosocial difficulties (adaptive behavior, social interactions). This hidden handicap is the main long-term sequels of CHD, even before cardiovascular sequels, in individuals who often underwent multiple heart operations in early childhood. NDs concern not only complex CHD, but also simple CHD repaired in childhood and considered cured.
The origin of TND associated with CHD is largely unknown. To date, few genetic or environmental causes have been clearly identified, but recent work has suggested that a common origin may link cardiac malformation and neurodevelopmental abnormality.
The CATAMARAN - Pediatrics project is designed to detect potential neurodevelopmental delays associated with CHD as early as age 3, and to identify individual susceptibility factors involved in the occurrence of NDs in CHD children.
### Conditions Module
**Conditions:**
- Congenital Heart Defects
- Neurodevelopmental Disorder
**Keywords:**
- Congenital Heart Defects
- Neurodevelopmental Disorder
- Genetics
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SCREENING
#### Enrollment Info
**Count:** 1200
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The study population will consist of 400 children aged 3 to 11 and their two parents.
**Intervention Names:**
- Other: Blood sampling
- Diagnostic Test: Assessment of neurodevelopment
**Label:** CATAMARAN - Pediatrics
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- CATAMARAN - Pediatrics
**Description:** An EDTA blood sample will be taken from the children and their two parents. Sample volume will be 2 x 3mL.
**Name:** Blood sampling
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- CATAMARAN - Pediatrics
**Description:** The children will be seen by a neuropsychologist, who will then determine whether or not they have neurodevelopmental disorders.
**Name:** Assessment of neurodevelopment
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Measure:** Assessment of the prevalence of neurodevelopmental disorders in children aged 3-11 years with critical congenital heart defects.
**Time Frame:** 14 days
#### Secondary Outcomes
**Description:** The presence of rare genetic variants associated with neurodevelopmental disorders will be determined by a 30X whole genome sequencing approach based on the association study of congenital heart defects with neurodevelopmental disorders versus congenital heart defects without neurodevelopmental disorders.
**Measure:** Identify rare genetic variants associated with genome-wide neurodevelopmental disorders in patients with congenital heart defects.
**Time Frame:** 14 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Child with critical MCC operated on for heart surgery during the first three months of life
* Parents and child affiliated with or benefiting from a social security or similar scheme
* Parents' and child's good understanding of the French language
* Free, informed and written consent of both parents for themselves and for the child
* Free, informed and written consent of the child aged 6 and over
* Biological parents
Exclusion Criteria:
* Genetic anomaly or malformative syndrome associated with neurodevelopmental abnormalities, identified prior to inclusion
* Neurodevelopmental assessment not practicable
**Maximum Age:** 11 Years
**Minimum Age:** 3 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** albanelouen.baruteau@chu-nantes.fr
**Name:** Alban Baruteau
**Phone:** 02 40 08 77 42
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Brest
**Contacts:**
***Contact 1:***
- **Email:** Guillaume.deverriere@chu-brest.fr
- **Name:** Guillaume DEVERRIERE
- **Role:** CONTACT
***Contact 2:***
- **Name:** Guillaume DEVERRIERE
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** Chu Brest
**State:** Bretagne
**Zip:** 29200
**Location 2:**
**City:** Rennes
**Country:** France
**Facility:** CHU Rennes
**State:** Bretagne
**Zip:** 35000
**Location 3:**
**City:** Nantes
**Country:** France
**Facility:** CHU Nantes
**State:** Loire-Atlantique
**Zip:** 44000
**Location 4:**
**City:** Angers
**Country:** France
**Facility:** CHU Angers
**State:** Maine-et-Loire
**Zip:** 49000
**Location 5:**
**City:** Tours
**Country:** France
**Facility:** CHU Tours
**State:** Val De Loire
**Zip:** 37000
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001523
- Term: Mental Disorders
- ID: D000018376
- Term: Cardiovascular Abnormalities
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000006331
- Term: Heart Diseases
- ID: D000000013
- Term: Congenital Abnormalities
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M9418
- Name: Heart Defects, Congenital
- Relevance: HIGH
- As Found: Congenital Heart Defects
- ID: M30644
- Name: Neurodevelopmental Disorders
- Relevance: HIGH
- As Found: Neurodevelopmental Disorders
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M12
- Name: Congenital Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M20503
- Name: Cardiovascular Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006330
- Term: Heart Defects, Congenital
- ID: D000065886
- Term: Neurodevelopmental Disorders
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442579
**Brief Title:** The Influence of Cortical Lateralization on Selective Motor Control of the Arm Swing During Independent Walking After Stroke.
**Official Title:** The Influence of Cortical Lateralization on Selective Motor Control of the Arm Swing During Independent Walking After Stroke.
#### Organization Study ID Info
**ID:** ONZ-2024-0089
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Ghent
#### Secondary ID Infos
**Domain:** FWO
**ID:** 11PEU24N
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2026-09-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University Ghent
**Class:** OTHER
**Name:** VU University of Amsterdam
**Class:** OTHER
**Name:** Vrije Universiteit Brussel
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Ghent
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The upper limbs play an essential role for safe and efficient walking in healthy persons and persons post-stroke. Nevertheless, in current post-stroke gait rehabilitation (research) the upper limbs are barely targeted. To address this gap, my project aims to investigate the selective motor control of the upper limbs during walking and the contribution of the cortical activity to the arm swing in independent walkers after stroke.
To gain insight in the direct effects of stroke on the arm swing, the primary motor control of the arm swing will be evaluated by determining muscle synergies (i.e group of muscles working together as a task-specific functional unit). Additionally, the cortical activity (EEG-analysis) during walking of persons post-stroke will be compared to healthy controls and the relationship between stroke-induced changes in cortical activity and arm swing deviations will be assessed. Furthermore, I will evaluate whether improvements in cortical activity relate to improvements in primary motor control of the arm swing.
This innovative project will be the first to investigate the direct coupling between the cortex and the muscle synergies in persons post-stroke during independent walking to investigate the arm swing. These fundamental insights in the primary motor control of the arm swing and the contribution of the cortical activity will allow to develop targeted interventions aiming to improve arm swing and as such optimize post-stroke gait rehabilitation.
Research questions:
1. How can muscle synergies explain arm swing alterations in independent walkers after stroke?
2. How do stroke-induced changes in cortical activity relate to arm swing deviations in persons after stroke?
3. Are changes in primary motor control of the upper limb during walking related to normalization of brain activity in independent walkers after stroke?
### Conditions Module
**Conditions:**
- Stroke, Ischemic
- Healthy
**Keywords:**
- EMG
- EEG
- Gait
- Arm swing
- Kinematics
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 84
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 3 Months
### Arms Interventions Module
#### Arm Group 1
**Description:** Persons with a first ever ischemic stroke
**Intervention Names:**
- Other: Walking on a treadmill
**Label:** Stroke
#### Arm Group 2
**Description:** Age and gender matched healthy controls
**Intervention Names:**
- Other: Walking on a treadmill
**Label:** Control
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control
- Stroke
**Description:** Participants have to walk without holding handrails and without bodyweight support for at least 200 gait cycles. They are asked to walk at comfortable walking speed while watching forward to a screen without virtual reality projection. Arm should be next to the body to allow arm swing if possible.
**Name:** Walking on a treadmill
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** Quantifies the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The highest score is 42.
**Measure:** National Institutes of Health Stroke Scale (NIHSS)
**Time Frame:** Single point of assessment at inclusion (only for stroke survivors)
**Description:** Quantifies the general impairment caused by a stroke after a follow-up period of three months. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The highest score is 42.
**Measure:** National Institutes of Health Stroke Scale (NIHSS)
**Time Frame:** Single point of assessment 3 months after inclusion (only for stroke survivors)
**Description:** Assesses specifc motor impairments of the upper limbs of stroke survivors. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively.
**Measure:** Fugl-Meyer assesment - Upper limbs
**Time Frame:** Single point of assessment at inclusion (only for stroke survivors)
**Description:** Assesses specifc motor impairments of the upper limbs of stroke survivors after a follow-up period of three months. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively.
**Measure:** Fugl-Meyer assesment - Upper limbs
**Time Frame:** Single point of assessment 3 months after inclusion (only for stroke survivors)
**Description:** Quantifies spasticity by assessing the muscle's response (0-5) to different stretch velocities (V1, V2 or V3) and by determining the spasticity angle (R1 or R2).
**Measure:** Tardieu scale
**Time Frame:** Single point of assessment at inclusion (only for stroke survivors)
**Description:** Quantifies spasticity by assessing the muscle's response (0-5) to different stretch velocities (V1, V2 or V3) and by determining the spasticity angle (R1 or R2).
**Measure:** Tardieu scale
**Time Frame:** Single point of assessment 3 months after inclusion (only for stroke survivors)
**Description:** Examins the walking capacity of a stroke survivor by measuring how long it takes to walk a distance of 10 meters (in seconds).
**Measure:** 10 Meter Walking Test
**Time Frame:** Single point of assessment at inclusion (only for stroke survivors)
**Description:** Examins the walking capacity of a stroke survivor by measuring how long it takes to walk a distance of 10 meters (in seconds).
**Measure:** 10 Meter Walking Test
**Time Frame:** Single point of assessment 3 months after inclusion (only for stroke survivors)
#### Primary Outcomes
**Description:** The number of muscle synergies needed to account for 90% variance in muscle activity measured by surface EMG during walking in stroke survivors compared to healthy controls. Following muscles will be examined:
* tibialis anterior,
* gastrocnemius lateralis
* soleus
* vastus medialis
* vastus lateralis
* rectus femoris
* biceps femoris
* gluteus medius
* erector spinae
* latissimus dorsi
* anterior deltoid
* posterior deltoid
* biceps brachii
* triceps brachii
**Measure:** Number of muscle synergies
**Time Frame:** Single point of assessment at inclusion
**Description:** The number of muscle synergies needed to account for 90% variance in muscle activity measured by surface EMG during walking in stroke survivors after a follow-up period of three months. Following muscles will be examined:
* tibialis anterior,
* gastrocnemius lateralis
* soleus
* vastus medialis
* vastus lateralis
* rectus femoris
* biceps femoris
* gluteus medius
* erector spinae
* latissimus dorsi
* anterior deltoid
* posterior deltoid
* biceps brachii
* triceps brachii
**Measure:** Number of muscle synergies
**Time Frame:** Single point of assessment 3 months after inclusion (only for stroke survivors)
**Description:** The number or distribution of muscle weightings within a synergy during walking in stroke survivors compared to healthy controls.
The distribution of muscle activation averages over one gait cycle measured by surface EMG of following muscles:
* tibialis anterior,
* gastrocnemius lateralis
* soleus
* vastus medialis
* vastus lateralis
* rectus femoris
* biceps femoris
* gluteus medius
* erector spinae
* latissimus dorsi
* anterior deltoid
* posterior deltoid
* biceps brachii
* triceps brachii
**Measure:** Weight of muscle synergies
**Time Frame:** Single point of assessment at inclusion
**Description:** The number or distribution of muscle weightings within a synergy during walking in stroke survivors after a follow-up period of three months.
The distribution of muscle activation averages over one gait cycle measured by surface EMG of following muscles:
* tibialis anterior,
* gastrocnemius lateralis
* soleus
* vastus medialis
* vastus lateralis
* rectus femoris
* biceps femoris
* gluteus medius
* erector spinae
* latissimus dorsi
* anterior deltoid
* posterior deltoid
* biceps brachii
* triceps brachii
**Measure:** Weight of muscle synergies
**Time Frame:** Single point of assessment 3 months after inclusion (only for stroke survivors)
**Description:** The amount of cortical lateralization during walking in stroke survivors compared to healthy controls. The score ranges from -1 to +1 with BSI = 0 reprenting perfect symmetry. Positive values represent higher power in the right hemishere compared to the left hemisphere, vice versa for negative values. For left side lesions, BSI was multiplied by -1.
**Measure:** Brain symmetry index (BSI)
**Time Frame:** Single point of assessment at inclusion
**Description:** The amount of cortical lateralization during walking in stroke survivors after a follow-up period of three months. The score ranges from -1 to +1 with BSI = 0 reprenting perfect symmetry. Positive values represent higher power in the right hemishere compared to the left hemisphere, vice versa for negative values. For left side lesions, BSI was multiplied by -1.
**Measure:** Brain symmetry index (BSI)
**Time Frame:** Single point of assessment 3 months after inclusion (only for stroke survivors)
#### Secondary Outcomes
**Description:** Movements of the upper limb during walking measured by 3D kinematics and expressed as angles (°)
**Measure:** Upper limb kinematics
**Time Frame:** Single point of assessment at inclusion
**Description:** Movements of the upper limb during walking measured by 3D kinematics and expressed as angles (°)
**Measure:** Upper limb kinematics
**Time Frame:** Single point of assessment 3 months after inclusion (only for stroke survivors)
**Description:** The amount of coherence (i.e. phase locking) between the muscle synergies and cortical activity during walking in stroke survivors compared to healthy controls. Higher values (0-1) indicate a better linear association.
**Measure:** Cortico-synergy coherence
**Time Frame:** Single point of assessment at inclusion
**Description:** The amount of coherence (i.e phase locking) between the muscle synergies and cortical activity during walking in stroke survivors after a follow-up period of three months. Higher values (0-1) indicate a better linear association.
**Measure:** Cortico-synergy coherence
**Time Frame:** Single point of assessment 3 months after inclusion (only for stroke survivors)
### Eligibility Module
**Eligibility Criteria:** Stroke
Inclusion Criteria:
* First-ever, ischemic and cerebral stroke
* Maximum one-year post-stroke
* Able to walk at least 10 minutes (FAC ≥ 3)
* Presence of upper limb paresis (NIHSS item 5a/b \> 0)
Exclusion Criteria:
* Other neurological disorders
Healthy controls
Inclusion criteria:
* Older than 18 years
* Able to walk at least 10 minutes
Exlusion criteria:
* Pregnancy
**Healthy Volunteers:** True
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Participants will be recruited directly from the University Hospital of Ghent through the rehabilitation centre (Prof Dr Kristine Oostra - Prof Dr Katie Bouche) and through the deparment for acute neurology (Prof Dr Veerle De Herdt). Flyers will also be distributed on social media and through rehabilitation physicians of the different hospitals in the Ghent area.
Patients will be informed of the study by their treating physician. The latter asks if the researchers may contact them to explain the study. The researcher will explain the study and provide the ICF to the potential candidate. Only upon agreement will an appointment for the study be scheduled.
Patients who are not directly addressed by the doctor but only see a flyer in the waiting room can contact the researcher via the contact details on the flyer.
Healthy controls will be recruited via an adapted flyer on social media (Facebook, X, LinkedIn).
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** Arne.Defour@UGent.be
**Name:** Arne Defour, Msc.
**Phone:** 09 332 12 43
**Role:** CONTACT
**Contact 2:**
**Email:** Anke.VanBladel@UGent.be
**Name:** Anke Van Bladel, PhD
**Phone:** 09 332 12 43
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Ghent
**Contacts:**
***Contact 1:***
- **Email:** Anke.VanBladel@UGent.be
- **Name:** Anke Van Bladel, PhD
- **Phone:** 093321243
- **Role:** CONTACT
***Contact 2:***
- **Name:** Arne Defour, Msc.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Belgium
**Facility:** Ghent University Hospital
**State:** Oost-Vlaanderen
#### Overall Officials
**Official 1:**
**Affiliation:** Ghent University and Ghent University Hospital
**Name:** Anke Van Bladel, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## 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: Stroke, Ischemic
- 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:** NCT06442566
**Acronym:** ACTION
**Brief Title:** ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain
**Official Title:** Sequential Trial of Adding Buprenorphine, Cognitive Behavioral Treatment, and Transcranial Magnetic Stimulation to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain (ACTION)
#### Organization Study ID Info
**ID:** Pro00130123
#### Organization
**Class:** OTHER
**Full Name:** Medical University of South Carolina
#### Secondary ID Infos
**ID:** 1R01DA058620
**Link:** https://reporter.nih.gov/quickSearch/1R01DA058620
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2029-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-03-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institute on Drug Abuse (NIDA)
#### Lead Sponsor
**Class:** OTHER
**Name:** Medical University of South Carolina
#### Responsible Party
**Investigator Affiliation:** Medical University of South Carolina
**Investigator Full Name:** Kelly Barth
**Investigator Title:** Professor-Faculty
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** True
**Is US Export:** True
### Description Module
**Brief Summary:** This study will sequentially evaluate three novel and scalable interventions for at-risk individuals on long term opioid therapy for chronic pain: (1) low-dose transdermal buprenorphine initiation without a period of opioid withdrawal; (2) a brief Cognitive Behavioral Intervention for pain (CBI); and (3) "accelerated" rTMS over the left dorsolateral prefrontal cortex, by examining standardized repeated measures of clinical outcomes at baseline, during treatment, and at 4-, 12-, 24- and 52-week follow-up.
**Detailed Description:** With little evidence available to guide the provision of clinical care for patients on long-term opioid therapy (LTOT) in whom the risks outweigh the benefits, major questions remain about optimizing the risk/benefit profile of LTOT, including: how to best engage patients voluntarily in this process; the safety, tolerability and effectiveness of newer treatment approaches; and optimal treatment selection. The primary objective of the proposed study is to begin to systematically address gaps in this important area to improve pain, reduce risk, and improve quality of life for individuals on LTOT.
### Conditions Module
**Conditions:**
- Opioid Withdrawal
- Chronic Pain
**Keywords:**
- opioids, long-term opioid use, chronic pain, TMS
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SEQUENTIAL
**Intervention Model Description:** SMART
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** Arm 1 open label, double blind procedures for randomization of BUP and TMS
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 240
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Buprenorphine Patch
**Label:** open label BUP
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: Buprenorphine Patch
- Drug: Placebo
**Label:** Real vs Placebo BUP
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Intervention Names:**
- Device: Transcranial Magnetic Stimulation (TMS)
- Device: Sham Transcranial Magnetic Stimulation (TMS)
**Label:** Real vs Sham TMS
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Real vs Placebo BUP
- open label BUP
**Description:** Buprenorphine patch dosing will be individualized based on each participant's current morphine-equivalent dose (per package insert/recommendations; between 5mcg and 20mcg per hour). Dosage based on baseline MEQ (\<30 MEQ = 5mcg/hr patch, 30-80 MEQ =10-15mcg/hour patch; \>80 MEQ = 20mcg/hour patch), which will remain on for 7 days (Phase Ia Days 1-7), as tolerated
**Name:** Buprenorphine Patch
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Real vs Placebo BUP
**Description:** double-blinded randomization to placebo or transdermal buprenorphine
**Name:** Placebo
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Real vs Sham TMS
**Description:** double-blinded randomization to REAL intermittent theta burst (iTBS) rTMS
**Name:** Transcranial Magnetic Stimulation (TMS)
**Type:** DEVICE
#### Intervention 4
**Arm Group Labels:**
- Real vs Sham TMS
**Description:** double-blinded randomization to SHAM intermittent theta burst (iTBS) rTMS
**Name:** Sham Transcranial Magnetic Stimulation (TMS)
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Tolerability of open-label transdermal buprenorphine. Buprenorphine tolerability defined as the proportion of patients who do not discontinue buprenorphine due to adverse effects or intolerance.
**Measure:** Buprenorphine Tolerability
**Time Frame:** up to Day-13
**Description:** Pain severity is measured by the Brief Pain Inventory (BPI) Severity Scale and is typically scored as the mean of the four severity items ("average," "worst," "usual," "now," range 0-10) with a higher score being worse.
**Measure:** Pain Severity -with Buprenorphine Patch
**Time Frame:** up to Day-20
#### Secondary Outcomes
**Description:** Buprenorphine transition rate defined as the proportion of participants who spontaneously elect to continue buprenorphine after Phase I.
**Measure:** Buprenorphine Transition Rate
**Time Frame:** Day-20
**Description:** Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference (PROPr) score summarizes multiple domains into a single score anchored at 0 (as bad as dead) and 1 (perfect or ideal health). This score quantifies the value that individuals place on different states of health.
PROPr is calculated from the scores for the 7 PROMIS domains: Cognition, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities.
**Measure:** Quality of Life -with Buprenorphine Patch
**Time Frame:** up to Day-20
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 18yrs;
* English-speaking;
* On LTOT, defined as taking daily prescription opioid therapy for 90 days or more;
* Past week average morphine equivalent dose (MED) ≥50;
* Willing and able to complete written informed consent;
* Willing and able to use a mobile/cell phone;
* Have at least one additional risk for opioid toxicity or overdose from the following list:
* Taking benzodiazepines with opioids
* Substance Use Disorder diagnosis \[non-tobacco; Opioid Risk Tool\]
* Having ever experienced an overdose
* Current major medical problem \[e.g. mod-severe liver disease, pancreatitis, chronic pulmonary disease, untreated sleep apnea, hospitalized for an acute medical issue in the past 6 months\]
* Response to Brief Pain Iinventory Item 8 \<30%, suggesting less than moderately clinically meaningful response to pain treatment
* Co-morbid psychiatric diagnosis \[Opioid Risk Tool\]
* Signs of opioid misuse \[any score \>0 on the following COMM Items: 3, 4, 5, 9, 10, 11, 14, 15, 16\]
* Opioid Risk Tool \>3 or Current Opioid Misuse Measure ≥ 9
* Struggling with the following side effects from opioids \[self-report\]: Dizziness and/or falls Difficult-to-manage stomach pain, nausea, constipation or GI issues, Fatigue or low energy, Sleepiness or sedation, Trouble with memory or thinking clearly \[COMM Item 1\>0\], Other troublesome side effect \[open answer\]
Exclusion Criteria:
* Known seizure disorder;
* On anti-convulsant medication;
* Known allergy to buprenorphine;
* Active moderate or severe non-opioid substance use disorder (DSMV criteria);
* Active suicidal Ideation;
* Known bipolar disorder;
* Cognitive disorder limiting ability to consent or fully participate in the BCI intervention;
* Severe medical condition (e.g. malignancy), likely to limit life expectancy or study participation;
* Receiving methadone or buprenorphine treatment for OUD or pain;
* On naltrexone;
* Pregnancy;
* Currently Incarcerated;
* Hypokalemia;
* Clinically unstable cardiac or pulmonary disease;
* Taking medications that prolong QTc interval or personal/immediate family history of Long QT Syndrome.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** stephen@musc.edu
**Name:** Kelly Barth
**Phone:** 843-792-0686
**Role:** CONTACT
**Contact 2:**
**Email:** mendozra@musc.edu
**Name:** Rafael Mendoza
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Charleston
**Contacts:**
***Contact 1:***
- **Email:** stephen@musc.edu
- **Name:** Kelly Barth
- **Role:** CONTACT
***Contact 2:***
- **Email:** mendozra@musc.edu
- **Name:** Rafael Mendoza
- **Role:** CONTACT
***Contact 3:***
- **Name:** Kelly Barth
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Medical University of South Carolina
**State:** South Carolina
**Zip:** 29407
#### Overall Officials
**Official 1:**
**Affiliation:** Medical University of South Carolina
**Name:** Kelly Barth
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M29442
- Name: Chronic Pain
- Relevance: HIGH
- As Found: Chronic Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: HIGH
- As Found: Chronic
### Condition Browse Module - Meshes
- ID: D000059350
- Term: Chronic Pain
### Intervention Browse Module - Ancestors
- ID: D000000701
- Term: Analgesics, Opioid
- ID: D000009294
- Term: Narcotics
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000009292
- Term: Narcotic Antagonists
### Intervention Browse Module - Browse Branches
- Abbrev: Analg
- Name: Analgesics
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: NarcAntag
- Name: Narcotic Antagonists
### Intervention Browse Module - Browse Leaves
- ID: M11982
- Name: Morphine
- Relevance: LOW
- As Found: Unknown
- ID: M5317
- Name: Buprenorphine
- Relevance: HIGH
- As Found: Incision
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M12245
- Name: Narcotics
- Relevance: LOW
- As Found: Unknown
- ID: M12243
- Name: Narcotic Antagonists
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000002047
- Term: Buprenorphine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442553
**Brief Title:** New Generation Low Level Laser Effect in Myofacial Pain Syndrome
**Official Title:** New Generation Low Level Laser Effect on Masseter Muscle Oxygenation, Bite Force and Algometric Changes in Myofacial Pain Syndrome: A Randomised, Placebo-controlled Clinical Trial
#### Organization Study ID Info
**ID:** KARAGOZOGLUI
#### Organization
**Class:** OTHER
**Full Name:** University of Gaziantep
### Status Module
#### Completion Date
**Date:** 2024-04-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-03-25
**Type:** ACTUAL
#### Start Date
**Date:** 2024-01-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Gaziantep
#### Responsible Party
**Investigator Affiliation:** University of Gaziantep
**Investigator Full Name:** İREM KARAGOZOGLU
**Investigator Title:** Assist. Prof.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Low level laser treatments have been used to treat painful trigger points in myofascial pain syndrome (MPS), but the effectiveness of the appropriate laser type and parameters is still uncertain. The aim of this study was to compare the effectiveness of different types of low level laser treatment (LLLT) in reducing pain levels, changing oxygen saturation and bite force in patients with MPS.
**Detailed Description:** A total of 45 patients with MPS were randomly divided into three groups. First group received LLLT with GRR laser over massater muscle region. Patients in the second group were treated with Nd:YAG laser and the same protocol with Nd:YAG laser was performed in the placebo group using sham device. Pain was evaluated by visual analogue scale (VAS), change in oxygen concentration in the massater muscle was measured by functional near-infrared spectroscopy- fNIRS and bite force was measured with Flexiforce sensors before and after treatment.
### Conditions Module
**Conditions:**
- Myofascial Pain Syndrome
**Keywords:**
- low level laser therapy
- myofascial pain syndrome
- bite forces
- visual analogue scale
- gaalas laser
- neodymium doped yttrium aluminum garnet lasers
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** FACTORIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 45
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** patients received 15 sessions GRR laser treatment for 3 weeks
**Intervention Names:**
- Device: GRR laser
**Label:** GRR laser
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** patients received 10 sessions Nd:YAG laser treatment for 2 weeks
**Intervention Names:**
- Device: Nd:YAG laser
**Label:** Nd:YAG Laser
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** patients received 10 sessions emission-free laser treatment for 2 weeks
**Intervention Names:**
- Device: Nd:YAG laser
**Label:** placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- GRR laser
**Description:** A total of 15 sessions were applied to each patient for three weeks, five times per week.
**Name:** GRR laser
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Nd:YAG Laser
- placebo
**Description:** A total of 10 sessions, five sessions per week, were applied
**Name:** Nd:YAG laser
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Patients were asked to rate the intensity of their pain on a scale from 0 to 10. They were told that a score of 0 meant no pain, a score of 10 meant severe pain and a score of 5 meant moderate pain
**Measure:** change from baseline in pain on the 10 point visual analogue scale (VAS) at week 3
**Time Frame:** baseline and week 3
**Description:** oxygen concentration in the massater muscle was measured by functional near-infrared spectroscopy- fNIRS (ARGES cerebro, Hemosoft Inc., Ankara, Turkey) before and after treatment for each patient.
**Measure:** change from baseline in oxygen concentration in the massater muscle at week 3
**Time Frame:** baseline and week 3
**Description:** bite force values were recorded by Flexiforce sensors before and after treatment for each patient.
**Measure:** change from baseline in bite force values at week 3
**Time Frame:** baseline and week 3
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
-patients with symptoms of temporomandibular disorders and diagnosed with MPS as a result of the clinical examination.
Exclusion Criteria:
* Patients with internal TMJ irregularities or degenerative joint changes,
* patients with restricted mouth opening, deviation or deflection,
* patients with systemic diseases,
* pregnant women,
* patients who had received MPS treatment within the previous year
**Healthy Volunteers:** True
**Maximum Age:** 30 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Şehitkamil
**Country:** Turkey
**Facility:** İrem Karagözoğlu
**State:** Gazi̇antep
**Zip:** 27310
#### Overall Officials
**Official 1:**
**Affiliation:** GAZİANTEP ÜNİVERSİTESİ DİŞ HEKİMLİĞİ FAKÜLTESİ
**Name:** İREM KARAGÖZOĞLU
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000005155
- Term: Facial Nerve Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000003389
- Term: Cranial Nerve Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- 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: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12381
- Name: Neuralgia
- Relevance: LOW
- As Found: Unknown
- ID: M8299
- Name: Facial Neuralgia
- Relevance: HIGH
- As Found: Myofacial Pain Syndrome
- ID: M21089
- Name: Facies
- Relevance: LOW
- As Found: Unknown
- ID: M8300
- Name: Facial Pain
- Relevance: HIGH
- As Found: Myofacial Pain
- 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: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M8298
- Name: Facial Nerve 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: M6605
- Name: Cranial Nerve Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009209
- Term: Myofascial Pain Syndromes
- ID: D000005356
- Term: Fibromyalgia
- ID: D000005156
- Term: Facial Neuralgia
- ID: D000013577
- Term: Syndrome
- ID: D000005157
- Term: Facial Pain
- ID: D000013001
- Term: Somatoform Disorders
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442540
**Brief Title:** Effects of Intra Muscular Electrotherapy Combined With Manipulative Therapy in Patients With Sacral Torsion
**Official Title:** Effects of Intra Muscular Electrotherapy Combined With Manipulative Therapy in Patients With Sacral Torsion
#### Organization Study ID Info
**ID:** FUI/CTR/2024/11
#### Organization
**Class:** OTHER
**Full Name:** Foundation University Islamabad
### Status Module
#### Completion Date
**Date:** 2024-06-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-05-20
**Type:** ACTUAL
#### Start Date
**Date:** 2023-07-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Foundation University Islamabad
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study is a randomised controlled trial and the purpose of this study is to determine the effect of intra muscular electrotherapy combined with manipulative therapy in terms of pain, mobility, range of motion, and disability."
**Detailed Description:** The purpose of this study is to determine the effect of intra muscular electrotherapy combined with manipulative therapy in terms of pain, mobility, range of motion, and disability in patients with sacral torsion." (age : 22-44 years )
1. Numeric pain rating scale
2. Inclinometer Lumbar Flexion
3. Oswestry Disability Questionairre
4. Goniometer SLR ROM Data will be collected before and after the intervention protocol for each participant.
Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Pre and post intervention scores will be recorded.
### Conditions Module
**Conditions:**
- Sacroiliac Joint Dysfunction
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized Controlled Trial
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 32
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** HVLA thrust for SI Joint once per week:
Core stability exercises Intramuscular electrotherapy / 3 sessions per week 10 mins / frequency 100hz muscles( piriformis, erector spinae )
**Intervention Names:**
- Procedure: Manipulation
- Procedure: Core Stability Exercises
- Procedure: Intramusular electrotherapy
**Label:** Group 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Hot pack 10 mins soft tissue / myofacial release ( piriformis, erector spinae ) Piriformis stretching core stability exercises
**Intervention Names:**
- Procedure: Physical Agents
- Procedure: Core Stability Exercises
- Procedure: Soft tissue mobility
**Label:** Group 2
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group 2
**Description:** Hot pack
**Name:** Physical Agents
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Group 1
**Description:** HVLA manipulation of SI joint
**Name:** Manipulation
**Type:** PROCEDURE
#### Intervention 3
**Arm Group Labels:**
- Group 1
- Group 2
**Description:** Supine abdominal draw-in Hold 8s 3s off x 2 Abdominal draw-in, with one knee drawn to the chest. Hold 8s 3s off x 2 Abdominal draw-in, with the heels sliding backward one after the other. 10 reps 3s off x 2 Abdominal draw-in, with both knees drawn to the chest. Hold 8s 3s off x 2 Supine twist 15 reps 3s off x 3 Prone bridging on elbows Hold 8s 3s off x 3 Side bridging on elbows Hold 8s 3s off x 3 Quadruped opposite arm-leg lift Hold 8s 3s off x 3 Advance to the stage 2 when the patient can hold 30 reps for an 8-sec hold.
**Name:** Core Stability Exercises
**Type:** PROCEDURE
#### Intervention 4
**Arm Group Labels:**
- Group 1
**Description:** Intramuscular electrotherapy/ 3 sessions per week
**Name:** Intramusular electrotherapy
**Type:** PROCEDURE
#### Intervention 5
**Arm Group Labels:**
- Group 2
**Description:** Stretching and Myofacial Release of piriformis and erector spinae
**Name:** Soft tissue mobility
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Numeric Pain Rating Scale (NPRS): ICC (0.93-0.96) It has a scale of 0-10 or 0-100 points and can be given verbally or in writing
**Measure:** Pain Intensity
**Time Frame:** 4 weeks
**Description:** Lumbar ROM will be measured using Inclinometer
**Measure:** Lumbar ROM
**Time Frame:** 4 weeks
**Description:** SLR ROM will be measured using Goniometer
**Measure:** SLR ROM
**Time Frame:** 4 weeks
**Description:** Oswestry disability questionairre
**Measure:** Level of Disability
**Time Frame:** 4 Weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria:
* Age group: 22-44 years old
* Both males and females
* Clinically diagnosed sacral torsion
* Patients with pain intensity of at least 5 on NPRS
* Positive backward bent test
* Positive forward bent test
* Uneven Sacral sulcus
* Uneven ILA of sacrum
* Piriformis syndrome
Exclusion criteria :
* Any congenital deformities
* Demonstrated neurological deficit.
* Pregnant females
* History of spinal surgery
* Spondylolisthesis
* Severe lumbar spondylosis
* Spinal stenosis
* Serious spinal conditions like infection, tumors, osteoporosis, spinal fracture
* osteoporosis
**Maximum Age:** 44 Years
**Minimum Age:** 22 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** usamaibrar35@gmail.com
**Name:** Usama Ibrar, MS-MSKPT*
**Phone:** 03035954053
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rawalpindi
**Contacts:**
***Contact 1:***
- **Email:** nida.mushtaq@fui.edu.pk
- **Name:** Nida Mushtaq, DPT,MSNMPT
- **Phone:** 033300418548
- **Role:** CONTACT
**Country:** Pakistan
**Facility:** Foundation University College of Physical Therapy
**State:** Punjab
**Status:** RECRUITING
**Zip:** 46000
## 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: M10621
- Name: Joint Diseases
- Relevance: HIGH
- As Found: Joint Dysfunction
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007592
- Term: Joint Diseases
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442527
**Acronym:** VR-TMS
**Brief Title:** Using Virtual Reality Before Transcranial Magnetic Stimulation for the Treatment of OCD
**Official Title:** Using Virtual Reality Before Transcranial Magnetic Stimulation for the Treatment of OCD
#### Organization Study ID Info
**ID:** 2000037937
#### Organization
**Class:** OTHER
**Full Name:** Yale University
### Status Module
#### Completion Date
**Date:** 2025-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Yale University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** This study will focus on the use of Virtual Reality (VR) technology in patients receiving treatment using Transcranial Magnetic Stimulation (TMS) for Obsessive-Compulsive Disorder (OCD)
### Conditions Module
**Conditions:**
- Obsessive-Compulsive Disorder
**Keywords:**
- TMS
- Transcranial Magnetic Stimulation
- Virtual Reality
- VR
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 5
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This single arm will include all participants of the study, who will all receive the intervention
**Intervention Names:**
- Device: Virtual Reality
**Label:** Treatment Group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment Group
**Description:** Virtual reality gear and content will be used prior to TMS session as part of the provocation items
**Name:** Virtual Reality
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Tolerability will be assessed by open-ended interview of the patient about their experience and any difficulty tolerating VR
**Measure:** Tolerability of VR treatment by qualitative assessment
**Time Frame:** Within 1 hour after each treatment session
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participants must be at least 18 years old
* Patients must have been clinically evaluated by a Yale Interventional Psychiatry Service physician who has deemed them appropriate to receive TMS for the treatment of OCD
* Ability and willingness, in the investigator's judgement, to comply with the study procedure and study requirements.
Exclusion Criteria:
* Hearing or visual impairment to the degree that would interfere with ability to see or hear VR content.
* Difficulty in understanding spoken or written English
* Pregnancy
* History of seizure disorder
* Unable to provide informed consent
* Dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to understand the study procedure (per investigator judgment)
* Any implanted medical device, risk of interference with which by the VR device in the investigator's judgment can put patient at additional undue risk.
* Any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study.
* Was previously enrolled/randomized into the study
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** mina.ansari@yale.edu
**Name:** Mina Ansari
**Phone:** 2036889719
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** New Haven
**Country:** United States
**Facility:** Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit
**State:** Connecticut
**Zip:** 06520
#### Overall Officials
**Official 1:**
**Affiliation:** Assistant Professor, Departement of Psychiatry, Yale University
**Name:** Sina Nikayin, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001523
- Term: Mental Disorders
- ID: D000001008
- Term: Anxiety Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M6419
- Name: Compulsive Personality Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M12706
- Name: Obsessive-Compulsive Disorder
- Relevance: HIGH
- As Found: Obsessive-Compulsive Disorder
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009771
- Term: Obsessive-Compulsive Disorder
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442514
**Acronym:** PASS-IVR
**Brief Title:** Pain and Smoking Study - Interactive Voice Response
**Official Title:** Enhancing an Intervention for Smokers With Chronic Pain Using IVR: A Randomized Clinical Trial of Smoking Cessation Counseling for Veterans
#### Organization Study ID Info
**ID:** IIR 22-070
#### Organization
**Class:** FED
**Full Name:** VA Office of Research and Development
### Status Module
#### Completion Date
**Date:** 2028-05-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-05-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-12-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** FED
**Name:** VA Office of Research and Development
#### 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:** PASS2 aims to expand upon the recently completed study (PASS intervention), which tested the telephone delivery of a cognitive behavioral intervention (CBI). This study will use Interactive Voice Response (IVR) to optimize the intervention's effectiveness for smoking cessation among Veteran smokers with chronic pain.
**Detailed Description:** Veterans with chronic pain represent an important population in which to focus smoking cessation efforts. Smoking cessation among patients with chronic medical illnesses substantially decreases morbidity and mortality; yet, many patients (\>50%) with chronic pain continue to smoke.
This study aims to:
1. Determine whether the existing integrated pain and smoking cessation (PASS intervention) augmented with IVR (PASS-IVR) is superior to treatment as usual (e.g., referral to standard VA smoking cessation clinic) enhanced with pharmacotherapy tele-consult (E-TAU) at 6 (primary endpoint) and 12 months on cigarette abstinence rates among non-depressed Veterans with chronic pain.
2. Determine whether PASS-IVR is superior to E-TAU at 6 (primary endpoint) and 12 months on pain interference.
3. Examine critical components of the intervention process to inform future program implementation.
### Conditions Module
**Conditions:**
- Smoking
- Pain
- Smoking Cessation
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 220
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** An intervention that includes a proactive telehealth intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain, and nightly Interactive Voice Response (IVR) calls. Veterans in PASS-IVR will also be offered 12-weeks of pharmacotherapy (e.g., NRT patches and one of two rescue methods such as nicotine lozenge or gum or varenicline) via telemedicine consult. The NRT dose and delivery route will be tailored to the number of cigarettes smoked per day (using an established protocol).
**Intervention Names:**
- Behavioral: PASS-IVR
**Label:** PASS-IVR
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Treatment as usual includes referral to the local smoking cessation clinic where Veterans may select a virtual individual or group based cognitive behavioral smoking cessation program with a trained psychology intern, postdoctoral fellow or staff psychologist. In conjunction, Veterans are encouraged but not required, by clinic staff, to connect with the VA Quitline and the VA's Annie text-messaging service to support their quit. Veterans are strongly encouraged to consider pharmacotherapy (e.g., NRT patches and one of two rescue methods such as nicotine lozenge or gum or varenicline). The NRT dose and delivery route will be tailored to the number of cigarettes smoked per day (using an established protocol - interested Veterans will be offered a telemedicine consult for this service
**Intervention Names:**
- Other: Treatment as Usual
**Label:** Treatment as Usual
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- PASS-IVR
**Description:** An intervention that includes a proactive telehealth intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain, and nightly Interactive Voice Response (IVR) calls to report smoking status, pain, and pedometer-measured step counts, which the clinician will use to provide individualized feedback.
**Name:** PASS-IVR
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Treatment as Usual
**Description:** Referral to the local smoking cessation VA clinic.
**Name:** Treatment as Usual
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** In keeping with the SNRT recommendations for measuring abstinence, we will use prolonged abstinence as our main outcome and allow for a grace period around quit date. During the 6- and 12-month follow-ups, patients will be asked about prolonged abstinence, "Since \[end of the grace period\] have you ever smoked at least a part of a cigarette on each of 7 consecutive days?" and "After \[end of the grace period\] have you smoked any in each of 2 consecutive weeks".
**Measure:** Cigarette Smoking Abstinence Rates
**Time Frame:** 6-month and 12-month follow-up
#### Secondary Outcomes
**Description:** Patients will be asked whether they have smoked a cigarette, even a puff, in the past 7 days and, if no, will be asked whether they have smoked a cigarette, even a puff, in the past 30 days.
**Measure:** Point prevalent abstinence
**Time Frame:** 6-month and 12-month follow-up
**Description:** Pain intensity and interference will be assessed using the 11-item BPI. The BPI also assesses chronicity of pain and areas of the body with pain. The interference subscale has demonstrated adequate internal consistency and robust concurrent validity and responsivity among patients with chronic non-cancer pain. We have also added the PROMIS 8-item pain interference measure and the PROMIS 3-item pain intensity measure which has comparable responsiveness to BPI and excellent internal consistency (.96).
**Measure:** Pain intensity and pain-related functional interference
**Time Frame:** baseline, 6-months follow-up, and 12-months follow-up
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* being an enrolled Veteran at VACHS;
* current tobacco use;
* willingness to make a quit attempt;
* significant chronic pain defined as \>/=4 on the pain intensity portion of the Brief Pain Inventory (BPI) for more than 90 days.
Exclusion Criteria:
* active diagnosis of dementia or psychosis in medical record;
* severely impaired hearing or speech;
* lack of telephone access;
* enrollment in concurrent research study that might affect main outcomes of this study;
* terminal illness;
* non-English speaking;
* pregnancy;
* provider advising against exercise;
* planned surgeries; and
* clinically significant depressive symptoms (\>10 PHQ-9).
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** Lori.Bastian@va.gov
**Name:** Lori A Bastian, MD MPH
**Phone:** (203) 932-5711
**Phone Ext:** 3830
**Role:** CONTACT
**Contact 2:**
**Email:** Mary.Driscoll3@va.gov
**Name:** Mary Driscoll, PhD
**Phone:** (203) 932-5744
**Phone Ext:** 3631
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** West Haven
**Contacts:**
***Contact 1:***
- **Email:** Lori.Bastian@va.gov
- **Name:** Lori A Bastian, MD MPH
- **Phone:** (203) 932-5711
- **Phone Ext:** 3830
- **Role:** CONTACT
***Contact 2:***
- **Name:** Lori Anne Bastian, MD MPH
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** VA Connecticut Healthcare System West Haven Campus, West Haven, CT
**State:** Connecticut
**Zip:** 06516-2770
#### Overall Officials
**Official 1:**
**Affiliation:** VA Connecticut Healthcare System West Haven Campus, West Haven, CT
**Name:** Lori Anne Bastian, MD MPH
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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: M29442
- Name: Chronic Pain
- 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: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M12478
- Name: Nicotine
- Relevance: LOW
- As Found: Unknown
- ID: M278
- Name: Varenicline
- Relevance: LOW
- As Found: Unknown
- ID: T482
- Name: Varenicline
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442501
**Acronym:** PREGMPOXCO
**Brief Title:** Observational Mondkeypox Pregnancy Cohort
**Official Title:** Pregnancy Monkeypox Cohort Study in the South Kivu Province in the DRC
#### Organization Study ID Info
**ID:** University of Antwerp
#### Organization
**Class:** OTHER
**Full Name:** Universiteit Antwerpen
### Status Module
#### Completion Date
**Date:** 2027-02-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-10-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Patrick Kototo
#### Lead Sponsor
**Class:** OTHER
**Name:** Robert Colebunders
#### Responsible Party
**Investigator Affiliation:** Universiteit Antwerpen
**Investigator Full Name:** Robert Colebunders
**Investigator Title:** Prof
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** PREGMPOXCO study addresses the escalating Mpox virus (MPXV) infections among pregnant women in South Kivu, DRC following a novel MPXV sub-lineage, predominantly transmitted through heterosexual contact, stressing critical gaps in our understanding of MPXV's impact on pregnant populations. To better understand this altered transmission pattern of MPXV and its impact on this vulnerable population, PREGMPOX will employ both passive and active surveillance techniques to methodologically capture MPXV incidence among pregnant women over two years, integrating data from routine antenatal care and targeted community outreach to timely assess the MPXV's effects on maternal and neonatal health. In sentinel study sites in hot spot areas, the incidence of mpox among pregnant women will be investigated and potential transmission routes determined. MPXV(+) pregnant women will be asked to participate in a cohort study where they will be followed until delivery to document pregnancy outcomes (e.g.: miscarriage, stillbirths, preterm deliveries, neonatal mpox), maternal immune response, virus abundance and pathological changes in the placenta. This will help to determine specific risk factors and modes and frequencies of vertical transmission to the unborn, and generate a list of clinical and immunological predictors for adverse outcomes for pregnant women and neonates. Data on MVA-BN exposure will also be captured to report on its real world effectiveness. As a prerequisite to evaluate the safety of the MVA-BN vaccine and tecovirimat treatment in pregnant women according to the new DRC guidelines, we will establish a comprehensive register of adverse pregnancy outcomes, using a pharmacovigilance model to monitor and analyse adverse events following immunization and treatment. The results of our multidisciplinary studies will be crucial for developing guidelines and recommendations to manage mpox more effectively during pregnancy, and for potentially influencing global health policies.
**Detailed Description:** The PREGMPOX study employs a prospective cohort design enriched with a nested case-control component, adeptly tracking the dynamics of MPXV infection among pregnant women.
This approach incorporates a rigorous baseline data collection phase that enhances the understanding of initial disease presentation and risk factors associated with confirmed MPXV infection. Such detailed profiling at baseline is critical for identifying early disease characteristics and potential co-factors affecting outcomes. Further, follow-up and endline assessments are strategically planned to estimate the incidence of new infections and assess mother-child health outcomes in various groups: those testing positive versus negative for MPXV, vaccinated versus unvaccinated individuals, and comparisons between those treated with tecovirimat versus those who are not. This structured analysis allows for an in-depth evaluation of intervention effectiveness and safety. The study design also includes a test-negative case-control approach as a secondary analytical method. While not the primary focus-given the high specificity of PCR in confirming MPXV in over 90% of cases-this approach is valuable for confirming intervention effectiveness under natural conditions. This methodology is designed to avoid the ethical concerns often associated with randomized control trials in vulnerable populations, ensuring the feasibility and relevance of the study's outcomes. PREGMPOX employs a strategic combination of passive and active surveillance methods to comprehensively track the spread of MPXV among pregnant women, aiming to capture the full spectrum of the virus's impact. Passive surveillance is embedded into routine antenatal care, where healthcare providers systematically monitor and document MPXV symptoms, leveraging the existing healthcare infrastructure. This allows for the continuous collection of data within a clinical setting. In contrast, active surveillance extends beyond the confines of healthcare facilities, involving community health workers who engage directly with the community to identify and document MPXV cases that might not otherwise come to clinical attention. This includes setting up specialized screening stations that facilitate the detection of cases in non-clinical environments. This dual surveillance approach is vital due to the severe risks associated with MPXV, particularly the high rates of foetal demise linked to severe infections. By combining both surveillance strategies, PREGMPOX enhances its capability for early detection and effective response, including prompt referral for necessary interventions. This comprehensive data collection and proactive case finding strategy are crucial for implementing timely interventions that could prevent severe outcomes in pregnant women and their foetuses, thereby mitigating the broader impact of the MPXV outbreak. PREGMPOX will also contribute to basic research in this vulnerable population where data is scarce by conducting immunological and histopathological assessments to understand the mechanisms underlying the impact of MPVX infection on pregnancy. These assessments will be conducted through a nested case-control study within the larger cohort. Samples will be collected at specific time points to evaluate immune responses to MPVX infection or vaccination and to study placental pathology in infected cases.
### Conditions Module
**Conditions:**
- Monkey Pox
### Design Module
#### Bio Spec
**Description:** skin and mucosal swabs, blood, placenta
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 150
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** MPXV infected pregnant women
**Intervention Names:**
- Other: routine care
**Label:** MPXV infected pregnant women
#### Arm Group 2
**Description:** Not MPXV infected pregnant women
**Intervention Names:**
- Other: routine care
**Label:** Not MPXV infected pregnant women
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MPXV infected pregnant women
- Not MPXV infected pregnant women
**Description:** routine care
**Name:** routine care
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** health of the mother and child
**Measure:** pregnancy outcome
**Time Frame:** at delivery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 1. Pregnancy status: all women confirmed to be pregnant at the time of recruitment.
2. Age: women of all age (ascent to be asked for non-legal age to allow for the pair mother-child to benefit with earlier diagnosis and other befit the study might offer).
3. Geographical inclusion: residing within the catchment areas of the selected healthcare facilities in South Kivu to ensure that they are likely to continue receiving follow-up care at the participating sites throughout their pregnancy.
4. Symptomatic and asymptomatic participation:
* Symptomatic: pregnant women presenting with symptoms suggestive of mpox, such as fever, rash/skin lesion, or lymphadenopathy.
* Asymptomatic: pregnant women attending routine antenatal visits who do not exhibit symptoms but are screened as part of the study's surveillance efforts or who report a confirmed case of mpox in the household/or among closed contacts 5. Consent: women who provide written informed consent to participate in the study, having understood the purpose, procedures, potential risks, and benefits of the study.
Exclusion Criteria:1. Non-consent: pregnant women who do not consent/or their parent-caregiver to participate in the study.
2. Medical exclusions: women with pre-existing medical conditions that, as determined by clinical judgment, may either put them at risk due to participation in the study or could confound the study results (e.g., conditions that significantly alter immune response such as confirmed cancer).
3. Plans to relocate: women who plan to move out of the geographical study area during the study period, which would interfere with follow-up.
4. Participation in other studies: women currently participating in other clinical trials that might interfere with the results of this study, especially trials involving new experimental treatments for mpox or other infectious diseases.
-
**Healthy Volunteers:** True
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Pregnant women in the South Kivu province of the DRC at risk for mpox
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** robert.colebunders@uantwerpen.be
**Name:** Robert Colebunders, MD, PhD
**Phone:** 0486920149
**Role:** CONTACT
**Contact 2:**
**Name:** Joseph Siewe Fodjo, MD, PhD
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011213
- Term: Poxviridae Infections
- ID: D000004266
- Term: DNA 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
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M25604
- Name: Mpox (monkeypox)
- Relevance: HIGH
- As Found: Monkey Pox
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14094
- Name: Poxviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7442
- Name: DNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: T3865
- Name: Monkeypox
- Relevance: HIGH
- As Found: Monkey Pox
### Condition Browse Module - Meshes
- ID: D000045908
- Term: Mpox (monkeypox)
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442488
**Brief Title:** Wearable Wireless Respiratory Monitoring System That Detects and Predicts Opioid Induced Respiratory Depression
**Official Title:** Wearable Wireless Respiratory Monitoring System That Detects and Predicts Opioid Induced Respiratory Depression
#### Organization Study ID Info
**ID:** 1R44DA059491-01
**Link:** https://reporter.nih.gov/quickSearch/1R44DA059491-01
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** Thomas Jefferson University
### Status Module
#### Completion Date
**Date:** 2024-09-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** RTM Vital Signs, LLC
#### Lead Sponsor
**Class:** OTHER
**Name:** Jeffrey Joseph
#### Responsible Party
**Investigator Affiliation:** Thomas Jefferson University
**Investigator Full Name:** Jeffrey Joseph
**Investigator Title:** Professor of Anesthesiology
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is Unapproved Device:** True
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** An observational study will be conducted in approximately 14 participants to evaluate the ability of a wearable, wireless acoustic Respiratory Monitoring System (RMS) to accurately measure a participant's respiratory rate, tidal volume, minute ventilation, and duration of apnea in a noisy environment. Sensor accuracy will be measured with adaptive filtering and active noise cancellation turned on versus turned off.
**Detailed Description:** The Respiratory Monitoring System (RMS) consists of a miniature acoustic sensor and a soft flexible cradle that is adhered to the skin of the neck over the proximal trachea (within the sternal notch) with medical grade adhesive. The sensor body consists of a miniature bell stethoscope head, electronics, a microphone that faces the trachea and a microphone that faces the external environment, a Bluetooth low energy transmitter/receiver, an antenna, and a rechargeable battery. The sensor is secured by the cradle at the optimal location to measures the sounds of airflow in the proximal trachea during inhalation and exhalation.
Proprietary machine learning/AI algorithms convert the sounds of airflow into the measurements of respiratory rate (RR), tidal volume (TV), minute ventilation (MV), and duration of apnea. Sensor information is transmitted to a bedside PC that displays the vital sign data in real-time. The wearable, wireless RMS is being developed for hospital and outpatient use as a tool to detect and predict respiratory compromise/clinical deterioration in a more-timely and accurately manor (fewer false alerts/alarms) than current methods.
The breathing data from 14 to 20 participants will be recorded during one study session lasting approximately 90 minutes with the sensor/cradle adhered to the neck over the proximal trachea. Reference breathing data will be recorded simultaneously using a hospital ventilator's pneumotach and capnometer attached to a tight-fitting face mask.
Each subject will be instructed to breath the following protocol 3 or 4 times:
Record RMS data and pneumotach/capnometer data for \~400 seconds with the study subject breathing a normal RR and TV.
Record RMS data and pneumotach/capnometer data for \~70 seconds with the study subject breathing a normal RR and an increased TV.
Record RMS data and pneumotach/capnometer data for \~70 seconds with the study subject breathing a normal RR and decreased TV.
Record RMS data and pneumotach/capnometer data for \~120 seconds with the study subject breathing a normal RR and normal TV with a period of apnea in the middle (15 seconds).
Record RMS data and pneumotach/capnometer data for \~120 seconds with the study subject breathing a normal RR and decreased TV, with a period of apnea in the middle (15 seconds).
Record RMS data and pneumotach/capnometer data for \~120 seconds with the study subject breathing a decreased RR and decrease TV with a period of apnea in the middle (15 seconds).
RMS data will be compared to reference pneumotach/capnometer data (RR, TV, MV, and duration of apnea) to determine the accuracy of measurement. Data will be recorded in an environment with simulated hospital noise with adaptive filtering and active noise cancellation turned on and turned off.
This observational human study will compare the signal-to-noise ratio (SNR) and the measurement accuracy of the RMS in a noisy environment with the adaptive filtering and active noise cancellation turned on versus turned off.
Participants will be contacted by telephone 3 to 4 days later to confirm no adverse effects from the study methods or wearing the sensor.
### Conditions Module
**Conditions:**
- Respiratory Insufficiency
- Clinical Deterioration
**Keywords:**
- Respiratory Monitoring System
- Detection of Respiratory Insufficiency
- Prediction of Respiratory Insufficiency
- Wearable, Wireless Respiratory Sensor
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 14
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Comparing the SNR and accuracy of measurement (RR, TV, MV, apnea duration) in a noisy external environment when the RMS has adaptive filtering and active noise cancellation turned on versus turned off.
**Name:** Respiratory Monitoring System
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** RMS breathing data and reference pneumotach/capnogram data will be recorded with RMS adaptive filtering and active noise cancellation turned on and turned off to calculate the accuracy of RR measurement.
**Measure:** Accuracy of respiratory rate (RR) measurement in a noisy environment when RMS adaptive filtering and active noise cancellation is turned on versus turned off.
**Time Frame:** 90 minutes
**Description:** RMS breathing data and reference pneumotach/capnogram data will be recorded with RMS adaptive filtering and active noise cancellation turned on and turned off to calculate the accuracy of TV measurement.
**Measure:** Accuracy of tidal volume (TV) measurement in a noisy environment when RMS adaptive filtering and active noise cancellation is turned on versus turned off.
**Time Frame:** 90 minutes
**Description:** RMS breathing data and reference pneumotach/capnogram data will be recorded with RMS adaptive filtering and active noise cancellation turned on and turned off to calculate the accuracy of MV measurement.
**Measure:** Accuracy of minute ventilation (MV) measurement in a noisy environment when RMS adaptive filtering and active noise cancellation is turned on versus turned off.
**Time Frame:** 90 minutes
**Description:** RMS breathing data and reference pneumotach/capnogram data will be recorded with RMS adaptive filtering and active noise cancellation turned on and turned off to calculate the accuracy of duration of apnea measurement.
**Measure:** Accuracy of duration of apnea measurement in a noisy environment when RMS adaptive filtering and active noise cancellation is turned on versus turned off.
**Time Frame:** 90 minutes
#### Secondary Outcomes
**Description:** RMS breathing data and reference pneumotach/capnogram data will be recorded with RMS adaptive filtering and active noise cancellation turned on and turned off to calculate the sensor's signal-to-noise ratio.
**Measure:** Measure the signal-to-noise ratio of the RMS output signal in a noisy external environment with adaptive filtering and active noise cancellation turned on and off.
**Time Frame:** 90 minutes
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age 18 to 70 years.
2. BMI 20 to 38.
3. Subject understands the English language, understands the risks, benefits, and alternatives to this research study, and is willing and able to give written informed consent.
Exclusion Criteria:
1. Age \<18 years\>70.
2. BMI \< 20 or \> 38.
3. Does not understand written and spoken English.
4. Anxiety or claustrophobia related to wearing a face mask.
5. History of skin irritation or inflammation related to the adhesive, adhesive tape, or materials used in the trachea sound sensor or facemask.
6. Active infection or inflammation of the skin above the proximal trachea.
7. Excessive facial hair that may prevent a tight seal around the facemask.
8. Unstable cardiac, vascular, pulmonary, hepatic, renal, immune function at the discretion of the investigator.
9. Pregnancy or breast feeding.
10. Current participation in an industry sponsored pharmaceutical study or a medical device study.
**Healthy Volunteers:** True
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** 14 participants that meet the inclusion/exclusion criteria. Approximately equal number of male/female participants.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** Jeffrey.Joseph@Jefferson.edu
**Name:** Jeffrey I Joseph, DO
**Phone:** 215-620-9999
**Role:** CONTACT
**Contact 2:**
**Email:** Marc.Torjman@Jefferson.edu
**Name:** Marc C Torjman, PhD
**Phone:** 215-603-6401
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Philadelphia
**Contacts:**
***Contact 1:***
- **Email:** melissa.mccarey@jefferson.edu
- **Name:** Melissa McCarey
- **Phone:** 215-503-7417
- **Role:** CONTACT
**Country:** United States
**Facility:** Thomas Jefferson University
**State:** Pennsylvania
**Status:** RECRUITING
**Zip:** 19107
### IPD Sharing Statement Module
**Description:** We do not plan to share IPD data with other researchers.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Yu L, Ting CK, Hill BE, Orr JA, Brewer LM, Johnson KB, Egan TD, Westenskow DR. Using the entropy of tracheal sounds to detect apnea during sedation in healthy nonobese volunteers. Anesthesiology. 2013 Jun;118(6):1341-9. doi: 10.1097/ALN.0b013e318289bb30.
**PMID:** 23407106
**Citation:** Chen G, de la Cruz I, Rodriguez-Villegas E. Automatic lung tidal volumes estimation from tracheal sounds. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:1497-500. doi: 10.1109/EMBC.2014.6943885.
**PMID:** 25570253
**Citation:** Thakor NV, Zhu YS. Applications of adaptive filtering to ECG analysis: noise cancellation and arrhythmia detection. IEEE Trans Biomed Eng. 1991 Aug;38(8):785-94. doi: 10.1109/10.83591.
**PMID:** 1937512
**Citation:** Ramsay MA, Usman M, Lagow E, Mendoza M, Untalan E, De Vol E. The accuracy, precision and reliability of measuring ventilatory rate and detecting ventilatory pause by rainbow acoustic monitoring and capnometry. Anesth Analg. 2013 Jul;117(1):69-75. doi: 10.1213/ANE.0b013e318290c798. Epub 2013 Apr 30.
**PMID:** 23632055
**Citation:** Harper VP, Pasterkamp H, Kiyokawa H, Wodicka GR. Modeling and measurement of flow effects on tracheal sounds. IEEE Trans Biomed Eng. 2003 Jan;50(1):1-10. doi: 10.1109/TBME.2002.807327.
**PMID:** 12617519
**Citation:** Patino M, Kalin M, Griffin A, Minhajuddin A, Ding L, Williams T, Ishman S, Mahmoud M, Kurth CD, Szmuk P. Comparison of Postoperative Respiratory Monitoring by Acoustic and Transthoracic Impedance Technologies in Pediatric Patients at Risk of Respiratory Depression. Anesth Analg. 2017 Jun;124(6):1937-1942. doi: 10.1213/ANE.0000000000002062.
**PMID:** 28448390
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000018450
- Term: Disease Progression
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### 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: M14968
- Name: Respiratory Insufficiency
- Relevance: HIGH
- As Found: Respiratory Insufficiency
- ID: M1541
- Name: Clinical Deterioration
- Relevance: HIGH
- As Found: Clinical Deterioration
- ID: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M20559
- Name: Disease Progression
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012131
- Term: Respiratory Insufficiency
- ID: D000075902
- Term: Clinical Deterioration
### Intervention Browse Module - Browse Branches
- Abbrev: Analg
- Name: Analgesics
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11982
- Name: Morphine
- Relevance: LOW
- As Found: Unknown
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442475
**Brief Title:** Low Dose Mosunetuzumab for the Treatment of Patients With Indolent B-Cell Lymphoma
**Official Title:** Low Dose Mosunetuzumab for Indolent B-Cell Lymphoma
#### Organization Study ID Info
**ID:** RG1124175
#### Organization
**Class:** OTHER
**Full Name:** University of Washington
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2024-02289
**Type:** REGISTRY
**Domain:** Fred Hutch/University of Washington Cancer Consortium
**ID:** 20417
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-02-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-08-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Washington
#### 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 phase II trial tests the safety, side effects and effectiveness of mosunetuzumab in treating patients with slow growing (indolent) B-cell lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread.
**Detailed Description:** OUTLINE:
Patients receive mosunetuzumab intravenously (IV) over 2-4 hours on days 1, 8, 15 and 22. Patients also undergo blood sample collection and positron emission tomography (PET)/computed tomography (CT) on study. Patients may undergo CT and/or magnetic resonance imaging (MRI) as clinically indicated and may undergo collection of oral and/or rectal swabs on study.
After completion of study treatment, patients are followed up at week 13, at 6 months, and then for up to 5 years per institutional standards.
### Conditions Module
**Conditions:**
- Ann Arbor Stage II Follicular Lymphoma
- Ann Arbor Stage II Marginal Zone Lymphoma
- Ann Arbor Stage III Follicular Lymphoma
- Ann Arbor Stage III Marginal Zone Lymphoma
- Ann Arbor Stage IV Follicular Lymphoma
- Ann Arbor Stage IV Marginal Zone Lymphoma
- Grade 1 Follicular Lymphoma
- Grade 2 Follicular Lymphoma
- Grade 3a Follicular Lymphoma
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients receive mosunetuzumab IV over 2-4 hours on days 1, 8, 15 and 22. Patients also undergo blood sample collection and PET/CT on study. Patients may undergo CT and/or MRI as clinically indicated and may undergo collection of oral and/or rectal swabs on study.
**Intervention Names:**
- Procedure: Biospecimen Collection
- Procedure: Computed Tomography
- Procedure: Magnetic Resonance Imaging
- Biological: Mosunetuzumab
- Procedure: Positron Emission Tomography
- Other: Questionnaire Administration
**Label:** Treatment (mosunetuzumab)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment (mosunetuzumab)
**Description:** Undergo blood, oral, and/or rectal sample collection
**Name:** Biospecimen Collection
**Other Names:**
- Biological Sample Collection
- Biospecimen Collected
- Specimen Collection
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Treatment (mosunetuzumab)
**Description:** Undergo PET/CT or 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 3
**Arm Group Labels:**
- Treatment (mosunetuzumab)
**Description:** Undergo MRI
**Name:** Magnetic Resonance Imaging
**Other Names:**
- Magnetic Resonance
- Magnetic Resonance Imaging (MRI)
- Magnetic resonance imaging (procedure)
- Magnetic Resonance Imaging Scan
- Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
- MR
- MR Imaging
- MRI
- MRI Scan
- MRIs
- NMR Imaging
- NMRI
- Nuclear Magnetic Resonance Imaging
- sMRI
- Structural MRI
**Type:** PROCEDURE
#### Intervention 4
**Arm Group Labels:**
- Treatment (mosunetuzumab)
**Description:** Given IV
**Name:** Mosunetuzumab
**Other Names:**
- Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody BTCT4465A
- BTCT 4465A
- BTCT-4465A
- BTCT4465A
- CD20/CD3 BiMAb BTCT4465A
- Lunsumio
- Mosunetuzumab-axgb
- RG 7828
- RG-7828
- RG7828
- RO7030816
**Type:** BIOLOGICAL
#### Intervention 5
**Arm Group Labels:**
- Treatment (mosunetuzumab)
**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
#### Intervention 6
**Arm Group Labels:**
- Treatment (mosunetuzumab)
**Description:** Ancillary studies
**Name:** Questionnaire Administration
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** OR will be defined as complete response and partial response at the end of therapy based on the latest version of Lugano criteria. Response rates will be calculated using simple binomial proportions and the corresponding 95% confidence interval will be derived.
**Measure:** Overall response (OR)
**Time Frame:** Up to week 13
#### Secondary Outcomes
**Description:** All AEs will be graded in severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be summarized by type, severity, duration, and attribution.
**Measure:** Incidence of adverse events (AE's)
**Time Frame:** Up to 30 days after last dose of study treatment
**Description:** CRS will be graded by the American Society for Transplantation and Cellular Therapy Consensus Grading system.
**Measure:** Incidence of grade 3 or greater cytokine release syndrome (CRS)
**Time Frame:** Up to 30 days after last dose of study treatment
**Measure:** Incidence of Immune Effector Cell Associated Neurotoxicity syndrome
**Time Frame:** Up to 30 days after last dose of study treatment
**Description:** Kaplan-Meier methodology will be used to estimate PFS.
**Measure:** Progression free survival (PFS)
**Time Frame:** At initiation of study treatment to disease progression, up to 5 years
**Measure:** Duration of response
**Time Frame:** Up to 5 years
**Description:** Kaplan-Meier methodology will be used to estimate time to next lymphoma treatment.
**Measure:** Time to next lymphoma treatment
**Time Frame:** At initiation of study treatment to initiation of next therapy, up to 5 years
**Description:** Kaplan-Meier methodology will be used to estimate time to cytotoxic treatment.
**Measure:** Time to cytotoxic treatment
**Time Frame:** At initiation of study treatment to initiation of cytotoxic treatment, up to 5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18 years or older at time of signing informed consent
* Capable of understanding and providing written informed consent
* Histologically confirmed indolent B-cell non-Hodgkin lymphoma with no prior systemic therapy. Eligible histologies include:
* Follicular lymphoma (grade 1-2 or 3A)
* Marginal zone lymphoma
* Ann Arbor stage II-IV disease
* No prior therapy for lymphoma
* Have low-tumor burden disease, defined by Groupe D'Etude des Lymphomes Folliculaires (GELF) criteria:
* Nodal or extranodal tumor mass \< 7 cm
* Involvement of less than 3 nodal sites with a diameter \> 3 cm
* No systemic or B symptoms
* No splenomegaly \> 16 cm by imaging
* No local risk of vital organ compression
* No pleural or peritoneal serous effusions
* No leukemic phase (\> 5,0000/uL circulating lymphocytes)
* No significant cytopenias defined as platelets \< 100,000/uL, hemoglobin \< 10 g/dL, or absolute neutrophil count (ANC) \< 1500/uL
* Have measurable nodal disease, including at least 1 disease site measuring at least 1.5 cm in longest dimension on CT or fludeoxyglucose F-18 (FDG)-PET, or a FDG-avid extranodal measurable site measuring at least 1.0 cm in longest dimension. Measurable disease also includes spleen size more than 13 cm in vertical length
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Creatinine clearance ≥ 50 mL/min calculated by Cockcroft-Gault equation
* Total bilirubin ≤ 1.5 x the upper limit of normal (ULN), except in patients with Gilbert's syndrome who may have a total bilirubin up to ≤ 3 x ULN
* Aspartate aminotransferase (AST) ≤ 3 x the ULN
* Alanine aminotransferase (ALT) ≤ 3 x the ULN
* Gamma glutamyl transferase (GGT) ≤ 3 x the ULN
* Negative serum or urine pregnancy test within 7 days of initiating mosunetuzumab for women of childbearing potential, defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year
* Fertile male and woman of childbearing potential must agree to use highly effective contraceptive methods from start of treatment to at least 3 months after the last dose of mosunetuzumab
Exclusion Criteria:
* Any prior therapy for lymphoma
* History of severe allergic reaction to monoclonal antibody therapy
* History of a second primary malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. Malignancies treated curatively or at low-risk of progressing at the judgment of the principal investigator (PI) may be included
* Known active and uncontrolled bacterial, viral, fungal, mycobacterial, or other infection at study enrollment
* Infection with human immunodeficiency virus (unless viral load is undetectable and CD4 count ≥ 200)
* Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \[HbBsAg\] serology):
* Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable at the time of screening. These patients must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated by institutional standards
* Autoimmune disease requiring active therapy
* History of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
* Evidence of significant concurrent disease or medical condition that could interfere with the conduct of the study, or put the patient at significant risk including, but not limited to, significant cardiovascular disease (e.g., New York Heart Association class III or IV cardiac disease, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
* Ongoing systemic corticosteroid treatment, with the exception of corticosteroid use for other (non-tumor and non-immunosuppressive) indications up to a maximum of 10 mg/day of prednisone or equivalent
* Prior use of any monoclonal antibody within 4 weeks before the first mosunetuzumab administration
* Prior solid organ transplantation
* Pregnant or breast-feeding women, or intending to become pregnant during the study or within 3 months of the last dose of mosunetuzumab
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** agopal@uw.edu
**Name:** Ajay Gopal
**Phone:** 206-606-2037
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Seattle
**Contacts:**
***Contact 1:***
- **Email:** agopal@uw.edu
- **Name:** Ajay Gopal
- **Phone:** 206-606-2037
- **Role:** CONTACT
***Contact 2:***
- **Name:** Ajay Gopal
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Fred Hutch/University of Washington Cancer Consortium
**State:** Washington
**Zip:** 98109
#### Overall Officials
**Official 1:**
**Affiliation:** Fred Hutch/University of Washington Cancer Consortium
**Name:** Ajay Gopal
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000008206
- Term: Lymphatic Diseases
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
- ID: D000008228
- Term: Lymphoma, Non-Hodgkin
- ID: D000016393
- Term: Lymphoma, B-Cell
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11220
- Name: Lymphoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: M18828
- Name: Lymphoma, B-Cell
- Relevance: LOW
- As Found: Unknown
- ID: M11221
- Name: Lymphoma, Follicular
- Relevance: HIGH
- As Found: Follicular lymphoma
- ID: M20554
- Name: Lymphoma, B-Cell, Marginal Zone
- Relevance: HIGH
- As Found: Marginal zone lymphoma
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M11225
- Name: Lymphoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M11203
- Name: Lymphatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10206
- Name: Immunoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11222
- Name: Lymphoma, Non-Hodgkin
- Relevance: LOW
- As Found: Unknown
- ID: T3543
- Name: Lymphosarcoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: T640
- Name: B-cell Lymphoma
- Relevance: HIGH
- As Found: B-cell Lymphoma
- ID: T2361
- Name: Follicular Lymphoma
- Relevance: HIGH
- As Found: Follicular lymphoma
- ID: T3612
- Name: Marginal Zone Lymphoma
- Relevance: HIGH
- As Found: Marginal zone lymphoma
- ID: T3043
- Name: Indolent B Cell Lymphoma
- Relevance: HIGH
- As Found: Indolent B-cell Lymphoma
### Condition Browse Module - Meshes
- ID: D000008223
- Term: Lymphoma
- ID: D000008224
- Term: Lymphoma, Follicular
- ID: D000018442
- Term: Lymphoma, B-Cell, Marginal Zone
### Intervention Browse Module - Ancestors
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4230
- Name: Antibodies, Monoclonal
- Relevance: LOW
- As Found: Unknown
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M19201
- Name: Muromonab-CD3
- Relevance: LOW
- As Found: Unknown
- ID: M20194
- Name: Antibodies, Bispecific
- Relevance: HIGH
- As Found: Leukemia in remission
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000018033
- Term: Antibodies, Bispecific
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442462
**Brief Title:** Study of SPG302 in Adults With Schizophrenia
**Official Title:** A Randomized, Placebo-controlled, Double-blind Phase 2 Study to Assess the Efficacy, Safety, Tolerability, and Pharmacodynamics of SPG302 in Adult Participants Diagnosed With Schizophrenia
#### Organization Study ID Info
**ID:** SPG302-SCZ-201
#### Organization
**Class:** INDUSTRY
**Full Name:** Spinogenix
### Status Module
#### Completion Date
**Date:** 2025-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Spinogenix
#### 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 Phase 2 study described herein will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia.
**Detailed Description:** This Phase 2 study will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia. This is a randomized, placebo-controlled study of SPG302 administered once daily for six weeks.
This study will entail five visits to the study site for screening, study procedures, and receipt of investigational medication for use at home.
### Conditions Module
**Conditions:**
- Schizophrenia
**Keywords:**
- synaptogenesis
- synapse
- dendritic spines
### 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:** 32
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants with schizophrenia will be randomized to receive SPG302 300 mg or placebo (two capsules of 150 mg) once daily for six weeks.
**Intervention Names:**
- Drug: SPG302
**Label:** Active SPG302 to be administered to participants with Schizophrenia
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Participants with schizophrenia will be randomized to receive SPG302 300 mg or placebo (two capsules of 150 mg) once daily for six weeks.
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo comparator to be administered to participants with Schizophrenia
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Active SPG302 to be administered to participants with Schizophrenia
**Description:** small synthetic molecule
**Name:** SPG302
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo comparator to be administered to participants with Schizophrenia
**Description:** Placebo
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The PANSS is a scale to measure symptom severity of schizophrenia. Thirty symptoms of schizophrenia are evaluated by a clinician on a seven point sale, with 1 = absence of symptoms and 7 = extremely severe symptoms. This study will rate each score change by calculating the difference between baseline scale and completion of study intervention.
**Measure:** Positive and Negative Symptoms Scale (PANSS Score) as determined by clinician
**Time Frame:** 6 weeks
**Description:** Electroencephalograms (EEG) will provide a non-invasive measurement of brain activity. This test will be used to measure specific brain responses to stimuli, including attention and decision making electrical activity and detection of unexpected changes in the auditory environment.
**Measure:** Electroencephalogram analysis to assess brain electrical activity
**Time Frame:** 6 weeks
**Description:** Participants will follow visual targets on a computer screen to assess for accuracy of following the item, and smoothness of eye movements. The visual target on the computer screen will follow several different tracking patterns and at various speeds.
**Measure:** Change in smooth pursuit eye tracking from baseline
**Time Frame:** 6 weeks
#### Secondary Outcomes
**Description:** Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms, and abnormal findings on physical examination, vital signs, ECG, and standard laboratory examination results (SAEs).
**Measure:** Safety and tolerability of SPG302 in patients with schizophrenia
**Time Frame:** 6 weeks
**Description:** Change in the Clinical Global Impression of Improvement (CGI-I) is a 3-item observer-rated scale that measures illness severity, global improvement or change, and therapeutic response. It is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients).
**Measure:** Change in Global Impressions Improvement scale as determined by clinician
**Time Frame:** 6 weeks
**Description:** Change in the Clinical Global Impression of Severity (CGI-S) is a 3-item observer-rated scale that measures illness severity, global improvement or change, and therapeutic response. It is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients).
**Measure:** Change in Global Impressions Severity scale as determined by clinician
**Time Frame:** 6 weeks
**Description:** This is a 26-item questionnaire which collects self-reported data on physical health, psychological health, social relationships, and environmental health. Each section is scored from 1 to 5, with higher scores indicate higher quality of life. Scores from each section are then added together for an overall score, with higher score indicating higher quality of life.
**Measure:** World Health Organization Quality of Life - Abbreviated Assessment Questionnaire-brief version from baseline
**Time Frame:** 6 weeks
**Description:** The BACS is a standardized neuropsychological test to assess the cognitive functions that are often impacted by schizophrenia. These functions are verbal memory, working memory, verbal fluency, processing speed, executive functioning, and motor speed. A higher score indicates higher functioning.
**Measure:** Change in BACS (Brief Assessment Cognition Schizophrenia) score from baseline
**Time Frame:** 6 weeks
**Description:** Personal and Social Performance (PSP) evaluates overall functioning in daily life. A higher score indicates higher functioning.
**Measure:** Change in Personal and Social Performance from baseline
**Time Frame:** 6 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 45-65
* Primary diagnosis of schizophrenia
* Clinical laboratory values within normal range or \< 1.5 times ULN
* Currently prescribed only one antipsychotic medication
* Able and willing to provide written informed consent
Exclusion Criteria:
* Any physical or psychological condition that prohibits study completion
* Known cardiac disease
* Active or history of malignancy in the past 5 years
* Serious infection that will not be resolved by first day of study intervention.
* History of clinically significant CNS event or diagnosis in the past 5 years.
* Acute illness within 30 days of Day 1
* History of suicidal behavior or suicidal ideation
* History of chronic alcohol use or substance abuse in the last 5 years
* HIV, hepatitis B and/or hepatitis C positive
* Vaccines within 14 days
* Receipt of investigational products within 30 days
* Blood donation within 30 days
* Pregnant or breastfeeding
**Maximum Age:** 65 Years
**Minimum Age:** 45 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** Leo.Chen@monash.edu
**Name:** Leo Chen, Dr.
**Phone:** +61 3 9076 6564
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Monash University
**Name:** Leo Chen, Dr.
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** University of Melbourne
**Name:** Malcolm Hopwood, Dr.
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000019967
- Term: Schizophrenia Spectrum and Other Psychotic Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M15376
- Name: Schizophrenia
- Relevance: HIGH
- As Found: Schizophrenia
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21838
- Name: Schizophrenia Spectrum and Other Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012559
- Term: Schizophrenia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442449
**Brief Title:** Booster Dose of sIPV Co-administered With MMR and HepA-I.
**Official Title:** Open-labeled, Randomized, Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of Booster Dose of sIPV Co-administered With MMR and HepA-I.
#### Organization Study ID Info
**ID:** PRO-sIPV-4003
#### Organization
**Class:** INDUSTRY
**Full Name:** Sinovac Biotech Co., Ltd
### Status Module
#### Completion Date
**Date:** 2025-03-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-02-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Sinovac Biotech Co., Ltd
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This is an Open-labeled, Randomized, Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of Booster Dose of Sabin Strain Inactivated Poliovirus Vaccine (Vero cell) (sIPV) Co-administered with Measles, Mumps, Rubella (MMR) Combined Live Attenuated Vaccine and Inactivated Hepatitis A (Hep-A) Vaccine.
**Detailed Description:** The trial plans to enroll 960 infants aged 18 months (+4 months) who had completed three primary doses of sIPV vaccine and were assigned in a 2:2:2:1:1 ratio to four groups including trial group 1, trial group 2, control group 1, control group 2, control group 2, with informed consent from the participant's guardian. Trial group 1 receive one dose of sIPV co-administered with one dose of MMR vaccine. Trial group 2 receive one dose of sIPV co-administered with one dose of inactivated hepatitis A vaccine. Control group 1 receive one dose of sIPV, control group 2 receive one dose of MMR vaccine, and control group 3 receive one dose of inactivated hepatitis A vaccine. About 3.0 ml of venous blood will be collected from all participants before and 30 days after vaccination for antibody detection. Immediate reactions will be observed for 30 minutes after vaccination, and adverse events occured from 0 to day 30 after vaccination will be collected.
### Conditions Module
**Conditions:**
- Poliomyelitis
**Keywords:**
- sIPV
- immunogenicity
- safety
- Combination Vaccination
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized Controlled Trial (RCT)
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 960
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** vaccination with sIPV+MMR
**Intervention Names:**
- Biological: sIPV
- Biological: MMR
**Label:** Trial group 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** vaccination with sIPV+HepA-I
**Intervention Names:**
- Biological: sIPV
- Biological: HepA-I
**Label:** Trial group 2
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** vaccination with sIPV
**Intervention Names:**
- Biological: sIPV
**Label:** Control group 1
**Type:** ACTIVE_COMPARATOR
#### Arm Group 4
**Description:** vaccination with MMR
**Intervention Names:**
- Biological: MMR
**Label:** Control group 2
**Type:** ACTIVE_COMPARATOR
#### Arm Group 5
**Description:** vaccination with HepA-I
**Intervention Names:**
- Biological: HepA-I
**Label:** Control group 3
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control group 1
- Trial group 1
- Trial group 2
**Description:** vaccination with sIPV
**Name:** sIPV
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- Control group 2
- Trial group 1
**Description:** vaccination with MMR
**Name:** MMR
**Type:** BIOLOGICAL
#### Intervention 3
**Arm Group Labels:**
- Control group 3
- Trial group 2
**Description:** vaccination with HepA-I
**Name:** HepA-I
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** -The SCRs of neutralizing antibody against different poliovirus serotypes (Type I, II and III) at day 30 after sIPV vaccination.
**Measure:** seroconversion rates (SCRs) of sIPV neutralizing antibody against different poliovirus serotypes (Type I, II and III)
**Time Frame:** 30 days
**Description:** SCRs of anti-measles IgG antibodies 30 days after vaccination
**Measure:** SCRs of anti-meascles IgG antibodies
**Time Frame:** 30 days
**Description:** SCRs of anti-mumps IgG antibodies 30 days after vaccination
**Measure:** SCRs of anti-mumps IgG antibodies
**Time Frame:** 30 days
**Description:** SCRs of anti-rubella IgG antibodies 30 days after vaccination
**Measure:** SCRs of anti-rubella IgG antibodies
**Time Frame:** 30 days
**Description:** SCRs of anti-hepatitis A antibodies 30 days after vaccination
**Measure:** SCRs of anti-hepatitis A IgG antibodies
**Time Frame:** 30 days
#### Secondary Outcomes
**Description:** SPRs and GMC of anti-measles virus IgG antibodies 30 days after vaccination.
**Measure:** Seropositivity rates (SPRs) and GMC of anti-measles virus IgG antibodies
**Time Frame:** 30 days
**Description:** SPRs and GMC of anti-mumps virus IgG antibodies 30 days after vaccination;
**Measure:** SPRs and GMC of anti-mumps virus IgG antibodies
**Time Frame:** 30 days
**Description:** SPRs and GMC of anti-rubella virus IgG antibodies 30 days after vaccination;
**Measure:** SPRs and GMC of anti-rubella virus IgG antibodies
**Time Frame:** 30 days
**Description:** SPRs and GMC of anti- hepatitis A virus IgG antibodies 30 days after vaccination;
**Measure:** SPRs and GMC of anti- hepatitis A virus IgG antibodies
**Time Frame:** 30 days
**Description:** -GMTs of antibody of neutralizing antibody against different poliovirus serotypes (Type I, II and III) at day 30 after sIPV vaccination;
**Measure:** Geometric Mean Titer (GMT) of sIPV neutralizing antibody against different poliovirus serotypes (Type I, II and III)
**Time Frame:** 30 days
**Description:** - SPRs of neutralizing antibodies against different poliovirus serotypes (Type I, II and III) at day 30 after vaccination.
**Measure:** - SPRs of neutralizing antibodies against different poliovirus serotypes (Type I, II and III)
**Time Frame:** 30 days
**Description:** - Incidence of ARs from 0 to 30 days after vaccination;
**Measure:** - Incidence of adverse reactions (ARs)
**Time Frame:** 30 days
**Description:** - Incidence of SAEs 0\~30 days after vaccination.
**Measure:** - Incidence of serious adverse events (SAEs)
**Time Frame:** 30 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* (1) healthy toddlers aged 18 months (+4 months);
* (2) completed three doses of sIPV primary immunization;
* (3) completed one dose of MMR vaccination;
* (4) able to provide proof of vaccination;
* (5) able to provide legal proof of identity;
* (6) The guardians of the participants were able to understand and agree to sign the informed consent.
Exclusion Criteria:
* (1) a history of vaccination with a polio-containing vaccine component in addition to three sIPV primary doses, according to the vaccination certificate;
* (2) have received a second dose of MMR vaccine or a vaccine containing a vaccine for measles, mumps or rubella, or hepatitis A vaccine (inactivated or attenuated), according to the vaccination certificate;
* (3) previous history of polio or measles or mumps or rubella or hepatitis A;
* (4) known severe allergy to the vaccine or vaccine components, such as urticaria, dyspnea, angioedema;
* (5) severe congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
* (6) with autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, asplenia, functional asplenia, and HIV infection);
* (7) abnormal coagulation function (such as coagulation factor deficiency, platelet abnormality), or obvious bleeding, hematoma, or ecchymosis after previous intramuscular injection or venipuncture;
* (8) have/have had a serious neurological disease (e.g., encephalopathy, epilepsy, convulsions \[other than febrile convulsions\]) or psychosis, a family history of neurological disease or psychosis;
* (9) receiving immunosuppressive or other immunomodulatory therapy, cytotoxic therapy within the past 6 months, or planning to receive such treatment during the trial;
* (10) have received an immune globulin or other blood products within the past 6 months or plan to receive such treatment during the trial;
* (11) receipt of other investigational vaccines within 30 days before vaccination with the investigational vaccines;
* (12) receipt of live attenuated vaccine within 28 days before vaccination with the investigational vaccine;
* (13) receipt of subunit or inactivated vaccine within 7 days before vaccination with the investigational vaccine;
* (14) acute diseases or acute episodes of chronic diseases within the past 7 days;
* (15) Axillary temperature \>37.0℃ if fever occurred before vaccination;
* (16) which are unsuitable for participation in the clinical trial as judged by the investigators.
**Healthy Volunteers:** True
**Maximum Age:** 22 Months
**Minimum Age:** 18 Months
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** panhongxing@126.com
**Name:** Pan Hong xing
**Phone:** 18118996996
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Nanjing
**Contacts:**
***Contact 1:***
- **Email:** panhongxing@126.com
- **Name:** Pan Hongxing
- **Phone:** 18118996996
- **Role:** CONTACT
***Contact 2:***
- **Name:** Pan Hongxing
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health)
**State:** Jiangsu
**Zip:** 210009
#### Overall Officials
**Official 1:**
**Affiliation:** Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health)
**Name:** Pan Hongxing
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009187
- Term: Myelitis
- ID: D000002494
- Term: Central Nervous System Infections
- ID: D000007239
- Term: Infections
- ID: D000004769
- Term: Enterovirus Infections
- ID: D000010850
- Term: Picornaviridae Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000013118
- Term: Spinal Cord Diseases
- ID: D000090862
- Term: Neuroinflammatory Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC10
- Name: Nervous 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: M13939
- Name: Poliomyelitis
- Relevance: HIGH
- As Found: Poliomyelitis
- ID: M12142
- Name: Myelitis
- 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: M7930
- Name: Enterovirus Infections
- 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
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15915
- Name: Spinal Cord Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2803
- Name: Neuroinflammatory Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4606
- Name: Poliomyelitis
- Relevance: HIGH
- As Found: Poliomyelitis
- ID: T3988
- Name: Myelitis
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011051
- Term: Poliomyelitis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442436
**Brief Title:** A Study of Nemtabrutinib in Participants With Moderate Hepatic Impairment (MK-1026-015)
**Official Title:** A Study to Evaluate the Pharmacokinetics of Nemtabrutinib in Participants With Moderate Hepatic Impairment
#### Organization Study ID Info
**ID:** 1026-015
#### Organization
**Class:** INDUSTRY
**Full Name:** Merck Sharp & Dohme LLC
#### Secondary ID Infos
**Domain:** Merck
**ID:** MK-1026-015
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-12-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-24
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Merck Sharp & Dohme LLC
#### 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 compare the plasma pharmacokinetics (PK) of nemabrutinib (MK-1026) following a single oral dose of nemtabrutinib in participants with moderate hepatic impairment to that of healthy matched control participants and to evaluate the safety and tolerability of nemtabrutinib.
### Conditions Module
**Conditions:**
- Hepatic Impairment (HI)
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 16
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants with moderate hepatic impairment will receive a single oral dose of 25 mg nemtabrutinib on Day 1.
**Intervention Names:**
- Drug: Nemtabrutinib
**Label:** Panel A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Healthy control participants will receive a single oral dose of 25 mg nemtabrutinib on Day 1.
**Intervention Names:**
- Drug: Nemtabrutinib
**Label:** Panel B
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Panel A
- Panel B
**Description:** 25 mg nemtabrutinib (1 x 5 mg and 1 x 20 mg tablets) administered orally as a single dose.
**Name:** Nemtabrutinib
**Other Names:**
- MK-1026
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The AUC0-inf of nemtabrutinib in plasma will be determined in each arm.
**Measure:** Area Under the Curve from Dosing to Infinity (AUC0-inf) of Nemtabrutinib in Plasma
**Time Frame:** Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
**Description:** The Cmax of nemtabrutinib in plasma will be determined in each arm.
**Measure:** Maximum Concentration (Cmax) of Nemtabrutinib in Plasma
**Time Frame:** Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
#### Secondary Outcomes
**Description:** The AUC0-last of nemtabrutinib in plasma will be determined in each arm.
**Measure:** Area Under the Curve from Dosing to last (AUC0-last) of Nemtabrutinib in Plasma
**Time Frame:** Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
**Description:** The C24 of nemtabrutinib in plasma will be determined in each arm.
**Measure:** Concentration 24 (C24) Hours Postdose of Nemtabrutinib in Plasma
**Time Frame:** 24 hours postdose
**Description:** The Tmax of nemtabrutinib in plasma will be determined in each arm.
**Measure:** Time to Maximum Concentration (Tmax) of Nemtabrutinib in Plasma
**Time Frame:** Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
**Description:** The t½ of nemtabrutinib in plasma will be determined in each arm.
**Measure:** Apparent Terminal Half-life (t1/2) of Nemtabrutinib in Plasma
**Time Frame:** Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
**Description:** The CL/F of nemtabrutinib in plasma will be determined in each arm.
**Measure:** Apparent Total Clearance (CL/F) of Nemtabrutinib in Plasma
**Time Frame:** Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
**Description:** The Vz/F of nemtabrutinib in plasma will be determined in each arm.
**Measure:** Apparent Volume of Distribution During Terminal Phase (Vz/F) of Nemtabrutinib in Plasma
**Time Frame:** Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
**Description:** An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing AEs will be reported.
**Measure:** Number of Participants who Experience One or More Adverse Events (AEs)
**Time Frame:** Up to ~15 days
**Description:** An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study treatment due to an AE will be reported.
**Measure:** Number of Participants Who Discontinue From the Study Due to an Adverse Event (AE)
**Time Frame:** Up to ~15 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Has a body mass index (BMI) between 18.0 and 40.0 kg/m2, inclusive.
* Is assigned male or female sex at birth. Participants assigned female sex at birth must not be pregnant or breast feeding and must be of nonchild bearing potential.
* Who agrees to use contraception.
* Has provided documented informed consent for the study.
* Has a diagnosis of chronic (\>6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic impairment with features of cirrhosis due to any etiology (moderate HI only).
* Has moderate hepatic impairment (class B) by the Child-Pugh classification system (moderate HI only).
* Is in general good health (except for Moderate HI).
Exclusion Criteria:
* Has a clinically significant condition that may affect absorption of the study drug in the opinion of the investigator, including gastric restrictions and bariatric surgery (eg, gastric bypass).
* Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years.
* Has a history of cancer (malignancy).
* Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (systemic allergic reaction) to prescription or nonprescription drugs or food.
* Had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy.
* Has received any vaccine starting from 14 days prior to study or is scheduled to receive any vaccine through 30 days following study intervention.
* Was dosed in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to check-in (Day -1).
* Is under the age of consent.
* Is heavy smoker or heavy user of nicotine-containing products (\>20 cigarettes or equivalent/day).
* Is regular user of cannabis or any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months.
* Consumes greater than 3 servings of alcoholic beverages per day.
* Consumes excessive amounts, defined as greater than 6 servings of coffee, tea, cola, (1 serving is approximately equivalent to 120 mg of caffeine) energy drinks, or other caffeinated beverages per day.
* Is unwilling to comply with the study restrictions.
* Has a history or illness that in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study (moderate HI only).
* Has a history of recent variceal bleeds (for moderate HI only).
* Has evidence of hepatorenal syndrome (for moderate HI only).
* Has fluctuating or rapidly deteriorating hepatic function within the prestudy period, in the opinion of the investigator (for moderate HI only).
* Is not in sufficient health, with regard to stability of HI, to undergo participation in the study with anticipated survival of \<3 months, in keeping with a Model for End-Stage Liver Disease (MELD) scoreof ≥25 (for moderate HI only).
* Has a history of liver or other solid organ transplantation (for moderate HI only).
* Has an active infection requiring systemic therapy (for moderate HI only).
* Who requires paracentesis more often than 2 times per month (for moderate HI only).
* Has a transjugular intrahepatic portosystemic shunt and/or has undergone portacaval shunting (for moderate HI only).
* Has encephalopathy Grade 3 or worse within 28 days before administration of study intervention (for moderate HI only).
* Has received antiviral and/or immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to study start (for moderate HI only).
* Is positive for human immunodeficiency virus (HIV)-1 or HIV-2 or using HIV protease inhibitors (for moderate HI only).
* Is positive for HBV (for moderate HI only).
* Is positive for HCV (for moderate HI only).
* Is taking medications to treat chronic medical conditions and has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of the medication(s) for the probhibited period of time in study (for moderate HI only).
* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological (history of a bleeding disorder, abnormal bleeding or a hereditary or acquired coagulation or platelet disorder), hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke, intracranial hemorrhage, and chronic seizures) abnormalities or diseases (for healthy control participants only).
* Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or HIV at the prestudy (screening) visit (for healthy control participants only).
* Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies (for healthy control participants only).
**Healthy Volunteers:** True
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### IPD Sharing Statement Module
**Description:** http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
**IPD Sharing:** YES
**URL:** http://engagezone.msd.com/ds_documentation.php
### References Module
#### See Also Links
**Label:** Merck Clinical Trials Information
**URL:** http://www.merckclinicaltrials.com
## 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
### Condition Browse Module - Browse Leaves
- ID: M11107
- Name: Liver Diseases
- Relevance: HIGH
- As Found: Hepatic Impairment
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008107
- Term: Liver Diseases
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442423
**Brief Title:** Open-Label Psilocybin
**Official Title:** Safety, Feasibility, and Tolerability of Psilocybin Treatment for Individuals With Functional Impairment Related to Mood, Anxiety, Trauma and/or Addiction Symptoms: An Open-label Proof-of-concept Study
#### Organization Study ID Info
**ID:** 2000037785
#### Organization
**Class:** OTHER
**Full Name:** Yale University
### Status Module
#### Completion Date
**Date:** 2027-07
**Type:** ESTIMATED
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-28
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Usona Institute
#### Lead Sponsor
**Class:** OTHER
**Name:** Yale University
#### Responsible Party
**Investigator Affiliation:** Yale University
**Investigator Full Name:** Benjamin Kelmendi, MD
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The primary objective of this study is to investigate the safety, feasibility, and tolerability of psilocybin treatment in individuals with functional impairment due to psychiatric symptoms.The secondary objective of this study is to determine whether individuals with functional impairments due to psychiatric symptoms will experience statistically significant symptom reduction and functional improvement from baseline symptom measurements (Visit 3) to 1-week (Visit 7), 4-weeks (Visit 8), and 6-weeks (Visit 9) post dosing. We will recruit individuals with mood, anxiety, trauma, addictive, or related symptomatology, and who have functional impairment associated with these symptoms. We will not limit recruitment to any particular DSM diagnosis; we allow for comorbidity and only exclude based on safety considerations. Critically, this approach will allow us to assess the tolerability of our interventions in individuals who would typically be excluded from efficacy studies due to various comorbid DSM conditions.
We will employ an open-label study where participants will be given one dose of oral psilocybin 25mg. We will also have follow-up visits at 1, 4, and 6 weeks and an optional long-term follow-up at 3, 6, and 12 months.
**Detailed Description:** In this Phase 1b proof-of-concept clinical trial, we aim to investigate the safety, feasibility, and tolerability of treatment of oral psilocybin in participants with functional impairment due to depressive, anxiety, trauma addictive, or other psychiatric symptomatology, allowing for comorbidity and diagnostic complexity to mirror potential real-world clinical scenarios. Secondarily, we will assess improvement in functional status and symptomatology.
We will employ an open-label study design, with participants receiving one dose of oral psilocybin. This is an open-label clinical trial with a single treatment arm and no blinding. All participants will receive 25 mg of oral psilocybin. All dosing will be accompanied by non-directive support before, during, and after treatment sessions.The rationale for conducting this study lies in recognizing that the narrow inclusion and exclusion criteria commonly employed in clinical trials may raise issues of external validity. While previous research has predominantly focused on specific diagnostic categories, our study aims to address these limitations by exploring the safety, feasibility, and tolerability of psilocybin in a heterogeneous population.
This study also recognizes the importance of symptom-related functional impairment as a cross-cutting construct relevant to all diagnostic categories.This is a Phase 1b open-label clinical trial to determine the feasibility, tolerability and safety of psilocybin to reduce psychiatric symptoms in participants experiencing functional impairment. Participants will receive one dose of oral psilocybin (25mg). Follow-up visits for assessments and measures at 1-week, 4-week, and 6-week post psilocybin dosing. Long-term follow-up visits assessments and measures for participants who consent to long-term follow-up (reassessments of study measures) for 3-month, 6-month, and 12-month post dosing.
Psilocybin (4-hydroxy-N,N-dimethyltryptamine) occurs in nature in many species of mushrooms, including the genera Psilocybe, Conocybe, Gymnopilus, Panaeolus, and Strophparia. Its chemical formula is C12H17N2O4P. Psilocybin is a potent agonist at 5-HT2A/C receptors; potency of binding by related compounds to these receptors correlates with human potency as hallucinogens. Psilocybin is currently a Schedule I substance. Psilocybin will be orally administered in this study. Psilocybin will be administered in an opaque, size 2 gelatin capsule with approximately 180 ml of water to be orally ingested at Visit 5. The dose of psilocybin will be 25 mg.
Descriptives for all safety measures (e.g., C-SSRS total and subscale scores, vitals, documented adverse events) will be compiled at all assessment intervals. Classification of adverse events will follow institute and regulatory body guidelines. Subsequent summary descriptives may focus on safety indices surrounding the dosing session and 1-week, 4 weeks, and 6-weeks after dosing. In addition, we will perform descriptives and non-parametric analysis screen failure rates (including analysis of ineligibility), drop out rates pre and post dosing to determine feasibility and tolerability.
### Conditions Module
**Conditions:**
- Safety, Feasibility, and Tolerability of Psilocybin Treatment in Individuals With Functional Impairment Due to Psychiatric Symptoms
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** We will employ an unblinded, open-label study where all participants will be given one dose of oral psilocybin 25mg. We will also have follow-up visits at 1, 4, and 6 weeks and an optional long-term follow-up at 3, 6, and 12 months.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Psilocybin will be administered in an opaque, size 2 gelatin capsule with approximately 180 ml of water to be orally ingested at Visit 5. The dose of psilocybin will be 25 mg.
**Intervention Names:**
- Drug: Psilocybin
**Label:** Open-label
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Open-label
**Description:** Psilocybin will be administered in an opaque, size 2 gelatin capsule with approximately 180 ml of water to be orally ingested at Visit 5. The dose of psilocybin will be 25 mg.This is an open-label clinical trial with a single treatment arm. This is an open-label clinical trial with no blinding.
**Name:** Psilocybin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** A questionnaire used to assess suicide risk
**Measure:** Columbia-Suicide Severity Rating Scale (C-SSRS)
**Time Frame:** 12 months
**Description:** This log is cumulative and captures adverse events (including serious adverse events) of all participants throughout the study
**Measure:** Adverse Events Log
**Time Frame:** 12 months
#### Secondary Outcomes
**Description:** a 36-item measure that assesses disability in adults age 18 years and older
**Measure:** World Health Organization Disability Assessment Schedule
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Psychiatric symptom(s) causing a functional impairment as established by a trained clinician on the DIAMOND and WHODAS - an assessment instrument for health and disability.
2. English fluency - able to understand the process of consent and the risk and benefits associated with the study, and able to provide written (signed and dated) informed consent form.
3. Agree to sign a medical release for the investigators to communicate directly with the outside provider(s) to confirm treatment and medical history.
4. Agree to set up safe transportation after leaving the site following the dosing session. Acceptable arrangements include: arranging for a friend/family member to drive them home; using a rideshare service.
5. Agree to commit to all study procedures, including psilocybin dosing session, preparatory and integration sessions, and follow-up visits, and completing evaluation instruments and commit to respond to all necessary telephone or email contacts.
6. Ability to orally ingest pills for psilocybin dosing visit.
7. Agree to adhere to lifestyle modifications (see section 6.1.7) throughout the study duration
8. Agree to refrain from taking any medications on the day of dosing, except as approved by the PI/Co-I.
9. Agree to refrain from taking or starting any new psychiatric medications until after 4 weeks post dosing session. Should the participant's outside treating provider recommend starting a new psychiatric medication, or if participant desires, participant will be required to notify the study team. Treating physician will be required to attest to knowledge of patient being enrolled in this clinical trial and notify study team of treatment change.
10. Must provide an adult contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the PI and/or study personnel in the event of an emergency, and who can provide transportation for study visits if necessary and independently comment on any changes in the participant's mood or behavior after the administration of psilocybin.
11. Be medically stable (no medical issues based on physical exam, labs and medical evaluation) as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an ECG, and routine blood and urinalysis laboratory tests.
12. Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least one month prior to screening and is expected to remain stable during participation in the study.
If participant is of childbearing potential, must have a negative urine pregnancy test at study entry and prior to the dosing session. Participants who are FOCBP must not plan to become pregnant or donate eggs, starting at least 1 month before receiving the trial intervention and for at least 1 week after the final follow-up visit.
A FOCBP is defined as a female who is considered fertile following menarche and until becoming postmenopausal, unless permanently sterile (see below).
Females in the following categories are not considered FOCBP:
* Premenarchal.
* Premenopausal with 1 of the following:
1. Documented hysterectomy or bilateral salpingectomy/tubal occlusion/oophorectomy.
2. Postmenopausal.
* A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
* Females receiving hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use 1 of the nonhormonal, highly effective contraception methods if they wish to continue their HRT during the trial.
13. If participant is of childbearing potential, must agree to use adequate birth control and not attempt to become pregnant during study up to 4 weeks post dosing session.
Exclusion Criteria:
Psychiatric Exclusion Criteria:
1. Personal or immediate (first-degree relative) family history of formally diagnosed schizophrenia or other psychotic disorders (e.g., delusional disorder, schizoaffective disorder), or bipolar I disorder.
2. Active suicidal intent or suicidal or non-suicidal self-injurious behaviors, as defined by a "yes" response to question 4 on C-SSRS within the past 6 months at screening or prior to dosing (Active Suicidal Ideation with Some Intent to Act, with or without Specific Plan)
3. Use of hallucinogens or psychedelic substances within the 3 months prior to enrollment.
4. History of regular or frequent use of hallucinogens (e.g., microdosing, attending regular retreats either outside the US or in the 'underground' within the country, regular psychedelic church attendance, etc.)
5. Unwillingness to abstain from use of hallucinogens and psychedelics outside of the study up to 4 weeks post dosing session.
6. Unwillingness or inability to abstain from alcohol, crack/cocaine, or non-prescribed opioids at least 24 hours prior to the day of dosing, up to 24 hours after the dosing session.
7. Changes to psychotropic medication and/or dosages within the past 3 months.
8. Current or recent (within 2 weeks of enrollment) MAOI, Lithium, and/or methadone use
9. Has a psychiatric condition that precludes the establishment of therapeutic rapport as evidenced by long-term patterns of unstable relationships, a history of significant stress-related paranoia, or identity disturbances
10. History of a medically significant suicide attempt within the last 5 years.
11. Use of any other investigational drugs within 30 days prior to Screening.
General Medical/Laboratory Exclusion Criteria:
1. Hypertension at screening is defined as: systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg, averaged across three assessments
2. History of cardiovascular disease, including but not limited to clinically significant coronary artery disease, cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction, angina pectoris, coronary artery bypass graft or artificial heart valve, stroke, transient ischemic attack, or any clinically significant arrhythmia
3. Any clinically significant abnormal electrocardiogram (ECG) finding, such as findings suggestive of ischemia or infarct, complete bundle branch block, atrial fibrillation or other symptomatic arrhythmias, or predominantly non-sinus rhythm, at Screening
4. Resting QT interval with Fridericia's correction (QTcF) ≥ 450 msec (male) or ≥ 470 msec (female) at Screening, or inability to determine QTcF interval
5. Presence of risk factors for torsades de pointes, including: long QT syndrome, uncontrolled hypokalemia or hypomagnesemia, history of cardiac failure, history of clinically significant/symptomatic bradycardia, family history of idiopathic sudden death or congenital long QT syndrome, or concomitant use of a torsadogenic medication
6. Moderate-to-severe hepatic impairment, defined as a Child-Pugh score ≥ 5, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 x the upper limit of normal (ULN), or bilirubin \> 1.5 x ULN, unless this is attributable to Gilbert's syndrome
7. Moderate-to-severe renal impairment, defined as an estimated glomerular filtration rate of \< 50 mL/min/1.73 m2 at Screening
8. Uncontrolled diabetes with an HbA1c \> 8
9. Significant uncontrolled hypothyroidism (thyroid stimulating hormone \[TSH\] \< 0.8 x lower limit of normal) with the exception of stably treated hypothyroidism and uncontrolled hyperthyroidism (thyroid stimulating hormone \[TSH\] \< 0.8 x \> 1.5 x upper limit of normal).
10. Any other condition, disorder or finding which in the opinion of the investigator would adversely impact participant safety or the ability of the participant to complete the study, including compliance with all study requirements and procedures
**Healthy Volunteers:** True
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** ben.kelmendi@yale.edu
**Name:** Benjamin Kelmendi, MD
**Phone:** 860-857-3692
**Role:** CONTACT
**Contact 2:**
**Email:** rachael.grazioplene@yale.edu
**Name:** Rachael Grazioplene, PhD
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Yale University
**Name:** Benjamin Kelmendi, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M19100
- Name: Behavior, Addictive
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Ancestors
- ID: D000006213
- Term: Hallucinogens
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000011619
- Term: Psychotropic Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M14419
- Name: Psilocybin
- Relevance: HIGH
- As Found: Frozen
- ID: M9305
- Name: Hallucinogens
- Relevance: LOW
- As Found: Unknown
- ID: M14474
- Name: Psychotropic Drugs
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000011562
- Term: Psilocybin
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442410
**Brief Title:** Comparison of DTM™ SCS Therapy Combined With CMM to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Spine Surgery
**Official Title:** Comparison of Differential Target Multiplexed Spinal Cord Stimulation (DTM™ SCS) Therapy Combined With CMM to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Surgery
#### Organization Study ID Info
**ID:** MDT24011
#### Organization
**Class:** INDUSTRY
**Full Name:** MedtronicNeuro
#### Secondary ID Infos
**Domain:** ISRCTN Registry
**ID:** ISRCTN10663814
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2023-10-17
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-05-09
**Type:** ACTUAL
#### Start Date
**Date:** 2020-07-24
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** SGX International LLC
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** MedtronicNeuro
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this investigational study is to document the safety, clinical effectiveness and health economic analytics of DTM™ SCS programming delivered through the Intellis™ neurostimulator in subjects with chronic, intractable pain of the trunk with or without lower limb pain, including unilateral or bilateral pain without prior history of spine surgery and refractory to conservative treatment and are not candidates for lumbar spinal surgery.
### Conditions Module
**Conditions:**
- Pain, Intractable
- Pain, Chronic
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups:
* DTM™ SCS programming approach with Conventional Medical Management (CMM)
* CMM alone
There is an optional two-way crossover to the other treatment group available for all subjects who remain in the study at the 6-months visit.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 115
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Subjects will undergo a Trial Phase with DTM™ SCS programming. Stimulation will be delivered from an external neurostimulator. Those who have a "successful Trial Phase" will proceed to permanent implantation of the Intellis™ SCS system to evaluate DTM™ SCS therapy and will undergo up to 24 months of stimulation delivery.
Subjects randomized to either treatment group will have the optional possibility to crossover to the alternative treatment arm after the 6-month visit. If the subject and investigator believe that the DTM™ SCS + CMM treatment has not generated sufficient pain relief to warrant continued treatment, then the subject will be provided with the option to crossover to the CMM group. If all SCS programming attempts fail, then DTM™ SCS therapy will be switched off and the subject will continue with their CMM treatment and will visit the clinic approximately a total of 18 months follow-up in the study (i.e. 6 months DTM™ SCS and 12 months CMM).
**Intervention Names:**
- Device: DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system
- Other: Conventional Medical Management (CMM)
**Label:** Test Group - DTM™ SCS programming approach with Conventional Medical Management (CMM)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The choice of appropriate CMM will be made by the Investigator as determined to be the best standard of care for each individual subject i.e. optimized individual conventional therapy. These treatments would be generally consistent with the American College of Physicians and the American Pain Society Guidelines as published in the Annals of Internal Medicine and European/UK guidelines. Subjects in this group will also undergo up to 24 months of CMM.
Subjects randomized to either treatment group will have the optional possibility to crossover to the alternative treatment arm after the 6-month visit. If the subject and investigator believe that the CMM treatment has not generated sufficient pain relief to warrant continued treatment, then the subject will be provided with the option to crossover to the DTM™ SCS therapy group. Following their device activation, they will attend visits approximately a total of 18 months follow-up in the study (i.e. 6 months CMM and 12 months DTM™ SCS).
**Intervention Names:**
- Other: Conventional Medical Management (CMM)
**Label:** Control Group - Conventional Medical Management (CMM) alone
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Test Group - DTM™ SCS programming approach with Conventional Medical Management (CMM)
**Description:** Along with the appropriate Conventional Medical Management treatment made by the Investigator, the subject will be trialed and implanted with an Intellis™ neurostimulator system using DTM™ SCS programming parameters.
**Name:** DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Control Group - Conventional Medical Management (CMM) alone
- Test Group - DTM™ SCS programming approach with Conventional Medical Management (CMM)
**Description:** The CMM treatment can be modified at any moment by the investigators based on their clinical evaluation and local standard of care. They may also consists of one or more of the following treatments: medications, combined physical and psychological management, physical therapy, back rehabilitation program, spinal manipulation and spinal mobilization, traction, acupuncture, cognitive behavioral therapy, biofeedback, nerve blocks, radio frequency ablation, epidural steroid injections, transcutaneous electrical nerve stimulation, intradiscal electrothermal therapy, nucleoplasty, also called plasma disc decompression (PDD) or similar
**Name:** Conventional Medical Management (CMM)
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%
**Measure:** Percentage of Individual Responders
**Time Frame:** 6 months
#### Secondary Outcomes
**Description:** Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%
**Measure:** Percentage of Individual Responders
**Time Frame:** 1 month
**Description:** Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%
**Measure:** Percentage of Individual Responders
**Time Frame:** 3 months
**Description:** Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%
**Measure:** Percentage of Individual Responders
**Time Frame:** 9 months
**Description:** Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%
**Measure:** Percentage of Individual Responders
**Time Frame:** 12 months
**Description:** Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%
**Measure:** Percentage of Individual Responders
**Time Frame:** 18 months
**Description:** Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%
**Measure:** Percentage of Individual Responders
**Time Frame:** 24 months
**Description:** Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS.
**Measure:** Change from Baseline in Visual Analog Scale (VAS) back pain score
**Time Frame:** 1 month
**Description:** Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS.
**Measure:** Change from Baseline in Visual Analog Scale (VAS) back pain score
**Time Frame:** 3 months
**Description:** Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS.
**Measure:** Change from Baseline in Visual Analog Scale (VAS) back pain score
**Time Frame:** 6 months
**Description:** Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS.
**Measure:** Change from Baseline in Visual Analog Scale (VAS) back pain score
**Time Frame:** 9 months
**Description:** Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS.
**Measure:** Change from Baseline in Visual Analog Scale (VAS) back pain score
**Time Frame:** 12 months
**Description:** Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS.
**Measure:** Change from Baseline in Visual Analog Scale (VAS) back pain score
**Time Frame:** 18 months
**Description:** Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS.
**Measure:** Change from Baseline in Visual Analog Scale (VAS) back pain score
**Time Frame:** 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Be a candidate for SCS system (trial and implant)
* Have been diagnosed with chronic, refractory axial low back pain with or without lower limb pain, with a neuropathic component as assessed by the investigator, 6 months refractory to conventional therapy and are not eligible for spine surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy) at the time of enrollment
* Has an average back pain intensity ≥ 6.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment
* Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided.
* Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand and sign the written inform consent
* Be 18 years of age or older at the time of enrollment
* Be on a stable pain medication regime, as determined by the study investigator, for at least 30 days prior to enrolling in this study
* Be willing and able to comply with study-related requirements, procedures, and visits
Exclusion Criteria:
* Had a previous spinal surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy)
* Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available Intellis™ SCS systems as determined by the Investigator
* Has a diagnosed back condition with inflammatory causes of back pain (e.g., onset of severe pain with activity), serious spinal pathology and/or neurological disorders as determined by the Investigator
* Be concurrently participating in another clinical study
* Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump, etc.
* Has pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study endpoints, as determined by the Investigator
* Has mechanical spine instability as determined by the Investigator
* Has undergone, within 30 days prior to enrollment, an interventional procedure and/or surgery to treat back and/or leg pain, which is providing significant pain relief
* Has unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the investigator
* Be involved in an injury claim under current litigation or has a pending or approved worker's compensation claim
* Be pregnant (determined by urine testing unless female subject is surgically sterile or post-menopausal. If female, sexually active, and childbearing age, subject must be willing to use a reliable form of birth control.)
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Roeselare
**Country:** Belgium
**Facility:** AZ Delta
**Location 2:**
**City:** Sint-Niklaas
**Country:** Belgium
**Facility:** AZ Nikolaas
**Location 3:**
**City:** Wilrijk
**Country:** Belgium
**Facility:** GZA - Sint Augustinus Ziekenhuis
**Location 4:**
**City:** Düsseldorf
**Country:** Germany
**Facility:** Universitätsklinikum Düsseldorf
**Location 5:**
**City:** München
**Country:** Germany
**Facility:** München Klinik Bogenhausen
**Location 6:**
**City:** Elst
**Country:** Netherlands
**Facility:** Rijnstate - Locatie Elst
**Location 7:**
**City:** Maastricht
**Country:** Netherlands
**Facility:** Maastricht University Medical Center
**Location 8:**
**City:** Zeist
**Country:** Netherlands
**Facility:** Diakonessenhuis Locatie Zeist
**Location 9:**
**City:** A Coruña
**Country:** Spain
**Facility:** Hospital Clínico Universitario de Santiago
**Location 10:**
**City:** Majadahonda
**Country:** Spain
**Facility:** Hospital Universitario Puerta de Hierro Majadahonda
**Location 11:**
**City:** Sevilla
**Country:** Spain
**Facility:** Hospital Universitario Virgen del Rocío
**Location 12:**
**City:** Valencia
**Country:** Spain
**Facility:** Hospital Clínico Universitario de Valencia
#### Overall Officials
**Official 1:**
**Affiliation:** Medtronic
**Name:** Charisma Kumar
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** ISRCTN Registry posting
**URL:** https://doi.org/10.1186/ISRCTN10663814
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4714
- Name: Back Pain
- Relevance: HIGH
- As Found: Back Pain
- ID: M13068
- Name: Pain, Intractable
- Relevance: HIGH
- As Found: Pain, Intractable
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M29442
- Name: Chronic Pain
- Relevance: HIGH
- As Found: Pain, Chronic
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001416
- Term: Back Pain
- ID: D000059350
- Term: Chronic Pain
- ID: D000010148
- Term: Pain, Intractable
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442397
**Brief Title:** Anti-Inflammatory Lifestyle Intervention for Emerging Adult Cancer Survivors
**Official Title:** Feasibility and Acceptability of an Anti-Inflammatory Lifestyle Intervention for Emerging Adult Cancer Survivors
#### Organization Study ID Info
**ID:** MCC-24-21095
#### Organization
**Class:** OTHER
**Full Name:** Virginia Commonwealth University
#### Secondary ID Infos
**Domain:** Virginia Commonwealth University
**ID:** HM20029744
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2025-10-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-10-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-28
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Virginia Commonwealth University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** To test the feasibility and acceptability of AILI and associated research procedures among emerging adult cancer survivors (EACS) age 18-29.
**Detailed Description:** This is a single-arm pilot trial designed to assess the feasibility and acceptability of an anti-inflammatory lifestyle intervention (AILI) for emerging adults (EA) adapted for emerging adult cancer survivors (EACS).
### Conditions Module
**Conditions:**
- Survivorship
**Keywords:**
- Adult Cancer Survivors
- Anti-Inflammatory Lifestyle for Cancer Survivors
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 19
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** A 16-week program consisting of 12 75-minute virtual group meetings
**Intervention Names:**
- Behavioral: Anti-Inflammatory Lifestyle Intervention
**Label:** Anti-Inflammatory Lifestyle Intervention
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Anti-Inflammatory Lifestyle Intervention
**Description:** Content includes training in empirically-supported strategies to improve psychological function (e.g., restructuring negative thoughts, distress tolerance), with a focus on changing discrete behaviors linked to inflammation (e.g., sleep, processed foods, physical activity), all intertwined with evidence-based behavior change content adapted to meet the needs of EACS. Participants will also receive digital tools to facilitate daily self-monitoring (Fitbit activity monitor, wireless scales, self-monitoring app) and generate information for tailored weekly e-coaching
**Name:** Anti-Inflammatory Lifestyle Intervention
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The percentage of participants that enroll
**Measure:** Test the feasibility of Anti-Inflammatory Lifestyle Intervention (AILI) and associated research procedures among emerging adult cancer survivors (EACS) age 18-29
**Time Frame:** Day 0, At end of recruitment period
**Description:** The percentage of participants that complete the post intervention questionnaire
**Measure:** Test the feasibility of AILI and associated research procedures among EACS age 18-29
**Time Frame:** 4 months
**Description:** The percentage of participants that complete the post intervention blood draw
**Measure:** Test the feasibility of Anti-Inflammatory Lifestyle Intervention (AILI) and associated research procedures among EACS age 18-29.
**Time Frame:** 4 months
**Description:** The percentage of participants that complete all study sessions
**Measure:** Assess the acceptability of AILI and associated research procedures among EACS age 18-29.
**Time Frame:** 4 months
**Description:** The percentage of participants that wear the Fitbit \>/= 60% throughout the intervention period.
**Measure:** Assess the acceptability of AILI and associated research procedures among EACS age 18-29.
**Time Frame:** 4 months
**Description:** Intervention satisfaction ratings\>/= 4 on a 1-5 Likert scale at 4 months, where (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree.
**Measure:** Assess the acceptability of AILI and associated research procedures among EACS age 18-29.
**Time Frame:** 4 months
**Description:** Research procedure satisfaction ratings\>/= 3 on a 1-5 Likert scale, where (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree.
**Measure:** Assess the acceptability of AILI and associated research procedures among EACS age 18-29.
**Time Frame:** 4 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Cancer diagnosis of any type
Exclusion Criteria:
* Individuals who are currently receiving active chemotherapy and/or radiation therapy will be excluded given that their dietary and physical activity requirements may vary widely and are outside the parameters of the current study.
* Individuals who are currently pregnant or lactating will be ineligible for the current trial given different nutritional needs and potential safety concerns, as well as physiological and hormonal differences that could interfere with our ability to test the study aims.
* Current involvement in a weight loss program or current use of weight loss medication is an exclusion for the proposed trial because it undermines the internal validity of the study given we are interested in the potential of the integrated lifestyle intervention to promote weight loss. If individuals are engaging in other programs or taking medications, we would not know whether weight losses observed during this study were due to the intervention or some other weight loss method.
* Individuals will be excluded if they report any other uncontrolled medical conditions that may pose a safety issue given the recommendations for the diet and unsupervised physical activity (e.g., uncontrolled hypertension). We will refer individuals who have blood pressure levels \>140/90 mmHg as part of baseline screening to their physician and exclude them from this study unless their treating physician determines s/he is a suitable candidate based on the specifics of the protocol and provides written medical consent for participation. Participants who report a history of or current treatment for medical conditions (e.g., hypertension) will be asked to obtain MD consent to participate because this treatment program involves unsupervised physical activity, as well as experiential physical activity during treatment sessions; it is important to ensure that the exercise that will be promoted in the program will be safe and appropriate for these individuals given their medical history. Similarly, this program promotes specific changes to diet which may or may not be endorsed by an individual's physician given their medical condition.
* Individuals with rheumatologic and gastrointestinal conditions associated with severe systemic inflammation (e.g., rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease) will be ineligible for participation given a heightened inflammatory response as well as the frequent use of medications that may modulate inflammation, representing a confound to test the study aims.
* Individuals with medical conditions resulting in known perturbations in the hypothalamic-pituitary-adrenal axis (e.g., endogenous hypercortisolemia \[Cushing's syndrome\] or adrenal insufficiency) will be ineligible for participation as this represents a confound to test the study aims.
* Individuals who report a heart condition, chest pain during periods of activity or rest, or loss of consciousness as assessed by the Physical Activity Readiness Questionnaire (PAR-Q) administered during screening will be excluded. Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate. As noted above, this treatment program involves unsupervised physical activity, as well as experiential physical activity during treatment sessions; it is important to ensure that the exercise that will be promoted in the program will be safe and appropriate for these individuals given the symptoms they have reported at screening.
* Report of lifetime diagnosis of Anorexia Nervosa or Bulimia Nervosa, or any compensatory behaviors (vomiting, laxative abuse) within the previous 3 months, as these individuals are at higher risk for disordered eating behaviors and their clinical history/present symptoms place them at elevated risk for potential adverse effects from participation in an intervention targeting eating and physical activity, particularly one that involves frequent self-weighing and monitoring of dietary intake.
* Hospitalization for depression or other psychiatric disorder within the past 12 months will be an exclusion given potential psychological safety concerns. Although the AILI will teach evidence-based strategies for emotion regulation and management of affective states, the program is not designed to treat mental health disorders. Moreover, individuals who have experienced severe psychological symptoms requiring hospitalization in the recent past could experience harm or worsening of symptoms because of the self-monitoring of mood/affect promoted in this study and the group discussion.
* Individuals with a lifetime history of bipolar disorder or psychotic disorder will be excluded because the proposed AILI would be poorly suited to the needs of individuals with severe mental illness and could serve to exacerbate symptoms.
* Indication of current suicidal intent as reported on the Beck Depression Inventory-II, which will be administered in person at the baseline assessment. Any individual who scores 3 on item 9 will be ineligible for the study. While suicidal ideation (i.e., thoughts of harming oneself) is common, having a plan or intent to harm oneself presents much greater risk to the individual and participation in this study would be contraindicated as the treatment program is not well suited to meet their needs and a higher level of care (e.g., individual psychological treatment) is warranted.
* Inability to speak and read English is an exclusion criterion given that all written measures and treatment materials are in English, and interventionists are English-speaking.
**Maximum Age:** 29 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** phillipst5@vcu.edu
**Name:** Tyler Phillips
**Phone:** 804-828-1965
**Role:** CONTACT
**Contact 2:**
**Email:** MasseyCPC@vcu.edu
**Name:** Massey Cancer Prevention & Control Team
**Phone:** 804-828-1965
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Richmond
**Contacts:**
***Contact 1:***
- **Email:** phillipst5@vcu.edu
- **Name:** Tyler Phillips
- **Phone:** 804-828-1965
- **Role:** CONTACT
***Contact 2:***
- **Email:** MasseyCPC@vcu.edu
- **Name:** Massey Cancer Prevention & Control Team
- **Phone:** 804-828-1965
- **Role:** CONTACT
***Contact 3:***
- **Name:** Autumn Lanoye, Ph.D
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Virginia Commonwealth University, School of Medicine
**State:** Virginia
**Zip:** 23298
#### Overall Officials
**Official 1:**
**Affiliation:** Virginia Commonwealth University
**Name:** Autumn Lanoye, Ph.D
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** There are no plans to share individual participant data at this time.
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: HIGH
- As Found: Risk Assessment
### Intervention Browse Module - Meshes
- ID: D000000893
- Term: Anti-Inflammatory Agents
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442384
**Brief Title:** Remote Trial - Tobacco Product Standard (VLNC)
**Official Title:** Fully Remote Randomized Controlled Trial Exploring the Role of Non-combustible Tobacco Products in the Context of a Nicotine Product Standard for Cigarettes
#### Organization Study ID Info
**ID:** 2023LS188
#### Organization
**Class:** OTHER
**Full Name:** Masonic Cancer Center, University of Minnesota
### Status Module
#### Completion Date
**Date:** 2026-02-28
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-02-28
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-11-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Masonic Cancer Center, University of Minnesota
#### 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 pilot project is to explore the feasibility of a real-world marketplace study design examining the effects of a reduced nicotine product standard for cigarettes on smoking in the context of a flavor restriction vs. no restriction on e-cigarettes in smokers switched to very low nicotine content cigarettes.
### Conditions Module
**Conditions:**
- Tobacco Use
**Keywords:**
- reducing nicotine cigarettes
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Smokers who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Participants will then be randomly assigned to a 4-week intervention
**Intervention Names:**
- Other: Tobacco and non-tobacco e-cigarettes
**Label:** VLNC cigarettes plus access to tobacco and non-tobacco flavored e-cigarettes
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Smokers who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Participants will then be randomly assigned to a 4-week intervention
**Intervention Names:**
- Other: Tobacco only e-cigarettes
**Label:** VLNC cigarettes plus access to only tobacco flavored e-cigarettes
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- VLNC cigarettes plus access to tobacco and non-tobacco flavored e-cigarettes
**Description:** Participants with no e-cigarette restrictions.
**Name:** Tobacco and non-tobacco e-cigarettes
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- VLNC cigarettes plus access to only tobacco flavored e-cigarettes
**Description:** Participants restricted to tobacco flavored e-cigarettes only.
**Name:** Tobacco only e-cigarettes
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Percent of participants that drop-out by 4 week visit
**Measure:** Percent of participants that drop-out by 4 week visit
**Time Frame:** 4 weeks
#### Secondary Outcomes
**Description:** Change in mean cigarettes per day (CPD) based on 7 day ITR data before visit 00 and week 4 visits
**Measure:** Change in mean cigarettes per day (CPD)
**Time Frame:** Baseline to 4 weeks
**Measure:** Number of participants experiencing smoke free days
**Time Frame:** 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Self-report of daily smoking of at least 5 to 25 cigarettes for \>3 months by self-report.
* Carbon monoxide indicative of regular smoking (CO \> 6ppm) prior to randomization.
* Has regular access to a smartphone, tablet or computer with functioning camera and internet access for telehealth visits and surveys and to take photos of receipts.
* Lives in an area where VLN® cigarettes are being marketed (these locations may vary during the course of the study).
Exclusion Criteria:
* Unstable health conditions (any significant serious, unstable medical condition including, but not limited to, cardiovascular disease, liver or kidney disease, COPD, bronchitis, within the past 3 months, seizure disorder and cancer (cancer-free \<5 years except some skin cancers can be within 5 years), or a COVID-19 positive test or COVID-19 symptoms in the last 14 days or as determined by the licensed medical professional at each site).
* Unstable mental health (to be determined by medical history, Patient Health Questionnaire-2 (Prime-MD) and GAD-2 after review by the licensed medical professional).
* Excessive drinking or problems with drinking or drugs-including marijuana (assessed by PI or licensed medical professional).
* Currently pregnant, breastfeeding or intending to become pregnant for the duration of the study or unwilling to agree to use adequate protection to avoid pregnancy.
* Taking exclusionary medications, unstable dosing of medications, or unstable control of symptoms for ongoing medical conditions (medications or conditions that would impact patient safety to be determined by the licensed medical professional).
* Recent experience with VLNC cigarettes (purchasing of the VLNC cigarettes in the past year)
* Household member enrolled in the study concurrently.
* Participated in prior research study during the past three months that would impact baseline smoking or response to study products.
* Inability to independently read and comprehend the consent form and follow other written study instructions, materials or measures or behavior indicating inability to fully participate in study procedures. Participants are required to complete the protocol at home independently and must show ability to comply with directions.
* Unstable living environment that would compromise the ability to sequester study products or complete study procedures.
**Healthy Volunteers:** True
**Minimum Age:** 21 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** hatsu001@umn.edu
**Name:** Dorothy Hatsukami, PhD
**Phone:** 612-626-2121
**Role:** CONTACT
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- 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:** NCT06442371
**Brief Title:** Additional Effects of Quranic Listening Meditation in Combination With High Intensity Interval Training in Obese Adults
**Official Title:** Additional Effects of Quranic Listening Meditation in Combination With High Intensity Interval Training on Cardiovascular Fitness and Mental Health in Obese Adults
#### Organization Study ID Info
**ID:** Rec/01809 Warda Zaman
#### Organization
**Class:** OTHER
**Full Name:** Riphah International University
### Status Module
#### Completion Date
**Date:** 2024-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-10
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Riphah International University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** To determine the additional effects of Quranic listening meditation, in combination with High-Intensity Interval Training on cardiovascular fitness and mental health in obese adults.
### Conditions Module
**Conditions:**
- Obesity
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 52
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: High Intensity interval training + Quranic Listening
**Label:** High Intensity interval training + Quranic Listening
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Other: High intensity interval training
**Label:** High Intensity interval training
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- High Intensity interval training + Quranic Listening
**Description:** In this group, participants will receive protocol of High Intensity interval training which includes squats, jumping jacks, front kicks and rope jumps 3 days per week for 6 weeks, including warmup and cool down session along with Quranic listening meditation.
**Name:** High Intensity interval training + Quranic Listening
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- High Intensity interval training
**Description:** In this group, participants will receive only High intensity interval training which includes squats, jumping jacks, front kicks and rope jumps 3 days per week for 6 weeks, including warmup and cool down periods with no Quranic listening meditation
**Name:** High intensity interval training
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The Modified Borg Dyspnea Scale is numerical rating scale ranging from 0 to 10 and is used to measure dyspnea that patient report during sub-maximal exercise and is regularly administered during six-minute walk test. Changes from the baseline will be measured
**Measure:** Modified BORG Scale
**Time Frame:** 6 week
**Description:** Changes from the baseline, Body Mass Index can be define as statistical index utilizing an individual\'s height and weight to give an estimation of muscle versus fat in female and male of all ages. It is determined by taking an individual weight in kilograms, separated by their height in meters squared, or BMI = weight (in kg)/height (in m square).
**Measure:** 6 Min walk test (Distance in meters)
**Time Frame:** 6 week
**Description:** A generalized equation can be used to determined peak VO2 (Peak rate of oxygen consumption). The generalized equation can be used to accurately estimate mean peak VO2 from mean 6 MWD, among groups of patients with diverse diseases without the need for cardiopulmonary exercise testing. The equation is:
Mean peak VO2(ml/kg/mins) = 4.948 + 0.023\*Mean 6 MWD (meter) Changes From the Baseline will be measured
**Measure:** Peak VO2 with formula
**Time Frame:** 6 week
**Description:** Changes from the baseline, Body Mass Index can be define as statistical index utilizing an individuals height and weight to give an estimation of muscle versus fat in female and male of all ages. It is determined by taking an individual weight in kilograms, separated by their height in meters squared, or BMI = weight (in kg)/height (in m square).
**Measure:** Body Mas Index
**Time Frame:** 6 week
**Description:** Heart rate recovery (HRR) is a measurement of how quickly your heart can settle back into its normal state following a workout. It is the variation in heart rate between the time when you are exercising and when you stop.
**Measure:** Heart Rate recovery
**Time Frame:** 6 week
**Description:** Depression Anxiety and Stress Scale DASS (-42), The 42-item DASS-42 self-report scale was designed to measure the negative emotional states of stress, anxiety, and depression. As part of the larger process of clinical assessment, the DASS's main value in a clinical environment is to identify the location of emotional disturbance. The DASS's primary purpose is to evaluate the severity of the main symptoms of stress, anxiety, and depression.
**Measure:** Depression Anxiety and Stress Scale
**Time Frame:** 6 week
**Description:** Changes from the Baseline, Systolic Blood pressure (SBP) and Diastolic Blood Pressure (DBP) will be measured through sphygmomanometer
**Measure:** Systolic and diastolic blood pressure
**Time Frame:** 6 week
**Description:** Change in plasma total cholesterol, high density lipoproteins cholesterol (HDL), and low density lipoproteins cholesterol (LDL) after each treatment.
**Measure:** Change in blood lipid profile
**Time Frame:** 6 week
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Obese adults (BMI ≥ 30)
* Age range: 18-45 years
* No previous experience with Quranic listening meditation since last 4 weeks.
* No contraindications for engaging in high-intensity physical activity
* Able to attend regular sessions at clinic and follow the study protocol.
* Willingness to undergo pre and post-assessments for cardiovascular fitness and mental health measures.
Exclusion Criteria:
* Individuals with a history of the medical condition being studied
* Those who are currently taking medication that may affect the study
* Participants with a history of mental health disorders
* Individuals who are pregnant or breastfeeding
* Those who have previously participated in a similar study
* Participants with a history of substance abuse or addiction
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** iqbal.tariq@riphah.edu.pk
**Name:** Muhammad Iqbal Tariq, PhD*
**Phone:** 03338236752
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Abbottābād
**Contacts:**
***Contact 1:***
- **Email:** iqbal.tariq@riphah.edu.pk
- **Name:** Muhammad Iqbal Tariq, PhD*
- **Phone:** 03338236752
- **Role:** CONTACT
***Contact 2:***
- **Name:** Warda Zamman
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Pakistan
**Facility:** physiotherapy department, Jinnah international hospital
**State:** Khyber PkahtoonKhwa
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Riphah International University
**Name:** Muhammad Iqbal Tariq, PhD*
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442358
**Brief Title:** Self Biophysical Profile Using a Home Ultrasound Device Proof of Concept
**Official Title:** BPP for ME: Self Biophysical Profile Proof of Concept
#### Organization Study ID Info
**ID:** HUM00244136
#### Organization
**Class:** INDUSTRY
**Full Name:** PulseNmore
### Status Module
#### Completion Date
**Date:** 2024-09-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-10
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Michigan
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** PulseNmore
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is Unapproved Device:** True
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The objective of this study is to assess if patients presenting for antenatal testing can complete a Bio Physical Score (BPP) with a home-use ultrasound with remote clinician guidance.
### Conditions Module
**Conditions:**
- Perinatal Care
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 25
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Pregnant participants will use Pulsenmore ES device to perform BPP while guided remotely by a clinician
**Intervention Names:**
- Device: Pulsenmore ES home ultrasound device
**Label:** Single Arm home ultrasound in pregnant women require BPP
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Single Arm home ultrasound in pregnant women require BPP
**Description:** Pulsenmore ES device is a portable home used ultrasound device which allow the patient to perform an ultrasound scan from the comfort of their home under the supervision of a healthcare provider
**Name:** Pulsenmore ES home ultrasound device
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Assessment will done by determining fetal movement, fetal tone, fetal breathing, and amniotic fluid level
**Measure:** Assess feasibility and proof of concept that the Pulsenmore home ultrasound device can be used to complete the biophysical profile (BPP) for fetal well being
**Time Frame:** One day
#### Secondary Outcomes
**Description:** The results of BPP acquired with Pulsenmore device will be compared to standard of care BPP
**Measure:** Assess preliminary effectiveness and compare participant results to standard of care BPP
**Time Frame:** One day
**Description:** Patients will answer a questionnaire about their experience using Pulsenmore device
**Measure:** Assess patient reported experience measures and patient reported outcomes with using the Pulsenmore home ultrasound device.
**Time Frame:** One day
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 18 years old
* Singleton pregnancy
* Gestational age ≥ 24 0/7 weeks
* No known major fetal or genetic anomalies (may include: isolated pyelectasis, isolated --VSD, multicystic dysplastic kidney, cleft lip/palate, club foot, etc.)
* Ability to understand and sign informed consent in English
* Ability to read and understand instructions in English
* Ability to hold an ultrasound probe and respond to clinician instructions
* BMI less than 40 at initial prenatal visit
* Scheduled biophysical profile (BPP)
* Any maternal/pregnancy complications requiring antenatal testing, including but not limited to intrauterine growth restriction, chronic or gestational hypertension, preexisting or gestational diabetes, autoimmune disorder, etc.
Exclusion Criteria:
* Multiple gestation
* Known major fetal structural anomaly or aneuploidy
* Known fetal or genetic anomalies
* Ruptured membranes
* Uterine complaints, such as painful contractions
* Maternal concern for decreased fetal movement
* Not evaluated vaginal bleeding (not including spotting)
* Fetal or maternal criteria that require urgent delivery
* BMI ≥ 40 at initial prenatal visit
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** dwyersar@med.umich.edu
**Name:** Sarah Dwyer
**Phone:** 734-647-7484
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Ann Arbor
**Contacts:**
***Contact 1:***
- **Email:** dwyersar@med.umich.edu
- **Name:** Sarah Dwyer
- **Phone:** 734-647-7484
- **Role:** CONTACT
***Contact 2:***
- **Name:** Alex Peahl, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Michigan
**State:** Michigan
**Status:** RECRUITING
**Zip:** 48109
#### Overall Officials
**Official 1:**
**Affiliation:** University of Michigan
**Name:** Alex Peahl, MD
**Role:** PRINCIPAL_INVESTIGATOR
### 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:** NCT06442345
**Brief Title:** Pneumocystis Jirovecii Genotyping
**Official Title:** Real-time Pneumocystis Jirovecii Genotyping to Support Clinical Decision Making in the Management of Nosocomial Outbreaks
#### Organization Study ID Info
**ID:** 23PA004
#### Organization
**Class:** OTHER
**Full Name:** Nottingham University Hospitals NHS Trust
### Status Module
#### Completion Date
**Date:** 2026-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Nottingham University Hospitals NHS Trust
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** We share our lives with microorganisms, and these generally do not pose a problem if an individual is healthy with a normal immune system. However, if the immune system was not functioning properly (e.g., cancer patients), they are at risk of infection. One microorganism, a fungus called Pneumocystis jirovecii (PCP), can cause severe chest infections in patients without properly functioning immune systems, leading to hospitalisation and death if untreated. If patients remain without a functioning immune system, they have a greater chance of repeated infection.
PCP spreads through air from person-to-person and can survive on environmental surfaces. Patients can be infected after contact with these surfaces. Hospitals have a responsibility to ensure PCP infected patients do not pass it on to other unwell patients. In cases where PCP has infected multiple patients, knowing if the same fungi has been passed along (or transmitted) from patient-to-patient is vital in understanding if there is an outbreak in the hospital. Understanding how similar (the relatedness) the PCP strain is allows healthcare workers to detect any transmission between patients or the environment.
To understand how related each patient's PCP infection is we will utilise a laboratory test called multilocus sequence typing (MLST). This test looks at sections of the fungi's genetic code using deoxyribonucleic acid (DNA) sequencing to create a code (genotype) which tells us how related one PCP is to others tested, allowing comparison between patients and ultimately spotting transmission.
Our aim is to develop this sequencing test using PCP positive patient samples and ensure it performs to high-quality standards. Surplus material from seventy known PCP positive patient samples will be tested. Each sample will be analysed to see if the DNA genotype matches or is similar to other patient samples we have tested, helping to understand how PCP may spread between patients.
**Detailed Description:** We share our lives with microorganisms, and these generally do not pose a problem if an individual is healthy with a normal immune system. However, if the immune system was not functioning properly (e.g., cancer patients), they are at risk of infection. One microorganism, a fungus called Pneumocystis jirovecii (PCP), can cause severe chest infections in patients without properly functioning immune systems, leading to hospitalisation and death if untreated. If patients remain without a functioning immune system, they have a greater chance of repeated infection.
PCP spreads through air from person-to-person and can survive on environmental surfaces. Patients can be infected after contact with these surfaces. Hospitals have a responsibility to ensure PCP infected patients do not pass it on to other unwell patients. In cases where PCP has infected multiple patients, knowing if the same fungi has been passed along (or transmitted) from patient-to-patient is vital in understanding if there is an outbreak in the hospital. Understanding how similar (the relatedness) the PCP strain is allows healthcare workers to detect any transmission between patients or the environment.
To understand how related each patient's PCP infection is we will utilise a laboratory test called multilocus sequence typing (MLST). This test looks at sections of the fungi's genetic code using deoxyribonucleic acid (DNA) sequencing to create a code (genotype) which tells us how related one PCP is to others tested, allowing comparison between patients and ultimately spotting transmission.
Our aim is to develop this sequencing test using PCP positive patient samples and ensure it performs to high-quality standards. Surplus material from seventy known PCP positive patient samples will be tested. Each sample will be analysed to see if the DNA genotype matches or is similar to other patient samples we have tested, helping to understand how PCP may spread between patients.
### Conditions Module
**Conditions:**
- Pneumocystis Pneumonia
**Keywords:**
- PCP
- Genotyping
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 70
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** The previously published MLST scheme by Pasic et al (2020) using alleles β-TUB, CYB, mt26S and SOD will be assessed, with each allele optimised and verified for implementation for Objective 2.
**Measure:** Objective 1: Development of a MLST PCP genotyping assay within NUH.
**Time Frame:** 18 months
#### Secondary Outcomes
**Description:** Following successful implementation of the MLST assay, up to 70 known PCP positive total nucleic acid samples will be tested using the MLST assay. Genotypes will be identified and phylogenetic analysis performed to assess the relatedness of the population. From this we will assess for possible transmission events between patients using patient metadata and hospital bed movements/clinic visits. Furthermore, data analysis will help understand if certain PCP genotypes are more likely to occur in specific patient groups, and if there are links to disease severity, mortality \& transmission.
**Measure:** Objective 2: Analyse PCP positive patient samples and identify the PCP genotype, assessing links between patient metadata and genotype
**Time Frame:** 18 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Total nucleic acid extracts from adult patients (over 18 years old) with a positive PCP diagnosis (\& detected at \> 50 copies/10ul) from routine respiratory panel testing.
Exclusion Criteria:
* Total nucleic acid extracts from patients with a negative PCP diagnosis from routine respiratory panel testing
* Total nucleic acid extracts from non-adult patients (under 18 years old).
* PCP positive total nucleic extract samples with \< 50 copies/10ul.
* Patients included on the UK National Opt-Out register
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Adults PCP positive patients over the age of 18 years.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011014
- Term: Pneumonia
- ID: D000012141
- Term: Respiratory Tract Infections
- ID: D000007239
- Term: Infections
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000008172
- Term: Lung Diseases, Fungal
- ID: D000009181
- Term: Mycoses
- ID: D000001423
- Term: Bacterial Infections and Mycoses
- ID: D000016720
- Term: Pneumocystis Infections
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M13910
- Name: Pneumonia, Pneumocystis
- Relevance: HIGH
- As Found: Pneumocystis
- ID: M13904
- Name: Pneumonia
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11169
- Name: Lung Diseases, Fungal
- Relevance: LOW
- As Found: Unknown
- ID: M12136
- Name: Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M4722
- Name: Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M4721
- Name: Bacterial Infections and Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M19082
- Name: Pneumocystis Infections
- Relevance: LOW
- As Found: Unknown
- ID: T4598
- Name: Pneumocystis Jirovecii Pneumonia
- Relevance: HIGH
- As Found: Pneumocystis
- ID: T4599
- Name: Pneumocystosis
- Relevance: HIGH
- As Found: Pneumocystis
### Condition Browse Module - Meshes
- ID: D000011020
- Term: Pneumonia, Pneumocystis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442332
**Acronym:** RECYCLIST WP4
**Brief Title:** Long-term Consequences of Cyclist Injuries
**Official Title:** Recording Cyclist Crashes and Long-term Injury Consequences by New Smart Tools (ReCyCLIST). Work Package 4: Long-term Consequences of Cyclist Injuries
#### Organization Study ID Info
**ID:** 427057
#### Organization
**Class:** OTHER_GOV
**Full Name:** Norwegian Institute of Public Health
#### Secondary ID Infos
**Domain:** The Research Council of Norway
**ID:** 326767
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2024-04-26
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-04-26
**Type:** ACTUAL
#### Start Date
**Date:** 2023-06-26
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Norwegian Centre for Transport Research
**Class:** OTHER
**Name:** Oslo University Hospital
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Norwegian Institute of Public Health
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** There is a lack of knowledge about the extent of bicycle injuries in Norway. Among other things, a significant underreporting of bicycle injuries has been found in the official road traffic accident statistics based on police-registered accidents. Furthermore, there is a lack of knowledge about the long-term consequences of serious bicycle injuries. The main purpose of this project is to generate new knowledge about the consequences of bicycle injuries for later disability, employment status and use of prescribed drugs. In addition, we want to study whether such long-term consequences vary according to demographic and socioeconomic characteristics, as well as to assess the degree of overlap between bicycle injuries registered in the official road traffic accident statistics and bicycle injuries registered in the health service, including an assessment of the severity of the injury. We will use a retrospective analysis where a population-based dataset from the National Population Register is linked with information on injured cyclists from Statistics Norway's database on police-reported road traffic accidents, the Norwegian Patient Register, the National Trauma Registry and the Norwegian Cause of Death Registry. In order to study the long-term consequences of bicycle injuries, we will also compile information on social security benefits and employment from Statistics Norway's historical events database (FD-Trygd) and the use of prescribed drugs from the Norwegian Prescribed Drug Registry. We will also collect information on income and educational attainment from registers in Statistics Norway. The project will contribute to increased knowledge about the societal and individual burden of bicycle injuries, knowledge that is crucial for prioritizing and implementing necessary preventive measures.
**Detailed Description:** Research protocol
Long-term consequences of cyclist injuries
1. Project organisation The research activity described in this protocol constitutes one work package of the research project ReCyCLIST (Recording Cyclist Crashes and Long-term Injury Consequences by new Smart Tools). The ReCyCLIST project is a collaboration between research institutes from the health and transport sciences, public authorities, medical expertise, web-tool developers, and end-user organisations. The project is coordinated by the Institute of Transport Economics (TØI), with Torkel Bjørnskau as overall project manager. Additional project partners in this work package include the National Institute of Public Health (NIPH) and the Norwegian Trauma Registry (NTR)/Oslo University Hospital (OUS).
The project group in this work package, which in the following will be referred to as "the project", consists of the following researchers:
* Torkel Bjørnskau (TØI)
* Ingeborg Hesjevoll (TØI)
* Rikke Ingebrigtsen (TØI)
* Katrine Karlsen (TØI)
* Eyvind Ohm (NIPH) - project leader
* Christian Madsen (NIPH)
* Elling Tufte Bere (NIPH)
* Yusman Bin Kamaleri (NIPH)
* Svetlana Skurtveit (NIPH)
* Olav Røise (NTR/OUS)
2. Background Increased use of bicycles and other modes of active transport is regarded as essential if we are to reach global goals in reducing greenhouse gas emissions, air pollution and vehicle congestion \[1-2\]. The positive health effects of bicycling are also well documented \[3-6\]. To facilitate a shift in mode of transport from car to bicycle, national and local authorities in many countries have imposed car use restrictions in urban areas and made substantial investments in cycling infrastructure. Such initiatives have contributed to an increase in the popularity of bicycling during later years, and the Covid-19 pandemic has further escalated this trend. Other prominent trends are the increased use of e-bikes and the rapid uptake of e-scooters and other micro mobility devices.
A potential downside of these trends, however, is an increase in crashes and injuries \[7\]. Research has established that bicyclists have a much higher risk of injuries than car occupants \[8-9\]. Yet, the true number of bicycle injuries is largely unknown. As in other European countries, bicycle injuries in Norway are vastly underreported in official road accident statistics \[10\], and the level of underreporting is increasing \[8\]. There is a huge mismatch between official road traffic statistics based on police-reported accidents and the number of injured cyclists receiving health care. This discrepancy is particularly large for single-bicycle crashes (i.e., crashes where only one cyclist and no other vehicle is involved) \[11\]. Thus, official road accident statistics provide a poor basis for monitoring trends in bicycle injuries and for designing preventive measures.
Furthermore, little is known about the long-term consequences of bicycle injuries, including their impact on health-related quality of life and other functional outcomes \[12\]. A particular concern involves post-injury opioid use and the risk of dependence on prescription drugs in the management of chronic pain \[13\]. For targeted prevention of such long-term consequences, more knowledge is also needed about sociodemographic risk factors.
In this project, we aim to address these knowledge gaps by applying a retrospective register-based design, where we link individual-level data on cyclist injuries, sociodemographic characteristics, welfare benefits, employment status and use of prescribed drugs from different nationwide registers.
3. Objectives
This project has three primary objectives:
1. To assess the degree of overlap of cyclist injuries registered in the official road accident statistics and in the health services, and thereby map the level of underreporting of cyclist injuries in the former data source
2. To obtain knowledge of long-term consequences of cyclist injuries with respect to:
1. Disability
2. Employment status
3. Use of prescribed drugs
3. To examine whether such long-term consequences vary by sociodemographic characteristics
4 Methodology
4.1 STUDY DESIGN To address these issues, we aim to construct a population-based dataset containing census data (including sociodemographic information) from the National Population Register for all individuals residing in Norway in the period 2008-2021. This dataset is to be linked with information on injuries registered in four data sources: 1) Statistics Norway's (SSB) database on police-reported road traffic accidents, 2) the National Patient Registry (NPR), 3) the Norwegian Trauma Registry (NTR) and 4) the Norwegian Cause of Death Registry (DÅR). To analyse long-term consequences of cyclist injuries with respect to disability, employment status and use of prescribed drugs, we will further link data for adults aged 18-67 years from SSB's historical events database (FD-Trygd) and the Norwegian Prescribed Drug Registry. Finally, to examine socioeconomic differences in risk of such long-term consequences, we will link data on educational attainment and income, both supplied by SSB.
The overall population-based design of our study was chosen to enhance the validity of our estimates and to facilitate the interpretation of our statistical analyses. For instance, when assessing long-term consequences of cyclist injuries and how these vary by sociodemographic characteristics, it is paramount to collect this type of information also for individuals that have not been involved in bicycle crashes. By including the whole population, we will generate a more powerful comparison group than other potential designs and reduce potential sources of bias. Moreover, this design will allow for more robust estimates of incidence rates and risk factors for the outcome variables by including valid estimates of person-time at risk. To control for the occurrence of non-cycle injuries that may influence functional outcomes, we will also collect information on other types of injuries, both for injured cyclists and for the population at large.
4.2 DESCRIPTION OF DATA SOURCES
1. The National Population Register: Census data for all residents of Norway in the period 2008-2021, including the following information:
* Month and year of birth
* Sex
* Immigrant status and country of origin
* Marital status
* Residential code - classification of individuals as resident, emigrated or dead (with month and year for change of code)
* Municipality of residence
* Encrypted ID number for individual-level linkage with other registers
2. Police-reported road traffic accidents: Information about all road traffic accidents reported to the police in the period 2008-2021, including the following variables:
* Date of crash
* Municipality and location of crash (X- and Y coordinates)
* Road category (European route, national road, county road etc.)
* Type of road (highway, pedestrian zone, walking/cycling path etc.)
* Speed limit
* Accident type (single accident, rear-end collision, head-on collision etc.)
* Type of vehicle (passenger car, heavy goods vehicle, bicycle, motorcycle, bus etc.)
* Classification of road user (driver/passenger of car, rider/passenger of motorcycle/moped/bicycle, pedestrian etc.)
* Age and sex of injured person
* Injury severity (killed, very seriously injured, seriously injured, slightly injured, unspecified)
* Suspicion of alcohol intoxication
* Protective equipment (seat belt, helmet use)
* Counterpart in collision (motor vehicle (light/heavy), bicycle, pedestrian etc.)
3. National Patient Registry: Information about all injury contacts in secondary care registered in NPR in the period 2008-2021, identified by diagnostic codes from chapter XIX and chapter XX of the tenth edition of the International Statistical Classification of Diseases and Health Related Problems (ICD-10). For these patients, we will include the following information:
* Date of treatment
* Place of treatment (hospital ID)
* Injury diagnoses (principal and secondary)
In addition, we will include injury data for all patients registered in the common minimum dataset for personal injury (FMDS). This dataset contains information about the external circumstances of injuries treated in secondary care, including the following variables:
* Date and time of injury
* Intent (accident, self-harm, assault)
* Place of occurrence (road/street, residence, workplace, playground etc.)
* Type of transport vehicle
* Activity (sport/leisure, work, education etc.)
* Injury mechanism
* Injury severity
* Municipality where injury occurred
* Location of road traffic crash (X- and Y-coordinates)
4. Norwegian Trauma Registry: Since 2015, NTR contains nationwide data on patients admitted to hospital with potentially severe injury (i.e., high- and low energy trauma patients). From this register, we aim to use information about all injured patients admitted to trauma-receiving hospitals in the period 2015-2021, including the following variables:
* Date and time of injury
* Municipality where injury occurred
* ASA score before injury (a measure of physiological status/comorbidity developed by the American Society of Anesthesiologists to predict operative risk)
* Glasgow Outcome Scale (measure of functional status) before injury and at discharge from hospital
* Helmet use
* Intent
* Injury mechanism
* Type of traffic accident
* Sport and leisure accident
* Dead on arrival
* Days of hospital stay
* Dead within 30 days of injury
* Abbreviated Injury Scale (AIS)
* Injury Severity Scale (ISS)
* New Injury Severity Scale (NISS)
5. The Cause of Death Registry: Information about all fatal injuries registered in the period 2008-2021, identified by diagnostic codes from chapter XX of ICD-10 as underlying cause of death, including the following variables:
• Month and year of death
* Resident in Norway at time of death
* Age in years
* Municipality of residence
* Country of death
* Municipality where death occurred
* Special circumstances
* Place where injury occurred
* Activity related to injury
* Underlying cause of death (chapter XX)
* Main injury (codes from chapter XIX)
* Contributing causes of death
6. FD-Trygd: FD-Trygd is Statistics Norway's historical events database, which links basic demographic data with employment records and information about services and benefits administered by the Norwegian Labour and Welfare Administration (NAV). We aim to use the following variables from this database:
• Sickness benefit
* Work assessment allowance
* Disability benefit
* Old age pension and early retirement pension
* Basic benefit and attendance benefit
* Employment (including occupation)
* Job seeker status
7. The Norwegian Prescribed Drug Registry: Information on analgesics and other psychopharmaceutical drugs dispensed from pharmacies to individual patients living outside institutions in the period 2008-2021, including the following variables:
* Prescriber's project ID
* Prescriber's profession and specialty
* Patient's sex and year/month of birth
* Patient's residential municipality
* Dispensing number
* Dispensing date
* Number of packages per filled prescription
* Number of DDDs (defined daily dose) per filled prescription
* Regulation (legal basis)
* Reimbursement Code
* Reimbursement Code ICD
* Reimbursement Code ICPC
* Article number (unique product identifier)
* ATC (Anatomical Therapeutic Chemical) code at 5th level for all N codes (anatomical main group: nervous system) apart from N04 (anti-Parkinson drugs), plus codes M01A (anti-inflammatory and antirheumatic products, non-steroids), M02A (topical products for joint and muscular pain), M03BA (muscle relaxants, peripherally acting agents) and H02A (corticosteroids for systemic use, plain)
* Prescription category (narcotic drug, other addictive drug, prescription drug)
8. The National Education Database (NUDB): From this database we will include information about highest educational attainment, coded according to the Norwegian Standard Classification of Education, and the year this level was achieved. The database is administered by Statistics Norway.
9. Statistics Norway's income database: Statistics Norway collects income data by linking different administrative registers and statistical data sources, including tax returns. From this database we will include the following variables:
• Pensionable income
• Total income
* Household income
* Taxable gross wealth
4.3 STATISTICAL ANALYSIS To map the degree of overlap of cyclist injuries between health registers (NPR, NTR and DÅR) and the official road traffic accident statistics, we will compare the number and characteristics of such injuries (in total and in different sub-populations) registered in these four data sources. To obtain knowledge of long-term consequences of cyclist injuries, we will perform descriptive analyses to examine disability rates, employment status and use of prescription drugs. We will further use Poisson regression to model incidence rates with respect to various injury-related factors (injury severity, type of accident, injury mechanism, helmet use etc.) and to examine the degree to which these long-term consequences vary by sex, age, and other sociodemographic variables.
4.4 REQUIRED PERMISSIONS
The project will require permissions from:
• The Regional Committees for Medical and Health Research Ethics (REC) for advance ethical approval
• Statistics Norway (SSB) for access to microdata from the National Population Register, the police-reported road accident database, FD-Trygd and socioeconomic data (including data from NUDB)
• The Norwegian Directorate of Health for access to injury data in NPR
* Oslo University Hospital (OUS) for access to trauma data in NTR
* The Norwegian Institute of Public Health (NIPH) for approval of Data Protection Impact Assessment (DPIA) and for access to data in DÅR and the Norwegian Prescribed Drug Registry
4.5 PROCEDURE FOR DATA LINKAGE Statistics Norway will define the study population as described in paragraph 4.1 and generate project-specific ID numbers with linkage to the unique personal ID numbers given to all Norwegian residents. Statistics Norway will then link data from the National Population Register, the police-reported road accident database, FD-Trygd and sociodemographic data according to specifications described in paragraph 4.2. Likewise, the Norwegian Directorate of Health, NTR and NIPH will link their respective data. After linkage, each data owner will send these datasets (in which the unique personal ID number is deleted and replaced by the project-specific ID number) to the project. The Norwegian Directorate of Health, NTR and NIPH will subsequently delete the file linking the personal ID numbers and project-specific ID numbers, which will for the duration of the project be stored securely by Statistics Norway.
5 Significance and ethical aspects The study will improve our understanding of the societal and individual burden of bicycle injuries and provide new knowledge of their long-term consequences. Exploring sociodemographic risk factors will further guide policy makers in identifying effective safety measures.
The project will follow ethical guidelines for statistical analysis and presentation of results, considering both privacy issues and statistical robustness. A potential risk involves identification of individuals. However, the files received by the project contain no directly identifiable information, as unique personal ID numbers are replaced by project-specific ID numbers. To minimise the risk of backwards identification, analyses will be performed on files containing only the variables needed to address the different research questions. For instance, to assess the degree of overlap between injured cyclists in health registries and the official road traffic accident database, analyses will be restricted to variables common to these data sources, thus omitting information on welfare benefits, use of prescription drugs and socioeconomic variables. Level of detail will also be reduced, for instance by categorising age into 5-year age groups. In addition, analyses of long-term consequences of bicycle injuries (including sociodemographic differences in such consequences) will be restricted to adults aged 18-67 years.
Another potential risk is stigma attached to specific groups of individuals, for instance those receiving welfare benefits. However, this project will not present detailed information about such groups. All results will be presented on aggregate level, and results based on few observations (\< 6 individuals) will not be presented or discussed.
The project will include sensitive information about individuals (e.g., medical diagnoses, use of prescription drugs, receipt of welfare benefits and measures of comorbidity/functional status). However, we will not collect any new data, but utilise data already registered in other data sources. The use of these data is regulated by law. To ensure secure storing of data, we will use Services for sensitive data (TSD), which is a service where users can collect, store, share and analyse data within a secure environment with a high degree of safety .
6 Project timeline
The project will be developed in tasks with the following timeline:
• Task 1 Preparation and linkage of registers: January 2022 - February 2023
• Task 2 Main data analysis: February 2023 - May 2023
• Task 3 Estimation of overlap between different registries: March 2023 - June 2023
• Task 4 Dissemination: by December 2026
7 Funding The ReCyCLIST project is funded by the Research Council of Norway (NFR) and Agder County.
8 Dissemination A designated ReCyCLIST project website (https://www.toi.no/recyclist/) will be used for regular communication of project updates and results.
For this specific work package, we plan to submit three focused articles to peer-reviewed international journals, for open access publication. The following are tentative titles with suggested articles in brackets.
1. Degree of overlap between injured cyclists in official police-reported accident statistics and hospital data (Journal of Transport \& Health) 2. Long-term health consequences of bicycle crashes (Accident Analysis \& Prevention or Journal of Transport \& Health) 3. Sociodemographic differences in long-term consequences of bicycle crashes (BMC Public Health or European Journal of Public Health)
In addition, results from this project will be presented at national and international seminars and conferences. Nationally, the most relevant will be the yearly conferences arranged by the Norwegian Public Roads Administration, the Norwegian Safety Forum, and the Norwegian Council for Road Safety (Trygg Trafikk). Internationally, relevant conferences include the biannual Safe Communities Conference, the annual International Cycling Safety Conference, and the biannual Transportation Research Arena.
9 References
1. United Nations (2021). Cycling and Sustainable Development Goals. Accessed December 6th 2021. Available from: https://unric.org/en/sustainable-development-goals-cycling/
2. European Cyclists' Federation (2016). Cycling delivers on the global goals: shifting towards a better economy, society, and planet for all. Accessed December 6th 2021. Available from: https://ecf.com/sites/ecf.com/files/The%20Global%20Goals_internet.pdf
3. de Hartog, J.J., Boogaard, H., Nijland, H. \& Hoek, G. (2010). Do the health benefits of cycling outweigh the risks? Environ Health Perspect, 118(8), 1109-1116.
4. Holm, A.L., Glümer, C. \& Diderichsen, F. (2012). Health impact assessment of increased cycling to place of work or education in Copenhagen. BMJ Open, 2, e001135. doi: 10.1136/bmjopen-2012-001135.
5. Mueller, N., Rojas-Rueda, D., Cole-Hunter, T., de Nazelle, A., Dons, E., Gerike, R., et al. (2015). Health impact assessment of active transportation: a systematic review. Prev Med, 76, 103-114.
6. Rojas-Rueda, D., de Nazelle, A., Teixidó, O., Nieuwenhuijsen, M.J. (2013). Health impact assessment of increasing public transport and cycling use in Barcelona: a morbidity and burden of disease approach. Prev Med, 57(5), 573-579.
7. Næss, I., Galteland, P., Skaga, N.O., Eken, T., Helseth, E., Ramm-Pettersen, J. (2020). The number of patients hospitalized with bicycle injuries is increasing: A cry for better road safety. Accid Anal Prev, 148. doi:10.1016/j.aap.2020.105836.
8. Bjørnskau, T. (2020). Road traffic risk in Norway 2017/18. TØI-report 1782/2020. Institute of Transport Economics: Oslo.
9. Nilsson, P., Stigson, H., Ohlin, M., \& Strandroth, J. (2016). Modelling the effect on injuries and fatalities when changing mode of transport from car to bicycle. Accid Anal Prev, 100, 30-36.
10. Shinar, D., Valero-Mora, P., van Strijp-Houtenbos, M., Haworth, N., Schramm, A., De Bruyne, G., Cavallo, V., et al. (2018). Under-reporting bicycle accidents to police in the COST TUI1101 international survey: cross-country comparisons and associated factors. Accid Anal Prev, 110, 177-186.
11. Schepers, P., Agerholm, N., Amoros, E., Benington, R., Bjørnskau, T., Dhondt, S., et al. (2015). An international review of the frequency of single-bicycle crashes (SBCs) and their relation to bicycle modal share. Inj Prev, 21(e1), e138-e143.
12. Kjeldgård, L., Ohlin, M., Elrud, R., Stigson, H., Alexanderson, K., \& Friberg, E. (2019). Bicycle chrashes and sickness absence: a population-based Swedish register study of all individuals of working ages. BMC Public Health, 19, 943. doi:10.1186/s12889-019-7284-1.
13. Berecki-Gisolf, J., Hassani-Mahmooei, B., Collie, A., \& McClure, R. (2016). Prescription opioid and benzodiazepine use after road traffic injury. Pain Medicine, 117, 304-313.
### Conditions Module
**Conditions:**
- Work Disability
- Employment Status
- Use of Prescribed Drugs
- Injuries
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 6491274
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Persons injured while using a bike
**Label:** Cyclist injured
#### Arm Group 2
**Description:** Matched controls not injured
**Label:** Controls
### Outcomes Module
#### Primary Outcomes
**Description:** Sickness absence and disability pension
**Measure:** Work disability
**Time Frame:** 2008 to 2022
**Description:** Working or not and type of work
**Measure:** Employment status
**Time Frame:** 2008 to 2022
**Description:** Information on analgesics and other psychopharmaceutical drugs dispensed from pharmacies to individual patients living outside institutions
**Measure:** Use of prescribed drugs
**Time Frame:** 2008 to 2022
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Individuals residing in Norway between 2008 and 2022
Exclusion Criteria:
* No
**Maximum Age:** 120 Years
**Minimum Age:** 0 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Individuals residing in Norway between 2008 and 2022
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Oslo
**Country:** Norway
**Facility:** Norwegian Institute of Public Health
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M17685
- Name: Wounds and Injuries
- Relevance: HIGH
- As Found: Injury
### Condition Browse Module - Meshes
- ID: D000014947
- Term: Wounds and Injuries
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442319
**Brief Title:** The Efficiency and Safety of PRP Treatment After Anterior Cruciate Ligament Reconstruction.
**Official Title:** The Efficiency and Safety of Platelet-rich Plasma Intra-articular Injections After Anterior Cruciate Ligament Reconstruction: MRI and Clinical Outcome Analysis.
#### Organization Study ID Info
**ID:** NicolausCopernicusU
#### Organization
**Class:** OTHER
**Full Name:** Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz
### Status Module
#### Completion Date
**Date:** 2030-04-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2028-04-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz
#### 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 anterior cruciate ligament (ACL) is the main stabilizer of the knee joint, as it controls anteroposterior and rotatory knee laxity. The number of ACL injuries has increased in the past three decades because more and more people participate in recreational and competitive sporting activities. Injury to the ACL often leads to functional instability, damage to the meniscus and articular cartilage, and an increased risk for osteoarthritis (OA). Emphasizes the fact that ACL has limited healing potential 'The gold standard' treatment is ACL reconstruction, with over 200,000 reconstruction surgeries performed annually in the United States. However, despite the success of surgery in restoring functional stability, it has been found so far in several studies that the prevalence of moderate to severe arthritis in long-term radiographic follow-up is more than 50% after ACL reconstruction within 5 to 15 years or sooner. ACL-injured knees had at least 3 times higher risk of arthritis than uninjured contralateral knees. Early osteoarthritis was observed on magnetic resonance imaging (MRI) up to 11 years following ACL injury after operative and nonoperative management. Because ACL injuries predominantly occur in individuals between the ages of 15 and 25 years, symptoms of OA most often affect patients during their most productive years. This is worrisome because most patients who sustain ACL tears are free of the risk of other factors for developing OA.Consequently, posttraumatic OA after ACL reconstruction ultimately translates into a large economic effect on the healthcare system owing to the young age of this population. Platelet-rich plasma is an autologous solution of highly concentrated platelets dispersed in a small capacity of plasma. Enthusiasm for the therapeutic potential of platelets is based on its rich omplement of anabolic growth factors and anti-inflammatory cytokines in the platelets, which induce cellular proliferation, migration, differentiation, angiogenesis, and extracellular matrix synthesis. In addition, the functional mechanisms of PRP in OA treatment have been explained by its effect on modulating critical pro-inflammatory mediators and catabolic enzymes, as well as maintaining joint homeostasis. The reasons for this early incidence of post-traumatic OA remain unclear, but the underlying mechanisms have been speculated to involve some combination of cartilage damage at the time of injury, and posttraumatic molecular changes in the joint, including immune reactions or persistent secondary inflammation. We hypothesized that PRP injection after ACL reconstruction could prevent cartilage damage, act anti-inflammatory, and provide better clinical and radiological outcomes seen in MRI.
### Conditions Module
**Conditions:**
- ACL Injury
- Knee Osteoarthritis
- Knee Injuries
**Keywords:**
- PRP, ACL reconstruction, knee osteoarthritis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Biological: Platelet-rich plasma
**Label:** Platelet-rich Plasma
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Biological: Platelet-rich plasma
**Label:** Hyaluronic Acid
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Hyaluronic Acid
- Platelet-rich Plasma
**Description:** Platelet-rich plasma intra-articular injection in patients after anterior cruciate ligament reconstruction
**Name:** Platelet-rich plasma
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** The 2 primary outcomes were 12-month change in overall average knee pain scores (11-point scale; range, 0-10, with higher scores indicating worse pain; minimum clinically important difference of 1.8) and percentage change in cartilage volume as assessed by magnetic resonance imaging (MRI).
**Measure:** Pain and cartilage volume
**Time Frame:** 12 months
#### Secondary Outcomes
**Description:** The assesment of synovial fluid volume and fat pad synovitis seen in ultrasonography and MRI
**Measure:** Synovitis
**Time Frame:** 6 and 12 months post-treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* subject is 18-45 years old
* subject has BMI \< 40 kg/m2
* subject had ACL reconstrution
* small asymptomatic meniscal lesions that won't require repair
* subject must be willing to abstain from other intra-articular treatments of the knee for the duration of the study.
* subject is willing to discontinue all analgesics including nonsteroidal anti-inflammatory drugs (NSAIDs), except tramadol and paracetamol, at least one month before the synovial fluid aspiration and through the completion of the study
* subject is able to understand and comply with the requirements of the study and voluntarily provides consent
Exclusion Criteria:
* subject has a history of metabolic diseases, endocrine disorders, rheumatic and connective tissue diseases, cancer, hormonal contraception, steroid therapy, antibiotic therapy
* subject had an intraarticular injection into the affected joint
* subject had previous operations (beside ACL reconstruction) or fractures of the affected limb
* subject has a history of nicotine, alcohol, or drug addiction
* subject has a meniscal tear that requires suturing or total meniscectomy seen on MRI
* subject has multi-ligament knee injuries or multi-organ injury
* subject has significant varus or valgus deformity greater than 10 degrees in either knee, determined by an X-ray
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** dszwedow@yahoo.com
**Name:** Dawid Szwedowski, MD, PhD
**Phone:** 608075237
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Toruń
**Contacts:**
***Contact 1:***
- **Email:** dszwedow@yahoo.com
- **Name:** Dawid Szwedowski, MD, PhD
- **Phone:** 608075237
- **Role:** CONTACT
***Contact 2:***
- **Email:** dszwedow@yahoo.com
- **Phone Ext:** Szwedowski
- **Role:** CONTACT
***Contact 3:***
- **Name:** Dawid Szwedowski, MD, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Poland
**Facility:** Dawid Szwedowski
**Status:** RECRUITING
**Zip:** 87-100
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Lohmander LS, Ostenberg A, Englund M, Roos H. High prevalence of knee osteoarthritis, pain, and functional limitations in female soccer players twelve years after anterior cruciate ligament injury. Arthritis Rheum. 2004 Oct;50(10):3145-52. doi: 10.1002/art.20589.
**PMID:** 15476248
**Citation:** Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS. A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med. 2010 Jul 22;363(4):331-42. doi: 10.1056/NEJMoa0907797. Erratum In: N Engl J Med. 2010 Aug 26;363(9):893.
**PMID:** 20660401
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001168
- Term: Arthritis
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000012216
- Term: Rheumatic Diseases
- ID: D000007869
- Term: Leg Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M22168
- Name: Osteoarthritis, Knee
- Relevance: HIGH
- As Found: Knee Osteoarthritis
- ID: M12926
- Name: Osteoarthritis
- Relevance: HIGH
- As Found: Osteoarthritis
- ID: M10738
- Name: Knee Injuries
- Relevance: HIGH
- As Found: Knee Injuries
- ID: M601
- Name: Anterior Cruciate Ligament Injuries
- Relevance: HIGH
- As Found: ACL Injury
- ID: M17685
- Name: Wounds and Injuries
- Relevance: HIGH
- As Found: Injury
- ID: M4476
- Name: Arthritis
- Relevance: LOW
- As Found: Unknown
- ID: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15045
- Name: Rheumatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6323
- Name: Collagen Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10881
- Name: Leg Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010003
- Term: Osteoarthritis
- ID: D000020370
- Term: Osteoarthritis, Knee
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000007718
- Term: Knee Injuries
- ID: D000070598
- Term: Anterior Cruciate Ligament Injuries
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M9878
- Name: Hyaluronic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442306
**Brief Title:** Evaluation of Pain Neuroscience Education for Patients Who Experience Chronic Pain With Concurrent Opioid Dependence
**Official Title:** Development of a Pain Neuroscience Education Program for Patients Who Are Opioid Dependence With Concurrent Chronic Musculoskeletal Pain
#### Organization Study ID Info
**ID:** 53966
#### Organization
**Class:** OTHER
**Full Name:** Wichita State University
### Status Module
#### Completion Date
**Date:** 2021-01-15
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-02
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2021-01-15
**Type:** ACTUAL
#### Start Date
**Date:** 2020-01-03
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-06-02
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Kentucky
#### Lead Sponsor
**Class:** OTHER
**Name:** Wichita State University
#### Responsible Party
**Investigator Affiliation:** University of Kentucky
**Investigator Full Name:** Nicole D Windsor
**Investigator Title:** Physical Therapist, PhD student, Teaching assistant
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Chronic musculoskeletal pain (CMP) is estimated to affect over 100 million adults and is targeted as an instigator of opioid dependence (OpD). Opioid medications are often the first response for patients suffering with CMP; yet over 10 million people admit to misusing opioids annually. With the opioid epidemic, the healthcare system now has a population of patients who experience CMP with concurrent OpD (CMP/OpD). This persistent problem can create a perfect storm of kinesiophobia, reduced self-efficacy, and physical dysfunction. A critical component to chronic pain management is understanding how patients view their pain experience. Education may be one key that unlocks the door to functional improvement, but traditional physical therapy (PT) education utilizes anatomical models that focus on tissue damage and peripheral sources of pain. Researchers have explored educating people about pain via Pain Neuroscience Education (PNE), a cognitive-based intervention that facilitates understanding of the biological processes underpinning the pain state. PNE may facilitate understanding pain experiences that are normal and expected, with the intent to reduce fear and increase pain self-efficacy. As yet, utilization of PNE has not been researched in patients with CMP/OpD. Therefore, authors hypothesize that the introduction of an adapted PNE (a-PNE) curriculum, as a single intervention, may facilitate positive changes in kinesiophobia, pain self-efficacy, and knowledge of the neurophysiology of pain for patients with CMP/OpD.
**Detailed Description:** Methods Study Design This study was a pre-test-post-test, quasi-experimental design with patients suffering from CMP/OpD being treated at a family practice clinic associated with University of Kentucky. A quasi-experimental study was chosen due to the small sample of convenience.
Patients Patients were recruited from an opioid management program (OMP) at the referenced family practice clinic. At the time of study recruitment, the OMP had 31 patients participating monthly.
Procedures The 21 participating patients were divided into two groups via a coin toss; 13 were included in the experimental group (PNE) and eight were included in the general health education control group (GHE).
All patients reviewed and signed the IRB approved consent/HIPAA form and performed the MMSE. Each patient completed the Tampa Scale of Kinesiophobia (TSK-11), Pain Self-Efficacy Questionnaire (PSEQ), and the Neurophysiology of Pain Questionnaire (NPQ) at the onset of the study. All intervention sessions were completed once per month directly after the patient's regularly scheduled monthly OMP appointment.
The PNE group received the a-PNE curriculum which was created with patient-friendly verbiage and used to educate subjects about the inner workings of the nervous system. The a-PNE curriculum, a PowerPoint presentation was divided into four, 15-minute, one-on-one sessions with the PI in a private treatment room to facilitate discussion and minimize distractions. The educational information was related directly to the patients' CMP/OpD experience to personalize the intervention and presented at a pace that was appropriate for each patient. At the conclusion of each session, the PNE group was provided handouts containing information that was reviewed during that session. At the end of the a-PNE intervention, the patients completed the three questionnaires.
The GHE group was provided practical education for healthy living over four monthly sessions, 15-minutes per session. The GHE intervention was comprised of topics promoting healthy living in a one-on-one session with the PI in a private treatment room to facilitate discussion. At the conclusion of each session, the GHE group was provided handouts containing information that was reviewed during the session. At the end of the GHE intervention, the patients completed the three questionnaires.
It should be noted that no patients were receiving other physical therapy interventions throughout the time of the study. The principal investigator removed exercise-related language and overt physical therapy-related topics to focus primarily on the psychosocial constructs for both groups. Considering the many factors surrounding this cohort, multiple sessions were chosen for the two groups to minimize the effects of CMP/OpD of decreased attention span, decreased working memory and decreased cognitive flexibility, which has been demonstrated in the literature.
Ninety days after the completion of the intervention sessions and the post-program assessments, a follow-up data collection was performed in which all patients completed the three questionnaires. After the research study was complete and all data collected, the GHE subjects were offered the identical a-PNE intervention which was utilized with the PNE group.
Statistical Analysis Statistical analyses were performed using the SPSS software (v.27.0, SPSS, Inc., Chicago, IL, USA). The significance level was set at P\<0.05. The scores of three patients who did not complete the study were removed from the data set.
Normative distribution was evaluated utilizing the Shapiro-Wilk test. Descriptive statistics, including means and standard deviations (SD), were gathered for baseline demographic data. A group (a-PNE or GHE) by time (pre-intervention, post-intervention, and 90-day post-intervention) interaction analysis of variance (ANOVA) was completed for each dependent variable. Analysis included the Mauchly's Test of Sphericity to correct for violations. Bonferroni's correction was used as needed. Pearson's correlation was performed to inquire of correlation between variables.
Paired samples t-tests were conducted on each group and utilized to analyze pre-intervention to post-intervention and pre-intervention to 90-day post-intervention scores for each of the three dependent variables.
### Conditions Module
**Conditions:**
- Chronic Pain
- Opioid Dependence
**Keywords:**
- Chronic Musculoskeletal Pain
- Opioid Dependence
- Pain Neuroscience Education
- Neurophysiology of Pain Questionnaire
- Pain Self-Efficacy Questionnaire
- Tampa Scale for Kinesiophobia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Quasi-experimental study with a Pain Neuroscience Education group and a General Health Education group.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 21
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The PNE group received the a-PNE education curriculum which was created with patient-friendly verbiage and used to educate subjects about the inner workings of the nervous system. The a-PNE curriculum, a PowerPoint presentation was divided into four, 15-minute, one-on-one sessions with the PI in a private treatment room to facilitate discussion and minimize distractions. The educational information was related directly to the patients' CMP/OpD experience to personalize the intervention and presented at a pace that was appropriate for each patient. At the conclusion of each session, the PNE group was provided handouts containing information that was reviewed during that session. At the end of the a-PNE intervention, the patients completed the three questionnaires.
**Intervention Names:**
- Other: Pain Neuroscience Education
**Label:** Pain Neuroscience Education group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The GHE group was provided practical education for healthy living over four monthly sessions, 15-minutes per session. The GHE intervention was comprised of topics promoting healthy living in a one-on-one session with the PI in a private treatment room to facilitate discussion. At the conclusion of each session, the GHE group was provided handouts containing information that was reviewed during the session. At the end of the GHE intervention, the patients completed the three questionnaires.
**Intervention Names:**
- Other: General Health Education
**Label:** General Health Education group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Pain Neuroscience Education group
**Description:** Pain Neuroscience Education (PNE) is a cognitive-based education intervention that aims to change pain beliefs in patients experiencing CMP. Researchers have found PNE beneficial in assisting patients to reframe their understanding, attitudes, thoughts, and beliefs regarding their pain experience. PNE directs patients to relate chronic pain to overly sensitive nerves rather than assumed tissue damage. Further, PNE encourages patients to perform daily activities, work, and function in society, all despite pain. This facilitates behavior changes that are key in amending a patient's biopsychosocial state. Multiple sources make a strong case for the incorporation of PNE in having positive effects on reducing physical disability and modulating fear and anxiety in patients with CMP. Researchers have established a positive influence of PNE toward decreased kinesiophobia and have demonstrated a relation between increased self-efficacy and increased functional ability.
**Name:** Pain Neuroscience Education
**Other Names:**
- Neuroscience Education
- Biopsychosocial pain education
- Pain neurophysiology education
- Pain science education
- Therapeutic neuroscience education
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- General Health Education group
**Description:** General Health Education included: 20 Benefits of Walking 30 Minutes a Day; Why You Should Quit: Smoking Cessation; Heat vs. Cold: How to Use it For Pain Control; Sleep Hygiene.
**Name:** General Health Education
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Kinesiophobia was measured by the 11-question TSK-11. Kinesiophobia is the fear of movement, or the fear of pain associated with movement. Subjects rate each item on a 4-point Likert scale with scoring ranging from "strongly disagree" to "strongly agree". The TSK-11 tool specifically assesses a subject's fear of pain due to movement and is a valid and reliable tool for measuring kinesiophobia. The highest score available on the TSK-11 is 44 points, with higher scores indicating increased fear. The minimum detectible change (MDC) for the TSK-11 is 5.6, minimal clinically important difference (MCID) is 6 points, and test-retest reliability is 0.81 (95% CI, 0.58-0.93).
**Measure:** Tampa Scale for Kinesiophobia (TSK-11)
**Time Frame:** Pre-intervention (baseline), post-intervention (4-months past baseline), and 90-day post-intervention (7-months past baseline)
**Description:** The patient's confidence with function despite pain, or self-efficacy, was measured by the Pain Self-Efficacy Questionnaire (PSEQ). The PSEQ measures a patient's confidence in performing certain tasks, despite pain, and has a maximum score of 60 points which relates to the most positive outcome for the subject (with zero being the lowest self-efficacy). The PSEQ is a valid and reliable tool for measuring pain self-efficacy with a test-retest reliability of 0.85 (95% CI, 0.74-0.92), MDC of 10.9 and MCID of 11 points.
**Measure:** Pain Self-Efficacy Questionnaire (PSEQ)
**Time Frame:** Pre-intervention (baseline), post-intervention (4-months past baseline), and 90-day post-intervention (7-months past baseline)
**Description:** Knowledge gained and retained regarding the neurophysiology supporting the CMP experience was measured via the Neurophysiology of Pain Questionnaire (NPQ). The NPQ is a 12-item assessment that seeks to measure how a subject understands the biological mechanisms that sustain the pain experience. Statements are answered true, false, or unsure. There are 12 points possible with a higher score indicating more retained pain knowledge. Post-intervention, the NPQ will ascertain the subject's understanding of the a-PNE curriculum. The NPQ currently has no test-retest reliability, MDC or MCID available.
**Measure:** Neurophysiology of Pain Questionnaire
**Time Frame:** Pre-intervention (baseline), post-intervention (4-months past baseline), and 90-day post-intervention (7-months past baseline)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Subjects who were actively participating in an Opioid Management Program.
Exclusion Criteria:
* 18 years of age or younger
* Score of 24 or less on the Mini Mental State Examination
**Maximum Age:** 95 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Lexington
**Country:** United States
**Facility:** University of Kentucky
**State:** Kentucky
**Zip:** 40506
#### Overall Officials
**Official 1:**
**Affiliation:** University of Kentucky
**Name:** Anne Harrison, PhD
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** University of Kentucky
**Name:** Nicole D Windsor, PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** University of Kentucky
**Name:** Tony English, PhD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** Data can be accessed by emailing nicole.windsor@wichita.edu
**Description:** Inquiries can be made to principal investigator. Study protocol, Subject de-identified demographics, outcome measure scores, statistical analysis.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
**IPD Sharing:** YES
**Time Frame:** Data is available at any time.
### References Module
#### References
**Citation:** Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.
**PMID:** 27351541
**Citation:** Dahlhamer J, Lucas J, Zelaya C, Nahin R, Mackey S, DeBar L, Kerns R, Von Korff M, Porter L, Helmick C. Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults - United States, 2016. MMWR Morb Mortal Wkly Rep. 2018 Sep 14;67(36):1001-1006. doi: 10.15585/mmwr.mm6736a2.
**PMID:** 30212442
**Citation:** Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.
**PMID:** 22133255
**Citation:** Louw A, Puentedura EL, Mintken P. Use of an abbreviated neuroscience education approach in the treatment of chronic low back pain: a case report. Physiother Theory Pract. 2012 Jan;28(1):50-62. doi: 10.3109/09593985.2011.562602. Epub 2011 Jul 3.
**PMID:** 21721995
**Citation:** Louw A, Zimney K, O'Hotto C, Hilton S. The clinical application of teaching people about pain. Physiother Theory Pract. 2016 Jul;32(5):385-95. doi: 10.1080/09593985.2016.1194652. Epub 2016 Jun 28.
**PMID:** 27351903
**Citation:** Moseley GL, Nicholas MK, Hodges PW. A randomized controlled trial of intensive neurophysiology education in chronic low back pain. Clin J Pain. 2004 Sep-Oct;20(5):324-30. doi: 10.1097/00002508-200409000-00007.
**PMID:** 15322439
**Citation:** Bodes Pardo G, Lluch Girbes E, Roussel NA, Gallego Izquierdo T, Jimenez Penick V, Pecos Martin D. Pain Neurophysiology Education and Therapeutic Exercise for Patients With Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):338-347. doi: 10.1016/j.apmr.2017.10.016. Epub 2017 Nov 11.
**PMID:** 29138049
**Citation:** Moseley L. Combined physiotherapy and education is efficacious for chronic low back pain. Aust J Physiother. 2002;48(4):297-302. doi: 10.1016/s0004-9514(14)60169-0.
**PMID:** 12443524
**Citation:** Lluch E, Duenas L, Falla D, Baert I, Meeus M, Sanchez-Frutos J, Nijs J. Preoperative Pain Neuroscience Education Combined With Knee Joint Mobilization for Knee Osteoarthritis: A Randomized Controlled Trial. Clin J Pain. 2018 Jan;34(1):44-52. doi: 10.1097/AJP.0000000000000511.
**PMID:** 28514231
**Citation:** Beltran-Alacreu H, Lopez-de-Uralde-Villanueva I, Fernandez-Carnero J, La Touche R. Manual Therapy, Therapeutic Patient Education, and Therapeutic Exercise, an Effective Multimodal Treatment of Nonspecific Chronic Neck Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2015 Oct;94(10 Suppl 1):887-97. doi: 10.1097/PHM.0000000000000293.
**PMID:** 25888653
**Citation:** Watson JA, Ryan CG, Cooper L, Ellington D, Whittle R, Lavender M, Dixon J, Atkinson G, Cooper K, Martin DJ. Pain Neuroscience Education for Adults With Chronic Musculoskeletal Pain: A Mixed-Methods Systematic Review and Meta-Analysis. J Pain. 2019 Oct;20(10):1140.e1-1140.e22. doi: 10.1016/j.jpain.2019.02.011. Epub 2019 Mar 1.
**PMID:** 30831273
**Citation:** Wood L, Hendrick PA. A systematic review and meta-analysis of pain neuroscience education for chronic low back pain: Short-and long-term outcomes of pain and disability. Eur J Pain. 2019 Feb;23(2):234-249. doi: 10.1002/ejp.1314. Epub 2018 Oct 14.
**PMID:** 30178503
**Citation:** Souza CM, Martins J, Libardoni TC, de Oliveira AS. Self-efficacy in patients with chronic musculoskeletal conditions discharged from physical therapy service: A cross-sectional study. Musculoskeletal Care. 2020 Sep;18(3):365-371. doi: 10.1002/msc.1469. Epub 2020 Apr 8.
**PMID:** 32267617
**Citation:** Tsuji H, Tetsunaga T, Tetsunaga T, Nishida K, Misawa H, Ozaki T. The factors driving self-efficacy in intractable chronic pain patients: a retrospective study. J Orthop Surg Res. 2019 Dec 30;14(1):473. doi: 10.1186/s13018-019-1535-9.
**PMID:** 31888662
**Citation:** Archer KR, Phelps KD, Seebach CL, Song Y, Riley LH 3rd, Wegener ST. Comparative study of short forms of the Tampa Scale for Kinesiophobia: fear of movement in a surgical spine population. Arch Phys Med Rehabil. 2012 Aug;93(8):1460-2. doi: 10.1016/j.apmr.2012.03.024. Epub 2012 Apr 3.
**PMID:** 22481127
**Citation:** Mintken PE, Cleland JA, Whitman JM, George SZ. Psychometric properties of the Fear-Avoidance Beliefs Questionnaire and Tampa Scale of Kinesiophobia in patients with shoulder pain. Arch Phys Med Rehabil. 2010 Jul;91(7):1128-36. doi: 10.1016/j.apmr.2010.04.009.
**PMID:** 20599053
**Citation:** Hapidou EG, O'Brien MA, Pierrynowski MR, de Las Heras E, Patel M, Patla T. Fear and Avoidance of Movement in People with Chronic Pain: Psychometric Properties of the 11-Item Tampa Scale for Kinesiophobia (TSK-11). Physiother Can. 2012 Summer;64(3):235-41. doi: 10.3138/ptc.2011-10.
**PMID:** 23729957
**Citation:** Briet JP, Bot AG, Hageman MG, Menendez ME, Mudgal CS, Ring DC. The pain self-efficacy questionnaire: validation of an abbreviated two-item questionnaire. Psychosomatics. 2014 Nov-Dec;55(6):578-85. doi: 10.1016/j.psym.2014.02.011. Epub 2014 Feb 28.
**PMID:** 25016359
**Citation:** Chiarotto A, Falla D, Polli A, Monticone M. Validity and Responsiveness of the Pain Self-Efficacy Questionnaire in Patients With Neck Pain Disorders. J Orthop Sports Phys Ther. 2018 Mar;48(3):204-216. doi: 10.2519/jospt.2018.7605. Epub 2017 Dec 19.
**PMID:** 29257925
**Citation:** Chiarotto A, Vanti C, Cedraschi C, Ferrari S, de Lima E Sa Resende F, Ostelo RW, Pillastrini P. Responsiveness and Minimal Important Change of the Pain Self-Efficacy Questionnaire and Short Forms in Patients With Chronic Low Back Pain. J Pain. 2016 Jun;17(6):707-18. doi: 10.1016/j.jpain.2016.02.012. Epub 2016 Mar 11.
**PMID:** 26975193
**Citation:** Catley MJ, O'Connell NE, Moseley GL. How good is the neurophysiology of pain questionnaire? A Rasch analysis of psychometric properties. J Pain. 2013 Aug;14(8):818-27. doi: 10.1016/j.jpain.2013.02.008. Epub 2013 May 4.
**PMID:** 23651882
**Citation:** Vaughan B, Mulcahy J, Fitzgerald K, Austin P. Evaluating Patient's Understanding of Pain Neurophysiology: Rasch Analysis of the Neurophysiology of Pain Questionnaire. Clin J Pain. 2019 Feb;35(2):133-139. doi: 10.1097/AJP.0000000000000658.
**PMID:** 30260841
**Citation:** van Ittersum MW, van Wilgen CP, van der Schans CP, Lambrecht L, Groothoff JW, Nijs J. Written pain neuroscience education in fibromyalgia: a multicenter randomized controlled trial. Pain Pract. 2014 Nov;14(8):689-700. doi: 10.1111/papr.12137. Epub 2013 Nov 20.
**PMID:** 24251724
**Citation:** Wijma AJ, Speksnijder CM, Crom-Ottens AF, Knulst-Verlaan JMC, Keizer D, Nijs J, van Wilgen CP. What is important in transdisciplinary pain neuroscience education? A qualitative study. Disabil Rehabil. 2018 Sep;40(18):2181-2191. doi: 10.1080/09638288.2017.1327990. Epub 2017 May 19.
**PMID:** 28524700
**Citation:** Tellez-Garcia M, de-la-Llave-Rincon AI, Salom-Moreno J, Palacios-Cena M, Ortega-Santiago R, Fernandez-de-Las-Penas C. Neuroscience education in addition to trigger point dry needling for the management of patients with mechanical chronic low back pain: A preliminary clinical trial. J Bodyw Mov Ther. 2015 Jul;19(3):464-72. doi: 10.1016/j.jbmt.2014.11.012. Epub 2014 Nov 22.
**PMID:** 26118519
**Citation:** Amer-Cuenca JJ, Pecos-Martin D, Martinez-Merinero P, Lluch Girbes E, Nijs J, Meeus M, Ferrer Pena R, Fernandez-Carnero J. How Much Is Needed? Comparison of the Effectiveness of Different Pain Education Dosages in Patients with Fibromyalgia. Pain Med. 2020 Apr 1;21(4):782-793. doi: 10.1093/pm/pnz069.
**PMID:** 31216027
**Citation:** Louw A, Puentedura EJ, Zimney K, Schmidt S. Know Pain, Know Gain? A Perspective on Pain Neuroscience Education in Physical Therapy. J Orthop Sports Phys Ther. 2016 Mar;46(3):131-4. doi: 10.2519/jospt.2016.0602.
**PMID:** 26928735
**Citation:** Louw A, Sluka KA, Nijs J, Courtney CA, Zimney K. Revisiting the Provision of Pain Neuroscience Education: An Adjunct Intervention for Patients but a Primary Focus of Clinician Education. J Orthop Sports Phys Ther. 2021 Feb;51(2):57-59. doi: 10.2519/jospt.2021.9804. Epub 2020 Oct 19.
**PMID:** 33076759
## Document Section
### Large Document Module
#### Large Docs
- Date: 2020-01-03
- Filename: ICF_000.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 242962
- Type Abbrev: ICF
- Upload Date: 2024-05-09T16:17
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009135
- Term: Muscular Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000079524
- Term: Narcotic-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: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: BC25
- Name: Substance Related Disorders
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M29444
- Name: Musculoskeletal Pain
- Relevance: HIGH
- As Found: Musculoskeletal Pain
- ID: M29442
- Name: Chronic Pain
- Relevance: HIGH
- As Found: Chronic Pain
- ID: M2922
- Name: Kinesiophobia
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12244
- Name: Opioid-Related Disorders
- Relevance: HIGH
- As Found: Opioid Dependence
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12092
- Name: Muscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2057
- Name: Narcotic-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
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: HIGH
- As Found: Chronic
### Condition Browse Module - Meshes
- ID: D000059352
- Term: Musculoskeletal Pain
- ID: D000059350
- Term: Chronic Pain
- ID: D000009293
- Term: Opioid-Related Disorders
### Intervention Browse Module - Browse Branches
- Abbrev: Analg
- Name: Analgesics
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442293
**Brief Title:** Safety and Tolerability of 2 Dietary Supplement Beverages Designed to Maintain Healthy Blood Pressure.
**Official Title:** An Evaluation of the Safety and Tolerability of 2 Dietary Supplement Beverages Designed to Maintain Normal Blood Pressure in Normal, Healthy Individuals.
#### Organization Study ID Info
**ID:** 202401CT
#### Organization
**Class:** INDUSTRY
**Full Name:** USANA Health Sciences
### Status Module
#### Completion Date
**Date:** 2024-08-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-02
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-23
**Study First Submit QC Date:** 2024-06-02
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** USANA Health Sciences
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study is designed to evaluate the safety and tolerability of two distinct dietary supplement beverage formulations designed to maintain normal blood pressure. In this study, safety and tolerability will be assessed among otherwise healthy, normotensive individuals.
**Detailed Description:** The objective of this study is to evaluate the safety of 2 dietary supplement beverage formulations in healthy, normotensive individuals. The study period will be 29 days in length, during which we will monitor and catalogue the blood pressure (BP), heart rate (HR), comprehensive metabolic panel (CMP), complete blood count (CBC), as well as self-reported side effects of all subjects on a daily basis. Note that each beverage will be evaluated at multiple doses: Beverage 1 will be monitored at a low, medium and high dose, where the medium and high dose is quantitatively twice (2X) and thrice (3X) the low dose (1X), respectively. Similarly, we will evaluate Beverage 2 at a low dose and high dose where the high dose is quantitatively twice (2X) of the low dose (1X). A placebo treatment will also be incorporated into this study as well. As such, there will be 6 groups in this study. Three subjects will be assigned to each treatment group for a total of 18 subjects.
### Conditions Module
**Conditions:**
- Safety Issues
- Tolerance
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** single blind, placebo controlled
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 18
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** a placebo (microcrystalline cellulose) identical in size, shape and color to the treatment
**Intervention Names:**
- Dietary Supplement: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
#### Arm Group 2
**Description:** A beverage containing natural ingredients at a low dose
**Intervention Names:**
- Dietary Supplement: Treatment 1
**Label:** Circulatory Beverage - low dose
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** A beverage containing natural ingredients at a medium dose
**Intervention Names:**
- Dietary Supplement: Treatment 1
**Label:** Circulatory Beverage - medium dose
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** A beverage containing natural ingredients at a high dose
**Intervention Names:**
- Dietary Supplement: Treatment 1
**Label:** Circulatory Beverage - high dose
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** A traditional Chinese medicine-based beverage containing natural ingredients at a low dose
**Intervention Names:**
- Dietary Supplement: Treatment 2
**Label:** TCM Beverage - low dose
**Type:** EXPERIMENTAL
#### Arm Group 6
**Description:** A traditional Chinese medicine-based beverage containing natural ingredients at a high dose
**Intervention Names:**
- Dietary Supplement: Treatment 2
**Label:** TCM Beverage - high dose
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Circulatory Beverage - high dose
- Circulatory Beverage - low dose
- Circulatory Beverage - medium dose
**Description:** A dietary supplement containing beet root extract, arginine and citrulline
**Name:** Treatment 1
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- TCM Beverage - high dose
- TCM Beverage - low dose
**Description:** A traditional Chinese medicine (TCM)-based dietary supplement containing chrysanthemum extract and eucommia bark extract
**Name:** Treatment 2
**Type:** DIETARY_SUPPLEMENT
#### Intervention 3
**Arm Group Labels:**
- Placebo
**Description:** a placebo supplement that is similar in appearance to treatment 1
**Name:** Placebo
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** An assessment of adverse symptoms categorized as either respiratory, cardiovascular, neurological or gastrointestinal. If symptoms present, they are rated on a scale from 1 to 10, with indicating very mild symptoms and 10 indicating very severe symptoms.
**Measure:** Aggregate Adverse Symptom Score
**Time Frame:** 4 weeks
#### Secondary Outcomes
**Description:** An assessment of subjects' blood pressure throughout the 4-week study period.
**Measure:** Blood pressure assessment
**Time Frame:** 4 weeks
**Description:** An assessment of subjects' heart rate throughout the 4-week study period.
**Measure:** Heart rate monitoring
**Time Frame:** 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* You are male or female between the ages of 18 and 50 (inclusive)
* You are in generally good health and taking no medications known to treat or affect blood pressure (e.g., angiotensin converting enzyme (ACE) inhibitors, calcium channel blockers, diuretics)
* You have a Body Mass Index of 18.5 to 30.0
* You have a resting blood pressure of systolic blood pressure (SBP) of 90 - 120 mm Hg and a diastolic blood pressure (DBP) 60 - 80 mm Hg
* You are comfortable reading and speaking in English
* You are fully able and willing to comply with the requirements of the study
* You are fully able and willing to keep scheduled appointments
* You have no known food allergies or intolerances
* Female individuals will be asked to complete a pregnancy screening test.
Exclusion Criteria:
* You are pregnant, attempting to become pregnant, or are currently lactating
* You currently use prescription or over-the-counter medications that may interfere with absorption of the test supplement or confound results (e.g., thiazide and loop diuretics for hypertension, corticosteroids)
* You have clinically important gastrointestinal, renal, hepatic, cardiac, pulmonary, pancreatic, neurologic or biliary disorders or conditions. Individuals with type 1 or type 2 diabetes will be excluded from the study
* You have illnesses or other medical conditions that will prevent or interfere with giving an informed consent, or with participation in the study.
* You have scheduling difficulties or lack of transportation that will prevent or interfere with their ability to attend all the necessary study visits.
* You have participated as a subject in any other clinical study within 30 days of the screening visit.
* You have a history of alcohol abuse or other substance abuse within the previous 2 years.
* You are currently using tobacco products including chewing tobacco and cigarettes.
**Healthy Volunteers:** True
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** mark.levy@usanainc.com
**Name:** Mark Levy, PhD
**Phone:** (801) 954-7783
**Role:** CONTACT
**Contact 2:**
**Email:** rolando.maddela@usanainc.com
**Name:** Rolando Maddela, MPH
**Phone:** (801) 954-7568
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Salt Lake City
**Country:** United States
**Facility:** USANA Health Sciences
**State:** Utah
**Zip:** 84120
#### Overall Officials
**Official 1:**
**Affiliation:** USANA Health Sciences
**Name:** Mark Levy, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AA
- Name: Amino Acids
- Abbrev: Ot
- Name: Other Dietary Supplements
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M4854
- Name: Benzocaine
- Relevance: LOW
- As Found: Unknown
- ID: T1
- Name: Arginine
- Relevance: LOW
- As Found: Unknown
- ID: T433
- Name: Tannic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T114
- Name: Chrysanthemum
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442280
**Acronym:** DAPA-TONIC
**Brief Title:** SGLT-2 Inhibitor and High-Dose Furosemide Plus Small-Volume Hypertonic Saline Solution in Acute HF
**Official Title:** Enhanced Diuresis and Natriuresis in Acute Decompensated Heart Failure Patients Treated With SGLT-2 Inhibitor and High-Dose Furosemide Plus Small-Volume Hypertonic Saline Solution: A Clinical Trial
#### Organization Study ID Info
**ID:** UPalermo7
#### Organization
**Class:** OTHER
**Full Name:** University of Palermo
### Status Module
#### Completion Date
**Date:** 2026-03-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-01-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-19
**Study First Submit QC Date:** 2024-06-02
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Palermo
#### Responsible Party
**Investigator Affiliation:** University of Palermo
**Investigator Full Name:** Antonino Tuttolomondo
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of the current investigation is to demonstrate the efficacy of high-dose furosemide plus small-volume hypertonic saline solution and a Sodium-Glucose cotransporter-2 (SGLT-2) inhibitor among patients admitted for acute exacerbation of heart failure, in determining a significant increase in diuresis and natriuresis. It is also accompanied by a rapid reduction in body weight and a substantial decrease in hospitalization length without compromising renal function.
**Detailed Description:** All enrolled patients will undergo a comprehensive physical examination post-randomization. This examination will involve a meticulous assessment of congestive heart failure (CHF) indicators, encompassing the measurement of bodyweight (BW) (taken in the morning before breakfast), supine and standing blood pressure (BP \[average of 3 readings\]), and heart rate (HR). Fasting blood samples will be collected daily throughout the hospital stay to ascertain serum laboratory parameters (creatinine, sodium, potassium, and N-terminal pro b-type natriuretic peptide) until achieving a clinically stabilized condition. Urine output will be measured daily, also to detect creatinine, sodium, potassium urinary levels and glycosuria. Additionally, an electrocardiogram and echocardiogram (to derive EF using the modified Simpson rule with 2 cross-sectional views \[4- and 2-chamber apical views\], right atrium volume (RA volume, ml/m2), left atrial volume (LA volume ml/m2), inferior vena cava diameter (IVC diameter, cm), interventricular septum thickness at end-diastole (IVSd, cm), right ventricular basal diameter at end-diastole (RVD1 basal, mm), right ventricular mid diameter at end-diastole (RVD2 mid, mm), right ventricular longitudinal diameter at end-diastole (RVD3 long, mm), right ventricular outflow tract at proximal and distal (RVOT prox and distal, mm), fractional area change (FAC, %), E wave dominant (m/s), A wave dominant (m/s), tricuspid valve E/A wave ratio (E/ATrV), tissue Doppler echocardiography (TDE, ms), eak velocity in early diastole of tricuspid annulus (TDI) (m/s), tricuspid valve e'/a' ratio (TDI, m/s), peak systolic velocity tricuspid annulus (Pulsed TDI, m/s) will be conducted prior to hospital discharge.
Patients will be categorized into 4 groups: the first group will undergo 15 minutes intravenous infusion of furosemide combined with hypertonic saline solutions (100 mL) twice daily along with severe water restriction (\< 500 mL); the second group will receive intravenous furosemide as a bolus twice daily and severe water restriction (\< 500 mL) without hypertonic saline solutions; the third group will undergo 15 minutes intravenous infusion of furosemide combined with hypertonic saline solutions (100 mL) twice daily, severe water restriction (\< 500 mL), and SGLT2 inhibitors (Dapagliflozin); the fourth group will receive intravenous furosemide as a bolus without hypertonic saline solutions twice daily, severe water restriction (\< 500 mL), and SGLT2 inhibitors (Dapagliflozin). The groups will maintain a normal sodium intake (120 mmol/day). The daily furosemide dosage will be determined based on diuretic requirements, urinary output, BP readings, and the severity of congestion signs and symptoms. The hypertonic saline solutions dosage for each patient (in groups 1 and 3) will be determined following these guidelines: for serum Na values of 125 milliequivalent/L, the hypertonic saline solutions concentration will be 4.6%; for serum Na values between 126 and 135 milliequivalent/L, the hypertonic saline solutions concentration will be 3.5%; and for serum Na values of 135 milliequivalent/L, the hypertonic saline solutions concentration will range between 1.4% and 2.4%. Throughout the study period, patients diagnosed with Heart Failure with Reduced Ejection Fraction (HFrEF) will receive angiotensin converting enzyme inhibitors, sartans, angiotensin receptor-neprilysin inhibitors, beta blockers, and mineralocorticoid inhibitors. The objective is to optimize heart failure therapy in alignment with the most recent European Society of Cardiology guidelines published in August 2023. Daily, there will be meticulous monitoring of body weight (in the morning before breakfast) and 24-hour urinary volume measurements. Serum and urinary laboratory parameters will be assessed daily until achieving a clinically stabilized condition, defined as a shift in New York Heart Association functional class to at least second b and reaching the ideal body weight calculated via the Lorenz formula. Upon attaining this clinically stabilized state, intravenous administration of furosemide and hypertonic saline solutions will cease, transitioning to oral furosemide administration, while maintaining the unchanged optimal therapy post-discharge according to the standard protocol.
### Conditions Module
**Conditions:**
- Heart Failure Acute
- Diabetes Type 2
- Heart Failure With Reduced Ejection Fraction
- Heart Failure With Preserved Ejection Fraction
**Keywords:**
- Acute Heart Failure
- Diabetes Type 2
- SGLT-2 inhibitors
- Furosemide
- Hypertonic Solution
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Patients will be categorized into 4 groups: the first group will undergo 15 minutes intravenous infusion of furosemide combined with hypertonic saline solution (100 mL) twice daily along with severe water restriction (\< 500 mL); the second group will receive intravenous furosemide as a bolus twice daily and severe water restriction (\< 500 mL) without hypertonic saline solution; the third group will undergo 15 minutes intravenous infusion of furosemide combined with hypertonic saline solution (100 mL) twice daily, severe water restriction (\< 500 mL), and SGLT2 inhibitors (Dapagliflozin); the fourth group will receive intravenous furosemide as a bolus without hypertonic saline solution twice daily, severe water restriction (\< 500 mL), and SGLT2 inhibitors (Dapagliflozin).
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 544
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This group will undergo a 15-minute intravenous infusion of furosemide combined with hypertonic saline solutions (100 mL) twice daily, severe water restriction (\< 500 mL), and SGLT2 inhibitors (Dapagliflozin).
**Intervention Names:**
- Drug: Dapagliflozin tablet
- Drug: Hypertonic Saline Solution, 1 Ml
**Label:** Dapa-Tonic
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** This group will undergo a 15-minute intravenous infusion of furosemide combined with hypertonic saline solutions (100 mL) twice daily along with severe water restriction (\< 500 mL).
**Intervention Names:**
- Drug: Hypertonic Saline Solution, 1 Ml
**Label:** Tonic-Placebo
**Type:** PLACEBO_COMPARATOR
#### Arm Group 3
**Description:** This group will undergo intravenous furosemide twice daily and severe water restriction (\< 500 mL) without hypertonic saline solutions.
**Intervention Names:**
- Drug: Furosemide Injection
**Label:** Furosemide-Placebo
**Type:** PLACEBO_COMPARATOR
#### Arm Group 4
**Description:** This group will undergo intravenous furosemide without hypertonic saline solutions twice daily, severe water restriction (\< 500 mL), and SGLT2 inhibitors (Dapagliflozin).
**Intervention Names:**
- Drug: Dapagliflozin tablet
- Drug: Furosemide Injection
**Label:** Dapa-Furo
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dapa-Furo
- Dapa-Tonic
**Description:** Dapagliflozin 10 mg 1 tablet once daily
**Name:** Dapagliflozin tablet
**Other Names:**
- SGLT2 inhibitor
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Dapa-Tonic
- Tonic-Placebo
**Description:** Intravenous infusion of furosemide combined with hypertonic saline solutions (100 mL) twice daily
**Name:** Hypertonic Saline Solution, 1 Ml
**Other Names:**
- Hypertonic Solution, Saline
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Dapa-Furo
- Furosemide-Placebo
**Description:** Furosemide 20 mg
**Name:** Furosemide Injection
**Other Names:**
- FUROSEMIDE
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Daily urinary volume (mL) are detected by chemiluminescence immunoassay.
**Measure:** Diuresis from the baseline and up to 1 week
**Time Frame:** an average of 1 week
**Description:** Daily natriuresis (mEq/L) are detected by chemiluminescence immunoassay.
**Measure:** Natriuresis from the baseline and up to 1 week
**Time Frame:** an average of 1 week
**Description:** Duration of hospital stay in days.
**Measure:** Length of hospital stay
**Time Frame:** immediately after the intervention
#### Secondary Outcomes
**Description:** Daily evaluation of creatinine (mg/dL).
**Measure:** Kidney function during treatment
**Time Frame:** an average of 1 week
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* acute heart failure;
* diabetes type 2.
Exclusion Criteria:
* low estimated glomerular filtration rate;
* hypernatremia;
* diabetes type 1;
* non-cardiac causes of dyspnea;
* cardiogenic shock;
* recent occurrence of Acute Coronary Syndrome;
* ketoacidosis;
* hyperosmolar hyperglycemic syndrome.
**Maximum Age:** 89 Years
**Minimum Age:** 40 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** bruno.tuttolomondo@unipa.it
**Name:** Antonino Tuttolomondo, Professor
**Phone:** +39 091 6552115
**Role:** CONTACT
**Contact 2:**
**Email:** miceli.gpp@gmail.com
**Name:** Giuseppe Miceli, PhD
**Phone:** +39 0916552197
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** A.O.U.P. Paolo Giaccone Palermo
**Name:** Giuseppe Miceli, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available. Erratum In: Eur Heart J. 2021 Oct 14;:
**PMID:** 34447992
**Citation:** Liszkowski M, Nohria A. Rubbing salt into wounds: hypertonic saline to assist with volume removal in heart failure. Curr Heart Fail Rep. 2010 Sep;7(3):134-9. doi: 10.1007/s11897-010-0018-4.
**PMID:** 20607462
**Citation:** Arrigo M, Jessup M, Mullens W, Reza N, Shah AM, Sliwa K, Mebazaa A. Acute heart failure. Nat Rev Dis Primers. 2020 Mar 5;6(1):16. doi: 10.1038/s41572-020-0151-7.
**PMID:** 32139695
**Citation:** Parrinello G, Di Pasquale P, Torres D, Cardillo M, Schimmenti C, Lupo U, Iatrino R, Petrantoni R, Montaina C, Giambanco S, Paterna S. Troponin I release after intravenous treatment with high furosemide doses plus hypertonic saline solution in decompensated heart failure trial (Tra-HSS-Fur). Am Heart J. 2012 Sep;164(3):351-7. doi: 10.1016/j.ahj.2012.05.025. Epub 2012 Aug 17.
**PMID:** 22980301
**Citation:** Parrinello G, Paterna S, Di Pasquale P, Torres D, Mezzero M, Cardillo M, Fasullo S, La Rocca G, Licata G. Changes in estimating echocardiography pulmonary capillary wedge pressure after hypersaline plus furosemide versus furosemide alone in decompensated heart failure. J Card Fail. 2011 Apr;17(4):331-9. doi: 10.1016/j.cardfail.2010.11.003. Epub 2010 Dec 24.
**PMID:** 21440872
**Citation:** Paterna S, Di Pasquale P, Parrinello G, Fornaciari E, Di Gaudio F, Fasullo S, Giammanco M, Sarullo FM, Licata G. Changes in brain natriuretic peptide levels and bioelectrical impedance measurements after treatment with high-dose furosemide and hypertonic saline solution versus high-dose furosemide alone in refractory congestive heart failure: a double-blind study. J Am Coll Cardiol. 2005 Jun 21;45(12):1997-2003. doi: 10.1016/j.jacc.2005.01.059.
**PMID:** 15963399
**Citation:** Xie Y, Wei Y, Li D, Pu J, Ding H, Zhang X. Mechanisms of SGLT2 Inhibitors in Heart Failure and Their Clinical Value. J Cardiovasc Pharmacol. 2023 Jan 1;81(1):4-14. doi: 10.1097/FJC.0000000000001380.
**PMID:** 36607775
**Citation:** Solomon SD, Vaduganathan M, Claggett BL, de Boer RA, DeMets D, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Belohlavek J, Chiang CE, Willem Borleffs CJ, Comin-Colet J, Dobreanu D, Drozdz J, Fang JC, Alcocer Gamba MA, Al Habeeb W, Han Y, Cabrera Honorio JW, Janssens SP, Katova T, Kitakaze M, Merkely B, O'Meara E, Kerr Saraiva JF, Tereschenko SN, Thierer J, Vardeny O, Verma S, Vinh PN, Wilderang U, Zaozerska N, Lindholm D, Petersson M, McMurray JJV. Baseline Characteristics of Patients With HF With Mildly Reduced and Preserved Ejection Fraction: DELIVER Trial. JACC Heart Fail. 2022 Mar;10(3):184-197. doi: 10.1016/j.jchf.2021.11.006.
**PMID:** 35241246
**Citation:** Heerspink HJL, Stefansson BV, Correa-Rotter R, Chertow GM, Greene T, Hou FF, Mann JFE, McMurray JJV, Lindberg M, Rossing P, Sjostrom CD, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020 Oct 8;383(15):1436-1446. doi: 10.1056/NEJMoa2024816. Epub 2020 Sep 24.
**PMID:** 32970396
**Citation:** Ostermann M, Bellomo R, Burdmann EA, Doi K, Endre ZH, Goldstein SL, Kane-Gill SL, Liu KD, Prowle JR, Shaw AD, Srisawat N, Cheung M, Jadoul M, Winkelmayer WC, Kellum JA; Conference Participants. Controversies in acute kidney injury: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Conference. Kidney Int. 2020 Aug;98(2):294-309. doi: 10.1016/j.kint.2020.04.020. Epub 2020 Apr 26.
**PMID:** 32709292
**Citation:** Clark WF, Sontrop JM, Macnab JJ, Suri RS, Moist L, Salvadori M, Garg AX. Urine volume and change in estimated GFR in a community-based cohort study. Clin J Am Soc Nephrol. 2011 Nov;6(11):2634-41. doi: 10.2215/CJN.01990211. Epub 2011 Sep 1.
**PMID:** 21885793
**Citation:** Oh SW, Han SY. Loop Diuretics in Clinical Practice. Electrolyte Blood Press. 2015 Jun;13(1):17-21. doi: 10.5049/EBP.2015.13.1.17. Epub 2015 Jun 30.
**PMID:** 26240596
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000003920
- Term: Diabetes Mellitus
- 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
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M7119
- Name: Diabetes Mellitus, Type 2
- Relevance: HIGH
- As Found: Diabetes Type 2
- ID: M9421
- Name: Heart Failure
- Relevance: HIGH
- As Found: Heart Failure
- ID: M9419
- Name: Heart Diseases
- 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: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006333
- Term: Heart Failure
- ID: D000003924
- Term: Diabetes Mellitus, Type 2
### Intervention Browse Module - Ancestors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000007004
- Term: Hypoglycemic Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000004232
- Term: Diuretics
- ID: D000045283
- Term: Natriuretic Agents
- ID: D000049994
- Term: Sodium Potassium Chloride Symporter Inhibitors
- ID: D000049990
- Term: Membrane Transport Modulators
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: NaAg
- Name: Natriuretic Agents
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
### Intervention Browse Module - Browse Leaves
- ID: M348449
- Name: Dapagliflozin
- Relevance: HIGH
- As Found: 0.9
- ID: M1691
- Name: Sodium-Glucose Transporter 2 Inhibitors
- Relevance: HIGH
- As Found: Termination
- ID: M8784
- Name: Furosemide
- Relevance: HIGH
- As Found: Micrograms
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: HIGH
- As Found: Procedure
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7411
- Name: Diuretics
- Relevance: LOW
- As Found: Unknown
- ID: M26153
- Name: Sodium Potassium Chloride Symporter Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000529054
- Term: Dapagliflozin
- ID: D000077203
- Term: Sodium-Glucose Transporter 2 Inhibitors
- ID: D000005665
- Term: Furosemide
- ID: D000019999
- Term: Pharmaceutical Solutions
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442267
**Acronym:** CASUAL-ECMO
**Brief Title:** Comparing Anticoagulation Strategies Using UFH, Argatroban and LMWH for ECMO Support
**Official Title:** A Three-arm Randomized Controlled Non-inferiority Pilot Study Comparing Anticoagulation Strategies Using Unfractionated Heparin, Argatroban and Low-molecular-weight Heparin for Extracorporeal Membrane Oxygenation Support
#### Organization Study ID Info
**ID:** 1644/2022
#### Organization
**Class:** OTHER
**Full Name:** Medical University of Vienna
### Status Module
#### Completion Date
**Date:** 2026-11-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-02
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-07-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-27
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-06-02
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Medical University of Vienna
#### Responsible Party
**Investigator Affiliation:** Medical University of Vienna
**Investigator Full Name:** Johannes Gratz
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A three-arm randomized controlled non-inferiority pilot study comparing anticoagulation strategies using unfractionated heparin, argatroban and enoxaparin for extracorporeal membrane oxygenation support conducted as an investigator-initiated, prospective, parallel group, open-label, active comparator controlled, single center, phase IV study to evaluate the non-inferiority of enoxaparin or argatroban for anticoagulation during ECMO therapy in comparison to the current standard, unfractionated heparin, as measured by the incidence of thromboembolic events during the duration of ECMO therapy
### Conditions Module
**Conditions:**
- Respiratory Insufficiency
- Circulatory Failure
- Thromboembolism
- Bleeding
**Keywords:**
- ECMO
- Anticoagulation
- Thromboembolic Event
- Bleeding
- extracorporeal life support
- anticoagulant
- heparin
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Anticoagulation for the duration of the study will be conducted using subcutaneous Enoxaparin
**Intervention Names:**
- Drug: Enoxaparin Injectable Solution
**Label:** Enoxaparin group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Anticoagulation for the duration of the study will be conducted using intravenous Argatroban.
**Intervention Names:**
- Drug: Argatroban, 1 Mg/mL Intravenous Solution
**Label:** Argatroban group
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Anticoagulation for the duration of the study will be conducted using intravenous unfractionated heparin
**Intervention Names:**
- Drug: Unfractionated heparin
**Label:** Unfractionated heparin group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Enoxaparin group
**Description:** Subcutaneous Enoxaparin will be dosed at 0.5 mg/kg twice daily
**Name:** Enoxaparin Injectable Solution
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Argatroban group
**Description:** Intravenous Argatroban will be administered as a continuous infusion of 0.1-1 µg/kg/min with a target modified thrombin time measured using Hemoclot of 0,40 - 0,60 µg/mL.
**Name:** Argatroban, 1 Mg/mL Intravenous Solution
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Unfractionated heparin group
**Description:** Unfractionated heparin will be administered as a continuous infusion of 7.5-20 units/kg/h with a target Anti FXa calibrated for UFH of 0.3-0.5 u/mL.
**Name:** Unfractionated heparin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Clinically relevant thromboembolic events (Clinical suspicion; confirmation via imaging)
* Pulmonary embolism, deep vein thrombosis
* Intracardiac thrombosis
* Arterial thromboembolism including myocardial and cerebral infarction
* Deep vein thrombosis (detected during daily routine sonography)
* Need to exchange ECMO circuit due to acute or incipient clotting
**Measure:** Incidence of thromboembolic events during ECMO therapy
**Time Frame:** through duration of the ECMO run; an average of 14 days
#### Secondary Outcomes
**Description:** Incidence of bleeding events classified according to BARC Criteria
**Measure:** Bleeding events
**Time Frame:** through duration of the ECMO run; an average of 14 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* either
* require ECMO support or
* have been started on ECMO therapy within the last 12 hours
Exclusion Criteria:
* Patients exhibiting contraindications to anticoagulation in general or any of the three investigated substances
* Patients who are pregnant
* Patients suffering from a clinically relevant pre-existing coagulopathy
* Patients, for whom screening, randomization and implementation of study protocol cannot be initiated within 12 hours after cannulation
* Patients receiving ongoing therapeutic systemic anticoagulation prior to ECMO implantation, or exhibiting an indication for therapeutic anticoagulation (e.g., pulmonary embolism)
* Patients whose total duration of ECMO support lasts less than 24 hours
* Patients with start of ECMO support during CPR (eCPR)
* Patients with passive decarboxylation, without an active pumping system
* Patients, who have been weaned off ECMO support within the last 30 days
* Patients with central ECMO cannulation and/or after cardiopulmonary bypass
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** vincenz.scharner@meduniwien.ac.at
**Name:** Vincenz Scharner, MD
**Phone:** +43 1 40400
**Phone Ext:** 4100
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Vienna
**Contacts:**
***Contact 1:***
- **Email:** vincenz.scharner@meduniwien.ac.at
- **Name:** Vincenz Scharner, Dr. med.
- **Role:** CONTACT
**Country:** Austria
**Facility:** Medical University of Vienna
**Status:** RECRUITING
**Zip:** 1090
#### Overall Officials
**Official 1:**
**Affiliation:** Medical Univeristy of Vienna
**Name:** Johannes Gratz, PD, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000016769
- Term: Embolism and Thrombosis
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M5114
- Name: Body Weight
- Relevance: LOW
- As Found: Unknown
- ID: M14968
- Name: Respiratory Insufficiency
- Relevance: HIGH
- As Found: Respiratory Insufficiency
- ID: M16682
- Name: Thromboembolism
- Relevance: HIGH
- As Found: Thromboembolism
- ID: M9556
- Name: Hemorrhage
- Relevance: LOW
- As Found: Unknown
- ID: M15577
- Name: Shock
- Relevance: HIGH
- As Found: Circulatory Failure
- 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
- 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
- ID: D000013923
- Term: Thromboembolism
- ID: D000012769
- Term: Shock
### Intervention Browse Module - Ancestors
- ID: D000000925
- Term: Anticoagulants
- ID: D000005343
- Term: Fibrinolytic Agents
- ID: D000050299
- Term: Fibrin Modulating Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000991
- Term: Antithrombins
- ID: D000015842
- Term: Serine Proteinase Inhibitors
- ID: D000011480
- Term: Protease Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000010975
- Term: Platelet Aggregation Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: FiAg
- Name: Fibrinolytic Agents
- Abbrev: AnCoag
- Name: Anticoagulants
- Abbrev: PlAggInh
- Name: Platelet Aggregation Inhibitors
- Abbrev: Coag
- Name: Coagulants
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: AA
- Name: Amino Acids
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: HIGH
- As Found: Procedure
- ID: M9579
- Name: Heparin
- Relevance: HIGH
- As Found: Enoxaparin
- ID: M20152
- Name: Enoxaparin
- Relevance: HIGH
- As Found: Fluorouracil
- ID: M46053
- Name: Calcium heparin
- Relevance: HIGH
- As Found: Enoxaparin
- ID: M58143
- Name: Argatroban
- Relevance: HIGH
- As Found: Narrow Band Imaging
- ID: M4244
- Name: Anticoagulants
- Relevance: LOW
- As Found: Unknown
- ID: M16676
- Name: Thrombin
- 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
- ID: M137075
- Name: Enoxaparin sodium
- 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: M8473
- Name: Fibrinolytic Agents
- 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: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M13865
- Name: Platelet Aggregation Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: T18
- Name: Serine
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000006493
- Term: Heparin
- ID: D000017984
- Term: Enoxaparin
- ID: C000006871
- Term: Calcium heparin
- ID: C000031942
- Term: Argatroban
- ID: D000019999
- Term: Pharmaceutical Solutions
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442254
**Brief Title:** The Effects of Virtual Reality in Intensive Care Patients
**Official Title:** Examining the Effects of Virtual Reality on Early Vital Variables and Spillovers in Intensive Care Patients
#### Organization Study ID Info
**ID:** 23-152
#### Organization
**Class:** OTHER
**Full Name:** Istinye University
### Status Module
#### Completion Date
**Date:** 2024-07-26
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-02
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-07-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-01
**Study First Submit QC Date:** 2024-06-02
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Istinye University
#### Responsible Party
**Investigator Affiliation:** Istinye University
**Investigator Full Name:** Yasemin Çırak
**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:** Weakness of respiratory muscles delays weaning from the ventilator, prolongs hospital stay and increases treatment costs. Conventional treatments for respiratory muscles reverse these negative effects. İntensive care services are a set of services that have a very important place in public health care due to the vital support and they provide to all critically ill patients. This care services are constantly improving with the use of technological innovations. With the development of technology, virtual reality application has begun to be used therapeutically in the field of physiotherapy. Virtual reality is the combination of reality and imagination with fictions created using technology. Today, developers can surprisingly create realistic worlds filled with artificial intelligence that behaves believably. Studies have shown positive effects of virtual reality on acute respiratory frequency, pain and fatigue, and in light of this, it was predicted that it would be beneficial to apply to intensive care patients. This study will shed light on the rehabilitation of patients in intensive care and contribute to the literature.
**Detailed Description:** In the study, it was aimed to benefit from the effects of virtual reality application in intensive care patients and have a positive effect on vital signs and respiratory parameters in the early period.
This study will be randomly divided into two groups and it is planned to include 17 partipitants in each group. The first group will receive only conventional treatment, and the second group will receive virtual reality application in addition to conventional treatment. To evaluate the effectiveness of the application, vital signs, respiratory muscle strength, grip strength, blood gas analysis, shortness of breath and fatigue will be evaluated. Additionally, Richmond Agitation Sedation Scale (RASS), Nonverbal Pain Scale, Glaskow coma scale, Physical Function Test in Intensive Care (PFIT)-CPax (Chelsea Critical Care Physical Assessment Tool) scales will be used. All evaluations will be made before and after the application and a comparison will be made between the two groups.
### Conditions Module
**Conditions:**
- Virtual Reality
- Intensive Care Unit Acquired Weakness
**Keywords:**
- virtual reality
- intensive care
- respiratory muscle strength
- respiratory function
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** Both the participants and the person analyzing the study do not know which is the study and control group.
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 34
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** In the intervention group, virtual reality application will be applied in addition to conventional treatment. In the application, which will be done with VR glasses, a video of walking on Istiklal Street in Istanbul's Beyoğlu district will be watched. To evaluate the effectiveness of the application, vital signs, respiratory muscle strength, grip strength, blood gas analysis, dyspnea and fatigue will be evaluated. Additionally, Richmond Agitation Sedation Scale (RASS), Non-Verbal Pain Scale, Glaskow coma scale, Physical Function Test in Intensive Care (PFIT)- CPax (Chelsea Critical Care Physical Assessment Tool) scales will be used.
**Intervention Names:**
- Other: Virtual Reality
**Label:** Virtual Reality Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Conventional treatment will be applied in the control group. Participants' vital signs, respiratory muscle strength, grip strength, blood gas analysis, dyspnea and fatigue will be evaluated. Additionally, Richmond Agitation Sedation Scale (RASS), Non-Verbal Pain Scale, Glaskow coma scale, Physical Function Test in Intensive Care (PFIT)- CPax (Chelsea Critical Care Physical Assessment Tool) scales will be used.
**Label:** Control Group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Virtual Reality Group
**Description:** In the application, which will be done with VR glasses, a video of walking on Istiklal Street in Istanbul's Beyoğlu district will be watched.
**Name:** Virtual Reality
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Maximal inspiratory pressure (MIP) is a measure of the strength of inspiratory muscles, primarily the diaphragm, and allows for the assessment of ventilatory failure, restrictive lung disease and respiratory muscle strength. MIP is measured at residual volume of lung.
**Measure:** Respiratory Muscle Strength
**Time Frame:** 3 days
**Description:** For respiratory muscle strength, maximal expiratory pressure (MEP) will evaluate using an electronic pressure transducer. MEP is measured from total lung capacity.particularly the diaphragm, while MEPs measure the strength of abdominal and intercostal muscles.
For respiratory muscle strength, maximal inspiratory pressure (MIP), and maximal expiratory pressure (MEP) were evaluated using an electronic pressure transducer. MIP was measured at residual volume, and MEP was measured from total lung capacity.
**Measure:** Respiratory Muscle Strength
**Time Frame:** 3 days
**Description:** Interrater reliability. In many intensive care units, the Richmond Agitation-Sedation Scale (RASS) is used to assess the level of sedation. This scale is designed with a three-step procedure that can help give a RASS score range of -5 to +4.The RASS score ranges from -5 (unarousable) to +4 (combative), with 0 meaning alert and calm.
**Measure:** Richmond Agitation-Sedation Scale
**Time Frame:** 3 days
**Description:** It evaluates morbidity through six systems (liver, central nervous system, respiratory system, cardiovascular system, renal and coagulation). For each system, points between 1 and 4 are given and the total score is evaluated between 6 and 24. In this score, as the score increases for each system, organ failure is considered to occur.
**Measure:** SOFA (Sequential Organ Failure Assessment)
**Time Frame:** 3 days
**Description:** A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson\[1\]. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.For pain intensity according to VAS, "no pain" is usually rated as 0 points and "worst pain imaginable" as 10 points. Ranges for pain intensity; \<3. mild pain, 3-6 moderate pain, \>6 severe pain
**Measure:** Visuel Anaolog Scale
**Time Frame:** 3 days
**Description:** It is a tool that healthcare providers use to measure decreases in consciousness. The scores from each section of the scale are useful for describing disruptions in nervous system function and also help providers track changes. It's the most widely used tool for measuring comas and decreases in consciousness.The components of the Glasgow Coma Scale include 4 different scores for the eye-opening response, 5 for the verbal response, and 6 for the motor response. The total score has values between 3 and 15. Three is the worst and 15 is the highest.
**Measure:** The Glasgow Coma Scale
**Time Frame:** 3 days
**Description:** It is a general measure of disease severity based on current physiologic measurements, age \& previous health conditions. The score can help in the assessment of patients to determine the level \& degree of diagnostic \& therapeutic intervention.APACHE II total score consists of three subheadings: acute physiology score, age and chronic health assessment; the highest value is 71. Mortality is 25% when the total score is 25, and increases to 80% when the total score is 35 and above.
**Measure:** APACHE II Score
**Time Frame:** 3 days
**Description:** İt is a test used on male and female patients in the intensive care unit (ICU) to assess physical and respiratory function impairments and morbidity.
**Measure:** Chelsea Critical Care Physical Assessment Tool (CPAx)
**Time Frame:** 3 days
**Description:** The average normal body temperature is generally accepted as 37°C. Some studies have shown that the "normal" body temperature can have a wide range, from 36.1°C to 37.2°C
**Measure:** Body temperature
**Time Frame:** 3 days
**Description:** Normal blood pressure for most adults is defined as a systolic pressure of less than 120 and a diastolic pressure of less than 80. Elevated blood pressure is defined as a systolic pressure between 120 and 129 with a diastolic pressure of less than 80.
**Measure:** Blood pressure
**Time Frame:** 3 days
**Description:** The normal range of breathing rate per minute in an average adult, for a person at rest, is 12 - 20 breaths per minute. Any person having a breathing rate under 12 or over 25 is considered to be breathing abnormally.
**Measure:** Respiratory rate
**Time Frame:** 3 days
**Description:** The normal pulse for healthy adults ranges from 60 to 100 beats per minute. The pulse rate may fluctuate and increase with exercise, illness, injury, and emotions.
**Measure:** Pulse rate
**Time Frame:** 3 days
**Description:** The PFIT-s is a battery outcome measure involving four components: sit to stand assistance, marching on the spot cadence, shoulder flexor and knee extensor strength.
**Measure:** The Physical Function in ICU Test
**Time Frame:** 3 days
#### Secondary Outcomes
**Description:** Hand muscle strength will be measured with a jamar device.
**Measure:** Hand Strength
**Time Frame:** 3 days
**Description:** It is a categorical scale with a score from 0 to 10, where 0 represents normal breathing and 10 represents maximum dyspnea.
**Measure:** Modified Borg Dyspnea Scale
**Time Frame:** 3 days
**Description:** It is the partial pressure of oxygen in arterial blood. It is used to evaluate oxygenation. Normal values are 80-100 mmHg.
**Measure:** Pa02
**Time Frame:** 3 days
**Description:** It is the partial pressure of carbon dioxide in arterial blood. It is an indicator of alveolar ventilation. Normal values are 35-45 mmHg.
**Measure:** PaCO2
**Time Frame:** 3 days
**Description:** It is the serum concentration of bicarbonate ion. It is an important buffer in the blood and is used to evaluate the metabolic component of acid-base balance. Standard bicarbonate: It is the bicarbonate value that should be present in the blood under standard conditions (37°C temperature and 40 mmHg PCO2). Normally it is 22-26 mEq/L.
**Measure:** HCO3
**Time Frame:** 3 days
**Description:** It is used to determine the H+ status of the blood. It shows that the patient is in acidosis or alkalosis, but it is not possible to understand the type by pH. Normal values are 7.35-7.45.
**Measure:** Ph
**Time Frame:** 3 days
**Description:** The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) is a tool used to assess delirium among patients in the intensive care unit. The CAM-ICU assesses for the four features of delirium: Feature 1 is an acute change in mental status or a fluctuating mental status, Feature 2, is inattention, Feature 3, is altered level of consciousness and Feature 4, is disorganized thinking.
**Measure:** Confusion Assessment Method for the ICU
**Time Frame:** 3 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Individuals receiving inpatient treatment in intensive care who volunteer to participate in the research or who are allowed by their first-degree relatives if they are unconscious,
* Being over 18 years of age
* Being eligible to receive physiotherapy and rehabilitation from an intensive care physician
* Are in clinically stable condition
Exclusion Criteria:
* Patients with coagulation disorders (PT (Prothrombin Time); INR (International Normalized Ratio) value higher than 1.5 and platelet amount less than 50,000 m³)
* Patients with signs of increased intracranial pressure
* Skin wounds, ulcerations, allergic reactions
* Patients in contact isolation due to infection
* In shock
* Having malignancy
* Having multiple organ failure
* Having visual impairment
* Patients who are unconscious
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** vedat.goken@istinye.edu.tr
**Name:** Vedat Göken, MSC
**Phone:** 05364262835
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** İstinye University
**Name:** Yasemin Çırak, Prof.Dr.
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) might be considered to be shared with clinicians studying in the same field one year after the publication of the study
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Berger D, Bloechlinger S, von Haehling S, Doehner W, Takala J, Z'Graggen WJ, Schefold JC. Dysfunction of respiratory muscles in critically ill patients on the intensive care unit. J Cachexia Sarcopenia Muscle. 2016 Sep;7(4):403-12. doi: 10.1002/jcsm.12108. Epub 2016 Mar 9.
**PMID:** 27030815
**Citation:** Makhabah DN, Martino F, Ambrosino N. Peri-operative physiotherapy. Multidiscip Respir Med. 2013 Jan 23;8(1):4. doi: 10.1186/2049-6958-8-4.
**PMID:** 23343253
**Citation:** Yousefnia-Darzi F, Hasavari F, Khaleghdoost T, Kazemnezhad-Leyli E, Khalili M. Effects of thoracic squeezing on airway secretion removal in mechanically ventilated patients. Iran J Nurs Midwifery Res. 2016 May-Jun;21(3):337-42. doi: 10.4103/1735-9066.180374.
**PMID:** 27186214
**Citation:** Kalanuria AA, Ziai W, Mirski M. Ventilator-associated pneumonia in the ICU. Crit Care. 2014 Mar 18;18(2):208. doi: 10.1186/cc13775. No abstract available. Erratum In: Crit Care. 2016;20:29. Zai, Wendy [corrected to Ziai, Wendy].
**PMID:** 25029020
**Citation:** Ratnovsky A, Elad D, Halpern P. Mechanics of respiratory muscles. Respir Physiol Neurobiol. 2008 Nov 30;163(1-3):82-9. doi: 10.1016/j.resp.2008.04.019. Epub 2008 May 15.
**PMID:** 18583200
**Citation:** Castro-Avila AC, Seron P, Fan E, Gaete M, Mickan S. Effect of Early Rehabilitation during Intensive Care Unit Stay on Functional Status: Systematic Review and Meta-Analysis. PLoS One. 2015 Jul 1;10(7):e0130722. doi: 10.1371/journal.pone.0130722. eCollection 2015.
**PMID:** 26132803
**Citation:** Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10. doi: 10.1001/jama.286.21.2703.
**PMID:** 11730446
**Citation:** Corner EJ, Wood H, Englebretsen C, Thomas A, Grant RL, Nikoletou D, Soni N. The Chelsea critical care physical assessment tool (CPAx): validation of an innovative new tool to measure physical morbidity in the general adult critical care population; an observational proof-of-concept pilot study. Physiotherapy. 2013 Mar;99(1):33-41. doi: 10.1016/j.physio.2012.01.003. Epub 2012 Mar 30.
**PMID:** 23219649
**Citation:** Alves da Cruz MM, Ricci-Vitor AL, Bonini Borges GL, Fernanda da Silva P, Ribeiro F, Marques Vanderlei LC. Acute Hemodynamic Effects of Virtual Reality-Based Therapy in Patients of Cardiovascular Rehabilitation: A Cluster Randomized Crossover Trial. Arch Phys Med Rehabil. 2020 Apr;101(4):642-649. doi: 10.1016/j.apmr.2019.12.006. Epub 2020 Jan 8.
**PMID:** 31926142
**Citation:** Taslimipour S, Rojhani-Shirazi Z, Hemmati L, Rezaei I. Effects of a Virtual Reality Dance Training Program on Kyphosis Angle and Respiratory Parameters in Young Women With Postural Hyperkyphosis: A Randomized Controlled Clinical Trial. J Sport Rehabil. 2020 May 13;30(2):293-299. doi: 10.1123/jsr.2019-0303.
**PMID:** 32404535
**Citation:** Pazzaglia C, Imbimbo I, Tranchita E, Minganti C, Ricciardi D, Lo Monaco R, Parisi A, Padua L. Comparison of virtual reality rehabilitation and conventional rehabilitation in Parkinson's disease: a randomised controlled trial. Physiotherapy. 2020 Mar;106:36-42. doi: 10.1016/j.physio.2019.12.007. Epub 2019 Dec 23.
**PMID:** 32026844
**Citation:** Rodrigues IM, Lima AG, Santos AED, Santos ACA, Nascimento LSD, Serra MVCL, Pereira TJS, Barbosa FDS, Seixas VM, Monte-Silva K, Scipioni KRDDS, Cruz DMCD, Piscitelli D, Goffredo M, Gois-Junior MB, Zanona AF. A Single Session of Virtual Reality Improved Tiredness, Shortness of Breath, Anxiety, Depression and Well-Being in Hospitalized Individuals with COVID-19: A Randomized Clinical Trial. J Pers Med. 2022 May 19;12(5):829. doi: 10.3390/jpm12050829.
**PMID:** 35629250
**Citation:** Parker A, Sricharoenchai T, Needham DM. Early Rehabilitation in the Intensive Care Unit: Preventing Physical and Mental Health Impairments. Curr Phys Med Rehabil Rep. 2013 Dec;1(4):307-314. doi: 10.1007/s40141-013-0027-9.
**PMID:** 24436844
**Citation:** Trampisch US, Franke J, Jedamzik N, Hinrichs T, Platen P. Optimal Jamar dynamometer handle position to assess maximal isometric hand grip strength in epidemiological studies. J Hand Surg Am. 2012 Nov;37(11):2368-73. doi: 10.1016/j.jhsa.2012.08.014.
**PMID:** 23101534
**Citation:** Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
**PMID:** 12421743
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4554
- Name: Asthenia
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442241
**Brief Title:** A Safety and Immunogenicity Trial of a Respiratory Syncytial Virus Vaccine, LYB005 in Healthy Adults
**Official Title:** A Phase I, Randomized, Observer-Blinded, Parallel-Controlled, Dose Escalation Study to Evaluate the Safety and Immunogenicity of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell), LYB005, in Healthy Adults Aged 18 Years and Older
#### Organization Study ID Info
**ID:** LYB005-CT-AUS-101
#### Organization
**Class:** INDUSTRY
**Full Name:** Guangzhou Patronus Biotech Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-02
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-28
**Study First Submit QC Date:** 2024-06-02
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Yantai Patronus Biotech Co., Ltd.
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Guangzhou Patronus Biotech Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A phase 1, randomized, observer-blinded, parallel-controlled, dose escalation study in Australia will evaluate the safety and immunogenicity of the RSV vaccine candidate LYB005 with or without adjuvant in healthy adults aged 18 years and older.
**Detailed Description:** The study design includes an age- and dose-escalation (low/middle/high dose) in two adult age groups (young adults \[18-59 years\] and older adults \[≥60 years\]). Study will be conducted in two parts, part 1 will enrolled young adults and part 2 will enroll older adults. A sentinel dosing approach will be used for close monitoring of safety to minimize risk to participants. Participants will be divided into the sentinel cohort and the remainder of cohort. Participants in part 1 will receive of one of two RSV vaccine formulations at one of 3 antigen dose levels or placebo. Participants in part 2 will receive of one of two RSV vaccine formulations at one of 3 antigen dose levels or positive control AREXVY. Detailed characterization of safety (including safety laboratory evaluation) and immune responses will be observed.
### Conditions Module
**Conditions:**
- Respiratory Syncytial Virus (RSV)
- RSV Infection
**Keywords:**
- RSV vaccine
- Virus Like Particle
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 84
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Young adults (18-59 years old) will receive a single injection of low dose LYB005 (30μg) without adjuvant on Day 1.
**Intervention Names:**
- Biological: LYB005 low dose without adjuvant
**Label:** Group 1 (LYB005 low dose without adjuvant; young adults)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Young adults (18-59 years old) will receive a single injection of middle dose LYB005 (60μg) without adjuvant on Day 1.
**Intervention Names:**
- Biological: LYB005 middle dose without adjuvant
**Label:** Group 2 (LYB005 middle dose without adjuvant; young adults)
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Young adults (18-59 years old) will receive a single injection of high dose LYB005 (120μg) without adjuvant on Day 1.
**Intervention Names:**
- Biological: LYB005 high dose without adjuvant
**Label:** Group 3 (LYB005 high dose without adjuvant; young adults)
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Young adults (18-59 years old) will receive a single injection of low dose LYB005 (30μg) with adjuvant on Day 1.
**Intervention Names:**
- Biological: LYB005 low dose with adjuvant
**Label:** Group 4 (LYB005 low dose with adjuvant; young adults)
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** Young adults (18-59 years old) will receive a single injection of middle dose LYB005 (60μg) with adjuvant on Day 1.
**Intervention Names:**
- Biological: LYB005 middle dose with adjuvant
**Label:** Group 5 (LYB005 middle dose with adjuvant; young adults)
**Type:** EXPERIMENTAL
#### Arm Group 6
**Description:** Young adults (18-59 years old) will receive a single injection of high dose LYB005 (120μg) with adjuvant on Day 1.
**Intervention Names:**
- Biological: LYB005 high dose with adjuvant
**Label:** Group 6 (LYB005 high dose with adjuvant; young adults)
**Type:** EXPERIMENTAL
#### Arm Group 7
**Description:** Young adults (18-59 years old) will receive a single injection of placebo on Day 1.
**Intervention Names:**
- Biological: Placebo
**Label:** Group 7 (placebo; young adults)
**Type:** PLACEBO_COMPARATOR
#### Arm Group 8
**Description:** Older adults (≥60 years old) will receive a single injection of low dose LYB005 (30μg) without adjuvant on Day 1.
**Intervention Names:**
- Biological: LYB005 low dose without adjuvant
**Label:** Group 8 (LYB005 low dose without adjuvant; older adults)
**Type:** EXPERIMENTAL
#### Arm Group 9
**Description:** Older adults (≥60 years old) will receive a single injection of middle dose LYB005 (60μg) without adjuvant on Day 1.
**Intervention Names:**
- Biological: LYB005 middle dose without adjuvant
**Label:** Group 9 (LYB005 middle dose without adjuvant; older adults)
**Type:** EXPERIMENTAL
#### Arm Group 10
**Description:** Older adults (≥60 years old) will receive a single injection of high dose LYB005 (120μg) without adjuvant on Day 1.
**Intervention Names:**
- Biological: LYB005 high dose without adjuvant
**Label:** Group 10 (LYB005 high dose without adjuvant; older adults)
**Type:** EXPERIMENTAL
#### Arm Group 11
**Description:** Older adults (≥60 years old) will receive a single injection of low dose LYB005 (30μg) with adjuvant on Day 1.
**Intervention Names:**
- Biological: LYB005 low dose with adjuvant
**Label:** Group 11 (LYB005 low dose with adjuvant; older adults)
**Type:** EXPERIMENTAL
#### Arm Group 12
**Description:** Older adults (≥60 years old) will receive a single injection of middle dose LYB005 (60μg) with adjuvant on Day 1.
**Intervention Names:**
- Biological: LYB005 middle dose with adjuvant
**Label:** Group 12 (LYB005 middle dose with adjuvant; older adults)
**Type:** EXPERIMENTAL
#### Arm Group 13
**Description:** Older adults (≥60 years old) will receive a single injection of high dose LYB005 (120μg) with adjuvant on Day 1.
**Intervention Names:**
- Biological: LYB005 high dose with adjuvant
**Label:** Group 13 (LYB005 high dose with adjuvant; older adults)
**Type:** EXPERIMENTAL
#### Arm Group 14
**Description:** Older adults (≥60 years old) will receive a single injection of positive control AREXVY on Day 1.
**Intervention Names:**
- Biological: Positive control
**Label:** Group 14 (AREXVY; older adults)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group 1 (LYB005 low dose without adjuvant; young adults)
- Group 8 (LYB005 low dose without adjuvant; older adults)
**Description:** Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
**Name:** LYB005 low dose without adjuvant
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- Group 2 (LYB005 middle dose without adjuvant; young adults)
- Group 9 (LYB005 middle dose without adjuvant; older adults)
**Description:** Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
**Name:** LYB005 middle dose without adjuvant
**Type:** BIOLOGICAL
#### Intervention 3
**Arm Group Labels:**
- Group 10 (LYB005 high dose without adjuvant; older adults)
- Group 3 (LYB005 high dose without adjuvant; young adults)
**Description:** Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
**Name:** LYB005 high dose without adjuvant
**Type:** BIOLOGICAL
#### Intervention 4
**Arm Group Labels:**
- Group 11 (LYB005 low dose with adjuvant; older adults)
- Group 4 (LYB005 low dose with adjuvant; young adults)
**Description:** Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
**Name:** LYB005 low dose with adjuvant
**Type:** BIOLOGICAL
#### Intervention 5
**Arm Group Labels:**
- Group 12 (LYB005 middle dose with adjuvant; older adults)
- Group 5 (LYB005 middle dose with adjuvant; young adults)
**Description:** Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
**Name:** LYB005 middle dose with adjuvant
**Type:** BIOLOGICAL
#### Intervention 6
**Arm Group Labels:**
- Group 13 (LYB005 high dose with adjuvant; older adults)
- Group 6 (LYB005 high dose with adjuvant; young adults)
**Description:** Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
**Name:** LYB005 high dose with adjuvant
**Type:** BIOLOGICAL
#### Intervention 7
**Arm Group Labels:**
- Group 7 (placebo; young adults)
**Description:** 0.9% sodium chloride injection. Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
**Name:** Placebo
**Type:** BIOLOGICAL
#### Intervention 8
**Arm Group Labels:**
- Group 14 (AREXVY; older adults)
**Description:** AREXVY. Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
**Name:** Positive control
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** The incidence and severity of any adverse events (AEs) within 30 minutes after the vaccination
**Measure:** Immediate AEs for 30 minutes post-vaccination
**Time Frame:** 30 mins after vaccination
**Description:** The incidence and severity of any solicited local and systemic AEs and unsolicited AEs within 7 days after the vaccination
**Measure:** Solicited local and systemic AEs and unsolicited AEs
**Time Frame:** Within 7 days after vaccination
**Description:** The incidence and severity of any unsolicited AEs within 28 days after the vaccination
**Measure:** Unsolicited AEs
**Time Frame:** Within 28 days after vaccination
**Description:** The occurrence of clinically significant laboratory abnormalities 3 days, 7 days, 28 days and 90 days after vaccination
**Measure:** Clinically significant laboratory abnormalities
**Time Frame:** Day 4, Day 8, Day 29 and Day 91
**Description:** The incidence of any serious adverse events (SAEs) and adverse events of special interest (AESIs) within 6 months after the vaccination
**Measure:** Serious adverse events (SAEs) and adverse events of special interest (AESIs)
**Time Frame:** Within 6 months after the vaccination
#### Secondary Outcomes
**Description:** The geometric mean titer (GMT) of RSV A and RSV B neutralizing antibodies at 14 days and 28 days after the vaccination; the geometric mean concentration (GMC) of RSV PreF antibodies at 14 days and 28 days after the vaccination.
**Measure:** To observe the humoral immunity (antibodies level) of LYB005 vaccine
**Time Frame:** Day 15 and Day 29
**Description:** The GMT of RSV A and RSV B neutralizing antibodies at 3 and 6 months after the vaccination; the GMC of RSV PreF antibodies at 3 and 6 months after the vaccination
**Measure:** To observe the persistence of humoral immunity (antibodies level) of LYB005 vaccine
**Time Frame:** Day 91 and Day 181
**Description:** The geometric mean fold rise (GMFR) of RSV A and RSV B neutralizing antibodies at 14 days and 28 days after the vaccination; the GMFR of RSV PreF antibodies at 14 days and 28 days after the vaccination.
**Measure:** To observe the humoral immunity (increase in antibodies level) of LYB005 vaccine
**Time Frame:** Day 15 and Day 29
**Description:** The GMFR of RSV A and RSV B neutralizing antibodies at 3 and 6 months after the vaccination; the GMFR of RSV PreF antibodies at 3 and 6 months after the vaccination
**Measure:** To observe the persistence of humoral immunity (increase in antibodies level) of LYB005 vaccine
**Time Frame:** Day 91 and Day 181
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Part 1-A male or female aged 18-59 years at screening; Part 2-A male or female aged 60 years and older at screening.
2. Written informed consent obtained from the subject before any assessment is performed.
3. Subjects who the investigator believes that they can and will comply with the requirements of the protocol. (e.g., complete the diary cards, and complete follow-up visits).
4. Subjects must have a Body Mass Index (BMI) between ≥18.0 and ≤35.0 kg/m2 at screening.
5. Female subjects who are not pregnant or lactating. Female subjects with childbearing potential and their partners should use highly effective, medically accepted double-barrier contraception and will not have pregnancy and fertility plan and refrain from donating ovum until study completion.
* A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
* Highly effective double-barrier contraception is defined as use of a condom AND one of the following: birth control pills (The Pill), depot or injectable birth control, intrauterine device (IUD), NuvaRing®, implantable contraception (e.g., Implanon).
* Note: There is no contraception requirement for female subjects with non-childbearing potential (WNCBP).
6. Males participating in this study who are involved in heterosexual sexual activity with a female partner of childbearing potential must agree to use highly effective, medically accepted double-barrier contraception (as described above) and refrain from donating sperm until study completion; male participants with WNCBP partners must use a condom only.
Exclusion Criteria:
1. Tympanic temperature \> 37.5°C at screening or prior to vaccination.
2. History or presence of any respiratory infection symptoms within 7 days prior to vaccination.
3. Previous vaccination against Respiratory Syncytial Virus (RSV). Planned administration of RSV vaccination during the study (including an investigational or non-registered vaccine), except for the investigational vaccine in this trial.
4. Received a live attenuated vaccine within 28 days before vaccination or received other vaccines within 14 days before vaccination.
5. Received any immunoglobulins or blood/plasma products within 3 months prior to vaccination.
6. Individuals with the following diseases: 1）Any acute disease or acute attack of chronic diseases or using antipyretic, analgesic or anti-allergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) within 24 h prior to enrolment; 2）Allergies to any component of the investigational vaccine; 3）Subject has any clinically significant history of allergic conditions to other vaccines; 4）History of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) or psychiatric disorders (bipolar disorder, schizophrenia, etc.) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study; 5）Asplenia, or functional asplenia; 6）Congenital or acquired immunodeficiency or autoimmune disease; 7）Chronic administration (≥14 consecutive days) of glucocorticoid (reference value for dose: ≥20 mg/day prednisone or equivalent) or other immunosuppressive agents within the past 3 months, with the exception of inhaled or topical steroids, or short-term use (\<14 consecutive days) of oral corticosteroids; 8）Have severe cardiovascular diseases (cardiopulmonary disease, pulmonary edema), severe hepatic or renal diseases, and diabetes complications that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study; 9）History of severe thrombocytopenia or other coagulation disorders which may be contraindications for an IM; 10）Severe hypertension uncontrolled by medication with systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg; 11）Positive test for hepatitis C virus (HCV), hepatitis B surface antigen (HbsAg), human immunodeficiency virus (HIV) at screening.
7. Clinically significant laboratory abnormalities determined by the investigator at screening.
8. A positive urine drug test or alcohol breath test at screening or Day 1.
9. Recent participated in another clinical trial, with receipt of the investigational drug/vaccine within 30 days prior to screening. Currently participating in or those planning to participate in another clinical trial during the study.
10. Have donated blood or plasma within 2 weeks prior to screening.
11. Other conditions that may impact the subject's safety or influence the assessment of vaccine response, as determined by the investigator.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** melbourne@nucleusnetwork.com
**Name:** Nucleus Network Melbourne Nucleus Network Melbourne
**Phone:** 1800 243 733
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Nucleus Network Pty Ltd.
**Name:** Christina Chang, M.D
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014777
- Term: Virus Diseases
- ID: D000007239
- Term: Infections
- ID: D000018186
- Term: Pneumovirus Infections
- ID: D000018184
- Term: Paramyxoviridae Infections
- ID: D000018701
- Term: Mononegavirales Infections
- ID: D000012327
- Term: RNA Virus Infections
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M20494
- Name: Respiratory Syncytial Virus Infections
- Relevance: HIGH
- As Found: RSV Infection
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M20330
- Name: Paramyxoviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M20778
- Name: Mononegavirales Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000018357
- Term: Respiratory Syncytial Virus Infections
### Intervention Browse Module - Browse Branches
- Abbrev: 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
- ID: M17360
- Name: Vaccines
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442228
**Acronym:** PCOS
**Brief Title:** History of Polycystic Ovary Syndrome in First-degree Relatives
**Official Title:** Investigation of the History of Polycystic Ovary Syndrome in First-degree Relatives of Male Partners of Couples Presenting for Infertility Treatment
#### Organization Study ID Info
**ID:** 2024/05
#### Organization
**Class:** OTHER
**Full Name:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2025-01-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-02
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-06-02
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
#### Responsible Party
**Investigator Affiliation:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
**Investigator Full Name:** Mujde Can Ibanoglu
**Investigator Title:** Assoc. Prof
**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 was to investigate the semen analysis results of male patients with first-degree relatives meeting the diagnostic criteria for PCOS.
**Detailed Description:** Polycystic ovary syndrome (PCOS) is an endocrine metabolic disorder characterised by menstrual irregularity, anovulation, clinical and/or biochemical signs of hyper androgenism (hirsutism and/or acne), micropolycystic ovaries and metabolic abnormalities.
This syndrome is clustered in family members and appears to be inherited through an oligogenic mechanism (1,2). As a result of familial clustering of the PCOS phenotype, metabolic risks have been shown to increase in family members, independent of gender.
The presence of a genetic background in the etiopathogenesis of PCOS means that men may also have signs and symptoms equivalent to PCOS. In addition, the genes responsible for PCOS susceptibility in women are also transferred to male relatives of these individuals. Hormonal and metabolic abnormalities have been identified in male relatives of women with PCOS. These men have shown a higher prevalence of early-onset (\<35 years) androgenetic alopecia (AGA), type 2 DM and cardivascular diseases. In addition, prostate cancer, benign prostatic hyperplasia (BPH) and prostatitis have also been defined more frequently in this group of individuals (1,3).
In addition, differences in responses to gonadotropin-releasing hormone (GnRH) and FSH and LH levels were found in the brothers of women with PCOS compared to control groups.
According to genome studies (GWAS), FSHB gene on chromosome 11p14.1 represents the PCOS susceptibility focus in women (1). Genetic variations in FSHB affect male reproductive function. In fact, polymorphisms of the FSHB promoter have been associated with lower sperm count, higher LH, lower FSH and lower testicular volume (3,4).
In the light of this information, in this study, it was planned to evaluate the comparison of semen analysis results of male patients with a first-degree relative diagnosed with PCOS with the control group.
### Conditions Module
**Conditions:**
- Polycystic Ovary Syndrome
**Keywords:**
- male
- polycystic ovary syndrome
- infertility
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SCREENING
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Individuals who have undergone spermiogram analysis at Etlik Zübeyde Hanım Gynecology Training and Research Hospital and whose first-degree relatives have a family history of PCOS will be included in the study group. Individuals who have undergone a spermiogram in our hospital, who fulfill the inclusion criteria and who do not have a family history of PCOS will be studied as a control group.
**Intervention Names:**
- Diagnostic Test: spermiogram test
**Label:** study group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- study group
**Description:** Approximately 7 mL of blood sample will be taken by the health personnel in a vacuum gel tube for hormonal and biochemical analyses. The blood samples will be centrifuged at 1000xg for 20 minutes by the researchers. In the next step, the supernatant portion will be separated and transferred to 3 mL ependorfs. Serum samples will be stored in the -800C deep freezer of our hospital until the time of analysis.
Sperm samples from individuals will be collected in our hospital in accordance with the protocol and the results will be reported.
**Name:** spermiogram test
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Semen parameters
**Measure:** The results of semen analysis in male patients with first-degree female relatives who fulfill the diagnostic criteria for PCOS
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* The study will include male partners between the ages of 18-40 who have no known disease, who give spermiogram test for the evaluation of infertile couple in our hospital and who have accepted the consent form verbally and in writing.
Exclusion Criteria:
* Exclusion criteria;
1. History of any chronic disease, urinary tract or reproductive disease, neurological or psychiatric condition in the male patient and recent fever (≥38°C in the last 3 months)
2. Those with a history of vasectomy, cryptorchism, radiation history, chemotherapy, infections, sexual dysfunction and endocrine hypogonadism
3. Especially those with a history of finasteride and dutasteride drug use.
**Healthy Volunteers:** True
**Maximum Age:** 40 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Di Guardo F, Ciotta L, Monteleone M, Palumbo M. Male Equivalent Polycystic Ovarian Syndrome: Hormonal, Metabolic, and Clinical Aspects. Int J Fertil Steril. 2020 Jul;14(2):79-83. doi: 10.22074/ijfs.2020.6092. Epub 2020 Jul 15.
**PMID:** 32681618
**Citation:** Cannarella R, Condorelli RA, Mongioi LM, La Vignera S, Calogero AE. Does a male polycystic ovarian syndrome equivalent exist? J Endocrinol Invest. 2018 Jan;41(1):49-57. doi: 10.1007/s40618-017-0728-5. Epub 2017 Jul 15.
**PMID:** 28711970
**Citation:** Duskova M, Starka L. The existence of a male equivalent of the polycystic ovary syndrome--the present state of the issue. Prague Med Rep. 2006;107(1):17-25.
**PMID:** 16752800
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000010048
- Term: Ovarian Cysts
- ID: D000003560
- Term: Cysts
- ID: D000009369
- Term: Neoplasms
- ID: D000010049
- Term: Ovarian Diseases
- ID: D000000291
- Term: Adnexal Diseases
- ID: D000005831
- Term: Genital Diseases, Female
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000006058
- Term: Gonadal Disorders
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
### Condition Browse Module - Browse Leaves
- ID: M10290
- Name: Infertility
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M13970
- Name: Polycystic Ovary Syndrome
- Relevance: HIGH
- As Found: Polycystic Ovary Syndrome
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6765
- Name: Cysts
- Relevance: LOW
- As Found: Unknown
- ID: M12971
- Name: Ovarian Cysts
- Relevance: LOW
- As Found: Unknown
- ID: M12972
- Name: Ovarian Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M3643
- Name: Adnexal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8943
- Name: Genital Diseases, Female
- Relevance: LOW
- As Found: Unknown
- ID: 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: M9163
- Name: Gonadal Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011085
- Term: Polycystic Ovary Syndrome
- ID: D000013577
- Term: Syndrome
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442215
**Acronym:** TECARE
**Brief Title:** Selection of Surgical Technique in Rectal Cancer
**Official Title:** Selection of Surgical Technique in Rectal Cancer Through the Development of a Predictive Model for Optimal Oncological Outcomes
#### Organization Study ID Info
**ID:** 2024.017
#### Organization
**Class:** OTHER
**Full Name:** Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
### Status Module
#### Completion Date
**Date:** 2026-04-03
**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:** 2025-04-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-03
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### 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
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Currently, there is no prediction scale available to identify patients with rectal neoplasms as technically complex in the middle and lower thirds; that is, those who are at high risk of affected circumferential margins and low quality of the mesorectum. The application of a predictive model that allows preoperative identification of the group of patients in whom optimal results in mesorectal quality and circumferential margin are less likely to be obtained through laparoscopic or minimally invasive surgery would enable the selection of patients who will require and justify all efforts and healthcare resources to improve surgical outcomes.
Therefore, the investigators aim to create a predictive model to identify these patients, allowing the discrimination of which patients will benefit from different techniques, or even which ones would be opportune to initially consider an open approach.
### Conditions Module
**Conditions:**
- Rectal Neoplasms
**Keywords:**
- Rectal cancer
- Surgery
- Minimal invasive surgery
- Oncological outcomes
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 333
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients diagnosed with rectal neoplasia undergoing elective surgery between 2017 and 2021 at medical centers within the national territory.
**Intervention Names:**
- Other: Data collection
**Label:** Patients undergoing elective surgery for rectal neoplasm
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patients undergoing elective surgery for rectal neoplasm
**Description:** Collection of preoperative demographic, clinical, and radiological variables from patients who meet the inclusion criteria in order to identify possible risk factors for suboptimal surgical treatment
**Name:** Data collection
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Surgical resection with affected margins (proximal-distal and/or circumferential \< 1mm) and/or incomplete or nearly complete mesorectal resection
**Measure:** Suboptimal oncological outcomes
**Time Frame:** 15 postoperative days
#### Secondary Outcomes
**Description:** Conversion to open surgery and anastomotic dehiscence rates
**Measure:** Surgical and Postoperative complications
**Time Frame:** 30 postoperative days
**Description:** Recurrence of the tumoral disease at the pelvic level and distant recurrence is defined as s the recurrence of the disease in other distant organs.
**Measure:** Overall and disease free survival
**Time Frame:** 3-years surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Scheduled surgery for anterior resection of the rectum meeting oncological criteria with mesorectal excision.
* Age ≥ 18 years.
* Histology of adenocarcinoma with or without neoadjuvant chemotherapy or chemoradiotherapy.
* Initial stage T1-T4a. Any N. Any M.
* Intention for R0 resection.
Exclusion Criteria:
* Colorectal tumor with histology different from adenocarcinoma.
* Synchronous colon tumor.
* Benign pathology or adenoma.
* Tis.
* T4b or oncological multivisceral resections.
* History of neoplastic colorectal surgery or local excision or TAMIS.
* Perforated or obstructive rectal neoplasm.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients diagnosed with rectal neoplasia undergoing elective surgery during a period of time from 2017 to 2021
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** nortega.girona.ics@gencat.cat
**Name:** Nuria Ortega, MD
**Phone:** 972 940 200
**Phone Ext:** 2825
**Role:** CONTACT
**Contact 2:**
**Email:** lcornejo@idibgi.org
**Name:** Lidia Cornejo, MSC
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Girona
**Contacts:**
***Contact 1:***
- **Email:** nortega.girona.ics@gencat.cat
- **Name:** Nuria Ortega, MD
- **Phone:** 972420200
- **Phone Ext:** 2825
- **Role:** CONTACT
**Country:** Spain
**Facility:** Hospital Universitari Dr. Josep Trueta de Girona
**Status:** RECRUITING
**Zip:** 17300
### 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 Neoplasms
- 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
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442202
**Brief Title:** Balanced Nutritional Diet Intervention Among Obese Women
**Official Title:** Balanced Nutritional Diet Intervention on Body Composition Among Different FTO RS9939609 Gene in Obese Young Women In Bandung, Indonesia: A Randomised Controlled Trial
#### Organization Study ID Info
**ID:** IPB-202405.01
#### Organization
**Class:** OTHER
**Full Name:** Universitas Padjadjaran
### Status Module
#### Completion Date
**Date:** 2024-01-15
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-01
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-01-15
**Type:** ACTUAL
#### Start Date
**Date:** 2023-11-08
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-06-01
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Universitas Padjadjaran
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Food intake along with the gene are important factors that influence human nutrition status and health. Indonesia has a balanced nutrition diet guide for ideal food consumption. The FTO rs9939609 gene is known to be related to obesity. This study aimed to examine the effect of a balanced nutritional diet intervention on body composition among different single nucleotide polymorphisms (SNP) of the FTO rs9939609 gene in obese young women in Bandung City, West Java, Indonesia.
**Detailed Description:** A Balanced Nutrition Diet is a group of food menus that contain carbohydrates, fats, proteins, vitamins and minerals which are prepared based on the principles of diversity, balanced, regular and safe proportions in types and quantities that suit the body's needs adapted from the My Meal Dish Content/"Isi Piringku"; and "Tumpeng Gizi Seimbang" rule based on the Balanced Nutrition Guidelines of the Republic of Indonesia Minister of Health Regulation No. 41 year 2014. Although a balanced nutritional diet has not been widely used as a dietary intervention for obese people compared to the Mediterranean diet, there is research that shows that providing a low-calorie balanced nutritional diet based on traditional Indonesian food for 8 weeks can reduce body weight and body mass index, waist circumference, and body fat percentage of the research subjects were statistically significant.
Apart from eating habits, genetic factors also play an important role in the development of obesity. One of the most important genes associated with obesity is the FTO (fat mass and obesity-related) gene located on chromosome 16. Several polymorphisms in the FTO gene are known to be associated with increased body mass index (BMI) and other anthropometric values, severe obesity conditions, and risk of diabetes mellitus, although there are differences in different ethnicities. Several studies have also examined the association of the FTO gene with several parameters related to cardiovascular risk. The FTO rs9939609 gene polymorphism is one of the genes commonly studied in relation to obesity. The rs9939609 FTO gene consists of TT, TA, and AA genotypes. Allele A is a group of mutant genotypes or is called a risk allele (TA and AA) while TT is a group of wild genotypes or is considered a non-risk allele.
Evidence suggests that compared with TT wild type, the risk allele A FTO rs9939609 gene showed significantly higher body weight, body mass index, waist circumference, hip circumference, and waist-to-hip ratio. The waist-hip circumference ratio is a stronger indicator of cardiovascular disease than body mass index. The A allele carriers of the FTO rs9939609 polymorphism had a higher fat percentage. Until now, no one has ever linked the FTO gene polymorphism and the Balanced Nutrition Diet intervention, which is a reference in Indonesia, as well as its effect on the body composition of obese young women, especially in Sundanese ethnicity. This study aimed to examine the effect of a balanced nutritional diet intervention on body composition among 2 types of the FTO rs9939609 gene in obese young women in Bandung City, Indonesia.
### Conditions Module
**Conditions:**
- Obese Women
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 38
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Subjects with allele A carriers (AA/AT) FTO rs9939609 gene type, took a Balanced Nutritional Diet Intervention for 28 days. Besides, this group received nutritional education. Twelve (12) subjects were included in this group.
**Intervention Names:**
- Dietary Supplement: Balanced Nutritional Diet
- Behavioral: Nutritional Education
**Label:** Allele A + Diet Intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Subjects with T homozygote FTO rs9939609 gene type, took a Balanced Nutritional Diet Intervention for 28 days. Besides, this group received nutritional education. Eight (8) subjects were included in this group.
**Intervention Names:**
- Dietary Supplement: Balanced Nutritional Diet
- Behavioral: Nutritional Education
**Label:** T Homozygote + Diet Intervention
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Subjects with allele A carriers (AA/AT) FTO rs9939609 gene type, control group, eat ad libitum. This group also received nutritional education. Ten (10) subjects were included in this group.
**Intervention Names:**
- Behavioral: Nutritional Education
**Label:** Allele A Control
**Type:** PLACEBO_COMPARATOR
#### Arm Group 4
**Description:** Subjects with T Homogyzot FTO rs9939609 gene type, control group, eat ad libitum. This group also received nutritional education. Eight (8) subjects were included in this group.
**Intervention Names:**
- Behavioral: Nutritional Education
**Label:** T Homozygote Control
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Allele A + Diet Intervention
- T Homozygote + Diet Intervention
**Description:** Food was provided during the intervention period 3 (three) times each day, i.e. breakfast, lunch and dinner. The food menu used a 30-day menu cycle. The characteristics of the Balanced Nutrition Diet that have been provided based on the distribution of the composition of the macronutrients that will be intervened in are as follows: 45-55% carbohydrates, 15-20% protein, and 20-25% fat (Ministry of Health 2014). The type of diet and portions that were given were the same for each menu unless there were certain food restrictions or allergies, and then the type of food was adjusted specifically to that individual. The calories that will be given range from 300-400 Cal for breakfast, 400-500 Cal for lunch, and 300-500 Cal for dinner.
The choice of carbohydrates should be varied and prioritise complex carbohydrates such as whole grains. The choice of protein type is prioritised from low-fat protein sources and half of it is vegetable protein.
**Name:** Balanced Nutritional Diet
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Allele A + Diet Intervention
- Allele A Control
- T Homozygote + Diet Intervention
- T Homozygote Control
**Description:** Nutritional education is provided via online Zoom meetings with the help of educational media in the form of PowerPoint presentations/videos before entering the intervention period. The educational material that will be provided is regarding Guidelines for Balanced Nutrition, Food Safety, and Healthy Lifestyles (stress management and sleep time). The subject's understanding of the material provided was evaluated using an online quiz platform.
**Name:** Nutritional Education
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Body composition will be measured twice, i.e. before randomization and 28 days after randomization. The measurement include body weight (kg); body height (cm); Body Mass Index (kg/m2); Waist circumference (cm); Hip circumference (cm); Waist-hip ratio; Visceral fat; Fat percentage (%); Resting metabolism (Cal); Total subcutaneous fat (%); Subcutaneous trunk (%); Subcutaneous arms (%); Subcutaneous legs (%); Total skeletal muscle (%); Skeletal trunk (%); Skeletal arms (%); Skeletal legs (%)
**Measure:** Change of Body Compostition
**Time Frame:** 28 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Obese women (fat percentage\>35%) who had light to moderate physical activity based on PAL or who rarely exercised
* Sundanese ethnicity
* Aged 18-25 years
* Normal fasting blood glucose levels
* Willing to participate and sign an informed consent
Exclusion Criteria:
* Being pregnant and breastfeeding
* Had a history of chronic disease
* Regularly consuming antioxidant supplements and/or phytopharmaceuticals
* Currently participating in other research
**Maximum Age:** 25 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Bogor
**Country:** Indonesia
**Facility:** Prodi Gizi IPB
#### Overall Officials
**Official 1:**
**Affiliation:** IPB University
**Name:** Prodi Gizi
**Role:** PRINCIPAL_INVESTIGATOR
## Document Section
### Large Document Module
#### Large Docs
- Date: 2023-10-10
- Filename: Prot_SAP_ICF_000.pdf
- Has ICF: True
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
- Size: 1192949
- Type Abbrev: Prot_SAP_ICF
- Upload Date: 2024-05-26T23:54
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000050177
- Term: Overweight
- ID: D000044343
- Term: Overnutrition
- ID: D000009748
- Term: Nutrition Disorders
- ID: D000001835
- Term: Body Weight
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12701
- Name: Obesity
- Relevance: HIGH
- As Found: Obese
- ID: M26186
- Name: Overweight
- Relevance: LOW
- As Found: Unknown
- ID: M25307
- Name: Overnutrition
- Relevance: LOW
- As Found: Unknown
- ID: M12684
- Name: Nutrition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5114
- Name: Body Weight
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009765
- Term: Obesity
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442189
**Acronym:** PCOS
**Brief Title:** The Results of the Mediterranean Diet for PCOS
**Official Title:** Prospective Evaluation of the Effects of the Mediterranean Diet on the Reproductive and Metabolic Parameters of Patients Diagnosed With Polycystic Ovary Syndrome (PCOS) and a Body Mass Indexof Over 25 kg/m2
#### Organization Study ID Info
**ID:** 01/06 22.01.2024
#### Organization
**Class:** OTHER
**Full Name:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-09-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-02
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-20
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-06-02
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
#### Responsible Party
**Investigator Affiliation:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
**Investigator Full Name:** Mujde Can Ibanoglu
**Investigator Title:** Assoc. Prof
**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 was to evaluate the effects of the application of a Mediterranean diet on the reproductive and metabolic parameters in the 3rd month in patients with a body mass index of 25 and more who were followed up in our clinic due to a PCOS diagnosis.
**Detailed Description:** Polycystic ovary syndrome (PCOS) is an endocrine-metabolic disorder characterized by menstrual irregularities, anovulation, clinical and/or biochemical symptoms of hyperandrogenism (hirsutism and/or acne), micropolycystic ovaries and metabolic abnormalities. Phenotype A: HA + OD + PCOM; phenotype B: HA + OD; phenotype C: HA + PCOM and phenotype D: OD + PCOM). According to the Rotterdam criteria, endocrine and metabolic abnormalities are lowest in the OD + PCOM group among these 4 different phenotype groups. The prevalence and distribution of metabolic abnormalities (insulin resistance, metabolic disease and glucose intolerance) among the phenotypes do not differ significantly between the 4 groups. Therefore, metabolic abnormalities and distribution characteristics are not suitable to distinguish different clinical PCOS phenotypes. Some inflammatory cytokines are elevated in PCOS, which is characterized by chronic low-grade inflammation. Although the exact mechanisms of inflammation in PCOS are not yet fully understood, it is thought to be mediated by obesity, insulin resistance and high androgen levels. This inflammatory state has a negative impact on the risk of future health problems and quality of life in PCOS. Therefore, strategies to reduce inflammation are considered important. Establishing medical nutrition therapy for PCOS has significant implications for reducing this inflammation and preventing the disease. At this point, the Mediterranean diet, which has been shown to have a protective effect against many diseases, is receiving a lot of attention. Among the components of the Mediterranean diet, omega-3 fatty acids, antioxidants and fiber in particular can contribute to reducing inflammation through various mechanisms. The international scientific community has strongly emphasized the role of the Mediterranean diet and the lifestyle it inspires in increasing life expectancy and improving public health. For these reasons, the Mediterranean diet can be considered as a nutrient pool containing nutraceuticals and bioactive components in foods that can positively influence health both directly and through their own epigenetic mechanisms. Recent studies suggest that the Mediterranean diet can influence both the incidence and severity of PCOS and the treatment of the disease.
The main objective of our study is to evaluate the effect of the MedDiet, which is known to be anti-inflammatory and based on energy restriction and the Mediterranean dietary approach, on the reproductive and metabolic parameters of PCOS patients with a higher than normal body mass index.
### Conditions Module
**Conditions:**
- Polycystic Ovary Syndrome
- Diet Habit
**Keywords:**
- polycystic ovary syndrome
- Mediterranean diet
- obesity
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 98
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 3 Months
### Arms Interventions Module
#### Arm Group 1
**Description:** Once the baseline values have been determined at the first visit, all tests are repeated after the diet has been followed for 3 months.
**Intervention Names:**
- Dietary Supplement: Mediterranean Diet
**Label:** 3. month
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 3. month
**Description:** The aim was to evaluate the effects of the application of a Mediterranean diet on the reproductive and metabolic parameters in the 3rd month of patients with a body mass index of 25 and more who were treated in our clinic due to a diagnosis of PCOS.
**Name:** Mediterranean Diet
**Other Names:**
- Baseline
- 3. Month
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** Homeostasis model assessment (HoMA)-IR
**Measure:** the effect of applying a Mediterranean diet on Homa-IR in PCOS
**Time Frame:** 3 months
**Description:** PREDIMED questionnaire
**Measure:** PREDIMED in PCOS
**Time Frame:** 3 months
**Description:** Fasting plasma glucose
**Measure:** the effect of applying a Mediterranean diet on glucose in PCOS
**Time Frame:** 3 months
**Description:** HbA1c values
**Measure:** the effect of applying a Mediterranean diet on HbA1c in PCOS
**Time Frame:** 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* At the age of 18-40 years,
* No underlying metabolic disease (type 2 diabetes, hypertension, diagnosed anemia),
* With a body mass index of 25 and above,
* Female patients attending the PCOS clinic and under the care of our hospital's dietitian will be enrolled in the study.
Exclusion Criteria:
1. Age \< 18 and \> 40 years;
2. Menopause, pregnancy or breastfeeding in the last 6 months;
3. Hyperandrogenism and/or biochemical hyperandrogenemia due to secondary etiologies, including congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia, thyroid dysfunction and adrenal disorders),
4. Pre-existing systemic or psychiatric disease
5. Use of drugs that affect carbohydrate or lipid metabolism (oral contraceptive pills, metformin, anti-epileptics, antipsychotics, statins and fish oil);
6. Certain eating regimens or hypocaloric diet in the last three months; supplementing with antioxidants, vitamins or minerals;
7. Non-steroidal anti-inflammatory drugs, diuretics, etc. use of medications that may affect fluid balance
8. Female patients with implanted pacemakers or defibrillators due to the theoretical possibility of interference with device activity.
**Healthy Volunteers:** True
**Maximum Age:** 40 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
**Study Population:** People receiving care at the PCOS Clinic of Etlik Zübeyde Hanım Gynecology Training and Research Hospital who have a body mass index of 25 or more and follow a Mediterranean diet will be included in the study group.
98 subjects who agreed to participate in the study and accepted the informed consent verbally and in writing will be included in the study. The study was designed to be prospective. Data will be collected after 0 and 3 months.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** Drmujdecan@gmail.com
**Name:** Mujde Can Ibanoglu
**Phone:** 05323089488
**Role:** CONTACT
**Contact 2:**
**Email:** ustunyaprak@yahoo.com
**Name:** Yaprak Engin-Ustun
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Ankara Etlik Zubeyde Hanım Women's Health Training and Research Hospital, Ankara, Turkey.
**Name:** Mujde Can Ibanoglu
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Legro RS, Kunselman AR, Dodson WC, Dunaif A. Prevalence and predictors of risk for type 2 diabetes mellitus and impaired glucose tolerance in polycystic ovary syndrome: a prospective, controlled study in 254 affected women. J Clin Endocrinol Metab. 1999 Jan;84(1):165-9. doi: 10.1210/jcem.84.1.5393.
**PMID:** 9920077
**Citation:** Barrea L, Arnone A, Annunziata G, Muscogiuri G, Laudisio D, Salzano C, Pugliese G, Colao A, Savastano S. Adherence to the Mediterranean Diet, Dietary Patterns and Body Composition in Women with Polycystic Ovary Syndrome (PCOS). Nutrients. 2019 Sep 23;11(10):2278. doi: 10.3390/nu11102278.
**PMID:** 31547562
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000010048
- Term: Ovarian Cysts
- ID: D000003560
- Term: Cysts
- ID: D000009369
- Term: Neoplasms
- ID: D000010049
- Term: Ovarian Diseases
- ID: D000000291
- Term: Adnexal Diseases
- ID: D000005831
- Term: Genital Diseases, Female
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000091662
- Term: Genital Diseases
- ID: D000006058
- Term: Gonadal Disorders
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M13970
- Name: Polycystic Ovary Syndrome
- Relevance: HIGH
- As Found: Polycystic Ovary Syndrome
- ID: M6765
- Name: Cysts
- Relevance: LOW
- As Found: Unknown
- ID: M12971
- Name: Ovarian Cysts
- Relevance: LOW
- As Found: Unknown
- ID: M12972
- Name: Ovarian Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M3643
- Name: Adnexal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8943
- Name: Genital Diseases, Female
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M9163
- Name: Gonadal Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011085
- Term: Polycystic Ovary Syndrome
- ID: D000013577
- Term: Syndrome
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442176
**Brief Title:** Choroid In Coronary Artery Disease
**Official Title:** Choroid Thickness May Shed Light On Early Coronary Artery Disease
#### Organization Study ID Info
**ID:** BSH-131/21
#### Organization
**Class:** OTHER_GOV
**Full Name:** Bursa Yüksek İhtisas Education and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-04-21
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-02
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-03-01
**Type:** ACTUAL
#### Start Date
**Date:** 2021-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-06-02
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Bursa Yüksek İhtisas Education and Research Hospital
#### Responsible Party
**Investigator Affiliation:** Bursa Yüksek İhtisas Education and Research Hospital
**Investigator Full Name:** ERHAN TENEKECIOGLU
**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:** Purpose: To investigate any relationship between choroid thickness (CTh) and coronary artery disease (CAD), particularly in its earlier stages before clinically evident.
Design: Retrospective, cross-sectional observational study
Methods:
Setting: The study was performed in two institutions; patients were recruited in Balikesir City Hospital. The ophthalmological examinations and coronary angiograms were performed in Balikesir City Hospital. The analysis of the coronary angiograms including Gensini scoring were conducted in Bursa Education and Research Hospital.
Study Population: The study group comprised 68 patients with documented CAD and 60 healthy control subjects. Patients with high myopia, cataracts, retinal vascular disease, retinal surgery, retinal dystrophy, laser photocoagulation, intravitreal anti-VEGF treatment, glaucoma, uveitis, retinal disorders, any systemic diseases were excluded from the study groups.
Observation Procedure: Refractive examination, corrected visual acuity, intraocular pressure measurements, anterior and posterior segment examinations. Following measurements of macular thickness and retinal nerve fiber layer, choroidal thickness of both eyes was assessed by enhanced depth imaging optical coherence tomography.
### Conditions Module
**Conditions:**
- Choroid Diseases
**Keywords:**
- Coronary Artery Disease
- Choroid
- Gensini Score
- Optical Coherence Tomography
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** OTHER
#### Enrollment Info
**Count:** 128
**Type:** ACTUAL
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 1 Day
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Diagnostic Test: OCT
**Label:** Control Healthy group
#### Arm Group 2
**Intervention Names:**
- Diagnostic Test: OCT
**Label:** Coronary Artery Disease Group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control Healthy group
- Coronary Artery Disease Group
**Description:** Enhanced depth imaging optical coherence tomography (EDI-OCT) using the Heidelberg Spectralis HRA + OCT (Heidelberg Engineering, Inc., Franklin, MA, USA)
**Name:** OCT
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** micron
**Measure:** Choroidal thickness in Healthy Subjects
**Time Frame:** 1 day
**Description:** micron
**Measure:** Choroidal thickness in patients with coronary artery disease
**Time Frame:** 1 day
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Normal coronaries at coronary angiography for healthy control group
* Without any coronary artery disease equivalent diseases such as peripheral artery disease, cerebrovascular disease and stroke for healthy control group
* Ability to give informed consent for the study
* Coronary artery disease with stenosis detected in coronary angiogram for coronary artery disease group
Exclusion Criteria:
* High myopia (\> 6D)
* Cataracts
* Retinal vascular disease
* Retinal surgery
* Retinal dystrophy
* Laser photocoagulation
* Intravitreal anti-VEGF treatment
* Glaucoma
* Uveitis
* Retinal disorders (comprising diabetic macular edema, diabetic/hypertensive retinopathy, vein occlusions, retinal dystrophy, epiretinal membrane, vitreomacular traction, age-related macular degeneration)
* Any systemic diseases
* Obesity (body-mass index ≥30 kg/m²)
**Healthy Volunteers:** True
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** All study participants had coronary angiography performed by the Department of Cardiology on an elective scheduled basis following ischaemic changes detected on treadmill stress test or at least 5% ischaemic burden determined at conventional single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI).
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Balıkesir
**Country:** Turkey
**Facility:** Balikesir City Hospital
#### Overall Officials
**Official 1:**
**Affiliation:** Balikesir City Hospital
**Name:** Hakan Tenekecioglu, MD
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** Balikesir City Hospital
**Name:** Iskender Kadife, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** Saglik Bilimleri Universitesi
**Name:** Erhan Tenekecioglu
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000001161
- Term: Arteriosclerosis
- ID: D000001157
- Term: Arterial Occlusive Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000014603
- Term: Uveal Diseases
- ID: D000005128
- Term: Eye Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M6546
- Name: Coronary Artery Disease
- Relevance: HIGH
- As Found: Coronary Artery Disease
- ID: M18406
- Name: Choroid Diseases
- Relevance: HIGH
- As Found: Choroid Disease
- ID: M19506
- Name: Myocardial Ischemia
- Relevance: HIGH
- As Found: Coronary Artery Disease
- ID: M6549
- Name: Coronary Disease
- Relevance: HIGH
- As Found: Coronary Artery Disease
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4469
- Name: Arteriosclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M4465
- Name: Arterial Occlusive Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17351
- Name: Uveal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T5824
- Name: Uveal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015862
- Term: Choroid Diseases
- ID: D000003324
- Term: Coronary Artery Disease
- ID: D000017202
- Term: Myocardial Ischemia
- ID: D000003327
- Term: Coronary Disease
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442163
**Acronym:** AVAPS
**Brief Title:** Average Volume-assured Pressure Support as Rescue Therapy in Obesity Hypoventilation Syndrome
**Official Title:** Outcome Measures of Auto-titrating Average Volume-assured Pressure Support (AVAPS) as Rescue Therapy After CPAP Titration Failure in Patients With Obesity Hypoventilation Syndrome: Adherence and Sleep Quality
#### Organization Study ID Info
**ID:** 5000231
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2024-04-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-02
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-04-30
**Type:** ACTUAL
#### Start Date
**Date:** 2020-05-12
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-06-02
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assiut University
#### Responsible Party
**Investigator Affiliation:** Assiut University
**Investigator Full Name:** Doaa Magdy Eid
**Investigator Title:** professor of pulmonary medecine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** It remains unclear whether CPAP therapy should be prescribed if significant hypoxemia persists during CPAP titration, despite optimization of upper airway obstructive events, if maximum CPAP pressure is reached.
The goal was to examine the effects of 6 months of home AVAPS therapy in patients with obesity hypoventilation syndrome as a potential option for patients who failed CPAP titration due to persistent hypoxemia.
**Detailed Description:** Obesity hypoventilation syndrome (OHS) is one of the leading indications of home non-invasive ventilation (NIV) initiation. In patients with OHS, NIV improves daytime vigilance, decreases PaCO2, improves sleep quality, and improves physical activity.
Thus, the primary aim of this study was to evaluate the effects of 6-month noninvasive ventilation with average volume-assured pressure support (AVAPS-AE) ventilation on objective sleep quality and adherence to therapy in stable patients with OHS who failed CPAP titration.
### Conditions Module
**Conditions:**
- Obesity Hypoventilation Syndrome (OHS)
**Keywords:**
- ventilation, Obesity
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 20
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Each participant underwent initial baseline diagnostic polysomnograms (PSG) documenting the presence of OSA based on standard diagnostic criteria. After baseline (PSG) and patient's consent, patients performed full night CPAP titration in the sleep laboratory within 7 days of the baseline PSG, and AVAPS-AE titration.
**Intervention Names:**
- Device: AVAPS study was performed within 1 week of the CPAP titration attempt failure, using the auto-titrating EPAP (AE), the OmniLab Advanced +, System One device (Philips Respironics, Murrysville, PA, U.S.
**Label:** All Clinically stable OHS patients with a body mass index of 30 kg/m2 and daytime hypercapnia (PaCO2
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- All Clinically stable OHS patients with a body mass index of 30 kg/m2 and daytime hypercapnia (PaCO2
**Description:** After attending an educational session (in the presence of a family member) with hands-on training, the AVAP -AE devices were provided to the patients.
During the study, one month after AVAPS -AE initiation, patients had direct immediate access to medical and technical support through phone contact during daytime working hours.
**Name:** AVAPS study was performed within 1 week of the CPAP titration attempt failure, using the auto-titrating EPAP (AE), the OmniLab Advanced +, System One device (Philips Respironics, Murrysville, PA, U.S.
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** polysomnographic parameter (apnea hypopnea index (events/hours)
**Measure:** To compare the initial diagnostic, and therapeutic sleep study parameters using either CPAP and (AVAPS-AE) titration study in patients with OHS.
**Time Frame:** 1 week
#### Secondary Outcomes
**Description:** Patients had follow-up appointments at two distinct time points, after 3 month and final visit after 6 month of home AVAPS- AE therapy, to address sleep quality using: Self-assessed sleep quality (0: very poor/10: very good). Objective assessment of adherence to AVAPS- AE therapy was recorded. The ATS criteria defined "good adherence" to PAP as "using PAP therapy regularly for \> 4 h/night for \>70% of the recorded time"
**Measure:** The effects of 6 month of home AVAPS- AE therapy on patient adherence and sleep quality in OHS patients who failed CPAP titration due to persistent hypoxemia.
**Time Frame:** at 1 ,3,6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* All Clinically stable OHS patients with
* Body mass index of 30 kg/m2 ,
* Daytime hypercapnia (PaCO2 \>45 mm Hg) who had failed to respond to CPAP therapy
* had no other cause for their chronic respiratory failure and were naive to any PAP therapy.
Exclusion Criteria:
* Patients with evidence of acute respiratory failure (patients with worsening symptoms during the last 2 weeks before the screening visit, a breathing frequency of 30 breaths/ minute, or signs of respiratory infections)
* Patients who had been intubated during the last 3 months
* Patients who had received any other form of ventilatory support before hospital admission were also excluded from the study
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Assiut
**Country:** Egypt
**Facility:** Assuit University Hospital
**State:** Assuit
**Zip:** 711111
#### Overall Officials
**Official 1:**
**Affiliation:** Assiut University
**Name:** Doaa Magdy
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** after being published
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000050177
- Term: Overweight
- ID: D000044343
- Term: Overnutrition
- ID: D000009748
- Term: Nutrition Disorders
- ID: D000001835
- Term: Body Weight
- ID: D000012131
- Term: Respiratory Insufficiency
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000012818
- Term: Signs and Symptoms, Respiratory
- ID: D000020181
- Term: Sleep Apnea, Obstructive
- ID: D000012891
- Term: Sleep Apnea Syndromes
- ID: D000001049
- Term: Apnea
- ID: D000020919
- Term: Sleep Disorders, Intrinsic
- ID: D000020920
- Term: Dyssomnias
- ID: D000012893
- Term: Sleep Wake Disorders
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M12701
- Name: Obesity
- Relevance: HIGH
- As Found: Obesity
- ID: M10090
- Name: Hypoventilation
- Relevance: HIGH
- As Found: Hypoventilation
- ID: M13740
- Name: Obesity Hypoventilation Syndrome
- Relevance: HIGH
- As Found: Obesity Hypoventilation Syndrome
- ID: M26186
- Name: Overweight
- Relevance: LOW
- As Found: Unknown
- ID: M25307
- Name: Overnutrition
- Relevance: LOW
- As Found: Unknown
- ID: M12684
- Name: Nutrition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5114
- Name: Body Weight
- Relevance: LOW
- As Found: Unknown
- ID: M14968
- Name: Respiratory Insufficiency
- 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
- ID: M15623
- Name: Signs and Symptoms, Respiratory
- Relevance: LOW
- As Found: Unknown
- ID: M15694
- Name: Sleep Apnea Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M22010
- Name: Sleep Apnea, Obstructive
- Relevance: LOW
- As Found: Unknown
- ID: M4361
- Name: Apnea
- Relevance: LOW
- As Found: Unknown
- ID: M22242
- Name: Parasomnias
- Relevance: LOW
- As Found: Unknown
- ID: M22654
- Name: Sleep Disorders, Intrinsic
- Relevance: LOW
- As Found: Unknown
- ID: M22655
- Name: Dyssomnias
- Relevance: LOW
- As Found: Unknown
- ID: M15696
- Name: Sleep Wake Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007040
- Term: Hypoventilation
- ID: D000010845
- Term: Obesity Hypoventilation Syndrome
- ID: D000009765
- Term: Obesity
- ID: D000013577
- Term: Syndrome
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442150
**Acronym:** LCMD
**Brief Title:** LCMD for Type 2 Diabetes Remission: Evaluation of Effectiveness and Exploration of Individual Differences
**Official Title:** Low-Calorie Medicinal Diet for Type 2 Diabetes Remission: Evaluation of Effectiveness and Exploration of Individual Differences
#### Organization Study ID Info
**ID:** SHMHTCM LCDM
#### Organization
**Class:** OTHER
**Full Name:** Shanghai Municipal Hospital of Traditional Chinese Medicine
### Status Module
#### Completion Date
**Date:** 2027-11-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-01-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Shanghai Municipal Hospital of Traditional Chinese Medicine
#### Responsible Party
**Investigator Affiliation:** Shanghai Municipal Hospital of Traditional Chinese Medicine
**Investigator Full Name:** Feng Tao
**Investigator Title:** Director of Endocrinology
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Type 2 diabetes (T2DM) has become a major public health problem. Achieving remission (HbA1c\<6.5% without glucose-lowering medications) has recently become a new treatment goal. Low-calorie diets effectively induce remission, but adverse effects like fatigue, appetite, and constipation hinder success. Integrating traditional Chinese medicine (TCM) herbs into a low-calorie diet may alleviate adverse effects and improve remission rates.
This project investigates the efficacy of a Low-Calorie Medicine Diet (LCMD) in achieving T2DM remission among overweight/obese individuals through a randomized controlled trial. The investigators will explore individual differences in remission and elucidate the underlying biological mechanisms, focusing on the brain-gut-microbiota axis. By integrating nutrition and TCM dietetics, this project provides a novel, evidence-based approach to managing T2DM in Chinese populations.
**Detailed Description:** Type 2 diabetes (T2DM) has become a major public health problem, and effective prevention and treatment strategies are urgently needed. Recently, the understanding of T2DM has shifted to "a disease that can be remission." Achieving remission, defined as HbA1c\<6.5% without using glucose-lowering medications, has become a new treatment goal for T2DM. Evidence suggests that a low-calorie diet is an effective approach to induce remission. Our previous research (NCT05472272) also demonstrated that a low-calorie diet can achieve remission in Chinese T2DM patients.
However, adverse effects during the intervention, such as fatigue, appetite, and constipation, have become significant barriers to successful remission. These symptoms often result in poor adherence to the intervention plan and, consequently, failure to achieve remission. In traditional Chinese medicine (TCM), fatigue and constipation are typical symptoms of "Qi Vacuity", while hunger is more associated with "Yin Vacuity". "Herb is the food" is a unique concept in TCM. Integrating TCM herbs into a low-calorie diet may help alleviate these adverse effects and improve the likelihood of achieving diabetes remission.
This project aims to investigate the efficacy of a Low-Calorie Medicine Diet (LCMD) in achieving remission of T2DM among overweight/obese individuals through a randomized controlled trial. The investigators will also explore individual differences in achieving remission and elucidate the underlying biological mechanisms, focusing on the brain-gut-microbiota axis. By integrating theories from nutrition and TCM dietetics, this project seeks to provide a novel, evidence-based approach to the management of T2DM in Chinese populations.
### Conditions Module
**Conditions:**
- Type 2 Diabetes Mellitus in Obese
- Type 2 Diabetes
**Keywords:**
- Remission of type 2 diabetes
- Low Calorie Diet
- Medicined Diet
- Brain-Gut-Microbiome axis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Parallel Assignment
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Due to the unique nature of the intervention, it is not feasible to mask the participants and investigators in the treatment allocation. However, the outcomes assessor will be blinded to minimize potential bias in data analysis.
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 170
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive a Low-Calorie Diet (815-835 kcal/day; approximately 43% carbohydrate, 29% protein, and 29% fat) meals for 12 weeks, followed by a gradual food reintroduction phase combined with physical activity support for 12 weeks.
**Intervention Names:**
- Combination Product: Low-Calorie Diet
**Label:** LCD Group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Participants will receive a Low-Calorie Medicine Diet (815-835 kcal/day; approximately 43% carbohydrate, 29% protein, and 29% fat) meals product for 12 weeks, followed by a gradual food reintroduction phase combined with physical activity support for 12 weeks.
**Intervention Names:**
- Combination Product: Low-Calorie Medicine Diet
**Label:** LCMD Group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- LCMD Group
**Description:** Low-Calorie Medicine Diet meals which are 815-835 kcal/day (approximately 43% carbohydrate, 29% protein, and 29% fat), combined with physical activity.
**Name:** Low-Calorie Medicine Diet
**Type:** COMBINATION_PRODUCT
#### Intervention 2
**Arm Group Labels:**
- LCD Group
**Description:** Low-Calorie Diet meals which are 815-835 kcal/day (approximately 43% carbohydrate, 29% protein, and 29% fat), combined with physical activity.
**Name:** Low-Calorie Diet
**Type:** COMBINATION_PRODUCT
### Outcomes Module
#### Primary Outcomes
**Description:** The proportion of participants achieving diabetes remission, which is defined as having a glycated hemoglobin (HbA1c) level less than 6.5% while receiving no pharmacological therapy for diabetes for at least 3 months.
**Measure:** Number of participants achieving diabetes remission as assessed by American Diabetes Association criteria
**Time Frame:** Baseline to 24 and 52 weeks
**Description:** Proportion of participants achieving significant weight loss (≥12kg/10kg).
**Measure:** Number of participants achieving significant weight loss, defined as a reduction of at least 12kg from baseline body weight
**Time Frame:** Baseline to 12, 24 and 52 weeks
#### Secondary Outcomes
**Description:** Insulin sensitivity is evaluated with insulin tolerance tests at the pre-specified time points.
**Measure:** Change from baseline in insulin sensitivity as assessed by insulin tolerance test
**Time Frame:** Baseline to 12, 24 and 52 weeks
**Description:** Beta cell function is evaluated with arginine stimulation test at the pre-specified time points.
**Measure:** Change from baseline in beta cell function as assessed by arginine stimulation test
**Time Frame:** Baseline to 12, 24 and 52 weeks
**Description:** Liver and pancreatic fat will be assessed using magnetic resonance imaging (MRI) or proton magnetic resonance spectroscopy (1H-MRS). Liver fat content will be quantified as the proton density fat fraction (PDFF) in percentage, while pancreatic fat content will be expressed as the percentage of fat signal relative to the total signal in the region of interest (ROI).
**Measure:** Change from baseline in liver fat content and pancreatic fat content as assessed by magnetic resonance imaging
**Time Frame:** Baseline to 12, 24 and 52 weeks
**Description:** Glucose homeostasis parameters will be assessed, including fasting blood glucose (FBG) in mmol/L, postprandial blood glucose (PBG) in mmol/L 2 hours after a standardized meal, glycated hemoglobin (HbA1c) in percentage, and time in range (TIR), which represents the percentage of time that blood glucose levels remain within the target range (3.9-10.0 mmol/L) as assessed using continuous glucose monitoring (CGM) or self-monitoring of blood glucose (SMBG).
**Measure:** Change from baseline in plasma glucose concentration
**Time Frame:** Baseline to 12, 24 and 52 weeks
**Description:** Lipid profile parameters will be assessed, including total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG). All lipid parameters will be measured in mmol/L after at least 8 hours of fasting.
**Measure:** Change from baseline in fasting serum lipid levels, including total cholesterol, LDL-C, HDL-C, and triglycerides
**Time Frame:** Baseline to 12, 24 and 52 weeks
**Description:** Brain functional connectivity and activity will be assessed using functional magnetic resonance imaging (fMRI) during resting state and task-based paradigms. Resting-state fMRI will be used to evaluate the intrinsic functional connectivity among brain regions, focusing on networks related to appetite regulation and cognitive control.
**Measure:** Change from baseline in brain functional connectivity and activity as assessed by functional magnetic resonance imaging
**Time Frame:** Baseline to 12, 24 and 52 weeks
**Description:** Gut microbiota composition and its metabolites will be assessed through the analysis of fecal samples. 16S rRNA gene sequencing will be used to evaluate gut microbial diversity and composition, focusing on the relative abundance of key bacterial taxa at the phylum, family, and genus levels. Metabolomic profiles, including short-chain fatty acids (SCFAs), bile acids, and amino acids, will be quantified using gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-mass spectrometry (LC-MS).
**Measure:** Change from baseline in gut microbiota composition and its metabolites as assessed by 16S rRNA gene sequencing and metabolomics analysis
**Time Frame:** Baseline to 12, 24 and 52 weeks
**Description:** Quality of life will be assessed using various validated questionnaires, including the 36-Item Short Form Health Survey (SF-36) for general health status, the EuroQol Five-Dimension (EQ-5D) questionnaire for health-related quality of life, and the Diabetes-Specific Quality of Life (DSQL) questionnaire for diabetes-specific health-related quality of life. The SF-36 and EQ-5D scores range from 0 to 100, with higher scores indicating better health status. The DSQL scores range from 0 to 100, with lower scores indicating better diabetes-specific quality of life.
**Measure:** Change from baseline in the quality of life score as assessed by a validated questionnaire (e.g., SF-36, EQ-5D)
**Time Frame:** Baseline to 12, 24 and 52 weeks
**Description:** Safety will include adverse event incidence, changes in routine blood, urine, and stool tests, alanine transaminase, uric acid, etc. Frequency of constipation and dizziness, as well as scores from PAC-SYM, FSS, FCQ-T, and VAS for hunger, will be assessed.
**Measure:** Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
**Time Frame:** 12, 24 and 52 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Physician-diagnosed T2DM
* The history of T2DM less than 6 years
* Most recent HbA1c higher than 6.5%
* Body mass index: 24-45 kg/m2
* Fasting C-p ≥1.1 ng/ml
* Inability to provide informed consent
Exclusion Criteria:
* Type 1 diabetes, type 2 diabetes currently treated with insulin, or HbA1c ≥12%
* Cardiovascular events within 6 months before trial
* Current use of anti-obesity medications, eating disorders, dieting behaviors, or weight loss \>5 kg within 6 months before trial
* Chronic kidney disease stage 3b or above (eGFR \<30 mL/min/1.73m²)
* Any condition causing fluid overload, such as heart failure or liver cirrhosis
* Previously diagnosed psychiatric disorders (e.g., schizophrenia, post-traumatic stress disorder, obsessive-compulsive disorder), uncontrolled depression, or epilepsy
* Severe arthritis or active gout
* Active gallstone disease or known as asymptomatic gallstones
* Concurrent enrollment in another clinical trial
* Pregnancy, lactation, or planned conception during the study
* Substance abuse
* Known malignancy
* Comorbidities increasing dietary intervention risk (e.g., biliary disorders)
* Long-term use of antibiotics, corticosteroids, NSAIDs, or PPIs
* Chronic gastrointestinal disorders affecting gut microbiota (e.g., ulcerative colitis)
* Severe hepatic impairment (ALT \>2.5× ULN)
* Inability to provide informed consent
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** taofeng@shutcm.edu.cn
**Name:** Feng Tao, M.D.
**Phone:** +86 (021) 56639828
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shanghai
**Country:** China
**Facility:** Shanghai Municipal Hospital of Traditional Chinese Medicine
**State:** Shanghai
**Zip:** 200074
#### Overall Officials
**Official 1:**
**Affiliation:** Shanghai Municipal Hospital of Traditional Chinese Medicine
**Name:** Feng Tao, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### 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: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes
- ID: M7119
- Name: Diabetes Mellitus, Type 2
- Relevance: HIGH
- As Found: Type 2 Diabetes
- ID: M12701
- Name: Obesity
- 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
### 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:** NCT06442137
**Brief Title:** A Clinical Trial of Chazhu Xiaozhi Decoction Against Non-alcoholic Fatty Liver Disease
**Official Title:** Effect of Chazhu Xiaozhi Decoction on Non-alcoholic Fatty Liver Disease: a Randomized Clinical Trial
#### Organization Study ID Info
**ID:** CXD20240523
#### Organization
**Class:** OTHER
**Full Name:** Shanghai Municipal Hospital of Traditional Chinese Medicine
#### Secondary ID Infos
**Domain:** Shanghai Municipal Health Commission
**ID:** 20234Y0142
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**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:** Shanghai Municipal Hospital of Traditional Chinese Medicine
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to learn if drug Chazhu Xiaozhi decoction works to treat non-alcoholic fatty liver disease in adults. It will also learn about the safety of drug Chazhu Xiaozhi decoction. The main questions it aims to answer are:
Does drug Chazhu Xiaozhi decoction improve the degree of hepatic steatosis in patients with non-alcoholic fatty liver disease? What medical problems do participants have when taking drug Chazhu Xiaozhi decoction? Researchers will compare drug Chazhu Xiaozhi decoction to a placebo (a look-alike substance that contains no drug) to see if drug Chazhu Xiaozhi decoction works to treat non-alcoholic fatty liver disease.
Participants will:
Take drug Chazhu Xiaozhi decoction or a placebo every day for eight weeks Keep a record of their symptoms and the degree of hepatic steatosis before and after the treatment
### Conditions Module
**Conditions:**
- Hepatic Steatosis
- Symptoms and Signs
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Participants are assigned to one of two groups in parallel for the duration of the study
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** The control placebo is a ten-fold dilution of the Chazhu Xiaozhi decoction, supplemented with colorants and bittering agents to mimic the appearance and color of the treatment drug. An independent researcher (not involved in the trial operations or evaluations) is responsible for managing the randomization sequence and drug coding, and will distribute the appropriate drugs to participants at the right times. This ensures that the trial operators and evaluators are unaware of the treatment type; only the independent researcher has this knowledge. During the experiment, the assessment of treatment effects and the recording of adverse events are carried out by independent evaluators who are unaware of the treatment groups. Both the trial operators and the evaluators do not have access to the drug coding and randomization sequence.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 70
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** These medicines of Chazhu Xiaozhi decoction are uniformly decocted, prepared, and packaged by the Pharmacy of Shanghai Municipal Hospital of Traditional Chinese Medicine. The administration is oral, taken twice daily, one packet each time, for a treatment period of 8 weeks.
In addition, following the guidelines, all participants will receive lifestyle interventions, including diet and exercise health education before enrollment to ensure calorie control and exercise compliance.
**Intervention Names:**
- Drug: Chazhu Xiaozhi decoction
**Label:** Treatment group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** These placebo medicines are uniformly decocted, prepared, and packaged by the Pharmacy of Shanghai Municipal Hospital of Traditional Chinese Medicine. The administration is oral, taken twice daily, one packet each time, for a treatment period of 8 weeks.
In addition, following the guidelines, all participants will receive lifestyle interventions, including diet and exercise health education before enrollment to ensure calorie control and exercise compliance.
**Intervention Names:**
- Drug: Control placebo
**Label:** Control group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment group
**Description:** Below is the composition of Chazhu Xiaozhi decoction: Camellia Sinensis Radix 15g, Atractylodis Rhizoma 15g, Herba Gynostemmatis Pentaphylli 15g, Ilicis Cornutae Folium 15g, Alismatis Rhizoma 9g, Nelumbinis Folium 6g, Crataegi Fructus 6g, Polygoni Orientalis Fructus 3g.
**Name:** Chazhu Xiaozhi decoction
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Control group
**Description:** The control placebo is a ten-fold dilution of the Chazhu Xiaozhi decoction, supplemented with colorants and bittering agents to mimic the appearance and color of the treatment drug.
**Name:** Control placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** A liver fiber diagnostic instrument (Fibro Touch) is used to perform instantaneous elastic hardness testing. The controlled attenuation parameter usually represents liver fat content, whereas higher scores mean a worse outcome.
**Measure:** controlled attenuation parameter
**Time Frame:** through study completion, an average of 8 weeks
**Description:** The traditional Chinese medicine syndrome scale includes evaluations of symptoms such as discomfort in the right flank, bloating in the epigastric region, bitter mouth, dry mouth, loose and loose stools, fatigue and fatigue throughout the body, loss of appetite, nausea, dizziness, and yellow urine, with a score range from 0 to 3, and higher scores mean a worse outcome.
**Measure:** traditional Chinese medicine syndrome scale
**Time Frame:** through study completion, an average of 8 weeks
#### Secondary Outcomes
**Description:** weighing on a scale
**Measure:** body weight
**Time Frame:** through study completion, an average of 8 weeks
**Description:** calculate
**Measure:** body mass index
**Time Frame:** through study completion, an average of 8 weeks
**Description:** serum biochemistry
**Measure:** fasting blood glucose
**Time Frame:** through study completion, an average of 8 weeks
**Description:** serum biochemistry
**Measure:** alanine aminotransferase
**Time Frame:** through study completion, an average of 8 weeks
**Description:** serum biochemistry
**Measure:** aspartate transaminase
**Time Frame:** through study completion, an average of 8 weeks
**Description:** serum biochemistry
**Measure:** γ-glutamyl transpeptidase
**Time Frame:** through study completion, an average of 8 weeks
**Description:** serum biochemistry
**Measure:** triglyceride
**Time Frame:** through study completion, an average of 8 weeks
**Description:** serum biochemistry
**Measure:** total cholesterol
**Time Frame:** through study completion, an average of 8 weeks
**Description:** serum biochemistry
**Measure:** creatinine
**Time Frame:** through study completion, an average of 8 weeks
**Description:** serum biochemistry
**Measure:** urea nitrogen
**Time Frame:** through study completion, an average of 8 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
According to the diagnostic criteria, patients with NAFLD and Spleen Deficiency and Damp-Heat Syndrome are selected. The specific criteria are as follows:
1. Age 18-50 years, both genders eligible;
2. Meets the diagnostic criteria for NAFLD;
3. Meets the diagnostic criteria for Traditional Chinese Medicine Spleen Deficiency and Damp-Heat Syndrome;
4. Has significant risk factors: CAP≥238dB/m, Body Mass Index (BMI) ≥23 kg/m², Triglycerides ≥1.7 mmol/L;
5. Has not received any anti-NAFLD medication treatment in the past month;
6. Normal major organ function, including heart, kidney, and liver functions, specifically: no significant abnormalities on electrocardiogram; normal serum creatinine and urea nitrogen; normal serum bilirubin and albumin levels;
7. Has sufficient cognitive and understanding abilities to comprehend the study content and its potential risks and benefits;
8. Voluntarily participates in the study and signs an informed consent form.
Exclusion Criteria:
1. Has liver steatosis due to other definitive causes, such as alcoholic liver disease, drug-induced liver injury, viral hepatitis infections (e.g., hepatitis B, hepatitis C, etc.);
2. Has other serious liver diseases, such as autoimmune liver diseases, primary biliary cholangitis, Wilson's disease, etc.;
3. Has severe dysfunction of major organs such as the heart, kidneys, lungs, etc., such as severe heart failure (NYHA functional classification III or above), renal failure (glomerular filtration rate eGFR \< 30 mL/min/1.73m²), acute exacerbation of chronic obstructive pulmonary disease, etc.;
4. Has other serious systemic diseases, such as malignant tumors, active systemic lupus erythematosus, etc.;
5. Known allergy or intolerance to any component of the study medication;
6. Has participated in another clinical trial within the last three months;
7. Pregnant women, lactating women, or women of childbearing age who refuse to use effective contraception during the trial;
8. Has severe mental illness or behavioral disorders that may affect adherence to the study protocol;
9. Other conditions that the researcher considers unsuitable for participation in this study.
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Shanghai
**Country:** China
**Facility:** Shanghai Municipal Hospital of Traditional Chinese Medicine
**State:** Shanghai
**Zip:** 200071
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## 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: 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: M30540
- Name: Non-alcoholic Fatty Liver Disease
- Relevance: HIGH
- As Found: Non-alcoholic Fatty Liver Disease
- 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: Hepatic Steatosis
### Condition Browse Module - Meshes
- ID: D000008107
- Term: Liver Diseases
- ID: D000005234
- Term: Fatty Liver
- ID: D000065626
- Term: Non-alcoholic Fatty Liver Disease
### Intervention Browse Module - Browse Branches
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
- ID: T312
- Name: Tea
- Relevance: LOW
- As Found: Unknown
- ID: T181
- Name: Hawthorn
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442124
**Brief Title:** The Effect of BMI on Gluteus Maximum Activity in Adulthood With Sacroiliac Dysfunction
**Official Title:** The Effect of BMI on Gluteus Maximum Activity in Adulthood With Sacroiliac Dysfunction
#### Organization Study ID Info
**ID:** P.T-REC-012/005149
#### Organization
**Class:** OTHER
**Full Name:** Ahram Canadian University
### Status Module
#### Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-02
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-20
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-12
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-06-02
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ahram Canadian University
#### Responsible Party
**Investigator Affiliation:** Ahram Canadian University
**Investigator Full Name:** Mohamed Ababa
**Investigator Title:** lecturer of internal physical therapy
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** PURPOSE:
This study will be conducted to investigate the effect of BMI on gluteus maximum activity in adulthood with sacroiliac dysfunction BACKGROUND: Sacroiliac joint (SIJ) pain is pain arising from SIJ structures and SIJ dysfunction (SIJD) generally refers to aberrant position or movement of SIJ structures . An estimated 15-30% of all low back pain cases are due to SIJ pain The present study will be conducted to add a new information to the body of knowledge of physical therapy profession as it will investigate the effect of BMI on gluteus maximum activity in adulthood with sacroiliac dysfunction
HYPOTHESES:
. •There will be no effect of BMI on gluteus maximum activity in adulthood with sacroiliac dysfunction
RESEARCH QUESTION:
* Do BMI has an effect on gluteus maximum activity in adulthood with sacroiliac dysfunction?
### Conditions Module
**Conditions:**
- Sacroiliac Joint Dysfunction
- Obesity
- EMG
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** o Group (A): will includes subjects with sacroiliac dysfunction and their body mass index \< 25
**Intervention Names:**
- Diagnostic Test: Electromyography (EMG)
**Label:** Group (A):
#### Arm Group 2
**Description:** o Group (B): will includes subjects with sacroiliac dysfunction and their body mass index \> 25.
**Intervention Names:**
- Diagnostic Test: Electromyography (EMG)
**Label:** Group (B):
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group (A):
- Group (B):
**Description:** The present study will be conducted to add a new information to the body of knowledge of physical therapy profession as it will investigate the effect of BMI on gluteus maximum activity recorded by EMG in adulthood with sacroiliac dysfunction
**Name:** Electromyography (EMG)
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Measure:** gluteus maximum muscle activity measured by Electromyography (EMG)
**Time Frame:** up to 8 weeks
**Measure:** weight and height will be combined to report BMI in kg/m^2)
**Time Frame:** up to 8 weeks
**Measure:** visual analogue scale for pain
**Time Frame:** up to 8 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
- adulthood with sacroiliac dysfunction
* Their ages will range from 20-40 years old.
* Their BMI will be less than 20- 30kg/m2.
* All of them suffer from mild to moderate degree of sacroiliac pain.
* The subjects complain from sacroiliac pain for 1 month ago
Exclusion Criteria:
* Exclusion criteria were a history of any of the following condition:
* inflammatory diseases or any rheumatic disorders,
* a history of vertebral fractures
* surgical spinal fixation.
* •any neurological disorders like MS
**Maximum Age:** 40 Years
**Minimum Age:** 20 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
**Study Population:** Subjects:
A total of 60 male \& female subjects, diagnosed with sacroiliac dysfunction participated in this study. Their BMI will from 20- 30kg/m2.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Giza
**Contacts:**
***Contact 1:***
- **Email:** mohamed.ababa@acu.rdu.eg
- **Name:** Mohamed Ahmed, lecturer
- **Phone:** 01006794075
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Ahram Canadian university
**Status:** RECRUITING
**Zip:** 12573
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009140
- Term: Musculoskeletal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC05
- Name: Musculoskeletal Diseases
### Condition Browse Module - Browse Leaves
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M10621
- Name: Joint Diseases
- Relevance: HIGH
- As Found: Joint Dysfunction
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007592
- Term: Joint Diseases
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442111
**Acronym:** Ferritin
**Brief Title:** The Role of Intravenous Ferritin in Optimizing Postoperative Recovery Following Pancreaticoduodenectomy
**Official Title:** The Role of Intravenous Ferritin in Optimizing Postoperative Recovery Following Pancreaticoduodenectomy: A Multicenter, Randomized, Controlled Trial
#### Organization Study ID Info
**ID:** Seoul_IDA
#### Organization
**Class:** OTHER
**Full Name:** Seoul St. Mary's Hospital
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Seoul St. Mary's Hospital
#### Responsible Party
**Investigator Affiliation:** Seoul St. Mary's Hospital
**Investigator Full Name:** Taeho Hong
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Iron deficiency anemia is well known as a risk factor that worsens postoperative morbidity and patient prognosis. Several studies have shown that intravenous iron administration before surgery is effective in reducing the risk of iron deficiency anemia and improving the postoperative prognosis. However, the risk of iron deficiency anemia after surgery is increased due to the resection of the duodenum, the main organ for iron absorption. Very few studies have been conducted on the postoperative effects of higher pancreatoduodenectomy.
Observe changes in hematological parameters in patients who underwent pancreaticoduodenectomy due to periampullary tumor and confirm the role of intravenous iron supplementation in optimizing postoperative recovery.
**Detailed Description:** Iron deficiency anemia (IDA) has multifactorial causes, including bleeding, insufficient iron absorption, and anemia related to malignant tumors or chronic diseases, which are cytokine-mediated diseases, and is a disease commonly observed in cancer patients. Since cancer surgery generally involves wide resection and tissue manipulation for radical lymph node dissection, systemic inflammation may occur after surgery. This may increase the risk of IDA in patients undergoing surgery by inducing a key regulator of systemic iron hemostasis that impairs intestinal iron absorption.
Pancreaticoduodenectomy, a representative surgery for periampullary neoplastic lesions, is a major surgery accompanied by moderate bleeding and large-scale tissue damage, which predisposes to IDA, and is highly likely to be accompanied by severe bleeding and blood transfusion. The perioperative blood transfusion rate has decreased with the advancement of surgical instruments and techniques, but still remains high at up to 60%. Moreover, since pancreaticoduodenectomy inevitably removes the duodenum, which absorbs iron into the body, the iron absorption function is physiologically impaired, making the patient vulnerable to IDA. Additionally, after pancreaticoduodenectomy, oral intake is often lacking for a relatively long period of time due to complex anastomosis. Therefore, the risk of IDA after pancreaticoduodenectomy may be very high regardless of the presence or absence of preoperative anemia.
IDA is a well-known risk factor for postoperative morbidity and poor prognosis of postoperative patients, and allogeneic transfusion to correct anemia is associated with an increased risk of developing infectious and non-infectious complications, including cancer recurrence, cardiac complications, and prolonged hospitalization. Available.
Research results are currently being published showing that correcting anemia through preoperative intravenous iron injection can improve the patient\'s postoperative prognosis. In the field of colon or heart surgery, the effect of preventing the occurrence of IDA in people diagnosed with IDA before surgery has been reported. In particular, in patients with postoperative anemia, serum hemoglobin, ferritin, and transferrin saturation levels improved rapidly, and indiscriminate blood transfusion was prevented. Another study showed that it was effective in reducing postoperative blood transfusion and intensive care unit length of stay in elderly patients. However, there is a lack of research on the effect of preoperative iron injections on postoperative clinical outcomes after pancreatoduodenectomy, where most patients are elderly and have high intraoperative bleeding.
Therefore, the purpose of this study was to evaluate changes in hematological parameters in patients who underwent pancreaticoduodenectomy due to periampullary lesions and their effect on improving clinical outcomes within 12 weeks after surgery.
### Conditions Module
**Conditions:**
- Pancreaticojuodenectomy
**Keywords:**
- Iron-deficiency anemia
- Ferric carboxymaltose
- perioperative outcome
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 106
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** inclusion criteria : patients with periampullary tumor for whom pancreaticoduodenectomy is planned.
**Intervention Names:**
- Drug: The intravenous ferritin group
- Drug: The placebo group
**Label:** The experimental group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** inclusion criteria : patients with periampullary tumor for whom pancreaticoduodenectomy is planned.
**Intervention Names:**
- Drug: The intravenous ferritin group
- Drug: The placebo group
**Label:** The placebo group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- The experimental group
- The placebo group
**Description:** Administer intravenous ferritin approximately 3-7 days before surgery (0.9% normal saline 250ml + 1000 mg of ferric carboxymaltose \[Ferinject™, Vifor Pharma, Glattbrugg, Dwitzerland\], inject over 15 minutes)
**Name:** The intravenous ferritin group
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- The experimental group
- The placebo group
**Description:** Administer intravenous 10ml of normal saline (Isotonic Sodium Chloride Injection Daihan(50mL/bag)) approximately 3-7 days before surgery
**Name:** The placebo group
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** If your hemoglobin level increases from baseline to week 12 by more than 2 g/dL or 14 and your hemoglobin level is more than 11 g/dL
**Measure:** Number of hemoglobin responders by 12 weeks after surgery
**Time Frame:** 12 weeks
#### Secondary Outcomes
**Description:** Postoperative transfusion rate (%) : If blood transfusion is required within 72 hours after surgery
**Measure:** Postoperative transfusion rate
**Time Frame:** 12 weeks
**Description:** morbidity (%) : postoperative complications (infectious, non-infectious complications)
**Measure:** morbidity
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* patients who diagnosed periampullary tumor
* age under 75, over 18 years
Exclusion Criteria:
1. palliative or emergency surgery,
2. incurable or metastatic disease state,
3. insufficient data,
4. accompanying hematologic disorders that may cause anemia,
5. loss to follow-up,
6. ferritin Contraindications to intravenous administration (pregnancy or lactation, age under 18 years, history of severe asthma or infection, chronic renal failure, simultaneous oral and intravenous iron administration, allergic reaction to iron)
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** gshth@catholic.ac.kr
**Name:** Tae ho Hong
**Phone:** +82-10-5206-5266
**Role:** CONTACT
**Contact 2:**
**Email:** carin337@naver.com
**Name:** Sung eun Park
**Phone:** +82-10-5775-9351
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Catholic University Seoul St. Mary's Hospital
**Name:** Sung eun Park
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M20857
- Name: Anemia, Iron-Deficiency
- Relevance: LOW
- As Found: Unknown
- ID: M2781
- Name: Iron Deficiencies
- Relevance: LOW
- As Found: Unknown
- ID: M4070
- Name: Anemia
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M10533
- Name: Iron
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442098
**Brief Title:** Camp SMART Speech to Print Summer Literacy Camp
**Official Title:** Camp SMART Speech to Print Summer Literacy Camp
#### Organization Study ID Info
**ID:** HS-2024-0077
#### Organization
**Class:** OTHER
**Full Name:** San Diego State University
### Status Module
#### Completion Date
**Date:** 2024-08-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-08-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-11
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** San Diego State 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 project aims to explore the feasibility and efficacy of a 6-week, intensive summer literacy intervention provided to children in 1st-3rd grades.
**Detailed Description:** 1. Purpose/objective:
To determine the feasibility and preliminary effectiveness of a 6-week literacy summer camp for improving language and literacy outcomes of children with identified language or literacy difficulties.
2. Methods:
This intervention will be provided by students in the speech and hearing clinic on SDSU's campus. The summer clinical sessions last for 8 weeks. Week 1 will be used for the pre-testing of each participant's baseline language (morphological awareness, phonological awareness, morphosyntax, vocabulary, and narrative language skills) and reading (letter knowledge, nonword reading, reading fluency and reading comprehension). In weeks 2-7, the intervention will take place. This will consist of 3, 3-hour sessions per week. Finally, in week 8, the investigators will conduct post-testing of children's language and reading skills.
3. Subjects:
The investigators will recruit a maximum of 12 students who are in the summer after Kindergarten, first, or second grade. The investigators will be recruiting students from the local community who either a) have IEPs with eligibility of SLI or SLD-reading or b) have documented parent or teacher concern for reading and/or language skills as determined by parent questionnaire.
4. Planned analyses:
Planned analyses will include analysis of improvement in each of the language and reading skills from pre-test to post-test. The investigators will also include probes of performance of reading skills to allow for single subject analysis. The investigators will develop fidelity rubrics to explore the fidelity of intervention implementation and will analyze how fidelity relates to individual-child-level improvement.
### Conditions Module
**Conditions:**
- Reading Disorder, Developmental
**Keywords:**
- Literacy Intervention
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** Alternating Treatment Single Subject Design
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 12
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Children in this condition will receive 7 sessions of code-focused reading intervention followed by 7 sessions of morphology-focused reading intervention.
**Intervention Names:**
- Behavioral: CAMP SMART Literacy Summer Camp
**Label:** Code First
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Children in this condition will receive 7 sessions of morphology-focused reading intervention followed by 7 sessions of code-focused reading intervention.
**Intervention Names:**
- Behavioral: CAMP SMART Literacy Summer Camp
**Label:** Morphology First
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Code First
- Morphology First
**Description:** Multimodal approach to reading intervention
**Name:** CAMP SMART Literacy Summer Camp
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Experimenter-created lists of CVC words that children will be asked to spell
**Measure:** Spelling Probes
**Time Frame:** Children will spell 10 CVC words at the conclusion of each of their 14 intervention sessions. Their performance will be charted and tracked.
#### Secondary Outcomes
**Description:** Standardized measure of language and reading skills that assesses real and non-word reading and spelling as well as oral language skills in English.
**Measure:** Test of Integrated Language and Literacy Skills standard score
**Time Frame:** Administered prior to the initiation of the intervention and upon conclusion of the intervention.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Students who are in the summer after Kindergarten, first, or second grade.
* Students from the local community who either a) have IEPs with eligibility of SLI or SLD-reading or b) have documented parent or teacher concern for reading and/or language skills as determined by parent questionnaire.
* Children who fit the above criteria will additionally be determined eligible for the intervention based on language or reading composite skills one or more standard deviations below the mean on the Test of Integrated Language and Literacy Skills (TILLS).
* Children who are rising 4th, 5th, or 6th graders and who have an IEP with eligibility of SLI or SLD-Reading and who demonstrate composite scores one or more standard deviations below the mean on the TILLS may be considered if space remains after recruitment of 1st-3rd graders.
Exclusion Criteria:
* Students who do not either a) have an IEP or b) have documented parent or teacher concern based on parent questionnaire.
* Students who score within the typical range on the TILLS.
* Students who are deaf or blind.
**Maximum Age:** 11 Years
**Minimum Age:** 6 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** aadams2@sdsu.edu
**Name:** Ashley Sanabria, PhD
**Phone:** 619-594-6140
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** San Diego
**Contacts:**
***Contact 1:***
- **Email:** cgoodwiler@sdsu.edu
- **Name:** Carrie Goodwiler, MA
- **Phone:** 619-594-3915
- **Role:** CONTACT
**Country:** United States
**Facility:** SDSU Speech, Language, and Hearing Clnic
**State:** California
**Status:** RECRUITING
**Zip:** 92182
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007806
- Term: Language Disorders
- ID: D000003147
- Term: Communication Disorders
- ID: D000019954
- Term: Neurobehavioral Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000067559
- Term: Specific Learning Disorder
- ID: D000007859
- Term: Learning Disabilities
- ID: D000065886
- Term: Neurodevelopmental 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: M7584
- Name: Dyslexia
- Relevance: HIGH
- As Found: Reading Disorder, Developmental
- ID: M10823
- Name: Language Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M6374
- Name: Communication Disorders
- 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: M10872
- Name: Learning Disabilities
- Relevance: LOW
- As Found: Unknown
- ID: M168
- Name: Specific Learning Disorder
- 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: D000004410
- Term: Dyslexia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442085
**Brief Title:** Virtual Reality Training for Trauma Resuscitation
**Official Title:** Immersive Virtual Reality Versus Mannequin-based Simulation Training for Trauma Resuscitation: a Randomized Controlled Non-inferiority Trial
#### Organization Study ID Info
**ID:** RigaStradinsU
#### Organization
**Class:** OTHER
**Full Name:** Riga Stradins University
### Status Module
#### Completion Date
**Date:** 2020-12-14
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2020-09-30
**Type:** ACTUAL
#### Start Date
**Date:** 2020-03-06
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Riga Stradins University
#### Responsible Party
**Investigator Affiliation:** Riga Stradins University
**Investigator Full Name:** Ainars Stepens
**Investigator Title:** Lead researcher in Institute of Public Health
**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 individual training with an immersive virtual reality Trauma Simulator was compared to live mannequin-based simulation training in a facilitated group. The results showed that virtual reality simulator led to non-inferior effects on trauma resuscitation skills to mannequin-based simulation. Trauma Simulator had good usability, was well received by the participants, and had minimal adverse effects.
**Detailed Description:** Background: Despite its high potential, the effect of immersive virtual reality simulation (VRS) in trauma resuscitation training has not been studied. The aim of this study was to test the hypothesis that VRS is non-inferior to mannequin-based simulation (MBS) in trauma resuscitation training.
Methods: In a single-center, randomized controlled non-inferiority trial, we compared individual training with an immersive virtual reality Trauma Simulator to live MBS training in a facilitated group. The primary outcome was the Trauma Score (ranging from 55 (worse) to 177 (best outcome)) during the MBS assessment. The secondary outcomes were the Trauma Score VRS assessment, System Usability Scale (ranging from 0 (worse) -100 (best outcome)), and Simulation Sickness Questionnaire (ranging from 0 (worse) to 235.62 (best outcome)).
### Conditions Module
**Conditions:**
- Virtual Reality
**Keywords:**
- Virtual reality
- trauma
- simulation-based education
- resuscitation
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** This was a prospective, single-center, randomized, controlled, non-inferiority, simulation-based trial comparing the use of virtual reality simulation vs. mannequin based simulation in a simulated trauma scenario.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** All assessments of the student performances were recorded either by video camera (mannequin based simulation) or screen capture (virtual reality simulation). All videos were assessed by two blinded raters independently. In order to maintain consistency, virtual reality recordings were also scored manually by the raters, instead of the automated Trauma Simulator built-in tool. The video data were stored for the reviews and deleted afterwards.
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 38
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** volunteers receiving mannequin based simulation training (control), then assessed for primary outcome, analyzed for primary outcome.
**Intervention Names:**
- Other: Teaching of trauma resuscitation by using mannequin based simulation
**Label:** Medical students - volunteers receiving mannequin based simulation training
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** volunteers receiving virtual reality simulation training (intervention), then assessed for primary outcome, analyzed for primary outcome.
**Intervention Names:**
- Other: Teaching of trauma resuscitation by using virtual reality simulation
**Label:** Medical students - volunteers receiving virtual reality simulation training
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Medical students - volunteers receiving virtual reality simulation training
**Description:** The intervention was teaching of trauma resuscitation by using VRS. Following welcome and a video lecture by Advance Trauma Life Support certified physician, the intervention group participants were orientated (15 minutes) to the VRS environment, head-mounted display (Oculus Rift S or Oculus Quest, Oculus, USA) and hand controllers by playing game First Steps (Oculus, USA). Then the participants were training by using the "Internal Hemorrhage" scenario in Trauma Simulator.
**Name:** Teaching of trauma resuscitation by using virtual reality simulation
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Medical students - volunteers receiving mannequin based simulation training
**Description:** Volunteers were trained in groups of three or four by using mannequin-based rapid cycle deliberate practice simulation facilitated by a critical care physician. Next, the volunteers had 50 min training of the same trauma scenario as the intervention group. The simulation facility was set-up as close as possible to the virtual reality environment.
**Name:** Teaching of trauma resuscitation by using mannequin based simulation
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The primary outcome of the study is Trauma Score (range 55 (worst) to 177(best outcome) during an individual assessment in a mannequin-based simulation environment. The assessment was based on the video recordings analyzing students during performing in the scenario. The Trauma Score is an assessment tool developed by military emergency medicine experts for the Trauma Simulator.
**Measure:** Trauma Score
**Time Frame:** Within a Day
#### Secondary Outcomes
**Description:** Trauma Score in the VRS environment served as a secondary outcome. System Usability Scale: a 10-item questionnaire (range 0-100, where 0 is the worst, 100 the best performance) was used to assess usability of Trauma Simulator.
**Measure:** Trauma Score in VRS
**Time Frame:** Within a VR session (less than 10minutes per person)
**Description:** The students will receive pre and post surveys. The surveys are structured to evaluate students' experience before and after the training. As a reference, the evaluation tools are made, based on Bangor et al., 2009. A custom, six-question survey (5-point Likert scale) was used to assess the perception of Virtual Reality simulation before and after the study. Presence of cybersickness was evaluated by using Simulation Sickness Questionnaire (SSQ).15 SSQ assesses 16 symptoms of motion sickness in three domains: nausea (7 symptoms), disorientation (7 symptoms), and oculomotor effects (7 symptoms). Each symptom is self-reported as none (0), slight (1), moderate (2), and severe (3). Total Severity score is calculated as the sum of individual symptom scores in each domain multiplied by 3.74 in accordance with Kennedy et al. (1993), thus the final score ranges from 0 (worst) to 235.62 (best outcome).
**Measure:** Pre- and Post-Surveys
**Time Frame:** Within a Day
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria: fluency in English. Exclusion Criteria: history of motion sickness
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Riga
**Country:** Latvia
**Facility:** Medical Education Technology Centre of Riga Stradins University
#### Overall Officials
**Official 1:**
**Affiliation:** Institute of Public Health, Riga Stradiņš University
**Name:** Ainars Stepens, PhD, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Participants were volunteers. Their data has been protected by General data protection regulation (GDPR). The anonymized Trauma Score of each participant group is available upon request.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Bangor A, Kortum P: Determining what individual SUS scores mean: adding an adjective rating scale. Journal of Usability Studies. 2009;4:114-123.
**Citation:** Kennedy RS, Lane NE, Berbaum KS, Lilienthal MG: Simulator Sickness Questionnaire: an enhanced method for quantifying simulator sickness. The International Journal of Aviation Psychology. 1993;3:203-220.
#### See Also Links
**Label:** POWER (SAMPLE SIZE) CALCULATORS'
**URL:** https://www.sealedenvelope.com/power/continuous-noninferior/
**Label:** G. C. Urbaniak and S. Plous, 'RESEARCH RANDOMIZER - RANDOM SAMPLING AND RANDOM ASSIGNMENT MADE EASY!
**URL:** https://www.randomizer.org
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442072
**Acronym:** CT_DoBetter
**Brief Title:** Global Controlled Trial on Effects of an Online Self-Help Program for of Ambitious Altruists on Their Mental Health, Wellbeing, and Productivity: Comparing Versions With IFS vs. CBT, Buddy- vs. Group-, Standard- vs. Minimum-Guidance Intensity.
**Official Title:** Global Controlled Trial on Effects of a Guided Online Self-Help Program for of Ambitious Altruists on Their Mental Health, Wellbeing, and Productivity
#### Organization Study ID Info
**ID:** CT2024RW
#### Organization
**Class:** OTHER
**Full Name:** Rethink Wellbeing
### Status Module
#### Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Maastricht University
#### Lead Sponsor
**Class:** OTHER
**Name:** Rethink Wellbeing
#### 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 study aims to compare different versions of a 16-week online self-help program in terms of their effect on self-assessed mental health, well-being, and productivity. The versions differ in their intensity (standard, low) and type (buddy, group) of guidance, the applied psychotherapeutic approaches taught (IFS, CBT). We expect to recruit a sample of \~150 ambitious altruists and have them self-select into the four program versions. Participants take part in surveys before, at weeks 8, 12, and 16 to self-assess their productivity, mental health burden, quality of life, and other risk and protection factors. Weekly screenings will provide data on objective and subjective success components such as participant engagement, working alliance, and treatment adherence, which will be correlated with primary and secondary outcomes.
**Detailed Description:** Aim:
This study aims to compare different versions of an online self-help program in terms of their effect on self-assessed mental health, well-being, and productivity. The goal is to find out if a version might be more effective or similarly effective but less costly than the original one.
Control groups:
The original program version is an 8-week course with weekly guided group sessions of 2 hours: Third Wave CBT methods are taught by a workbook and practised in between the sessions. The pre-post results, on 42 ambitious altruists, showed significant moderate effects on all scales after week 12. In this study, we aim to compare the effects of the original version with 1. one using a buddy instead of the group format, 2. one using less guidance (3 instead of 9 group sessions), and 3. one using Internal Family Systems instead of Third Wave CBT. Instead of 8 weeks, we spaced out the same amount of sessions for the program after week 6, so that the last follow-up session will take place for everyone at week 16 now.
Sample:
We expect to deliver the program to \~150 participants, and each version to at least 25 of those. Ambitious altruists will be recruited via posts on Facebook and Slack online groups and personal contact to organizations associated with Effective Altruism. People will self-select into the different program versions. We exclude those in acute crisis, those with very low self-assessed social competence, and those who report not being ambitiously altruistic. We match groups and buddies based on availability and on, who we believe will bond better, i.e., similar age and career stage.
Measurements. Participants take part in Google form surveys before, at weeks 8, 12, and 16. These measure productivity (WPAI:GH), mental health burden (symptoms of interpersonal sensitivity, and OCD by BSI, depressiveness and anxiety by GAD7 \& PHQ8), quality of life (WHOQOL-BREF, MHC-SF, ONS-4 LS), and other relevant factors (loneliness by UCLA-3, self-esteem by Rosenberg Self-esteem Scale, connection/will to do good by IWAH). An independent researcher, likely from Maastricht University, will likely check our data, calculate the results, and publish a paper about it to reduce potential biases. Also, participants' engagement will be assessed, i.e., no-shows, and dropouts, and participants attend a weekly screening in weeks 1-8, 12, and 16 to rate different success components, e.g. session engagement, working alliance, and treatment adherence. Those measures will be correlated with the primary and secondary outcomes at one point to see what influences outcomes and how strongly.
We applied to get an official letter of exemption from an ethics review due to these reasons:
* The study is only part of the already existing programs, nothing is changed in the operations affecting the participants due to the evaluation/study run
* Measurements are part of routine progress tracking
* The data is being used for publication purposes but does not introduce new risks
* The interventions as well as the data collection are 100% non-invasive and include a signed participant consent.
* The sampling excludes potentially vulnerable individuals, i.e., those in a current crisis.
### Conditions Module
**Conditions:**
- Treatment Adherence and Compliance
- Anxiety
- Depression
- Mental Health Issue
- Quality of Life
- Well-Being, Psychological
- Social Functioning
- Cognitive Dysfunction
- Interpersonal Relations
- Self Esteem
- Loneliness
- Functioning, Psychosocial
- Functioning, Social
**Keywords:**
- Mental Health
- CBT
- Productivtiy
- Controlled trial
- Effectiveness
- Prevention
- guided self-help
- IFS
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 150
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** * 9 group sessions, at week 0-6, 8, 12, 18
* groups of 4-6 peers and a trained facilitator
* participants work through the tailored Third Wave CBT workbook by Rethink Wellbeing, one chapter each week
* in between sessions, people practice the new skills learned in the workbook and are supported in an online community, guided by a trained psychologist and psychotherapist
**Intervention Names:**
- Behavioral: guided online self-help program
**Label:** CBT Group Standard Guidance
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** * 9 1:1 sessions after buddies get training in supporting each other - at week 0-6, 8, 12, 18
* groups of up to 30 peers and a trained facilitator
* participants work through the tailored Third Wave CBT workbook by Rethink Wellbeing, one chapter each week
* in between buddy-sessions, people practice the new skills learned in the workbook and are supported in an online community, guided by a trained psychologist and psychotherapist
**Intervention Names:**
- Behavioral: guided online self-help program
**Label:** CBT Buddy Standard Guidance
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** * 3 instead of 9 sessions, in week 1, 8 and 16.
* groups of up to 30 peers and a trained facilitator
* participants work through the tailored Third Wave CBT workbook by Rethink Wellbeing, one chapter each week
* in between, people practice the new skills learned in the workbook and are supported in an online community, guided by a trained psychologist and psychotherapist
**Intervention Names:**
- Behavioral: guided online self-help program
**Label:** CBT Group Minimum Guidance
**Type:** ACTIVE_COMPARATOR
#### Arm Group 4
**Description:** * 9 group sessions, at week 0-6, 8, 12, 18
* groups of 4-6 peers and a trained facilitator
* Internal Family Systems methods taught instead of CBT methods as in every other group
* participants work through the book "Self-Therapy: A Step-By-Step Guide to Creating Wholeness and Healing Your Inner Child Using IFS, A New, Cutting-Edge Psychotherapy" by Jay Earley, a few chapters each week
* in between, people practice the new skills learned in the workbook and are supported in an online community, guided by a trained psychologist and psychotherapist
**Intervention Names:**
- Behavioral: guided online self-help program
**Label:** IFS Group Standard Guidance
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- CBT Buddy Standard Guidance
- CBT Group Minimum Guidance
- CBT Group Standard Guidance
- IFS Group Standard Guidance
**Description:** 16 weeks of training and application of psychotherapeutic methods
**Name:** guided online self-help program
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** by WPAI:GH: Work Productivity \& Activity Impairment Questionnaire. The item values will be merged into one scale by turning each into a z-score while higher numbers will mean a higher productivity, and then calculating the average.
**Measure:** Productivity
**Time Frame:** Week 0, 8, 12, 16
**Description:** symptoms of interpersonal sensitivity, and executive dysfunction by BSI, of depressiveness and anxiety by GAD7 \& PHQ8. The scores will be merged into one by turning each of the 4 scales into a z-score while higher numbers will mean a larger burden, and then calculating the average.
**Measure:** Mental health burden
**Time Frame:** Week 0, 8, 12, 16
**Description:** psychological, social and emotional functioning as well as quality of life by WHOQOL-BREF, MHC-SF ONS-4 LS. The scores will be merged into one by turning each of the scales into a z-score while higher numbers will mean a higher wellbeing, and then calculating the average.
**Measure:** Wellbeing
**Time Frame:** Week 0, 8, 12, 16
#### Secondary Outcomes
**Description:** UCLA-3
**Measure:** Loneliness
**Time Frame:** Week 0, 8, 12, 16
**Description:** Rosenberg Self-esteem Scale
**Measure:** Self-esteem
**Time Frame:** Week 0, 8, 12, 16
**Description:** by IWAH
**Measure:** Connection/will to do good
**Time Frame:** Week 0, 8, 12, 16
**Description:** % of participants announcing their drop-out or not showing up to 2+ sessions, higher numbers mean higher dropout
**Measure:** Program dropout
**Time Frame:** Week 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16
**Description:** Treatment adherence, session engagement, working alliance, session attendance rate. The scores will be merged into one by turning each of the values into a z-score while higher numbers will mean a higher engagement, and then calculating the average.
**Measure:** Weekly engagement
**Time Frame:** Week 1, 2, 3, 4, 5, 6, 8, 12, 16
### Eligibility Module
**Eligibility Criteria:** Exclusion Criteria:
* average of self-assessed sociality negative
* people in acute crisis (they confirm and sign to not be in such a state)
* people who self-report not to be ambitiously altruistic, i.g., not involved in the effective altruism community, or working on or planning to work on something impactful that might help others.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** inga@rethinkwellbeing.org
**Name:** Inga Grossmann, PhD.
**Phone:** +4915209828014
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Wapenveld
**Contacts:**
***Contact 1:***
- **Name:** Inga Grossmann, PhD.
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Rethink Wellbeing
**Zip:** 8191TM
#### Overall Officials
**Official 1:**
**Affiliation:** Rethink Wellbeing
**Name:** Inga Grossmann, PhD.
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003072
- Term: Cognition Disorders
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7061
- Name: Depressive Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M7058
- Name: Depression
- Relevance: LOW
- As Found: Unknown
- ID: M29705
- Name: Cognitive Dysfunction
- Relevance: HIGH
- As Found: Cognitive Dysfunction
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M6301
- Name: Cognition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
### Condition Browse Module - Meshes
- ID: D000060825
- Term: Cognitive Dysfunction
### Intervention Browse Module - Browse Branches
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M14474
- Name: Psychotropic Drugs
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442059
**Brief Title:** Clinical Variables and Dyspnea and Fear of Movement in Chronic Obstructive Pulmonary Patients
**Official Title:** Examination of the Relationship Between Clinical Variables and Dyspnea and Fear of Movement in Chronic Obstructive Pulmonary Patients
#### Organization Study ID Info
**ID:** Kırıkkaleu-Caglanyetim
#### Organization
**Class:** OTHER
**Full Name:** Kırıkkale University
### Status Module
#### Completion Date
**Date:** 2024-10-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-10-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-10-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Kırıkkale University
#### Responsible Party
**Investigator Affiliation:** Kırıkkale University
**Investigator Full Name:** Saniye Aydoğan Arslan
**Investigator Title:** assoc. prof. Dr.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Patients diagnosed with COPD who applied to the Pulmonary Diseases Department of Kırıkkale Yüksek İhtisas Hospital will be included in the study. The aim of our study: It is aimed to investigate the effect of fear of movement due to dyspnea on respiratory function, muscle strength, physical performance and balance in Chronic Obstructive Pulmonary Disease Patients.
**Detailed Description:** At Kırıkkale Yüksek İhtisas Hospital, individuals with COPD who meet the inclusion and exclusion criteria and volunteer to participate in the study will be included. The number of patients to be included in our study will be determined by power analysis.
Sociodemographic information (Age, Gender, Body Mass Index, Smoking history) of the individuals included in the research will be recorded.
Regarding COPD symptoms:
Whether the cough is productive or non-productive, its frequency and period Presence of sputum, type, amount, color, presence of hemoptysis, Presence of chest pain, Presence of peripheral edema, You will be asked about the presence of resting and/or exertional dyspnea, orthopnea, paroxysmal nocturnal dyspnea (PND).
1. Respiratory Muscle Strength: It will be measured using an electronic, mobile, intraoral pressure measuring device.
2. Peripheral Muscle Strength Evaluation: Quadriceps muscle strength will be evaluated using a dynomometer.
3. Physical Performance: A 6-minute walk test will be used to determine the physical fitness levels of individuals.
4. Balance Level: Mini-BEST Test will be used to determine the balance level
5. Kinesiophobia Level Due to Dyspnea:
It will be evaluated with the Breathlessness Beliefs Questionnaire (BBQ). When the literature was examined, no study was found that examined all of these factors together in patients with COPD. Existing studies have shown that the effects of variables are different and it is stated that more studies are needed.
### Conditions Module
**Conditions:**
- COPD
- Kinesiophobia Due to Dyspnea
**Keywords:**
- Chronic obstructive pulmonary disease, kinesiophobia, physical performance, dyspnea
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 29
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients over the age of 45 who have been diagnosed with COPD and whose clinical condition is stable
**Intervention Names:**
- Other: Kinesiophobia Level Due to Dyspnea
**Label:** copd
### Interventions
#### Intervention 1
**Arm Group Labels:**
- copd
**Description:** Kinesiophobia Level Due to Dyspnea
**Name:** Kinesiophobia Level Due to Dyspnea
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** It will be evaluated with the Breathlessness Beliefs Questionnaire (BBQ).BBQ; It is a scale consisting of 11 questions that evaluates the person's kinesiophobia and anxiety due to breathlessness. Patients give scores to each question ranging from 1 (strongly disagree) to 5 (strongly agree). High scores indicate high levels of kinesiophobia and anxiety due to breathlessness.
**Measure:** Kinesiophobia Level Due to Dyspnea
**Time Frame:** 12 moon
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Being diagnosed with COPD Be clinically stable for the last four weeks Not using antibiotics for the last four weeks being over 45 years old, Volunteering to participate in the study
Exclusion Criteria:
* Not being able to cooperate with the evaluations to be made, Having any physical disability that may affect walking and balance Having severe neuromuscular, musculoskeletal and rheumatological problems accompanying COPD
**Maximum Age:** 85 Years
**Minimum Age:** 45 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** At Kırıkkale Yüksek İhtisas Hospital, individuals with COPD who meet the inclusion and exclusion criteria and volunteer to participate in the study will be included.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Kırıkkale
**Contacts:**
***Contact 1:***
- **Email:** fztsaniye1982@gmail.com
- **Name:** Saniye AYDOĞAN ARSLAN, Assoc. Dr.
- **Phone:** 5053333457
- **Phone Ext:** 90
- **Role:** CONTACT
***Contact 2:***
- **Email:** caglanuryetim@gmail.com
- **Name:** Çağla Nur YETİM, Pt
- **Phone:** 5465325176
- **Phone Ext:** 90
- **Role:** CONTACT
***Contact 3:***
- **Name:** Saniye Assoc. Dr. AYDOĞAN ARSLAN
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Çağla Nur Pt YETİM
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 5:***
- **Name:** Selma Dr DEMİR
- **Role:** SUB_INVESTIGATOR
**Country:** Turkey
**Facility:** Saniye Aydoğan Arslan
**Status:** RECRUITING
**Zip:** 71100
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000012818
- Term: Signs and Symptoms, Respiratory
- ID: D000010698
- Term: Phobic Disorders
- ID: D000001008
- Term: Anxiety Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7591
- Name: Dyspnea
- Relevance: HIGH
- As Found: Dyspnea
- ID: M2922
- Name: Kinesiophobia
- Relevance: HIGH
- As Found: Kinesiophobia
- ID: M11170
- Name: Lung Diseases, Obstructive
- Relevance: LOW
- As Found: Unknown
- ID: M23449
- Name: Pulmonary Disease, Chronic Obstructive
- 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
- ID: M15623
- Name: Signs and Symptoms, Respiratory
- Relevance: LOW
- As Found: Unknown
- ID: M13603
- Name: Phobic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4324
- Name: Anxiety 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: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004417
- Term: Dyspnea
- ID: D000092442
- Term: Kinesiophobia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442046
**Acronym:** SCOPE
**Brief Title:** Strengthening the Connections to Opportunities for Prevention Engagement
**Official Title:** Strengthening the Connections to Opportunities for Prevention Engagement (SCOPE)
#### Organization Study ID Info
**ID:** 24-052
#### Organization
**Class:** OTHER
**Full Name:** Connecticut Children's Medical Center
### Status Module
#### Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** The Tow Foundation
#### Lead Sponsor
**Class:** OTHER
**Name:** Kevin Borrup
#### Responsible Party
**Investigator Affiliation:** Connecticut Children's Medical Center
**Investigator Full Name:** Kevin Borrup
**Investigator Title:** Executive Director, Injury Prevention Center
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The Strengthening the Connections to Opportunities for Prevention Engagement (SCOPE) project will create a pathway for children and families from the City of Hartford to connect with a Connecticut Children's Care Coordinator (CC) in an effort to reduce levels of violence exposure.
**Detailed Description:** The Strengthening the Connections to Opportunities for Prevention Engagement (SCOPE) project will create a pathway for children and families from the City of Hartford to connect with a Connecticut Children's Care Coordinator (CC) when they are determined to have high levels of violence exposure.
SCOPE seeks to decrease future violence exposure and increase resiliency of children with high levels of exposure to violence through Emergency Department (ED)-based case management and connections with community partners.
Hypothesis 1: VPET scores within the intervention group will show significant reductions across the study period. The percent of patients with positive VPET positive scores within the intervention group will show significant reductions from the expected 79% to 70% as compared to the control group that will have the expected 79%
Hypothesis 2: The Child and Youth Resilience Measure-Revised (CYRM) scores for the intervention group will increase by 10%, and will be significantly higher than the control group.
Hypothesis 3: At least 75% of the intervention group will be assessed as "positive" for having made a connection with community services.
Hypothesis 4: 90% of parents with children receiving case management will report being satisfied with the case management services and community connected services.
Hypothesis 5: Retention within the intervention group will be at or above 50%, with at least half of participants remaining engaged in the project.
Hypothesis 6: Compared to the control group, the intervention group will have fewer documented injuries and ED visits during the 12-month period post-enrollment.
### Conditions Module
**Conditions:**
- Interpersonal Violence
- Structural Violence
**Keywords:**
- youth violence prevention
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 225
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Enrolled subjects will provide the study team with email, mobile, work phone, physical contact address, and contact numbers for two or more close contacts. Families will be contacted monthly by the case manager assist with additional supports they might need. Quarterly, patients and families will be contacted and patients will be asked to complete VPET and other measures. The intervention group will receive active case management to connect affected youth to community services.
**Intervention Names:**
- Other: Active Case Management
- Other: Treatment as usual
**Label:** Intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The comparison group will receive treatment as usual which consists of a list of community resources and a recommendation that youth not already connected with a community service provider be connected.
**Intervention Names:**
- Other: Treatment as usual
**Label:** Treatment as Usual
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention
**Description:** A case manager will work with families post-discharge to ensure that youth are connected to an appropriate community support. Case managers will also work with families to identify any social needs and provide support in accessing services as needed.
**Name:** Active Case Management
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Intervention
- Treatment as Usual
**Description:** Subjects will receive a list of youth serving community service agencies and provided a recommendation to connect to them.
**Name:** Treatment as usual
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** A reduction in exposure as measured using the Violence Prevention Emergency Tool (VPET) that provides a range from 0 to 21 with a 4 or more considered elevated.
**Measure:** Change from baseline violence exposure at 12 months
**Time Frame:** Baseline and months 3, 6, 9, and 12
#### Secondary Outcomes
**Description:** The Child and Youth Resilience Measure-Revised (CYRM) is a validated scale with resilience scores that range from 17 to 85 with a higher score indicating greater resilience.
**Measure:** Change in resilience score from baseline at 12 months
**Time Frame:** Baseline and months 3, 6, 9, and 12
**Description:** A dichotomous yes/no variable answering the question of are you currently connected to services at a community agency?
**Measure:** Difference in connections between intervention and control at 3-month intervals.
**Time Frame:** Quarterly measure at 0, 3, 6, 9, and 12 months
**Description:** Level of satisfaction with case management services as indicated along a 5-point scale from Not satisfied to Completely satisfied. Higher levels of satisfaction are related with other improved outcomes from baseline.
**Measure:** Level of satisfaction with case management services after 12 months of services
**Time Frame:** At 12-months of case management.
**Description:** Hospital documented injuries during the study period will be assessed on a quarterly schedule.
**Measure:** Difference in reported injuries between the intervention and control condition.
**Time Frame:** baseline, 3, 6, 9, 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* At least 8 years of age and not older than 17 years of age (until 18th birthday)
* Hartford resident based on zip code of primary residence or parent report?
* Accompanied by a parent or guardian who can provide consent
* Capable of providing assent/consent
* Able to provide consent in English or Spanish
* Presenting at CT Children's during recruitment hours
Exclusion Criteria:
* Patients whose primary complaint is for behavioral health
* Patients in Connecticut Department of Children and Families (DCF) or police custody
**Healthy Volunteers:** True
**Maximum Age:** 17 Years
**Minimum Age:** 8 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** Srsmith@ccmckids.org
**Name:** Sharon Smith, MD
**Phone:** 8605459295
**Role:** CONTACT
**Contact 2:**
**Email:** RBeebe01@connecticutchildrens.org
**Name:** Rebecca Beebe, PhD
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Connecticut Children's
**Name:** Kevin Borrup, DrPH
**Role:** PRINCIPAL_INVESTIGATOR
### 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:** NCT06442033
**Acronym:** GEARS
**Brief Title:** Genetics and Aerobic Exercise to Slow Parkinson's Disease Trial
**Official Title:** Genetics and Aerobic Exercise to Slow Parkinson's Disease (GEARS) Trial
#### Organization Study ID Info
**ID:** 24-100
#### Organization
**Class:** OTHER
**Full Name:** The Cleveland Clinic
### Status Module
#### Completion Date
**Date:** 2028-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institutes of Health (NIH)
#### Lead Sponsor
**Class:** OTHER
**Name:** Jay Alberts
#### Responsible Party
**Investigator Affiliation:** The Cleveland Clinic
**Investigator Full Name:** Jay Alberts
**Investigator Title:** Center Director
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The proposed multi-site, Genetics and Aerobic Exercise to Slow PD (GEARS) Trial will, for the first time, determine the interplay between genetics and exercise in altering PD progression. In sum, 200 PD patients will be recruited from the Cleveland and Salt Lake City metro areas to participate in the Pedaling for Parkinson's (PFP) community-based exercise program. Participants will exercise at community-based sites 3x/week for 12 months. All participants will undergo genotyping using an array that includes the genome backbone and common risk variants associated to increase risk for multiple neurological disorders including PD.
**Detailed Description:** A long-standing unmet need in the treatment of Parkinson's disease (PD) is the identification of a disease-modifying intervention (e.g. pharmaceutical, surgical or behavioral). A growing body of evidence indicates that high-intensity aerobic exercise, when delivered in a highly supervised, well-controlled laboratory setting, improves PD symptomology. Two fundamental gaps remain related to the widespread utilization of exercise to slow PD: 1) are community-based exercise programs effective in altering disease progression and 2) what is the role of genetics in modulating the disease altering effects of high-intensity aerobic exercise? Our underlying hypothesis is that high-intensity, community-based exercise slows disease progression in PD and does so more effectively in individuals with a lower genetic/biological burden. Genetic burden for PD will be determined through the calculation of a PD polygenic risk score (PRS).
Total study duration is \~12.5 months to accommodate data collection sessions and enrollment in PFP class. The study consists of five in-person assessments at the Cleveland Clinic or the University of Utah: informed consent, enrollment (On- and Off-medication separated by at least 24 hrs), 6 months (Off-medication), and 12 months (Off-medication). Asking participants to withhold medication for Off-state examinations imposes a burden, but the Off-state (12 hours off meds) will increase insight into the direct effect of exercise on PD and provides more reliable, less confounded time comparisons. Antiparkinsonian medication will be reconciled at Baseline, 6- and 12-month timepoints. Outcome metrics are provided in Table 1. Notably, all outcome metrics will be collected at each time point after the consent appointment (baseline on, baseline off, 6 month and 12 month) with the exception of the quality of life metrics (Neuro-QoL and MDS-UPDRS I, II, IV) which will be collected at one of the two baseline assessments (instead of both baseline assessments), 6 month, and 12 month; the quality of life questionnaires ask questions about one's quality of life over the previous 7 days and are non-specific to medication state. Genetic data and demographics will be gathered at the first enrollment assessment visit. Following the two enrollment visits, the participant will begin attending PFP classes 3x/wk at the community center most convenient to them. Participants will be recruited and enrolled on a continuous basis.
### Conditions Module
**Conditions:**
- Parkinson Disease
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Single Group
##### Masking Info
**Masking:** NONE
**Masking Description:** A historical control group will be utilized for analysis from a previous project. All participants in this study will be exercising in the community setting.
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Phases:**
- PHASE2
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All participants will exercise in a community setting 3x/week for 12 months
**Intervention Names:**
- Other: High intensity stationary cycling
**Label:** Interventional Arm
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Interventional Arm
**Description:** All community based exercise sessions are: 3x/week for 40 min, which includes a 5-min warm up \& cool down and a 30-minute main exercise set. Exercise parameters will be set by a neurologically trained physical therapist and will be progressed over time with the ultimate goal of the individual reaching moderate-vigorous exercise. Moderate-vigorous exercise for this project is defined as a cadence of 75+ rpms and a target HR of 60-80% of their age-predicted max
**Name:** High intensity stationary cycling
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Rater-observed PD global motor symptoms
**Measure:** MDS-UPDRS III
**Time Frame:** Enrollment On and Off Medications, 6 months post-enrollment, and 12 months post-enrollment
#### Secondary Outcomes
**Description:** Upper extremity dexterity
**Measure:** Nine Hole Peg Test
**Time Frame:** Enrollment On and Off Medications, 6 months post-enrollment, and 12 months post-enrollment
**Description:** Sit to stand from chair, ambulate 3m, turn, return to chair and sit
**Measure:** Timed Up & Go
**Time Frame:** Enrollment On and Off Medications, 6 months post-enrollment, and 12 months post-enrollment
**Description:** Cardiovascular Fitness
**Measure:** Six Minute Walk Test
**Time Frame:** Enrollment On and Off Medications, 6 months post-enrollment, and 12 months post-enrollment
**Description:** Symbol/digit matching; test of information processing speed, implicit learning
**Measure:** Processing Speed
**Time Frame:** Enrollment On and Off Medications, 6 months post-enrollment, and 12 months post-enrollment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Adult with a diagnosis of PD by a physician or physician extender
2. Hoehn and Yahr stage I-III
3. Demonstrate the ability to safely mount and dismount a stationary cycle
4. Reliable transportation to the community exercise facility
5. Smartphone device for activity data monitoring
6. On a stable dose of anti-parkinsonian medication
Exclusion Criteria:
1. Participation in disease modifying PD-related clinical trial or study
2. Diagnosis of dementia or any neurocognitive impairment that compromises one's ability to provide informed consent.
3. Implanted deep brain stimulation electrodes or focused ultrasound for PD management
4. Recommendation for medical clearance using the American College of Sports Medicine (ACSM) Preparticipation Health Screen a. If the ACSM screen recommends medical clearance, the participant must obtain medical clearance by their health care provider prior to participation.
b. Those who choose not to obtain physician clearance will not be eligible for participation.
e) A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in a cycling intervention f) Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke) g) Current cardiac arrhythmia
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** jansena@ccf.org
**Name:** Elizabeth Jansen, MPH
**Phone:** 216-780-9160
**Role:** CONTACT
**Contact 2:**
**Email:** rosenfa2@ccf.org
**Name:** Anson Rosenfeldt, DPT
**Phone:** 216-644-7617
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020734
- Term: Parkinsonian Disorders
- ID: D000001480
- Term: Basal Ganglia Diseases
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000009069
- Term: Movement Disorders
- ID: D000080874
- Term: Synucleinopathies
- ID: D000019636
- Term: Neurodegenerative Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
### Condition Browse Module - Browse Leaves
- ID: M13213
- Name: Parkinson Disease
- Relevance: HIGH
- As Found: Parkinson's Disease
- ID: M22494
- Name: Parkinsonian Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M25603
- Name: Ganglion Cysts
- Relevance: LOW
- As Found: Unknown
- ID: M16358
- Name: Synovial Cyst
- Relevance: LOW
- As Found: Unknown
- ID: M4774
- Name: Basal Ganglia Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12029
- Name: Movement Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M2217
- Name: Synucleinopathies
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010300
- Term: Parkinson Disease
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442020
**Brief Title:** Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy.
**Official Title:** Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy: Randomized Controlled Trial
#### Organization Study ID Info
**ID:** RS1874/23
#### Organization
**Class:** OTHER
**Full Name:** Regina Elena Cancer Institute
### Status Module
#### Completion Date
**Date:** 2026-09-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-09-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-09-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Regina Elena Cancer 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 study deals with the hypothesis that LiESWT in addition to the administration of PDE5i can improve sexuality rehabilitation with faster recovery of a valid erection and higher IIEF-5 scores in the short and medium-term follow-up.
**Detailed Description:** Prospective randomized controlled trial (RCT) designed to provide high level evidences describing the role of Low-intensity Extracorporeal Shock Wave Therapy LiESWT plus early introduction of PDE5i vs early PDE5i alone on penile rehabilitation of erectile dysfunction ED after treatment of post-Robot-Assisted (RA) Radical Prostatectomy (RP) RARP
### Conditions Module
**Conditions:**
- Erectile Dysfunction
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 158
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Therapeutic association between low intensity extracorporeal shock waves LiESWT and the early introduction of the phosphodiesterase 5 inhibitor PDE5i
**Intervention Names:**
- Procedure: Tadalafil (PDE5i)
**Label:** GROUP 1: LiESWT in association with PDE5i
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Control group, administration of the phosphodiesterase 5 inhibitor PDE5i, as per clinical practice
**Intervention Names:**
- Procedure: Tadalafil (PDE5i)
**Label:** GROUP 2: PDE5i alone
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- GROUP 1: LiESWT in association with PDE5i
- GROUP 2: PDE5i alone
**Description:** Tadalafil at a dose of 5mg/day
**Name:** Tadalafil (PDE5i)
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** To evaluate the impact that the use of low intensity extracorporeal shock waves LiESWT in combination with the early administration of phosphodiesterase 5 inhibitors has on the patient in the process of penile rehabilitation in erectile dysfunction following post-assisted radical prostatectomy robot
**Measure:** Impact of LiESWT
**Time Frame:** 3 years
#### Secondary Outcomes
**Description:** Compare the rate of patients achieving orgasm. The International Index of Erectile Function short form (IIEF-5) questionnaire is the recognized tool for assessing erectile function both before surgery and during follow-up.
**Measure:** Assess how many patients reach orgasm
**Time Frame:** 3 years
**Description:** Compare health-related quality of life outcomes through a validated self-administered questionnaire preoperatively and at postoperative follow-up assessment.
**Measure:** Questionnaires of Quality of life
**Time Frame:** 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients aged ≤75 yrs;
* Low-risk PCa (PSA \<10 ng/mL and GS \<7, ISUP grade 1, and cT1-2a) undergoing nerve sparing RARP;
* preoperative IIEF-5 score ≥ 17;
* First PSA (45d after surgery) \<0.2
* compliants patients able to follow the study protocol and fill in IIEF-5 scores and EORTC quality of life questionnaires;
* patients able to provide a written informed consent for the trial.
Exclusion Criteria:
* anaesthesiologic contraindications to robotic surgery;
* patients submitted to pelvic radiotherapy or androgen deprivation;
* patients reporting major postoperative complications (CD≥3);
* cardiovascular contraindications to PDE5i medical treatment.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** giuseppe.simone@ifo.it
**Name:** Giuseppe Simone, Doctor
**Phone:** 06-5266.5005
**Phone Ext:** +39
**Role:** CONTACT
**Contact 2:**
**Email:** riccardo.mastroianni@ifo.it
**Name:** Riccardo Mastroianni, Doctor
**Phone:** 06-5266.5005
**Phone Ext:** +39
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rome
**Contacts:**
***Contact 1:***
- **Email:** giuseppe.simone@ifo.it
- **Name:** Giuseppe Simone, Doctor
- **Phone:** 06-5266.5005
- **Phone Ext:** +39
- **Role:** CONTACT
***Contact 2:***
- **Email:** riccardo.mastroianni@ifo.it
- **Name:** Riccardo Mastroianni, Doctor
- **Phone:** 06-5266.5005
- **Phone Ext:** +39
- **Role:** CONTACT
**Country:** Italy
**Facility:** "Regina Elena" National Cancer Institute
**Status:** RECRUITING
**Zip:** 00144
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005832
- Term: Genital Diseases, Male
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000012735
- Term: Sexual Dysfunction, Physiological
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000020018
- Term: Sexual Dysfunctions, Psychological
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M15577
- Name: Shock
- Relevance: LOW
- As Found: Unknown
- ID: M10217
- Name: Erectile Dysfunction
- Relevance: HIGH
- As Found: Erectile Dysfunction
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8944
- Name: Genital Diseases, Male
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15546
- Name: Sexual Dysfunction, Physiological
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21873
- Name: Sexual Dysfunctions, Psychological
- 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: D000007172
- Term: Erectile Dysfunction
### Intervention Browse Module - Ancestors
- ID: D000014665
- Term: Vasodilator Agents
- ID: D000058986
- Term: Phosphodiesterase 5 Inhibitors
- ID: D000010726
- Term: Phosphodiesterase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000064804
- Term: Urological Agents
### Intervention Browse Module - Browse Branches
- Abbrev: VaDiAg
- Name: Vasodilator Agents
- Abbrev: Urol
- Name: Urological Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M279
- Name: Tadalafil
- Relevance: HIGH
- As Found: Tab
- ID: M29332
- Name: Phosphodiesterase 5 Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M17412
- Name: Vasodilator Agents
- Relevance: LOW
- As Found: Unknown
- ID: M13629
- Name: Phosphodiesterase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000068581
- Term: Tadalafil
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06442007
**Acronym:** Mindset-PK
**Brief Title:** Universally Delivered Interventions for Young People
**Official Title:** A 3-arm Multi-Center Exploratory Trial of Universally Delivered Interventions for Prevention of Anxiety and Depression in Young People in Pakistan
#### Organization Study ID Info
**ID:** Mindset-PK
#### Organization
**Class:** OTHER
**Full Name:** Pakistan Institute of Living and Learning
### Status Module
#### Completion Date
**Date:** 2025-03-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Fatima Jinnah Women University
#### Lead Sponsor
**Class:** OTHER
**Name:** Pakistan Institute of Living and Learning
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Mental health problems are amongst the major contributors to disease burden globally.
According to a recent study, 34% of young people worldwide (aged 10-19) suffer from depression and more than half of this population belongs to Southeast Asia such as Pakistan, India, and China.
Existing evidence shows that the access to mental health services in LMICs is limited and even fewer child psychiatric services are available.
One approach to overcome barriers such as limited availability of trained mental health professionals and risk of stigma may involve the use of simple, brief, scalable interventions based on basic psychological principles rather than treatment of psychopathology.
This study adapts and evaluates two brief interventions called behavioral activation single session intervention (BA-SSI) and 4-session Mindset intervention (MI) for teenage depression and anxiety in Pakistan, where access to mental health care is constrained by societal stigma and a shortage of clinicians.
**Detailed Description:** A 3-arm multi-center cluster exploratory Randomized Controlled Trial to determine the feasibility, acceptability and preliminary effectiveness of a universally delivered, culturally adapted, potentially low cost, 4-session Mindset intervention (MI) and behavioral activation single session intervention (BA-SSI) for school going young persons (YP) (12-15 years) in Pakistan.
Proposed study is designed using the updated Medical Research Council (MRC) Framework for the development and evaluation of complex interventions.
Three public schools will be recruited from each of 10 cities across Pakistan: Karachi, Hyderabad, Nawabshah, Thatta, Lahore, Gujrat, Rawalpindi, Multan, Quetta, and Peshawar.
All the participants, regardless of their treatment arm, will be assessed at baseline, 1 month post-baseline and at 3-month.
### Conditions Module
**Conditions:**
- Distress, Emotional
**Keywords:**
- adolescents
- anxiety
- depression
- single session interventions
- growth mindset
- Pakistan
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Three arm study. Schools would be the unit of cluster.
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 564
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This is comprised of 5 five components:
1. Discussion on the rationale of the behavioral activation
2. Awareness raising about distress, including how behavior shapes feelings and thoughts;
3. a life values assessment
4. the creation of an activity action plan
5. an exercise in which youths write about benefits that might result from engaging in each activity, an obstacle that might keep them from doing the activities and a strategy for overcoming the identified obstacles.
**Intervention Names:**
- Behavioral: Behavioral Activation - single session intervention (BA-SSI)
**Label:** Behavioral Activation - single session intervention (BA-SSI)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** This is comprised of a growth mindset module (2 sessions), a gratitude module (1 session) and a value affirmations module (1 session). Sessions are delivered weekly (over 4 weeks) and each session lasts for an hour. Reading and writing activities and group discussions are included in each session. Participants are supposed to complete homework exercises are assigned between sessions.
**Intervention Names:**
- Behavioral: 4-session Mindset intervention
**Label:** 4-session Mindset intervention
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** At end of the study, this group will be offered to choose one intervention from two active interventions mentioned above.
**Label:** Waiting list control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Behavioral Activation - single session intervention (BA-SSI)
**Description:** Single session intervention
**Name:** Behavioral Activation - single session intervention (BA-SSI)
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- 4-session Mindset intervention
**Description:** This is comprised of 4 sessions.
**Name:** 4-session Mindset intervention
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** This will be monitored through a research trial log. This log will include information about number of schools approached, number of schools eligible to participate, number of schools consented to participate, number of YP approached, number of eligible YP and number of those who consented to participate
**Measure:** Feasibility of recruitment
**Time Frame:** Total recruitment period is 3 months. Change in numbers will be recorded from first month of recruitment to 3rd month of recruitment
**Description:** Session attendance for each participant in active study arms for each session will be recorded and maintained in participant intervention log.
**Measure:** Feasibility of intervention
**Time Frame:** Retention of participants in the Intervention at the completion of one month intervention period.
**Description:** The Patient Health Questionnaire -8 will be used to assess the symptoms of depression. PHQ-8 scores are highly correlated with PHQ-9 scores, and the same cutoffs can be used to assess depression severity
**Measure:** Depression
**Time Frame:** Change in scores from baseline to 3-month follow up.
#### Secondary Outcomes
**Description:** It is a 47-item, youth self-report questionnaire with subscales including: separation anxiety disorder (SAD), social phobia (SP), generalized anxiety disorder (GAD), panic disorder (PD), obsessive compulsive disorder (OCD), and major depressive disorder (MDD). It also yields a Total Anxiety Scale (sum of the 5 anxiety subscales) and a Total Internalizing Scale (sum of all 6 subscales). Items are rated on a 4-point Likert-scale from 0 ("never") to 3 ("always").
**Measure:** The Revised Child Anxiety and Depression Scale
**Time Frame:** Change in scores from baseline to 3-month follow up
**Description:** The mindset scale is comprised of 3 items regarding participants' views about the mindset such as intelligence, personality etc. There is not cutoff score. Higher total summed scores indicate stronger fixed mindsets, and lower scores, stronger growth mindsets.
**Measure:** Growth Mindset scale
**Time Frame:** Change in scores from baseline to 3-month follow up
**Description:** A 4-item short version of the Hopelessness Scale includes all the affective, cognitive and motivational components of hopelessness.
**Measure:** Beck's hopelessness Scale short version
**Time Frame:** Change in scores from baseline to 3-month follow up
**Description:** This scale provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys. higher score indicare greater disability. there is no cutoff score.
**Measure:** EuroQol Quality of Life scale
**Time Frame:** Change in scores from baseline to 3-month follow up
**Description:** youths will be asked to complete a series of questions regarding their experience with the intervention to which they were assigned. highre score will indicate greater level of acceptability. there is no cut off score.
**Measure:** Program Feedback Scale
**Time Frame:** Total acceptability score at completion of one month intervention period.
### Eligibility Module
**Eligibility Criteria:** Young persons (YP)
Inclusion Criteria:
* Youth is between the age 12-15 years (inclusive) at the time of study enrollment.
* Youth has one parent or legal guardian to give consent.
* Youth speaks Urdu well enough to complete the paper based intervention.
Exclusion Criteria:
* Intellectual disability, as this may undermine comprehension of intervention material.
* Adolescent with history of hospitalization or those who received inpatient treatment for a mental health problem within the past two months as the intervention being tested and this study is not designed for adolescent with acute medical and/or psychiatric treatment needs (if identified with any acute medical and/or psychiatric problem, they would be referred to appropriate health services through parents).
Schools Inclusion Criteria
Schools in the study areas are eligible to participate if they meet all the following criteria:
1. the school authority agrees to participate;
2. the schools shall be non-specialist public schools;
3. school contains at least 80 students; Exclusion criteria
If the school meet the following exclusion criteria, they are ineligible to participate:
1. the school authority refuses to participate;
2. a specialist and/or independent or private school;
**Healthy Volunteers:** True
**Maximum Age:** 15 Years
**Minimum Age:** 12 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** tayyebakiran@gmail.com
**Name:** Tayyeba Kiran, PhD
**Phone:** 0923328262142
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rawalpindi
**Contacts:**
***Contact 1:***
- **Email:** tayyebakiran@gmail.com
- **Name:** Tayyeba Kiran, PhD
- **Phone:** 0923328262142
- **Role:** CONTACT
**Country:** Pakistan
**Facility:** Public school for boys 1
**State:** Punjab
### IPD Sharing Statement Module
**Description:** This is the feasibility study and interventions will continue to refine and adapt. The IP is owned by the Pakistan Institute of Living and Learning
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7061
- Name: Depressive Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M7058
- Name: Depression
- Relevance: LOW
- As Found: Unknown
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06441994
**Acronym:** Alpha-PS1
**Brief Title:** Clinical Trial of Targeted Alpha Therapy for Prostate Cancer
**Official Title:** A Phase I Investigator-initiated Clinical Trial of a Novel Targeted Alpha Therapy for Patients With Castration-resistant Prostate Cancer
#### Organization Study ID Info
**ID:** APS1-001
#### Organization
**Class:** OTHER
**Full Name:** Osaka University
### Status Module
#### Completion Date
**Date:** 2027-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-03
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-03-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** Japan Agency for Medical Research and Development
#### Lead Sponsor
**Class:** OTHER
**Name:** Osaka University
#### Responsible Party
**Investigator Affiliation:** Osaka University
**Investigator Full Name:** Tadashi Watabe
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** PSW-1025 is administered intravenously to patients with castration-resistant prostate cancer to evaluate its tolerability, safety, pharmacokinetics, absorbed dose, and efficacy, as well as to determine the recommended dose for Phase II.
**Detailed Description:** PSW-1025 is administered intravenously to patients with castration-resistant prostate cancer to evaluate its tolerability, safety, pharmacokinetics, absorbed dose, and efficacy, as well as to determine the recommended dose for Phase II. PSW-1025 (At-211 PSMA-5) is an alpha-ray-emitting drug labeled with Astatine (At-211) that targets PSMA (Prostate Specific Membrane Antigen).
### Conditions Module
**Conditions:**
- Prostate Cancer
**Keywords:**
- Astatine (At-211)
- Targeted alpha therapy
- PSMA (Prostate Specific Membrane Antigen)
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 15
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: PSW-1025
**Label:** Administration arm
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Administration arm
**Description:** PSMA (prostate specific membrane antigen)-targeted alpha therapy drug labeled with Astatine (At-211)
**Name:** PSW-1025
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Treatment-related adverse events as assessed by CTCAE v5.0
**Time Frame:** until 6 months after administration
**Measure:** Dose Limiting Toxicity
**Time Frame:** within 4 weeks after single administration
#### Secondary Outcomes
**Measure:** Number of participants with adverse events and their details
**Time Frame:** until 6 months after administration
**Measure:** Blood pressure (mmHg) and heart rate (bpm)
**Time Frame:** until 6 months after administration
**Measure:** Symptoms of the participants
**Time Frame:** until 6 months after administration
**Measure:** Hematological tests (blood cell counts)
**Time Frame:** until 6 months after administration
**Measure:** Urine tests (occult blood and urine protein)
**Time Frame:** until 6 months after administration
**Measure:** Electrocorticogram
**Time Frame:** until 6 months after administration
**Measure:** Prostate-Specific Antigen (PSA) (ng/ml)
**Time Frame:** until 6 months after administration
**Measure:** Tumor size on CT (mm)
**Time Frame:** until 6 months after administration
**Measure:** Excretion rates in urine, feces, and breath (%injected dose)
**Time Frame:** until 24 hours after administration
**Measure:** Absorbed doses in major organs (Gy)
**Time Frame:** until 24 hours after administration
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients with progressive castration-resistant prostate cancer who meet the following conditions (1) and (2) (1) Patients with progressive increase of serum Prostate-Specific Antigen (PSA) (\>=2ng/mL, three consecutive increases at least one week apart, and two increases of more than 50% from the lowest value), or with the tumor growth or appearance of new lesions detected by imaging studies (2) Patients with the serum testosterone at castration level (\< 50ng/dL)
2. Patients who meet the following conditions (1) and (2), resistant to standard treatment or not indicated for the generally approved standard treatments (1) Patients who have received at least one of the following treatments
* Inhibitors of androgen receptor signaling (enzalutamide, apalutamide, dalortamide, etc.)
* Inhibitors of Cytochrome P450 17 (CYP 17) (abiraterone acetate) (2) Patients previously treated with the taxane-based chemotherapy (docetaxel or cabazitaxel) or not adapted for the taxane-based chemotherapy (including refusal cases)\* \* Targeting for the patients who have received cabazitaxel therapy after docetaxel therapy, or patients for whom cabazitaxel therapy was not indicated (including refusal cases) after docetaxel therapy, or patients for whom both docetaxel therapy and cabazitaxel therapy were not indicated (including refusal cases)
3. Patients aged 18 years or older at the time of consent acquisition
4. Patients with stable general condition with PS (Performance status) of 0 to 2 in ECOG (Eastern Cooperative Oncology Group)
5. Patients who can be expected to survive for 6 months or more, judging from clinical symptoms and medical examination findings
6. Patients without or with controlled symptomatic brain metastases
7. Patients with no clinically significant abnormal findings in electrocardiogram, respiratory rate, and blood oxygen saturation within 30 days before the enrollment
8. Patients whose laboratory values within 30 days before the enrollment are within the range specified in the protocol
9. Patients who can use appropriate contraception during the clinical trial period according to the protocol
10. Patients who thoroughly listened to the explanation of the clinical trial, agreed to the various study procedures outlined in the clinical trial protocol and signed the consent document
Exclusion Criteria:
1. Patients who received systemic antitumor therapy (e.g. chemotherapy, immunotherapy, biologic therapy such as monoclonal antibodies, excluding androgen receptor signaling inhibitors) within 4 weeks before enrollment
2. Patients who received radium chloride (Radium, 223Ra) or 177Lu (Lutetium)-PSMA-617 within 6 months before registration
3. Patients currently receiving treatment with other cytotoxic chemotherapy, immunotherapy, radioligand therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitors, AKT inhibitors
4. Patients with active double cancer (simultaneous double cancer and ectopic double cancer with a disease-free period of 5 years or less)
5. Patients who received other investigational drugs within 5 weeks prior to enrollment
6. Patients with uncontrollable active infections
7. Hepatitis B surface antigen positive, Hepatitis C Virus antibody positive (patients with HCV-RNA level below the limit of detection can be registered) or Human Immunodeficiency Virus antibody positive patients
8. Patients with mental illness or psychiatric symptoms who are judged to be difficult to participate in clinical trials
9. Other patients who are judged to be inappropriate by the investigator, etc.
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** watabe.tadashi.med@osaka-u.ac.jp
**Name:** Tadashi Watabe, M.D., Ph.D.
**Phone:** +81-6-6879-3434
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Suita
**Contacts:**
***Contact 1:***
- **Email:** watabe.tadashi.med@osaka-u.ac.jp
- **Name:** Tadashi Watabe, M.D., Ph.D.
- **Phone:** +81-6-6879-3434
- **Role:** CONTACT
**Country:** Japan
**Facility:** Osaka University Hospital
**State:** Osaka
**Status:** RECRUITING
**Zip:** 565-0871
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005834
- Term: Genital Neoplasms, Male
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000005832
- Term: Genital Diseases, Male
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000011469
- Term: Prostatic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14335
- Name: Prostatic Neoplasms
- Relevance: HIGH
- As Found: Prostate Cancer
- ID: M8946
- Name: Genital Neoplasms, Male
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8944
- Name: Genital Diseases, Male
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14333
- Name: Prostatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011471
- Term: Prostatic Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06441981
**Brief Title:** Public Perception and Policy for SARS-CoV-2 Whole Genome Sequencing and Genomics for All
**Official Title:** Closing the Gap in Public Perception and Policy for SARS-CoV-2 Whole Genome Sequencing and Genomics for All
#### Organization Study ID Info
**ID:** WGS Project
#### Organization
**Class:** OTHER
**Full Name:** Indonesia University
### Status Module
#### Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-10-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-10-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Oxford University Clinical Research Unit
#### Lead Sponsor
**Class:** OTHER
**Name:** Indonesia University
#### Responsible Party
**Investigator Affiliation:** Indonesia University
**Investigator Full Name:** Rina Agustina
**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:** Gap in understanding undermines government and public support for SC2-WGS, and other wide-scale genomic sequencing (Gut microbiome, Genome Wide Sequencing for Prenatal Detection, Tuberculosis Metagenomic sequencing, Nutrigenetics and Cancer Next Generation Sequencing) as a routine part of the pandemic response, especially in low- and middle-income countries. However, such gaps can be closed with systematic efforts to define and measure specific misperceptions, and subsequently design and use targeted messages and promotional materials. We propose here in the following specific aims to first determine the entire set of beliefs and emotions regarding SC2-WGS and other genomic sequencing (Gut microbiome, Genome Wide Sequencing for Prenatal Detection, Tuberculosis Metagenomic sequencing, Nutrigenetics and Cancer Next Generation Sequencing), then identify and measure limiting belief constructs, and then create social media and communication media to address and overcome limiting beliefs strategically. The goal is to increase public and policymaker support for SC2-WGS and other genomic sequencing (Gut microbiome, Genome Wide Sequencing for Prenatal Detection, Tuberculosis Metagenomic sequencing, Nutrigenetics and Cancer Next Generation Sequencing) resources and actions for pandemic control.
**Detailed Description:** Implementing WGS, it is advisable to involve a variety of relevant actors and to consider the opinions of various stakeholders, including those who are not professionals in the field. This might resolve the implementation problem that could occur if psychological and social dimensions or, in other words, not strictly scientific criteria are not adequately integrated in decision making concerning complex issues such as innovations in genetics. In most cases, the reaction towards genetic information corresponds with a specific personal view of how to handle medical information and thus amplifies already existing mental phenomena (fear, stress, worries, etc.), tendencies of self-improvement and self-care and curiosity and playfulness.38 In the Study from Lewis et al, investigated in this relation the specific personality traits of participants of the first implementations of WGS, who were characterized as optimistic and resilient. This is a phenomenon often found in the group of early adopters of new technologies in general as described in the dimension knowing as empowerment to act, for some people, the willingness to know is caused by an attitude of openness towards the unknown and the desire to open new scenarios that could activate new opportunities for research as well as for themselves. This perspective highly reflects the currently dominant societal goal of health prevention and the main health policy discourse and practice of precaution. People have different perceptions of WGS and its imaginable integration into our health care system or our daily lives, and various approaches to decision-making regarding the potential use of WGS could be observed.
There are suboptimal national resources, inadequate specimen sampling strategies, to optimize epidemiological and clinical inference. There is a gap in the meta-data to interpret SC2-WGS information and other genomic sequencing (Gut microbiome, Genome Wide Sequencing for Prenatal Detection, Tuberculosis Metagenomic sequencing, Nutrigenetics and Cancer Next Generation Sequencing) in a complete and rapid manner. This understanding gap can undermine broad-scale government and public support as a routine part of the pandemic response, especially in low- and middle-income countries.
Therefore an intervention is needed in the form of genomic sequencing education. Before the intervention stage, there will be taking survey data which will be collected using the themes from the FGD results and will focus on assessing public perceptions regarding SC2-WGS and other genomic sequencing. These themes will be formulated into short statements and answered by respondents using a Likert scale. The survey will involve 100-200 respondents via WhatsApp chat bot. Subjects will be asked to express their reactions to short statements on a 4-point Likert scale. The subject will also be asked to express his emotional reaction to the statement with a series of binary questions related to positive or negative feelings. The survey results will be analyzed quantitatively to see the total score and distribution of each statement.
The next stage in this research is to develop social media and communication media. At this stage we will formulate public messages and strategies to improve perceptions based on the survey results. The public message formulated will be useful for educating the public using various social media platforms.
The intervention stage will be carried out by distributing information regarding genome sequencing via bots. After the intervention is carried out, changes in perception will be assessed before and after the intervention through pre-test and post-test questionnaires
### Conditions Module
**Conditions:**
- Knowledge, Attitudes, Practice
**Keywords:**
- Genome Sequencing
- Public Perception
- Public Policy
- COVID-19
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** The questionnaire in whatsapp chatbot format will be given to 100 and up to 200 persons from each targeted population. There Four targeted population namely, The public overall (comprised mostly of 18-29 years old adults whom have the most cases), Vulnerable groups (including the elderly between 50-80 years old, parents of children 0-12 years, and pregnant women), Doctors and other frontline health workers, and Program implementers and policy makers.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 800
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Educational material is provided via WhatsApp chatbot. After being educated, respondents were given a test to determine the increase in understanding of the material.
**Intervention Names:**
- Behavioral: Education
**Label:** Behavioral Education
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Behavioral Education
**Description:** Educational material brochures will be given to 800 respondents. Educational material is provided via WhatsApp chatbot. After being educated, respondents were given a test to determine the increase in understanding of the material.
**Name:** Education
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Assessment of respondents' knowledge regarding the educational material provided, calculated based on the number of questions answered correctly.
**Measure:** Knowledge
**Time Frame:** 2 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Living or working in Jakarta
* Young adult
* Adult
* Elderly
* Health workers
* Public Policy
Exclusion Criteria:
- Living or working outside Jakarta
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 21 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** r.agustina@ui.ac.id
**Name:** Rina Agustina
**Phone:** +622129189160
**Phone Ext:** 201052
**Role:** CONTACT
**Contact 2:**
**Email:** manajer.riset.fkui1@gmail.com
**Name:** Rahyussalim Rahyussalim
**Phone:** +622129189160
**Phone Ext:** 201908
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Jakarta Pusat
**Contacts:**
***Contact 1:***
- **Name:** Rina Agustina
- **Phone:** 0213912477
- **Role:** CONTACT
***Contact 2:***
- **Name:** Rina Agustina, MD, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Anuraj H Shankar, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Erfi Prafiantini, MD
- **Role:** SUB_INVESTIGATOR
**Country:** Indonesia
**Facility:** Department of Nutrition (FKUI-RSCM); and Human Nutrition Research Center, Indonesian Medical Education Research Institute (HNRC-IMERI) Faculty of Medicine, Universitas Indonesia
**State:** DKI Jakarta
**Status:** RECRUITING
**Zip:** 10430
#### Overall Officials
**Official 1:**
**Affiliation:** https://imeri.fk.ui.ac.id
**Name:** Rina Agustina
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Schumann S, Gschmeidler B, Pellegrini G. Knowing, relationships and trust-citizens' perceptions of whole genome sequencing for the Genetics Clinic of the Future. J Community Genet. 2021 Jan;12(1):67-80. doi: 10.1007/s12687-020-00486-0. Epub 2020 Sep 30.
**PMID:** 32997319
**Citation:** Lewis KL, Han PK, Hooker GW, Klein WM, Biesecker LG, Biesecker BB. Characterizing Participants in the ClinSeq Genome Sequencing Cohort as Early Adopters of a New Health Technology. PLoS One. 2015 Jul 17;10(7):e0132690. doi: 10.1371/journal.pone.0132690. eCollection 2015.
**PMID:** 26186621
#### See Also Links
**Label:** Re-Thinking Science: Knowledge and the Public in an Age of Uncertainty
**URL:** https://www.academia.edu/17329773/Re_Thinking_Science_Knowledge_and_the_Public_in_an_Age_of_Uncertainty_by_Helga_Nowotny_Peter_Scott_and_Michael_Gibbons
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M2561
- Name: COVID-19
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |