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## Protocol Section
### Identification Module
**NCT ID:** NCT06438445
**Brief Title:** Effects of Royal Jelly Supplementation in Chronic Kidney Disease
**Official Title:** Effects of Royal Jelly Supplementation on Inflammation and Cellular Senescence in Chronic Kidney Disease Patients Under Hemodialysis
#### Organization Study ID Info
**ID:** Interventional
#### Organization
**Class:** OTHER
**Full Name:** Universidade Federal Fluminense
### Status Module
#### Completion Date
**Date:** 2024-12-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-27
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-05-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Universidade Federal Fluminense
#### 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 study is to evaluate the effects of royal jelly on inflammation and cellular senescence in patients with chronic kidney disease (CKD) on hemodialysis (HD).
**Detailed Description:** Royal jelly is a substance produced in the hypopharyngeal glands of bees that operate young, and rich in bioactive compounds such as polyphenols, free fatty acids and exclusive peptides capable of mitigating inflammation and premature aging (genomic instability, mitochondrial dysfunction, shortening of telomeres) existing in patients with chronic kidney disease (CKD) on hemodialysis. However, to date there are no studies evaluating the effects of royal jelly on such complications in patients with RDC. Objectives: To evaluate the effects of royal jelly on inflammation and cellular senescence in patients with CKD. Methods: Clinical, longitudinal, randomized study, with washout and crossover period. Patients with CKD on HD received 140 mL bottles containing propolis and turmeric, and were instructed to take 10 mL/day (dosing cup), containing a dose equivalent to 110 mg/day of standardized green propolis extract (EPP-AF) plus 130 mg of curcuminoids/day or placebo for 8 weeks. After this supplementation, patients will enter the washout period (8 weeks) and after this period, the intervention group will receive placebo and vice versa. The collection of biological material (blood and feces) will be done before and after each study period. The mRNA expression of the transcription factors Nrf2 and NF-κB, as well as their target genes, antioxidant enzymes, inflammatory cytokines and the expression of genes and proteins that modulate the protein will be evaluated using rtPCR, western blotting and assay methods. multiplex. Uremic toxins from the intestinal microbiota such as indoxyl sulfate (IS), p-cresyl sulfate (p-CS) and Indole-3-acetic acid (IAA) will be confirmed by HPLC and plasma lipopolysaccharide (LPS) levels will be analyzed by ELISA. The determination of antioxidant capacity will be determined by the FRAP, ORAC AND DPPH methods. The analysis of the composition of the intestinal microbiota will be evaluated by high-throughput sequencing of the V4-V5 region of the 16S ribosomal RNA gene. Nutritional status and dietary intake will also be assessed.
### Conditions Module
**Conditions:**
- Kidney Failure, Chronic
- Oxidative Stress
- Hemodialysis
**Keywords:**
- Cellular Senescence
- Renal Dialysis
- Renal Insufficiency, Chronic
- Oxidative Stress
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with chronic kidney disease on hemodialysis will receive capsules containing 500mg of royal jelly/day for two months.
**Intervention Names:**
- Dietary Supplement: Real Jelly
**Label:** Real Jelly Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients with chronic kidney disease on hemodialysis will receive capsules containing 500mg of placebo/ day for two months.
**Intervention Names:**
- Dietary Supplement: Placebo
**Label:** Placebo group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Real Jelly Group
**Description:** Participants will receive 500mg of royal jelly capsules per day for two months.
**Name:** Real Jelly
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Placebo group
**Description:** Participants will receive 500mg of placebo capsules per day for two months.
**Name:** Placebo
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** The mRNA levels of Nrf2, Keap1, Bach1, NLPR3, NF-kB, HO-1, NQO1, p14, p16, p21 and p53 as well as VCAM, ICAM and E-selectin and TLR-4, TNFR and AhR receptors will be evaluated from peripheral blood mononuclear cells.
**Measure:** Change in inflammatory biomarkers
**Time Frame:** 6 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* patients with CKD undergoing hemodialysis for more than 6 months
* patients with arteriovenous fistula (AVF) as vascular access.
Exclusion Criteria:
* pregnant,
* lactating,
* smoker
* patients using antibiotics and antioxidant supplements in the last three months
* patients with autoimmune and infectious diseases,
* patients with cancer, liver disease, and AIDS
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Denise Mafra
**Phone:** 21985683003
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rio de Janeiro
**Country:** Brazil
**Facility:** Denise Mafra
**State:** RJ
**Zip:** 22260050
## 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: 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: M26717
- Name: Renal Insufficiency, Chronic
- Relevance: HIGH
- As Found: Chronic Kidney Disease
- ID: M26718
- Name: Renal Insufficiency
- Relevance: HIGH
- As Found: Kidney Failure
- ID: M10699
- Name: Kidney Failure, Chronic
- Relevance: HIGH
- As Found: Kidney Failure, Chronic
- ID: M10293
- Name: Inflammation
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: HIGH
- As Found: Chronic
### Condition Browse Module - Meshes
- ID: D000007674
- Term: Kidney Diseases
- ID: D000051436
- Term: Renal Insufficiency, Chronic
- ID: D000051437
- Term: Renal Insufficiency
- ID: D000007676
- Term: Kidney Failure, Chronic
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M14295
- Name: Propolis
- Relevance: LOW
- As Found: Unknown
- ID: T364
- Name: Bee Products
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06438432
**Acronym:** Activ'Tronc
**Brief Title:** Trunk Activity Rehabilitation in Young Children With Cerebral Palsy
**Official Title:** Trunk Activity Rehabilitation in Young Children With Cerebral Palsy
#### Organization Study ID Info
**ID:** RR-Flavigny-2023-2
#### Organization
**Class:** OTHER
**Full Name:** Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
### Status Module
#### Completion Date
**Date:** 2024-10-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-27
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-10-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-25
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Children with CP exhibit trunk control issues from early childhood, affecting their balance and gait. These issues manifest as unstable walking, increased step width, and more pronounced anterior deceleration of the sternum. Previous studies have shown that early action of the triceps surae compensates for the deficit in trunk postural control. Rehabilitation targeting the trunk has shown significant improvements in postural control and gait.
The main objective is to demonstrate that RAIT significantly reduces the peak anterior deceleration of the sternum at the beginning of the stance phase during barefoot spontaneous walking, with an enhanced effect from prolonged RAIT duration.
Secondary objectives include reducing the downward deceleration of the fifth lumbar vertebra (L5), step width, gait variability index, and improving scores on the early clinical balance scale and the global motor function evaluation.
Participants, children with spastic paraparesis or spastic hemiparesis capable of walking independently, are divided into two groups: one group continuing their usual rehabilitation for 3 months followed by RAIT for 9 months (RH-RAIT), and one group following RAIT for 12 months (RAIT-RAIT). RH involves rehabilitation exercises for lower limb muscles, while RAIT focuses on improving trunk postural control through activities involving intermediate postures.
Functional motor assessments will be conducted initially, then at 3, 6, and 12 months. These include clinical evaluations, gait analysis (step width, gait variability index, anterior foot support), and an analysis of static standing displacement using an inertial sensor placed at L5.
At M0, children with CP are expected to show higher values for deceleration peaks and gait variability indices, and lower scores on evaluation scales compared to typically developing (TD) children. After RAIT, an improvement in judgment criteria is expected: reduction in deceleration peaks, cycle width, gait variability index, anterior foot support, and an increase in scores on the ECPE and EMFG-66-SI.
This study aims to confirm that rehabilitation through trunk-involving activities is more effective than usual rehabilitation in improving postural control and gait dynamics in young children with cerebral palsy, suggesting that this approach could become a standard rehabilitation practice from early childhood.
### Conditions Module
**Conditions:**
- Children With Cerebral Palsy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### 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:** A first group of children will continue their usual rehabilitation (RH) for the first 3 months and then have RAIT for the following 9 months.
**Intervention Names:**
- Other: RAIT
**Label:** RH-RAIT
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The second group of children will have RAIT from the outset during the 12 months of the study.
**Intervention Names:**
- Other: RAIT
**Label:** RAIT-RAIT
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- RAIT-RAIT
- RH-RAIT
**Description:** The RAIT program focuses on improving postural control and balance of the entire body, including the trunk and other affected muscles, through autonomous actions in intermediate postures. This approach uses fundamental automatic control of postural support and balance to enhance the use of affected muscles during all postural and locomotor tasks. The child controls their balance during various voluntary actions from intermediate postures like alternating between four-legged and cobra postures, or swinging from the camel posture. These actions, less difficult than standing and walking, are expected to benefit the latter. The child also performs more challenging trunk movements, requiring dissociation of scapular and pelvic girdle movements or reducing lumbar lordosis.
**Name:** RAIT
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Varaible obtained via the analysis of walking on a zeno treadmill. A reduced value is expected after RAIT rehabilitation.
**Measure:** Peak anterior deceleration of the sternum at the start of weight-bearing
**Time Frame:** At inclusion, then 3, 6 and 12 months later
#### Secondary Outcomes
**Description:** The Evaluation Motrice Fonctionnelle Globale 66 (EMFG-66) is a standardized 66-item clinical score used to assess global motor function and its evolution over time in children with cerebral palsy. The EMFG-66-SI is a faster (approx. 20 to 30 minutes vs. 60 to 80 minutes), validated scoring method for the EMFG-66, using 15 to 39 items. The higher the score, the better.
**Measure:** EMFG-66-SI
**Time Frame:** At inclusion, then 3, 6 and 12 months later
**Description:** This is a 13-item clinical scale for assessing postural stability (balance ability) in children with cerebral palsy, with two subscales: one dedicated to head and trunk postural control, the other to sitting and standing postural control.The scale has been validated for children aged 1.5 to 11, regardless of GMFCS level (40,47). The scale has been validated for children aged 1.5 to 11, regardless of GMFCS level.)The optimal score is 100. Administering the scale takes around 15 minutes. The higher the score, the better.
**Measure:** The Early Clinical Balance Scale
**Time Frame:** At inclusion, then 3, 6 and 12 months later
**Description:** This questionnaire for parents, based on the child's voluntary movements for sitting, transferring and mobility, provides a 5-level classification of the severity of the child's cerebral palsy. Score between 1 and 5. The higher the score, the more severe the cerebral palsy.
**Measure:** Global Motor Function Classification System family report questionnaire
**Time Frame:** At inclusion
**Description:** This is a questionnaire designed for parents to assess the upper limb and hand abilities in different functional situations of their child with CP. This questionnaire, validated for children with CP from the age of 2, will help to assess the expected improvement in hand and upper limb function linked to RAIT. The higher the score, the better.
**Measure:** "Reach out" questionnaire
**Time Frame:** At inclusion, then 3, 6 and 12 months later
**Description:** This examination consists of measuring the amplitude of movement of the main joints in one or more planes, using a goniometer. Check against standards for each joint
**Measure:** Neuro-orthopaedic assessment
**Time Frame:** At inclusion, then 3, 6 and 12 months later
**Description:** This examination consists of measuring spasticity of the main muscles, by mobilizing a joint at slow and then fast speed to elicit a stretch reflex. Score between 0 and 4. 4 indicates the highest level of spasticity.
**Measure:** Neuro-orthopaedic assessment
**Time Frame:** At inclusion, then 3, 6 and 12 months later
**Description:** This examination consists of measuring the muscular strength of the main muscle groups, by asking the subject to mobilize a joint against resistance. Score between 0 and 5. The higher the score, the better.
**Measure:** Neuro-orthopaedic assessment
**Time Frame:** At inclusion, then 3, 6 and 12 months later
**Description:** varaible obtained via the analysis of walking on a zeno treadmill. A reduced value is expected after RAIT rehabilitation.
**Measure:** peak downward deceleration of L5 at the start of support
**Time Frame:** At inclusion, then 3, 6 and 12 months later
**Description:** Composite score based on 9 spatio-temporal parameters that quantifies the distance between the amount of variability observed in an asymptomatic reference group and the amount of variability observed in the patient. This index assesses gait instability and the risk of falling. It is usually high in children with CP.
**Measure:** Gait variability index
**Time Frame:** At inclusion, then 3, 6 and 12 months later
**Description:** Varaible obtained via the analysis of walking on a zeno treadmill. A reduced value is expected after RAIT rehabilitation.
**Measure:** Cycle width
**Time Frame:** At inclusion, then 3, 6 and 12 months later
**Description:** Ratio between the integrated pressure of the forefoot and the integrated pressure of the whole foot during the 1st double support. This variable will be higher the more the foot is supported on the ground by the forefoot, as in the PC child, and lower the more the foot is supported by the heel, as in the typically developing child.
**Measure:** Anterior support of the foot during 1st double support
**Time Frame:** At inclusion, then 3, 6 and 12 months later
**Description:** Score developed for children with cerebral palsy, assessing the extent of kinematic deviations compared to typically developing children. (0 = normal, 1 = moderate or mild pathology, 2 = severe pathology). So 0 here means the best EVGS score.
**Measure:** Edinburgh walk visual score
**Time Frame:** At inclusion, then 3, 6 and 12 months later
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
For children with CP
* Age between 18 months and 5 years 6 months
* CP type: spastic paraparesis or spastic hemiparesis, GMFCS I to II
* No or moderate retraction of the sural triceps (ankle dorsiflexion: \> 5° on clinical examination, knee straight)
* Sufficient level of understanding to carry out activities involving the trunk in the form of self-exercises (rehabilitation protocol), as well as clinical assessments and functional explorations.
* Acceptance by the physiotherapist in charge of the child's follow-up to collaborate in carrying out the RAIT.
* Affiliated with a social security scheme
For children with DT
* Age between 18 months and 5 years 6 months
* Walking acquired before age 18 months
* Sufficient level of understanding to perform clinical assessments and functional explorations
* Affiliated with a social security scheme
Exclusion Criteria:
For children with CP
* Previous surgery on lower limbs less than 1 year ago
* Botulinum toxin A injection less than 6 months ago
* Any change in rehabilitative and/or orthopedic management in the last 2 months
* Hip flessum \> 20
* Presence of subacute or chronic pain on standing or walking
For children with DT
- Neurological and/or orthopedic disorders that may influence gait
**Healthy Volunteers:** True
**Maximum Age:** 6 Years
**Minimum Age:** 18 Months
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jonathan Pierret, PhD
**Phone:** +33 3 83 52 6761
**Role:** CONTACT
**Contact 2:**
**Name:** Christian Beyaert, PU-PH
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Nancy
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jonathan Pierret, PhD
- **Phone:** +33 3 82 52 6761
- **Role:** CONTACT
***Contact 2:***
- **Name:** Christian Beyaert, PU-PH
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** Institut Régional de Médecine Physique et de Réadaptation
**Status:** RECRUITING
**Zip:** 54000
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000001925
- Term: Brain Damage, Chronic
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5796
- Name: Cerebral Palsy
- Relevance: HIGH
- As Found: Cerebral Palsy
- ID: M13157
- Name: Paralysis
- Relevance: LOW
- As Found: Unknown
- ID: M5207
- Name: Brain Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M5202
- Name: Brain Damage, Chronic
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002547
- Term: Cerebral Palsy
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06438419
**Acronym:** MOVOSCILLCBGT
**Brief Title:** Parkinsonism-Related Oscillations in the Cortico-Basal Ganglia-Thalamic Network During Movement: Beyond the Frequency Range
**Official Title:** Parkinsonism-Related Oscillations in the Cortico-Basal Ganglia-Thalamic Network During Movement: Beyond the Frequency Range
#### Organization Study ID Info
**ID:** CHUBX 2023/63
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Bordeaux
### Status Module
#### Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-27
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Université de Bordeaux, IMN, UMR CNRS 5293
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Bordeaux
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Expression of hypokinetic and hyperkinetic motor symptoms in Parkinson's disease (PD) is associated with pathological synchronous oscillations of neuronal activity (local field potential/LFP) in the cortico-subcortical network with a wide frequency range. In the present project, we propose to study cortico-subcortical oscillations and their synchronization in patients operated for PD (subthalamic deep brain stimulation (STN-DBS)) during distinct pharmacological and stimulation conditions (hypokinetic and hyperkinetic), using a simple motor task.
**Detailed Description:** To define the link between the characteristics of neuronal oscillations (frequency, amplitude, phase relationship) within the cortico-subcortical network and the movement, we designed a simple motor task of gripping/pulling a lever. The LFPs will be collected at the cortical and subcortical levels (STN) during the motor task using a high-resolution EEG (HR-EEG) and the Percept™ system (Medtronic). Recordings will be realized in four conditions: without pharmacological treatment and without stimulation (Off condition), without pharmacological treatment and during stimulation (DBS condition), during pharmacological treatment and without stimulation (DOPA condition) and during pharmacological treatment and stimulation (DOPA+DBS condition).
### Conditions Module
**Conditions:**
- Parkinson Disease
- Hyperkinesis
- Hypokinesia
**Keywords:**
- Parkinson disease
- hypokinetic disorders
- dyskinesia
- networks
- basal ganglia
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patient with idiopathic Parkinson's disease and having a STN DBS with a PERCEPT™ for less than a year or being candidate for subthalamic nucleus deep brain stimulation with the PERCEPT™ device (first-implantation)
**Intervention Names:**
- Other: Electrophysiological recordings
**Label:** Recruited patient
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Recruited patient
**Description:** Electrophysiological recordings will be made during a motor task in four different conditions:
1. without pharmacological treatment and without stimulation (Off condition),
2. without pharmacological treatment and during stimulation (DBS condition),
3. during pharmacological treatment and without stimulation (DOPA condition),
4. during pharmacological treatment and stimulation (DOPA+DBS condition).
**Name:** Electrophysiological recordings
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Statistically significant difference in the cortico-subcortical electrophysiological coherence value between a movement performed in hypokinetic condition and a movement performed in hyperkinetic condition
**Measure:** Cortico-subcortical electrophysiological coherence
**Time Frame:** At inclusion (D0)
#### Secondary Outcomes
**Description:** Demonstration of a significant difference in spectral signal power between movement in hypokinetic and hyperkinetic conditions.
**Measure:** Spectral signal power
**Time Frame:** At inclusion (D0)
**Description:** Demonstration of a significant effect of STN-DBS on spectral signal power and cortico-subcortical synchronization during movement in hypokinetic or hyperkinetic conditions
**Measure:** Effect of STN-DBS on spectral signal power
**Time Frame:** At inclusion (D0)
**Description:** Demonstration of a statistical correlation between semiological characteristics (hypo- and hyperkinesia, movement parameters (reaction time and movement time)) and electrophysiological characteristics.
**Measure:** Correlation between semiological characteristics
**Time Frame:** At inclusion (D0)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male or Female
* 18 to 75 years-old
* With idiopathic Parkinson's disease
* Having a STN-DBS with a PERCEPT™ for less than a year or being candidate for STN-DBS with the PERCEPT™ device (first-implantation)
* Able to perform the simple motor task
* Patients covered by a health insurance scheme
* Giving free, informed, written consent signed by the participant and the investigator.
Exclusion Criteria:
* Be incapable of giving consent personally.
* Be subject to a legal protection measure (curatorship, guardianship) or be placed under judicial protection.
* Being pregnant or breastfeeding
* Present a serious and/or decompensated somatic or psychiatric illness.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** GUEHL Dominique, Pr
**Phone:** 5 57 82 12 42
**Phone Ext:** +33
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Claire BRANDET
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Bordeaux
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dominique Guehl, Pr
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Claire BRANDET
- **Role:** CONTACT
**Country:** France
**Facility:** Bordeaux University Hospital
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001480
- Term: Basal Ganglia Diseases
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000009069
- Term: Movement Disorders
- ID: D000080874
- Term: Synucleinopathies
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000003560
- Term: Cysts
- ID: D000009369
- Term: Neoplasms
- ID: D000017520
- Term: Mucinoses
- ID: D000003240
- Term: Connective Tissue Diseases
- ID: D000020820
- Term: Dyskinesias
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
### Condition Browse Module - Browse Leaves
- ID: M25603
- Name: Ganglion Cysts
- Relevance: HIGH
- As Found: Ganglion
- ID: M13213
- Name: Parkinson Disease
- Relevance: HIGH
- As Found: Parkinson's Disease
- ID: M22494
- Name: Parkinsonian Disorders
- Relevance: HIGH
- As Found: Parkinsonism
- ID: M20582
- Name: Hypokinesia
- Relevance: HIGH
- As Found: Hypokinesia
- ID: M9999
- Name: Hyperkinesis
- Relevance: HIGH
- As Found: Hyperkinesis
- ID: M22574
- Name: Dyskinesias
- Relevance: LOW
- As Found: Unknown
- ID: M16358
- Name: Synovial Cyst
- Relevance: LOW
- As Found: Unknown
- ID: M6765
- Name: Cysts
- Relevance: LOW
- As Found: Unknown
- ID: M4774
- Name: Basal Ganglia Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12029
- Name: Movement Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M2217
- Name: Synucleinopathies
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19781
- Name: Mucinoses
- Relevance: LOW
- As Found: Unknown
- ID: M6464
- Name: Connective Tissue Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000045888
- Term: Ganglion Cysts
- ID: D000010300
- Term: Parkinson Disease
- ID: D000020734
- Term: Parkinsonian Disorders
- ID: D000018476
- Term: Hypokinesia
- ID: D000006948
- Term: Hyperkinesis
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M7471
- Name: Dihydroxyphenylalanine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06438406
**Brief Title:** Postural Assessment, Therapeutic Exercise and Orthotic Devices in the Prevention of Haemophilic Arthropathy
**Official Title:** Postural Assessment, Therapeutic Exercise and Orthotic Devices in the Prevention of Haemophilic Arthropathy
#### Organization Study ID Info
**ID:** MFR052024
#### Organization
**Class:** OTHER
**Full Name:** University of Palermo
### Status Module
#### Completion Date
**Date:** 2024-05-27
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-27
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-10-30
**Type:** ACTUAL
#### Start Date
**Date:** 2023-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### 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:** Haemophilic arthropathy (HA) is the most frequent complication of haemophilia and is often associated with a severe deterioration in quality of life. It is caused by repeated joint bleeding resulting in chronic proliferative synovitis and progressive destruction of articular cartilage. The most frequently affected joints are the knees, ankles and elbows.
The aim of this study is to verify the use of lower limb orthoses in combination with postural rehabilitation, assessing the incidence of spontaneous haemarthroses and haematomas as the primary endpoint and pain and QoL as secondary endpoints.
We conducted a prospective observational, randomised and controlled study on outpatients attending the UOC of Recovery and Functional Rehabilitation of the AOUP Paolo Giaccone of Palermo for haemophilic arthropathy sent by the UO of Haematology of the same hospital. The study period was between January 2017 and March 2023.
The patients recruited were randomly divided into two groups by means of a computer-generated random number system: group A, consisting of patients who were prescribed orthoses and a 20-session rehabilitation programme; group B, consisting of patients who were only prescribed orthoses for the lower limbs. The rehabilitation programme was based on the Back School method.
All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2).
Two arthropathic-specific scales were used to assess outcomes, namely the Hemophilia Joint Health Score (HJHS), which reflects joint function and status, and the Functional Independence Score in Hemophilia (FISH), which relates to the patient\'s quality of life. We also used the Numerical Rating Scale (NRS) for joint pain. Finally, postural assessment was performed in static posture, observing the patient\'s alignment in different planes and using the APECS (AI Posture Evaluation and Correction System ®) mobile app. During the re-evaluations, any new haemarthroses and haematomas were also assessed.
### Conditions Module
**Conditions:**
- Haemophilic Arthropathy
- Orthosis
- Foot Malalignment
**Keywords:**
- haemophilic arthropathy
- orthosis
- postural assestment
- foot malalignment
- therapeutic exercise
- haemarthroses
- haematomas
- HJHS
- FISH
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 15
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Group A consisting of patients who were prescribed orthoses, to use gradually, and a 20-session rehabilitation programme, based on the Back School method
**Intervention Names:**
- Device: Orthotic devices and therapeutic exercise (Group A)
- Device: Orthotic devices (Group B)
**Label:** Orthotic devices and therapeutic exercise (Group A)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Group B consisting of patients who were only prescribed orthoses for the lower limbs
**Intervention Names:**
- Device: Orthotic devices and therapeutic exercise (Group A)
- Device: Orthotic devices (Group B)
**Label:** Orthotic devices (Group B)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Orthotic devices (Group B)
- Orthotic devices and therapeutic exercise (Group A)
**Description:** Group A consisting of patients who were prescribed orthoses, to use gradually, and a 20-session rehabilitation programme, based on the Back School method
**Name:** Orthotic devices and therapeutic exercise (Group A)
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Orthotic devices (Group B)
- Orthotic devices and therapeutic exercise (Group A)
**Description:** Group B consisting of patients who were only prescribed orthoses for the lower limbs
**Name:** Orthotic devices (Group B)
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** During re-evaluations, the possible appearance of new haemarthroses and haematomas was assessed ,which were absent at the baseline examination
**Measure:** prevention of haemophilic arthropathy
**Time Frame:** All patients were assessed at 3 months (T1) and after 6 months (T2).
#### Secondary Outcomes
**Description:** This score is a performance-based assessment tool used to measure the functional ability of patients. The maximum score is 32 (the greatest autonomy).
**Measure:** Functional Independence Score in Hemophilia (FISH)
**Time Frame:** All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2)
**Description:** The Hemophilia Joint Health Score is a rating scale that measures joint health in the domains of anatomical structure and function (biomechanics) of the joints most frequently affected by haemorrhage in haemophilia: knees, ankles, elbows.
**Measure:** Hemophilia Joint Health Score (HJHS)
**Time Frame:** All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2)
**Description:** The NRS scale is a one-dimensional 11-point scale that assesses pain intensity in adults, with a range from 0 to 10, corresponding to 'no pain' and 'worst pain imaginable'
**Measure:** Numerical Rating Scale (NRS)
**Time Frame:** All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* diagnosis of severe haemophilia A or B;
* age ≥ 6 years and ≤ 50 years;
* presence of hindfoot and/or arch misalignment;
* prophylaxis with factor deficient (VIII or IX).
Exclusion Criteria:
* patients with prosthetic implants/synthetic means
* uncooperative patients
**Gender Based:** True
**Maximum Age:** 50 Years
**Minimum Age:** 6 Years
**Sex:** MALE
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Palermo
**Country:** Italy
**Facility:** A.O.U.P. Paolo Giaccone
**Zip:** 90127
### IPD Sharing Statement Module
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
- ANALYTIC_CODE
**IPD Sharing:** YES
**URL:** https://www.unipa.it/persone/docenti/l/giulia.letiziamauro/
## 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
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10621
- Name: Joint Diseases
- Relevance: HIGH
- As Found: Arthropathy
- ID: M9493
- Name: Hematoma
- Relevance: LOW
- As Found: Unknown
- ID: M9483
- Name: Hemarthrosis
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T2713
- Name: Hemophilic Arthropathy
- Relevance: HIGH
- As Found: Hemophilic Arthropathy
### Condition Browse Module - Meshes
- ID: D000007592
- Term: Joint Diseases
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06438393
**Acronym:** SAFE-CT
**Brief Title:** Screening Coronary Artery Disease Using artiFicial intelligencE in Non-contrast Computed Tomography
**Official Title:** Screening Coronary Artery Disease Using artiFicial intelligencE in Non-contrast Computed Tomography
#### Organization Study ID Info
**ID:** SAFE-CT
#### Organization
**Class:** OTHER
**Full Name:** Universidade do Porto
### Status Module
#### Completion Date
**Date:** 2027-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-27
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-02
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Oxford
**Class:** OTHER
**Name:** University of Edinburgh
#### Lead Sponsor
**Class:** OTHER
**Name:** Universidade do Porto
#### 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 improve direct patient care by reducing the risks of futile exposure to ionizing radiation and iodinated contrast in patients referred for coronary computed tomography angiography
**Detailed Description:** Since the last NICE guidelines update recommending computed tomography coronary angiography (CTCA) as the first line of investigation for patients with suspected coronary artery disease (CAD), there has been a high burden in the healthcare system and unnecessary exposition to radiation and iodine-containing contrast medium, especially in the youngest. Around 35% of patients who currently undergo CTCA have normal coronaries which means those patients were unnecessary exposed to radiation and contrast. A CTCA screening strategy to rule out CAD is needed to comply with the ALARA ("As Low As Reasonable Achievable") principles preventing radiation risks, reducing unnecessary scans and directing healthcare resources to those who will benefit from a CTCA.
We designed the SAFE-CT (Screening coronary Artery disease using artiFicial intelligencE in noncontrast Computed Tomography) study to develop a state-of-art artificial intelligence method to detect CAD as defined on CTCA using high-dimensional data (radiomics) extracted from the non-contrast cardiac computed tomography (CT). The model will be trained in 15,000 subjects scanned with paired non-contrast CT and CTCA and externally validated in an independent cohort of 1,000 subjects. In a preliminary analysis, non-contrast CT radiomics improved calcium score performance and discriminated CAD with an AUC of 0.91 (95% CI: 0.83-1.00). The algorithm will be converted into a user-friendly plugin to automatically decide whether the patient needs contrast. A real-world multicentre cohort study will be planned for software prospective validation and the creation of a large-scale proteomic biobank to support the translation of imaging biomarkers worldwide.
SAFE-CT can change the current CT scanning workflow by creating software that accurately rules out any CAD in \>1/3 of patients referred for CTCA with low radiation and no contrast. This accurate machine learning model will be optimized to reach \>90% sensitivity and negative predictive value and will bring several advantages for patients and the healthcare system:
* Prevention of radiation and contrast exposition.
* Increased CTCA scanning capacity for complex cases.
* Widespread use of CT for CAD exclusion in the emergency department and in outpatient clinics of centres with no CTCA.
* Improved screening tool for CAD in asymptomatic subjects.
* Up- and downstream cost reduction.
The SAFE-CT project proposes a safer, low-cost, and personalized CTCA scanning strategy that fosters scientific and technological innovation with the potential to bring improvement to patient care and clinical practice, and, thereby, societal, and economic impact.
### Conditions Module
**Conditions:**
- Coronary Artery Disease
- Coronary Atheroscleroses
**Keywords:**
- Artificial intelligence
- Radiomics
- Deep learning
- Coronary artery disease
- Non-contrast computed tomography
### Design Module
#### Bio Spec
**Description:** Peripheral blood samples for proteomics analysis
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 1000
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** CAD: Presence of minimal coronary artery disease (i.e., coronary stenosis 0-25%) Normal coronary arteries: No visible coronary atherosclerosis
**Intervention Names:**
- Diagnostic Test: CT coronary angiography and non-contrast CT
**Label:** Stable chest pain and unknown CAD who underwent CTCA and CCS in the same scanning session
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Stable chest pain and unknown CAD who underwent CTCA and CCS in the same scanning session
**Description:** A CTCA is an X-ray computed tomography of the coronary arteries that allows visualization of coronary plaques with high temporal and spatial resolution, however, it implies the use of iodine contrast and exposition to clinically significant ionizing radiation.
Non-contrast ECG-gated CT ("calcium score" - CCS image). A non-contrast cardiac CT for CCS can be performed very quickly with significantly lower radiation (\~6 times lower) than CTCA and without the need for contrast.
**Name:** CT coronary angiography and non-contrast CT
**Other Names:**
- Non-contrast computed tomography
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Measure:** Build a non-contrast CT radiomic signature of CAD
**Time Frame:** 3 years
**Measure:** Implement a machine learning model to discriminate patients with no CAD from patients with at least minimal disease (CAD-RADS=0 vs. CAD-RADS>0).
**Time Frame:** 3 years
**Measure:** Implement a machine learning model to detect coronary inflammation as defined using the Fat Attenuation Index (FAI ≥ -70.1 HU) in patients with no visible coronary plaque (CAD-RADS=0).
**Time Frame:** 3 years
**Measure:** Build a user-friendly plugin to facilitate users experience and distribution of our technology in clinical practice.
**Time Frame:** 3 years
**Measure:** Evaluate the real-world operationality and performance of the plugin in an international multicentre prospective cohort study.
**Time Frame:** 3 years
**Measure:** Create a national registry of cardiac CT
**Time Frame:** 3 years
#### Secondary Outcomes
**Measure:** Setup a human blood biobank to identify the peripheral blood mononuclear cells (PBMCs) and plasma proteomics associated with CT data and clinical outcomes.
**Time Frame:** 3 years
**Measure:** Setup a public CT imaging repository
**Time Frame:** 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
- Patient with stable chest pain who underwent a CTCA
Exclusion Criteria:
* Missing non-contrast CT image (coronary calcium score image)
* Known coronary artery disease
* Prior myocardial infarction
* Prior PCI or CABG
**Healthy Volunteers:** True
**Maximum Age:** 100 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Stable chest pain patients with unknown CAD who underwent a CTCA with paired non-contrast CT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Porto
**Country:** Portugal
**Facility:** Faculty of Medicine of Porto
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000001161
- Term: Arteriosclerosis
- ID: D000001157
- Term: Arterial Occlusive Diseases
- ID: D000014652
- Term: Vascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M6546
- Name: Coronary Artery Disease
- Relevance: HIGH
- As Found: Coronary Artery Disease
- ID: M19506
- Name: Myocardial Ischemia
- Relevance: HIGH
- As Found: Coronary Artery Disease
- ID: M6549
- Name: Coronary Disease
- Relevance: HIGH
- As Found: Coronary Artery Disease
- ID: M26188
- Name: Atherosclerosis
- Relevance: HIGH
- As Found: Atherosclerosis
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4469
- Name: Arteriosclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M4465
- Name: Arterial Occlusive Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003324
- Term: Coronary Artery Disease
- ID: D000017202
- Term: Myocardial Ischemia
- ID: D000003327
- Term: Coronary Disease
- ID: D000050197
- Term: Atherosclerosis
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: Infe
- Name: Anti-Infective Agents
### Intervention Browse Module - Browse Leaves
- ID: M5381
- Name: Calcium
- Relevance: LOW
- As Found: Unknown
- ID: M5398
- Name: Calcium, Dietary
- Relevance: LOW
- As Found: Unknown
- ID: M10488
- Name: Iodine
- Relevance: LOW
- As Found: Unknown
- ID: M229695
- Name: Cadexomer iodine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06438380
**Brief Title:** User Experience of a Telemedicine Platform for the Follow-up of Post Intensive Care Syndrome (PICS)
**Official Title:** Experience of Critically Ill Patients in the Use of a Telemedicine Platform for the Follow-up of Post Intensive Care Syndrome (PICS) After ICU Discharge
#### Organization Study ID Info
**ID:** 2023/5126
#### Organization
**Class:** NETWORK
**Full Name:** Parc Tauli Research and Innovation Institute Foundation
### Status Module
#### Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-27
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** NETWORK
**Name:** Parc Tauli Research and Innovation Institute Foundation
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Survivors of critical illness may present with a set of physical, emotional and cognitive sequelae, known as Post Intensive Care Syndrome (PICS). These alterations can become chronic over time and significantly affect patients' quality of life. Therefore, follow-up and monitoring of critically ill patients after ICU discharge, for example through telemedicine, could be essential for the prevention, early detection and management of PICS.
Our main objective is to evaluate the suitability and user experience of a telemedicine platform from the perspective of critically ill patients. This study proposes the participation of ICU survivors in the design and improvement of a telemedicine platform for PICS follow-up through a qualitative approach. Participants will test the platform in person three months after discharge from the ICU and then undergo a semi-structured interview to assess their experience. The findings derived from this study may contribute to improve both the content and the format of the platform, optimizing resources and facilitating the management of post-ICU sequelae, which will have a positive impact on the patient's recovery process.
### Conditions Module
**Conditions:**
- Critical Illness
**Keywords:**
- Qualitative research
- Post-Intensive Care Syndrome
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 14
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** To evaluate the user experience of a telemedicine platform for monitoring post-intensive care syndrome from the perspective of critically ill patients after ICU discharge through semi-structured interviews
**Measure:** 1:1 semi-structured interviews
**Time Frame:** 3 months after ICU discharge
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult patients (≥18 years)
* Admitted to a medical/surgical ICU
* For respiratory failure, cardiogenic shock, or septic shock
* With an expected ICU stay of ≥48 hours
* Catalan and/or Spanish speakers
* Who are able to give informed consent by themselves
Exclusion Criteria:
* History of intellectual disability or other neurodevelopmental disorders, such as autism spectrum disorder
* History of neurological disorders, dementia or other neurodegenerative diseases, such as epilepsy, Alzheimer's disease, Parkinson's disease or multiple sclerosis
* History of brain damage, such as traumatic brain injury or stroke
* History of severe psychiatric illness, such as psychotic, bipolar, depressive, obsessive-compulsive, post-traumatic or personality disorder
* Suspected or confirmed substance use disorder
* Suspected or confirmed communicable disease in an isolated patient
* Uncorrected hearing or visual impairment
* Enrolled in another trial that does not allow co-enrollment
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Critically ill patients admitted to the ICU of the Parc Tauli Hospital (Sabadell, Spain).
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Marta Godoy-González, PhD student
**Phone:** +34937236673
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Sol Fernández-Gonzalo, PhD
**Phone:** +34937236673
**Role:** CONTACT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020969
- Term: Disease Attributes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M19010
- Name: Critical Illness
- Relevance: HIGH
- As Found: Critical Illness
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000016638
- Term: Critical Illness
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06438367
**Brief Title:** TGRX-326 Pharmacokinetic Mass Balance
**Official Title:** Mass Balance Study of [14C]TGRX-326 in Healthy Adult Chinese Male Participants
#### Organization Study ID Info
**ID:** TGRX-326-1004
#### Organization
**Class:** INDUSTRY
**Full Name:** Shenzhen TargetRx, Inc.
### Status Module
#### Completion Date
**Date:** 2024-10-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-27
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** The First Affiliated Hospital of Soochow University
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Shenzhen TargetRx, Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This is a pharmacokinetic study for TGRX-326 on mass balance to evaluate distribution, metabolism and excretion of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer.
**Detailed Description:** This study is designed as a single-center, single-dose, non-randomized and open-label study. The study will be conducted in healthy male participants to evaluate distribution, metabolic pathways and route of excretion of TGRX-326 using the Carbon-14 labelled isotope of TGRX-326 compound. Safety evaluation will also be conducted.
### Conditions Module
**Conditions:**
- Non Small Cell Lung Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 6
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** healthy subjects will be given 60mg/100uCi\[14C\]TGRX-326 in suspension
**Intervention Names:**
- Drug: [14C]TGRX-326
**Label:** Experimental: TGRX-326
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental: TGRX-326
**Description:** Healthy subjects will be given TGRX-326 60 mg orally on day 1.
**Name:** [14C]TGRX-326
**Other Names:**
- TGRX-326
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** \[C14\]TGRX-326 radioactivity detected in urine
**Measure:** Urine radioactivity
**Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing
**Description:** \[C14\]TGRX-326 radioactivity detected in feces
**Measure:** Fecal radioactivity
**Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing
**Description:** percentage of \[C14\]TGRX-326 radioactivity in plasma
**Measure:** Plasma AUC (Area under curve) percentage
**Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing
**Description:** percentage of \[C14\]TGRX-326 radioactivity in urine
**Measure:** Urine %Dose
**Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing
**Description:** percentage of \[C14\]TGRX-326 radioactivity in feces
**Measure:** Fecal %Dose
**Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing
**Description:** Maximum concentration of \[C14\]TGRX-326 measured in plasma
**Measure:** Plasma Cmax
**Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing
**Description:** Time to maximum concentration of \[C14\]TGRX-326 measured in plasma
**Measure:** Plasma Tmax
**Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing
#### Secondary Outcomes
**Description:** to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs)
**Measure:** Adverse events/serious adverse events
**Time Frame:** From screening through completion of study, an average of 1 to 1.5 months.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Healthy adult males
* Age between 18 and 45 years old (both limits included)
* Body weight index between 19.0 and 26.0 kg/m2 (both limits included), and body weight not less than 50.0kg
* Willing to consent
* Able to communicate with investigator and complete study according to study protocol
Exclusion Criteria:
* Clinically significant results from comprehensive physical and clinical examinations
* Positive results on hepatitis, HIV or syphilis
* Clinically significant results from eye examination
* Usage of inducer or inhibitor drugs to drug metabolism with 30 days prior to screening
* Usage of any prescription or non-prescription drug, Chinese herbal medicine or dietary supplements
* Presence of any significant medical history or clinical conditions that could affect study results per investigators' judgement
* Presence of any condition that could affect drug absorption
* Reception of major surgery within 6 months before screening, or surgical wounds not completely healed
* Presence of allergic reactions or may be allergic to ingredients in the investigational drug
* Presence of hemorrhoids, or having history of or is having conditions that cause bloody feces
* Habitual congestion or diarrhea
* Alcohol abuse or excessive alcohol consumption within 6 months before screening
* Excessive smoking within 3 months before screening
* Substance abuse or positive results on urine substance test
* Habits of grapefruit juice consumption or excessive caffeinated drinks consumption
* History of long-term exposure under radiation; or significant radiation exposure 1 year before this study; or participation in other radioactive drug studies
* Having difficulties to receive venous needle puncture, or cannot tolerate venous needle puncture, or history of hematophobia or needle sickness
* Participation in any other clinical studies within 3 months before screening
* Reception of vaccine within 1 months before screening, or planning to be vaccinated during the study
* Planning to have children or donate sperms during the study and within 1 year after the study, or Not agreeing to take contraceptive measures during and within 1 year after study completion
* Blood donation or blood loss of \> 400 ml within 3 months before screening; blood donation or blood loss of \> 200 ml within 1 month before screening; reception of blood transfusion within 1 months before screening, or planning to donate blood within 3 months after study completion
* Having special dietary requirements and unable to follow the uniform dietary plan in the study
* Any conditions that the investigator deemed unfit for the study
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Haifang Guo, PhD
**Phone:** +86-18762407693
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** The First Affiliated Hospital of Soochow University
**Name:** Liyan Miao, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002283
- Term: Carcinoma, Bronchogenic
- ID: D000001984
- Term: Bronchial Neoplasms
- ID: D000008175
- Term: Lung Neoplasms
- ID: D000012142
- Term: Respiratory Tract Neoplasms
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5546
- Name: Carcinoma, Non-Small-Cell Lung
- Relevance: HIGH
- As Found: Non-Small Cell Lung Cancer
- ID: M11172
- Name: Lung Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M5540
- Name: Carcinoma, Bronchogenic
- Relevance: LOW
- As Found: Unknown
- ID: M5260
- Name: Bronchial Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M14979
- Name: Respiratory Tract Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M16658
- Name: Thoracic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002289
- Term: Carcinoma, Non-Small-Cell Lung
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06438354
**Brief Title:** Non-surgical Step 3 Periodontal Treatment With/Without Adjunctive Protocol - Pilot RCT.
**Official Title:** Non-surgical Treatment of Residual Periodontal Pockets Using Sodium Hypochlorite/Amino Acid Gel and Cross-linked Hyaluronic Acid - a 9-month Randomized Controlled Clinical Trial.
#### Organization Study ID Info
**ID:** 64/2022
#### Organization
**Class:** OTHER
**Full Name:** University of Witten/Herdecke
### Status Module
#### Completion Date
**Date:** 2024-02-29
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-27
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-10-30
**Type:** ACTUAL
#### Start Date
**Date:** 2022-08-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Witten/Herdecke
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Study conducted in patients recruited at private praxis setting after completed step 2 periodontal therapy. Residual pockets ≥4mm with positive bleeding or such \>5mm randomly allocated to either conventional subgingival re-instrumentation (controls) or to same mechanical treatment with adjectively applied hypochlorite/aminoacid gel for antiseptic reason followed by subginigival placement of cross linked hyaluronic acid gel for sealing the site after instrumentation. Re-evaluations at 3 and 9 months controlled for clinical parameters such as Periodontal Probing Depth (PPD) (CAL), Clinical Attachment Level, Gingival Recession (GR), Bleeding on Probing (BOP). The hypothesis is, sites treated with adjunctive protocol show greater PPD reduction and greater CAL gain at 9-month evaluation.
### Conditions Module
**Conditions:**
- Periodontal Pocket
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 52
**Type:** ACTUAL
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Test arm, patients undergo subgingival instrumentation of residual active site together with an adjunctive treatment protocol.
**Intervention Names:**
- Biological: subgingival instrumentation plus Perisolv / hyaDent BG
**Label:** Group A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Control arm, patients undergo subgingival instrumentation of residual active site only.
**Intervention Names:**
- Procedure: subgingival instrumentation
**Label:** Group B
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group A
**Description:** Group A: Perisolv is applied prior to subgingival instrumentation for disinfecting purpose, hyaDent BG seals the site for accelerated blood clot stabilisation and support of cell proliferation.
**Name:** subgingival instrumentation plus Perisolv / hyaDent BG
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- Group B
**Description:** Group B: sites requiring re-treatment are subjected to subgingival scaling
**Name:** subgingival instrumentation
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Greater amount of CAL gain in the test group A vs. control group B anticipated
**Measure:** Clinical Attachment Level
**Time Frame:** 9 month post-op
#### Secondary Outcomes
**Description:** Greater reduction in PPD for group A vs. Group B anticipated
**Measure:** Periodontal Probing Depth
**Time Frame:** 9 months post-op
**Description:** Similar change in the GR depth anticipated for both groups
**Measure:** Gingival Recession
**Time Frame:** 9 months post-op
**Description:** greater reduction in BOP anticipated for group A vs. group B patients.
**Measure:** Bleeding on Probing
**Time Frame:** 9 months post-op
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* systemically healthy individuals, smokers and non-smokers, HbA1c \<7.5%, compliant and adhering to systematic periodontal treatment protocol incl. SPT visits, patients willing to complete a 9-month post-op observation period
Exclusion Criteria:
* rheumatoid arthritis, HbA1c ≥7.5%, treatment of periodontitis within past 12 months, use of systemic antibiotics in past 6 months, pregnant and lactating individuals
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Munich
**Country:** Germany
**Facility:** Implantat Competence Centrum München
**Zip:** 80333
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Ramanauskaite E, Machiulskiene V, Shirakata Y, Dvyliene UM, Nedzelskiene I, Sculean A. Clinical evaluation of sodium hypochlorite/amino acids and cross-linked hyaluronic acid adjunctive to non-surgical periodontal treatment: a randomized controlled clinical trial. Clin Oral Investig. 2023 Nov;27(11):6645-6656. doi: 10.1007/s00784-023-05271-0. Epub 2023 Sep 23.
**PMID:** 37740107
**Citation:** Shirakata Y, Nakamura T, Setoguchi F, Imafuji T, Shinohara Y, Matsumura S, Iwata M, Noguchi K, Ramanauskaite E, Sculean A. Histological evaluation of nonsurgical periodontal treatment with and without the use of sodium hypochlorite / amino acids and cross-linked hyaluronic acid gels in dogs. Clin Oral Investig. 2024 Apr 27;28(5):281. doi: 10.1007/s00784-024-05674-7.
**PMID:** 38676852
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010518
- Term: Periodontitis
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M13423
- Name: Periodontal Pocket
- Relevance: HIGH
- As Found: Periodontal Pocket
- ID: M13427
- Name: Periodontitis
- Relevance: LOW
- As Found: Unknown
- ID: M13419
- Name: Periodontal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12019
- Name: Mouth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010514
- Term: Periodontal Pocket
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infe
- Name: Anti-Infective Agents
### Intervention Browse Module - Browse Leaves
- ID: M9878
- Name: Hyaluronic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M15775
- Name: Sodium Hypochlorite
- Relevance: LOW
- As Found: Unknown
- ID: M44557
- Name: Eusol
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06438341
**Brief Title:** Preliminary Evaluation of the Safety and Tolerability of SPOT-mRNA01 Subcutaneously Administered in Healthy Subjects
**Official Title:** A Randomized, Double-blind, Placebo-controlled Exploratory Clinical Study to Evaluate the Safety and Tolerability of SPOT-mRNA01 Injection in Healthy Adult Subjects
#### Organization Study ID Info
**ID:** FM-T1-SH
#### Organization
**Class:** INDUSTRY
**Full Name:** Spot Biosystems Ltd.
### Status Module
#### Completion Date
**Date:** 2025-12-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-30
**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:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Spot Biosystems 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 a first-in-human, randomized, double-blind, placebo-controlled clinical study to evaluate the Safety and Tolerability of SPOT-mRNA01 injection in healthy adult volunteers.
**Detailed Description:** SPOT-mRNA01 (collagen 1 alpha 1 (COL1A1) mRNA-loaded EVs) can induce collagen protein grafts in dermal tissue, thereby supplementing collagen and reducing wrinkle formation in collagen-depleted skin. Therefore, SPOT-mRNA01 can provide a source of human collagen intradermally for cosmetic anti-aging use.
This is a first-in-human randomized, double-blind, placebo-controlled, single-dose, dose ascending, exploratory clinical study to evaluate the Safety and Tolerability of SPOT-mRNA01 administered by subcutaneous injection to healthy adult volunteers.
### Conditions Module
**Conditions:**
- Skin Aging
**Keywords:**
- SPOT-mRNA01
- EVs
- COL1A1 mRNA
### 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:** 10
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** SPOT-mRNA01 (COL1A1 mRNA-loaded EVs)
**Intervention Names:**
- Biological: SPOT-mRNA01
**Label:** SPOT-mRNA01
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Sterile isotonic solution
**Intervention Names:**
- Other: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- SPOT-mRNA01
**Description:** SPOT-mRNA01 (COL1A1 mRNA-loaded EVs) ,single-dose subcutaneous injection
**Name:** SPOT-mRNA01
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Sterile isotonic solution
**Name:** Placebo
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The investigator will collect a description of the events, time of onset and resolution, assessment of severity and causal relationship to SPOT-mRNA01.
**Measure:** Assessment of the safety and tolerability of SPOT-mRNA01 by recording adverse events
**Time Frame:** 3 months
#### Secondary Outcomes
**Description:** Local collagen expression in injection area biopsy by ELISA detection
**Measure:** Assessment of changes in collagen expression level after subcutaneous injection of SPOT-mRNA01
**Time Frame:** Days 4, 7 and 31
**Description:** Detecting local skin thickness in injection area biopsy by Masson trichrome stain
**Measure:** Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01
**Time Frame:** Days 4, 7 and 31
**Description:** Detecting local skin thickness by Skin ultrasound
**Measure:** Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01
**Time Frame:** Baseline and days 7, 15, 31, 61 and 91
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Aged 18 to 75 years inclusive at the time of informed consent.
Exclusion Criteria:
1. Any transient or chronic skin condition, disorder, or infection within 20 cm of the target areas before treatment that, in the opinion of the investigator, may confound study results.
2. History of laser treatment or chemical peels or any cosmetic anti-aging treatments to the target areas within six months of the study treatment.
3. History of surgical procedures to target areas, including removal of benign or malignant skin cancers that, in the opinion of the investigator, may confound study results.
4. Participant with a history of heavy smoking, alcohol or drug abuse or steroid treatment.
5. Pregnant or breast-feeding females.
6. History of anaphylaxis or allergic reactions to any constituent of the study product and/or local anesthetics, and/or history of severe abnormal drug reaction.
7. Those who have participated in clinical trials of other investigational drugs within 3 months before the study treatment.
8. Those who are not suitable for subcutaneous injection and biopsy.
9. Any condition that the investigator or primary physician believes may not be appropriate for participating the study.
-
**Healthy Volunteers:** True
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
## Document Section
### Large Document Module
#### Large Docs
- Date: 2023-08-14
- Filename: Prot_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: False
- Label: Study Protocol
- Size: 687192
- Type Abbrev: Prot
- Upload Date: 2024-05-24T07:36
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M8219
- Name: Exanthema
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06438328
**Brief Title:** Effectiveness of Scapular Muscle Training in Improving Grip Strength Among Lateral Epicondylitis Patients
**Official Title:** Effectiveness of Scapular Muscle Training in Improving Grip Strength Among Lateral Epicondylitis Patients
#### Organization Study ID Info
**ID:** MSRSW/Batch-Fall22/710
#### Organization
**Class:** OTHER
**Full Name:** Superior University
### Status Module
#### Completion Date
**Date:** 2024-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-24
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-04-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-11-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Muhammad Naveed Babur
#### Responsible Party
**Investigator Affiliation:** Superior University
**Investigator Full Name:** Muhammad Naveed Babur
**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 effectiveness of scapular muscular training along with conventional physiotherapy on the improving the grip strength of the patients suffering with the lateral epicondylitis was assessed by diving 56 patinets in two grousp as Group A (n=28) was treated with conventional physiotherapy treatment and Group B (n=28) was treated with Scapular strengthening and conventional physiotherapy protocol.
### Conditions Module
**Conditions:**
- Lateral Epicondylitis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 56
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Diagnostic Test: Left/ Right affected arm
**Label:** Left/ Right affected arm
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Other: Grip strength
**Label:** Grip strength
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Left/ Right affected arm
**Description:** Therapeutic exercises: eccentric and concentric exercises and wrist isometrics 10 repetitions of 3 sets with 10 seconds interval
**Name:** Left/ Right affected arm
**Type:** DIAGNOSTIC_TEST
#### Intervention 2
**Arm Group Labels:**
- Grip strength
**Description:** assessed by using modified sphygmomanometer in which it first inflated to 100 mmHg with closed valve. The pressure was reduced to 20mmHg and the resisted wrist extension performed at baseline and at the 4th week.
**Name:** Grip strength
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Measured by Patient-Rated Tennis Elbow Evaluation (PRTEE)from the scoring between 0-100 at baseline and at the 4th week.
**Measure:** Severity of Disability
**Time Frame:** 12 Months
**Description:** assessed by using modified sphygmomanometer in which it first inflated to 100 mmHg with closed valve. The pressure was reduced to 20mmHg and the resisted wrist extension performed at baseline and at the 4th week.
**Measure:** Grip strength:
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age: 20-50 years
* Gender: Male and Female
* Pain on the lateral epicondyle
* VAS scoring more than 4
* Positive test: Tomson test, Mill's test , Cozen;s sign and Maudsley's test
Exclusion Criteria:
* Any neurological/ Radiculopathy signs in upper limb
* Cervical pain
* Bilateral elbow pain
* History of elbow or wrist surgery
* Receiving any corticosteroid injection within last 6 months
**Maximum Age:** 50 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Bhakkar
**Country:** Pakistan
**Facility:** Fatima medical center near green town
**State:** Punjab
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M16486
- Name: Tennis Elbow
- Relevance: HIGH
- As Found: Lateral Epicondylitis
- ID: M10295
- Name: Influenza, Human
- Relevance: LOW
- As Found: Unknown
- ID: M27013
- Name: Tendinopathy
- 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: M12097
- Name: Musculoskeletal 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
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06438315
**Acronym:** SSCORE
**Brief Title:** SuperSaturated Oxygen Comprehensive Observational Registry
**Official Title:** SuperSaturated Oxygen Comprehensive Observational Registry
#### Organization Study ID Info
**ID:** EDC-5731
#### Organization
**Class:** INDUSTRY
**Full Name:** TherOx
### Status Module
#### Completion Date
**Date:** 2029-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** TherOx
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) registry, a prospectively designed observational study, aims to evaluate the clinical utility and effectiveness of SSO2 Therapy versus PCI alone among patients with anterior AMI in routine clinical practice. The goal is to collect real-world data from patients treated with SSO2 Therapy to determine its impact on the overall HF burden on patients and healthcare systems compared with usual care for treatment of patients with AMI. The SSCORE Registry will generate effectiveness and healthcare resource utilization data that will be used in cost-effectiveness analysis modeling.
### Conditions Module
**Conditions:**
- STEMI - ST Elevation Myocardial Infarction
- AMI
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 1000
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 2 Years
### Arms Interventions Module
#### Arm Group 1
**Description:** Treated with SSO2
**Intervention Names:**
- Other: No intervention
**Label:** SSO2
#### Arm Group 2
**Description:** Not treated with SSO2
**Intervention Names:**
- Other: No intervention
**Label:** Control
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control
- SSO2
**Description:** No intervention
**Name:** No intervention
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Rate of composite of CV death, new onset HF, any new inpatient or outpatient treatment for HF, or worsening of HF
**Measure:** CV death or Heart Failure burden at 1 year
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** Days to the composite of CV death, new onset HF, any new inpatient or outpatient treatment for HF, or worsening of HF
**Measure:** Time to CV death or HF burden
**Time Frame:** 2 years
**Description:** Rate of all cause mortality
**Measure:** Rate of all cause mortality
**Time Frame:** 2 years
**Description:** Rate of All-cause Hospitalization
**Measure:** Rate of All-cause Hospitalization
**Time Frame:** 2 years
**Description:** Rate of cardiovascular death
**Measure:** Rate of cardiovascular death
**Time Frame:** 2 years
**Description:** Rate of Hospitalization for Heart Failure
**Measure:** Rate of Hospitalization for Heart Failure
**Time Frame:** 2 years
**Description:** composite of rates of CV death, reinfarction, or HF hospitalization
**Measure:** Major Adverse Cardiovascular Events (MACE)
**Time Frame:** 2 years
**Description:** Rate of Reinfarction
**Measure:** Rate of Reinfarction
**Time Frame:** 2 years
**Description:** patient reported outcome, 0 to1, where 0 is death and 1 is perfect health
**Measure:** Change in EQ5D-3L Score
**Time Frame:** 2 years
**Description:** heart related patient reported outcome, scaled from 0 to 100, with 0 representing the worst symptoms and function and 100 representing the best
**Measure:** Change in KCCQ-23 Score
**Time Frame:** 2 years
**Description:** Rate of change of LVEF from baseline to time point
**Measure:** Change in LVEF%
**Time Frame:** 2 years
**Description:** Rate of change of NHYA classification from baseline to time point
**Measure:** Change in NYHA classification scale, I-IV
**Time Frame:** 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Men or women aged 18 years or older
* Presentation with AMI and successful revascularization of the infarct-related artery with PCI
* The subject or their legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Institutional Review Board (IRB)
Exclusion Criteria:
* Life expectancy of less than 2 years
* No access to medical records from either the index hospitalization or subsequent outpatient visits
* Currently participating in an investigational drug or device trial
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study will aim to prospectively enroll 500 subjects not treated with SSO2 Therapy (Prospective Control Cohort), 500 subjects who received SSO2 Therapy in accordance with the product label (SSO2 Treated On-Label) and any subjects that receive SSO2 at an institution that meet criteria IE criteria.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jennifer Gardner
**Phone:** 949-300-2811
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Henry Ford Hospital
**Name:** William W O'Neill, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Stone GW, Martin JL, de Boer MJ, Margheri M, Bramucci E, Blankenship JC, Metzger DC, Gibbons RJ, Lindsay BS, Weiner BH, Lansky AJ, Krucoff MW, Fahy M, Boscardin WJ; AMIHOT-II Trial Investigators. Effect of supersaturated oxygen delivery on infarct size after percutaneous coronary intervention in acute myocardial infarction. Circ Cardiovasc Interv. 2009 Oct;2(5):366-75. doi: 10.1161/CIRCINTERVENTIONS.108.840066. Epub 2009 Sep 15.
**PMID:** 20031745
**Citation:** David SW, Khan ZA, Patel NC, Metzger DC, Wood FO, Wasserman HS, Lotfi AS, Hanson ID, Dixon SR, LaLonde TA, Genereux P, Ozan MO, Maehara A, Stone GW. Evaluation of intracoronary hyperoxemic oxygen therapy in acute anterior myocardial infarction: The IC-HOT study. Catheter Cardiovasc Interv. 2019 Apr 1;93(5):882-890. doi: 10.1002/ccd.27905. Epub 2018 Sep 28.
**PMID:** 30265429
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007511
- Term: Ischemia
- ID: D000010335
- Term: Pathologic Processes
- ID: D000009336
- Term: Necrosis
- ID: D000017202
- Term: Myocardial Ischemia
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000014652
- Term: Vascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12155
- Name: Myocardial Infarction
- Relevance: HIGH
- As Found: Myocardial Infarction
- ID: M1072
- Name: ST Elevation Myocardial Infarction
- Relevance: HIGH
- As Found: ST Elevation Myocardial Infarction
- ID: M10282
- Name: Infarction
- Relevance: HIGH
- As Found: Infarction
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M12284
- Name: Necrosis
- Relevance: LOW
- As Found: Unknown
- ID: M6546
- Name: Coronary Artery Disease
- Relevance: LOW
- As Found: Unknown
- ID: M19506
- Name: Myocardial Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009203
- Term: Myocardial Infarction
- ID: D000072657
- Term: ST Elevation Myocardial Infarction
- ID: D000007238
- Term: Infarction
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06438302
**Acronym:** VENTINA
**Brief Title:** Effects of Nasal Ventilation on Cerebral and Pulmonary Function in Orally Intubated Patients
**Official Title:** Effects of Nasal Ventilation on Cerebral and Pulmonary Function in Orally Intubated Patients
#### Organization Study ID Info
**ID:** APHP240271
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique - Hôpitaux de Paris
### Status Module
#### Completion Date
**Date:** 2025-06-22
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-22
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-21
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assistance Publique - Hôpitaux de Paris
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The passage of air through the nasal cavity generates rhythmic oscillations transmitted by the olfactory bulb to the brain, which induces cerebral activation in functional areas and is associated with better cognitive performance compared to oral breathing. Consequently, the abolition of nasal ventilation in patients intubated via the orotracheal route could have deleterious effects on brain activity. Besides the loss of olfaction, the abolition of nasal ventilation could affect brain activity and respiratory control, consequently altering regional pulmonary ventilation.
The hypothesis of the study is that nasal ventilation through the passage of humidified nasal airflow in patients intubated via the orotracheal route would be associated with modulation of cerebral electrical activity and tissue oxygenation and a modification of regional pulmonary ventilation.
**Detailed Description:** The effects of nasal ventilation on cerebral activity will be studied on orally intubated and sedated patients in six experimental conditions. The first condition consists of nociceptive stimulation of the left upper limb as a negative control. In three conditions, the inspired fraction of oxygen (FiO2) will remain at 21% while applying three different rates of humidified nasal air at 0L/min, 30L/min and 60L/min respectively. The last two conditions consist of applying humidified nasal air at 30L/min and 60L/min with a FiO2 of 100%. The primary objective of this study is to evaluate the effects of high-flow humidified nasal air on electroencephalogram activity (root mean square gamma frequency) in sedated, orally intubated patients. The secondary objectives of the study are to evaluate the effects of high-flow humidified nasal air on cerebral perfusion and oxygenation, gas exchange and regional pulmonary ventilation in the same patients.
### Conditions Module
**Conditions:**
- Hypoxemic Acute Respiratory Failure
**Keywords:**
- nasal ventilation
- orotracheal intubation
- brain activity
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 22
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The study population will be adult patients with acute respiratory failure who are orally intubated and sedated. These patients should be free of neurological and psychiatric diseases prior to ICU admission. The choice of this particular population is justified by its exposure to mechanical ventilation and continuous sedation, which are recognized risk factors for brain damage.
**Intervention Names:**
- Device: EEG activity measurement
**Label:** Major mechanically ventilated patients intubated orotracheally
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Major mechanically ventilated patients intubated orotracheally
**Description:** The nasal ventilation device (placed as part of the research) (AIRVO 2; Fisher and Paykel Healthcare, Auckland, New Zealand) will be positioned via nasal cannulas adapted to the patient's anatomy. The FiO2 will be set at 21% and the flow rate will be fixed at 0 L/min at the inclusion visit. The temperature of the humidified nasal oxygenator will be set at 37°C.
Six 30-minute experimental conditions will be performed successively: 1) 0 L/min flow, FiO2 21%, 2) 30 L/min flow, FiO2 21%, 3) 30 L/min flow, FiO2 100%, 4) 60 L/min flow, FiO2 21%, 5) 60 L/min flow, FiO2 100%, 6) Negative control.
At the end of each condition, a 10-minute thoracic electrical impedance tomography recording, a 10-minute EEG recording, a 10-minute cerebral NIRS recording and an instantaneous temporal Doppler velocity measurement will be performed. A blood gas (1.5 mL) will also be taken at the end of each condition.
**Name:** EEG activity measurement
**Other Names:**
- Post-intubation nasal ventilation
- Additional blood samples (from care catheter 1.5 mL)
- Electrical impedance tomography
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** EEG spectral density spectrum of gamma frequency.
**Measure:** Study the effects of nasal ventilation on brain electrical activity using electroencephalogram recording (EEG) in sedated orotracheally intubated patients.
**Time Frame:** At inclusion (day 1) - step 1 to 6
#### Secondary Outcomes
**Description:** This outcome will be assessed by the evaluation of the Index of Pulsatility (IP) (IP=(Vs-Vd)/Vm: Vs: Systolic velocity; Vd: Diastolic Velocity; Vm: Mean Velocity)
**Measure:** Study the effects of nasal ventilation on cerebral perfusion
**Time Frame:** At inclusion (day 1) - step 1 to 6
**Description:** Cerebral tissue oxygenation (% of O2) measured by NIRS (Near Infrared Spectroscopy) electrodes
**Measure:** Study the effects of nasal ventilation on cerebral tissue oxygenation
**Time Frame:** At inclusion (day 1) - step 1 to 6
**Description:** Ratio of PaO2 (partial pressure of O2) /FiO2 (inspired oxygen fraction)
**Measure:** Study the effects of nasal ventilation on gas exchange
**Time Frame:** At inclusion (day 1) - step 1 to 6
**Description:** Evaluation of PaCO2 (partial pressure of CO2) (mmHG)
**Measure:** Study the effects of nasal ventilation on gas exchange
**Time Frame:** At inclusion (day 1) - step 1 to 6
**Description:** Evaluation of impedance variation by thoracic electrical impedance tomography.
**Measure:** Study the effects of nasal ventilation on regional lung ventilation distribution
**Time Frame:** At inclusion (day 1) - step 1 to 6
**Description:** Evaluation of ventilation homogeneity by I thoracic electrical impedance tomography.
**Measure:** Study the effects of nasal ventilation on regional lung ventilation distribution
**Time Frame:** At inclusion (day 1) - step 1 to 6
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age ≥ 18 years old
2. Hypoxemic acute respiratory failure
3. Intubation and mechanical ventilation since less than 4 days
4. PaO2/FiO2 ratio less than 150
5. RASS\<-4
6. Consent obtained from next of kin
7. Patient with health insurance
Exclusion Criteria:
1. Central nervous system diseases (stroke, MS, epilepsy)
2. Psychiatric illnesses (psychosis, depression) (indicated on patient's medical record)
3. Hemodynamic instability (noradrenalin\>2mg/h)
4. Patient on AME
5. Patients under legal protection (guardianship/curators)
6. Pregnant or breast-feeding women
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study population will be adult patients with acute respiratory failure who are orally intubated and sedated. These patients should be free of neurological and psychiatric diseases prior to ICU admission. The choice of this particular population is justified by its exposure to mechanical ventilation and continuous sedation, which are recognized risk factors for brain damage.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Martin Dres
**Phone:** 0142167809
**Role:** CONTACT
### IPD Sharing Statement Module
**Access Criteria:** Researchers who provide a methodologically sound proposal.
**Description:** The procedures carried out with the French data privacy authority (CNIL, "Commission nationale de l'informatique et des libertés") do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations
**Info Types:**
- STUDY_PROTOCOL
- ICF
**IPD Sharing:** YES
**Time Frame:** Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14968
- Name: Respiratory Insufficiency
- Relevance: HIGH
- As Found: Hypoxemic Acute Respiratory Failure
- ID: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012131
- Term: Respiratory Insufficiency
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06438289
**Acronym:** DISLOTIP
**Brief Title:** Ultrasound to Investigate Tip Dislodgment of Epicutaneous-caval Catheter.
**Official Title:** Use of Ultrasound to Investigate Tip Dislodgment of Epicutaneous-caval Catheter: a Multicentric Study
#### Organization Study ID Info
**ID:** Protocol 335
#### Organization
**Class:** OTHER
**Full Name:** Federico II University
### Status Module
#### Completion Date
**Date:** 2025-01-17
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-01-17
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-17
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Federico II University
#### Responsible Party
**Investigator Affiliation:** Federico II University
**Investigator Full Name:** Francesco Raimondi
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is a non-pharmacological, non-profit, prospective, observational multicenter study. Primarily, the study aims to demonstrate the feasibility of ultrasound methodology to study the secondary malposition of epicutaneous-caval catheters (ECC) in neonates.
After obtaining informed consent, the study involves performing ultrasound tip location on newborns who had an ECC placed. This will occur immediately after the placement and, if in a central position, subsequently at 60-120 minutes, 48-72 hours and 6-8 days post-placement. Data will be collected on various variables. Each Center will contribute at least 20 cases to the cohort and all data will be recorded in a database. The study is expected to last for 12 months
**Detailed Description:** Epicutaneous-caval catheters (ECCs) are among the most common central venous catheters used in neonatology. It is known that they can experience malpositioning over time from the moment of placement, leading to complications. In all studies conducted so far, tip location has been performed using X-ray. Ultrasound would be the ideal method for serial, bedside and radiatIon-free evaluation of ECC tip location to intercept any migrations. The primary endpoint of the study is to demonstrate the feasibility of ultrasound method for the assessment of secondary ECC malposition. Secondary endpoints include validating the results of previous Investigators monocentric study on the feasibility of ultrasound tip location applied to ECC and establishing the incidence of secondary malpositioning and the optimal timing for reassessing tip position after ECC placement. All neonates undergoing placement of 28 Gauge/1 French ECCs with a standardized securement system are included in the study, while neonates with major malformation are excluded. The study includes: obtaining written informed consent; performing ultrasound tip location using a standardized protocol (high right parasternal, apical four-chamber, short-axis left parasternal and bicaval subcostal views); If the tip is in a central position, repeating ultrasound tip location (using the same protocol) at 60-120 minutes, 48-72 hours and 6-8 days post-placement; collecting variables including sex, site of ECC insertion, weight at placement and at each tip location, postmenstrual age at placement and at each tip location, days of life at placement and at each tip location, respiratory support at placement and at each tip location, feasibility of ultrasound tip location for each ECC and for each specified time, ultrasound tip location result for each ECC and for each specified time and any displacement relative to the time of placement, as wall as any reported complications associated with secondary malpositioning. All ultrasound will be performed with the newborn in a standardized position: limb adducted and elbow extended if the catheter is placed from the upper limb, limb adducted and knee extended if the catheter is placed from the lower limb, neutral position if the catheter is placed from the scalp. The records of the ultrasound exams at each time for the first five cases enrolled by each Center will be sent to the Coordinator Center for evaluation of protocol compliance. Using the exact binomial method and setting a margin of error of 4% for a 95% of confidence interval, the investigators calculated that the sample size should be 196. The collected data will be recorded anonymously in an Excel database. Continuous variables will be expressed as means with minimum and maximum ranges, while categorical variables will be expressed as frequencies with percentages. Each case will be identified with an alphanumeric code to ensure data confidentiality. The principal investigator is the only person able to link the code to the identity of the patient. Parents, relative or guardians of eligible patients will be provided with all explanations regarding the experimental protocol by the study staff before enrollment. Information will be provided and parents will be given up to 12 hours to give their consent. The principal investigator will be responsible for the overall monitoring of data and the safety of the study participants. No funding or additional costs beyond common current practice are anticipated.
### Conditions Module
**Conditions:**
- Migration of Implant or Internal Device
**Keywords:**
- tip location
- ultrasound
- epicutaneous-caval catheter
- tip secondary migration
- newborn
- ECC
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 196
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** percentage, from 0% to 100%
**Measure:** Percentage of cases in which ultrasound tip location is feasible to study ECC secondary malposition
**Time Frame:** 8 days from the ECC placement
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* neonates undergoing placement of 28 G/1 Fr ECCs with a standardized securement system
Exclusion Criteria:
* neonates with major malformation
**Healthy Volunteers:** True
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** neonates undergoing placement of 28G/1 Fr ECCs with a standardized securement system
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Francesco Raimondi
**Phone:** +393392683848
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Fiorentino Grasso
**Phone:** +393290710660
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Naples
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Francesco Raimondi, Professor
- **Phone:** +393392683848
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Fiorentino Grasso, MD
- **Phone:** +393290710660
- **Role:** CONTACT
**Country:** Italy
**Facility:** AOU Federico II- Neonatal Intensive Care Unit
**Status:** RECRUITING
**Zip:** 80131
### References Module
#### References
**Citation:** Practice Guidelines for Central Venous Access 2020: An Updated Report by the American Society of Anesthesiologists Task Force on Central Venous Access. Anesthesiology. 2020 Jan;132(1):8-43. doi: 10.1097/ALN.0000000000002864. No abstract available.
**PMID:** 31821240
**Citation:** Barone G, Pittiruti M. Epicutaneo-caval catheters in neonates: New insights and new suggestions from the recent literature. J Vasc Access. 2020 Nov;21(6):805-809. doi: 10.1177/1129729819891546. Epub 2019 Dec 5.
**PMID:** 31804149
**Citation:** Costello JM, Clapper TC, Wypij D. Minimizing complications associated with percutaneous central venous catheter placement in children: recent advances. Pediatr Crit Care Med. 2013 Mar;14(3):273-83. doi: 10.1097/PCC.0b013e318272009b.
**PMID:** 23392365
**Citation:** de Jonge RC, Polderman KH, Gemke RJ. Central venous catheter use in the pediatric patient: mechanical and infectious complications. Pediatr Crit Care Med. 2005 May;6(3):329-39. doi: 10.1097/01.PCC.0000161074.94315.0A.
**PMID:** 15857534
**Citation:** Acun C, Baker A, Brown LS, Iglesia KA, Sisman J. Peripherally inserted central cathether migration in neonates: Incidence, timing and risk factors. J Neonatal Perinatal Med. 2021;14(3):411-417. doi: 10.3233/NPM-200684.
**PMID:** 33459671
**Citation:** Gupta R, Drendel AL, Hoffmann RG, Quijano CV, Uhing MR. Migration of Central Venous Catheters in Neonates: A Radiographic Assessment. Am J Perinatol. 2016 May;33(6):600-4. doi: 10.1055/s-0035-1570341. Epub 2016 Jan 5.
**PMID:** 26731179
**Citation:** Srinivasan HB, Tjin-A-Tam A, Galang R, Hecht A, Srinivasan G. Migration patterns of peripherally inserted central venous catheters at 24 hours postinsertion in neonates. Am J Perinatol. 2013 Nov;30(10):871-4. doi: 10.1055/s-0033-1333672. Epub 2013 Feb 4.
**PMID:** 23381907
**Citation:** Grasso F, Capasso A, Pacella D, Borgia F, Salome S, Capasso L, Raimondi F. Ultrasound Guided Catheter Tip Location in Neonates: A Prospective Cohort Study. J Pediatr. 2022 May;244:86-91.e2. doi: 10.1016/j.jpeds.2021.12.059. Epub 2021 Dec 28.
**PMID:** 34971654
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06438276
**Acronym:** JAPSY
**Brief Title:** Psychiatric Outreach Nurses Supporting Adolescent Mental Health
**Official Title:** Supporting Adolescent Mental Health by Psychiatric Outreach Nurses: A Mixed Method Evaluation Study
#### Organization Study ID Info
**ID:** JAPSY_20230
#### Organization
**Class:** OTHER
**Full Name:** University of Eastern Finland
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-06
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Wellbeing Services County of North Savo
**Class:** UNKNOWN
**Name:** The Foundation for Municipal Development
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Eastern Finland
#### 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 evaluates the effectiveness and cost-effectiveness of the outreach work of psychiatric registered nurses (RN) and the experiences of professionals in the field. The service is provided in school environment. First, the study will assess the effectiveness of brief interventions provided by psychiatric outreach nurses on the perceived mental health and quality of life of adolescents (12-16 year old pupils) and their use of social and health services, compared to the support/treatment provided by conventional student welfare services at 6 and 12 months follow-up. The intervention is an outreach service provided by psychiatric nurses. In the intervention, the psychiatric registered nurse will implement interventions such as usual care, discussion, psychoeducation, substance abuse skills and various methods (such as interpersonal psychotherapy = IPT-N and Cool Kids) and motivational interviewing.
Secondly, an economic evaluation of the service will be carried out at 6 and 12 months follow-up. The economic evaluation will be carried out from the perspective of the Wellbeing Services County, including the costs of implementing the intervention model and its effects on adolescents' use of student welfare services as well as other social and health services. Primarily, the economic evaluation will use quality-weighted life years as a measure of effectiveness. Also analysis using depression, anxiety and substance use measures will be conducted. Thirdly, the study will explore the experiences of psychiatric nurses implementing the service as well as the experiences of their collaborators in schools (public health nurses, school social workers, psychologists, doctors and teachers) about the service and its implementation.
**Detailed Description:** Quantitative research data will be used to evaluate the effectiveness of the psychiatric outreach care compared to conventional care (TAU). Psychiatric outreach registered nurses are currently available in some schools in several municipalities in the North Savo region in Finland. In the other schools, support is provided by so-called "usual" counselling and other support/treatment, e.g. by public health nurses, school social workers, school psychologists and school doctors.
The study design is a clustered controlled setting. The target sample size for quantitative data is 160 participants. The intervention group (n = 80) will consist of pupils receiving support/treatment from psychiatric outreach nurses. The control group (n = 80) will consist of pupils whose schools provide standard student welfare services and whose mental health status and support needs are similar to those of the intervention group.
The data will be collected through questionnaires administered to secondary school pupils to assess their mental health status and quality of life. The adolescents' service use in terms of student welfare services as well as Wellbeing Services County's social and health care services will be collected through questionnaires. At baseline, the use of services will be surveyed retrospectively over a six-month period.
The primary outcome variable of the intervention is the adolescent's perceived mental health status as assessed by the PHQ-9-A (Patient Health Questionnaire) measure of depression and the GAD-7 (generalized anxiety disorder) measure of anxiety. The secondary outcome variables are the adolescent's perceived quality of life (EQ-5D-Y, five dimensional quality of life measure) and substance use (ADSUME, Adolescents´ Substance Use Measurement). The study will primarily investigate the effect of psychiatric outreach nurses on treatment response. Secondarily, subgroups of at least 20 participants will be examined (e.g. controls for gender, age or other background variables).
Participants are assigned to the intervention or control group based on whether the services of an psychiatric outreach nurse is available in their school (intervention) or not (control).
For similarities and differences between the intervention and control groups, a descriptive analysis is performed using the chi-square test to compare categorical variables and the t-test or Mann-Whitney U-test to compare continuous variables. The effectiveness of the intervention will be analysed using statistical methods appropriate for panel data, taking into account the effects of possible correlation/multicollinearity on the results. Statistical methods will be used to control for the possible selection of a non-standardised design by including control variables in the models.
The economic evaluation of the intervention will use data on the use of social and health services, student welfare services and the cost of the intervention. Data on the costs of the intervention will be obtained from the Wellbeing Services County of North Savo. The costs of health and social services and student welfare services are calculated on the basis of the number of services used and the unit costs. The cost-effectiveness of the intervention is analysed in relation to the treatment as usual provided by student welfare services using incremental net monetary benefit or incremental net health benefit evaluation to examine differences in costs and/or health benefits between groups and in the above-mentioned outcomes at 6-month and 12-month follow-up. Primarily, the economic evaluation will use the EQ-5D-Y measure to calculate quality-weighted life-years. In addition, the results of the PHQ-9-A, GAD-7 and ADSUME measures will be analysed.
Eligibility Criteria: Pupils (12-16 years old) who seek help from a student welfare service due to mood disorders. In addition, a representative of the student welfare service (e.g. a public health nurse, school social worker, psychologist or doctor) or a representative of the student welfare service and an psychiatric outreach nurse assess together a person's eligibility for the study, taking into account the inclusion and exclusion criteria.
Inclusion criteria for the intervention and control groups will be one or more of the following symptoms: prolonged and/or complicated anxiety, mood symptoms, obsessive-compulsive and/or eating disorder symptoms, mild to moderate self-harm (e.g. death wishes or cutting). In addition, the young person's motivation to receive the service is an admission criterion.
Exclusion criteria: The psychiatric outreach nurse service is not suitable for persons with one or more of the following needs or life situations: pupils who need light support and guidance, young people with a single problem of low motivation for school, young people with a stressful life situation or relationship problems. On the other hand, the service is not intended for pupils who are in acute need of specialist care or for pupils with multidisciplinary problems for whom support measures have already been put in place, because of their mental health symptoms (e.g. severe depression, psychotic symptoms, severe and acute suicidal tendencies or a clear suicide plan). Exclusion criteria for the intervention and control groups also include situations where the young person has a long-lasting, already established mental health problem and/or a need for further treatment after a period of specialised hospital care. Exclusion criteria also include behavioural disorders where there is a clear underlying cause other than a mental disorder.
The qualitative perspective of the study focuses on those implementing the service (psychiatric outreach nurses) and their collaborators in schools (e.g. school social workers, public health nurses, school psychologists, doctors and teachers). The total number of interviewees is estimated to be 15-20. Data collection consists of individual semi-structured interviews to describe the interviewees' experiences of applying the new service approach in the school setting. As the approach is new in the Wellbeing Services County of North Savo, it is necessary to explore the experiences of both those implementing as well as their collaborators in terms of introducing the service, operation of the service, the perceived needs for the service as well as the needs for development of the service. The interviews will be carried out at the beginning of the study and at 12-month follow-up.
### Conditions Module
**Conditions:**
- Depression
- Anxiety
**Keywords:**
- mental health
- mental disorders
- adolescent
- outreach service
- school-based
- effectiveness
- economic evaluation
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 160
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Intervention group receiving psychiatric outreach nurse services: adolescents (12-16 years old) who seek help from student welfare services due to mood disorders and have access to psychiatric outreach nurse's service.
Control group receiving TAU: adolescents (12-16 years old) who seek help from student welfare services due to mood disorders and have no access to psychiatric outreach nurse's service.
**Intervention Names:**
- Behavioral: Psychiatric outreach nurse service
**Label:** Adolescents with mood disorders seeking help in student welfare services
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Adolescents with mood disorders seeking help in student welfare services
**Description:** Mental health service provided by psychiatric outreach nurses for 12-16 year old students in secondary schools
**Name:** Psychiatric outreach nurse service
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The effects of the outreach psychiatric nurse service on adolescent's perceived mental health status assessed by the Patient Health Questionnaire modified for adolescent (PHQ-9-A) measure of depression in 6-month and 12-month follow-up. The minimum value of the measure is 0 and maximum value 27. Higher scores is worse outcome.
**Measure:** Patient Health Questionnaire modified for adolescent to measure perceived mental health
**Time Frame:** 6-month and 12-month follow-up
**Description:** The effects of the outreach psychiatric nurse service on adolescent's perceived mental health status assessed by the Generalized Anxiety Disorder 7-item (GAD-7) measure of anxiety in 6-month and 12-month follow-up. The minimum value of the measure is 0 and maximum value 21. Higher scores is worse outcome.
**Measure:** Generalized Anxiety Disorder 7-item to measure adolescent's perceived mental health
**Time Frame:** 6-month and 12-month follow-up
#### Secondary Outcomes
**Description:** The effects of the outreach psychiatric nurse service on adolescent's perceived quality of life and substance use assessed by EuroQol- 5-Dimension 3-Level modified for adolescent (EQ-5D-Y-3L) measure in 6-month and 12-month follow-up. EQ-5D-Y will be converted to index-values \[theoretical range 0-1\] by using suitable value set. The higher value means better health related quality of life.
**Measure:** EuroQol-5-Dimension 3-Level modified for adolescent to measure perceived quality of life
**Time Frame:** 6-month and 12-month follow-up
**Description:** The effects of the outreach psychiatric nurse service on adolescent's substance use assessed by Adolescents' Substance Use Measurement (ADSUME) measure in 6-month and 12-month follow-up.The minimum value of the measure is 0 and maximum value 90. Higher scores is worse outcome
**Measure:** Adolescents' Substance Use Measurement to measure substance use
**Time Frame:** 6-month and 12-month follow-up
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adolescents (12-16 years old) who seek help from student welfare services due to mood disorders and who have one or more of the following conditions: prolonged and/or complicated anxiety, mood symptoms, obsessive-compulsive and/or eating disorder symptoms, mild to moderate self-harm (e.g. death wishes or cutting). In addition, person's motivation to receive the service provided is an admission criterion.
Exclusion Criteria:
* Persons with one or more of the following needs or life situations: adolescents who need light support and guidance, young people with a single problem of low motivation for school, young people with a stressful life situation or relationship problems. On the other hand, adolescents who are in acute need of specialist care or for adolescents with multidisciplinary problems for whom support measures have already been put in place, because of their mental health symptoms (e.g. severe depression, psychotic symptoms, severe and acute suicidal tendencies or a clear suicide plan).
* Exclusion criteria for the intervention and control groups also include situations where the adolescent has a long-lasting, already established mental health problem and/or a need for further treatment after a period of specialised hospital care.
* Exclusion criteria also include behavioural disorders where there is a clear underlying cause other than a mental disorder.
**Maximum Age:** 16 Years
**Minimum Age:** 12 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** Adolescent (12-16 year old) students of secondary schools in the municipalities of North Savo Wellbeing County who seek help from student welfare services due to mood disorders.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Anne Surakka, M.Soc.Sc, MHS (Health Econ.)
**Phone:** +358505292553
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Kuopio
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sanna Kukkonen, MHS
- **Phone:** +35817173311
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Sanna Voutilainen
- **Phone:** +35817173311
- **Role:** CONTACT
**Country:** Finland
**Facility:** Wellbeing Services County of North Savo
**State:** North Savo
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** University of Eastern Finland
**Name:** Johanna Lammintakanen, PhD, Professor
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depression
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7061
- Name: Depressive Disorder
- Relevance: LOW
- As Found: Unknown
- ID: 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: D000003863
- Term: Depression
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06438263
**Brief Title:** A Study to Evaluate Bioavailability of Rocatinlimab Autoinjector and Vial in Healthy Participants
**Official Title:** An Open-label, Phase 1, Single Dose, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Rocatinlimab (AMG 451) Autoinjector and Vial in Healthy Subjects
#### Organization Study ID Info
**ID:** 20220014
#### Organization
**Class:** INDUSTRY
**Full Name:** Amgen
### Status Module
#### Completion Date
**Date:** 2025-01-16
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-27
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-01-16
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Amgen
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
### Description Module
**Brief Summary:** The main objective of this study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) autoinjector dose compared to vial in healthy participants.
### Conditions Module
**Conditions:**
- Atopic Dermatitis
**Keywords:**
- Rocatinlimab
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 230
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will be randomized to receive a single dose of rocatinlimab vial solution for SC injection.
**Intervention Names:**
- Drug: Rocatinlimab
**Label:** Treatment A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will be randomized to receive a single dose of rocatinlimab autoinjector for SC injection.
**Intervention Names:**
- Drug: Rocatinlimab
**Label:** Treatment B
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment A
**Description:** Vial supplied as a single-use preservative free solution for SC injection.
**Name:** Rocatinlimab
**Other Names:**
- AMG 451
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Treatment B
**Description:** Autoinjector for SC injection.
**Name:** Rocatinlimab
**Other Names:**
- AMG 451
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Maximum Plasma Concentration (Cmax) of Rocatinlimab
**Time Frame:** Up to approximately 112 days
**Measure:** Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab
**Time Frame:** Up to approximately 112 days
**Measure:** AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab
**Time Frame:** Up to approximately 112 days
#### Secondary Outcomes
**Description:** TEAEs are any adverse events (AEs) that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECG), and clinical laboratory tests that occurred after study treatment administration will be recorded as TEAEs.
A serious AE (SAE) is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.
**Measure:** Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
**Time Frame:** Approximately 20 weeks
**Measure:** Number of Participants with Anti-rocatinlimab Antibodies
**Time Frame:** Up to approximately Day 112
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Participant has provided informed consent before initiation of any study-specific activities/procedures.
2. Healthy male or female participants, between 18 and 65 years of age (inclusive)
3. Body mass index between 18 and 32 kg/m2 (inclusive)
Exclusion Criteria:
1. History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
2. History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the ECG taken at Check-in.
3. A QT interval corrected for heart rate using Fridericia's method (QTcF) \> 450 msec in male participants or \> 470 msec in female participants or history/evidence of long QT syndrome at Screening or Check-in.
4. Systolic blood pressure ≥ 140 mmHg or ≤ 90 mmHg, or diastolic blood pressure ≥ 90 mmHg or ≤ 50 mmHg, or pulse rate ≥ 100 bpm or ≤ 40 bpm
5. History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Participants with seasonal allergies will be permitted.
6. Estimated glomerular filtration rate less than 70 mL/min/1.73 m2
7. Alanine aminotransferase or aspartate aminotransferase \> 1.5 times the upper limit of normal at Screening or Check-in.
8. Positive hepatitis B or hepatitis C panel (including positive hepatitis B surface antigen \[HBsAg\] and/or positive hepatitis C antibody) and/or positive human immunodeficiency virus test at Screening. Participants whose results are compatible with prior hepatitis B vaccination (positive hepatitis B surface antibody, negative hepatitis B core antibody, negative HBsAg) or prior infection (positive hepatitis B core antibody, positive hepatitis B surface antibody, negative HBsAg) may be included.
9. Participants who have received live vaccines within 5 weeks prior to Screening, or plan to receive live vaccines within 90 days after administration of an investigational product.
Inactive vaccination (e.g., non-live or nonreplicating agent), including coronavirus-2019 (COVID-19) vaccination, is allowed.
10. History of latent tuberculosis or active chronic, recurrent, or acute infection requiring treatment with systemic antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals which has not completely resolved, or for which therapy has not been completed, within 4 weeks before Screening.
11. Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before Check-in, excluding the following:
1. Acetaminophen (paracetamol) (up to 2 g per day) for analgesia will be allowed.
2. Hormonal contraception listed in Appendix 3 will be allowed.
3. Hormone replacement therapy (e.g., estrogen) and hormonal contraceptives will be allowed.
12. All herbal medicines (e.g., St. John's wort), vitamins, and supplements consumed by the participant within the 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee) and in consultation with the Sponsor.
13. Participant has received a dose of an investigational drug within the past 90 days or 5 half-lives, whichever is longer, prior to Check-in.
14. Have previously completed or withdrawn from this study or any other study investigating rocatinlimab or have previously received rocatinlimab.
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Amgen Call Center
**Phone:** 866-572-6436
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Amgen
**Name:** MD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
**Description:** De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
**IPD Sharing:** YES
**Time Frame:** Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
**URL:** http://www.amgen.com/datasharing
### References Module
#### See Also Links
**Label:** AmgenTrials clinical trials website
**URL:** http://www.amgentrials.com
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M7067
- Name: Dermatitis
- Relevance: HIGH
- As Found: Dermatitis
- ID: M7071
- Name: Dermatitis, Atopic
- Relevance: LOW
- As Found: Unknown
- ID: M7655
- Name: Eczema
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003872
- Term: Dermatitis
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06438250
**Brief Title:** 68Ga-FAPI-JH04 PET/CT: Dosimetry and Biodistribution Studies
**Official Title:** 68Ga-FAPI-JH04 PET/CT: Dosimetry and Biodistribution Study in Patients With Various Cancers
#### Organization Study ID Info
**ID:** FirstAHFujian-68Ga-FAPI-JH04
#### Organization
**Class:** OTHER
**Full Name:** First Affiliated Hospital of Fujian Medical University
### Status Module
#### Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-27
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** First Affiliated Hospital of Fujian Medical University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** 68Ga-FAPI-JH04 is a novel radiotracer targeting fibroblast activation protein (FAP). In this study, we observed the safety, biodistribution, and radiation dosimetry of 68Ga-JH040182 in patients with different types of cancer.
**Detailed Description:** Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, and showed high efficacy in tumor staging and restaging. 68Ga-FAPI-JH04, a novel radiopharmaceutical targeting FAP, demostrated high stability in vitro and in vivo, and can accumulate specifically in tumors with high binding affinity, safety, and selectivity in preclinical studies. In this study, the safety, biodistribution, and radiation dosimetry of 68Ga-FAPI-JH04 in patients with different types of cancer were observed to evaluate the dosimetric characteristics of 68Ga-FAPI-JH04.
### Conditions Module
**Conditions:**
- Malignant Neoplasm
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Drug: 68Ga-FAPI-JH04
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 5
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** PET imaging will begin at 3 min (30s/bed), 15min (1min/bed), 30min (2 min/bed), 60min (2 min/bed) and 150min (2 min/bed) after injection
**Intervention Names:**
- Drug: 68Ga-FAPI-JH04
**Label:** dynamic PET scans
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- dynamic PET scans
**Description:** The dose will be 148-222 MBq given intravenously.
**Name:** 68Ga-FAPI-JH04
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The safety evaluation of 68Ga-FAPI-JH04 PET/CT was performed for all patients based on the Common Toxicity Criteria for Adverse Events 5.0 (CTCAE 5.0) from baseline to follow up, including vital signs, health conditions, and laboratory tests.
**Measure:** safety and tolerability
**Time Frame:** Up to 1 week
#### Secondary Outcomes
**Description:** reported as relative uptake values per organ at 3min, 15min, 30min, 60min and 150 min per individual subject and as a mean over all subjects
**Measure:** Human biodistribution
**Time Frame:** From right after tracer injection to 150 min at post-injection
**Description:** radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects. Dosimetry will be calculated using the Hybrid-Dosimetry software.
**Measure:** Human dosimetry
**Time Frame:** From right after tracer injection to 150 min at post-injection
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Various solid tumors with available histopathological findings
* Signed informed consent
Exclusion Criteria:
* pregnant or lactational women
* who suffered from severe hepatic and renal insufficiency
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Weibing Miao, MD
**Phone:** +86-0591-87981618
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Guochang Wang, PhD
**Phone:** +86-0591-87981619
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Fuzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Weibing Miao, MD
- **Phone:** +86 591 87981618
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Guochang Wang, MD
- **Phone:** +86 591 87981619
- **Role:** CONTACT
**Country:** China
**Facility:** Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
**State:** Fujian
**Status:** RECRUITING
**Zip:** 350005
#### Overall Officials
**Official 1:**
**Affiliation:** The First Affiliated Hospital, Fujian Medical University
**Name:** Weibing Miao, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Meshes
- ID: D000009369
- Term: Neoplasms
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06438237
**Brief Title:** Validation of a Prediction Model for Inadequate Bowel Preparation
**Official Title:** Validation of a Prediction Model for Inadequate Bowel Preparation Before Colonoscopy Based on a Systematic Review and Meta-analysis
#### Organization Study ID Info
**ID:** V-PMIBP
#### Organization
**Class:** OTHER
**Full Name:** General Hospital of Shenyang Military Region
### Status Module
#### Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-27
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-06
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** General Hospital of Shenyang Military Region
#### Responsible Party
**Investigator Affiliation:** General Hospital of Shenyang Military Region
**Investigator Full Name:** Xingshun Qi
**Investigator Title:** Director of Gastroenterology
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** We have developed a novel inadequate bowel preparation prediction model based on a systematic review and meta-analysis. The goal of this observational study is to validate the accuracy of this model.
**Detailed Description:** A total of 615 patients undergoing colonoscopy will be enrolled. The primary outcome is quality of bowel preparation. The secondary outcomes include polyp/adenoma detection rate, willingness of undergoing colonoscopy again and adverse events.
### Conditions Module
**Conditions:**
- Bowel Preparation
- Colonoscopy
**Keywords:**
- Bowel preparation for colonoscopy
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 615
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients were informed to eat semi-liquid and non-slag diet for breakfast and lunch and full-liquid diet for dinner on the day before colonoscopy, and be fasting on the day of colonoscopy. A split-dose 3 L PEG regimen was used for all patients.
**Intervention Names:**
- Procedure: Bowel preparation before colonoscopy
**Label:** Patients undergoing colonoscopy
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patients undergoing colonoscopy
**Description:** Patients use purgative for bowel cleansing before colonoscopy.
**Name:** Bowel preparation before colonoscopy
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** A total BBPS score ≥6 with BBPS score ≥2 for each colon segment was considered to have adequate bowel preparation.
**Measure:** Quality of bowel preparation
**Time Frame:** During the procedure of colonoscopy
#### Secondary Outcomes
**Description:** Proportion of patients with at least one adenoma and/or polyp detected during colonoscopy
**Measure:** Adenoma and/or polyp detection rate
**Time Frame:** During the procedure of colonoscopy
**Description:** Number of polyps and/or adenomas detected during colonoscopy
**Measure:** Number of polyps and/or adenomas
**Time Frame:** During the procedure of colonoscopy
**Description:** Incidence of abdominal pain, bloating, nausea/vomiting after intake of PEG.
**Measure:** Adverse events
**Time Frame:** Before the procedure of colonoscopy
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. adult patients (age is ≥18 years old);
2. patients undergoing colonoscopy;
3. written informed consent.
Exclusion Criteria:
1. patients undergoing emergent colonoscopy;
2. patients with major psychiatric disorders;
3. pregnant or breast feeding patients;
4. patients with contraindications for colonoscopy (e.g., heart failure, renal insufficiency);
5. patients suspected to have intestinal obstruction, stenosis or perforation;
6. patients previously enrolled in this study.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Adult patients undergoing colonoscopy
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Xingshun Qi
**Phone:** 18909881019
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Weiyi Wang
**Phone:** 13019441024
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shenyang
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xingshun Qi
- **Phone:** 18909881019
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Weiyiy Wang
- **Phone:** 13019441024
- **Role:** CONTACT
**Country:** China
**Facility:** Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
**State:** Liaoning
**Status:** RECRUITING
**Zip:** 110840
#### Overall Officials
**Official 1:**
**Affiliation:** Department of Gastroenterology, General Hospital of Northern Theater Command
**Name:** Xingshun Qi
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.
**PMID:** 19136102
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M27664
- Name: Laxatives
- Relevance: LOW
- As Found: Unknown
- ID: M5651
- Name: Cathartics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06438224
**Brief Title:** Clinical Utility of Extracorporeal Shock Wave Therapy in Restoring Hand Function of Patients With Nerve Injury and Hypertrophic Scars Due to Burns
**Official Title:** Clinical Utility of Extracorporeal Shock Wave Therapy in Restoring Hand Function of Patients With Nerve Injury and Hypertrophic Scars Due to Burns
#### Organization Study ID Info
**ID:** HangangSHH-18
#### Organization
**Class:** OTHER
**Full Name:** Hangang Sacred Heart Hospital
### Status Module
#### Completion Date
**Date:** 2024-05-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-27
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-05-15
**Type:** ACTUAL
#### Start Date
**Date:** 2023-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hangang Sacred Heart 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:** Joint contractures and nerve injuries are common after hand burns. Extracorporeal shock wave therapy (ESWT) is effective not only for the regeneration of various tissues, including scar tissues, but also for reducing pain and pruritus in patients with burns. Researchers have attempted to explore the effects of ESWT on hand dysfunction caused by nerve injury following burns. We planned to evaluate the effects of ESWT (compared to sham stimulation) on hands with nerve injury and hypertrophic scars and thereby on hand function. The ESWT parameters were as follows: energy flux density, 0.05-0.30 mJ/mm2; frequency, 4 Hz; 1000 to 2000 impulses per treatment; and 12 treatments, one/week for 12 weeks. Outcome measures were as follows: 10-point visual analog scale for pain, Jebsen-Taylor hand function test, grip strength, Purdue Pegboard test, ultrasound measurement of scar thickness, and skin characteristics before and immediately after 12 weeks of treatment.
**Detailed Description:** Burns that occur in the hand cause early joint range-of-motion (ROM) limitations and hand muscle weakness that significantly affect quality of life. Hand burns, though restricted to a small total body surface area (TBSA), can have significant functional consequences. Joint contractures and nerve injuries are common after hand burns. Extracorporeal shock wave therapy (ESWT) is effective not only for the regeneration of various tissues, including scar tissues, but also for reducing pain and pruritus in patients with burns.
Researchers have attempted to explore the effects of ESWT on hand dysfunction caused by nerve injury following burns. We planned to evaluate the effects of ESWT (compared to sham stimulation) on hands with nerve injury and hypertrophic scars and thereby on hand function. The ESWT parameters were as follows: energy flux density, 0.05-0.30 mJ/mm2; frequency, 4 Hz; 1000 to 2000 impulses per treatment; and 12 treatments, one/week for 12 weeks. Outcome measures were as follows: 10-point visual analog scale for pain, Jebsen-Taylor hand function test, grip strength, Purdue Pegboard test, ultrasound measurement of scar thickness, and skin characteristics before and immediately after 12 weeks of treatment.
### Conditions Module
**Conditions:**
- Hand Injuries
- Extracorporeal Shock Wave Therapy
- Burns
**Keywords:**
- Extracorporeal shock wave therapy
- hypertrophic scar
- burns
- hand function
- nerve injury
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland), with an electromagnetic cylindrical coil source used to focus the shock wave. ESWT was performed around the primary treatment site, at an intensity of 100 impulses/cm2, an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, and frequency of 4 Hz. Regarding the volume of treatment, 1000-3000 impulses were administered per session for 12 sessions held at 1-week intervals. As in previous studies, the sham group was treated using an adapter that had the same shape but did not emit any energy
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** The outcome measurements and data analyses were performed by a trained and blinded outcome assessor who was not involved in the intervention.
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Those in the ESWT group were asked to select the most hypertrophic and retracting scars for treatment. ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland), with an electromagnetic cylindrical coil source used to focus the shock wave. ESWT was performed around the primary treatment site, at an intensity of 100 impulses/cm2, an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, and frequency of 4 Hz. Regarding the volume of treatment, 1000-3000 impulses were administered per session for 12 sessions held at 1-week intervals.
**Intervention Names:**
- Other: Extracorporeal shock wave therapy (ESWT)
**Label:** Extracorporeal shock wave therapy (ESWT)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** the sham group was treated using an adapter that had the same shape but did not emit any energy
**Intervention Names:**
- Other: sham stimulation
**Label:** sham group
**Type:** SHAM_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Extracorporeal shock wave therapy (ESWT)
**Description:** Those in the ESWT group were asked to select the most hypertrophic and retracting scars for treatment. ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland), with an electromagnetic cylindrical coil source used to focus the shock wave. ESWT was performed around the primary treatment site, at an intensity of 100 impulses/cm2, an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, and frequency of 4 Hz. Regarding the volume of treatment, 1000-3000 impulses were administered per session for 12 sessions held at 1-week intervals.
**Name:** Extracorporeal shock wave therapy (ESWT)
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- sham group
**Description:** the sham group was treated using an adapter that had the same shape but did not emit any energy
**Name:** sham stimulation
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** self-reported pain severity, ratings ranging from 0 (no pain) to 10 (unbearable pain
**Measure:** 10-point visual analog scale (VAS)
**Time Frame:** 12 weeks
#### Secondary Outcomes
**Description:** range of motion measurement
**Measure:** the total active motion (TAM) scoring system
**Time Frame:** 12 weeks
**Description:** The JTT consists of seven subtests, each scored on a 0-15-point scale, with higher scores indicating better hand function
**Measure:** Jebsen-Taylor hand function test (JTT)
**Time Frame:** 12 weeks
**Description:** quantified using a hand-held dynamometer (Lafayette Instrument, USA), with higher socres indicating more stronger
**Measure:** Grip and pinch strengths
**Time Frame:** 12 weeks
**Description:** quantified using ultrasonography (128 BW1 US system, Medison, Korea)
**Measure:** Scar thickness
**Time Frame:** 12 weeks
**Description:** Mexameter®(MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure the melanin levels and the severity of erythema. Higher values indicated darker and redder skin.
**Measure:** erythema and pigementation
**Time Frame:** 12 weeks
**Description:** measured using a Tewameter® (Courage-Khazaka Electronic GmbH, Germany) to evaluate water evaporation.
**Measure:** Trans-epidermal water loss (TEWL)
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* ≥ 18 years old
* had sustained a deep partial-thickness (second-degree) or a full-thickness (third-degree) burn in the right dominant hand, which had been treated with a split-thickness skin graft (STSG) after the thermal injury
* nerve injury to the hand was confirmed by electromyography
* \< 6 months prior to the enrollment
Exclusion Criteria:
* musculoskeletal diseases (fracture, amputation, rheumatoid arthritis, and degenerative joint diseases) of the hands
* acute infection
* malignant tumors
* coagulopathy
* pregnancy
* potential for additional skin damage if exposed to ESWT and conventional occupational therapy.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sung Rakyum
**Phone:** 82-2-2639-5900
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Seoul
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ragyem Sung
- **Phone:** 82-10-5939-2541
- **Role:** CONTACT
**Country:** Korea, Republic of
**Facility:** Hangang sacred heart hodpital
**Status:** RECRUITING
**Zip:** 07247
#### Overall Officials
**Official 1:**
**Affiliation:** handgang sacred heart hospital
**Name:** SO YOUNG JOO
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Thiele S, Thiele R, Gerdesmeyer L. Lateral epicondylitis: This is still a main indication for extracorporeal shockwave therapy. Int J Surg. 2015 Dec;24(Pt B):165-70. doi: 10.1016/j.ijsu.2015.09.034. Epub 2015 Oct 9.
**PMID:** 26455532
**Citation:** Cui HS, Hong AR, Kim JB, Yu JH, Cho YS, Joo SY, Seo CH. Extracorporeal Shock Wave Therapy Alters the Expression of Fibrosis-Related Molecules in Fibroblast Derived from Human Hypertrophic Scar. Int J Mol Sci. 2018 Jan 2;19(1):124. doi: 10.3390/ijms19010124.
**PMID:** 29301325
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020763
- Term: Pathological Conditions, Anatomical
- ID: D000002921
- Term: Cicatrix
- ID: D000005355
- Term: Fibrosis
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M15577
- Name: Shock
- Relevance: HIGH
- As Found: Shock
- ID: M10035
- Name: Hypertrophy
- Relevance: HIGH
- As Found: Hypertrophic
- ID: M19708
- Name: Cicatrix, Hypertrophic
- Relevance: HIGH
- As Found: Hypertrophic Scar
- ID: M5326
- Name: Burns
- Relevance: HIGH
- As Found: Burn
- ID: M9322
- Name: Hand Injuries
- Relevance: HIGH
- As Found: Hand Injuries
- ID: M6160
- Name: Cicatrix
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: HIGH
- As Found: Injury
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
- ID: M8485
- Name: Fibrosis
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012769
- Term: Shock
- ID: D000006984
- Term: Hypertrophy
- ID: D000017439
- Term: Cicatrix, Hypertrophic
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000002056
- Term: Burns
- ID: D000006230
- Term: Hand Injuries
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06438211
**Brief Title:** Comparison of Postoperative Analgesic Effectiveness of Superficial and Deep Serratus Plane Blocks for Mastectomy
**Official Title:** Comparison of Postoperative Analgesic Effectiveness of Superficial and Deep Serratus Plane Blocks in Patients Undergoing Mastectomy
#### Organization Study ID Info
**ID:** 2024/58
#### Organization
**Class:** OTHER
**Full Name:** TC Erciyes University
### Status Module
#### Completion Date
**Date:** 2025-05-25
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-02-24
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-24
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** TC Erciyes University
#### Responsible Party
**Investigator Affiliation:** TC Erciyes University
**Investigator Full Name:** Ayse Ulgey
**Investigator Title:** Professor doctor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Pain after breast surgery can be quite severe and can significantly affect quality of life. By successfully treating acute pain, it is aimed to prevent the formation of pain memory and to ensure that chronic pain never occurs. It is known that by using regional techniques, the use of general anesthetics and opioids can be reduced and their harmful effects can be limited. In this study, it will be compared the analgesic effectiveness of superficial and deep serratus plane blocks in the postoperative acute and chronic periods.
**Detailed Description:** Acute and chronic pain is a serious problem in patients undergoing breast surgery. Apart from the feeling of pain, it also causes psychological difficulties, increased hospital stays, delays or difficulties in mobilization, and so on. Due to all these reasons, postoperative pain control is very important.
Although opioids are the gold standard in the treatment of pain, their side effect profiles (sedation, respiratory depression, constipation, tolerance development, etc.) limit their use and different searches are on the agenda. There are studies showing that superficial and deep serratus plane blocks are effective in mastectomy operations. In this study, patients who underwent mastectomy these two blocks will be compared to see which one is superior and to investigate the differences that may occur in the acute and chronic periods.
After general anesthesia induction, a superficial serratus plane block will be performed on the first group of patients undergoing surgery by applying local anesthetic to the fascia between the serratus anterior and latissimus dorsi muscles at the level of the 4th and 5th ribs under ultrasound. then the patient will undergo surgical procedure. Likewise, for the second group of patients, after general anesthesia induction, a deep serratus plane block will be performed by applying local anesthetic between the rib and the serratus anterior muscle at the level of the 4th and 5th ribs, under ultrasound guidance, and the patient will be taken into surgery. Both groups of patients will be monitored for 24 hours after the operation with a patient-controlled analgesia device. Patients' pain scores, satisfaction scores, nausea and vomiting scores, and additional analgesic needs will be recorded 24 hours postoperatively.
### Conditions Module
**Conditions:**
- Mastectomy
- Postoperative Pain
- Analgesia
**Keywords:**
- serratus anterior plane block
- local anesthetic
- regional anesthesia
- postoperative analgesia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Single-shot ultrasound (Esaote Mylab30) guided Superficial SAP block with 30 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) at the T4- T5 ribs level (between the latissimus dorsi muscle and the serratus anterior muscle) was performed preoperatively to patients in the Superficial SAP group (Group I)
**Intervention Names:**
- Procedure: superficial or deep serratus anterior plane block for mastectomy
**Label:** Group I (superficial serratus anterior plane block)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Single- shot ultrasound (Esaote Mylab30) guided Deep SAP block with 30 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) at the T4- T5 ribs level ( between the serratus anterior muscle and the ribs) was performed preoperatively to patients in the Deep SAP group (Group I)
**Intervention Names:**
- Procedure: superficial or deep serratus anterior plane block for mastectomy
**Label:** Group II (deep serratus anterior plane block)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group I (superficial serratus anterior plane block)
- Group II (deep serratus anterior plane block)
**Description:** group I: superficial SAP Block for postoperative analgesia for mastectomy group II: deep SAP Block for postoperative analgesia for mastectomy
**Name:** superficial or deep serratus anterior plane block for mastectomy
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** How much morphine the patient consumed in the first 24 hours postoperatively with a patient-controlled anesthesia device
**Measure:** postoperative morphine consumption
**Time Frame:** 24 hours
#### Secondary Outcomes
**Description:** Determining patients' pain levels with a visual analog scale (VAS) between the scale of 1-10
**Measure:** measuring pain scors
**Time Frame:** 24 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* patients who will undergo mastectomy surgery
* patients who agreed to participate in the study
* ASA I-II patients
Exclusion Criteria:
* Patients planned for bilateral breast surgery
* Patients who have had previous breast surgery
* Patients with existing neuropathic pain or receiving treatment for neuropathic pain
* Patients with psychiatric disorders
* Patients with opioid addiction
* Patients allergic to local anesthetics
**Gender Based:** True
**Gender Description:** Since breast cancer is much more common in women than men and to ensure homogenization in the study, only female patients will be included.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ayşe Ülgey, MD
**Phone:** 05378201751
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Kayseri
**Country:** Turkey
**Facility:** University of Erciyes
**State:** Talas
**Zip:** 38100
#### Overall Officials
**Official 1:**
**Affiliation:** TC Erciyes University
**Name:** Ayşe Ülgey, MD
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010335
- Term: Pathologic Processes
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M13069
- Name: Pain, Postoperative
- Relevance: HIGH
- As Found: Postoperative Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010149
- Term: Pain, Postoperative
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M5315
- Name: Bupivacaine
- Relevance: LOW
- As Found: Unknown
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M4109
- Name: Anesthetics, Local
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06438198
**Acronym:** SWITCH-SAFE
**Brief Title:** Early Switch From Controlled to Assisted Ventilation
**Official Title:** Unraveling the (Patho)Physiological Mechanisms and Potential Clinical Benefits of an Early Switch From Controlled to Assisted Ventilation
#### Organization Study ID Info
**ID:** MEC-2024-0011
#### Organization
**Class:** OTHER
**Full Name:** Erasmus Medical Center
### Status Module
#### Completion Date
**Date:** 2026-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Erasmus Medical Center
#### Responsible Party
**Investigator Affiliation:** Erasmus Medical Center
**Investigator Full Name:** Annemijn Jonkman
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio \< 200 mmHg).
The intervention is that participants will be switched from controlled to assisted ventilation when PaO2/FiO2 ratio \> 200 mmHg.
The primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch.
**Detailed Description:** A crucial milestone in the trajectory of the mechanically ventilated patient is the switch from fully controlled mechanical ventilation to assisted ventilation. This switch should be made as early as feasible and safe, to limit the detrimental effects from prolonged controlled ventilation and sedation. However, there is also indirect evidence that excessive breathing effort during assisted ventilation may worsen lung injury (P-SILI). There are no guidelines that address this important switch moment.
Therefore, the overall aim of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio \< 200 mmHg).
Participants will be switched from controlled to assisted ventilation switch when PaO2/FiO2 ratio \> 200 mmHg and will be monitored continuously using electrical impedance tomography, and oesophageal and gastric pressure until 4 hours post-switch and twice daily for 72 hours or until switch failure (switch back to controlled ventilation within 72 hours).
The primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch.
### Conditions Module
**Conditions:**
- Acute Hypoxemic Respiratory Failure
- Mechanical Ventilation
**Keywords:**
- Electrical Impedance Tomography
- Esophageal manometry
- Controlled Mechanical Ventilation
- Assisted Mechanical Ventilation
- Respiratory Monitoring
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Switch from controlled to assisted mechanical ventilation when PaO2/FiO2-ratio \> 200 mmHg.
Before switch (on controlled ventilation) participants will undergo an electrical impedance tomography (EIT) perfusion measurement as well as a photon-counting CT (PCCT) scan to assess lung perfusion and ventilation/perfusion mismatch. From 15 minutes before until 4 hours after switch and 30 minutes twice daily for 72 hours or until switch failure participants will be monitored continuously using EIT, esophageal pressure and gastric pressure.
**Intervention Names:**
- Other: Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHg
**Label:** Mechanically ventilated adults
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Mechanically ventilated adults
**Description:** A pre-specified switch from controlled to assisted ventilation will be initiated when PaO2/FiO2-ratio \> 200 mmHg. The moment of switch is pre-specified but patient management and ventilator settings are up to the clinical team. Switch is complete when the patient triggers all breaths spontaneously. Switch success is defined if patient reaches 72 hours on assisted ventilation. Switch failure is defined if patient switches back to controlled ventilation for more than 2 hours before 72 hours.
**Name:** Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHg
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The change in regional lung stress as derived from EIT recordings by computing the regional ventilation distribution (ventral-to-dorsal ratio).
**Measure:** Regional lung stress
**Time Frame:** 72 hours
#### Secondary Outcomes
**Description:** Change in EIT parameters after transition from controlled to assisted ventilation (%)
**Measure:** Electrical Impedance Tomography (EIT) parameters
**Time Frame:** 72 hours
**Description:** Ventilation/perfusion mismatch during controlled ventilation measured with photon-counting CT scan
**Measure:** Photon-Counting Computed Tomography (PCCT)-derived ventilation/perfusion mismatch
**Time Frame:** 30 minutes
**Description:** Ventilation/perfusion mismatch during controlled ventilation measured with EIT
**Measure:** Electrical Impedance Tomography (EIT)-derived ventilation/perfusion mismatch
**Time Frame:** 30 minutes
**Description:** Change in respiratory mechanics after transition from controlled to assisted ventilation (cmH2O)
**Measure:** Respiratory mechanics
**Time Frame:** 72 hours
**Description:** Time-course of breathing effort during assisted ventilation as measured with esophageal manometry (cmH2O).
**Measure:** Breathing effort
**Time Frame:** 72 hours
**Description:** Percentage of asynchronous breaths during assisted ventilation
**Measure:** Patient-ventilator asynchrony
**Time Frame:** 72 hours
**Description:** Change in gas exchange after transition from controlled to assisted ventilation (%)
**Measure:** Gas exchange
**Time Frame:** 72 hours
**Description:** Change in hemodynamics after transition from controlled to assisted ventilation (%)
**Measure:** Hemodynamics
**Time Frame:** 72 hours
**Description:** Blood biomarkers concentrations including cytokines and chemokines (i.e., interleukins, TNF-alpha, MCP-1 and MIP-1beta, CD14) measured as the difference between baseline vs. 72h (%)
**Measure:** Blood inflammatory biomarkers
**Time Frame:** 72 hours
**Description:** Swivel-derived exhaled-breath condensate biomarkers concentrations including cytokines and chemokines (i.e., interleukins, TNF-alpha, MCP-1 and MIP-1beta, CD14) measured as the difference between baseline vs. 72h (%)
**Measure:** Breath condensate inflammatory biomarkers
**Time Frame:** 72 hours
**Description:** Ventilator-free days at day 28
**Measure:** Ventilator-free days
**Time Frame:** 28 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18 years old
* Written informed consent from a legal representative
* Mechanical ventilation via an endotracheal tube
* Acute hypoxemic respiratory failure with PaO2/FiO2 ratio \< 200 mmHg
* Under continuous sedation with or without paralysis
Exclusion Criteria:
* Expected mechanical ventilation duration of \<48 hours
* Pure chronic obstructive pulmonary disease exacerbation
* Pre-existent respiratory muscle disease
* Contraindication to EIT monitoring (as per clinical protocol, e.g. pacemaker, burns or thoracic wounds limiting electrode placement)
* Contra-indications to oesophageal manometry (as per clinical protocol, e.g., recent oesophageal surgery, oesophageal varices, severe bleeding disorders)
* Known pregnancy
* Anticipating withdrawal of life support and/or shift to palliation as the goal of care
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Annemijn Jonkman, PhD
**Phone:** +3110-7035142
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Erasmus Medical Center
**Name:** Annemijn Jonkman, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14968
- Name: Respiratory Insufficiency
- Relevance: HIGH
- As Found: Acute Hypoxemic Respiratory Failure
- ID: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012131
- Term: Respiratory Insufficiency
### Misc Info Module
- Version Holder: 2024-05-31
|
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